chemNLP/clinical-trials-v2 · Datasets at Hugging Face

NCT0531xxxx/NCT05312593.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05312593</url> </required_header> <id_info> <org_study_id>2022-AFTORAL IMPL</org_study_id> <nct_id>NCT05312593</nct_id> </id_info> <brief_title>Domiciliary Use of Hyaluronic Acid Gel Solutions vs Domiciliary Use of Chlorhexidine Mouthwash 0,20% for the Management of Peri-implant Mucositis Sites</brief_title> <official_title>Domiciliary Use of Hyaluronic Acid Gel Solutions vs Domiciliary Use of Chlorhexidine Mouthwash 0,20% for the Management of Peri-implant Mucositis Sites: a Randomized Clinical Trial</official_title> <sponsors> <lead_sponsor> <agency>University of Pavia</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>University of Pavia</source> <oversight_info> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> This is a randomized controlled clinical trial (RCT). After signing the informed consent, patients satisfying the inclusion criteria will undergo supragingival and subgingival professional oral hygiene of both arches performed with ultrasonic instrumentation with PEEK inserts, manual instrumentation with PEEK curettes and air polishing with glycine powder.  After that, the sample will be randomly divided into 2 groups based on the domiciliary assigned treatment:  - Aftoral® Oral Gel solution with Hyaluronic Acid, Xylitol and glycerophosphoinositol for the domiciliary use for 15 days for 2 peri-implant mucositis sites.  - Unidea® Chlorhexidine digluconate Mouthwash 0,20% administration for the domiciliary application for 15 days for 2 peri-implant sites.  The study will last 6 months. Patients will be visited at: T0, after 1 month from T0 (T1), after 3 months (T2), after 6 months (T3). Professional hygiene will be performed again at T2 and T3.  At each recall session were collected a satisfaction questionnaire of the products (taste, smell, consistency, persistence and ease of application) and the following periodontal clinical indices, using a PEEK probe on each peri-implant site:  - conditions of the marginal mucosa (swelling and erythema),  - migration of the marginal mucosa,  - PPD (Probing Pocket Depth),  - BOP% (Bleeding on Probing),  - BS (Bleeding Score),  - Suppuration,  - PCR% (Plaque Control Record), </textblock> </brief_summary> <detailed_description> <textblock> This is a randomized controlled clinical trial (RCT). 60 patients are expected to be enrolled. After signing the informed consent, patients satisfying the inclusion criteria will undergo supragingival and subgingival professional oral hygiene of both arches performed with ultrasonic instrumentation with PEEK inserts, manual instrumentation with PEEK curettes and air polishing with glycine powder.  After that, the sample will be randomly divided into 2 groups based on the domiciliary assigned treatment:  - Aftoral® Oral Gel solution with Hyaluronic Acid, Xylitol and glycerophosphoinositol for the domiciliary use for 15 days for 2 peri-implant mucositis sites.  - Unidea® Chlorhexidine digluconate Mouthwash 0,20% administration for the domiciliary application for 15 days for 2 peri-implant sites.  The study will last 6 months. Patients will be visited at: T0, after 1 month from T0 (T1), after 3 months (T2), and after 6 months (T3).  At T2 and T3, professional hygiene will be performed again.  At each recall session were collected a satisfaction questionnaire of the products (taste, smell, consistency, persistence and ease of application) and the following periodontal clinical indices, using a PEEK probe on each peri-implant site:  - conditions of the marginal mucosa (swelling and erythema),  - migration of the marginal mucosa,  - PPD (Probing Pocket Depth),  - BOP% (Bleeding on Probing),  - BS (Bleeding Score),  - Suppuration,  - PCR% (Plaque Control Record). </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">April 5, 2022</start_date> <completion_date type="Actual">November 3, 2022</completion_date> <primary_completion_date type="Actual">November 1, 2022</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Change in Probing Pocket Depth (PPD)</measure> <time_frame>Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)</time_frame> <description>Evaluation (in mm) of the depth of the gingival sulcus, through a millimeter periodontal PEEK probe; it is detected from the gingival margin to the bottom of the gingival sulcus or periodontal pocket, evaluated at 6 sites.</description> </primary_outcome> <primary_outcome> <measure>Change in Bleeding on Probing (BOP%)</measure> <time_frame>Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)</time_frame> <description>Quantitative assessment (percentage) of the bleeding sites (6 per tooth in total). Formula = n ° bleeding sites / n ° probed sites x100</description> </primary_outcome> <primary_outcome> <measure>Change in Bleeding Score (BS - Mombelli et al.)</measure> <time_frame>Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)</time_frame> <description>Scoring criteria: 0: no bleeding isolated visible spots blood forms a confluent red line on the mucosal margin profuse and copious bleeding</description> </primary_outcome> <primary_outcome> <measure>Change in Plaque Control Record (PCR%)</measure> <time_frame>Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)</time_frame> <description>Evaluation of the presence of plaque on the 4 surfaces of teeth on the total amount of dental surfaces. Formula = n ° sites with plaque / total n ° of dental surfaces x100</description> </primary_outcome> <primary_outcome> <measure>Change in marginal mucosa condition</measure> <time_frame>Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)</time_frame> <description>Scoring criteria: 0: normal mucosa minimal inflammation with color change and minor edema moderate inflammation with redness, edema and glazing severe inflammation with redness, edema, ulceration and spontaneous bleeding without probing</description> </primary_outcome> <primary_outcome> <measure>Change in mucosal margin</measure> <time_frame>Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)</time_frame> <description>Dichotomous scoring (migrated/non migrated)</description> </primary_outcome> <primary_outcome> <measure>Change in Suppuration (%)</measure> <time_frame>Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)</time_frame> <description>Dichotomous scoring (yes/no) of suppurating sites</description> </primary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">60</enrollment> <condition>Peri-implant Mucositis</condition> <arm_group> <arm_group_label>Trial Group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>A group of 30 patients will be randomly assigned to Hyaluronic Acid domiciliary treatment, applied into Peri-implant mucositis sites.</description> </arm_group> <arm_group> <arm_group_label>Control Group</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>A group of 30 patients will be randomly assigned to Chlorhexidine mouthwash domiciliary treatment, applied into Peri-implant mucositis sites.</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Aftoral Oral Gel</intervention_name> <description>Patients will use Aftoral® Oral Gel solution for the domiciliary application once a day for 15 days after the visits (no rinsing and eating for 30 minutes after gel solution application).</description> <arm_group_label>Trial Group</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Unidea Chlorhexidine mouthwash</intervention_name> <description>Patients will use chlorhexidine mouthwash 0,20% for the domiciliary application once a day for 15 days after the visits (no rinsing and eating for 30 minutes after mouthwash application).</description> <arm_group_label>Control Group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - age 18-70 years  - presence of 2 peri-implant mucositis sites with PPD > 5 mm  - no systemic, metabolic and autoimmune disease  - compliant patients  Exclusion Criteria:  - absence of dental implants  - neurologic, psychiatric and mental diseases  - patients taking bisphosphonates in the last 12 months  - patients taking antibiotics during the study  - pregnant and breastfeeding women  - patients undergoing anticancer treatment </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>70 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Andrea Scribante, DDS, PhD, MS</last_name> <role>Principal Investigator</role> <affiliation>University of Pavia</affiliation> </overall_official> <location> <facility> <name>Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia</name> <address> <city>Pavia</city> <state>Lombardy</state> <zip>27100</zip> <country>Italy</country> </address> </facility> </location> <location_countries> <country>Italy</country> </location_countries> <verification_date>September 2023</verification_date> <study_first_submitted>March 26, 2022</study_first_submitted> <study_first_submitted_qc>March 26, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 5, 2022</study_first_posted> <last_update_submitted>September 9, 2023</last_update_submitted> <last_update_submitted_qc>September 9, 2023</last_update_submitted_qc> <last_update_posted type="Actual">September 13, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>University of Pavia</investigator_affiliation> <investigator_full_name>Andrea Scribante</investigator_full_name> <investigator_title>Associate Professor, Principal Investigator</investigator_title> </responsible_party> <keyword>hyaluronic acid</keyword> <keyword>chrlorhexidine</keyword> <keyword>non-surgical periodontal therapy</keyword> <condition_browse>  <mesh_term>Mucositis</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Chlorhexidine</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>No</sharing_ipd> <ipd_description>Data will be available upon motivated request to the Principal Investigator.</ipd_description> </patient_data>  </clinical_study>

This is a randomized controlled clinical trial (RCT). After signing the informed consent, patients satisfying the inclusion criteria will undergo supragingival and subgingival professional oral hygiene of both arches performed with ultrasonic instrumentation with PEEK inserts, manual instrumentation with PEEK curettes and air polishing with glycine powder. After that, the sample will be randomly divided into 2 groups based on the domiciliary assigned treatment: - Aftoral® Oral Gel solution with Hyaluronic Acid, Xylitol and glycerophosphoinositol for the domiciliary use for 15 days for 2 peri-implant mucositis sites. - Unidea® Chlorhexidine digluconate Mouthwash 0,20% administration for the domiciliary application for 15 days for 2 peri-implant sites. The study will last 6 months. Patients will be visited at: T0, after 1 month from T0 (T1), after 3 months (T2), after 6 months (T3). Professional hygiene will be performed again at T2 and T3. At each recall session were collected a satisfaction questionnaire of the products (taste, smell, consistency, persistence and ease of application) and the following periodontal clinical indices, using a PEEK probe on each peri-implant site: - conditions of the marginal mucosa (swelling and erythema), - migration of the marginal mucosa, - PPD (Probing Pocket Depth), - BOP% (Bleeding on Probing), - BS (Bleeding Score), - Suppuration, - PCR% (Plaque Control Record), This is a randomized controlled clinical trial (RCT). 60 patients are expected to be enrolled. After signing the informed consent, patients satisfying the inclusion criteria will undergo supragingival and subgingival professional oral hygiene of both arches performed with ultrasonic instrumentation with PEEK inserts, manual instrumentation with PEEK curettes and air polishing with glycine powder. After that, the sample will be randomly divided into 2 groups based on the domiciliary assigned treatment: - Aftoral® Oral Gel solution with Hyaluronic Acid, Xylitol and glycerophosphoinositol for the domiciliary use for 15 days for 2 peri-implant mucositis sites. - Unidea® Chlorhexidine digluconate Mouthwash 0,20% administration for the domiciliary application for 15 days for 2 peri-implant sites. The study will last 6 months. Patients will be visited at: T0, after 1 month from T0 (T1), after 3 months (T2), and after 6 months (T3). At T2 and T3, professional hygiene will be performed again. At each recall session were collected a satisfaction questionnaire of the products (taste, smell, consistency, persistence and ease of application) and the following periodontal clinical indices, using a PEEK probe on each peri-implant site: - conditions of the marginal mucosa (swelling and erythema), - migration of the marginal mucosa, - PPD (Probing Pocket Depth), - BOP% (Bleeding on Probing), - BS (Bleeding Score), - Suppuration, - PCR% (Plaque Control Record). Inclusion Criteria: - age 18-70 years - presence of 2 peri-implant mucositis sites with PPD > 5 mm - no systemic, metabolic and autoimmune disease - compliant patients Exclusion Criteria: - absence of dental implants - neurologic, psychiatric and mental diseases - patients taking bisphosphonates in the last 12 months - patients taking antibiotics during the study - pregnant and breastfeeding women - patients undergoing anticancer treatment

NCT0531xxxx/NCT05312606.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05312606</url> </required_header> <id_info> <org_study_id>2022-AFTORAL PARO</org_study_id> <nct_id>NCT05312606</nct_id> </id_info> <brief_title>Domiciliary Use of Hyaluronic Acid Gel Solutions vs Domiciliary Use of Chlorhexidine Mouthwash 0,20% for the Management of Periodontal Patients</brief_title> <official_title>Domiciliary Use of Hyaluronic Acid Gel Solutions vs Domiciliary Use of Chlorhexidine Mouthwash 0,20% for the Management of Periodontal Patients: a Randomized Clinical Trial</official_title> <sponsors> <lead_sponsor> <agency>University of Pavia</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>University of Pavia</source> <oversight_info> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Brief Summary: This is a randomized controlled clinical trial (RCT). After signing the informed consent, patients satisfying the inclusion criteria will undergo supragingival and subgingival professional oral hygiene of both arches performed with ultrasonic instrumentation, manual instrumentation with Gracey curettes and air polishing with glycine powder.  After that, the sample will be randomly divided into 2 groups based on the domiciliary assigned treatment:  - Aftoral® Oral Gel solution with Hyaluronic Acid, Xylitol and glycerophosphoinositol as a domiciliary application for 15 days.  - Unidea® Chlorhexidine digluconate Mouthwash 0,20% administration as a domiciliary application for 15 days.  The study will last 6 months. Patients will be visited at: T0, after 1 month from T0 (T1), after 3 months (T2), after 6 months (T3). Professional hygiene will be performed again at T2 and T3.  At each recall session were collected a satisfaction questionnaire of the products (taste, smell, consistency, persistence and ease of application) and the following periodontal clinical indices, using a Periodontal probe on each site:  - Gingival Recession (R)  - PPD (Probing Pocket Depth),  - BOP% (Bleeding on Probing),  - CAL (Clinical Attachment Level),  - PCR% (Plaque Control Record),  - Tooth Mobility. </textblock> </brief_summary> <detailed_description> <textblock> This is a randomized controlled clinical trial (RCT). 40 patients are expected to be enrolled. After signing the informed consent, patients satisfying the inclusion criteria will undergo supragingival and subgingival professional oral hygiene of both arches performed with ultrasonic instrumentation, manual instrumentation with Gracey curettes and air polishing with glycine powder.  All patients will be treated at the Unit of Dental Hygiene, Section of Dentistry, Department of Clinical, Surgical, Diagnostic, and Pediatric Sciences of the University of Pavia.  After that, the sample will be randomly divided into 2 groups based on the domiciliary assigned treatment:  - Aftoral® Oral Gel solution with Hyaluronic Acid, Xylitol and glycerophosphoinositol as a domiciliary application for 15 days.  - Unidea® Chlorhexidine digluconate Mouthwash 0,20% administration as a domiciliary application for 15 days.  The study will last 6 months. Patients will be visited at: T0, after 1 month from T0 (T1), after 3 months (T2), and after 6 months (T3).  At T2 and T3, professional hygiene will be performed again.  At each recall session were collected a satisfaction questionnaire of the products (taste, smell, consistency, persistence and ease of application) and the following periodontal clinical indices, using a Periodontal probe on each site:  - Gingival Recession (R),  - PPD (Probing Pocket Depth),  - BOP% (Bleeding on Probing),  - CAL (Clinical Attachment Level),  - PCR% (Plaque Control Record),  - Tooth Mobility. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">April 4, 2022</start_date> <completion_date type="Actual">November 5, 2022</completion_date> <primary_completion_date type="Actual">November 1, 2022</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Change in Probing Pocket Depth (PPD)</measure> <time_frame>Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)</time_frame> <description>Evaluation (in mm) of the depth of the gingival sulcus, through a millimeter periodontal probe; it is detected from the gingival margin to the bottom of the gingival sulcus or periodontal pocket, evaluated at 6 sites.</description> </primary_outcome> <primary_outcome> <measure>Gingival Recession (R)</measure> <time_frame>Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)</time_frame> <description>Evaluation (in mm) of the displacement of marginal tissue, through a millimeter periodontal probe; it is detected from the cemento-enamel junction (CEJ) to the gingival margin.</description> </primary_outcome> <primary_outcome> <measure>Change in Bleeding on Probing (BOP%)</measure> <time_frame>Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)</time_frame> <description>Quantitative assessment (percentage) of the bleeding sites (6 per tooth in total). Formula = n ° bleeding sites / n ° probed sites x100</description> </primary_outcome> <primary_outcome> <measure>Change in Clinical Attachment Level (CAL)</measure> <time_frame>Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)</time_frame> <description>Evaluation (in mm) of the distance of the cemento-enamel junction (CEJ) to the bottom of the gingival sulcus or periodontal pocket, evaluated in 6 sites.</description> </primary_outcome> <primary_outcome> <measure>Change in Plaque Control Record (PCR%)</measure> <time_frame>Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)</time_frame> <description>Evaluation of the presence of plaque on the 4 surfaces of teeth on the total amount of dental surfaces. Formula = n ° sites with plaque / total n ° of dental surfaces x100</description> </primary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">30</enrollment> <condition>Periodontal Diseases</condition> <arm_group> <arm_group_label>Trial Group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Home treatment with hyaluronic acid.</description> </arm_group> <arm_group> <arm_group_label>Control Group</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Home treatment with chlorhexidine.</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Aftoral Oral gel</intervention_name> <description>Patients will use Aftoral® Oral Gel solution for the domiciliary application once a day for 15 days after the visits (no rinsing and eating for 30 minutes after gel solution application).</description> <arm_group_label>Trial Group</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Unidea Chlorhexidine digluconate mouthwash 0.20%</intervention_name> <description>Patients will use chlorhexidine mouthwash 0,20% for the domiciliary application once a day for 15 days after the visits (no rinsing and eating for 30 minutes after mouthwash application).</description> <arm_group_label>Control Group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - presence of periodontitis sites with PPD > 5 mm  - no systemic, metabolic and autoimmune disease  - compliant patients  Exclusion Criteria:  - neurologic, psychiatric and mental diseases  - patients taking bisphosphonates in the last 12 months  - patients taking antibiotics during the study  - pregnant and breastfeeding women  - patients undergoing anticancer treatment </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>70 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Andrea Scribante, DDS, PhD, MS</last_name> <role>Principal Investigator</role> <affiliation>University of Pavia</affiliation> </overall_official> <location> <facility> <name>Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia</name> <address> <city>Pavia</city> <state>Lombardy</state> <zip>27100</zip> <country>Italy</country> </address> </facility> </location> <location_countries> <country>Italy</country> </location_countries> <verification_date>December 2022</verification_date> <study_first_submitted>March 26, 2022</study_first_submitted> <study_first_submitted_qc>March 26, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 5, 2022</study_first_posted> <last_update_submitted>December 8, 2022</last_update_submitted> <last_update_submitted_qc>December 8, 2022</last_update_submitted_qc> <last_update_posted type="Actual">December 9, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>University of Pavia</investigator_affiliation> <investigator_full_name>Andrea Scribante</investigator_full_name> <investigator_title>Associate Professor, Principal Investigator</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Periodontal Diseases</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Chlorhexidine</mesh_term> <mesh_term>Chlorhexidine gluconate</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>No</sharing_ipd> <ipd_description>Data are available upon motivated request to the Principal Investigator.</ipd_description> </patient_data>  </clinical_study>

Brief Summary: This is a randomized controlled clinical trial (RCT). After signing the informed consent, patients satisfying the inclusion criteria will undergo supragingival and subgingival professional oral hygiene of both arches performed with ultrasonic instrumentation, manual instrumentation with Gracey curettes and air polishing with glycine powder. After that, the sample will be randomly divided into 2 groups based on the domiciliary assigned treatment: - Aftoral® Oral Gel solution with Hyaluronic Acid, Xylitol and glycerophosphoinositol as a domiciliary application for 15 days. - Unidea® Chlorhexidine digluconate Mouthwash 0,20% administration as a domiciliary application for 15 days. The study will last 6 months. Patients will be visited at: T0, after 1 month from T0 (T1), after 3 months (T2), after 6 months (T3). Professional hygiene will be performed again at T2 and T3. At each recall session were collected a satisfaction questionnaire of the products (taste, smell, consistency, persistence and ease of application) and the following periodontal clinical indices, using a Periodontal probe on each site: - Gingival Recession (R) - PPD (Probing Pocket Depth), - BOP% (Bleeding on Probing), - CAL (Clinical Attachment Level), - PCR% (Plaque Control Record), - Tooth Mobility. This is a randomized controlled clinical trial (RCT). 40 patients are expected to be enrolled. After signing the informed consent, patients satisfying the inclusion criteria will undergo supragingival and subgingival professional oral hygiene of both arches performed with ultrasonic instrumentation, manual instrumentation with Gracey curettes and air polishing with glycine powder. All patients will be treated at the Unit of Dental Hygiene, Section of Dentistry, Department of Clinical, Surgical, Diagnostic, and Pediatric Sciences of the University of Pavia. After that, the sample will be randomly divided into 2 groups based on the domiciliary assigned treatment: - Aftoral® Oral Gel solution with Hyaluronic Acid, Xylitol and glycerophosphoinositol as a domiciliary application for 15 days. - Unidea® Chlorhexidine digluconate Mouthwash 0,20% administration as a domiciliary application for 15 days. The study will last 6 months. Patients will be visited at: T0, after 1 month from T0 (T1), after 3 months (T2), and after 6 months (T3). At T2 and T3, professional hygiene will be performed again. At each recall session were collected a satisfaction questionnaire of the products (taste, smell, consistency, persistence and ease of application) and the following periodontal clinical indices, using a Periodontal probe on each site: - Gingival Recession (R), - PPD (Probing Pocket Depth), - BOP% (Bleeding on Probing), - CAL (Clinical Attachment Level), - PCR% (Plaque Control Record), - Tooth Mobility. Inclusion Criteria: - presence of periodontitis sites with PPD > 5 mm - no systemic, metabolic and autoimmune disease - compliant patients Exclusion Criteria: - neurologic, psychiatric and mental diseases - patients taking bisphosphonates in the last 12 months - patients taking antibiotics during the study - pregnant and breastfeeding women - patients undergoing anticancer treatment

NCT0531xxxx/NCT05312619.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05312619</url> </required_header> <id_info> <org_study_id>20212917</org_study_id> <nct_id>NCT05312619</nct_id> </id_info> <brief_title>The Burden of Lyme Disease (BOLD) in a Pandemic - Insights From an Online Cross-sectional and Prospective Cohort Survey</brief_title> <official_title>The Burden of Lyme Disease (BOLD) in a Pandemic</official_title> <sponsors> <lead_sponsor> <agency>Dr. Daniel Cameron & Associates</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Dr. Daniel Cameron & Associates</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> A cross-sectional descriptive survey of the BOLD for individuals after having been ill with COVID-19 or have taken the COVID-19 vaccine will be compared with that of individuals who have neither been ill with COVID-19 nor taken the COVID-19 vaccine. Individuals who have both been ill and taken the COVID-19 vaccine will be compared to identify any additive risk factors. </textblock> </brief_summary> <detailed_description> <textblock> Primary research question:  1. Will the BOLD be worse for individuals who have taken the COVID-19 vaccine?  Secondary research questions:  1. Will the BOLD be worse for individuals who have been ill with COVID-19?  2. What factors affect the BOLD in individuals a) after having been ill with COVID-19, and b) in those who have taken the COVID-19 vaccine? Do they differ?  3. If BOLD risk factors specific to either the COVID-19 vaccine or having been ill with COVID-19 are found, are they additive in people who have experienced both?  4. What is the prevalence of hesitancy in the Lyme disease community to the COVID-19 vaccine?  5. What is the severity of symptoms most likely to predict functional problems in individuals with Lyme disease who have been ill with COVID-19 or taken the COVID-19 vaccine? </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">July 7, 2021</start_date> <completion_date type="Anticipated">November 7, 2023</completion_date> <primary_completion_date type="Anticipated">July 7, 2023</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Other</observational_model> <time_perspective>Cross-Sectional</time_perspective> </study_design_info> <primary_outcome> <measure>Burden of Illness using a General Symptom Questionnaire-30 questionnaire (GSQ-30)</measure> <time_frame>7/21 to 7/23</time_frame> <description>Cross sectional</description> </primary_outcome> <enrollment type="Anticipated">2000</enrollment> <condition>COVID-19</condition> <condition>Lyme Disease</condition> <condition>COVID-19 Vaccine</condition> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Cross sectional survey</intervention_name> <description>A cross-sectional descriptive survey of the Burden of Lyme disease for individual with a history of Lyme disease who contract COVID-19 or are vaccinated against COVID-19</description> </intervention> <eligibility> <study_pop> <textblock> Individual with a history of Lyme disease who have contracted COVID-19 or have not. Also individual with a history of Lyme disease who have been vaccinated against COVID-19 or have not. </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - ≥12 years old  - a self-report of having been diagnosed with Lyme disease.  Exclusion Criteria:  - There are no exclusion criteria. </textblock> </criteria> <gender>All</gender> <minimum_age>12 Years</minimum_age> <maximum_age>N/A</maximum_age> </eligibility> <overall_contact> <last_name>Daniel Cameron, MD, MPH</last_name> <phone>9143251471</phone> <email>dcameron@danielcameronmd.com</email> </overall_contact> <location> <facility> <name>Daniel Cameron</name> <address> <city>Mount Kisco</city> <state>New York</state> <zip>10549</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Daniel Cameron, MD, MPH</last_name> <phone>914-325-1471</phone> <email>dcameron@danielcameronmd.com</email> </contact> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>March 28, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 5, 2022</study_first_posted> <last_update_submitted>March 28, 2022</last_update_submitted> <last_update_submitted_qc>March 28, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 5, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Dr. Daniel Cameron & Associates</investigator_affiliation> <investigator_full_name>Daniel Cameron</investigator_full_name> <investigator_title>Chief Investigator</investigator_title> </responsible_party> <condition_browse>  <mesh_term>COVID-19</mesh_term> <mesh_term>Lyme Disease</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

A cross-sectional descriptive survey of the BOLD for individuals after having been ill with COVID-19 or have taken the COVID-19 vaccine will be compared with that of individuals who have neither been ill with COVID-19 nor taken the COVID-19 vaccine. Individuals who have both been ill and taken the COVID-19 vaccine will be compared to identify any additive risk factors. Primary research question: 1. Will the BOLD be worse for individuals who have taken the COVID-19 vaccine? Secondary research questions: 1. Will the BOLD be worse for individuals who have been ill with COVID-19? 2. What factors affect the BOLD in individuals a) after having been ill with COVID-19, and b) in those who have taken the COVID-19 vaccine? Do they differ? 3. If BOLD risk factors specific to either the COVID-19 vaccine or having been ill with COVID-19 are found, are they additive in people who have experienced both? 4. What is the prevalence of hesitancy in the Lyme disease community to the COVID-19 vaccine? 5. What is the severity of symptoms most likely to predict functional problems in individuals with Lyme disease who have been ill with COVID-19 or taken the COVID-19 vaccine? Individual with a history of Lyme disease who have contracted COVID-19 or have not. Also individual with a history of Lyme disease who have been vaccinated against COVID-19 or have not. Inclusion Criteria: - ≥12 years old - a self-report of having been diagnosed with Lyme disease. Exclusion Criteria: - There are no exclusion criteria.

NCT0531xxxx/NCT05312632.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05312632</url> </required_header> <id_info> <org_study_id>ME2125-M082-401</org_study_id> <nct_id>NCT05312632</nct_id> </id_info> <brief_title>A Study to Evaluate the Efficacy and Safety of Safinamide Mesilate as Add-on Therapy to Levodopa in Parkinson's Disease Participants With Motor Fluctuation in South Korea</brief_title> <official_title>A Multi-center, Open-label Phase 4 Study Evaluating the Efficacy and Safety of Safinamide Mesilate as Add-on Therapy to Levodopa in Parkinson's Disease Patients With Motor Fluctuation in South Korea</official_title> <sponsors> <lead_sponsor> <agency>Eisai Korea Inc.</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Eisai Inc.</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The primary purpose of this study is to evaluate the change at the 18th week from baseline in daily "off" time measured by participant diary and Parkinson's Disease Questionnaire-39 (PDQ-39) in participants with Parkinson's Disease who are receiving levodopa. </textblock> </brief_summary> <overall_status>Completed</overall_status> <start_date type="Actual">April 5, 2022</start_date> <completion_date type="Actual">May 26, 2023</completion_date> <primary_completion_date type="Actual">May 26, 2023</primary_completion_date> <phase>Phase 4</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>N/A</allocation> <intervention_model>Single Group Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Change From Baseline in Daily OFF Time</measure> <time_frame>Baseline, Week 18</time_frame> <description>Information on daily "off" time and "on" time will be collected by participant diary card. Participants will receive participant diary card and will be trained on how to use it. At 30-minute intervals throughout the period, the participant/caregiver will record whether the participant is currently 1. in an "on" phase, 2. in an "on" phase with dyskinesia, 3. in an "off" phase, or 4. asleep. An "off" phase will be defined as lack of mobility, bradykinesia, or akinesia whereas in an "on" phase, the participant will be functioning as well as can be expected for that participant, irrespective of whether or not he or she is having dyskinesia. The daily "off" time is defined as the mean of the total daily "off" time during the last two 24-hour diary recording periods. Here, change from baseline in daily OFF time will be assessed.</description> </primary_outcome> <primary_outcome> <measure>Change From Baseline in PDQ-39 Score</measure> <time_frame>Baseline, Week 18</time_frame> <description>PDQ-39 comprises of 39 questions measuring eight dimensions of health: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication and bodily pain. Each dimension total score ranges from 0 (perfect health as assessed by the measure) to 100 (worst health as assessed by the measure).</description> </primary_outcome> <secondary_outcome> <measure>Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating (MDS-UPDRS) Part 3</measure> <time_frame>Baseline, Week 18</time_frame> <description>The MDS-UPDRS is rating tool used to follow longitudinal course of Parkinson's Disease. It is made up of 4 parts that assess: Part 1: Non-motor Aspects of Experiences of Daily Living; Part 2: Motor Aspects of Experiences of Daily Living; Part 3: Motor Examination; Part 4: Motor Complications. Part 3 evaluates the motor function. The scale consists of 18 items, with 33 separate ratings being performed on scale from 0 (normal) to 4 (severe). The total score ranges of MDS-UPDRS Part 3 from 0 to 132, with a lower score indicating better motor function and a higher score indicating more severe motor symptoms. The participant's speech, facial expressions, ability to arise from a chair, posture, gait, postural stability (retropulsion test), and body bradykinesia will be assessed. In addition, tremor at rest, action or postural tremor of hands, rigidity, toe/finger taps, hand movements (open/close), rapid alternating movements of hands (pronation/supination), and leg agility will be assessed.</description> </secondary_outcome> <secondary_outcome> <measure>Change From Baseline in MDS-UPDRS Part 4</measure> <time_frame>Baseline, Week 18</time_frame> <description>The MDS-UPDRS is rating tool used to follow longitudinal course of Parkinson's Disease. It is made up of 4 parts that assess: Part 1: Non-motor Aspects of Experiences of Daily Living; Part 2: Motor Aspects of Experiences of Daily Living; Part 3: Motor Examination; Part 4: Motor Complications. Part 4 raters use historical/objective information to assess 2 motor complications, dyskinesias and motor fluctuations including OFF-state dystonia. Raters use information from participant, caregiver, and the examination to answer 6 questions. The duration of disability caused and functional impact of any dyskinesias experienced by the participant are rated on a scale of 0 to 4. Scale consists of 6 items being performed on scale from 0 (normal) to 4 (severe). The total score ranges from 0 to 24, lower score indicating better motor function and higher score indicating more severe motor symptoms.</description> </secondary_outcome> <secondary_outcome> <measure>Change From Baseline in King's Parkinson's Disease Pain Scale (KPPS)</measure> <time_frame>Baseline, Week 18</time_frame> <description>KPPS is a Parkinson's Disease-specific pain scale that evaluates the localization, frequency, and intensity of pain. It has 14 items in 7 domains: 1. Musculoskeletal Pain; 2. Chronic Pain; 3. Fluctuation-related Pain; 4. Nocturnal Pain; 5. Oro-facial Pain; 6. Discoloration, Oedema/Swelling Pain; 7. Radicular Pain. Each item is scored by severity (0 [none] to 3 [very severe]) multiplied by frequency (0 [never] to 4 [all the time]), resulting in a subscore of 0 to 12, the sum of which gives the total score range from 0 to 168. Higher scores are indicative of more severity and frequency of pain.</description> </secondary_outcome> <secondary_outcome> <measure>Change From Baseline in Mini-Mental State Examination (MMSE)</measure> <time_frame>Baseline, Week 18</time_frame> <description>The MMSE is a brief practical screening test for cognitive dysfunction. The test consists of 5 sections (orientation, registration, attention and calculation, recall, and language) and has a total possible score of 30. Scores ranges from 0 (most impaired) to 30 (no impairment). It is useful as a quick method to assess the severity of cognitive dysfunction.</description> </secondary_outcome> <secondary_outcome> <measure>Number of Participants With Treatment-emergent Adverse events (TEAEs) and Serious Adverse Events (SAEs)</measure> <time_frame>Up to Week 19</time_frame> <description>Safety assessments will consist of monitoring and recording all adverse events (AEs); regular monitoring of clinical laboratory parameters; vital signs and 12-lead electrocardiogram (ECG), body weight, urine pregnancy test and physical examinations. A TEAE is defined as an AE that emerges during treatment, having been absent at pretreatment (Baseline) or reemerges during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, inpatient hospitalization, requires prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug), is a medically significant event.</description> </secondary_outcome> <secondary_outcome> <measure>Change From Baseline in Daily ON Time Without Dyskinesia</measure> <time_frame>Baseline, Week 18</time_frame> <description>Information on daily "off" time and "on" time will be collected by participant diary card. Participants will receive participant diary card and will be trained on how to use it. At 30-minute intervals throughout the period, the participant/caregiver will record whether the participant is currently 1. in an "on" phase, 2. in an "off" phase, or 3. asleep. Here, change from baseline in daily ON time without dyskinesia will be assessed. An "off" phase will be defined as lack of mobility, bradykinesia, or akinesia whereas in an "on" phase, the participant will be functioning as well as can be expected for that participant, irrespective of whether or not he or she is having dyskinesia. The daily "on" time is defined as the mean of the total daily "on" time during the last two 24-hour diary recording periods.</description> </secondary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Actual">201</enrollment> <condition>Parkinson Disease</condition> <arm_group> <arm_group_label>Safinamide Mesilate</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Participants with parkinson's disease will be administered Safinamide Mesilate 50 milligram (mg) tablet, orally, once daily as add-on therapy to levodopa for up to 2 weeks. After 2 weeks, at the discretion of an investigator, dose of Safinamide Mesilate will be increased to 100 mg tablets (two tablets of 50 mg each), orally, once daily for up to 18 weeks.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Safinamide Mesilate</intervention_name> <description>Safinamide Mesilate oral tablets.</description> <arm_group_label>Safinamide Mesilate</arm_group_label> <other_name>Equfina</other_name> <other_name>ME2125</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. Male or female, age greater than or equal to (>=) 19 years at the time of informed consent  2. Participants who meet the clinical diagnostic criteria of Movement Disorder Society (MDS) diagnostic criteria 2015 for Parkinson's disease, have motor fluctuations with >=1.5 hours of "off" time throughout the day which is confirmed at the time of Screening, and take levodopa 3 or more times a day  3. Parkinson's Disease participants who are receiving levodopa without Catechol O-methyltransferase (COMT) inhibitor and/or Monoamine oxidase-B (MAO-B) inhibitor  - Be levodopa-responsive and have been receiving treatment with levodopa (including controlled-release [CR], immediate-release [IR], or a combination of CR and IR), and/or benserazide/carbidopa at a stable dose at least 4 weeks prior to the screening visit  - Dose of levodopa at the screening visit can be maintained without escalation during the 18-week treatment period  - Participants taking dopamine agonists are being treated at a stable dose for at least 4 weeks prior to the screening visit and can be maintained without dose adjustment during the 18-week treatment period  4. Be able to maintain an accurate and complete diary with the help of a caregiver as needed, recording "on" time, "on" time with dyskinesia, "off" time, and time asleep  5. Be able to provide written informed consent  6. Participants whose cognitive function, at the discretion of an investigator, is at a level appropriate to participate in the clinical trial (that is., with a Global Deterioration Scale [GDS] score of 3 or less or a Clinical Dementia Rating [CDR] of 0.5 or less within 3 months prior to screening)  Exclusion Criteria:  1. Females who are planning for pregnancy, pregnant or breastfeeding  2. Prior use of safinamide  3. If participants have previously taken medication such as COMT inhibitor and/or MAO-B inhibitor, they have to take appropriate wash-out period for each medication (3 days for COMT inhibitor; 14 days for MAO-B inhibitor)  4. Use of medications for depression or psychosis within 5 weeks prior to screening  5. History of allergic response to levodopa, or other anti-Parkinsonian agents  6. Hypersensitivity or contraindications to MAO-B inhibitors  7. Confirmed ophthalmologic history including any of the following conditions: albino participants, family history of hereditary retinal disease, progressive and/or severe diminution of visual acuity (that is, 20/70 on Snellen Chart), retinitis pigmentosa, retinal pigmentation due to any cause, any active retinopathy or ocular inflammation (uveitis), or diabetic retinopathy  8. Participants who did not consent to having at least 7 days of washout period prior to visit 2, if known to take narcotic analgesics 7 days prior to screening visit (example, pethidine hydrochloride-containing products, tramadol hydrochloride, or tapentadol hydrochloride)  9. History of serotonergic medications administration (example, tricyclic antidepressants, tetracyclic antidepressants, selective serotonin reuptake inhibitors, serotonin-noradrenaline reuptake inhibitors, selective noradrenaline reuptake inhibitor, or noradrenergic and serotonergic antidepressant) within 5 weeks prior to screening visit  10. Administering central nervous system stimulants (example, methylphenidate hydrochloride, lisdexamfetamine mesilate)  11. Administering dextromethorphan  12. Participants with clinically significant liver function abnormalities defined as greater than (>) 1.5 times of the upper limit of the normal range of total bilirubin or >3 times of the upper limit of the normal range of Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST); re-examination and re-screening are allowed once within the screening period  13. Have a history of hypersensitivity to any of the ingredients of the product  14. Currently enrolled in another clinical trial or used any investigational drug/biologics or device within 30 days or 5*the half-life, whichever is longer, preceding informed consent </textblock> </criteria> <gender>All</gender> <minimum_age>19 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <location> <facility> <name>Eisai Site #11</name> <address> <city>Busan</city> <country>Korea, Republic of</country> </address> </facility> </location> <location> <facility> <name>Eisai Site #20</name> <address> <city>Busan</city> <country>Korea, Republic of</country> </address> </facility> </location> <location> <facility> <name>Eisai Site #3</name> <address> <city>Busan</city> <country>Korea, Republic of</country> </address> </facility> </location> <location> <facility> <name>Eisai Site #16</name> <address> <city>Daegu</city> <country>Korea, Republic of</country> </address> </facility> </location> <location> <facility> <name>Eisai Site #2</name> <address> <city>Daegu</city> <country>Korea, Republic of</country> </address> </facility> </location> <location> <facility> <name>Eisai Site #19</name> <address> <city>Daejeon</city> <country>Korea, Republic of</country> </address> </facility> </location> <location> <facility> <name>Eisai Site #10</name> <address> <city>Gwangju</city> <country>Korea, Republic of</country> </address> </facility> </location> <location> <facility> <name>Eisai Site #12</name> <address> <city>Gyeonggi-do</city> <country>Korea, Republic of</country> </address> </facility> </location> <location> <facility> <name>Eisai Site #15</name> <address> <city>Gyeonggi-do</city> <country>Korea, Republic of</country> </address> </facility> </location> <location> <facility> <name>Eisai Site #17</name> <address> <city>Gyeonggi-do</city> <country>Korea, Republic of</country> </address> </facility> </location> <location> <facility> <name>Eisai Site #5</name> <address> <city>Gyeonggi-do</city> <country>Korea, Republic of</country> </address> </facility> </location> <location> <facility> <name>Eisai Site #14</name> <address> <city>Incheon</city> <country>Korea, Republic of</country> </address> </facility> </location> <location> <facility> <name>Eisai Site #13</name> <address> <city>Seoul</city> <country>Korea, Republic of</country> </address> </facility> </location> <location> <facility> <name>Eisai Site #18</name> <address> <city>Seoul</city> <country>Korea, Republic of</country> </address> </facility> </location> <location> <facility> <name>Eisai Site #1</name> <address> <city>Seoul</city> <country>Korea, Republic of</country> </address> </facility> </location> <location> <facility> <name>Eisai Site #4</name> <address> <city>Seoul</city> <country>Korea, Republic of</country> </address> </facility> </location> <location> <facility> <name>Eisai Site #6</name> <address> <city>Seoul</city> <country>Korea, Republic of</country> </address> </facility> </location> <location> <facility> <name>Eisai Site #7</name> <address> <city>Seoul</city> <country>Korea, Republic of</country> </address> </facility> </location> <location> <facility> <name>Eisai Site #8</name> <address> <city>Seoul</city> <country>Korea, Republic of</country> </address> </facility> </location> <location> <facility> <name>Eisai Site #9</name> <address> <city>Seoul</city> <country>Korea, Republic of</country> </address> </facility> </location> <location_countries> <country>Korea, Republic of</country> </location_countries> <verification_date>May 2022</verification_date> <study_first_submitted>March 28, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 5, 2022</study_first_posted> <last_update_submitted>July 14, 2023</last_update_submitted> <last_update_submitted_qc>July 14, 2023</last_update_submitted_qc> <last_update_posted type="Actual">July 17, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Parkinson Disease</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Yes</sharing_ipd> <ipd_description>Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.</ipd_description> </patient_data>  </clinical_study>

The primary purpose of this study is to evaluate the change at the 18th week from baseline in daily "off" time measured by participant diary and Parkinson's Disease Questionnaire-39 (PDQ-39) in participants with Parkinson's Disease who are receiving levodopa. Inclusion Criteria: 1. Male or female, age greater than or equal to (>=) 19 years at the time of informed consent 2. Participants who meet the clinical diagnostic criteria of Movement Disorder Society (MDS) diagnostic criteria 2015 for Parkinson's disease, have motor fluctuations with >=1.5 hours of "off" time throughout the day which is confirmed at the time of Screening, and take levodopa 3 or more times a day 3. Parkinson's Disease participants who are receiving levodopa without Catechol O-methyltransferase (COMT) inhibitor and/or Monoamine oxidase-B (MAO-B) inhibitor - Be levodopa-responsive and have been receiving treatment with levodopa (including controlled-release [CR], immediate-release [IR], or a combination of CR and IR), and/or benserazide/carbidopa at a stable dose at least 4 weeks prior to the screening visit - Dose of levodopa at the screening visit can be maintained without escalation during the 18-week treatment period - Participants taking dopamine agonists are being treated at a stable dose for at least 4 weeks prior to the screening visit and can be maintained without dose adjustment during the 18-week treatment period 4. Be able to maintain an accurate and complete diary with the help of a caregiver as needed, recording "on" time, "on" time with dyskinesia, "off" time, and time asleep 5. Be able to provide written informed consent 6. Participants whose cognitive function, at the discretion of an investigator, is at a level appropriate to participate in the clinical trial (that is., with a Global Deterioration Scale [GDS] score of 3 or less or a Clinical Dementia Rating [CDR] of 0.5 or less within 3 months prior to screening) Exclusion Criteria: 1. Females who are planning for pregnancy, pregnant or breastfeeding 2. Prior use of safinamide 3. If participants have previously taken medication such as COMT inhibitor and/or MAO-B inhibitor, they have to take appropriate wash-out period for each medication (3 days for COMT inhibitor; 14 days for MAO-B inhibitor) 4. Use of medications for depression or psychosis within 5 weeks prior to screening 5. History of allergic response to levodopa, or other anti-Parkinsonian agents 6. Hypersensitivity or contraindications to MAO-B inhibitors 7. Confirmed ophthalmologic history including any of the following conditions: albino participants, family history of hereditary retinal disease, progressive and/or severe diminution of visual acuity (that is, 20/70 on Snellen Chart), retinitis pigmentosa, retinal pigmentation due to any cause, any active retinopathy or ocular inflammation (uveitis), or diabetic retinopathy 8. Participants who did not consent to having at least 7 days of washout period prior to visit 2, if known to take narcotic analgesics 7 days prior to screening visit (example, pethidine hydrochloride-containing products, tramadol hydrochloride, or tapentadol hydrochloride) 9. History of serotonergic medications administration (example, tricyclic antidepressants, tetracyclic antidepressants, selective serotonin reuptake inhibitors, serotonin-noradrenaline reuptake inhibitors, selective noradrenaline reuptake inhibitor, or noradrenergic and serotonergic antidepressant) within 5 weeks prior to screening visit 10. Administering central nervous system stimulants (example, methylphenidate hydrochloride, lisdexamfetamine mesilate) 11. Administering dextromethorphan 12. Participants with clinically significant liver function abnormalities defined as greater than (>) 1.5 times of the upper limit of the normal range of total bilirubin or >3 times of the upper limit of the normal range of Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST); re-examination and re-screening are allowed once within the screening period 13. Have a history of hypersensitivity to any of the ingredients of the product 14. Currently enrolled in another clinical trial or used any investigational drug/biologics or device within 30 days or 5*the half-life, whichever is longer, preceding informed consent

NCT0531xxxx/NCT05312645.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05312645</url> </required_header> <id_info> <org_study_id>5230175</org_study_id> <nct_id>NCT05312645</nct_id> </id_info> <brief_title>Diclofenac Gel in the Treatment of Cervicogenic Headache</brief_title> <acronym>DITCH</acronym> <official_title>Diclofenac Gel in the Treatment of Cervicogenic Headache: A Randomized, Double-Blind, Controlled Trial</official_title> <sponsors> <lead_sponsor> <agency>Loma Linda University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Loma Linda University</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>Yes</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> <is_us_export>Yes</is_us_export> </oversight_info> <brief_summary> <textblock> The intervention will consist of the nursing staff applying 2 grams of diclofenac 1% gel topically to the posterior cervical region four times daily. The control group will receive petroleum jelly topically to the posterior cervical region four times daily. Patients will receive a pre-intervention and post-intervention survey incorporating the Numeric Assessment Scale and Headache Impact Test-6. </textblock> </brief_summary> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">December 2023</start_date> <completion_date type="Anticipated">January 2025</completion_date> <primary_completion_date type="Anticipated">January 2025</primary_completion_date> <phase>Phase 3</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Pain Severity</measure> <time_frame>Change between baseline and day 14 of treatment.</time_frame> <description>Measured with the Numeric Assessment Scale (0 least severe, 10 most severe). This is a composite measurement between pre-intervention baseline and 14 days post-treatment.</description> </primary_outcome> <primary_outcome> <measure>Activities of Daily Living Function Assessment</measure> <time_frame>Change between baseline and day 14 of treatment.</time_frame> <description>Measured with Headache Impact Test-6 (score less than 49 indicates little to no impact on daily life, 50-55 indicates some impact, 56-59 indicates substantial impact, greater than 60 indicates severe impact). This is a composite measurement of activities of daily living function between pre-intervention baseline and 14 days post-treatment. Activities of daily living include, but are not limited to, household work, grooming, and social activities.</description> </primary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">50</enrollment> <condition>Cervicogenic Headache</condition> <arm_group> <arm_group_label>Diclofenac Gel</arm_group_label> <arm_group_type>Experimental</arm_group_type> </arm_group> <arm_group> <arm_group_label>Control</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Diclofenac 1% Topical</intervention_name> <description>2 grams topically four times daily for 2 weeks to posterior cervical spine</description> <arm_group_label>Diclofenac Gel</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Petroleum Jelly</intervention_name> <description>2 grams topically four times daily for 2 weeks to posterior cervical spine</description> <arm_group_label>Control</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - 18-90 Years old  - English Speaking  - Hospitalized at Loma Linda East Campus Rehabilitation Hospital  - Meet ICHD-3-III 11.2.1 criteria for cervicogenic headache (classified as "Definitive" when C4 is satisfied by trial participants, "Probable" when criteria A or B, together with D have been met and "Possible" when only 1 of the criteria listed in C together with criteria D has been met. Avijgan et al., 2019)  Exclusion Criteria:  - Headache secondary to intracranial pathology (i.e. tumors)  - History of cervical spine procedures  - Nerve blocks within past 4 weeks or steroid injections within past 6 months.  - Patients with fibromyalgia  - Chronic pain on continuous opiate regimen (use of opioids on most days >90 days)  - Known allergy to diclofenac gel  - History of coronary artery bypass graft or gastrointestinal bleed </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>90 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Duc Tran, MD, PhD</last_name> <role>Principal Investigator</role> <affiliation>Loma Linda University</affiliation> </overall_official> <overall_contact> <last_name>Duc Tran, MD, PhD</last_name> <phone>9095589273</phone> <email>DATran@llu.edu</email> </overall_contact> <overall_contact_backup> <last_name>Cristian Villegas, MD</last_name> <email>cvillegas@llu.edu</email> </overall_contact_backup> <verification_date>May 2023</verification_date> <study_first_submitted>March 28, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 5, 2022</study_first_posted> <last_update_submitted>May 24, 2023</last_update_submitted> <last_update_submitted_qc>May 24, 2023</last_update_submitted_qc> <last_update_posted type="Actual">May 25, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Headache</keyword> <keyword>Cervicogenic</keyword> <keyword>Diclofenac</keyword> <condition_browse>  <mesh_term>Post-Traumatic Headache</mesh_term> <mesh_term>Headache</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Diclofenac</mesh_term> <mesh_term>Petrolatum</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

The intervention will consist of the nursing staff applying 2 grams of diclofenac 1% gel topically to the posterior cervical region four times daily. The control group will receive petroleum jelly topically to the posterior cervical region four times daily. Patients will receive a pre-intervention and post-intervention survey incorporating the Numeric Assessment Scale and Headache Impact Test-6. Inclusion Criteria: - 18-90 Years old - English Speaking - Hospitalized at Loma Linda East Campus Rehabilitation Hospital - Meet ICHD-3-III 11.2.1 criteria for cervicogenic headache (classified as "Definitive" when C4 is satisfied by trial participants, "Probable" when criteria A or B, together with D have been met and "Possible" when only 1 of the criteria listed in C together with criteria D has been met. Avijgan et al., 2019) Exclusion Criteria: - Headache secondary to intracranial pathology (i.e. tumors) - History of cervical spine procedures - Nerve blocks within past 4 weeks or steroid injections within past 6 months. - Patients with fibromyalgia - Chronic pain on continuous opiate regimen (use of opioids on most days >90 days) - Known allergy to diclofenac gel - History of coronary artery bypass graft or gastrointestinal bleed

NCT0531xxxx/NCT05312658.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05312658</url> </required_header> <id_info> <org_study_id>2021-06579</org_study_id> <nct_id>NCT05312658</nct_id> </id_info> <brief_title>Aortic Compression Trial to Reduce Blood Loss at Cesarean Section</brief_title> <acronym>ACT</acronym> <official_title>Aortic Compression Trial - a Randomized Controlled Trial to Reduce Blood Loss at Cesarean Section (ACT)</official_title> <sponsors> <lead_sponsor> <agency>Karolinska Institutet</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>The Swedish Research Council</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Karolinska Institutet</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The ACT trial investigates if manual external aortic compression is an effective and acceptable preventive measure to reduce severe postpartum hemorrhage (PPH) in cesarean section.  Severe PPH is a maternal blood loss ≥1000 ml at childbirth. Severe PPH causes maternal mortality and morbidity. Severe PPH is more common in cesarean sections than in vaginal births. Routine oxytocin intravenous injection and swift placenta delivery through cord traction is recommended to prevent PPH. Manual external aortic compression is used in other obstetric situations to temporise blood loss and could be used prophylactically during cesarean section until bleeding control is attained. The Cochrane Library stated in 2020 that mechanical methods for the prevention and treatment of PPH, including aortic compression, urgently need scientific evaluation.  The ACT trial is a multicenter randomised controlled trial including aiming to include 2232 patients in four Swedish regions running over two years. The trial includes patients undergoing cesarean section. The intervention is routine manual external aortic compression immediately after the baby is delivered and the comparison is no routine external aortic compression. The primary outcome is proportion of patients with a calculated blood loss ≥1000 ml perioperatively or blood transfusion within 2 days. Secondary outcomes are mortality, serious morbidity (for example hysterectomy), surgery duration, hospital stay duration, patient experience, neonatal outcomes, and postnatal maternal health (depression, breastfeeding).  If proven effective and acceptable, external aortic compression is a simple and low-cost measure that could reduce severe PPH and improve obstetric care worldwide. </textblock> </brief_summary> <overall_status>Enrolling by invitation</overall_status> <start_date type="Actual">December 1, 2022</start_date> <completion_date type="Anticipated">December 2026</completion_date> <primary_completion_date type="Anticipated">December 2025</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <intervention_model_description>1:1 randomized controlled trial</intervention_model_description> <primary_purpose>Prevention</primary_purpose> <masking>Double (Investigator, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Calculated peripartum hemorrhage</measure> <time_frame>0-2 days postpartum</time_frame> <description>Calculated estimated blood loss greater than 1000 ml or a red-cell transfusion within 2 days after delivery. The calculated estimated blood loss = the estimated blood volume × (preoperative hematocrit - postoperative hematocrit) ÷ preoperative hematocrit. The estimated blood volume in milliliters is calculated as the admission body weight in kilograms × 85.</description> </primary_outcome> <secondary_outcome> <measure>Peripartum hemorrhage (g)</measure> <time_frame>0-6 hours postpartum</time_frame> <description>Blood loss at surgery, or shortly after, of 1000 g or more</description> </secondary_outcome> <secondary_outcome> <measure>Hemoglobin and EVF change</measure> <time_frame>0-3 days postpartum</time_frame> <description>Difference between prepoerative (0-48 h) and postpartum (24-48 h) B-Hemoglobin and erythrocyte volume fraction.</description> </secondary_outcome> <secondary_outcome> <measure>Transfusion</measure> <time_frame>0-7 days postpartum</time_frame> <description>Transfusion of blood products (erythrocyte/whole blood/plasma)</description> </secondary_outcome> <secondary_outcome> <measure>Maternal death</measure> <time_frame>0-42 days postpartum</time_frame> <description>Death of patient after cesarean section</description> </secondary_outcome> <secondary_outcome> <measure>Severe maternal morbidity</measure> <time_frame>0-42 days postpartum</time_frame> <description>Composite outcome including hysterectomy, intensive care, ischemic heart disease/heart failure, pulmonary edema, venous thromboembolism, cerebral insult.</description> </secondary_outcome> <secondary_outcome> <measure>Duration of surgery</measure> <time_frame>0-1 day postpartum</time_frame> <description>Time from incision start to skin closure stop (minutes)</description> </secondary_outcome> <secondary_outcome> <measure>Duration of hospital stay</measure> <time_frame>0-42 days postpartum</time_frame> <description>Time from incision start to discharge from the hospital (hours)</description> </secondary_outcome> <other_outcome> <measure>Patient experience of the operation</measure> <time_frame>1-3 days postpartum</time_frame> <description>Pain, nausea, breathing, overall experience rated with numeric rating scale 0-10</description> </other_outcome> <other_outcome> <measure>Postpartum depression</measure> <time_frame>6-8 weeks postpartum</time_frame> <description>Edinburgh Postnatal Depression Scale</description> </other_outcome> <other_outcome> <measure>Breastfeeding</measure> <time_frame>6-8 weeks postpartum</time_frame> <description>Breastfeeding Self-Efficacy Scale-Short Form</description> </other_outcome> <other_outcome> <measure>Uterine wall defect</measure> <time_frame>6 months postpartum</time_frame> <description>Ultrasound evaluation of the anterior uterine wall, measuring any niche and wall thickness.</description> </other_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">2232</enrollment> <condition>Post Partum Hemorrhage</condition> <condition>Cesarean Section Complications</condition> <condition>Anemia</condition> <arm_group> <arm_group_label>Routine external aortic compression</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>The assistant surgeon or nurse places heel of the hand or fist over the abdominal aorta immediately after the baby is born while the surgeon helps the baby out, the placenta is expulsed or fetched, and the surgeon gains control over bleeding. The compression should be held until controlled bleedning, for example until the first layer of the uterine incision is sutured. Maximum time of aortic compression is 20 minutes, then a 5 minute break is required, after which compression may be reapplied.</description> </arm_group> <arm_group> <arm_group_label>No external aortic compression</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>No routine aortic compression. If deemed vital to the mother, aortic compression should be exerted. Aortic compression may be exerted if bleeding exceeds 1000 ml.</description> </arm_group> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>External aortic compression</intervention_name> <description>External aortic compression by assistant in cesarean section.</description> <arm_group_label>Routine external aortic compression</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  Planned cesarean delivery, live fetus/fetuses if multiple pregnancy, gestational week 34+0 or more, signed informed consent.  Exclusion Criteria: Preoperative B-Hemoglobin <100 g/l, planned hysterectomy in the same procedure as the planned cesarean delivery, other condition as deemed by attending surgeon. </textblock> </criteria> <gender>Female</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Sophia Brismar Wendel, MD, PhD</last_name> <role>Principal Investigator</role> <affiliation>Danderyd Hospital Karolinska Institutet, Sweden</affiliation> </overall_official> <location> <facility> <name>Danderyd Hospital</name> <address> <city>Stockholm</city> <country>Sweden</country> </address> </facility> </location> <location_countries> <country>Sweden</country> </location_countries> <link> <url>https://www.snaks.se/act/</url> <description>Swedish network for national clinical studies in Obstetrics and Gynecology, information about ACT in Swedish</description> </link> <reference> <citation>Kellie FJ, Wandabwa JN, Mousa HA, Weeks AD. Mechanical and surgical interventions for treating primary postpartum haemorrhage. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD013663. doi: 10.1002/14651858.CD013663.</citation> <PMID>32609374</PMID> </reference> <verification_date>February 2023</verification_date> <study_first_submitted>March 28, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 5, 2022</study_first_posted> <last_update_submitted>February 16, 2023</last_update_submitted> <last_update_submitted_qc>February 16, 2023</last_update_submitted_qc> <last_update_posted type="Actual">February 21, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Karolinska Institutet</investigator_affiliation> <investigator_full_name>Sophia Brismar Wendel</investigator_full_name> <investigator_title>Associate professor, MD, PhD</investigator_title> </responsible_party> <keyword>Aortic compression</keyword> <keyword>Post partum hemorrhage</keyword> <keyword>Anemia</keyword> <keyword>Cesarean section</keyword> <condition_browse>  <mesh_term>Postpartum Hemorrhage</mesh_term> <mesh_term>Hemorrhage</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Yes</sharing_ipd> <ipd_description>Anonymized data will be shared with other researchers for a joint publication or for systematic review purposes with due citation.</ipd_description> <ipd_info_type>Study Protocol</ipd_info_type> <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type> <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type> <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type> <ipd_time_frame>From one year after the trial is finalized with no upper limit.</ipd_time_frame> <ipd_access_criteria>To be defined</ipd_access_criteria> </patient_data>  </clinical_study>

The ACT trial investigates if manual external aortic compression is an effective and acceptable preventive measure to reduce severe postpartum hemorrhage (PPH) in cesarean section. Severe PPH is a maternal blood loss ≥1000 ml at childbirth. Severe PPH causes maternal mortality and morbidity. Severe PPH is more common in cesarean sections than in vaginal births. Routine oxytocin intravenous injection and swift placenta delivery through cord traction is recommended to prevent PPH. Manual external aortic compression is used in other obstetric situations to temporise blood loss and could be used prophylactically during cesarean section until bleeding control is attained. The Cochrane Library stated in 2020 that mechanical methods for the prevention and treatment of PPH, including aortic compression, urgently need scientific evaluation. The ACT trial is a multicenter randomised controlled trial including aiming to include 2232 patients in four Swedish regions running over two years. The trial includes patients undergoing cesarean section. The intervention is routine manual external aortic compression immediately after the baby is delivered and the comparison is no routine external aortic compression. The primary outcome is proportion of patients with a calculated blood loss ≥1000 ml perioperatively or blood transfusion within 2 days. Secondary outcomes are mortality, serious morbidity (for example hysterectomy), surgery duration, hospital stay duration, patient experience, neonatal outcomes, and postnatal maternal health (depression, breastfeeding). If proven effective and acceptable, external aortic compression is a simple and low-cost measure that could reduce severe PPH and improve obstetric care worldwide. Inclusion Criteria: Planned cesarean delivery, live fetus/fetuses if multiple pregnancy, gestational week 34+0 or more, signed informed consent. Exclusion Criteria: Preoperative B-Hemoglobin <100 g/l, planned hysterectomy in the same procedure as the planned cesarean delivery, other condition as deemed by attending surgeon.

NCT0531xxxx/NCT05312671.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05312671</url> </required_header> <id_info> <org_study_id>J2208</org_study_id> <secondary_id>IRB00313218</secondary_id> <secondary_id>ML42154</secondary_id> <nct_id>NCT05312671</nct_id> </id_info> <brief_title>Atezolizumab Plus Etoposide and Platinum in Small Cell Bladder Cancer</brief_title> <official_title>Atezolizumab With Platinum and Etoposide Chemotherapy Followed by Cystectomy for Patients With Localized Small Cell Neuroendocrine Bladder Cancer</official_title> <sponsors> <lead_sponsor> <agency>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Genentech, Inc.</agency> <agency_class>Industry</agency_class> </collaborator> </sponsors> <source>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</source> <oversight_info> <is_fda_regulated_drug>Yes</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> This is a single arm, Phase II trial involving the use of atezolizumab plus platinum and etoposide for patients with locally advanced urothelial cancer. The primary goal of this trial is to assess the pathologic complete response rate at cystectomy in patients after being treated with a combination therapy of atezolizumab, platinum, and etoposide. </textblock> </brief_summary> <detailed_description> <textblock> The study population will include male and female patients over the age of 18 with invasive (cT1-cT4) small cell / neuroendocrine carcinoma of the bladder (MIBC), with or without urothelial cancer component, who are eligible for platinum based chemotherapy and immunotherapy. All patients will be fit to undergo surgical resection of their cancer by cystectomy. Patients with resectable N1 disease within the true pelvis are eligible.  Participants will receive:  Atezolizumab 1,200 mg IV Day 1 Etoposide 100 mg/m2 IV on Days 1-3 Carboplatin AUC 5 IV on Day 1 or Cisplatin 70 mg/m2 IV on Day 1 (Patients can be switched at investigator's discretion between cisplatin and carboplatin between cycles. Rationale must be provided.) Repeat q 21 days x 4 cycles  Atezolizumab will be administered by intravenous (IV) infusion at a fixed dose of 1200 mg Day 1 of every 21 day cycle with chemotherapy x 4 cycles. Following cystectomy, Atezolizumab maintenance Q 21 days will continue until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status (e.g., symptomatic deterioration such as pain secondary to disease), or up to 1 year (e.g., 16 cycles). </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">June 27, 2022</start_date> <completion_date type="Anticipated">June 2026</completion_date> <primary_completion_date type="Anticipated">June 2024</primary_completion_date> <phase>Phase 2</phase> <study_type>Interventional</study_type> <study_design_info> <allocation>N/A</allocation> <intervention_model>Single Group Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Pathologic complete response (ypCR) at cystectomy</measure> <time_frame>up to 18 months</time_frame> <description>The number of participants with pathological complete responses (ypCR) at cystectomy. Pathologic complete response is defined as post-treatment cystectomy tumor stages N0 and M0, with T-stage T0.</description> </primary_outcome> <secondary_outcome> <measure>Number of participants with non-muscle invasive disease</measure> <time_frame>up to 18 months</time_frame> <description>Non-muscle invasive disease is defined as <ypT1N0 at cystectomy.</description> </secondary_outcome> <secondary_outcome> <measure>Safety and tolerability of combination chemotherapy and cystectomy as assessed by number of participants experiencing adverse events</measure> <time_frame>4.5 years</time_frame> <description>Number of participants experiencing dose limiting toxicities and treatment-related adverse events, as defined by Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0).</description> </secondary_outcome> <secondary_outcome> <measure>Incidence of brain metastases in follow-up</measure> <time_frame>up to 5 years</time_frame> <description>Number of participants who develop brain metastases during follow-up</description> </secondary_outcome> <secondary_outcome> <measure>1-year overall survival rate (1-yr OS)</measure> <time_frame>up to 4 years</time_frame> <description>Number of participants alive 1 year after last dose</description> </secondary_outcome> <secondary_outcome> <measure>2-year overall survival rate (2-yr OS)</measure> <time_frame>up to 5 years</time_frame> <description>Number of participants alive 2 years after last dose</description> </secondary_outcome> <secondary_outcome> <measure>Disease Free Survival</measure> <time_frame>up to 5 years</time_frame> <description>Number of participants without disease recurrence</description> </secondary_outcome> <secondary_outcome> <measure>Feasibility of atezolizumab administration with platinum and etoposide chemotherapy prior to surgery</measure> <time_frame>up to 18 months</time_frame> <description>Number of participants during the first stage of the study (first 15 patients) proceeding to surgery without extended treatment related delays.</description> </secondary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Anticipated">63</enrollment> <condition>Small Cell Neuroendocrine Carcinoma of Bladder</condition> <condition>Bladder Cancer</condition> <condition>Urothelial Carcinoma Bladder</condition> <arm_group> <arm_group_label>Atezolizumab with Platinum and Etoposide, followed by cystectomy.</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>The study population will include male and female patients over the age of 18 with invasive (cT1-cT4) small cell / neuroendocrine carcinoma of the bladder (MIBC), with or without urothelial cancer component, who are eligible for platinum based chemotherapy and immunotherapy. All patients will be fit to undergo surgical resection of their cancer by cystectomy. Patients with resectable N1 disease within the true pelvis are eligible. Atezolizumab will be administered by intravenous (IV) infusion at a fixed dose of 1200 mg Day 1 of every 21 day cycle with chemotherapy x 4 cycles. Following cystectomy, Atezolizumab maintenance Q 21 days will continue until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status (e.g., symptomatic deterioration such as pain secondary to disease), or up to 1 year (e.g., 16 cycles).</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Atezolizumab</intervention_name> <description>Atezolizumab 20 mL (1200 mg) on Day 1, once every 3 weeks for up to 20 cycles (each cycle = 21 days)</description> <arm_group_label>Atezolizumab with Platinum and Etoposide, followed by cystectomy.</arm_group_label> <other_name>Tecentriq</other_name> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Carboplatin</intervention_name> <description>Carboplatin AUC 5 IV on Day 1, once every 3 weeks for first 4 cycles (each cycle = 21 days).</description> <arm_group_label>Atezolizumab with Platinum and Etoposide, followed by cystectomy.</arm_group_label> <other_name>CBDCA, Paraplatin, JM-8, NSC-241240</other_name> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Cisplatin</intervention_name> <description>Cisplatin 70 mg/m2 IV on Day 1, once every 3 weeks for first 4 cycles (each cycle = 21 days).</description> <arm_group_label>Atezolizumab with Platinum and Etoposide, followed by cystectomy.</arm_group_label> <other_name>Cis-Diaminedichloroplatinum, CDDP</other_name> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Etoposide</intervention_name> <description>Etoposide 100 mg/m2 IV on Days 1 - 3 every cycle for the first 4 cycles (each cycle = 21 days)</description> <arm_group_label>Atezolizumab with Platinum and Etoposide, followed by cystectomy.</arm_group_label> <other_name>VP-16, VePesid, VP-16-213, EPEG, epipodophyllotoxin, NSC # 141540</other_name> </intervention> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>Cystectomy</intervention_name> <description>Cystectomy should be performed within 42 days after completion of last administered study therapy of induction phase (first 4 cycles of chemotherapy).</description> <arm_group_label>Atezolizumab with Platinum and Etoposide, followed by cystectomy.</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Histologically confirmed invasive carcinoma of the bladder with pure, or any component of, small cell or high grade neuroendocrine features with or without urothelial cancer - localized ≥ cT1-T4aN1  A formalin-fixed paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or at least 15 slides containing unstained, freshly cut, serial sections should be submitted along with an associated pathology report prior to study enrollment. If less than 15 slides are available, the patient may still be eligible for the study, after Principal Investigator confirmation has been obtained.  If archival tumor tissue is unavailable or is determined to be unsuitable for required testing, tumor tissue must be obtained from a biopsy performed at screening.  - Medically fit to undergo chemotherapy, immunotherapy and cystectomy  - 18 years old at time of consent  - ECOG performance status of 0 or 1  - Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to randomization:  - ANC ≥ 1500 cells/μL without granulocyte colony-stimulating factor support  - Lymphocyte count ≥ 500/μL  - Platelet count ≥ 100,000/μL without transfusion  - Hemoglobin ≥ 9.0 g/dL -patients may be transfused to meet this criterion.  - INR or aPTT ≤ 1.5 × upper limit of normal (ULN) This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose.  - AST, ALT, and alkaline phosphatase ≤ 2.5 × ULN  - Serum bilirubin ≤ 1.5 × ULN Patients with known Gilbert disease who have serum bilirubin level ≤3 × ULN may be enrolled.  - Serum albumin >= 25 g/L (2.5 g/dL)  - Negative HIV test at screening (with the following exception: patients with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have a CD4 count >= 200/µL, and have an undetectable viral load)  - Negative hepatitis B surface antigen (HBsAg) test at screening  - Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening The HBV DNA test will be performed only for patients who have a negative HBsAg test and a positive total HBcAb test.  - Creatinine clearance >30. Patients receiving cisplatin must have creatinine clearance >50  - For women of childbearing potential (WOCBP): agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs, as defined below:  - Women must remain abstinent or use contraceptive methods with a failure rate of <1% per year during the treatment period and for 5 months after the final dose of atezolizumab and for 30 days after the final dose of cisplatin/ carboplatin and etoposide. Women must refrain from donating eggs during this same period.  - A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (>= 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements.  - Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.  The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception.  - For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below:  - With a female partner of childbearing potential who is not pregnant, or a pregnant female partner men who are not surgically sterile must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of < 1% per year during the treatment period and for 8 months after the final dose of atezolizumab and 120 days after the final dose of etoposide. Men must refrain from donating sperm during this same period.  - The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception.  - Patients who give a written informed consent obtained according to local guidelines  - Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study.  Exclusion Criteria:  - No prior systemic treatment for small-cell bladder cancer (SCBC)  - Patients with concurrent upper urinary tract (i.e. ureter, renal pelvis) invasive urothelial carcinoma. (NOTE: Patients with history of non-invasive (Ta, Tis) upper tract urothelial carcinoma that has been definitively treated with at least one post- treatment disease assessment (i.e. cytology, biopsy, imaging) that demonstrates no evidence of residual disease are eligible). Individual cases will be discussed at investigator discretion.  - Patients with another active second malignancy other than non-melanoma skin cancers and biochemical relapsed prostate cancer. Patients that have completed all necessary therapy and are considered to be at less than 30% risk of relapse are not considered to have an active second malignancy and are eligible for enrollment.  - Patients who have received prior systemic chemotherapy for urothelial bladder cancer.  Prior BCG and intravesical chemotherapy are allowed  - Any metastatic disease including leptomeningeal disease or brain metastasis on baseline brain imaging  - Uncontrolled tumor-related pain - Patients requiring pain medication must be on a stable regimen at study entry.  Patients requiring pain medication must be on a stable regimen at study entry.  Uncontrolled or symptomatic hypercalcemia (ionized calcium > 1.5 mmol/L, calcium > 12 mg/dL or corrected serum calcium > ULN  - Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions:  - Patients with a history of autoimmune-related hypothyroidism who are on thyroid- replacement hormone are eligible for the study.  - Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.  - Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:  - Rash must cover < 10% of body surface area  - Disease is well controlled at baseline and requires only low-potency topical corticosteroids  - No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months  - Individual cases can be discussed at investigator discretion. Refer to Appendix H for more details  - History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.  - Active tuberculosis  - Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina  - Patients who have undergone major surgery (e.g. intra-thoracic, intra- abdominal or intra-pelvic), open biopsy or significant traumatic injury ≤ 4 weeks prior to starting study drug, or patients who have had minor procedures (i.e. TURBT), percutaneous biopsies or placement of vascular access device ≤1 week prior to starting study drug, or who have not recovered from side effects of such procedure or injury  - History of malignancy other than small cell bladder cancer within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate > 90%), such as adequately treated carcinoma in situ of the cervix, non melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer  - Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia  - Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment. Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.  - Prior allogeneic stem cell or solid organ transplantation  - Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications  - Treatment with a live, attenuated vaccine (e.g., FluMist®) within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of Atezolizumab  - Current treatment with anti-viral therapy for HBV  - Treatment with investigational therapy within 28 days prior to initiation of study treatment  - Prior treatment with CD137 agonists or other immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies  - Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 [IL-2]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment  - Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti- TNF-α agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment.  - Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study after Principal Investigator confirmation has been obtained.  - History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins  - Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation  - Known allergy or hypersensitivity to any component of Cisplatin, carboplatin or etoposide  - Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months of atezolizumab after the final dose of study treatment. Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment.  - Patients who have had radiotherapy to the bladder, or radiotherapy ≤ 4 weeks prior to starting study drug, or who have not recovered from radiotherapy toxicities </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Jean Hoffman-Censits, MD</last_name> <role>Principal Investigator</role> <affiliation>Johns Hopkins University</affiliation> </overall_official> <overall_contact> <last_name>Deborah Schwartz, RN</last_name> <phone>410-502-4523</phone> <email>dschwa27@jhmi.edu</email> </overall_contact> <location> <facility> <name>Johns Hopkins University: Sibley Memorial Hospital</name> <address> <city>Washington</city> <state>District of Columbia</state> <zip>20016</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Carol Goldener, RN</last_name> <phone>202-660-5629</phone> <email>cgolden9@jhmi.edu</email> </contact> <investigator> <last_name>Jean Hoffman-Censits, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>Johns Hopkins University: Sidney Kimmel Comprehensive Cancer Center</name> <address> <city>Baltimore</city> <state>Maryland</state> <zip>21287</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Deborah Schwartz, RN</last_name> <phone>410-502-4523</phone> <email>dschwa27@jhmi.edu</email> </contact> <investigator> <last_name>Jean Hoffman-Censtis, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>June 2023</verification_date> <study_first_submitted>March 28, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 5, 2022</study_first_posted> <last_update_submitted>June 22, 2023</last_update_submitted> <last_update_submitted_qc>June 22, 2023</last_update_submitted_qc> <last_update_posted type="Actual">June 26, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Small Cell Bladder Cancer</keyword> <keyword>Atezolizumab</keyword> <keyword>Cisplatin</keyword> <keyword>Carboplatin</keyword> <keyword>Platinum</keyword> <keyword>Etoposide</keyword> <keyword>Cystectomy</keyword> <condition_browse>  <mesh_term>Carcinoma</mesh_term> <mesh_term>Urinary Bladder Neoplasms</mesh_term> <mesh_term>Carcinoma, Neuroendocrine</mesh_term> <mesh_term>Carcinoma, Small Cell</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Cisplatin</mesh_term> <mesh_term>Carboplatin</mesh_term> <mesh_term>Etoposide</mesh_term> <mesh_term>Atezolizumab</mesh_term> <mesh_term>Podophyllotoxin</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

This is a single arm, Phase II trial involving the use of atezolizumab plus platinum and etoposide for patients with locally advanced urothelial cancer. The primary goal of this trial is to assess the pathologic complete response rate at cystectomy in patients after being treated with a combination therapy of atezolizumab, platinum, and etoposide. The study population will include male and female patients over the age of 18 with invasive (cT1-cT4) small cell / neuroendocrine carcinoma of the bladder (MIBC), with or without urothelial cancer component, who are eligible for platinum based chemotherapy and immunotherapy. All patients will be fit to undergo surgical resection of their cancer by cystectomy. Patients with resectable N1 disease within the true pelvis are eligible. Participants will receive: Atezolizumab 1,200 mg IV Day 1 Etoposide 100 mg/m2 IV on Days 1-3 Carboplatin AUC 5 IV on Day 1 or Cisplatin 70 mg/m2 IV on Day 1 (Patients can be switched at investigator's discretion between cisplatin and carboplatin between cycles. Rationale must be provided.) Repeat q 21 days x 4 cycles Atezolizumab will be administered by intravenous (IV) infusion at a fixed dose of 1200 mg Day 1 of every 21 day cycle with chemotherapy x 4 cycles. Following cystectomy, Atezolizumab maintenance Q 21 days will continue until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status (e.g., symptomatic deterioration such as pain secondary to disease), or up to 1 year (e.g., 16 cycles). Inclusion Criteria: - Histologically confirmed invasive carcinoma of the bladder with pure, or any component of, small cell or high grade neuroendocrine features with or without urothelial cancer - localized ≥ cT1-T4aN1 A formalin-fixed paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or at least 15 slides containing unstained, freshly cut, serial sections should be submitted along with an associated pathology report prior to study enrollment. If less than 15 slides are available, the patient may still be eligible for the study, after Principal Investigator confirmation has been obtained. If archival tumor tissue is unavailable or is determined to be unsuitable for required testing, tumor tissue must be obtained from a biopsy performed at screening. - Medically fit to undergo chemotherapy, immunotherapy and cystectomy - 18 years old at time of consent - ECOG performance status of 0 or 1 - Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to randomization: - ANC ≥ 1500 cells/μL without granulocyte colony-stimulating factor support - Lymphocyte count ≥ 500/μL - Platelet count ≥ 100,000/μL without transfusion - Hemoglobin ≥ 9.0 g/dL -patients may be transfused to meet this criterion. - INR or aPTT ≤ 1.5 × upper limit of normal (ULN) This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose. - AST, ALT, and alkaline phosphatase ≤ 2.5 × ULN - Serum bilirubin ≤ 1.5 × ULN Patients with known Gilbert disease who have serum bilirubin level ≤3 × ULN may be enrolled. - Serum albumin >= 25 g/L (2.5 g/dL) - Negative HIV test at screening (with the following exception: patients with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have a CD4 count >= 200/µL, and have an undetectable viral load) - Negative hepatitis B surface antigen (HBsAg) test at screening - Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening The HBV DNA test will be performed only for patients who have a negative HBsAg test and a positive total HBcAb test. - Creatinine clearance >30. Patients receiving cisplatin must have creatinine clearance >50 - For women of childbearing potential (WOCBP): agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs, as defined below: - Women must remain abstinent or use contraceptive methods with a failure rate of <1% per year during the treatment period and for 5 months after the final dose of atezolizumab and for 30 days after the final dose of cisplatin/ carboplatin and etoposide. Women must refrain from donating eggs during this same period. - A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (>= 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements. - Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception. - For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below: - With a female partner of childbearing potential who is not pregnant, or a pregnant female partner men who are not surgically sterile must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of < 1% per year during the treatment period and for 8 months after the final dose of atezolizumab and 120 days after the final dose of etoposide. Men must refrain from donating sperm during this same period. - The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception. - Patients who give a written informed consent obtained according to local guidelines - Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study. Exclusion Criteria: - No prior systemic treatment for small-cell bladder cancer (SCBC) - Patients with concurrent upper urinary tract (i.e. ureter, renal pelvis) invasive urothelial carcinoma. (NOTE: Patients with history of non-invasive (Ta, Tis) upper tract urothelial carcinoma that has been definitively treated with at least one post- treatment disease assessment (i.e. cytology, biopsy, imaging) that demonstrates no evidence of residual disease are eligible). Individual cases will be discussed at investigator discretion. - Patients with another active second malignancy other than non-melanoma skin cancers and biochemical relapsed prostate cancer. Patients that have completed all necessary therapy and are considered to be at less than 30% risk of relapse are not considered to have an active second malignancy and are eligible for enrollment. - Patients who have received prior systemic chemotherapy for urothelial bladder cancer. Prior BCG and intravesical chemotherapy are allowed - Any metastatic disease including leptomeningeal disease or brain metastasis on baseline brain imaging - Uncontrolled tumor-related pain - Patients requiring pain medication must be on a stable regimen at study entry. Patients requiring pain medication must be on a stable regimen at study entry. Uncontrolled or symptomatic hypercalcemia (ionized calcium > 1.5 mmol/L, calcium > 12 mg/dL or corrected serum calcium > ULN - Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions: - Patients with a history of autoimmune-related hypothyroidism who are on thyroid- replacement hormone are eligible for the study. - Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study. - Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met: - Rash must cover < 10% of body surface area - Disease is well controlled at baseline and requires only low-potency topical corticosteroids - No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months - Individual cases can be discussed at investigator discretion. Refer to Appendix H for more details - History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted. - Active tuberculosis - Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina - Patients who have undergone major surgery (e.g. intra-thoracic, intra- abdominal or intra-pelvic), open biopsy or significant traumatic injury ≤ 4 weeks prior to starting study drug, or patients who have had minor procedures (i.e. TURBT), percutaneous biopsies or placement of vascular access device ≤1 week prior to starting study drug, or who have not recovered from side effects of such procedure or injury - History of malignancy other than small cell bladder cancer within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate > 90%), such as adequately treated carcinoma in situ of the cervix, non melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer - Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia - Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment. Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study. - Prior allogeneic stem cell or solid organ transplantation - Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications - Treatment with a live, attenuated vaccine (e.g., FluMist®) within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of Atezolizumab - Current treatment with anti-viral therapy for HBV - Treatment with investigational therapy within 28 days prior to initiation of study treatment - Prior treatment with CD137 agonists or other immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies - Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 [IL-2]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment - Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti- TNF-α agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment. - Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study after Principal Investigator confirmation has been obtained. - History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins - Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation - Known allergy or hypersensitivity to any component of Cisplatin, carboplatin or etoposide - Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months of atezolizumab after the final dose of study treatment. Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment. - Patients who have had radiotherapy to the bladder, or radiotherapy ≤ 4 weeks prior to starting study drug, or who have not recovered from radiotherapy toxicities

NCT0531xxxx/NCT05312684.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05312684</url> </required_header> <id_info> <org_study_id>22-2476</org_study_id> <nct_id>NCT05312684</nct_id> </id_info> <brief_title>The Relationship Between Anticholinergic Burden and Postoperative Complications After Cardiac Surgery in Older Adults</brief_title> <official_title>The Relationship Between Anticholinergic Burden and Postoperative Complications After Cardiac Surgery in Older Adults</official_title> <sponsors> <lead_sponsor> <agency>Gulhane Training and Research Hospital</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Gulhane Training and Research Hospital</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Drugs with anticholinergic properties are widely prescribed in the elderly population, despite increasing evidence in the literature regarding side effects and adverse outcomes. As is known, many drugs have anticholinergic activity, which means that they block the binding of the neurotransmitter acetylcholine to the muscarinic receptor. In this case, the occurrence of anticholinergic side effects becomes inevitable. Central effects such as cognitive impairment, dizziness, sedation, confusion or delirium, and peripheral effects such as dry mouth, dry eyes, constipation, urinary retention, and tachycardia begin to be seen in patients. Anticholinergic load refers to the cumulative effect of taking one or more drugs with anticholinergic activity. This cumulative effect is a strong indicator of cognitive and physical deterioration, especially in the elderly population. It is also associated with adverse outcomes such as falls, impaired functioning, and higher rates of hospitalization and death.  Anticholinergic load scales include scales that facilitate the work of physicians used in clinical practice to predict anticholinergic side effects in humans. Although there are many different scales used at this point, one of the scales with the highest validity and reliability in recent studies are Anticholinergic cognitive burden scale (ACB) and Anticholinergic risk scale (ARS). To the best of our knowledge, we could not find any study on postoperative complications, length of hospital stay and mortality after cardiac surgery with these scales. Therefore, we aimed to examine the relationship between possible complications after cardiac surgery and anticholinergic load scales showing the cumulative effect of preoperative drugs. </textblock> </brief_summary> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">April 1, 2022</start_date> <completion_date type="Anticipated">December 1, 2022</completion_date> <primary_completion_date type="Anticipated">September 1, 2022</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Cohort</observational_model> <time_perspective>Retrospective</time_perspective> </study_design_info> <primary_outcome> <measure>Postoperative complication</measure> <time_frame>1 month fellow-up</time_frame> <description>Dindo classification</description> </primary_outcome> <number_of_groups>2</number_of_groups> <enrollment type="Anticipated">500</enrollment> <condition>Postoperative Complications</condition> <arm_group> <arm_group_label>High anticholinergic burden</arm_group_label> <description>ACB scale score 1 or >1 as a high anticholinergic buden</description> </arm_group> <arm_group> <arm_group_label>Normal anticholinergic burden</arm_group_label> <description>ACB scale score <1 as a control group</description> </arm_group> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>cardiac surgery</intervention_name> <description>cardiovascular surgery including valve repair/replacement or CABG or combined procedures</description> <arm_group_label>High anticholinergic burden</arm_group_label> <arm_group_label>Normal anticholinergic burden</arm_group_label> </intervention> <eligibility> <study_pop> <textblock> It is planned to include patients over the age of 65 who underwent cardiac surgery in the study population. </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - It is planned to include patients over the age of 65 who underwent cardiac surgery in the research population.  - Gender discrimination will not be considered.  Exclusion Criteria:  - Those who are under the age of 65,  - Those who have non-cardiac surgery,  - Those whose drug records cannot be accessed </textblock> </criteria> <gender>All</gender> <minimum_age>65 Years</minimum_age> <maximum_age>100 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Bilal Katipoglu</last_name> <role>Principal Investigator</role> <affiliation>Gulhane Training and Research Hospital</affiliation> </overall_official> <overall_contact> <last_name>Bilal Katipoglu, MD</last_name> <phone>+905543330380</phone> <email>drbilal07@gmail.com</email> </overall_contact> <location> <facility> <name>Gulhane training and research hospital</name> <address> <city>Ankara</city> <zip>06670</zip> <country>Turkey</country> </address> </facility> <contact> <last_name>Bilal Katipoglu, MD</last_name> <phone>+905543330380</phone> <email>drbilal07@gmail.com</email> </contact> </location> <location_countries> <country>Turkey</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>March 28, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 5, 2022</study_first_posted> <last_update_submitted>March 28, 2022</last_update_submitted> <last_update_submitted_qc>March 28, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 5, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Gulhane Training and Research Hospital</investigator_affiliation> <investigator_full_name>Bilal Katipoglu</investigator_full_name> <investigator_title>M.D</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Postoperative Complications</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Undecided</sharing_ipd> </patient_data>  </clinical_study>

Drugs with anticholinergic properties are widely prescribed in the elderly population, despite increasing evidence in the literature regarding side effects and adverse outcomes. As is known, many drugs have anticholinergic activity, which means that they block the binding of the neurotransmitter acetylcholine to the muscarinic receptor. In this case, the occurrence of anticholinergic side effects becomes inevitable. Central effects such as cognitive impairment, dizziness, sedation, confusion or delirium, and peripheral effects such as dry mouth, dry eyes, constipation, urinary retention, and tachycardia begin to be seen in patients. Anticholinergic load refers to the cumulative effect of taking one or more drugs with anticholinergic activity. This cumulative effect is a strong indicator of cognitive and physical deterioration, especially in the elderly population. It is also associated with adverse outcomes such as falls, impaired functioning, and higher rates of hospitalization and death. Anticholinergic load scales include scales that facilitate the work of physicians used in clinical practice to predict anticholinergic side effects in humans. Although there are many different scales used at this point, one of the scales with the highest validity and reliability in recent studies are Anticholinergic cognitive burden scale (ACB) and Anticholinergic risk scale (ARS). To the best of our knowledge, we could not find any study on postoperative complications, length of hospital stay and mortality after cardiac surgery with these scales. Therefore, we aimed to examine the relationship between possible complications after cardiac surgery and anticholinergic load scales showing the cumulative effect of preoperative drugs. It is planned to include patients over the age of 65 who underwent cardiac surgery in the study population. Inclusion Criteria: - It is planned to include patients over the age of 65 who underwent cardiac surgery in the research population. - Gender discrimination will not be considered. Exclusion Criteria: - Those who are under the age of 65, - Those who have non-cardiac surgery, - Those whose drug records cannot be accessed

NCT0531xxxx/NCT05312697.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05312697</url> </required_header> <id_info> <org_study_id>UX143-CL203</org_study_id> <nct_id>NCT05312697</nct_id> </id_info> <brief_title>Long-term Extension Study of Setrusumab in Adults With Type I, III, or IV Osteogenesis Imperfecta</brief_title> <official_title>A Phase 2b, Multicenter, Long-term Extension Study of Setrusumab in Adults With Type I, III, or IV Osteogenesis Imperfecta</official_title> <sponsors> <lead_sponsor> <agency>Ultragenyx Pharmaceutical Inc</agency> <agency_class>Industry</agency_class> </lead_sponsor> <collaborator> <agency>Mereo BioPharma</agency> <agency_class>Industry</agency_class> </collaborator> </sponsors> <source>Ultragenyx Pharmaceutical Inc</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>Yes</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The primary objective of the study is to evaluate bone mineral density (BMD) after 12 months of retreatment with monthly setrusumab in adults with osteogenesis imperfecta (OI). </textblock> </brief_summary> <detailed_description> <textblock> UX143-CL203 is a long-term extension study in adults with OI who participated in the ASTEROID study (also referred to as MBPS205) [NCT03118570]. The UX143-CL203 study comprises Observation, Retreatment, and Extension Periods. There is no intervention during the Observation Period. During the single-arm Retreatment Period, participants receive open-label setrusumab once a month (QM) for 12 months. Following the Retreatment Period, participants enter an Extension Period in which they will continue treatment with open-label setrusumab at different dosing frequencies. </textblock> </detailed_description> <overall_status>Terminated</overall_status> <why_stopped> Sponsor decision not related to safety concerns </why_stopped> <start_date type="Actual">April 28, 2022</start_date> <completion_date type="Actual">July 7, 2022</completion_date> <primary_completion_date type="Actual">July 7, 2022</primary_completion_date> <phase>Phase 2</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Sequential Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Percentage Change From Retreatment Baseline in Lumbar Spine Bone Mineral Density (BMD) Measured by Dual-Energy X-Ray Absorptiometry (DXA) After 12 Months of Setrusumab</measure> <time_frame>Retreatment Baseline, Month 12</time_frame> </primary_outcome> <secondary_outcome> <measure>Percentage Change From Retreatment Baseline in Total Hip BMD Measured by DXA at Month 12 of the Retreatment Period</measure> <time_frame>Retreatment Baseline, Month 12</time_frame> </secondary_outcome> <secondary_outcome> <measure>Annualized New Fracture Rate as Confirmed by Radiograph During the Retreatment Period</measure> <time_frame>Up to Month 12</time_frame> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">2</enrollment> <condition>Osteogenesis Imperfecta</condition> <arm_group> <arm_group_label>Setrusumab QM -->Setrusumab QM</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>During Retreatment Period: Setrusumab will be administered via intravenous (IV) infusion once a month (QM) for 12 months. During Extension Period: Setrusumab will be administered via IV infusion QM for at least 12 months or until commercially available.</description> </arm_group> <arm_group> <arm_group_label>Setrusumab QM --> Setrusumab TBD</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>During Retreatment Period: Setrusumab will be administered via IV infusion QM for 12 months. During Extension Period: Setrusumab will be administered via IV infusion at a dose frequency to be determined (TBD) for at least 12 months or until commercially available.</description> </arm_group> <intervention> <intervention_type>Biological</intervention_type> <intervention_name>Setrusumab</intervention_name> <description>A fully human anti-sclerostin monoclonal antibody (mAb)</description> <arm_group_label>Setrusumab QM --> Setrusumab TBD</arm_group_label> <arm_group_label>Setrusumab QM -->Setrusumab QM</arm_group_label> <other_name>UX143</other_name> <other_name>BPS804</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Males or females who participated in the Phase 2b ASTEROID study  - Females of childbearing potential must consent to use highly effective contraception during the Observation, Retreatment, and Extension Periods through 2 months after the last dose of setrusumab and agree not to become pregnant  Exclusion Criteria:  - Known hypersensitivity to setrusumab or its excipients that, in the judgment of the Investigator, places the participant at increased risk for adverse effects  - Presence or history of any condition that, in the view of the Investigator, would interfere with participation, pose undue risk, or would confound interpretation of results  - Pregnant or breastfeeding or planning to become pregnant (self or partner) at any time during the study  - Not willing or able to discontinue bisphosphonates 6 months prior to the Retreatment Screening Visit  Once enrolled in UX143-CL203, individuals who meet any of the following exclusion criteria will not be eligible to participate in the Retreatment Period:  - Concurrent participation in any study that is examining the safety and efficacy of any investigational product or investigational medical device that alters bone health during the Retreatment and Extension Periods, per discretion of the Investigator in consultation with the Medical Monitor.  - Calcium levels outside the normal range at the Retreatment Screening Visit. If the participant's calcium level is not within the normal range, decision to retest should be made in conjunction with the Medical Monitor  - Glomerular filtration rate (GFR) ≤ 29 mL/min at the Retreatment Screening Visit. If the participant's GFR is ≤ 29 mL/min, decision to retest should be made in conjunction with the Medical Monitor  - History of skeletal malignancies or bone metastases at any time  - History of neural foraminal stenosis (except if due to scoliosis)  - History of myocardial infarction, angina pectoris, ischemic stroke or transient ischemic attack (Investigators should consider whether the potential benefits of treatment outweigh the potential risks in patients with other cardiovascular risk factors such as hypertension, hyperlipidemia, familial hyperlipidemia, family history of premature ischemic cardiovascular disease, smoking, diabetes mellitus, and metabolic syndrome.)  - History of or concomitant uncontrolled diseases such as hypo-/hyperparathyroidism, hypo-/hyperthyroidism, Paget's disease, abnormal thyroid function or thyroid disease or other endocrine disorders or conditions that could affect bone metabolism eg, Stage IV/V renal disease  - A history of rickets or osteomalacia or any skeletal condition (other than OI) leading to long-bone deformities and/or increased risk of fractures  - Documented alcohol and/or drug abuse within 12 months prior to dosing or evidence of such abuse as indicated by the laboratory results during the screening/baseline assessments  - Documented history of significant psychiatric or medical disorder that would prevent the participant complying with the requirements of the protocol or would make it unsafe for the participant to participate in the study as judged by the investigator  - Current/previously reported allergy to the study drug or any of its excipients or the class of drug under investigation  - History of external radiation </textblock> </criteria> <gender>All</gender> <minimum_age>19 Years</minimum_age> <maximum_age>80 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Medical Director</last_name> <role>Study Director</role> <affiliation>Ultragenyx Pharmaceutical Inc</affiliation> </overall_official> <location> <facility> <name>New Mexico Clinical Research & Osteoporosis Center</name> <address> <city>Albuquerque</city> <state>New Mexico</state> <zip>87106</zip> <country>United States</country> </address> </facility> </location> <location_countries> <country>United States</country> </location_countries> <link> <url>https://ultrarareadvocacy.com/conditions-we-study/osteogenesis-imperfecta-oi/</url> <description>Ultragenyx Patient Advocacy/OI Disease Information</description> </link> <verification_date>June 2023</verification_date> <study_first_submitted>March 28, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 5, 2022</study_first_posted> <disposition_first_submitted>June 27, 2023</disposition_first_submitted> <disposition_first_submitted_qc>June 27, 2023</disposition_first_submitted_qc> <disposition_first_posted type="Actual">June 29, 2023</disposition_first_posted> <last_update_submitted>June 27, 2023</last_update_submitted> <last_update_submitted_qc>June 27, 2023</last_update_submitted_qc> <last_update_posted type="Actual">June 29, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Osteogenesis Imperfecta</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

The primary objective of the study is to evaluate bone mineral density (BMD) after 12 months of retreatment with monthly setrusumab in adults with osteogenesis imperfecta (OI). UX143-CL203 is a long-term extension study in adults with OI who participated in the ASTEROID study (also referred to as MBPS205) [NCT03118570]. The UX143-CL203 study comprises Observation, Retreatment, and Extension Periods. There is no intervention during the Observation Period. During the single-arm Retreatment Period, participants receive open-label setrusumab once a month (QM) for 12 months. Following the Retreatment Period, participants enter an Extension Period in which they will continue treatment with open-label setrusumab at different dosing frequencies. Inclusion Criteria: - Males or females who participated in the Phase 2b ASTEROID study - Females of childbearing potential must consent to use highly effective contraception during the Observation, Retreatment, and Extension Periods through 2 months after the last dose of setrusumab and agree not to become pregnant Exclusion Criteria: - Known hypersensitivity to setrusumab or its excipients that, in the judgment of the Investigator, places the participant at increased risk for adverse effects - Presence or history of any condition that, in the view of the Investigator, would interfere with participation, pose undue risk, or would confound interpretation of results - Pregnant or breastfeeding or planning to become pregnant (self or partner) at any time during the study - Not willing or able to discontinue bisphosphonates 6 months prior to the Retreatment Screening Visit Once enrolled in UX143-CL203, individuals who meet any of the following exclusion criteria will not be eligible to participate in the Retreatment Period: - Concurrent participation in any study that is examining the safety and efficacy of any investigational product or investigational medical device that alters bone health during the Retreatment and Extension Periods, per discretion of the Investigator in consultation with the Medical Monitor. - Calcium levels outside the normal range at the Retreatment Screening Visit. If the participant's calcium level is not within the normal range, decision to retest should be made in conjunction with the Medical Monitor - Glomerular filtration rate (GFR) ≤ 29 mL/min at the Retreatment Screening Visit. If the participant's GFR is ≤ 29 mL/min, decision to retest should be made in conjunction with the Medical Monitor - History of skeletal malignancies or bone metastases at any time - History of neural foraminal stenosis (except if due to scoliosis) - History of myocardial infarction, angina pectoris, ischemic stroke or transient ischemic attack (Investigators should consider whether the potential benefits of treatment outweigh the potential risks in patients with other cardiovascular risk factors such as hypertension, hyperlipidemia, familial hyperlipidemia, family history of premature ischemic cardiovascular disease, smoking, diabetes mellitus, and metabolic syndrome.) - History of or concomitant uncontrolled diseases such as hypo-/hyperparathyroidism, hypo-/hyperthyroidism, Paget's disease, abnormal thyroid function or thyroid disease or other endocrine disorders or conditions that could affect bone metabolism eg, Stage IV/V renal disease - A history of rickets or osteomalacia or any skeletal condition (other than OI) leading to long-bone deformities and/or increased risk of fractures - Documented alcohol and/or drug abuse within 12 months prior to dosing or evidence of such abuse as indicated by the laboratory results during the screening/baseline assessments - Documented history of significant psychiatric or medical disorder that would prevent the participant complying with the requirements of the protocol or would make it unsafe for the participant to participate in the study as judged by the investigator - Current/previously reported allergy to the study drug or any of its excipients or the class of drug under investigation - History of external radiation

NCT0531xxxx/NCT05312710.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05312710</url> </required_header> <id_info> <org_study_id>AVTA 20-01</org_study_id> <nct_id>NCT05312710</nct_id> </id_info> <brief_title>Safety and Efficacy of APG-157 in Head and Neck Cancer</brief_title> <official_title>Phase 2 Study to Evaluate the Safety and Efficacy of APG-157 as Neoadjuvant/Induction Therapy for Patients With Head and Neck Squamous Cell Cancer (HNSCC) of the Oral Cavity and/or Oropharynx</official_title> <sponsors> <lead_sponsor> <agency>Aveta Biomics, Inc.</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Aveta Biomics, Inc.</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>Yes</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The purpose of this clinical research study is to study safety and efficacy of orally administered APG-157 as the neoadjuvant/induction therapy in newly diagnosed, locally advanced patients with Head & Neck Cancer of oral cavity and/or oropharynx.  The study hypothesis is that neoadjuvant use of APG-157 will reduce the tumor burden prior to any definitive therapy to improve the outcomes over current standard of care. </textblock> </brief_summary> <detailed_description> <textblock> The patient will receive neoadjuvant therapy (APG-157) during the period between initial diagnosis and time of definitive treatment. APG-157 is an orally administered drug in a form of pastille (soft lozenge) taken three times a day. It dissolves in the mouth. After the neoadjuvant treatment, the patient undergoes surgery or any other definitive therapy and/or postoperative radiotherapy as determined by the patient's doctor. Duration of treatment is four weeks that may be extended up to six weeks by mutual consent of the patients and the investigators.  Objectives:  1. To conduct Phase 2A to determine how tumor size, tumor tissue biomarkers, and the cancer stem cell markers, in head and neck squamous cell cancer patients are affected by the administration APG-157 pastilles using imaging and other clinical measurements.  2. To determine the degrees of response of each patient to APG-157 (considering patient's diagnosis/staging and local treatment) using proposed primary, secondary and exploratory endpoints.  3. The results from this study will be used to finalize the design of subsequent Phase 2B study (single arm for specific patient population and local treatment) to demonstrate statistically significant efficacy outcomes. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">April 22, 2022</start_date> <completion_date type="Anticipated">July 2024</completion_date> <primary_completion_date type="Anticipated">July 2024</primary_completion_date> <phase>Phase 2</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>N/A</allocation> <intervention_model>Single Group Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Imaging to assess drug's ability to impact tumor size</measure> <time_frame>Baseline to end of dosing is four weeks (extendable up to 6 weeks) of APG-157 dosing. Baseline is at time of diagnosis. End of dosing is day before surgery or start of other definitive therapy and/or radiation</time_frame> <description>Change in Tumor Size from Baseline to end of dosing using MRI with or without contrast and PET/CT imaging.</description> </primary_outcome> <secondary_outcome> <measure>Biopsy</measure> <time_frame>Baseline to end of dosing is four weeks (extendable up to 6 weeks) of APG-157 dosing. Baseline is at time of diagnosis. End of dosing is day before surgery or start of other definitive therapy and/or radiation</time_frame> <description>Change in Immunohistochemistry profile (including the levels of tumor infiltrating lymphocytes TILs) of tumor biopsy from baseline to end of dosing.</description> </secondary_outcome> <secondary_outcome> <measure>Saliva Profile</measure> <time_frame>Baseline to end of dosing is four weeks (extendable up to 6 weeks) of APG-157 dosing. Baseline is at time of diagnosis. End of dosing is day before surgery or start of other definitive therapy and/or radiation</time_frame> <description>Change in cytokine levels (IL-1β , TNF-α, IL-8) and oral microbiome (phyla and genus level changes in microbial composition using 16s RNA sequencing) in saliva from baseline to end of dosing.</description> </secondary_outcome> <secondary_outcome> <measure>Cell-free RNA analyses of saliva and blood</measure> <time_frame>Baseline to end of dosing is four weeks (extendable up to 6 weeks) of APG-157 dosing. Baseline is at time of diagnosis. End of dosing is day before surgery or start of other definitive therapy and/or radiation</time_frame> <description>Change in cell-free RNA biomarkers in blood and saliva from baseline to end of dosing.</description> </secondary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Anticipated">24</enrollment> <condition>Head and Neck Cancer</condition> <condition>Squamous Cell Carcinoma of Oral Cavity</condition> <condition>Squamous Cell Carcinoma of the Oropharynx</condition> <arm_group> <arm_group_label>APG-157</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Two pastilles (100 mg) taken three times a day (i.e. before meal time).</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>APG-157</intervention_name> <description>Treatment</description> <arm_group_label>APG-157</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  A. Biopsy proven oral cavity or oropharyngeal Squamous Cell Carcinoma.  B. Newly diagnosed, treatment naive Stage I, Stage II, Stage III or Stage IV HNSCC patients. Staging is done according to the International Union Against Cancer's (UICC) classification system for oral cancer. Acceptable TNM staging is T1-4, N0-2, M0.  C. Patients who are scheduled to receive the following therapy after APG-157 treatment.  1. Local Therapy with Curative Intent Surgery alone or surgery followed by radiation.  2. Therapy with Palliative Intent Radiation alone. Radiation with concurrent radiosensitizing chemotherapeutic agents only using QUAD-shot protocol. Radiosensitizing chemotherapeutic agents are limited to carboplatin or cetuximab.  3. Patients who refuse surgery or are unfit for any local therapy.  Exclusion Criteria:  A. Patients whose definitive, local treatment is available in less than four weeks from initial diagnosis. For example, some patients who are scheduled to receive chemo-radiation therapy as the local therapy with curative intent.  B. Pregnant women.  C. Prior Chemotherapy or radiation therapy within the last 8 weeks.  D. Patients with recurrent or metastatic cancer.  E. Tooth abscesses.  F. Bleeding gums or cracked teeth.  G. Patients who have had surgery of the oral cavity, teeth, or gums within the previous 8 weeks.  H. Patients who have had a fracture of the mandible or maxilla within the previous 8 weeks.  I. Inability to complete enrollment forms due to any mental status or language problems (e.g. dementia, head injury, overall illness).  J. Patients with other related diseases or the oral cavity or oropharynx, as determined to be significant by the PI. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Marilene B Wang, MD</last_name> <role>Principal Investigator</role> <affiliation>VA Los Angeles/UCLA</affiliation> </overall_official> <overall_official> <last_name>Elizabeth Franzmann, MD</last_name> <role>Principal Investigator</role> <affiliation>University of Miami Sylvester Comprehensive Cancer Center</affiliation> </overall_official> <overall_contact> <last_name>Marilene B Wang, MD</last_name> <phone>310 268-3748</phone> <email>marilene.wang@va.gov</email> </overall_contact> <location> <facility> <name>VAGLAHS, West Los Angeles</name> <address> <city>Los Angeles</city> <state>California</state> <zip>90073</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Marilene B Wang, MD</last_name> <phone>310-268-3748</phone> <email>marilene.wang@va.gov</email> </contact> </location> <location> <facility> <name>University of Miami Sylvester Comprehensive Cancer Center</name> <address> <city>Miami</city> <state>Florida</state> <zip>33136</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Elizabeth Franzmann, MD</last_name> <phone>305-243-5955</phone> <email>EFranzmann@med.miami.edu</email> </contact> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>August 2023</verification_date> <study_first_submitted>March 16, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 5, 2022</study_first_posted> <last_update_submitted>August 1, 2023</last_update_submitted> <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc> <last_update_posted type="Actual">August 2, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Neoadjuvant</keyword> <keyword>Induction Therapy</keyword> <keyword>Oral Cancer</keyword> <keyword>Oropharyngeal Cancer</keyword> <condition_browse>  <mesh_term>Carcinoma</mesh_term> <mesh_term>Carcinoma, Squamous Cell</mesh_term> <mesh_term>Head and Neck Neoplasms</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

The purpose of this clinical research study is to study safety and efficacy of orally administered APG-157 as the neoadjuvant/induction therapy in newly diagnosed, locally advanced patients with Head & Neck Cancer of oral cavity and/or oropharynx. The study hypothesis is that neoadjuvant use of APG-157 will reduce the tumor burden prior to any definitive therapy to improve the outcomes over current standard of care. The patient will receive neoadjuvant therapy (APG-157) during the period between initial diagnosis and time of definitive treatment. APG-157 is an orally administered drug in a form of pastille (soft lozenge) taken three times a day. It dissolves in the mouth. After the neoadjuvant treatment, the patient undergoes surgery or any other definitive therapy and/or postoperative radiotherapy as determined by the patient's doctor. Duration of treatment is four weeks that may be extended up to six weeks by mutual consent of the patients and the investigators. Objectives: 1. To conduct Phase 2A to determine how tumor size, tumor tissue biomarkers, and the cancer stem cell markers, in head and neck squamous cell cancer patients are affected by the administration APG-157 pastilles using imaging and other clinical measurements. 2. To determine the degrees of response of each patient to APG-157 (considering patient's diagnosis/staging and local treatment) using proposed primary, secondary and exploratory endpoints. 3. The results from this study will be used to finalize the design of subsequent Phase 2B study (single arm for specific patient population and local treatment) to demonstrate statistically significant efficacy outcomes. Inclusion Criteria: A. Biopsy proven oral cavity or oropharyngeal Squamous Cell Carcinoma. B. Newly diagnosed, treatment naive Stage I, Stage II, Stage III or Stage IV HNSCC patients. Staging is done according to the International Union Against Cancer's (UICC) classification system for oral cancer. Acceptable TNM staging is T1-4, N0-2, M0. C. Patients who are scheduled to receive the following therapy after APG-157 treatment. 1. Local Therapy with Curative Intent Surgery alone or surgery followed by radiation. 2. Therapy with Palliative Intent Radiation alone. Radiation with concurrent radiosensitizing chemotherapeutic agents only using QUAD-shot protocol. Radiosensitizing chemotherapeutic agents are limited to carboplatin or cetuximab. 3. Patients who refuse surgery or are unfit for any local therapy. Exclusion Criteria: A. Patients whose definitive, local treatment is available in less than four weeks from initial diagnosis. For example, some patients who are scheduled to receive chemo-radiation therapy as the local therapy with curative intent. B. Pregnant women. C. Prior Chemotherapy or radiation therapy within the last 8 weeks. D. Patients with recurrent or metastatic cancer. E. Tooth abscesses. F. Bleeding gums or cracked teeth. G. Patients who have had surgery of the oral cavity, teeth, or gums within the previous 8 weeks. H. Patients who have had a fracture of the mandible or maxilla within the previous 8 weeks. I. Inability to complete enrollment forms due to any mental status or language problems (e.g. dementia, head injury, overall illness). J. Patients with other related diseases or the oral cavity or oropharynx, as determined to be significant by the PI.

NCT0531xxxx/NCT05312723.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05312723</url> </required_header> <id_info> <org_study_id>20-01-0074</org_study_id> <nct_id>NCT05312723</nct_id> </id_info> <brief_title>Sleep Disturbance in Chronic Rhinitis</brief_title> <official_title>Sleep Disturbance in Chronic Rhinitis: Evaluation of Nasal Symptoms, Sleep Disorder Questionnaires, and Sleep Architecture in Allergic & Non-Allergic Rhinitis in Dr. Cipto Mangunkusumo Hospital</official_title> <sponsors> <lead_sponsor> <agency>Indonesia University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Indonesia University</source> <oversight_info> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The aim of this study is to evaluate the characteristic of sleep disturbance in allergic and non-allergic rhinitis in Dr. Cipto Mangunkusumo Hospital, Jakarta. A cross sectional analytic descriptive study with consecutive sampling was performed. A total of 22 chronic rhinitis patients, consisted of 11 allergic and 11 non-allergic rhinitis were evaluated of their sleep disturbance's characteristics. </textblock> </brief_summary> <detailed_description> <textblock> At first, all recruited subjects were evaluated for total nasal symptom scores (TNSS) and nasal obstruction symptoms evaluation scores (NOSE). Sleep disorder was assessed using Epworth Sleepiness Scale (ESS), Pittsburg Sleep Quality Index (PSQI) questionnaires, and polysomnography (PSG). Both the allergic and non-allergic rhinitis groups will be compared in terms of their sleep disturbance characteristics (from comparing ESS, PSQI, and PSG results). </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">March 15, 2020</start_date> <completion_date type="Actual">August 15, 2020</completion_date> <primary_completion_date type="Actual">August 15, 2020</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Other</observational_model> <time_perspective>Cross-Sectional</time_perspective> </study_design_info> <primary_outcome> <measure>Mean value of TNSS based on VAS symptoms</measure> <time_frame>Evaluation is done at Day 1(cross-sectional)</time_frame> <description>Clinical symptoms was evaluated by visual analogue scale (VAS) based on total nasal symptoms score (TNSS). Total nasal symptoms score are based on four symptoms, which are rhinorrea, sneezing, itchy nose, and nose obstruction. Each symptom will be given a score between 1 (most mild symptom) until 5 (most severe symptom). The minum score for VAS based on TNSS is 4 (most mild symptom) and the maximum score is 40 (most severe symptom). VAS score less than five indicates a controlled rhinitis symptoms, while ≥ 5 indicates that symptoms are not controlled.</description> </primary_outcome> <primary_outcome> <measure>Nasal obstruction symtpms evaluation (NOSE) score</measure> <time_frame>Evaluation is done at Day 1 (cross-sectional)</time_frame> <description>Nasal obstruction symptoms was evaluated by NOSE score. It evaluates 5 items that indicates nasal obstruction symptoms that was experienced in the past 1 month. Each item has a score range from 0 to 20. It has a minimum score of 0 and a maximum score of 100. Score 5-25 indicates mild nasal obstruction, score 30-50 indicates moderate nasal obstruction, score 55-75 indicates severe nasal obstruction, and score > 80 indicates extreme nasal obstruction.</description> </primary_outcome> <primary_outcome> <measure>Sleep quality from Epworth sleepiness scale (ESS)</measure> <time_frame>Evaluation is done at Day 1 (cross-sectional)</time_frame> <description>Sleep quality assessed by Epworth sleepiness scale. ESS is a self-administered questionnaire consisted of 8 questions. It assessed the chances of falling asleep while engaged in different activities. Each item scored 0-3, with a minimum score of 0 (low normal daytime sleepiness) and a maximum score of 24 (severe daytime sleepiness). In this study, the cut off is score 5-9 indicates mild daytime sleepiness and score > 10 indicates severe daytime sleepiness.</description> </primary_outcome> <primary_outcome> <measure>Sleep quality from Pittsburg Sleep Quality Index (PSQI)</measure> <time_frame>Evaluation is done at Day 1 (cross-sectional)</time_frame> <description>Sleep quality assessed by Pittsburg Sleep Quality Index. PSQI consisted of 10 questions. These 10 questions were divided to 7 components, including subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, use of sleep medication, and daytime dysfunction. Each component score range from 0-23. Total score can range from 0 to 21. Score < 5 indicates good sleep quality and > 5 indicates poor sleep quality</description> </primary_outcome> <primary_outcome> <measure>Objective sleep measurement using polysomnography (PSG)</measure> <time_frame>Evaluation is done at Day 1 (cross-sectional)</time_frame> <description>Sleep parameters were objectively measured using polysomnography (PSG). Sleep architecture was assessed using non-rapid eye movement (NREM)/ rapid eye movement (REM) and respiratory analysis was assessed using respiratory disturbance index - rapid eye movement (RDI-REM) and respiratory effort related arousals (RERA). All the parameters will be presented as numeric data.</description> </primary_outcome> <number_of_groups>2</number_of_groups> <enrollment type="Actual">22</enrollment> <condition>Sleep Disturbance</condition> <arm_group> <arm_group_label>Rhinitis allergy</arm_group_label> <description>Patients with rhinitis symptoms and positive skin pric test to one or more allergens.</description> </arm_group> <arm_group> <arm_group_label>Non-rhinitis allergy</arm_group_label> <description>Patients with rhinitis symptoms and negative skin pric test to one or more allergens.</description> </arm_group> <eligibility> <study_pop> <textblock> Allergic and non-allergic rhinitis patients </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - All male and female between 18-60 years old with chronic rhinitis symptoms and sleep disorder  - Did not receive intranasal steroid within the last one month  - Have psychiatric disorder  Exclusion Criteria:  - Polyp  - Nasal or sinonasal tumor  - Septum deviation  - Chronic rhinosinusitis  - Adenoid hypertrophy  - Tonsil hypertrophy  - Macroglossia  - Oropharyngeal tumor </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>60 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Nina Irawati</last_name> <role>Principal Investigator</role> <affiliation>Indonesia University</affiliation> </overall_official> <location> <facility> <name>RSUPN Dr. Cipto Mangunkusumo</name> <address> <city>Jakarta Pusat</city> <state>DKI Jakarta</state> <zip>10430</zip> <country>Indonesia</country> </address> </facility> </location> <location_countries> <country>Indonesia</country> </location_countries> <verification_date>April 2022</verification_date> <study_first_submitted>March 28, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 5, 2022</study_first_posted> <last_update_submitted>April 6, 2022</last_update_submitted> <last_update_submitted_qc>April 6, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 14, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Indonesia University</investigator_affiliation> <investigator_full_name>Nina Irawati</investigator_full_name> <investigator_title>Head of Allergy Immunology Division, Otorhinolaryngology Head and Neck Surgery Department</investigator_title> </responsible_party> <keyword>allergic</keyword> <keyword>nasal congestion</keyword> <keyword>daytime sleepiness</keyword> <keyword>polysomnography</keyword> <condition_browse>  <mesh_term>Rhinitis</mesh_term> <mesh_term>Dyssomnias</mesh_term> <mesh_term>Parasomnias</mesh_term> </condition_browse>  </clinical_study>

The aim of this study is to evaluate the characteristic of sleep disturbance in allergic and non-allergic rhinitis in Dr. Cipto Mangunkusumo Hospital, Jakarta. A cross sectional analytic descriptive study with consecutive sampling was performed. A total of 22 chronic rhinitis patients, consisted of 11 allergic and 11 non-allergic rhinitis were evaluated of their sleep disturbance's characteristics. At first, all recruited subjects were evaluated for total nasal symptom scores (TNSS) and nasal obstruction symptoms evaluation scores (NOSE). Sleep disorder was assessed using Epworth Sleepiness Scale (ESS), Pittsburg Sleep Quality Index (PSQI) questionnaires, and polysomnography (PSG). Both the allergic and non-allergic rhinitis groups will be compared in terms of their sleep disturbance characteristics (from comparing ESS, PSQI, and PSG results). Allergic and non-allergic rhinitis patients Inclusion Criteria: - All male and female between 18-60 years old with chronic rhinitis symptoms and sleep disorder - Did not receive intranasal steroid within the last one month - Have psychiatric disorder Exclusion Criteria: - Polyp - Nasal or sinonasal tumor - Septum deviation - Chronic rhinosinusitis - Adenoid hypertrophy - Tonsil hypertrophy - Macroglossia - Oropharyngeal tumor

NCT0531xxxx/NCT05312736.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05312736</url> </required_header> <id_info> <org_study_id>GYROS</org_study_id> <nct_id>NCT05312736</nct_id> </id_info> <brief_title>Gyrate Atrophy Ocular and Systemic Study</brief_title> <acronym>GYROS</acronym> <official_title>Gyrate Atrophy Ocular and Systemic Study</official_title> <sponsors> <lead_sponsor> <agency>Jaeb Center for Health Research</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Conquering Gyrate Atrophy Foundation</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Food and Drug Administration (FDA)</agency> <agency_class>U.S. Fed</agency_class> </collaborator> <collaborator> <agency>Department of Health and Human Services</agency> <agency_class>U.S. Fed</agency_class> </collaborator> </sponsors> <source>Jaeb Center for Health Research</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The Gyrate Atrophy Ocular and Systemic Study characterizes the natural history of ornithine levels and retinal degeneration (RD) associated with disease-causing OAT variants in the presence of standard care dietary treatment regimens over 4 years. The research goal is to understand the impact of OAT mutations on plasma ornithine levels and retinal degeneration. </textblock> </brief_summary> <detailed_description> <textblock> Gyrate atrophy is a rare inherited chorioretinal degeneration that is associated with hyperornithinemia, an inborn error of metabolism caused by autosomal recessive mutations in the ornithine aminotransferase (OAT) gene. Gyrate atrophy is characterized by childhood-onset nyctalopia and sharply demarcated areas of chorioretinal atrophy that initially involve the midperipheral fundus. The atrophic areas typically coalesce and enlarge towards the posterior pole in the second and third decades of life, leading to severe visual field constriction and vision loss if left untreated. The current standard care treatment of gyrate atrophy is an arginine restricted diet that is implemented in practice using dietary protein restriction with essential amino acid supplementation. However, dietary treatment is highly burdensome on patients and negatively impacts quality of life such that only about ~20% of patients are able to comply. Strict adherence to dietary protein restriction (particularly through adolescence), essential amino acid supplementation, and nutritional management of body weight especially during intercurrent illness and pregnancy are among the challenges of treatment. Periods of suboptimal dietary control led to plasma ornithine elevation and progressive chorioretinal degeneration.  Investigators are developing gene therapy as a potential one-time treatment that could arrest disease progression while avoiding or reducing the need for dietary treatment. To facilitate a future interventional gene therapy clinical trial, there is a need to evaluate natural history of and the relationship between potential clinical trial outcome measures.  The objectives of the OAT gene natural history study are as follows:  1. Natural History  1. Characterize the natural history of retinal degeneration associated with disease-causing OAT variants in the presence of standard care dietary treatment regimens over four (4) years, using functional, structural, and patient-reported outcome measures.  2. Characterize the natural history of ornithine levels associated with disease-causing OAT variants in the presence of standard care dietary treatment regimens over four (4) years.  3. Determine within-patient variability of ornithine levels associated with disease-causing OAT variants in the presence of standard care dietary treatment regimens over four (4) years.  4. Evaluate inter-eye correlation on ocular measures.  2. Metabolic-Structure-Function Relationships  1. Explore relationship of structural outcomes with functional outcomes in individuals with disease-causing OAT variants.  2. Explore relationship of plasma ornithine levels with structural and functional outcomes in individuals with disease-causing OAT variants.  3. Identify Rapid Progressors  1. Explore possible risk factors (genotype, phenotype, environmental, comorbidities, and dietary therapy/supplements) for progression of the functional, structural, and patient-reported outcome measures over four (4) years in individuals with disease-causing OAT variants.  2. Explore possible risk factors (genotype, phenotype, environmental, comorbidities, and dietary therapy/supplements) for ornithine levels over four (4) years in individuals with disease-causing OAT variants.  The expected impact of the OAT gene natural history study is to inform a future interventional clinical trial design and implementation, including the following:  1. Determine within-patient variability of ornithine levels.  2. Develop quantitative measures of progression of the area of preserved retina and establish its reproducibility, sensitivity to change, and relationship with other measures.  3. Establish rates of progression of retinal degeneration on all functional, structural, and patient-reported outcome measures, and determine which measures are most sensitive to change.  4. Determine primary time points and duration for a planned future treatment trial.  5. Use variability and inter-eye correlation of outcomes for trial sample size calculations.  6. Identify candidates for the future trial, including eligibility criteria based on risk factors and cut points for severity of disease most likely to benefit from treatment.  7. Establish study procedures and workflows for practical implementation of the same testing procedures in a future trial. </textblock> </detailed_description> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">August 30, 2023</start_date> <completion_date type="Anticipated">January 31, 2028</completion_date> <primary_completion_date type="Anticipated">August 31, 2027</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Cohort</observational_model> <time_perspective>Prospective</time_perspective> </study_design_info> <primary_outcome> <measure>Structural Outcome: Characterize Change using Quantitative Measures of Progression of the Area of Preserved Retina</measure> <time_frame>Baseline and every year until study completion (4 years)</time_frame> <description>Measured by Wide Field Fundus Autofluorescence (FAF)</description> </primary_outcome> <primary_outcome> <measure>Structural Outcome: Characterize Change using Quantitative Measures of Progression of the Area of Preserved Retina (Use with FAF for assessments)</measure> <time_frame>Baseline and every year until study completion (4 years)</time_frame> <description>Measured by wide field color photography</description> </primary_outcome> <primary_outcome> <measure>Metabolic Outcome: Characterize Change in Plasma Ornithine Level</measure> <time_frame>Baseline and every year until study completion (4 years)</time_frame> <description>Obtained by fasting plasma amino acids panel and evaluated by a central lab</description> </primary_outcome> <primary_outcome> <measure>Metabolic Outcome: Characterize Change in Blood Spot Ornithine Level</measure> <time_frame>Baseline and every 4 months until study completion (4 years)</time_frame> <description>Obtained by fasting blood spot test amino acids panel and evaluated by a central lab</description> </primary_outcome> <secondary_outcome> <measure>Structural Outcome: Ellipsoid zone (EZ) area</measure> <time_frame>Baseline and every year until study completion (4 years)</time_frame> <description>Measured by Spectral Domain Optical Coherence Tomography (SD-OCT)</description> </secondary_outcome> <secondary_outcome> <measure>Structural Outcome: Area of Post Subcapsular Cataract</measure> <time_frame>Baseline and every year until study completion (4 years)</time_frame> <description>Measured by Red Reflex Photography</description> </secondary_outcome> <secondary_outcome> <measure>Structural Outcome: Foveal Avascular Zone (FAZ) Area and Macular Vessel Density</measure> <time_frame>Baseline and every year until study completion (4 years)</time_frame> <description>Measured by OCTA Ancillary Test at Subset of Sites</description> </secondary_outcome> <secondary_outcome> <measure>Functional Outcome: Visual Field Sensitivity Measured with Quantitative Topographic Analysis (Hill of Vision)</measure> <time_frame>Screening visit and every year until study completion (4 years) with the exception of baseline.</time_frame> <description>Measured by Octopus 900 Pro</description> </secondary_outcome> <secondary_outcome> <measure>Functional Outcome: Early Treatment of Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score</measure> <time_frame>Screening visit and every year until study completion (4 years) with the exception of baseline.</time_frame> <description>Measured on the Electronic Visual Acuity (EVA) system or ETDRS charts.</description> </secondary_outcome> <secondary_outcome> <measure>Functional Outcome: Low Visual Acuity Test - for participants unable to see ETDRS letters</measure> <time_frame>Screening visit and every year until study completion (4 years) with the exception of baseline.</time_frame> <description>Measured on the Berkeley Rudimentary Vision Test (BRVT)</description> </secondary_outcome> <secondary_outcome> <measure>Functional Outcome: ETDRS Best Corrected Low Luminance Visual Acuity Letter Score</measure> <time_frame>Screening visit and every year until study completion (4 years) with the exception of baseline.</time_frame> <description>Measured on the Electronic Visual Acuity (EVA) system or ETDRS charts.</description> </secondary_outcome> <secondary_outcome> <measure>Functional Outcome: Change in Mean Retinal Sensitivity</measure> <time_frame>Baseline and every year until study completion (4 years)</time_frame> <description>Measured by Fundus-Guided Microperimetry (MP)</description> </secondary_outcome> <secondary_outcome> <measure>Functional Outcome: Change in Full-Field Retinal Sensitivity</measure> <time_frame>Baseline and every year until study completion (4 years)</time_frame> <description>Measured by full-field stimulus threshold (FST) testing to blue, white, and red stimuli</description> </secondary_outcome> <secondary_outcome> <measure>Functional Outcome: Change in Retinal Function</measure> <time_frame>Baseline and every year until study completion (4 years)</time_frame> <description>Measured by full-field electroretinogram (ERG) amplitudes and timing in response to rod- and cone-specific stimuli.</description> </secondary_outcome> <secondary_outcome> <measure>Metabolic Outcome: Proline, lysine, glutamine, glutamate, arginine, and related metabolite: creatine and its precursor guanidinoacetate</measure> <time_frame>Two (2) fasting plasma samples collected on two (2) different days, within ten (10) days of Baseline Visit date and every year until study completion (4 years)</time_frame> <description>Obtained by fasting plasma amino acids panel and evaluated by a central lab</description> </secondary_outcome> <secondary_outcome> <measure>Metabolic Outcome: Level of dietary protein control</measure> <time_frame>Baseline and every year until study completion (4 years)</time_frame> <description>Obtained from serum albumin sample evaluated by a central lab</description> </secondary_outcome> <other_outcome> <measure>Patient Reported Outcomes Adults 18 years or older</measure> <time_frame>Baseline and every two years until study completion (4 years)</time_frame> <description>Measured by Michigan Retinal Degeneration Questionnaire (MRDQ) Visual Symptom and Impact Outcomes Patient Reported Outcome (ViSIO-PRO) Patient-Reported Outcomes Measurement Information System (PROMIS®-29)</description> </other_outcome> <other_outcome> <measure>Patient Reported Outcomes Adolescents 12-17 years</measure> <time_frame>Baseline and every two years until study completion (4 years)</time_frame> <description>Measured by Visual Symptom and Impact Outcomes Patient Reported Outcome (ViSIO-PRO) L. V. Prasad-Functional Vision Questionnaire (LVP-FVQ II)</description> </other_outcome> <number_of_groups>3</number_of_groups> <enrollment type="Anticipated">45</enrollment> <condition>Gyrate Atrophy</condition> <condition>Gyrata of Choroid and Retina; Atrophy</condition> <condition>Ornithine-δ-aminotransferase</condition> <condition>OAT</condition> <condition>Chorioretinal Degeneration</condition> <arm_group> <arm_group_label>Vision Cohort 1</arm_group_label> <description>Criteria that must be met in the better eye* at the Screening Visit: visual acuity ETDRS letter score of 54 or more (approximate Snellen equivalent 20/80 or better) and visual field** diameter 10 degrees or more in every meridian of the central field The better eye is defined as the eye with the better Screening Visit ETDRS visual acuity. However, if both eyes have the same visual acuity, which is defined as the same Snellen equivalent, then the determination will be made at investigator discretion. In this scenario, the investigator will consider the eye with better fixation or clearer ocular media to permit highest quality retinal imaging. The visual field (VF) is defined as the clinically determined kinetic VF III4e performed within the last 18 months prior to the Screening Visit or performed on the day of the Screening Visit.</description> </arm_group> <arm_group> <arm_group_label>Vision Cohort 2</arm_group_label> <description>Criteria that must be met in the better eye* at the Screening Visit: visual acuity ETDRS letter score of 19-53 (approximate Snellen equivalent 20/100 - 20/400) OR visual acuity ETDRS letter score of 54 or more (approximate Snellen equivalent 20/80 or better) and visual field** diameter less than 10 degrees in any meridian of the central field. The better eye is defined as the eye with the better Screening Visit ETDRS visual acuity. However, if both eyes have the same visual acuity, which is defined as the same Snellen equivalent, then the determination will be made at investigator discretion. In this scenario, the investigator will consider the eye with better fixation or clearer ocular media to permit highest quality retinal imaging. The visual field (VF) is defined as the clinically determined kinetic VF III4e performed within the last 18 months prior to the Screening Visit or performed on the day of the Screening Visit.</description> </arm_group> <arm_group> <arm_group_label>Vision Cohort 3</arm_group_label> <description>Criteria that must be met in the better eye* at the Screening Visit: visual acuity ETDRS letter score of 18 or less (approximate Snellen equivalent 20/500 or worse). The better eye is defined as the eye with the better Screening Visit ETDRS visual acuity. However, if both eyes have the same visual acuity, which is defined as the same Snellen equivalent, then the determination will be made at investigator discretion. In this scenario, the investigator will consider the eye with better fixation or clearer ocular media to permit highest quality retinal imaging. The visual field (VF) is defined as the clinically determined kinetic VF III4e performed within the last 18 months prior to the Screening Visit or performed on the day of the Screening Visit.</description> </arm_group> <biospec_retention>Samples With DNA</biospec_retention> <biospec_descr> <textblock> blood samples and skin biopsy </textblock> </biospec_descr> <eligibility> <study_pop> <textblock> The target population for GYROS will be patients with gyrate atrophy associated with disease-causing variants in the OAT gene. </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Participants must meet all the following inclusion criteria at the Screening Visit in order to be eligible to enroll into the genetic screening phase.  - Willing to participate in the study and able to communicate consent during the consent process.  - Willing and able to complete all study visit assessments at each visit over the forty-eight (48) month study period. Age ≥ 12 years.  Must meet one (1) of the Genetic Screening Criteria below:  - At least 2 disease-causing variants in the OAT gene which are homozygous or heterozygous in trans, based on a report from a clinically certified lab, or a report from a research lab that has been pre-approved by the study Genetics Committee.  - At least 2 disease-causing variants in the OAT gene with unknown phase, based on a report from a clinically certified lab, or a report from a research lab that has been pre-approved by the study Genetics Committee, AND must meet both of the following phenotype criteria: .Classic fundus appearance of gyrate atrophy (based on investigator discretion) AND Elevated ornithine levels >300 μmol/L (documented on any prior lab report).  Note: if a participant has a variant(s) of unknown significance, they will still qualify if they meet the Genetic Screening Criteria above. Ocular Inclusion Criteria Participant must meet the following criteria at the Screening Visit to enroll into the genetic screening phase.  Both eyes must have a clinical diagnosis of retinal dystrophy. Both eyes must permit good quality photographic imaging (e.g., but not limited to, clear ocular media, adequate pupil dilation, stable fixation).  Exclusion Criteria:  - Participants must not meet any of the following exclusion criteria at the Screening Visit in order to be eligible to enroll into the genetic screening phase.  - Single pathogenic or likely pathogenic genetic variants known to be associated with autosomal dominant retinitis pigmentosa/retinal dystrophy (AD, heterozygous), X-374 linked retinitis pigmentosa/retinal dystrophy (XL, hemizygous), or mitochondrial inheritance.  - Expected to enter experimental treatment trial at any time during this study. History of more than 1 year of cumulative treatment, at any time, with an agent associated with pigmentary retinopathy, including hydroxychloroquine, chloroquine, thioridazine, and deferoxamine. Note: Since this is a Natural History Study collecting data on the progression of Gyrate Atrophy, pregnant women will not be specifically excluded from participation.  Ocular Exclusion Criteria:  - If either eye has any of the following ocular exclusion criteria at the Screening Visit, then the participant is not eligible to enroll into the genetic screening phase.  - Current vitreous hemorrhage.  - Current or any history of tractional or rhegmatogenous retinal detachment.  - Current or any history of (for example, but not limited to prior to cataract or refractive surgery) spherical equivalent of the refractive error worse than -8 Diopters of myopia. • • • History of intraocular surgery (for example, but not limited to cataract surgery, vitrectomy, penetrating keratoplasty, or LASIK) within the last 3 months.  - Current or any history of confirmed diagnosis of glaucoma (for example, but not limited to glaucomatous VF changes or nerve changes, or history of glaucoma filtering surgery). e. Current or any history of retinal vascular occlusion or proliferative diabetic retinopathy.  - History or current evidence of ocular disease that, in the opinion of the investigator, may confound assessment of visual function.  - The following medications and treatments are prohibited as they can affect progression of retinal pigmentosa. The participant must not have received or planning to receive the following treatments.  - Any use of ocular stem cell or gene therapy.  - Any treatment with ocriplasmin.  - Treatment with Ozurdex (dexamethasone), Iluvien or Yutiq (fluocinolone 404 acetonide) intravitreal implant.  The following medications and treatments are excluded within the specified timeframe:  - Treatment with an ophthalmic oligonucleotide within the last 9 months (last treatment date is less than 9 months prior to Screening Visit date).  - Treatment with any other product within five times the expected half-life of the product (time from last treatment date to Screening Visit date is at least 4115 times the half-life of the given product).  - Treatment that can alter visual acuity between Screening and Baseline (e.g., periorbital injections.) </textblock> </criteria> <gender>All</gender> <minimum_age>12 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Mandeep S. Singh, MD</last_name> <role>Study Chair</role> <affiliation>John Hopkin's - Wilmer Eye Institute</affiliation> </overall_official> <overall_official> <last_name>David Valle, MD</last_name> <role>Study Chair</role> <affiliation>John Hopkin's - Wilmer Eye Institute</affiliation> </overall_official> <overall_contact> <last_name>Coordinating Center</last_name> <phone>8139758690</phone> <email>ffb@jaeb.org</email> </overall_contact> <location> <facility> <name>University of California San Francisco</name> <address> <city>San Francisco</city> <state>California</state> <zip>94158</zip> <country>United States</country> </address> </facility> <contact> <last_name>Jacque Duncan, MD</last_name> <phone>415-502-5161</phone> <email>Roxanna.Rabiee@ucsf.edu</email> </contact> </location> <location> <facility> <name>Johns Hopkins University, Wilmer Eye Institute</name> <address> <city>Baltimore</city> <state>Maryland</state> <zip>21287</zip> <country>United States</country> </address> </facility> <contact> <last_name>Mandeep Singh, MD</last_name> <phone>443-287-7912</phone> <email>Mfrey3@jhmi.edu</email> </contact> <contact_backup> <phone>410-502-1231</phone> <email>Sthom142@jhmi.edu</email> </contact_backup> </location> <location> <facility> <name>Harvard Univ., Massachusetts Eye and Ear Infirmary</name> <address> <city>Boston</city> <state>Massachusetts</state> <zip>02114</zip> <country>United States</country> </address> </facility> <contact> <last_name>Rachel Huckfeldt, MD, PhD</last_name> </contact> </location> <location> <facility> <name>Mayo Clinic</name> <address> <city>Rochester</city> <state>Minnesota</state> <zip>55905</zip> <country>United States</country> </address> </facility> <contact> <last_name>Brittni Scruggs, MD, PhD</last_name> <phone>507-538-8119</phone> <email>wernimont.suzanne@mayo.edu</email> </contact> </location> <location> <facility> <name>Center for Advanced Retinal and Ocular Therapeutics</name> <address> <city>Philadelphia</city> <state>Pennsylvania</state> <zip>19104</zip> <country>United States</country> </address> </facility> <contact> <last_name>Katherine Uyhazi, MD, PhD</last_name> <phone>215-662-6396</phone> <email>mariejel.weber@pennmedicine.upenn.edu</email> </contact> </location> <location> <facility> <name>INRET Clínica e Centro de Pesquisa</name> <address> <city>Santa Efigênia</city> <zip>30150-270</zip> <country>Brazil</country> </address> </facility> </location> <location> <facility> <name>University of Toronto, Hospital for Sick Children</name> <address> <city>Toronto</city> <state>Ontario</state> <zip>M5G0A4</zip> <country>Canada</country> </address> </facility> <contact> <last_name>Ajoy Vincent, MBBS, MS</last_name> <phone>416.813.7654 Ext: 222838</phone> <email>neema.thaliath@sickkids.ca</email> </contact> </location> <location> <facility> <name>Helsinki University Hospital</name> <address> <city>Helsinki</city> <zip>00280</zip> <country>Finland</country> </address> </facility> <contact> <last_name>Eeva-Marja Sankila, MD, PhD</last_name> </contact> </location> <location> <facility> <name>Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts, INSERM-DGOS CIC1423</name> <address> <city>Paris</city> <zip>75012</zip> <country>France</country> </address> </facility> <contact> <last_name>Isabelle Audo, MD, PhD</last_name> <phone>33(0) 1 40 02 14 55</phone> <email>tdib@15-20.fr</email> </contact> </location> <location> <facility> <name>University of Tuebingen, Centre for Ophthalmology</name> <address> <city>Tübingen</city> <zip>72076</zip> <country>Germany</country> </address> </facility> <contact> <last_name>Andrea Rindtorff, MD</last_name> <phone>49 7071 29 87747</phone> <email>laura.kuehlewein@med.uni-tuebingen.de</email> </contact> </location> <location> <facility> <name>Moorfields Eye Hospital</name> <address> <city>London</city> <zip>UK EC1V 2PD</zip> <country>United Kingdom</country> </address> </facility> <contact> <last_name>Michel Michaelides, MD (Res)</last_name> </contact> </location> <location_countries> <country>Brazil</country> <country>Canada</country> <country>Finland</country> <country>France</country> <country>Germany</country> <country>United Kingdom</country> <country>United States</country> </location_countries> <removed_countries> <country>Israel</country> </removed_countries> <link> <url>https://public.jaeb.org/ffb</url> <description>Foundation Fighting Blindness Public Website</description> </link> <verification_date>August 2023</verification_date> <study_first_submitted>March 28, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 5, 2022</study_first_posted> <last_update_submitted>August 21, 2023</last_update_submitted> <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc> <last_update_posted type="Actual">August 23, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Gyrate Atrophy</keyword> <keyword>OAT</keyword> <condition_browse>  <mesh_term>Gyrate Atrophy</mesh_term> <mesh_term>Atrophy</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Yes</sharing_ipd> <ipd_description>After the study is completed, the de-identified, archived data will be transmitted to and stored at the FFB Consortium Coordinating Center, under the supervision of Allison Ayala, for use by other researchers including those outside of the study.</ipd_description> <ipd_info_type>Study Protocol</ipd_info_type> <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type> <ipd_time_frame>After manuscript is published</ipd_time_frame> <ipd_access_criteria>Users accessing data must enter an email address</ipd_access_criteria> </patient_data>  </clinical_study>

The Gyrate Atrophy Ocular and Systemic Study characterizes the natural history of ornithine levels and retinal degeneration (RD) associated with disease-causing OAT variants in the presence of standard care dietary treatment regimens over 4 years. The research goal is to understand the impact of OAT mutations on plasma ornithine levels and retinal degeneration. Gyrate atrophy is a rare inherited chorioretinal degeneration that is associated with hyperornithinemia, an inborn error of metabolism caused by autosomal recessive mutations in the ornithine aminotransferase (OAT) gene. Gyrate atrophy is characterized by childhood-onset nyctalopia and sharply demarcated areas of chorioretinal atrophy that initially involve the midperipheral fundus. The atrophic areas typically coalesce and enlarge towards the posterior pole in the second and third decades of life, leading to severe visual field constriction and vision loss if left untreated. The current standard care treatment of gyrate atrophy is an arginine restricted diet that is implemented in practice using dietary protein restriction with essential amino acid supplementation. However, dietary treatment is highly burdensome on patients and negatively impacts quality of life such that only about ~20% of patients are able to comply. Strict adherence to dietary protein restriction (particularly through adolescence), essential amino acid supplementation, and nutritional management of body weight especially during intercurrent illness and pregnancy are among the challenges of treatment. Periods of suboptimal dietary control led to plasma ornithine elevation and progressive chorioretinal degeneration. Investigators are developing gene therapy as a potential one-time treatment that could arrest disease progression while avoiding or reducing the need for dietary treatment. To facilitate a future interventional gene therapy clinical trial, there is a need to evaluate natural history of and the relationship between potential clinical trial outcome measures. The objectives of the OAT gene natural history study are as follows: 1. Natural History 1. Characterize the natural history of retinal degeneration associated with disease-causing OAT variants in the presence of standard care dietary treatment regimens over four (4) years, using functional, structural, and patient-reported outcome measures. 2. Characterize the natural history of ornithine levels associated with disease-causing OAT variants in the presence of standard care dietary treatment regimens over four (4) years. 3. Determine within-patient variability of ornithine levels associated with disease-causing OAT variants in the presence of standard care dietary treatment regimens over four (4) years. 4. Evaluate inter-eye correlation on ocular measures. 2. Metabolic-Structure-Function Relationships 1. Explore relationship of structural outcomes with functional outcomes in individuals with disease-causing OAT variants. 2. Explore relationship of plasma ornithine levels with structural and functional outcomes in individuals with disease-causing OAT variants. 3. Identify Rapid Progressors 1. Explore possible risk factors (genotype, phenotype, environmental, comorbidities, and dietary therapy/supplements) for progression of the functional, structural, and patient-reported outcome measures over four (4) years in individuals with disease-causing OAT variants. 2. Explore possible risk factors (genotype, phenotype, environmental, comorbidities, and dietary therapy/supplements) for ornithine levels over four (4) years in individuals with disease-causing OAT variants. The expected impact of the OAT gene natural history study is to inform a future interventional clinical trial design and implementation, including the following: 1. Determine within-patient variability of ornithine levels. 2. Develop quantitative measures of progression of the area of preserved retina and establish its reproducibility, sensitivity to change, and relationship with other measures. 3. Establish rates of progression of retinal degeneration on all functional, structural, and patient-reported outcome measures, and determine which measures are most sensitive to change. 4. Determine primary time points and duration for a planned future treatment trial. 5. Use variability and inter-eye correlation of outcomes for trial sample size calculations. 6. Identify candidates for the future trial, including eligibility criteria based on risk factors and cut points for severity of disease most likely to benefit from treatment. 7. Establish study procedures and workflows for practical implementation of the same testing procedures in a future trial. blood samples and skin biopsy The target population for GYROS will be patients with gyrate atrophy associated with disease-causing variants in the OAT gene. Inclusion Criteria: - Participants must meet all the following inclusion criteria at the Screening Visit in order to be eligible to enroll into the genetic screening phase. - Willing to participate in the study and able to communicate consent during the consent process. - Willing and able to complete all study visit assessments at each visit over the forty-eight (48) month study period. Age ≥ 12 years. Must meet one (1) of the Genetic Screening Criteria below: - At least 2 disease-causing variants in the OAT gene which are homozygous or heterozygous in trans, based on a report from a clinically certified lab, or a report from a research lab that has been pre-approved by the study Genetics Committee. - At least 2 disease-causing variants in the OAT gene with unknown phase, based on a report from a clinically certified lab, or a report from a research lab that has been pre-approved by the study Genetics Committee, AND must meet both of the following phenotype criteria: .Classic fundus appearance of gyrate atrophy (based on investigator discretion) AND Elevated ornithine levels >300 μmol/L (documented on any prior lab report). Note: if a participant has a variant(s) of unknown significance, they will still qualify if they meet the Genetic Screening Criteria above. Ocular Inclusion Criteria Participant must meet the following criteria at the Screening Visit to enroll into the genetic screening phase. Both eyes must have a clinical diagnosis of retinal dystrophy. Both eyes must permit good quality photographic imaging (e.g., but not limited to, clear ocular media, adequate pupil dilation, stable fixation). Exclusion Criteria: - Participants must not meet any of the following exclusion criteria at the Screening Visit in order to be eligible to enroll into the genetic screening phase. - Single pathogenic or likely pathogenic genetic variants known to be associated with autosomal dominant retinitis pigmentosa/retinal dystrophy (AD, heterozygous), X-374 linked retinitis pigmentosa/retinal dystrophy (XL, hemizygous), or mitochondrial inheritance. - Expected to enter experimental treatment trial at any time during this study. History of more than 1 year of cumulative treatment, at any time, with an agent associated with pigmentary retinopathy, including hydroxychloroquine, chloroquine, thioridazine, and deferoxamine. Note: Since this is a Natural History Study collecting data on the progression of Gyrate Atrophy, pregnant women will not be specifically excluded from participation. Ocular Exclusion Criteria: - If either eye has any of the following ocular exclusion criteria at the Screening Visit, then the participant is not eligible to enroll into the genetic screening phase. - Current vitreous hemorrhage. - Current or any history of tractional or rhegmatogenous retinal detachment. - Current or any history of (for example, but not limited to prior to cataract or refractive surgery) spherical equivalent of the refractive error worse than -8 Diopters of myopia. • • • History of intraocular surgery (for example, but not limited to cataract surgery, vitrectomy, penetrating keratoplasty, or LASIK) within the last 3 months. - Current or any history of confirmed diagnosis of glaucoma (for example, but not limited to glaucomatous VF changes or nerve changes, or history of glaucoma filtering surgery). e. Current or any history of retinal vascular occlusion or proliferative diabetic retinopathy. - History or current evidence of ocular disease that, in the opinion of the investigator, may confound assessment of visual function. - The following medications and treatments are prohibited as they can affect progression of retinal pigmentosa. The participant must not have received or planning to receive the following treatments. - Any use of ocular stem cell or gene therapy. - Any treatment with ocriplasmin. - Treatment with Ozurdex (dexamethasone), Iluvien or Yutiq (fluocinolone 404 acetonide) intravitreal implant. The following medications and treatments are excluded within the specified timeframe: - Treatment with an ophthalmic oligonucleotide within the last 9 months (last treatment date is less than 9 months prior to Screening Visit date). - Treatment with any other product within five times the expected half-life of the product (time from last treatment date to Screening Visit date is at least 4115 times the half-life of the given product). - Treatment that can alter visual acuity between Screening and Baseline (e.g., periorbital injections.)

NCT0531xxxx/NCT05312749.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05312749</url> </required_header> <id_info> <org_study_id>2021/09-45</org_study_id> <nct_id>NCT05312749</nct_id> </id_info> <brief_title>The Effect of Web Based Progressive Muscle Relaxation Exercise on Clinical Stress and Anxiety of Nursing Students</brief_title> <official_title>The Effect of Web-Based Progressive Muscle Relaxation Exercise on the Perceived Stress and Anxiety Level of Nursing Students Found in Clinical Practice for the First Time: A Randomized Controlled Trial</official_title> <sponsors> <lead_sponsor> <agency>Ataturk University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Ataturk University</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Purpose: The study was conducted to examine the effect of web-based progressive muscle relaxation exercise on the perceived stress and anxiety level of nursing students who were in clinical practice for the first time.  Method: This randomized controlled study was conducted at a state university in Turkey. The sample of the study consisted of a total of 66 nursing students, 36 of whom were control and 30 interventions, who were educated in the 2021-2022 academic year, were in clinical practice for the first time and agreed to participate in the research. The intervention group was asked to perform a total of 36 sessions of progressive muscle relaxation exercise, 3 days a week for 12 weeks. Data; It was collected using the "Sociodemographic Characteristics Form", "State-Trait Anxiety Inventory (DSQ)" and "Perceived Stress Inventory (PSI)". </textblock> </brief_summary> <overall_status>Completed</overall_status> <start_date type="Actual">September 27, 2021</start_date> <completion_date type="Actual">December 25, 2021</completion_date> <primary_completion_date type="Actual">October 25, 2021</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Supportive Care</primary_purpose> <masking>Single (Investigator)</masking> </study_design_info> <primary_outcome> <measure>The State-Trait Anxiety Inventory</measure> <time_frame>12 week</time_frame> <description>The State-Trait Anxiety Inventory was developed by Spielberger et al. (1970) (Spielger, Gorsuch, & Lushene, 1970). The validity and reliability of the scale in Turkey was established by Öner and Le Compte (1983) (Öner & Le Compte, 1983). The scale consists of two parts, the State Anxiety Inventory and the Trait Anxiety Inventory. The first 20 items assess situational anxiety, and the last 20 items assess trait anxiety. In this study, the "State Anxiety Inventory", which is the first 20 items, was used to evaluate situational anxiety. State Anxiety Scale; It was developed to determine how an individual feels at a certain moment and under certain conditions. The scale is 4-point Likert type. Scores from the scale range from 20 to 80. Higher scores indicate higher levels of anxiety.</description> </primary_outcome> <primary_outcome> <measure>Perceived Stress Scale</measure> <time_frame>12 week</time_frame> <description>The Perceived Stress Scale was developed by Cohen, Kamarck, and Mermelstein in 1983 to determine the level of stress that threatens human health (Cohen et al. 1983). Its Turkish validity and reliability were determined by Eskin et al. (2013) (Eskin et al., 2013). PSS-14 consists of 2 factors: "insufficient self-efficacy" and "stress" perception. The scale is a 5-point Likert type scale and consists of 14 items. As the scores obtained from the scale increase, the level of stress perceived by the person also increases. PSS scores range from 0 to 56, with 0-35 point range indicating normal stress level and 35-56 point range indicating that the individual is under stress.</description> </primary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">66</enrollment> <condition>Anxiety</condition> <condition>Stress</condition> <condition>Nursing Students</condition> <condition>Relaxation Program</condition> <arm_group> <arm_group_label>Experimental:</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Experimental: will do progressive relaxation exercises</description> </arm_group> <arm_group> <arm_group_label>Control</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>won't do progressive relaxation exercises</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>progressive relaxation exercises</intervention_name> <description>progressive relaxation exercises</description> <arm_group_label>Experimental:</arm_group_label> <other_name>progressive muscle relaxation exercises</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Being over 18 years old  - Studying in the 2021-2022 academic year  - Being in 2nd grade  - Not going into clinical practice before  Exclusion Criteria:  - Being under the age of 18  - Not studying in the 2021-2022 academic year  - Being in 1st, 3rd or 4th grade  - Prior clinical practice </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Gülcan B.TURAN, PH</last_name> <role>Study Director</role> <affiliation>Firat University</affiliation> </overall_official> <location> <facility> <name>Atatürk university nursing faculty</name> <address> <city>Erzurum</city> <state>Center</state> <zip>25240</zip> <country>Turkey</country> </address> </facility> </location> <location> <facility> <name>Fırat Üniversitesi</name> <address> <city>Elazığ</city> <country>Turkey</country> </address> </facility> </location> <location_countries> <country>Turkey</country> </location_countries> <link> <url>https://www.learntechlib.org/p/199022/.</url> <description>Carver, M. L., & O'Malley, M. (2015). Progressive muscle relaxation to decrease anxiety in clinical simulations. Teaching and Learning in Nursing, 10(2), 57-62.</description> </link> <verification_date>April 2022</verification_date> <study_first_submitted>March 16, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 5, 2022</study_first_posted> <last_update_submitted>April 4, 2022</last_update_submitted> <last_update_submitted_qc>April 4, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 11, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Ataturk University</investigator_affiliation> <investigator_full_name>gülcan bahcecioğlu</investigator_full_name> <investigator_title>Principal Investigator</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Anxiety Disorders</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> <ipd_description>The article is intended to be shared after it is published.</ipd_description> </patient_data>  </clinical_study>

Purpose: The study was conducted to examine the effect of web-based progressive muscle relaxation exercise on the perceived stress and anxiety level of nursing students who were in clinical practice for the first time. Method: This randomized controlled study was conducted at a state university in Turkey. The sample of the study consisted of a total of 66 nursing students, 36 of whom were control and 30 interventions, who were educated in the 2021-2022 academic year, were in clinical practice for the first time and agreed to participate in the research. The intervention group was asked to perform a total of 36 sessions of progressive muscle relaxation exercise, 3 days a week for 12 weeks. Data; It was collected using the "Sociodemographic Characteristics Form", "State-Trait Anxiety Inventory (DSQ)" and "Perceived Stress Inventory (PSI)". Inclusion Criteria: - Being over 18 years old - Studying in the 2021-2022 academic year - Being in 2nd grade - Not going into clinical practice before Exclusion Criteria: - Being under the age of 18 - Not studying in the 2021-2022 academic year - Being in 1st, 3rd or 4th grade - Prior clinical practice

NCT0531xxxx/NCT05312762.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05312762</url> </required_header> <id_info> <org_study_id>ABSPL/01/2021</org_study_id> <nct_id>NCT05312762</nct_id> </id_info> <brief_title>To Evaluate the Efficacy and Safety of MaxioCel Versus Aquacel Extra for the Management of Chronic Wounds</brief_title> <official_title>An Open Label, Multicentre, Randomized Phase IV Clinical Trial to Evaluate the Safety and Efficacy of MaxioCel Compared With Aquacel Extra for the Management of Exuding Chronic Wounds</official_title> <sponsors> <lead_sponsor> <agency>Axio Biosolutions Pvt. Ltd.</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Axio Biosolutions Pvt. Ltd.</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The objective of this study is to evaluate the efficacy and safety of MaxioCel vs Aquacel Extra in the management of exuding ulcers/wounds over a period of 4 weeks </textblock> </brief_summary> <detailed_description> <textblock> The current study intends to compare the efficacy of the chitosan wound dressing (MaxioCel) with another marketed dressing (Aquacel Extra). MaxioCel is made up of chitosan and Aquacel Extra with carboxymethyl cellulose. Both are polymeric dressings. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">April 27, 2022</start_date> <completion_date type="Anticipated">March 11, 2023</completion_date> <primary_completion_date type="Anticipated">March 11, 2023</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Wound Area Measurement</measure> <time_frame>Week 1, Week 2, Week 3, Week 4</time_frame> <description>Wound area (cm2) to be recorded at baseline and weekly visits to assess % change in wound area.</description> </primary_outcome> <secondary_outcome> <measure>Pain Management</measure> <time_frame>Week 1, Week 2, Week 3, Week 4</time_frame> <description>Changes in pain using Numeric Rating Scale (0-10). 0 means no pain, 10 means severe pain/worst possible pain</description> </secondary_outcome> <secondary_outcome> <measure>Exudate Management</measure> <time_frame>Week 1, Week 2, Week 3, Week 4</time_frame> <description>Change in Exudate levels will be evaluated. Exudate levels will be evaluated as per below categories: None, Scant, Small, Moderate, Large</description> </secondary_outcome> <secondary_outcome> <measure>Changes in Epithilizing / Granulating Tissues</measure> <time_frame>Week 1, Week 2, Week 3, Week 4</time_frame> <description>measured by % change in Epithelizing and granulating tissues</description> </secondary_outcome> <secondary_outcome> <measure>Bates Janesen Wound Assessment Score</measure> <time_frame>Week 1, Week 2, Week 3, Week 4</time_frame> <description>The status of wound as per 13 items mentioned in the Bates-Jensen Wound Assessment Tool will be evaluated. Higher the total score, the more severe the wound status.Minimum score - 13 ; Maximum score - 65</description> </secondary_outcome> <secondary_outcome> <measure>Scar Management</measure> <time_frame>Week 4</time_frame> <description>Vancouver Scar Scale will be used at the final visit to evaluate the scar formation at wound site. Minimum score - 0; Maximum score - 13</description> </secondary_outcome> <secondary_outcome> <measure>Clinician opinion related to dressing</measure> <time_frame>Week 4</time_frame> <description>Dressing usability / use of dressing will be evaluated via questionnaire. The options for rating will be Excellent, Good, Fair, Poor. For few questions, options will be Yes or No</description> </secondary_outcome> <secondary_outcome> <measure>Patient opinion related to dressing</measure> <time_frame>Week 4</time_frame> <description>Patients comfort levels with use of dressing will be evaluated via questionnaire. The options for rating will be Excellent, Good, Fair, Poor. For few questions, options will be Yes or No</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">118</enrollment> <condition>Wound</condition> <arm_group> <arm_group_label>MaxioCel</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Microfiber wound dressing</description> </arm_group> <arm_group> <arm_group_label>AquaCel Extra</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Hydrofiber dressing</description> </arm_group> <intervention> <intervention_type>Device</intervention_type> <intervention_name>MaxioCel</intervention_name> <description>Microfiber wound dressing</description> <arm_group_label>MaxioCel</arm_group_label> <other_name>Chitosan Wound Dressing</other_name> </intervention> <intervention> <intervention_type>Device</intervention_type> <intervention_name>AquaCel Extra</intervention_name> <description>Hydrofiber dressing</description> <arm_group_label>AquaCel Extra</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Male or female 18 years old or above (till 80 years)  - Patients who are willing to sign the written informed consent  - Clinically diagnosed with an unhealed or non-healing diabetic foot ulcer / venous ulcer / arterial ulcer / other ulcers / wounds, etc.  - Wound duration between 1 to 24 months  - A target wound area between 1 cm2 and 50 cm2  - Exuding wounds / ulcers  Exclusion Criteria:  - Known allergy/hypersensitivity to the dressing  - Pregnant women  - Underlying or diagnosed with serious diseases or deemed unsuitable for this clinical study by the study's clinician  - Dry wounds  - Being treated with a high dose of steroids or immunosuppressant therapy or systemic antibiotics  - Presenting a progressive neoplastic lesion treated with radiotherapy or chemotherapy  - Patients who had Deep Vein Thrombosis in the previous 3 months  - Ulcers with clinical signs of infection or erysipelas of the lower limb or biofilm  - Subjects included in clinical study at present or during the past 30 days  - Clinical suspicion of osteomyelitis </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>80 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Shailee Mehta, MSc</last_name> <role>Study Chair</role> <affiliation>Axio Biosolutions Pvt. Ltd.</affiliation> </overall_official> <overall_contact> <last_name>Shailee Mehta, MSc.</last_name> <phone>+919879009940</phone> <email>clinicalstudy@axiobio.com</email> </overall_contact> <location> <facility> <name>Saveetha Medical College Hospital</name> <address> <city>Chennai</city> <state>Tamil Nadu</state> <zip>602105</zip> <country>India</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Gowtham</last_name> </contact> </location> <location> <facility> <name>Hycare Super Speciality Hospital</name> <address> <city>Chennai</city> <state>Tamilnadu</state> <zip>600106</zip> <country>India</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Gowtham</last_name> </contact> </location> <location> <facility> <name>Vijaya hospitals</name> <address> <city>Chennai</city> <country>India</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Dr Rajkumar</last_name> </contact> </location> <location> <facility> <name>Kamineni Hospitals Pvt Ltd</name> <address> <city>Hyderabad</city> <country>India</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Satyanarayana</last_name> </contact> <investigator> <last_name>Satyanarayana G</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>Yalamanchi hospital and research center vijayawada</name> <address> <city>Vijayawada</city> <country>India</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>9948024196</last_name> </contact> <investigator> <last_name>Dr Sadasiva rao Yalamanchi</last_name> <role>Principal Investigator</role> </investigator> </location> <location_countries> <country>India</country> </location_countries> <verification_date>January 2023</verification_date> <study_first_submitted>March 18, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 5, 2022</study_first_posted> <last_update_submitted>January 20, 2023</last_update_submitted> <last_update_submitted_qc>January 20, 2023</last_update_submitted_qc> <last_update_posted type="Actual">January 23, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Wounds and Injuries</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Carboxymethylcellulose Sodium</mesh_term> <mesh_term>Chitosan</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>Undecided</sharing_ipd> </patient_data>  </clinical_study>

The objective of this study is to evaluate the efficacy and safety of MaxioCel vs Aquacel Extra in the management of exuding ulcers/wounds over a period of 4 weeks The current study intends to compare the efficacy of the chitosan wound dressing (MaxioCel) with another marketed dressing (Aquacel Extra). MaxioCel is made up of chitosan and Aquacel Extra with carboxymethyl cellulose. Both are polymeric dressings. Inclusion Criteria: - Male or female 18 years old or above (till 80 years) - Patients who are willing to sign the written informed consent - Clinically diagnosed with an unhealed or non-healing diabetic foot ulcer / venous ulcer / arterial ulcer / other ulcers / wounds, etc. - Wound duration between 1 to 24 months - A target wound area between 1 cm2 and 50 cm2 - Exuding wounds / ulcers Exclusion Criteria: - Known allergy/hypersensitivity to the dressing - Pregnant women - Underlying or diagnosed with serious diseases or deemed unsuitable for this clinical study by the study's clinician - Dry wounds - Being treated with a high dose of steroids or immunosuppressant therapy or systemic antibiotics - Presenting a progressive neoplastic lesion treated with radiotherapy or chemotherapy - Patients who had Deep Vein Thrombosis in the previous 3 months - Ulcers with clinical signs of infection or erysipelas of the lower limb or biofilm - Subjects included in clinical study at present or during the past 30 days - Clinical suspicion of osteomyelitis

NCT0531xxxx/NCT05312775.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05312775</url> </required_header> <id_info> <org_study_id>PSHN.0005.2021</org_study_id> <nct_id>NCT05312775</nct_id> </id_info> <brief_title>Niche In CEsarean Scar Trial (NICEST)</brief_title> <official_title>Single Versus Double-layer Closure of The Cesarean Scar In Niche Development: A Randomized Clinical Trial</official_title> <sponsors> <lead_sponsor> <agency>Nguyen Thi Thu Ha</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Hanoi Obstetrics and Gynecology Hospital</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Rationale: Cesarean delivery (CD) rates are increasing rapidly worldwide. The consequences of cesarean section not only affect the next pregnancies such as uterine rupture or malplacentation but also cause many gynecological complications or infertility due to the formation of cesarean scar defect (CSD) or Niche. One of the major factors for Niche formation is the techniques of hysterotomy closure at the time of cesarean delivery. Most common hysterotomy closures include single and double layers closure. However, there is limited literature to prove which technique decreases niche creation and associated gynecological complications.  Objective: To compare the effect of uterine closure techniques during CD on the formation of Niche evaluated on transvaginal ultrasound and gynecological complications.  Study design: a double-blinded, single-center, randomized clinical trial. Setting: Hanoi Obstetrics & Gynecology Hospital (HOGH), Viet Nam. Study population: All women at gestational age ≥ 37 0/7 weeks who undergo a primary CD (planned or unplanned).  Intervention: After informed consent, women will be randomized to either unlocked single layer closure or unlocked double-layer closures of cesarean uterine scar in a 1:1 ratio Primary outcome: The proportion of Niche over time (at 6, 12, 18, 24 months after CD) in the two groups.  Power calculation: A sample size of 389 women is needed for each group. Nature and extent of the burden and risks associated with participation, benefit, and group relatedness: Both uterine closure methods followed by the Vietnam Ministry of Health (VN-MOH), transvaginal ultrasound is also not harmful. It is believed that there are no potential increased risks to patients taking part in this trial because of the standard care and management they receive. </textblock> </brief_summary> <detailed_description> <textblock> Pregnancies at term, indicated for cesarean delivery for the first time, will be fully consulted information related to this study before surgery. Written consent will be obtained from each eligible pregnant woman before randomization into the study.  After signing the informed consent form, eligible women will be randomly assigned in a 1:1 ratio to receive either single-layer closure or double-layer closure, using block randomization with a variable block size of 4, 6. The computer-generated random list will be prepared by an independent statistician who has no other involvement in the study. To ensure allocation concealment, opaque and sealed envelopes will be prepared and controlled by two administrative staff in the Clinical Trial Unit who have no involvement in clinical work. Whenever there is an eligible participant, these two staff will hand over the envelope in sequence to the clinician. As the result, surgeons will not be blinded, but participants and sonographers will be unaware of closure techniques. Apart from randomization, patients will be followed up and treated according to local protocol.  The cesarean section with two uterine scar closure techniques will be performed by well-trained obstetricians. Participants and sonographers will be blinded for the closure technique.  Intervention (double-layer closure) In both study groups, women will undergo a CD following a standard way with respect to the mode of hysterotomy, non-closure of the peritoneum. In the intervention group, double-layer closure of the uterus will be performed using unlocked multifilament continuous running sutures for both layers and the endometrial layer will be included in the first layer. The second layer is a continuous running suture that imbricates the first layer.  Control group (single-layer closure) The control group will receive a single-layer closure using unlocked continuous running multifilament sutures and the endometrial layer will be included.  Complication during surgery  The cases that have complications during surgery will be excluded from the study. Complications encompass:  - Maternal mortality  - Maternal admitted ICU  - Hysterectomy  - Damage to internal organs (bowel, bladder or ureters).  - Complications during postoperative period requiring further surgery. Follow-up Participants will be contacted via telephone to notify about follow-up visits within 10 days of the first day of every menstrual cycle at 6 months, 12 months, 18 months, 24 months (give or take 2 weeks).  Every regular follow-up visit, the participants will be examined and transvaginal ultrasound followed by saline infusion sonohysterography to evaluate Niche. The ultrasound evaluation is standardized as proposed by the latest standard of ISUOG(2019).  Reproductive outcomes at two years follow-up: Percentage of women that conceived at any time during the follow-up duration, time of conception, and results of said pregnancies (ongoing pregnancy, terminated pregnancy due to medical/ social indication).  Niche evaluation Every regular follow-up visit, the participants will be examined and transvaginal ultrasound followed by sonohysterography to evaluate Niche. The Niche evaluation is standardized as proposed by the latest standard of ISUOG(2019). </textblock> </detailed_description> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">January 1, 2023</start_date> <completion_date type="Anticipated">October 2026</completion_date> <primary_completion_date type="Anticipated">April 2026</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Prevention</primary_purpose> <masking>Double (Participant, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>The proportion of Niche at 6 months after cesarean delivery of Single-layer uterine closure group</measure> <time_frame>from delivery to 6 months from delivery</time_frame> <description>The proportion of Niche at 6 months after cesarean delivery of Single-layer uterine closure group.</description> </primary_outcome> <primary_outcome> <measure>The proportion of Niche at 12 months after cesarean delivery of Single-layer uterine closure group</measure> <time_frame>from delivery to 12 months from delivery</time_frame> <description>The proportion of Niche at 12 months after cesarean delivery of Single-layer uterine closure group.</description> </primary_outcome> <primary_outcome> <measure>The proportion of Niche at 18 months after cesarean delivery of Single-layer uterine closure group</measure> <time_frame>from delivery to 18 months from delivery</time_frame> <description>The proportion of Niche at 18 months after cesarean delivery of Single-layer uterine closure group.</description> </primary_outcome> <primary_outcome> <measure>The proportion of Niche at 24 months after cesarean delivery of Single-layer uterine closure group</measure> <time_frame>from delivery to 24 months from delivery</time_frame> <description>The proportion of Niche at 24 months after cesarean delivery of Single-layer uterine closure group.</description> </primary_outcome> <primary_outcome> <measure>The proportion of Niche at 6 months after cesarean delivery of Double-layer uterine closure group</measure> <time_frame>from delivery to 6 months from delivery)</time_frame> <description>The proportion of Niche at 6 months after cesarean delivery of Double-layer uterine closure group.</description> </primary_outcome> <primary_outcome> <measure>The proportion of Niche at 12 months after cesarean delivery of Double-layer uterine closure group</measure> <time_frame>from delivery to 12 months from delivery</time_frame> <description>The proportion of Niche at 12 months after cesarean delivery of Double-layer uterine closure group.</description> </primary_outcome> <primary_outcome> <measure>The proportion of Niche at 18 months after cesarean delivery of Double-layer uterine closure group</measure> <time_frame>from delivery to 18 months from delivery</time_frame> <description>The proportion of Niche at 18 months after cesarean delivery of Double-layer uterine closure group.</description> </primary_outcome> <primary_outcome> <measure>The proportion of Niche at 24 months after cesarean delivery of Double-layer uterine closure group</measure> <time_frame>from delivery to 24 months from delivery</time_frame> <description>The proportion of Niche at 24 months after cesarean delivery of Double-layer uterine closure group.</description> </primary_outcome> <secondary_outcome> <measure>Number of participants with post-partum hemorrhage.</measure> <time_frame>Within 24 hours from delivery</time_frame> <description>Defined as blood loss more than 1000ml with 24 hours after cesarean delivery</description> </secondary_outcome> <secondary_outcome> <measure>Number of participants having uterine atony</measure> <time_frame>During operation</time_frame> <description>Defined as use of two or more uterotonics other oxytocin; other surgical interventions such as compression by hand and/or sutures, uterine arteries ligation, embolization, hypogastric arteries ligation, or balloon tamponade</description> </secondary_outcome> <secondary_outcome> <measure>Number of participants with maternal infection</measure> <time_frame>from delivery until maternal hospital discharge, assessed up to 28 days after delivery</time_frame> <description>Maternal infection as defined: Fever: defined as axillary temperature ≥ 37.5 degrees Celsius. Start of intravenous broad-spectrum antibiotics (with evidence of infection confirmed by clinical and subclinical presentation) Endometritis, myometritis or urinary tract infection (proven positive vaginal discharge/urine culture)</description> </secondary_outcome> <secondary_outcome> <measure>Number of participants having postmenstrual spotting in women with Niche</measure> <time_frame>from delivery to 6 months, 12 months, 18 months, 24 months after cesarean delivery, up to 24 months from delivery</time_frame> <description>Postmenstrual spotting is brownish discharge for more than two days at the end of menstruation with a total duration (menstruation and spotting) of more than seven days, or intermenstrual bleeding that starts after the end of menstruation, assessed at 6 months, 12 months, 18 months and 24 months after delivery.</description> </secondary_outcome> <secondary_outcome> <measure>Duration of postmenstrual spotting in women with Niche</measure> <time_frame>from delivery to 6 months, 12 months, 18 months, 24 months after cesarean delivery, up to 24 months from delivery</time_frame> <description>Duration of postmenstrual spotting in women with Niche defined as the average number of days of postmenstrual spotting in 6 months, in which duration of postmenstrual spotting in each month will be counted as follows: days with brownish discharge (more than two days) when the total duration of menstruation and spotting exceeds seven days plus days with intermenstrual bleeding, assessed at 6 months, 12 months, 18 months and 24 months after cesarean delivery.</description> </secondary_outcome> <secondary_outcome> <measure>Number of participants suffering from dysmenorrhea in women with Niche</measure> <time_frame>from delivery to 6 months, 12 months, 18 months, 24 months after cesarean delivery, up to 24 months from delivery</time_frame> <description>Number of participants suffering from dysmenorrhea in women with Niche, assessed at 6 months, 12 months, 18 months and 24 months after cesarean delivery</description> </secondary_outcome> <secondary_outcome> <measure>Dysmenorrhea severity in women with Niche</measure> <time_frame>from delivery to 6 months, 12 months, 18 months, 24 months after cesarean delivery, up to 24 months from delivery</time_frame> <description>Participants with dysmenorrhea self-assessed pain levels and scored 1 to 10 rely on the Numeric Rating Scale (NRS). The average score in span of 6 months will be calculated and the highest score will be noticed to reveal dysmenorrhea severity at 6 months, 12 months, 18 months, 24 months after cesarean delivery</description> </secondary_outcome> <secondary_outcome> <measure>Number of participants suffering from suprapubic pain in women with Niche</measure> <time_frame>from delivery to 6 months, 12 months, 18 months, 24 months after cesarean delivery, up to 24 months from delivery</time_frame> <description>Number of participants suffering from suprapubic pain in women with Niche, assessed at 6 months, 12 months, 18 months and 24 months after cesarean delivery</description> </secondary_outcome> <secondary_outcome> <measure>Suprapubic pain severity in women with Niche</measure> <time_frame>from delivery to 6 months, 12 months, 18 months, 24 months after cesarean delivery, up to 24 months from delivery</time_frame> <description>Participants with suprapubic pain self-assessed pain levels and scored 1 to 10 rely on the Numeric Rating Scale (NRS). The average score in span of 6 months will be calculated and the highest score will be noticed to reveal suprapubic pain severity at 6 months, 12 months, 18 months, 24 months after cesarean delivery</description> </secondary_outcome> <secondary_outcome> <measure>Number of participants suffering from dyspareunia in women with Niche</measure> <time_frame>from delivery to 6 months, 12 months, 18 months, 24 months after cesarean delivery, up to 24 months from delivery</time_frame> <description>Number of participants suffering from dyspareunia in women with Niche, assessed at 6 months, 12 months, 18 months and 24 months after cesarean delivery</description> </secondary_outcome> <secondary_outcome> <measure>Dyspareunia severity in women with Niche</measure> <time_frame>from delivery to 6 months, 12 months, 18 months, 24 months after cesarean delivery, up to 24 months from delivery</time_frame> <description>Participants with dyspareunia self-assessed pain levels and scored 1 to 10 rely on the Numeric Rating Scale (NRS). The average score in span of 6 months will be calculated and the highest score will be noticed to reveal dyspareunia severity at 6 months, 12 months, 18 months, 24 months after delivery</description> </secondary_outcome> <secondary_outcome> <measure>Niche length</measure> <time_frame>from delivery to 6 months, 12 months, 18 months, 24 months after cesarean delivery, up to 24 months from delivery</time_frame> <description>The length at Niche base will be measured in the sagittal plane on transvaginal ultrasound, assessed at 6 months, 12 months, 18 months and 24 months after cesarean delivery.</description> </secondary_outcome> <secondary_outcome> <measure>Niche depth</measure> <time_frame>: from delivery to 6 months, 12 months, 18 months, 24 months after cesarean delivery, up to 24 months from delivery</time_frame> <description>The largest depth of Niche will be measured in the sagittal plane on ultrasound, assessed at 6 months, 12 months, 18 months and 24 months after cesarean delivery.</description> </secondary_outcome> <secondary_outcome> <measure>Number of branches of Niche</measure> <time_frame>from delivery to 6 months, 12 months, 18 months, 24 months after cesarean delivery, up to 24 months from delivery</time_frame> <description>Number of branches of Niche will be measured in the transverse plane on transvaginal ultrasound, assessed at 6 months, 12 months, 18 months and 24 months after cesarean delivery.</description> </secondary_outcome> <secondary_outcome> <measure>Residual myometrial thickness (RMT)</measure> <time_frame>from delivery to 6 months, 12 months, 18 months, 24 months after cesarean delivery, up to 24 months from delivery</time_frame> <description>Thinnest point of residual myometrial thickness will be measured in the sagittal plane on transvaginal ultrasound, regardless of direction (measured perpendicular to serosa but not necessarily to uterine cavity), from the main Niche or branch with the thinnest RMT. Fibroid is not included in RMT measurement, assessed at 6 months, 12 months, 18 months and 24 months after cesarean delivery.</description> </secondary_outcome> <secondary_outcome> <measure>Ratio of residual myometrial thickness per adjacent myometrial thickness (RMT/AMT)</measure> <time_frame>from delivery to 6 months, 12 months, 18 months, 24 months after cesarean delivery, up to 24 months from delivery</time_frame> <description>Adjacent myometrial thickness will be measured close to Niche in the sagittal plane on transvaginal ultrasound, where myometrium is thickness. Ratio of RMT/AMT will be assessed at 6 months, 12 months, 18 months and 24 months after cesarean delivery.</description> </secondary_outcome> <secondary_outcome> <measure>Niche-vesicovaginal fold distance</measure> <time_frame>from delivery to 6 months, 12 months, 18 months, 24 months after cesarean delivery, up to 24 months from delivery</time_frame> <description>Distance between Niche and vesicovaginal fold will be measured in the sagittal plane on transvaginal ultrasound, from level of top main Niche (where residual myometrial thickness is smallest (dotted line)) to vesicovaginal fold, assessed at 6 months, 12 months, 18 months and 24 months after cesarean delivery.</description> </secondary_outcome> <secondary_outcome> <measure>Niche-external os distance</measure> <time_frame>from delivery to 6 months, 12 months, 18 months, 24 months after cesarean delivery, up to 24 months from delivery</time_frame> <description>Distance between niche and external os will be measured parallel to cervical canal, from most distal point of niche to external os in the sagittal plane on transvaginal ultrasound, assessed at 6 months, 12 months, 18 months and 24 months after cesarean delivery.</description> </secondary_outcome> <secondary_outcome> <measure>Evaluating the correlation between Niche characteristics and gynecological symptoms</measure> <time_frame>from delivery to 6 months, 12 months, 18 months, 24 months after cesarean delivery, up to 24 months from delivery</time_frame> <description>Correlation between characteristics of Niche (include length, depth, branches, RMT, RMT/AMT, Niche-vesicovaginal fold distance and Niche-external os distance) and gynecological symptoms (involve postmenstrual spotting, dysmenorrhea, suprapubic pain and dyspareunia) will be analyzed at 6 months, 12 months, 18 months and 24 months after cesarean delivery</description> </secondary_outcome> <secondary_outcome> <measure>Evaluating factors contributing to Niche development</measure> <time_frame>from delivery to 6 months, 12 months, 18 months, 24 months after cesarean delivery, up to 24 months from delivery</time_frame> <description>Correlation between Niche formation and risk factors include labor (cervical dilation, duration of labor), planned or unplanned cesarean section, maternal factors, short-term outcomes such as uterine atony, post-partum hemorrhage, post-partum blood transfusion, maternal infection will be analyzed at 6 months, 12 months, 18 months and 24 months after cesarean delivery</description> </secondary_outcome> <secondary_outcome> <measure>Comparison between the rate of niche detection by regular TVUS and sonohysterography</measure> <time_frame>from delivery to 6 months, 12 months, 18 months, 24 months after cesarean delivery, up to 24 months from delivery</time_frame> <description>Comparison between rate of niche detection (percentage) in all follow-up events by regular TVUS and sonohysterography</description> </secondary_outcome> <other_outcome> <measure>Reproductive outcome during 2 years of follow-up</measure> <time_frame>24 months from delivery</time_frame> <description>Percentage of women that conceived at any time during 2 years of follow-up</description> </other_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">938</enrollment> <condition>Niche</condition> <arm_group> <arm_group_label>Single-layer uterine closure</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Women will undergo a CD following a standard way with respect to the mode of hysterotomy, non-closure of the peritoneum. The control group will receive a single-layer closure using unlocked continuous running multifilament sutures and the endometrial layer will be included</description> </arm_group> <arm_group> <arm_group_label>Double-layer uterine closure</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Women will undergo a CD following a standard way with respect to the mode of hysterotomy, non-closure of the peritoneum. In the intervention group, double-layer closure of the uterus will be performed using unlocked multifilament continuous running sutures for both layers and the endometrial layer will be included in the first layer. The second layer is a continuous running suture that imbricates the first layer</description> </arm_group> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>Double-layer uterine closure</intervention_name> <description>In the intervention group, double-layer closure of the uterus will be performed using unlocked multifilament continuous running sutures for both layers and the endometrial layer will be included in the first layer. The second layer is a continuous running suture that imbricates the first layer</description> <arm_group_label>Double-layer uterine closure</arm_group_label> </intervention> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>Single-layer uterine closure</intervention_name> <description>The control group will receive a single-layer closure using unlocked continuous running multifilament sutures and the endometrial layer will be included</description> <arm_group_label>Single-layer uterine closure</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Pregnant women who undergo a primary CD (planned or unplanned)  - Age ≥ 18 years.  - Gestational age ≥ 37 0/7 weeks  Exclusion Criteria:  - Previous major uterine surgery (e.g. laparoscopic or laparotomic fibroid resection, septum resection).  - Women with abnormal menstrual bleeding (e.g. cervical dysplasia, communicating hydrosalpinx, uterine anomaly or endocrine disorders disturbing ovulation, drugs, polyps, fibroids, etc.).  - Women with dysmenorrhea, dyspareunia, suprapubic pain.  - Abnormal placenta: Placenta privia, Placenta percreta… in the current pregnancy. </textblock> </criteria> <gender>Female</gender> <minimum_age>18 Years</minimum_age> <maximum_age>60 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Anh D Nguyen, PhD. MD</last_name> <role>Study Director</role> <affiliation>Hanoi Obstetric and Gynecology Hospital</affiliation> </overall_official> <overall_official> <last_name>Yves Ville, PhD. MD</last_name> <role>Study Chair</role> <affiliation>Hôpital Necker-Enfants Malades</affiliation> </overall_official> <overall_official> <last_name>Ha TT Nguyen, PhD.MD</last_name> <role>Principal Investigator</role> <affiliation>Hanoi Obstetric and Gynecology Hospital</affiliation> </overall_official> <overall_official> <last_name>Giang TT Duong, MD</last_name> <role>Principal Investigator</role> <affiliation>Hanoi Obstetric and Gynecology Hospital</affiliation> </overall_official> <overall_contact> <last_name>Ha TT Nguyen, PhD.MD</last_name> <phone>0989661093</phone> <email>dr.hanguyen@hogh.vn</email> </overall_contact> <overall_contact_backup> <last_name>Giang TT Duong, MD</last_name> <phone>0084972186390</phone> <email>dttgnts41@gmail.com</email> </overall_contact_backup> <location> <facility> <name>Hanoi Obstetrics and Gynecology Hospital</name> <address> <city>Hà Nội</city> <state>Hanoi</state> <zip>100000</zip> <country>Vietnam</country> </address> </facility> </location> <location_countries> <country>Vietnam</country> </location_countries> <reference> <citation>Delport S. Global epidemiology of use of and disparities in caesarean sections. Lancet. 2019 Jul 6;394(10192):23-24. doi: 10.1016/S0140-6736(19)30717-2. Epub 2019 Jul 4. No abstract available.</citation> <PMID>31282354</PMID> </reference> <reference> <citation>Naji O, Wynants L, Smith A, Abdallah Y, Saso S, Stalder C, Van Huffel S, Ghaem-Maghami S, Van Calster B, Timmerman D, Bourne T. Does the presence of a Caesarean section scar affect implantation site and early pregnancy outcome in women attending an early pregnancy assessment unit? Hum Reprod. 2013 Jun;28(6):1489-96. doi: 10.1093/humrep/det110. Epub 2013 Apr 12.</citation> <PMID>23585560</PMID> </reference> <reference> <citation>Naji O, Wynants L, Smith A, Abdallah Y, Stalder C, Sayasneh A, McIndoe A, Ghaem-Maghami S, Van Huffel S, Van Calster B, Timmerman D, Bourne T. Predicting successful vaginal birth after Cesarean section using a model based on Cesarean scar features examined by transvaginal sonography. Ultrasound Obstet Gynecol. 2013 Jun;41(6):672-8. doi: 10.1002/uog.12423.</citation> <PMID>23371440</PMID> </reference> <reference> <citation>Roberge S, Demers S, Berghella V, Chaillet N, Moore L, Bujold E. Impact of single- vs double-layer closure on adverse outcomes and uterine scar defect: a systematic review and metaanalysis. Am J Obstet Gynecol. 2014 Nov;211(5):453-60. doi: 10.1016/j.ajog.2014.06.014. Epub 2014 Jun 6.</citation> <PMID>24912096</PMID> </reference> <reference> <citation>Hesselman S, Hogberg U, Ekholm-Selling K, Rassjo EB, Jonsson M. The risk of uterine rupture is not increased with single- compared with double-layer closure: a Swedish cohort study. BJOG. 2015 Oct;122(11):1535-41. doi: 10.1111/1471-0528.13015. Epub 2014 Aug 4.</citation> <PMID>25088680</PMID> </reference> <reference> <citation>Clark EA, Silver RM. Long-term maternal morbidity associated with repeat cesarean delivery. Am J Obstet Gynecol. 2011 Dec;205(6 Suppl):S2-10. doi: 10.1016/j.ajog.2011.09.028. Epub 2011 Oct 6.</citation> <PMID>22114995</PMID> </reference> <reference> <citation>Jordans IPM, de Leeuw RA, Stegwee SI, Amso NN, Barri-Soldevila PN, van den Bosch T, Bourne T, Brolmann HAM, Donnez O, Dueholm M, Hehenkamp WJK, Jastrow N, Jurkovic D, Mashiach R, Naji O, Streuli I, Timmerman D, van der Voet LF, Huirne JAF. Sonographic examination of uterine niche in non-pregnant women: a modified Delphi procedure. Ultrasound Obstet Gynecol. 2019 Jan;53(1):107-115. doi: 10.1002/uog.19049.</citation> <PMID>29536581</PMID> </reference> <reference> <citation>Bij de Vaate AJ, van der Voet LF, Naji O, Witmer M, Veersema S, Brolmann HA, Bourne T, Huirne JA. Prevalence, potential risk factors for development and symptoms related to the presence of uterine niches following Cesarean section: systematic review. Ultrasound Obstet Gynecol. 2014 Apr;43(4):372-82. doi: 10.1002/uog.13199.</citation> <PMID>23996650</PMID> </reference> <reference> <citation>Dodd JM, Anderson ER, Gates S, Grivell RM. Surgical techniques for uterine incision and uterine closure at the time of caesarean section. Cochrane Database Syst Rev. 2014 Jul 22;(7):CD004732. doi: 10.1002/14651858.CD004732.pub3.</citation> <PMID>25048608</PMID> </reference> <reference> <citation>Di Spiezio Sardo A, Saccone G, McCurdy R, Bujold E, Bifulco G, Berghella V. Risk of Cesarean scar defect following single- vs double-layer uterine closure: systematic review and meta-analysis of randomized controlled trials. Ultrasound Obstet Gynecol. 2017 Nov;50(5):578-583. doi: 10.1002/uog.17401. Epub 2017 Oct 9.</citation> <PMID>28070914</PMID> </reference> <reference> <citation>Hanacek J, Vojtech J, Urbankova I, Krcmar M, Krepelka P, Feyereisl J, Krofta L. Ultrasound cesarean scar assessment one year postpartum in relation to one- or two-layer uterine suture closure. Acta Obstet Gynecol Scand. 2020 Jan;99(1):69-78. doi: 10.1111/aogs.13714. Epub 2019 Sep 26.</citation> <PMID>31441500</PMID> </reference> <reference> <citation>Stegwee SI, Jordans IPM, van der Voet LF, Bongers MY, de Groot CJM, Lambalk CB, de Leeuw RA, Hehenkamp WJK, van de Ven PM, Bosmans JE, Pajkrt E, Bakkum EA, Radder CM, Hemelaar M, van Baal WM, Visser H, van Laar JOEH, van Vliet HAAM, Rijnders RJP, Sueters M, Janssen CAH, Hermes W, Feitsma AH, Kapiteijn K, Scheepers HCJ, Langenveld J, de Boer K, Coppus SFPJ, Schippers DH, Oei ALM, Kaplan M, Papatsonis DNM, de Vleeschouwer LHM, van Beek E, Bekker MN, Huisjes AJM, Meijer WJ, Deurloo KL, Boormans EMA, van Eijndhoven HWF, Huirne JAF. Single- versus double-layer closure of the caesarean (uterine) scar in the prevention of gynaecological symptoms in relation to niche development - the 2Close study: a multicentre randomised controlled trial. BMC Pregnancy Childbirth. 2019 Mar 4;19(1):85. doi: 10.1186/s12884-019-2221-y.</citation> <PMID>30832681</PMID> </reference> <reference> <citation>Dahlke JD, Mendez-Figueroa H, Maggio L, Sperling JD, Chauhan SP, Rouse DJ. The Case for Standardizing Cesarean Delivery Technique: Seeing the Forest for the Trees. Obstet Gynecol. 2020 Nov;136(5):972-980. doi: 10.1097/AOG.0000000000004120.</citation> <PMID>33030865</PMID> </reference> <verification_date>August 2022</verification_date> <study_first_submitted>March 1, 2022</study_first_submitted> <study_first_submitted_qc>April 1, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>August 4, 2022</last_update_submitted> <last_update_submitted_qc>August 4, 2022</last_update_submitted_qc> <last_update_posted type="Actual">August 5, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor-Investigator</responsible_party_type> <investigator_affiliation>Hanoi Obstetrics and Gynecology Hospital</investigator_affiliation> <investigator_full_name>Nguyen Thi Thu Ha</investigator_full_name> <investigator_title>Deputy Director</investigator_title> </responsible_party> <keyword>single-layer uterine closure</keyword> <keyword>double-layer uterine closure</keyword> <keyword>niche</keyword> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Rationale: Cesarean delivery (CD) rates are increasing rapidly worldwide. The consequences of cesarean section not only affect the next pregnancies such as uterine rupture or malplacentation but also cause many gynecological complications or infertility due to the formation of cesarean scar defect (CSD) or Niche. One of the major factors for Niche formation is the techniques of hysterotomy closure at the time of cesarean delivery. Most common hysterotomy closures include single and double layers closure. However, there is limited literature to prove which technique decreases niche creation and associated gynecological complications. Objective: To compare the effect of uterine closure techniques during CD on the formation of Niche evaluated on transvaginal ultrasound and gynecological complications. Study design: a double-blinded, single-center, randomized clinical trial. Setting: Hanoi Obstetrics & Gynecology Hospital (HOGH), Viet Nam. Study population: All women at gestational age ≥ 37 0/7 weeks who undergo a primary CD (planned or unplanned). Intervention: After informed consent, women will be randomized to either unlocked single layer closure or unlocked double-layer closures of cesarean uterine scar in a 1:1 ratio Primary outcome: The proportion of Niche over time (at 6, 12, 18, 24 months after CD) in the two groups. Power calculation: A sample size of 389 women is needed for each group. Nature and extent of the burden and risks associated with participation, benefit, and group relatedness: Both uterine closure methods followed by the Vietnam Ministry of Health (VN-MOH), transvaginal ultrasound is also not harmful. It is believed that there are no potential increased risks to patients taking part in this trial because of the standard care and management they receive. Pregnancies at term, indicated for cesarean delivery for the first time, will be fully consulted information related to this study before surgery. Written consent will be obtained from each eligible pregnant woman before randomization into the study. After signing the informed consent form, eligible women will be randomly assigned in a 1:1 ratio to receive either single-layer closure or double-layer closure, using block randomization with a variable block size of 4, 6. The computer-generated random list will be prepared by an independent statistician who has no other involvement in the study. To ensure allocation concealment, opaque and sealed envelopes will be prepared and controlled by two administrative staff in the Clinical Trial Unit who have no involvement in clinical work. Whenever there is an eligible participant, these two staff will hand over the envelope in sequence to the clinician. As the result, surgeons will not be blinded, but participants and sonographers will be unaware of closure techniques. Apart from randomization, patients will be followed up and treated according to local protocol. The cesarean section with two uterine scar closure techniques will be performed by well-trained obstetricians. Participants and sonographers will be blinded for the closure technique. Intervention (double-layer closure) In both study groups, women will undergo a CD following a standard way with respect to the mode of hysterotomy, non-closure of the peritoneum. In the intervention group, double-layer closure of the uterus will be performed using unlocked multifilament continuous running sutures for both layers and the endometrial layer will be included in the first layer. The second layer is a continuous running suture that imbricates the first layer. Control group (single-layer closure) The control group will receive a single-layer closure using unlocked continuous running multifilament sutures and the endometrial layer will be included. Complication during surgery The cases that have complications during surgery will be excluded from the study. Complications encompass: - Maternal mortality - Maternal admitted ICU - Hysterectomy - Damage to internal organs (bowel, bladder or ureters). - Complications during postoperative period requiring further surgery. Follow-up Participants will be contacted via telephone to notify about follow-up visits within 10 days of the first day of every menstrual cycle at 6 months, 12 months, 18 months, 24 months (give or take 2 weeks). Every regular follow-up visit, the participants will be examined and transvaginal ultrasound followed by saline infusion sonohysterography to evaluate Niche. The ultrasound evaluation is standardized as proposed by the latest standard of ISUOG(2019). Reproductive outcomes at two years follow-up: Percentage of women that conceived at any time during the follow-up duration, time of conception, and results of said pregnancies (ongoing pregnancy, terminated pregnancy due to medical/ social indication). Niche evaluation Every regular follow-up visit, the participants will be examined and transvaginal ultrasound followed by sonohysterography to evaluate Niche. The Niche evaluation is standardized as proposed by the latest standard of ISUOG(2019). Inclusion Criteria: - Pregnant women who undergo a primary CD (planned or unplanned) - Age ≥ 18 years. - Gestational age ≥ 37 0/7 weeks Exclusion Criteria: - Previous major uterine surgery (e.g. laparoscopic or laparotomic fibroid resection, septum resection). - Women with abnormal menstrual bleeding (e.g. cervical dysplasia, communicating hydrosalpinx, uterine anomaly or endocrine disorders disturbing ovulation, drugs, polyps, fibroids, etc.). - Women with dysmenorrhea, dyspareunia, suprapubic pain. - Abnormal placenta: Placenta privia, Placenta percreta… in the current pregnancy.

NCT0531xxxx/NCT05312788.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05312788</url> </required_header> <id_info> <org_study_id>ASRB001313/EB/IBMS</org_study_id> <nct_id>NCT05312788</nct_id> </id_info> <brief_title>Effect of Barley Supplemented Wheat Bread on Markers of Cardiovascular and Renal Health</brief_title> <official_title>Effect of Barley Supplemented Wheat Bread on Markers of Cardiovascular and Renal Health: A Randomized Controlled Trial</official_title> <sponsors> <lead_sponsor> <agency>Khyber Medical University Peshawar</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Khyber Medical University Peshawar</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The disruption of colonic microbiota has been linked to a number of diseases, mainly cardiovascular and kidney diseases. One possible means to improve the microbiota is to increase dietary fiber intake as the intake of dietary fiber shifts the fermentation from proteolytic saccharolytic fermentation.  Beta-glucans are soluble dietary fibers mainly found in oats and barley. Results from previous studies suggest that the consumption of barley reduces the risk of cardiovascular and kidney diseases. Therefore, this study will explore the effect of barley beta-glucans on markers of Cardiovascular and Renal health. </textblock> </brief_summary> <overall_status>Completed</overall_status> <start_date type="Actual">May 4, 2022</start_date> <completion_date type="Actual">August 10, 2022</completion_date> <primary_completion_date type="Actual">August 10, 2022</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Prevention</primary_purpose> <masking>Single (Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Change in Serum Thiobarbituric acid reactive substances (TBARs) from baseline to 4 weeks</measure> <time_frame>Baseline and after 4 weeks</time_frame> </primary_outcome> <primary_outcome> <measure>Change in Serum Total antioxidant capacity (TAC) from baseline to 4 weeks</measure> <time_frame>Baseline and after 4 weeks</time_frame> </primary_outcome> <primary_outcome> <measure>Change in Serum Nitric oxide from baseline to 4 weeks</measure> <time_frame>Baseline and after 4 weeks</time_frame> </primary_outcome> <primary_outcome> <measure>change in Serum E-selectin from baseline to 4 weeks</measure> <time_frame>Baseline and after 4 weeks</time_frame> </primary_outcome> <primary_outcome> <measure>Change in Serum P-cresyl sulfate from baseline to 4 weeks</measure> <time_frame>Baseline and after 4 weeks</time_frame> </primary_outcome> <primary_outcome> <measure>Change in Serum Indoxyl sulfate from baseline to 4 weeks</measure> <time_frame>Baseline and after 4 weeks</time_frame> </primary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">25</enrollment> <condition>Cardiovascular Diseases</condition> <condition>Kidney Diseases</condition> <arm_group> <arm_group_label>Whole wheat bread</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> <description>Whole wheat bread will be used as control bread.</description> </arm_group> <arm_group> <arm_group_label>Barley supplemented wheat bread</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Barley supplemented wheat bread (50% substitution) will be used as experimental bread.</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Effect of Barley Supplemented Wheat Bread on markers of Cardiovascular and Renal Health</intervention_name> <description>Intervention will involve intake of 50% barley substituted wheat bread.</description> <arm_group_label>Barley supplemented wheat bread</arm_group_label> <arm_group_label>Whole wheat bread</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Healthy individuals of age 18 years or older  - BMI ranged between 18.5 and 24.9  Exclusion Criteria:  - Celiac disease, Cancer, Diabetes , cardiovascular diseases  - Gastro intestinal tract disease  - Pregnant women  - Use of pre-, pro- or antibiotics 15 days before the enrollment into the study  - Food allergy to food used in the trial </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>65 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <location> <facility> <name>Khyber Medical University, Peshawar</name> <address> <city>Peshawar</city> <state>KPK</state> <zip>25000</zip> <country>Pakistan</country> </address> </facility> </location> <location_countries> <country>Pakistan</country> </location_countries> <reference> <citation>Cosola C, De Angelis M, Rocchetti MT, Montemurno E, Maranzano V, Dalfino G, Manno C, Zito A, Gesualdo M, Ciccone MM, Gobbetti M, Gesualdo L. Beta-Glucans Supplementation Associates with Reduction in P-Cresyl Sulfate Levels and Improved Endothelial Vascular Reactivity in Healthy Individuals. PLoS One. 2017 Jan 20;12(1):e0169635. doi: 10.1371/journal.pone.0169635. eCollection 2017.</citation> <PMID>28107445</PMID> </reference> <reference> <citation>Sirich TL, Plummer NS, Gardner CD, Hostetter TH, Meyer TW. Effect of increasing dietary fiber on plasma levels of colon-derived solutes in hemodialysis patients. Clin J Am Soc Nephrol. 2014 Sep 5;9(9):1603-10. doi: 10.2215/CJN.00490114. Epub 2014 Aug 21.</citation> <PMID>25147155</PMID> </reference> <reference> <citation>Bacchetti T, Tullii D, Masciangelo S, Gesuita R, Skrami E, Bruge F, Silvestri S, Orlando P, Tiano L, Ferretti G. Effect of a barley-vegetable soup on plasma carotenoids and biomarkers of cardiovascular disease. J Clin Biochem Nutr. 2015 Jul;57(1):66-73. doi: 10.3164/jcbn.15-11. Epub 2015 Jun 5.</citation> <PMID>26236103</PMID> </reference> <reference> <citation>Gaesser GA, Rodriguez J, Patrie JT, Whisner CM, Angadi SS. Effects of Glycemic Index and Cereal Fiber on Postprandial Endothelial Function, Glycemia, and Insulinemia in Healthy Adults. Nutrients. 2019 Oct 6;11(10):2387. doi: 10.3390/nu11102387.</citation> <PMID>31590437</PMID> </reference> <verification_date>April 2023</verification_date> <study_first_submitted>February 28, 2022</study_first_submitted> <study_first_submitted_qc>April 1, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>April 6, 2023</last_update_submitted> <last_update_submitted_qc>April 6, 2023</last_update_submitted_qc> <last_update_posted type="Actual">April 10, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Khyber Medical University Peshawar</investigator_affiliation> <investigator_full_name>Bibi Hajira</investigator_full_name> <investigator_title>Assistant Professor</investigator_title> </responsible_party> <keyword>TBARs</keyword> <keyword>TAC</keyword> <keyword>pCS</keyword> <keyword>Barley</keyword> <keyword>Beta-glucan</keyword> <keyword>E-selectin</keyword> <keyword>NO</keyword> <condition_browse>  <mesh_term>Kidney Diseases</mesh_term> <mesh_term>Cardiovascular Diseases</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

The disruption of colonic microbiota has been linked to a number of diseases, mainly cardiovascular and kidney diseases. One possible means to improve the microbiota is to increase dietary fiber intake as the intake of dietary fiber shifts the fermentation from proteolytic saccharolytic fermentation. Beta-glucans are soluble dietary fibers mainly found in oats and barley. Results from previous studies suggest that the consumption of barley reduces the risk of cardiovascular and kidney diseases. Therefore, this study will explore the effect of barley beta-glucans on markers of Cardiovascular and Renal health. Inclusion Criteria: - Healthy individuals of age 18 years or older - BMI ranged between 18.5 and 24.9 Exclusion Criteria: - Celiac disease, Cancer, Diabetes , cardiovascular diseases - Gastro intestinal tract disease - Pregnant women - Use of pre-, pro- or antibiotics 15 days before the enrollment into the study - Food allergy to food used in the trial

NCT0531xxxx/NCT05312801.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05312801</url> </required_header> <id_info> <org_study_id>LMY-920-001</org_study_id> <nct_id>NCT05312801</nct_id> </id_info> <brief_title>Phase 1 Study of BAFF CAR-T Cells (LMY-920) for Non-Hodgkin Lymphoma</brief_title> <official_title>LMY-920 for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma</official_title> <sponsors> <lead_sponsor> <agency>Luminary Therapeutics</agency> <agency_class>Industry</agency_class> </lead_sponsor> <collaborator> <agency>Case Comprehensive Cancer Center</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Luminary Therapeutics</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>Yes</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Therapy with chimeric antigen receptor T (CAR-T) cells has demonstrated activity against refractory lymphoma, however not all tumors respond or remain in response to CD19 targeted CAR-T cells. We posit that CAR-T cells expressing BAFF (BAFF CAR-T cells) can become another strategy to treat refractory lymphoma, even after relapse following cluster of differentiation antigen 19 (CD19) targeting CAR-T treatment.  This phase 1 study will evaluate safe dose and provide initial signal of the activity of BAFF CAR-T cells against relapsed non-Hodgkin lymphoma using a single lymphodepletion regimen and using a BAFF CAR-T cell manufacturing process. </textblock> </brief_summary> <detailed_description> <textblock> LMY-920 is an autologous CAR-T cell therapy consisting of autologous cluster of differentiation 4 (CD4) positive and cluster of differentiation 8 (CD8) positive human T cells that are genetically engineered using the non-viral transposon system to express the BAFF-ligand CAR-T that target BAFF receptor family members to eliminate malignant B cells.  BAFF receptor family includes B-cell activating factor receptor (BR3), B-cell maturation antigen (BCMA) and transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI). These receptors are present on non-Hodgkin lymphoma.  The goal of LMY-920-001 phase 1 study is to find recommended phase 2 dose of LMY-920 for treatment of patients with relapsed or refractory non-Hodgkin lymphoma. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Anticipated">January 23, 2023</start_date> <completion_date type="Anticipated">September 2, 2024</completion_date> <primary_completion_date type="Anticipated">June 1, 2024</primary_completion_date> <phase>Phase 1</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>N/A</allocation> <intervention_model>Sequential Assignment</intervention_model> <intervention_model_description>Open label, dose escalation study. Dose Levels 1 x 10 million BAFF+ CAR cells/kg 2 x 10 million BAFF+ CAR cells/kg 4 x 10 million BAFF+ CAR cells/kg 8 x 10 million BAFF+ CAR cells/kg</intervention_model_description> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>To determine recommended phase II dose of human LMY-920.</measure> <time_frame>24 months</time_frame> <description>Maximum tolerated dose.</description> </primary_outcome> <secondary_outcome> <measure>To establish toxicity profile for the infusion of LMY-920.</measure> <time_frame>24 months</time_frame> <description>Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. All adverse events during study will be collected, categorized, and graded. Attribution of relatedness to the investigational agent will be assigned.</description> </secondary_outcome> <secondary_outcome> <measure>To determine the objective response rate .</measure> <time_frame>24 months</time_frame> <description>Response rate.</description> </secondary_outcome> <secondary_outcome> <measure>To determine the complete response rate.</measure> <time_frame>24 months</time_frame> <description>Response rate.</description> </secondary_outcome> <secondary_outcome> <measure>To determine the duration of response.</measure> <time_frame>24 months</time_frame> <description>Duration of response.</description> </secondary_outcome> <secondary_outcome> <measure>To determine the progression-free survival.</measure> <time_frame>24 months</time_frame> <description>Progression-free survival.</description> </secondary_outcome> <secondary_outcome> <measure>To determine the overall survival.</measure> <time_frame>24 months</time_frame> <description>Overall survival.</description> </secondary_outcome> <secondary_outcome> <measure>To determine incidence of adverse events.</measure> <time_frame>24 months</time_frame> <description>Incidence of adverse events.</description> </secondary_outcome> <secondary_outcome> <measure>To determine incidence of anti- LMY-920 antibodies.</measure> <time_frame>24 months</time_frame> <description>Incidence of anti- LMY-920 antibodies.</description> </secondary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Anticipated">20</enrollment> <condition>Lymphoma, Non-Hodgkin Lymphoma, B-Cell</condition> <arm_group> <arm_group_label>LMY-920 dose escalation</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Open label, dose escalation study with up to four dose levels of LMY-920. The maximum tolerated dose (MTD) of LMY-920 will be determined using dose-escalation 3+3 design.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>BAFF CAR-T</intervention_name> <description>Autologous CAR-T cell therapy expressing the BAFF-ligand.</description> <arm_group_label>LMY-920 dose escalation</arm_group_label> <other_name>LMY-920</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. Subjects must have histologically confirmed non-Hodgkin lymphoma relapsed after 2 or more lines of therapy or disease refractory to chemotherapy (defined as progressive disease or stable disease lasting ≤6 months, as best response to most recent chemotherapy regimen; or disease progression or recurrence ≤12 months after prior autologous stem cell transplantation (ASCT).  2. No evidence of central nervous system (CNS) lymphoma.  3. Male or female > 18 years of age.  4. Eastern Cooperative Oncology Group Performance status ≤ 2.  5. At least one measurable lesion.  6. >2 weeks since prior radiation therapy or systemic therapy at the time of leukapheresis.  7. Total bilirubin ≤ 1.5 mg/dL (except in patients with Gilbert's syndrome).  8. Aspartate aminotransferase/alanine transferase ≤ 2.5 X institutional upper limit of normal.  9. Serum creatinine < 1.5 mg/dL.  10. Cardiac ejection fraction of >50%, and no evidence of pericardial effusion, as determined by an echocardiogram.  11. Adequate pulmonary function as defined as pulse oximetry ≥ 92% on room air.  12. Subjects (or legal guardians) must have the ability to understand and the willingness to sign a written informed consent document.  13. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of < 1% per year during the treatment period and for at least 90 days after the BAFF CAR-T cell infusion.  14. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm.  Exclusion Criteria:  1. ASCT within 6 weeks of informed consent.  2. History of allogeneic hematopoietic stem cell transplantation.  3. Active graft-versus-host disease.  4. Active central nervous system or meningeal involvement by lymphoma or leukemia.  5. Active malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast).  6. Less than 28 days elapsed between prior treatment with investigational agent(s) and the day of lymphocyte collection.  7. New York Heart Association class IV congestive heart failure.  8. Cardiovascular disorders including unstable angina pectoris, clinically significant cardiac arrhythmias, myocardial infarction or stroke (including transient ischemic attack, or other ischemic event) within 6 months prior to registration.  9. Active infection requiring intravenous systemic treatment.  10. HIV seropositivity.  11. Pregnant or breastfeeding women.  12. Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy.  13. Serologic status reflecting active hepatitis B or C infection.  14. Patients with history of clinically relevant CNS pathology such as epilepsy, seizure disorders, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia and Parkinson's disease.  15. Subjects with uncontrolled intercurrent illness.  16. Known additional malignancies which require systemic treatment.  17. History of autoimmune disease with requirement of immunosuppressive medications (other than low dose steroids) within 6 months. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Paolo F. Caimi, MD</last_name> <role>Principal Investigator</role> <affiliation>Cleveland Clinic Taussig Cancer Institute</affiliation> </overall_official> <overall_contact> <last_name>Paolo F. Caimi, MD</last_name> <phone>216 445-4635</phone> <email>CAIMIP@ccf.org</email> </overall_contact> <location> <facility> <name>University Hospitals Seidman Cancer Center</name> <address> <city>Cleveland</city> <state>Ohio</state> <zip>44106</zip> <country>United States</country> </address> </facility> <status>Not yet recruiting</status> <contact> <last_name>Leland Metheny, MD</last_name> <phone>216-844-0139</phone> <email>Leland.Metheny@uhhospitals.org</email> </contact> </location> <location> <facility> <name>Taussig Cancer Institute | Cleveland Clinic</name> <address> <city>Cleveland</city> <state>Ohio</state> <zip>44195</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Paolo F Caimi, MD</last_name> <email>caimip@ccf.org</email> </contact> <contact_backup> <last_name>Kimberly Grundey, MSN RN</last_name> <phone>2164424583</phone> <email>mailto:GRUNDEK@ccf.org</email> </contact_backup> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>January 2023</verification_date> <study_first_submitted>March 24, 2022</study_first_submitted> <study_first_submitted_qc>April 1, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>January 11, 2023</last_update_submitted> <last_update_submitted_qc>January 11, 2023</last_update_submitted_qc> <last_update_posted type="Actual">January 13, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>non-Hodgkin lymphoma.</keyword> <condition_browse>  <mesh_term>Lymphoma</mesh_term> <mesh_term>Lymphoma, Non-Hodgkin</mesh_term> <mesh_term>Lymphoma, B-Cell</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Therapy with chimeric antigen receptor T (CAR-T) cells has demonstrated activity against refractory lymphoma, however not all tumors respond or remain in response to CD19 targeted CAR-T cells. We posit that CAR-T cells expressing BAFF (BAFF CAR-T cells) can become another strategy to treat refractory lymphoma, even after relapse following cluster of differentiation antigen 19 (CD19) targeting CAR-T treatment. This phase 1 study will evaluate safe dose and provide initial signal of the activity of BAFF CAR-T cells against relapsed non-Hodgkin lymphoma using a single lymphodepletion regimen and using a BAFF CAR-T cell manufacturing process. LMY-920 is an autologous CAR-T cell therapy consisting of autologous cluster of differentiation 4 (CD4) positive and cluster of differentiation 8 (CD8) positive human T cells that are genetically engineered using the non-viral transposon system to express the BAFF-ligand CAR-T that target BAFF receptor family members to eliminate malignant B cells. BAFF receptor family includes B-cell activating factor receptor (BR3), B-cell maturation antigen (BCMA) and transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI). These receptors are present on non-Hodgkin lymphoma. The goal of LMY-920-001 phase 1 study is to find recommended phase 2 dose of LMY-920 for treatment of patients with relapsed or refractory non-Hodgkin lymphoma. Inclusion Criteria: 1. Subjects must have histologically confirmed non-Hodgkin lymphoma relapsed after 2 or more lines of therapy or disease refractory to chemotherapy (defined as progressive disease or stable disease lasting ≤6 months, as best response to most recent chemotherapy regimen; or disease progression or recurrence ≤12 months after prior autologous stem cell transplantation (ASCT). 2. No evidence of central nervous system (CNS) lymphoma. 3. Male or female > 18 years of age. 4. Eastern Cooperative Oncology Group Performance status ≤ 2. 5. At least one measurable lesion. 6. >2 weeks since prior radiation therapy or systemic therapy at the time of leukapheresis. 7. Total bilirubin ≤ 1.5 mg/dL (except in patients with Gilbert's syndrome). 8. Aspartate aminotransferase/alanine transferase ≤ 2.5 X institutional upper limit of normal. 9. Serum creatinine < 1.5 mg/dL. 10. Cardiac ejection fraction of >50%, and no evidence of pericardial effusion, as determined by an echocardiogram. 11. Adequate pulmonary function as defined as pulse oximetry ≥ 92% on room air. 12. Subjects (or legal guardians) must have the ability to understand and the willingness to sign a written informed consent document. 13. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of < 1% per year during the treatment period and for at least 90 days after the BAFF CAR-T cell infusion. 14. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm. Exclusion Criteria: 1. ASCT within 6 weeks of informed consent. 2. History of allogeneic hematopoietic stem cell transplantation. 3. Active graft-versus-host disease. 4. Active central nervous system or meningeal involvement by lymphoma or leukemia. 5. Active malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast). 6. Less than 28 days elapsed between prior treatment with investigational agent(s) and the day of lymphocyte collection. 7. New York Heart Association class IV congestive heart failure. 8. Cardiovascular disorders including unstable angina pectoris, clinically significant cardiac arrhythmias, myocardial infarction or stroke (including transient ischemic attack, or other ischemic event) within 6 months prior to registration. 9. Active infection requiring intravenous systemic treatment. 10. HIV seropositivity. 11. Pregnant or breastfeeding women. 12. Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy. 13. Serologic status reflecting active hepatitis B or C infection. 14. Patients with history of clinically relevant CNS pathology such as epilepsy, seizure disorders, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia and Parkinson's disease. 15. Subjects with uncontrolled intercurrent illness. 16. Known additional malignancies which require systemic treatment. 17. History of autoimmune disease with requirement of immunosuppressive medications (other than low dose steroids) within 6 months.

NCT0531xxxx/NCT05312814.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05312814</url> </required_header> <id_info> <org_study_id>21-051-NPT</org_study_id> <nct_id>NCT05312814</nct_id> </id_info> <brief_title>Clinical Utility of the Addition of a SNP-based NIPT Zygosity Determination in Twin Pregnancy Management.</brief_title> <acronym>ZTWINS</acronym> <official_title>Clinical Utility of the Addition of a SNP-based NIPT Zygosity Determination in Twin Pregnancy Management.</official_title> <sponsors> <lead_sponsor> <agency>Natera, Inc.</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Natera, Inc.</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The ZTWINS registry study is an observational, prospective, multi-center study observing women carrying a twin pregnancy who receive snp-based non-invasive prenatal screening and zygosity assessment as part of their medical care. </textblock> </brief_summary> <detailed_description> <textblock> This observational data collection study will include subjects with ultrasound-confirmed twin pregnancy and planned NIPS zygosity assessment as a part of their clinical care. Initial chorionicity assessment and, when available, planned twin pregnancy management (e.g., frequency of prenatal ultrasounds, maternal fetal medicine (MFM) referral etc) will be recorded in the study database. Following zygosity results being returned through clinical care NIPS, updated chorionicity & amnionicity will again be recorded in the study database. Other clinical data in the medical record as part of clinical care, including monochorionic twin pregnancy complications (TTTS, FTC referral, etc), placenta pathology findings, and delivery and neonatal outcomes will also be recorded in the study database. There will be no study blood sample collection or other study procedures performed as part of this study. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">October 1, 2021</start_date> <completion_date type="Anticipated">November 2023</completion_date> <primary_completion_date type="Anticipated">November 2023</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Cohort</observational_model> <time_perspective>Prospective</time_perspective> </study_design_info> <primary_outcome> <measure>Assess clinical utility of combining NIPT-based zygosity measurements with ultrasound chorionicity assessments for the management of twin pregnancies.</measure> <time_frame>2 years</time_frame> <description>Primary outcome will be measured by determining the overall frequency of NIPT-determined monozygosity among twin pregnancies; the frequency of discordance between NIPT-determined zygosity and ultrasound only chorionicity assessments; and the proportion of twin pregnancies with twin--twin transfusion syndrome (TTTS) that are diagnosed late as compared with historical rates.</description> </primary_outcome> <primary_outcome> <measure>Frequency of monozygosity</measure> <time_frame>2 years</time_frame> <description>Measuring overall frequency of NIPT-determined monozygosity among twin pregnancies, measured by the number monozygotic pregnancies over the total number of twin pregnancies in the study.</description> </primary_outcome> <primary_outcome> <measure>Frequency of changed chorionicity assessment</measure> <time_frame>2 years</time_frame> <description>The frequency of discordance between NIPT-determined zygosity and ultrasound only chorionicity assessments, as measured by the total number of pregnancies with a change in chorinicity assessment following the NIPT-based zygsity results release.</description> </primary_outcome> <primary_outcome> <measure>Frequency of late TTTS diagnosis</measure> <time_frame>2 years</time_frame> <description>The frequency of late diagnosis of Twin to Twin Transfusion Syndrome (TTTS) in twin pregnancies with TTTS will be compared with historical rates of late TTTS diagnosis.</description> </primary_outcome> <number_of_groups>1</number_of_groups> <enrollment type="Anticipated">700</enrollment> <condition>Twin to Twin Transfusion Syndrome</condition> <condition>Pregnancy Complications</condition> <condition>Multiple Gestation; Maternal Care</condition> <arm_group> <arm_group_label>Twin pregnancies undergoing non-invasive prenatal screening</arm_group_label> <description>Women carrying a twin pregnancy undergoing non-invasive prenatal screening for zygosity and aneuploidy syndromes. No drug/device will be administered; clinical data will be collected for research analysis.</description> </arm_group> <eligibility> <study_pop> <textblock> Pregnant women carrying a twin pregnancy </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Women with an ultrasound confirmation of twin pregnancy  Exclusion Criteria:  - Singleton or non-twin multiple pregnancy </textblock> </criteria> <gender>Female</gender> <minimum_age>18 Years</minimum_age> <maximum_age>55 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Ruben Quintero, MD</last_name> <role>Principal Investigator</role> <affiliation>The Fetal Institute</affiliation> </overall_official> <overall_contact> <last_name>ZTWINS Team</last_name> <phone>(650) 249-9090</phone> <email>ztwins@natera.com</email> </overall_contact> <location> <facility> <name>Rady Children's Specialists of San Diego, San Diego Perinatal Center</name> <address> <city>San Diego</city> <state>California</state> <zip>92123</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Deirdre McCullough, MD</last_name> </contact> </location> <location> <facility> <name>University of Colorado</name> <address> <city>Aurora</city> <state>Colorado</state> <zip>80045</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>K.Joseph Hurt, MD, PhD</last_name> </contact> </location> <location> <facility> <name>Anne Arundel Medical Center/Luminis Health</name> <address> <city>Annapolis</city> <state>Maryland</state> <zip>21401</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Clark Johnson, MD</last_name> </contact> </location> <location> <facility> <name>Mayo Clinic</name> <address> <city>Rochester</city> <state>Minnesota</state> <zip>55905</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Myra Wick, MD, PhD</last_name> </contact> </location> <location> <facility> <name>Carnegie Imaging for Women</name> <address> <city>New York</city> <state>New York</state> <zip>10128</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Andrei Rebarber, MD</last_name> </contact> </location> <location> <facility> <name>University of Rochester</name> <address> <city>Rochester</city> <state>New York</state> <zip>14642</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Neil Seligman, MD</last_name> </contact> </location> <location> <facility> <name>UNC Chapel Hill</name> <address> <city>Chapel Hill</city> <state>North Carolina</state> <zip>27516</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Neeta Vora, MD</last_name> </contact> </location> <location> <facility> <name>Seven Hills/ Axia</name> <address> <city>Cincinnati</city> <state>Ohio</state> <zip>45242</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Gerard Reilly, MD</last_name> </contact> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>April 2022</verification_date> <study_first_submitted>February 24, 2022</study_first_submitted> <study_first_submitted_qc>April 1, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>April 4, 2022</last_update_submitted> <last_update_submitted_qc>April 4, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 12, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Pregnancy Complications</mesh_term> <mesh_term>Fetofetal Transfusion</mesh_term> </condition_browse>  </clinical_study>

The ZTWINS registry study is an observational, prospective, multi-center study observing women carrying a twin pregnancy who receive snp-based non-invasive prenatal screening and zygosity assessment as part of their medical care. This observational data collection study will include subjects with ultrasound-confirmed twin pregnancy and planned NIPS zygosity assessment as a part of their clinical care. Initial chorionicity assessment and, when available, planned twin pregnancy management (e.g., frequency of prenatal ultrasounds, maternal fetal medicine (MFM) referral etc) will be recorded in the study database. Following zygosity results being returned through clinical care NIPS, updated chorionicity & amnionicity will again be recorded in the study database. Other clinical data in the medical record as part of clinical care, including monochorionic twin pregnancy complications (TTTS, FTC referral, etc), placenta pathology findings, and delivery and neonatal outcomes will also be recorded in the study database. There will be no study blood sample collection or other study procedures performed as part of this study. Pregnant women carrying a twin pregnancy Inclusion Criteria: - Women with an ultrasound confirmation of twin pregnancy Exclusion Criteria: - Singleton or non-twin multiple pregnancy

NCT0531xxxx/NCT05312827.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05312827</url> </required_header> <id_info> <org_study_id>2022-4546</org_study_id> <nct_id>NCT05312827</nct_id> </id_info> <brief_title>Training Intervention and Program of Support (TIPS): Fostering Family-centred Telehealth in Pediatric Rehabilitation</brief_title> <acronym>TIPS</acronym> <official_title>Training Intervention and Program of Support (TIPS) for Fostering the Adoption of Family-centred Telehealth Interventions in Pediatric Rehabilitation: A Pan-Canadian Implementation-effectiveness Study</official_title> <sponsors> <lead_sponsor> <agency>Université de Sherbrooke</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Canadian Institutes of Health Research (CIHR)</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Université de Sherbrooke</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Timely access to family-centred services for children with disability and their families is important to support their development and well-being. Currently, many children face long wait times and barriers to services. Lack of access can lead to negative impacts for children and stress for their families. With the COVID-19 pandemic, these issues have been made more challenging with the loss of rehabilitation support for children, increasing stress on families. During this time, therapists moved to telehealth service delivery to support children and families.  We know that telehealth can improve access to services, children's outcomes, and family satisfaction, and that telehealth a key element of Family Centred Services (FCS) in pediatric rehabilitation. FCC include practices that promote flexibility, respect and dignity for families' views, knowledge and strengths, effective information sharing, partnership and collaboration in decision making, and coordinated and comprehensive care. FCC focuses on developing collaborative family-provider relationships, where parents are active participants in collaborative goal-setting, therapy planning, implementation, and evaluation, and where activities are integrated within daily routines and contexts (e.g., home and community). Compared to traditional service delivery methods, telehealth offers opportunities to enhance FCC practices. FCC provides alternate, convenient, and flexible ways to partner with families, respecting their characteristics and barriers, allows knowledge and information sharing about the child within their contexts, supports family decision making and parents' well-being, and has been recognized as an important addition to comprehensive care coordination and service delivery.  Telehealth is an important and effective alternative for families living in both urban and remote or underserved areas and can be more convenient than in-person visits (e.g., less travel time, schedule flexibility). However, the use of telehealth prior to the pandemic was low in pediatric rehabilitation. In addition, many therapists report delivering telehealth without prior experience, and lack confidence, knowledge, and training in effective intervention strategies. Although therapists' knowledge, skills and attitudes toward telehealth can improve with time and experience, training and support are required for behavioural changes to occur.  Following the pandemic, there has been continued support for the use of FCT and for its ongoing use to support families of children with disability. Pediatric rehabilitation therapists, service managers, professional associations, policy makers, and families are all making the case for not "returning to normal", and are asking for help to keep telehealth as part of FCS care.  The goal of the current study is to evaluate the use and effectiveness of a Training Intervention and Program of Support (TIPS) to increase the uptake of FCT in pediatric rehabilitation centres across Canada.  The main research question is: Can TIPS be adapted to increase the use of FCT interventions by therapists working in different contexts?  The primary objectives are to:  1. Evaluate the use of FCT regarding:  1. Therapists' desire to use vs actual use of FCT practices  2. Use of FCT practices as they were intended to be used  Secondary objectives are to:  2. Describe the variations required to adapt the TIPS to meet each site's needs  3. Identify factors that influence FCT use and adherence  4. Evaluate the effectiveness with regards to:  1. Service wait-times  2. Family-centredness of services  3. Changes in service delivery  5. Evaluate the costs (and possible cost savings) related to increased use of FCT  The primary hypotheses are that therapists' desire to adopt FCT and deliver FCT practices as intended will (i) improve slightly in the short term (i.e., one-month post-TIPS), yet (ii) will improve significantly post-TIPS, (iii) while actual use will vary over time, across sites and therapists, and will depend on therapist-, client-, organizational- and system-factors. For the secondary hypotheses, the investigators expect that, for sites with the largest changes in desire to use and use of FCT practices as intended, (iv) wait times will significantly decrease and (v) families' perceptions of service quality will significantly improve post-TIPS. </textblock> </brief_summary> <detailed_description> <textblock> INTRODUCTION Timely access to family-centred services for children with disability and their families is crucial to support their development and well-being. Currently, many children face long wait times (i.e., up to 2 years) and organizational, geographic and/or cultural barriers to services. Lack of access can lead to negative developmental, health and social consequences for children (e.g., suboptimal development, academic difficulties) and their families (e.g., stress). The COVID-19 pandemic further exacerbated these issues, as rehabilitation support for children was lost, increasing parental mental health burden (e.g., increased stress, depression). To minimize the negative impacts of these service disruptions, therapists were required to shift to telehealth service delivery.  Evidence exists of the efficacy of telehealth to improve service access, children's outcomes, and family satisfaction and acceptability, supporting the integration of telehealth as a key element of Family Centred Services (FCS) in pediatric rehabilitation. Telehealth can be defined as 'any asynchronous or real time clinical intervention provided remotely by therapists to patients and/or caregivers. It has been recognized as an important alternative for families living in underserved or remote areas. However, some families in well-served urban locations also prefer the convenience of telehealth over in-person visits (e.g., less travel time, schedule flexibility). Prior to the pandemic, a systematic review of pediatric rehabilitation telehealth randomized controlled trials supported the efficacy of such interventions for a wide range of outcomes and diverse populations. Further publications demonstrated the efficacy and acceptability of telehealth, further supporting its integration into comprehensive FCS models.  The established efficacy of telehealth highlights a critical knowledge-to-practice gap. Before the pandemic, the adoption of telehealth was low in pediatric rehabilitation. In an international survey conducted in August 2019 (1,133 pediatric therapists from 76 countries), 3.9% were using telehealth; a follow-up survey with a subsample in May 2020 highlighted that 70.1% had adopted telehealth. Many reported doing so without prior experience, and lacked confidence, knowledge, and training in effective intervention strategies. When asked what support was required to implement telehealth, training was by far the most frequently cited - and included communication skills with families over the phone and internet, safe and effective use of platforms, reliable assessment, and intervention strategies with children of various ages and health conditions. Although therapists' knowledge, skills and attitudes toward telehealth can improve with time and experience, training and support are required for behavioural changes to occur. Unfortunately, there is a paucity of evidence related to how personal and contextual factors may influence telehealth training and support. Targeting therapists' knowledge, skills, and attitudes, associated with their intention to adopt telehealth, and their professional role within FCS, appear vital to the implementation of telehealth.  For the purposes of this study, family-centred telehealth (FCT) is defined as pediatric rehabilitation which uses family-centred care (FCC) practices while working with families remotely. FCC is recognized as a best practice approach in pediatric rehabilitation. Described as a partnership approach, FCC is based on the belief that the child's well-being and care needs are best supported within the family context through effective family-provider collaborations. Moreover, FCC's central tenet is the assumption that the processes of care delivery are as important to the child and family outcomes as the specific characteristic of the clinical intervention delivered. It is characterized by practices that promote clinical flexibility, respect and dignity for families' perspectives, knowledge, strengths and characteristics, effective information sharing (general and specific), partnership and collaboration between parties to support decision making, and coordinated and comprehensive care delivery. Furthermore, FCC occurs in the therapeutic environment that optimizes the development of a collaborative family-provider relationship, where parents are active participants in collaborative goal-setting, therapy planning, implementation, and evaluation, and where activities are integrated within daily routines and contexts (e.g., home and community). Compared to more traditional service delivery methods, telehealth offers opportunities to enhance FCC practices. It provides alternate, convenient, and flexible ways to partner with families, respecting their characteristics (e.g., single parenting) and constraints (e.g., geographical, temporal, financial), allows real-time knowledge acquisition and information sharing about the child within their contexts, supports family decision making and parents' psychosocial well-being (i.e., decreasing anxiety, stress, and depression), and has been recognized as an important addition to comprehensive care coordination and service delivery.  Considerable momentum exists supporting the uptake of FCT and fostering its ongoing sustainable use within accessible and supportive services for the families of children with disability following the pandemic. Pediatric rehabilitation therapists, service managers, professional associations, policy makers, and patients alike are calling for resistance to "returning to normal", and instead are requesting help to sustain telehealth as part of the FCS continuum of care. The proposed study aims to evaluate the implementation and effectiveness of a Training Intervention and Program of Support (TIPS) to enhance the adoption of FCT in pediatric rehabilitation centres across Canada.  RESEARCH QUESTIONS AND OBJECTIVES The main research question is: Can TIPS be co-adapted to enhance the adoption of FCT interventions by therapists working in different contexts?  Primary objectives are to:  1. Evaluate the implementation with regard to:  1. Therapists' intention to adopt vs actual adoption of FCT practices  2. Fidelity of FCT practices  Secondary objectives are to:  2. Document the contextual variations required to co-adapt the TIPS to meet each site's needs  3. Identify factors influencing FCT adoption and fidelity  4. Evaluate the effectiveness with regards to:  1. Service wait-times  2. Families' perception of service quality (i.e., family-centredness)  3. Changes in service delivery  5. Evaluate the costs (and possible cost savings) related to increased use of FCT  The primary hypotheses are that therapists' intention to adopt FCT and fidelity of FCT practices will (i) improve minimally in the short term (i.e., one-month post-TIPS), yet (ii) will improve significantly post-implementation of TIPS, (iii) while actual adoption and engagement will fluctuate over time, across sites and therapists, and will depend on therapist-, client-, organizational- and system-factors. For the secondary hypotheses, the investigators expect that, for sites with the largest effect change in intention to adopt and fidelity of FCT practices, (iv) wait times will significantly decrease and (v) families' perceptions of service quality will significantly improve post-implementation of TIPS.  METHODS Implementation science conceptual framework The study framework builds on implementation science frameworks that aim to accelerate the translational research pipeline, bridging the current knowledge-to-practice gap. Specifically, the Consolidated Framework for Implementation Research (CFIR) will guide the identification of factors influencing adoption of FCT and will help engage leaders in participating sites in adapting the TIPS to their own contextual drivers, while maintaining the FCT key ingredients. A hybrid design will be used, as recommended when the traditional research pipeline efficacy-effectiveness-implementation is too time consuming, and considered unethical, failing to adequately respond to the urgency of the expressed need. A Type 3 hybrid design was chosen, primarily focusing on implementation indicators, while also collecting some effectiveness outcomes, with comparative assessments occurring at the therapist, service and/or family level. This design is recommended when there is: 1) momentum for implementation within the health care system; 2) strong face validity and indirect evidence for the clinical intervention and implementation strategy to support generalizability; 3) minimal risk associated with the clinical intervention and the implementation strategy; and 4) evidence of feasibility for the implementation strategy and support in the clinical and organization context under study. The present study meets all these criteria, as there is: 1) momentum for the sustainability of telehealth implemented during and following the COVID-19 pandemic; 2) strong and growing evidence of effectiveness for telehealth, as well as for training and support knowledge translation strategies; 3) promising results from our studies supporting the safe use of TIPS to implement FCT; and 4) well-established evidence of implementation feasibility of telehealth.  Design A 4-year pan-Canadian stakeholder-oriented, mixed-method implementation-effectiveness design will be used. TIPS will be implemented in all sites in a same region during the same month, and sequentially introduced across all regions, 2 months apart. An interrupted time series (ITS) was selected to assess primary implementation outcomes (obj. 1), as recommended for research in real-world settings. An ITS consists of observing the same dependent variables over time, with a break in the series of observations corresponding to the introduction of an intervention. If the intervention is effective, a change in the series' pre- and post-intervention averages will be observed.  Intervention Informed by implementation strategies recognized as effective in pediatric rehabilitation, TIPS is a multifaceted intervention, comprised of the following components: 1) a 10-hour intensive training program offered to participating therapists at each site over a one-month period, which includes 4 hours of self-paced learning modules and a 6-hour mandatory interactive webinar; and 2) an 11-month program of support which is composed of monthly mentoring meetings at each site led by the local therapist champion, and a national virtual community of practice (vCoP) facilitated by 3 national knowledge brokers (KBs) - an occupational therapist (OT), a physiotherapist (PT) and a speech-language pathologist (SLP) - experienced in FCT in pediatric rehabilitation, offered simultaneously to all participating therapists across Canada.  The TIPS self-paced learning modules are informed by contemporary frameworks of FCC, and relevant family-oriented services. More specifically, they will address the key ingredients associated with the FCT processes and provide practice examples. These key ingredients include: 1) service operations (e.g., service coordination, organization and structures, care planning and goal setting), 2) participatory (e.g., parent engagement, focus on individual family's needs) and 3) relational (e.g., active listening, respect, empathy, reciprocity) caregiving, 4) communicating general (e.g., access to current and future services, parent groups) and specific (e.g., co-morbidities associated with child's condition) information, as well as 6) coaching (e.g., parent task analysis, caregiver implemented strategies with natural contexts, solution-focused coaching)., and 7) engagement strategies. Multimedia (e.g., videos, presentations) content for the asynchronous training modules will be developed by several members of the study team, through ongoing consultation with experts in the field, using education course creation software. The curriculum will then be uploaded to a password protected online platform, for which a unique username and password will be required. Knowledge acquisition, based on the specified learning objectives and the key messages targeted in each training module, will be assessed through short pedagogical quizzes. Completion of the asynchronous modular training and knowledge assessment will be recommended prior to undertaking the synchronous webinar(s).  A 6-hour synchronous webinar component will also be delivered by members of the research team and the 3 national KBs. These webinars will engage therapists in discussion (e.g., case studies), interactive activities (e.g., role play, simulations) to build their critical thinking on how to implement these practices in their context. The webinar content will be adapted for each site in consultation with the Local Leadership Team, (i.e., the site manager, a therapist champion, and a parent/patient partner). This co-adaptation phase will ensure content is tailored to individual site contexts (e.g., engagement practices, site clinical goal-setting processes, service coordination as per team procedures), learner-centred and clinically relevant. The FCT interventions can be implemented using a variety of technologies, including various videoconferencing options, online platforms, websites, email systems, and even telephone. Therapists will be encouraged to consider various asynchronous and real-time technologies, which best respond to families' needs and preferences, and those approved by their organizations. The research team will refrain from recommending specific technologies. There is no prescribed frequency or duration for the FCT interventions; therapist participants will work with families according to their goals and preferences, and organizational policies.  Finally, a program of support will be offered for the remaining year via monthly videoconference mentoring meetings, and access to the vCoP also housed on the password-protected platform. Monthly meetings will focus on sharing site-specific successes, challenges, proposing solutions and reporting results, as well as sharing useful and practical resources. The vCoP will be used to canvas for solutions to address challenges at a national level, share successes, discuss specific cases for guidance, feedback and input, and to share useful tips and tricks, and resources. The structure of our vCoP was informed by previous work related to vCoP and KBs (i.e., individuals with content and leadership expertise, who foster information sharing and research evidence use).  Study Settings Participating sites are publicly funded organizations providing outpatient pediatric rehabilitation services to children aged 0-12 years with or at risk of disability. 'Disability' is used inclusively to recognize all medical diagnoses resulting in limitations in function, such as cerebral palsy and autism spectrum disorder. The term "at risk" includes children presenting with delayed development who may not yet have a diagnosis but have clear functional limitations and qualify for rehabilitation services. The upper age limit of 12 years was chosen, as best practices regarding transition of care suggest that different relationships should be fostered with adolescents over 12 years. The 20 participating sites selected based on various characteristics (e.g., populations, size, services provided, catchment area) thought to influence outcomes, the effect of which will be explored, are clustered into 6 provincial regions. TIPS will be sequentially introduced (i.e., 2 months apart) to each of the regions. To limit the risk of contamination, TIPS will be introduced to all sites in the same region in the same month. However, training will be conducted on a site-by-site basis to create team cohesion. The 2-month interval for implementation between regions gives flexibility for organizing implementation and data collection activities based on site availability and vacation schedules.  Study participants  Participants will belong to at least one of the following categories:  1. Managers (n=20, one per site): Person responsible for rehabilitation services at the site, or their delegate. The managers were identified during the selection of study sites. As members of the Local Leadership Team, managers participate in the co-adaptation of TIPS to their site and could be called upon to contribute to their site's monthly mentoring meetings. They will aid in the recruitment of therapists, parents, a therapist-champion, and a parent-partner for their site.  2. Therapists (n=600 with 50% anticipated response; n=300): PTs, OTs, SLPs providing outpatient pediatric rehabilitation services to children aged 0-12 years in each site, recruited via the managers and interested in utilizing FCT. Therapists will participate in the TIPS program, complete data collection instruments as prescribed, and aid in the recruitment of parents.  3. Parents (n=20/therapist with an anticipated response rate of 33%; n=2000 families per assessment time point): One-time data collection will be undertaken with two samples (one pre-, the other post-implementation) of parents or caregivers who received services (either in-person, virtually, or both) from at least one participating therapist in the previous 3 months.  4. Therapist-champion (n=20, one per site): Therapist selected based on their telehealth experience and on peer recognition within their organization. Therapist-champions are members of the Local Leadership Team participating in the co-adaptation of TIPS to their site and will oversee the monthly mentoring meetings.  5. Parent/patient-partner (n=20, one per site): Parent/patient-partners will primarily be recruited from family, parent or patient advisory committees at the participating sites or, in the absence of such initiatives, from regional, provincial, or national patient engagement programs. As members of the Local Leadership Team, parent/patient-partners participate in the co-adaptation of TIPS to their site and could be called upon to contribute to their site's monthly mentoring meetings.  Recruitment procedures will be flexible and will be adapted to the preferences, policies and procedures at each site. The recruitment of participants may be undertaken by email, sent directly to the potential participant by the research team (ex: therapists) or by the manager or therapist on behalf of the research team (e.g., parents).  Data collection Implementation data will be collected at least three times during each study period: pre-, per-, and post-implementation of TIPS. The additional data collection time point at 1 month per-TIPS will allow the documentation of the short-term impact of TIPS. Statistical analysis models will account for the inequivalent time intervals across study periods. A pre-post design was chosen to measure the intervention effectiveness outcomes and costs, using easily accessible service indicators and questionnaires administered to parents (obj. 4 + obj. 5), as per Type 3 hybrid designs. Qualitative data will be collected during (i.e., recording of monthly local mentoring meetings, and other meetings (as deemed appropriate by the therapist champion), in the vCoP discussions (as threads) and after (i.e., interviews with managers, therapist-champions, therapists and families) the implementation of TIPS.  Sample size justification Number of sites: A total of 20 sites across 8 Canadian provinces (grouped in 6 regions for the roll out of the intervention) are included in the study. Whenever possible, at least 3 sites per province were included to ensure sample diversity and enable the exploration of the provincial health systems' effects on the outcomes as well as to estimate site-related variations in outcomes. Five regions will include sites in the same province, while one region will consist of sites from 3 provinces where only one rehabilitation program was available.  Number of therapists: At the therapist level, implementation outcomes will be assessed 3 times during each period (pre-, per-, and post-TIPS implementation). Assuming an autocorrelation of repeated measures of r<0.3, data collected from 300 therapists will provide >80% power to detect moderate effect sizes (Cohen's d ≥ 0.5), employing a first-order autoregressive segmented regression model and a global type I error level of 5% accounting for multiplicity of outcome assessments (Sidak's correction).  Number of families: With a minimum expected sample size of 20 families per therapist being assessed pre- and/or post-TIPS implementation, statistical power will be >90% to detect even small effect-sizes (0.1< Cohen's d < 0.3) for the effectiveness outcomes i.e., change in wait times and change in families' perceptions of service quality.  Data analysis To evaluate the implementation (obj. 1), longitudinal mixed modeling accounting for and considering potential methodological issues associated with ITS analysis (e.g., auto-correlation, time-varying confounders) will be used to analyse implementation indicators (i.e., ADOPT-VR (Assessing Determinants of Prospective Take-up of Virtual Reality), therapists' self-reported FCT frequency, FCT fidelity self-perceived checklist, PRIME-SP). Changes will be documented short term (i.e., one month after the introduction of the TIPS) and long term (i.e., at the end of the TIPS, 12 months after its introduction). Models will be covariate-adjusted to reduce potential confounding bias, including the therapists' characteristics (e.g., gender, years of experience) and site characteristics (e.g., service provided, geography, general patients characteristics) to estimate associations of key explanatory variables alongside TIPS. Secondary analyses will explore heterogeneity in changes of outcome measures across genders, sites, therapists, and health jurisdiction levels.  To document site-specific co-adaptations of TIPS (obj. 2), proposed adaptations and decisions made by Local Leadership Team committee members will be documented during the discussion group in real-time on the logic model and in the TIPS training materials.  To identify factors influencing adoption and fidelity (obj. 3), recordings of monthly therapists' meetings, potential meetings between KBs and therapist champions) will be analyzed thematically, using a deductive-inductive approach guided by the Consolidated Framework for Implementation Research (CFIR) domains. Guided by an exploratory mixed methods approach, qualitative findings will be integrated with quantitative questionnaire results to further detail inferences.  To evaluate effectiveness (obj. 4) via estimated change in wait times (pre vs post), the confounder-adjusted analysis using generalized linear mixed effect models (GLMM) will employ a log-link function to account for the typically right-skewed nature of time data. Estimated fixed (intervention) effects for the effectiveness outcomes will be reported with Sidak-corrected 95% confidence intervals. To evaluate effectiveness via MPOC-20 (Measure of Process of Care - 20 questions) data, GLMM with nested random effects (families within therapists within sites) will be employed to control for the correlated nature of the data (i.e., the possibility that families have responded once or twice to the MPOC-20) and to account for therapist and site cluster effects. Analyses will be conducted for each of the five MPOC-20 domains and controlled for the same confounding variables described in the analysis for objective 1, as well as for family level variables (e.g., sociocultural background, child's age and gender).  Video-recorded interview data from therapists, managers, and parents will be analysed thematically using an inductive approach to better understand the breadth and depth of changes to pediatric rehabilitation service delivery, according to various stakeholder perspectives. Integration of quantitative and qualitative data using the aforementioned explanatory approach will allow us to uncover the plethora of effects of FCT on pediatric rehabilitation service delivery.  Total system costs related to the implementation of the TIPS, as well as the costs per participating therapist and per site, accounting for different organizational characteristics, will be calculated. Relative cost, an estimation of costs per client seen by therapist, and incremental ratios (i.e., change in costs to use the TIPS divided by change in the primary implementation indicators and secondary effectiveness outcomes) will also be calculated. Finally, societal costs, including families' costs and savings, will also be computed.  Ethical considerations The research ethics committees overseeing the 20 participating sites will approve this research project and be informed of any potential revisions of the protocol. Informed consent will be sought prior to data collection from participating managers, therapists, and parents. Participants will be assigned a unique identification number for denominalization purposes. Whenever posting content to the vCoP, therapists will be encouraged to use their name to promote open exchanges on the platform, but all users will also have the option of using a pseudonym if they prefer. The implementation of the TIPS (e.g., training, meetings) and all data collection (surveys, vCoP, interviews) will take place entirely online. Secure data collection and management solutions (e.g., REDCap, PIERCE) will be used to collect and store study data on institutional servers.  The implementation of TIPS will be gradual across regions, thus ensuring that the sites within the region are ready to participate in the project, taking into consideration institutional challenges such as availability of personnel or timeliness of the implementation of new telehealth modalities. Participants will be informed that study data will not constitute an evaluation of their professional performance. Some concerns are present in the literature that telehealth could increase health inequity and that wealthier families might benefit more from it. This project aims to support the use of FCT interventions with all Canadians families with a child with, or at risk of disability, while considering the interactions between personal, socio-economic, and cultural characteristics, as recommended. The team delivering TIPS is fully bilingual. TIPS and the study's data collection will be available in Canada's two official languages. A pre- and per-implementation consultation process will also be undertaken with First Nations Elders in order to take into account the needs of indigenous communities when delivering TIPS.  KNOWLEDGE TRANSFER In addition to the Local Leadership Team and the support provided to therapist champions, patient-oriented principles will be used within an integrated knowledge translation (iKT) approach to collaborate with knowledge users throughout the research process in order to inform research decisions. Specifically, four members of the research team (two parent-partner and two rehabilitation managers) have specifically been involved as knowledge users, and will be part of the study's Steering Committee. Principles for engaging with non-researchers in research will be respected (e.g., reviewing mutual expectations, providing meeting flexibility and clarification opportunities). The impact of the iKT approach will be assessed, using patient and organizational engagement criteria. Expected knowledge translation strategies include the presentation of study and site-specific data via a webinar for each participating site, as well as the publication of study findings via peer-reviewed publications and via public-facing publications on the research team's and project partners' websites, social media, and newsletters.  EXPECTED OUTCOMES This study will generate knowledge about how to implement family-centred telehealth and rehabilitation practices, inclusive of all families of children with, or at risk of, disability. The knowledge will be contextualized to support therapists working in varied settings and will contribute to building local capacity to sustain the use of FCT interventions. All training materials will be available across Canada and beyond. By increasing therapists' ability to provide telehealth services, the investigators hope to contribute to the transformation of pediatric rehabilitation service delivery, improve access to services, and foster greater well-being for families of children with, or at risk of, disability. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">October 17, 2022</start_date> <completion_date type="Anticipated">October 2024</completion_date> <primary_completion_date type="Anticipated">October 2024</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>N/A</allocation> <intervention_model>Single Group Assignment</intervention_model> <intervention_model_description>A 4-year pan-Canadian stakeholder-oriented, mixed-method implementation-effectiveness design will be used. TIPS will be implemented in all sites in a same region during the same month, and sequentially introduced across all regions, 2 months apart. An interrupted time series (ITS) was selected to assess primary implementation outcomes (obj. 1), as recommended for research in real-world settings. An ITS consists of observing the same dependent variables over time, with a break in the series of observations corresponding to the introduction of an intervention. If the intervention is effective, a change in the series' pre- and post-intervention averages will be observed.</intervention_model_description> <primary_purpose>Health Services Research</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>TIPS Therapist Survey-1</measure> <time_frame>3 months prior to TIPS implementation</time_frame> <description>The TIPS Therapist Survey contains sociodemographic information about the study participant (e.g., discipline, site, province, age), as well as the Therapists' Implementation Questionnaire (TIQ). The TIQ includes the ACCEPT-VFCC (Assessment of Competencies and Contributors to Enhance Practice Transition to Virtual Family Centred Care), a newly created tool inspired by the ADOPT-VR, yet specifically designed for telerehabilitation, the Family Centered Telerehabilitation (FCT) fidelity self-perceived checklist and the PRIME-SP (Pediatric Rehabilitation Intervention Measure of Engagement - Service Provider version).</description> </primary_outcome> <primary_outcome> <measure>TIPS Therapist Survey-2</measure> <time_frame>2 months prior to TIPS implementation</time_frame> <description>The TIPS Therapist Survey contains sociodemographic information about the study participant (e.g., discipline, site, province, age), as well as the Therapists' Implementation Questionnaire (TIQ). The TIQ includes the ACCEPT-VFCC (Assessment of Competencies and Contributors to Enhance Practice Transition to Virtual Family Centred Care), a newly created tool inspired by the ADOPT-VR, yet specifically designed for telerehabilitation, the Family Centered Telerehabilitation (FCT) fidelity self-perceived checklist and the PRIME-SP (Pediatric Rehabilitation Intervention Measure of Engagement - Service Provider version).</description> </primary_outcome> <primary_outcome> <measure>TIPS Therapist Survey-3</measure> <time_frame>1 month prior to TIPS implementation</time_frame> <description>The TIPS Therapist Survey contains sociodemographic information about the study participant (e.g., discipline, site, province, age), as well as the Therapists' Implementation Questionnaire (TIQ). The TIQ includes the ACCEPT-VFCC (Assessment of Competencies and Contributors to Enhance Practice Transition to Virtual Family Centred Care), a newly created tool inspired by the ADOPT-VR, yet specifically designed for telerehabilitation, the Family Centered Telerehabilitation (FCT) fidelity self-perceived checklist and the PRIME-SP (Pediatric Rehabilitation Intervention Measure of Engagement - Service Provider version).</description> </primary_outcome> <primary_outcome> <measure>TIPS Therapist Survey-4</measure> <time_frame>on day 1 of TIPS implementation</time_frame> <description>The TIPS Therapist Survey contains sociodemographic information about the study participant (e.g., discipline, site, province, age), as well as the Therapists' Implementation Questionnaire (TIQ). The TIQ includes the ACCEPT-VFCC (Assessment of Competencies and Contributors to Enhance Practice Transition to Virtual Family Centred Care), a newly created tool inspired by the ADOPT-VR, yet specifically designed for telerehabilitation, the Family Centered Telerehabilitation (FCT) fidelity self-perceived checklist and the PRIME-SP (Pediatric Rehabilitation Intervention Measure of Engagement - Service Provider version).</description> </primary_outcome> <primary_outcome> <measure>TIPS Therapist Survey-5</measure> <time_frame>1 month post TIPS commencement</time_frame> <description>The TIPS Therapist Survey contains sociodemographic information about the study participant (e.g., discipline, site, province, age), as well as the Therapists' Implementation Questionnaire (TIQ). The TIQ includes the ACCEPT-VFCC (Assessment of Competencies and Contributors to Enhance Practice Transition to Virtual Family Centred Care), a newly created tool inspired by the ADOPT-VR, yet specifically designed for telerehabilitation, the Family Centered Telerehabilitation (FCT) fidelity self-perceived checklist and the PRIME-SP (Pediatric Rehabilitation Intervention Measure of Engagement - Service Provider version).</description> </primary_outcome> <primary_outcome> <measure>TIPS Therapist Survey-6</measure> <time_frame>4 months post TIPS commencement</time_frame> <description>The TIPS Therapist Survey contains sociodemographic information about the study participant (e.g., discipline, site, province, age), as well as the Therapists' Implementation Questionnaire (TIQ). The TIQ includes the ACCEPT-VFCC (Assessment of Competencies and Contributors to Enhance Practice Transition to Virtual Family Centred Care), a newly created tool inspired by the ADOPT-VR, yet specifically designed for telerehabilitation, the Family Centered Telerehabilitation (FCT) fidelity self-perceived checklist and the PRIME-SP (Pediatric Rehabilitation Intervention Measure of Engagement - Service Provider version).</description> </primary_outcome> <primary_outcome> <measure>TIPS Therapist Survey-7</measure> <time_frame>8 months post TIPS commencement</time_frame> <description>The TIPS Therapist Survey contains sociodemographic information about the study participant (e.g., discipline, site, province, age), as well as the Therapists' Implementation Questionnaire (TIQ). The TIQ includes the ACCEPT-VFCC (Assessment of Competencies and Contributors to Enhance Practice Transition to Virtual Family Centred Care), a newly created tool inspired by the ADOPT-VR, yet specifically designed for telerehabilitation, the Family Centered Telerehabilitation (FCT) fidelity self-perceived checklist and the PRIME-SP (Pediatric Rehabilitation Intervention Measure of Engagement - Service Provider version).</description> </primary_outcome> <primary_outcome> <measure>TIPS Therapist Survey-8</measure> <time_frame>12 months post TIPS commencement</time_frame> <description>The TIPS Therapist Survey contains sociodemographic information about the study participant (e.g., discipline, site, province, age), as well as the Therapists' Implementation Questionnaire (TIQ). The TIQ includes the ACCEPT-VFCC (Assessment of Competencies and Contributors to Enhance Practice Transition to Virtual Family Centred Care), a newly created tool inspired by the ADOPT-VR, yet specifically designed for telerehabilitation, the Family Centered Telerehabilitation (FCT) fidelity self-perceived checklist and the PRIME-SP (Pediatric Rehabilitation Intervention Measure of Engagement - Service Provider version).</description> </primary_outcome> <primary_outcome> <measure>TIPS Therapist Survey-9</measure> <time_frame>3 months following the end of TIPS implementation</time_frame> <description>The TIPS Therapist Survey contains sociodemographic information about the study participant (e.g., discipline, site, province, age), as well as the Therapists' Implementation Questionnaire (TIQ). The TIQ includes the ACCEPT-VFCC (Assessment of Competencies and Contributors to Enhance Practice Transition to Virtual Family Centred Care), a newly created tool inspired by the ADOPT-VR, yet specifically designed for telerehabilitation, the Family Centered Telerehabilitation (FCT) fidelity self-perceived checklist and the PRIME-SP (Pediatric Rehabilitation Intervention Measure of Engagement - Service Provider version).</description> </primary_outcome> <primary_outcome> <measure>TIPS Therapist Survey-10</measure> <time_frame>6 months following the end of TIPS implementation</time_frame> <description>The TIPS Therapist Survey contains sociodemographic information about the study participant (e.g., discipline, site, province, age), as well as the Therapists' Implementation Questionnaire (TIQ). The TIQ includes the ACCEPT-VFCC (Assessment of Competencies and Contributors to Enhance Practice Transition to Virtual Family Centred Care), a newly created tool inspired by the ADOPT-VR, yet specifically designed for telerehabilitation, the Family Centered Telerehabilitation (FCT) fidelity self-perceived checklist and the PRIME-SP (Pediatric Rehabilitation Intervention Measure of Engagement - Service Provider version).</description> </primary_outcome> <primary_outcome> <measure>TIPS Manager Survey (Pre-Implementation)-1</measure> <time_frame>3 months prior to the commencement of TIPS implementation</time_frame> <description>This survey includes sociodemographic information about the manager (e.g., academic degree, discipline, years of experience), the site profile (SPQ) which includes characteristics about the services provided, the organizations e-readiness, and service wait-time indicators.</description> </primary_outcome> <primary_outcome> <measure>TIPS Manager Survey (Pre-Implementation)-2</measure> <time_frame>on day 1 of TIPS implementation</time_frame> <description>This survey includes sociodemographic information about the manager (e.g., academic degree, discipline, years of experience), the site profile (SPQ) which includes characteristics about the services provided, the organizations e-readiness, and service wait-time indicators.</description> </primary_outcome> <primary_outcome> <measure>TIPS Manager Survey (Post-Implementation)</measure> <time_frame>within 6 months following the end of TIPS implementation</time_frame> <description>This survey includes sociodemographic information about the manager (e.g., academic degree, discipline, years of experience), the site profile (SPQ) which includes characteristics about the services provided, the organizational e-readiness, service wait-time indicators, as well as the addition of organizational costs.</description> </primary_outcome> <primary_outcome> <measure>TIPS Therapist Champion Survey</measure> <time_frame>once, 2 months prior to TIPS implementation</time_frame> <description>This one-time survey is limited to the participant's sociodemographic information (e.g., discipline, years of experience), as well as their telerehabilitation experience, expertise, and training.</description> </primary_outcome> <primary_outcome> <measure>TIPS Parent Survey-1</measure> <time_frame>once, prior to day 1 of TIPS implementation</time_frame> <description>This questionnaire contains The Family Questionnaire (Fam-Q) which collects sociodemographic information about the parent participants and their family (e.g., age, household income, family structure, remoteness) and the family costs and savings associated with accessing rehabilitation services, as well as the MPOC-20 (Measure of Process of Care - 20 questions).</description> </primary_outcome> <primary_outcome> <measure>TIPS Parent Survey-2</measure> <time_frame>once, within 6 months of the end of TIPS implementation</time_frame> <description>This questionnaire contains The Family Questionnaire (Fam-Q) which collects sociodemographic information about the parent participants and their family (e.g., age, household income, family structure, remoteness) and the family costs and savings associated with accessing rehabilitation services, as well as the MPOC-20 (Measure of Process of Care - 20 questions).</description> </primary_outcome> <primary_outcome> <measure>TIPS Parent Partner Survey</measure> <time_frame>once, 2 months prior to TIPS implementation</time_frame> <description>This one-time survey is limited to the participant's sociodemographic characteristics (e.g., age, household income), their comfort level with technology, and their experiences with the site and the various service options (including telerehabilitation)</description> </primary_outcome> <primary_outcome> <measure>Semi-Structured Interviews</measure> <time_frame>within 6 months following the end of TIPS implementation</time_frame> <description>To explore all changes in service delivery (both negative and positive), stakeholders will be invited to participate in a video-recorded semi-structured interview post-implementation. The samples will include all managers, a sample of therapists (all local site champions and a subsample of therapists showing high or low adoption in different sites); and parents with diverse sociocultural characteristics and levels of perception of quality of care and experience with FCT. Parent, manager, therapist and therapist champion interviews will all be conducted only once with each participant.</description> </primary_outcome> <secondary_outcome> <measure>TIPS Logic Model</measure> <time_frame>within 2 months prior to commencement of TIPS implementation</time_frame> <description>A TIPS logic model will be developed by the research team based on best evidence to address FCT needs identified by therapists in a national survey and those recently reported by pediatric therapists in the literature and presented to the Local Leadership Team members for feedback. A discussion group format will be used to gather the Local Leadership Team members' input on site-specific TIPS co-adaptation (i.e., logic model, training materials). To document the Local Leadership Team members' characteristics (e.g., years of experience) and expertise (e.g., involvement and experience with telehealth services), they will be asked to complete a sociodemographic questionnaire prior to the discussion group.</description> </secondary_outcome> <secondary_outcome> <measure>Monthly therapist mentoring meetings</measure> <time_frame>recorded at the frequency at which they occur (i.e., monthly) throughout the 11-months of the study in which they are scheduled</time_frame> <description>Recordings of local monthly therapists' meetings, along with the vCoP discussion threads will be used to identify factors influencing therapists' intention to adopt and use FCT, site FCT implementation challenges and successes, and will facilitate better understanding of the impact of TIPS on clinical practice changes.</description> </secondary_outcome> <secondary_outcome> <measure>Virtual community of practice discussion threads and posts</measure> <time_frame>collected regularly (i.e. monthly) over the 11 months of the support program</time_frame> <description>Virtual community of practice discussion threads, along with recordings of local monthly therapists' meetings, will be used to identify factors influencing therapists' intention to adopt and use FCT, site FCT implementation challenges and successes, and will facilitate better understanding of the impact of TIPS on clinical practice changes.</description> </secondary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Anticipated">2360</enrollment> <condition>Telerehabilitation</condition> <arm_group> <arm_group_label>Telehealth</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>The proposed pre-post study will evaluate the implementation and effectiveness of a Training Intervention and Program of Support (TIPS) to enhance the adoption of family-centred telehealth in pediatric rehabilitation centres across Canada. TIPS is a multifaceted intervention, comprised of the following: 1) a 10-hour intensive training program offered to participating therapists at each site over a one-month period, including 4 hours of self-paced learning modules and a 6-hour mandatory interactive webinar; and 2) an 11-month program of support which is composed of monthly mentoring meetings at each site led by the local therapist champion, and a national virtual community of practice facilitated by 3 national knowledge brokers - an occupational therapist, a physiotherapist and a speech-language pathologist - experienced in family-centred telehealth in pediatric rehabilitation, offered simultaneously to all participating therapists across Canada.</description> </arm_group> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>Training Intervention and Program of Support (TIPS) for fostering the adoption of family-centred telehealth interventions in pediatric rehabilitation</intervention_name> <description>The proposed pre-post study will evaluate the implementation and effectiveness of a Training Intervention and Program of Support (TIPS) to enhance the adoption of family-centred telehealth in pediatric rehabilitation centres across Canada. TIPS is a multifaceted intervention, comprised of the following: 1) a 10-hour intensive training program offered to participating therapists at each site over a one-month period, including 4 hours of self-paced learning modules and a 6-hour mandatory interactive webinar; and 2) an 11-month program of support which is composed of monthly mentoring meetings at each site led by the local therapist champion, and a national virtual community of practice facilitated by 3 national knowledge brokers - an occupational therapist, a physiotherapist and a speech-language pathologist - experienced in family-centred telehealth in pediatric rehabilitation, offered simultaneously to all participating therapists across Canada.</description> <arm_group_label>Telehealth</arm_group_label> <other_name>TIPS</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion/Exclusion Criteria:  Managers:  - Person responsible for rehabilitation services at the site, or their delegate  Therapists:  - PTs, OTs, SLPs providing outpatient pediatric rehabilitation services to children aged 0-12 years in each site, recruited via the managers and interested in utilizing FCT  Parents:  - Parents or caregivers who received services (either in-person, virtually, or both) from at least one participating therapist in the previous 3 months  Therapist champion:  - Therapist selected based on their telehealth experience and on peer recognition within their organization.  Parent/patient-partners:  - Recruited from family, parent or patient advisory committees at the participating sites or, in the absence of such initiatives, from regional, provincial, or national patient engagement programs.  All:  - Can speak French or English </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Chantal Camden, PhD</last_name> <role>Principal Investigator</role> <affiliation>École de réadaptation, CRCHUS, Université de Sherbrooke</affiliation> </overall_official> <overall_contact> <last_name>Chantal Camden, PhD</last_name> <phone>819-346-1110</phone> <phone_ext>70526</phone_ext> <email>chantal.camden@usherbrooke.ca</email> </overall_contact> <overall_contact_backup> <last_name>Jade Berbari</last_name> <phone>819-346-1110</phone> <phone_ext>15717</phone_ext> <email>Jade.berbari@usherbrooke.ca</email> </overall_contact_backup> <location> <facility> <name>Centre intégré universitaire de santé et de services sociaux du Saguenay-Lac-Saint-Jean</name> <address> <city>Chicoutimi</city> <state>Quebec</state> <zip>G7H 7K9</zip> <country>Canada</country> </address> </facility> <status>Not yet recruiting</status> <contact> <last_name>Jimmy Martel</last_name> <email>jimmy.martel@ssss.gouv.qc.ca</email> </contact> </location> <location> <facility> <name>Centre intégré universitaire de santé et des services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke</name> <address> <city>Sherbrooke</city> <state>Quebec</state> <zip>J1J 3H5</zip> <country>Canada</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Sophie Duguay</last_name> <phone>819-849-9102</phone> <phone_ext>57369</phone_ext> <email>sophie.duguay.ciussse-chus@ssss.gouv.qc.ca</email> </contact> </location> <location> <facility> <name>Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec</name> <address> <city>Trois-Rivières</city> <state>Quebec</state> <zip>G8Y 1T6</zip> <country>Canada</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Rina Dupont</last_name> <phone>819-378-4083</phone> <phone_ext>1060</phone_ext> <email>Rina_Dupont@ssss.gouv.qc.ca</email> </contact> </location> <location_countries> <country>Canada</country> </location_countries> <verification_date>November 2022</verification_date> <study_first_submitted>February 15, 2022</study_first_submitted> <study_first_submitted_qc>April 2, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>November 3, 2022</last_update_submitted> <last_update_submitted_qc>November 3, 2022</last_update_submitted_qc> <last_update_posted type="Actual">November 8, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Université de Sherbrooke</investigator_affiliation> <investigator_full_name>Chantal Camden</investigator_full_name> <investigator_title>Dr. Chantal Camden</investigator_title> </responsible_party> <keyword>telehealth</keyword> <keyword>family-centred</keyword> <keyword>pediatric rehabilitation</keyword> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Timely access to family-centred services for children with disability and their families is important to support their development and well-being. Currently, many children face long wait times and barriers to services. Lack of access can lead to negative impacts for children and stress for their families. With the COVID-19 pandemic, these issues have been made more challenging with the loss of rehabilitation support for children, increasing stress on families. During this time, therapists moved to telehealth service delivery to support children and families. We know that telehealth can improve access to services, children's outcomes, and family satisfaction, and that telehealth a key element of Family Centred Services (FCS) in pediatric rehabilitation. FCC include practices that promote flexibility, respect and dignity for families' views, knowledge and strengths, effective information sharing, partnership and collaboration in decision making, and coordinated and comprehensive care. FCC focuses on developing collaborative family-provider relationships, where parents are active participants in collaborative goal-setting, therapy planning, implementation, and evaluation, and where activities are integrated within daily routines and contexts (e.g., home and community). Compared to traditional service delivery methods, telehealth offers opportunities to enhance FCC practices. FCC provides alternate, convenient, and flexible ways to partner with families, respecting their characteristics and barriers, allows knowledge and information sharing about the child within their contexts, supports family decision making and parents' well-being, and has been recognized as an important addition to comprehensive care coordination and service delivery. Telehealth is an important and effective alternative for families living in both urban and remote or underserved areas and can be more convenient than in-person visits (e.g., less travel time, schedule flexibility). However, the use of telehealth prior to the pandemic was low in pediatric rehabilitation. In addition, many therapists report delivering telehealth without prior experience, and lack confidence, knowledge, and training in effective intervention strategies. Although therapists' knowledge, skills and attitudes toward telehealth can improve with time and experience, training and support are required for behavioural changes to occur. Following the pandemic, there has been continued support for the use of FCT and for its ongoing use to support families of children with disability. Pediatric rehabilitation therapists, service managers, professional associations, policy makers, and families are all making the case for not "returning to normal", and are asking for help to keep telehealth as part of FCS care. The goal of the current study is to evaluate the use and effectiveness of a Training Intervention and Program of Support (TIPS) to increase the uptake of FCT in pediatric rehabilitation centres across Canada. The main research question is: Can TIPS be adapted to increase the use of FCT interventions by therapists working in different contexts? The primary objectives are to: 1. Evaluate the use of FCT regarding: 1. Therapists' desire to use vs actual use of FCT practices 2. Use of FCT practices as they were intended to be used Secondary objectives are to: 2. Describe the variations required to adapt the TIPS to meet each site's needs 3. Identify factors that influence FCT use and adherence 4. Evaluate the effectiveness with regards to: 1. Service wait-times 2. Family-centredness of services 3. Changes in service delivery 5. Evaluate the costs (and possible cost savings) related to increased use of FCT The primary hypotheses are that therapists' desire to adopt FCT and deliver FCT practices as intended will (i) improve slightly in the short term (i.e., one-month post-TIPS), yet (ii) will improve significantly post-TIPS, (iii) while actual use will vary over time, across sites and therapists, and will depend on therapist-, client-, organizational- and system-factors. For the secondary hypotheses, the investigators expect that, for sites with the largest changes in desire to use and use of FCT practices as intended, (iv) wait times will significantly decrease and (v) families' perceptions of service quality will significantly improve post-TIPS. INTRODUCTION Timely access to family-centred services for children with disability and their families is crucial to support their development and well-being. Currently, many children face long wait times (i.e., up to 2 years) and organizational, geographic and/or cultural barriers to services. Lack of access can lead to negative developmental, health and social consequences for children (e.g., suboptimal development, academic difficulties) and their families (e.g., stress). The COVID-19 pandemic further exacerbated these issues, as rehabilitation support for children was lost, increasing parental mental health burden (e.g., increased stress, depression). To minimize the negative impacts of these service disruptions, therapists were required to shift to telehealth service delivery. Evidence exists of the efficacy of telehealth to improve service access, children's outcomes, and family satisfaction and acceptability, supporting the integration of telehealth as a key element of Family Centred Services (FCS) in pediatric rehabilitation. Telehealth can be defined as 'any asynchronous or real time clinical intervention provided remotely by therapists to patients and/or caregivers. It has been recognized as an important alternative for families living in underserved or remote areas. However, some families in well-served urban locations also prefer the convenience of telehealth over in-person visits (e.g., less travel time, schedule flexibility). Prior to the pandemic, a systematic review of pediatric rehabilitation telehealth randomized controlled trials supported the efficacy of such interventions for a wide range of outcomes and diverse populations. Further publications demonstrated the efficacy and acceptability of telehealth, further supporting its integration into comprehensive FCS models. The established efficacy of telehealth highlights a critical knowledge-to-practice gap. Before the pandemic, the adoption of telehealth was low in pediatric rehabilitation. In an international survey conducted in August 2019 (1,133 pediatric therapists from 76 countries), 3.9% were using telehealth; a follow-up survey with a subsample in May 2020 highlighted that 70.1% had adopted telehealth. Many reported doing so without prior experience, and lacked confidence, knowledge, and training in effective intervention strategies. When asked what support was required to implement telehealth, training was by far the most frequently cited - and included communication skills with families over the phone and internet, safe and effective use of platforms, reliable assessment, and intervention strategies with children of various ages and health conditions. Although therapists' knowledge, skills and attitudes toward telehealth can improve with time and experience, training and support are required for behavioural changes to occur. Unfortunately, there is a paucity of evidence related to how personal and contextual factors may influence telehealth training and support. Targeting therapists' knowledge, skills, and attitudes, associated with their intention to adopt telehealth, and their professional role within FCS, appear vital to the implementation of telehealth. For the purposes of this study, family-centred telehealth (FCT) is defined as pediatric rehabilitation which uses family-centred care (FCC) practices while working with families remotely. FCC is recognized as a best practice approach in pediatric rehabilitation. Described as a partnership approach, FCC is based on the belief that the child's well-being and care needs are best supported within the family context through effective family-provider collaborations. Moreover, FCC's central tenet is the assumption that the processes of care delivery are as important to the child and family outcomes as the specific characteristic of the clinical intervention delivered. It is characterized by practices that promote clinical flexibility, respect and dignity for families' perspectives, knowledge, strengths and characteristics, effective information sharing (general and specific), partnership and collaboration between parties to support decision making, and coordinated and comprehensive care delivery. Furthermore, FCC occurs in the therapeutic environment that optimizes the development of a collaborative family-provider relationship, where parents are active participants in collaborative goal-setting, therapy planning, implementation, and evaluation, and where activities are integrated within daily routines and contexts (e.g., home and community). Compared to more traditional service delivery methods, telehealth offers opportunities to enhance FCC practices. It provides alternate, convenient, and flexible ways to partner with families, respecting their characteristics (e.g., single parenting) and constraints (e.g., geographical, temporal, financial), allows real-time knowledge acquisition and information sharing about the child within their contexts, supports family decision making and parents' psychosocial well-being (i.e., decreasing anxiety, stress, and depression), and has been recognized as an important addition to comprehensive care coordination and service delivery. Considerable momentum exists supporting the uptake of FCT and fostering its ongoing sustainable use within accessible and supportive services for the families of children with disability following the pandemic. Pediatric rehabilitation therapists, service managers, professional associations, policy makers, and patients alike are calling for resistance to "returning to normal", and instead are requesting help to sustain telehealth as part of the FCS continuum of care. The proposed study aims to evaluate the implementation and effectiveness of a Training Intervention and Program of Support (TIPS) to enhance the adoption of FCT in pediatric rehabilitation centres across Canada. RESEARCH QUESTIONS AND OBJECTIVES The main research question is: Can TIPS be co-adapted to enhance the adoption of FCT interventions by therapists working in different contexts? Primary objectives are to: 1. Evaluate the implementation with regard to: 1. Therapists' intention to adopt vs actual adoption of FCT practices 2. Fidelity of FCT practices Secondary objectives are to: 2. Document the contextual variations required to co-adapt the TIPS to meet each site's needs 3. Identify factors influencing FCT adoption and fidelity 4. Evaluate the effectiveness with regards to: 1. Service wait-times 2. Families' perception of service quality (i.e., family-centredness) 3. Changes in service delivery 5. Evaluate the costs (and possible cost savings) related to increased use of FCT The primary hypotheses are that therapists' intention to adopt FCT and fidelity of FCT practices will (i) improve minimally in the short term (i.e., one-month post-TIPS), yet (ii) will improve significantly post-implementation of TIPS, (iii) while actual adoption and engagement will fluctuate over time, across sites and therapists, and will depend on therapist-, client-, organizational- and system-factors. For the secondary hypotheses, the investigators expect that, for sites with the largest effect change in intention to adopt and fidelity of FCT practices, (iv) wait times will significantly decrease and (v) families' perceptions of service quality will significantly improve post-implementation of TIPS. METHODS Implementation science conceptual framework The study framework builds on implementation science frameworks that aim to accelerate the translational research pipeline, bridging the current knowledge-to-practice gap. Specifically, the Consolidated Framework for Implementation Research (CFIR) will guide the identification of factors influencing adoption of FCT and will help engage leaders in participating sites in adapting the TIPS to their own contextual drivers, while maintaining the FCT key ingredients. A hybrid design will be used, as recommended when the traditional research pipeline efficacy-effectiveness-implementation is too time consuming, and considered unethical, failing to adequately respond to the urgency of the expressed need. A Type 3 hybrid design was chosen, primarily focusing on implementation indicators, while also collecting some effectiveness outcomes, with comparative assessments occurring at the therapist, service and/or family level. This design is recommended when there is: 1) momentum for implementation within the health care system; 2) strong face validity and indirect evidence for the clinical intervention and implementation strategy to support generalizability; 3) minimal risk associated with the clinical intervention and the implementation strategy; and 4) evidence of feasibility for the implementation strategy and support in the clinical and organization context under study. The present study meets all these criteria, as there is: 1) momentum for the sustainability of telehealth implemented during and following the COVID-19 pandemic; 2) strong and growing evidence of effectiveness for telehealth, as well as for training and support knowledge translation strategies; 3) promising results from our studies supporting the safe use of TIPS to implement FCT; and 4) well-established evidence of implementation feasibility of telehealth. Design A 4-year pan-Canadian stakeholder-oriented, mixed-method implementation-effectiveness design will be used. TIPS will be implemented in all sites in a same region during the same month, and sequentially introduced across all regions, 2 months apart. An interrupted time series (ITS) was selected to assess primary implementation outcomes (obj. 1), as recommended for research in real-world settings. An ITS consists of observing the same dependent variables over time, with a break in the series of observations corresponding to the introduction of an intervention. If the intervention is effective, a change in the series' pre- and post-intervention averages will be observed. Intervention Informed by implementation strategies recognized as effective in pediatric rehabilitation, TIPS is a multifaceted intervention, comprised of the following components: 1) a 10-hour intensive training program offered to participating therapists at each site over a one-month period, which includes 4 hours of self-paced learning modules and a 6-hour mandatory interactive webinar; and 2) an 11-month program of support which is composed of monthly mentoring meetings at each site led by the local therapist champion, and a national virtual community of practice (vCoP) facilitated by 3 national knowledge brokers (KBs) - an occupational therapist (OT), a physiotherapist (PT) and a speech-language pathologist (SLP) - experienced in FCT in pediatric rehabilitation, offered simultaneously to all participating therapists across Canada. The TIPS self-paced learning modules are informed by contemporary frameworks of FCC, and relevant family-oriented services. More specifically, they will address the key ingredients associated with the FCT processes and provide practice examples. These key ingredients include: 1) service operations (e.g., service coordination, organization and structures, care planning and goal setting), 2) participatory (e.g., parent engagement, focus on individual family's needs) and 3) relational (e.g., active listening, respect, empathy, reciprocity) caregiving, 4) communicating general (e.g., access to current and future services, parent groups) and specific (e.g., co-morbidities associated with child's condition) information, as well as 6) coaching (e.g., parent task analysis, caregiver implemented strategies with natural contexts, solution-focused coaching)., and 7) engagement strategies. Multimedia (e.g., videos, presentations) content for the asynchronous training modules will be developed by several members of the study team, through ongoing consultation with experts in the field, using education course creation software. The curriculum will then be uploaded to a password protected online platform, for which a unique username and password will be required. Knowledge acquisition, based on the specified learning objectives and the key messages targeted in each training module, will be assessed through short pedagogical quizzes. Completion of the asynchronous modular training and knowledge assessment will be recommended prior to undertaking the synchronous webinar(s). A 6-hour synchronous webinar component will also be delivered by members of the research team and the 3 national KBs. These webinars will engage therapists in discussion (e.g., case studies), interactive activities (e.g., role play, simulations) to build their critical thinking on how to implement these practices in their context. The webinar content will be adapted for each site in consultation with the Local Leadership Team, (i.e., the site manager, a therapist champion, and a parent/patient partner). This co-adaptation phase will ensure content is tailored to individual site contexts (e.g., engagement practices, site clinical goal-setting processes, service coordination as per team procedures), learner-centred and clinically relevant. The FCT interventions can be implemented using a variety of technologies, including various videoconferencing options, online platforms, websites, email systems, and even telephone. Therapists will be encouraged to consider various asynchronous and real-time technologies, which best respond to families' needs and preferences, and those approved by their organizations. The research team will refrain from recommending specific technologies. There is no prescribed frequency or duration for the FCT interventions; therapist participants will work with families according to their goals and preferences, and organizational policies. Finally, a program of support will be offered for the remaining year via monthly videoconference mentoring meetings, and access to the vCoP also housed on the password-protected platform. Monthly meetings will focus on sharing site-specific successes, challenges, proposing solutions and reporting results, as well as sharing useful and practical resources. The vCoP will be used to canvas for solutions to address challenges at a national level, share successes, discuss specific cases for guidance, feedback and input, and to share useful tips and tricks, and resources. The structure of our vCoP was informed by previous work related to vCoP and KBs (i.e., individuals with content and leadership expertise, who foster information sharing and research evidence use). Study Settings Participating sites are publicly funded organizations providing outpatient pediatric rehabilitation services to children aged 0-12 years with or at risk of disability. 'Disability' is used inclusively to recognize all medical diagnoses resulting in limitations in function, such as cerebral palsy and autism spectrum disorder. The term "at risk" includes children presenting with delayed development who may not yet have a diagnosis but have clear functional limitations and qualify for rehabilitation services. The upper age limit of 12 years was chosen, as best practices regarding transition of care suggest that different relationships should be fostered with adolescents over 12 years. The 20 participating sites selected based on various characteristics (e.g., populations, size, services provided, catchment area) thought to influence outcomes, the effect of which will be explored, are clustered into 6 provincial regions. TIPS will be sequentially introduced (i.e., 2 months apart) to each of the regions. To limit the risk of contamination, TIPS will be introduced to all sites in the same region in the same month. However, training will be conducted on a site-by-site basis to create team cohesion. The 2-month interval for implementation between regions gives flexibility for organizing implementation and data collection activities based on site availability and vacation schedules. Study participants Participants will belong to at least one of the following categories: 1. Managers (n=20, one per site): Person responsible for rehabilitation services at the site, or their delegate. The managers were identified during the selection of study sites. As members of the Local Leadership Team, managers participate in the co-adaptation of TIPS to their site and could be called upon to contribute to their site's monthly mentoring meetings. They will aid in the recruitment of therapists, parents, a therapist-champion, and a parent-partner for their site. 2. Therapists (n=600 with 50% anticipated response; n=300): PTs, OTs, SLPs providing outpatient pediatric rehabilitation services to children aged 0-12 years in each site, recruited via the managers and interested in utilizing FCT. Therapists will participate in the TIPS program, complete data collection instruments as prescribed, and aid in the recruitment of parents. 3. Parents (n=20/therapist with an anticipated response rate of 33%; n=2000 families per assessment time point): One-time data collection will be undertaken with two samples (one pre-, the other post-implementation) of parents or caregivers who received services (either in-person, virtually, or both) from at least one participating therapist in the previous 3 months. 4. Therapist-champion (n=20, one per site): Therapist selected based on their telehealth experience and on peer recognition within their organization. Therapist-champions are members of the Local Leadership Team participating in the co-adaptation of TIPS to their site and will oversee the monthly mentoring meetings. 5. Parent/patient-partner (n=20, one per site): Parent/patient-partners will primarily be recruited from family, parent or patient advisory committees at the participating sites or, in the absence of such initiatives, from regional, provincial, or national patient engagement programs. As members of the Local Leadership Team, parent/patient-partners participate in the co-adaptation of TIPS to their site and could be called upon to contribute to their site's monthly mentoring meetings. Recruitment procedures will be flexible and will be adapted to the preferences, policies and procedures at each site. The recruitment of participants may be undertaken by email, sent directly to the potential participant by the research team (ex: therapists) or by the manager or therapist on behalf of the research team (e.g., parents). Data collection Implementation data will be collected at least three times during each study period: pre-, per-, and post-implementation of TIPS. The additional data collection time point at 1 month per-TIPS will allow the documentation of the short-term impact of TIPS. Statistical analysis models will account for the inequivalent time intervals across study periods. A pre-post design was chosen to measure the intervention effectiveness outcomes and costs, using easily accessible service indicators and questionnaires administered to parents (obj. 4 + obj. 5), as per Type 3 hybrid designs. Qualitative data will be collected during (i.e., recording of monthly local mentoring meetings, and other meetings (as deemed appropriate by the therapist champion), in the vCoP discussions (as threads) and after (i.e., interviews with managers, therapist-champions, therapists and families) the implementation of TIPS. Sample size justification Number of sites: A total of 20 sites across 8 Canadian provinces (grouped in 6 regions for the roll out of the intervention) are included in the study. Whenever possible, at least 3 sites per province were included to ensure sample diversity and enable the exploration of the provincial health systems' effects on the outcomes as well as to estimate site-related variations in outcomes. Five regions will include sites in the same province, while one region will consist of sites from 3 provinces where only one rehabilitation program was available. Number of therapists: At the therapist level, implementation outcomes will be assessed 3 times during each period (pre-, per-, and post-TIPS implementation). Assuming an autocorrelation of repeated measures of r<0.3, data collected from 300 therapists will provide >80% power to detect moderate effect sizes (Cohen's d ≥ 0.5), employing a first-order autoregressive segmented regression model and a global type I error level of 5% accounting for multiplicity of outcome assessments (Sidak's correction). Number of families: With a minimum expected sample size of 20 families per therapist being assessed pre- and/or post-TIPS implementation, statistical power will be >90% to detect even small effect-sizes (0.1< Cohen's d < 0.3) for the effectiveness outcomes i.e., change in wait times and change in families' perceptions of service quality. Data analysis To evaluate the implementation (obj. 1), longitudinal mixed modeling accounting for and considering potential methodological issues associated with ITS analysis (e.g., auto-correlation, time-varying confounders) will be used to analyse implementation indicators (i.e., ADOPT-VR (Assessing Determinants of Prospective Take-up of Virtual Reality), therapists' self-reported FCT frequency, FCT fidelity self-perceived checklist, PRIME-SP). Changes will be documented short term (i.e., one month after the introduction of the TIPS) and long term (i.e., at the end of the TIPS, 12 months after its introduction). Models will be covariate-adjusted to reduce potential confounding bias, including the therapists' characteristics (e.g., gender, years of experience) and site characteristics (e.g., service provided, geography, general patients characteristics) to estimate associations of key explanatory variables alongside TIPS. Secondary analyses will explore heterogeneity in changes of outcome measures across genders, sites, therapists, and health jurisdiction levels. To document site-specific co-adaptations of TIPS (obj. 2), proposed adaptations and decisions made by Local Leadership Team committee members will be documented during the discussion group in real-time on the logic model and in the TIPS training materials. To identify factors influencing adoption and fidelity (obj. 3), recordings of monthly therapists' meetings, potential meetings between KBs and therapist champions) will be analyzed thematically, using a deductive-inductive approach guided by the Consolidated Framework for Implementation Research (CFIR) domains. Guided by an exploratory mixed methods approach, qualitative findings will be integrated with quantitative questionnaire results to further detail inferences. To evaluate effectiveness (obj. 4) via estimated change in wait times (pre vs post), the confounder-adjusted analysis using generalized linear mixed effect models (GLMM) will employ a log-link function to account for the typically right-skewed nature of time data. Estimated fixed (intervention) effects for the effectiveness outcomes will be reported with Sidak-corrected 95% confidence intervals. To evaluate effectiveness via MPOC-20 (Measure of Process of Care - 20 questions) data, GLMM with nested random effects (families within therapists within sites) will be employed to control for the correlated nature of the data (i.e., the possibility that families have responded once or twice to the MPOC-20) and to account for therapist and site cluster effects. Analyses will be conducted for each of the five MPOC-20 domains and controlled for the same confounding variables described in the analysis for objective 1, as well as for family level variables (e.g., sociocultural background, child's age and gender). Video-recorded interview data from therapists, managers, and parents will be analysed thematically using an inductive approach to better understand the breadth and depth of changes to pediatric rehabilitation service delivery, according to various stakeholder perspectives. Integration of quantitative and qualitative data using the aforementioned explanatory approach will allow us to uncover the plethora of effects of FCT on pediatric rehabilitation service delivery. Total system costs related to the implementation of the TIPS, as well as the costs per participating therapist and per site, accounting for different organizational characteristics, will be calculated. Relative cost, an estimation of costs per client seen by therapist, and incremental ratios (i.e., change in costs to use the TIPS divided by change in the primary implementation indicators and secondary effectiveness outcomes) will also be calculated. Finally, societal costs, including families' costs and savings, will also be computed. Ethical considerations The research ethics committees overseeing the 20 participating sites will approve this research project and be informed of any potential revisions of the protocol. Informed consent will be sought prior to data collection from participating managers, therapists, and parents. Participants will be assigned a unique identification number for denominalization purposes. Whenever posting content to the vCoP, therapists will be encouraged to use their name to promote open exchanges on the platform, but all users will also have the option of using a pseudonym if they prefer. The implementation of the TIPS (e.g., training, meetings) and all data collection (surveys, vCoP, interviews) will take place entirely online. Secure data collection and management solutions (e.g., REDCap, PIERCE) will be used to collect and store study data on institutional servers. The implementation of TIPS will be gradual across regions, thus ensuring that the sites within the region are ready to participate in the project, taking into consideration institutional challenges such as availability of personnel or timeliness of the implementation of new telehealth modalities. Participants will be informed that study data will not constitute an evaluation of their professional performance. Some concerns are present in the literature that telehealth could increase health inequity and that wealthier families might benefit more from it. This project aims to support the use of FCT interventions with all Canadians families with a child with, or at risk of disability, while considering the interactions between personal, socio-economic, and cultural characteristics, as recommended. The team delivering TIPS is fully bilingual. TIPS and the study's data collection will be available in Canada's two official languages. A pre- and per-implementation consultation process will also be undertaken with First Nations Elders in order to take into account the needs of indigenous communities when delivering TIPS. KNOWLEDGE TRANSFER In addition to the Local Leadership Team and the support provided to therapist champions, patient-oriented principles will be used within an integrated knowledge translation (iKT) approach to collaborate with knowledge users throughout the research process in order to inform research decisions. Specifically, four members of the research team (two parent-partner and two rehabilitation managers) have specifically been involved as knowledge users, and will be part of the study's Steering Committee. Principles for engaging with non-researchers in research will be respected (e.g., reviewing mutual expectations, providing meeting flexibility and clarification opportunities). The impact of the iKT approach will be assessed, using patient and organizational engagement criteria. Expected knowledge translation strategies include the presentation of study and site-specific data via a webinar for each participating site, as well as the publication of study findings via peer-reviewed publications and via public-facing publications on the research team's and project partners' websites, social media, and newsletters. EXPECTED OUTCOMES This study will generate knowledge about how to implement family-centred telehealth and rehabilitation practices, inclusive of all families of children with, or at risk of, disability. The knowledge will be contextualized to support therapists working in varied settings and will contribute to building local capacity to sustain the use of FCT interventions. All training materials will be available across Canada and beyond. By increasing therapists' ability to provide telehealth services, the investigators hope to contribute to the transformation of pediatric rehabilitation service delivery, improve access to services, and foster greater well-being for families of children with, or at risk of, disability. Inclusion/Exclusion Criteria: Managers: - Person responsible for rehabilitation services at the site, or their delegate Therapists: - PTs, OTs, SLPs providing outpatient pediatric rehabilitation services to children aged 0-12 years in each site, recruited via the managers and interested in utilizing FCT Parents: - Parents or caregivers who received services (either in-person, virtually, or both) from at least one participating therapist in the previous 3 months Therapist champion: - Therapist selected based on their telehealth experience and on peer recognition within their organization. Parent/patient-partners: - Recruited from family, parent or patient advisory committees at the participating sites or, in the absence of such initiatives, from regional, provincial, or national patient engagement programs. All: - Can speak French or English

NCT0531xxxx/NCT05312840.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05312840</url> </required_header> <id_info> <org_study_id>320.6750.2021-02-135</org_study_id> <nct_id>NCT05312840</nct_id> </id_info> <brief_title>Efficacy and Safety of Conventional and Low-dose Platinum Gemcitabine Combined With Cindilimab With Delayed Administration in First-line Treatment of Advanced Squamous Non-small Cell Lung Cancer</brief_title> <official_title>Efficacy and Safety of Conventional and Low-dose Platinum Gemcitabine Combined With Cindilimab With Delayed Administration in First-line Treatment of Advanced Squamous Non-small Cell Lung Cancer</official_title> <sponsors> <lead_sponsor> <agency>People's Hospital of Quzhou</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>People's Hospital of Quzhou</source> <oversight_info> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> <is_us_export>No</is_us_export> </oversight_info> <brief_summary> <textblock> To observe the efficacy and safety of conventional and low-dose platinum Gemcitabine combined with Cindilimab with delayed administration in first-line treatment of advanced squamous non-small cell lung cancer. </textblock> </brief_summary> <detailed_description> <textblock> At present, Cindilimab combined with Gemcitabine and platinum chemotherapy has obtained the indication of first-line treatment for patients with advanced squamous non-small cell lung cancer, and has become one of the standard first-line treatment schemes for patients with advanced squamous non-small cell lung cancer. However, in DRIENT12 study, although it was confirmed that Cindilimab combined with Gemcitabine and platinum chemotherapy regimen can further delay or prevent the growth of cancer cells compared with placebo combined with Gemcitabine and platinum, in the process of treatment, due to serious adverse drug reactions, a considerable number of patients need to reduce the therapeutic dose of therapeutic drugs, and the body function of patients is damaged in this process, It will inevitably affect the treatment cycle, and even some patients stop treatment due to serious adverse drug reactions, and the serious adverse reactions of chemotherapy drugs will destroy the immune microenvironment, which will eventually affect the efficacy of the anti-cancer treatment. In addition, the mechanism of action of Cindilidone is different from that of chemotherapeutic drugs. It can kill tumor cells and inhibit tumor growth by activating human immune function. Therefore, in the combined scheme, reducing the dose of chemotherapy drugs to avoid too strong side effects damaging human immune function, destroying tumor cells to release antigens after the use of chemotherapy drugs, and continuing PD-1 monoclonal antibody to enhance human anti-tumor immunity may achieve the equivalent or better anti-tumor efficacy obtained in ORIENT12 research, and reduce treatment-related adverse reactions at the same time. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">January 1, 2022</start_date> <completion_date type="Anticipated">December 31, 2024</completion_date> <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date> <phase>Phase 4</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>The objective response rate (ORR) of treatment was evaluated according to RECIST (v1.1).</measure> <time_frame>36 months</time_frame> <description>To evaluate the objective response rate (ORR) of subjects with advanced squamous non-small cell lung cancer treated with conventional and low-dose platinum Gemcitabine combined with Cindilimab with delayed administration in first-line treatment. ORR is defined as the proportion of subjects with complete response (CR) and partial response (PR) in the total subjects.</description> </primary_outcome> <primary_outcome> <measure>Assess the subject's progression free survival (PFS) according to RECIST (v1.1).</measure> <time_frame>36 months</time_frame> <description>To evaluate the progression free survival (PFS) of subjects with advanced squamous non-small cell lung cancer treated with conventional and low-dose platinum Gemcitabine combined with Cindilimab with delayed administration in first-line treatment. PFS is defined as the time from the beginning of treatment to the first imaging disease progression or death, whichever occurs first.</description> </primary_outcome> <primary_outcome> <measure>Assess the subject's disease control rate (DCR) according to RECIST (v1.1).</measure> <time_frame>36 months</time_frame> <description>To evaluate the disease control rate (DCR) of subjects with advanced squamous non-small cell lung cancer treated with conventional and low-dose platinum Gemcitabine combined with Cindilimab with delayed administration in first-line treatment. DCR is defined as the proportion of total subjects with complete remission (CR), partial remission (PR) and disease stability (SD).</description> </primary_outcome> <primary_outcome> <measure>The duration of remission (DOR) was assessed according to RECIST (v1.1).</measure> <time_frame>36 months</time_frame> <description>To evaluate the duration of remission (DOR) of subjects with advanced squamous non-small cell lung cancer treated with conventional and low-dose platinum Gemcitabine combined with Cindilimab with delayed administration in first-line treatment. DOR is defined as the time interval from the first recorded remission to disease progression or death, whichever occurs first.</description> </primary_outcome> <primary_outcome> <measure>The overall survival (OS) of the subjects was evaluated according to RECIST (v1.1).</measure> <time_frame>36 months</time_frame> <description>To evaluate the overall survival (OS) of subjects with advanced squamous non-small cell lung cancer treated with conventional and low-dose platinum Gemcitabine combined with Cindilimab with delayed administration in first-line treatment. OS is defined as the time from the beginning of treatment to the death of subjects from any cause.</description> </primary_outcome> <secondary_outcome> <measure>The incidence of adverse events was evaluated according to NCI CTCAE (v5.0).</measure> <time_frame>36 months</time_frame> <description>To evaluate the incidence of adverse events in subjects with advanced squamous non-small cell lung cancer treated with conventional and low-dose platinum Gemcitabine combined with Cindilimab with delayed administration in first-line treatment.</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">60</enrollment> <condition>Non Small Cell Lung Cancer</condition> <arm_group> <arm_group_label>Routine dose group</arm_group_label> <arm_group_type>Other</arm_group_type> <description>Routine dose group: Every three weeks as a cycle. On the first day of each cycle, Gemcitabine 1000mg / m2, Cisplatin 75mg / m2, Carboplatin auc5 were injected intravenously, and Gemcitabine 1000mg / m2 and Cindilimab 200mg were injected intravenously on the eighth day. After 4 or 6 cycles of treatment, if there is no disease progression, continue to use Cindilimab 200mg every three weeks until the disease progresses.</description> </arm_group> <arm_group> <arm_group_label>Low dose group</arm_group_label> <arm_group_type>Other</arm_group_type> <description>Low dose group: Every three weeks as a cycle. Gemcitabine 750mg / m2, Cisplatin 56mg / m2 or Carboplatin auc3 were injected intravenously on the first day of each cycle 75. On the eighth day, Gemcitabine 750mg / m2 and Cindilimab 200mg were injected intravenously. After 4 or 6 cycles of treatment, if there is no disease progression, continue to use Cindilimab 200mg every three weeks until the disease progresses.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Cisplatin / Carboplatin，Gemcitabine，Cindilimab</intervention_name> <description>1. Routine dose group: Every three weeks as a cycle. On the first day of each cycle, Gemcitabine 1000mg / m2, Cisplatin 75mg / m2 / Carboplatin auc5 were injected intravenously, and Gemcitabine 1000mg / m2 and Cindilimab 200mg were injected intravenously on the eighth day; 2. Low dose group: every three weeks as a cycle. On the first day of each cycle, Gemcitabine 750mg / m2, Cisplatin 56mg / m2 / Carboplatin auc3 were injected intravenously 75. On the eighth day, Gemcitabine 750mg / m2 and Cindilimab 200mg were injected intravenously.</description> <arm_group_label>Low dose group</arm_group_label> <arm_group_label>Routine dose group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Sign written informed consent before implementing any test related process.  - Age ≥ 18 years old and ≤ 75 years old.  - Subjects with histologically or cytologically confirmed locally advanced (iiib-iiic), metastatic or recurrent (stage IV) squamous NSCLC (TNM lung cancer staging, 8th Edition, International Association for the study of lung cancer and Joint Committee on American Classification of cancer), inoperable and radical concurrent radiotherapy and chemotherapy, and who have not received systematic treatment before.  - The gene status is unknown, or the gene status of known histological specimens confirms that there is no EGFR gene sensitive mutation or ALK gene fusion mutation.  - According to the evaluation criteria of solid tumor efficacy (RECIST v1.1), at least one lesion can be measured by imaging. Lesions located in the radiation field of previous radiotherapy can be regarded as measurable lesions if they are confirmed to have progression.  - Have not received any systematic antitumor treatment for advanced / metastatic diseases in the past. Subjects who have previously received platinum containing adjuvant / neoadjuvant chemotherapy or radical chemoradiotherapy for advanced diseases, if the interval between disease progression or recurrence and the end of the last chemotherapeutic drug treatment is at least 6 months, are allowed to be included in this study.  - Subjects with brain metastases who are asymptomatic or have stable symptoms after local treatment are allowed to be included as long as they meet the following conditions: 1) measurable lesions outside the central nervous system, 2) no symptoms of the central nervous system or no aggravation of symptoms for at least 2 weeks, 3) no glucocorticoid treatment is required, or glucocorticoid treatment is stopped within 7 days before the first administration, Or the dosage of glucocorticoid is stable and reduced to less than 10mg / day prednisone (or equivalent dose) within 7 days before the first administration.  - Patients were allowed to receive palliative radiotherapy, but the end time of radiotherapy was 7 days before the administration of the first study drug, and the toxicity related to radiotherapy recovered to less than or equal to grade 1 (CTCAE V5.0).  - ECoG score: 0-1.  - Expected survival time > 3 months.  - For adequate organ function, the subjects shall meet the following laboratory indexes: 1) the absolute value of neutrophils (ANC) ≥ 1.5x109/l without granulocyte colony stimulating factor in recent 14 days; 2) Platelets ≥ 100 without blood transfusion in recent 14 days × 109/L 3) Hemoglobin > 9g / dl without blood transfusion or erythropoietin in recent 14 days; 4) Total bilirubin ≤ 1.5 times the upper limit of normal value (ULN) 5) aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are ≤ 2.5 times ULN (ALT or AST ≤ 5 is allowed for subjects with liver metastasis × ULN） 6) Serum creatinine ≤ 1.5 times ULN and creatinine clearance rate (calculated by Cockcroft Gault formula) ≥ 60 ml / min; 7) Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN; 8) Normal thyroid function is defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH is beyond the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; 9) The myocardial enzyme spectrum is within the normal range (for example, simple laboratory abnormalities that are not clinically significant according to the comprehensive judgment of the researcher are also allowed to be included in the group).  - For female subjects of childbearing age, urine or serum pregnancy test shall be conducted within 3 days before receiving the first study drug administration (day 1 of cycle 1) and the result is negative. If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Women of non childbearing age are defined as having been postmenopausal for at least 1 year or having undergone surgical sterilization or hysterectomy.  - If there is a risk of pregnancy, all subjects (male or female) are required to use contraceptives with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last study drug administration (or 180 days after the last study drug administration).  Exclusion Criteria:  - Pathology is adenocarcinoma or small cell lung cancer (SCLC), including lung cancer mixed with SCLC and NSCLC.  - Received radiotherapy before administration of the first study drug, Meet one of the following conditions: 1) more than 30% of bone marrow had received radiotherapy within 14 days before treatment; 2) received radiotherapy for lung lesions within 6 weeks before treatment and the dose was > 30Gy (the enrolled subjects must recover from the toxicity of previous radiotherapy to grade 1 or below, do not need glucocorticoid treatment and have no history of radiation pneumonia) 3) The end time of palliative radiotherapy was within 7 days before the administration of the first study drug.  - Other malignant diseases other than NSCLC diagnosed within 5 years before the first administration (excluding radical skin basal cell carcinoma, skin squamous epithelial carcinoma, and / or radical resection of carcinoma in situ).  - Currently participating in intervention clinical research treatment, or receiving other research drugs or using research instruments within 4 weeks before the first administration.  - Previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that stimulate or co inhibit T cell receptors (e.g., CTLA-4, OX-40, CD137).  - Received systemic treatment with Chinese patent medicine with anti NSCLC indications or drugs with immunomodulatory effect (including thymosin, interferon and interleukin, except for local use to control pleural effusion) within 2 weeks before the first administration.  - Active autoimmune diseases requiring systemic treatment (such as the use of disease relief drugs, glucocorticoids or immunosuppressants) occurred within 2 years before the first administration. Alternative therapies (such as thyroxine, insulin or physiological glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic treatment.  - Being treated with systemic glucocorticoids (excluding nasal spray, inhaled or other local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first administration of the study; Note: it is allowed to use glucocorticoids in physiological doses (≤ 10 mg / day prednisone or equivalent).  - There is clinically uncontrollable pleural effusion / peritoneal effusion (subjects who do not need to drain effusion or stop drainage for 3 days and have no significant increase in effusion can be enrolled).  - Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation.  - Those who are known to be allergic to active ingredients or excipients such as cindilimab, pemetrexed, gemcitabine, carboplatin and cisplatin.  - Not fully recovered from toxicity and / or complications caused by any intervention before starting treatment (i.e. ≤ grade 1 or reaching baseline, excluding fatigue or hair loss).  - Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1 / 2 antibody positive).  - untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number at the same time was higher than the upper limit of normal value in the laboratory of the research center). Note: hepatitis B patients who met the following criteria can also be admitted into the group: 1) HBV viral load <1000 copy /ml (200 IU/ml) before the first dose, the subjects should receive anti HBV therapy to avoid reactivation of the virus during the whole course of chemotherapy (2). Subjects with anti HBc (+), HBsAg (-), anti HBs (-) and HBV viral load (-), Prophylactic anti HBV treatment is not required, but virus reactivation needs to be closely monitored.  - Active HCV infected subjects (HCV antibody positive and HCV-RNA level above the lower limit of detection).  - Have received live vaccine within 30 days before the first administration (cycle 1, day 1); Note: it is allowed to receive inactivated virus vaccine for injection against seasonal influenza within 30 days before the first administration; However, live attenuated influenza vaccines administered intranasal are not allowed.  - Pregnant or lactating women.  - There are any serious or uncontrollable systemic diseases, such as: 1) there are significant abnormalities in rhythm, conduction or morphology of resting ECG and the symptoms are serious and difficult to control, such as complete left bundle branch block, heart block above grade II, ventricular arrhythmia or atrial fibrillation; 2) Unstable angina pectoris, congestive heart failure, chronic heart failure with New York Heart Association (NYHA) grade ≥ 2; 3) Myocardial infarction occurred within 6 months before enrollment; 4) Poor blood pressure control (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); 5) A history of noninfectious pneumonia requiring glucocorticoid treatment within 1 year before the first administration, or the current presence of clinically active interstitial lung disease; 6) Active pulmonary tuberculosis; 7) There are active or uncontrolled infections requiring systemic treatment; 8) There were clinically active diverticulitis, abdominal abscess and gastrointestinal obstruction; 9) Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis; 10) poor control of diabetes (fasting blood glucose (FBG) > 10mmol/L). 11) Urine routine examination showed that urinary protein was ≥ + +, and the 24-hour urinary protein was confirmed to be more than 1.0 g; 12) Subjects with mental disorders and unable to cooperate with treatment.  - There is no evidence that the participants in the study group have abnormal medical history or other potential conditions that may hinder the study group from participating in the study. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>75 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Xuru Jin</last_name> <role>Principal Investigator</role> <affiliation>People's Hospital of Quzhou</affiliation> </overall_official> <overall_contact> <last_name>Xuru Jin</last_name> <phone>13857782369</phone> <email>hjh2018hjh@163.com</email> </overall_contact> <location> <facility> <name>Quzhou people's Hospital</name> <address> <city>Quzhou</city> <state>Zhejiang</state> <country>China</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Xuru Jin</last_name> <phone>13857782369</phone> <email>hjh2018hjh@163.com</email> </contact> </location> <location_countries> <country>China</country> </location_countries> <verification_date>April 2022</verification_date> <study_first_submitted>March 14, 2022</study_first_submitted> <study_first_submitted_qc>April 2, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>April 2, 2022</last_update_submitted> <last_update_submitted_qc>April 2, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>People's Hospital of Quzhou</investigator_affiliation> <investigator_full_name>Jin Xuru</investigator_full_name> <investigator_title>chief physician</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Lung Neoplasms</mesh_term> <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Carboplatin</mesh_term> <mesh_term>Gemcitabine</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

To observe the efficacy and safety of conventional and low-dose platinum Gemcitabine combined with Cindilimab with delayed administration in first-line treatment of advanced squamous non-small cell lung cancer. At present, Cindilimab combined with Gemcitabine and platinum chemotherapy has obtained the indication of first-line treatment for patients with advanced squamous non-small cell lung cancer, and has become one of the standard first-line treatment schemes for patients with advanced squamous non-small cell lung cancer. However, in DRIENT12 study, although it was confirmed that Cindilimab combined with Gemcitabine and platinum chemotherapy regimen can further delay or prevent the growth of cancer cells compared with placebo combined with Gemcitabine and platinum, in the process of treatment, due to serious adverse drug reactions, a considerable number of patients need to reduce the therapeutic dose of therapeutic drugs, and the body function of patients is damaged in this process, It will inevitably affect the treatment cycle, and even some patients stop treatment due to serious adverse drug reactions, and the serious adverse reactions of chemotherapy drugs will destroy the immune microenvironment, which will eventually affect the efficacy of the anti-cancer treatment. In addition, the mechanism of action of Cindilidone is different from that of chemotherapeutic drugs. It can kill tumor cells and inhibit tumor growth by activating human immune function. Therefore, in the combined scheme, reducing the dose of chemotherapy drugs to avoid too strong side effects damaging human immune function, destroying tumor cells to release antigens after the use of chemotherapy drugs, and continuing PD-1 monoclonal antibody to enhance human anti-tumor immunity may achieve the equivalent or better anti-tumor efficacy obtained in ORIENT12 research, and reduce treatment-related adverse reactions at the same time. Inclusion Criteria: - Sign written informed consent before implementing any test related process. - Age ≥ 18 years old and ≤ 75 years old. - Subjects with histologically or cytologically confirmed locally advanced (iiib-iiic), metastatic or recurrent (stage IV) squamous NSCLC (TNM lung cancer staging, 8th Edition, International Association for the study of lung cancer and Joint Committee on American Classification of cancer), inoperable and radical concurrent radiotherapy and chemotherapy, and who have not received systematic treatment before. - The gene status is unknown, or the gene status of known histological specimens confirms that there is no EGFR gene sensitive mutation or ALK gene fusion mutation. - According to the evaluation criteria of solid tumor efficacy (RECIST v1.1), at least one lesion can be measured by imaging. Lesions located in the radiation field of previous radiotherapy can be regarded as measurable lesions if they are confirmed to have progression. - Have not received any systematic antitumor treatment for advanced / metastatic diseases in the past. Subjects who have previously received platinum containing adjuvant / neoadjuvant chemotherapy or radical chemoradiotherapy for advanced diseases, if the interval between disease progression or recurrence and the end of the last chemotherapeutic drug treatment is at least 6 months, are allowed to be included in this study. - Subjects with brain metastases who are asymptomatic or have stable symptoms after local treatment are allowed to be included as long as they meet the following conditions: 1) measurable lesions outside the central nervous system, 2) no symptoms of the central nervous system or no aggravation of symptoms for at least 2 weeks, 3) no glucocorticoid treatment is required, or glucocorticoid treatment is stopped within 7 days before the first administration, Or the dosage of glucocorticoid is stable and reduced to less than 10mg / day prednisone (or equivalent dose) within 7 days before the first administration. - Patients were allowed to receive palliative radiotherapy, but the end time of radiotherapy was 7 days before the administration of the first study drug, and the toxicity related to radiotherapy recovered to less than or equal to grade 1 (CTCAE V5.0). - ECoG score: 0-1. - Expected survival time > 3 months. - For adequate organ function, the subjects shall meet the following laboratory indexes: 1) the absolute value of neutrophils (ANC) ≥ 1.5x109/l without granulocyte colony stimulating factor in recent 14 days; 2) Platelets ≥ 100 without blood transfusion in recent 14 days × 109/L 3) Hemoglobin > 9g / dl without blood transfusion or erythropoietin in recent 14 days; 4) Total bilirubin ≤ 1.5 times the upper limit of normal value (ULN) 5) aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are ≤ 2.5 times ULN (ALT or AST ≤ 5 is allowed for subjects with liver metastasis × ULN） 6) Serum creatinine ≤ 1.5 times ULN and creatinine clearance rate (calculated by Cockcroft Gault formula) ≥ 60 ml / min; 7) Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN; 8) Normal thyroid function is defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH is beyond the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; 9) The myocardial enzyme spectrum is within the normal range (for example, simple laboratory abnormalities that are not clinically significant according to the comprehensive judgment of the researcher are also allowed to be included in the group). - For female subjects of childbearing age, urine or serum pregnancy test shall be conducted within 3 days before receiving the first study drug administration (day 1 of cycle 1) and the result is negative. If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Women of non childbearing age are defined as having been postmenopausal for at least 1 year or having undergone surgical sterilization or hysterectomy. - If there is a risk of pregnancy, all subjects (male or female) are required to use contraceptives with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last study drug administration (or 180 days after the last study drug administration). Exclusion Criteria: - Pathology is adenocarcinoma or small cell lung cancer (SCLC), including lung cancer mixed with SCLC and NSCLC. - Received radiotherapy before administration of the first study drug, Meet one of the following conditions: 1) more than 30% of bone marrow had received radiotherapy within 14 days before treatment; 2) received radiotherapy for lung lesions within 6 weeks before treatment and the dose was > 30Gy (the enrolled subjects must recover from the toxicity of previous radiotherapy to grade 1 or below, do not need glucocorticoid treatment and have no history of radiation pneumonia) 3) The end time of palliative radiotherapy was within 7 days before the administration of the first study drug. - Other malignant diseases other than NSCLC diagnosed within 5 years before the first administration (excluding radical skin basal cell carcinoma, skin squamous epithelial carcinoma, and / or radical resection of carcinoma in situ). - Currently participating in intervention clinical research treatment, or receiving other research drugs or using research instruments within 4 weeks before the first administration. - Previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that stimulate or co inhibit T cell receptors (e.g., CTLA-4, OX-40, CD137). - Received systemic treatment with Chinese patent medicine with anti NSCLC indications or drugs with immunomodulatory effect (including thymosin, interferon and interleukin, except for local use to control pleural effusion) within 2 weeks before the first administration. - Active autoimmune diseases requiring systemic treatment (such as the use of disease relief drugs, glucocorticoids or immunosuppressants) occurred within 2 years before the first administration. Alternative therapies (such as thyroxine, insulin or physiological glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic treatment. - Being treated with systemic glucocorticoids (excluding nasal spray, inhaled or other local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first administration of the study; Note: it is allowed to use glucocorticoids in physiological doses (≤ 10 mg / day prednisone or equivalent). - There is clinically uncontrollable pleural effusion / peritoneal effusion (subjects who do not need to drain effusion or stop drainage for 3 days and have no significant increase in effusion can be enrolled). - Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation. - Those who are known to be allergic to active ingredients or excipients such as cindilimab, pemetrexed, gemcitabine, carboplatin and cisplatin. - Not fully recovered from toxicity and / or complications caused by any intervention before starting treatment (i.e. ≤ grade 1 or reaching baseline, excluding fatigue or hair loss). - Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1 / 2 antibody positive). - untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number at the same time was higher than the upper limit of normal value in the laboratory of the research center). Note: hepatitis B patients who met the following criteria can also be admitted into the group: 1) HBV viral load <1000 copy /ml (200 IU/ml) before the first dose, the subjects should receive anti HBV therapy to avoid reactivation of the virus during the whole course of chemotherapy (2). Subjects with anti HBc (+), HBsAg (-), anti HBs (-) and HBV viral load (-), Prophylactic anti HBV treatment is not required, but virus reactivation needs to be closely monitored. - Active HCV infected subjects (HCV antibody positive and HCV-RNA level above the lower limit of detection). - Have received live vaccine within 30 days before the first administration (cycle 1, day 1); Note: it is allowed to receive inactivated virus vaccine for injection against seasonal influenza within 30 days before the first administration; However, live attenuated influenza vaccines administered intranasal are not allowed. - Pregnant or lactating women. - There are any serious or uncontrollable systemic diseases, such as: 1) there are significant abnormalities in rhythm, conduction or morphology of resting ECG and the symptoms are serious and difficult to control, such as complete left bundle branch block, heart block above grade II, ventricular arrhythmia or atrial fibrillation; 2) Unstable angina pectoris, congestive heart failure, chronic heart failure with New York Heart Association (NYHA) grade ≥ 2; 3) Myocardial infarction occurred within 6 months before enrollment; 4) Poor blood pressure control (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); 5) A history of noninfectious pneumonia requiring glucocorticoid treatment within 1 year before the first administration, or the current presence of clinically active interstitial lung disease; 6) Active pulmonary tuberculosis; 7) There are active or uncontrolled infections requiring systemic treatment; 8) There were clinically active diverticulitis, abdominal abscess and gastrointestinal obstruction; 9) Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis; 10) poor control of diabetes (fasting blood glucose (FBG) > 10mmol/L). 11) Urine routine examination showed that urinary protein was ≥ + +, and the 24-hour urinary protein was confirmed to be more than 1.0 g; 12) Subjects with mental disorders and unable to cooperate with treatment. - There is no evidence that the participants in the study group have abnormal medical history or other potential conditions that may hinder the study group from participating in the study.

NCT0531xxxx/NCT05312853.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05312853</url> </required_header> <id_info> <org_study_id>21-02552</org_study_id> <nct_id>NCT05312853</nct_id> </id_info> <brief_title>Evaluating the Diagnostic and Predictive Value of Non-invasive Tests (NITs) on the Progression of Chronic Liver Disease.</brief_title> <acronym>NASH-Biomarker</acronym> <official_title>Evaluating the Diagnostic and Predictive Value of Non-invasive Tests (NITs) on the Progression of Chronic Liver Disease.</official_title> <sponsors> <lead_sponsor> <agency>Johannes Gutenberg University Mainz</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Boehringer Ingelheim</agency> <agency_class>Industry</agency_class> </collaborator> <collaborator> <agency>Nordic Bioscience A/S</agency> <agency_class>Industry</agency_class> </collaborator> </sponsors> <source>Johannes Gutenberg University Mainz</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Primary objective is to study the relevance of non-invasive test (NITs) in predicting disease stage (diagnostic biomarker) and outcome (predictive biomarker) in patients with suspected or established liver disease and cirrhosis. </textblock> </brief_summary> <detailed_description> <textblock> Non-invasive tests (NITs) may complement and even reduce the need for liver biopsy in the diagnosis and follow up care of patients with chronic liver disease (CLD). NITs either include serum biomarkers (direct or indirect) or ultrasound-based tests, including vibration controlled transient elastography (VCTE), or a combination of both incorporated into several surrogate scores. </textblock> </detailed_description> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">April 15, 2022</start_date> <completion_date type="Anticipated">December 31, 2032</completion_date> <primary_completion_date type="Anticipated">April 15, 2032</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Case-Only</observational_model> <time_perspective>Prospective</time_perspective> </study_design_info> <primary_outcome> <measure>Cross-sectional correlation of clinical phenotype data with non-invasive tests to develop and validate optimum biomarker approaches for the diagnosis and risk stratification of CLD.</measure> <time_frame>3 years</time_frame> <description>1. The primary objective of this observational study is to assemble a cohort of well-characterised patients with chronic liver disease (CLD) and to collect associated clinical information, biological samples and imaging data for cross-sectional and longitudinal analyses in order to robustly validate diagnostic and predictive non-invasive tests (NITs) for the diagnosis, risk assessment (prognosis) and monitoring of patients with liver disease.</description> </primary_outcome> <secondary_outcome> <measure>2The secondary objectives are to explore the pathophysiology of chronic liver disease using a range of starte-of-the-art scientific techniques and an integrated data-analysis approach.</measure> <time_frame>3 years</time_frame> <description>Longitudinal correlation of clinical phenotype data with blood-based biomarkers (genetic, epigenetic, transcriptomic, metabolomics, proteomic and metagenomic) and/or imaging biomarkers to develop and validate optimum biomarker approaches for the diagnosis, risk stratification and monitoring of CLD. Study of symptom burden in patients with CLD (Quality of Life). Study the underlying pathogenic processes contributing to disease progression in CLD</description> </secondary_outcome> <enrollment type="Anticipated">250</enrollment> <condition>Chronic Liver Disease</condition> <biospec_retention>Samples With DNA</biospec_retention> <biospec_descr> <textblock> 1. 3 x 5mls into EDTA (purple) Vacutainer blood tubes - used for plasma collection for subsequent biomarker or metabolomic/proteomic/miRNA/cell-free DNA analyses and cellular DNA extraction.  2. 4 x 5mls (or 2 x 10mls) into GOLD top SST Vacutainer tubes (serum) - used for serum collection for subsequent biomarker or metabolomic/proteomic/miRNA/cell-free DNA analyses. [Note: RED top Vacutainer tubes (serum) may be substituted if GOLD tubes are not available locally].  3. 1 x 5mls into PAX tube for RNA preservation - for peripheral blood RNA extraction. </textblock> </biospec_descr> <eligibility> <study_pop> <textblock> The study population will be patients (aged ≥18 years) with risk factors for chronic liver disease recruited at the I. Department of Medicine of the University Medical Center Mainz in Germany. </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  1. Age ≥18 years  2. Clinically suspected chronic liver disease based on any of:  1. Patient with historical liver biopsy providing histological evidence of any liver disease or,  2. Patient undergoing liver biopsy for suspected chronic liver disease with biochemical and/or radiological findings consistent with liver disease or,  3. Patient with clinical and radiological evidence of cirrhosis (in absence of an alternative aetiology)  4. Patients with metabolic risk factors predisposing to CLD  Exclusion Criteria:  1. Refusal or inability (lack of capacity) to give informed consent.  2. Age < 18 years  3. Pregnancy  4. An active malignancy.  5. Life expectation of < 5 years.  6. Patients not meeting inclusion criteria or judged by the investigator to be unsuitable for inclusion in the study. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>99 Years</maximum_age> </eligibility> <overall_official> <last_name>Joern Schattenberg, Prof. Dr.</last_name> <role>Principal Investigator</role> <affiliation>Hepatology</affiliation> </overall_official> <overall_contact> <last_name>Joern Schattenberg, Prof. Dr.</last_name> <phone>+49 (0) 6131 17</phone> <phone_ext>6074</phone_ext> <email>joern.schattenberg@unimedizin-mainz.de</email> </overall_contact> <overall_contact_backup> <last_name>Belinda Schröder, MSc</last_name> <phone>+49 (0) 6131 17</phone> <phone_ext>6075</phone_ext> <email>belinda.schroeder@unimedizin-mainz.de</email> </overall_contact_backup> <location> <facility> <name>University Medical Center of the Johannes Gutenber Univeristy</name> <address> <city>Mainz</city> <zip>55131</zip> <country>Germany</country> </address> </facility> </location> <location_countries> <country>Germany</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>March 28, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>March 28, 2022</last_update_submitted> <last_update_submitted_qc>March 28, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Johannes Gutenberg University Mainz</investigator_affiliation> <investigator_full_name>Jörn M. Schattenberg</investigator_full_name> <investigator_title>Prof. Dr.</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Liver Diseases</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> <ipd_description>The data and samples held by the Registry will be the property of the PI Prof. Jörn Schattenberg and the University Medical Center Mainz. Publication will be the responsibility of the PI in line with the polices established with partners in separate agreements and the requirements of the European Commission for open access publication. Scientific contributions will be duly and appropriately acknowledged in line with the 'Uniform Requirements for Articles Submitted to Biomedical Journals' produced by the Committee of Medical Journal Editors (2008).</ipd_description> </patient_data>  </clinical_study>

Primary objective is to study the relevance of non-invasive test (NITs) in predicting disease stage (diagnostic biomarker) and outcome (predictive biomarker) in patients with suspected or established liver disease and cirrhosis. Non-invasive tests (NITs) may complement and even reduce the need for liver biopsy in the diagnosis and follow up care of patients with chronic liver disease (CLD). NITs either include serum biomarkers (direct or indirect) or ultrasound-based tests, including vibration controlled transient elastography (VCTE), or a combination of both incorporated into several surrogate scores. 1. 3 x 5mls into EDTA (purple) Vacutainer blood tubes - used for plasma collection for subsequent biomarker or metabolomic/proteomic/miRNA/cell-free DNA analyses and cellular DNA extraction. 2. 4 x 5mls (or 2 x 10mls) into GOLD top SST Vacutainer tubes (serum) - used for serum collection for subsequent biomarker or metabolomic/proteomic/miRNA/cell-free DNA analyses. [Note: RED top Vacutainer tubes (serum) may be substituted if GOLD tubes are not available locally]. 3. 1 x 5mls into PAX tube for RNA preservation - for peripheral blood RNA extraction. The study population will be patients (aged ≥18 years) with risk factors for chronic liver disease recruited at the I. Department of Medicine of the University Medical Center Mainz in Germany. Inclusion Criteria: 1. Age ≥18 years 2. Clinically suspected chronic liver disease based on any of: 1. Patient with historical liver biopsy providing histological evidence of any liver disease or, 2. Patient undergoing liver biopsy for suspected chronic liver disease with biochemical and/or radiological findings consistent with liver disease or, 3. Patient with clinical and radiological evidence of cirrhosis (in absence of an alternative aetiology) 4. Patients with metabolic risk factors predisposing to CLD Exclusion Criteria: 1. Refusal or inability (lack of capacity) to give informed consent. 2. Age < 18 years 3. Pregnancy 4. An active malignancy. 5. Life expectation of < 5 years. 6. Patients not meeting inclusion criteria or judged by the investigator to be unsuitable for inclusion in the study.

NCT0531xxxx/NCT05312866.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05312866</url> </required_header> <id_info> <org_study_id>9325</org_study_id> <nct_id>NCT05312866</nct_id> </id_info> <brief_title>Intraoperative Retrolaminar Block as Opioid Free Anesthesia After Posterior Lumber Spine Discectomy</brief_title> <official_title>Intraoperative Retrolaminar Block as Opioid Free Anesthesia and Enhanced Recovery After Posterior Lumber Spine Discectomy: A Randomized Controlled Study</official_title> <sponsors> <lead_sponsor> <agency>Zagazig University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Zagazig University</source> <oversight_info> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Opioid-free intraoperative protocols have been successfully used in specific surgical populations with equal or superior results to classic general anesthetic approaches. In instances where opioid-free anesthesia may not be entirely feasible, there exists a continually growing body of evidence that the modern anesthesiologist has a potent pharmacologic and regional anesthetic arsenal that can reduce the amount of opioids required to effectively treat pain.  Retrolaminar block is considered a new, easy and simple technique with decreasing incidence of complications such as hypotension, pleural and nerve injury. Its efficacy had been investigated in trauma patients </textblock> </brief_summary> <detailed_description> <textblock> - Null hypothesis: Intraoperative retrolaminar block will not produce opioid sparing anesthetic effect and enhanced recovery after posterior lumber spine discectomy.  - Alternative hypothesis: Intraoperative retrolaminar block will produce opioid sparing anesthetic effect and enhanced recovery after posterior lumber spine discectomy. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">May 1, 2022</start_date> <completion_date type="Actual">December 1, 2022</completion_date> <primary_completion_date type="Actual">December 1, 2022</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>Double (Participant, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>The recovery time</measure> <time_frame>up to 1 hour postoperative</time_frame> <description>The recovery time (time from discontinuation of isoflurane to first response to verbal command) will be recorded, then the patient will be transferred to the post anesthesia care unite (PACU) on standard monitors.</description> </primary_outcome> <secondary_outcome> <measure>pain intensity</measure> <time_frame>up to 24 hours postoperative</time_frame> <description>pain intensity measured using visual analogue scale from 0= no pain to 10= worst pain</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">72</enrollment> <condition>Opioid Free Anesthesia</condition> <arm_group> <arm_group_label>Standard analgesia (paracetamol +fentanyl)</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Patients will receive standard analgesia (paracetamol 15mg/kg plus fentanyl 1ug/kg) iv</description> </arm_group> <arm_group> <arm_group_label>Retrolaminar block with bupivacaine + magnesium sulfate + dexamethasone</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Patients will receive intraopertative retrolaminar block: 15 ml of bupivacaine 0. 25 % plus 2ml magnesium sulfate 10% (200mg) plus 2ml (8mg) dexamethasone on each side by slipping the needle of injection on the bone of spinous process and lamina.</description> </arm_group> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>Standard analgesia (paracetamol +fentanyl)</intervention_name> <description>Patients will receive standard analgesia (paracetamol 15mg/kg plus fentanyl 1ug/kg) iv</description> <arm_group_label>Standard analgesia (paracetamol +fentanyl)</arm_group_label> </intervention> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>Retrolaminar block with bupivacaine + magnesium sulfate + dexamethasone</intervention_name> <description>Patients will receive intraopertative retrolaminar block: 15 ml of bupivacaine 0. 25 % plus 2ml magnesium sulfate 10% (200mg) plus 2ml (8mg) dexamethasone on each side by slipping the needle of injection on the bone of spinous process and lamina.</description> <arm_group_label>Retrolaminar block with bupivacaine + magnesium sulfate + dexamethasone</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Written informed consent from the patient.  - Age: 21-60 years old.  - Sex: both sex (males and females).  - American Society of Anesthesiologist Physical status: ASA 1& II.  - Body Mass Index (BMI) = (25-30 kg/m2).  - Type of operation: elective posterior Lumbar discectomy from L3 to L5 disc space.  Exclusion Criteria:  - Altered mental state.  - Patients with known history of allergy to study drugs.  - Advanced hepatic, renal, cardiovascular, and respiratory diseases.  - Patients with chronic pain.  - Patients receiving anticoagulants.  - Contraindications of regional anesthesia, e.g., allergy to local anesthetics, coagulopathy, or septic focus at site of injection. </textblock> </criteria> <gender>All</gender> <minimum_age>21 Years</minimum_age> <maximum_age>60 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Alshaimaa Kamel, M.D</last_name> <role>Principal Investigator</role> <affiliation>Zagazig University</affiliation> </overall_official> <location> <facility> <name>Faculty of Human Medicine, Zagazig University</name> <address> <city>Zagazig</city> <state>Alsharquia</state> <zip>44511</zip> <country>Egypt</country> </address> </facility> </location> <location_countries> <country>Egypt</country> </location_countries> <verification_date>December 2022</verification_date> <study_first_submitted>March 27, 2022</study_first_submitted> <study_first_submitted_qc>April 5, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>December 13, 2022</last_update_submitted> <last_update_submitted_qc>December 13, 2022</last_update_submitted_qc> <last_update_posted type="Actual">December 16, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Zagazig University</investigator_affiliation> <investigator_full_name>Alshaimaa Abdel Fattah Kamel</investigator_full_name> <investigator_title>principle investigator</investigator_title> </responsible_party> <intervention_browse>  <mesh_term>Acetaminophen</mesh_term> <mesh_term>Dexamethasone</mesh_term> <mesh_term>Magnesium Sulfate</mesh_term> <mesh_term>Fentanyl</mesh_term> <mesh_term>Bupivacaine</mesh_term> </intervention_browse>  </clinical_study>

Opioid-free intraoperative protocols have been successfully used in specific surgical populations with equal or superior results to classic general anesthetic approaches. In instances where opioid-free anesthesia may not be entirely feasible, there exists a continually growing body of evidence that the modern anesthesiologist has a potent pharmacologic and regional anesthetic arsenal that can reduce the amount of opioids required to effectively treat pain. Retrolaminar block is considered a new, easy and simple technique with decreasing incidence of complications such as hypotension, pleural and nerve injury. Its efficacy had been investigated in trauma patients - Null hypothesis: Intraoperative retrolaminar block will not produce opioid sparing anesthetic effect and enhanced recovery after posterior lumber spine discectomy. - Alternative hypothesis: Intraoperative retrolaminar block will produce opioid sparing anesthetic effect and enhanced recovery after posterior lumber spine discectomy. Inclusion Criteria: - Written informed consent from the patient. - Age: 21-60 years old. - Sex: both sex (males and females). - American Society of Anesthesiologist Physical status: ASA 1& II. - Body Mass Index (BMI) = (25-30 kg/m2). - Type of operation: elective posterior Lumbar discectomy from L3 to L5 disc space. Exclusion Criteria: - Altered mental state. - Patients with known history of allergy to study drugs. - Advanced hepatic, renal, cardiovascular, and respiratory diseases. - Patients with chronic pain. - Patients receiving anticoagulants. - Contraindications of regional anesthesia, e.g., allergy to local anesthetics, coagulopathy, or septic focus at site of injection.

NCT0531xxxx/NCT05312879.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05312879</url> </required_header> <id_info> <org_study_id>VX21-147-301</org_study_id> <secondary_id>2021-004762-35</secondary_id> <nct_id>NCT05312879</nct_id> </id_info> <brief_title>Phase 2/3 Adaptive Study of VX-147 in Adults and Adolescents With APOL1- Mediated Proteinuric Kidney Disease</brief_title> <official_title>A Phase 2/3 Adaptive, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VX-147 in Subjects Aged 12 Years and Older With APOL1-mediated Proteinuric Kidney Disease</official_title> <sponsors> <lead_sponsor> <agency>Vertex Pharmaceuticals Incorporated</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Vertex Pharmaceuticals Incorporated</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>Yes</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The purpose of this study is to evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of VX-147 in participants aged 12 years and older with apolipoprotein L1 (APOL1)-mediated proteinuric kidney disease. </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">March 30, 2022</start_date> <completion_date type="Anticipated">June 2026</completion_date> <primary_completion_date type="Anticipated">May 2026</primary_completion_date> <phase>Phase 2/Phase 3</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Sequential Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Percent Change From Baseline in Urine Protein to Creatinine Ratio (UPCR) at Week 48 (Assessed at the Week 48 Interim Analysis)</measure> <time_frame>From Baseline at Week 48</time_frame> </primary_outcome> <primary_outcome> <measure>Estimated Glomerular Filtration Rate (eGFR) Slope Assessed at the Week 48 Interim Analysis</measure> <time_frame>From Baseline Through >= Week 48</time_frame> </primary_outcome> <primary_outcome> <measure>eGFR Slope Assessed at Study Completion</measure> <time_frame>From Baseline Through Study Completion (Approximately 2 Years After the Last Participant Enrolls)</time_frame> </primary_outcome> <secondary_outcome> <measure>Time to Composite Clinical Outcome of a Sustained Decline of >=30 Percent (%) in eGFR, the Onset of end-stage Kidney Disease or Death</measure> <time_frame>From Baseline Through Study Completion (Approximately 2 Years After the Last Participant Enrolls)</time_frame> </secondary_outcome> <secondary_outcome> <measure>Safety and Tolerability as Assessed by Number of Participants With Adverse events (AEs) and Serious Adverse Events (SAEs)</measure> <time_frame>Day 1 Through Study Completion (Approximately 2 Years After the Last Participant Enrolls)</time_frame> </secondary_outcome> <secondary_outcome> <measure>Maximum Plasma Concentration (Cmax) of VX-147</measure> <time_frame>Day 1 and Week 40</time_frame> </secondary_outcome> <secondary_outcome> <measure>Area Under the Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-147</measure> <time_frame>Day 1 and Week 40</time_frame> </secondary_outcome> <secondary_outcome> <measure>Observed Pre-dose Plasma Concentration (Ctrough) of VX-147</measure> <time_frame>Day 1 up to Week 40</time_frame> </secondary_outcome> <number_of_arms>4</number_of_arms> <enrollment type="Anticipated">466</enrollment> <condition>Proteinuric Kidney Disease</condition> <arm_group> <arm_group_label>Phase 2: VX-147</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Participants will be randomized to receive different dose levels of VX-147.</description> </arm_group> <arm_group> <arm_group_label>Phase 2: Placebo</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> <description>Participants will receive placebo matched to VX-147.</description> </arm_group> <arm_group> <arm_group_label>Phase 3: VX-147</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Participants will receive VX-147 with the dose to be based on the outcome of Phase 2.</description> </arm_group> <arm_group> <arm_group_label>Phase 3: Placebo</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> <description>Participants will receive placebo matched to VX-147.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>VX-147</intervention_name> <description>Tablets for oral administration.</description> <arm_group_label>Phase 2: VX-147</arm_group_label> <arm_group_label>Phase 3: VX-147</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Placebo</intervention_name> <description>Tablets for oral administration.</description> <arm_group_label>Phase 2: Placebo</arm_group_label> <arm_group_label>Phase 3: Placebo</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Key Inclusion Criteria:  - APOL1 genotype of G1/G1, G2/G2, or G1/G2  - Proteinuric kidney disease  Key Exclusion Criteria:  - Solid organ or bone marrow transplant  - Uncontrolled hypertension  - History of diabetes mellitus  - Known underlying cause of kidney disease including but not limited to sickle cell disease  Other protocol defined Inclusion/Exclusion criteria apply. </textblock> </criteria> <gender>All</gender> <minimum_age>12 Years</minimum_age> <maximum_age>65 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_contact> <last_name>Medical Information</last_name> <phone>617-341-6777</phone> <email>medicalinfo@vrtx.com</email> </overall_contact> <location> <facility> <name>Nephrology Consultants, LLC</name> <address> <city>Huntsville</city> <state>Alabama</state> <zip>35805</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>AKDHC Medical Research Service LLC - Banner Desert Office</name> <address> <city>Mesa</city> <state>Arizona</state> <zip>85202</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>AKDHC Medical Research Service LLC</name> <address> <city>Phoenix</city> <state>Arizona</state> <zip>85016</zip> <country>United States</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>The Medical Research Group, Inc</name> <address> <city>Fresno</city> <state>California</state> <zip>93720</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Cedars-Sinai Medical Center</name> <address> <city>Los Angeles</city> <state>California</state> <zip>90048</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>UCLA Division of Nephrology</name> <address> <city>Los Angeles</city> <state>California</state> <zip>90095</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kaiser Permanente, Sacramento</name> <address> <city>Sacramento</city> <state>California</state> <zip>95825</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>UCSF School of Medicine</name> <address> <city>San Francisco</city> <state>California</state> <zip>94143</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center</name> <address> <city>Torrance</city> <state>California</state> <zip>90502</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kidney and Hypertension Center</name> <address> <city>Victorville</city> <state>California</state> <zip>92395</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Greater Hartford Nephrology</name> <address> <city>Bloomfield</city> <state>Connecticut</state> <zip>06002</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Nephrology & Hypertension Associates, PC</name> <address> <city>Middlebury</city> <state>Connecticut</state> <zip>06762</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Yale University</name> <address> <city>New Haven</city> <state>Connecticut</state> <zip>06510</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>The George Washington University Medical Faculty Associates - Kidney Disease & Hypertension</name> <address> <city>Washington</city> <state>District of Columbia</state> <zip>20037</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Bay Pines Healthcare System</name> <address> <city>Bay Pines</city> <state>Florida</state> <zip>33744</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Nova Clinical Research, LLC</name> <address> <city>Bradenton</city> <state>Florida</state> <zip>34209</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>AMR-Miami</name> <address> <city>Coral Gables</city> <state>Florida</state> <zip>33134</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Horizon Research Group, LLC</name> <address> <city>Coral Gables</city> <state>Florida</state> <zip>33134</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>South Florida Nephrology Group PA, Research Div.</name> <address> <city>Coral Springs</city> <state>Florida</state> <zip>33071</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>North Florida/South Georgia Veterans Health System</name> <address> <city>Gainesville</city> <state>Florida</state> <zip>32608</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>University of Florida, Shands Hospital</name> <address> <city>Gainesville</city> <state>Florida</state> <zip>32610</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Velocity Clinical Research - Hallandale Beach</name> <address> <city>Hallandale Beach</city> <state>Florida</state> <zip>33009</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Qway Research</name> <address> <city>Hialeah</city> <state>Florida</state> <zip>33010</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Elixia Pines, LLC</name> <address> <city>Hollywood</city> <state>Florida</state> <zip>33024</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>South Florida Research Institute</name> <address> <city>Lauderdale Lakes</city> <state>Florida</state> <zip>33313</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Cordova Research Institute</name> <address> <city>Miami</city> <state>Florida</state> <zip>33155</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>MedBio Trials</name> <address> <city>Miami</city> <state>Florida</state> <zip>33180</zip> <country>United States</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Mid Florida Kidney and Hypertension Care, PL</name> <address> <city>Sanford</city> <state>Florida</state> <zip>32771</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Genesis Clinical Research</name> <address> <city>Tampa</city> <state>Florida</state> <zip>33603</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Elixia Tampa, LLC</name> <address> <city>Temple Terrace</city> <state>Florida</state> <zip>33637</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Advanced Clinical Research of Atlanta</name> <address> <city>Atlanta</city> <state>Georgia</state> <zip>30309</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Morehouse School of Medicine, Grady Memorial Hospital</name> <address> <city>Atlanta</city> <state>Georgia</state> <zip>30310</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Children's Healthcare of Atlanta - Center for Advanced Pediatrics</name> <address> <city>Atlanta</city> <state>Georgia</state> <zip>30322</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Fides Clinical Research</name> <address> <city>Atlanta</city> <state>Georgia</state> <zip>30342</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Medical College of Georgia (MCG)</name> <address> <city>Augusta</city> <state>Georgia</state> <zip>30912-3140</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Coastal Medical Research</name> <address> <city>Brunswick</city> <state>Georgia</state> <zip>31520</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Clincept - Warm Springs</name> <address> <city>Columbus</city> <state>Georgia</state> <zip>31904</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Renal Associates, LLC</name> <address> <city>Columbus</city> <state>Georgia</state> <zip>31904</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Javara Inc./Privia Medical Group Georgia, PLLC</name> <address> <city>Fayetteville</city> <state>Georgia</state> <zip>30214</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Georgia Nephrology</name> <address> <city>Lawrenceville</city> <state>Georgia</state> <zip>30046</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Inova Clinical Trials and Research Center</name> <address> <city>Tyrone</city> <state>Georgia</state> <zip>30290</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Indiana University</name> <address> <city>Indianapolis</city> <state>Indiana</state> <zip>46202</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Nephrology Physicians, LLC</name> <address> <city>Mishawaka</city> <state>Indiana</state> <zip>46545</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>University of Kansas Medical Center</name> <address> <city>Kansas City</city> <state>Kansas</state> <zip>66160</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Renal Associates of Baton Rouge</name> <address> <city>Baton Rouge</city> <state>Louisiana</state> <zip>70808</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Tulane University School of Medicine</name> <address> <city>New Orleans</city> <state>Louisiana</state> <zip>70112</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>University Medical Center - New Orleans</name> <address> <city>New Orleans</city> <state>Louisiana</state> <zip>70112</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Ochsner Medical Center - New Orleans</name> <address> <city>New Orleans</city> <state>Louisiana</state> <zip>70121</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Northwest Louisiana Nephrology, LLC - Shreveport</name> <address> <city>Shreveport</city> <state>Louisiana</state> <zip>71101</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Javara Inc./Privia Medical Group, LLC MidAtlantic - Main Research Site</name> <address> <city>Annapolis</city> <state>Maryland</state> <zip>21401</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>University of Maryland Medical Center</name> <address> <city>Baltimore</city> <state>Maryland</state> <zip>21201</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Johns Hopkins Hospital</name> <address> <city>Baltimore</city> <state>Maryland</state> <zip>21287</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Javara Inc./Privia Medical Group, LLC MidAtlantic-Silver Spring, MD</name> <address> <city>Silver Spring</city> <state>Maryland</state> <zip>20901</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Tufts Medical Center</name> <address> <city>Boston</city> <state>Massachusetts</state> <zip>02111</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Boston Medical Center</name> <address> <city>Boston</city> <state>Massachusetts</state> <zip>02118</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Beth Israel Deaconess Medical Center</name> <address> <city>Boston</city> <state>Massachusetts</state> <zip>02215</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Renal and Transplant Associates of New England, PC</name> <address> <city>Springfield</city> <state>Massachusetts</state> <zip>01107</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kidney Care and Transplant Services of New England</name> <address> <city>West Springfield</city> <state>Massachusetts</state> <zip>01089</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Henry Ford Hospital</name> <address> <city>Detroit</city> <state>Michigan</state> <zip>48202</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>AA Medical Research Center</name> <address> <city>Flint</city> <state>Michigan</state> <zip>48504</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Sparrow Clinical Research Institute</name> <address> <city>Lansing</city> <state>Michigan</state> <zip>48912</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>St. Clair Nephrology Research</name> <address> <city>Roseville</city> <state>Michigan</state> <zip>48066</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>InterMed Consultants</name> <address> <city>Edina</city> <state>Minnesota</state> <zip>55435</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Minneapolis VA Healthcare System</name> <address> <city>Minneapolis</city> <state>Minnesota</state> <zip>55417</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Nephrology Associates, P.C.</name> <address> <city>Columbus</city> <state>Mississippi</state> <zip>39705</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>University of Mississippi</name> <address> <city>Grenada</city> <state>Mississippi</state> <zip>38901</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Nephrology and Hypertension Associates, LTD</name> <address> <city>Tupelo</city> <state>Mississippi</state> <zip>38801</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Washington University Saint Louis</name> <address> <city>Saint Louis</city> <state>Missouri</state> <zip>63130</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>St. Louis Heart and Vascular, P.C.</name> <address> <city>Saint Louis</city> <state>Missouri</state> <zip>63136</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Nevada Kidney Disease and Hypertension Centers</name> <address> <city>Las Vegas</city> <state>Nevada</state> <zip>89106</zip> <country>United States</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Kidney Specialists of Southern Nevada</name> <address> <city>Las Vegas</city> <state>Nevada</state> <zip>89128</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Rutgers New Jersey Medical School</name> <address> <city>Newark</city> <state>New Jersey</state> <zip>07103</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>New Mexico VA Healthcare System</name> <address> <city>Albuquerque</city> <state>New Mexico</state> <zip>87108</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Renal Medicine Associates</name> <address> <city>Albuquerque</city> <state>New Mexico</state> <zip>87109</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Albert Einstein Hospital - Montefiore Medical Center</name> <address> <city>Bronx</city> <state>New York</state> <zip>10461-1900</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kidney Medical Associates, PLLC</name> <address> <city>Bronx</city> <state>New York</state> <zip>10461</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>James J. Peters VA Medical Center</name> <address> <city>Bronx</city> <state>New York</state> <zip>10468</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>SUNY Downstate Health Sciences University</name> <address> <city>Brooklyn</city> <state>New York</state> <zip>11203</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Nephrology Associates, P.C. - Queens</name> <address> <city>Flushing</city> <state>New York</state> <zip>11365</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Zucker School of Medicine at Hofstra/Northwell</name> <address> <city>Great Neck</city> <state>New York</state> <zip>11021</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Clinical Research Development Associates LLC</name> <address> <city>Laurelton</city> <state>New York</state> <zip>11413</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>New York University Grossman School of Medicine</name> <address> <city>New York</city> <state>New York</state> <zip>10016</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Icahn School of Medicine at Mount Sinai</name> <address> <city>New York</city> <state>New York</state> <zip>10029</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Columbia University - Division of Nephrology</name> <address> <city>New York</city> <state>New York</state> <zip>10032</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>NYC Health + Hospital/Harlem</name> <address> <city>New York</city> <state>New York</state> <zip>10037</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>North Carolina Nephrology P.A. - Cary Office</name> <address> <city>Cary</city> <state>North Carolina</state> <zip>27511</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>UNC Clinical and Translational Research Center</name> <address> <city>Chapel Hill</city> <state>North Carolina</state> <zip>27599-7155</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Eastern Nephrology Associates - Greenville Office</name> <address> <city>Greenville</city> <state>North Carolina</state> <zip>27834</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Eastern Nephrology Associates - Jacksonville Office</name> <address> <city>Jacksonville</city> <state>North Carolina</state> <zip>28546</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Eastern Nephrology Associates - Kinston Office</name> <address> <city>Kinston</city> <state>North Carolina</state> <zip>28504</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Eastern Nephrology Associates - New Bern Office</name> <address> <city>New Bern</city> <state>North Carolina</state> <zip>28562</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Eastern Nephrology Associates - Wilmington Office</name> <address> <city>Wilmington</city> <state>North Carolina</state> <zip>28401</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Brookview Hills Research Associates</name> <address> <city>Winston-Salem</city> <state>North Carolina</state> <zip>27103</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Cincinnati VA Medical Center</name> <address> <city>Cincinnati</city> <state>Ohio</state> <zip>45220</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>University Hospitals Cleveland Medical Center</name> <address> <city>Cleveland</city> <state>Ohio</state> <zip>44106</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Cleveland Clinic</name> <address> <city>Cleveland</city> <state>Ohio</state> <zip>44195</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Ohio State University</name> <address> <city>Columbus</city> <state>Ohio</state> <zip>43201</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Thomas Jefferson University</name> <address> <city>Philadelphia</city> <state>Pennsylvania</state> <zip>19107</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Temple University Hospital</name> <address> <city>Philadelphia</city> <state>Pennsylvania</state> <zip>19140</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Einstein Medical Center (NDKD)</name> <address> <city>Philadelphia</city> <state>Pennsylvania</state> <zip>19141</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Children's Hospital of Pittsburgh of UPMC</name> <address> <city>Pittsburgh</city> <state>Pennsylvania</state> <zip>15224</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Lifespan Clinical Research Center</name> <address> <city>East Providence</city> <state>Rhode Island</state> <zip>02915</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Medical University of South Carolina</name> <address> <city>Charleston</city> <state>South Carolina</state> <zip>29425</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Columbia Nephrology Associates, PA</name> <address> <city>Columbia</city> <state>South Carolina</state> <zip>29203</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Carolina Nephrology, PA</name> <address> <city>Spartanburg</city> <state>South Carolina</state> <zip>29306</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Vanderbilt University Medical Center, Nephrology Clinical Trials Center</name> <address> <city>Nashville</city> <state>Tennessee</state> <zip>37232</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Arlington Nephrology</name> <address> <city>Arlington</city> <state>Texas</state> <zip>76015</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Baylor Scott & White Research Institute</name> <address> <city>Dallas</city> <state>Texas</state> <zip>75204</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Dallas Renal Group - 2</name> <address> <city>Dallas</city> <state>Texas</state> <zip>75230</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Nephrotex Research Group</name> <address> <city>Dallas</city> <state>Texas</state> <zip>75231</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Dallas Renal Group - 1</name> <address> <city>Dallas</city> <state>Texas</state> <zip>75237</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Davita Clinical Research - El Paso</name> <address> <city>El Paso</city> <state>Texas</state> <zip>79925</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Ronald Ralph MD PA</name> <address> <city>Houston</city> <state>Texas</state> <zip>77054-2101</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Prolato Clinical Research Center</name> <address> <city>Houston</city> <state>Texas</state> <zip>77054</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Houston Medical Research Institute, LLC</name> <address> <city>Houston</city> <state>Texas</state> <zip>77074</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Clinical Research Strategies - Romano North Main Office</name> <address> <city>Houston</city> <state>Texas</state> <zip>77090</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Southwest Houston Research, Ltd</name> <address> <city>Houston</city> <state>Texas</state> <zip>77099</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Texas Tech University Health Sciences Center</name> <address> <city>Lubbock</city> <state>Texas</state> <zip>79430</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>San Antonio Kidney</name> <address> <city>San Antonio</city> <state>Texas</state> <zip>78229</zip> <country>United States</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>University of Texas Health San Antonio</name> <address> <city>San Antonio</city> <state>Texas</state> <zip>78229</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>San Antonio Kidney</name> <address> <city>San Antonio</city> <state>Texas</state> <zip>78251</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Kidney Specialists of N Houston, PLLC</name> <address> <city>Shenandoah</city> <state>Texas</state> <zip>77384</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Renal Physicians of Montgomery County, PA</name> <address> <city>The Woodlands</city> <state>Texas</state> <zip>77384</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Tranquil Clinical Research</name> <address> <city>Webster</city> <state>Texas</state> <zip>77598</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>University of Virginia Health - Nephrology Clinical Research Center</name> <address> <city>Charlottesville</city> <state>Virginia</state> <zip>22908</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>TKS Research, P.L.L.C.</name> <address> <city>Norfolk</city> <state>Virginia</state> <zip>23502</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>York Clinical Research, LLC</name> <address> <city>Norfolk</city> <state>Virginia</state> <zip>23540</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Nephrology Associates of Tidewater, LTD</name> <address> <city>Virginia Beach</city> <state>Virginia</state> <zip>23454</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Milwaukee Nephrologists, SC</name> <address> <city>Wauwatosa</city> <state>Wisconsin</state> <zip>53226</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Cliniques Universitaires Saint-Luc</name> <address> <city>Woluwe-Saint-Lambert</city> <state>Brussels</state> <country>Belgium</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Instituto Pro-Renal</name> <address> <city>Curitiba</city> <country>Brazil</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>PUC Trials - Unidade Epicenter</name> <address> <city>Curitiba</city> <country>Brazil</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Federal University of Goiás (UFG)</name> <address> <city>Goiania</city> <country>Brazil</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Cmip-Centro Mineiro de Pesquisa Ltda</name> <address> <city>Juiz de Fora</city> <country>Brazil</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Eurolatino Juiz de Fora Pesquisas Médicas Ltda</name> <address> <city>Juiz de Fora</city> <country>Brazil</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Santa Casa de Misericórdia de Belo Horizonte</name> <address> <city>Minas Gerais</city> <country>Brazil</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Irmandade da Santa Casa de Misericórdia de Porto Alegre</name> <address> <city>Porto Alegre</city> <country>Brazil</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>UFRS - Hospital de Clínicas</name> <address> <city>Porto Alegre</city> <country>Brazil</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>USP - Ribeirão Preto</name> <address> <city>Ribeirão Preto</city> <country>Brazil</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Hospital São Lucas</name> <address> <city>Rio de Janeiro</city> <country>Brazil</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Hospital Universitário Pedro Ernesto</name> <address> <city>Rio de Janeiro</city> <country>Brazil</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Pedro Ernesto University Hospital</name> <address> <city>Rio de Janeiro</city> <country>Brazil</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>CSB Group of Nephrology Brazil</name> <address> <city>Salvador</city> <country>Brazil</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Fundação Faculdade Regional de Medicina de São José do Rio Preto</name> <address> <city>São José do Rio Preto</city> <country>Brazil</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Hospital do Rim - Fundação Oswaldo Ramos - Ambulatorio NEFRITE</name> <address> <city>São Paulo</city> <country>Brazil</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>University of Sao Paulo</name> <address> <city>São Paulo</city> <country>Brazil</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Recherche GCP Research</name> <address> <city>Montreal</city> <country>Canada</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Women's College Hospital</name> <address> <city>Toronto</city> <country>Canada</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Hopital Henri Mondor</name> <address> <city>Créteil</city> <country>France</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>CHU Grenoble Alpes - Hôpital Nord Michallon</name> <address> <city>Grenoble</city> <country>France</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Hôpital Bicêtre AP-HP</name> <address> <city>Le Kremlin Bicêtre</city> <country>France</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>CHU Dupuytren 2</name> <address> <city>Limoges</city> <country>France</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Hôpital de la Conception, Centre de néphrologie et transplantation rénale</name> <address> <city>Marseille</city> <zip>13385</zip> <country>France</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Ambroise Paré Hospital</name> <address> <city>Paris</city> <country>France</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Hopitaux Universitaires Est Parisien - Hopital Tenon</name> <address> <city>Paris</city> <country>France</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Service de Nephrologie - Hopital Universitaire Necker</name> <address> <city>Paris</city> <country>France</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Université Paris-Descartes / Hôpital Européen Georges Pompidou</name> <address> <city>Paris</city> <country>France</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>AURA Nord Saint Ouen</name> <address> <city>Saint-Ouen</city> <country>France</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Centre Hospitalier Universitaire CHU de Toulouse Hopital de Rangueil</name> <address> <city>Toulouse</city> <country>France</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Komfo Anokye Teaching Hospital</name> <address> <city>Kumasi</city> <country>Ghana</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>University of Amsterdam</name> <address> <city>Amsterdam</city> <country>Netherlands</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Unidade Autónoma de Nefrologia</name> <address> <city>Amadora</city> <country>Portugal</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Hospital Beatriz Angelo</name> <address> <city>Loures</city> <country>Portugal</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>GCM Medical Group, PSC</name> <address> <city>San Juan</city> <zip>00917</zip> <country>Puerto Rico</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Hospital Clinic de Barcelona</name> <address> <city>Barcelona</city> <country>Spain</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Hospital Universitari Vall d'Hebron</name> <address> <city>Barcelona</city> <country>Spain</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Reina Sofia University Hospital</name> <address> <city>Córdoba</city> <country>Spain</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Hospital Universitario 12 de Octubre</name> <address> <city>Madrid</city> <country>Spain</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Hospital Universitario Virgen Macarena</name> <address> <city>Seville</city> <country>Spain</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital</name> <address> <city>Birmingham</city> <country>United Kingdom</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Epsom and St Helier University Hospitals NHS Trust - St Helier Hospital - South West SW Thames Institute for Renal Research</name> <address> <city>Carshalton</city> <country>United Kingdom</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>University Hospitals of Leicester NHS Trust - Leicester General Hospital</name> <address> <city>Leicester</city> <country>United Kingdom</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Barts Health NHS Trust, The Royal London Hospital</name> <address> <city>London</city> <country>United Kingdom</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Guy's & St Thomas NHS Foundation Trust, Guy's Hospital</name> <address> <city>London</city> <country>United Kingdom</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Royal Free NHS Trust</name> <address> <city>London</city> <country>United Kingdom</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>St George's University Hospitals NHS Foundation Trust</name> <address> <city>London</city> <country>United Kingdom</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Manchester Royal Infirmary</name> <address> <city>Manchester</city> <country>United Kingdom</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>The Medicines Evaluation Unit</name> <address> <city>Manchester</city> <country>United Kingdom</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>King's College Hospital NHS Foundation Trust - Guthrie Clinic</name> <address> <city>Southwark</city> <country>United Kingdom</country> </address> </facility> <status>Recruiting</status> </location> <location_countries> <country>Belgium</country> <country>Brazil</country> <country>Canada</country> <country>France</country> <country>Ghana</country> <country>Netherlands</country> <country>Portugal</country> <country>Puerto Rico</country> <country>Spain</country> <country>United Kingdom</country> <country>United States</country> </location_countries> <verification_date>February 2023</verification_date> <study_first_submitted>March 28, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>August 22, 2023</last_update_submitted> <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc> <last_update_posted type="Actual">August 23, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Kidney Diseases</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> <ipd_description>Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing</ipd_description> </patient_data>  </clinical_study>

The purpose of this study is to evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of VX-147 in participants aged 12 years and older with apolipoprotein L1 (APOL1)-mediated proteinuric kidney disease. Key Inclusion Criteria: - APOL1 genotype of G1/G1, G2/G2, or G1/G2 - Proteinuric kidney disease Key Exclusion Criteria: - Solid organ or bone marrow transplant - Uncontrolled hypertension - History of diabetes mellitus - Known underlying cause of kidney disease including but not limited to sickle cell disease Other protocol defined Inclusion/Exclusion criteria apply.

NCT0531xxxx/NCT05312892.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05312892</url> </required_header> <id_info> <org_study_id>212413</org_study_id> <nct_id>NCT05312892</nct_id> </id_info> <brief_title>Sympathetic Mechanisms in Obesity-Crossover Design</brief_title> <official_title>Sympathetic Mechanisms in the Cardiovascular and Metabolic Alterations of Obesity, Crossover Design Study.</official_title> <sponsors> <lead_sponsor> <agency>Vanderbilt University Medical Center</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Vanderbilt University Medical Center</source> <oversight_info> <is_fda_regulated_drug>Yes</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> We will study obese hypertensive subjects in a randomized, crossover study to determine if two weeks sympathetic blockade improves endogenous glucose production. Subjects will be studied on 3 different occasions after two weeks of receiving either placebo, amlodipine (vasodilator arm) or moxonidine (study arm). The order of the studies will be determined using computer-generated randomization. Patients will be blinded as to which treatment they are receiving on each day. An investigator blinded to the treatment assignment will perform the analysis of the data. </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">May 20, 2022</start_date> <completion_date type="Anticipated">December 31, 2029</completion_date> <primary_completion_date type="Anticipated">December 31, 2027</primary_completion_date> <phase>Phase 1/Phase 2</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Crossover Assignment</intervention_model> <primary_purpose>Basic Science</primary_purpose> <masking>Double (Participant, Investigator)</masking> </study_design_info> <primary_outcome> <measure>Endogenous glucose production</measure> <time_frame>During two-step insulin clamp (six hours)</time_frame> <description>Rate of appearance and disappearance of labeled glucose</description> </primary_outcome> <number_of_arms>3</number_of_arms> <enrollment type="Anticipated">12</enrollment> <condition>Obesity</condition> <condition>Hypertension</condition> <arm_group> <arm_group_label>Placebo</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> <description>Subjects will received 2 weeks of capsules containing placebo.</description> </arm_group> <arm_group> <arm_group_label>Amlodipine</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Subjects will received 2 weeks of capsules containing amlodipine.</description> </arm_group> <arm_group> <arm_group_label>Moxonidine</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Subjects will received 2 weeks of capsules containing moxonidine.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Amlodipine</intervention_name> <description>Subjects will receive either an antihypertensive (amlodipine or moxonidine) medication or placebo for two weeks, then cross over to the second arm, and then after 2 weeks of the second drug/placebo, will be switched to the third arm.</description> <arm_group_label>Amlodipine</arm_group_label> <other_name>Antihypertensive</other_name> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Moxonidine</intervention_name> <description>Moxonidine</description> <arm_group_label>Moxonidine</arm_group_label> <other_name>Antihypertensive</other_name> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Placebo</intervention_name> <description>Placebo</description> <arm_group_label>Placebo</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Males and females of all races between 18 and 65 years of age  - Hypertension defined by two or more properly measured seated blood pressure readings >130/85 mmHg or currently on antihypertensive medication.  - Obesity will be defined as having a body mass index (BMI) ≥ 30 kg/m2.  - Able and willing to provide informed consent.  Exclusion Criteria:  - Pregnancy or breast feeding  - Current smokers or history of heavy smoking (>2 packs/day)  - History of alcohol or drug abuse  - Previous allergic reaction to study medications  - Type I diabetes.  - Cardiovascular disease other than hypertension such as myocardial infarction within 6 months prior to enrollment, presence of angina pectoris, significant arrhythmia, congestive heart failure (LV hypertrophy acceptable), deep vein thrombosis, pulmonary embolism, second or third degree heart block, mitral valve stenosis, aortic stenosis, or hypertrophic cardiomyopathy  - History of serious cerebrovascular disease such as cerebral hemorrhage, stroke, or transient ischemic attack  - History or presence of immunological or hematological disorders  - Impaired renal function  - Treatment with chronic systemic glucocorticoid therapy (more than 7 consecutive days in 1 month)  - Treatment with any investigational drug in the 1 month preceding the study  - Inability to give, or withdraw, informed consent  - Other factors which in the investigator's opinion would prevent the subject from completing the protocol (i.e., clinically significant abnormalities on clinical, mental examination or laboratory testing or inability to comply with protocol, inability to find IV access) </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>65 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <location> <facility> <name>Vanderbilt University Medical Center</name> <address> <city>Nashville</city> <state>Tennessee</state> <zip>37232</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Cynthia Laws, MS</last_name> <phone>615-421-1994</phone> <email>autonomicgroup@vumc.org</email> </contact> <contact_backup> <last_name>Alfredo Gamboa, MD</last_name> <email>alfredo.gamboa@vumc.org</email> </contact_backup> <investigator> <last_name>Italo Biaggioni, MD</last_name> <role>Sub-Investigator</role> </investigator> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>February 2023</verification_date> <study_first_submitted>March 28, 2022</study_first_submitted> <study_first_submitted_qc>April 5, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>February 9, 2023</last_update_submitted> <last_update_submitted_qc>February 9, 2023</last_update_submitted_qc> <last_update_posted type="Actual">February 10, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Vanderbilt University Medical Center</investigator_affiliation> <investigator_full_name>Italo Biaggioni</investigator_full_name> <investigator_title>Professor of Medicine</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Obesity</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Amlodipine</mesh_term> <mesh_term>Antihypertensive Agents</mesh_term> <mesh_term>Moxonidine</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>Undecided</sharing_ipd> </patient_data>  </clinical_study>

We will study obese hypertensive subjects in a randomized, crossover study to determine if two weeks sympathetic blockade improves endogenous glucose production. Subjects will be studied on 3 different occasions after two weeks of receiving either placebo, amlodipine (vasodilator arm) or moxonidine (study arm). The order of the studies will be determined using computer-generated randomization. Patients will be blinded as to which treatment they are receiving on each day. An investigator blinded to the treatment assignment will perform the analysis of the data. Inclusion Criteria: - Males and females of all races between 18 and 65 years of age - Hypertension defined by two or more properly measured seated blood pressure readings >130/85 mmHg or currently on antihypertensive medication. - Obesity will be defined as having a body mass index (BMI) ≥ 30 kg/m2. - Able and willing to provide informed consent. Exclusion Criteria: - Pregnancy or breast feeding - Current smokers or history of heavy smoking (>2 packs/day) - History of alcohol or drug abuse - Previous allergic reaction to study medications - Type I diabetes. - Cardiovascular disease other than hypertension such as myocardial infarction within 6 months prior to enrollment, presence of angina pectoris, significant arrhythmia, congestive heart failure (LV hypertrophy acceptable), deep vein thrombosis, pulmonary embolism, second or third degree heart block, mitral valve stenosis, aortic stenosis, or hypertrophic cardiomyopathy - History of serious cerebrovascular disease such as cerebral hemorrhage, stroke, or transient ischemic attack - History or presence of immunological or hematological disorders - Impaired renal function - Treatment with chronic systemic glucocorticoid therapy (more than 7 consecutive days in 1 month) - Treatment with any investigational drug in the 1 month preceding the study - Inability to give, or withdraw, informed consent - Other factors which in the investigator's opinion would prevent the subject from completing the protocol (i.e., clinically significant abnormalities on clinical, mental examination or laboratory testing or inability to comply with protocol, inability to find IV access)

NCT0531xxxx/NCT05312905.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05312905</url> </required_header> <id_info> <org_study_id>MirrorCog2021</org_study_id> <nct_id>NCT05312905</nct_id> </id_info> <brief_title>Mirror Therapy in Stroke</brief_title> <official_title>Home-based Mirror Therapy and Cognitive Therapeutic Exercises After Stroke</official_title> <sponsors> <lead_sponsor> <agency>Istanbul Medipol University Hospital</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Istanbul Medipol University Hospital</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Little is known about mirror therapy and cognitive exercises applied together in patients with stroke by means of telerehabilitation. The aim of this study is to investigate the effects of home-based mirror therapy combined with cognitive exercises on upper extremity functions and cognition in adults with stroke and to compare these effects with mirror therapy alone. </textblock> </brief_summary> <overall_status>Completed</overall_status> <start_date type="Actual">June 10, 2021</start_date> <completion_date type="Actual">January 7, 2022</completion_date> <primary_completion_date type="Actual">December 20, 2021</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>Single (Participant)</masking> <masking_description>Participants will be included in the study and randomly divided into two groups using block randomization in Microsoft Excel-RANDOMISE 'RAND(WS)' function.</masking_description> </study_design_info> <primary_outcome> <measure>Mini-Mental State Examination</measure> <time_frame>changes after 8 weeks</time_frame> <description>The Mini-Mental State Examination (MMSE) is a 30-point test. Higher values mean better performance.</description> </primary_outcome> <primary_outcome> <measure>Fugl-Meyer Upper Extremity Motor Assessment</measure> <time_frame>changes after 8 weeks</time_frame> <description>The Fugl-Meyer Assessment scale is an ordinal scale that has 3 points for each item. A zero score is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully. The total possible scale score is 226. Higher scores mean better performance.</description> </primary_outcome> <secondary_outcome> <measure>Stroke-Specific Quality of Life Scale</measure> <time_frame>changes after 8 weeks</time_frame> <description>Specific Quality Of Life scale (SSQOL) is a patient-centered outcome measure intended to provide an assessment of health-related quality of life specific to patients with stroke. The original test consists of 49 items encompassing 12 domains. Each item is ranked on a 5-point scale, with higher scores indicating better function.</description> </secondary_outcome> <secondary_outcome> <measure>Beck Depression Scale</measure> <time_frame>changes after 8 weeks</time_frame> <description>The Beck Depression Scale is a 21-item self-report inventory designed to assess the presence and severity in depressive symptoms. Each item is rated on a 4-point Likert-type scale ranging from 0 to 3, based on the severity in the last two weeks. Higher scores indicating worse level of depression.</description> </secondary_outcome> <secondary_outcome> <measure>Barthel Activity of Daily Living Scale</measure> <time_frame>changes after 8 weeks</time_frame> <description>The Barthel Index (BI) measures the extent to which somebody can function independently and has mobility in their activities of daily living (ADL) i.e. feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair transfer, ambulation and stair climbing. Eight factors are rated to produce an overall score on a point scale of 0 to 100. Then, an assignment is given as "excellent" for 95 to 100 points; "good" for 84 to 94 points, "fair" for 65 to 83 points, or "poor" for less than 65 points, higher scores indicating better function.</description> </secondary_outcome> <secondary_outcome> <measure>Modified Ashworth Scale</measure> <time_frame>changes after 8 weeks</time_frame> <description>The modified Ashworth scale is a muscle tone assessment scale used to assess the resistance experienced during passive range of motion, which does not require any instrumentation and is quick to perform.This scale grades the muscle tone from 0 (normal) to 4 (severe spasticity). The usage of this scale is easy; however, the results depend on the evaluator. Higher scores indicating sever spasticity.</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">30</enrollment> <condition>Stroke</condition> <condition>Cognitive Therapy</condition> <condition>Telerehabilitation</condition> <arm_group> <arm_group_label>Mirror Therapy</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Exercises including mirror therapy will be applied to the participants in the Mirror Therapy group. The mirror will be placed in such a way that the affected extremity of the patient could not be seen behind the mirror and the healthy extremity would be in front of his eyes, the patient will perform the exercises indicated by the physiotherapist with his intact extremity, looking into the mirror. The exercises will be performed in sessions lasting 60 minutes, 3 days a week, over 8 weeks.</description> </arm_group> <arm_group> <arm_group_label>Mirror+Cognitive Therapy</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>The participants in the Mirror+Cognitive Therapy will be given a cognitive task with the application of mirror therapy. Cognitive tasks with mirror therapy will be applied in sessions lasting 60 minutes, 3 days a week, over 8 weeks.</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Mirror Therapy</intervention_name> <description>Mirror Therapy applied alone</description> <arm_group_label>Mirror Therapy</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Mirror Therapy + Cognitive Therapy</intervention_name> <description>Mirror Therapy supported with Cognitive Exercises</description> <arm_group_label>Mirror+Cognitive Therapy</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  Age 40 years old and over having had a stroke having unilateral involvement having sufficient communication skills to answer oral and written questions and following instructions 20< points in MMSE  Exclusion Criteria:  a stroke history under the age of 40 not having a verbal or written communication level that cannot fulfill the study conditions </textblock> </criteria> <gender>All</gender> <minimum_age>40 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <location> <facility> <name>Istanbul Medipol University</name> <address> <city>Istanbul</city> <zip>34815</zip> <country>Turkey</country> </address> </facility> </location> <location_countries> <country>Turkey</country> </location_countries> <verification_date>April 2022</verification_date> <study_first_submitted>March 14, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>April 7, 2022</last_update_submitted> <last_update_submitted_qc>April 7, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 14, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Istanbul Medipol University Hospital</investigator_affiliation> <investigator_full_name>Farzin Hajebrahimi, PhD</investigator_full_name> <investigator_title>Principal Investigator</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Stroke</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> <ipd_description>The data that support the findings of this study will be available on reasonable request from the Principle Investigator. The data are not publicly available due to ethical issues.</ipd_description> </patient_data>  </clinical_study>

Little is known about mirror therapy and cognitive exercises applied together in patients with stroke by means of telerehabilitation. The aim of this study is to investigate the effects of home-based mirror therapy combined with cognitive exercises on upper extremity functions and cognition in adults with stroke and to compare these effects with mirror therapy alone. Inclusion Criteria: Age 40 years old and over having had a stroke having unilateral involvement having sufficient communication skills to answer oral and written questions and following instructions 20< points in MMSE Exclusion Criteria: a stroke history under the age of 40 not having a verbal or written communication level that cannot fulfill the study conditions

NCT0531xxxx/NCT05312918.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05312918</url> </required_header> <id_info> <org_study_id>ANRS 12427 DoReaL</org_study_id> <nct_id>NCT05312918</nct_id> </id_info> <brief_title>Large Scale Transition to a Dolutegravir-based First-line ART in the South: Virological Response and Impact on HIV Drug Resistance in a Real Life Context (DoReaL Study)</brief_title> <official_title>Large Scale Transition to a Dolutegravir-based First-line ART in the South: Virological Response and Impact on HIV Drug Resistance in a Real Life Context (DoReaL Study)</official_title> <sponsors> <lead_sponsor> <agency>ANRS, Emerging Infectious Diseases</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>CIRBA, Abidjan, Ivory Coast</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>SEREFO, Bamako, Mali</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>BIOLIM/FSS/UL, Lomé, Togo</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>ANRS, Emerging Infectious Diseases</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Main objective The main objective of the study is to assess the virological efficacy of a Dolutegravir-based first-line ART in use under real-life conditions in national programs in resource-limited settings in patients infected with HIV-1 and initially under a NNRTI-based first-line, and determine the impact of NRTI resistance on the success of the new strategy.  Secondary objectives  - Determine the level of virological suppression (HIV-1 RNA <200 copies/ml) at 6, 12 and 24 months after transition from an NNRTI first-line to a DTG first-line.  - Determine the level of virological suppression at the WHO threshold (HIV-1 RNA <1000 copies/ml).  - To determine the frequency of development of resistance and the profiles of mutations in patients with virological failure (HIV-1 RNA ≥200 copies/ml) and the potential impact on the 2nd line strategies combining DTG and currently recommended by the WHO.  - To determine the impact of pre-transition resistance to NRTIs on the virological suppression under DTG first-line and on the development of resistance to integrase inhibitors.  - Study pre-transition resistance acquired under DTG first-lines at the thresholds of 20% and 5% of the viral population, respectively using Sanger and Ultra-deep Sequencing (UDS) approaches.  Identify program factors associated with virological failure and/or the development of drug resistance. </textblock> </brief_summary> <detailed_description> <textblock> Antiretroviral therapy (ART) has dramatically changed the pronostic of HIV/AIDS infection over the last 20 years, by reducing the mortality and morbibidity associted with the infection. This is mostly true in sub-Saharan African, the most affected region of the world. The UNAIDS 2019 report confirms this fact, and shows a significant reduction in the number of deaths related to HIV infection as access to antiretrovirals (ARV) increases. However, in the absence of cure by current treatments, the management and treatment of the infection should still be considered for life. This makes this management complex and challenging. Indeed, the risk of failure to treatment is real, this risk is accompanied by that of developing resistance to treatment, which should lead to a change in treatment. The limited number of molecules therefore requires the development of strategies that must be effective in maintaining virological suppression for as long as possible and should also limit the emergence and circulation of resistant viruses. To address these priorities, the World Health Organization (WHO) recommends since 2016, the introduction of a first-line ART more efficient and more robust, combining molecules with a high genetic barrier to resistance. In its latest 2019 recommendations for resource-limited countries, WHO recommends a first-line ART comprising two nucleoside reverse transcriptase inhibitors (NRTIs) and one integrase inhibitor (INI), preferably tenofovir (TDF)+Lamivudine (3TC )/emtricitabine (FTC)+dolutegravir (DTG). This new strategy is expected in the context of sub-Saharan Africa, where the increase of pre-treatment and acquired HIV drug resistance has been worrying for several years, but raises a certain number of uncertainties. Indeed, available and published data on the effectiveness of DTG are mainly from studies conducted in Northern countries, very few clinical trials have evaluated or are underway to evaluate the strategy in Southern countries and virtually no evaluation of the effectiveness of this approach in the context of real life in the South has been conducted to date. In addition, few or no recommendations have been made to accompany this transition to a new DTG-based first-line in the South. This is of greater concern for patients who are currently under non-NRTI-based first-line , and who will be switched to a new DTG-based first-line. This population will certainly include very variable virological profiles, ranging from patients in virological suppression, to patients who are not virologically suppressed, with potential accumulation of resistance mutations. In the absence of clear and funded recommendations for the organization of these transitions, the risk of this transition producing results below expectations is real and significant. In addition, the reality of the management of HIV infection in the South regularly faces significant challenges associated with limited financial and human resources. This often makes it difficult to apply decisions made even at the national level. For illustration, despite the unanimity around the use of viral load for monitoring people on ART, access to and the availability of this test in daily practice remains challenging in many countries. It is therefore essential to evaluate the virological response in people who will be switched from the current first-line, to the new first-line, in real life conditions, in the South. This study, developed and considered as a priority by the AC43 working group "Medical Virology" of the ANRS, aims to evaluate this new strategy in real life context in three countries of sub-Saharan Africa, Côte d'Ivoire, Mali and Togo. The main objective is to assess the virological efficacy of the DTG-based first-line in real life conditions, for patients initially receiving an NNRTI-based first-line, followed-up in the national programs and determine the impact of baseline NRTI-drug resistance on the success of the new strategy. All these three countries have adopted the new WHO recommendations and the deployment of the DTG-based first-line is being initiated. It is therefore essential that this research be conducted along side with this ongoing transition, so that the results will help developping adequate recommendations that will allow programs in the South to better organise the transition, to improve the therapeutic and virological monitoring of patients, to prevent early failures, and the emergence and rapid circulation of drug resistance. </textblock> </detailed_description> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">May 2022</start_date> <completion_date type="Anticipated">October 2024</completion_date> <primary_completion_date type="Anticipated">March 2023</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Cohort</observational_model> <time_perspective>Prospective</time_perspective> </study_design_info> <primary_outcome> <measure>Proportion virological success</measure> <time_frame>48 weeks</time_frame> <description>Proportion of patients with virological success at Week 48 (Month 12), defined by a VL <200 copies/ml.</description> </primary_outcome> <secondary_outcome> <measure>Virological suppression at W24 (VL< 200 copies/ml)</measure> <time_frame>24 weeks</time_frame> <description>Proportion of patients with virological suppression at W24 (VL< 200 copies/ml).</description> </secondary_outcome> <secondary_outcome> <measure>Virological suppression at W96 (VL< 200 copies/ml)</measure> <time_frame>96 weeks</time_frame> <description>Proportion of patients with virological suppression at W96 (VL< 200 copies/ml).</description> </secondary_outcome> <secondary_outcome> <measure>Virological suppression at VL thresholds of 200 copies/ml, considering the first point of viral load and the control viral load if the first point of viral load was >200 copies/ml.</measure> <time_frame>36 weeks</time_frame> <description>Proportion of patients with virological suppression at VL thresholds of 200 copies/ml, considering the first point of viral load at W24 and the control viral load at W36 if the first point of viral load was >200 copies/ml.</description> </secondary_outcome> <secondary_outcome> <measure>Virological suppression at VL thresholds of 200 copies/ml, considering the first point of viral load and the control viral load if the first point of viral load was >200 copies/ml.</measure> <time_frame>60 weeks</time_frame> <description>Proportion of patients with virological suppression at VL thresholds of 200 copies/ml, considering the first point of viral load at W48, and the control viral load at W60 if the first point of viral load was >200 copies/ml.</description> </secondary_outcome> <secondary_outcome> <measure>Virological suppression at VL thresholds of 200 copies/ml, considering the first point of viral load and the control viral load if the first point of viral load was >200 copies/ml.</measure> <time_frame>108 weeks</time_frame> <description>Proportion of patients with virological suppression at VL thresholds of 200 copies/ml, considering the first point of viral load at W96, and the control viral load at W108 if the first point of viral load was >200 copies/ml.</description> </secondary_outcome> <secondary_outcome> <measure>Virological suppression at the WHO threshold (< 1000 copies/ml).</measure> <time_frame>24 weeks</time_frame> <description>Proportion of patients with virological suppression at the WHO threshold at W24 (< 1000 copies/ml).</description> </secondary_outcome> <secondary_outcome> <measure>Virological suppression at the WHO threshold (< 1000 copies/ml).</measure> <time_frame>48 weeks</time_frame> <description>Proportion of patients with virological suppression at the WHO threshold at W48 (< 1000 copies/ml).</description> </secondary_outcome> <secondary_outcome> <measure>Virological suppression at the WHO threshold (< 1000 copies/ml).</measure> <time_frame>96 weeks</time_frame> <description>Proportion of patients with virological suppression at the WHO threshold at W96 (< 1000 copies/ml).</description> </secondary_outcome> <secondary_outcome> <measure>Virological suppression at VL thresholds of 1000 copies/ml, considering the first point of viral load, and the control viral load if the first point of viral load was >1000 copies/ml.</measure> <time_frame>36 weeks</time_frame> <description>Proportion of patients with virological suppression at VL thresholds of 1000 copies/ml, considering the first point of viral load at W24, and the control viral load at W36 if the first point of viral load was >1000 copies/ml.</description> </secondary_outcome> <secondary_outcome> <measure>Virological suppression at VL thresholds of 1000 copies/ml, considering the first point of viral load, and the control viral load if the first point of viral load was >1000 copies/ml.</measure> <time_frame>60 weeks</time_frame> <description>Proportion of patients with virological suppression at VL thresholds of 1000 copies/ml, considering the first point of viral load at W48, and the control viral load at W60 if the first point of viral load was >1000 copies/ml.</description> </secondary_outcome> <secondary_outcome> <measure>Virological suppression at VL thresholds of 1000 copies/ml, considering the first point of viral load, and the control viral load if the first point of viral load was >1000 copies/ml.</measure> <time_frame>108 weeks</time_frame> <description>Proportion of patients with virological suppression at VL thresholds of 1000 copies/ml, considering the first point of viral load at W96, and the control viral load at W108 if the first point of viral load was >1000 copies/ml.</description> </secondary_outcome> <secondary_outcome> <measure>Virological suppression at the optimal threshold (<50 copies/ml)</measure> <time_frame>24 weeks</time_frame> <description>Proportion of patients with virological suppression at the optimal threshold at W24 (<50 copies/ml)</description> </secondary_outcome> <secondary_outcome> <measure>Virological suppression at the optimal threshold (<50 copies/ml)</measure> <time_frame>48 weeks</time_frame> <description>Proportion of patients with virological suppression at the optimal threshold at W48 (<50 copies/ml)</description> </secondary_outcome> <secondary_outcome> <measure>Virological suppression at the optimal threshold (<50 copies/ml)</measure> <time_frame>96 weeks</time_frame> <description>Proportion of patients with virological suppression at the optimal threshold at W96 (<50 copies/ml)</description> </secondary_outcome> <secondary_outcome> <measure>Virological suppression at VL thresholds of 50 copies/ml, considering the first point of viral load, and the control viral load if the first point of viral load was >50 copies/ml.</measure> <time_frame>36 weeks</time_frame> <description>Proportion of patients with virological suppression at VL thresholds of 50 copies/ml, considering the first point of viral load at W24, and the control viral load at W36 if the first point of viral load was >50 copies/ml.</description> </secondary_outcome> <secondary_outcome> <measure>Virological suppression at VL thresholds of 50 copies/ml, considering the first point of viral load, and the control viral load if the first point of viral load was >50 copies/ml.</measure> <time_frame>60 weeks</time_frame> <description>Proportion of patients with virological suppression at VL thresholds of 50 copies/ml, considering the first point of viral load at W48, and the control viral load at W60 if the first point of viral load was >50 copies/ml.</description> </secondary_outcome> <secondary_outcome> <measure>Virological suppression at VL thresholds of 50 copies/ml, considering the first point of viral load, and the control viral load if the first point of viral load was >50 copies/ml.</measure> <time_frame>108 weeks</time_frame> <description>Proportion of patients with virological suppression at VL thresholds of 50 copies/ml, considering the first point of viral load at W96, and the control viral load at W108 if the first point of viral load was >50 copies/ml.</description> </secondary_outcome> <secondary_outcome> <measure>Proportion of patients with virological suppression at VL thresholds of 50, 200 copies/ml and 1000 copies/ml, depending on the viral load at the time of switch</measure> <time_frame>24 weeks</time_frame> <description>Proportion of patients with virological suppression at VL thresholds of 50, 200 copies/ml and 1000 copies/ml, at W24, depending on the viral load at the time of switch according to 3 groups (VL of D0 <200 copies/ml, between 200 and 1000 copies/ml, and ≥1000 copies/ml)</description> </secondary_outcome> <secondary_outcome> <measure>Proportion of patients with virological suppression at VL thresholds of 50, 200 copies/ml and 1000 copies/ml, depending on the viral load at the time of switch</measure> <time_frame>48 weeks</time_frame> <description>Proportion of patients with virological suppression at VL thresholds of 50, 200 copies/ml and 1000 copies/ml, at W48, depending on the viral load at the time of switch according to 3 groups (VL of D0 <200 copies/ml, between 200 and 1000 copies/ml, and ≥1000 copies/ml)</description> </secondary_outcome> <secondary_outcome> <measure>Proportion of patients with virological suppression at VL thresholds of 50, 200 copies/ml and 1000 copies/ml, depending on the viral load at the time of switch</measure> <time_frame>96 weeks</time_frame> <description>Proportion of patients with virological suppression at VL thresholds of 50, 200 copies/ml and 1000 copies/ml, at W96, depending on the viral load at the time of switch according to 3 groups (VL of D0 <200 copies/ml, between 200 and 1000 copies/ml, and ≥1000 copies/ml)</description> </secondary_outcome> <secondary_outcome> <measure>Frequency of drug resistance</measure> <time_frame>24 weeks</time_frame> <description>Frequency of resistance mutations acquired at confirmed virological failure, at VL thresholds of 200 copies/ml and 1000 copies/ml.</description> </secondary_outcome> <secondary_outcome> <measure>Profiles of resistance mutations</measure> <time_frame>24 weeks</time_frame> <description>Profiles of resistance mutations acquired at confirmed virological failure, at VL thresholds of 200 copies/ml and 1000 copies/ml.</description> </secondary_outcome> <secondary_outcome> <measure>Frequency of drug resistance</measure> <time_frame>48 weeks</time_frame> <description>Frequency of resistance mutations acquired at confirmed virological failure, at VL thresholds of 200 copies/ml and 1000 copies/ml.</description> </secondary_outcome> <secondary_outcome> <measure>Profiles of resistance mutations</measure> <time_frame>48 weeks</time_frame> <description>Profiles of resistance mutations acquired at confirmed virological failure, at VL thresholds of 200 copies/ml and 1000 copies/ml.</description> </secondary_outcome> <secondary_outcome> <measure>Frequency of drug resistance</measure> <time_frame>96 weeks</time_frame> <description>Frequency of resistance mutations acquired at confirmed virological failure, at VL thresholds of 200 copies/ml and 1000 copies/ml.</description> </secondary_outcome> <secondary_outcome> <measure>Profiles of resistance mutations</measure> <time_frame>96 weeks</time_frame> <description>Profiles of resistance mutations acquired at confirmed virological failure, at VL thresholds of 200 copies/ml and 1000 copies/ml.</description> </secondary_outcome> <secondary_outcome> <measure>GSS (Genotypic susceptibility score)</measure> <time_frame>24 weeks</time_frame> <description>Proportion of patients with a GSS ≤1 at W24</description> </secondary_outcome> <secondary_outcome> <measure>GSS (Genotypic susceptibility score)</measure> <time_frame>48 weeks</time_frame> <description>Proportion of patients with a GSS ≤1 at W48</description> </secondary_outcome> <secondary_outcome> <measure>GSS (Genotypic susceptibility score)</measure> <time_frame>96 weeks</time_frame> <description>Proportion of patients with a GSS ≤1 at W96.</description> </secondary_outcome> <secondary_outcome> <measure>Frequency of pre-transition resistance mutations to NRTIs</measure> <time_frame>At baseline, before DTG initiation</time_frame> <description>Frequency of pre-transition resistance mutations to NRTIs</description> </secondary_outcome> <secondary_outcome> <measure>Proportion of HIV minority variants</measure> <time_frame>Up to 108 weeks.</time_frame> <description>Proportion of minority variants (5% threshold) in patients with resistance mutations to NRTIs and/or DTG in the event of virological failure.</description> </secondary_outcome> <enrollment type="Anticipated">603</enrollment> <condition>HIV Infections</condition> <biospec_retention>Samples With DNA</biospec_retention> <biospec_descr> <textblock> Whole blood samples will be collected for this study and will be used for viral load testing and drug resistance evaluation. </textblock> </biospec_descr> <eligibility> <study_pop> <textblock> HIV-1 infected individuals who are transitioning from an NNRTI-based first-line to a Dolutegravir-based first-line treatment. </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Aged 18 years or over.  - Infected with HIV-1.  - On an NNRTI-based first-line for at least 6 months.  - Initiating a new 1st line ART based on DTG according to national recommendations.  - Agree to participate in the study and provide free, written and informed consent.  Exclusion Criteria:  - Infection with HIV-2 or HIV1+2.  - Ongoing participation in another virological study on HIV infection </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> </eligibility> <overall_official> <last_name>Avelin AGHOKENG</last_name> <role>Study Director</role> <affiliation>IRD 224 - CNRS 5290 - UM1-UM2</affiliation> </overall_official> <overall_official> <last_name>Anoumou Claver DAGNRA</last_name> <role>Study Director</role> <affiliation>BIOLIM - FSS - UL</affiliation> </overall_official> <overall_contact> <last_name>Avelin AGHOKENG</last_name> <phone>04 67 41 59 58</phone> <email>avelin.aghokeng@ird.fr</email> </overall_contact> <overall_contact_backup> <last_name>Anoumou Claver DAGNRA</last_name> <phone>228 900 156 56</phone> <email>claverdagnra@gmail.com</email> </overall_contact_backup> <location> <facility> <name>CIRBA</name> <address> <city>Abidjan</city> <country>Côte D'Ivoire</country> </address> </facility> <contact> <last_name>Thomas d'Aquin TONI</last_name> <phone>225 05 89 81 49</phone> <email>tonithomasd@gmail.com</email> </contact> </location> <location> <facility> <name>SEREFO</name> <address> <city>Bamako</city> <country>Mali</country> </address> </facility> <contact> <last_name>Almoustapha MIAGA</last_name> <email>amaiga@icermali.org</email> </contact> </location> <location> <facility> <name>Biolim/Fss/Ul</name> <address> <city>Lomé</city> <country>Togo</country> </address> </facility> <contact> <last_name>Anoumou Claver DAGNRA</last_name> <phone>228 900 156 56</phone> <email>claverdagnra@gmail.com</email> </contact> </location> <location_countries> <country>Côte D'Ivoire</country> <country>Mali</country> <country>Togo</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>September 22, 2021</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>March 28, 2022</last_update_submitted> <last_update_submitted_qc>March 28, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>HIV Infections</keyword> <keyword>Dolutegravir</keyword> <keyword>HIV drug resistance</keyword> <keyword>Real Life</keyword> <condition_browse>  <mesh_term>HIV Infections</mesh_term> </condition_browse>  </clinical_study>

Main objective The main objective of the study is to assess the virological efficacy of a Dolutegravir-based first-line ART in use under real-life conditions in national programs in resource-limited settings in patients infected with HIV-1 and initially under a NNRTI-based first-line, and determine the impact of NRTI resistance on the success of the new strategy. Secondary objectives - Determine the level of virological suppression (HIV-1 RNA <200 copies/ml) at 6, 12 and 24 months after transition from an NNRTI first-line to a DTG first-line. - Determine the level of virological suppression at the WHO threshold (HIV-1 RNA <1000 copies/ml). - To determine the frequency of development of resistance and the profiles of mutations in patients with virological failure (HIV-1 RNA ≥200 copies/ml) and the potential impact on the 2nd line strategies combining DTG and currently recommended by the WHO. - To determine the impact of pre-transition resistance to NRTIs on the virological suppression under DTG first-line and on the development of resistance to integrase inhibitors. - Study pre-transition resistance acquired under DTG first-lines at the thresholds of 20% and 5% of the viral population, respectively using Sanger and Ultra-deep Sequencing (UDS) approaches. Identify program factors associated with virological failure and/or the development of drug resistance. Antiretroviral therapy (ART) has dramatically changed the pronostic of HIV/AIDS infection over the last 20 years, by reducing the mortality and morbibidity associted with the infection. This is mostly true in sub-Saharan African, the most affected region of the world. The UNAIDS 2019 report confirms this fact, and shows a significant reduction in the number of deaths related to HIV infection as access to antiretrovirals (ARV) increases. However, in the absence of cure by current treatments, the management and treatment of the infection should still be considered for life. This makes this management complex and challenging. Indeed, the risk of failure to treatment is real, this risk is accompanied by that of developing resistance to treatment, which should lead to a change in treatment. The limited number of molecules therefore requires the development of strategies that must be effective in maintaining virological suppression for as long as possible and should also limit the emergence and circulation of resistant viruses. To address these priorities, the World Health Organization (WHO) recommends since 2016, the introduction of a first-line ART more efficient and more robust, combining molecules with a high genetic barrier to resistance. In its latest 2019 recommendations for resource-limited countries, WHO recommends a first-line ART comprising two nucleoside reverse transcriptase inhibitors (NRTIs) and one integrase inhibitor (INI), preferably tenofovir (TDF)+Lamivudine (3TC )/emtricitabine (FTC)+dolutegravir (DTG). This new strategy is expected in the context of sub-Saharan Africa, where the increase of pre-treatment and acquired HIV drug resistance has been worrying for several years, but raises a certain number of uncertainties. Indeed, available and published data on the effectiveness of DTG are mainly from studies conducted in Northern countries, very few clinical trials have evaluated or are underway to evaluate the strategy in Southern countries and virtually no evaluation of the effectiveness of this approach in the context of real life in the South has been conducted to date. In addition, few or no recommendations have been made to accompany this transition to a new DTG-based first-line in the South. This is of greater concern for patients who are currently under non-NRTI-based first-line , and who will be switched to a new DTG-based first-line. This population will certainly include very variable virological profiles, ranging from patients in virological suppression, to patients who are not virologically suppressed, with potential accumulation of resistance mutations. In the absence of clear and funded recommendations for the organization of these transitions, the risk of this transition producing results below expectations is real and significant. In addition, the reality of the management of HIV infection in the South regularly faces significant challenges associated with limited financial and human resources. This often makes it difficult to apply decisions made even at the national level. For illustration, despite the unanimity around the use of viral load for monitoring people on ART, access to and the availability of this test in daily practice remains challenging in many countries. It is therefore essential to evaluate the virological response in people who will be switched from the current first-line, to the new first-line, in real life conditions, in the South. This study, developed and considered as a priority by the AC43 working group "Medical Virology" of the ANRS, aims to evaluate this new strategy in real life context in three countries of sub-Saharan Africa, Côte d'Ivoire, Mali and Togo. The main objective is to assess the virological efficacy of the DTG-based first-line in real life conditions, for patients initially receiving an NNRTI-based first-line, followed-up in the national programs and determine the impact of baseline NRTI-drug resistance on the success of the new strategy. All these three countries have adopted the new WHO recommendations and the deployment of the DTG-based first-line is being initiated. It is therefore essential that this research be conducted along side with this ongoing transition, so that the results will help developping adequate recommendations that will allow programs in the South to better organise the transition, to improve the therapeutic and virological monitoring of patients, to prevent early failures, and the emergence and rapid circulation of drug resistance. Whole blood samples will be collected for this study and will be used for viral load testing and drug resistance evaluation. HIV-1 infected individuals who are transitioning from an NNRTI-based first-line to a Dolutegravir-based first-line treatment. Inclusion Criteria: - Aged 18 years or over. - Infected with HIV-1. - On an NNRTI-based first-line for at least 6 months. - Initiating a new 1st line ART based on DTG according to national recommendations. - Agree to participate in the study and provide free, written and informed consent. Exclusion Criteria: - Infection with HIV-2 or HIV1+2. - Ongoing participation in another virological study on HIV infection

NCT0531xxxx/NCT05312931.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05312931</url> </required_header> <id_info> <org_study_id>ReFA</org_study_id> <nct_id>NCT05312931</nct_id> </id_info> <brief_title>Retention of Knowledge and Skills of First Aid After Change in Concept of Teaching First Aid</brief_title> <acronym>ReFA</acronym> <official_title>Retention of Knowledge and Skills of First Aid After Change in Concept of Teaching First Aid</official_title> <sponsors> <lead_sponsor> <agency>Brno University Hospital</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Brno University Hospital</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The investigators will evaluate the effect of simulation-based education in First Aid practice on knowledge and skills retention. </textblock> </brief_summary> <detailed_description> <textblock> In autumn semester 2020 a new concept of the subject First aid for the students of General medicine and Dentistry at Faculty of Medicine of Masaryk University was introduced. This concept based on evidence-based medical education puts different principles such as simulation-based education, learner-centred learning, peer learning and outcome-based education into practice.  First aid training (FAT) is indispensable part of the curriculum and knowledge of the first year medical students. The investigator´s aim is to evaluate if the new concept of the first aid training led to improvement in knowledge and mainly in skills of the students. Investigator´s null hypothesis is that the new concept does not lead to improvement in the long-term retention of the knowledge and the skills than the original concept. The investigators will compare tested knowledge and skills of the students who underwent FAT in autumn semester 2019 (original concept, group A) and the students who underwent FAT in autumn semester 2020 (new concept, group B).  The evaluation of the two groups will happen in the interval of 20-24 months after the completion of the FAT. Group A will be evaluated in autumn semester 2021, group B in autumn semester 2022. The evaluation method will be based on a knowledge test and a OSCE (objective structured clinical examination) stations.  Applying principles of evidence-based medical education into practice and designing FAT according to simulation-based education could lead better long-term retention of knowledge and skills of the students. </textblock> </detailed_description> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">May 1, 2022</start_date> <completion_date type="Anticipated">April 30, 2023</completion_date> <primary_completion_date type="Anticipated">April 30, 2023</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Cohort</observational_model> <time_perspective>Prospective</time_perspective> </study_design_info> <primary_outcome> <measure>Measurement of CPR quality - chest compression/ventilation ratio</measure> <time_frame>Up to 36 months</time_frame> <description>CPR quality will be measured with CPR monitoring (qCPR Anne - compression/ventilation feedback software). Attributes of CPR and a method of measurement: chest compression/ventilation ratio - investigator will count the number of chest compressions and a number of ventilation in each cycle in 2 min CPR. It will be statistically analyzed.</description> </primary_outcome> <primary_outcome> <measure>Measurement of CPR quality - percentage of adequate depth of chest compressions</measure> <time_frame>Up to 36 months</time_frame> <description>CPR quality will be measured with CPR monitoring (qCPR Anne - compression/ventilation feedback software). Attributes of CPR and a method of measurement: percentage of adequate depth of chest compressions (%) in 2 min CPR. Adequate depth of chest compression (5 - 6 cm). Method of mesurement: (qCPR Anne - compression/ventilation feedback software).</description> </primary_outcome> <primary_outcome> <measure>Measurement of CPR quality - the longest pause in chest compressions (s)</measure> <time_frame>Up to 36 months</time_frame> <description>CPR quality will be measured with CPR monitoring (qCPR Anne - compression/ventilation feedback software). Attributes of CPR and a method of measurement: the longest pause in chest compressions (s) in 2 min CPR. Method of mesurement: (qCPR Anne - compression/ventilation feedback software).</description> </primary_outcome> <primary_outcome> <measure>Measurement of CPR quality - percentage of chest compression when thorax was adequately released</measure> <time_frame>Up to 36 months</time_frame> <description>CPR quality will be measured with CPR monitoring (qCPR Anne - compression/ventilation feedback software). Attributes of CPR and a method of measurement: percentage of chest compression when thorax was adequately released (%) in 2 min CPR. Method of mesurement: (qCPR Anne - compression/ventilation feedback software).</description> </primary_outcome> <primary_outcome> <measure>Measurement of CPR quality - rescue breaths</measure> <time_frame>Up to 36 months</time_frame> <description>CPR quality will be measured with CPR monitoring (qCPR Anne - compression/ventilation feedback software). Attributes of CPR and a method of measurement: the number of detectable rescue breaths and number of unsuccessful rescue breaths during 2 min in CPR will be recorded. Detectable rescue breath means that the software was able to detect the rescue breath. Unsuccessful rescue breath means that the student tried to deliver rescue breath but the software was not able to detect it. Method of mesurement: (qCPR Anne - compression/ventilation feedback software).</description> </primary_outcome> <primary_outcome> <measure>Measurement of CPR quality - frequency of chest compressions</measure> <time_frame>Up to 36 months</time_frame> <description>CPR quality will be measured with CPR monitoring (qCPR Anne - compression/ventilation feedback software). Attributes of CPR and a method of measurement: frequency of chest compressions (compressions/min) in 2 min CPR will be measured with qCPR software. Method of mesurement: (qCPR Anne - compression/ventilation feedback software).</description> </primary_outcome> <secondary_outcome> <measure>Comparison of group A and B: Chest compressions/ventilation ratio</measure> <time_frame>up to 36 months</time_frame> <description>Statistic analysis will be used in a comparison of Chest compressions/ventilation ratio in groups A and B. Chest compressions/ventilation ratio - good ratio 30:2 according to ERC.</description> </secondary_outcome> <secondary_outcome> <measure>Comparison of group A and B: Depth of chest compressions</measure> <time_frame>up to 36 months</time_frame> <description>Statistic analysis will be used to compare the depth of chest compressions in groups A and B. Depth of chest compressions: adequate chest compression is 5-6 cm.</description> </secondary_outcome> <secondary_outcome> <measure>Comparison of group A and B: Frequency of chest compression</measure> <time_frame>up to 36 months</time_frame> <description>Statistic analysis will be used in a comparison of the frequency of chest compression in groups A and B. Frequency of chest compression: adequate average frequency is 100-120/min.</description> </secondary_outcome> <secondary_outcome> <measure>Comparison of group A and B: The longest pause in chest compressions</measure> <time_frame>up to 36 months</time_frame> <description>Statistic analysis will be used in a comparison of the longest pause in chest compressions in groups A and B. The longest pause in chest compressions: adequate is up to 10s.</description> </secondary_outcome> <secondary_outcome> <measure>Comparison of group A and B: rescue breaths</measure> <time_frame>up to 36 months</time_frame> <description>Statistic analysis will be used in a comparison of the longest pause in chest compressions in groups A and B. The number of detectable rescue breaths and number of unsuccessful rescue breaths during 2 min in CPR will be statistically analyzed.</description> </secondary_outcome> <number_of_groups>2</number_of_groups> <enrollment type="Anticipated">30</enrollment> <condition>First Aid</condition> <arm_group> <arm_group_label>Group A</arm_group_label> <description>students who underwent original concept of First Aid</description> </arm_group> <arm_group> <arm_group_label>Group B</arm_group_label> <description>student who underwent new concept of First Aid</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>OSCE</intervention_name> <description>Students undergo OSCE (objective structured clinical exams). It means students will perform CPR for 2 min and their success rate will be monitored.</description> <arm_group_label>Group A</arm_group_label> <arm_group_label>Group B</arm_group_label> </intervention> <eligibility> <study_pop> <textblock> Students of General medicine and Dentistry of the Faculty of Medicine of Masaryk University who underwent FAT in autumn semester 2020 and 2021 and have not been involved in Student as Teacher programme. </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Students of General medicine and Dentistry of the Faculty of Medicine of Masaryk University who underwent FAT in autumn semester 2020 and 2021 and have not been involved in Student as Teacher programme.  Exclusion Criteria:  - Students of General medicine and Dentistry of the Faculty of Medicine of Masaryk University who underwent FAT in different time intervals or who underwent FAT in autumn semester 2020 and 2021 and also have been involved in Student as Teacher programme. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>30 Years</maximum_age> </eligibility> <overall_official> <last_name>Martina Kosinová, MD</last_name> <role>Study Chair</role> <affiliation>Masaryk University Faculty of Medicine</affiliation> </overall_official> <overall_contact> <last_name>Tereza Prokopová, MD</last_name> <phone>+420736669784</phone> <email>prokopova.tereza@gmail.com</email> </overall_contact> <overall_contact_backup> <last_name>Tereza Vafková, MD</last_name> <phone>+420774131121</phone> <email>tereza.vafkova@med.muni.cz</email> </overall_contact_backup> <verification_date>March 2022</verification_date> <study_first_submitted>February 17, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>March 28, 2022</last_update_submitted> <last_update_submitted_qc>March 28, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Brno University Hospital</investigator_affiliation> <investigator_full_name>Tereza Prokopova, MD</investigator_full_name> <investigator_title>Principal investigator</investigator_title> </responsible_party> <keyword>retention of knowledge</keyword> <keyword>retention of skills</keyword> <keyword>First Aid</keyword> <patient_data> <sharing_ipd>No</sharing_ipd> <ipd_description>The investigators do not plan to share IPD.</ipd_description> </patient_data>  </clinical_study>

The investigators will evaluate the effect of simulation-based education in First Aid practice on knowledge and skills retention. In autumn semester 2020 a new concept of the subject First aid for the students of General medicine and Dentistry at Faculty of Medicine of Masaryk University was introduced. This concept based on evidence-based medical education puts different principles such as simulation-based education, learner-centred learning, peer learning and outcome-based education into practice. First aid training (FAT) is indispensable part of the curriculum and knowledge of the first year medical students. The investigator´s aim is to evaluate if the new concept of the first aid training led to improvement in knowledge and mainly in skills of the students. Investigator´s null hypothesis is that the new concept does not lead to improvement in the long-term retention of the knowledge and the skills than the original concept. The investigators will compare tested knowledge and skills of the students who underwent FAT in autumn semester 2019 (original concept, group A) and the students who underwent FAT in autumn semester 2020 (new concept, group B). The evaluation of the two groups will happen in the interval of 20-24 months after the completion of the FAT. Group A will be evaluated in autumn semester 2021, group B in autumn semester 2022. The evaluation method will be based on a knowledge test and a OSCE (objective structured clinical examination) stations. Applying principles of evidence-based medical education into practice and designing FAT according to simulation-based education could lead better long-term retention of knowledge and skills of the students. Students of General medicine and Dentistry of the Faculty of Medicine of Masaryk University who underwent FAT in autumn semester 2020 and 2021 and have not been involved in Student as Teacher programme. Inclusion Criteria: - Students of General medicine and Dentistry of the Faculty of Medicine of Masaryk University who underwent FAT in autumn semester 2020 and 2021 and have not been involved in Student as Teacher programme. Exclusion Criteria: - Students of General medicine and Dentistry of the Faculty of Medicine of Masaryk University who underwent FAT in different time intervals or who underwent FAT in autumn semester 2020 and 2021 and also have been involved in Student as Teacher programme.

NCT0531xxxx/NCT05312944.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05312944</url> </required_header> <id_info> <org_study_id>PASS (29BRC20.0176)</org_study_id> <nct_id>NCT05312944</nct_id> </id_info> <brief_title>Polymyalgia Rheumatica Associated to Primary Sjogren Syndrome</brief_title> <acronym>PASS</acronym> <official_title>Polymyalgia Rheumatica Associated to Primary Sjogren Syndrome : A French Multicentric Retrospective Study (PASS)</official_title> <sponsors> <lead_sponsor> <agency>University Hospital, Brest</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>University Hospital, Brest</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> To determine the phenotype of patients having PMR symptoms and primary Sjogren syndrome (pSS), we used a French national call to identify patients combining both diseases and collected retrospective clinical and biological data. </textblock> </brief_summary> <detailed_description> <textblock> A national call to identify patients combining pSS and PMR was disseminated in France. Patients with Sjögren's syndrome associated with rheumatoid arthritis were excluded. We described the global population having both diseases and compared them to two historic prospective cohorts of isolated pSS (the prospective cohort of primary Sjögren DiapSS), or isolated PMR (TENOR, a cohort of recent PMR), regarding clinical, imaging and treatments characteristics. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">March 2, 2021</start_date> <completion_date type="Anticipated">March 2, 2023</completion_date> <primary_completion_date type="Anticipated">March 2, 2023</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Cohort</observational_model> <time_perspective>Retrospective</time_perspective> </study_design_info> <primary_outcome> <measure>clinical data</measure> <time_frame>at diagnosis</time_frame> <description>pain (pain scale)</description> </primary_outcome> <primary_outcome> <measure>biological data</measure> <time_frame>at diagnosis</time_frame> <description>biology (CRP in mg/L)</description> </primary_outcome> <primary_outcome> <measure>biological data</measure> <time_frame>at diagnosis</time_frame> <description>presence of anti-SSA/SSB (yes/no)</description> </primary_outcome> <primary_outcome> <measure>histological data</measure> <time_frame>at diagnosis</time_frame> <description>accesories salivary glands biopsies (focus score)</description> </primary_outcome> <primary_outcome> <measure>imaging data</measure> <time_frame>at diagnosis</time_frame> <description>US (presence of shoulder involvement yes/no; hip involvement yes/no)</description> </primary_outcome> <primary_outcome> <measure>treatments data</measure> <time_frame>at inclusion ( day 0)</time_frame> <description>use of methotrexate yes/no; abatacept yes/no, rituximab yes/no, corticosteroids yes/no; pilocarpine yes/no; hydroxychloroquine yes/no</description> </primary_outcome> <enrollment type="Anticipated">15</enrollment> <condition>Polymyalgia Rheumatica</condition> <condition>Sjogren's Syndrome</condition> <eligibility> <study_pop> <textblock> patients fulfilling the ACR/EULAR 2012 criteria for PMR and the ACR/EULAR 2016 criteria for pSS </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - fulfilling the ACR/EULAR 2012 criteria for PMR and the ACR/EULAR 2016 criteria for pSS  Exclusion Criteria:  - </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_contact> <last_name>Valerie Devauchelle-Pensec</last_name> <phone>+332 9834 7264</phone> <email>valerie.devauchelle-pensec@chu-brest.fr</email> </overall_contact> <location> <facility> <name>CHRU Brest</name> <address> <city>Brest</city> <zip>29200</zip> <country>France</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Valerie DEVAUCHELLE-PENSEC, Dr</last_name> <phone>+332 9834 7264</phone> <email>valerie.devauchelle-pensec@chu-brest.fr</email> </contact> </location> <location_countries> <country>France</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>February 17, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>March 28, 2022</last_update_submitted> <last_update_submitted_qc>March 28, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Sjogren's Syndrome</mesh_term> <mesh_term>Polymyalgia Rheumatica</mesh_term> <mesh_term>Giant Cell Arteritis</mesh_term> <mesh_term>Syndrome</mesh_term> </condition_browse>  </clinical_study>

To determine the phenotype of patients having PMR symptoms and primary Sjogren syndrome (pSS), we used a French national call to identify patients combining both diseases and collected retrospective clinical and biological data. A national call to identify patients combining pSS and PMR was disseminated in France. Patients with Sjögren's syndrome associated with rheumatoid arthritis were excluded. We described the global population having both diseases and compared them to two historic prospective cohorts of isolated pSS (the prospective cohort of primary Sjögren DiapSS), or isolated PMR (TENOR, a cohort of recent PMR), regarding clinical, imaging and treatments characteristics. patients fulfilling the ACR/EULAR 2012 criteria for PMR and the ACR/EULAR 2016 criteria for pSS Inclusion Criteria: - fulfilling the ACR/EULAR 2012 criteria for PMR and the ACR/EULAR 2016 criteria for pSS Exclusion Criteria: -

NCT0531xxxx/NCT05312957.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05312957</url> </required_header> <id_info> <org_study_id>AbantIBU mb6</org_study_id> <nct_id>NCT05312957</nct_id> </id_info> <brief_title>Efficacy of Erector Spinae Plane Block in Caridac Surgery</brief_title> <official_title>Evaluation of the Analgesic Effect of Erector Spinae Plane Block in Patients Undergoing Coronary Artery Bypass Graft Surgery: A Randomized Controlled Trial Study</official_title> <sponsors> <lead_sponsor> <agency>Abant Izzet Baysal University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Abant Izzet Baysal University</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Introduction: Opioid-based pharmacological treatment is frequently used in the treatment of pain after coronary artery bypass graft (CABG) surgery. If adequate postoperative analgesia is not provided in such surgeries, pulmonary and cardiovascular complications may develop. This study aimed to provide effective analgesia and reduce postoperative opioid consumption by applying preemptive erector spinae plane (ESP) block.  Methods: A total of 50 patients who underwent CABG surgery were included in this prospective randomized controlled study. Patients were randomly divided into two groups: the ESP group and the control group. The intervention to the ESP group was applied bilaterally at the T5 level before the surgery. The primary outcome was postoperative opioid consumption; the other outcomes included visual analog scale scores, intraoperative opioid consumption, and duration of hospital stay. </textblock> </brief_summary> <detailed_description> <textblock> Study Design and Patient: This prospective randomized study was conducted with the approval of the local ethics committee of the Bolu Abant Izzet Baysal University in Turkey (Approval date 03/11/2020; Decision no. 2020/243). All patients who agreed to participate in the study were informed about the purpose of the study and the anesthesia method to be used, and their written consent was obtained. Sixty-five patients, aged 50-75 years, at the risk of American Society of Anesthesiologists (ASA) III, who was planned off-pump CABG surgery were invited to the study between November 2020 and April 2021. In the preoperative evaluation, patients with hypersensitivity to the drugs to be used or the substances in their composition, having moderate or severe left ventricular dysfunction, bleeding disorders, liver and kidney failure, chronic obstructive pulmonary disease, patients who do not have sufficient intellectual capacity to use the PCA device, and who refused to participate in the study were excluded from the study. In the intraoperative period, patients who needed a cardiopulmonary bypass pump and those who needed an aortic balloon pump support were excluded from the study. In the postoperative period, patients for whom the extubation duration was longer than four hours and those who required re-exploration were excluded from the study The groups were randomized; It was divided into Group E (ESP Group) and Group C (Control Group). The Ramdom.org program (https://www.random.org/lists/?mode=advanced) was used for the randomization of the groups. Demographic data (gender, age, weight, height, body mass index (BMI)) of all patients were recorded. The patients were taken to the operating room without premedication. and electrocardiography (ECG), heart rate (HR) Sist, and peripheral oxygen saturation (SpO2) values were monitored and two peripheral vascular accesses were established with an 18-gauge intravenous (IV) cannula. To provide continuous arterial blood pressure monitoring, the radial artery was cannulated by applying topical anesthesia after the Allen test.  Interventions In Group E patients, a prone position was given before general anesthesia induction. Compliance with the rules of asepsis-antisepsis was achieved. A Sonosite-180 Plus model USG (L38/10-5 MHz Transducer, SonoSite Inc., Bothell, WA 98021 USA) was used for the intervention. An adjusted linear probe was used, which was set to a depth of 2-5 cm and a frequency of 10-15 MHz. The probe was placed craniocaudally in the parasagittal plane approximately 3 cm lateral to the T5 spinous process. The T5 transverse process is detected using a planal approach. Before the procedure, the skin, subcutaneous tissue, trapezius, rhomboid, and erector spinae muscles were identified, and local anesthesia was administered using 2% lidocaine (Aritmal 2% ampoule, Osel Medicine Istanbul, Turkey). When the block needle (Stimuplex B. Braun R, Melsungen, Germany) touched the transverse process, 0.5-1 mL of the 0.9% NaCl test dose was administered between the erector spinae muscle fascia and the vertebral transverse process, and the needle location was confirmed. Then, 20 ml of 0.25% bupivacaine (Buvasin 0.5% Vem Medicine Istanbul, Turkey) was administered to this area, and an ESP block was applied (Figure 1). The same procedure was performed on the opposite side, and a bilateral ESP block was applied. The block was considered successful when cold loss developed. No preoperative procedure was applied to the Group C patients.  Anesthetic Management For the induction of general anesthesia, 2 µg/kg fentanyl (Talinat 50 mcg/ml VEM İlaç San. ve Tic. A.Ş. İstanbul, Turkey), 2 mg/kg propofol (Propofol Lipuro 1% 10mg/ml ampoule, B. Braun, Melsungen, Germany), and 0.6 mg/kg rocuronium (Esmeron 50mg/5ml Merck Sharp Dohme İlaçları Ltd. Şti. Levent/Istanbul) were given intravenously and the patient was intubated after adequate muscle relaxation was achieved. Then, central venous access was achieved. For anesthesia maintenance, 2% sevoflurane (Sevorane® Liquid 100%, AbbVie, Queenborough Kent, England) was used in 50% air and 50% oxygen. Fentanyl (0.5-2 mcg/kg) was administered 1-2 minutes before the thorax incision. An additional 1-2 mcg/kg of intravenous (IV) fentanyl was administered to patients with a 20% increase in blood pressure or heart rate. After induction, 1 mcg/kg fentanyl, and 0.25 mg/kg rocuronium were administered at half-hour intervals in both groups. Before cross-clamping the ascending aorta, the systolic pressure had aimed to be below 100 mmHg. To maintain a systolic pressure below 100 mmHg, patients were administered 1-2 mcg/kg fentanyl when necessary. Intraoperative fentanyl consumption was recorded. During anesthesia, intermittent arterial blood gas monitoring was performed on all patients. The anesthesia and surgery durations of the patients were recorded, and they were taken to the intensive care unit (ICU) as intubated after the operation. The patients were extubated within 4 hours postoperatively. Patient-controlled analgesia devices were applied to all patients after extubation. Tramadol HCl (Tramosel 100 mg/2 ml Haver Pharma İlaç A.Ş, Istanbul/Turkey) was adjusted as IV bolus 20 mg doses of tramadol HCl every time a button was pressed, at a concentration of 5mg/ml. The device was adjusted to allow a maximum dose of 400 mg in 24 hours, with a lock-in time of 20 minutes; total tramadol consumption was recorded. After extubation, VAS values were recorded at the 1st, 2nd, 4th, 8th, 12th, 18th, 24th, 36th, and 48th postoperative hours. During the 0-1, 1-12, 12-24, 24-36, and 36-48 time zones, heart rate, systolic blood pressure, mean blood pressure, diastolic blood pressure, and peripheral oxygen saturation were monitored and recorded. Nausea, vomiting, pruritus, desaturation, urinary retention, and other side effects were followed up and recorded in the patient follow-up after extubation. Postoperative nausea and vomiting were treated with 4mg of ondansetron (IV) (Ondaren 4mg/2ml Vem İlaç A.Ş Istanbul, Turkey), and rash and itching with 45.5 mg of pheniramine (IV) (Avil amp 45.5mg/2ml Sandoz İlaç A.Ş. Istanbul/Turkey). When the VAS was above four, IV 0.05 mg/kg morphine (Morphine HCL® 0.01 g/ml amp Galen İlaç A.Ş./Turkey) was administered as rescue analgesia. The extubation and ICU discharge times of the patients in both groups were recorded </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">October 14, 2020</start_date> <completion_date type="Actual">December 1, 2021</completion_date> <primary_completion_date type="Actual">April 10, 2021</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <intervention_model_description>Group ESP;The probe was placed craniocaudally in the parasagittal plane approximately 3 cm lateral to the T5 spinous process T5 transverse process is detected. When the block needle (Stimuplex B. Braun R, Melsungen, Germany) touched the transverse process, 0.5-1 mL of the 0.9% NaCl test dose was administered between the erector spinae muscle fascia and the vertebral transverse process, and the needle location was confirmed. Then, 20 ml of 0.25% bupivacaine was administered to this area, and an ESP block was applied Group Control : no intervention</intervention_model_description> <primary_purpose>Prevention</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>measuring opioid consumption after surgery</measure> <time_frame>0-1hours</time_frame> <description>tramadol consumption (mg)</description> </primary_outcome> <primary_outcome> <measure>measuring opioid consumption after surgery</measure> <time_frame>1-12hours,</time_frame> <description>tramadol consumption (mg)</description> </primary_outcome> <primary_outcome> <measure>measuring opioid consumption after surgery</measure> <time_frame>12-24hours,</time_frame> <description>tramadol consumption (mg)</description> </primary_outcome> <primary_outcome> <measure>measuring opioid consumption after surgery</measure> <time_frame>24-36hours,</time_frame> <description>tramadol consumption (mg)</description> </primary_outcome> <primary_outcome> <measure>measuring opioid consumption after surgery</measure> <time_frame>36-48hours</time_frame> <description>tramadol consumption (mg)</description> </primary_outcome> <secondary_outcome> <measure>Evaluation of the postoperative visual analog scale(VAS) score</measure> <time_frame>1st hours</time_frame> <description>postoperative VAS score ( VAS ;subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain.")</description> </secondary_outcome> <secondary_outcome> <measure>Evaluation of the postoperative VAS score</measure> <time_frame>2nd hours</time_frame> <description>postoperative VAS score(0 no pain-10 "worst pain.")</description> </secondary_outcome> <secondary_outcome> <measure>Evaluation of the postoperative VAS score</measure> <time_frame>4th hours</time_frame> <description>postoperative VAS (0 no pain-10 "worst pain.")</description> </secondary_outcome> <secondary_outcome> <measure>Evaluation of the postoperative VAS score</measure> <time_frame>8th hours</time_frame> <description>postoperative VAS score (0 no pain-10 "worst pain.")</description> </secondary_outcome> <secondary_outcome> <measure>Evaluation of the postoperative VAS score</measure> <time_frame>12th hours</time_frame> <description>postoperative VAS score (0 no pain-10 "worst pain.")</description> </secondary_outcome> <secondary_outcome> <measure>Evaluation of the postoperative VAS score</measure> <time_frame>18th hours</time_frame> <description>postoperative VAS score (0 no pain-10 "worst pain.")</description> </secondary_outcome> <secondary_outcome> <measure>Evaluation of the postoperative VAS score</measure> <time_frame>24thhours</time_frame> <description>postoperative VAS score (0 no pain-10 "worst pain.")</description> </secondary_outcome> <secondary_outcome> <measure>valuation of the postoperative VAS score</measure> <time_frame>36th hours</time_frame> <description>postoperative VAS score (0 no pain-10 "worst pain.")</description> </secondary_outcome> <secondary_outcome> <measure>valuation of the postoperative VAS score</measure> <time_frame>48th hours</time_frame> <description>postoperative VAS score (0 no pain-10 "worst pain.")</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">40</enrollment> <condition>Postoperative Pain</condition> <arm_group> <arm_group_label>Group ESP</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>The probe was placed craniocaudally in the parasagittal plane approximately 3 cm lateral to the T5 spinous process. The T5 transverse process is detected and When the block needle touched the transverse process,Then, 20 ml of 0.25% bupivacaine was administered to this area, and an ESP block was applied</description> </arm_group> <arm_group> <arm_group_label>Group Control</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>Group Control: Tramadol HCL was administered from vein with a patient-controlled analgesia device after extubation.</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>erector spinae plane block</intervention_name> <description>Group ESP (Arm 1)The probe was placed craniocaudally in the parasagittal plane approximately 3 cm lateral to the T5 spinous process. The T5 transverse process is detected .When the block needle (Stimuplex B. Braun R, Melsungen, Germany) touched the transverse process, 0.5-1 mL of the 0.9% NaCl test dose was administered between the erector spinae muscle fascia and the vertebral transverse process, and the needle location was confirmed.Then, 20 ml of 0.25% bupivacaine was administered to this area, Group Control (Arm 2) :No intervention</description> <arm_group_label>Group ESP</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - aged 50-75 years,  - at the risk of American Society of Anesthesiologists (ASA) III,  - patients who were planned off- pump CABG surgery  Exclusion Criteria:  - In the preoperative evaluation,  - patients with hypersensitivity to the drugs to be used or the substances in their composition  - patients moderate or severe left ventricular dysfunction, with bleeding disorders, with liver and kidney failure, with chronic obstructive pulmonary disease  - patients who do not have sufficient intellectual capacity to use the PCA device,  - patients who refused to participate in the study ----In the intraoperative period, patients who needed a cardiopulmonary bypass pump and those who needed an aortic balloon pump support -----In the postoperative period, patients for whom the extubation duration was longer than four hours and those who required re-exploration were excluded from the study </textblock> </criteria> <gender>All</gender> <minimum_age>50 Years</minimum_age> <maximum_age>75 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <location> <facility> <name>Abant Izzet Baysal University Medical School,</name> <address> <city>Bolu</city> <zip>14280</zip> <country>Turkey</country> </address> </facility> </location> <location_countries> <country>Turkey</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>December 15, 2021</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>March 29, 2022</last_update_submitted> <last_update_submitted_qc>March 29, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Erector spinae plane block,</keyword> <keyword>coronary artery bypass graft surgery,</keyword> <keyword>postoperative pain.</keyword> <keyword>opioid consumption</keyword> <condition_browse>  <mesh_term>Pain, Postoperative</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Introduction: Opioid-based pharmacological treatment is frequently used in the treatment of pain after coronary artery bypass graft (CABG) surgery. If adequate postoperative analgesia is not provided in such surgeries, pulmonary and cardiovascular complications may develop. This study aimed to provide effective analgesia and reduce postoperative opioid consumption by applying preemptive erector spinae plane (ESP) block. Methods: A total of 50 patients who underwent CABG surgery were included in this prospective randomized controlled study. Patients were randomly divided into two groups: the ESP group and the control group. The intervention to the ESP group was applied bilaterally at the T5 level before the surgery. The primary outcome was postoperative opioid consumption; the other outcomes included visual analog scale scores, intraoperative opioid consumption, and duration of hospital stay. Study Design and Patient: This prospective randomized study was conducted with the approval of the local ethics committee of the Bolu Abant Izzet Baysal University in Turkey (Approval date 03/11/2020; Decision no. 2020/243). All patients who agreed to participate in the study were informed about the purpose of the study and the anesthesia method to be used, and their written consent was obtained. Sixty-five patients, aged 50-75 years, at the risk of American Society of Anesthesiologists (ASA) III, who was planned off-pump CABG surgery were invited to the study between November 2020 and April 2021. In the preoperative evaluation, patients with hypersensitivity to the drugs to be used or the substances in their composition, having moderate or severe left ventricular dysfunction, bleeding disorders, liver and kidney failure, chronic obstructive pulmonary disease, patients who do not have sufficient intellectual capacity to use the PCA device, and who refused to participate in the study were excluded from the study. In the intraoperative period, patients who needed a cardiopulmonary bypass pump and those who needed an aortic balloon pump support were excluded from the study. In the postoperative period, patients for whom the extubation duration was longer than four hours and those who required re-exploration were excluded from the study The groups were randomized; It was divided into Group E (ESP Group) and Group C (Control Group). The Ramdom.org program (https://www.random.org/lists/?mode=advanced) was used for the randomization of the groups. Demographic data (gender, age, weight, height, body mass index (BMI)) of all patients were recorded. The patients were taken to the operating room without premedication. and electrocardiography (ECG), heart rate (HR) Sist, and peripheral oxygen saturation (SpO2) values were monitored and two peripheral vascular accesses were established with an 18-gauge intravenous (IV) cannula. To provide continuous arterial blood pressure monitoring, the radial artery was cannulated by applying topical anesthesia after the Allen test. Interventions In Group E patients, a prone position was given before general anesthesia induction. Compliance with the rules of asepsis-antisepsis was achieved. A Sonosite-180 Plus model USG (L38/10-5 MHz Transducer, SonoSite Inc., Bothell, WA 98021 USA) was used for the intervention. An adjusted linear probe was used, which was set to a depth of 2-5 cm and a frequency of 10-15 MHz. The probe was placed craniocaudally in the parasagittal plane approximately 3 cm lateral to the T5 spinous process. The T5 transverse process is detected using a planal approach. Before the procedure, the skin, subcutaneous tissue, trapezius, rhomboid, and erector spinae muscles were identified, and local anesthesia was administered using 2% lidocaine (Aritmal 2% ampoule, Osel Medicine Istanbul, Turkey). When the block needle (Stimuplex B. Braun R, Melsungen, Germany) touched the transverse process, 0.5-1 mL of the 0.9% NaCl test dose was administered between the erector spinae muscle fascia and the vertebral transverse process, and the needle location was confirmed. Then, 20 ml of 0.25% bupivacaine (Buvasin 0.5% Vem Medicine Istanbul, Turkey) was administered to this area, and an ESP block was applied (Figure 1). The same procedure was performed on the opposite side, and a bilateral ESP block was applied. The block was considered successful when cold loss developed. No preoperative procedure was applied to the Group C patients. Anesthetic Management For the induction of general anesthesia, 2 µg/kg fentanyl (Talinat 50 mcg/ml VEM İlaç San. ve Tic. A.Ş. İstanbul, Turkey), 2 mg/kg propofol (Propofol Lipuro 1% 10mg/ml ampoule, B. Braun, Melsungen, Germany), and 0.6 mg/kg rocuronium (Esmeron 50mg/5ml Merck Sharp Dohme İlaçları Ltd. Şti. Levent/Istanbul) were given intravenously and the patient was intubated after adequate muscle relaxation was achieved. Then, central venous access was achieved. For anesthesia maintenance, 2% sevoflurane (Sevorane® Liquid 100%, AbbVie, Queenborough Kent, England) was used in 50% air and 50% oxygen. Fentanyl (0.5-2 mcg/kg) was administered 1-2 minutes before the thorax incision. An additional 1-2 mcg/kg of intravenous (IV) fentanyl was administered to patients with a 20% increase in blood pressure or heart rate. After induction, 1 mcg/kg fentanyl, and 0.25 mg/kg rocuronium were administered at half-hour intervals in both groups. Before cross-clamping the ascending aorta, the systolic pressure had aimed to be below 100 mmHg. To maintain a systolic pressure below 100 mmHg, patients were administered 1-2 mcg/kg fentanyl when necessary. Intraoperative fentanyl consumption was recorded. During anesthesia, intermittent arterial blood gas monitoring was performed on all patients. The anesthesia and surgery durations of the patients were recorded, and they were taken to the intensive care unit (ICU) as intubated after the operation. The patients were extubated within 4 hours postoperatively. Patient-controlled analgesia devices were applied to all patients after extubation. Tramadol HCl (Tramosel 100 mg/2 ml Haver Pharma İlaç A.Ş, Istanbul/Turkey) was adjusted as IV bolus 20 mg doses of tramadol HCl every time a button was pressed, at a concentration of 5mg/ml. The device was adjusted to allow a maximum dose of 400 mg in 24 hours, with a lock-in time of 20 minutes; total tramadol consumption was recorded. After extubation, VAS values were recorded at the 1st, 2nd, 4th, 8th, 12th, 18th, 24th, 36th, and 48th postoperative hours. During the 0-1, 1-12, 12-24, 24-36, and 36-48 time zones, heart rate, systolic blood pressure, mean blood pressure, diastolic blood pressure, and peripheral oxygen saturation were monitored and recorded. Nausea, vomiting, pruritus, desaturation, urinary retention, and other side effects were followed up and recorded in the patient follow-up after extubation. Postoperative nausea and vomiting were treated with 4mg of ondansetron (IV) (Ondaren 4mg/2ml Vem İlaç A.Ş Istanbul, Turkey), and rash and itching with 45.5 mg of pheniramine (IV) (Avil amp 45.5mg/2ml Sandoz İlaç A.Ş. Istanbul/Turkey). When the VAS was above four, IV 0.05 mg/kg morphine (Morphine HCL® 0.01 g/ml amp Galen İlaç A.Ş./Turkey) was administered as rescue analgesia. The extubation and ICU discharge times of the patients in both groups were recorded Inclusion Criteria: - aged 50-75 years, - at the risk of American Society of Anesthesiologists (ASA) III, - patients who were planned off- pump CABG surgery Exclusion Criteria: - In the preoperative evaluation, - patients with hypersensitivity to the drugs to be used or the substances in their composition - patients moderate or severe left ventricular dysfunction, with bleeding disorders, with liver and kidney failure, with chronic obstructive pulmonary disease - patients who do not have sufficient intellectual capacity to use the PCA device, - patients who refused to participate in the study ----In the intraoperative period, patients who needed a cardiopulmonary bypass pump and those who needed an aortic balloon pump support -----In the postoperative period, patients for whom the extubation duration was longer than four hours and those who required re-exploration were excluded from the study

NCT0531xxxx/NCT05312970.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05312970</url> </required_header> <id_info> <org_study_id>S2473</org_study_id> <nct_id>NCT05312970</nct_id> </id_info> <brief_title>Varithena Versus Endothermal Ablation of the Great Saphenous Vein (VERITAS)</brief_title> <acronym>VERITAS</acronym> <official_title>A Phase 4 Randomized Trial Comparing Varithena to Endothermal Ablation for the Treatment of the Great Saphenous Vein</official_title> <sponsors> <lead_sponsor> <agency>Boston Scientific Corporation</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Boston Scientific Corporation</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>Yes</is_fda_regulated_drug> <is_fda_regulated_device>Yes</is_fda_regulated_device> <is_us_export>No</is_us_export> </oversight_info> <brief_summary> <textblock> The purpose of this study is to observe insights into the benefits of Varithena compared to Endothermal Ablation (ETA) in the treatment of the great saphenous vein. </textblock> </brief_summary> <detailed_description> <textblock> To collect comparative evidence on patient reported outcomes of Varithena compared to ETA when used to treat the incompetent great saphenous vein (GSV). ETA will include either radiofrequency ablation or endovenous laser ablation according to the site's standard practice. To provide long term (1-year, 2-year, and 3-year) outcomes. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">February 10, 2023</start_date> <completion_date type="Anticipated">November 30, 2026</completion_date> <primary_completion_date type="Anticipated">February 28, 2024</primary_completion_date> <phase>Phase 4</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <intervention_model_description>Randomized controlled trial 1:1 assignment</intervention_model_description> <primary_purpose>Other</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Change in Varicose Veins Symptoms Questionnaire (VVSymQ)</measure> <time_frame>Baseline to 3-month post treatment</time_frame> <description>Mean change in Varicose Veins Symptoms Questionnaire (VVSymQ) between baseline and 3-month post treatment</description> </primary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">100</enrollment> <condition>Varicose Veins</condition> <arm_group> <arm_group_label>Varithena®</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Varithena® (polidocanol injectable foam) 1%</description> </arm_group> <arm_group> <arm_group_label>FDA-approved ETA systems</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>FDA-approved ETA systems, including Radiofrequency ablation (RFA) systems or Endovenous laser ablation (EVLA) systems.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Varithena®</intervention_name> <description>Varithena® (polidocanol injectable foam) 1%</description> <arm_group_label>Varithena®</arm_group_label> </intervention> <intervention> <intervention_type>Device</intervention_type> <intervention_name>FDA-approved Endothermal Ablation (ETA) systems</intervention_name> <description>FDA-approved ETA systems, including Radiofrequency ablation (RFA) systems or Endovenous laser ablation (EVLA) systems.</description> <arm_group_label>FDA-approved ETA systems</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Age ≥ 18  - Primary GSV incompetence, defined as reflux > 0.5 seconds on Duplex ultrasound in a single limb (Note the contralateral limb can have varicosities or SVI if intervention is not required within 3 months i.e. asymptomatic)  - Failed conservative therapy (compression, diet, exercise, leg elevation)  - CEAP Clinical Condition Classification C2 - C6  - Vein diameter 5-10mm, inclusive  - GSV treatable length > 10cm  - Superficial venous disease manifest by clinical symptoms (rVCSS ≥ 4)  - Able to comprehend and sign an informed consent document and complete written study questionnaires  - Willing and able to return for scheduled follow-up visits (7-days, 3-months, 6-months, 12-months, 24-months, and 36-months post-procedure)  - Willingness to comply with post-treatment compression protocol  Exclusion Criteria:  - Allergy to polidocanol, xylocaine, or epinephrine  - Deep vein thrombosis or pulmonary embolism within 3 months prior to randomization or hypercoagulable disorder  - Post thrombotic deep vein disease above the calf veins  - Pregnancy or lactating (within 30 days of randomization)  - Symptomatic peripheral arterial disease or ankle-brachial pressure index (ABPI) < 0.8  - Previous treatment to targeted incompetent GSV or previous superficial thrombophlebitis in targeted GSV  - Previous venous intervention in affected limb in past 3 months  - Local aneurysmal GSV segments  - Inability to walk unaided  - Inability to wear post-procedure compression bandaging and stockings  - Patients with clinically significant reflux of the small saphenous vein (SSV) or anterior accessory saphenous vein (AASV)  - In the clinical judgement of the investigator, patient who will require ipsilateral deep venous intervention within 3 months following randomized treatment  - In the clinical judgement of the investigator, patient who will require contralateral venous intervention (superficial or deep) within 3 months following randomized treatment  - Patient on therapeutic anticoagulants  - Active malignancy  - Life expectancy < 2 years  - Documented COVID-19 infection currently or within 2 months prior to randomization  - Enrollment in another clinical trial that could confound the endpoint within 3 months prior to screening or within 3 months following enrollment </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_contact> <last_name>Timothy Keo</last_name> <phone>425.599.3814</phone> <email>Timothy.Keo@bsci.com</email> </overall_contact> <overall_contact_backup> <last_name>Sharon Mensah</last_name> <phone>612.403.7653</phone> <email>Sharon.Mensah@bsci.com</email> </overall_contact_backup> <location> <facility> <name>Vascular Care Connecticut</name> <address> <city>Darien</city> <state>Connecticut</state> <zip>06820</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Paul J Gagne, MD</last_name> </contact> </location> <location> <facility> <name>Cardiovascular Institute of the South</name> <address> <city>Houma</city> <state>Louisiana</state> <zip>70360</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Craig Walker, MD</last_name> </contact> </location> <location> <facility> <name>Vein Healthcare Center</name> <address> <city>South Portland</city> <state>Maine</state> <zip>04106</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Cindy Asbjornsen, DO</last_name> </contact> </location> <location> <facility> <name>Englewood Hospital and Medical Center</name> <address> <city>Englewood</city> <state>New Jersey</state> <zip>07631</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Steven Elias, MD</last_name> </contact> </location> <location> <facility> <name>Stony Brook University Hospital</name> <address> <city>Stony Brook</city> <state>New York</state> <zip>11794</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Antonios P Gasparis, MD</last_name> </contact> </location> <location> <facility> <name>Lake Washington Vascular</name> <address> <city>Bellevue</city> <state>Washington</state> <zip>98004</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Kathleen Gibson, MD</last_name> </contact> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>August 2023</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>August 24, 2023</last_update_submitted> <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc> <last_update_posted type="Actual">August 28, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Great Saphenous Vein Incompetence</keyword> <condition_browse>  <mesh_term>Varicose Veins</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Polidocanol</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

The purpose of this study is to observe insights into the benefits of Varithena compared to Endothermal Ablation (ETA) in the treatment of the great saphenous vein. To collect comparative evidence on patient reported outcomes of Varithena compared to ETA when used to treat the incompetent great saphenous vein (GSV). ETA will include either radiofrequency ablation or endovenous laser ablation according to the site's standard practice. To provide long term (1-year, 2-year, and 3-year) outcomes. Inclusion Criteria: - Age ≥ 18 - Primary GSV incompetence, defined as reflux > 0.5 seconds on Duplex ultrasound in a single limb (Note the contralateral limb can have varicosities or SVI if intervention is not required within 3 months i.e. asymptomatic) - Failed conservative therapy (compression, diet, exercise, leg elevation) - CEAP Clinical Condition Classification C2 - C6 - Vein diameter 5-10mm, inclusive - GSV treatable length > 10cm - Superficial venous disease manifest by clinical symptoms (rVCSS ≥ 4) - Able to comprehend and sign an informed consent document and complete written study questionnaires - Willing and able to return for scheduled follow-up visits (7-days, 3-months, 6-months, 12-months, 24-months, and 36-months post-procedure) - Willingness to comply with post-treatment compression protocol Exclusion Criteria: - Allergy to polidocanol, xylocaine, or epinephrine - Deep vein thrombosis or pulmonary embolism within 3 months prior to randomization or hypercoagulable disorder - Post thrombotic deep vein disease above the calf veins - Pregnancy or lactating (within 30 days of randomization) - Symptomatic peripheral arterial disease or ankle-brachial pressure index (ABPI) < 0.8 - Previous treatment to targeted incompetent GSV or previous superficial thrombophlebitis in targeted GSV - Previous venous intervention in affected limb in past 3 months - Local aneurysmal GSV segments - Inability to walk unaided - Inability to wear post-procedure compression bandaging and stockings - Patients with clinically significant reflux of the small saphenous vein (SSV) or anterior accessory saphenous vein (AASV) - In the clinical judgement of the investigator, patient who will require ipsilateral deep venous intervention within 3 months following randomized treatment - In the clinical judgement of the investigator, patient who will require contralateral venous intervention (superficial or deep) within 3 months following randomized treatment - Patient on therapeutic anticoagulants - Active malignancy - Life expectancy < 2 years - Documented COVID-19 infection currently or within 2 months prior to randomization - Enrollment in another clinical trial that could confound the endpoint within 3 months prior to screening or within 3 months following enrollment

NCT0531xxxx/NCT05312983.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05312983</url> </required_header> <id_info> <org_study_id>2021-062</org_study_id> <secondary_id>2021-A02543-38</secondary_id> <nct_id>NCT05312983</nct_id> </id_info> <brief_title>Development of a Battery of Audiological Tests for the Precision Diagnosis of Age-related Hearing Loss</brief_title> <acronym>AUDIOGENAGE</acronym> <official_title>Development of a Battery of Audiological Tests for the Precision Diagnosis of Age-related Hearing Loss</official_title> <sponsors> <lead_sponsor> <agency>Institut Pasteur</agency> <agency_class>Industry</agency_class> </lead_sponsor> <collaborator> <agency>CEntre de Recherche et d'Innovation en Audiologie Humaine</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Laboratoire de correction auditive</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Institut Pasteur</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Age-related hearing loss, or presbycusis, is caused by many genetic and environmental factors. Its prevalence poses a public health challenge of early identification and effective hearing aid treatment. However, the lack of screening and of a validated audiological test battery to diagnose an individual's needs and to guide hearing aid adjustments is a major obstacle.  Furthermore, monogenic forms of hearing loss affect only one functional module of hearing. The audiological test(s) dependent on the function of this module are affected, in a progressive manner, but not the others. A previous study showed that in early onset presbycusis patients, a quarter of the subjects tested were affected by monogenic presbycusis.  The collection of audiological and vestibular tests, carried out on proven monogenic presbycusis patients and compared to that of normal hearing patients, would constitute a battery of tests allowing a precision diagnosis, then developed to all forms of presbycusis in order to study if the identification of abnormal functional modules can usefully guide the diagnosis and the early fitting. </textblock> </brief_summary> <detailed_description> <textblock> The AUDIOGENAGE project is a multi-center, non-invasive case-control study conducted by CERIAH (CEntre de Recherche et d'Innovation en Human Audiology) and LCA (Laboratory de correction auditive) in 700 volunteer participants identified in two groups:  - 500 Patients with age-related hearing loss of anticipated onset,  - 200 Control subjects, considered as normal hearing for their age at inclusion.  All participants will undergo 6h audiological and vestibular tests, and also neurocognitive test (self-questionnaire). These tests will be conducted over 2 to 4 visits. A 10 mL-blood sample will be collected for a genetic analysis. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">July 28, 2022</start_date> <completion_date type="Anticipated">July 28, 2028</completion_date> <primary_completion_date type="Anticipated">July 28, 2024</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>N/A</allocation> <intervention_model>Single Group Assignment</intervention_model> <intervention_model_description>2 groups : 500 participants with early onset presbycusis 200 participants with normal hearing for their age</intervention_model_description> <primary_purpose>Diagnostic</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Measurement of specificity and sensitivity of the audiological test battery in participants with early-onset presbycusis after identification of pathogenic variants by sequencing and division into subgroups.</measure> <time_frame>2 years</time_frame> <description>specifity and sensitivity will be calculated to identify which tests or combinations of audiological and vestibular tests will be the most discriminating in characterizing each functional module of hearing from participants with monogenic forms of presbycusis of anticipated onset, each affecting a determined functional module, in comparison with an age-matched control group.</description> </primary_outcome> <secondary_outcome> <measure>Normative values for audiological and vestibular tests will be determined</measure> <time_frame>4 years and 6 months</time_frame> <description>Measurement of values by age range for all audiological and vestibular tests from the results of participants in the control group</description> </secondary_outcome> <secondary_outcome> <measure>Whole-exome sequencing of samples from participants with non-monogenic presbycusis</measure> <time_frame>4 years and 6 months</time_frame> <description>Whole-exome sequencing will be performed to establish a list of new candidate genes for predisposition to presbycusis.</description> </secondary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Anticipated">700</enrollment> <condition>Presbyacusis</condition> <arm_group> <arm_group_label>people over the age of 40 who agree to participate in the research.</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>They are either people who have a hearing loss about 20 years older than their age and wear a hearing aid (or come in for a hearing aid), or people with normal hearing for their age.</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Audiological and vestibular tests</intervention_name> <description>6h of audiological and vestibular tests divide in 3 sessions : Session A : objective audiological tests Session B ; subjective audiological tests Session C : balance tests.</description> <arm_group_label>people over the age of 40 who agree to participate in the research.</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Blood sampling</intervention_name> <description>A 10 mL blood sample will be collected during the study.</description> <arm_group_label>people over the age of 40 who agree to participate in the research.</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>neurocognitive self-questionnaire</intervention_name> <description>Four self-questionnaires to fill out to measure sleep quality, memory and emotional state</description> <arm_group_label>people over the age of 40 who agree to participate in the research.</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  For all participants:  - Be over the age of 40,  - Be affiliated to a social security system,  - Have a good command of the French language (oral and written).  For the group of participants with anticipated presbycusis:  - Having a hearing aid recipient or coming for a first hearing aid recipient .  For healthy volunteers:  - Have no known hearing loss.  Exclusion Criteria:  - Report having been chronically exposed to loud sounds.  - Have a history of ototoxic substances,  - To have sequelae of ear infections and/or a history of ENT disease that permanently affects hearing or balance,  - Have an ethnic origin for which the Pasteur Institute does not have information on the frequency of variants of the genes studied.  - Have type II diabetes,  - Have a neurological or psychiatric condition that interferes with comprehension or ability to move,  - Be under guardianship,  - Be deprived of liberty by judicial or administrative decision, or be subject to legal protection,  - Not being subject to a social security system,  - Taking narcotic substances, alcohol or medication that diminishes cognitive abilities. </textblock> </criteria> <gender>All</gender> <minimum_age>40 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Paul Avan, MD</last_name> <role>Principal Investigator</role> <affiliation>CERIAH</affiliation> </overall_official> <overall_contact> <last_name>Celine Quinsac</last_name> <phone>+33 (0)1 76 53 50 29</phone> <email>celine.quinsac@pasteur.fr</email> </overall_contact> <overall_contact_backup> <last_name>Paul Avan, MD</last_name> <phone>+33 (0)1 76 53 50 94</phone> <email>paul.avan@uca.fr</email> </overall_contact_backup> <location> <facility> <name>Laboratoire de correction auditive</name> <address> <city>Paris</city> <zip>75001</zip> <country>France</country> </address> </facility> <status>Not yet recruiting</status> <contact> <last_name>Arnaud Coez, PharmD</last_name> <phone>+33 (0)1 42 96 87 70</phone> <email>arnaud.coez.ext@pasteur.fr</email> </contact> </location> <location> <facility> <name>CEntre de Recherche et d'Innovation en Audiologie Humaine</name> <address> <city>Paris</city> <zip>75012</zip> <country>France</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Paul Avan, MD</last_name> <phone>+33 (0)1 76 53 50 94</phone> <email>paul.avan@uca.fr</email> </contact> </location> <location_countries> <country>France</country> </location_countries> <verification_date>August 2022</verification_date> <study_first_submitted>February 25, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>August 16, 2022</last_update_submitted> <last_update_submitted_qc>August 16, 2022</last_update_submitted_qc> <last_update_posted type="Actual">August 17, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>presbyacusis</keyword> <keyword>aging</keyword> <keyword>audiology</keyword> <keyword>genetic</keyword> <condition_browse>  <mesh_term>Hearing Loss</mesh_term> <mesh_term>Presbycusis</mesh_term> </condition_browse>  </clinical_study>

Age-related hearing loss, or presbycusis, is caused by many genetic and environmental factors. Its prevalence poses a public health challenge of early identification and effective hearing aid treatment. However, the lack of screening and of a validated audiological test battery to diagnose an individual's needs and to guide hearing aid adjustments is a major obstacle. Furthermore, monogenic forms of hearing loss affect only one functional module of hearing. The audiological test(s) dependent on the function of this module are affected, in a progressive manner, but not the others. A previous study showed that in early onset presbycusis patients, a quarter of the subjects tested were affected by monogenic presbycusis. The collection of audiological and vestibular tests, carried out on proven monogenic presbycusis patients and compared to that of normal hearing patients, would constitute a battery of tests allowing a precision diagnosis, then developed to all forms of presbycusis in order to study if the identification of abnormal functional modules can usefully guide the diagnosis and the early fitting. The AUDIOGENAGE project is a multi-center, non-invasive case-control study conducted by CERIAH (CEntre de Recherche et d'Innovation en Human Audiology) and LCA (Laboratory de correction auditive) in 700 volunteer participants identified in two groups: - 500 Patients with age-related hearing loss of anticipated onset, - 200 Control subjects, considered as normal hearing for their age at inclusion. All participants will undergo 6h audiological and vestibular tests, and also neurocognitive test (self-questionnaire). These tests will be conducted over 2 to 4 visits. A 10 mL-blood sample will be collected for a genetic analysis. Inclusion Criteria: For all participants: - Be over the age of 40, - Be affiliated to a social security system, - Have a good command of the French language (oral and written). For the group of participants with anticipated presbycusis: - Having a hearing aid recipient or coming for a first hearing aid recipient . For healthy volunteers: - Have no known hearing loss. Exclusion Criteria: - Report having been chronically exposed to loud sounds. - Have a history of ototoxic substances, - To have sequelae of ear infections and/or a history of ENT disease that permanently affects hearing or balance, - Have an ethnic origin for which the Pasteur Institute does not have information on the frequency of variants of the genes studied. - Have type II diabetes, - Have a neurological or psychiatric condition that interferes with comprehension or ability to move, - Be under guardianship, - Be deprived of liberty by judicial or administrative decision, or be subject to legal protection, - Not being subject to a social security system, - Taking narcotic substances, alcohol or medication that diminishes cognitive abilities.

NCT0531xxxx/NCT05312996.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05312996</url> </required_header> <id_info> <org_study_id>I-0017</org_study_id> <nct_id>NCT05312996</nct_id> </id_info> <brief_title>Autonomic Nervous System Function - Hypertension</brief_title> <official_title>Perceived Stress and Patterns of Autonomic Function: a Protocol Development Study</official_title> <sponsors> <lead_sponsor> <agency>Life University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Life University</source> <oversight_info> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The Life University Center for Chiropractic Research is conducting a research study to better understand the physiological differences, in terms of Autonomic nervous system function, between individuals with Hypertension and control individuals with out hypertension. Data will be gathered using Heart Rate Variability (HRV), and Galvanic Skin Response (GSR). A series of tests will be conducted to elicit Autonomic Nervous system responses. These tests include Cold Face Test (mammalian dive reflex), Cold Pressor test, Sit to stand, and the Valsalva maneuver. </textblock> </brief_summary> <detailed_description> <textblock> The objective of the study is to ascertain the level of autonomic health in persons with hypertension versus a healthy population. Further, via the implemented protocol, the study will attempt to develop a sequence of autonomic nervous system tests to be used in future studies and clinical settings </textblock> </detailed_description> <overall_status>Suspended</overall_status> <why_stopped> Prioritizing other studies </why_stopped> <start_date type="Actual">October 1, 2021</start_date> <completion_date type="Anticipated">October 26, 2023</completion_date> <primary_completion_date type="Anticipated">October 26, 2023</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Non-Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Basic Science</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Heart Rate Varability</measure> <time_frame>Through study completion, an average of 1 year</time_frame> <description>Caretaker Heart Rate Variability (HRV) Electrocardiogram (ECG) wrist monitor and chest patch.</description> </primary_outcome> <primary_outcome> <measure>Galvanic Skin Response</measure> <time_frame>Through study completion, an average of 1 year</time_frame> <description>Galvanic Skin Response- measuring autonomic response-via perspiration</description> </primary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">30</enrollment> <condition>Hypertension</condition> <arm_group> <arm_group_label>Hypertension</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Hypertension test group.</description> </arm_group> <arm_group> <arm_group_label>Active Comparator</arm_group_label> <arm_group_type>Other</arm_group_type> <description>Non Hypertension compare group.</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Heart Rate Variability</intervention_name> <description>Caretaker Heart Rate Variability ECG wrist monitor and chest patch.</description> <arm_group_label>Active Comparator</arm_group_label> <arm_group_label>Hypertension</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Galvanic Skin Response (Biopac)</intervention_name> <description>Galvanic Skin Response- measuring autonomic response-via perspiration</description> <arm_group_label>Active Comparator</arm_group_label> <arm_group_label>Hypertension</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Participants will be included in the hypertension group if they present with the following:  - Hypertension, defined as:  - Self-reported or previously diagnosed with elevated resting state blood pressure (120-129 systolic and less than 80 mmHg diastolic) or stage 1 hypertension with a blood pressure of Systolic between 130- and 139-mm Hg with a diastolic of 80-89 mmHg.  - Or medically diagnosed and managed stage 2 hypertension with blood pressure of Systolic between 140- and 159-mm Hg or diastolic 90 and 99 mm  - between the ages of 18-65  - Able to wear a monitor on their right wrist.  - Able to wear a pulse oximeter on their left hand.  Participants will be included in the healthy group if they present with the following:  - between the ages of 18-65  - Able to wear a monitor on their right wrist.  - Able to wear a pulse oximeter on their left hand. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>65 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Stephanie Sullivan, DC, PhD</last_name> <role>Study Director</role> <affiliation>Life Univeristy</affiliation> </overall_official> <location> <facility> <name>Dr. Sid E. Williams Center for Chiropractic Research</name> <address> <city>Atlanta</city> <state>Georgia</state> <zip>30308</zip> <country>United States</country> </address> </facility> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>May 2023</verification_date> <study_first_submitted>March 2, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>May 2, 2023</last_update_submitted> <last_update_submitted_qc>May 2, 2023</last_update_submitted_qc> <last_update_posted type="Actual">May 3, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Hypertension</mesh_term> </condition_browse>  </clinical_study>

The Life University Center for Chiropractic Research is conducting a research study to better understand the physiological differences, in terms of Autonomic nervous system function, between individuals with Hypertension and control individuals with out hypertension. Data will be gathered using Heart Rate Variability (HRV), and Galvanic Skin Response (GSR). A series of tests will be conducted to elicit Autonomic Nervous system responses. These tests include Cold Face Test (mammalian dive reflex), Cold Pressor test, Sit to stand, and the Valsalva maneuver. The objective of the study is to ascertain the level of autonomic health in persons with hypertension versus a healthy population. Further, via the implemented protocol, the study will attempt to develop a sequence of autonomic nervous system tests to be used in future studies and clinical settings Participants will be included in the hypertension group if they present with the following: - Hypertension, defined as: - Self-reported or previously diagnosed with elevated resting state blood pressure (120-129 systolic and less than 80 mmHg diastolic) or stage 1 hypertension with a blood pressure of Systolic between 130- and 139-mm Hg with a diastolic of 80-89 mmHg. - Or medically diagnosed and managed stage 2 hypertension with blood pressure of Systolic between 140- and 159-mm Hg or diastolic 90 and 99 mm - between the ages of 18-65 - Able to wear a monitor on their right wrist. - Able to wear a pulse oximeter on their left hand. Participants will be included in the healthy group if they present with the following: - between the ages of 18-65 - Able to wear a monitor on their right wrist. - Able to wear a pulse oximeter on their left hand.

NCT0531xxxx/NCT05313009.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313009</url> </required_header> <id_info> <org_study_id>103408</org_study_id> <nct_id>NCT05313009</nct_id> </id_info> <brief_title>Tarlox and Sotorasib in Patients With KRAS G12C Mutations</brief_title> <official_title>A Phase Ib / II Trial of Tarloxotinib and Sotorasib in Patients With KRAS G12C Mutations</official_title> <sponsors> <lead_sponsor> <agency>Medical University of South Carolina</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Rain Oncology Inc</agency> <agency_class>Industry</agency_class> </collaborator> </sponsors> <source>Medical University of South Carolina</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>Yes</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> <is_us_export>Yes</is_us_export> </oversight_info> <brief_summary> <textblock> This is a Phase IB dose expansion trial with safety lead-in evaluating the safety, clinical activity/efficacy of the combination of tarloxotinib and sotorasib in patients with KRAS G12C mutation who have progressed on any small molecule targeting KRAS G12C mutant Non-Small Cell lung cancer. </textblock> </brief_summary> <detailed_description> <textblock> KRAS acts as a key protein in transducing signals from cell surface receptors, such as receptor tyrosine kinases (RTKs) into cells to initiate a network of cytoplasmic and nuclear signaling cascades that mediate key processes, such as cell cycle entry and cell survival that regulate normal tissue homeostasis. Due to the central importance of KRAS in mediating critical cellular processes, there are significant interconnected signaling feedback pathways that protect normal cells from uncontrolled proliferation and cell death. These signaling feedback pathways are also activated by tumor cells upon inhibition of mutated KRAS, which may result in intrinsic or acquired resistance to small molecule KRAS G12C inhibitors. Pre-clinical studies in non-small cell lung cancer (NSCLC) have shown that a key pathway that may be activated upon KRAS inhibition is the upstream ERBB RTKs, which provides the rationale for dual KRAS and ERBB blockade in overcoming resistance mechanisms in KRAS mutated NSCLC.  Lung cancer is the second most common cancer and the leading cause of cancer death in the United States. There were approximately 247,270 new cases of lung cancer that occurred in 2020. Prior studies have reported that lung cancer resulted in more deaths than breast cancer, prostate cancer, colorectal cancer, and leukemia combined in men ≥40 years old and women ≥60 years old. The past decade has seen a revolution of new advances in the management of non-small cell lung cancer (NSCLC) with remarkable progresses in screening, diagnosis, and treatment. The advances in systemic treatment have been driven primarily by the development of molecularly targeted therapeutics, immune-checkpoint inhibitors and anti-angiogenic agents, all of which have transformed this field with significantly improved patient outcomes. Despite these advances, most patients with advanced NSCLC have incurable disease, particularly after failure of a platinum-based chemotherapy regimen and check point inhibitors.  One of the earliest identified molecular drivers of NSCLC is the GTPase transductor protein called KRAS. It is a member of the RAS family of oncogenes and at the apex of multiple signaling pathways central to tumor cell proliferation. KRAS mutant lung cancers have worse outcomes in both early stage and advanced metastatic settings, illustrating the critical need for novel agents targeting KRAS-driven NSCLC. KRAS G12C mutations are present in ~15% of lung adenocarcinomas and 0-8% of other cancers. The missense mutation at codon 12 interferes with the GTPase, activating protein mediated GTP hydrolysis and shifting the equilibrium between the signaling-competent KRAS-GTP and signaling incompetent KRAS-GDP in favor of the GTP bound state. This process links upstream cell surface receptors such as the ERBB family (EGFR, HER-2, HER-3, HER-4) to downstream pathways such as RAF/MEK/ERK and PI3K/AKT/mTOR which leads to uncontrolled cell proliferation and survival.  Attempts to identify small molecular inhibitors of KRAS have been unsuccessful for many years as there was a lack of a clearly defined deep pocket in the structure of RAS outside of the nucleotide binding site and the challenge of targeting the nucleotide binding site due to extraordinarily high affinity of GTP. Recently, several pioneering studies have identified small molecule cysteine-reactive inhibitors that covalently modify the mutant KRAS G12C protein to reveal an allosteric switch II pocket. The induction of the structurally disordered pocket by these small molecule inhibitors converts the GTP preference of naïve KRAS G12C to the inactive GDP bound state, impairing its interaction with downstream effectors.  AMG510/Sotorasib was the first KRAS G12C inhibitor to the enter the clinic. A Phase I/II clinical trial involving 129 patients included 59 patients with KRAS G12C mutated NSCLC who had progressed on prior standard therapies. Patients were enrolled in dose escalation and expansion cohorts to receive daily sotorasib monotherapy (960 mg PO daily). At a median follow up of 12.2 months, approximately 50% of NSCLC patients demonstrated tumor regression with a confirmed objective response rate (ORR) of 37.1% (95% CI 28.6-46.2%) and a disease control rate (DCR) of 80.6% (95% CI 72.6-87.2%). The median time to objective response was 1.4 months and median duration of response was 10 months, with median progression free survival (PFS) of 6.8 months. The FDA has now accepted a new drug application and granted it a priority review for the treatment of patients with KRAS G12C mutant locally advanced or metastatic NSCLC following at least 1 prior systemic treatment, with an expected decision date by August 2021.  Although the results from these early-stage clinical trials showed promise, ~50% of KRAS G12C mutant NSCLC patients failed to respond to therapy and rate of relapse is high calling for the need for novel combinations to overcome intrinsic and acquired resistance mechanisms in this subset of patients.  It was previously thought that constitutively active oncogenic KRAS induces growth factor independence. However, recent evidence has suggested that specific KRAS mutant isoforms such as KRAS G12C may be regulated by upstream activation of several receptor tyrosine kinases. The pattern of RTK dependence appears to vary between KRAS G12C mutant cancer but numerous RTKs are involved in the adaptive feedback mechanism to G12C inhibition. This may be mediated through an adaptive RAS pathway activation. Silencing oncogenic KRAS in EGFR/HER dependent cells reduced cellular growth and induced a modest apoptotic signal. The depletion of KRAS expression by mutant specific siRNA was accompanied by a reduction in AKT phosphorylation in the ERBB dependent subset and activation of STAT3, which suggests a feedback loop via STAT3 that re-establishes oncogenic signaling thereby compensating for the loss of AKT survival signals. Pan ERBB inhibition in these KRAS G12C mutated NSCLC lines resulted in a potent suppression of growth and inhibition of receptor signaling and downstream signaling effectors. Thus, sole silencing of oncogenic KRAS may not be an effective therapeutic strategy in KRAS-addicted cancers since upstream events and feedback loops are likely to attenuate or annul the effects of the therapeutic intervention.  These pre-clinical studies provide a solid ground to evaluate the use of pan-ERBB inhibitors in combination with KRAS G12C inhibitors in patients with KRAS mutant lung tumors.  Tarloxotinib is a recently discovered novel prodrug that releases a potent, irreversible pan-ERBB (EGFR, HER2 and HER4) TKI. It is designed to be inactive under normal oxygen conditions but undergoes fragmentations under low oxygen conditions (hypoxia) to release the potent irreversible active metabolite (tarloxotinib-E) that has activity against both normal and mutant versions of the ERBB family. Selective production of tarloxotinib-E under hypoxic conditions generates a therapeutic window where it is selectively activated in hypoxic tumor regions to deliver higher drug delivery to tumor tissue. This reduces systemic exposure which avoids on-target EGFR related toxicities than standard EGFR TKI. In a mouse xenograft model of a human derived EGFR exon 20 insertion, intra-tumoral tarloxotinib-E levels were 20 time higher than skin and 50 times higher than plasma demonstrating selective tumor conversion. This strategy broadens the therapeutic window leading to improved efficacy, while reducing toxicity. Multiple pre-clinical studies have further demonstrated the efficacy of tarloxotinib compared to standard EGFR inhibitors.  Phase I clinical trials to determine the MTD and DLTs of tarloxotinib enrolled 27 patients with locally advanced or metastatic solid tumors. Of the patients that received tarloxotinib as a weekly 1-hour infusion, 6 patients received the drug at the recommended Phase 2 dose of 150 mg/m2 with good tolerance.  The combination of tarloxotinib with sotorasib is poised to provide highly specific tumor inhibition while targeting the vertical KRAS signaling pathway with minimal toxicity. The combination is unlikely to result in clinically relevant drug-drug interaction (DDI) based on absorption, metabolism, elimination or protein-binding. Tarloxotinib is intravenously administered while sotorasib is a small molecule that is administered orally; no absorption interactions are expected. </textblock> </detailed_description> <overall_status>Active, not recruiting</overall_status> <start_date type="Actual">March 7, 2022</start_date> <completion_date type="Anticipated">December 1, 2023</completion_date> <primary_completion_date type="Actual">July 7, 2023</primary_completion_date> <phase>Phase 1/Phase 2</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Non-Randomized</allocation> <intervention_model>Sequential Assignment</intervention_model> <intervention_model_description>(1) Safety lead-in: A minimum of 6 patients and as many as 18 patients will be enrolled in a safety lead-in cohort to evaluate the safety of the combination of tarloxotinib and sotorasib. (2) Dose expansion: Once the tarloxotinib RP2Dc is reached, an expansion cohort of up to 12 patients will be enrolled to evaluate the safety of the combination of tarloxotinib and sotorasib.</intervention_model_description> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Objective Response</measure> <time_frame>Repeat assessment at least 4 weeks after the first detection of response.</time_frame> <description>(OR = CR+PR) measured by CT and assessed per RECIST 1.1. Complete response (CR) and partial response (PR) require confirmatory CT</description> </primary_outcome> <secondary_outcome> <measure>Duration of Response</measure> <time_frame>At least 4 weeks.</time_frame> <description>measured from the date of first response (CR or PR) to date of disease progression (taking as reference for progressive disease the smallest measurements recorded since the treatment started) or death.</description> </secondary_outcome> <secondary_outcome> <measure>Disease control rate</measure> <time_frame>Through study completion, an average of 18 months.</time_frame> <description>(DCR) based on patient who had CR or PR or Stable disease (SD)</description> </secondary_outcome> <secondary_outcome> <measure>Best overall response</measure> <time_frame>A minimum timeframe of 8 weeks is required for a BOR of SD.</time_frame> <description>(BOR) determined from a sequence of responses assessed. Two objective status determinations of CR before progression are required for a BOR of CR. Two determinations of PR or better before progression, but not qualifying for a CR, are required for a BOR of PR.</description> </secondary_outcome> <secondary_outcome> <measure>Progression free survival</measure> <time_frame>From the date of first study drug dose to the date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 100 months.</time_frame> <description>(PFS) as measured from the date of first study drug dose to the date of the first objective documentation of radiographic disease progression or death due to any cause.</description> </secondary_outcome> <secondary_outcome> <measure>Overall survival</measure> <time_frame>From the date of first study drug dose to the date of death by any cause, up to approximately 100 months.</time_frame> <description>(OS) as measured from the date of first study drug dose to the date of death by any cause.</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">5</enrollment> <condition>Non-Small Cell Lung Cancer</condition> <arm_group> <arm_group_label>STAGE 1: SAFETY LEAD IN (n=6-18, depending on number of DLs explored)</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>SAFETY LEAD IN (n=6-18, depending on number of DLs explored) 3+3 design dependent on DLTs</description> </arm_group> <arm_group> <arm_group_label>STAGE 2: EFFICACY (n=12)</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>EFFICACY (n=12)</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Sotorasib and Tarloxotinib</intervention_name> <description>Sotorasib 960 mg PO daily + tarloxotinib 150 mg/m2 IV weekly</description> <arm_group_label>STAGE 1: SAFETY LEAD IN (n=6-18, depending on number of DLs explored)</arm_group_label> <arm_group_label>STAGE 2: EFFICACY (n=12)</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Sotorasib and Tarloxotinib</intervention_name> <description>Sotorasib 960 mg PO daily + tarloxotinib IV weekly at the combination RP2D (RP2Dc).</description> <arm_group_label>STAGE 1: SAFETY LEAD IN (n=6-18, depending on number of DLs explored)</arm_group_label> <arm_group_label>STAGE 2: EFFICACY (n=12)</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. Histologically confirmed diagnosis of squamous or non-squamous NSCLC with KRAS G12C mutation  2. Unresectable or metastatic disease  3. No available treatment with curative intent  4. Must have previously received treatment with at least a platinum-containing chemotherapy regimen  5. Must have previously received at least one month trial of sotorasib or a therapy targeting KRAS G12C mutation with documented progression. If sotorasib dose from prior therapy was reduced for toxicity, patients that meet the above criteria are expected to receive study treatment at the reduced dose.  6. Must have measurable or evaluable disease as defined by RECIST 1.1  7. Age >18 years  8. Life expectancy of at least 3 months  9. Recovery from adverse effect of prior therapy at the time of enrollment  10. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1  11. Laboratory values within the screening period:  1. Absolute neutrophile count > 1000/mm3  2. Platelet count > 100,000 /mm3  3. Hemoglobin > 8 in the absence of transfusions for at least 2 weeks  4. Total bilirubin < 1.5 x upper limit of normal (or < 3 x ULN if associated with liver metastases or Gilbert's disease)  5. Aspartate transaminase (AST) or alanine transaminase (ALT) < 3 x ULN (or < 5x ULN if associated with liver metastases  6. Creatinine clearance (CrCl) > 60 mL/min  12. Women of child-bearing potential agrees to use contraception while participating in the study and for a period of 6 months following termination of study treatment  13. Completed informed consent process  14. Willing to comply with clinical trial instructions and requirements.  Exclusion Criteria:  1. Active brain metastases. Patients are eligible if brain metastases are asymptomatic measuring no more than 2.0 cm each and confined to the cerebral hemispheres if neurologically stable and must be on a stable or tapering dose of corticosteroids for at least 2 weeks prior to C1D1.  2. History of intestinal disease or major gastric surgery likely to alter absorption of study treatment or inability to swallow pills  3. Congestive heart failure > NYHA Class 3  4. QTc > 480 milliseconds or family history of Long QT syndrome  5. Ongoing need for a medication with a known risk of Torsades de Pointes that cannot be switched to alternative treatment prior to study entry.  6. Pregnancy or breast feeding  7. Has known activating oncogene-driver mutations, including but not limited to KRAS, ALK, ROS1, RET, BRAF, NTRK1/2/3, MET, EGFR  8. Previously have received anti-EGFR or anti-HER2 TKIs  9. Previously have received anti-EGFR or anti-HER2 monoclonal antibodies  10. Clinically active or symptomatic interstitial lung disease  11. AST and ALT>3xULN if no hepatic metastases are present; >5xULN if hepatic metastases are present; total bilirubin >1.5xULN; 3xULN with direct bilirubin >1.5 x ULN in the presence of Gilbert's syndrome  12. Known concurrently malignancy that is expected to require active treatment within 2 years or may interfere with the interpretation of the efficacy and safety outcomes of this study.  13. Infection requiring systemic treatment within 7 days prior to cycle 1 day1. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <location> <facility> <name>Hollings Cancer Center at Medical University of South Carolina</name> <address> <city>Charleston</city> <state>South Carolina</state> <zip>29425</zip> <country>United States</country> </address> </facility> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>July 2023</verification_date> <study_first_submitted>February 14, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>July 7, 2023</last_update_submitted> <last_update_submitted_qc>July 7, 2023</last_update_submitted_qc> <last_update_posted type="Actual">July 11, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Sotorasib</mesh_term> </intervention_browse>  </clinical_study>

This is a Phase IB dose expansion trial with safety lead-in evaluating the safety, clinical activity/efficacy of the combination of tarloxotinib and sotorasib in patients with KRAS G12C mutation who have progressed on any small molecule targeting KRAS G12C mutant Non-Small Cell lung cancer. KRAS acts as a key protein in transducing signals from cell surface receptors, such as receptor tyrosine kinases (RTKs) into cells to initiate a network of cytoplasmic and nuclear signaling cascades that mediate key processes, such as cell cycle entry and cell survival that regulate normal tissue homeostasis. Due to the central importance of KRAS in mediating critical cellular processes, there are significant interconnected signaling feedback pathways that protect normal cells from uncontrolled proliferation and cell death. These signaling feedback pathways are also activated by tumor cells upon inhibition of mutated KRAS, which may result in intrinsic or acquired resistance to small molecule KRAS G12C inhibitors. Pre-clinical studies in non-small cell lung cancer (NSCLC) have shown that a key pathway that may be activated upon KRAS inhibition is the upstream ERBB RTKs, which provides the rationale for dual KRAS and ERBB blockade in overcoming resistance mechanisms in KRAS mutated NSCLC. Lung cancer is the second most common cancer and the leading cause of cancer death in the United States. There were approximately 247,270 new cases of lung cancer that occurred in 2020. Prior studies have reported that lung cancer resulted in more deaths than breast cancer, prostate cancer, colorectal cancer, and leukemia combined in men ≥40 years old and women ≥60 years old. The past decade has seen a revolution of new advances in the management of non-small cell lung cancer (NSCLC) with remarkable progresses in screening, diagnosis, and treatment. The advances in systemic treatment have been driven primarily by the development of molecularly targeted therapeutics, immune-checkpoint inhibitors and anti-angiogenic agents, all of which have transformed this field with significantly improved patient outcomes. Despite these advances, most patients with advanced NSCLC have incurable disease, particularly after failure of a platinum-based chemotherapy regimen and check point inhibitors. One of the earliest identified molecular drivers of NSCLC is the GTPase transductor protein called KRAS. It is a member of the RAS family of oncogenes and at the apex of multiple signaling pathways central to tumor cell proliferation. KRAS mutant lung cancers have worse outcomes in both early stage and advanced metastatic settings, illustrating the critical need for novel agents targeting KRAS-driven NSCLC. KRAS G12C mutations are present in ~15% of lung adenocarcinomas and 0-8% of other cancers. The missense mutation at codon 12 interferes with the GTPase, activating protein mediated GTP hydrolysis and shifting the equilibrium between the signaling-competent KRAS-GTP and signaling incompetent KRAS-GDP in favor of the GTP bound state. This process links upstream cell surface receptors such as the ERBB family (EGFR, HER-2, HER-3, HER-4) to downstream pathways such as RAF/MEK/ERK and PI3K/AKT/mTOR which leads to uncontrolled cell proliferation and survival. Attempts to identify small molecular inhibitors of KRAS have been unsuccessful for many years as there was a lack of a clearly defined deep pocket in the structure of RAS outside of the nucleotide binding site and the challenge of targeting the nucleotide binding site due to extraordinarily high affinity of GTP. Recently, several pioneering studies have identified small molecule cysteine-reactive inhibitors that covalently modify the mutant KRAS G12C protein to reveal an allosteric switch II pocket. The induction of the structurally disordered pocket by these small molecule inhibitors converts the GTP preference of naïve KRAS G12C to the inactive GDP bound state, impairing its interaction with downstream effectors. AMG510/Sotorasib was the first KRAS G12C inhibitor to the enter the clinic. A Phase I/II clinical trial involving 129 patients included 59 patients with KRAS G12C mutated NSCLC who had progressed on prior standard therapies. Patients were enrolled in dose escalation and expansion cohorts to receive daily sotorasib monotherapy (960 mg PO daily). At a median follow up of 12.2 months, approximately 50% of NSCLC patients demonstrated tumor regression with a confirmed objective response rate (ORR) of 37.1% (95% CI 28.6-46.2%) and a disease control rate (DCR) of 80.6% (95% CI 72.6-87.2%). The median time to objective response was 1.4 months and median duration of response was 10 months, with median progression free survival (PFS) of 6.8 months. The FDA has now accepted a new drug application and granted it a priority review for the treatment of patients with KRAS G12C mutant locally advanced or metastatic NSCLC following at least 1 prior systemic treatment, with an expected decision date by August 2021. Although the results from these early-stage clinical trials showed promise, ~50% of KRAS G12C mutant NSCLC patients failed to respond to therapy and rate of relapse is high calling for the need for novel combinations to overcome intrinsic and acquired resistance mechanisms in this subset of patients. It was previously thought that constitutively active oncogenic KRAS induces growth factor independence. However, recent evidence has suggested that specific KRAS mutant isoforms such as KRAS G12C may be regulated by upstream activation of several receptor tyrosine kinases. The pattern of RTK dependence appears to vary between KRAS G12C mutant cancer but numerous RTKs are involved in the adaptive feedback mechanism to G12C inhibition. This may be mediated through an adaptive RAS pathway activation. Silencing oncogenic KRAS in EGFR/HER dependent cells reduced cellular growth and induced a modest apoptotic signal. The depletion of KRAS expression by mutant specific siRNA was accompanied by a reduction in AKT phosphorylation in the ERBB dependent subset and activation of STAT3, which suggests a feedback loop via STAT3 that re-establishes oncogenic signaling thereby compensating for the loss of AKT survival signals. Pan ERBB inhibition in these KRAS G12C mutated NSCLC lines resulted in a potent suppression of growth and inhibition of receptor signaling and downstream signaling effectors. Thus, sole silencing of oncogenic KRAS may not be an effective therapeutic strategy in KRAS-addicted cancers since upstream events and feedback loops are likely to attenuate or annul the effects of the therapeutic intervention. These pre-clinical studies provide a solid ground to evaluate the use of pan-ERBB inhibitors in combination with KRAS G12C inhibitors in patients with KRAS mutant lung tumors. Tarloxotinib is a recently discovered novel prodrug that releases a potent, irreversible pan-ERBB (EGFR, HER2 and HER4) TKI. It is designed to be inactive under normal oxygen conditions but undergoes fragmentations under low oxygen conditions (hypoxia) to release the potent irreversible active metabolite (tarloxotinib-E) that has activity against both normal and mutant versions of the ERBB family. Selective production of tarloxotinib-E under hypoxic conditions generates a therapeutic window where it is selectively activated in hypoxic tumor regions to deliver higher drug delivery to tumor tissue. This reduces systemic exposure which avoids on-target EGFR related toxicities than standard EGFR TKI. In a mouse xenograft model of a human derived EGFR exon 20 insertion, intra-tumoral tarloxotinib-E levels were 20 time higher than skin and 50 times higher than plasma demonstrating selective tumor conversion. This strategy broadens the therapeutic window leading to improved efficacy, while reducing toxicity. Multiple pre-clinical studies have further demonstrated the efficacy of tarloxotinib compared to standard EGFR inhibitors. Phase I clinical trials to determine the MTD and DLTs of tarloxotinib enrolled 27 patients with locally advanced or metastatic solid tumors. Of the patients that received tarloxotinib as a weekly 1-hour infusion, 6 patients received the drug at the recommended Phase 2 dose of 150 mg/m2 with good tolerance. The combination of tarloxotinib with sotorasib is poised to provide highly specific tumor inhibition while targeting the vertical KRAS signaling pathway with minimal toxicity. The combination is unlikely to result in clinically relevant drug-drug interaction (DDI) based on absorption, metabolism, elimination or protein-binding. Tarloxotinib is intravenously administered while sotorasib is a small molecule that is administered orally; no absorption interactions are expected. Inclusion Criteria: 1. Histologically confirmed diagnosis of squamous or non-squamous NSCLC with KRAS G12C mutation 2. Unresectable or metastatic disease 3. No available treatment with curative intent 4. Must have previously received treatment with at least a platinum-containing chemotherapy regimen 5. Must have previously received at least one month trial of sotorasib or a therapy targeting KRAS G12C mutation with documented progression. If sotorasib dose from prior therapy was reduced for toxicity, patients that meet the above criteria are expected to receive study treatment at the reduced dose. 6. Must have measurable or evaluable disease as defined by RECIST 1.1 7. Age >18 years 8. Life expectancy of at least 3 months 9. Recovery from adverse effect of prior therapy at the time of enrollment 10. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 11. Laboratory values within the screening period: 1. Absolute neutrophile count > 1000/mm3 2. Platelet count > 100,000 /mm3 3. Hemoglobin > 8 in the absence of transfusions for at least 2 weeks 4. Total bilirubin < 1.5 x upper limit of normal (or < 3 x ULN if associated with liver metastases or Gilbert's disease) 5. Aspartate transaminase (AST) or alanine transaminase (ALT) < 3 x ULN (or < 5x ULN if associated with liver metastases 6. Creatinine clearance (CrCl) > 60 mL/min 12. Women of child-bearing potential agrees to use contraception while participating in the study and for a period of 6 months following termination of study treatment 13. Completed informed consent process 14. Willing to comply with clinical trial instructions and requirements. Exclusion Criteria: 1. Active brain metastases. Patients are eligible if brain metastases are asymptomatic measuring no more than 2.0 cm each and confined to the cerebral hemispheres if neurologically stable and must be on a stable or tapering dose of corticosteroids for at least 2 weeks prior to C1D1. 2. History of intestinal disease or major gastric surgery likely to alter absorption of study treatment or inability to swallow pills 3. Congestive heart failure > NYHA Class 3 4. QTc > 480 milliseconds or family history of Long QT syndrome 5. Ongoing need for a medication with a known risk of Torsades de Pointes that cannot be switched to alternative treatment prior to study entry. 6. Pregnancy or breast feeding 7. Has known activating oncogene-driver mutations, including but not limited to KRAS, ALK, ROS1, RET, BRAF, NTRK1/2/3, MET, EGFR 8. Previously have received anti-EGFR or anti-HER2 TKIs 9. Previously have received anti-EGFR or anti-HER2 monoclonal antibodies 10. Clinically active or symptomatic interstitial lung disease 11. AST and ALT>3xULN if no hepatic metastases are present; >5xULN if hepatic metastases are present; total bilirubin >1.5xULN; 3xULN with direct bilirubin >1.5 x ULN in the presence of Gilbert's syndrome 12. Known concurrently malignancy that is expected to require active treatment within 2 years or may interfere with the interpretation of the efficacy and safety outcomes of this study. 13. Infection requiring systemic treatment within 7 days prior to cycle 1 day1.

NCT0531xxxx/NCT05313022.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313022</url> </required_header> <id_info> <org_study_id>202-COV-1003</org_study_id> <nct_id>NCT05313022</nct_id> </id_info> <brief_title>Safety and Immunogenicity of Recombinant SARS-CoV-2 Spike Protein Vaccine (CHO Cell) for the Prevention of COVID-19</brief_title> <official_title>A Randomized, Double-blinded, Placebo-controlled Clinical Trial to Evaluate the Immunogenicity and Safety of the Recombinant SARS-CoV-2 Vaccine (CHO Cell) in Healthy Adults Aged 60 Years and Above</official_title> <sponsors> <lead_sponsor> <agency>Shanghai Zerun Biotechnology Co.,Ltd</agency> <agency_class>Industry</agency_class> </lead_sponsor> <collaborator> <agency>Walvax Biotechnology Co., Ltd.</agency> <agency_class>Industry</agency_class> </collaborator> </sponsors> <source>Shanghai Zerun Biotechnology Co.,Ltd</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The purpose of this double-blind, randomized, controlled study is to assess safety, reactogenicity, and immunogenicity of ZR-202-CoV, administered as 2 injections (i.m) at 28 days apart in adult subjects 60 years of age and above. </textblock> </brief_summary> <overall_status>Active, not recruiting</overall_status> <start_date type="Actual">January 18, 2022</start_date> <completion_date type="Anticipated">June 2023</completion_date> <primary_completion_date type="Actual">May 13, 2022</primary_completion_date> <phase>Phase 1/Phase 2</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Prevention</primary_purpose> <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Geometric mean titer (GMT) of SARS-CoV-2 neutralising antibody</measure> <time_frame>28 days after each dose</time_frame> </primary_outcome> <primary_outcome> <measure>Proportion of participants achieving seroconversion for SARS-CoV-2 neutralising antibody</measure> <time_frame>28 days after each dose</time_frame> </primary_outcome> <primary_outcome> <measure>Geometric mean increase (GMI) of SARS-CoV-2 neutralising antibodies</measure> <time_frame>28 days after each dose</time_frame> </primary_outcome> <primary_outcome> <measure>Geometric mean titer (GMT) of SARS-CoV-2 specific IgG binding antibodies.</measure> <time_frame>28 days after each dose</time_frame> </primary_outcome> <primary_outcome> <measure>Proportion of participants achieving seroconversion for SARS-CoV-2 specific IgG binding antibodies..</measure> <time_frame>28 days after each dose</time_frame> </primary_outcome> <primary_outcome> <measure>Geometric mean increase (GMI) of SARS-CoV-2 specific IgG binding antibodies.</measure> <time_frame>28 days after each dose</time_frame> </primary_outcome> <secondary_outcome> <measure>Incidence of adverse events (AEs) after vaccination</measure> <time_frame>28 days after the first or second vaccination</time_frame> <description>Percentage of participants with AEs for 28 days following each vaccination (Days 0, 28) by intensity, relevance.</description> </secondary_outcome> <secondary_outcome> <measure>Incidence of solicited adverse events (AEs) after vaccination</measure> <time_frame>30 minutes and 7 days after the first or second vaccination</time_frame> <description>Percentage of participants with solicited AEs for 30 minutes and 7 days following each vaccination (Days 0, 28) by intensity, relevance</description> </secondary_outcome> <secondary_outcome> <measure>Incidence of unsolicited adverse events (AEs) after vaccination</measure> <time_frame>28 days after the first or second vaccination</time_frame> <description>Percentage of participants with unsolicited AEs for 28 days following each vaccination (Days 0, 28) by intensity, relevance.</description> </secondary_outcome> <secondary_outcome> <measure>Proportion of subjects with abnormal markers of hematology, biochemistry, urinalysis, thyroid and coagulation parameters</measure> <time_frame>Day 4 after first or second vaccination</time_frame> <description>Safety Laboratory Values (Serum Chemistry, Hematology)</description> </secondary_outcome> <secondary_outcome> <measure>Incidence of serious AEs (SAEs) and adverse events of special interest (AESIs)</measure> <time_frame>up to 12month after last dose vaccination</time_frame> <description>Percentage of participants with SAEs or AESIs for 12month after last dose vaccination</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">84</enrollment> <condition>COVID-19</condition> <arm_group> <arm_group_label>ZR-202-CoV</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Adult healthy subjects (60 years of age above, inclusive) receive ZR-202-CoV at Day 0 and Day 28</description> </arm_group> <arm_group> <arm_group_label>Placebo</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> <description>Adult healthy subjects (60 years of age and above) receive 2 doses of placebo (saline) at Day 0 and Day 28</description> </arm_group> <intervention> <intervention_type>Biological</intervention_type> <intervention_name>ZR-202-CoV</intervention_name> <description>Adjuvanted Recombinant SARS-CoV-2 S-protein Subunit Vaccine</description> <arm_group_label>ZR-202-CoV</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Placebo</intervention_name> <description>Normal saline solution</description> <arm_group_label>Placebo</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Having understood the contents of the clinical study and ICF, and having signed the ICF.  - Adults of both genders, 60 years of age and older.  - Adults who can provide legal proof of identity.  - SARS-COV-2 antibody screening negative at screening visit.  Exclusion Criteria:  - Having a clear or suspected allergy to the test vaccine ingredients (including S protein, aluminum hydroxide adjuvant or CpG adjuvant), or have a history of severe allergy to any previous vaccine (such as acute allergic reaction, dyspnea or angioneurotic edema, etc.) (inquiries);  - Having a history of SARS or MERS infection, or a previous infection of COVID-19 (previous nucleic acid or serum antibody test was positive) (inquiries);  - Previous vaccination with SARS-CoV-2 vaccine(including SARS-CoV-2 vaccine for clinical trial) or received other vaccines within 28 days prior to the first dose of vaccine;  - Abnormal skin (such as inflammation, induration, redness and swelling, large area scar, etc.) on both sides of the arm at the vaccination site and affecting the vaccination or safety observation(examination);  - Axillary body temperature ≥37.3℃ before the first dose vaccination(examination);  - Safety laboratory abnormal of any of the below:  1. Liver function: ALT or ALT > 1.25*ULN  2. Kidney function: serum creatinine (Cr) > ULN  3. Glycated hemoglobin (HbA1c) ≥ 8.0%  - Uncontrolled epilepsy or other progressive neurological diseases (inquiries);  - Immunocompromised or have been diagnosed with Human Immunodeficiency Virus (HIV) infection, lymphoma, leukemia, Systemic lupus erythematosus, SLE, rheumatoid arthritis, inflammatory bowel disease or other autoimmune diseases (inquiries);  - Asplenia or functional asplenia (inquiries);  - Having a history of coagulation disorder or abnormal coagulation function (e.g., lack of coagulation factors or thrombocytopenia) and assessed by investigators that are not suitable for the study (inquiry);  - Having malignant tumor that not been cured clinically and been assessed by investigators as not suitable for the study (inquiry);  - Having acute diseases or acute onset or poorly controlled chronic diseases(e.g. hypertension patients with blood pressure > 160/100mmHg, diabetes patients with ketoacidosis, etc.) within 14 days before the first dose vaccination and assessed by investigators as not suitable for the study (inquiry);  - Use of systemic drugs that affect immune function within 6 months prior to the first dose vaccination for a long time (more than 14 consecutive days), such as immunosuppressant, cytotoxic drugs, inhaled corticosteroids (not including allergic rhinitis treated with corticosteroid spray), unless the investigators determines that the drug will not interfere with, limit, or obfuscate the evaluation prescribed by the protocol, or may endanger the safety of the subject (inquiry);  - Treatment with whole blood, plasma or immunoglobulin within 3 months prior to the first dose(inquiry);  - Any other factors that, in the investigator's judgment, are inappropriate for participation in the clinical study. </textblock> </criteria> <gender>All</gender> <minimum_age>60 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <location> <facility> <name>Clinical Trial Institution for Anning First Hospital</name> <address> <city>Kunming</city> <state>Yunan</state> <country>China</country> </address> </facility> </location> <location_countries> <country>China</country> </location_countries> <verification_date>April 2023</verification_date> <study_first_submitted>March 5, 2022</study_first_submitted> <study_first_submitted_qc>April 5, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>April 18, 2023</last_update_submitted> <last_update_submitted_qc>April 18, 2023</last_update_submitted_qc> <last_update_posted type="Actual">April 19, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>COVID-19</mesh_term> </condition_browse>  </clinical_study>

The purpose of this double-blind, randomized, controlled study is to assess safety, reactogenicity, and immunogenicity of ZR-202-CoV, administered as 2 injections (i.m) at 28 days apart in adult subjects 60 years of age and above. Inclusion Criteria: - Having understood the contents of the clinical study and ICF, and having signed the ICF. - Adults of both genders, 60 years of age and older. - Adults who can provide legal proof of identity. - SARS-COV-2 antibody screening negative at screening visit. Exclusion Criteria: - Having a clear or suspected allergy to the test vaccine ingredients (including S protein, aluminum hydroxide adjuvant or CpG adjuvant), or have a history of severe allergy to any previous vaccine (such as acute allergic reaction, dyspnea or angioneurotic edema, etc.) (inquiries); - Having a history of SARS or MERS infection, or a previous infection of COVID-19 (previous nucleic acid or serum antibody test was positive) (inquiries); - Previous vaccination with SARS-CoV-2 vaccine(including SARS-CoV-2 vaccine for clinical trial) or received other vaccines within 28 days prior to the first dose of vaccine; - Abnormal skin (such as inflammation, induration, redness and swelling, large area scar, etc.) on both sides of the arm at the vaccination site and affecting the vaccination or safety observation(examination); - Axillary body temperature ≥37.3℃ before the first dose vaccination(examination); - Safety laboratory abnormal of any of the below: 1. Liver function: ALT or ALT > 1.25*ULN 2. Kidney function: serum creatinine (Cr) > ULN 3. Glycated hemoglobin (HbA1c) ≥ 8.0% - Uncontrolled epilepsy or other progressive neurological diseases (inquiries); - Immunocompromised or have been diagnosed with Human Immunodeficiency Virus (HIV) infection, lymphoma, leukemia, Systemic lupus erythematosus, SLE, rheumatoid arthritis, inflammatory bowel disease or other autoimmune diseases (inquiries); - Asplenia or functional asplenia (inquiries); - Having a history of coagulation disorder or abnormal coagulation function (e.g., lack of coagulation factors or thrombocytopenia) and assessed by investigators that are not suitable for the study (inquiry); - Having malignant tumor that not been cured clinically and been assessed by investigators as not suitable for the study (inquiry); - Having acute diseases or acute onset or poorly controlled chronic diseases(e.g. hypertension patients with blood pressure > 160/100mmHg, diabetes patients with ketoacidosis, etc.) within 14 days before the first dose vaccination and assessed by investigators as not suitable for the study (inquiry); - Use of systemic drugs that affect immune function within 6 months prior to the first dose vaccination for a long time (more than 14 consecutive days), such as immunosuppressant, cytotoxic drugs, inhaled corticosteroids (not including allergic rhinitis treated with corticosteroid spray), unless the investigators determines that the drug will not interfere with, limit, or obfuscate the evaluation prescribed by the protocol, or may endanger the safety of the subject (inquiry); - Treatment with whole blood, plasma or immunoglobulin within 3 months prior to the first dose(inquiry); - Any other factors that, in the investigator's judgment, are inappropriate for participation in the clinical study.

NCT0531xxxx/NCT05313035.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313035</url> </required_header> <id_info> <org_study_id>CoV2-020322</org_study_id> <nct_id>NCT05313035</nct_id> </id_info> <brief_title>Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine</brief_title> <official_title>A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma) Adjuvanted With Alum+CpG 1018 in Healthy Populations Aged 18 Years and Above in Indonesia</official_title> <sponsors> <lead_sponsor> <agency>PT Bio Farma</agency> <agency_class>Industry</agency_class> </lead_sponsor> <collaborator> <agency>Faculty of Medicine, Universitas Indonesia, Jakarta</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Faculty of Medicine, Diponegoro University, Semarang</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Faculty of Medicine, Universitas Andalas, Padang</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Faculty of Medicine, Universitas Hassanudin, Makassar</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>PT Bio Farma</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> <is_us_export>No</is_us_export> </oversight_info> <brief_summary> <textblock> This trial is observer-blind, comparative, randomized, placebo-controlled phase 2 study. The population is healthy subjects aged 18 and above </textblock> </brief_summary> <detailed_description> <textblock> The phase 2 is dose-ranging study which will recruit 360 subjects to compare two vaccine formulas to placebo (1:1:1), to evaluate the safety and immunogenicity of the vaccine. The subjects will be given 2 doses of investigational product with 28 days interval between doses.  One selected vaccine formula will be evaluated for safety and persistence antibody until 6 months after the last dose. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">April 13, 2022</start_date> <completion_date type="Actual">February 28, 2023</completion_date> <primary_completion_date type="Actual">July 22, 2022</primary_completion_date> <phase>Phase 2/Phase 3</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>Double (Participant, Investigator)</masking> <masking_description>Vaccine candidate and placebo are masking, lot number is masking</masking_description> </study_design_info> <primary_outcome> <measure>Immunogenicity of the candidate vaccine</measure> <time_frame>14 days after the last dose</time_frame> <description>seroconversion rate of antibody (IgG and neutralization antibody)</description> </primary_outcome> <secondary_outcome> <measure>Safety of the candidate vaccine</measure> <time_frame>28 days after each dose</time_frame> <description>percentage of subjects with solicited and unsolicited Adverse Events (AE)</description> </secondary_outcome> <secondary_outcome> <measure>Serious Adverse Event (SAE) of the vaccine</measure> <time_frame>6 months after the last dose</time_frame> <description>percentage of subjects with at least 1 SAE</description> </secondary_outcome> <secondary_outcome> <measure>Persistence antibody of vaccine candidate</measure> <time_frame>14 days, 28 days, 3 months, 6 months after the last dose</time_frame> <description>GMT of antibody (IgG and neutralization antibody)</description> </secondary_outcome> <secondary_outcome> <measure>Persistence antibody of vaccine candidate</measure> <time_frame>14 days, 28 days, 3 months, 6 months after the last dose</time_frame> <description>seropositive rate of antibody (IgG and neutralization antibody)</description> </secondary_outcome> <number_of_arms>3</number_of_arms> <enrollment type="Actual">360</enrollment> <condition>COVID-19</condition> <arm_group> <arm_group_label>Vaccine Candidate Formula 1</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>2 doses of vaccine candidate formula 1 administered with 28 days interval (0.5 mL per dose)</description> </arm_group> <arm_group> <arm_group_label>Vaccine Candidate Formula 2</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>2 doses of vaccine candidate formula 2 administered with 28 days interval (0.5 mL per dose)</description> </arm_group> <arm_group> <arm_group_label>Control</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> <description>2 doses of placebo administered with 28 days interval (0.5 mL per dose)</description> </arm_group> <intervention> <intervention_type>Biological</intervention_type> <intervention_name>SARS-CoV-2 protein subunit recombinant vaccine</intervention_name> <description>candidate vaccine manufactured by PT. Bio Farma</description> <arm_group_label>Vaccine Candidate Formula 1</arm_group_label> <arm_group_label>Vaccine Candidate Formula 2</arm_group_label> </intervention> <intervention> <intervention_type>Biological</intervention_type> <intervention_name>placebo</intervention_name> <description>the placebo is NaCl injection manufactured by PT. Bio Farma</description> <arm_group_label>Control</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. Clinically healthy subjects aged 18 years and above.  2. Subjects have been informed properly regarding the study and signed the informed consent form.  3. Subjects will commit to comply with the instructions of the investigator and the schedule of the trial.  Exclusion Criteria:  1. Subjects concomitantly enrolled or scheduled to be enrolled in another trial.  2. History of vaccination with any COVID-19 vaccine.  3. History of COVID-19 within 1 month (for mild-moderate disease) or 3 months (for severe disease) prior to enrollment.  4. Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun).  5. Women who are pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results).  6. History of uncontrolled asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema.  7. History of blood disorders contraindicating intramuscular injection.  8. Patients with serious chronic diseases (serious cardiovascular diseases, uncontrolled hypertension and diabetes, liver and kidney diseases, malignant tumors, etc) which according to the investigator might interfere with the assessment of the trial objectives.  9. History of confirmed or suspected immunosuppressive or immunodeficient state, or received in the previous 4 weeks a treatment likely to alter the immuneresponse (intravenous immunoglobulins, blood-derived products or long-term corticosteroid therapy (> 2 weeks)).  10. History of uncontrolled epilepsy or other progressive neurological disorders, such as Guillain-Barre syndrome.  11. Subjects receive any vaccination (other than COVID-19 vaccine) within 1 month before and after IP immunization.  12. Subjects plan to move from the study area before the end of study period. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Prof. Dr. Soedjatmiko SpA(K), MSi, MD</last_name> <role>Principal Investigator</role> <affiliation>Fakultas Kedokteran Universitas Indonesia</affiliation> </overall_official> <location> <facility> <name>Faculty of Medicine, Diponegoro University, Semarang</name> <address> <city>Semarang</city> <state>Central Java</state> <country>Indonesia</country> </address> </facility> </location> <location> <facility> <name>Faculty of Medicine Universitas Hassanudin</name> <address> <city>Makassar</city> <state>South Sulawesi</state> <country>Indonesia</country> </address> </facility> </location> <location> <facility> <name>Faculty of Medicine, Universitas Andalas, Padang</name> <address> <city>Padang</city> <state>West Sumatera</state> <country>Indonesia</country> </address> </facility> </location> <location_countries> <country>Indonesia</country> </location_countries> <verification_date>April 2023</verification_date> <study_first_submitted>April 5, 2022</study_first_submitted> <study_first_submitted_qc>April 5, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>April 12, 2023</last_update_submitted> <last_update_submitted_qc>April 12, 2023</last_update_submitted_qc> <last_update_posted type="Actual">April 13, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>COVID-19 vaccine</keyword> <keyword>healthy population</keyword> <condition_browse>  <mesh_term>COVID-19</mesh_term> </condition_browse>  </clinical_study>

This trial is observer-blind, comparative, randomized, placebo-controlled phase 2 study. The population is healthy subjects aged 18 and above The phase 2 is dose-ranging study which will recruit 360 subjects to compare two vaccine formulas to placebo (1:1:1), to evaluate the safety and immunogenicity of the vaccine. The subjects will be given 2 doses of investigational product with 28 days interval between doses. One selected vaccine formula will be evaluated for safety and persistence antibody until 6 months after the last dose. Inclusion Criteria: 1. Clinically healthy subjects aged 18 years and above. 2. Subjects have been informed properly regarding the study and signed the informed consent form. 3. Subjects will commit to comply with the instructions of the investigator and the schedule of the trial. Exclusion Criteria: 1. Subjects concomitantly enrolled or scheduled to be enrolled in another trial. 2. History of vaccination with any COVID-19 vaccine. 3. History of COVID-19 within 1 month (for mild-moderate disease) or 3 months (for severe disease) prior to enrollment. 4. Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun). 5. Women who are pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results). 6. History of uncontrolled asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema. 7. History of blood disorders contraindicating intramuscular injection. 8. Patients with serious chronic diseases (serious cardiovascular diseases, uncontrolled hypertension and diabetes, liver and kidney diseases, malignant tumors, etc) which according to the investigator might interfere with the assessment of the trial objectives. 9. History of confirmed or suspected immunosuppressive or immunodeficient state, or received in the previous 4 weeks a treatment likely to alter the immuneresponse (intravenous immunoglobulins, blood-derived products or long-term corticosteroid therapy (> 2 weeks)). 10. History of uncontrolled epilepsy or other progressive neurological disorders, such as Guillain-Barre syndrome. 11. Subjects receive any vaccination (other than COVID-19 vaccine) within 1 month before and after IP immunization. 12. Subjects plan to move from the study area before the end of study period.

NCT0531xxxx/NCT05313048.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313048</url> </required_header> <id_info> <org_study_id>APSantiCo-Study</org_study_id> <nct_id>NCT05313048</nct_id> </id_info> <brief_title>Prospective Observational Study to Evaluate a Possible Change in APS Antibody Profiles After COVID-19 Infection or Vaccination</brief_title> <acronym>APSantiCo</acronym> <official_title>The APSantiCo Observational Study - Prospective Observational Study to Evaluate a Possible Change in APS Antibody Profiles After COVID-19 Infection or Vaccination</official_title> <sponsors> <lead_sponsor> <agency>Cardioangiologisches Centrum Bethanien</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Cardioangiologisches Centrum Bethanien</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Prospective observational study to evaluate a possible change in APS antibody profiles after COVID-19 infection or vaccination </textblock> </brief_summary> <detailed_description> <textblock> Prospective observational study to evaluate a possible change in antiphospholipid antibody profiles after coronavirus disease 2019 (COVID-19) infection or vaccination.  Patients with antiphospholipid syndrome (APS) with thromboembolic complications recorded using the retrospective database of the APSANTICO registry (ClinicalTrials.gov Identifier: NCT05195372) will serve as a baseline for a prospective observational study to investigate the extent to which COVID 19 infection and/or COVID 19 vaccination alters APS antibody profiles.  Current literature suggests that patients who have been or are infected with COVID-19 are at higher risk of thrombosis. This increased risk is due to, among other things, damaged endothelium, slower blood flow and observed hypercoagulability of the blood.  It has also been described that COVID-19 patients may have a higher prevalence of lupus anticoagulant. Based on these assumptions, one of the aims of the prospective observational study is to determine whether and to what extent COVID-19 infection affects the antibody profile of APS patients.  In addition, atypical thrombosis with thrombocytopenia has been repeatedly reported recently as a rare side effect after COVID-19 vaccination with two recombinant adenoviral vectors encoding the spike protein antigen of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (ChAdOx1 nCov-19, AstraZeneca and Ad26.COV2.S, Johnson&Johnson).  The extent to which thrombosis could also occur after messenger RNA (mRNA) vaccines has not yet been clearly proven.  Furthermore, it is unclear whether COVID-19 infections and/or vaccinations can possibly influence the expression and level of antiphospholipid antibody titres. Therefore, another aim of the prospective observational study is to compare the antiphospholipid antibody results available from the retrospective registry before COVID-19 vaccination or COVID-19 infection with the antibody results after COVID-19 infection and/or vaccination. For this purpose, the patients who were recorded in the retrospective register are contacted by post with an information letter and then called in by telephone to the investigators coagulation centre for a follow-up examination after the COVID-19 vaccinations have been carried out and/or after COVID-19 infection. Then, during this examination, a blood sample is taken to monitor the course of the antiphospholipid antibodies. In addition, patients are offered a test of COVID-19 nucleocapsid antibodies and COVID-19 spike antibodies free of charge to check the success of the vaccination. This is of particular interest as some of these patients are taking immunosuppressive drugs due to an underlying autoimmune disease, which could weaken the immune response. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">March 15, 2022</start_date> <completion_date type="Actual">October 24, 2022</completion_date> <primary_completion_date type="Actual">October 24, 2022</primary_completion_date> <study_type>Observational [Patient Registry]</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Cohort</observational_model> <time_perspective>Prospective</time_perspective> </study_design_info> <target_duration>12 Months</target_duration> <primary_outcome> <measure>change in APS antibody status after surviving COVID-19 infection and/or receiving COVID-19 vaccination</measure> <time_frame>2015-2022</time_frame> <description>The main observational variable is the change in APS antibody status in patients with antiphospholipid syndrome after surviving COVID-19 infection and/or receiving COVID-19 vaccination.</description> </primary_outcome> <enrollment type="Actual">82</enrollment> <condition>Antiphospholipid Syndrome</condition> <condition>COVID-19 Infection</condition> <condition>COVID-19 Vaccination</condition> <biospec_retention>Samples Without DNA</biospec_retention> <biospec_descr> <textblock> frozen citrated plasma samples </textblock> </biospec_descr> <eligibility> <study_pop> <textblock> Patients with antiphospholipid syndrome with thromboembolic clinical manifestations (venous thromboembolism, pulmonary embolism, thrombophlebitis etc.) or Patients with APS antibody risk profile (single/double/triple positivity) </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Minimum age of 18 years  - Confirmed antiphospholipid syndrome with thromboembolic clinical manifestations (venous thromboembolism, pulmonary embolism, thrombophlebitis etc.)  - Patients with APS antibody risk profile (single/double/triple positivity)  - Written consent for participation in the prospective APSantiCo observational study  Exclusion Criteria:  - APS with isolated pregnancy complications  - No anticoagulation medication  - Inadequately diagnosed APS  - Non-compliance on the part of the patient </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Edelgard Lindhoff-Last, Prof. MD</last_name> <role>Study Chair</role> <affiliation>Cardioangiology Center Bethanien</affiliation> </overall_official> <location> <facility> <name>Cardioangiology Center Bethanien (CCB)</name> <address> <city>Frankfurt am Main</city> <zip>60389</zip> <country>Germany</country> </address> </facility> </location> <location_countries> <country>Germany</country> </location_countries> <verification_date>December 2022</verification_date> <study_first_submitted>April 5, 2022</study_first_submitted> <study_first_submitted_qc>April 5, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>December 20, 2022</last_update_submitted> <last_update_submitted_qc>December 20, 2022</last_update_submitted_qc> <last_update_posted type="Actual">December 21, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Cardioangiologisches Centrum Bethanien</investigator_affiliation> <investigator_full_name>Prof. Dr. med. E. Lindhoff-Last</investigator_full_name> <investigator_title>Clinical Professor</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Infections</mesh_term> <mesh_term>Communicable Diseases</mesh_term> <mesh_term>COVID-19</mesh_term> <mesh_term>Antiphospholipid Syndrome</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Prospective observational study to evaluate a possible change in APS antibody profiles after COVID-19 infection or vaccination Prospective observational study to evaluate a possible change in antiphospholipid antibody profiles after coronavirus disease 2019 (COVID-19) infection or vaccination. Patients with antiphospholipid syndrome (APS) with thromboembolic complications recorded using the retrospective database of the APSANTICO registry (ClinicalTrials.gov Identifier: NCT05195372) will serve as a baseline for a prospective observational study to investigate the extent to which COVID 19 infection and/or COVID 19 vaccination alters APS antibody profiles. Current literature suggests that patients who have been or are infected with COVID-19 are at higher risk of thrombosis. This increased risk is due to, among other things, damaged endothelium, slower blood flow and observed hypercoagulability of the blood. It has also been described that COVID-19 patients may have a higher prevalence of lupus anticoagulant. Based on these assumptions, one of the aims of the prospective observational study is to determine whether and to what extent COVID-19 infection affects the antibody profile of APS patients. In addition, atypical thrombosis with thrombocytopenia has been repeatedly reported recently as a rare side effect after COVID-19 vaccination with two recombinant adenoviral vectors encoding the spike protein antigen of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (ChAdOx1 nCov-19, AstraZeneca and Ad26.COV2.S, Johnson&Johnson). The extent to which thrombosis could also occur after messenger RNA (mRNA) vaccines has not yet been clearly proven. Furthermore, it is unclear whether COVID-19 infections and/or vaccinations can possibly influence the expression and level of antiphospholipid antibody titres. Therefore, another aim of the prospective observational study is to compare the antiphospholipid antibody results available from the retrospective registry before COVID-19 vaccination or COVID-19 infection with the antibody results after COVID-19 infection and/or vaccination. For this purpose, the patients who were recorded in the retrospective register are contacted by post with an information letter and then called in by telephone to the investigators coagulation centre for a follow-up examination after the COVID-19 vaccinations have been carried out and/or after COVID-19 infection. Then, during this examination, a blood sample is taken to monitor the course of the antiphospholipid antibodies. In addition, patients are offered a test of COVID-19 nucleocapsid antibodies and COVID-19 spike antibodies free of charge to check the success of the vaccination. This is of particular interest as some of these patients are taking immunosuppressive drugs due to an underlying autoimmune disease, which could weaken the immune response. frozen citrated plasma samples Patients with antiphospholipid syndrome with thromboembolic clinical manifestations (venous thromboembolism, pulmonary embolism, thrombophlebitis etc.) or Patients with APS antibody risk profile (single/double/triple positivity) Inclusion Criteria: - Minimum age of 18 years - Confirmed antiphospholipid syndrome with thromboembolic clinical manifestations (venous thromboembolism, pulmonary embolism, thrombophlebitis etc.) - Patients with APS antibody risk profile (single/double/triple positivity) - Written consent for participation in the prospective APSantiCo observational study Exclusion Criteria: - APS with isolated pregnancy complications - No anticoagulation medication - Inadequately diagnosed APS - Non-compliance on the part of the patient

NCT0531xxxx/NCT05313061.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313061</url> </required_header> <id_info> <org_study_id>H-2112-019-1279</org_study_id> <nct_id>NCT05313061</nct_id> </id_info> <brief_title>MTX Hold During Covid-19 Booster</brief_title> <official_title>Effect of One-week Discontinuation of Methotrexate on Immunogenicity of COVID-19 Booster Vaccination in Patients With Rheumatoid Arthritis: A Randomized Pilot Study</official_title> <sponsors> <lead_sponsor> <agency>Seoul National University Hospital</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Seoul National University Hospital</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> To investigate the effect of MTX discontinuation for 1 week on vaccination response to Covid-19 booster vaccination in RA patients. </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">December 29, 2021</start_date> <completion_date type="Anticipated">December 30, 2022</completion_date> <primary_completion_date type="Anticipated">December 30, 2022</primary_completion_date> <phase>Phase 3</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>Single (Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Covid-19 antibody titer before and after Covid-19 vacciation</measure> <time_frame>2 weeks</time_frame> <description>Titer and geometric mean titers (GMTs) of neurolizing antibody after vaccination</description> </primary_outcome> <secondary_outcome> <measure>T cell activation after vaccination</measure> <time_frame>2, 4, 16 weeks</time_frame> <description>Percentage of activated T cells after vaccination</description> </secondary_outcome> <secondary_outcome> <measure>B cell activation after vaccination</measure> <time_frame>2, 4, 16 weeks</time_frame> <description>Percentage of activated b cells after vaccination</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">40</enrollment> <condition>Rheumatoid Arthritis</condition> <arm_group> <arm_group_label>MTX continue</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Group will continue MTX after vaccination</description> </arm_group> <arm_group> <arm_group_label>MTX 1 week hold</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Group will continue MTX for 1 week after vaccination</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>MTX</intervention_name> <description>MTX continuation</description> <arm_group_label>MTX 1 week hold</arm_group_label> <arm_group_label>MTX continue</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Males or females ≥ 19 years of age at time of consent  - Have a diagnosis of RA per ACR criteria  - Require methotrexate for RA treatment  - Subject to a Covid-19 booster vaccination  - Must understand and voluntarily sign an informed consent form including writing consent for data protection  Exclusion Criteria:  - Pregnant or lactating females  - Previous anaphylactic response to the vaccine components  - Any other rheumatic disease such as systemic lupus erythematosus, mixed connective tissue disease, dermatomyositis/polymyositis, and vasculitis except for secondary Sjogren's disease  - Any condition including laboratory abnormality which places the subject at unacceptable risk  - Subjects who decline to participate </textblock> </criteria> <gender>All</gender> <minimum_age>19 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <location> <facility> <name>Seoul National University Hospital</name> <address> <city>Seoul</city> <zip>03080</zip> <country>Korea, Republic of</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Eun Bong Lee, MD PhD</last_name> <phone>82-2-2072-3944</phone> <email>leb7616@snu.ac.kr</email> </contact> <contact_backup> <last_name>Jina Yeo, MD</last_name> <phone>82-2-2072-2957</phone> <email>hi.thinmint@gmail.com</email> </contact_backup> </location> <location_countries> <country>Korea, Republic of</country> </location_countries> <reference> <citation>Park JK, Lee YJ, Shin K, Ha YJ, Lee EY, Song YW, Choi Y, Winthrop KL, Lee EB. Impact of temporary methotrexate discontinuation for 2 weeks on immunogenicity of seasonal influenza vaccination in patients with rheumatoid arthritis: a randomised clinical trial. Ann Rheum Dis. 2018 Jun;77(6):898-904. doi: 10.1136/annrheumdis-2018-213222. Epub 2018 Mar 23.</citation> <PMID>29572291</PMID> </reference> <reference> <citation>Park JK, Lee MA, Lee EY, Song YW, Choi Y, Winthrop KL, Lee EB. Effect of methotrexate discontinuation on efficacy of seasonal influenza vaccination in patients with rheumatoid arthritis: a randomised clinical trial. Ann Rheum Dis. 2017 Sep;76(9):1559-1565. doi: 10.1136/annrheumdis-2017-211128. Epub 2017 May 3.</citation> <PMID>28468794</PMID> </reference> <reference> <citation>Curtis JR, Johnson SR, Anthony DD, Arasaratnam RJ, Baden LR, Bass AR, Calabrese C, Gravallese EM, Harpaz R, Kroger A, Sadun RE, Turner AS, Williams EA, Mikuls TR. American College of Rheumatology Guidance for COVID-19 Vaccination in Patients With Rheumatic and Musculoskeletal Diseases: Version 3. Arthritis Rheumatol. 2021 Oct;73(10):e60-e75. doi: 10.1002/art.41928. Epub 2021 Aug 4.</citation> <PMID>34346564</PMID> </reference> <verification_date>April 2022</verification_date> <study_first_submitted>December 28, 2021</study_first_submitted> <study_first_submitted_qc>April 4, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>April 4, 2022</last_update_submitted> <last_update_submitted_qc>April 4, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Seoul National University Hospital</investigator_affiliation> <investigator_full_name>Eun Bong Lee</investigator_full_name> <investigator_title>Professor</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Arthritis</mesh_term> <mesh_term>Arthritis, Rheumatoid</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

To investigate the effect of MTX discontinuation for 1 week on vaccination response to Covid-19 booster vaccination in RA patients. Inclusion Criteria: - Males or females ≥ 19 years of age at time of consent - Have a diagnosis of RA per ACR criteria - Require methotrexate for RA treatment - Subject to a Covid-19 booster vaccination - Must understand and voluntarily sign an informed consent form including writing consent for data protection Exclusion Criteria: - Pregnant or lactating females - Previous anaphylactic response to the vaccine components - Any other rheumatic disease such as systemic lupus erythematosus, mixed connective tissue disease, dermatomyositis/polymyositis, and vasculitis except for secondary Sjogren's disease - Any condition including laboratory abnormality which places the subject at unacceptable risk - Subjects who decline to participate

NCT0531xxxx/NCT05313074.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313074</url> </required_header> <id_info> <org_study_id>013_2021RC_IN695</org_study_id> <nct_id>NCT05313074</nct_id> </id_info> <brief_title>SARS-CoV-2 Specific Immune Response After COVID-19 Vaccination in Cancer Patients</brief_title> <official_title>SARS-CoV-2 Specific Immune Response After COVID-19 Vaccination in Cancer Patients</official_title> <sponsors> <lead_sponsor> <agency>National Cancer Institute, Thailand</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Mahidol University</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>National Cancer Institute, Thailand</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Our study highlights a low degree of neutralization-afforded protection mounted by CoronaVac in cancer patients when compared with healthy volunteers, especially patients who received chemotherapy. Further booster doses, beyond the conventional two-dose regimen might be needed for recipients of CoronaVac to maintain a long-term anamnestic response. </textblock> </brief_summary> <detailed_description> <textblock> A total of 311 participants, including 107 patients with solid tumor and 204 healthy volunteers who received 2 doses of CoronaVac were recruited from National Cancer Institute of Thailand between 2020-2021. Blood samples were collected after second dose of CoronaVac for 15 days and the neutralizing antibody (NAb) titers were detected using live-virus neutralization.SARS-CoV-2 antibody positivity was detected in 77 (72%) patients and 199 (97.5%) healthy volunteers. Antibody positivity rate was lowest (67.2%) in patients who received chemotherapy, followed by patients with post-treatment (74.2%) and patients who planned to start treatment (91.7%). Our study highlights a low degree of neutralization-afforded protection mounted by CoronaVac in cancer patients when compared with healthy volunteers, especially patients who received chemotherapy. Further booster doses, heterologous or otherwise, beyond the conventional two-dose regimen might be needed for recipients of CoronaVac to maintain a long-term anamnestic response. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">March 23, 2021</start_date> <completion_date type="Actual">February 25, 2022</completion_date> <primary_completion_date type="Actual">February 25, 2022</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Non-Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <intervention_model_description>Cancer patients and healthy volunteers will be compared for effectiveness of CoronaVac vaccine in parallel after 2 doses of vaccination for 15 days by neutralizing antibody test</intervention_model_description> <primary_purpose>Prevention</primary_purpose> <masking>None (Open Label)</masking> <masking_description>All participants, including patients with solid tumor and healthy volunteers will be received 2 doses of CoronaVac at National Cancer Institute of Thailand between 2020-2021. Blood samples will be collected after second dose of Sinovac for 15 days and the neutralizing antibody (NAb) titers will be detected using live-virus neutralization</masking_description> </study_design_info> <primary_outcome> <measure>Immune response of Coronavac vaccine in Thai cancer patients</measure> <time_frame>15 days after 2 doses of vaccination</time_frame> <description>Immune response of of the inactivated COVID-19 vaccine (Coronavac) in Thai cancer patients</description> </primary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">311</enrollment> <condition>COVID-19</condition> <condition>Cancer</condition> <arm_group> <arm_group_label>Healthy volunteers</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> <description>Healthcare workers at National Cancer Institute</description> </arm_group> <arm_group> <arm_group_label>Cancer patients</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Cancer patients were divided into 3 groups based on treatment status including active cancer on treatment Planned to start treatment Post-treatment (<6 months)</description> </arm_group> <intervention> <intervention_type>Biological</intervention_type> <intervention_name>CoronaVac vaccine</intervention_name> <description>An inactivated virus COVID-19 vaccine developed by the Chinese company Sinovac Biotech.</description> <arm_group_label>Cancer patients</arm_group_label> <arm_group_label>Healthy volunteers</arm_group_label> <other_name>Sinovac</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Male or Female age at least 18 years  - Patients with a diagnosis of solid tumors  - Ability to understand the patient information and study consent. Signed and dated written informed consent must be available before performing any study-related procedure  - Willing and able to comply with the study procedures.  - Willing to receive a Coronavac vaccine (Sinovac).  Exclusion Criteria:  - Patients who cannot provide consent </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Thanarath Imsuwansri, MD</last_name> <role>Principal Investigator</role> <affiliation>National Cancer Institute of Thailand</affiliation> </overall_official> <location> <facility> <name>National Cancer Institute</name> <address> <city>Ratchathewi</city> <state>Bangkok</state> <zip>10400</zip> <country>Thailand</country> </address> </facility> </location> <location_countries> <country>Thailand</country> </location_countries> <verification_date>April 2022</verification_date> <study_first_submitted>April 4, 2022</study_first_submitted> <study_first_submitted_qc>April 4, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>April 9, 2022</last_update_submitted> <last_update_submitted_qc>April 9, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 15, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>National Cancer Institute, Thailand</investigator_affiliation> <investigator_full_name>Thanarath Imsuwansri, MD</investigator_full_name> <investigator_title>Head of Research Division</investigator_title> </responsible_party> <keyword>COVID-19</keyword> <keyword>Cancer</keyword> <keyword>Immune response</keyword> <condition_browse>  <mesh_term>COVID-19</mesh_term> </condition_browse>  </clinical_study>

Our study highlights a low degree of neutralization-afforded protection mounted by CoronaVac in cancer patients when compared with healthy volunteers, especially patients who received chemotherapy. Further booster doses, beyond the conventional two-dose regimen might be needed for recipients of CoronaVac to maintain a long-term anamnestic response. A total of 311 participants, including 107 patients with solid tumor and 204 healthy volunteers who received 2 doses of CoronaVac were recruited from National Cancer Institute of Thailand between 2020-2021. Blood samples were collected after second dose of CoronaVac for 15 days and the neutralizing antibody (NAb) titers were detected using live-virus neutralization.SARS-CoV-2 antibody positivity was detected in 77 (72%) patients and 199 (97.5%) healthy volunteers. Antibody positivity rate was lowest (67.2%) in patients who received chemotherapy, followed by patients with post-treatment (74.2%) and patients who planned to start treatment (91.7%). Our study highlights a low degree of neutralization-afforded protection mounted by CoronaVac in cancer patients when compared with healthy volunteers, especially patients who received chemotherapy. Further booster doses, heterologous or otherwise, beyond the conventional two-dose regimen might be needed for recipients of CoronaVac to maintain a long-term anamnestic response. Inclusion Criteria: - Male or Female age at least 18 years - Patients with a diagnosis of solid tumors - Ability to understand the patient information and study consent. Signed and dated written informed consent must be available before performing any study-related procedure - Willing and able to comply with the study procedures. - Willing to receive a Coronavac vaccine (Sinovac). Exclusion Criteria: - Patients who cannot provide consent

NCT0531xxxx/NCT05313087.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313087</url> </required_header> <id_info> <org_study_id>21-08-054-528</org_study_id> <nct_id>NCT05313087</nct_id> </id_info> <brief_title>COVID-19 Vaccine Response in Chronic Respiratory Conditions</brief_title> <official_title>COVID-19 Vaccine Response and Durability In Patients With Chronic Respiratory and Medical Disorders</official_title> <sponsors> <lead_sponsor> <agency>National Jewish Health</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>National Jewish Health</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The investigators will assess the antibody, T cell and B cell responses to SARS-CoV-2 vaccination before and every 3 months for 18 months after the initial vaccination or subsequent vaccinations (boosters) in adults and children including patients with chronic medical conditions. </textblock> </brief_summary> <detailed_description> <textblock> HYPOTHESES  1. Patients with chronic respiratory diseases will have a lower antibody response to SARS-CoV-2 virus after vaccination and shorter durability of the response than control subjects without chronic disorders.  2. Patients on corticosteroids and other immunomodulator medications for chronic medical disorders will have a lower antibody response to SARS-CoV-2 after vaccination and shorter durability of the response than subjects with chronic disorders who are not being treated with corticosteroids and immunomodulator medications.  SPECIFIC AIMS  1. Enroll up to 1,000 patients receiving a SARS-CoV-2 vaccination (initial or subsequent vaccinations) in an observational study to determine vaccine antibody response and durability.  1. Obtain blood samples to measure antibody assess the antibody, T cell and B cell responses to SARS-CoV-2 vaccination before and every 3 months for 18 months after the initial vaccination or subsequent vaccinations (boosters) .  2. Categorize patients by their age, gender, race, ethnicity, underlying chronic disease, disease severity, medical therapy and comorbidities.  3. Assess the clinical effectiveness of the vaccine to prevent COVID-19 infections.  3. Determine the clinical features and gene expression of patients who are less responsive (have lower antibody levels and shorter duration of antibody response) to SARS-CoV-2 vaccinations.  STUDY DESIGN Patient population - up to 1,000.  Consisting of patients in the following groups:  1. Controls - who are NOT in any of the groups listed below.  2. Previous COVID infection  3. Asthma receiving immunomodulator medications  4. Asthma receiving chronic oral steroids  5. Asthma - NOT receiving immunomodulator medications or chronic oral steroids  6. Chronic Obstructive Pulmonary Disease (COPD)  7. Rheumatoid Arthritis receiving immunomodulator medications  8. Rheumatoid Arthritis NOT receiving immunomodulator medications  9. Interstitial lung disease  10. Cancer patients receiving chemotherapy  11. Bronchiectasis  12. Cystic fibrosis </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">February 3, 2021</start_date> <completion_date type="Anticipated">December 30, 2024</completion_date> <primary_completion_date type="Anticipated">December 30, 2024</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Cohort</observational_model> <time_perspective>Prospective</time_perspective> </study_design_info> <primary_outcome> <measure>Antibody response</measure> <time_frame>after SARS-CoV-2 vaccinations</time_frame> <description>quantitative spike protein antibody, binding antibody units (BAU)</description> </primary_outcome> <secondary_outcome> <measure>Antibody change</measure> <time_frame>Change 3 months after vaccinations</time_frame> <description>Quantitative spike protein antibody, binding antibody units (BAU)</description> </secondary_outcome> <secondary_outcome> <measure>Antibody change</measure> <time_frame>Change 6 months after vaccinations</time_frame> <description>Quantitative spike protein antibody, binding antibody units (BAU)</description> </secondary_outcome> <secondary_outcome> <measure>Antibody change</measure> <time_frame>Change 9 months after vaccinations</time_frame> <description>Quantitative spike protein antibody, binding antibody units (BAU)</description> </secondary_outcome> <secondary_outcome> <measure>Antibody change</measure> <time_frame>Change 12 months after vaccinations</time_frame> <description>Quantitative spike protein antibody, binding antibody units (BAU)</description> </secondary_outcome> <secondary_outcome> <measure>Antibody change</measure> <time_frame>Change 18 months after vaccinations</time_frame> <description>Quantitative spike protein antibody, binding antibody units (BAU)</description> </secondary_outcome> <number_of_groups>12</number_of_groups> <enrollment type="Anticipated">600</enrollment> <condition>SARS-CoV Infection</condition> <arm_group> <arm_group_label>Controls - who are NOT in any of the groups listed below</arm_group_label> <description>Adults and children age 5 and over.</description> </arm_group> <arm_group> <arm_group_label>Previous COVID infection</arm_group_label> <description>Adults and children age 5 and over.</description> </arm_group> <arm_group> <arm_group_label>Asthma receiving immunomodulator medications</arm_group_label> <description>Adults and children age 5 and over.</description> </arm_group> <arm_group> <arm_group_label>Asthma receiving chronic oral steroids</arm_group_label> <description>Adults and children age 5 and over.</description> </arm_group> <arm_group> <arm_group_label>Asthma - NOT receiving immunomodulator medications or chronic oral steroids</arm_group_label> <description>Adults and children age 5 and over.</description> </arm_group> <arm_group> <arm_group_label>Chronic Obstructive Pulmonary Disease (COPD</arm_group_label> <description>Adults</description> </arm_group> <arm_group> <arm_group_label>Rheumatoid Arthritis receiving immunomodulator medications</arm_group_label> <description>Adults and children age 5 and over.</description> </arm_group> <arm_group> <arm_group_label>Rheumatoid Arthritis NOT receiving immunomodulator medications</arm_group_label> <description>Adults and children age 5 and over.</description> </arm_group> <arm_group> <arm_group_label>Interstitial lung disease</arm_group_label> <description>Adults and children age 5 and over.</description> </arm_group> <arm_group> <arm_group_label>Cancer patients receiving chemotherapy</arm_group_label> <description>Adults and children age 5 and over.</description> </arm_group> <arm_group> <arm_group_label>Bronchiectasis</arm_group_label> <description>Adults and children age 5 and over.</description> </arm_group> <arm_group> <arm_group_label>Cystic fibrosis</arm_group_label> <description>Adults and children age 5 and over.</description> </arm_group> <intervention> <intervention_type>Biological</intervention_type> <intervention_name>COVID-19 vaccine</intervention_name> <description>assess response to vaccine</description> <arm_group_label>Asthma - NOT receiving immunomodulator medications or chronic oral steroids</arm_group_label> <arm_group_label>Asthma receiving chronic oral steroids</arm_group_label> <arm_group_label>Asthma receiving immunomodulator medications</arm_group_label> <arm_group_label>Bronchiectasis</arm_group_label> <arm_group_label>Cancer patients receiving chemotherapy</arm_group_label> <arm_group_label>Chronic Obstructive Pulmonary Disease (COPD</arm_group_label> <arm_group_label>Controls - who are NOT in any of the groups listed below</arm_group_label> <arm_group_label>Cystic fibrosis</arm_group_label> <arm_group_label>Interstitial lung disease</arm_group_label> <arm_group_label>Previous COVID infection</arm_group_label> <arm_group_label>Rheumatoid Arthritis NOT receiving immunomodulator medications</arm_group_label> <arm_group_label>Rheumatoid Arthritis receiving immunomodulator medications</arm_group_label> </intervention> <biospec_retention>Samples With DNA</biospec_retention> <biospec_descr> <textblock> DNA, RNA, serum, plasma </textblock> </biospec_descr> <eligibility> <study_pop> <textblock> Patients with chronic medical conditions seen at our medical center (National Jewish Health) </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Receipt of a SARS-CoV-2 vaccination  Exclusion Criteria:  - None </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Barry Make, MD</last_name> <role>Principal Investigator</role> <affiliation>National Jewish Health</affiliation> </overall_official> <overall_contact> <last_name>Barry Make, MD</last_name> <phone>303-398-1993</phone> <email>makeb@njhealth.org</email> </overall_contact> <overall_contact_backup> <last_name>Michael Wechsler, MD</last_name> <phone>303-398-1085</phone> <email>wechslerm@njhealth.org</email> </overall_contact_backup> <location> <facility> <name>National Jewish Health</name> <address> <city>Denver</city> <state>Colorado</state> <zip>80206</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Barry Make, MD</last_name> <phone>303-398-1993</phone> <email>makeb@njhealth.org</email> </contact> <contact_backup> <last_name>Barry Make, MD</last_name> <phone>3033981993</phone> <email>makeb@njhealth.org</email> </contact_backup> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>April 2022</verification_date> <study_first_submitted>June 1, 2021</study_first_submitted> <study_first_submitted_qc>April 4, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>April 4, 2022</last_update_submitted> <last_update_submitted_qc>April 4, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>National Jewish Health</investigator_affiliation> <investigator_full_name>Barry Make</investigator_full_name> <investigator_title>Professor of Medicine</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Severe Acute Respiratory Syndrome</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Yes</sharing_ipd> <ipd_description>Results will be shared once the study results are analyzed and published.</ipd_description> <ipd_info_type>Study Protocol</ipd_info_type> <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type> <ipd_time_frame>Results will be shared once the study results are analyzed and published.</ipd_time_frame> </patient_data>  </clinical_study>

The investigators will assess the antibody, T cell and B cell responses to SARS-CoV-2 vaccination before and every 3 months for 18 months after the initial vaccination or subsequent vaccinations (boosters) in adults and children including patients with chronic medical conditions. HYPOTHESES 1. Patients with chronic respiratory diseases will have a lower antibody response to SARS-CoV-2 virus after vaccination and shorter durability of the response than control subjects without chronic disorders. 2. Patients on corticosteroids and other immunomodulator medications for chronic medical disorders will have a lower antibody response to SARS-CoV-2 after vaccination and shorter durability of the response than subjects with chronic disorders who are not being treated with corticosteroids and immunomodulator medications. SPECIFIC AIMS 1. Enroll up to 1,000 patients receiving a SARS-CoV-2 vaccination (initial or subsequent vaccinations) in an observational study to determine vaccine antibody response and durability. 1. Obtain blood samples to measure antibody assess the antibody, T cell and B cell responses to SARS-CoV-2 vaccination before and every 3 months for 18 months after the initial vaccination or subsequent vaccinations (boosters) . 2. Categorize patients by their age, gender, race, ethnicity, underlying chronic disease, disease severity, medical therapy and comorbidities. 3. Assess the clinical effectiveness of the vaccine to prevent COVID-19 infections. 3. Determine the clinical features and gene expression of patients who are less responsive (have lower antibody levels and shorter duration of antibody response) to SARS-CoV-2 vaccinations. STUDY DESIGN Patient population - up to 1,000. Consisting of patients in the following groups: 1. Controls - who are NOT in any of the groups listed below. 2. Previous COVID infection 3. Asthma receiving immunomodulator medications 4. Asthma receiving chronic oral steroids 5. Asthma - NOT receiving immunomodulator medications or chronic oral steroids 6. Chronic Obstructive Pulmonary Disease (COPD) 7. Rheumatoid Arthritis receiving immunomodulator medications 8. Rheumatoid Arthritis NOT receiving immunomodulator medications 9. Interstitial lung disease 10. Cancer patients receiving chemotherapy 11. Bronchiectasis 12. Cystic fibrosis DNA, RNA, serum, plasma Patients with chronic medical conditions seen at our medical center (National Jewish Health) Inclusion Criteria: - Receipt of a SARS-CoV-2 vaccination Exclusion Criteria: - None

NCT0531xxxx/NCT05313100.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313100</url> </required_header> <id_info> <org_study_id>2012.04.HD.067</org_study_id> <nct_id>NCT05313100</nct_id> </id_info> <brief_title>Sugammadex and Smoker's Neuromuscular Block</brief_title> <official_title>The Evaluation of the Effects of the Use of Rocuronium and Sugammadex on Neuromuscular Block in Smoker</official_title> <sponsors> <lead_sponsor> <agency>Duzce University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Duzce University</source> <oversight_info> <has_dmc>No</has_dmc> </oversight_info> <brief_summary> <textblock> We compared the durations of antagonizing and of the severity of effect of sugammadex used in antagonizing the rocuronium in smoker and non-smoker total 40 patients with using Train of Four(TOF) neuromuscular monitorization. </textblock> </brief_summary> <detailed_description> <textblock> 40 patients from American Society of Anesthesiologist (ASA) I- II class, being smokers for at least 10 years or non-smokers, who will undergo elective surgery were included in this randomized prospective study. Patients underwent routine monitoring and neuromuscular monitoring. Propofol 2 mg/kg and intravenous fentanyl 1 mcg/kg were applied at induction. After the loss of eyelash reflex, intravenous rocuronium 0,6 mg/kg was administered. The patient was intubated at a Train of Four count of 2. Anesthesia was continued with 50% O2 + 50% air and sevoflurane 2 % . Rocuronium 0,15 mg/kg was administered when TOF (Train of Four) counter reached 2 during the operation. Sugammadex 2 mg/kg was administered at the end of the operation. The time to reach Train of Four values of 0,7-0,8-0,9 were recorded. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date>April 2012</start_date> <completion_date type="Actual">August 2013</completion_date> <primary_completion_date type="Actual">January 2013</primary_completion_date> <phase>Phase 4</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Prevention</primary_purpose> <masking>Double (Participant, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Neuromuscular block recovery time</measure> <time_frame>six months</time_frame> <description>Time to reach TOF %90 measurement after given neuromuscular blocker reverse agent</description> </primary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">40</enrollment> <condition>Neuromuscular Blockade</condition> <condition>Smoking</condition> <arm_group> <arm_group_label>Smokers</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>The patients who have smoked at least 10 packs or have been smoking for 10 years and currently smoking were included in the smoker group At the end of operation for reversal of neuromuscular blockade sugammadex used.</description> </arm_group> <arm_group> <arm_group_label>Nonsmokers</arm_group_label> <arm_group_type>Sham Comparator</arm_group_type> <description>The patients who never smoked were included in the non-smoker group At the end of operation for reversal of neuromuscular blockade sugammadex used.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>sugammadex</intervention_name> <description>At the end of the operation, at least 15 minutes after the last dose of rocuronium, sugammadex 2 mg / kg was administered both of groups</description> <arm_group_label>Nonsmokers</arm_group_label> <arm_group_label>Smokers</arm_group_label> <other_name>bridion</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Elective surgery,  - 1-2 according to the ASA ( American Society of Anesthesiologist ) physical status classification.  - Patients who have smoked at least 10 packs or have been smoking for 10 years and currently smoking  - Or never smoked patients  Exclusion Criteria:  - neuromuscular diseases  - radiotherapy and/or chemotherapy anamnesis,  - liver and/or renal disease,  - electrolyte balance,  - history of drug use which affects neuromuscular transmission,  - Body Mass Index (BMI) of more than 27,  - use alcohol </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>60 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Gulbin Sezen</last_name> <role>Study Director</role> <affiliation>Duzce University</affiliation> </overall_official> <verification_date>April 2022</verification_date> <study_first_submitted>August 6, 2015</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>April 11, 2022</last_update_submitted> <last_update_submitted_qc>April 11, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 18, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>sugammadex</keyword> <keyword>smoking</keyword> <keyword>neuromuscular blockade</keyword> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

We compared the durations of antagonizing and of the severity of effect of sugammadex used in antagonizing the rocuronium in smoker and non-smoker total 40 patients with using Train of Four(TOF) neuromuscular monitorization. 40 patients from American Society of Anesthesiologist (ASA) I- II class, being smokers for at least 10 years or non-smokers, who will undergo elective surgery were included in this randomized prospective study. Patients underwent routine monitoring and neuromuscular monitoring. Propofol 2 mg/kg and intravenous fentanyl 1 mcg/kg were applied at induction. After the loss of eyelash reflex, intravenous rocuronium 0,6 mg/kg was administered. The patient was intubated at a Train of Four count of 2. Anesthesia was continued with 50% O2 + 50% air and sevoflurane 2 % . Rocuronium 0,15 mg/kg was administered when TOF (Train of Four) counter reached 2 during the operation. Sugammadex 2 mg/kg was administered at the end of the operation. The time to reach Train of Four values of 0,7-0,8-0,9 were recorded. Inclusion Criteria: - Elective surgery, - 1-2 according to the ASA ( American Society of Anesthesiologist ) physical status classification. - Patients who have smoked at least 10 packs or have been smoking for 10 years and currently smoking - Or never smoked patients Exclusion Criteria: - neuromuscular diseases - radiotherapy and/or chemotherapy anamnesis, - liver and/or renal disease, - electrolyte balance, - history of drug use which affects neuromuscular transmission, - Body Mass Index (BMI) of more than 27, - use alcohol

NCT0531xxxx/NCT05313113.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313113</url> </required_header> <id_info> <org_study_id>KKYFHTPBVGDE85</org_study_id> <nct_id>NCT05313113</nct_id> </id_info> <brief_title>The Effect of Self-made Fetal Movement and Position Tracking on Prenatal Attachment and Pregnancy Distress</brief_title> <official_title>The Effect of Self-made Fetal Movement and Position Tracking on Prenatal Attachment and Pregnancy Distress</official_title> <sponsors> <lead_sponsor> <agency>TC Erciyes University</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Kahramanmaras Sutcu Imam University</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>TC Erciyes University</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> This study was conducted to determine the effect of self-made fetal movement counting and fetal position tracking on prenatal attachment and prenatal distress. </textblock> </brief_summary> <detailed_description> <textblock> Attachment, which is the basis for establishing social relationships, is the intense feelings that people develop towards the people they consider important. These strong emotions begin with the mother, who is the first person to interact with the individual. When the woman learns that she is pregnant, she becomes curious about her baby, dreams related to the baby, and starts communicating with her baby. Therefore, when baby movements are felt, prenatal attachment becomes stronger, and the cornerstones of attachment are formed.  The early development of safe and positive attachment composes the basis of healthy development. In the later years of childhood, safe attachment is effective on healthy processes, such as being more positive, establishing close, constructive and respectful relationships, and a high sense of trust, while unsafe attachment is associated with emotional, social, physical, and mental psychopathologies.  The mother's touching her baby over her abdomen, trying to guess the parts of the baby, following baby movements, communicating with the baby by focusing and spending private time with the baby increase the physical and psychological contact with the baby. Thus, the baby can be accepted by the mother as an individual, and the attachment between the mother and baby can increase.  Fetal movement counting is defined as tracking uninterrupted fetal movements for at least 15-20 minutes by lying on the left side in a calm environment at any time during the day when this baby is awake. Fetal position tracking is described as trying to guess the parts of the baby by placing the mother's hand on the abdomen. Thanks to fetal movement and position tracking, the state of fetal health can be determined, mother-baby attachment can be increased, and pregnancy distress can be reduced. Pregnant women also may experience negative emotions because of stress, anxiety, anxious anticipation, deterioration of body perception, adaptation to the new situation, anxiety about being a parent, increasing financial needs, fear of birth, and insufficient social support. Hence pregnancy distress can prevent a pleasant pregnancy period and can cause a negative effect on mother-baby attachment.  In order to increase attachment, mothers can be trained on fetal movement and position tracking. This training can be integrated into routine prenatal care since it can be taught quickly. Moreover, it is helpful and economically viable and providing early recognition of fetal risk.  This study was conducted to determine the effect of self-made fetal movement and position tracking on prenatal attachment and pregnancy distress. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">July 15, 2019</start_date> <completion_date type="Actual">May 20, 2020</completion_date> <primary_completion_date type="Actual">August 15, 2019</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Supportive Care</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>The mean prenatal attachment level (mean±SD)</measure> <time_frame>between 24-28 gestational weeks and after 30 days</time_frame> <description>The mean prenatal attachment was assessed using ''Prenatal attachment inventory''. The inventory consists of 21 Likert-type items. Each item is scored between 1 and 4. Therefore, the minimum score of the inventory is 21, while the maximum score of the inventory is 84. The pregnant between 24-28 gestational weeks were filled with face-to-face interviews at the first interview and 30 days after the training.</description> </primary_outcome> <primary_outcome> <measure>The mean pregnancy distress level (mean±SD)</measure> <time_frame>between 24-28 gestational weeks and after 30 days</time_frame> <description>The mean pregnancy distress was assessed using "Pregnancy Distress Scale".The TPDS consists of 16 items and two sub-dimensions as negative affect and partner involvement. The TPDS is 4-point likert type. Each item is scored between 0 and 3. Thus, the total score of TPDS is ranged between 0 and 48 on the scale. The higher the score, the higher the pregnancy distress. The pregnant between 24-28 gestational weeks were filled with face-to-face interviews at the first interview and 30 days after the training.</description> </primary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">85</enrollment> <condition>Prenatal Attachment</condition> <condition>Fetal Position Tracking</condition> <condition>Distress</condition> <arm_group> <arm_group_label>Experimental group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>In the first stage, pregnant women were trained to implement fetal movement count and position tracking. The training was provided face to face and lasted 30-45 minutes. How to determine the position of the fetus and I. and II. Leopold maneuvers are also taught. In the second stage, the pregnant women were interviewed twice a week by telephone.Thus, it was provided that pregnant women had fetal tracked at least once a day, at any time of the day, when the fetus was awake and most active, in a suitable position and a comfortable environment, for at least 15-20 minutes continuously for four weeks. Pregnant women phoned the researcher when they wanted. At the same time, the participants continued to their routine prenatal care.</description> </arm_group> <arm_group> <arm_group_label>Control Group</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>The pregnant women continued to their routine prenatal care. No intervention was applied to the pregnant women in addition to their routine prenatal care.The pregnant women were called about whether continuing their routine care or having any problems during the research.</description> </arm_group> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>Experimental</intervention_name> <description>Pregnant women were trained to implement fetal movement count and position tracking. The training was provided face to face and lasted 30-45 minutes. The training content included topics such as setting a comfortable environment and suitable position for the pregnant, when the fetus is active and asleep during the day, how to count and how to evaluate the movements. How to determine the position of the fetus and I. and II. Leopold maneuvers are also taught. In the second stage, the pregnant women were interviewed twice a week by telephone.Thus, it was provided that pregnant women had fetal tracked at least once a day, at any time of the day, when the fetus was awake and most active, in a suitable position and a comfortable environment, for at least 15-20 minutes continuously for four weeks. Pregnant women phoned the researcher when they wanted. At the same time, the participants continued to their routine prenatal care.</description> <arm_group_label>Experimental group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - least literate  - between the ages of 19-35  - Effective communication  - first pregnancy  - having a single fetus  - Pregnancy week between 24 and 28.  Exclusion Criteria:  - Pregnancy using assisted reproductive techniques  - Having a risky pregnancy (preeclampsia, placenta previa, gestational diabetes etc.)  - Pregnant women with a chronic disease (heart, systemic, circulatory disorder, psychiatric, etc.) were not included in the study. </textblock> </criteria> <gender>Female</gender> <gender_based>Yes</gender_based> <gender_description>focused on pregnancy women</gender_description> <minimum_age>19 Years</minimum_age> <maximum_age>35 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <location> <facility> <name>Erciyes University</name> <address> <city>Kayseri̇</city> <zip>38280</zip> <country>Turkey</country> </address> </facility> </location> <location_countries> <country>Turkey</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>February 7, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>March 28, 2022</last_update_submitted> <last_update_submitted_qc>March 28, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>TC Erciyes University</investigator_affiliation> <investigator_full_name>AYSUN BADEM</investigator_full_name> <investigator_title>Assistant Professor</investigator_title> </responsible_party> <keyword>Prenatal attachment</keyword> <keyword>Pregnancy</keyword> <keyword>Fetal Position Tracking</keyword> <keyword>Fetal Movement Count</keyword> <keyword>Distress</keyword> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

This study was conducted to determine the effect of self-made fetal movement counting and fetal position tracking on prenatal attachment and prenatal distress. Attachment, which is the basis for establishing social relationships, is the intense feelings that people develop towards the people they consider important. These strong emotions begin with the mother, who is the first person to interact with the individual. When the woman learns that she is pregnant, she becomes curious about her baby, dreams related to the baby, and starts communicating with her baby. Therefore, when baby movements are felt, prenatal attachment becomes stronger, and the cornerstones of attachment are formed. The early development of safe and positive attachment composes the basis of healthy development. In the later years of childhood, safe attachment is effective on healthy processes, such as being more positive, establishing close, constructive and respectful relationships, and a high sense of trust, while unsafe attachment is associated with emotional, social, physical, and mental psychopathologies. The mother's touching her baby over her abdomen, trying to guess the parts of the baby, following baby movements, communicating with the baby by focusing and spending private time with the baby increase the physical and psychological contact with the baby. Thus, the baby can be accepted by the mother as an individual, and the attachment between the mother and baby can increase. Fetal movement counting is defined as tracking uninterrupted fetal movements for at least 15-20 minutes by lying on the left side in a calm environment at any time during the day when this baby is awake. Fetal position tracking is described as trying to guess the parts of the baby by placing the mother's hand on the abdomen. Thanks to fetal movement and position tracking, the state of fetal health can be determined, mother-baby attachment can be increased, and pregnancy distress can be reduced. Pregnant women also may experience negative emotions because of stress, anxiety, anxious anticipation, deterioration of body perception, adaptation to the new situation, anxiety about being a parent, increasing financial needs, fear of birth, and insufficient social support. Hence pregnancy distress can prevent a pleasant pregnancy period and can cause a negative effect on mother-baby attachment. In order to increase attachment, mothers can be trained on fetal movement and position tracking. This training can be integrated into routine prenatal care since it can be taught quickly. Moreover, it is helpful and economically viable and providing early recognition of fetal risk. This study was conducted to determine the effect of self-made fetal movement and position tracking on prenatal attachment and pregnancy distress. Inclusion Criteria: - least literate - between the ages of 19-35 - Effective communication - first pregnancy - having a single fetus - Pregnancy week between 24 and 28. Exclusion Criteria: - Pregnancy using assisted reproductive techniques - Having a risky pregnancy (preeclampsia, placenta previa, gestational diabetes etc.) - Pregnant women with a chronic disease (heart, systemic, circulatory disorder, psychiatric, etc.) were not included in the study.

NCT0531xxxx/NCT05313126.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313126</url> </required_header> <id_info> <org_study_id>2020-A03558-31</org_study_id> <nct_id>NCT05313126</nct_id> </id_info> <brief_title>Immuno-epidemiological and Socio-behavioral Evaluation of Release of Sterile Male Aedes Albopictus Mosquitoes on Human-vector Contacts</brief_title> <acronym>EXPOCAP</acronym> <official_title>Immuno-epidemiological and Socio-behavioral Evaluation of Release of Sterile Male Aedes Albopictus Mosquitoes on Human-vector Contacts</official_title> <sponsors> <lead_sponsor> <agency>Institut de Recherche pour le Developpement</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Institut de Recherche pour le Developpement</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> This trial is based on 2 complementary components, named ExpAlbo Biomarker and CAPAlbo Questionnaire  1. ExpAlbo Biomarker (Exposure to the Aedes albopictus mosquito): This component concerns the epidemiological evaluation of the effectiveness of the release of sterile male mosquitoes on the level of exposure of individuals to the bites of the tiger mosquito through the use of a new immunological biomarker of the human-vector contact, developed over the past 20 years by the IRD-MIVEGEC team. Indeed, when a person is bitten by a mosquito, he or she develops a defence reaction, called an immune reaction, against the mosquito's saliva. The main objective of this study is to measure this immune response, and more specifically the antibody response specifically directed against compounds (peptide = small fragment of a protein) in mosquito saliva, and to determine whether this anti-saliva antibody response, and therefore exposure to mosquito bites, decreases when the mosquito control strategy is applied.  2. CAPAlbo Questionnaire: This component is concerned with assessing the impact of sterile male mosquito releases on perceptions and practices related to exposure to Aedes albopictus based on population-based questionnaire surveys. The main objective of these surveys is to determine whether changes in objective exposure to Aedes albopictus mosquitoes are associated with changes in the perception of the nuisance and in the lifestyle habits of respondents, particularly those related to the prevention of mosquito bites (such as the use of repellents or mosquito nets). </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">November 9, 2021</start_date> <completion_date type="Anticipated">June 2023</completion_date> <primary_completion_date type="Anticipated">June 2023</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Non-Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <intervention_model_description>A Cluster-Non Randomized Controlled Trial</intervention_model_description> <primary_purpose>Prevention</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Immunological indicators</measure> <time_frame>6 months</time_frame> <description>Biomarker based on the measurement of human IgG antibody levels specific to one peptide of Aedes saliva (i.e. Nterm-24kDa salivary peptide)</description> </primary_outcome> <primary_outcome> <measure>Immunological indicators</measure> <time_frame>12 months</time_frame> <description>Biomarker based on the measurement of human IgG antibody levels specific to one peptide of Aedes saliva (i.e. Nterm-24kDa salivary peptide)</description> </primary_outcome> <primary_outcome> <measure>Exposure to Aedes mosquito</measure> <time_frame>6 months</time_frame> <description>self-perceived exposure to mosquito will be assessed by questionnaire</description> </primary_outcome> <primary_outcome> <measure>Exposure to Aedes mosquito</measure> <time_frame>12 months</time_frame> <description>self-perceived exposure to mosquito will be assessed by questionnaire</description> </primary_outcome> <secondary_outcome> <measure>Protective behavior</measure> <time_frame>6 months</time_frame> <description>a composite indicator derived from a questionnaire will rate the protective behavior of the participants to avoid mosquito bites</description> </secondary_outcome> <secondary_outcome> <measure>Protective behavior</measure> <time_frame>12 months</time_frame> <description>a composite indicator derived from a questionnaire will rate the protective behavior of the participants to avoid mosquito bites</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">500</enrollment> <condition>Mosquito Bite</condition> <arm_group> <arm_group_label>sterile male Aedes albopictus-exposed</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Sterile male Aedes albopictus are released in the area.</description> </arm_group> <arm_group> <arm_group_label>control</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>Sterile male Aedes albopictus are not released in the area.</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>sterile insect technique (TIS)</intervention_name> <description>Sterile male Aedes albopictus mosquitos are released in the area/neighborhood</description> <arm_group_label>sterile male Aedes albopictus-exposed</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - To inhabit on a regular basis in the intervention/control area  - To speak French </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_contact> <last_name>Franck Remoué, PhD</last_name> <phone>+33 (0)4 67 41 61 30</phone> <email>franck.remoue@ird.fr</email> </overall_contact> <overall_contact_backup> <last_name>Jocelyn Raude, PhD</last_name> <phone>+33 (0)2 99 02 26 15</phone> <email>jocelyn.raude@ehesp.fr</email> </overall_contact_backup> <location> <facility> <name>population générale (quartier Duparc (Sainte Marie) et Quartier Bois rouge)</name> <address> <city>La Réunion</city> <country>France</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Cécile Brengues</last_name> <email>cecile.brengues@ird.fr</email> </contact> </location> <location_countries> <country>France</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>January 5, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>March 28, 2022</last_update_submitted> <last_update_submitted_qc>March 28, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Infertility</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Undecided</sharing_ipd> </patient_data>  </clinical_study>

This trial is based on 2 complementary components, named ExpAlbo Biomarker and CAPAlbo Questionnaire 1. ExpAlbo Biomarker (Exposure to the Aedes albopictus mosquito): This component concerns the epidemiological evaluation of the effectiveness of the release of sterile male mosquitoes on the level of exposure of individuals to the bites of the tiger mosquito through the use of a new immunological biomarker of the human-vector contact, developed over the past 20 years by the IRD-MIVEGEC team. Indeed, when a person is bitten by a mosquito, he or she develops a defence reaction, called an immune reaction, against the mosquito's saliva. The main objective of this study is to measure this immune response, and more specifically the antibody response specifically directed against compounds (peptide = small fragment of a protein) in mosquito saliva, and to determine whether this anti-saliva antibody response, and therefore exposure to mosquito bites, decreases when the mosquito control strategy is applied. 2. CAPAlbo Questionnaire: This component is concerned with assessing the impact of sterile male mosquito releases on perceptions and practices related to exposure to Aedes albopictus based on population-based questionnaire surveys. The main objective of these surveys is to determine whether changes in objective exposure to Aedes albopictus mosquitoes are associated with changes in the perception of the nuisance and in the lifestyle habits of respondents, particularly those related to the prevention of mosquito bites (such as the use of repellents or mosquito nets). Inclusion Criteria: - To inhabit on a regular basis in the intervention/control area - To speak French

NCT0531xxxx/NCT05313139.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313139</url> </required_header> <id_info> <org_study_id>1521/21</org_study_id> <nct_id>NCT05313139</nct_id> </id_info> <brief_title>Surveillance of Vaccine-induced Immunity Against Ebola in Previously Vaccinated Health Care Workers</brief_title> <acronym>EBOSURV</acronym> <official_title>Surveillance of rVSV-ZEBOV Vaccine-induced Immunity Against Ebola Virus in Previously Vaccinated Health Care Workers < EBOSURV ></official_title> <sponsors> <lead_sponsor> <agency>Institute of Tropical Medicine, Belgium</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Institute of Tropical Medicine, Belgium</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> <is_us_export>No</is_us_export> </oversight_info> <brief_summary> <textblock> During the previous Ebola virus disease (EVD) outbreaks, the institute National de Recherche Biomédicale (INRB) and other institutional's staff in Democratic Republic of the Congo (DRC) got vaccinated with the rVSV-ZEBOV vaccine. However, the longevity of Ebola virus (EBOV)-specific immune responses after vaccination has not been studied extensively (only 1-2 years) nor comprehensively (only humoral), despite the wide use of this vaccine. With the re-emergence of Ebola in North-Kivu from a previously vaccinated individual, and the new planned vaccination campaign (considering homologous booster doses for previously vaccinated HCW) in light of the new outbreak in Beni, assessing the persistence and quality of vaccine-induced anti-EBOV immune responses is pertinent and timely. </textblock> </brief_summary> <detailed_description> <textblock> Despite the availability of new effective therapeutics, Ebola Virus Disease (EVD) remains a highly lethal disease, with significant collateral impact on the society. In addition, during the last decades, EVD outbreaks appear to become more and more frequent. The disease, therefore, continues to pose a significant public health concern to many areas in West and Central Africa, most notably in the Democratic Republic of the Congo (DRC), where the majority of outbreaks occur.  Fortunately, safe and effective vaccines are now available and these have become a crucial part of the current outbreak response. Most widely used in the DRC is the rVSV-ZEBOV vaccine (licensed as ErveboTM), which was recently approved for human use by both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).  Many questions regarding EVD vaccines in general and rVSV-ZEBOV in particular remain unanswered. Currently, there is no data beyond the 2-year time point for antibody titers and more in depth investigations on IgG subclass restrictions or cellular immunity are lacking. However, previous data from non-human primate (NHP) models collectively indicate that Ebola virus (EBOV)-specific CD4+ T cells play a critical role in generating the protective antibody responses and could therefore play a vital part upon re-challenge or prove a vital predictor of poor immunity generation, durability and vaccine failure. These findings argue for an integrated and comprehensive assessment of both durable circulating nAb as well as memory CD4 T cell responses and B cell compartments to fully assess the quality of the long-lived recall responses after a single dose rVSV-ZEBOV vaccination. In addition, there are no post marketing studies that have assessed long-lived immunity outside of a clinical trial environment in routine vaccination campaigns.  Recent events have showed that acquiring such data is of the utmost importance. During the 10th EVD outbreak in DRC in North-Kivu, a person, previously vaccinated with rVSV-ZEBOV, still developed the disease and even relapsed several months later (9). These unresolved questions on the persistence of anti-EBOV immune responses are therefore highly relevant.  Due to concerns on the durability of the immune response after vaccination with rVSV-ZEBOV, a booster dose might be necessary to adequately protect front line health care workers. In this context, the INRB Goma performed a small pilot survey among their personnel, during which they found low binding antibody titers in their previously vaccinated staff (unpublished results). As in October 2021 a new EVD outbreak in North-Kivu was declared, the INRB Goma, in consultation with WHO, decided to, therefore, revaccinate some of their staff that are part of the outbreak response. This would be the first time that the rVSV-ZEBOV vaccine is administered as a booster dose, and documenting the immune response following boostering will be crucial.  The aim of this study is, therefore, to monitor the persistence of the vaccine induced humoral and cellular immune responses following primary vaccination with Ervebo, among recently and previously vaccinated health care staff at INRB Kinshasa and Goma, who received Ervebo as part of the outbreak response.  General objective To comprehensively assess the quality, durability and boostability of the immune response against EBOV glycoprotein antigen in previously and recently rVSV-ZEBOV vaccinated staff  Specific objectives  - Compare EBOV-specific IgG and neutralizing antibodies (nAb) titres at D28 in primary vaccinated staff, and at <1 year, 1-2 years, and 2-3 years and >3 years after primary vaccination in previously vaccinated staff  - Compare the EBOV-specific memory T and B cell responses at D28 in primary vaccinated staff, and at <1 year, 1-2 years, and 2-3 years and >3 years after primary vaccination in previously vaccinated staff  - To characterize the phenotype and quality of the vaccine-induced B and T cell response (isotypes, cell type, polyfunctionality)  - Describe the correlation between humoral and cellular immunity with regard to strength and durability of response after rVSV-ZEBOV vaccination  - In those receiving a booster dose, assess and compare the level of boostability at <1 year, 1-2 years, 2-3 years and >3 years after primary vaccination  - Identify factors influencing the serological and cellular durability and boostability, and the composite immune index expressed as strong, moderate and limited immunity, by vaccination time strata (recently vaccinated, <1 year, 1-2 years, 2-3 years and >3 years)  Exploratory objectives  - Compare vaccine-induced immunity by vaccination time strata (recently vaccinated, <1 year, 1-2 years, and 2-3 years and >3 years, before and after booster dose ) to immunity obtained after natural infection, using a biobanked EVD survivors' cohort  This is a cross-sectional vaccination serosurvey of health care workers (HCWs) from INRB Kinshasa and INRB Goma that were vaccinated with rVSV-ZEBOV, with a short longitudinal follow-up (D0, D7, D28) restricted to recently vaccinated staff to study boostability.  An Ebola outbreak is currently ongoing in Beni. In response to the outbreak and as part of the immunization program, INRB Goma staff that are processing samples from the outbreak area will be offered to be vaccinated against EVD. Recently vaccinated staff, defined as those receiving primary or booster dose, will also be asked for their willingness to participate in the present study, but then with a short and additional longitudinal follow-up.  In our exploratory objective, the vaccine-induced immunity (by vaccination time strata) will be compared to immunity obtained after natural infection. This will depend on whether a solid matched design can be constructed with the the biobanked EVD survivor's cohort from INRB Kinshasa. Only samples from participants that consented to long-term storage and future Ebola-related research will be used.  Recruitment Strategy A list of vaccine recipients is available, including 568 HCWs who received the rVSV-ZEBOV vaccine. All recipients from this list will be contacted by representatives of one of the study sites for their interest in the study and invited to be included in the study. Recruitment will stop once 45 persons per vaccination time strata (<1 year, 1-2 years, and 2-3 years, and >3 years) are reached.  Recently vaccinated staff will be recruited via the current immunization program in place in DRC. All recipients from this list will be contacted by representatives of the study for their interest in the study. Recruitment will stop once 45 persons per group are reached.  Sample Size and Power The study is a cross-sectional vaccination serosurvey across 'time from vaccination' strata, with a longitudinal follow-up restricted to recently vaccinated staff, amongst 245 participants (unvaccinated (n=20), primary vaccinated (n=45), <1 year (n=45), 1-2 years (n=45), 2-3 years (n=45), >3 years (n=45) after primary vaccination).  General overview of study procedures Previously vaccinated health care workers that agree to participate will be scheduled for a single study visit. For recently vaccinated HCWs, 3 study visits will be organized. For logistical reasons, predefined recruitment days will be organized to pool patient visits as much as possible. Depending on their place of residence, the visit will be performed at either the INRB laboratory in Kinshasa or in Goma. During these visits, a questionnaire at D0, will be filled in by the participants. Blood sample of 3 x 10mL Lithium Heparine tubes will be collected. In case of multiple visits, blood samples will be collected at every visit. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">December 13, 2021</start_date> <completion_date type="Anticipated">December 31, 2022</completion_date> <primary_completion_date type="Anticipated">August 31, 2022</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Case-Control</observational_model> <time_perspective>Cross-Sectional</time_perspective> </study_design_info> <primary_outcome> <measure>EBOV glycoprotein (GP)-specific T and B cell Spot Forming Units</measure> <time_frame>Day 0</time_frame> <description>EBOV glycoprotein (GP)-specific T and B cell Spot Forming Units (SFU) per 10^6 cells determined by Elipot/Fluorospot assay</description> </primary_outcome> <primary_outcome> <measure>EBOV glycoprotein (GP)-specific T and B cell Spot Forming Units</measure> <time_frame>Day 7</time_frame> <description>EBOV glycoprotein (GP)-specific T and B cell Spot Forming Units (SFU) per 10^6 cells determined by Elipot/Fluorospot assay</description> </primary_outcome> <primary_outcome> <measure>EBOV glycoprotein (GP)-specific T and B cell Spot Forming Units</measure> <time_frame>Day 28</time_frame> <description>EBOV glycoprotein (GP)-specific T and B cell Spot Forming Units (SFU) per 10^6 cells determined by Elipot/Fluorospot assay</description> </primary_outcome> <secondary_outcome> <measure>Geometric mean titers (GMT) of GP-specific IgG and neutralizing antibodies (nAb)</measure> <time_frame>Day 0</time_frame> <description>Geometric mean titers (GMT) of GP-specific IgG and neutralizing antibodies (nAb)</description> </secondary_outcome> <secondary_outcome> <measure>Geometric mean titers (GMT) of GP-specific IgG and neutralizing antibodies (nAb)</measure> <time_frame>Day 7</time_frame> <description>Geometric mean titers (GMT) of GP-specific IgG and neutralizing antibodies (nAb)</description> </secondary_outcome> <secondary_outcome> <measure>Geometric mean titers (GMT) of GP-specific IgG and neutralizing antibodies (nAb)</measure> <time_frame>Day 28</time_frame> <description>Geometric mean titers (GMT) of GP-specific IgG and neutralizing antibodies (nAb)</description> </secondary_outcome> <secondary_outcome> <measure>Seroprevalence status based on GP specific antibodies (Ab)</measure> <time_frame>Day 0</time_frame> <description>Seroprevalence status based on GP specific antibodies (Ab)</description> </secondary_outcome> <secondary_outcome> <measure>Seroprevalence status based on GP specific antibodies (Ab)</measure> <time_frame>Day 7</time_frame> <description>Seroprevalence status based on GP specific antibodies (Ab)</description> </secondary_outcome> <secondary_outcome> <measure>Seroprevalence status based on GP specific antibodies (Ab)</measure> <time_frame>Day 28</time_frame> <description>Seroprevalence status based on GP specific antibodies (Ab)</description> </secondary_outcome> <secondary_outcome> <measure>Phenotypic and isotypic classification of GP-responsive T and B cells, respectively</measure> <time_frame>Day 0</time_frame> <description>Phenotypic and isotypic classification of GP-responsive T and B cells, respectively</description> </secondary_outcome> <secondary_outcome> <measure>Phenotypic and isotypic classification of GP-responsive T and B cells, respectively</measure> <time_frame>Day 7</time_frame> <description>Phenotypic and isotypic classification of GP-responsive T and B cells, respectively</description> </secondary_outcome> <secondary_outcome> <measure>Phenotypic and isotypic classification of GP-responsive T and B cells, respectively</measure> <time_frame>Day 28</time_frame> <description>Phenotypic and isotypic classification of GP-responsive T and B cells, respectively</description> </secondary_outcome> <secondary_outcome> <measure>Correlation coefficients between humoral and cellular responses</measure> <time_frame>Day 0</time_frame> <description>Correlation coefficients between humoral and cellular responses</description> </secondary_outcome> <secondary_outcome> <measure>Correlation coefficients between humoral and cellular responses</measure> <time_frame>Day 7</time_frame> <description>Correlation coefficients between humoral and cellular responses</description> </secondary_outcome> <secondary_outcome> <measure>Correlation coefficients between humoral and cellular responses</measure> <time_frame>Day 28</time_frame> <description>Correlation coefficients between humoral and cellular responses</description> </secondary_outcome> <secondary_outcome> <measure>Effect of age, vaccination history, comorbidities and coinfections on serological and cellular titers and on composite immune index, expressed as strong, moderate and limited immunity</measure> <time_frame>Day 0</time_frame> <description>Effect of age, vaccination history, comorbidities and coinfections on serological and cellular titers and on composite immune index, expressed as strong, moderate and limited immunity</description> </secondary_outcome> <number_of_groups>6</number_of_groups> <enrollment type="Anticipated">245</enrollment> <condition>Immune Response</condition> <arm_group> <arm_group_label>Unvaccinated participants</arm_group_label> <description>Participants who did received the rVSV-ZEBOV vaccine nor had any prior close contact with EBOV patients nor presenting a travel history to East DRC</description> </arm_group> <arm_group> <arm_group_label>Primary vaccinated participants</arm_group_label> <description>Participants who received a first rVSV-ZEBOV vaccine dose as part of the WHO vaccination campaign organized in Goma region (end of 2021), of which vaccination date and brand is known</description> </arm_group> <arm_group> <arm_group_label>Participants vaccinated < 1 year ago (from date of enrollment)</arm_group_label> <description>Participants who received a rVSV-ZEBOV vaccine dose less than a year prior to inclusion of which vaccination date and brand is known</description> </arm_group> <arm_group> <arm_group_label>Participants vaccinated 1-2 years ago (from date of enrollment)</arm_group_label> <description>Participants who received a rVSV-ZEBOV vaccine dose between 1-2 years prior to inclusion of which vaccination date and brand is known</description> </arm_group> <arm_group> <arm_group_label>Participants vaccinated 2-3 years ago (from date of enrollment)</arm_group_label> <description>Participants who received a rVSV-ZEBOV vaccine dose between 2-3 years prior to inclusion of which vaccination date and brand is known</description> </arm_group> <arm_group> <arm_group_label>Participants vaccinated > 3 years ago (from date of enrollment)</arm_group_label> <description>Participants who received a rVSV-ZEBOV vaccine dose > 3 years prior to inclusion of which vaccination date and brand is known</description> </arm_group> <biospec_retention>Samples Without DNA</biospec_retention> <biospec_descr> <textblock> Blood sampling, 3x10mL Lithium Heparine tubes collected by venipuncture </textblock> </biospec_descr> <eligibility> <study_pop> <textblock> Health care workers from Institut National de Recherche Biomédicale (INRB) Kinshasa and Institut National de Recherche Biomédicale (INRB) Goma, who previously or recently received (primary and booster dose), or did not receive (cf. controls) the rVSV-ZEBOV vaccine. </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Subject is willing and able to give informed consent for participation in the study  - Subject can be contacted by phone, email or physical address  - Subject is aged 18 years or above  - Subject must have a ID card (or other identification document)  For vaccinated group:  - Subject must be receiving the rVSV-ZEBOV vaccine (first or second dose) at time of inclusion OR has received a first rVSV-ZEBOV vaccine dose prior to inclusion of which vaccination date and brand is known  For unvaccinated group (controls):  Subject must NOT have received the rVSV-ZEBOV vaccine nor had any prior close contact with EBOV patients  Exclusion Criteria:  - Subject was previously diagnosed with EVD  - Subject has any contraindication to venipuncture, as determined by clinical judgement </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Mulangu Sabue, Prof</last_name> <role>Study Chair</role> <affiliation>Institut National de Recherche Biomédicale (INRB), Kinshasa</affiliation> </overall_official> <overall_official> <last_name>Kavunga Hugo, Prof</last_name> <role>Study Chair</role> <affiliation>Institut National de Recherche Biomédicale (INRB), Goma</affiliation> </overall_official> <overall_official> <last_name>Mukadi Daniel, MD</last_name> <role>Study Chair</role> <affiliation>Institut National de Recherche Biomédicale (INRB), Goma</affiliation> </overall_official> <overall_contact> <last_name>Laurene Peckeu-Abboud, PhD</last_name> <phone>+32 3 247 66 66</phone> <email>lpeckeu@itg.be</email> </overall_contact> <overall_contact_backup> <last_name>Wim Adriaensen, Prof</last_name> <phone>+32 3 247 66 66</phone> <email>wadriaensen@itg.be</email> </overall_contact_backup> <location> <facility> <name>Institut National de Recherche Biomédicale (INRB)</name> <address> <city>Goma</city> <country>Congo, The Democratic Republic of the</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Kavunga Hugo, Prof</last_name> </contact> <contact_backup> <last_name>Mukadi Daniel, MD</last_name> </contact_backup> </location> <location> <facility> <name>Institut National de Recherche Biomédicale (INRB)</name> <address> <city>Kinshasa</city> <country>Congo, The Democratic Republic of the</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Mulangu Sabue, Prof</last_name> </contact> </location> <location_countries> <country>Congo, The Democratic Republic of the</country> </location_countries> <verification_date>May 2022</verification_date> <study_first_submitted>March 15, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>May 18, 2022</last_update_submitted> <last_update_submitted_qc>May 18, 2022</last_update_submitted_qc> <last_update_posted type="Actual">May 19, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <patient_data> <sharing_ipd>Undecided</sharing_ipd> </patient_data>  </clinical_study>

During the previous Ebola virus disease (EVD) outbreaks, the institute National de Recherche Biomédicale (INRB) and other institutional's staff in Democratic Republic of the Congo (DRC) got vaccinated with the rVSV-ZEBOV vaccine. However, the longevity of Ebola virus (EBOV)-specific immune responses after vaccination has not been studied extensively (only 1-2 years) nor comprehensively (only humoral), despite the wide use of this vaccine. With the re-emergence of Ebola in North-Kivu from a previously vaccinated individual, and the new planned vaccination campaign (considering homologous booster doses for previously vaccinated HCW) in light of the new outbreak in Beni, assessing the persistence and quality of vaccine-induced anti-EBOV immune responses is pertinent and timely. Despite the availability of new effective therapeutics, Ebola Virus Disease (EVD) remains a highly lethal disease, with significant collateral impact on the society. In addition, during the last decades, EVD outbreaks appear to become more and more frequent. The disease, therefore, continues to pose a significant public health concern to many areas in West and Central Africa, most notably in the Democratic Republic of the Congo (DRC), where the majority of outbreaks occur. Fortunately, safe and effective vaccines are now available and these have become a crucial part of the current outbreak response. Most widely used in the DRC is the rVSV-ZEBOV vaccine (licensed as ErveboTM), which was recently approved for human use by both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Many questions regarding EVD vaccines in general and rVSV-ZEBOV in particular remain unanswered. Currently, there is no data beyond the 2-year time point for antibody titers and more in depth investigations on IgG subclass restrictions or cellular immunity are lacking. However, previous data from non-human primate (NHP) models collectively indicate that Ebola virus (EBOV)-specific CD4+ T cells play a critical role in generating the protective antibody responses and could therefore play a vital part upon re-challenge or prove a vital predictor of poor immunity generation, durability and vaccine failure. These findings argue for an integrated and comprehensive assessment of both durable circulating nAb as well as memory CD4 T cell responses and B cell compartments to fully assess the quality of the long-lived recall responses after a single dose rVSV-ZEBOV vaccination. In addition, there are no post marketing studies that have assessed long-lived immunity outside of a clinical trial environment in routine vaccination campaigns. Recent events have showed that acquiring such data is of the utmost importance. During the 10th EVD outbreak in DRC in North-Kivu, a person, previously vaccinated with rVSV-ZEBOV, still developed the disease and even relapsed several months later (9). These unresolved questions on the persistence of anti-EBOV immune responses are therefore highly relevant. Due to concerns on the durability of the immune response after vaccination with rVSV-ZEBOV, a booster dose might be necessary to adequately protect front line health care workers. In this context, the INRB Goma performed a small pilot survey among their personnel, during which they found low binding antibody titers in their previously vaccinated staff (unpublished results). As in October 2021 a new EVD outbreak in North-Kivu was declared, the INRB Goma, in consultation with WHO, decided to, therefore, revaccinate some of their staff that are part of the outbreak response. This would be the first time that the rVSV-ZEBOV vaccine is administered as a booster dose, and documenting the immune response following boostering will be crucial. The aim of this study is, therefore, to monitor the persistence of the vaccine induced humoral and cellular immune responses following primary vaccination with Ervebo, among recently and previously vaccinated health care staff at INRB Kinshasa and Goma, who received Ervebo as part of the outbreak response. General objective To comprehensively assess the quality, durability and boostability of the immune response against EBOV glycoprotein antigen in previously and recently rVSV-ZEBOV vaccinated staff Specific objectives - Compare EBOV-specific IgG and neutralizing antibodies (nAb) titres at D28 in primary vaccinated staff, and at <1 year, 1-2 years, and 2-3 years and >3 years after primary vaccination in previously vaccinated staff - Compare the EBOV-specific memory T and B cell responses at D28 in primary vaccinated staff, and at <1 year, 1-2 years, and 2-3 years and >3 years after primary vaccination in previously vaccinated staff - To characterize the phenotype and quality of the vaccine-induced B and T cell response (isotypes, cell type, polyfunctionality) - Describe the correlation between humoral and cellular immunity with regard to strength and durability of response after rVSV-ZEBOV vaccination - In those receiving a booster dose, assess and compare the level of boostability at <1 year, 1-2 years, 2-3 years and >3 years after primary vaccination - Identify factors influencing the serological and cellular durability and boostability, and the composite immune index expressed as strong, moderate and limited immunity, by vaccination time strata (recently vaccinated, <1 year, 1-2 years, 2-3 years and >3 years) Exploratory objectives - Compare vaccine-induced immunity by vaccination time strata (recently vaccinated, <1 year, 1-2 years, and 2-3 years and >3 years, before and after booster dose ) to immunity obtained after natural infection, using a biobanked EVD survivors' cohort This is a cross-sectional vaccination serosurvey of health care workers (HCWs) from INRB Kinshasa and INRB Goma that were vaccinated with rVSV-ZEBOV, with a short longitudinal follow-up (D0, D7, D28) restricted to recently vaccinated staff to study boostability. An Ebola outbreak is currently ongoing in Beni. In response to the outbreak and as part of the immunization program, INRB Goma staff that are processing samples from the outbreak area will be offered to be vaccinated against EVD. Recently vaccinated staff, defined as those receiving primary or booster dose, will also be asked for their willingness to participate in the present study, but then with a short and additional longitudinal follow-up. In our exploratory objective, the vaccine-induced immunity (by vaccination time strata) will be compared to immunity obtained after natural infection. This will depend on whether a solid matched design can be constructed with the the biobanked EVD survivor's cohort from INRB Kinshasa. Only samples from participants that consented to long-term storage and future Ebola-related research will be used. Recruitment Strategy A list of vaccine recipients is available, including 568 HCWs who received the rVSV-ZEBOV vaccine. All recipients from this list will be contacted by representatives of one of the study sites for their interest in the study and invited to be included in the study. Recruitment will stop once 45 persons per vaccination time strata (<1 year, 1-2 years, and 2-3 years, and >3 years) are reached. Recently vaccinated staff will be recruited via the current immunization program in place in DRC. All recipients from this list will be contacted by representatives of the study for their interest in the study. Recruitment will stop once 45 persons per group are reached. Sample Size and Power The study is a cross-sectional vaccination serosurvey across 'time from vaccination' strata, with a longitudinal follow-up restricted to recently vaccinated staff, amongst 245 participants (unvaccinated (n=20), primary vaccinated (n=45), <1 year (n=45), 1-2 years (n=45), 2-3 years (n=45), >3 years (n=45) after primary vaccination). General overview of study procedures Previously vaccinated health care workers that agree to participate will be scheduled for a single study visit. For recently vaccinated HCWs, 3 study visits will be organized. For logistical reasons, predefined recruitment days will be organized to pool patient visits as much as possible. Depending on their place of residence, the visit will be performed at either the INRB laboratory in Kinshasa or in Goma. During these visits, a questionnaire at D0, will be filled in by the participants. Blood sample of 3 x 10mL Lithium Heparine tubes will be collected. In case of multiple visits, blood samples will be collected at every visit. Blood sampling, 3x10mL Lithium Heparine tubes collected by venipuncture Health care workers from Institut National de Recherche Biomédicale (INRB) Kinshasa and Institut National de Recherche Biomédicale (INRB) Goma, who previously or recently received (primary and booster dose), or did not receive (cf. controls) the rVSV-ZEBOV vaccine. Inclusion Criteria: - Subject is willing and able to give informed consent for participation in the study - Subject can be contacted by phone, email or physical address - Subject is aged 18 years or above - Subject must have a ID card (or other identification document) For vaccinated group: - Subject must be receiving the rVSV-ZEBOV vaccine (first or second dose) at time of inclusion OR has received a first rVSV-ZEBOV vaccine dose prior to inclusion of which vaccination date and brand is known For unvaccinated group (controls): Subject must NOT have received the rVSV-ZEBOV vaccine nor had any prior close contact with EBOV patients Exclusion Criteria: - Subject was previously diagnosed with EVD - Subject has any contraindication to venipuncture, as determined by clinical judgement

NCT0531xxxx/NCT05313152.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313152</url> </required_header> <id_info> <org_study_id>59870002</org_study_id> <nct_id>NCT05313152</nct_id> </id_info> <brief_title>Study of TAVO103A in Healthy Volunteers</brief_title> <official_title>A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAVO103A in Adult Healthy Subjects</official_title> <sponsors> <lead_sponsor> <agency>Tavotek Biotherapeutics</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Tavotek Biotherapeutics</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>Yes</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> This is a Phase 1, single ascending dose study designed to investigate TAVO103A, administered as an IV infusion up to 60 minutes in length to healthy adult subjects. This study is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TAVO103A. </textblock> </brief_summary> <detailed_description> <textblock> This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose (SAD), single site study. There will be up to 5 SAD cohorts with 6 subjects enrolled into each. Subjects will be randomized at a ratio of 2:1 to receive TAVO103A or placebo. Subjects will be evaluated for safety throughout the study up through day 196. </textblock> </detailed_description> <overall_status>Active, not recruiting</overall_status> <start_date type="Actual">April 5, 2022</start_date> <completion_date type="Anticipated">June 30, 2023</completion_date> <primary_completion_date type="Anticipated">April 26, 2023</primary_completion_date> <phase>Phase 1</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Prevention</primary_purpose> <masking>Double (Participant, Investigator)</masking> </study_design_info> <primary_outcome> <measure>The severity of adverse effects according to the CTCAE Guidance for Industry, Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials [Time Frame: Day 1 through Day 196]</measure> <time_frame>196 days</time_frame> <description>To investigate the safety and tolerability of TAVO103A in healthy volunteers. The Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials will be graded according to the National Cancer Institute's Common Terminology Criteria for AEs, Version 5.0. Which will have a minimum value of Grade 1, or mild, and a maximum value of Grade 4, or Potentially Life Threatening.</description> </primary_outcome> <primary_outcome> <measure>Changes in vital signs including oral temperature or tympanic temperature (C°) [Time Frame: Day 1 through Day 196]</measure> <time_frame>196 days</time_frame> <description>To investigate the safety and tolerability of TAVO103A in healthy volunteers.</description> </primary_outcome> <primary_outcome> <measure>Changes in vital signs including respiratory rate (breaths per minute) [Time Frame: Day 1 through Day 196]</measure> <time_frame>196 days</time_frame> <description>To investigate the safety and tolerability of TAVO103A in healthy volunteers.</description> </primary_outcome> <primary_outcome> <measure>Changes in vital signs including systolic and diastolic blood pressure (mmHg) [Time Frame: Day 1 through Day 196]</measure> <time_frame>196 days</time_frame> <description>To investigate the safety and tolerability of TAVO103A in healthy volunteers.</description> </primary_outcome> <primary_outcome> <measure>Changes in vital signs including pulse rate (beats per minute) [Time Frame: Day 1 through Day 196]</measure> <time_frame>196 days</time_frame> <description>To investigate the safety and tolerability of TAVO103A in healthy volunteers.</description> </primary_outcome> <secondary_outcome> <measure>Immunogenicity of TAVO103A [Time Frame: Day 1 through Day 196]</measure> <time_frame>196 days</time_frame> <description>Incidence of anti-drug antibodies (ADA) following dosing of TAVO103A</description> </secondary_outcome> <secondary_outcome> <measure>Cmax (Maximum observed serum concentration ) [Time Frame: Day 1 through Day 196]</measure> <time_frame>196 days</time_frame> <description>To investigate the pharmacokinetics of TAVO103A in healthy volunteers.</description> </secondary_outcome> <secondary_outcome> <measure>tmax (time that Cmax was observed) [Time Frame: Day 1 through Day 196]</measure> <time_frame>196 days</time_frame> <description>To investigate the pharmacokinetics of TAVO103A in healthy volunteers.</description> </secondary_outcome> <secondary_outcome> <measure>AUC-last (Area under the serum concentration-time curve from time 0 to the time of the last quantifiable concentration; calculated using the linear/log trapezoid rule) [Time Frame: Day 1 through Day 196]</measure> <time_frame>196 days</time_frame> <description>To investigate the pharmacokinetics of TAVO103A in healthy volunteers.</description> </secondary_outcome> <secondary_outcome> <measure>AUC-inf (Area under the serum concentration-time curve from time 0 extrapolated to infinity) [Time Frame: Day 1 through Day 196]</measure> <time_frame>196 days</time_frame> <description>To investigate the pharmacokinetics of TAVO103A in healthy volunteers.</description> </secondary_outcome> <secondary_outcome> <measure>AUC0-t (Area under the serum concentration-time curve from time 0 to time t) [Time Frame: Day 1 through Day 196]</measure> <time_frame>196 days</time_frame> <description>To investigate the pharmacokinetics of TAVO103A in healthy volunteers.</description> </secondary_outcome> <secondary_outcome> <measure>t½ (Terminal elimination half-life) [Time Frame: Day 1 through Day 196]</measure> <time_frame>196 days</time_frame> <description>To investigate the pharmacokinetics of TAVO103A in healthy volunteers.</description> </secondary_outcome> <secondary_outcome> <measure>λz (Terminal elimination rate constant) [Time Frame: Day 1 through Day 196]</measure> <time_frame>196 days</time_frame> <description>To investigate the pharmacokinetics of TAVO103A in healthy volunteers.</description> </secondary_outcome> <secondary_outcome> <measure>CL (Systemic clearance) [Time Frame: Day 1 through Day 196]</measure> <time_frame>196 days</time_frame> <description>To investigate the pharmacokinetics of TAVO103A in healthy volunteers.</description> </secondary_outcome> <secondary_outcome> <measure>Vd (Volume of distribution) [Time Frame: Day 1 through Day 196]</measure> <time_frame>196 days</time_frame> <description>To investigate the pharmacokinetics of TAVO103A in healthy volunteers.</description> </secondary_outcome> <number_of_arms>4</number_of_arms> <enrollment type="Anticipated">30</enrollment> <condition>Healthy Subjects</condition> <arm_group> <arm_group_label>TAVO103A Low Dose</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>TAVO103A: TAVO103A single ascending dose IV infusion.</description> </arm_group> <arm_group> <arm_group_label>TAVO10A Medium Dose</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>TAVO103A: TAVO103A single ascending dose IV infusion.</description> </arm_group> <arm_group> <arm_group_label>TAVO103A High Dose</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>TAVO103A: TAVO103A single ascending dose IV infusion.</description> </arm_group> <arm_group> <arm_group_label>Placebo</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> <description>Placebo single ascending dose IV infusion.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>TAVO103A</intervention_name> <description>TAVO103A single ascending dose IV infusion.</description> <arm_group_label>TAVO103A High Dose</arm_group_label> <arm_group_label>TAVO103A Low Dose</arm_group_label> <arm_group_label>TAVO10A Medium Dose</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Placebo</intervention_name> <description>Placebo single ascending dose IV infusion.</description> <arm_group_label>Placebo</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Males and females ≥ 18 and ≤ 65 years of age, inclusive.  - Subjects must have a body weight range of ≥ 50 kg and ≤ 100 kg, inclusive, and a BMI ≥ 18.0 and ≤ 30.0 kg/m2, inclusive.  - Subjects must be healthy based on clinical laboratory tests performed at Screening and Day -1.  - Females of childbearing potential who are sexually active with a male partner must agree to use a highly effective method of contraception from screening through the end of the study.  - Males who are sexually active and nonsterile, and whose partners are females of childbearing potential must agree to use condoms from screening through the end of the study.  - Males must agree to not donate sperm from screening through the end of the study.  - Subjects must be able to communicate effectively with the study personnel.  - Subjects must be nonsmokers, defined as having abstained from tobacco- or nicotine-containing products in the 6 months prior to Screening.  - Subjects will be considered eligible according to the following tuberculosis screening criteria's.  - Subjects must sign an informed consent form.  Exclusion Criteria:  - Positive pregnancy test or is lactating at any time during the study.  - History or presence of conditions which, in the judgment of the investigator, are known to interfere with the absorption, distribution, metabolism, or excretion of drugs.  - History or presence of conditions that may place the subject at increased risk as determined by the investigator.  - Subject currently has or has had a history of any clinically significant medical illness or medical disorders the investigator considers should exclude the subject.  - Subject has a QT corrected according to Fridericia's formula (QTcF) interval > 450 msec (males) or > 470 msec (for females), has a complete left or right bundle branch block, or has a history or current evidence of additional risk factors for Torsades de Pointes.  - History of surgery or major trauma within 16 weeks of Screening, or will not have fully recovered from surgery, or has surgery planned during the time the subject is expected to participate in the study, or within 17 weeks after the last dose of study drug administration.  - Subject plans to undergo non-major elective surgery within 4 weeks prior to study drug administration through EOS.  - Subject has a known or suspected intolerance or hypersensitivity to any biologic medication or known allergies or clinically significant reactions to murine, chimeric, or human proteins, monoclonal antibodies or antibody fragments, or to any components of the formulation of TAVO103A and its excipients used in this study.  - History of alcohol abuse, illicit drug use, physical dependence to any opioid, or any history of drug abuse or addiction within 12 months of Screening.  - Use of prescription medications within 14 days or any drugs that induce or inhibit study drug-specific cytochrome 450(s) within 14 days or 5 half-lives (if known), whichever is longer, prior to administration of the study drug. By exception, prescription drugs, such as hormonal birth control or hormone replacement therapy, will be permitted.  - Use of OTC drugs (including herbal preparations) within 7 days or 5 half-lives (if known), whichever is longer, prior to administration of the study drug. Common OTC drugs are acceptable with investigator approval.  - Has received a vaccination within 30 days prior to administration of the study drug  - Has taken other investigational drugs or participated in any clinical study within 30 days or 5 half-lives (if known) of the investigational drug's PK, PD, or biological activity (if known), whichever is longer, prior to administration of the study drug in this study or is currently participating in another clinical study.  - Significant blood loss (> 450 mL) or has donated 1 or more units of blood or plasma within 6 weeks prior to study participation.  - Strenuous activity within 48 hours prior to CRU admission.  - Consumption of alcohol or caffeine-containing food or beverages within 3 days prior to CRU admission  - Positive urine drugs of abuse, alcohol breath test, or cotinine screen at any time during the study.  - Positive test for HIV-1 or HIV-2 antibodies.  - Positive test for hepatitis B virus or hepatitis C virus consistent with current infection. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>65 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <location> <facility> <name>ICON</name> <address> <city>Salt Lake City</city> <state>Utah</state> <zip>84124</zip> <country>United States</country> </address> </facility> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>April 2023</verification_date> <study_first_submitted>March 28, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>April 11, 2023</last_update_submitted> <last_update_submitted_qc>April 11, 2023</last_update_submitted_qc> <last_update_posted type="Actual">April 12, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

This is a Phase 1, single ascending dose study designed to investigate TAVO103A, administered as an IV infusion up to 60 minutes in length to healthy adult subjects. This study is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TAVO103A. This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose (SAD), single site study. There will be up to 5 SAD cohorts with 6 subjects enrolled into each. Subjects will be randomized at a ratio of 2:1 to receive TAVO103A or placebo. Subjects will be evaluated for safety throughout the study up through day 196. Inclusion Criteria: - Males and females ≥ 18 and ≤ 65 years of age, inclusive. - Subjects must have a body weight range of ≥ 50 kg and ≤ 100 kg, inclusive, and a BMI ≥ 18.0 and ≤ 30.0 kg/m2, inclusive. - Subjects must be healthy based on clinical laboratory tests performed at Screening and Day -1. - Females of childbearing potential who are sexually active with a male partner must agree to use a highly effective method of contraception from screening through the end of the study. - Males who are sexually active and nonsterile, and whose partners are females of childbearing potential must agree to use condoms from screening through the end of the study. - Males must agree to not donate sperm from screening through the end of the study. - Subjects must be able to communicate effectively with the study personnel. - Subjects must be nonsmokers, defined as having abstained from tobacco- or nicotine-containing products in the 6 months prior to Screening. - Subjects will be considered eligible according to the following tuberculosis screening criteria's. - Subjects must sign an informed consent form. Exclusion Criteria: - Positive pregnancy test or is lactating at any time during the study. - History or presence of conditions which, in the judgment of the investigator, are known to interfere with the absorption, distribution, metabolism, or excretion of drugs. - History or presence of conditions that may place the subject at increased risk as determined by the investigator. - Subject currently has or has had a history of any clinically significant medical illness or medical disorders the investigator considers should exclude the subject. - Subject has a QT corrected according to Fridericia's formula (QTcF) interval > 450 msec (males) or > 470 msec (for females), has a complete left or right bundle branch block, or has a history or current evidence of additional risk factors for Torsades de Pointes. - History of surgery or major trauma within 16 weeks of Screening, or will not have fully recovered from surgery, or has surgery planned during the time the subject is expected to participate in the study, or within 17 weeks after the last dose of study drug administration. - Subject plans to undergo non-major elective surgery within 4 weeks prior to study drug administration through EOS. - Subject has a known or suspected intolerance or hypersensitivity to any biologic medication or known allergies or clinically significant reactions to murine, chimeric, or human proteins, monoclonal antibodies or antibody fragments, or to any components of the formulation of TAVO103A and its excipients used in this study. - History of alcohol abuse, illicit drug use, physical dependence to any opioid, or any history of drug abuse or addiction within 12 months of Screening. - Use of prescription medications within 14 days or any drugs that induce or inhibit study drug-specific cytochrome 450(s) within 14 days or 5 half-lives (if known), whichever is longer, prior to administration of the study drug. By exception, prescription drugs, such as hormonal birth control or hormone replacement therapy, will be permitted. - Use of OTC drugs (including herbal preparations) within 7 days or 5 half-lives (if known), whichever is longer, prior to administration of the study drug. Common OTC drugs are acceptable with investigator approval. - Has received a vaccination within 30 days prior to administration of the study drug - Has taken other investigational drugs or participated in any clinical study within 30 days or 5 half-lives (if known) of the investigational drug's PK, PD, or biological activity (if known), whichever is longer, prior to administration of the study drug in this study or is currently participating in another clinical study. - Significant blood loss (> 450 mL) or has donated 1 or more units of blood or plasma within 6 weeks prior to study participation. - Strenuous activity within 48 hours prior to CRU admission. - Consumption of alcohol or caffeine-containing food or beverages within 3 days prior to CRU admission - Positive urine drugs of abuse, alcohol breath test, or cotinine screen at any time during the study. - Positive test for HIV-1 or HIV-2 antibodies. - Positive test for hepatitis B virus or hepatitis C virus consistent with current infection.

NCT0531xxxx/NCT05313165.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313165</url> </required_header> <id_info> <org_study_id>LF-CA-PR-53</org_study_id> <nct_id>NCT05313165</nct_id> </id_info> <brief_title>PROMISE III: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia</brief_title> <official_title>Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia: The PROMISE III Trial</official_title> <sponsors> <lead_sponsor> <agency>LimFlow, Inc.</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>LimFlow, Inc.</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>Yes</is_fda_regulated_device> <is_unapproved_device>Yes</is_unapproved_device> </oversight_info> <brief_summary> <textblock> A prospective, single-arm, multi-center study designed to gather additional information on the LimFlow System. </textblock> </brief_summary> <detailed_description> <textblock> The objective of this study is to provide additional information on the LimFlow System for creating an AV connection in the Below The Knee (BTK) vascular system using an endovascular, minimally invasive approach to arterialize the pedal veins for the treatment of chronic limb-threatening ischemia in subjects ineligible for conventional endovascular or surgical limb salvage procedures. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">December 22, 2022</start_date> <completion_date type="Anticipated">May 1, 2027</completion_date> <primary_completion_date type="Anticipated">May 1, 2027</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>N/A</allocation> <intervention_model>Single Group Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Amputation Free Survival</measure> <time_frame>6 Months</time_frame> <description>Freedom from major (above-ankle) amputation and death (all-cause mortality)</description> </primary_outcome> <secondary_outcome> <measure>Primary Patency</measure> <time_frame>30 Days</time_frame> <description>Absence of occlusion of the endovascular intervention that is maintained without the need for additional or secondary surgical or endovascular procedures</description> </secondary_outcome> <secondary_outcome> <measure>Primary Patency</measure> <time_frame>6 Months</time_frame> <description>Absence of occlusion of the endovascular intervention that is maintained without the need for additional or secondary surgical or endovascular procedures</description> </secondary_outcome> <secondary_outcome> <measure>Primary Assisted Patency</measure> <time_frame>30 Days</time_frame> <description>Absence of occlusion of the endovascular intervention maintained with the use of additional or secondary surgical or endovascular procedures, as long as occlusion of the primary treated site has not occurred</description> </secondary_outcome> <secondary_outcome> <measure>Primary Assisted Patency</measure> <time_frame>6 Months</time_frame> <description>Absence of occlusion of the endovascular intervention maintained with the use of additional or secondary surgical or endovascular procedures, as long as occlusion of the primary treated site has not occurred</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Patency</measure> <time_frame>30 Days</time_frame> <description>Absence of occlusion of the endovascular intervention that is maintained with the use of additional or secondary surgical or endovascular procedures after occlusion occurs</description> </secondary_outcome> <secondary_outcome> <measure>Secondary Patency</measure> <time_frame>6 Months</time_frame> <description>Absence of occlusion of the endovascular intervention that is maintained with the use of additional or secondary surgical or endovascular procedures after occlusion occurs</description> </secondary_outcome> <secondary_outcome> <measure>Limb Salvage</measure> <time_frame>30 Days</time_frame> <description>Percentage of subjects with freedom from above-ankle amputation of the index limb</description> </secondary_outcome> <secondary_outcome> <measure>Limb Salvage</measure> <time_frame>3 Months</time_frame> <description>Percentage of subjects with freedom from above-ankle amputation of the index limb</description> </secondary_outcome> <secondary_outcome> <measure>Limb Salvage</measure> <time_frame>6 Months</time_frame> <description>Percentage of subjects with freedom from above-ankle amputation of the index limb</description> </secondary_outcome> <secondary_outcome> <measure>Change in Rutherford Classification</measure> <time_frame>30 Days</time_frame> <description>A change of one class or greater</description> </secondary_outcome> <secondary_outcome> <measure>Change in Rutherford Classification</measure> <time_frame>3 Months</time_frame> <description>A change of one class or greater</description> </secondary_outcome> <secondary_outcome> <measure>Change in Rutherford Classification</measure> <time_frame>6 Months</time_frame> <description>A change of one class or greater</description> </secondary_outcome> <secondary_outcome> <measure>Technical Success</measure> <time_frame>Intraprocedurally</time_frame> <description>The successful creation of an arteriovenous fistula in the desired limb location with immediate morphological success</description> </secondary_outcome> <secondary_outcome> <measure>Procedural Success</measure> <time_frame>30 Days</time_frame> <description>The combination of technical success, and absence of all-cause death, above-ankle amputation or clinically driven major re-intervention of the stent graft</description> </secondary_outcome> <secondary_outcome> <measure>Target Wound Healing</measure> <time_frame>30 Days</time_frame> <description>Complete healing of the patient's target wound</description> </secondary_outcome> <secondary_outcome> <measure>Target Wound Healing</measure> <time_frame>3 Months</time_frame> <description>Complete healing of the patient's target wound</description> </secondary_outcome> <secondary_outcome> <measure>Target Wound Healing</measure> <time_frame>6 Months</time_frame> <description>Complete healing of the patient's target wound</description> </secondary_outcome> <secondary_outcome> <measure>Target Wound Healing</measure> <time_frame>12 Months</time_frame> <description>Complete healing of the patient's target wound</description> </secondary_outcome> <secondary_outcome> <measure>All Wound Healing</measure> <time_frame>30 Days</time_frame> <description>Complete healing of the patient's wounds</description> </secondary_outcome> <secondary_outcome> <measure>All Wound Healing</measure> <time_frame>3 Months</time_frame> <description>Complete healing of the patient's wounds</description> </secondary_outcome> <secondary_outcome> <measure>All Wound Healing</measure> <time_frame>6 Months</time_frame> <description>Complete healing of the patient's wounds</description> </secondary_outcome> <secondary_outcome> <measure>All Wound Healing</measure> <time_frame>12 Months</time_frame> <description>Complete healing of the patient's wounds</description> </secondary_outcome> <secondary_outcome> <measure>All Wound Area Reduction</measure> <time_frame>30 Days</time_frame> <description>Reduction in area of the patient's wounds</description> </secondary_outcome> <secondary_outcome> <measure>All Wound Area Reduction</measure> <time_frame>3 Months</time_frame> <description>Reduction in area of the patient's wounds</description> </secondary_outcome> <secondary_outcome> <measure>All Wound Area Reduction</measure> <time_frame>6 Months</time_frame> <description>Reduction in area of the patient's wounds</description> </secondary_outcome> <secondary_outcome> <measure>All Wound Area Reduction</measure> <time_frame>12 Months</time_frame> <description>Reduction in area of the patient's wounds</description> </secondary_outcome> <secondary_outcome> <measure>Freedom from Contrast-Induced Nephropathy</measure> <time_frame>72 hours</time_frame> <description>Subjects without acute (within 72 hours after intravenous contrast administration) impairment of renal function, measured as an absolute ≥0.5 mg/dL (44 μmol/L) increase compared to baseline SCr value that results in a value above the upper limit of the normal range.</description> </secondary_outcome> <secondary_outcome> <measure>Procedure Time</measure> <time_frame>Intraprocedurally</time_frame> <description>The time of the first puncture (venous or arterial) to when the last catheter is removed</description> </secondary_outcome> <secondary_outcome> <measure>Radiation Exposure</measure> <time_frame>Intraprocedurally</time_frame> <description>Patient radiation exposure (in milligray) during the procedure</description> </secondary_outcome> <secondary_outcome> <measure>Contrast Volume</measure> <time_frame>Intraprocedurally</time_frame> <description>The total volume of contrast media (in milliliters) given during the procedure</description> </secondary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Anticipated">100</enrollment> <condition>Critical Limb Ischemia</condition> <condition>Chronic Limb-Threatening Ischemia Nos of Native Arteries of Extremities</condition> <condition>Peripheral Arterial Disease</condition> <arm_group> <arm_group_label>Treated with LimFlow</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Treatment with the LimFlow Stent Graft System</description> </arm_group> <intervention> <intervention_type>Device</intervention_type> <intervention_name>LimFlow Stent Graft System</intervention_name> <description>Creation of an arteriovenous fistula in the desired limb location</description> <arm_group_label>Treated with LimFlow</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. Subject must be ≥ 18 and ≤ 95 years of age  2. Clinical diagnosis of chronic limb-threatening ischemia, defined as any of the following clinical assessments: previous angiogram or hemodynamic evidence of severely diminished arterial inflow of the index limb (e.g., ABI ≤ 0.39, TP / TcPO2 < 30 mm Hg) and  1. Rutherford Classification 5, ischemic ulceration or  2. Rutherford Classification 6, ischemic gangrene  3. Subject has been assessed by the Principal Investigator and determined that no conventional distal bypass, surgical or endovascular therapy for limb salvage is feasible due to either a) absence of a usable pedal artery target (endovascular or surgical approach), or b) the presence of a pedal artery target with absence of a viable single-segment vein in either lower extremity or either arm that could be used for autogenous vein conduit.  4. Proximally, the Target In-flow Artery at the cross-over point must fall within the recommended vessel diameter ranges for the LimFlow stent graft by visual estimation.  5. Subject is willing and able to sign the informed consent form.  6. Subject is enrolled in an acceptable wound care network and has an adequate support network to ensure that subject is compliant with medication regimen and follow-up study visits.  7. Prior to enrollment (7-day window), women of childbearing potential must have a negative pregnancy test.  8. Primary wound is stable (e.g., not rapidly deteriorating and/or showing signs of healing).  9. Stable glycemic control, HbA1C < 10% (<269mg/dL)  10. Subjects requiring dialysis may be included, provided they meet all the following requirements:  - On dialysis for > 6 months  - Autologous arteriovenous (AV) fistula or peritoneal access used for hemodialysis  - Serum albumin > 30 g/liter  - BMI > 20  Exclusion Criteria:  1. Concomitant hepatic insufficiency, thrombophlebitis in the target limb, or non-treatable coagulation disorder within the past 90 days.  2. Active immunodeficiency disorder or currently receiving immunosuppressant therapy for an immunodeficiency disorder.  3. Prior peripheral arterial bypass procedure above or below the knee which would inhibit proximal inflow to the stent graft.  4. Absence of adequate viable tissue in target foot.  5. Life expectancy less than 12 months.  6. Documented myocardial infarction or stroke within previous 90 days.  7. Active infection (e.g., fever, significantly elevated WBC count >20.0 x 109/L, and/or positive blood culture) at the time of the index procedure that may preclude insertion of a prosthesis or require major amputation (e.g., osteomyelitis proximal to metatarsals).  8. Known or suspected allergies or contraindications to aspirin or P2Y12 inhibitors, heparin, stainless steel, nitinol or contrast agent that cannot be adequately pre-treated.  9. Subject is currently taking anti-coagulants, which in the opinion of the investigator, interferes with the subject's ability to participate in the study (i.e., intermittent interruption of therapy for procedure may compromise subject's safety).  10. Lower extremity vascular disease that may inhibit the procedure and/or jeopardize wound healing (e.g., vasculitis, Buerger's disease, significant edema in the target limb, deep venous thrombus in the target vein, hyperpigmentation, or medial ulceration above the ankle).  11. Significant acute or chronic kidney disease with a serum creatinine of > 2.5 mg/dl in subjects not undergoing dialysis.  12. Severe heart failure (e.g., NYHA Class IV), which in the opinion of the investigator may compromise subject's ability to safely undergo a percutaneous procedure.  13. Any significant concurrent medical, psychological, or social condition, which may significantly interfere with the subject's optimal participation in the study, in the opinion of the investigator.  14. The subject is currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.  15. Subject is unwilling, unable, or unlikely for cognitive or social reasons to comply with any of the protocol or follow-up requirements. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>95 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Daniel Clair, MD</last_name> <role>Principal Investigator</role> <affiliation>Vanderbilt University</affiliation> </overall_official> <overall_official> <last_name>Mehdi Shishehbor</last_name> <role>Principal Investigator</role> <affiliation>University Hospital Cleveland</affiliation> </overall_official> <overall_contact> <last_name>Erin Towery</last_name> <phone>888-478-7705</phone> <email>etowery@limflow.com</email> </overall_contact> <location> <facility> <name>Yale University</name> <address> <city>New Haven</city> <state>Connecticut</state> <zip>06519</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Caelan Watts</last_name> <email>caelan.watts@yale.edu</email> </contact> <investigator> <last_name>Cassius Chaar, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>The Cardiac and Vascular Institute</name> <address> <city>Gainesville</city> <state>Florida</state> <zip>32605</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Marti Roberson</last_name> <phone>352-359-1561</phone> <email>mroberson@tcavi.com</email> </contact> <investigator> <last_name>Arthur Lee, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>University of Florida</name> <address> <city>Gainesville</city> <state>Florida</state> <zip>32608</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Nancy Hanson</last_name> <email>nancy.hanson@surgery.ufl.edu</email> </contact> <investigator> <last_name>Ben Jacobs, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>Massachusetts General Hospital</name> <address> <city>Boston</city> <state>Massachusetts</state> <zip>02114</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Erin McSweeney</last_name> <phone>617-726-2264</phone> <email>emcsweeney@mgh.harvard.edu</email> </contact> <investigator> <last_name>Anahita Dua, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>Boston Medical Center</name> <address> <city>Boston</city> <state>Massachusetts</state> <zip>02118</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Nolan Joyce</last_name> <phone>617-638-8624</phone> <email>Nolan.Joyce@bmc.org</email> </contact> <investigator> <last_name>Alik Farber</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>Dartmouth-Hitchcock Medical Center</name> <address> <city>Lebanon</city> <state>New Hampshire</state> <zip>03766</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Michelle Keyes</last_name> <phone>603-650-7966</phone> <email>Michelle.R.Keyes@hitchcock.org</email> </contact> <investigator> <last_name>Joceyln Beach, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>Presbyterian Healthcare</name> <address> <city>Albuquerque</city> <state>New Mexico</state> <zip>87113</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Kristin Flores</last_name> <phone>505-563-2716</phone> <email>kflores15@phs.org</email> </contact> <investigator> <last_name>Steve Henao</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>Atrium Health</name> <address> <city>Charlotte</city> <state>North Carolina</state> <zip>28204</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Madelyn Smyth</last_name> <email>Madelyn.Smyth@atriumhealth.org</email> </contact> <investigator> <last_name>Gregory Stanley</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>University Hospitals Cleveland Medical Center</name> <address> <city>Cleveland</city> <state>Ohio</state> <zip>44106</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Amy McKnight</last_name> <phone>216-983-4896</phone> <email>amy.mcknight@uhhospitals.org</email> </contact> <investigator> <last_name>Mehdi Shishehbor, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>Vanderbilt University Medical Center</name> <address> <city>Nashville</city> <state>Tennessee</state> <zip>37212</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Celia Nunez</last_name> <phone>615-322-4559</phone> <email>Celia.m.nunez@vumc.org</email> </contact> <investigator> <last_name>Daniel Clair</last_name> <role>Principal Investigator</role> </investigator> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>July 2023</verification_date> <study_first_submitted>March 12, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>July 24, 2023</last_update_submitted> <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc> <last_update_posted type="Actual">July 27, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>CLTI</keyword> <keyword>PAD</keyword> <keyword>CLI</keyword> <condition_browse>  <mesh_term>Peripheral Arterial Disease</mesh_term> <mesh_term>Peripheral Vascular Diseases</mesh_term> <mesh_term>Chronic Limb-Threatening Ischemia</mesh_term> <mesh_term>Ischemia</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> <ipd_description>No plan to share</ipd_description> </patient_data>  </clinical_study>

A prospective, single-arm, multi-center study designed to gather additional information on the LimFlow System. The objective of this study is to provide additional information on the LimFlow System for creating an AV connection in the Below The Knee (BTK) vascular system using an endovascular, minimally invasive approach to arterialize the pedal veins for the treatment of chronic limb-threatening ischemia in subjects ineligible for conventional endovascular or surgical limb salvage procedures. Inclusion Criteria: 1. Subject must be ≥ 18 and ≤ 95 years of age 2. Clinical diagnosis of chronic limb-threatening ischemia, defined as any of the following clinical assessments: previous angiogram or hemodynamic evidence of severely diminished arterial inflow of the index limb (e.g., ABI ≤ 0.39, TP / TcPO2 < 30 mm Hg) and 1. Rutherford Classification 5, ischemic ulceration or 2. Rutherford Classification 6, ischemic gangrene 3. Subject has been assessed by the Principal Investigator and determined that no conventional distal bypass, surgical or endovascular therapy for limb salvage is feasible due to either a) absence of a usable pedal artery target (endovascular or surgical approach), or b) the presence of a pedal artery target with absence of a viable single-segment vein in either lower extremity or either arm that could be used for autogenous vein conduit. 4. Proximally, the Target In-flow Artery at the cross-over point must fall within the recommended vessel diameter ranges for the LimFlow stent graft by visual estimation. 5. Subject is willing and able to sign the informed consent form. 6. Subject is enrolled in an acceptable wound care network and has an adequate support network to ensure that subject is compliant with medication regimen and follow-up study visits. 7. Prior to enrollment (7-day window), women of childbearing potential must have a negative pregnancy test. 8. Primary wound is stable (e.g., not rapidly deteriorating and/or showing signs of healing). 9. Stable glycemic control, HbA1C < 10% (<269mg/dL) 10. Subjects requiring dialysis may be included, provided they meet all the following requirements: - On dialysis for > 6 months - Autologous arteriovenous (AV) fistula or peritoneal access used for hemodialysis - Serum albumin > 30 g/liter - BMI > 20 Exclusion Criteria: 1. Concomitant hepatic insufficiency, thrombophlebitis in the target limb, or non-treatable coagulation disorder within the past 90 days. 2. Active immunodeficiency disorder or currently receiving immunosuppressant therapy for an immunodeficiency disorder. 3. Prior peripheral arterial bypass procedure above or below the knee which would inhibit proximal inflow to the stent graft. 4. Absence of adequate viable tissue in target foot. 5. Life expectancy less than 12 months. 6. Documented myocardial infarction or stroke within previous 90 days. 7. Active infection (e.g., fever, significantly elevated WBC count >20.0 x 109/L, and/or positive blood culture) at the time of the index procedure that may preclude insertion of a prosthesis or require major amputation (e.g., osteomyelitis proximal to metatarsals). 8. Known or suspected allergies or contraindications to aspirin or P2Y12 inhibitors, heparin, stainless steel, nitinol or contrast agent that cannot be adequately pre-treated. 9. Subject is currently taking anti-coagulants, which in the opinion of the investigator, interferes with the subject's ability to participate in the study (i.e., intermittent interruption of therapy for procedure may compromise subject's safety). 10. Lower extremity vascular disease that may inhibit the procedure and/or jeopardize wound healing (e.g., vasculitis, Buerger's disease, significant edema in the target limb, deep venous thrombus in the target vein, hyperpigmentation, or medial ulceration above the ankle). 11. Significant acute or chronic kidney disease with a serum creatinine of > 2.5 mg/dl in subjects not undergoing dialysis. 12. Severe heart failure (e.g., NYHA Class IV), which in the opinion of the investigator may compromise subject's ability to safely undergo a percutaneous procedure. 13. Any significant concurrent medical, psychological, or social condition, which may significantly interfere with the subject's optimal participation in the study, in the opinion of the investigator. 14. The subject is currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study. 15. Subject is unwilling, unable, or unlikely for cognitive or social reasons to comply with any of the protocol or follow-up requirements.

NCT0531xxxx/NCT05313178.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313178</url> </required_header> <id_info> <org_study_id>IRB-21-57</org_study_id> <nct_id>NCT05313178</nct_id> </id_info> <brief_title>Changes in Plasma Amino Acid Appearance After Adding Bacillus Coagulans GBI-30, 6086 to Milk Protein Concentrate</brief_title> <acronym>ABC</acronym> <official_title>Acute Changes in Plasma Amino Acid Appearance After Adding Bacillus Coagulans GBI-30, 6086 to Milk Protein Concentrate in Older Women</official_title> <sponsors> <lead_sponsor> <agency>Lindenwood University</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Increnovo, LLC</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Lindenwood University</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The purpose of this study is to examine the pattern of plasma amino acid appearance after a two-week daily regimen of milk protein concentrate supplementation with and without the addition of Bacillus coagulans GBI-30, 6086 among older women. </textblock> </brief_summary> <detailed_description> <textblock> Once determined eligible and providing consent, participants will be assigned in a randomized, double-blind, crossover fashion to ingest a single daily 25-gram dose of a milk protein concentrate or a similar dose of milk protein concentrate plus bacillus coagulans GBI-30, 6086. Upon arrival for each study visit, participants will have their resting heart rate, blood pressure, body mass, height, and body composition measured. Upon ingestion of their final assigned supplementation dose, standard multiple sample phlebotomy approaches will be used to collect approximately 10mL of venous blood from a forearm vein at specific time intervals up to four hours after ingestion of their final assigned supplementation dose for that period in the study protocol. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">November 20, 2020</start_date> <completion_date type="Actual">February 1, 2022</completion_date> <primary_completion_date type="Actual">February 1, 2022</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Crossover Assignment</intervention_model> <intervention_model_description>Randomized, double-blind, crossover study design</intervention_model_description> <primary_purpose>Other</primary_purpose> <masking>Double (Participant, Investigator)</masking> <masking_description>Supplements blinded to participant and investigator by third party</masking_description> </study_design_info> <primary_outcome> <measure>Plasma Concentrations of Amino Acids in Blood</measure> <time_frame>4 hours</time_frame> <description>Plasma Concentrations of Amino Acids in Blood</description> </primary_outcome> <secondary_outcome> <measure>Adverse Events</measure> <time_frame>4 hours</time_frame> <description>Incidence and associations of reported adverse events</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">30</enrollment> <condition>Protein Malabsorption</condition> <arm_group> <arm_group_label>Milk Protein</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> <description>25-gram dose of milk protein concentrate</description> </arm_group> <arm_group> <arm_group_label>Milk Protein and Probiotic</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>25-gram dose of milk protein concentrate with bacillus coagulans GBI-30, 6086</description> </arm_group> <intervention> <intervention_type>Dietary Supplement</intervention_type> <intervention_name>Bacillus Coagulans GBI-30, 6086</intervention_name> <description>In a randomized, double-blind, crossover fashion, study participants will supplement on a daily basis for two weeks during one study period with a 25-gram dose of either milk protein concentrate or a 25-gram dose of milk protein concentrate with bacillus coagulans GBI-30, 6086. Each dose will be ingested at the same time of day with 8 - 12 fluid ounces of cold tap water. All participants will be required to complete a supplementation log to document when each dose of their assigned protein is consumed. Upon completion of their first assigned study protocol period, participants will observe a three-week washout period by returning to their normal dietary intake and physical activity habits before beginning supplementation for the remaining study period.</description> <arm_group_label>Milk Protein</arm_group_label> <arm_group_label>Milk Protein and Probiotic</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - All participants will be between the ages of 50-70 years  - Completing at least 30 minutes of physical activity at minimum three days per week  Exclusion Criteria:  - As indicated on a medical history form they complete, any individual who is currently being treated for or diagnosed with a cardiac, respiratory, circulatory, musculoskeletal, metabolic, obesity (defined as body mass index > 30 kg/m2), immune, autoimmune, psychiatric, hematological, neurological or endocrinological disorder or disease  - Any woman who is taking a medication known to impact digestive function or hormonal functions that may impact how our body digests, absorbs, or metabolizes nutrients  - Any woman currently taking a probiotic or a dietary supplement that may impact digestive function or hormonal functions that may impact how our body digests, absorbs, or metabolizes nutrients  - Participants who are determined to not be weight stable defined as measured body mass deviating by 2% or more.  - Participants who do not or are not willing to abstain from alcohol, nicotine, and caffeine for overnight (8-10 hours)  - Participants who do not or are not willing to abstain from exercise for 24 hours prior to each visit  - Women who are pregnant  - Women who are lactose intolerant </textblock> </criteria> <gender>Female</gender> <minimum_age>50 Years</minimum_age> <maximum_age>70 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <location> <facility> <name>Lindenwood University</name> <address> <city>Saint Charles</city> <state>Missouri</state> <zip>63301</zip> <country>United States</country> </address> </facility> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>March 29, 2022</last_update_submitted> <last_update_submitted_qc>March 29, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Malabsorption Syndromes</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

The purpose of this study is to examine the pattern of plasma amino acid appearance after a two-week daily regimen of milk protein concentrate supplementation with and without the addition of Bacillus coagulans GBI-30, 6086 among older women. Once determined eligible and providing consent, participants will be assigned in a randomized, double-blind, crossover fashion to ingest a single daily 25-gram dose of a milk protein concentrate or a similar dose of milk protein concentrate plus bacillus coagulans GBI-30, 6086. Upon arrival for each study visit, participants will have their resting heart rate, blood pressure, body mass, height, and body composition measured. Upon ingestion of their final assigned supplementation dose, standard multiple sample phlebotomy approaches will be used to collect approximately 10mL of venous blood from a forearm vein at specific time intervals up to four hours after ingestion of their final assigned supplementation dose for that period in the study protocol. Inclusion Criteria: - All participants will be between the ages of 50-70 years - Completing at least 30 minutes of physical activity at minimum three days per week Exclusion Criteria: - As indicated on a medical history form they complete, any individual who is currently being treated for or diagnosed with a cardiac, respiratory, circulatory, musculoskeletal, metabolic, obesity (defined as body mass index > 30 kg/m2), immune, autoimmune, psychiatric, hematological, neurological or endocrinological disorder or disease - Any woman who is taking a medication known to impact digestive function or hormonal functions that may impact how our body digests, absorbs, or metabolizes nutrients - Any woman currently taking a probiotic or a dietary supplement that may impact digestive function or hormonal functions that may impact how our body digests, absorbs, or metabolizes nutrients - Participants who are determined to not be weight stable defined as measured body mass deviating by 2% or more. - Participants who do not or are not willing to abstain from alcohol, nicotine, and caffeine for overnight (8-10 hours) - Participants who do not or are not willing to abstain from exercise for 24 hours prior to each visit - Women who are pregnant - Women who are lactose intolerant

NCT0531xxxx/NCT05313191.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313191</url> </required_header> <id_info> <org_study_id>NYPC ERC# 2019-002</org_study_id> <nct_id>NCT05313191</nct_id> </id_info> <brief_title>Prospective Evaluation of Pencil Beam Scanning Proton Therapy for Previously Irradiated Tumors</brief_title> <acronym>ReRT</acronym> <official_title>Prospective Evaluation of Pencil Beam Scanning Proton Therapy for Previously Irradiated Tumors</official_title> <sponsors> <lead_sponsor> <agency>The New York Proton Center</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>The New York Proton Center</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>Yes</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The goal of this clinical research trial is to study the use of differing investigational doses and scheduling for Proton Therapy for tumors previously treated with radiation therapy. Generally, when patients are first treated for cancer with radiation therapy, they are treated with traditional photon (or x-ray) radiation therapy, which uses high-energy waves to kill tumor cells. In some cases, the cancer either returns or a new tumor can present in a different part of the body. With the usual radiation treatment, the photon beams travel all the way through the body. As a result, healthy tissues in front of and behind the tumor are exposed to radiation. Physicians who treat these cases where the tumor has returned often use a much lower dose of radiation to prevent patients from experiencing serious and long-term side-effects. This dose is often not strong enough to destroy the cancerous tumor. Alternatively, they may also treat a smaller area than would be indicated for complete tumor eradication, again in an attempt to prevent serious and long-term toxicities, but at the cost of optimally treating the cancer. Proton therapy, however, may offer a chance to safely deliver a more effective dose and volume of radiation as it is more targeted and can spare healthy tissues surrounding the tumor.  The reason we are conducting this research study is to look at whether Proton therapy can be a better way to treat reoccurring tumors in patients who have previously received radiation therapy to the same area, compared to treatment approaches used to date. </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">January 24, 2022</start_date> <completion_date type="Anticipated">January 2027</completion_date> <primary_completion_date type="Anticipated">January 2027</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Non-Randomized</allocation> <intervention_model>Single Group Assignment</intervention_model> <intervention_model_description>Phase: Registry, Phase I, Phase II Study Design/Methodology: Cohort-defined, single arm prospective study</intervention_model_description> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>To determine the cumulative rate of CTCAE v5.0 Grade ≥3 acute and late treatment related adverse events within 1 year of definitive reirradiation completion using proton therapy for recurrent or second primary tumor.</measure> <time_frame>5 years</time_frame> </primary_outcome> <secondary_outcome> <measure>To determine the 1 year freedom from local failure.</measure> <time_frame>1 year</time_frame> </secondary_outcome> <secondary_outcome> <measure>To determine the 1 year freedom from progression free survival.</measure> <time_frame>1 year</time_frame> </secondary_outcome> <secondary_outcome> <measure>To determine the 1 year freedom from overall survival.</measure> <time_frame>1 year</time_frame> </secondary_outcome> <secondary_outcome> <measure>To determine the acute cumulative rate of CTCAE v5.0 Grade ≥3 treatment related adverse events at 90 days of reirradiation completion.</measure> <time_frame>90 days</time_frame> </secondary_outcome> <secondary_outcome> <measure>To determine the late cumulative rate of CTCAE v5.0 Grade ≥3 treatment related adverse events at 2 years of reirradiation completion.</measure> <time_frame>2 years</time_frame> </secondary_outcome> <secondary_outcome> <measure>To characterize patient reported outcomes within 1 year of reirradiation using the MDASI BT forms for intracranial tumors.</measure> <time_frame>1 years</time_frame> </secondary_outcome> <secondary_outcome> <measure>To characterize patient reported outcomes within 1 year of reirradiation using the CTB COMP forms for intracranial tumors.</measure> <time_frame>1 years</time_frame> </secondary_outcome> <secondary_outcome> <measure>To characterize patient reported outcomes within 1 year of reirradiation using the MDASI SP form for spinal tumors.</measure> <time_frame>1 year</time_frame> </secondary_outcome> <number_of_arms>8</number_of_arms> <enrollment type="Anticipated">1800</enrollment> <condition>CNS Cancer</condition> <condition>Head and Neck Cancer</condition> <condition>GI Cancer</condition> <condition>Gynecologic Cancer</condition> <condition>Prostate Cancer</condition> <condition>Thoracic Cancer</condition> <condition>Breast Cancer</condition> <arm_group> <arm_group_label>Cohort 1: Central Nervous System</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Group 1 Definitive Reirradiation Phase II Patients w/history of intracranial or spinal (extradural, intradural, and/or intramedullary) CNS tumors for which radiation therapy was prev. delivered either to gross disease or in the postoperative setting Min. 6 month interval b/w RT courses Overlap of prior RT field (50% IDL) Subgroup analysis: receipt of surgery for recurrence/second IC tumor; concurrent ST; tumor histology Group 2 CNS Reirradiation Registry Patients for whom a repeat course of RT to the CNS is indicated for recurrent disease or secondary primary Postop or intact setting Min. 6 month interval b/w RT courses Overlap of prior RT field (50% IDL) Histologically/clinically documented recurrent CNS tumor (benign or malignant) Glioblastoma (histologic or molecular including IDH wildtype) Astrocytoma (molecular IDH1 mutant) Oligodendroglioma (molecular 1p19q co deleted) Meningioma Ependymoma Chordoma/chondrosarcoma</description> </arm_group> <arm_group> <arm_group_label>Cohort 2: Head/Neck</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Group 1 Full Dose Reirradiation Phase II Patients w/history of HNC for which RT was delivered definitively, now with recurrence to h/n amenable to full dose reRT Gross unresected disease or PORT 2/2 RF Received at least 40 Gy overlapping w/new target region Min. 6 month interval b/w RT courses Overlap of prior RT field (50% IDL) Subgroup analysis: surgery, HPV status, concurrent ST Group 2 Early (<6months for prior RT) Palliative H/N ReRT Phase I Patients w/history of HNC for which RT was delivered definitively/adjuvant setting, now with biopsy proven recurrence to h/n with indication for palliative RT At least 30 Gy prior RT overlapping with new treatment volume <6 month interval between RT courses Group 3 Head/Neck ReRT Registry Patients w/history of HNC for which RT was delivered now with recurrence/secondary primary requiring reRT Postop or definitive Prior RT dose at least 30 Gy overlapping w/new treatment volume Min.6 month interval b/w RT courses</description> </arm_group> <arm_group> <arm_group_label>Cohort 3: Breast</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Group 1 Partial Breast Reirradiation (Phase II) Patients with a history of breast cancer s/p BCT, now with small (≤3cm), unicentric, ipsilateral breast cancer recurrence receiving repeat BCT Node negative Negative margins No LVI Lumpectomy cavity:whole breast <30% Minimum 1 year interval between RT courses Group 2: Regional LN and Breast/CW ReRT (Phase II) Patients with a history of breast cancer s/p RT , now with recurrence or new primary with indication for reirradiation to the breast/chest wall and regional LN Minimum 1 year interval between RT courses Negative metastatic workup (PET/CT or CT C/A/P + bone scan) Excludes concurrent chemotherapy Group 3: Breast Reirradiation Registry Patients with a history of breast cancer s/p RT , now with recurrence or new primary breast cancer with indication for reirradiation Some overlaps of dose with prior RT course Negative metastatic workup (PET/CT or CT C/A/P + bone scan) Excludes concurrent chemotherapy</description> </arm_group> <arm_group> <arm_group_label>Cohort 4: Thoracic</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Group 1: Definitive Reirradiation for Locally Advanced Disease Single arm, prospective, phase II study Patients with a history of lung cancer s/p definitive RT , now with local recurrence of new primary centrally located and w/I 50% IDL of prior RT field Definitive reRT concurrent systemic therapy Adequate pulmonary function defined as an FEV1 of >35% (with or without bronchodilator) within 90 days prior to registration Minimum 6 month interval between RT courses Negative metastatic workup Group 2: Thoracic Registry Study Registry design Patients with histologically confirmed thoracic malignancy (NSCLC, SCLC , mesothelioma, thymoma, carcinoid, intrathoracic sarcoma) with prior thoracic RT Minimum 3 month interval between RT courses Negative metastatic workup</description> </arm_group> <arm_group> <arm_group_label>Cohort 5: Gastrointestinal</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Group 1 Esophagus & GEJ Reirradiation Phase II Patients w/history of E/GEJ cancer s/p RT, now w/recurrent/new primary nonmetastatic E/GEJ cancer for which salvage RT is recommended Negative metastatic workup Group 2 Liver Reirradiation Phase II Patients w/history of HCC, cholangiocarcinoma or liver mets (any histology), s/p prior EBRT, now with in field recurrence/new primary/met, for which definitive reRT is recommended CTP A or B7 Excl. prev. Y 90/radioembolization Allow prior TACE Overlap w/50% IDL prior RT Adequate bone marrow function Group 3 Lower GI Reirradiation Phase II Patients w/history of rectal/anal cancer s/p RT now w/recurrent/new primary nonmetastatic rectal/anal cancer for whom salvage RT is recommended +/ chemotherapy Negative metastatic workup (PET/CT or CT C/A/P) Group 4 GI Reirradiation Registry •Patients w/histologically document recurrent or new GI malignancy with prior history of RT w/overlap of current RT volume by the 50% IDL</description> </arm_group> <arm_group> <arm_group_label>Cohort 6: Genitourinary</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Group 1 Locally recurrent prostate cancer w/in prev. radiation field Phase II Patients w/recurrent prostate adenocarcinoma w/in prev. irradiated field w/indication for repeat course of radiation Min. 1 year interval b/w RT courses Prostate gland or recurrent tumor <100 cc or 6 cm in largest dimension No persistent grade 2+ toxicity from prior radiation Negative metastatic workup (bone scan, CT scan or PSMA/axumin scan Group 2 Regional prostate cancer recurrence adjacent to the previous field Phase II Patients w/recurrent prostate adenocarcinoma beyond prior RT field (outside 50% IDL) but w/in pelvis) Min.1 year interval b/w RT courses (EBRT or brachy) No persistent grade 2+ toxicity from prior radiation Group 3 Prostate Reirradiation Registry Patients w/recurrent prostate adenocarcinoma (prostate gland, postop bed, or pelvi c LN) who require RT to the prostate or pelvis in the setting of prior pelvis RT No DM Concurrent chemotherapy excl.</description> </arm_group> <arm_group> <arm_group_label>Cohort 7: Gynecological</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Group 1: Locally recurrent gynecological cancer within previous field Single arm, prospective, phase II study design Patients with history of gyn cancer for which definitive or adjuvant/salvage PORT was given, now with recurrence within 50% IDL recommended for radiotherapy At least 1 year between RT courses No persistent grade 3+ toxicity from prior RT Concurrent chemotherapy excluded Uncontrolled or widely metastatic disease Life expectancy >6 months</description> </arm_group> <arm_group> <arm_group_label>Cohort 8: Registry</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>Registry design Any cancer patient for whom RT is indicated in the setting of prior RT and do not meet eligibility criteria for other cohorts Overlap of 50% IDL of current treatment volume with prior RT field</description> </arm_group> <intervention> <intervention_type>Radiation</intervention_type> <intervention_name>Pencil Beam Scanning Proton Therapy</intervention_name> <description>Use of Pencil Beam Scanning Proton Therapy compared with historical outcomes using photon therapy for the reirradiation of recurrent or new primary malignancies</description> <arm_group_label>Cohort 1: Central Nervous System</arm_group_label> <arm_group_label>Cohort 2: Head/Neck</arm_group_label> <arm_group_label>Cohort 3: Breast</arm_group_label> <arm_group_label>Cohort 4: Thoracic</arm_group_label> <arm_group_label>Cohort 5: Gastrointestinal</arm_group_label> <arm_group_label>Cohort 6: Genitourinary</arm_group_label> <arm_group_label>Cohort 7: Gynecological</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Age 18 years  - Patient provides study specific informed consent prior to study entry.  - Documented history and physical exam within 90 days prior to registration.  - ECOG PS 0, 1, or 2 within 90 days prior to registration  Exclusion Criteria:  - Non malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow up.  - Prior invasive non study malignancy unless disease free for ≥ 3 years  - Non melanoma skin cancer, low risk prostate cancer, well differentiated thyroid cancers, in situ carcinomas of the oral cavity, cervix, and other organs, and tumors that are not thought to impact the life expectancy of the patient are permissible.  - History of active connective tissue disorder (i.e., systemic lupus erythematosus, scleroderma), dermatomyositis, xeroderma pigmentosum </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_contact> <last_name>Isabelle Choi, MD</last_name> <phone>646-968-9060</phone> <email>research@nyproton.com</email> </overall_contact> <location> <facility> <name>The New York Proton Center</name> <address> <city>New York</city> <state>New York</state> <zip>10035</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Isabelle Choi, MD</last_name> <phone>646-968-9060</phone> <email>research@nyproton.com</email> </contact> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>March 21, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>March 29, 2022</last_update_submitted> <last_update_submitted_qc>March 29, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Reirradiation</keyword> <keyword>Cancer</keyword> <keyword>Proton Therapy</keyword> <keyword>Radiation Therapy</keyword> <condition_browse>  <mesh_term>Head and Neck Neoplasms</mesh_term> <mesh_term>Central Nervous System Neoplasms</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

The goal of this clinical research trial is to study the use of differing investigational doses and scheduling for Proton Therapy for tumors previously treated with radiation therapy. Generally, when patients are first treated for cancer with radiation therapy, they are treated with traditional photon (or x-ray) radiation therapy, which uses high-energy waves to kill tumor cells. In some cases, the cancer either returns or a new tumor can present in a different part of the body. With the usual radiation treatment, the photon beams travel all the way through the body. As a result, healthy tissues in front of and behind the tumor are exposed to radiation. Physicians who treat these cases where the tumor has returned often use a much lower dose of radiation to prevent patients from experiencing serious and long-term side-effects. This dose is often not strong enough to destroy the cancerous tumor. Alternatively, they may also treat a smaller area than would be indicated for complete tumor eradication, again in an attempt to prevent serious and long-term toxicities, but at the cost of optimally treating the cancer. Proton therapy, however, may offer a chance to safely deliver a more effective dose and volume of radiation as it is more targeted and can spare healthy tissues surrounding the tumor. The reason we are conducting this research study is to look at whether Proton therapy can be a better way to treat reoccurring tumors in patients who have previously received radiation therapy to the same area, compared to treatment approaches used to date. Inclusion Criteria: - Age 18 years - Patient provides study specific informed consent prior to study entry. - Documented history and physical exam within 90 days prior to registration. - ECOG PS 0, 1, or 2 within 90 days prior to registration Exclusion Criteria: - Non malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow up. - Prior invasive non study malignancy unless disease free for ≥ 3 years - Non melanoma skin cancer, low risk prostate cancer, well differentiated thyroid cancers, in situ carcinomas of the oral cavity, cervix, and other organs, and tumors that are not thought to impact the life expectancy of the patient are permissible. - History of active connective tissue disorder (i.e., systemic lupus erythematosus, scleroderma), dermatomyositis, xeroderma pigmentosum

NCT0531xxxx/NCT05313204.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313204</url> </required_header> <id_info> <org_study_id>Pro00095678</org_study_id> <nct_id>NCT05313204</nct_id> </id_info> <brief_title>Exercise and Pregnancy in People With Multiple Sclerosis</brief_title> <official_title>Physiological Responses to Exercise During Pregnancy in People With Multiple Sclerosis</official_title> <sponsors> <lead_sponsor> <agency>University of Alberta</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>University of Alberta</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The purpose of this study is to examine acute physiological responses to exercise and activity patterns of people with multiple sclerosis (MS) during pregnancy and postpartum. </textblock> </brief_summary> <detailed_description> <textblock> Multiple sclerosis (MS) is an inflammatory autoimmune condition of the central nervous system, which causes demyelination of axons, and largely affects females aged 20-40 years. However, knowledge gaps surrounding MS in pregnancy and postpartum remain. Particularly, no research has examined the effects of exercise or physical activity patterns, in people with MS throughout pregnancy and postpartum. Current guidelines for exercise in pregnancy note that people with impairments may safely meet activity recommendations; however, medical consultation is recommended. This study aims to provide information regarding the physiological responses to exercise, as well as the physical activity patterns of pregnant and postpartum people with MS.  Numerous studies have found pregnant individuals with MS experience reduced rates of relapse (periods of symptom exacerbation) during pregnancy, most significantly in the third trimester. Additionally, increased rates of relapse in the three months following delivery among people with MS has been commonly observed. These unique periods combined with maternal adaptations during and following pregnancy may impact responses to exercise during and following pregnant in people with MS. To our knowledge, no research has investigated the physiological responses to exercise nor physical activity patterns in individuals with MS during or following pregnancy. These data will be used to develop prospective interventions aimed at determining the causal links between adaptations to pregnancy and postpartum and exercise tolerance in people with MS. They will also be a critical first step towards the eventual development of evidence-based guidelines for pregnant and postpartum people with MS.  Pregnant and postpartum individuals will be sent the equipment and questionnaires needed to participate in this virtual study. Participants will complete a 20-minute moderate-intensity exercise bout (60-70% heart rate reserve) using their own cardiovascular exercise equipment or walking outside. During exercise, participants will wear a heart rate monitor to measure heart rate prior to, during and following exercise, as well as complete a fatigue assessment prior-to, immediately, and 30- and 60-minutes following exercise. Additionally, participants will wear a continuous glucose monitor (Freestyle Libre Pro) throughout the exercise and for seven days following exercise. Participants will also wear two non-invasive activity monitoring devices that measure their activity and sedentary time for seven full days. Lastly, participants with MS will track their MS symptoms for seven full days. These data will have implications in understanding the acute cardiovascular response to moderate-intensity exercise among pregnant and postpartum people with MS. This is an important first step in understanding the benefits of pre- and postnatal physical activity among people with MS. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">September 1, 2020</start_date> <completion_date type="Anticipated">August 1, 2023</completion_date> <primary_completion_date type="Anticipated">August 1, 2023</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Cohort</observational_model> <time_perspective>Cross-Sectional</time_perspective> </study_design_info> <primary_outcome> <measure>Heart rate</measure> <time_frame>40 minutes</time_frame> <description>Resting heart rate will be measured immediately prior-to exercise. Change in heart rate will be measured during and following exercise.</description> </primary_outcome> <primary_outcome> <measure>Fatigue</measure> <time_frame>10 minutes</time_frame> <description>Fatigue will be assessed immediately before, immediately following, 30- and 60-minutes following exercise using the Visual Analog Scale to Assess Fatigue Severity.</description> </primary_outcome> <primary_outcome> <measure>Physical activity and sedentary behaviour</measure> <time_frame>7 days</time_frame> <description>Participants will wear an accelerometer and activPAL (Actigraph wGT3X-BT Monitor, Actigraph LLC; activPAL, PAL Technologies Ltd.) for seven consecutive days and nights to record 24-hour physical activity and sleep/wake measurements.</description> </primary_outcome> <secondary_outcome> <measure>Glucose</measure> <time_frame>40 minutes</time_frame> <description>Glucose response to exercise.</description> </secondary_outcome> <number_of_groups>4</number_of_groups> <enrollment type="Anticipated">60</enrollment> <condition>Multiple Sclerosis</condition> <condition>Pregnancy</condition> <arm_group> <arm_group_label>Pregnant with Multiple Sclerosis</arm_group_label> <description>Pregnant individuals (> 13 weeks) with a Multiple Sclerosis diagnosis.</description> </arm_group> <arm_group> <arm_group_label>Pregnant without Multiple Sclerosis</arm_group_label> <description>Pregnant individuals (> 13 weeks) without Multiple Sclerosis.</description> </arm_group> <arm_group> <arm_group_label>Postpartum with Multiple Sclerosis</arm_group_label> <description>Postpartum individuals (< 1 year since delivery) with a Multiple Sclerosis diagnosis.</description> </arm_group> <arm_group> <arm_group_label>Postpartum without Multiple Sclerosis</arm_group_label> <description>Postpartum individuals (< 1 year since delivery) without Multiple Sclerosis.</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Moderate-intensity cardiovascular exercise</intervention_name> <description>The participant will be instructed to first rest quietly for 10 minutes wearing a heart rate monitor. The participant will then be instructed to exercise at an intensity of 60-70% heart rate reserve (HRR) for 20 minutes. The participant may choose any kind of cardiovascular exercise modality they prefer, as long as the exercise will meet the prescribed intensity. Following exercise, participants will rest quietly for 10 minutes wearing the heart rate monitor.</description> <arm_group_label>Postpartum with Multiple Sclerosis</arm_group_label> <arm_group_label>Postpartum without Multiple Sclerosis</arm_group_label> <arm_group_label>Pregnant with Multiple Sclerosis</arm_group_label> <arm_group_label>Pregnant without Multiple Sclerosis</arm_group_label> </intervention> <eligibility> <study_pop> <textblock> Pregnant (> 13 weeks) and postpartum (< 1 year since delivery) individuals with Multiple Sclerosis. </textblock> </study_pop> <sampling_method>Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Multiple Sclerosis diagnosis  - Pregnant with a single baby (> 13 weeks) or Postpartum (< 1 year since delivery)  - Free of cardiovascular disease  Exclusion Criteria:  - Pregnant individuals who have absolute contraindications to exercise as outlined by the Canadian Guidelines for Exercise in Pregnancy PARMed-X questionnaire OR relative contraindications that prevent them from exercise as confirmed by their medical professional.  - High-order pregnancies, e.g. twins or above. </textblock> </criteria> <gender>Female</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Margie Davenport, PhD</last_name> <role>Principal Investigator</role> <affiliation>University of Alberta</affiliation> </overall_official> <overall_contact> <last_name>Miranda L Kimber, MSc</last_name> <phone>780-492-0642</phone> <email>mkimber@ualberta.ca</email> </overall_contact> <overall_contact_backup> <last_name>Margie Davenport, PhD</last_name> <phone>780-492-0642</phone> <email>mdavenpo@ualberta.ca</email> </overall_contact_backup> <location> <facility> <name>University of Alberta</name> <address> <city>Edmonton</city> <state>Alberta</state> <zip>T6G</zip> <country>Canada</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Margie Davenport, PhD</last_name> <phone>780-492-0642</phone> <email>mdavenpo@ualberta.ca</email> </contact> </location> <location_countries> <country>Canada</country> </location_countries> <verification_date>September 2022</verification_date> <study_first_submitted>March 28, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>September 12, 2022</last_update_submitted> <last_update_submitted_qc>September 12, 2022</last_update_submitted_qc> <last_update_posted type="Actual">September 13, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Multiple Sclerosis</mesh_term> <mesh_term>Sclerosis</mesh_term> </condition_browse>  </clinical_study>

The purpose of this study is to examine acute physiological responses to exercise and activity patterns of people with multiple sclerosis (MS) during pregnancy and postpartum. Multiple sclerosis (MS) is an inflammatory autoimmune condition of the central nervous system, which causes demyelination of axons, and largely affects females aged 20-40 years. However, knowledge gaps surrounding MS in pregnancy and postpartum remain. Particularly, no research has examined the effects of exercise or physical activity patterns, in people with MS throughout pregnancy and postpartum. Current guidelines for exercise in pregnancy note that people with impairments may safely meet activity recommendations; however, medical consultation is recommended. This study aims to provide information regarding the physiological responses to exercise, as well as the physical activity patterns of pregnant and postpartum people with MS. Numerous studies have found pregnant individuals with MS experience reduced rates of relapse (periods of symptom exacerbation) during pregnancy, most significantly in the third trimester. Additionally, increased rates of relapse in the three months following delivery among people with MS has been commonly observed. These unique periods combined with maternal adaptations during and following pregnancy may impact responses to exercise during and following pregnant in people with MS. To our knowledge, no research has investigated the physiological responses to exercise nor physical activity patterns in individuals with MS during or following pregnancy. These data will be used to develop prospective interventions aimed at determining the causal links between adaptations to pregnancy and postpartum and exercise tolerance in people with MS. They will also be a critical first step towards the eventual development of evidence-based guidelines for pregnant and postpartum people with MS. Pregnant and postpartum individuals will be sent the equipment and questionnaires needed to participate in this virtual study. Participants will complete a 20-minute moderate-intensity exercise bout (60-70% heart rate reserve) using their own cardiovascular exercise equipment or walking outside. During exercise, participants will wear a heart rate monitor to measure heart rate prior to, during and following exercise, as well as complete a fatigue assessment prior-to, immediately, and 30- and 60-minutes following exercise. Additionally, participants will wear a continuous glucose monitor (Freestyle Libre Pro) throughout the exercise and for seven days following exercise. Participants will also wear two non-invasive activity monitoring devices that measure their activity and sedentary time for seven full days. Lastly, participants with MS will track their MS symptoms for seven full days. These data will have implications in understanding the acute cardiovascular response to moderate-intensity exercise among pregnant and postpartum people with MS. This is an important first step in understanding the benefits of pre- and postnatal physical activity among people with MS. Pregnant (> 13 weeks) and postpartum (< 1 year since delivery) individuals with Multiple Sclerosis. Inclusion Criteria: - Multiple Sclerosis diagnosis - Pregnant with a single baby (> 13 weeks) or Postpartum (< 1 year since delivery) - Free of cardiovascular disease Exclusion Criteria: - Pregnant individuals who have absolute contraindications to exercise as outlined by the Canadian Guidelines for Exercise in Pregnancy PARMed-X questionnaire OR relative contraindications that prevent them from exercise as confirmed by their medical professional. - High-order pregnancies, e.g. twins or above.

NCT0531xxxx/NCT05313217.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313217</url> </required_header> <id_info> <org_study_id>PRO20220124</org_study_id> <nct_id>NCT05313217</nct_id> </id_info> <brief_title>Spine Position and Neural Sensitivity</brief_title> <official_title>The Influence of Spine Position on Measures of Lower Extremity Neural Sensitivity</official_title> <sponsors> <lead_sponsor> <agency>University of Hartford</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>University of Hartford</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The purpose of this research study is to see if there is a relationship between the tightness of the hamstring muscles (muscles on the back of the thighs), reported sensations related to stretch of the nerves of the lower extremity, and different positions of participants' backs. We will investigate the qualitative differences as provided verbally by participants (sensation felt at maximum knee extension angle) and quantitative differences as provided by surface electromyographic (EMG) measurements of hamstring activity and inclinometer measures of the knee angle. </textblock> </brief_summary> <detailed_description> <textblock> The Slump Test, introduced by Maitland in 1978, has been a clinical staple for determining adverse neural tension or altered neurodynamics and neurosensitivity related to intradiscal derangement or stenotic narrowing of the lumbar spine. The slump test is a highly reliable, common clinical tool used to assess neural tissue mechanosensitivity in patients with both spinal and lower limb pain. However, it is unclear if the slump test can be used to differentiate between those with true adverse neural tension compared to those with neurosensitivity due to compression of the neuroforaminal interface. The positioning of the slump test places maximal tension on the neural tissues both caudally and cranially, either reducing knee extension angle (KEA) in the affected side as opposed to the unaffected side, provoking radicular symptoms, or both. Hall's research found that there was mechanical activity in the hamstring muscles that came on with neural tension testing. This finding can be used to objectively assess when a participant is at their peak tolerable limit of neural tension in specific trunk positions during the slump test. Observation and clinical experience suggest there may be a subset of individuals who have increased neural tension in the slump test during spinal extension (shortening of the nerves) as opposed to flexion (stretch of the nerves). To date, there has been little research that has objectively demonstrated how trunk position affects neural tension during the slump test. Our research aims to determine if there is a difference in patient reported symptoms and hamstring activity between trunk flexion and extension during the slump test with healthy, younger individuals with no recent history of low back pain (LBP) or related symptoms. We expect to find a difference in range of motion (ROM), symptoms, and hamstring activity when the slump test is done in spinal flexion as opposed to spinal extension. This research will help to establish the prevalence of greater sensitivity in the extended vs flexed posture and establish a normative set of symptoms as described by healthy individuals. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">March 28, 2022</start_date> <completion_date type="Actual">July 31, 2022</completion_date> <primary_completion_date type="Actual">July 31, 2022</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>N/A</allocation> <intervention_model>Single Group Assignment</intervention_model> <intervention_model_description>Quasi-experimental single group laboratory study</intervention_model_description> <primary_purpose>Basic Science</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Knee Extension Angle</measure> <time_frame>single testing session at enrollment</time_frame> <description>A measurement of the degree of knee extension achieved during the KEA, Slump, and extended slump tests</description> </primary_outcome> <secondary_outcome> <measure>EMG activity, biceps femoris</measure> <time_frame>single session at enrollment</time_frame> <description>surface EMG activity of the biceps femoris during KEA, SLR, slump, and extended slump referenced to hamstring maximal voluntary isometric contraction</description> </secondary_outcome> <secondary_outcome> <measure>qualitative data- extent, nature, and intensity of pain</measure> <time_frame>single testing session at enrollment</time_frame> <description>for each test, the most distal extent of symptoms and intensity on the 11 point numeric pain rating scale will be collected. Participants will be asked to describe the nature of the symptoms experienced during the test (e.g. stretch, pain, pull, tingle, etc)</description> </secondary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Actual">40</enrollment> <condition>Sciatic Nerve</condition> <condition>Postural Lordosis</condition> <condition>Nerve Pain</condition> <arm_group> <arm_group_label>neural tension testing</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>All participants in this arm will undergo four tests: KEA, SLR, Slump, and Extended Slump</description> </arm_group> <intervention> <intervention_type>Diagnostic Test</intervention_type> <intervention_name>Knee extension angle</intervention_name> <description>Knee Extension Angle (KEA): This test will be administered with an ankle-foot orthosis (AFO) maintaining the participants ankle in neutral. The participant will lie supine on the examination table with the contralateral lower extremity (LE) stabilized on the support surface using a mobilization strap. The hip of the lower being examined will be flexed to 90 degrees. The participant will then actively straighten their lower leg while maintaining upper leg in same position Once the participant feels they are at maximal knee extension (patient instructed to straighten leg as far as what is comfortable), the angle will be measured with iPhone Inclinometer. Participant asked to report any symptoms they are feeling and where (recorded for qualitative analysis)</description> <arm_group_label>neural tension testing</arm_group_label> <other_name>KEA</other_name> </intervention> <intervention> <intervention_type>Diagnostic Test</intervention_type> <intervention_name>Straight Leg Raise</intervention_name> <description>Straight Leg Raise (SLR): Position the participant in supine on the plinth with knees extended and L LE strapped to the plinth The participant will keep the AFO donned on the R distal ankle to keep the ankle in neutral position. A researcher will passively lift the participant's right leg moving at a slow but consistent pace of approximately 15 degrees per second, while keeping it straight until a significant resistance is detected or the participant reports a production of symptoms, whichever occurs first. Measurement of the SLR angle will be assessed with iPhone inclinometer. Participant asked to report any symptoms they are feeling and where (recorded for qualitative analysis)</description> <arm_group_label>neural tension testing</arm_group_label> <other_name>SLR</other_name> </intervention> <intervention> <intervention_type>Diagnostic Test</intervention_type> <intervention_name>Slump Test</intervention_name> <description>Slump Test Procedure: Participant will be instructed to sit upright with their legs over the edge of table AFO remains on R leg Participant will sequentially flex trunk, look down at the floor Participant will extend R knee until symptoms are felt. Measure of angle with iPhone inclinometer placed at superior aspect of medial malleolus Participant asked to report any symptoms they are feeling and where (recorded for qualitative analysis)</description> <arm_group_label>neural tension testing</arm_group_label> </intervention> <intervention> <intervention_type>Diagnostic Test</intervention_type> <intervention_name>Extended slump test</intervention_name> <description>Extended Slump Procedure: Participant will be instructed to sit upright with their legs over the edge of table AFO remains on R leg Participant is asked to arch their lower back into maximal extension in sitting, stabilized to research bench to maintain hyper-lordosis posture. The participant is asked first flex cervical spine, then to extend their knee until it reaches full ROM or symptoms are felt that limit ROM. Knee extension ROM is assessed with iPhone inclinometer at superior aspect of medial malleolus. Participant asked to report any symptoms they are feeling and where (recorded for qualitative analysis)</description> <arm_group_label>neural tension testing</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - healthy individuals between the ages of 18 and 65 without low back pain.  Exclusion Criteria:  - Known previous diagnoses of sciatica or disc herniation  - Diagnosis of scoliosis  - History of pain in the low back or back of the leg  - History of back surgeries  - Any recent hamstring injuries  - Any recent fractures  - History of osteoporosis  - Have feeling of pins and needles down the leg  - Have a known nervous system disorder  - Have a known systemic inflammatory condition  - Have Rheumatoid Arthritis  - Known history of cardiovascular issues  - Have a known connective tissue disorder  - Bowel/bladder issues  - Are or may be pregnant  - Type 1 or type 2 diabetes mellitus  - Active/history of cancer  - Allergy to adhesives  - Are actively involved in a lawsuit regarding personal bodily injury or receiving workman's compensation  - Currently taking/have recently taken antibiotics known as fluoroquinolones (ie. Cipro, Levaquin, Noroxin) </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>65 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Brian Swanson, PT, DSc</last_name> <role>Principal Investigator</role> <affiliation>University of Hartford</affiliation> </overall_official> <location> <facility> <name>University of Hartford</name> <address> <city>West Hartford</city> <state>Connecticut</state> <zip>06117</zip> <country>United States</country> </address> </facility> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>May 2023</verification_date> <study_first_submitted>March 28, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>May 9, 2023</last_update_submitted> <last_update_submitted_qc>May 9, 2023</last_update_submitted_qc> <last_update_posted type="Actual">May 10, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Lordosis</mesh_term> <mesh_term>Neuralgia</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Yes</sharing_ipd> <ipd_description>Data will be shared upon request following completion of this study</ipd_description> <ipd_info_type>Study Protocol</ipd_info_type> <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type> <ipd_time_frame>Following study completion and manuscript submission</ipd_time_frame> <ipd_access_criteria>upon request</ipd_access_criteria> </patient_data>  </clinical_study>

The purpose of this research study is to see if there is a relationship between the tightness of the hamstring muscles (muscles on the back of the thighs), reported sensations related to stretch of the nerves of the lower extremity, and different positions of participants' backs. We will investigate the qualitative differences as provided verbally by participants (sensation felt at maximum knee extension angle) and quantitative differences as provided by surface electromyographic (EMG) measurements of hamstring activity and inclinometer measures of the knee angle. The Slump Test, introduced by Maitland in 1978, has been a clinical staple for determining adverse neural tension or altered neurodynamics and neurosensitivity related to intradiscal derangement or stenotic narrowing of the lumbar spine. The slump test is a highly reliable, common clinical tool used to assess neural tissue mechanosensitivity in patients with both spinal and lower limb pain. However, it is unclear if the slump test can be used to differentiate between those with true adverse neural tension compared to those with neurosensitivity due to compression of the neuroforaminal interface. The positioning of the slump test places maximal tension on the neural tissues both caudally and cranially, either reducing knee extension angle (KEA) in the affected side as opposed to the unaffected side, provoking radicular symptoms, or both. Hall's research found that there was mechanical activity in the hamstring muscles that came on with neural tension testing. This finding can be used to objectively assess when a participant is at their peak tolerable limit of neural tension in specific trunk positions during the slump test. Observation and clinical experience suggest there may be a subset of individuals who have increased neural tension in the slump test during spinal extension (shortening of the nerves) as opposed to flexion (stretch of the nerves). To date, there has been little research that has objectively demonstrated how trunk position affects neural tension during the slump test. Our research aims to determine if there is a difference in patient reported symptoms and hamstring activity between trunk flexion and extension during the slump test with healthy, younger individuals with no recent history of low back pain (LBP) or related symptoms. We expect to find a difference in range of motion (ROM), symptoms, and hamstring activity when the slump test is done in spinal flexion as opposed to spinal extension. This research will help to establish the prevalence of greater sensitivity in the extended vs flexed posture and establish a normative set of symptoms as described by healthy individuals. Inclusion Criteria: - healthy individuals between the ages of 18 and 65 without low back pain. Exclusion Criteria: - Known previous diagnoses of sciatica or disc herniation - Diagnosis of scoliosis - History of pain in the low back or back of the leg - History of back surgeries - Any recent hamstring injuries - Any recent fractures - History of osteoporosis - Have feeling of pins and needles down the leg - Have a known nervous system disorder - Have a known systemic inflammatory condition - Have Rheumatoid Arthritis - Known history of cardiovascular issues - Have a known connective tissue disorder - Bowel/bladder issues - Are or may be pregnant - Type 1 or type 2 diabetes mellitus - Active/history of cancer - Allergy to adhesives - Are actively involved in a lawsuit regarding personal bodily injury or receiving workman's compensation - Currently taking/have recently taken antibiotics known as fluoroquinolones (ie. Cipro, Levaquin, Noroxin)

NCT0531xxxx/NCT05313230.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313230</url> </required_header> <id_info> <org_study_id>RECHMPL21_0739</org_study_id> <nct_id>NCT05313230</nct_id> </id_info> <brief_title>Safety and Efficacy of Intermittent Renal Replacement Therapy Using CITRASATE in Critically-ill Patients</brief_title> <acronym>CITRA-SAFE</acronym> <official_title>Safety and Efficacy of Intermittent Renal Replacement Therapy Using CITRASATE in Critically-ill Patients: A Retrospective Series</official_title> <sponsors> <lead_sponsor> <agency>University Hospital, Montpellier</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>University Hospital, Montpellier</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Renal Replacement Therapy (RRT) needs an extracorporeal circulation to conduct blood to the dialysis membrane and driving back to the patient. This extracorporeal circulation induces inevitably a risk of coagulation activation and premature clotting of the circuit. Heparin is thereby commonly used to prevent such thrombosis but exposed patient to risk of hemorrhage. This risk of hemorrhage may be important in ICU population, particularly in severe trauma patients.  The calcium is an important determinant of coagulation cascade. The use of specific citrate enriched dialysate without calcium (CITRASATE®) allows to suddenly lower the calcium concentration in extracorporeal plasma, leading to a regional ineffectiveness of clotting and limited heparin needs. This low calcium plasmatic concentration into the extracorporeal circulation has however to be normalized to not generate a systemic hypocalcemia. In our ICU, a local calcium substitution protocol based on dialysate flow is used in clinical practice.  Commonly used in our unit, there is a lack data to evaluate the CITRASATE dialysate in a critical population.  The aim goal of our study will be to assess safety and efficacy of intermittent renal replacement therapy using CITRASATE® in critically-ill patients. </textblock> </brief_summary> <detailed_description> <textblock> This is a retrospective descriptive study. The included patients will be those who had a Sustained Low Efficiency Dialysis using CITRASATE® dialysate in CHU Lapeyronie in Montpellier, France between 01/01/2019 and 31/12/2021 Using PMSI code, we estimate that 61 patients could be enrolled in this period and each patient could be almost 6 dialysis session. We estimate we could analyzed 300 to 350 sessions. This sample must be confirmed by the opening of medical records.  A data collection will be focused on the RRT parameters, clinical complications until ICU discharge and outcome, extracted from medical records.  The main endpoint will be to determine the prevalence of ionized calcium troubles (hypocalcemia <0,8 mmol/L or Hypercalcemia >1,4 mmol/L) per and post dialysis using CITRASATE® with our restitution protocol, and their therapeutic consequences.  The secondary endpoints will be to describe the efficacy of CITRASATE® with our restitution protocol during RRT meant by an optimal dialysis dose and the absence of premature clotting of the circuit. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">February 1, 2022</start_date> <completion_date type="Anticipated">June 30, 2022</completion_date> <primary_completion_date type="Anticipated">June 1, 2022</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Other</observational_model> <time_perspective>Prospective</time_perspective> </study_design_info> <primary_outcome> <measure>change of blood ionized calcium level disorders</measure> <time_frame>baseline, per dialysis session</time_frame> <description>Retrospective assessment of the prevalence of ionized calcium troubles (hypocalcemia <0,8 mmol/L or Hypercalcemia >1,4 mmol/L) per and post-dialysis using CITRASATE® with our restitution protocol, and their therapeutic consequences.</description> </primary_outcome> <primary_outcome> <measure>change of blood ionized calcium level disorders</measure> <time_frame>Day 1 (post dialysis session)</time_frame> <description>Retrospective assessment of the prevalence of ionized calcium troubles (hypocalcemia <0,8 mmol/L or Hypercalcemia >1,4 mmol/L) per and post-dialysis using CITRASATE® with our restitution protocol, and their therapeutic consequences.</description> </primary_outcome> <secondary_outcome> <measure>Description of therapeutic consequences required</measure> <time_frame>day 1</time_frame> <description>therapeutic consequences required in order to treat the ionized calcium troubles</description> </secondary_outcome> <secondary_outcome> <measure>Description of Clotting event</measure> <time_frame>day 1</time_frame> <description>the efficacy of CITRASATE® with our restitution protocol during RRT absence</description> </secondary_outcome> <secondary_outcome> <measure>Description of Dialysis dose</measure> <time_frame>day 1</time_frame> <description>the efficacy of CITRASATE® with our restitution protocol during RRT (optimal dialysis dose)</description> </secondary_outcome> <number_of_groups>1</number_of_groups> <enrollment type="Anticipated">61</enrollment> <condition>Acute Kidney Injury</condition> <condition>Chronic Kidney Infection</condition> <arm_group> <arm_group_label>CITRASAFE</arm_group_label> <description>Patient underwent CITRASATE dialysis session</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>CITRASATE SLED</intervention_name> <description>Applying of CITRASATE SLED</description> <arm_group_label>CITRASAFE</arm_group_label> </intervention> <eligibility> <study_pop> <textblock> Patient underwent a RRT in the DAR Lapeyronie (CHU Montpellier) between the 01/01/2019 and the 31/12/2021 </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion criteria:  - Age ≥18 years  - Patient underwent a RRT in the DAR Lapeyronie (CHU Montpellier) between the 01/01/2019 and the 31/12/2021  Exclusion criteria:  - Patient underwent RRT without CITRASATE® protocol  - Lack of data  - Ethical limitation </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Jonathan CHARBIT, MD</last_name> <role>Principal Investigator</role> <affiliation>University Hospital, Montpellier</affiliation> </overall_official> <overall_contact> <last_name>Jonathan CHARBIT, MD</last_name> <phone>467338256</phone> <phone_ext>33</phone_ext> <email>j-charbit@chu-montpellier.fr</email> </overall_contact> <location> <facility> <name>Uhmontpellier</name> <address> <city>Montpellier</city> <state>Montepllier</state> <zip>34295</zip> <country>France</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Jonathan CHARBIT, MD</last_name> <phone>467338256</phone> <phone_ext>33</phone_ext> <email>j-charbit@chu-montpellier.fr</email> </contact> </location> <location_countries> <country>France</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>January 6, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>March 28, 2022</last_update_submitted> <last_update_submitted_qc>March 28, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Renal Replacement Therapy</keyword> <keyword>CITRASATE</keyword> <condition_browse>  <mesh_term>Acute Kidney Injury</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Undecided</sharing_ipd> <ipd_description>NC</ipd_description> </patient_data>  </clinical_study>

Renal Replacement Therapy (RRT) needs an extracorporeal circulation to conduct blood to the dialysis membrane and driving back to the patient. This extracorporeal circulation induces inevitably a risk of coagulation activation and premature clotting of the circuit. Heparin is thereby commonly used to prevent such thrombosis but exposed patient to risk of hemorrhage. This risk of hemorrhage may be important in ICU population, particularly in severe trauma patients. The calcium is an important determinant of coagulation cascade. The use of specific citrate enriched dialysate without calcium (CITRASATE®) allows to suddenly lower the calcium concentration in extracorporeal plasma, leading to a regional ineffectiveness of clotting and limited heparin needs. This low calcium plasmatic concentration into the extracorporeal circulation has however to be normalized to not generate a systemic hypocalcemia. In our ICU, a local calcium substitution protocol based on dialysate flow is used in clinical practice. Commonly used in our unit, there is a lack data to evaluate the CITRASATE dialysate in a critical population. The aim goal of our study will be to assess safety and efficacy of intermittent renal replacement therapy using CITRASATE® in critically-ill patients. This is a retrospective descriptive study. The included patients will be those who had a Sustained Low Efficiency Dialysis using CITRASATE® dialysate in CHU Lapeyronie in Montpellier, France between 01/01/2019 and 31/12/2021 Using PMSI code, we estimate that 61 patients could be enrolled in this period and each patient could be almost 6 dialysis session. We estimate we could analyzed 300 to 350 sessions. This sample must be confirmed by the opening of medical records. A data collection will be focused on the RRT parameters, clinical complications until ICU discharge and outcome, extracted from medical records. The main endpoint will be to determine the prevalence of ionized calcium troubles (hypocalcemia <0,8 mmol/L or Hypercalcemia >1,4 mmol/L) per and post dialysis using CITRASATE® with our restitution protocol, and their therapeutic consequences. The secondary endpoints will be to describe the efficacy of CITRASATE® with our restitution protocol during RRT meant by an optimal dialysis dose and the absence of premature clotting of the circuit. Patient underwent a RRT in the DAR Lapeyronie (CHU Montpellier) between the 01/01/2019 and the 31/12/2021 Inclusion criteria: - Age ≥18 years - Patient underwent a RRT in the DAR Lapeyronie (CHU Montpellier) between the 01/01/2019 and the 31/12/2021 Exclusion criteria: - Patient underwent RRT without CITRASATE® protocol - Lack of data - Ethical limitation

NCT0531xxxx/NCT05313243.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313243</url> </required_header> <id_info> <org_study_id>2000029793</org_study_id> <nct_id>NCT05313243</nct_id> </id_info> <brief_title>Pembrolizumab and Brentuximab Vedotin in Subjects With Relapsed/Refractory T-cell Lymphoma</brief_title> <official_title>Phase 2 Study of Pembrolizumab and Brentuximab Vedotin in Subjects With Relapsed/Refractory CD30 Positive T-cell Lymphoma</official_title> <sponsors> <lead_sponsor> <agency>Tarsheen Sethi</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Yale University</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>Yes</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> This is a single arm, open label, multicenter study phase 2 study of pembrolizumab and brentuximab in subjects with relapsed/refractory CD30 positive T-cell lymphoma (including peripheral T-cell lymphoma and cutaneous T-cell lymphoma) who have received at least one prior therapy. We hypothesize that this combination is effective and will produce an overall response rate of ~65%. Pembrolizumab and brentuximab will be administered for 16 cycles in patients with responsive disease. Pembrolizumab will be continued for an additional 19 cycles (total 35 cycles). Response assessments will occur at pre-specified intervals. Dose adjustments for specific toxicities with either drugs are detailed in the protocol. Based on statistical analysis 43 subjects will need to be accrued to evaluate for disease response based on historical control. </textblock> </brief_summary> <detailed_description> <textblock> CD30- Positive Peripheral T cell (PTCL) and Cutaneous T cell Lymphomas (CTCL):  T-cell Non-Hodgkin Lymphoma (NHL) includes a clinically heterogeneous group of mature T-cell lymphomas accounting for 10-12% of all NHL. Peripheral T- cell Lymphoma (PTCL) present with clinically aggressive disease with a poor outcome [with the exception of ALK+ Anaplastic Large Cell Lymphomas (ALCL)] and patients experience a high incidence of relapsed/ refractory disease that poses a therapeutic challenge.  Despite progress in the past decade in understanding the biology of T-cell lymphomas, with the use of next generation sequencing and molecular profiling of archived tissue samples, there is yet an unmet need in therapeutic options. Amidst the wide range of T-cell lymphoma histologies, PTCL NOS is the most common histological subtype followed by ALCL, angioimmunoblastic lymphoma (AITL) and cutaneous T-cell lymphoma (CTCL). The other histological subtypes (Enteropathy associated T-cell Lymphoma, hepatosplenic T cell lymphoma, NK/T cell lymphoma etc.) account for <5% of T-cell subtypes. Unfortunately, the rare subtypes of T-cell Lymphoma are usually excluded from later phase trials due to their dismal prognosis.  Therapeutic Challenge in Relapsed/ Refractory PTCL and CTCL:  For patients with disease relapse following upfront chemotherapy, stem cell transplantation (SCT) is an option. However, this type of aggressive approach is only feasible in a minority of patients. Despite the advances in the therapeutic arsenal, most of these agents have a modest response rate of 20-30%. More than half of these patients who do respond initially, will ultimately relapse. Conventional chemotherapy in combination with novel agents has been under clinical evaluation with minor improvements in response rates compared with historical controls. Therefore, the urge to optimize therapy by incorporating newer treatments such as novel agents that have a more targeted approach continues to be critically important.  CTCL presents as a chronic disease with a poor prognosis in advanced stage disease. While recently approved agents have expanded the treatment repertoire for CTCL, there is still a need for additional agents as median response with current options averaging about a year(1).  In this context, the efficacy of the novel combination of CD30 directed antibody Brentuximab and PD-1 inhibitor Pembrolizumab in PTCL and CTCL is not known. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Anticipated">August 15, 2023</start_date> <completion_date type="Anticipated">July 30, 2028</completion_date> <primary_completion_date type="Anticipated">April 30, 2028</primary_completion_date> <phase>Phase 2</phase> <study_type>Interventional</study_type> <study_design_info> <allocation>N/A</allocation> <intervention_model>Single Group Assignment</intervention_model> <intervention_model_description>All subjects are scheduled to receive up to 16 cycles of combinatorial treatment with brentuximab + pembrolizumab, followed by up to 19 additional cycles of pembrolizumab monotherapy</intervention_model_description> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>The best overall response with the combination of brentuximab and pembrolizumab.</measure> <time_frame>3 cycles (63 Days)</time_frame> <description>As assessed by the Lugano criteria for PTCL(16) and the global response score for CTCL(17)</description> </primary_outcome> <secondary_outcome> <measure>Occurrence of toxicity</measure> <time_frame>2 Years</time_frame> <description>As assessed by using the NCI Common Terminology Criteria for Adverse Events version 5 (CTCAE v5) for grading</description> </secondary_outcome> <secondary_outcome> <measure>Progression free survival (PFS)</measure> <time_frame>2 Years</time_frame> <description>Defined as the time from enrollment to earliest of progression, death or follow-up</description> </secondary_outcome> <secondary_outcome> <measure>Overall survival (OS)</measure> <time_frame>2 Years</time_frame> <description>Defined as the time from enrollment to death or last follow-up</description> </secondary_outcome> <secondary_outcome> <measure>Time to treatment failure</measure> <time_frame>2 Years</time_frame> <description>Defined as interval from initiation of chemotherapy to premature discontinuation for any reason.</description> </secondary_outcome> <secondary_outcome> <measure>Duration of response</measure> <time_frame>2 Years</time_frame> <description>Defined as the interval from response initiation (when either CR or PR is first determined) to progression or death, whichever occurs first.</description> </secondary_outcome> <secondary_outcome> <measure>Time to progression</measure> <time_frame>2 Years</time_frame> <description>Defined as the time from treatment initiation to tumor progression.</description> </secondary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Anticipated">43</enrollment> <condition>T-Cell Lymphoma</condition> <arm_group> <arm_group_label>Brentuximab vedotin (brentuximab) and pembrolizumab</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>All subjects are scheduled to receive up to 16 cycles of combinatorial treatment with brentuximab + pembrolizumab, followed by up to 19 additional cycles of pembrolizumab monotherapy. After receiving 35 total doses of pembrolizumab (i.e. scheduled for 16 doses in the combinatorial setting and 8 doses as monotherapy), a subject's pembrolizumab treatment will be complete.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Brentuximab vedotin</intervention_name> <description>Brentuximab vedotin is an antibody-drug conjugate medication used to treat relapsed or refractory Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (ALCL), a type of T cell non-Hodgkin lymphoma. It selectively targets tumor cells expressing the CD30 antigen, a defining marker of Hodgkin lymphoma and ALCL.</description> <arm_group_label>Brentuximab vedotin (brentuximab) and pembrolizumab</arm_group_label> <other_name>Adcetris</other_name> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Pembrolizumab</intervention_name> <description>Pembrolizumab is a humanized antibody used in cancer immunotherapy that treats melanoma, lung cancer, head and neck cancer, Hodgkin lymphoma, stomach cancer, cervical cancer, and certain types of breast cancer.</description> <arm_group_label>Brentuximab vedotin (brentuximab) and pembrolizumab</arm_group_label> <other_name>Keytruda</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of T-cell Non-Hodgkin lymphoma (T-NHL) will be enrolled in this study.  2. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.  4. Histologically confirmed T-cell Non-Hodgkin lymphoma (T-NHL), including:  - Peripheral T-cell lymphoma not other specified (PTCL nos)  - Angioimmunoblastic T-cell lymphoma (AITL)  - Anaplastic large-cell lymphoma (ALCL)  - Natural killer (NK)/T-cell lymphoma (nodal or extranodal)  - Cutaneous T-cell lymphoma (CTCL), including mycosis fungoides (MF)/sezary syndrome  - Transformed T-cell lymphoma  - Enteropathy-associated T-cell lymphoma (EATL);  - Subcutaneous panniculitis-like T-cell lymphoma (SCPTCL)  - Hepatosplenic T- cell lymphomas.  5. Presence of CD30 (>1%) by IHC on a previous biopsy sample  6. Relapsed/refractory disease having failed at least one prior systemic therapy Note: Single agent Brentuximab could have been a prior line of therapy EXCEPT those with ≥ grade 2 side effects leading to treatment discontinuation or those refractory to Brentuximab  7. For patients with peripheral T-cell lymphoma (PTCL): At least one measurable target lesion ≥1.5 cm  8. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:  - Not a woman of childbearing potential (WOCBP)  - A woman of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test during screening within 72 hours prior to receiving first dose of protocol-indicated treatment, and must agree to follow instructions for using acceptable contraception from the time of signing consent, and at least 120 days (4 months) after her final dose of pembrolizumab.  9. A male participant must agree to use contraception during the treatment period and for at least at least 120 days (4 months) after the final dose of pembrolizumab. and refrain from donating sperm during this period.  10. Adequate organ and bone marrow function resulted ≤ 10 days prior to first dose of protocol-indicated treatment:  Exclusion Criteria:  1. Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).  2. Patients with adult T-cell leukemia/ lymphoma (ATLL)  3. Has received prior systemic anti-cancer therapy including investigational agents ≤ 4 weeks prior to first dose of study treatment on Cycle 1, Day 1. Could consider shorter interval for kinase inhibitors or other short half-life drugs.  Note: concurrent use of bexarotene or vorinostat (where the dose has been stable for the 8 weeks prior to initiating therapy on trial) is permitted for CTCL. Concurrent use of topical steroids or therapies for CTCL is allowed.  Participants must have recovered from all AEs due to previous therapies to ≤ Grade 1 or to baseline value (i.e. condition prior to initiation of the therapy associated with the AE). Participants with ≤Grade 2 neuropathy as AE may be eligible.  If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.  4. Pregnant or breast-feeding females. A WOCBP who has a positive urine pregnancy test at screening. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. In the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for subject to start receiving study medication.  5. Has received radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.  6. Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.  7. Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.  8. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.  Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.  9. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.  10. Has active autoimmune disease that has required systemic treatment in the past one year (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).  Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.  11. Active uncontrolled infection requiring systemic therapy (patients must be afebrile for ≥ 48 hours off antibiotics prior to first protocol treatment). If fever is attributed to tumor fever (B symptom) then this criteria would not apply.  12. Active myocarditis, regardless of etiology; or New York Heart Association (NYHA) functional classification III-IV heart failure.  13. Known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.  14. Disease free of prior malignancies for ≥ 1 year with exception of currently treated basal cell or squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast. (Other malignancies will require advance discussion and agreement between the investigator and the sponsor-investigator regarding risk of recurrence.)  15. Known severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.  16. Has a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is required unless mandated by local health authority.  17. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.  18. Has a history or current evidence of any condition (e.g. renal disease that would preclude treatment or obstructive pulmonary disease and history of bronchospasm), therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.  19. Clinically significant history of liver disease, including current alcohol abuse or cirrhosis.  20. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.  21. Has a known history of active TB (Bacillus Tuberculosis).  22. Prior allogeneic stem cell transplant within last 5 years or active graft vs. host disease (GVHD).  23. Patients with grade 2 or higher peripheral neuropathy </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Tarsheen Sethi, MD</last_name> <role>Principal Investigator</role> <affiliation>Yale University</affiliation> </overall_official> <overall_contact> <last_name>Maxime Oriol, BS</last_name> <phone>2037856497</phone> <email>maxime.oriol@yale.edu</email> </overall_contact> <overall_contact_backup> <last_name>Julie Holub</last_name> <email>Julie.holub@yale.edu</email> </overall_contact_backup> <location> <facility> <name>Yale Smilow Cancer Hospital</name> <address> <city>New Haven</city> <state>Connecticut</state> <zip>06510</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Kylie Boyhen</last_name> <phone>203-752-7835</phone> <email>kylie.boyhen@yale.edu</email> </contact> <investigator> <last_name>Tarsheen Sethi, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location_countries> <country>United States</country> </location_countries> <results_reference> <citation>Prince HM, Kim YH, Horwitz SM, Dummer R, Scarisbrick J, Quaglino P, Zinzani PL, Wolter P, Sanches JA, Ortiz-Romero PL, Akilov OE, Geskin L, Trotman J, Taylor K, Dalle S, Weichenthal M, Walewski J, Fisher D, Dreno B, Stadler R, Feldman T, Kuzel TM, Wang Y, Palanca-Wessels MC, Zagadailov E, Trepicchio WL, Zhang W, Lin HM, Liu Y, Huebner D, Little M, Whittaker S, Duvic M; ALCANZA study group. 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Epub 2018 May 2.</citation> <PMID>29720488</PMID> </results_reference> <verification_date>July 2023</verification_date> <study_first_submitted>March 28, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>July 10, 2023</last_update_submitted> <last_update_submitted_qc>July 10, 2023</last_update_submitted_qc> <last_update_posted type="Actual">July 11, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor-Investigator</responsible_party_type> <investigator_affiliation>Yale University</investigator_affiliation> <investigator_full_name>Tarsheen Sethi</investigator_full_name> <investigator_title>MD, MSCI, Assistant Professor of Medicine</investigator_title> </responsible_party> <keyword>Relapsed</keyword> <keyword>Refractory</keyword> <keyword>CD30 positive</keyword> <keyword>Peripheral T-cell lymphoma</keyword> <keyword>Cutaneous T-cell lymphoma</keyword> <keyword>Pembrolizumab</keyword> <keyword>Brentuximab</keyword> <condition_browse>  <mesh_term>Lymphoma</mesh_term> <mesh_term>Lymphoma, T-Cell</mesh_term> <mesh_term>Lymphoma, T-Cell, Peripheral</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Pembrolizumab</mesh_term> <mesh_term>Brentuximab Vedotin</mesh_term> </intervention_browse>  </clinical_study>

This is a single arm, open label, multicenter study phase 2 study of pembrolizumab and brentuximab in subjects with relapsed/refractory CD30 positive T-cell lymphoma (including peripheral T-cell lymphoma and cutaneous T-cell lymphoma) who have received at least one prior therapy. We hypothesize that this combination is effective and will produce an overall response rate of ~65%. Pembrolizumab and brentuximab will be administered for 16 cycles in patients with responsive disease. Pembrolizumab will be continued for an additional 19 cycles (total 35 cycles). Response assessments will occur at pre-specified intervals. Dose adjustments for specific toxicities with either drugs are detailed in the protocol. Based on statistical analysis 43 subjects will need to be accrued to evaluate for disease response based on historical control. CD30- Positive Peripheral T cell (PTCL) and Cutaneous T cell Lymphomas (CTCL): T-cell Non-Hodgkin Lymphoma (NHL) includes a clinically heterogeneous group of mature T-cell lymphomas accounting for 10-12% of all NHL. Peripheral T- cell Lymphoma (PTCL) present with clinically aggressive disease with a poor outcome [with the exception of ALK+ Anaplastic Large Cell Lymphomas (ALCL)] and patients experience a high incidence of relapsed/ refractory disease that poses a therapeutic challenge. Despite progress in the past decade in understanding the biology of T-cell lymphomas, with the use of next generation sequencing and molecular profiling of archived tissue samples, there is yet an unmet need in therapeutic options. Amidst the wide range of T-cell lymphoma histologies, PTCL NOS is the most common histological subtype followed by ALCL, angioimmunoblastic lymphoma (AITL) and cutaneous T-cell lymphoma (CTCL). The other histological subtypes (Enteropathy associated T-cell Lymphoma, hepatosplenic T cell lymphoma, NK/T cell lymphoma etc.) account for <5% of T-cell subtypes. Unfortunately, the rare subtypes of T-cell Lymphoma are usually excluded from later phase trials due to their dismal prognosis. Therapeutic Challenge in Relapsed/ Refractory PTCL and CTCL: For patients with disease relapse following upfront chemotherapy, stem cell transplantation (SCT) is an option. However, this type of aggressive approach is only feasible in a minority of patients. Despite the advances in the therapeutic arsenal, most of these agents have a modest response rate of 20-30%. More than half of these patients who do respond initially, will ultimately relapse. Conventional chemotherapy in combination with novel agents has been under clinical evaluation with minor improvements in response rates compared with historical controls. Therefore, the urge to optimize therapy by incorporating newer treatments such as novel agents that have a more targeted approach continues to be critically important. CTCL presents as a chronic disease with a poor prognosis in advanced stage disease. While recently approved agents have expanded the treatment repertoire for CTCL, there is still a need for additional agents as median response with current options averaging about a year(1). In this context, the efficacy of the novel combination of CD30 directed antibody Brentuximab and PD-1 inhibitor Pembrolizumab in PTCL and CTCL is not known. Inclusion Criteria: 1. Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of T-cell Non-Hodgkin lymphoma (T-NHL) will be enrolled in this study. 2. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 4. Histologically confirmed T-cell Non-Hodgkin lymphoma (T-NHL), including: - Peripheral T-cell lymphoma not other specified (PTCL nos) - Angioimmunoblastic T-cell lymphoma (AITL) - Anaplastic large-cell lymphoma (ALCL) - Natural killer (NK)/T-cell lymphoma (nodal or extranodal) - Cutaneous T-cell lymphoma (CTCL), including mycosis fungoides (MF)/sezary syndrome - Transformed T-cell lymphoma - Enteropathy-associated T-cell lymphoma (EATL); - Subcutaneous panniculitis-like T-cell lymphoma (SCPTCL) - Hepatosplenic T- cell lymphomas. 5. Presence of CD30 (>1%) by IHC on a previous biopsy sample 6. Relapsed/refractory disease having failed at least one prior systemic therapy Note: Single agent Brentuximab could have been a prior line of therapy EXCEPT those with ≥ grade 2 side effects leading to treatment discontinuation or those refractory to Brentuximab 7. For patients with peripheral T-cell lymphoma (PTCL): At least one measurable target lesion ≥1.5 cm 8. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: - Not a woman of childbearing potential (WOCBP) - A woman of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test during screening within 72 hours prior to receiving first dose of protocol-indicated treatment, and must agree to follow instructions for using acceptable contraception from the time of signing consent, and at least 120 days (4 months) after her final dose of pembrolizumab. 9. A male participant must agree to use contraception during the treatment period and for at least at least 120 days (4 months) after the final dose of pembrolizumab. and refrain from donating sperm during this period. 10. Adequate organ and bone marrow function resulted ≤ 10 days prior to first dose of protocol-indicated treatment: Exclusion Criteria: 1. Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137). 2. Patients with adult T-cell leukemia/ lymphoma (ATLL) 3. Has received prior systemic anti-cancer therapy including investigational agents ≤ 4 weeks prior to first dose of study treatment on Cycle 1, Day 1. Could consider shorter interval for kinase inhibitors or other short half-life drugs. Note: concurrent use of bexarotene or vorinostat (where the dose has been stable for the 8 weeks prior to initiating therapy on trial) is permitted for CTCL. Concurrent use of topical steroids or therapies for CTCL is allowed. Participants must have recovered from all AEs due to previous therapies to ≤ Grade 1 or to baseline value (i.e. condition prior to initiation of the therapy associated with the AE). Participants with ≤Grade 2 neuropathy as AE may be eligible. If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment. 4. Pregnant or breast-feeding females. A WOCBP who has a positive urine pregnancy test at screening. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. In the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for subject to start receiving study medication. 5. Has received radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease. 6. Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. 7. Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed. 8. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment. Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent. 9. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. 10. Has active autoimmune disease that has required systemic treatment in the past one year (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. 11. Active uncontrolled infection requiring systemic therapy (patients must be afebrile for ≥ 48 hours off antibiotics prior to first protocol treatment). If fever is attributed to tumor fever (B symptom) then this criteria would not apply. 12. Active myocarditis, regardless of etiology; or New York Heart Association (NYHA) functional classification III-IV heart failure. 13. Known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment. 14. Disease free of prior malignancies for ≥ 1 year with exception of currently treated basal cell or squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast. (Other malignancies will require advance discussion and agreement between the investigator and the sponsor-investigator regarding risk of recurrence.) 15. Known severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients. 16. Has a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is required unless mandated by local health authority. 17. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority. 18. Has a history or current evidence of any condition (e.g. renal disease that would preclude treatment or obstructive pulmonary disease and history of bronchospasm), therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. 19. Clinically significant history of liver disease, including current alcohol abuse or cirrhosis. 20. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 21. Has a known history of active TB (Bacillus Tuberculosis). 22. Prior allogeneic stem cell transplant within last 5 years or active graft vs. host disease (GVHD). 23. Patients with grade 2 or higher peripheral neuropathy

NCT0531xxxx/NCT05313256.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313256</url> </required_header> <id_info> <org_study_id>CHUBX 2021/36</org_study_id> <nct_id>NCT05313256</nct_id> </id_info> <brief_title>Quick Epidural Top-up With Alkalinized Lidocaine for Emergent Caesarean Delivery</brief_title> <acronym>QETAL</acronym> <official_title>Alkalinization of Adrenalized Lidocaine in Extending Epidural Analgesia for Extremely Urgent Cesarean Section During Labor: a Randomized Controlled Trial.</official_title> <sponsors> <lead_sponsor> <agency>University Hospital, Bordeaux</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>University Hospital, Bordeaux</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Prospective randomized study comparing the use of lidocaine 2% with epinephrine buffered with sodium bicarbonate and lidocaine 2% with epinephrine as epidural top-up for extremely urgent cesarean section during labour. </textblock> </brief_summary> <detailed_description> <textblock> General anesthesia in pregnant women remains burdened by a significant maternal-fetal morbidity and mortality. An increased risk of orotracheal intubation difficulty, gastric inhalation syndrome and neonatal respiratory depression is described.  The rate of epidural analgesia during labor is about 85% in France. In addition to the comfort provided, epidural analgesia allows emergency Caesarean sections to be performed by converting epidural analgesia to epidural anesthesia, a technique known as "epidural extension" or "epidural top-up". The effectiveness and the time necessary to obtain this surgical anesthesia depends on the protocols used and determines the possibility of performing fetal extractions, even the most urgent ones, without resorting to general anesthesia.  We define an extremely urgent cesarean delivery as a delivery required in the event of an immediate threat to maternal or fetal vital prognosis, with a target of less than 15 minutes between the extraction decision time and birth.  In France, the latest recommendations date from 2007 and recommend the practice of epidural extension with 15 to 20 ml of 2% adrenaline lidocaine. With this technique, surgical anesthesia is typically obtained within 10 to 15 minutes. This time remains too long in certain obstetrical emergency situations, notably extremely urgent cesarean sections, which require frequent recourse to general anesthesia to compensate for this length of nerve block installation.  The alkalinization of local anesthetics with sodium bicarbonate has been experimentally studied since the 1970s and makes it possible to accelerate the time of action of local anesthetics. Alkalinization of local anesthetics is practiced in 35% of epidural extensions in Denmark and 12% of epidural extensions in the United Kingdom.  Since 2016, this technique has been used in the anesthesia departments of maternity units of Bayonne and Bordeaux hospitals. In the former, a retrospective study of 51 cases from January 2019 to July 2019 showed a decrease of more than 80% in the rate of recourse to general anesthesia in extremely urgent caesarean sections (4/4 vs 0/7) and a 50% decrease in the time required to obtain adequate epidural anesthesia (5 min vs 10 min).  The main objective of the current prospective study is to prospectively confirm the decrease in the use of general anesthesia in extremely urgent cesarean sections. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">July 14, 2022</start_date> <completion_date type="Anticipated">November 2023</completion_date> <primary_completion_date type="Anticipated">November 2023</primary_completion_date> <phase>Phase 2/Phase 3</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>Single (Participant)</masking> </study_design_info> <primary_outcome> <measure>Resort to general anaesthesia</measure> <time_frame>15 minutes after inclusion</time_frame> <description>Resort to general anaesthesia for insufficient analgesia after epidural extension for extremely urgent caesarean section.</description> </primary_outcome> <secondary_outcome> <measure>Delay between fetal extraction decision and birth</measure> <time_frame>Between inclusion and birth</time_frame> <description>Minutes between the decision to extract the fetus by the obstetrical team and the clamping of the umbilical cord</description> </secondary_outcome> <secondary_outcome> <measure>Delay between fetal extraction decision and incision</measure> <time_frame>Between inclusion and cesarean section</time_frame> <description>Minutes between the decision to extract the fetus by the obstetrical team and the surgical incision</description> </secondary_outcome> <secondary_outcome> <measure>Maternal complications</measure> <time_frame>up to 24 hours after inclusion</time_frame> <description>Maternal complications after epidural top-up, including nausea-vomiting in the peroperative and postoperative period, desaturation episode, difficult orotracheal intubation, bronchial inhalation syndrome, hypotensive episode before fetal extraction, extended sensory or motor block.</description> </secondary_outcome> <secondary_outcome> <measure>Complementary medicines</measure> <time_frame>Between inclusion and cesarean section</time_frame> <description>Use and characterization of complementary medicines necessary for maternal well-being during caesarean section.</description> </secondary_outcome> <secondary_outcome> <measure>Postpartum hemorrhage</measure> <time_frame>up to 24 hours after inclusion</time_frame> <description>Postpartum hemorrhage (blood loss of more than 500 ml)</description> </secondary_outcome> <secondary_outcome> <measure>Paediatric wellness</measure> <time_frame>at birth</time_frame> <description>Paediatric wellness criteria (umbilical cord pH less than 7.0 ; umbilical cord lactate)</description> </secondary_outcome> <secondary_outcome> <measure>Anesthesia level</measure> <time_frame>one hour after surgical incision</time_frame> <description>Anesthesia level one hour after surgical incision</description> </secondary_outcome> <secondary_outcome> <measure>Maternal satisfaction</measure> <time_frame>up to 4 hours after inclusion</time_frame> <description>Maternal satisfaction regarding analgesia and anesthesia during caesarean section.</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">66</enrollment> <condition>Obstetric Labor Complications</condition> <arm_group> <arm_group_label>Experimental group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>In this arm patients will receive for epidural extension a Lidocaine epinephrine buffered with sodium bicarbonate.</description> </arm_group> <arm_group> <arm_group_label>Comparator group</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>In this arm patients will receive for epidural extension only Lidocaine epinephrine.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Lidocaine epinephrine buffered with sodium bicarbonate</intervention_name> <description>When an extremely urgent fetal extraction by caesarean section is decided, the patient will be randomized. An epidural top-up will then be performed with Lidocaine epinephrine buffered with sodium bicarbonate.</description> <arm_group_label>Experimental group</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Lidocaine epinephrine</intervention_name> <description>When an extremely urgent fetal extraction by caesarean section is decided, the patient will be randomized. An epidural top-up will then be performed with Lidocaine epinephrine.</description> <arm_group_label>Comparator group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Adult patients, affiliated to social security  - Informed consent signed by the participant and the investigating physician at the latest after the therapeutic intervention  - Initial indication for vaginal delivery  - Benefiting from emergency caesarean section during labour for fetal extraction with a maximum 15-minute decision-to-delivery delay (i.e. extremely urgent caesarean section)  Exclusion Criteria:  - Opposition to participation in research before delivery  - Refusal or impossibility of informed consent  - Lack of understanding or significant language barrier  - Initial indication for general anaesthesia defined by the following situations: non-functional epidural analgesia, altered consciousness, eclampsia, suspicion of amniotic embolism, confirmed or suspected severe haemorrhage occurring before birth  - Contraindication to the use of the products defined in the protocol : adrenalized lidocaine ; sodium bicarbonate.  - Persons placed under judicial protection </textblock> </criteria> <gender>Female</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Thomas LECHAT, Dr</last_name> <role>Principal Investigator</role> <affiliation>University Hospital, Bordeaux</affiliation> </overall_official> <overall_official> <last_name>Antoine BENARD, Dr</last_name> <role>Study Chair</role> <affiliation>University Hospital, Bordeaux</affiliation> </overall_official> <overall_official> <last_name>Karine NOUETTE-GAULAIN, Pr</last_name> <role>Study Director</role> <affiliation>University Hospital, Bordeaux</affiliation> </overall_official> <overall_contact> <last_name>Thomas DENIER D'APRIGNY</last_name> <phone>0556795679</phone> <phone_ext>+33</phone_ext> <email>thomas.denier-daprigny@chu-bordeaux.fr</email> </overall_contact> <overall_contact_backup> <last_name>Nicolas BOURGOIN</last_name> <phone>0556795679</phone> <phone_ext>+33</phone_ext> <email>nicolas.bourgoin@chu-bordeaux.fr</email> </overall_contact_backup> <location> <facility> <name>CH de la Côte Basque</name> <address> <city>Bayonne</city> <country>France</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Jérémy HENRIOT, Dr</last_name> <email>jhenriot@ch-cotebasque.fr</email> </contact> <investigator> <last_name>Jérémy HENRIOT, Dr</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>CHU de Bordeaux</name> <address> <city>Bordeaux</city> <country>France</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Thomas DENIER D'APRIGNY</last_name> <email>thomas.denier-daprigny@chu-bordeaux.fr</email> </contact> <contact_backup> <last_name>Nicolas BOURGOIN</last_name> <email>nicolas.bourgoin@chu-bordeaux.fr</email> </contact_backup> <investigator> <last_name>Thomas LECHAT, Dr</last_name> <role>Principal Investigator</role> </investigator> </location> <location_countries> <country>France</country> </location_countries> <verification_date>September 2022</verification_date> <study_first_submitted>March 28, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>September 26, 2022</last_update_submitted> <last_update_submitted_qc>September 26, 2022</last_update_submitted_qc> <last_update_posted type="Actual">September 28, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>epidural analgesia</keyword> <keyword>caesarean section</keyword> <keyword>sodium bicarbonate</keyword> <keyword>local anesthetics</keyword> <keyword>obstetric labor</keyword> <keyword>alkalinization</keyword> <keyword>extremely urgent</keyword> <condition_browse>  <mesh_term>Obstetric Labor Complications</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Lidocaine</mesh_term> <mesh_term>Epinephrine</mesh_term> <mesh_term>Racepinephrine</mesh_term> <mesh_term>Epinephryl borate</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Prospective randomized study comparing the use of lidocaine 2% with epinephrine buffered with sodium bicarbonate and lidocaine 2% with epinephrine as epidural top-up for extremely urgent cesarean section during labour. General anesthesia in pregnant women remains burdened by a significant maternal-fetal morbidity and mortality. An increased risk of orotracheal intubation difficulty, gastric inhalation syndrome and neonatal respiratory depression is described. The rate of epidural analgesia during labor is about 85% in France. In addition to the comfort provided, epidural analgesia allows emergency Caesarean sections to be performed by converting epidural analgesia to epidural anesthesia, a technique known as "epidural extension" or "epidural top-up". The effectiveness and the time necessary to obtain this surgical anesthesia depends on the protocols used and determines the possibility of performing fetal extractions, even the most urgent ones, without resorting to general anesthesia. We define an extremely urgent cesarean delivery as a delivery required in the event of an immediate threat to maternal or fetal vital prognosis, with a target of less than 15 minutes between the extraction decision time and birth. In France, the latest recommendations date from 2007 and recommend the practice of epidural extension with 15 to 20 ml of 2% adrenaline lidocaine. With this technique, surgical anesthesia is typically obtained within 10 to 15 minutes. This time remains too long in certain obstetrical emergency situations, notably extremely urgent cesarean sections, which require frequent recourse to general anesthesia to compensate for this length of nerve block installation. The alkalinization of local anesthetics with sodium bicarbonate has been experimentally studied since the 1970s and makes it possible to accelerate the time of action of local anesthetics. Alkalinization of local anesthetics is practiced in 35% of epidural extensions in Denmark and 12% of epidural extensions in the United Kingdom. Since 2016, this technique has been used in the anesthesia departments of maternity units of Bayonne and Bordeaux hospitals. In the former, a retrospective study of 51 cases from January 2019 to July 2019 showed a decrease of more than 80% in the rate of recourse to general anesthesia in extremely urgent caesarean sections (4/4 vs 0/7) and a 50% decrease in the time required to obtain adequate epidural anesthesia (5 min vs 10 min). The main objective of the current prospective study is to prospectively confirm the decrease in the use of general anesthesia in extremely urgent cesarean sections. Inclusion Criteria: - Adult patients, affiliated to social security - Informed consent signed by the participant and the investigating physician at the latest after the therapeutic intervention - Initial indication for vaginal delivery - Benefiting from emergency caesarean section during labour for fetal extraction with a maximum 15-minute decision-to-delivery delay (i.e. extremely urgent caesarean section) Exclusion Criteria: - Opposition to participation in research before delivery - Refusal or impossibility of informed consent - Lack of understanding or significant language barrier - Initial indication for general anaesthesia defined by the following situations: non-functional epidural analgesia, altered consciousness, eclampsia, suspicion of amniotic embolism, confirmed or suspected severe haemorrhage occurring before birth - Contraindication to the use of the products defined in the protocol : adrenalized lidocaine ; sodium bicarbonate. - Persons placed under judicial protection

NCT0531xxxx/NCT05313269.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313269</url> </required_header> <id_info> <org_study_id>21-0258-A</org_study_id> <nct_id>NCT05313269</nct_id> </id_info> <brief_title>Inter-fascial Plane Between the SArtorius Muscle and FEmoral Artery (ISAFE)</brief_title> <acronym>ISAFE</acronym> <official_title>Inter-fascial Plane Between the SArtorius Muscle and FEmoral Artery (ISAFE): a Novel Technique for Adductor Canal Catheter Insertion.</official_title> <sponsors> <lead_sponsor> <agency>University of Toronto</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Mount Sinai Hospital, Canada</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>University of Toronto</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Total knee arthroplasty (TKA) is a frequent performed surgery. Adequate pain management is an important feature. Analgesic duration of single shot nerve blocks is limited to no more than 24h. Conversely, the use of continuous nerve block (CNB) through a perineural catheter and infusion of local anesthetic may increase duration of analgesia and provide better outcomes. Continuous adductor canal block (CACB) has been proven superior when compared to single-injection adductor canal block (SACB) for TKA analgesia. However, safety concerns such as intravenous insertion, nerve injury, or catheter displacement must always be considered. The purpose of this study is to evaluate the Inter-fascial Plane between SArtorius Muscle and FEmoral Artery (ISAFE) approach for adductor canal catheter placement, in terms of catheter dislodgment, clinical effectiveness and complications, in comparison with the classical approach, as TKA postoperative analgesia modality. We hypothesize that ISAFE approach can result in a smaller rate of dislodgments in the way that it increases the clinical benefit of CACB. </textblock> </brief_summary> <detailed_description> <textblock> Introduction Total knee arthroplasty (TKA) is an effective treatment for end stage osteoarthritis, with over 75,000 TKA performed in Canada annually (https://www.cihi.ca/en/hip-and-knee-replacements-in-canada-cjrr-annual-report) and an incidence rate of 135 per 100000 of population, among OECD countries, in 2017 (https://www.oecd-ilibrary.org/sites/2fc83b9a-en/index.html?itemId=/content/component/2fc83b9 a-en). Historically, TKA has been associated with a significant level of postoperative pain, which can be a barrier to an early discharge. In order to optimize analgesia and minimize opioid consumption and its associated side effects, regional anesthesia techniques traditionally used for TKA include peripheral nerve blocks such as femoral and adductor canal blocks (ACB). These blocks typically provide superior analgesia by anesthetizing peripheral nerves that supply sensory innervation to the surgical site. Specifically, the ACB is of great value as it does not cause the quadriceps weakness motor block that the femoral nerve block provides, thereby facilitating early patient mobilization and discharge. An even newer technique has also emerged called the IPACK (infiltration between the popliteal artery and capsule of the knee), which has been used in some centers to replace sciatic blocks to cover posterior knee pain experienced by many TKA patients, without affecting motor function of the lower leg and foot. Recently, continuous adductor canal blocks (CACB) via an inserted adductor canal catheter (ACC) have started to replace single injection blocks, as they extend the block duration and offer prolonged analgesia. Studies evaluating CACB have it to be superior when compared to single-injection adductor canal block (SACB) for inpatients post-TKA analgesia. Currently at Sinai Health, CACB has become the standard of care for inpatient TKA with all patients routinely being offered this analgesic modality.  Placing a successful ACC is not without risk or technical difficulty. The classic insertion approach involves placing the tip of the ACC near the saphenous nerve in the mid-thigh area. The proximity of the femoral artery (FA) and femoral vein (FV) to the saphenous nerve adds the risk of vascular puncture and intravascular placement of the ACC. Specifically, the FV is deeper and more difficult to visualize as it is compressible, and can be easily punctured if the needle is manipulated in its proximity. Intravenous placement of an ACC will result local anesthetic systemic toxicity (LAST), a potentially lethal albeit very rare complication, and therefore effort should be made to avoid this at all costs. Lastly, a more common obstacle when placing ACC is ensuring that the catheter stays inside the adductor canal. Since the adductor canal itself is very narrow, the catheter tip can easily migrate out of the canal with patient movement and mobilization, resulting in no sensory block and inadequate analgesia. It is not uncommon for patients to initially have well working CACB, but to experience significant rebound pain on postoperative days (POD) 1 or 2 due to catheter dislodgement out of the canal.  In order to address these issues we have developed a novel insertion approach for ACC is inserted into the inter-fascial plane between the Sartorius muscle and femoral artery (ISAFE). In this technique, the needle is inserted into the plane between the sartorius muscle and FA. A catheter is then threaded between the artery and muscle, well away from the FV. This facilitates keeping the needle away from the vein and maintaining more catheter length inside the adductor canal, thereby preventing catheter dislodgement. The insertion angle of the needle is shallower when compared to the classic ACC technique, allowing for better needle visualization, and steering clear of the FV. While the needle is still in close proximity to the FA, this vessel is easier to visualize, more difficult to puncture, and is much less likely to result in LAST.  While the ISAFE technique is an exciting novel approach for ACC insertion, it still requires evaluation in terms of analgesia efficacy and superiority in terms of reducing catheter dislodgement.  Significance There are no published prospective randomized controlled trials that compare insertion techniques for ACC and their respective outcomes in terms of catheter positioning, dislodgement, and safety. As TKA is a frequent type of surgery and has the prediction to increase its incidence for the next years, there is significant importance in investigations about interventions which may improve its recovery in an outpatient regime. A postoperative analgesic technique that offers better pain control, has less adverse effects, reduces the opioid analgesia requirement and is safe may have additional impact on decreasing health care cost and may lead to an enhanced recovery and better quality of life.  Objectives The primary objective will be to evaluate the rate of ACC dislodgement when using the ISAFE approach for CACB in patients undergoing TKA (by measuring cumulative postoperative opioid consumption), in comparison with the classical ACC insertion technique.  The secondary objective is to assess the quality of analgesia as measured by pain scores and opioid consumption, and complications relating to the perineural catheter use.  Hypothesis The ISAFE insertion approach for ACC in patients undergoing TKA will lead to a reducing in catheter dislodgement rates.  Methods Study type This will be a Randomized controlled prospective trial, blinded for patient and evaluator, in patients undergoing inpatient TKA at Sinai Health. After Hospital's Ethics in Research Board approval, the recruitment will begin. Patients will be assessed about their eligibility for participating and after plain clear information about the study interventions they will or will not authorize their inclusion and data collection, through the signature of a written consent.  Perioperative management and interventions The subjects will have their surgeries booked in advance and they will be submitted to the pre anesthesia consult at the Pre Admission Unit a few days before the surgery. The study proposal will be explained to the patients on that occasion and they will receive a booklet with the information about the study as well as the consent form that they will bring home to review. They will have the time between the pre anesthesia assessment and the surgery (at least 24 hours) to review and consent to the study.  Patients will be randomized to one of the two groups using a computer-generated random numbers table. The randomization will be done before the beginning of the study and will define which study number is going to be managed as intervention group (ISAFE approach) or control group (classic approach). Each patient will receive a study number following the order of their entrance on the study and that number will be already linked for one of the two groups. Closed envelopes will be prepared ahead and each of them will have the name of the group related to its study number. Once the the patient is included, the professional who inserts the catheter will check inside the envelope which group the patient is randomized to, in order to perform the predicted technique. A list with the study numbers and the randomization will be kept by the research assistant, under password protection, and will be shared with other researches only after recruitment is finished. The research coordinator, and the professional who performs the postoperative adductor canal assessments will be blinded to which group each patient was randomized to. The professional who inserts the catheters will not be blinded as they will need to know which insertion approach to take.  All patients will receive the same perioperative management. Patients will initially be brought to a dedicated block room where a safety checklist will be performed by the block room team. Standard Canadian Anesthesia Society monitoring will be provided. Mild sedation with Midazolam 0.5-2mg and Fentanyl 25-100mcg might be administered for anxiolysis and analgesia. After proper cleaning of the ipsilateral thigh, under sterile technique and ultrasound guidance (Sonosite Edge II ultrasound machine), an adductor canal block (injection of 15 mL of Ropivacaine 0.5% with epinephrine 1:200,000) and an IPACK block (injection of 15 mL of Ropivacaine 0.25% with epinephrine 1:200,000) will be performed. Cumulative local anesthetic doses will be preemptively calculated to avoid a total Ropivacaine dose of > 3mg/kg. After the peripheral nerve blocks, all patients will receive standard spinal or general anesthesia. All intraoperative opioids administered will be recorded. In the intra-operative period, each patient will receive IV Cefazolin 2g, Tranexamic acid 20mg/kg, Dexamethasone 0.1mg/kg, and Ondansetron 4mg. At the end of the procedure the surgeons will infiltrate the surgical site with 200 mg of Ropivacaine 0.2%.  After surgery, the patient will be taken to the Post Anesthesia Care Unit. At this moment, an Arrow® (StimuCath® Continuous Peripheral Nerve Block Catheter) continuous adductor canal block catheter will be inserted using a Sonosite Edge II ultrasound machine. A bolus of 5-10mL of saline solution (NaCl 0.9%) with epinephrine 1:200,000 will be given, after negative aspiration, following adductor canal catheter insertion and the patient will be monitored for any heart rate change in order to rule out intravascular catheter placement. The catheter will be well secured with an adhesive fixation device to avoid displacement. Following catheter placement, the catheter will be aspirated to check for blood to ensure there is no intravascular placement. The peripheral nerve catheter will be connected to an elastomeric infusion pump and will infuse Ropivacaine 0.2% at a rate of 5 ml/hour, as per the standard Sinai Health practice for inpatient CACB. Adductor canal catheter will be placed following the surgery in the post-anesthetic care unit in order to avoid catheter displacement by the thigh tourniquet used intraoperatively. The adductor canal catheter stays in place infusing for 48 hours. The patients are discharged home after achieving the discharge criteria by orthopedics team in charge, keeping the peripheral nerve catheter with the same infusion rate, if they go home before completing the 48 hours of infusion. Prior to going home, patients receive education and written information (educational pamphlet) regarding monitoring for local anesthetic systemic toxicity symptoms, possible CABC associated complications including potential transient muscle weakness, and instructions on patient removal of the catheter after infusion end. This pamphlet contains contact information for anesthesia team or Acute Pain Service, in case of any events, adverse effects or questions the patients may have about the peripheral nerve catheter. A phone number to contact each patient at home is collected before they are discharged and they are followed up by phone calls, during the infusion period. This is already done as standard of care for all knee arthroplasty surgeries.Standard oral analgesic scheme will be prescribed to every patient (Acetaminophen 650mg QID, Celecoxib 200mg BID, Hydromorphone 1-2mg PRN Q4Hs).  Sample size The sample size was calculated based on previous study that ACC dislodgement rate of 13%. This study measured catheter dislodgement at the skin, so we believe this rate significantly underestimates the rate of dislodgement out of the adductor canal and that sonographic assessments will have a much higher sensitivity for such events. Local pilot data suggests that using the ISAFE approach, ACC dislodgements are only 5%. Using a predicted catheter dislodgement rate of 25% for conventional approach, and an expected reduction for of dislodgement rate down to 5% with ISAFE approach, considering α=0.05 and a power of 80%, 49 subjects will be needed in each group for a total of 98 patients. To compensate for anticipated dropouts from the study, we plan for an inclusion of 100 patients.  Study data analysis Normal distributed variables values will be presented and analyzed as mean values +- standard deviation. Non-normal distributed variables values will be presented and analyzed as median and minimum and maximum values. Qualitative variables will be presented as frequency of occurrence. Statistical test to be performed might be: t-Student, Kruskal-Wallis and Chi-square. Statistical software will be used for analysis: SPSS 13.0 for Windows (SPSS Inc, Chicago, IL, USA) and GraphPad Prism Version 4.00 for Windows (GraphPad Software, San Diego, CA, USA). </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">April 28, 2022</start_date> <completion_date type="Actual">March 28, 2023</completion_date> <primary_completion_date type="Actual">February 28, 2023</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Catheter dislodgement</measure> <time_frame>24 hours</time_frame> <description>Rate of migration of the catheter tip to outside the adductor canal, verified by ultrasound assessment</description> </primary_outcome> <secondary_outcome> <measure>Pain intensity</measure> <time_frame>24 and 48 hours</time_frame> <description>Numerical verbal scale for pain intensity (from 0 to 10, 0 being no pain and 10 the worst pain ever)</description> </secondary_outcome> <secondary_outcome> <measure>Opioid consumption</measure> <time_frame>24 and 48 hours</time_frame> <description>Amount of opioid in Oral Morphine Equivalents</description> </secondary_outcome> <secondary_outcome> <measure>Number of attempts for catheter insertion</measure> <time_frame>4 hours</time_frame> <description>Number of attempts that were necessary for adductor canal catheter insertion</description> </secondary_outcome> <secondary_outcome> <measure>Incidence of catheter insertion related complications</measure> <time_frame>4 hours</time_frame> <description>Paresthesia, catheter leakage, blood aspiration or vascular puncture</description> </secondary_outcome> <secondary_outcome> <measure>Potential complications related to continuous adductor canal block catheter</measure> <time_frame>24 and 48 hours</time_frame> <description>Patients are asked about ipsilateral lower limb weakness (any degree of weakness), falls, signs of local infection (redness, pain, swelling and yellow exudate), pruritus, burning, tingling and shock sensation on saphenous nerve territory, symptoms of local anesthetic systemic toxicity (numbness on lips or tongue, metal taste, tinnitus), leakage from catheter or insertion site, and catheter exteriorization</description> </secondary_outcome> <secondary_outcome> <measure>Ultrasound assessment of the dislodgement of the catheter</measure> <time_frame>24 hours</time_frame> <description>Distance between the catheter location and its original position and its distance from the saphenous nerve</description> </secondary_outcome> <secondary_outcome> <measure>Incidence of sensory block</measure> <time_frame>24 hours</time_frame> <description>Block to ice sensation on saphenous nerve territory</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">100</enrollment> <condition>Anesthesia, Conduction</condition> <condition>Arthroplasty, Replacement, Knee</condition> <arm_group> <arm_group_label>ISAFE technique</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Adductor canal block catheter tip located in the fascial plane between sartorious muscle and femoral artery.</description> </arm_group> <arm_group> <arm_group_label>Conventional technique</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Adductor canal block catheter tip located in lateral to the femoral artery.</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>ISAFE technique for adductor canal catheter insertion</intervention_name> <description>Adductor canal block catheter tip located in the fascial plane between sartorious muscle and femoral artery.</description> <arm_group_label>ISAFE technique</arm_group_label> <other_name>ISAFE approach</other_name> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Conventional technique for adductor canal catheter insertion</intervention_name> <description>Adductor canal block catheter tip located lateral to the femoral artery.</description> <arm_group_label>Conventional technique</arm_group_label> <other_name>Conventional approach</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Patients undergoing primary or revision Total Knee Arthroplasty in the inpatient setting. Non-pregnant patients older than 21 years of age, with American Society of Anesthesiologists (ASA) physical status I-IV.  Exclusion Criteria:  - Patients undergoing outpatient TKA. Chronic opioid use of oral morphine 30mg equivalent per day for last 2 consecutive weeks. Patients with contraindications to the insertion of an adductor canal catheter (severe anatomic abnormalities, local or systemic infection, or a history of previous surgery at the site of catheter placement). </textblock> </criteria> <gender>All</gender> <minimum_age>21 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Yehoshua Gleicher, MD, MSc</last_name> <role>Study Chair</role> <affiliation>University of Toronto</affiliation> </overall_official> <location> <facility> <name>Mount Sinai Hospital</name> <address> <city>Toronto</city> <state>Ontario</state> <zip>M5G 1X5</zip> <country>Canada</country> </address> </facility> </location> <location_countries> <country>Canada</country> </location_countries> <reference> <citation>Price AJ, Alvand A, Troelsen A, Katz JN, Hooper G, Gray A, Carr A, Beard D. Knee replacement. Lancet. 2018 Nov 3;392(10158):1672-1682. doi: 10.1016/S0140-6736(18)32344-4.</citation> <PMID>30496082</PMID> </reference> <reference> <citation>Cullom C, Weed JT. Anesthetic and Analgesic Management for Outpatient Knee Arthroplasty. Curr Pain Headache Rep. 2017 May;21(5):23. doi: 10.1007/s11916-017-0623-y.</citation> <PMID>28283810</PMID> </reference> <reference> <citation>Sankineani SR, Reddy ARC, Eachempati KK, Jangale A, Gurava Reddy AV. Comparison of adductor canal block and IPACK block (interspace between the popliteal artery and the capsule of the posterior knee) with adductor canal block alone after total knee arthroplasty: a prospective control trial on pain and knee function in immediate postoperative period. Eur J Orthop Surg Traumatol. 2018 Oct;28(7):1391-1395. doi: 10.1007/s00590-018-2218-7. Epub 2018 May 2.</citation> <PMID>29721648</PMID> </reference> <reference> <citation>Yu R, Wang H, Zhuo Y, Liu D, Wu C, Zhang Y. Continuous adductor canal block provides better performance after total knee arthroplasty compared with the single-shot adductor canal block?: An updated meta-analysis of randomized controlled trials. Medicine (Baltimore). 2020 Oct 23;99(43):e22762. doi: 10.1097/MD.0000000000022762.</citation> <PMID>33120783</PMID> </reference> <reference> <citation>Leung P, Dickerson DM, Denduluri SK, Mohammed MK, Lu M, Anitescu M, Luu HH. Postoperative continuous adductor canal block for total knee arthroplasty improves pain and functional recovery: A randomized controlled clinical trial. J Clin Anesth. 2018 Sep;49:46-52. doi: 10.1016/j.jclinane.2018.06.004. Epub 2018 Jun 8.</citation> <PMID>29890381</PMID> </reference> <reference> <citation>Edwards RM, Currigan DA, Bradbeer S, Mitchell C. Does a catheter over needle system reduce infusate leak in continuous peripheral nerve blockade: a randomised controlled trial. Anaesth Intensive Care. 2018 Sep;46(5):468-473. doi: 10.1177/0310057X1804600507.</citation> <PMID>30189820</PMID> </reference> <reference> <citation>Dos Santos Fernandes H, Siddiqui N, Peacock S, Vidal E, Wolfstadt J, Gleicher Y. Inter-fascial space between SArtorius muscle and FEmoral artery (ISAFE): A suggested approach for Adductor Canal catheter placement. J Clin Anesth. 2022 Feb;76:110571. doi: 10.1016/j.jclinane.2021.110571. Epub 2021 Nov 8. No abstract available.</citation> <PMID>34763273</PMID> </reference> <reference> <citation>Sun C, Zhang X, Song F, Zhao Z, Du R, Wu S, Ma Q, Cai X. Is continuous catheter adductor canal block better than single-shot canal adductor canal block in primary total knee arthroplasty?: A GRADE analysis of the evidence through a systematic review and meta-analysis. Medicine (Baltimore). 2020 May;99(20):e20320. doi: 10.1097/MD.0000000000020320.</citation> <PMID>32443383</PMID> </reference> <verification_date>June 2023</verification_date> <study_first_submitted>March 28, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>June 1, 2023</last_update_submitted> <last_update_submitted_qc>June 1, 2023</last_update_submitted_qc> <last_update_posted type="Actual">June 6, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>University of Toronto</investigator_affiliation> <investigator_full_name>Hermann dos Santos Fernandes</investigator_full_name> <investigator_title>Principal Investigator</investigator_title> </responsible_party> <patient_data> <sharing_ipd>Yes</sharing_ipd> <ipd_description>Anonymized REDCap data base, after conclusion of the study.</ipd_description> <ipd_info_type>Study Protocol</ipd_info_type> <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type> <ipd_time_frame>At the conclusion of the study</ipd_time_frame> </patient_data>  </clinical_study>

Total knee arthroplasty (TKA) is a frequent performed surgery. Adequate pain management is an important feature. Analgesic duration of single shot nerve blocks is limited to no more than 24h. Conversely, the use of continuous nerve block (CNB) through a perineural catheter and infusion of local anesthetic may increase duration of analgesia and provide better outcomes. Continuous adductor canal block (CACB) has been proven superior when compared to single-injection adductor canal block (SACB) for TKA analgesia. However, safety concerns such as intravenous insertion, nerve injury, or catheter displacement must always be considered. The purpose of this study is to evaluate the Inter-fascial Plane between SArtorius Muscle and FEmoral Artery (ISAFE) approach for adductor canal catheter placement, in terms of catheter dislodgment, clinical effectiveness and complications, in comparison with the classical approach, as TKA postoperative analgesia modality. We hypothesize that ISAFE approach can result in a smaller rate of dislodgments in the way that it increases the clinical benefit of CACB. Introduction Total knee arthroplasty (TKA) is an effective treatment for end stage osteoarthritis, with over 75,000 TKA performed in Canada annually (https://www.cihi.ca/en/hip-and-knee-replacements-in-canada-cjrr-annual-report) and an incidence rate of 135 per 100000 of population, among OECD countries, in 2017 (https://www.oecd-ilibrary.org/sites/2fc83b9a-en/index.html?itemId=/content/component/2fc83b9 a-en). Historically, TKA has been associated with a significant level of postoperative pain, which can be a barrier to an early discharge. In order to optimize analgesia and minimize opioid consumption and its associated side effects, regional anesthesia techniques traditionally used for TKA include peripheral nerve blocks such as femoral and adductor canal blocks (ACB). These blocks typically provide superior analgesia by anesthetizing peripheral nerves that supply sensory innervation to the surgical site. Specifically, the ACB is of great value as it does not cause the quadriceps weakness motor block that the femoral nerve block provides, thereby facilitating early patient mobilization and discharge. An even newer technique has also emerged called the IPACK (infiltration between the popliteal artery and capsule of the knee), which has been used in some centers to replace sciatic blocks to cover posterior knee pain experienced by many TKA patients, without affecting motor function of the lower leg and foot. Recently, continuous adductor canal blocks (CACB) via an inserted adductor canal catheter (ACC) have started to replace single injection blocks, as they extend the block duration and offer prolonged analgesia. Studies evaluating CACB have it to be superior when compared to single-injection adductor canal block (SACB) for inpatients post-TKA analgesia. Currently at Sinai Health, CACB has become the standard of care for inpatient TKA with all patients routinely being offered this analgesic modality. Placing a successful ACC is not without risk or technical difficulty. The classic insertion approach involves placing the tip of the ACC near the saphenous nerve in the mid-thigh area. The proximity of the femoral artery (FA) and femoral vein (FV) to the saphenous nerve adds the risk of vascular puncture and intravascular placement of the ACC. Specifically, the FV is deeper and more difficult to visualize as it is compressible, and can be easily punctured if the needle is manipulated in its proximity. Intravenous placement of an ACC will result local anesthetic systemic toxicity (LAST), a potentially lethal albeit very rare complication, and therefore effort should be made to avoid this at all costs. Lastly, a more common obstacle when placing ACC is ensuring that the catheter stays inside the adductor canal. Since the adductor canal itself is very narrow, the catheter tip can easily migrate out of the canal with patient movement and mobilization, resulting in no sensory block and inadequate analgesia. It is not uncommon for patients to initially have well working CACB, but to experience significant rebound pain on postoperative days (POD) 1 or 2 due to catheter dislodgement out of the canal. In order to address these issues we have developed a novel insertion approach for ACC is inserted into the inter-fascial plane between the Sartorius muscle and femoral artery (ISAFE). In this technique, the needle is inserted into the plane between the sartorius muscle and FA. A catheter is then threaded between the artery and muscle, well away from the FV. This facilitates keeping the needle away from the vein and maintaining more catheter length inside the adductor canal, thereby preventing catheter dislodgement. The insertion angle of the needle is shallower when compared to the classic ACC technique, allowing for better needle visualization, and steering clear of the FV. While the needle is still in close proximity to the FA, this vessel is easier to visualize, more difficult to puncture, and is much less likely to result in LAST. While the ISAFE technique is an exciting novel approach for ACC insertion, it still requires evaluation in terms of analgesia efficacy and superiority in terms of reducing catheter dislodgement. Significance There are no published prospective randomized controlled trials that compare insertion techniques for ACC and their respective outcomes in terms of catheter positioning, dislodgement, and safety. As TKA is a frequent type of surgery and has the prediction to increase its incidence for the next years, there is significant importance in investigations about interventions which may improve its recovery in an outpatient regime. A postoperative analgesic technique that offers better pain control, has less adverse effects, reduces the opioid analgesia requirement and is safe may have additional impact on decreasing health care cost and may lead to an enhanced recovery and better quality of life. Objectives The primary objective will be to evaluate the rate of ACC dislodgement when using the ISAFE approach for CACB in patients undergoing TKA (by measuring cumulative postoperative opioid consumption), in comparison with the classical ACC insertion technique. The secondary objective is to assess the quality of analgesia as measured by pain scores and opioid consumption, and complications relating to the perineural catheter use. Hypothesis The ISAFE insertion approach for ACC in patients undergoing TKA will lead to a reducing in catheter dislodgement rates. Methods Study type This will be a Randomized controlled prospective trial, blinded for patient and evaluator, in patients undergoing inpatient TKA at Sinai Health. After Hospital's Ethics in Research Board approval, the recruitment will begin. Patients will be assessed about their eligibility for participating and after plain clear information about the study interventions they will or will not authorize their inclusion and data collection, through the signature of a written consent. Perioperative management and interventions The subjects will have their surgeries booked in advance and they will be submitted to the pre anesthesia consult at the Pre Admission Unit a few days before the surgery. The study proposal will be explained to the patients on that occasion and they will receive a booklet with the information about the study as well as the consent form that they will bring home to review. They will have the time between the pre anesthesia assessment and the surgery (at least 24 hours) to review and consent to the study. Patients will be randomized to one of the two groups using a computer-generated random numbers table. The randomization will be done before the beginning of the study and will define which study number is going to be managed as intervention group (ISAFE approach) or control group (classic approach). Each patient will receive a study number following the order of their entrance on the study and that number will be already linked for one of the two groups. Closed envelopes will be prepared ahead and each of them will have the name of the group related to its study number. Once the the patient is included, the professional who inserts the catheter will check inside the envelope which group the patient is randomized to, in order to perform the predicted technique. A list with the study numbers and the randomization will be kept by the research assistant, under password protection, and will be shared with other researches only after recruitment is finished. The research coordinator, and the professional who performs the postoperative adductor canal assessments will be blinded to which group each patient was randomized to. The professional who inserts the catheters will not be blinded as they will need to know which insertion approach to take. All patients will receive the same perioperative management. Patients will initially be brought to a dedicated block room where a safety checklist will be performed by the block room team. Standard Canadian Anesthesia Society monitoring will be provided. Mild sedation with Midazolam 0.5-2mg and Fentanyl 25-100mcg might be administered for anxiolysis and analgesia. After proper cleaning of the ipsilateral thigh, under sterile technique and ultrasound guidance (Sonosite Edge II ultrasound machine), an adductor canal block (injection of 15 mL of Ropivacaine 0.5% with epinephrine 1:200,000) and an IPACK block (injection of 15 mL of Ropivacaine 0.25% with epinephrine 1:200,000) will be performed. Cumulative local anesthetic doses will be preemptively calculated to avoid a total Ropivacaine dose of > 3mg/kg. After the peripheral nerve blocks, all patients will receive standard spinal or general anesthesia. All intraoperative opioids administered will be recorded. In the intra-operative period, each patient will receive IV Cefazolin 2g, Tranexamic acid 20mg/kg, Dexamethasone 0.1mg/kg, and Ondansetron 4mg. At the end of the procedure the surgeons will infiltrate the surgical site with 200 mg of Ropivacaine 0.2%. After surgery, the patient will be taken to the Post Anesthesia Care Unit. At this moment, an Arrow® (StimuCath® Continuous Peripheral Nerve Block Catheter) continuous adductor canal block catheter will be inserted using a Sonosite Edge II ultrasound machine. A bolus of 5-10mL of saline solution (NaCl 0.9%) with epinephrine 1:200,000 will be given, after negative aspiration, following adductor canal catheter insertion and the patient will be monitored for any heart rate change in order to rule out intravascular catheter placement. The catheter will be well secured with an adhesive fixation device to avoid displacement. Following catheter placement, the catheter will be aspirated to check for blood to ensure there is no intravascular placement. The peripheral nerve catheter will be connected to an elastomeric infusion pump and will infuse Ropivacaine 0.2% at a rate of 5 ml/hour, as per the standard Sinai Health practice for inpatient CACB. Adductor canal catheter will be placed following the surgery in the post-anesthetic care unit in order to avoid catheter displacement by the thigh tourniquet used intraoperatively. The adductor canal catheter stays in place infusing for 48 hours. The patients are discharged home after achieving the discharge criteria by orthopedics team in charge, keeping the peripheral nerve catheter with the same infusion rate, if they go home before completing the 48 hours of infusion. Prior to going home, patients receive education and written information (educational pamphlet) regarding monitoring for local anesthetic systemic toxicity symptoms, possible CABC associated complications including potential transient muscle weakness, and instructions on patient removal of the catheter after infusion end. This pamphlet contains contact information for anesthesia team or Acute Pain Service, in case of any events, adverse effects or questions the patients may have about the peripheral nerve catheter. A phone number to contact each patient at home is collected before they are discharged and they are followed up by phone calls, during the infusion period. This is already done as standard of care for all knee arthroplasty surgeries.Standard oral analgesic scheme will be prescribed to every patient (Acetaminophen 650mg QID, Celecoxib 200mg BID, Hydromorphone 1-2mg PRN Q4Hs). Sample size The sample size was calculated based on previous study that ACC dislodgement rate of 13%. This study measured catheter dislodgement at the skin, so we believe this rate significantly underestimates the rate of dislodgement out of the adductor canal and that sonographic assessments will have a much higher sensitivity for such events. Local pilot data suggests that using the ISAFE approach, ACC dislodgements are only 5%. Using a predicted catheter dislodgement rate of 25% for conventional approach, and an expected reduction for of dislodgement rate down to 5% with ISAFE approach, considering α=0.05 and a power of 80%, 49 subjects will be needed in each group for a total of 98 patients. To compensate for anticipated dropouts from the study, we plan for an inclusion of 100 patients. Study data analysis Normal distributed variables values will be presented and analyzed as mean values +- standard deviation. Non-normal distributed variables values will be presented and analyzed as median and minimum and maximum values. Qualitative variables will be presented as frequency of occurrence. Statistical test to be performed might be: t-Student, Kruskal-Wallis and Chi-square. Statistical software will be used for analysis: SPSS 13.0 for Windows (SPSS Inc, Chicago, IL, USA) and GraphPad Prism Version 4.00 for Windows (GraphPad Software, San Diego, CA, USA). Inclusion Criteria: - Patients undergoing primary or revision Total Knee Arthroplasty in the inpatient setting. Non-pregnant patients older than 21 years of age, with American Society of Anesthesiologists (ASA) physical status I-IV. Exclusion Criteria: - Patients undergoing outpatient TKA. Chronic opioid use of oral morphine 30mg equivalent per day for last 2 consecutive weeks. Patients with contraindications to the insertion of an adductor canal catheter (severe anatomic abnormalities, local or systemic infection, or a history of previous surgery at the site of catheter placement).

NCT0531xxxx/NCT05313282.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313282</url> </required_header> <id_info> <org_study_id>TRIPLET-III</org_study_id> <nct_id>NCT05313282</nct_id> </id_info> <brief_title>A Trial of Hepatic Arterial Infusion Combined With Apatinib and Camrelizumab Versus Apatinib and Camrelizumab for C-staged Hepatocellular Carcinoma in BCLC Classification</brief_title> <acronym>TRIPLET-III</acronym> <official_title>A Randomized Controlled, Open-label, Multicenter Phase III Clinical Trial to Evaluate the Effectiveness and Safety of Hepatic Arterial Infusion Chemotherapy (HAIC) of Oxaliplatin, 5-fluorouracil and Leucovorin (mFOLFOX7) Combined With Apatinib and Camrelizumab Versus Apatinib and Camrelizumab for C-staged Hepatocellular Carcinoma in BCLC Classification.</official_title> <sponsors> <lead_sponsor> <agency>Sun Yat-sen University</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Jiangsu HengRui Medicine Co., Ltd.</agency> <agency_class>Industry</agency_class> </collaborator> </sponsors> <source>Sun Yat-sen University</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> This study was designed to evaluate the effectiveness and safety of hepatic arterial infusion chemotherapy combined with Apatinib and Camrelizumab (treatment group) versus Apatinib and Camrelizumab (control group) for C-staged Hepatocellular Carcinoma in BCLC classification.  The primary outcome measure is to evaluate the progression-free-survival (PFS) of treatment group and control group for C-staged Hepatocellular Carcinoma in BCLC classification.  The secondary Outcome measures include the overall survival (OS), time to progress (TTP), time-to-response (TTR), duration of response (DOR), objective response rate (ORR) and disease control rate (DCR) of treatment group and control group for C-staged Hepatocellular Carcinoma in BCLC classification.  Moreover, this study aims to assess the safety and tolerability of treatment group and control group for C-staged Hepatocellular Carcinoma in BCLC classification. </textblock> </brief_summary> <detailed_description> <textblock> Primary liver cancer is a common malignant tumor of the digestive system in the world. There are about 854,000 new incidences and 810,000 mortality each year. In China, there is a high incidence of liver cancer, with about 466,000 new cases and 422,000 mortality each year. Hepatocellular carcinoma (HCC) accounted for about 90% of primary liver cancer in pathological type. Most patients have reached advanced stage or with distant metastasis when diagnosed and the natural median survival time is only 3 to 4 months. Then only systemic therapy is recommended for patients in advanced HCC in many global guidelines.  Hepatic arterial infusion chemotherapy (HAIC) of mFOLFOX7, anti-angiogenic targeting drugs, and antibody immunotherapy against programmed death molecule-1 (PD-1) immunological checkpoints are effective treatment options for advanced hepatocellular carcinoma. Many clinical studies have shown that the two-two combination of the above three treatment options can improve the anti-tumor overall response rate, the survival rate and even achieve clinical complete remission of patients with advanced HCC.  Shi Ming et al reported HAIC combined with systemic targeted therapy has a better survival outcome compared to systemic targeted therapy mono-therapy [OS 13.37 vs 7.13 months, PFS 7.03 vs 2.6 months] in JAMA Oncology. Although the toxicity of combination therapy is slightly higher than that of sorafenib monotherapy, these adverse effects are tolerable.  In addition, in a phase Ib study of Camrelizumab combined with apatinib in the treatment of advanced liver cancer, gastric cancer or gastroesophageal junction cancer showed that in 16 patients with HCC, the ORR was 50.0% and the DCR was 93.8%. When the dose of apatinib was 250 mg, the median PFS was 7.2 months. Camrelizumab combined with low dose apatinib can effectively reduce the incidence of adverse reactions, ≥10% of patients have treatment-related adverse reactions (all levels), no treatment-related adverse reactions leading to death. Therefore, low-dose anti-angiogenic drugs can inhibit tumor angiogenesis on the one hand, reduce immunosuppression by inducing normalization of blood vessels, enhance effector immune cell infiltration, and enhance anti-tumor immunity.  In summary, for patients of C-staged Hepatocellular Carcinoma, HAIC, anti-angiogenic targeted therapy, and anti-PD-1 immunotherapy have their important status, and the combination of any two treatments brings about synergy effect. Then, could the combination of the three treatment methods further improve the outcome of advanced hepatocellular carcinoma? A phase-II study conducted by our team revealed that a combination of hepatic arterial infusion chemotherapy, targeted drugs (Apatinib), and anti-PD-1 immunotherapy (Camrelizumab) showed promising clinical benefits and acceptable safety for BCLC Stage C HCC, as the confirmed ORR was 61.54% per RECIST 1.1. However, there is no prospective randomized study to prove the efficacy and safety of HAIC combined with apatinib and camrelizumab. So this study was designed to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy combined with Apatinib and Camrelizumab versus Apatinib and Camrelizumab to provide a more effective and toxic-tolerable treatment for patients in C-staged Hepatocellular Carcinoma in BCLC classification. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">June 15, 2022</start_date> <completion_date type="Anticipated">June 1, 2025</completion_date> <primary_completion_date type="Anticipated">November 1, 2024</primary_completion_date> <phase>Phase 3</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>The progression-free survival (PFS) by RECIST 1.1</measure> <time_frame>From date of first dose of study drug to the date of first documentation of disease progression or death, whichever occurs first (up to approximately 3 years)</time_frame> </primary_outcome> <secondary_outcome> <measure>The progression-free survival (PFS) by mRECIST</measure> <time_frame>From date of first dose of study drug to the date of first documentation of disease progression or death, whichever occurs first (up to approximately 3 years)</time_frame> </secondary_outcome> <secondary_outcome> <measure>The overall survival (OS)</measure> <time_frame>From date of first dose of study drug to the date of first documentation of death from any cause, whichever occurs first (up to approximately 3 years)</time_frame> </secondary_outcome> <secondary_outcome> <measure>Time to progress (TTP) by RECIST 1.1 and mRECIST</measure> <time_frame>From date of first dose of study drug until disease progression or death (up to approximately 3 years)</time_frame> </secondary_outcome> <secondary_outcome> <measure>Time to response (TTR) by RECIST 1.1 and mRECIST</measure> <time_frame>From date of first dose of study drug until the first documentation of CR or PR</time_frame> </secondary_outcome> <secondary_outcome> <measure>Duration of response (DOR) by RECIST 1.1 and mRECIST</measure> <time_frame>From the first documentation of CR or PR to the first date of documentation of disease progression or death whichever occurs first (up to approximately 3 years)</time_frame> <description>DOR is defined as the time from the first documentation of CR or PR to the date of first documentation of disease progression or death (whichever occurs first) as assessed by RECIST 1.1 and mRECIST</description> </secondary_outcome> <secondary_outcome> <measure>Objective response rate (ORR) by RECIST 1.1 and mRECIST</measure> <time_frame>From date of first dose of study drug until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination (up to approximately 3 years)</time_frame> <description>ORR is defined as the percentage of participants who have best overall response (BOR) of complete response (CR) or partial response (PR) at the time of data cutoff as assessed by RECIST 1.1 and mRECIST</description> </secondary_outcome> <secondary_outcome> <measure>The disease control rate (DCR)</measure> <time_frame>From date of first dose of study drug until disease progression, stable disease, development of unacceptable toxicity, withdrawal of consent, or sponsor termination (up to approximately 3 years)</time_frame> <description>DCR is defined as the percentage of participants who have best overall response (BOR) of complete response (CR) or partial response (PR) or stable disease (SD) at the time of data cutoff as assessed by RECIST 1.1 and mRECIST</description> </secondary_outcome> <secondary_outcome> <measure>Number of participants with treatment-related adverse events as assessed by CTCAE v4.0</measure> <time_frame>From the start date of the Treatment Phase until date of death from any cause (up to approximately 3 years)</time_frame> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">140</enrollment> <condition>C-staged Hepatocellular Carcinoma in BCLC Classification</condition> <arm_group> <arm_group_label>treatment group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>combination of hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin (mFOLFOX7) , targeted drugs (Apatinib 250mg), and anti-PD-1 immunotherapy (Camrelizumab 200mg)</description> </arm_group> <arm_group> <arm_group_label>control group</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>combination of targeted drugs (Apatinib 250mg), and anti-PD-1 immunotherapy (Camrelizumab 200mg)</description> </arm_group> <intervention> <intervention_type>Combination Product</intervention_type> <intervention_name>Hepatic Arterial Infusion combined with Apatinib and Camrelizumab</intervention_name> <description>Drug: FOLFOX Protocol (Oxaliplatin, fluorouracil, and leucovorin); Camrelizumab for injection and Apatinib-Mesylate Tablets Procedure: 1. On the first day of treatment, HAIC was conducted through a catheter intubated into the tumor feeding artery under DSA guidance with the following chemotherapeutic drugs (mFOLFOX7, oxaliplatin 85 mg/m2 2 hours, folinic acid 400 mg/m2, 5-FU 2500 mg/m2 46 hours) pumped into the tumor artery. The HAIC is repeated every 3 weeks. The cumulative maximum sessions of HAIC is up to 6 times. 2. Taking Apatinib-Mesylate Tablets (250 mg/tablet) orally on the 8th day 30minutes after meals, once a day, for continuous medication. 3. On the 22nd day of treatment, namely the second session of HAIC, intravenous infusion of Camrelizumab 200mg every 3 weeks. 4. The cumulative maximum drug use period is up to 2 years. The patient is concurrent on medication until the treatment discontinuation criteria specified in the protocol appear.</description> <arm_group_label>treatment group</arm_group_label> </intervention> <intervention> <intervention_type>Combination Product</intervention_type> <intervention_name>Apatinib combined with Camrelizumab</intervention_name> <description>Drug: Camrelizumab for injection and Apatinib-Mesylate Tablets Procedure: 1. Taking Apatinib-Mesylate Tablets (250 mg/tablet) orally 30minutes after meals, once a day, for continuous medication 2. Intravenous infusion of Camrelizumab 200mg every 2 weeks.</description> <arm_group_label>control group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. The patient voluntarily joins the study and signs an informed consent;  2. Age ≥ 18 years old,both men and women;  3. Clinical or pathologically confirmed unresectable BCLC C-stage hepatocellular carcinoma according to AASLD: HCC with vascular invasion and/or extrahepatic metastasis which is not suitable for radical surgery and/or local therapy, or progressed after surgery and/or local therapy  4. No prior systemic therapy;  5. At least one intrahepatic evaluable tumor existed according to RECIST 1.1;  6. Child-Pugh score small or equal to 6 points ;  7. Patient can swallow tablet normally;  8. ECOG score: 0 to 1 (according to the ECOG score classification);  9. The expected survival is longer than 12 weeks;  10. The laboratory parameters meets the following requirements (no blood components and cell growth factors are allowed within 14 days before the first dose):  - Absolute neutrophil count ≥ 3.0 × 10^9 / L;  - Platelets ≥ 80 × 10^9 / L;  - Hemoglobin ≥ 90 g / L;  - serum albumin ≥ 28 g / L;  - Thyroid stimulating hormone (TSH) ≤ 1 × ULN (if abnormalities should be considered at the same time FT3, FT4 levels, patients with FT3 and FT4 levels in normal range can also be enrolled);  - bilirubin ≤ 1.5 × ULN (within 7 days prior to the first dose);  - ALT ≤ 3 x ULN and AST ≤ 3 x ULN (within 7 days prior to the first dose);  - AKP ≤ 2.5 × ULN; serum creatinine ≤ 1.5 × ULN;  11. Patients with active hepatitis B virus (HBV) infection recieve anti-HBV therapy at the screening stage and are willing to receive antiviral therapy throughout the study period; hepatitis C virus (HCV) ribonucleic acid (RNA)-positive patients must receive antiviral therapy according to local standard treatment guidelines;  12. For female that non-surgical sterilization or in childbearing age need to use a medically approved contraceptive (such as an intrauterine device, contraceptive or condom) during the study period and within 3 months after the end of the study treatment period; For female that non-surgical sterilization or in childbearing age must have a negative serum or urine HCG test within 72 hours prior to study enrollment; and must be non-lactating; for male patients whose partner in a childbearing age, effective methods of contraception should be given during the trial and at the end of Camrelizumab injection.  Exclusion Criteria:  1. The patient has any active auto-immune disease or a history of auto-immune disease (such as the following, but not limited to: auto-immune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, thyroid hyperfunction; patients with vitiligo. For patient with history of asthma, complete remission of asthma in childhood without any intervention after adulthood can be included, while those asthma patients who require bronchodilators for medical intervention cannot be included.);  2. The patient is using immunosuppressive agents or systemic hormonal therapy for immunosuppression purposes (dose > 10 mg/day of prednisone or other therapeutic hormones) and continues to be used within 2 weeks prior to enrollment;  3. Severe allergic reactions to other monoclonal antibodies;  4. Known for a history of central nervous system metastasis or hepatic encephalopathy;  5. Having a history of organ transplantation;  6. Patients with clinically symptomatic ascites who require puncture, drainage, or ascites drainage within 3 months, except for those who have a small amount of ascites but no clinical symptoms;  7. Suffering from hypertension, and cannot be well controlled by antihypertensive drugs (systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥90 mmHg);  8. Suffering heart diseases with clinical symptoms or those not well controlled, such as: (1) heart failure in NYHA class 2 or higher; (2) unstable angina; (3) myocardial infarction occurred within 1 year; (4) clinically symptomatic supraventricular or ventricular arrhythmia requiring treatment or intervention; (5) Tc > 450ms (male); QTc > 470ms (female);  9. Coagulation dysfunction (INR>2.0, PT>16s), bleeding tendency or receiving thrombolysis or anticoagulant therapy, allowing prophylactic use of low-dose aspirin or low molecular heparin;  10. There are significant clinically significant bleeding symptoms or clear bleeding tendency within 3 months before enrollment, such as hemoptysis of 2.5ml or more per day, gastrointestinal bleeding, esophageal varices with bleeding risk, hemorrhagic gastric ulcer or vasculitis, etc. If the fecal occult blood is positive in the baseline period, it can be watched, then gastroscope is needed for those fecal occult blood is still positive. If the gastroscope indicates severe esophageal varices, it cannot be enrolled, except for those who have undergone gastroscopy within a month or less to exclude such cases);  11. Events of arterial/venous thrombosis occurring within the first 6 months of enrollment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;  12. There are known hereditary or acquired bleeding and thrombophilia (such as hemophilia patients, coagulopathy, thrombocytopenia, etc.);  13. Urine routine indicates that urine protein ≥ ++ and 24-hour urine protein amount > 1.0g was confirmed;  14. The patient has active infection, unexplained fever (≥38.5 °C) within 3 days before administration, or baseline white blood cell count>15×109/L; 15 Patients with congenital or acquired immunodeficiency (such as HIV-infected patients);  16. HBV-DNA>2000 IU/ml (or 104 copies/ml); or HCV-RNA>103 copies/ml; or HBsAg+ and anti-HCV antibody positive patients; 17. The patient has had other malignant tumors in the past 3 years or at the same time (except for cured skin basal cell carcinoma and cervical carcinoma in situ); 18. Patients with bone metastases who had received palliative radiotherapy >4% of the bone marrow area within 4 weeks prior to participation in the study; 19. Patients have previously received other anti-PD-1 antibody therapy or other immunotherapy against PD-1/PD-L1, or have received apatinib before; 20. Inoculation of a live vaccine within less than 4 weeks prior to study or possibly during the study period; 21. Pregnant or lactating women, or women of childbearing age who are unwilling to take contraceptive measures; 22. According to the investigators, the patient has other factors that may affect the results of the study or lead to the termination of the study, such as alcohol abuse, drug abuse, other serious diseases (including mental illness) requiring combined treatment, and serious laboratory tests, abnormalities, accompanied by factors such as family or society, which may affect the safety of enrolled patients. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_contact> <last_name>Yang-kui Gu, Prof.</last_name> <phone>13822197618</phone> <phone_ext>13822197618</phone_ext> <email>guyk@sysucc.org.cn</email> </overall_contact> <overall_contact_backup> <last_name>Meng-xuan Zuo, Dr.</last_name> <phone>18924266069</phone> <phone_ext>18924266069</phone_ext> <email>zuomx@sysucc.org.cn</email> </overall_contact_backup> <location> <facility> <name>Sun Yat-sen University Cancer Center</name> <address> <city>Guangzhou</city> <state>Guangdong</state> <zip>510060</zip> <country>China</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Yang-kui Gu, Prof.</last_name> <phone>13822197618</phone> <phone_ext>13822197618</phone_ext> <email>guyk@sysucc.org.cn</email> </contact> </location> <location> <facility> <name>Sun Yat-Sen Memorial Hospital</name> <address> <city>Guangzhou</city> <state>Guangdong</state> <zip>510120</zip> <country>China</country> </address> </facility> <status>Not yet recruiting</status> <contact> <last_name>Zhi-yu Xiao, Prof.</last_name> <phone>13682283695</phone> <phone_ext>13682283695</phone_ext> </contact> </location> <location> <facility> <name>Nanfang Hospital of Southern Medical University</name> <address> <city>Guangzhou</city> <state>Guangdong</state> <zip>510510</zip> <country>China</country> </address> </facility> <status>Not yet recruiting</status> <contact> <last_name>Jing-zhang Chen, Prof.</last_name> <phone>13802522545</phone> <phone_ext>13802522545</phone_ext> </contact> </location> <location> <facility> <name>The Third Affiliated Hospital of Sun Yat-Sen University</name> <address> <city>Guanzhou</city> <state>Guangdong</state> <zip>510630</zip> <country>China</country> </address> </facility> <status>Not yet recruiting</status> <contact> <last_name>Nan Lin, Prof.</last_name> <phone>13925027138</phone> <phone_ext>13925027138</phone_ext> </contact> </location> <location> <facility> <name>Xiangya Hospital of Central South University</name> <address> <city>Changsha</city> <state>Hunan</state> <zip>410013</zip> <country>China</country> </address> </facility> <status>Not yet recruiting</status> <contact> <last_name>Liang-rong Shi, Prof.</last_name> <phone>13974886662</phone> <phone_ext>13974886662</phone_ext> </contact> </location> <location_countries> <country>China</country> </location_countries> <reference> <citation>Lyu N, Kong Y, Mu L, Lin Y, Li J, Liu Y, Zhang Z, Zheng L, Deng H, Li S, Xie Q, Guo R, Shi M, Xu L, Cai X, Wu P, Zhao M. Hepatic arterial infusion of oxaliplatin plus fluorouracil/leucovorin vs. sorafenib for advanced hepatocellular carcinoma. J Hepatol. 2018 Jul;69(1):60-69. doi: 10.1016/j.jhep.2018.02.008. Epub 2018 Feb 20.</citation> <PMID>29471013</PMID> </reference> <reference> <citation>He M, Li Q, Zou R, Shen J, Fang W, Tan G, Zhou Y, Wu X, Xu L, Wei W, Le Y, Zhou Z, Zhao M, Guo Y, Guo R, Chen M, Shi M. Sorafenib Plus Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil, and Leucovorin vs Sorafenib Alone for Hepatocellular Carcinoma With Portal Vein Invasion: A Randomized Clinical Trial. JAMA Oncol. 2019 Jul 1;5(7):953-960. doi: 10.1001/jamaoncol.2019.0250.</citation> <PMID>31070690</PMID> </reference> <verification_date>June 2022</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>June 15, 2022</last_update_submitted> <last_update_submitted_qc>June 15, 2022</last_update_submitted_qc> <last_update_posted type="Actual">June 16, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Sun Yat-sen University</investigator_affiliation> <investigator_full_name>Yang-kui Gu</investigator_full_name> <investigator_title>Associate Professor</investigator_title> </responsible_party> <keyword>C-staged Hepatocellular Carcinoma</keyword> <keyword>hepatic arterial infusion chemotherapy</keyword> <keyword>anti-PD-1 immunotherapy</keyword> <keyword>Camrelizumab</keyword> <keyword>anti-angiogenic targeted therapy</keyword> <keyword>Apatinib</keyword> <condition_browse>  <mesh_term>Carcinoma</mesh_term> <mesh_term>Carcinoma, Hepatocellular</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Apatinib</mesh_term> </intervention_browse>  </clinical_study>

This study was designed to evaluate the effectiveness and safety of hepatic arterial infusion chemotherapy combined with Apatinib and Camrelizumab (treatment group) versus Apatinib and Camrelizumab (control group) for C-staged Hepatocellular Carcinoma in BCLC classification. The primary outcome measure is to evaluate the progression-free-survival (PFS) of treatment group and control group for C-staged Hepatocellular Carcinoma in BCLC classification. The secondary Outcome measures include the overall survival (OS), time to progress (TTP), time-to-response (TTR), duration of response (DOR), objective response rate (ORR) and disease control rate (DCR) of treatment group and control group for C-staged Hepatocellular Carcinoma in BCLC classification. Moreover, this study aims to assess the safety and tolerability of treatment group and control group for C-staged Hepatocellular Carcinoma in BCLC classification. Primary liver cancer is a common malignant tumor of the digestive system in the world. There are about 854,000 new incidences and 810,000 mortality each year. In China, there is a high incidence of liver cancer, with about 466,000 new cases and 422,000 mortality each year. Hepatocellular carcinoma (HCC) accounted for about 90% of primary liver cancer in pathological type. Most patients have reached advanced stage or with distant metastasis when diagnosed and the natural median survival time is only 3 to 4 months. Then only systemic therapy is recommended for patients in advanced HCC in many global guidelines. Hepatic arterial infusion chemotherapy (HAIC) of mFOLFOX7, anti-angiogenic targeting drugs, and antibody immunotherapy against programmed death molecule-1 (PD-1) immunological checkpoints are effective treatment options for advanced hepatocellular carcinoma. Many clinical studies have shown that the two-two combination of the above three treatment options can improve the anti-tumor overall response rate, the survival rate and even achieve clinical complete remission of patients with advanced HCC. Shi Ming et al reported HAIC combined with systemic targeted therapy has a better survival outcome compared to systemic targeted therapy mono-therapy [OS 13.37 vs 7.13 months, PFS 7.03 vs 2.6 months] in JAMA Oncology. Although the toxicity of combination therapy is slightly higher than that of sorafenib monotherapy, these adverse effects are tolerable. In addition, in a phase Ib study of Camrelizumab combined with apatinib in the treatment of advanced liver cancer, gastric cancer or gastroesophageal junction cancer showed that in 16 patients with HCC, the ORR was 50.0% and the DCR was 93.8%. When the dose of apatinib was 250 mg, the median PFS was 7.2 months. Camrelizumab combined with low dose apatinib can effectively reduce the incidence of adverse reactions, ≥10% of patients have treatment-related adverse reactions (all levels), no treatment-related adverse reactions leading to death. Therefore, low-dose anti-angiogenic drugs can inhibit tumor angiogenesis on the one hand, reduce immunosuppression by inducing normalization of blood vessels, enhance effector immune cell infiltration, and enhance anti-tumor immunity. In summary, for patients of C-staged Hepatocellular Carcinoma, HAIC, anti-angiogenic targeted therapy, and anti-PD-1 immunotherapy have their important status, and the combination of any two treatments brings about synergy effect. Then, could the combination of the three treatment methods further improve the outcome of advanced hepatocellular carcinoma? A phase-II study conducted by our team revealed that a combination of hepatic arterial infusion chemotherapy, targeted drugs (Apatinib), and anti-PD-1 immunotherapy (Camrelizumab) showed promising clinical benefits and acceptable safety for BCLC Stage C HCC, as the confirmed ORR was 61.54% per RECIST 1.1. However, there is no prospective randomized study to prove the efficacy and safety of HAIC combined with apatinib and camrelizumab. So this study was designed to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy combined with Apatinib and Camrelizumab versus Apatinib and Camrelizumab to provide a more effective and toxic-tolerable treatment for patients in C-staged Hepatocellular Carcinoma in BCLC classification. Inclusion Criteria: 1. The patient voluntarily joins the study and signs an informed consent; 2. Age ≥ 18 years old,both men and women; 3. Clinical or pathologically confirmed unresectable BCLC C-stage hepatocellular carcinoma according to AASLD: HCC with vascular invasion and/or extrahepatic metastasis which is not suitable for radical surgery and/or local therapy, or progressed after surgery and/or local therapy 4. No prior systemic therapy; 5. At least one intrahepatic evaluable tumor existed according to RECIST 1.1; 6. Child-Pugh score small or equal to 6 points ; 7. Patient can swallow tablet normally; 8. ECOG score: 0 to 1 (according to the ECOG score classification); 9. The expected survival is longer than 12 weeks; 10. The laboratory parameters meets the following requirements (no blood components and cell growth factors are allowed within 14 days before the first dose): - Absolute neutrophil count ≥ 3.0 × 10^9 / L; - Platelets ≥ 80 × 10^9 / L; - Hemoglobin ≥ 90 g / L; - serum albumin ≥ 28 g / L; - Thyroid stimulating hormone (TSH) ≤ 1 × ULN (if abnormalities should be considered at the same time FT3, FT4 levels, patients with FT3 and FT4 levels in normal range can also be enrolled); - bilirubin ≤ 1.5 × ULN (within 7 days prior to the first dose); - ALT ≤ 3 x ULN and AST ≤ 3 x ULN (within 7 days prior to the first dose); - AKP ≤ 2.5 × ULN; serum creatinine ≤ 1.5 × ULN; 11. Patients with active hepatitis B virus (HBV) infection recieve anti-HBV therapy at the screening stage and are willing to receive antiviral therapy throughout the study period; hepatitis C virus (HCV) ribonucleic acid (RNA)-positive patients must receive antiviral therapy according to local standard treatment guidelines; 12. For female that non-surgical sterilization or in childbearing age need to use a medically approved contraceptive (such as an intrauterine device, contraceptive or condom) during the study period and within 3 months after the end of the study treatment period; For female that non-surgical sterilization or in childbearing age must have a negative serum or urine HCG test within 72 hours prior to study enrollment; and must be non-lactating; for male patients whose partner in a childbearing age, effective methods of contraception should be given during the trial and at the end of Camrelizumab injection. Exclusion Criteria: 1. The patient has any active auto-immune disease or a history of auto-immune disease (such as the following, but not limited to: auto-immune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, thyroid hyperfunction; patients with vitiligo. For patient with history of asthma, complete remission of asthma in childhood without any intervention after adulthood can be included, while those asthma patients who require bronchodilators for medical intervention cannot be included.); 2. The patient is using immunosuppressive agents or systemic hormonal therapy for immunosuppression purposes (dose > 10 mg/day of prednisone or other therapeutic hormones) and continues to be used within 2 weeks prior to enrollment; 3. Severe allergic reactions to other monoclonal antibodies; 4. Known for a history of central nervous system metastasis or hepatic encephalopathy; 5. Having a history of organ transplantation; 6. Patients with clinically symptomatic ascites who require puncture, drainage, or ascites drainage within 3 months, except for those who have a small amount of ascites but no clinical symptoms; 7. Suffering from hypertension, and cannot be well controlled by antihypertensive drugs (systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥90 mmHg); 8. Suffering heart diseases with clinical symptoms or those not well controlled, such as: (1) heart failure in NYHA class 2 or higher; (2) unstable angina; (3) myocardial infarction occurred within 1 year; (4) clinically symptomatic supraventricular or ventricular arrhythmia requiring treatment or intervention; (5) Tc > 450ms (male); QTc > 470ms (female); 9. Coagulation dysfunction (INR>2.0, PT>16s), bleeding tendency or receiving thrombolysis or anticoagulant therapy, allowing prophylactic use of low-dose aspirin or low molecular heparin; 10. There are significant clinically significant bleeding symptoms or clear bleeding tendency within 3 months before enrollment, such as hemoptysis of 2.5ml or more per day, gastrointestinal bleeding, esophageal varices with bleeding risk, hemorrhagic gastric ulcer or vasculitis, etc. If the fecal occult blood is positive in the baseline period, it can be watched, then gastroscope is needed for those fecal occult blood is still positive. If the gastroscope indicates severe esophageal varices, it cannot be enrolled, except for those who have undergone gastroscopy within a month or less to exclude such cases); 11. Events of arterial/venous thrombosis occurring within the first 6 months of enrollment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; 12. There are known hereditary or acquired bleeding and thrombophilia (such as hemophilia patients, coagulopathy, thrombocytopenia, etc.); 13. Urine routine indicates that urine protein ≥ ++ and 24-hour urine protein amount > 1.0g was confirmed; 14. The patient has active infection, unexplained fever (≥38.5 °C) within 3 days before administration, or baseline white blood cell count>15×109/L; 15 Patients with congenital or acquired immunodeficiency (such as HIV-infected patients); 16. HBV-DNA>2000 IU/ml (or 104 copies/ml); or HCV-RNA>103 copies/ml; or HBsAg+ and anti-HCV antibody positive patients; 17. The patient has had other malignant tumors in the past 3 years or at the same time (except for cured skin basal cell carcinoma and cervical carcinoma in situ); 18. Patients with bone metastases who had received palliative radiotherapy >4% of the bone marrow area within 4 weeks prior to participation in the study; 19. Patients have previously received other anti-PD-1 antibody therapy or other immunotherapy against PD-1/PD-L1, or have received apatinib before; 20. Inoculation of a live vaccine within less than 4 weeks prior to study or possibly during the study period; 21. Pregnant or lactating women, or women of childbearing age who are unwilling to take contraceptive measures; 22. According to the investigators, the patient has other factors that may affect the results of the study or lead to the termination of the study, such as alcohol abuse, drug abuse, other serious diseases (including mental illness) requiring combined treatment, and serious laboratory tests, abnormalities, accompanied by factors such as family or society, which may affect the safety of enrolled patients.

NCT0531xxxx/NCT05313295.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313295</url> </required_header> <id_info> <org_study_id>FiNeuro</org_study_id> <nct_id>NCT05313295</nct_id> </id_info> <brief_title>Physical Therapy Treatment on Children and Adolescents With Neurological Pathologies</brief_title> <official_title>Effects of the Physical Therapy Treatment on Children and Adolescents With Chronic and Neurological Pathologies Affecting Their Sensorimotor Abilities.</official_title> <sponsors> <lead_sponsor> <agency>Universidad de Almeria</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Universidad de Almeria</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> To evaluate the positive effects of a home-based physical therapy intervention added to the usual physical therapy programs performed in children with neurological pathologies that induce sensorimotor impairments that affect their quality of life and the importance of the implications of their families in their treatment. </textblock> </brief_summary> <overall_status>Completed</overall_status> <start_date type="Actual">November 1, 2018</start_date> <completion_date type="Actual">May 10, 2023</completion_date> <primary_completion_date type="Actual">November 30, 2022</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>Double (Care Provider, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Motor Function Measure</measure> <time_frame>One Year</time_frame> <description>Measurement scale for motor function applied to neuromuscular diseases (MFM): It was created in France in order to perform a better evaluation of global motor function in patients with Duchenne's muscular dystrophy (DMD), both for ambulatory and non-ambulatory patients. It has two versions, MFM 20 for children under 6 years of age and MFM 32 for children over 6 years of age. The scale considers three dimensions: (D1) standing station and transfers; (D2) axial and proximal motor skills and (D3) distal motor skills. The sum of the three results in a global percentage that provides an updated overview of the patient's functional diagnosis. (Trundell et al., 2020)</description> </primary_outcome> <secondary_outcome> <measure>Brooke Upper Extremity Scale</measure> <time_frame>One Year</time_frame> <description>It is a scale of levels from 1 to 5 for the motor functional classification of the upper limbs. (Brooke et al., 1989) It is graded according to the motor ability of the child evaluated in the following categories: (1) bring the arms towards the ceiling (2) raises arms above head but bends elbows (3) cannot raise hands above head, but can bring glass of water to mouth (4) holds pen or picks up coin and ( 5) It does not have any useful function with the hand. The lower the score, the better the upper extremity motor function. (Mayhew et al., 2013) In addition, this scale is frequently used in the DMD population and its intraclass correlation coefficient (ICC) is .99 .(Lue et al., 2006)</description> </secondary_outcome> <secondary_outcome> <measure>Vignos Scale</measure> <time_frame>One Year</time_frame> <description>It is a functional classification that scores from 1 to 10, where the highest number represents the most intense progressive condition of DMD reflected in the patient's ambulation. The possible categories are: (1) walks and climbs stairs without assistance (2) walks and climbs stairs with assistance or handrails (3) walks and climbs stairs slowly with the assistance of handrails (4) walks without assistance and gets up from a chair but does not climb stairs (5) walks without assistance but cannot get up from a chair or climb stairs (6) walks only with the aid of long orthoses (7) walks with long orthoses but needs help to maintain balance (8) stands upright with orthoses but unable to walk or with assistance, (9) in a wheelchair and (10) confined to bed.(Fernandes et al., 2014; Martini et al., 2015)</description> </secondary_outcome> <secondary_outcome> <measure>Timed Up and Go Test</measure> <time_frame>One Year</time_frame> <description>Determines the patient's risk of falling. The test is performed under a stopwatch, asking the patient to get up from a chair (with or without support), stand up, walk 3 meters, turn around and come back to sit on the chair again. If the patient takes more than 20 seconds to perform, they have a high risk of falling; and between 10 and 20 seconds will indicate fragility. (Alkan et al., 2017)</description> </secondary_outcome> <secondary_outcome> <measure>Six Minutes Walk Distance</measure> <time_frame>One Year</time_frame> <description>It consists of quantifying in meters the distance traveled in 6 minutes by the patient. The more meters walked, the less impairment.(Mcdonald et al., 2013) Individualized periodic assessment of 6 Minutes Walking Distance (6MWD) is the most widely accepted primary clinical endpoint in Duchenne's muscular dystrophy (DMD) clinical trials(Goemans et al., 2016); and provides a better prognosis than those based solely on age. After analyzing its test-retest reliability in DMD, its ICC is 0.92. (Mcdonald et al., 2013)</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">30</enrollment> <condition>Neurologic Disorder</condition> <condition>Duchenne</condition> <condition>Pediatric Disorder</condition> <condition>Sensorimotor Disorder Nos</condition> <arm_group> <arm_group_label>Home-based Physiotherapy</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Two days a week of physical therapy (mobilizations, manual therapy, stretching, respiratory techniques) + 3 hours extra of home-based physiotherapy (stretching, active mobilizations)</description> </arm_group> <arm_group> <arm_group_label>Usual physiotherapy</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Two days a week of physical therapy (mobilizations, manual therapy, stretching, respiratory techniques)</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Home-based physiotherapy</intervention_name> <description>Manual Therapy, passive and active mobilizations, stretching, respiratory techniques</description> <arm_group_label>Home-based Physiotherapy</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Usual Physiotherapy</intervention_name> <description>Usual care provided for the management of neurological disorders in children</description> <arm_group_label>Usual physiotherapy</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Parents agree to include their children on the study  - Affiliated to the Duchenne Parents Project Association (Spain)  - Between 3-18 years old  Exclusion Criteria:  - Other pathological conditions  - Parents refuse the participation on the study </textblock> </criteria> <gender>All</gender> <minimum_age>3 Years</minimum_age> <maximum_age>18 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>María del Mar Sánchez-Joya, PhD</last_name> <role>Study Chair</role> <affiliation>Universidad de Almeria</affiliation> </overall_official> <location> <facility> <name>María del Mar Sánchez-Joya</name> <address> <city>Almería</city> <zip>04120</zip> <country>Spain</country> </address> </facility> </location> <location_countries> <country>Spain</country> </location_countries> <reference> <citation>Alemdaroglu I, Karaduman A, Yilmaz OT, Topaloglu H. Different types of upper extremity exercise training in Duchenne muscular dystrophy: effects on functional performance, strength, endurance, and ambulation. Muscle Nerve. 2015 May;51(5):697-705. doi: 10.1002/mus.24451. Epub 2015 Mar 5.</citation> <PMID>25196721</PMID> </reference> <reference> <citation>Alkan H, Mutlu A, Firat T, Bulut N, Karaduman AA, Yilmaz OT. Effects of functional level on balance in children with Duchenne Muscular Dystrophy. Eur J Paediatr Neurol. 2017 Jul;21(4):635-638. doi: 10.1016/j.ejpn.2017.02.005. Epub 2017 Feb 20.</citation> <PMID>28259452</PMID> </reference> <reference> <citation>Hind D, Parkin J, Whitworth V, Rex S, Young T, Hampson L, Sheehan J, Maguire C, Cantrill H, Scott E, Epps H, Main M, Geary M, McMurchie H, Pallant L, Woods D, Freeman J, Lee E, Eagle M, Willis T, Muntoni F, Baxter P. Aquatic therapy for children with Duchenne muscular dystrophy: a pilot feasibility randomised controlled trial and mixed-methods process evaluation. Health Technol Assess. 2017 May;21(27):1-120. doi: 10.3310/hta21270.</citation> <PMID>28627356</PMID> </reference> <reference> <citation>Goemans N, Vanden Hauwe M, Signorovitch J, Swallow E, Song J; Collaborative Trajectory Analysis Project (cTAP). Individualized Prediction of Changes in 6-Minute Walk Distance for Patients with Duchenne Muscular Dystrophy. PLoS One. 2016 Oct 13;11(10):e0164684. doi: 10.1371/journal.pone.0164684. eCollection 2016.</citation> <PMID>27737016</PMID> </reference> <reference> <citation>Jansen M, van Alfen N, Geurts AC, de Groot IJ. Assisted bicycle training delays functional deterioration in boys with Duchenne muscular dystrophy: the randomized controlled trial "no use is disuse". Neurorehabil Neural Repair. 2013 Nov-Dec;27(9):816-27. doi: 10.1177/1545968313496326. Epub 2013 Jul 24.</citation> <PMID>23884013</PMID> </reference> <verification_date>May 2023</verification_date> <study_first_submitted>February 27, 2022</study_first_submitted> <study_first_submitted_qc>April 5, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>May 22, 2023</last_update_submitted> <last_update_submitted_qc>May 22, 2023</last_update_submitted_qc> <last_update_posted type="Actual">May 23, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Universidad de Almeria</investigator_affiliation> <investigator_full_name>María del Mar Sánchez Joya</investigator_full_name> <investigator_title>Associate Professor</investigator_title> </responsible_party> <keyword>Childhood</keyword> <keyword>Neurologic disorder</keyword> <keyword>Duchenne</keyword> <condition_browse>  <mesh_term>Muscular Dystrophy, Duchenne</mesh_term> <mesh_term>Nervous System Diseases</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Yes</sharing_ipd> <ipd_description>The data that support the findings of this study are available from the corresponding author upon reasonable request.</ipd_description> <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type> <ipd_time_frame>Data will become available for one year once the study is finished</ipd_time_frame> <ipd_access_criteria>Reasonable request to reproduce the intervention performed on this study</ipd_access_criteria> </patient_data>  </clinical_study>

To evaluate the positive effects of a home-based physical therapy intervention added to the usual physical therapy programs performed in children with neurological pathologies that induce sensorimotor impairments that affect their quality of life and the importance of the implications of their families in their treatment. Inclusion Criteria: - Parents agree to include their children on the study - Affiliated to the Duchenne Parents Project Association (Spain) - Between 3-18 years old Exclusion Criteria: - Other pathological conditions - Parents refuse the participation on the study

NCT0531xxxx/NCT05313308.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313308</url> </required_header> <id_info> <org_study_id>TAK-815-5001</org_study_id> <nct_id>NCT05313308</nct_id> </id_info> <brief_title>A Survey of Midazolam in People With Status Epilepticus</brief_title> <official_title>BUCCOLAM OROMUCOSAL SOLUTION - Special Drug Use Surveillance</official_title> <sponsors> <lead_sponsor> <agency>Takeda</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Takeda</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> This study is a survey in Japan of midazolam oromucosal solution used to treat people with status epilepticus. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.  The main aim of the study is to check for side effects related from midazolam oromucosal solution and to check if midazolam oromucosal solution improves symptoms of status epilepticus. During the study, participants with status epilepticus will take midazolam oromucosal solution according to their clinic's standard practice. The study doctors will check for side effects from midazolam for 6 months. </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">June 1, 2021</start_date> <completion_date type="Anticipated">May 31, 2026</completion_date> <primary_completion_date type="Anticipated">May 31, 2025</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Cohort</observational_model> <time_perspective>Prospective</time_perspective> </study_design_info> <primary_outcome> <measure>Number of Participants Who Experienced At Least One Treatment-Emergent Adverse Event (TEAE)</measure> <time_frame>Up to 24 hours after drug administration</time_frame> <description>An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product. It does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a pharmaceutical product (including an investigational product for a new indication in Japan), whether or not related to the pharmaceutical product.</description> </primary_outcome> <primary_outcome> <measure>Number of Participants With Serious Adverse Events</measure> <time_frame>Up to 24 hours after drug administration</time_frame> <description>A serious AE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.</description> </primary_outcome> <primary_outcome> <measure>Number of Participants With Therapeutic Success</measure> <time_frame>Up to 30 minutes after drug administration</time_frame> <description>Therapeutic success is defined as cessation of seizure activity within 10 minutes and sustained absence of seizure activity for 30 minutes following the first dose of midazolam oromucosal solution. Number of participants with therapeutic success will be reported.</description> </primary_outcome> <number_of_groups>1</number_of_groups> <enrollment type="Anticipated">50</enrollment> <condition>Epilepsy</condition> <arm_group> <arm_group_label>Midazolam</arm_group_label> <description>Participants will receive a single age-specific dose midazolam oromucosal solution through buccal mucosa upon onset of seizures. Dose will be dependent by age of participants as follows: >= 52 weeks and < 1 year; 2.5 mg/dose of midazolam, for >= 1 year and < 5 years; 5 mg/dose of midazolam, for >= 5 years and < 10 years; 7.5 mg/dose of midazolam, for >= 10 years and < 18 years; 10 mg/dose of midazolam. Participants received interventions as part of routine medical care.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Midazolam</intervention_name> <description>Midazolam oromucosal solution</description> <arm_group_label>Midazolam</arm_group_label> <other_name>BUCCOLAM oromucosal solution</other_name> <other_name>SHP615</other_name> <other_name>TAK-815</other_name> </intervention> <eligibility> <study_pop> <textblock> Participants with status epilepticus who received midazolam oromucosal solution </textblock> </study_pop> <sampling_method>Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria  - Participants with non-convulsive status epilepticus  - Participants treated with study drug outside the medical institution  - Participants receiving an additional dose of study drug  Exclusion Criteria Participants have any contraindication to midazolam. </textblock> </criteria> <gender>All</gender> <minimum_age>N/A</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Study Director</last_name> <role>Study Director</role> <affiliation>Takeda</affiliation> </overall_official> <overall_contact> <last_name>Takeda Contact</last_name> <phone>+1-877-825-3327</phone> <email>medinfoUS@takeda.com</email> </overall_contact> <location> <facility> <name>Takeda selected site</name> <address> <city>Tokyo</city> <country>Japan</country> </address> </facility> <status>Recruiting</status> </location> <location_countries> <country>Japan</country> </location_countries> <verification_date>April 2023</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>April 5, 2023</last_update_submitted> <last_update_submitted_qc>April 5, 2023</last_update_submitted_qc> <last_update_posted type="Actual">April 7, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Epilepsy</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Midazolam</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>Yes</sharing_ipd> <ipd_description>Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.</ipd_description> <ipd_info_type>Study Protocol</ipd_info_type> <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type> <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type> <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type> <ipd_access_criteria>IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.</ipd_access_criteria> <ipd_url>https://vivli.org/ourmember/takeda/</ipd_url> </patient_data>  </clinical_study>

This study is a survey in Japan of midazolam oromucosal solution used to treat people with status epilepticus. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study. The main aim of the study is to check for side effects related from midazolam oromucosal solution and to check if midazolam oromucosal solution improves symptoms of status epilepticus. During the study, participants with status epilepticus will take midazolam oromucosal solution according to their clinic's standard practice. The study doctors will check for side effects from midazolam for 6 months. Participants with status epilepticus who received midazolam oromucosal solution Inclusion Criteria - Participants with non-convulsive status epilepticus - Participants treated with study drug outside the medical institution - Participants receiving an additional dose of study drug Exclusion Criteria Participants have any contraindication to midazolam.

NCT0531xxxx/NCT05313321.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313321</url> </required_header> <id_info> <org_study_id>145076</org_study_id> <nct_id>NCT05313321</nct_id> </id_info> <brief_title>Survival of the Insignia Stem in Total Hip Arthroplasty</brief_title> <official_title>Mid-term Survival of the Insignia Stem in Primary Total Hip Arthroplasty</official_title> <sponsors> <lead_sponsor> <agency>University of Utah</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>University of Utah</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>Yes</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The investigators primary objective of this study is to evaluate radiographic fit and fill of the Insignia stem and identify risk factors for aseptic failure. The investigators hypotheses being tested is: the newly designed Insignia stem demonstrates acceptable radiographic fit and fill by reviewing radiolucent lines <2mm. </textblock> </brief_summary> <detailed_description> <textblock> Total hip arthroplasty is one of the most functionally restorative procedures in modern medicine. Since its introduction in the mid twentieth century significant advancements in implant materials have occurred. There is debate on the design of the femoral stem in total hip arthroplasty. The use of uncemented, Hydroxyapatite (HA)-coated femoral stems have been shown to be reliable and are commonly used. One such implant is the Insignia™ Hip Stem (Stryker, Kalamazoo, MI, USA).  The Insignia™ Hip Stem is a collared stem that features a plasma-sprayed Hydroxyapatite (HA) coating over plasma-sprayed titanium in the proximal region and a plasma-sprayed HA coating over grit blast in the distal region and collar underside. Unfortunately, with it's novelty comes a lack of clinical follow-up and evaluation. As such, the investigators purpose of this study is to evaluate the early radiographic of the Insignia™ Hip Stem. </textblock> </detailed_description> <overall_status>Enrolling by invitation</overall_status> <start_date type="Actual">March 17, 2022</start_date> <completion_date type="Anticipated">March 2026</completion_date> <primary_completion_date type="Anticipated">March 2026</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Case-Only</observational_model> <time_perspective>Prospective</time_perspective> </study_design_info> <primary_outcome> <measure>Radiographs review</measure> <time_frame>Pre-operative</time_frame> <description>Reviewing radiographic radiolucent lines <2mm</description> </primary_outcome> <primary_outcome> <measure>Radiographs review</measure> <time_frame>6-weeks post-operative</time_frame> <description>Reviewing radiographic radiolucent lines <2mm</description> </primary_outcome> <primary_outcome> <measure>Radiographs review</measure> <time_frame>1-year post-operative</time_frame> <description>Reviewing radiographic radiolucent lines <2mm</description> </primary_outcome> <primary_outcome> <measure>Radiographs review</measure> <time_frame>2-years post-operative</time_frame> <description>Reviewing radiographic radiolucent lines <2mm</description> </primary_outcome> <number_of_groups>1</number_of_groups> <enrollment type="Anticipated">100</enrollment> <condition>Primary Total Hip Arthroplasty</condition> <arm_group> <arm_group_label>Primary total hip arthroplasty receiving the Insignia Stem</arm_group_label> <description>Patients undergoing primary total hip arthroplasty that will likely receive the Insignia Stem and associated Stryker Acetabular Component.</description> </arm_group> <intervention> <intervention_type>Device</intervention_type> <intervention_name>Primary total hip arthroplasty receiving the Insignia Stem</intervention_name> <description>Patients receiving the Insignia Stem and associated Stryker Acetabular Component for total hip arthroplasty</description> <arm_group_label>Primary total hip arthroplasty receiving the Insignia Stem</arm_group_label> <other_name>Total Hip Arthroplasty</other_name> </intervention> <eligibility> <study_pop> <textblock> Patients planning on undergoing primary total hip arthroplasty </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Patients age ≥18  - Patients planning on undergoing primary total hip arthroplasty that will likely receive the Insignia stem and associated Stryker Acetabular Component.  - Preoperative diagnosis of osteoarthritis  - Patients willing and able to comply with follow-up requirements  - Patients willing to sign an IRB approved consent and authorization document  Exclusion Criteria:  - Patients with inflammatory or pyogenic arthritis  - Body Mass Index (BMI)>40  - Bone stock that is inadequate for support or fixation of the prosthesis </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>100 Years</maximum_age> </eligibility> <overall_official> <last_name>Lucas Anderson, M.D.</last_name> <role>Principal Investigator</role> <affiliation>University of Utah Orthopaedics</affiliation> </overall_official> <location> <facility> <name>University of Utah Orthopaedic Center</name> <address> <city>Salt Lake City</city> <state>Utah</state> <zip>84108</zip> <country>United States</country> </address> </facility> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>June 2023</verification_date> <study_first_submitted>March 28, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>June 7, 2023</last_update_submitted> <last_update_submitted_qc>June 7, 2023</last_update_submitted_qc> <last_update_posted type="Actual">June 9, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>University of Utah</investigator_affiliation> <investigator_full_name>Lucas Anderson</investigator_full_name> <investigator_title>Principle Investigator</investigator_title> </responsible_party> <keyword>Primary Total Hip Arthroplasty</keyword> <keyword>Insignia™ Hip Stem</keyword> <keyword>Radiographic review</keyword> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

The investigators primary objective of this study is to evaluate radiographic fit and fill of the Insignia stem and identify risk factors for aseptic failure. The investigators hypotheses being tested is: the newly designed Insignia stem demonstrates acceptable radiographic fit and fill by reviewing radiolucent lines <2mm. Total hip arthroplasty is one of the most functionally restorative procedures in modern medicine. Since its introduction in the mid twentieth century significant advancements in implant materials have occurred. There is debate on the design of the femoral stem in total hip arthroplasty. The use of uncemented, Hydroxyapatite (HA)-coated femoral stems have been shown to be reliable and are commonly used. One such implant is the Insignia™ Hip Stem (Stryker, Kalamazoo, MI, USA). The Insignia™ Hip Stem is a collared stem that features a plasma-sprayed Hydroxyapatite (HA) coating over plasma-sprayed titanium in the proximal region and a plasma-sprayed HA coating over grit blast in the distal region and collar underside. Unfortunately, with it's novelty comes a lack of clinical follow-up and evaluation. As such, the investigators purpose of this study is to evaluate the early radiographic of the Insignia™ Hip Stem. Patients planning on undergoing primary total hip arthroplasty Inclusion Criteria: - Patients age ≥18 - Patients planning on undergoing primary total hip arthroplasty that will likely receive the Insignia stem and associated Stryker Acetabular Component. - Preoperative diagnosis of osteoarthritis - Patients willing and able to comply with follow-up requirements - Patients willing to sign an IRB approved consent and authorization document Exclusion Criteria: - Patients with inflammatory or pyogenic arthritis - Body Mass Index (BMI)>40 - Bone stock that is inadequate for support or fixation of the prosthesis

NCT0531xxxx/NCT05313334.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313334</url> </required_header> <id_info> <org_study_id>STUDY-21-01108</org_study_id> <nct_id>NCT05313334</nct_id> </id_info> <brief_title>GAMBIT Task With PTSD and Healthy Control Participants</brief_title> <acronym>GAMBIT</acronym> <official_title>Gamified Approach to Maximizing Biobehavioral Inhibition in Trauma-related Conditions (GAMBIT)</official_title> <sponsors> <lead_sponsor> <agency>Icahn School of Medicine at Mount Sinai</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Icahn School of Medicine at Mount Sinai</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> <is_us_export>No</is_us_export> </oversight_info> <brief_summary> <textblock> This is a pilot study of a digital training task called GAMBIT. This study will be the first to examine potential relationships between GAMBIT task completion and brain circuit flexibility, behavior, and symptoms in participants with PTSD. </textblock> </brief_summary> <detailed_description> <textblock> This is a single-site pilot study for the GAMBIT intervention, which is a computerized task that addresses behavioral inhibition. The primary objective of this study is to determine whether the GAMBIT task improves mental health symptoms associated with PTSD over time. The secondary objective of this study is to determine whether the GAMBIT task promotes flexibility in inhibitory control network as determined by functional neuroimaging. Additional laboratory measures associated with cognitive flexibility, and clinician and patient-rated symptom data, will be collected. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">November 18, 2022</start_date> <completion_date type="Anticipated">December 2024</completion_date> <primary_completion_date type="Anticipated">January 2024</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Non-Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Clinician Administered PTSD Scale for DSM-5 (CAPS-5) at Baseline</measure> <time_frame>Baseline</time_frame> <description>The CAPS is a structured clinical interview designed to assess the essential features of PTSD. A total symptom severity score is calculated on a scale of 0-80, with a higher score representing greater symptom severity.</description> </primary_outcome> <primary_outcome> <measure>Clinician Administered PTSD Scale for DSM-5 (CAPS-5) at Day 23</measure> <time_frame>Day 23</time_frame> <description>The CAPS is a structured clinical interview designed to assess the essential features of PTSD. A total symptom severity score is calculated on a scale of 0-80, with a higher score representing greater symptom severity.</description> </primary_outcome> <primary_outcome> <measure>Clinician Administered PTSD Scale for DSM-5 (CAPS-5) at Day 52</measure> <time_frame>Day 52</time_frame> <description>The CAPS is a structured clinical interview designed to assess the essential features of PTSD. A total symptom severity score is calculated on a scale of 0-80, with a higher score representing greater symptom severity.</description> </primary_outcome> <secondary_outcome> <measure>Inhibitory Control Network Flexibility at Baseline</measure> <time_frame>Baseline</time_frame> <description>Network flexibility will be determined from resting state FMRI-derived metrics using relatively novel statistical techniques.</description> </secondary_outcome> <secondary_outcome> <measure>Inhibitory Control Network Flexibility at Day 52</measure> <time_frame>Day 52</time_frame> <description>Network flexibility will be determined from resting state FMRI-derived metrics using relatively novel statistical techniques.</description> </secondary_outcome> <secondary_outcome> <measure>PTSD Checklist for DSM-5 (PCL-5) at Baseline</measure> <time_frame>Baseline</time_frame> <description>The PTSD Checklist for DSM-5 (PCL-5) is a widely used clinical self-report scale to evaluate current symptoms of PTSD. Each question on the 20-item checklist corresponds to a symptom of PTSD in the DSM-5. A total severity score is calculated on a scale of 0-80, with a higher score indicating greater severity.</description> </secondary_outcome> <secondary_outcome> <measure>PTSD Checklist for DSM-5 (PCL-5) Weekly for Weeks 1-6</measure> <time_frame>Weekly [Weeks 1-6]</time_frame> <description>The PTSD Checklist for DSM-5 (PCL-5) is a widely used clinical self-report scale to evaluate current symptoms of PTSD. Each question on the 20-item checklist corresponds to a symptom of PTSD in the DSM-5. A total severity score is calculated on a scale of 0-80, with a higher score indicating greater severity.</description> </secondary_outcome> <secondary_outcome> <measure>PTSD Checklist for DSM-5 (PCL-5) at Day 23</measure> <time_frame>Day 23</time_frame> <description>The PTSD Checklist for DSM-5 (PCL-5) is a widely used clinical self-report scale to evaluate current symptoms of PTSD. Each question on the 20-item checklist corresponds to a symptom of PTSD in the DSM-5. A total severity score is calculated on a scale of 0-80, with a higher score indicating greater severity.</description> </secondary_outcome> <secondary_outcome> <measure>PTSD Checklist for DSM-5 (PCL-5) at Day 52</measure> <time_frame>Day 52</time_frame> <description>The PTSD Checklist for DSM-5 (PCL-5) is a widely used clinical self-report scale to evaluate current symptoms of PTSD. Each question on the 20-item checklist corresponds to a symptom of PTSD in the DSM-5. A total severity score is calculated on a scale of 0-80, with a higher score indicating greater severity.</description> </secondary_outcome> <secondary_outcome> <measure>Combined Think/No-Think and Go/No-Go Paradigm</measure> <time_frame>up to 52 days</time_frame> <description>The combined Think/No-Think and Go/No-Go paradigm requires participants to learn 35 cue-target word pairs (for approximately 15 minutes) and then asked to alternatively suppress, recall, or think about the cue-target word pairs, when prompted. The percentage of correctly processed trials (go/think trials and no-go/no-think trials) are calculated per block, on a scale from 0% (0/35 trials) to 100% (35/35 trails), with higher recall scores on no-go/no-think trials indicating worse inhibitory control.</description> </secondary_outcome> <secondary_outcome> <measure>Face-Stroop Task</measure> <time_frame>up to 52 days</time_frame> <description>The Face-Stroop task is a modified version of the widely used Stroop task which assesses reaction time between congruent and incongruent stimuli. During the Face-Stroop task, participants are simultaneously presented with images of emotional faces and emotional words (e.g., "Happy", "Sad"), with some trials presenting congruent stimuli (happy face + "Happy") and other trials presenting incongruent stimuli (happy face + "Sad"), and asked to identify the faces and words separately. Variables of interest include reaction time (range 250-1000 milliseconds, with lower RT indicating better performance) and accuracy (0-100%, with greater accuracy denoting better performance).</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">50</enrollment> <condition>Posttraumatic Stress Disorder</condition> <arm_group> <arm_group_label>PTSD Group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>The PTSD Group will receive the GAMBIT intervention and complete all study tasks and assessments at every study visit (Visits 0-4). N=20 participants will be recruited for this arm.</description> </arm_group> <arm_group> <arm_group_label>Healthy Control Group</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>The Healthy Control Group will only complete study tasks and assessments at the screening visit (Visit 0) and the Pre-Assessment visit (Visit 1). This arm will not receive any intervention. N=20 participants will be recruited for this arm. Additionally, N=10 Healthy Control participants will be recruited for the Pilot Phase of the study.</description> </arm_group> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>GAMBIT Task</intervention_name> <description>The GAMBIT task is a novel inhibitory control task. Participants in the PTSD group will receive the GAMBIT intervention repeatedly over the study period.</description> <arm_group_label>PTSD Group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Male or female aged 18-55 years  - Participants must be able to provide informed consent  - Participants must have a level of understanding of the English language sufficient to agree to all tests and examinations required by the study and must be able to participate fully in the informed consent process  - Must meet criteria for one of the following study groups:  - PTSD Group:  i. Meets diagnostic criteria for current PTSD according to the Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5)  1. Has been exposed to a Criterion A trauma of the civilian type (e.g., non-combat, threatened or actual interpersonal violence) or non-civilian  2. Must have a total score ≥30 on the CAPS-5 (past-month version) at the time of screening, indicating moderate PTSD symptom severity, of at least 3 months symptom duration.  - Healthy Control Group:  i. Has no lifetime history of any psychiatric disorder  Exclusion Criteria:  - Current or lifetime history of schizophrenia or other psychotic disorder, bipolar disorder, obsessive-compulsive disorder (OCD), eating or feeding disorder, neurodevelopmental disorder, or neurocognitive disorder;  - Any neuropsychiatric disorder that is judged to be the primary presenting problem, other than that which is specified as study group eligibility criteria;  - Substance use disorder within the past 1 year;  - Urine toxicology positive for illicit drugs or dis-allowed concomitant medications as per study protocol; intermittent cannabis use that does not meet criteria for a substance use disorder may be permitted under the protocol.  - Suicidal ideation or risk of self-harm that is judged by the PI to be clinically significant and to warrant intervention  - Concurrent treatment with opioid medication, or with long-acting or daytime short-acting benzodiazepines within two weeks of study start  - Current cognitive impairment, as defined by a score <23 on the Montreal Cognitive Assessment (MoCA)  - Estimated IQ <80  - Currently receiving evidence-based psychotherapy for PTSD (e.g., prolonged exposure, cognitive processing therapy). </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>55 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Jonathan DePierro, PhD</last_name> <role>Principal Investigator</role> <affiliation>Icahn School of Medicine at Mount Sinai</affiliation> </overall_official> <overall_contact> <last_name>Jonathan DePierro, PhD</last_name> <phone>212-241-6539</phone> <email>jonathan.depierro@mssm.edu</email> </overall_contact> <overall_contact_backup> <last_name>Laurel Morris, PhD</last_name> <phone>212-241-2774</phone> <email>laurel.morris@mssm.edu</email> </overall_contact_backup> <location> <facility> <name>Icahn School of Medicine at Mount Sinai</name> <address> <city>New York</city> <state>New York</state> <zip>10029</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Jonathan DePierro, PhD</last_name> <phone>212-241-6539</phone> <email>jonathan.depierro@mssm.edu</email> </contact> <contact_backup> <last_name>Laurel Morris, PhD</last_name> <phone>212-241-2774</phone> <email>laurel.morris@mssm.edu</email> </contact_backup> <investigator> <last_name>Jonathan DePierro</last_name> <role>Principal Investigator</role> </investigator> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>January 2023</verification_date> <study_first_submitted>March 28, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>January 24, 2023</last_update_submitted> <last_update_submitted_qc>January 24, 2023</last_update_submitted_qc> <last_update_posted type="Actual">January 26, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Icahn School of Medicine at Mount Sinai</investigator_affiliation> <investigator_full_name>Jonathan M Depierro</investigator_full_name> <investigator_title>Assistant Professor, Psychiatry</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Stress Disorders, Post-Traumatic</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Yes</sharing_ipd> <ipd_description>Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).</ipd_description> <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type> <ipd_time_frame>Beginning 3 months and ending 5 years following article publication.</ipd_time_frame> </patient_data>  </clinical_study>

This is a pilot study of a digital training task called GAMBIT. This study will be the first to examine potential relationships between GAMBIT task completion and brain circuit flexibility, behavior, and symptoms in participants with PTSD. This is a single-site pilot study for the GAMBIT intervention, which is a computerized task that addresses behavioral inhibition. The primary objective of this study is to determine whether the GAMBIT task improves mental health symptoms associated with PTSD over time. The secondary objective of this study is to determine whether the GAMBIT task promotes flexibility in inhibitory control network as determined by functional neuroimaging. Additional laboratory measures associated with cognitive flexibility, and clinician and patient-rated symptom data, will be collected. Inclusion Criteria: - Male or female aged 18-55 years - Participants must be able to provide informed consent - Participants must have a level of understanding of the English language sufficient to agree to all tests and examinations required by the study and must be able to participate fully in the informed consent process - Must meet criteria for one of the following study groups: - PTSD Group: i. Meets diagnostic criteria for current PTSD according to the Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) 1. Has been exposed to a Criterion A trauma of the civilian type (e.g., non-combat, threatened or actual interpersonal violence) or non-civilian 2. Must have a total score ≥30 on the CAPS-5 (past-month version) at the time of screening, indicating moderate PTSD symptom severity, of at least 3 months symptom duration. - Healthy Control Group: i. Has no lifetime history of any psychiatric disorder Exclusion Criteria: - Current or lifetime history of schizophrenia or other psychotic disorder, bipolar disorder, obsessive-compulsive disorder (OCD), eating or feeding disorder, neurodevelopmental disorder, or neurocognitive disorder; - Any neuropsychiatric disorder that is judged to be the primary presenting problem, other than that which is specified as study group eligibility criteria; - Substance use disorder within the past 1 year; - Urine toxicology positive for illicit drugs or dis-allowed concomitant medications as per study protocol; intermittent cannabis use that does not meet criteria for a substance use disorder may be permitted under the protocol. - Suicidal ideation or risk of self-harm that is judged by the PI to be clinically significant and to warrant intervention - Concurrent treatment with opioid medication, or with long-acting or daytime short-acting benzodiazepines within two weeks of study start - Current cognitive impairment, as defined by a score <23 on the Montreal Cognitive Assessment (MoCA) - Estimated IQ <80 - Currently receiving evidence-based psychotherapy for PTSD (e.g., prolonged exposure, cognitive processing therapy).

NCT0531xxxx/NCT05313347.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313347</url> </required_header> <id_info> <org_study_id>S-656/2019-2</org_study_id> <nct_id>NCT05313347</nct_id> </id_info> <brief_title>Neural Correlates of Sensory Specific Satiety</brief_title> <acronym>Gusto</acronym> <official_title>A Pilot Study to Investigate Neural Processing During Sensory Specific Satiety Using Gustatory Stimulation</official_title> <sponsors> <lead_sponsor> <agency>University of Heidelberg Medical Center</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>University of Heidelberg Medical Center</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Sensory specific satiety, or the phenomenon that the pleasantness of a particular taste declines when certain types food are consumed to satiety, plays an important role in food choice and meal termination.The rewarding effect of sugar will be investigated in a group of 30 healthy participants with a body mass index ranging from 17.5 to 35kg/m2. A gustatory stimulation paradigm designed to induce sensory specific satiety for glucose will be employed. The aim is to assess neuronal stimulus processing in relation to the sensory satiety level and to investigate the relationship with everyday eating behavior. </textblock> </brief_summary> <detailed_description> <textblock> Sensory specific satiety, or the phenomenon that the pleasantness of a particular taste declines when certain types food are consumed to satiety, plays an important role in food choice and meal termination. Since changes in taste, smell and appetite are commonly observed in obesity, previous studies investigated the relation of sensory specific satiety to weight gain, but observed conflicting results. To gain a more detailed understanding of the relationship between sensory specific satiety and weight homeostasis, we will examine the rewarding effect of sugar in a group of 30 healthy participants with a body mass index ranging from 17.5 to 35kg/m2. We will employ a gustatory stimulation paradigm designed to induce sensory specific satiety for glucose. During fMRI scanning, glucose and water are applied orally using a gustometer. Furthermore, relevant hormonal satiety parameters are measured, as well as dietary behavior and food preferences in everyday life. This will allow us to assess neuronal stimulus processing in relation to the sensory satiety level and to investigate the relationship with everyday eating behavior. A better understanding of factors contributing to the development and maintenance of overweight are crucial for the development of new treatment options for obesity. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">February 1, 2022</start_date> <completion_date type="Anticipated">October 1, 2023</completion_date> <primary_completion_date type="Anticipated">July 1, 2023</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Case-Only</observational_model> <time_perspective>Cross-Sectional</time_perspective> </study_design_info> <primary_outcome> <measure>Choice of water compared to choice of sugar during Sensory Specific Satiety.</measure> <time_frame>1 hour</time_frame> <description>Comparing tasting of water with tasting of sugar (G10%) when participants are allowed to freely chose between the two during specific satiety for sugar.</description> </primary_outcome> <primary_outcome> <measure>Choice of water compared to passive ingestion of 20% sugar solution during Sensory Specific Satiety.</measure> <time_frame>1 hour</time_frame> <description>Comparison of voluntary tasting of water with the "forced" tasting of sugar during specific satiety for sugar.</description> </primary_outcome> <secondary_outcome> <measure>Influence of variations in BMI on brain activation during Sensory Specific Satiety.</measure> <time_frame>1 hour</time_frame> </secondary_outcome> <number_of_groups>1</number_of_groups> <enrollment type="Anticipated">30</enrollment> <condition>Satiety Response</condition> <condition>Functional Neuroimaging</condition> <condition>Obesity</condition> <arm_group> <arm_group_label>Healty Participants with varying BMI</arm_group_label> <description>30 healthy participants with a body mass index ranging from 17.5 to 35kg/m2.</description> </arm_group> <eligibility> <study_pop> <textblock> Healthy controls with BMI between 17,5 and 35 kg/m². </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  1. BMI between 17,5 and 35 kg/m².  2. Over age of 18 years.  3. Right-handedness.  4. Normal or corrected-to-normal vision.  5. Capacity to consent.  Exclusion Criteria:  1. History of head injury or surgery.  2. History of neurological disorder.  3. Severe psychiatric comorbidity.  4. Lifetime or current medical illness that could potentially affect appetite or weight (including eating disorders diagnosis)  5. Smoking.  6. Current psychotropic medication.  7. Inability to undergo fMRI scan (e.g. metallic implants, claustrophobia, pacemakers).  8. Pregnancy. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>55 Years</maximum_age> </eligibility> <overall_official> <last_name>joe simon, Ph.D.</last_name> <role>Principal Investigator</role> <affiliation>Heidelberg University</affiliation> </overall_official> <overall_contact> <last_name>joe simon, Ph.D.</last_name> <phone>+4962215638667</phone> <email>joe.simon@med.uni-heidelberg.de</email> </overall_contact> <location> <facility> <name>University Hospital Heidelberg</name> <address> <city>Heidelberg</city> <country>Germany</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Joe Simon, Dr. Dipl. Psych.</last_name> <phone>++49(0)6221-56-38667</phone> <email>joe.simon@med.uni-heidelberg.de</email> </contact> </location> <location_countries> <country>Germany</country> </location_countries> <verification_date>January 2023</verification_date> <study_first_submitted>March 28, 2022</study_first_submitted> <study_first_submitted_qc>April 5, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>January 12, 2023</last_update_submitted> <last_update_submitted_qc>January 12, 2023</last_update_submitted_qc> <last_update_posted type="Actual">January 13, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>University of Heidelberg Medical Center</investigator_affiliation> <investigator_full_name>Joe Simon</investigator_full_name> <investigator_title>Principal Investigator</investigator_title> </responsible_party> <keyword>fmri</keyword> <keyword>sensory specific satiety</keyword> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Sensory specific satiety, or the phenomenon that the pleasantness of a particular taste declines when certain types food are consumed to satiety, plays an important role in food choice and meal termination.The rewarding effect of sugar will be investigated in a group of 30 healthy participants with a body mass index ranging from 17.5 to 35kg/m2. A gustatory stimulation paradigm designed to induce sensory specific satiety for glucose will be employed. The aim is to assess neuronal stimulus processing in relation to the sensory satiety level and to investigate the relationship with everyday eating behavior. Sensory specific satiety, or the phenomenon that the pleasantness of a particular taste declines when certain types food are consumed to satiety, plays an important role in food choice and meal termination. Since changes in taste, smell and appetite are commonly observed in obesity, previous studies investigated the relation of sensory specific satiety to weight gain, but observed conflicting results. To gain a more detailed understanding of the relationship between sensory specific satiety and weight homeostasis, we will examine the rewarding effect of sugar in a group of 30 healthy participants with a body mass index ranging from 17.5 to 35kg/m2. We will employ a gustatory stimulation paradigm designed to induce sensory specific satiety for glucose. During fMRI scanning, glucose and water are applied orally using a gustometer. Furthermore, relevant hormonal satiety parameters are measured, as well as dietary behavior and food preferences in everyday life. This will allow us to assess neuronal stimulus processing in relation to the sensory satiety level and to investigate the relationship with everyday eating behavior. A better understanding of factors contributing to the development and maintenance of overweight are crucial for the development of new treatment options for obesity. Healthy controls with BMI between 17,5 and 35 kg/m². Inclusion Criteria: 1. BMI between 17,5 and 35 kg/m². 2. Over age of 18 years. 3. Right-handedness. 4. Normal or corrected-to-normal vision. 5. Capacity to consent. Exclusion Criteria: 1. History of head injury or surgery. 2. History of neurological disorder. 3. Severe psychiatric comorbidity. 4. Lifetime or current medical illness that could potentially affect appetite or weight (including eating disorders diagnosis) 5. Smoking. 6. Current psychotropic medication. 7. Inability to undergo fMRI scan (e.g. metallic implants, claustrophobia, pacemakers). 8. Pregnancy.

NCT0531xxxx/NCT05313360.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313360</url> </required_header> <id_info> <org_study_id>9080 - PTE 2021</org_study_id> <nct_id>NCT05313360</nct_id> </id_info> <brief_title>Association Between Sarcopenia and Urinary Incontinence And Effect Of Physical Activity Among Over 50 Years Old Adults</brief_title> <official_title>The Association Between Sarcopenia and Urinary Incontinence and the Effect of Physical Activity Among Over 50 Years Old Adults in South-Danubia</official_title> <sponsors> <lead_sponsor> <agency>University of Pecs</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>University of Pecs</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> As far as the investigators know, until this moment no research has investigated the prevalence of Sarcopenia in both sexes in Hungary. Additionally, no research discovered the association between sarcopenia and UI and the effect of physical activity level on these geriatric conditions in Hungary.  Furthermore, it is known that Sarcopenia and UI are causing negative psychological, physical, and social effects on the geriatrics who are suffering from these conditions, not to mention the increase in health care costs. In an attempt to decrease these negative effects, there is a need for a deeper understanding of these conditions by identifying the relationship between them and understanding the risk factors that might cause them. The finding of this study would help with determining those risk factors that are causing these geriatric conditions (Sarcopenia and UI).  Last, this study will provide accurate numbers and statistics to the Hungarian health organizations and educational institutions about the prevalence of sarcopenia and UI which will help shed the light on the importance of these problems among older adults in Hungary.  This Cross-sectional study aim to:  1. Explore and study physical activity levels among aging adults of both sexes in Hungary.  2. To determine the prevalence of sarcopenia and UI among elderly individuals in Hungary.  3. Investigate the associations between sarcopenia and urinary incontinence among older adults (≥ 50 years).  4. Identify the effect of physical activity level on the occurrence of Sarcopenia and Urinary incontinence  Hypothesis:  1. The investigators hypothesize that sarcopenia is a risk factor to have UI.  2. The investigators hypothesize that reduced physical activity level is also associated with sarcopenia and/or UI. </textblock> </brief_summary> <overall_status>Enrolling by invitation</overall_status> <start_date type="Actual">January 1, 2022</start_date> <completion_date type="Anticipated">August 1, 2023</completion_date> <primary_completion_date type="Anticipated">June 1, 2023</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Case-Only</observational_model> <time_perspective>Cross-Sectional</time_perspective> </study_design_info> <primary_outcome> <measure>Sarcopenia and urinary incontinence</measure> <time_frame>Day 1</time_frame> <description>Investigate the associations between sarcopenia and urinary incontinence among older adults (≥ 50 years).</description> </primary_outcome> <primary_outcome> <measure>Physical activity level effect</measure> <time_frame>Day 1</time_frame> <description>Identify the effect of Physical activity level on the occurrence of Sarcopenia and Urinary incontinence.</description> </primary_outcome> <secondary_outcome> <measure>Prevalence of Sarcopenia and Urinary incontinence</measure> <time_frame>Day 1</time_frame> <description>To determine the prevalence of sarcopenia and UI among elderly individuals in Hungary</description> </secondary_outcome> <secondary_outcome> <measure>insights into physical activity levels</measure> <time_frame>Day 1</time_frame> <description>Explore and study physical activity levels among aging adults of both sexes in Hungary</description> </secondary_outcome> <enrollment type="Anticipated">400</enrollment> <condition>Urinary Incontinence</condition> <condition>Sarcopenia</condition> <eligibility> <study_pop> <textblock> The study population is any participant who is 50 years or older, and living in the South Danubia region, in Hungary. </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  • Any person who is 50 years old or older  Exclusion Criteria:  • Individuals who cannot provide reliable clinical information due to cognitive disorders.  Individuals who are having any neurodegenerative disorders (E.g; Parkinson). </textblock> </criteria> <gender>All</gender> <minimum_age>50 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <location> <facility> <name>University of Pécs</name> <address> <city>Pécs</city> <country>Hungary</country> </address> </facility> </location> <location_countries> <country>Hungary</country> </location_countries> <verification_date>March 2023</verification_date> <study_first_submitted>January 6, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>March 21, 2023</last_update_submitted> <last_update_submitted_qc>March 21, 2023</last_update_submitted_qc> <last_update_posted type="Actual">March 23, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Urinary Incontinence</keyword> <keyword>Sarcopenia</keyword> <condition_browse>  <mesh_term>Sarcopenia</mesh_term> <mesh_term>Urinary Incontinence</mesh_term> <mesh_term>Enuresis</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

As far as the investigators know, until this moment no research has investigated the prevalence of Sarcopenia in both sexes in Hungary. Additionally, no research discovered the association between sarcopenia and UI and the effect of physical activity level on these geriatric conditions in Hungary. Furthermore, it is known that Sarcopenia and UI are causing negative psychological, physical, and social effects on the geriatrics who are suffering from these conditions, not to mention the increase in health care costs. In an attempt to decrease these negative effects, there is a need for a deeper understanding of these conditions by identifying the relationship between them and understanding the risk factors that might cause them. The finding of this study would help with determining those risk factors that are causing these geriatric conditions (Sarcopenia and UI). Last, this study will provide accurate numbers and statistics to the Hungarian health organizations and educational institutions about the prevalence of sarcopenia and UI which will help shed the light on the importance of these problems among older adults in Hungary. This Cross-sectional study aim to: 1. Explore and study physical activity levels among aging adults of both sexes in Hungary. 2. To determine the prevalence of sarcopenia and UI among elderly individuals in Hungary. 3. Investigate the associations between sarcopenia and urinary incontinence among older adults (≥ 50 years). 4. Identify the effect of physical activity level on the occurrence of Sarcopenia and Urinary incontinence Hypothesis: 1. The investigators hypothesize that sarcopenia is a risk factor to have UI. 2. The investigators hypothesize that reduced physical activity level is also associated with sarcopenia and/or UI. The study population is any participant who is 50 years or older, and living in the South Danubia region, in Hungary. Inclusion Criteria: • Any person who is 50 years old or older Exclusion Criteria: • Individuals who cannot provide reliable clinical information due to cognitive disorders. Individuals who are having any neurodegenerative disorders (E.g; Parkinson).

NCT0531xxxx/NCT05313373.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313373</url> </required_header> <id_info> <org_study_id>04/49</org_study_id> <nct_id>NCT05313373</nct_id> </id_info> <brief_title>The Effect of Virtual Reality on Women Undergoing Hysterosalpingography</brief_title> <official_title>The Effect of Virtual Reality On Women's Perceptıons of Fear, Pain, Anxiety and Satisfaction Undergoing Hysterosalpingography; A Randomized Controlled Research</official_title> <sponsors> <lead_sponsor> <agency>NESLİHAN YILMAZ SEZER</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Ankara University</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The aim of this study is to determine the effect of virtual reality on perceived pain, anxiety, fear, physiological reactions and satisfaction in women during the HSG procedure.  Hypotheses H01; In the HSG procedure, there was no difference between the pain score of the virtual reality group and the pain score of the control group.  H02; In the HSG procedure, there was no difference between the anxiety score of the virtual reality group and the anxiety score of the control group.  H03; In the HSG procedure, there was no difference between the satisfaction score of the virtual reality group and the satisfaction score of the control group.  H04; In the HSG procedure, there was no difference between the vital signs of the virtual reality group and the control group.  H05; In the HSG procedure, there was no difference between the fear score of the virtual reality group and the fear score of the control group.  The study will be carried out in two different groups. The practice will start with meeting the women who apply to the Radiology clinic for an HSG. After the women are evaluated in terms of eligibility criteria for the research, the women who are eligible will be informed about the research and written informed consent will be obtained from the women who accept. The random distribution of women to the study groups will be carried out using the Block Randomization method. The following applications will be made to the groups.  Virtual Reality Group In addition to the routine procedure, virtual reality glasses will be applied to the women in the virtual reality group of the research. Virtual reality glasses is a device that works on compatible smart mobile phones. After being taken to the gynecological table for the HSG procedure, the women included in the experimental group will be made to watch a video lasting an average of 10 minutes with virtual reality glasses until the procedure is completed. While watching the video, the relaxing music of the video will be played in the practice room with a bluetooth speaker.  Control Group Patients in the control group of the study will not be subjected to any treatment other than the routine procedure. </textblock> </brief_summary> <overall_status>Completed</overall_status> <start_date type="Actual">April 26, 2022</start_date> <completion_date type="Actual">June 30, 2022</completion_date> <primary_completion_date type="Actual">June 30, 2022</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Supportive Care</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Change in anxiety</measure> <time_frame>immediately before the HSG procedure and immediately after the HSG procedure</time_frame> <description>STAI-S consist of 20 items with four points Likert scales, each (not at all, somewhat, moderately so, very much so). Scores thus range between 20, indicating a low level of anxiety and 80, indicating a high level.</description> </primary_outcome> <primary_outcome> <measure>Change in the degree of pain experienced during the procedure</measure> <time_frame>immediately before the HSG procedure, and immediately after the HSG procedure, and 15 minutes after the HSG procedure</time_frame> <description>The pain was assessed using 0-100 mm VAS for determining perceptions of pain during the procedure. This scale is widely used and has demonstrated reliability and validity in the measurement of acute pain. A high score on the scale indicated a high level of pain and a score of 0 pointed to no pain at all (Bijur, Silver, & Gallagher, 2001). Each participant was asked to mark her current level of perceived pain along the scale, with the number corresponding to the marked point recorded as the pain score</description> </primary_outcome> <primary_outcome> <measure>Change in fear</measure> <time_frame>immediately before the HSG procedure, immediately after the HSG procedure, and 15 minutes after the HSG procedure</time_frame> <description>VAS is a 10-cm-long measurement tool. The left end of the scale reads "no fear at all" and the right end reads "the most intense fear possible". A high score on the scale indicated a high level of fear and a score of 0 pointed to no fear.</description> </primary_outcome> <secondary_outcome> <measure>the degree of satisfaction</measure> <time_frame>15 minutes after the HSG procedure</time_frame> <description>VAS is a 10-cm-long measurement tool. The left end of the scale reads "I am not satisfied at all" and the right end reads "very satisfied". A high score on the scale indicated a high level of satisfied and a score of 0 pointed to no satisfied.</description> </secondary_outcome> <secondary_outcome> <measure>Change in blood pressure</measure> <time_frame>immediately before the HSG procedure, and immediately after the HSG procedure, and 15 minutes after the HSG procedure</time_frame> <description>mmHg</description> </secondary_outcome> <secondary_outcome> <measure>Change in heart rate</measure> <time_frame>immediately before the HSG procedure, and immediately after the HSG procedure, and 15 minutes after the HSG procedure</time_frame> <description>beats per minute (bpm)</description> </secondary_outcome> <secondary_outcome> <measure>Change in body temperature</measure> <time_frame>immediately before the HSG procedure, and immediately after the HSG procedure, and 15 minutes after the HSG procedure</time_frame> <description>degrees Celsius</description> </secondary_outcome> <secondary_outcome> <measure>Change in the saturation of peripheral oxygen SpO2</measure> <time_frame>immediately before the HSG procedure, and immediately after the HSG procedure, and 15 minutes after the HSG procedure</time_frame> </secondary_outcome> <secondary_outcome> <measure>HSG result</measure> <time_frame>15 minutes after the HSG procedure</time_frame> <description>both tubes patent, one fallopian tubes occluded, both fallopian tubes occluded</description> </secondary_outcome> <secondary_outcome> <measure>contrast medium volume</measure> <time_frame>during HSG prosedure</time_frame> <description>milliliter (ml)</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">62</enrollment> <condition>Hysterosalpingography</condition> <arm_group> <arm_group_label>Virtual Reality Group</arm_group_label> <arm_group_type>Experimental</arm_group_type> </arm_group> <arm_group> <arm_group_label>Control Group</arm_group_label> <arm_group_type>No Intervention</arm_group_type> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Virtual Reality</intervention_name> <description>In addition to the routine procedure, virtual reality glasses will be applied to the women in the virtual reality group of the research. Virtual reality glasses is a device that works on compatible smart mobile phones. After being taken to the gynecological table for the HSG procedure, the women included in the experimental group will be made to watch a video lasting an average of 10 minutes with virtual reality glasses until the procedure is completed. While watching the video, the relaxing music of the video will be played.</description> <arm_group_label>Virtual Reality Group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - primary infertility  - Agreeing to participate in the research and obtaining written permission,  - No hearing or vision problems  - The first time HSG procedure will be applied  Exclusion Criteria:  - Didn't watch the whole video  - Those with motion-sensitive diseases such as vertigo, meniere  - Using any pharmacological pain-reducing method within 30 minutes  - Difficulty in the HSG process or completing the process with more than one attempt  - Use of antidepressants or sedatives  - Any history of allergy to radio-opaque dye </textblock> </criteria> <gender>Female</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <location> <facility> <name>Ankara University Fertility Diagnosis, Treatment, Research and Application Center</name> <address> <city>Ankara</city> <state>Mamak</state> <zip>06100</zip> <country>Turkey</country> </address> </facility> </location> <location> <facility> <name>Ankara University Fertility Diagnosis, Treatment, Research and Application Center</name> <address> <city>Ankara</city> <zip>06100</zip> <country>Turkey</country> </address> </facility> </location> <location_countries> <country>Turkey</country> </location_countries> <verification_date>January 2023</verification_date> <study_first_submitted>March 14, 2022</study_first_submitted> <study_first_submitted_qc>April 1, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>January 19, 2023</last_update_submitted> <last_update_submitted_qc>January 19, 2023</last_update_submitted_qc> <last_update_posted type="Actual">January 20, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor-Investigator</responsible_party_type> <investigator_affiliation>Ankara University</investigator_affiliation> <investigator_full_name>NESLİHAN YILMAZ SEZER</investigator_full_name> <investigator_title>Faculty of Nursing</investigator_title> </responsible_party> <patient_data> <sharing_ipd>Undecided</sharing_ipd> </patient_data>  </clinical_study>

The aim of this study is to determine the effect of virtual reality on perceived pain, anxiety, fear, physiological reactions and satisfaction in women during the HSG procedure. Hypotheses H01; In the HSG procedure, there was no difference between the pain score of the virtual reality group and the pain score of the control group. H02; In the HSG procedure, there was no difference between the anxiety score of the virtual reality group and the anxiety score of the control group. H03; In the HSG procedure, there was no difference between the satisfaction score of the virtual reality group and the satisfaction score of the control group. H04; In the HSG procedure, there was no difference between the vital signs of the virtual reality group and the control group. H05; In the HSG procedure, there was no difference between the fear score of the virtual reality group and the fear score of the control group. The study will be carried out in two different groups. The practice will start with meeting the women who apply to the Radiology clinic for an HSG. After the women are evaluated in terms of eligibility criteria for the research, the women who are eligible will be informed about the research and written informed consent will be obtained from the women who accept. The random distribution of women to the study groups will be carried out using the Block Randomization method. The following applications will be made to the groups. Virtual Reality Group In addition to the routine procedure, virtual reality glasses will be applied to the women in the virtual reality group of the research. Virtual reality glasses is a device that works on compatible smart mobile phones. After being taken to the gynecological table for the HSG procedure, the women included in the experimental group will be made to watch a video lasting an average of 10 minutes with virtual reality glasses until the procedure is completed. While watching the video, the relaxing music of the video will be played in the practice room with a bluetooth speaker. Control Group Patients in the control group of the study will not be subjected to any treatment other than the routine procedure. Inclusion Criteria: - primary infertility - Agreeing to participate in the research and obtaining written permission, - No hearing or vision problems - The first time HSG procedure will be applied Exclusion Criteria: - Didn't watch the whole video - Those with motion-sensitive diseases such as vertigo, meniere - Using any pharmacological pain-reducing method within 30 minutes - Difficulty in the HSG process or completing the process with more than one attempt - Use of antidepressants or sedatives - Any history of allergy to radio-opaque dye

NCT0531xxxx/NCT05313386.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313386</url> </required_header> <id_info> <org_study_id>BXCL501-202</org_study_id> <nct_id>NCT05313386</nct_id> </id_info> <brief_title>Study of BXCL501 In Agitation Associated With Delirium in ICU Patients</brief_title> <official_title>A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-controlled, Ascending Starting Dose Finding, Safety, and Efficacy Study of BXCL501 in Agitation Associated With Delirium in ICU Patients.</official_title> <sponsors> <lead_sponsor> <agency>BioXcel Therapeutics Inc</agency> <agency_class>Industry</agency_class> </lead_sponsor> <collaborator> <agency>Cognitive Research Corporation</agency> <agency_class>Industry</agency_class> </collaborator> </sponsors> <source>BioXcel Therapeutics Inc</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>Yes</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> This study is designed to determine and evaluate the optimal BXCL501 starting dose (StartD) that will safely and effectively reduce agitation associated with delirium in ICU patients. This is an ascending adaptive dose study evaluating the safety and efficacy of four potential starting doses of BXCL501 (120 μg, 180 μg, 240 μg, and 300 μg) in reducing agitation levels in adult ICU patients with delirium. For subjects 65 years of age and older, the potential doses will be reduced 50% in line with the Precedex (reference drug) label. The purpose of this clinical trial is to identify an optimally safe and effective BXCL501 </textblock> </brief_summary> <detailed_description> <textblock> This is a Phase 2, randomized, double-blind, placebo-controlled, ascending starting dose finding study assessing safety, efficacy, tolerability and PK of BXCL501 in four starting dose cohort groups to reduce agitation levels associated with delirium in patients within the ICU setting. Evaluation of four BXCL501 starting doses compared to placebo will be conducted according to the following ascending doses: Cohort 1 (120 μg or placebo); Cohort 2 (180 μg or placebo); Cohort 3 (240 μg or placebo); Cohort 4 (300 μg or placebo). For subjects 65 years of age and older, the starting doses in each cohort will be reduced 50% in line with the Precedex (reference drug) label. Safety, efficacy, and tolerability will be assessed throughout the treatment period at various timepoints. Subjects will receive the first starting dose (BXCL501 or placebo) when Baseline RASS score is ≥ +1. Repeat doses may be administered in increments of 120 μg every 3 to 6 hours post first dose (StartD) only if the RASS score remains ≥ +1. For subjects 65 years and older, repeat doses may start in increments of 60 μg every 3 to 6 hours post first dose only if RASS is still ≥+1. </textblock> </detailed_description> <overall_status>Withdrawn</overall_status> <why_stopped> The study stopped early, before enrolling its first participant </why_stopped> <start_date type="Actual">February 23, 2021</start_date> <completion_date type="Anticipated">February 21, 2022</completion_date> <primary_completion_date type="Anticipated">February 21, 2022</primary_completion_date> <phase>Phase 2</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Sequential Assignment</intervention_model> <intervention_model_description>Cohorts will be enrolled sequentially in this dose escalating design.</intervention_model_description> <primary_purpose>Treatment</primary_purpose> <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking> <masking_description>Randomized, double-blind, placebo-controlled</masking_description> </study_design_info> <primary_outcome> <measure>2-point or greater drop in RASS</measure> <time_frame>120 minutes</time_frame> <description>Identification of the dose leading to a 2-point or greater drop in RASS at 2 hours after starting dose administration, with initial RASS not ≤ -3</description> </primary_outcome> <secondary_outcome> <measure>The time to which a 2-point drop is seen in RASS score after starting dose administration</measure> <time_frame>24 Hours</time_frame> <description>The time to which a 2-point drop is seen in RASS score after starting dose administration.</description> </secondary_outcome> <secondary_outcome> <measure>Overall delirium improvement as measured by the CAM-ICU-7 Total Score during ICU stay</measure> <time_frame>24 Hours</time_frame> <description>Overall delirium improvement as measured by the CAM-ICU-7 Total Score during ICU stay</description> </secondary_outcome> <number_of_arms>4</number_of_arms> <enrollment type="Actual">0</enrollment> <condition>Agitation</condition> <condition>Delirium</condition> <arm_group> <arm_group_label>Cohort 1- 120 Micrograms</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>120 Micrograms film or Placebo film are given to patients in 3:1 ratio respectively. Repeat doses may be administered in increments of 120 μg every 3 to 6 hours post first dose (StartD) only if the RASS score remains ≥ +1. For subjects 65 years and older, repeat doses may start in increments of 60 μg every 3 to 6 hours post first dose only if RASS is still ≥+1.</description> </arm_group> <arm_group> <arm_group_label>Cohort 2- 180 Micrograms</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>180 Micrograms film or Placebo film are given to patients in 3:1 ratio respectively. Repeat doses may be administered in increments of 120 μg every 3 to 6 hours post first dose (StartD) only if the RASS score remains ≥ +1. For subjects 65 years and older, repeat doses may start in increments of 60 μg every 3 to 6 hours post first dose only if RASS is still ≥+1.</description> </arm_group> <arm_group> <arm_group_label>Cohort 3- 240 Micrograms</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Two 120 Micrograms films or two Placebo films are given to patients in 3:1 ratio respectively. Repeat doses may be administered in increments of 120 μg every 3 to 6 hours post first dose (StartD) only if the RASS score remains ≥ +1. For subjects 65 years and older, repeat doses may start in increments of 60 μg every 3 to 6 hours post first dose only if RASS is still ≥+1.</description> </arm_group> <arm_group> <arm_group_label>Cohort 4- 300 Micrograms</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>One 120 Micrograms film and one 180 Micrograms film or two Placebo films are given to patients in 3:1 ratio respectively. Repeat doses may be administered in increments of 120 μg every 3 to 6 hours post first dose (StartD) only if the RASS score remains ≥ +1. For subjects 65 years and older, repeat doses may start in increments of 60 μg every 3 to 6 hours post first dose only if RASS is still ≥+1.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>BXCL501</intervention_name> <description>BXCL501 is given in a film form</description> <arm_group_label>Cohort 1- 120 Micrograms</arm_group_label> <arm_group_label>Cohort 2- 180 Micrograms</arm_group_label> <arm_group_label>Cohort 3- 240 Micrograms</arm_group_label> <arm_group_label>Cohort 4- 300 Micrograms</arm_group_label> <other_name>Dexmedetomidine</other_name> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Placebo film</intervention_name> <description>Placebo is given in a film form</description> <arm_group_label>Cohort 1- 120 Micrograms</arm_group_label> <arm_group_label>Cohort 2- 180 Micrograms</arm_group_label> <arm_group_label>Cohort 3- 240 Micrograms</arm_group_label> <arm_group_label>Cohort 4- 300 Micrograms</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  Inclusion Criteria for Enrollment (Informed Consent):  1. ICU admitted male and female patients, ≥ 18 years, COVID 19 (+) and (-)  2. Subject or legally appointed representative (LAR) able to read, understand and provide informed consent, or to provide assent  Inclusion Criteria for Randomization:  3. Positive CAM-ICU  4. RASS score ≥ +1  5. Subject judged to be likely capable of self-administration  Exclusion Criteria:  1. Clinically significant ECG changes, brady- and tachyarrhythmias, QTc prolongation  2. Hepatic dysfunction  3. Pregnancy  4. Known allergy to Dexmedetomidine or Haloperidol. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <location> <facility> <name>BioXcel Clinical Research Site</name> <address> <city>Nashville</city> <state>Tennessee</state> <zip>37203</zip> <country>United States</country> </address> </facility> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>April 2022</verification_date> <study_first_submitted>March 31, 2021</study_first_submitted> <study_first_submitted_qc>April 1, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>April 1, 2022</last_update_submitted> <last_update_submitted_qc>April 1, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Delirium</mesh_term> <mesh_term>Psychomotor Agitation</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Dexmedetomidine</mesh_term> </intervention_browse>  </clinical_study>

This study is designed to determine and evaluate the optimal BXCL501 starting dose (StartD) that will safely and effectively reduce agitation associated with delirium in ICU patients. This is an ascending adaptive dose study evaluating the safety and efficacy of four potential starting doses of BXCL501 (120 μg, 180 μg, 240 μg, and 300 μg) in reducing agitation levels in adult ICU patients with delirium. For subjects 65 years of age and older, the potential doses will be reduced 50% in line with the Precedex (reference drug) label. The purpose of this clinical trial is to identify an optimally safe and effective BXCL501 This is a Phase 2, randomized, double-blind, placebo-controlled, ascending starting dose finding study assessing safety, efficacy, tolerability and PK of BXCL501 in four starting dose cohort groups to reduce agitation levels associated with delirium in patients within the ICU setting. Evaluation of four BXCL501 starting doses compared to placebo will be conducted according to the following ascending doses: Cohort 1 (120 μg or placebo); Cohort 2 (180 μg or placebo); Cohort 3 (240 μg or placebo); Cohort 4 (300 μg or placebo). For subjects 65 years of age and older, the starting doses in each cohort will be reduced 50% in line with the Precedex (reference drug) label. Safety, efficacy, and tolerability will be assessed throughout the treatment period at various timepoints. Subjects will receive the first starting dose (BXCL501 or placebo) when Baseline RASS score is ≥ +1. Repeat doses may be administered in increments of 120 μg every 3 to 6 hours post first dose (StartD) only if the RASS score remains ≥ +1. For subjects 65 years and older, repeat doses may start in increments of 60 μg every 3 to 6 hours post first dose only if RASS is still ≥+1. Inclusion Criteria: Inclusion Criteria for Enrollment (Informed Consent): 1. ICU admitted male and female patients, ≥ 18 years, COVID 19 (+) and (-) 2. Subject or legally appointed representative (LAR) able to read, understand and provide informed consent, or to provide assent Inclusion Criteria for Randomization: 3. Positive CAM-ICU 4. RASS score ≥ +1 5. Subject judged to be likely capable of self-administration Exclusion Criteria: 1. Clinically significant ECG changes, brady- and tachyarrhythmias, QTc prolongation 2. Hepatic dysfunction 3. Pregnancy 4. Known allergy to Dexmedetomidine or Haloperidol.

NCT0531xxxx/NCT05313399.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313399</url> </required_header> <id_info> <org_study_id>457</org_study_id> <nct_id>NCT05313399</nct_id> </id_info> <brief_title>Palatal Crib Versus Bonded Spurs in Early Treatment of Anterior Open Bite Caused by Non-nutritive Sucking Habits: RCT</brief_title> <official_title>Skeletal and Dentoalveolar Effects of Palatal Crib Versus Bonded Spurs in Early Treatment of Anterior Open Bite Caused by Non-nutritive Sucking Habits: A Randomised Clinical Trial.</official_title> <sponsors> <lead_sponsor> <agency>Reem Hatem Shams</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Cairo University</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The study evaluates the effects of palatal crib versus bonded spurs in the early treatment of anterior open bite caused by non-nutritive sucking habits. </textblock> </brief_summary> <detailed_description> <textblock> Habit is an unintentionally performed repeated activity. Development of habit is considered a part of the natural progression of maturation in children between infancy and three years of age, after this period, it is assumed to be unnatural. The most familiar and earliest noted habit is thumb sucking. It develops during infancy as a rooting reflex, after it ceases around three years of age .  Thumb sucking is defined as the placement of the thumb or one or more fingers in different depths into the mouth ). It emerges in two forms: nutritive and non-nutritive, where the first gives nourishment and the second implements a sense of security and amenity. It is common in children and is reported to be harmless for up to five years of age .  There is an association between the habit of thumb sucking and the development of skeletal open-bite among children. Anterior open bites (AOBs) are defined as an occlusion in which the lower incisors are not overlapped in the vertical plane by the upper incisors and do not occlude with them when the posterior teeth are in maximum intercuspation . Anterior open bite due to thumb sucking, and a secondary tongue thrust exaggerates the condition . If identified early, this can be avoided and appropriate treatment is delivered.  Approaches for habit intervention include counseling, positive reinforcement, a calendar with rewards, an adhesive bandage, bitter nail polish, long sleeves, and appliance therapy. It is recommended to start with the least invasive methods before using habit-breaking appliances. Habit-breaking appliances are either fixed or removable. Fixed appliance therapy may be considered after the age of 4 years. Appliances consisting of cribs in the anterior region are very efficient as reminders and physical restrainers . The palatal crib works as an obstacle in non-nutritive sucking and maintains the tongue in a more retruded position, halting its interposition between the incisors. Spur appliances change tongue action, close the open bite, and boost treatment stability, as it induces a permanent modification of the tongue's anterior rest posture by altering orofacial function, resulting in a change in form. Finally, the spur adjusts the sensory input to the brain. This proprioceptive change leads to an altered motor response, resulting in a new normal tongue rest posture (change in function) that allows the incisors to erupt. </textblock> </detailed_description> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">April 1, 2022</start_date> <completion_date type="Anticipated">May 1, 2023</completion_date> <primary_completion_date type="Anticipated">April 1, 2023</primary_completion_date> <phase>Phase 3</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>Single (Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Overbite distance correction in millimeter</measure> <time_frame>12 months</time_frame> <description>Digital dental model will be scanned using medit software to detect the changes that occur in the vertical distance ( in millimeter ) between incisal edges of the most erupted maxillary and mandibular central incisors in relation to the occlusal plane.</description> </primary_outcome> <secondary_outcome> <measure>Changes in maxillary mandibular plane angle</measure> <time_frame>12 months</time_frame> <description>standardised lateral cephalometric radiographs will be taken, and the variables will be digitally traced using Dolphin Imaging Software Version 11.5</description> </secondary_outcome> <secondary_outcome> <measure>Patient acceptance</measure> <time_frame>1 month</time_frame> <description>The questionnaire is consisted of 5 questions and has space for additional patient comments. The variables in the first four questions will assess speaking, eating, esthetics, and pain. The rating scale that will be used to quantify the effect of the spurs and the palatal crib on these variables 1 (easy), 2 (neutral), and 3 (difficult). The 5th question on the survey will assess the time needed by the patients to adjust the presence of the two appliances. Possible answers are 2 days or less, 1 week, 2 weeks, and longer.</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">30</enrollment> <condition>Anterior Open Bite</condition> <arm_group> <arm_group_label>control group</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>the group have open bite caused by non-nutritive sucking habits and treat them with palatal crib.</description> </arm_group> <arm_group> <arm_group_label>experimental group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>the group have open bite caused by by non-nutritive sucking habit and treat them with bonded spur.</description> </arm_group> <intervention> <intervention_type>Device</intervention_type> <intervention_name>Palatal Crib</intervention_name> <description>An intraoral appliance approach can be used as an adjunct method to stop the habit. Appliances consisting of cribs in the anterior region are very efficient as reminders and physical restrainers. The palatal crib works as an obstacle in non-nutritive sucking and maintains the tongue in a more retruded position, halting its interposition between the incisors.</description> <arm_group_label>control group</arm_group_label> </intervention> <intervention> <intervention_type>Device</intervention_type> <intervention_name>bonded spur</intervention_name> <description>Spur appliances change tongue action, close the open bite, and boost treatment stability, as it induces a permanent modification of the tongue's anterior rest posture by altering orofacial function, resulting in a change in form. Finally, the spur adjusts the sensory input to the brain. This proprioceptive change leads to an altered motor response, resulting in a new normal tongue rest posture (change in function) that allows the incisors to erupt</description> <arm_group_label>experimental group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. Children with nonnutritive sucking habits and/or tongue thrusting from 6 years to 11 years old.  2. Angle Class I malocclusions.  3. Anterior open bite equal to or greater than 1 mm.  4. Maxillary and mandibular permanent central incisors fully erupted (children in the first transitional period were eligible for treatment when the maxillary lateral incisors were beginning to erupt, and the maxillary central incisors were still showing an open bite).  Exclusion Criteria:  1. Children with loss of permanent teeth.  2. Crowding, maxillary constriction, or posterior crossbites.  3. Previous orthodontic treatment.  4. Presence of craniofacial anomalies or syndromes.  5. Tooth agenesis. </textblock> </criteria> <gender>All</gender> <minimum_age>6 Years</minimum_age> <maximum_age>11 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Ahmed H Elkhadem, Ass. professor</last_name> <role>Study Chair</role> <affiliation>Cairo University</affiliation> </overall_official> <overall_contact> <last_name>Reem H Shams, B.D.S</last_name> <phone>01099898731</phone> <phone_ext>002</phone_ext> <email>reem.shamseldin@dentistry.cu.edu.eg</email> </overall_contact> <overall_contact_backup> <last_name>maii M Ali, Lecturer</last_name> <phone>01012632608</phone> <phone_ext>022</phone_ext> <email>maii.ali@dentistry.cu.edu.eg</email> </overall_contact_backup> <link> <url>https://pubmed.ncbi.nlm.nih.gov/PMC8600830/</url> <description>correction of open bite caused by non-nutritive sucking habit by using palatal crib and bonded spur</description> </link> <reference> <citation>Leite JS, Matiussi LB, Salem AC, Provenzano MG, Ramos AL. Effects of palatal crib and bonded spurs in early treatment of anterior open bite: A prospective randomized clinical study. Angle Orthod. 2016 Sep;86(5):734-9. doi: 10.2319/031815-170.1. Epub 2015 Dec 31.</citation> <PMID>26719946</PMID> </reference> <verification_date>April 2022</verification_date> <study_first_submitted>March 22, 2022</study_first_submitted> <study_first_submitted_qc>April 1, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>April 1, 2022</last_update_submitted> <last_update_submitted_qc>April 1, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor-Investigator</responsible_party_type> <investigator_affiliation>Cairo University</investigator_affiliation> <investigator_full_name>Reem Hatem Shams</investigator_full_name> <investigator_title>Master Student</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Open Bite</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

The study evaluates the effects of palatal crib versus bonded spurs in the early treatment of anterior open bite caused by non-nutritive sucking habits. Habit is an unintentionally performed repeated activity. Development of habit is considered a part of the natural progression of maturation in children between infancy and three years of age, after this period, it is assumed to be unnatural. The most familiar and earliest noted habit is thumb sucking. It develops during infancy as a rooting reflex, after it ceases around three years of age . Thumb sucking is defined as the placement of the thumb or one or more fingers in different depths into the mouth ). It emerges in two forms: nutritive and non-nutritive, where the first gives nourishment and the second implements a sense of security and amenity. It is common in children and is reported to be harmless for up to five years of age . There is an association between the habit of thumb sucking and the development of skeletal open-bite among children. Anterior open bites (AOBs) are defined as an occlusion in which the lower incisors are not overlapped in the vertical plane by the upper incisors and do not occlude with them when the posterior teeth are in maximum intercuspation . Anterior open bite due to thumb sucking, and a secondary tongue thrust exaggerates the condition . If identified early, this can be avoided and appropriate treatment is delivered. Approaches for habit intervention include counseling, positive reinforcement, a calendar with rewards, an adhesive bandage, bitter nail polish, long sleeves, and appliance therapy. It is recommended to start with the least invasive methods before using habit-breaking appliances. Habit-breaking appliances are either fixed or removable. Fixed appliance therapy may be considered after the age of 4 years. Appliances consisting of cribs in the anterior region are very efficient as reminders and physical restrainers . The palatal crib works as an obstacle in non-nutritive sucking and maintains the tongue in a more retruded position, halting its interposition between the incisors. Spur appliances change tongue action, close the open bite, and boost treatment stability, as it induces a permanent modification of the tongue's anterior rest posture by altering orofacial function, resulting in a change in form. Finally, the spur adjusts the sensory input to the brain. This proprioceptive change leads to an altered motor response, resulting in a new normal tongue rest posture (change in function) that allows the incisors to erupt. Inclusion Criteria: 1. Children with nonnutritive sucking habits and/or tongue thrusting from 6 years to 11 years old. 2. Angle Class I malocclusions. 3. Anterior open bite equal to or greater than 1 mm. 4. Maxillary and mandibular permanent central incisors fully erupted (children in the first transitional period were eligible for treatment when the maxillary lateral incisors were beginning to erupt, and the maxillary central incisors were still showing an open bite). Exclusion Criteria: 1. Children with loss of permanent teeth. 2. Crowding, maxillary constriction, or posterior crossbites. 3. Previous orthodontic treatment. 4. Presence of craniofacial anomalies or syndromes. 5. Tooth agenesis.

NCT0531xxxx/NCT05313412.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313412</url> </required_header> <id_info> <org_study_id>C21-706 (EX-MKTG-127)</org_study_id> <nct_id>NCT05313412</nct_id> </id_info> <brief_title>Clinical Evaluation of Two Silicone Hydrogel Contact Lenses</brief_title> <official_title>Clinical Evaluation of Two Silicone Hydrogel Contact Lenses</official_title> <sponsors> <lead_sponsor> <agency>Coopervision, Inc.</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Coopervision, Inc.</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>Yes</is_fda_regulated_device> <is_us_export>Yes</is_us_export> </oversight_info> <brief_summary> <textblock> This study is to compare the short-term clinical performance and subjective acceptance of two silicone hydrogel soft contact lenses. </textblock> </brief_summary> <detailed_description> <textblock> This is a double-masked, randomized, bilateral crossover study to compare the short-term clinical performance of two silicone hydrogel soft contact lenses. Each lens type is worn for approximately six hours on separate study days, in random sequence. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">January 27, 2022</start_date> <completion_date type="Actual">April 21, 2022</completion_date> <primary_completion_date type="Actual">April 21, 2022</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Crossover Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>Double (Participant, Investigator)</masking> </study_design_info> <primary_outcome> <measure>Ease of Lens Insertion</measure> <time_frame>6 hours</time_frame> <description>Ease of Lens Insertion is measured on a scale of 0-100 (0-Unmanageable, Lenses impossible to insert; 100-Excellent. No problems with lens insertion)</description> </primary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">38</enrollment> <condition>Myopia</condition> <arm_group> <arm_group_label>Lens A, Then Lens B</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Participants will wear Lens A for six hours and then cross over to wear Lens B for six hours.</description> </arm_group> <arm_group> <arm_group_label>Lens B, Then Lens A</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Participants will wear Lens B for six hours and then cross over to wear Lens A for six hours.</description> </arm_group> <intervention> <intervention_type>Device</intervention_type> <intervention_name>Lens A (comfilcon A lens)</intervention_name> <description>6 hours</description> <arm_group_label>Lens A, Then Lens B</arm_group_label> <arm_group_label>Lens B, Then Lens A</arm_group_label> </intervention> <intervention> <intervention_type>Device</intervention_type> <intervention_name>Lens B (lehfilcon A lens)</intervention_name> <description>6 hours</description> <arm_group_label>Lens A, Then Lens B</arm_group_label> <arm_group_label>Lens B, Then Lens A</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. They are aged between 18 and 40 years.  2. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.  3. They are willing and able to follow the protocol.  4. They have successfully worn contact lenses within six months of starting the study.  5. They can be satisfactorily fitted with the study contact lenses.  6. They have a contact lens spherical prescription between -0.25 to - 6.00D (inclusive) based on the ocular refraction.  7. They have a spectacle cylindrical correction of -0.75D or less in each eye based on the ocular refraction.  8. They own and habitually wear single vision spectacles.  9. They can attain at least 0.20 logMAR distance high contrast visual acuity in each eye, with the study lenses.  10. They agree not to participate in other clinical research while enrolled on this study.  Exclusion Criteria:  1. They have an ocular disorder which would normally contraindicate contact lens wear.  2. They have a systemic disorder which would normally contraindicate contact lens wear.  3. They are using any topical medication such as eye drops or ointment.  4. They are aphakic.  5. They have had corneal refractive surgery.  6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.  7. They are pregnant or breastfeeding.  8. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (eg HIV) or a history of anaphylaxis or severe allergic reaction.  9. They have grade 3 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality, which would normally contraindicate contact lens wear.  10. They have taken part in any other clinical trial or research, within two weeks prior to starting this study, which may impact on this particular work. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>40 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Philip Morgan, PhD,MCOptom</last_name> <role>Principal Investigator</role> <affiliation>Eurolens Research</affiliation> </overall_official> <location> <facility> <name>Eurolens Research</name> <address> <city>Manchester</city> <country>United Kingdom</country> </address> </facility> </location> <location_countries> <country>United Kingdom</country> </location_countries> <verification_date>September 2022</verification_date> <study_first_submitted>March 24, 2022</study_first_submitted> <study_first_submitted_qc>April 1, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <results_first_submitted>April 17, 2023</results_first_submitted> <results_first_submitted_qc>April 17, 2023</results_first_submitted_qc> <results_first_posted type="Actual">May 9, 2023</results_first_posted> <last_update_submitted>April 17, 2023</last_update_submitted> <last_update_submitted_qc>April 17, 2023</last_update_submitted_qc> <last_update_posted type="Actual">May 9, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Myopia</mesh_term> </condition_browse> <provided_document_section> <provided_document> <document_type>Study Protocol and Statistical Analysis Plan</document_type> <document_has_protocol>Yes</document_has_protocol> <document_has_icf>No</document_has_icf> <document_has_sap>Yes</document_has_sap> <document_date>September 27, 2021</document_date> <document_url>https://ClinicalTrials.gov/ProvidedDocs/12/NCT05313412/Prot_SAP_000.pdf</document_url> </provided_document> </provided_document_section> <clinical_results> <participant_flow> <pre_assignment_details>Thirty-eight participants attended the initial visit with all participants completing the study.</pre_assignment_details> <group_list> <group group_id="P1"> <title>Lens A, Then Lens B</title> <description>Participants wore Lens A for 6 hours and then wore Lens B for 6 hours on two separate study days.</description> </group> <group group_id="P2"> <title>Lens B, Then Lens A</title> <description>Participants wore Lens B for 6 hours and then wore Lens A for 6 hours on two separate study days.</description> </group> </group_list> <period_list> <period> <title>Overall Study</title> <milestone_list> <milestone> <title>STARTED</title> <participants_list> <participants group_id="P1" count="19"/> <participants group_id="P2" count="19"/> </participants_list> </milestone> <milestone> <title>COMPLETED</title> <participants_list> <participants group_id="P1" count="19"/> <participants group_id="P2" count="19"/> </participants_list> </milestone> <milestone> <title>NOT COMPLETED</title> <participants_list> <participants group_id="P1" count="0"/> <participants group_id="P2" count="0"/> </participants_list> </milestone> </milestone_list> </period> </period_list> </participant_flow> <baseline> <group_list> <group group_id="B1"> <title>Overall Study</title> <description>Total study population</description> </group> </group_list> <analyzed_list> <analyzed> <units>Participants</units> <scope>Overall</scope> <count_list> <count group_id="B1" value="38"/> </count_list> </analyzed> </analyzed_list> <measure_list> <measure> <title>Age</title> <units>Participants</units> <param>Count of Participants</param> <class_list> <class> <analyzed_list> <analyzed> <units>Participants</units> <scope>Class</scope> <count_list> <count group_id="B1" value="38"/> </count_list> </analyzed> </analyzed_list> <category_list> <category> <title><=18 years</title> <measurement_list> <measurement group_id="B1" value="0"/> </measurement_list> </category> <category> <title>Between 18 and 65 years</title> <measurement_list> <measurement group_id="B1" value="38"/> </measurement_list> </category> <category> <title>>=65 years</title> <measurement_list> <measurement group_id="B1" value="0"/> </measurement_list> </category> </category_list> </class> </class_list> </measure> <measure> <title>Sex: Female, Male</title> <units>Participants</units> <param>Count of Participants</param> <class_list> <class> <analyzed_list> <analyzed> <units>Participants</units> <scope>Class</scope> <count_list> <count group_id="B1" value="38"/> </count_list> </analyzed> </analyzed_list> <category_list> <category> <title>Female</title> <measurement_list> <measurement group_id="B1" value="26"/> </measurement_list> </category> <category> <title>Male</title> <measurement_list> <measurement group_id="B1" value="12"/> </measurement_list> </category> </category_list> </class> </class_list> </measure> <measure> <title>Race and Ethnicity Not Collected</title> <population>Race and Ethnicity were not collected from any participant.</population> <units>Participants</units> <param>Count of Participants</param> <class_list> <class> <analyzed_list> <analyzed> <units>Participants</units> <scope>Class</scope> <count_list> <count group_id="B1" value="0"/> </count_list> </analyzed> </analyzed_list> </class> </class_list> </measure> </measure_list> </baseline> <outcome_list> <outcome> <type>Primary</type> <title>Ease of Lens Insertion</title> <description>Ease of Lens Insertion is measured on a scale of 0-100 (0-Unmanageable, Lenses impossible to insert; 100-Excellent. No problems with lens insertion)</description> <time_frame>6 hours</time_frame> <group_list> <group group_id="O1"> <title>Lens A</title> <description>Participants wore Lens A for six hours.</description> </group> <group group_id="O2"> <title>Lens B</title> <description>Participants wore Lens B for six hours.</description> </group> </group_list> <measure> <title>Ease of Lens Insertion</title> <description>Ease of Lens Insertion is measured on a scale of 0-100 (0-Unmanageable, Lenses impossible to insert; 100-Excellent. No problems with lens insertion)</description> <units>units on a scale</units> <param>Mean</param> <dispersion>Standard Deviation</dispersion> <analyzed_list> <analyzed> <units>Participants</units> <scope>Measure</scope> <count_list> <count group_id="O1" value="38"/> <count group_id="O2" value="38"/> </count_list> </analyzed> </analyzed_list> <class_list> <class> <category_list> <category> <measurement_list> <measurement group_id="O1" value="92.1" spread="10.3"/> <measurement group_id="O2" value="90.9" spread="17.4"/> </measurement_list> </category> </category_list> </class> </class_list> </measure> </outcome> </outcome_list> <reported_events> <time_frame>From dispense up to six hours on each lens type, for a total of 12 hours</time_frame> <group_list> <group group_id="E1"> <title>Lens A</title> <description>Participants wore Lens A for six hours.</description> </group> <group group_id="E2"> <title>Lens B</title> <description>Participants wore Lens B for six hours.</description> </group> </group_list> <serious_events> <category_list> <category> <title>Total</title> <event_list> <event> <sub_title>Total, all-cause mortality</sub_title> <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/> <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/> </event> <event> <sub_title>Total, serious adverse events</sub_title> <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/> <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/> </event> </event_list> </category> </category_list> </serious_events> <other_events> <frequency_threshold>0</frequency_threshold> <category_list> <category> <title>Total</title> <event_list> <event> <sub_title>Total, other adverse events</sub_title> <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/> <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/> </event> </event_list> </category> </category_list> </other_events> </reported_events> <certain_agreements> <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee> <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement> </certain_agreements> <point_of_contact> <name_or_title>Jose A. Vega, OD, MSc, FAAO</name_or_title> <organization>CooperVision</organization> <phone>925-621-3761</phone> <email>JVega2@coopervision.com</email> </point_of_contact> </clinical_results> </clinical_study>

This study is to compare the short-term clinical performance and subjective acceptance of two silicone hydrogel soft contact lenses. This is a double-masked, randomized, bilateral crossover study to compare the short-term clinical performance of two silicone hydrogel soft contact lenses. Each lens type is worn for approximately six hours on separate study days, in random sequence. Inclusion Criteria: 1. They are aged between 18 and 40 years. 2. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent. 3. They are willing and able to follow the protocol. 4. They have successfully worn contact lenses within six months of starting the study. 5. They can be satisfactorily fitted with the study contact lenses. 6. They have a contact lens spherical prescription between -0.25 to - 6.00D (inclusive) based on the ocular refraction. 7. They have a spectacle cylindrical correction of -0.75D or less in each eye based on the ocular refraction. 8. They own and habitually wear single vision spectacles. 9. They can attain at least 0.20 logMAR distance high contrast visual acuity in each eye, with the study lenses. 10. They agree not to participate in other clinical research while enrolled on this study. Exclusion Criteria: 1. They have an ocular disorder which would normally contraindicate contact lens wear. 2. They have a systemic disorder which would normally contraindicate contact lens wear. 3. They are using any topical medication such as eye drops or ointment. 4. They are aphakic. 5. They have had corneal refractive surgery. 6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus. 7. They are pregnant or breastfeeding. 8. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (eg HIV) or a history of anaphylaxis or severe allergic reaction. 9. They have grade 3 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality, which would normally contraindicate contact lens wear. 10. They have taken part in any other clinical trial or research, within two weeks prior to starting this study, which may impact on this particular work.

NCT0531xxxx/NCT05313425.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313425</url> </required_header> <id_info> <org_study_id>Ectoine after PRK</org_study_id> <nct_id>NCT05313425</nct_id> </id_info> <brief_title>Effect of Ectoine After Photorefractive Keratectomy (PRK).</brief_title> <official_title>Effect of Ectoine on Stromal Haze, Wound Healing and Pain After Photorefractive Keratectomy.</official_title> <sponsors> <lead_sponsor> <agency>Tanta University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Tanta University</source> <oversight_info> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> This is a comparative, open label, parallel group, non interventional study aims to assess the effect of Ectoine containing eye drops on stromal haze, pain and epithelial healing after Photorefractive keratectomy (PRK). The patient apply Ectohylo eye drops (Ectoine +Sodium Hyauronate) in the right eye and Polyfresh Extra eye drops (Carboxymethyl cellulose + Sodium Hyauronate ) in the left eye plus the routine post PRK treatment in both eyes. Post operative pain , epithelial healing and corneal densitometry is observed in both eyes. </textblock> </brief_summary> <detailed_description> <textblock> Photorefractive keratectomy (PRK) is a commonly used operation for laser vision correction. The main fears of this type of laser vision correction is corneal haze, delayed epithelial healing and postoperative severe pain. Ectoine is a natural compound that has the ability to protect biological membranes from damage and environmental effects. This study assess the use of Ectoine containing eye drops to protect the bare ocular surface and reduce inflammation after PRK that will inturn is expected to affect the post operative corneal haze, pain, and epithelial healing . </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">January 1, 2022</start_date> <completion_date type="Anticipated">October 2022</completion_date> <primary_completion_date type="Anticipated">May 2022</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Case-Only</observational_model> <time_perspective>Prospective</time_perspective> </study_design_info> <primary_outcome> <measure>Corneal Densitometry (assesed by Pentacam).</measure> <time_frame>3 months post operative</time_frame> <description>Post photo refractive keratectomy early haze (3 months after operation) assesed by Pentacam densitometry</description> </primary_outcome> <secondary_outcome> <measure>Pain score (0 -10)</measure> <time_frame>2 days</time_frame> <description>pain in the first 2 days post operative (graded 0 to 10)</description> </secondary_outcome> <secondary_outcome> <measure>Time of Epithelial healing (days)</measure> <time_frame>2-7 days</time_frame> <description>Time required for epithelial healing after PRK in days</description> </secondary_outcome> <number_of_groups>2</number_of_groups> <enrollment type="Anticipated">15</enrollment> <condition>Photorefractive Keratectomy</condition> <condition>Corneal Haze</condition> <arm_group> <arm_group_label>Ectoine Eye</arm_group_label> <description>The right eye of the studied group will be given 2% Ectoine containig , 0.2% sodium hyaluronate eye drops(Ectohylo) hourly.</description> </arm_group> <arm_group> <arm_group_label>Control eye</arm_group_label> <description>The left eye of the studied group will be give Carboxymethyl cellulose, 0.2% sodium hyaluronate eye drops(Polyfresh Extra) hourly.</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Ectohylo (R) eye drops</intervention_name> <description>using Ectohylo eye drops post operative after PRK in the right eyes of the patients</description> <arm_group_label>Ectoine Eye</arm_group_label> <other_name>Ectoine 2% eye drops</other_name> </intervention> <eligibility> <study_pop> <textblock> Patient enrolled for photorefractive keratectomy for correction of myopia and myopic astigmatism. </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Patient undergoing PRK for myopia and myopic astigmatism when astigmatism is 2.5 diopters or less and myopia with spherical equivalent -4 or less.  Exclusion Criteria:  - patient spherical equivalent more myopic than -4 diopters  - Patients with astigmatism more than 2.5 diopter  - Patients with anisometropia ( difference > 2 diopters)  - Patient with previous ocular surgery  - Patients with chronic systemic disease that can affect results of laser vision correction (e.g. rheumatoid arthritis)  - Pregnant and lactating females </textblock> </criteria> <gender>All</gender> <minimum_age>19 Years</minimum_age> <maximum_age>35 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Mohamed Elkadim</last_name> <role>Principal Investigator</role> <affiliation>Tanta University</affiliation> </overall_official> <overall_contact> <last_name>Mohamed Elkadim, MD</last_name> <phone>01004991183</phone> <email>mzekadem@gmail.com</email> </overall_contact> <location> <facility> <name>Tanta University</name> <address> <city>Tanta</city> <state>El Gharbia</state> <zip>31512</zip> <country>Egypt</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Mohamed Elkadim</last_name> <phone>01004991183</phone> <email>mzekadem@gmail.com</email> </contact> </location> <location_countries> <country>Egypt</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>March 29, 2022</last_update_submitted> <last_update_submitted_qc>March 29, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Tanta University</investigator_affiliation> <investigator_full_name>Mohamed Elkadim</investigator_full_name> <investigator_title>Lecturer of ophthalmology</investigator_title> </responsible_party> <keyword>PRK, surface ablation, corneal haze</keyword> <condition_browse>  <mesh_term>Corneal Opacity</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Ophthalmic Solutions</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>Yes</sharing_ipd> <ipd_description>Data obtained through this study may be provided to qualified researchers with academic interest in Cornea. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party</ipd_description> <ipd_info_type>Study Protocol</ipd_info_type> <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type> <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type> <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type> <ipd_time_frame>after publication for 5 months</ipd_time_frame> <ipd_access_criteria>Authorized Ophthalmologists specialized in cornea and refractive surgery</ipd_access_criteria> </patient_data>  </clinical_study>

This is a comparative, open label, parallel group, non interventional study aims to assess the effect of Ectoine containing eye drops on stromal haze, pain and epithelial healing after Photorefractive keratectomy (PRK). The patient apply Ectohylo eye drops (Ectoine +Sodium Hyauronate) in the right eye and Polyfresh Extra eye drops (Carboxymethyl cellulose + Sodium Hyauronate ) in the left eye plus the routine post PRK treatment in both eyes. Post operative pain , epithelial healing and corneal densitometry is observed in both eyes. Photorefractive keratectomy (PRK) is a commonly used operation for laser vision correction. The main fears of this type of laser vision correction is corneal haze, delayed epithelial healing and postoperative severe pain. Ectoine is a natural compound that has the ability to protect biological membranes from damage and environmental effects. This study assess the use of Ectoine containing eye drops to protect the bare ocular surface and reduce inflammation after PRK that will inturn is expected to affect the post operative corneal haze, pain, and epithelial healing . Patient enrolled for photorefractive keratectomy for correction of myopia and myopic astigmatism. Inclusion Criteria: - Patient undergoing PRK for myopia and myopic astigmatism when astigmatism is 2.5 diopters or less and myopia with spherical equivalent -4 or less. Exclusion Criteria: - patient spherical equivalent more myopic than -4 diopters - Patients with astigmatism more than 2.5 diopter - Patients with anisometropia ( difference > 2 diopters) - Patient with previous ocular surgery - Patients with chronic systemic disease that can affect results of laser vision correction (e.g. rheumatoid arthritis) - Pregnant and lactating females

NCT0531xxxx/NCT05313438.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313438</url> </required_header> <id_info> <org_study_id>CLN-1108-001</org_study_id> <nct_id>NCT05313438</nct_id> </id_info> <brief_title>The STIM-ADHF Study</brief_title> <official_title>Cardiac Pulmonary Nerve STIMulation in Acute Decompensated Heart Failure</official_title> <sponsors> <lead_sponsor> <agency>Cardionomic Inc.</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Cardionomic Inc.</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>Yes</is_fda_regulated_device> <is_unapproved_device>Yes</is_unapproved_device> <is_us_export>Yes</is_us_export> </oversight_info> <brief_summary> <textblock> The STIM-ADHF Study is a multi-center, observational study to assess the performance and safety of the CPNS System in patients with ADHF. </textblock> </brief_summary> <detailed_description> <textblock> The CPNS System is a neuromodulation system used to treat ADHF, a sudden or slow deterioration of chronic heart failure. The CPNS system is intended to provide acute (≤ 5 days) endovascular stimulation of the cardiac autonomic nerves in the right pulmonary artery (PA) in hospitalized ADHF patients. The system consists of an acute temporary neuromodulation stimulation catheter placed in the right pulmonary artery via venous access and a custom stimulator, denoiser, and associated cables. The CN2 Catheter is delivered to the right PA and provides an inotropic and/or lusitropic therapeutic effect by electrical stimulation to the terminal sympathetic nerve branches within the cardio-pulmonary plexus. The study will be conducted at up to 20 study sites worldwide. Up to 50 subjects who meet the eligibility criteria, will be enrolled, treated in-hospital with the Cardionomic CPNS System, monitored closely throughout the hospitalization and followed through 30 days post hospital discharge to evaluate the effect of the CPNS treatment. </textblock> </detailed_description> <overall_status>Active, not recruiting</overall_status> <start_date type="Actual">May 10, 2022</start_date> <completion_date type="Anticipated">September 2023</completion_date> <primary_completion_date type="Anticipated">September 2023</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>N/A</allocation> <intervention_model>Single Group Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Occurrence of related adverse events</measure> <time_frame>Enrolment to 30 Days post hospital discharge</time_frame> <description>The following measures will be characterized in all enrolled subjects: occurrence of all procedure, device and therapy related adverse events, serious adverse events and deaths</description> </primary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Actual">13</enrollment> <condition>Acute Decompensated Heart Failure</condition> <arm_group> <arm_group_label>CPNS Therapy</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Endovascular stimulation of the cardiac autonomic nerves in addition to standard of care.</description> </arm_group> <intervention> <intervention_type>Device</intervention_type> <intervention_name>CPNS Therapy</intervention_name> <description>Endovascular stimulation of the cardiac autonomic nerves in addition to standard of care</description> <arm_group_label>CPNS Therapy</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Admitted to the hospital or planned to be admitted with a principal diagnosis of acute decompensated heart failure  - BMI adjusted BNP ≥ 500 pg/mL or NT-proBNP ≥ 2000 pg/mL  - LVEF ≤ 50%  - At least one sign/symptom of fluid overload  - At least one of the following:  - Inadequate diuretic response  - At least one sign or symptom of low perfusion  Exclusion Criteria:  - Received an inotrope during current hospitalization  - Requires mechanical support  - Cardiogenic shock or impending cardiogenic shock  - Multi-organ failure  - Systolic blood pressure < 80mmHg or > 140mmHg  - Symptomatic hypotension  - eGFR < 25 mL/min/1.732  - Severe hepatic disease </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <location> <facility> <name>Semmelweis University, Heart and Vascular Center</name> <address> <city>Budapest</city> <country>Hungary</country> </address> </facility> </location> <location> <facility> <name>Hearth Faculty of Medicine, University of Pécs</name> <address> <city>Pécs</city> <country>Hungary</country> </address> </facility> </location> <location> <facility> <name>Szegedi Tudományegyetem ÁOK</name> <address> <city>Szeged</city> <country>Hungary</country> </address> </facility> </location> <location> <facility> <name>American Heart of Poland</name> <address> <city>Bielsko Biala</city> <country>Poland</country> </address> </facility> </location> <location> <facility> <name>Stredoslovenský Ústav srdcových a Cievnych Chorȏb, a.s.</name> <address> <city>Banská Bystrica</city> <zip>97401</zip> <country>Slovakia</country> </address> </facility> </location> <location> <facility> <name>CINRE s.r.o</name> <address> <city>Bratislava</city> <country>Slovakia</country> </address> </facility> </location> <location_countries> <country>Hungary</country> <country>Poland</country> <country>Slovakia</country> </location_countries> <verification_date>August 2023</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>August 30, 2023</last_update_submitted> <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc> <last_update_posted type="Actual">August 31, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Neurostimulation</keyword> <keyword>Contractility</keyword> <keyword>Right Pulmonary Artery</keyword> <condition_browse>  <mesh_term>Heart Failure</mesh_term> </condition_browse>  </clinical_study>

The STIM-ADHF Study is a multi-center, observational study to assess the performance and safety of the CPNS System in patients with ADHF. The CPNS System is a neuromodulation system used to treat ADHF, a sudden or slow deterioration of chronic heart failure. The CPNS system is intended to provide acute (≤ 5 days) endovascular stimulation of the cardiac autonomic nerves in the right pulmonary artery (PA) in hospitalized ADHF patients. The system consists of an acute temporary neuromodulation stimulation catheter placed in the right pulmonary artery via venous access and a custom stimulator, denoiser, and associated cables. The CN2 Catheter is delivered to the right PA and provides an inotropic and/or lusitropic therapeutic effect by electrical stimulation to the terminal sympathetic nerve branches within the cardio-pulmonary plexus. The study will be conducted at up to 20 study sites worldwide. Up to 50 subjects who meet the eligibility criteria, will be enrolled, treated in-hospital with the Cardionomic CPNS System, monitored closely throughout the hospitalization and followed through 30 days post hospital discharge to evaluate the effect of the CPNS treatment. Inclusion Criteria: - Admitted to the hospital or planned to be admitted with a principal diagnosis of acute decompensated heart failure - BMI adjusted BNP ≥ 500 pg/mL or NT-proBNP ≥ 2000 pg/mL - LVEF ≤ 50% - At least one sign/symptom of fluid overload - At least one of the following: - Inadequate diuretic response - At least one sign or symptom of low perfusion Exclusion Criteria: - Received an inotrope during current hospitalization - Requires mechanical support - Cardiogenic shock or impending cardiogenic shock - Multi-organ failure - Systolic blood pressure < 80mmHg or > 140mmHg - Symptomatic hypotension - eGFR < 25 mL/min/1.732 - Severe hepatic disease

NCT0531xxxx/NCT05313451.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313451</url> </required_header> <id_info> <org_study_id>1699</org_study_id> <nct_id>NCT05313451</nct_id> </id_info> <brief_title>Evaluation of the Effect of a Soluble Fiber Consumption on Immunity Response</brief_title> <acronym>NUTIVAC</acronym> <official_title>Evaluation of the Effect of a Soluble Fiber Consumption on the Immune Response Post-influenza Vaccination in Healthy Subjects Aged 50 to 70 Years</official_title> <sponsors> <lead_sponsor> <agency>CEN Biotech</agency> <agency_class>Industry</agency_class> </lead_sponsor> <collaborator> <agency>Roquette Freres</agency> <agency_class>Industry</agency_class> </collaborator> </sponsors> <source>CEN Biotech</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> At European level, the European Food Safety Agency has recognized two claims relating to the effects of prebiotics on the gastrointestinal sphere and on the immune system. In subjects aged 45-63, it was shown that a pre- and post-vaccination inulin consumption of 8g/day significantly increased the titer of antibodies directed against the H3N2 viral strain. The increase in bifidobacteria in the faeces confirmed that this effect was related to prebiotic capacities. The effect of prebiotics and probiotics on the immune response to influenza virus vaccination has been studied in two systematic reviews and meta-analyses. The authors show that the consumption of prebiotic fibers such as FOS, GOS, inulin, was also effective on the H3N2 strain, as on the H1N1 and B strains (antibody titers of 19.5%, 20.0% and 13.6% higher, respectively, compared to placebo).  The soluble fiber under study is a resistant dextrin meeting the definition of a prebiotic fibre. The prebiotic properties have been demonstrated in humans in several studies for doses ranging from 10 to 20 g/day. Similarly, studies show that the effects on immune functions are favorably impacted by a consumption of 10 g/day for 8 weeks . These results confirm those of a preclinical study conducted in mini-pigs.  The main objective of these study is to demonstrate that these prebiotic properties could help stimulate the post-vaccination immune response, and more specifically the production of antibodies directed against seasonal influenza viruses (following vaccination), and modulate the pro- and anti-inflammatory responses. </textblock> </brief_summary> <detailed_description> <textblock> Screened participants who met the eligibility criteria are randomized either in the control or test (soluble fiber) group.  They are asked to ingest placebo or test product at 15 g/d dosing for 60 days (2 months) . At the end of the first month (30 days) they get vaccinated against influenza virus. The effect of soluble fiber on immune response is assessed by the comparison of HI titration 30 days after vaccination between groups. </textblock> </detailed_description> <overall_status>Active, not recruiting</overall_status> <start_date type="Actual">February 7, 2022</start_date> <completion_date type="Anticipated">July 31, 2023</completion_date> <primary_completion_date type="Actual">August 18, 2022</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Other</primary_purpose> <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Change from baseline HI titers at 2 months</measure> <time_frame>at Month 1 (before influenza vaccination), at Month 2 (one month after influenza vaccination)</time_frame> <description>hemagglutination inhibition (HI) antibody titers after vaccination</description> </primary_outcome> <secondary_outcome> <measure>Intestinal Microbiota</measure> <time_frame>at month 0, At month 1, at month 2</time_frame> <description>The microbiota is characterized using the Shotgun bacterial DNA analysis method on feces samples</description> </secondary_outcome> <secondary_outcome> <measure>Inflammatory biomarker</measure> <time_frame>at month 0, at month 1, at month 2</time_frame> <description>Interleukins</description> </secondary_outcome> <secondary_outcome> <measure>Cytokin biomarker</measure> <time_frame>at month 0, at month 1, at month 2</time_frame> <description>Tumour Necrosis Factor alpha cytokin</description> </secondary_outcome> <secondary_outcome> <measure>Incidence of Treatment on hematologic blood parameters</measure> <time_frame>at month 0, at month 1, at month 2</time_frame> <description>Complete blood count</description> </secondary_outcome> <secondary_outcome> <measure>Incidence of Treatment on biochemical blood parameters</measure> <time_frame>at month 0, at month 1, at month 2</time_frame> <description>Transaminases</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">70</enrollment> <condition>Immune Response</condition> <arm_group> <arm_group_label>Soluble fiber</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Participants ingest 15 g daily of the experimental product for 2 months and receive the influenza vaccine at the end of the first month.</description> </arm_group> <arm_group> <arm_group_label>Placebo</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> <description>Participants ingest 15 g daily of the placebo product for 2 months and receive the influenza vaccine at the end of the first month.</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Soluble fiber</intervention_name> <description>15g/day during 2 months</description> <arm_group_label>Soluble fiber</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Placebo</intervention_name> <description>Maltodextrin 15g/day during 2 months</description> <arm_group_label>Placebo</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Main Inclusion Criteria:  - Subject with a body mass index (BMI) of 18.0-30.0 kg/m 2  - Subject with regular upper respiratory tract infections(nasopharyngitis, flu-like illness, flu, cold...)  - Subject accepting the anti-influenza virus vaccination  - Subject agreeing to maintain lifestyle and dietary habits over the study  Main Exclusion Criteria:  - Subject having had the flu during the current season  - Subject having presented a viral or bacterial infection in the past 7 days prior to inclusion  - Subject with a known allergy to one of the compounds of products administered in the study or in accordance with indications of the vaccine  - Subject having presented manifestations of allergy during previous flu vaccinations  - Subject with ongoing gastrointestinal disease or chronic gastrointestinal disease (IBS, Crohn's disease, etc.)  - Suffering from diabetes, an autoimmune disease, a disease inflammation or a major or progressive pathology  - Pregnant women (negative urine pregnancy test for women of childbearing age), breastfeeding or planning a pregnancy in the coming months  - Subject who has already received the influenza vaccine for the current season  - Subject having received any vaccination during the last month prior to inclusion  - Subject who received antibiotic therapy within the last two month  - Taking any dietary supplements or enriched foods that are presented as having an action on immunity and/or on the intestinal sphere (prebiotics, probiotics, vitamins, plant extracts...) in the last month.  - Taking immunomodulatory or immunosuppressive drugs  - Taking any treatment that the investigator believes may interfere with investigation endpoints. </textblock> </criteria> <gender>All</gender> <minimum_age>50 Years</minimum_age> <maximum_age>70 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <location> <facility> <name>CEN Nutriment</name> <address> <city>Dijon</city> <state>Bourgogne</state> <zip>21000</zip> <country>France</country> </address> </facility> </location> <location_countries> <country>France</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>March 2, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>March 1, 2023</last_update_submitted> <last_update_submitted_qc>March 1, 2023</last_update_submitted_qc> <last_update_posted type="Actual">March 2, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <patient_data> <sharing_ipd>Undecided</sharing_ipd> </patient_data>  </clinical_study>

At European level, the European Food Safety Agency has recognized two claims relating to the effects of prebiotics on the gastrointestinal sphere and on the immune system. In subjects aged 45-63, it was shown that a pre- and post-vaccination inulin consumption of 8g/day significantly increased the titer of antibodies directed against the H3N2 viral strain. The increase in bifidobacteria in the faeces confirmed that this effect was related to prebiotic capacities. The effect of prebiotics and probiotics on the immune response to influenza virus vaccination has been studied in two systematic reviews and meta-analyses. The authors show that the consumption of prebiotic fibers such as FOS, GOS, inulin, was also effective on the H3N2 strain, as on the H1N1 and B strains (antibody titers of 19.5%, 20.0% and 13.6% higher, respectively, compared to placebo). The soluble fiber under study is a resistant dextrin meeting the definition of a prebiotic fibre. The prebiotic properties have been demonstrated in humans in several studies for doses ranging from 10 to 20 g/day. Similarly, studies show that the effects on immune functions are favorably impacted by a consumption of 10 g/day for 8 weeks . These results confirm those of a preclinical study conducted in mini-pigs. The main objective of these study is to demonstrate that these prebiotic properties could help stimulate the post-vaccination immune response, and more specifically the production of antibodies directed against seasonal influenza viruses (following vaccination), and modulate the pro- and anti-inflammatory responses. Screened participants who met the eligibility criteria are randomized either in the control or test (soluble fiber) group. They are asked to ingest placebo or test product at 15 g/d dosing for 60 days (2 months) . At the end of the first month (30 days) they get vaccinated against influenza virus. The effect of soluble fiber on immune response is assessed by the comparison of HI titration 30 days after vaccination between groups. Main Inclusion Criteria: - Subject with a body mass index (BMI) of 18.0-30.0 kg/m 2 - Subject with regular upper respiratory tract infections(nasopharyngitis, flu-like illness, flu, cold...) - Subject accepting the anti-influenza virus vaccination - Subject agreeing to maintain lifestyle and dietary habits over the study Main Exclusion Criteria: - Subject having had the flu during the current season - Subject having presented a viral or bacterial infection in the past 7 days prior to inclusion - Subject with a known allergy to one of the compounds of products administered in the study or in accordance with indications of the vaccine - Subject having presented manifestations of allergy during previous flu vaccinations - Subject with ongoing gastrointestinal disease or chronic gastrointestinal disease (IBS, Crohn's disease, etc.) - Suffering from diabetes, an autoimmune disease, a disease inflammation or a major or progressive pathology - Pregnant women (negative urine pregnancy test for women of childbearing age), breastfeeding or planning a pregnancy in the coming months - Subject who has already received the influenza vaccine for the current season - Subject having received any vaccination during the last month prior to inclusion - Subject who received antibiotic therapy within the last two month - Taking any dietary supplements or enriched foods that are presented as having an action on immunity and/or on the intestinal sphere (prebiotics, probiotics, vitamins, plant extracts...) in the last month. - Taking immunomodulatory or immunosuppressive drugs - Taking any treatment that the investigator believes may interfere with investigation endpoints.

NCT0531xxxx/NCT05313464.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313464</url> </required_header> <id_info> <org_study_id>PREMIAM</org_study_id> <nct_id>NCT05313464</nct_id> </id_info> <brief_title>Effect of Parental Enteral Nutrition on Quality Of Parent-Child Interactions</brief_title> <acronym>PREMIAM</acronym> <official_title>Effect of Parental Enteral Nutrition on Quality Of Parent-Child Interactions: Prospective Randomized Monocentric Study (PREMIAM)</official_title> <sponsors> <lead_sponsor> <agency>Centre Hospitalier Intercommunal Creteil</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Le Laboratoire de Psychopathologie et Processus de Santé</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Centre Hospitalier Intercommunal Creteil</source> <oversight_info> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Studies underline both the importance of the link and contact that occurs in the earliest days of life and the need to involve parents early with their premature child.  However, the impact of parental nutrition on the later active nutrition and on the quality of parent-child interactions is currently unknown.  PREMIAM study investigates whether active parental participation in enteral nutrition improves the interactions between the infant and his parents, making them more sensitive to their baby's signals and promoting their relational adjustment. </textblock> </brief_summary> <detailed_description> <textblock> The importance of parental participation in the feeding of preterm infants has been highlighted by Gianni. In his study of 81 preterm infants in the tertiary centre , the early parental bottle feeding and the skin-to-skin contact were factors promoting withdrawal from enteral nutrition. Moreover, actively participate in care even complex, is desired by parents.  Recently, a study compared 10 parent-child dyads and showed that enteral nutrition pushed by a parent (parental nutrition, NP) in comparison of the electric syringe pump , allowed a better perception of the tube by the parents and gave them a sense of utility. The same team randomized 17 preterm infants, born after 28 WA( week amenorrhoea), to receive or not à parent-pushed enteral nutrition The child's behavior changes during nutrition were analyzed in both arms, after scoring of the videos feeding according to the NICAP® ( individualized neonatal assessment and developmental care program) method. Signs of well-being and relaxation of members were more present in case of parental involvement in the delivery of nutrition. These preliminary studies suggest that parental nutrition is well tolerated and improves the comfort of the child and parent during nutrition.  However, the impact of parental nutrition on the subsequent active nutrition and on the quality of parent-child interactions is currently unknown. </textblock> </detailed_description> <overall_status>Enrolling by invitation</overall_status> <start_date type="Actual">April 15, 2022</start_date> <completion_date type="Anticipated">December 28, 2024</completion_date> <primary_completion_date type="Anticipated">April 15, 2024</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Other</primary_purpose> <masking>Single (Participant)</masking> </study_design_info> <primary_outcome> <measure>behavioural interactions (visual, vocal, mimic)</measure> <time_frame>34 (W) weeks of gestational age</time_frame> <description>interactions during the first 10 minutes of an interactive sequence of a premature in the arms of his parent, filmed and coded with The Observer XT software to 34 WA, starting from 3 behaviors of the premature: vocalization, face look mother" and smile</description> </primary_outcome> <secondary_outcome> <measure>Mother and Father Self-Question Assessment of Parental Competence: The Cognitive and Parental Behaviour Scale (PACOTIS)</measure> <time_frame>at Month 4</time_frame> <description>Parents indicate on an eleven point scale (0 = not at all what I think, feel, or do; 10 = exactly what I think, feel, or do) to what extent each statement accurately describes their actions, thoughts or feelings in the context of interacting with their infants. The parental self-efficacy (6 items, α = .82), and perceived parental impact (5 items, α = .68) subscales include statements relating to beliefs about parenting competence and their impact on the child, while the parental hostile-reactive behaviours (7 items, α = .73), parental overprotection (5 items, α = .60), and parental warmth (5 items, α= .78) subscales assess parents' involvement in different types of behaviour with their child. Scores from each subscale are averaged out of 10; higher scores indicating greater use of these behaviours. the Perceived parental impact subscale items are reverse coded.</description> </secondary_outcome> <secondary_outcome> <measure>Edinburgh Postpartum Depression Risk Rating Scale (EPDS)</measure> <time_frame>at inclusion, at 32, 34 and 37 weeks of gestation</time_frame> <description>Questionnaire EPSD QUESTIONS 1, 2, & 4 (without an *) Are scored 0, 1, 2 or 3 with top box scored as 0 and the bottom box scored as 3. QUESTIONS 3, 5-10 (marked with an *) Are reverse scored, with the top box scored as a 3 and the bottom box scored as 0. Maximum score: 30 Possible Depression: 10 or greater Always look at item 10 (suicidal thoughts)</description> </secondary_outcome> <secondary_outcome> <measure>Parental Stressor Scale: Neonatal Intensive Care Unit (PSS: NICU)</measure> <time_frame>at 32, 34, and 37 weeks of gestation</time_frame> <description>The scale consists of four subscales that measure stress related to (a) the sights and sounds of the unit (5 items), (b) the appearance and behaviours of the infant (19 items), (c) the impact on the parents' role and their relationship with their baby (10 items), and (d) the staff behaviours and communications (11 items). There is also a general stress-level question that summarizes the parents' overall feeling of stress related to having an infant in the NICU. The responses to the PSS: NICU were scored on a 5- point Likert scale from 0 to 5 where 0 means no experience at all with the situation or phenomenon, 1 (not at all stressful) to 5 (extremely stressful). Mean scores and standard deviation were obtained for each subscale and total scale separately for mothers and fathers and the overall stress scores was then calculated. Parental stress levels were classified according to the points on Likert scale as low (1-1.9), moderate (2-3.9) and high (4-5).</description> </secondary_outcome> <secondary_outcome> <measure>Number of desaturation</measure> <time_frame>every day betwenn 32 and 34 weeks of gestation</time_frame> <description>Number of desaturation</description> </secondary_outcome> <secondary_outcome> <measure>Number of vomiting</measure> <time_frame>every day between 32 and 34 weeks of gestation</time_frame> <description>Number of vomiting</description> </secondary_outcome> <secondary_outcome> <measure>Exit age on return home</measure> <time_frame>through study completion, an average of 41 week of gestation</time_frame> <description>age of the infant when leaving the hospital</description> </secondary_outcome> <secondary_outcome> <measure>Parental time in hours</measure> <time_frame>at 34 week of gestation and 37 week of gestation, calculated over 7 days</time_frame> <description>time spend withe child</description> </secondary_outcome> <secondary_outcome> <measure>Number of meals and baths given by parents</measure> <time_frame>from 32 week of gestation to 37 week of gestation</time_frame> <description>Number of meals and baths given by parents</description> </secondary_outcome> <secondary_outcome> <measure>Duration of transition from passive to active feeding in number of days</measure> <time_frame>from 32 week of gestation to 37 week of gestation</time_frame> <description>Duration of transition from passive to active feeding in number of days</description> </secondary_outcome> <secondary_outcome> <measure>Average duration (minutes) of feeding/feeding</measure> <time_frame>at 37 week of gestation</time_frame> <description>Average duration (minutes) of feeding/feeding</description> </secondary_outcome> <secondary_outcome> <measure>Number and duration of skin-to-skin sessions in minutes</measure> <time_frame>from inclusion to exit of service ( up to 45 week of gestation)</time_frame> <description>Number and duration of skin-to-skin sessions in minutes</description> </secondary_outcome> <secondary_outcome> <measure>Duration of breastfeeding in number of days.</measure> <time_frame>from 32 week of gestation to 37 week of gestation</time_frame> <description>Duration of breastfeeding in number of days.</description> </secondary_outcome> <secondary_outcome> <measure>Number of children with infant formula change</measure> <time_frame>between 32 week of gestation and 37 week of gestation</time_frame> <description>Number of children with infant formula change</description> </secondary_outcome> <secondary_outcome> <measure>Evolution of the Z-weight score</measure> <time_frame>32 week of gestation at the exit of the child.</time_frame> <description>The score shows the standard deviation above or below the mean on the growth chart. If you have looked at a growth chart of a patient or your own child, you will recall it contains curve shaped lines with various percentiles on it. The middle line is the 50th%Ile and they extend out to the 97%ile percentile and 3rd%Ile. So, a z score of 0 is the equivalent of the 50th%ile or average of what you are measuring (weight, height, weight for height or BMI) for that age. A z score of +1 means your plots fall at the 15th%ile or 85th%Ile and a z score of +2 falls roughly at the 3rd or 97%Ile. z scores run positively (+1. +2.+3) or negatively (-1, -2. -3) and so on.</description> </secondary_outcome> <secondary_outcome> <measure>Brunet-Lézine and Neurological Evaluation of Amiel Tison simplified by a psychomotor specialized in the development of premature babies to assess the psychomotor development of infants at</measure> <time_frame>4 months of age corrected.</time_frame> <description>It may apply from the first month up to 5 years. It includes observations on posture, coordination, language, social-personal conduct. The Brunet-Lézine scale was developed by Odette Brunet and Irene Lézine. It provides a development quotient (Q.D.).</description> </secondary_outcome> <secondary_outcome> <measure>The Montreal Children's Hospital Feeding Scale [MCH-Feeding Scale]</measure> <time_frame>4 months of age corrected</time_frame> <description>scale for identification of feeding problems. The final scale consisted of 14 items covering the following feeding domains with some overlap: oral motor (items 8 and 11), oral sensory (items 7 and 8) and appetite (items 3 and 4). Other items covered maternal concerns about feeding (items 1, 2 and 12), mealtime behaviours (items 6 and 8), maternal strategies used (items 5, 9 and 10) and family reactions to their child's feeding (items 13 and 14). Each item is rated on a seven-point Likert scale with anchor points at either end. Seven items are scored from the negative to positive direction, and the other seven from the positive to negative direction. The primary feeder marks each item according to frequency or difficulty level of a particular behaviour or the level of parental concern. The total feeding problem score is obtained by adding the scores for each item after reversing the scores of seven items from negative to positive</description> </secondary_outcome> <secondary_outcome> <measure>Number bradycardia</measure> <time_frame>every day betwenn 32 and 34 weeks of gestation</time_frame> <description>Number bradycardia</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">42</enrollment> <condition>Premature</condition> <condition>Parent-Child Relations</condition> <arm_group> <arm_group_label>nutrition pushed by parents</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>enteral nutrition pushed by parents</description> </arm_group> <arm_group> <arm_group_label>syringe pump</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Enteral nutrition with syringe pump</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>parent-pushed enteral feeding</intervention_name> <description>skin-to-skin enteral nutrition pushed by the parent</description> <arm_group_label>nutrition pushed by parents</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>syringe-push enteral feeding</intervention_name> <description>skin to skin nutrition with syringe pump</description> <arm_group_label>syringe pump</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  Children born before 30 SA Age of child at start of study: 32 SA  Exclusion Criteria:  - Child with ongoing infection, neurological pathology More than one desaturation and/or bradycardia per hour within 12 last hours Balloon ventilation in last 12 hours  - Medical contraindication to oral nutrition  - Intubated child  - Parents with a disabling mental illness  - Parents not available  - Minor parents  - Parents under guardianship or protection of justice  - Refusal to sign consent  - Parents not affiliated with a social security system </textblock> </criteria> <gender>All</gender> <minimum_age>30 Weeks</minimum_age> <maximum_age>32 Weeks</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Nelly THOMAS</last_name> <role>Principal Investigator</role> <affiliation>Centre Hospitalier Intercommunal Créteil</affiliation> </overall_official> <location> <facility> <name>Centre Hospitalier Intercommunal Créteil</name> <address> <city>Créteil</city> <state>Val-deMarne</state> <zip>94000</zip> <country>France</country> </address> </facility> </location> <location_countries> <country>France</country> </location_countries> <verification_date>September 2023</verification_date> <study_first_submitted>February 4, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>September 5, 2023</last_update_submitted> <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc> <last_update_posted type="Actual">September 6, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Premature</keyword> <keyword>child at 32 of gestational age</keyword> <keyword>enteral nutrition</keyword> <keyword>skin to skin</keyword> <keyword>push on syringe pump</keyword> <keyword>Parent-Child Relations</keyword> <condition_browse>  <mesh_term>Premature Birth</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Studies underline both the importance of the link and contact that occurs in the earliest days of life and the need to involve parents early with their premature child. However, the impact of parental nutrition on the later active nutrition and on the quality of parent-child interactions is currently unknown. PREMIAM study investigates whether active parental participation in enteral nutrition improves the interactions between the infant and his parents, making them more sensitive to their baby's signals and promoting their relational adjustment. The importance of parental participation in the feeding of preterm infants has been highlighted by Gianni. In his study of 81 preterm infants in the tertiary centre , the early parental bottle feeding and the skin-to-skin contact were factors promoting withdrawal from enteral nutrition. Moreover, actively participate in care even complex, is desired by parents. Recently, a study compared 10 parent-child dyads and showed that enteral nutrition pushed by a parent (parental nutrition, NP) in comparison of the electric syringe pump , allowed a better perception of the tube by the parents and gave them a sense of utility. The same team randomized 17 preterm infants, born after 28 WA( week amenorrhoea), to receive or not à parent-pushed enteral nutrition The child's behavior changes during nutrition were analyzed in both arms, after scoring of the videos feeding according to the NICAP® ( individualized neonatal assessment and developmental care program) method. Signs of well-being and relaxation of members were more present in case of parental involvement in the delivery of nutrition. These preliminary studies suggest that parental nutrition is well tolerated and improves the comfort of the child and parent during nutrition. However, the impact of parental nutrition on the subsequent active nutrition and on the quality of parent-child interactions is currently unknown. Inclusion Criteria: Children born before 30 SA Age of child at start of study: 32 SA Exclusion Criteria: - Child with ongoing infection, neurological pathology More than one desaturation and/or bradycardia per hour within 12 last hours Balloon ventilation in last 12 hours - Medical contraindication to oral nutrition - Intubated child - Parents with a disabling mental illness - Parents not available - Minor parents - Parents under guardianship or protection of justice - Refusal to sign consent - Parents not affiliated with a social security system

NCT0531xxxx/NCT05313477.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313477</url> </required_header> <id_info> <org_study_id>Si 1045/2020</org_study_id> <nct_id>NCT05313477</nct_id> </id_info> <brief_title>The Effects of Vitamin D and Calcium Supplementation to Parathyroid Hormone in CHB Patients Treated With Tenofovir Disoproxil Fumarate</brief_title> <official_title>The Effects of Vitamin D and Calcium Supplementation to Parathyroid Hormone in CHB Patients Treated With Tenofovir Disoproxil Fumarate</official_title> <sponsors> <lead_sponsor> <agency>Mahidol University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Mahidol University</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Nucleot(s)ide is an antiviral drug that can reduce the number of viruses, reduce the risk of HCC, regress hepatic fibrosis and reduce death from Hepatitis B viral infection. Tenofovir disoproxil fumarate (TDF) is one of nucleotide analogue that is recommended to treated patients with Hepatitis B viral infection. However, long-term TDF therapy may have side effects especially nephrotoxicity and bone toxicity.  Previous studies in human immunodeficiency virus (HIV) infected patients who treated with TDF containing regimen antiretroviral therapy, in vitamin D supplement group had a statistic significance of low parathyroid hormone level and better in bone mineral density regardless of initial vitamin D level. Therefore, the main objective of this study is to evaluate the vitamin D and calcium supplement to patients with hepatitis B who have taken TDF, in parathyroid hormone level, bone mineral density, renal function and renal phosphate loss compared to patients who have no vitamin D and calcium supplement. </textblock> </brief_summary> <detailed_description> <textblock> Hepatitis B virus is a global public health problem. This infection leads to chronic hepatitis, cirrhosis and liver cancer. According to past statistics, infection with hepatitis B virus is a common cause of hepatocellular carcinoma about 60% in East-Asia and Africa and about 20% in Western countries. About 350-400 million people are infected worldwide. Infection with hepatitis B virus is also an important factor of death in 1million patients per year.  Nucleot(s)ide is an antiviral drug that can reduce the number of viruses, reduce the risk of HCC, regress hepatic fibrosis and reduce death from Hepatitis B viral infection. Nowadays, the recommendation of nucleot(s)ide prefers Tenofovir disoproxil fumarate (TDF), Tenofovir Alafenamide (TAF) and Entecavir (ETV) than Lamivudine, Adefovir and Telbivudine due to high potency and low resistance rate Tenofovir disoproxil fumarate (TDF) is one of nucleotide analogue that inhibits reverse transcriptase in HBV replication process. However, long-term TDF therapy may have side effects especially nephrotoxicity. The proposed mechanisms of nephrotoxicity of TDF are cumulative of TDF at proximal tubule of kidney leads to mitochondrial toxicity, downregulation of sodium-phosphorus cotransporter, sodium/ hydrogen exchanger 3 and aquaporin 2, decreased endothelial nitric oxide-synthase (eNOS) and renal vasoconstriction results in tubulopathy in renal proximal tubule, increase of phosphate loss in urine and increase od serum creatinine.  Moreover, TDF also affects to decrease bone mineral density (BMD) that related with renal phosphate loss, loss of osteoblast function, high parathyroid hormone level regardless of vitamin D level and high fibroblast growth factor 23 (FGF23) leads to worsen in bone mineralization Vitamin D has a protective effect and indicate for osteoporosis treatment. The chronic hepatitis B infected patients with vitamin D deficiency may have a poor prognosis in hepatic fibrosis and high HBV DNA level. Previous studies in human immunodeficiency virus (HIV) infected patients who treated with TDF containing regimen antiretroviral therapy, in vitamin D supplement group had a statistic significance of low parathyroid hormone level and better in bone mineral density regardless of initial vitamin D level. Therefore, the main objective of this study is to evaluate the vitamin D and calcium supplement to patients with hepatitis B who have taken TDF, in parathyroid hormone level, bone mineral density, renal function and renal phosphate loss compared to patients who have no vitamin D and calcium supplement. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">May 1, 2022</start_date> <completion_date type="Anticipated">November 30, 2023</completion_date> <primary_completion_date type="Anticipated">August 31, 2023</primary_completion_date> <phase>Phase 4</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Change in serum parathyroid hormone</measure> <time_frame>48weeks</time_frame> <description>Change from the baseline in serum parathyroid hormone as assessed by Electrochemiluminescent immunoassay (ECLIA)</description> </primary_outcome> <secondary_outcome> <measure>Change in bone mineral density</measure> <time_frame>48weeks</time_frame> <description>Change from the baseline in bone mineral density as assessed by Dual-energy X-ray absorptiometry (DXA)</description> </secondary_outcome> <secondary_outcome> <measure>Renal function changes</measure> <time_frame>48weeks</time_frame> <description>Change from the baseline in renal function (eGFR) based on creatinine as assessed by Enzymatic method</description> </secondary_outcome> <secondary_outcome> <measure>Change in renal phosphate loss</measure> <time_frame>48weeks</time_frame> <description>Change from the baseline in the tubular reabsorption of phosphate (TRP) as renal phosphate loss depended on serum creatinine, urine creatine (assessed by enzymatic method) and serum phosphate, urine phosphate (assessed by modification of the classical phosphomolybdate method by Fiske and Subbarow)</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">64</enrollment> <condition>Parathyroid Hormone</condition> <condition>Tenofovir Disoproxil Fumarate</condition> <condition>Chronic Hepatitis, B Virus Without Hepatitis Delta (Diagnosis)</condition> <condition>Vitamin D</condition> <arm_group> <arm_group_label>Supplement group</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Vitamin D2 supplement based on initial vitamin D level ≥ 20ng/mL -> vitamin D2 20,000unit/week 10-19.9ng/mL -> vitamin D2 40,000unit/week <10ng/mL -> vitamin D2 60,000unit/week Calcium carbonate 1000mg/day</description> </arm_group> <arm_group> <arm_group_label>No supplement group</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>no medication supplement</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Ergocalciferol Capsules</intervention_name> <description>Depend on initial 25(OH) vitamin D level If <10ng/mL, 60000U of Ergocalciferol capsules per week If 10-19.9ng/mL, 40000U of Ergocalciferol capsules per week If >20 ng/mL, 20000U of Ergocalciferol capsule per week</description> <arm_group_label>Supplement group</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Calcium carbonate</intervention_name> <description>1000mg of Calcium carbonate daily</description> <arm_group_label>Supplement group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Age between 18 - 75 years old  - Chronic hepatitis B infected patients treated with TDF monotherapy  - eGFR ≥ 60 mL/ min/ 1.73 m2  - HBV viral load <10 IU/ mL  Exclusion Criteria:  - HIV infection or hepatitis C co-infection  - Decompensated cirrhosis, including variceal bleeding, ascites, hepatic encephalopathy  - History of Hepatocellular carcinoma  - Active malignancy of cancer in other organs  - Pregnancy or lactation  - Primary hyperparathyroidism  - History of thyroid or parathyroid surgery  - History of radiation at neck area  - Any osteoporosis treatment or history of osteoporosis diagnosis  - Chronic kidney disease  - Current use of Vitamin D  - Adverse event or allergy to TDF  - Chronic hepatitis B patients with TDF resistance </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>70 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Watcharasak Chotiyaputta, Asso Prof</last_name> <role>Principal Investigator</role> <affiliation>Mahidol University</affiliation> </overall_official> <overall_contact> <last_name>Watcharasak Chotiyaputta, Asso Prof</last_name> <phone>6624197281</phone> <email>watcharasak.cho@mahidol.ac.th</email> </overall_contact> <overall_contact_backup> <last_name>Tawesak Tanwandee, Prof</last_name> <phone>6624197282</phone> <email>tawesak@gmail.com</email> </overall_contact_backup> <location> <facility> <name>Faculty of Medicine, Siriraj Hospital</name> <address> <city>Bangkok</city> <zip>10700</zip> <country>Thailand</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Watcharasak Chotiyaputta, MD</last_name> <phone>0851255489</phone> <email>watcharagi@gmail.com</email> </contact> </location> <location_countries> <country>Thailand</country> </location_countries> <results_reference> <citation>Trepo C, Chan HL, Lok A. 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Vitamin D3 supplementation increases fibroblast growth factor-23 in HIV-infected youths treated with tenofovir disoproxil fumarate. Antivir Ther. 2014;19(6):613-8. doi: 10.3851/IMP2755. Epub 2014 Feb 17.</citation> <PMID>24535626</PMID> </results_reference> <results_reference> <citation>Reid IR, Bolland MJ, Grey A. Effects of vitamin D supplements on bone mineral density: a systematic review and meta-analysis. Lancet. 2014 Jan 11;383(9912):146-55. doi: 10.1016/S0140-6736(13)61647-5. Epub 2013 Oct 11.</citation> <PMID>24119980</PMID> </results_reference> <results_reference> <citation>Reid IR. Vitamin D Effect on Bone Mineral Density and Fractures. Endocrinol Metab Clin North Am. 2017 Dec;46(4):935-945. doi: 10.1016/j.ecl.2017.07.005. Epub 2017 Sep 29.</citation> <PMID>29080644</PMID> </results_reference> <results_reference> <citation>Hoan NX, Tong HV, Song LH, Meyer CG, Velavan TP. Vitamin D deficiency and hepatitis viruses-associated liver diseases: A literature review. World J Gastroenterol. 2018 Jan 28;24(4):445-460. doi: 10.3748/wjg.v24.i4.445.</citation> <PMID>29398866</PMID> </results_reference> <results_reference> <citation>Overton ET, Chan ES, Brown TT, Tebas P, McComsey GA, Melbourne KM, Napoli A, Hardin WR, Ribaudo HJ, Yin MT. Vitamin D and Calcium Attenuate Bone Loss With Antiretroviral Therapy Initiation: A Randomized Trial. Ann Intern Med. 2015 Jun 16;162(12):815-24. doi: 10.7326/M14-1409.</citation> <PMID>26075752</PMID> </results_reference> <results_reference> <citation>Havens PL, Stephensen CB, Van Loan MD, Schuster GU, Woodhouse LR, Flynn PM, Gordon CM, Pan CG, Rutledge B, Harris DR, Price G, Baker A, Meyer WA 3rd, Wilson CM, Hazra R, Kapogiannis BG, Mulligan K; Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) 109 Study Team. Vitamin D3 Supplementation Increases Spine Bone Mineral Density in Adolescents and Young Adults With Human Immunodeficiency Virus Infection Being Treated With Tenofovir Disoproxil Fumarate: A Randomized, Placebo-Controlled Trial. Clin Infect Dis. 2018 Jan 6;66(2):220-228. doi: 10.1093/cid/cix753.</citation> <PMID>29020329</PMID> </results_reference> <verification_date>February 2023</verification_date> <study_first_submitted>March 7, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>February 1, 2023</last_update_submitted> <last_update_submitted_qc>February 1, 2023</last_update_submitted_qc> <last_update_posted type="Actual">February 3, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Mahidol University</investigator_affiliation> <investigator_full_name>Watcharasak Chotiyaputta</investigator_full_name> <investigator_title>Associate professor, Faculty of Medicine, Siriraj Hospital</investigator_title> </responsible_party> <keyword>Tenofovir disoproxil fumarate</keyword> <keyword>Tenofovir</keyword> <keyword>Chronic hepatitis B</keyword> <keyword>Parathyroid hormone</keyword> <keyword>Bone mineral density</keyword> <keyword>Renal phosphate loss</keyword> <keyword>Vitamin D</keyword> <keyword>Calcium</keyword> <keyword>TDF</keyword> <keyword>PTH</keyword> <keyword>CHB</keyword> <keyword>HBV</keyword> <condition_browse>  <mesh_term>Hepatitis A</mesh_term> <mesh_term>Hepatitis D</mesh_term> <mesh_term>Hepatitis B</mesh_term> <mesh_term>Hepatitis B, Chronic</mesh_term> <mesh_term>Hepatitis</mesh_term> <mesh_term>Hepatitis, Chronic</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Ergocalciferols</mesh_term> <mesh_term>Vitamin D</mesh_term> <mesh_term>Calcium Carbonate</mesh_term> <mesh_term>Calcium</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Nucleot(s)ide is an antiviral drug that can reduce the number of viruses, reduce the risk of HCC, regress hepatic fibrosis and reduce death from Hepatitis B viral infection. Tenofovir disoproxil fumarate (TDF) is one of nucleotide analogue that is recommended to treated patients with Hepatitis B viral infection. However, long-term TDF therapy may have side effects especially nephrotoxicity and bone toxicity. Previous studies in human immunodeficiency virus (HIV) infected patients who treated with TDF containing regimen antiretroviral therapy, in vitamin D supplement group had a statistic significance of low parathyroid hormone level and better in bone mineral density regardless of initial vitamin D level. Therefore, the main objective of this study is to evaluate the vitamin D and calcium supplement to patients with hepatitis B who have taken TDF, in parathyroid hormone level, bone mineral density, renal function and renal phosphate loss compared to patients who have no vitamin D and calcium supplement. Hepatitis B virus is a global public health problem. This infection leads to chronic hepatitis, cirrhosis and liver cancer. According to past statistics, infection with hepatitis B virus is a common cause of hepatocellular carcinoma about 60% in East-Asia and Africa and about 20% in Western countries. About 350-400 million people are infected worldwide. Infection with hepatitis B virus is also an important factor of death in 1million patients per year. Nucleot(s)ide is an antiviral drug that can reduce the number of viruses, reduce the risk of HCC, regress hepatic fibrosis and reduce death from Hepatitis B viral infection. Nowadays, the recommendation of nucleot(s)ide prefers Tenofovir disoproxil fumarate (TDF), Tenofovir Alafenamide (TAF) and Entecavir (ETV) than Lamivudine, Adefovir and Telbivudine due to high potency and low resistance rate Tenofovir disoproxil fumarate (TDF) is one of nucleotide analogue that inhibits reverse transcriptase in HBV replication process. However, long-term TDF therapy may have side effects especially nephrotoxicity. The proposed mechanisms of nephrotoxicity of TDF are cumulative of TDF at proximal tubule of kidney leads to mitochondrial toxicity, downregulation of sodium-phosphorus cotransporter, sodium/ hydrogen exchanger 3 and aquaporin 2, decreased endothelial nitric oxide-synthase (eNOS) and renal vasoconstriction results in tubulopathy in renal proximal tubule, increase of phosphate loss in urine and increase od serum creatinine. Moreover, TDF also affects to decrease bone mineral density (BMD) that related with renal phosphate loss, loss of osteoblast function, high parathyroid hormone level regardless of vitamin D level and high fibroblast growth factor 23 (FGF23) leads to worsen in bone mineralization Vitamin D has a protective effect and indicate for osteoporosis treatment. The chronic hepatitis B infected patients with vitamin D deficiency may have a poor prognosis in hepatic fibrosis and high HBV DNA level. Previous studies in human immunodeficiency virus (HIV) infected patients who treated with TDF containing regimen antiretroviral therapy, in vitamin D supplement group had a statistic significance of low parathyroid hormone level and better in bone mineral density regardless of initial vitamin D level. Therefore, the main objective of this study is to evaluate the vitamin D and calcium supplement to patients with hepatitis B who have taken TDF, in parathyroid hormone level, bone mineral density, renal function and renal phosphate loss compared to patients who have no vitamin D and calcium supplement. Inclusion Criteria: - Age between 18 - 75 years old - Chronic hepatitis B infected patients treated with TDF monotherapy - eGFR ≥ 60 mL/ min/ 1.73 m2 - HBV viral load <10 IU/ mL Exclusion Criteria: - HIV infection or hepatitis C co-infection - Decompensated cirrhosis, including variceal bleeding, ascites, hepatic encephalopathy - History of Hepatocellular carcinoma - Active malignancy of cancer in other organs - Pregnancy or lactation - Primary hyperparathyroidism - History of thyroid or parathyroid surgery - History of radiation at neck area - Any osteoporosis treatment or history of osteoporosis diagnosis - Chronic kidney disease - Current use of Vitamin D - Adverse event or allergy to TDF - Chronic hepatitis B patients with TDF resistance

NCT0531xxxx/NCT05313490.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313490</url> </required_header> <id_info> <org_study_id>HR-4040</org_study_id> <nct_id>NCT05313490</nct_id> </id_info> <brief_title>Exercise Fatiguability in Older Adults: The Protective Effects of Dietary Nitrate Supplementation</brief_title> <official_title>Exercise Fatiguability in Older Adults: The Protective Effects of Dietary Nitrate Supplementation</official_title> <sponsors> <lead_sponsor> <agency>Marquette University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Marquette University</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Vascular and skeletal muscle function decline with age and are associated with decreased nitric oxide (NO) bioavailability. Dietary nitrate supplementation in the form of beet root juice increases NO bioavailability and improves exercise tolerance in younger adults, yet its effects on fatigability in older adults are largely unknown. The proposed research will investigate the impact of increased NO bioavailability on vascular function, skeletal muscle bioenergetics, and fatigability in older (≥65 yrs) men and women. </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">May 1, 2022</start_date> <completion_date type="Anticipated">December 31, 2023</completion_date> <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Crossover Assignment</intervention_model> <primary_purpose>Basic Science</primary_purpose> <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Change in fatigability of the knee extensor muscles with beetroot juice supplementation</measure> <time_frame>Day 8 (after 7 days of placebo supplementation) and day 29 (after 14 days of a washout period with no supplementation plus 7 days of beetroot juice supplementation)</time_frame> <description>Fatigability will be quantified as the reduction in limb muscle power output during a 4-minute dynamic fatiguing exercise task using a dynamometer. Fatigability after 7 days of beetroot juice supplementation will be compared with fatigability after 7 days of placebo supplementation, with the outcome measure being the change (or difference) between these two supplementation conditions.</description> </primary_outcome> <secondary_outcome> <measure>Change in femoral artery blood flow with beetroot juice supplementation</measure> <time_frame>Day 8 (after 7 days of placebo supplementation) and day 29 (after 14 days of a washout period with no supplementation plus 7 days of beetroot juice supplementation)</time_frame> <description>Femoral artery blood flow will be quantified as the change in femoral artery blood flow during a 4-minute dynamic fatiguing exercise task using a ultrasonography. Femoral artery blood flow after 7 days of beetroot juice supplementation will be compared with Femoral artery blood flow after 7 days of placebo supplementation, with the outcome measure being the change (or difference) between these two supplementation conditions.</description> </secondary_outcome> <secondary_outcome> <measure>Change in muscle efficiency with beetroot juice supplementation</measure> <time_frame>Day 8 (after 7 days of placebo supplementation) and day 29 (after 14 days of a washout period with no supplementation plus 7 days of beetroot juice supplementation)</time_frame> <description>Muscle efficiency will be quantified as the ATP cost of contraction using phosphorus magnetic resonance spectroscopy (P-MRS). Muscle efficiency after 7 days of beetroot juice supplementation will be compared with muscle efficiency after 7 days of placebo supplementation, with the outcome measure being the change (or difference) between these two supplementation conditions.</description> </secondary_outcome> <other_outcome> <measure>Change in plasma nitrate concentration with beetroot juice supplementation</measure> <time_frame>Day 8 (after 7 days of placebo supplementation) and day 29 (after 14 days of a washout period with no supplementation plus 7 days of beetroot juice supplementation)</time_frame> <description>Plasma nitrate concentration will be quantified using a nitrate colorimetric assay. Plasma nitrate concentration after 7 days of beetroot juice supplementation will be compared with plasma nitrate concentration after 7 days of placebo supplementation, with the outcome measure being the change (or difference) between these two supplementation conditions.</description> </other_outcome> <other_outcome> <measure>Change in plasma nitrite concentration with beetroot juice supplementation</measure> <time_frame>Day 8 (after 7 days of placebo supplementation) and day 29 (after 14 days of a washout period with no supplementation plus 7 days of beetroot juice supplementation)</time_frame> <description>Plasma nitrite concentration will be quantified using a nitrite colorimetric assay. Plasma nitrite concentration after 7 days of beetroot juice supplementation will be compared with plasma nitrite concentration after 7 days of placebo supplementation, with the outcome measure being the change (or difference) between these two supplementation conditions.</description> </other_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">40</enrollment> <condition>Aging</condition> <arm_group> <arm_group_label>Beetroot Juice</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>The subject will ingest 140mL of a nitrate-rich beetroot juice each day for 7 consecutive days.</description> </arm_group> <arm_group> <arm_group_label>Placebo Beetroot Juice</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> <description>The subject will ingest 140mL of a placebo (nitrate-depleted) beetroot juice each day for 7 consecutive days.</description> </arm_group> <intervention> <intervention_type>Dietary Supplement</intervention_type> <intervention_name>Beetroot Juice</intervention_name> <description>7 days of 140 mL per day of beetroot juice</description> <arm_group_label>Beetroot Juice</arm_group_label> <other_name>James White Drinks Beet It Sport 400</other_name> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Placebo Beetroot Juice</intervention_name> <description>7 days of 140 mL per day of placebo beetroot juice</description> <arm_group_label>Placebo Beetroot Juice</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Healthy men and women ≥ 60 years old  Exclusion Criteria:  1. body mass index ≥40 kg/m2;  2. type 1 or type 2 diabetes or HbA1c >6.5%  3. uncontrolled hypertension;  4. active cancer, cancer in remission, or having received treatment for any form of cancer in the previous five years;  5. coronary artery disease;  6. cardiovascular disease (e.g., PAD, PVD);  7. abnormal and untreated thyroid function;  8. chronic and/or regular nonsteroidal anti-inflammatory drugs (NSAID) consumption,  9. tobacco use (includes smoking);  10. any condition that presents a limitation to exercise (e.g., severe arthritis, COPD, neuromuscular disorder, moderate or severe cognitive impairment, Alzheimer's Disease, severe untreated sleep apnea). </textblock> </criteria> <gender>All</gender> <minimum_age>60 Years</minimum_age> <maximum_age>90 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_contact> <last_name>Timothy Fulton, PhD</last_name> <phone>319-290-5529</phone> <email>timothy.fulton@marquette.edu</email> </overall_contact> <location> <facility> <name>Marquette University</name> <address> <city>Milwaukee</city> <state>Wisconsin</state> <zip>53233</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Lauren J Opielinski, MS</last_name> <email>hunterlab@marquette.edu</email> </contact> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>August 2022</verification_date> <study_first_submitted>February 14, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>August 22, 2022</last_update_submitted> <last_update_submitted_qc>August 22, 2022</last_update_submitted_qc> <last_update_posted type="Actual">August 24, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Marquette University</investigator_affiliation> <investigator_full_name>Timothy Fulton</investigator_full_name> <investigator_title>Principal Investigator</investigator_title> </responsible_party> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Vascular and skeletal muscle function decline with age and are associated with decreased nitric oxide (NO) bioavailability. Dietary nitrate supplementation in the form of beet root juice increases NO bioavailability and improves exercise tolerance in younger adults, yet its effects on fatigability in older adults are largely unknown. The proposed research will investigate the impact of increased NO bioavailability on vascular function, skeletal muscle bioenergetics, and fatigability in older (≥65 yrs) men and women. Inclusion Criteria: - Healthy men and women ≥ 60 years old Exclusion Criteria: 1. body mass index ≥40 kg/m2; 2. type 1 or type 2 diabetes or HbA1c >6.5% 3. uncontrolled hypertension; 4. active cancer, cancer in remission, or having received treatment for any form of cancer in the previous five years; 5. coronary artery disease; 6. cardiovascular disease (e.g., PAD, PVD); 7. abnormal and untreated thyroid function; 8. chronic and/or regular nonsteroidal anti-inflammatory drugs (NSAID) consumption, 9. tobacco use (includes smoking); 10. any condition that presents a limitation to exercise (e.g., severe arthritis, COPD, neuromuscular disorder, moderate or severe cognitive impairment, Alzheimer's Disease, severe untreated sleep apnea).

NCT0531xxxx/NCT05313503.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313503</url> </required_header> <id_info> <org_study_id>KETOMIGRAINE2021</org_study_id> <nct_id>NCT05313503</nct_id> </id_info> <brief_title>KETOMIGRAINE: Ketogenic Diet in Drug-resistant Chronic Migraineurs</brief_title> <official_title>KETOMIGRAINE: "Ketogenic Diet in Patients With Drug-resistant Chronic Migraine, "Non-responder" to Treatment With Monoclonal Antibody Targetting CGRP Pathway: a Pilot Study, Open Label"</official_title> <sponsors> <lead_sponsor> <agency>IRCCS National Neurological Institute "C. Mondino" Foundation</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>IRCCS National Neurological Institute "C. Mondino" Foundation</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Our protocol, named "KETOMIGRAINE", is based on the prescription of a Ketogenic Diet (KD) to twenty subjects with diagnosis of Chronic Migraine (CM), resistant to oral preventive treatments and non-responders to monoclonal antibodies targeting the CGRP pathway. The trial starts with one month of baseline during which are verified inclusion/exclusion criteria. After that, participants will assume KD for three months, a transitional diet (TD) for other three months. Follows a period of three months of free diet (FD). Neurological and dietician visits are scheduled during the course of the trial. </textblock> </brief_summary> <detailed_description> <textblock> The duration of the trial for individual participants is approximately 10 months, divided as follows: 1 month of baseline + 3 months of KD + 3 months of TD+ 3 months of follow-up.  The protocol includes 6 neurological evaluations (T0-T5); 11 dietary evaluations, some of which can be remote visits, and will be defined below with the acronym "V" (V1-V11).  The planned activities are listed below:  - T0 screening: neurological and general physical examination, extended anamnestic evaluation, evaluation of the inclusion / exclusion criteria. Signature of the informed consent for participation in the research study, assignment of an identification code (increasing number starting from 01); headache diary delivery for prospective baseline data collection.  - T1 baseline (30 days +/- 3 after T0): assessment of compliance in filling in the headache diary and confirming the diagnosis of chronic migraine; execution of electrocardiogram, pregnancy test (if female patient with childbearing potential) and blood tests (renal, hepatic, lipidic, endocrinological profile); first dietary visit (V1 - anthropometric measurements-BMI, interview on eating habits), nutritional instrumental evaluations (calorimetry and body composition).  - T2 Day 1 (Enrollment -7 days +/- 3 after T1): verification of inclusion and exclusion criteria with the results of blood tests; blood sample for collection of PACAP, CGRP and metabolites of kynurenines; compilation of the disability and impact questionnaires - MIDAS and HIT-6; compilation of Migraine Specific Quality of Life Questionnaire (MSQ); dietary assessment (V2): prescription of the KD that the patient will follow for the next 3 months. Subjects overweight will follow a KD with a low-calorie content (low-calorie ketogenic diet); patients with a lower BMI will follow a normo-caloric diet: those represent the two subgroups of the study. Both subtypes of diet (normo and low-calorie) will induce at the same way ketosis; the only difference between the two subgroups is the fact that one will be associated with weight loss and the other not. During the three months of KD, dietician evaluations will be carried out every two weeks, alternating those remotely with those onsite (V3-V7). The dietary visits at the end of the 1st, 2nd and 3rd month of KD will be carried out onsite and the ketone dosage will be carried out using blood sticks.  - T3 (3 months from T2 - end of KD and start of transitional diet - TD): evaluation of the headache diary and compilation of the disability and impact scales - MIDAS and HIT-6); repetition of blood tests in order to check dietary tolerance; blood sample for CGRP, PACAP, metabolites of kynurenines (II point); repetition of instrumental measurements (calorimetry and body composition); dietary visit (V8) for the last check of ketonemia and prescription of TD. This type of diet is not ketogenic and is characterized by the gradual introduction of carbohydrates starting from breakfast, it will last for 3 months. Onsite dietary visits (V9-V10) follow on a monthly basis  - T4 (3 months after T3 - end of TD and start of free diet - FD): neurological and dietary visit (V 11) at the end of 3 months of TD. The patient will start a free diet, during which he/she can eat what is preferred.  - T5 (3 months after T4 - end of study): The last visit is a follow-up, 9 months after T2, its purpose is to evaluate the trend of headache parameters, BMI and biochemical markers studied (III point). During this visit will be filled the following questionnaires: disability and impact questionnaires - MIDAS and HIT-6, Migraine Specific Quality of Life Questionnaire (MSQ), Patient's Global Impression of Change (PGIC). </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">January 14, 2022</start_date> <completion_date type="Anticipated">November 30, 2023</completion_date> <primary_completion_date type="Anticipated">January 30, 2023</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>N/A</allocation> <intervention_model>Single Group Assignment</intervention_model> <intervention_model_description>interventional, monocentric, open label</intervention_model_description> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Change of mean monthly migraine days</measure> <time_frame>During the 3 months of Ketogenic diet period</time_frame> <description>The primary endpoint is the change of mean monthly migraine days during the treatment phase compared to the baseline period. The number of migraine days will be established by the analysis of the headache diary that the patients are required to fill in for the duration of the study</description> </primary_outcome> <secondary_outcome> <measure>Change of number of headache day per month</measure> <time_frame>Through study completion, an average of 10 months</time_frame> <description>Evaluation of the change of headache day per month during the study. The number of headache days will be established by the analysis of the headache diary that the patients are required to fill in for the duration of the study</description> </secondary_outcome> <secondary_outcome> <measure>Change of doses of symptomatic drug intake per month</measure> <time_frame>Through study completion, an average of 10 months</time_frame> <description>Evaluation of the change of doses of symptomatic drug intake per month. The number of doses of symptomatic drug intake days will be established by the analysis of the headache diary that the patients are required to fill in for the duration of the study</description> </secondary_outcome> <secondary_outcome> <measure>Change of number of days of moderate to severe headache</measure> <time_frame>Through study completion, an average of 10 months</time_frame> <description>Evaluation of the change of days of moderate to severe headache during the study. The number of moderate to severe headache days will be established by the analysis of the headache diary that the patients are required to fill in for the duration of the study</description> </secondary_outcome> <secondary_outcome> <measure>Change of days of symptomatic drug intake per month</measure> <time_frame>Through study completion, an average of 10 months</time_frame> <description>Evaluation of the change of days of symptomatic drug intake per month. The number of days of symptomatic drug intake days will be established by the analysis of the headache diary that the patients are required to fill in for the duration of the study</description> </secondary_outcome> <secondary_outcome> <measure>Change of average pain intensity</measure> <time_frame>Through study completion, an average of 10 months</time_frame> <description>Evaluation of the change of average pain intensity during the study. The average pain intensity will be established by the analysis of the headache diary that the patients are required to fill in for the duration of the study</description> </secondary_outcome> <secondary_outcome> <measure>change in disability of headache</measure> <time_frame>Through study completion, an average of 10 months</time_frame> <description>Evaluation of the change in disability of headache by measuring the variation in points of the questionnaire filled out by the patient named MIDAS (Migraine Disability Assessment). It has 5 items and evaluates the disability caused by headache. A higher score means more disability caused by headache.</description> </secondary_outcome> <secondary_outcome> <measure>change in impact of headache</measure> <time_frame>Through study completion, an average of 10 months</time_frame> <description>Evaluation of the change in impact of headache by measuring the variation in points of the questionnaire filled out by the patient named HIT-6 (Headache Impact Test-6). It has 6 item and evaluates the impact of headache on routinary activities. A higher score means more impact caused by headache.</description> </secondary_outcome> <secondary_outcome> <measure>change in total pain burden</measure> <time_frame>Through study completion, an average of 10 months</time_frame> <description>The purpose is to evaluate the change in total pain burden (number of hours of headache * pain intensity on a scale from 1 to 3) over three months of the KD. These data are established by the analysis of the headache diary hat the patient fills out during all the protocol phases.</description> </secondary_outcome> <secondary_outcome> <measure>change in quality of life</measure> <time_frame>Through study completion, an average of 10 months</time_frame> <description>The change in quality of life is evalueted through the administration of questionnare named: "Migraine Specific Quality of Life Questionnaire" (MSQ) that has 14 items. High score means higher influence of migraine in daily activities.</description> </secondary_outcome> <secondary_outcome> <measure>Patient's Global Impression of Change</measure> <time_frame>Through study completion, an average of 10 months</time_frame> <description>The patients impression of change is evaluated with the administration of a questionnaire: "Patient's Global Impression of Change (PGIC)" that has 1 item with 7 answer options, the seventh option is the best impression of change.</description> </secondary_outcome> <secondary_outcome> <measure>Evaluation of persistence of KD benefits</measure> <time_frame>Through study completion, an average of 10 months</time_frame> <description>The persistence of KD benefits after a period of follow-up is measured by processing the difference in monthly migraine days at the end of follow-up compared to migraine days during KD.</description> </secondary_outcome> <secondary_outcome> <measure>Mechanism of action of KD</measure> <time_frame>During the 3 months of Ketogenic diet period</time_frame> <description>In-depth comprehension of the mechanism of action of KD by evaluating the variation of the plasma levels of neuropeptides involved in the pathophysiology of migraine (Calcitonin Gene Related Peptide CGRP and Peptide Activating Adenylate Cyclase of the Pituitary - PACAP) and of some metabolites of kynurenines (kynurenic and quinolinic acid). These data are obtained by blood samplings.</description> </secondary_outcome> <other_outcome> <measure>Effect of KD in the subgroups identified by the type of diet (normal-calorie and low-calorie diet)</measure> <time_frame>Through study completion, an average of 10 months</time_frame> <description>The exploratory outcome is to describe the effect of KD in the subgroups identified by the type of diet (normal-calorie and low-calorie diet) in terms of difference of headache days' reduction / per month; the data will be obtained with the analysis of the headache diary filled by the patients.</description> </other_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Anticipated">20</enrollment> <condition>Chronic Migraine, Headache</condition> <arm_group> <arm_group_label>Ketogenic Diet</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Ketogenic diet</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>ketogenic diet</intervention_name> <description>We propose a type of KD named MAD (Modified Atkins Diet) characterized by the following percentages of macronutrients: 65% fats, 27% proteins and 8% carbohydrates.</description> <arm_group_label>Ketogenic Diet</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Age: 18-65 years old  - Chronic migraine, diagnosed according to ICHD-3 criteria.  - Patients with resistant form of migraine defined as: persistence of 8 days of headache per month; therapeutic failure (after therapeutic treatment of adequate dose and duration) or contraindication of 3 classes of drugs with validated evidence of efficacy in the prevention of migraine.  - Non-responder (absence of reduction of MIDAS score of at least 50% after at least 3 months of treatment) to at least one anti-CGRP monoclonal antibody  - Absence of prophylactic therapies for migraine or prophylaxis therapy with a single drug taken at a stable dose for at least two months  - BMI > 16.5 kg/m2 and < 35 kg/m2  - Hypothesized compliance in filling the headache diary and following the prescribed diet  Exclusion Criteria:  - Kidney failure  - Liver failure  - Heart failure  - Recent heart attack  - Pancreatitis  - Alcoholism  - Severe osteoporosis  - Other neurological disorders, including other forms of primary headache, except sporadic episodic tension-type headache  - Diabetes Mellitus  - Severe lipid metabolism disorders  - Women of childbearing age without active contraception  - Pregnancy or breastfeeding  - Psychiatric disorders that the clinician thinks may interfere with patient compliance / eating disorders  - Other anomalies considered significant in preliminary examinations (blood tests and EKG) </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>65 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Cristina Tassorelli, Prof</last_name> <role>Study Director</role> <affiliation>IRCCS Mondino Foundation, Pavia</affiliation> </overall_official> <overall_contact> <last_name>Marta Allena, MD</last_name> <phone>+390382380207</phone> <email>marta.allena@mondino.it</email> </overall_contact> <overall_contact_backup> <last_name>Lara Ahmad, MD</last_name> <phone>+390382380390</phone> <email>lara.ahmad@mondino.it</email> </overall_contact_backup> <location> <facility> <name>Headache Science Center</name> <address> <city>Pavia</city> <zip>27100</zip> <country>Italy</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Cristina Tassorelli, Prof</last_name> <phone>+390382380425</phone> <email>cristina.tassorelli@mondino.it</email> </contact> <contact_backup> <last_name>Marta Allena, MD</last_name> <phone>+390382380207</phone> <email>marta.allena@mondino.it</email> </contact_backup> </location> <location_countries> <country>Italy</country> </location_countries> <reference> <citation>de Almeida Rabello Oliveira M, da Rocha Ataide T, de Oliveira SL, de Melo Lucena AL, de Lira CE, Soares AA, de Almeida CB, Ximenes-da-Silva A. Effects of short-term and long-term treatment with medium- and long-chain triglycerides ketogenic diet on cortical spreading depression in young rats. Neurosci Lett. 2008 Mar 21;434(1):66-70. doi: 10.1016/j.neulet.2008.01.032. Epub 2008 Jan 19.</citation> <PMID>18281154</PMID> </reference> <results_reference> <citation>Di Lorenzo C, Coppola G, Sirianni G, Di Lorenzo G, Bracaglia M, Di Lenola D, Siracusano A, Rossi P, Pierelli F. Migraine improvement during short lasting ketogenesis: a proof-of-concept study. Eur J Neurol. 2015 Jan;22(1):170-7. doi: 10.1111/ene.12550. Epub 2014 Aug 25.</citation> <PMID>25156013</PMID> </results_reference> <results_reference> <citation>Bongiovanni D, Benedetto C, Corvisieri S, Del Favero C, Orlandi F, Allais G, Sinigaglia S, Fadda M. Effectiveness of ketogenic diet in treatment of patients with refractory chronic migraine. Neurol Sci. 2021 Sep;42(9):3865-3870. doi: 10.1007/s10072-021-05078-5. Epub 2021 Feb 1.</citation> <PMID>33527209</PMID> </results_reference> <verification_date>March 2022</verification_date> <study_first_submitted>March 11, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>March 28, 2022</last_update_submitted> <last_update_submitted_qc>March 28, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Ketogenic Diet</keyword> <keyword>reistant migraine</keyword> <keyword>CGRP</keyword> <keyword>headache</keyword> <keyword>pain</keyword> <condition_browse>  <mesh_term>Migraine Disorders</mesh_term> <mesh_term>Headache</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Our protocol, named "KETOMIGRAINE", is based on the prescription of a Ketogenic Diet (KD) to twenty subjects with diagnosis of Chronic Migraine (CM), resistant to oral preventive treatments and non-responders to monoclonal antibodies targeting the CGRP pathway. The trial starts with one month of baseline during which are verified inclusion/exclusion criteria. After that, participants will assume KD for three months, a transitional diet (TD) for other three months. Follows a period of three months of free diet (FD). Neurological and dietician visits are scheduled during the course of the trial. The duration of the trial for individual participants is approximately 10 months, divided as follows: 1 month of baseline + 3 months of KD + 3 months of TD+ 3 months of follow-up. The protocol includes 6 neurological evaluations (T0-T5); 11 dietary evaluations, some of which can be remote visits, and will be defined below with the acronym "V" (V1-V11). The planned activities are listed below: - T0 screening: neurological and general physical examination, extended anamnestic evaluation, evaluation of the inclusion / exclusion criteria. Signature of the informed consent for participation in the research study, assignment of an identification code (increasing number starting from 01); headache diary delivery for prospective baseline data collection. - T1 baseline (30 days +/- 3 after T0): assessment of compliance in filling in the headache diary and confirming the diagnosis of chronic migraine; execution of electrocardiogram, pregnancy test (if female patient with childbearing potential) and blood tests (renal, hepatic, lipidic, endocrinological profile); first dietary visit (V1 - anthropometric measurements-BMI, interview on eating habits), nutritional instrumental evaluations (calorimetry and body composition). - T2 Day 1 (Enrollment -7 days +/- 3 after T1): verification of inclusion and exclusion criteria with the results of blood tests; blood sample for collection of PACAP, CGRP and metabolites of kynurenines; compilation of the disability and impact questionnaires - MIDAS and HIT-6; compilation of Migraine Specific Quality of Life Questionnaire (MSQ); dietary assessment (V2): prescription of the KD that the patient will follow for the next 3 months. Subjects overweight will follow a KD with a low-calorie content (low-calorie ketogenic diet); patients with a lower BMI will follow a normo-caloric diet: those represent the two subgroups of the study. Both subtypes of diet (normo and low-calorie) will induce at the same way ketosis; the only difference between the two subgroups is the fact that one will be associated with weight loss and the other not. During the three months of KD, dietician evaluations will be carried out every two weeks, alternating those remotely with those onsite (V3-V7). The dietary visits at the end of the 1st, 2nd and 3rd month of KD will be carried out onsite and the ketone dosage will be carried out using blood sticks. - T3 (3 months from T2 - end of KD and start of transitional diet - TD): evaluation of the headache diary and compilation of the disability and impact scales - MIDAS and HIT-6); repetition of blood tests in order to check dietary tolerance; blood sample for CGRP, PACAP, metabolites of kynurenines (II point); repetition of instrumental measurements (calorimetry and body composition); dietary visit (V8) for the last check of ketonemia and prescription of TD. This type of diet is not ketogenic and is characterized by the gradual introduction of carbohydrates starting from breakfast, it will last for 3 months. Onsite dietary visits (V9-V10) follow on a monthly basis - T4 (3 months after T3 - end of TD and start of free diet - FD): neurological and dietary visit (V 11) at the end of 3 months of TD. The patient will start a free diet, during which he/she can eat what is preferred. - T5 (3 months after T4 - end of study): The last visit is a follow-up, 9 months after T2, its purpose is to evaluate the trend of headache parameters, BMI and biochemical markers studied (III point). During this visit will be filled the following questionnaires: disability and impact questionnaires - MIDAS and HIT-6, Migraine Specific Quality of Life Questionnaire (MSQ), Patient's Global Impression of Change (PGIC). Inclusion Criteria: - Age: 18-65 years old - Chronic migraine, diagnosed according to ICHD-3 criteria. - Patients with resistant form of migraine defined as: persistence of 8 days of headache per month; therapeutic failure (after therapeutic treatment of adequate dose and duration) or contraindication of 3 classes of drugs with validated evidence of efficacy in the prevention of migraine. - Non-responder (absence of reduction of MIDAS score of at least 50% after at least 3 months of treatment) to at least one anti-CGRP monoclonal antibody - Absence of prophylactic therapies for migraine or prophylaxis therapy with a single drug taken at a stable dose for at least two months - BMI > 16.5 kg/m2 and < 35 kg/m2 - Hypothesized compliance in filling the headache diary and following the prescribed diet Exclusion Criteria: - Kidney failure - Liver failure - Heart failure - Recent heart attack - Pancreatitis - Alcoholism - Severe osteoporosis - Other neurological disorders, including other forms of primary headache, except sporadic episodic tension-type headache - Diabetes Mellitus - Severe lipid metabolism disorders - Women of childbearing age without active contraception - Pregnancy or breastfeeding - Psychiatric disorders that the clinician thinks may interfere with patient compliance / eating disorders - Other anomalies considered significant in preliminary examinations (blood tests and EKG)

NCT0531xxxx/NCT05313516.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313516</url> </required_header> <id_info> <org_study_id>DALA1052</org_study_id> <nct_id>NCT05313516</nct_id> </id_info> <brief_title>OKKO Space Academy to Check Children's Vision at Home</brief_title> <official_title>OKKO Space Academy App: Families Checking Their Child's Vision at Home During Amblyopia Treatment</official_title> <sponsors> <lead_sponsor> <agency>Moorfields Eye Hospital NHS Foundation Trust</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Moorfields Eye Hospital NHS Foundation Trust</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The purpose of this study is to determine the feasibility of the OKKO Space Academy app as a vision measuring and home-monitoring tool for children aged 3-8 years undergoing amblyopia treatment.  There are three objectives to this work:  1. Determine the feasibility of the OKKO Space Academy app for use between clinic visits from the child's and family perspective (i.e., acceptability, usability and engagement).  2. Assess the variability in day-to-day OKKO Health measurements between clinic visits (e.g., do the interim OKKO home vision measurements predict improvements in visual acuity?)  3. Explore agreement between the OKKO Space Academy measures of visual acuity against in-clinic measurements (usual standard of care), including an exploration of intra- and inter-session repeatability. </textblock> </brief_summary> <overall_status>Enrolling by invitation</overall_status> <start_date type="Actual">June 26, 2022</start_date> <completion_date type="Anticipated">February 1, 2023</completion_date> <primary_completion_date type="Anticipated">January 31, 2023</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>N/A</allocation> <intervention_model>Single Group Assignment</intervention_model> <primary_purpose>Other</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Feasibility and acceptability of home monitoring using the OKKO Health app</measure> <time_frame>3 months</time_frame> <description>The feasibility and acceptability of the OKKO Space Academy app for use between clinic visits from the child's and family perspective. This will be assessed through a purpose built questionnaire.</description> </primary_outcome> <primary_outcome> <measure>Engagement of home monitoring using the OKKO Health app</measure> <time_frame>3 months</time_frame> <description>The rate of engagement with the OKKO Space Academy app for use between clinic visits by the child (patient) and the family.</description> </primary_outcome> <primary_outcome> <measure>Variability in app data.</measure> <time_frame>3 months</time_frame> <description>The variability in day-to-day OKKO Health measurements between clinic visits (e.g., do the interim OKKO home vision measurements predict changes in visual acuity?)</description> </primary_outcome> <primary_outcome> <measure>Visual acuity</measure> <time_frame>3 months</time_frame> <description>Exploring the agreement between the OKKO Space Academy measures of visual acuity against in-clinic measurements (usual standard of care), including an exploration of intra- and inter-session repeatability.</description> </primary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Anticipated">100</enrollment> <condition>Amblyopia</condition> <arm_group> <arm_group_label>OKKO Health app</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Use of OKKO Health app for home monitoring.</description> </arm_group> <intervention> <intervention_type>Device</intervention_type> <intervention_name>OKKO Health app</intervention_name> <description>Use of OKKO Health app for home monitoring.</description> <arm_group_label>OKKO Health app</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Age 3.01 - 8.99 years with amblyopia  - Currently undergoing or at first visit to start amblyopia patching treatment  - Vision is fully corrected in glasses  - Visual acuity between -0.02 and 0.98 logMAR  - Have daily access to an approved smartphone or tablet  - Parent/child able to read and understand English  - Patient (child) able to understand spoken English  Exclusion Criteria:  - Parent not able to read and understand English  - Patient (child) not able to understand spoken English  - Parent/child not willing to participate  - Parent unable to give consent  - Any other ocular comorbidities  - Child has cognitive impairment or intellectual disability </textblock> </criteria> <gender>All</gender> <minimum_age>3 Years</minimum_age> <maximum_age>9 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <location> <facility> <name>Moorfields Eye Hospital</name> <address> <city>London</city> <country>United Kingdom</country> </address> </facility> </location> <location_countries> <country>United Kingdom</country> </location_countries> <verification_date>July 2022</verification_date> <study_first_submitted>December 1, 2021</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>July 21, 2022</last_update_submitted> <last_update_submitted_qc>July 21, 2022</last_update_submitted_qc> <last_update_posted type="Actual">July 26, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Amblyopia</mesh_term> </condition_browse>  </clinical_study>

The purpose of this study is to determine the feasibility of the OKKO Space Academy app as a vision measuring and home-monitoring tool for children aged 3-8 years undergoing amblyopia treatment. There are three objectives to this work: 1. Determine the feasibility of the OKKO Space Academy app for use between clinic visits from the child's and family perspective (i.e., acceptability, usability and engagement). 2. Assess the variability in day-to-day OKKO Health measurements between clinic visits (e.g., do the interim OKKO home vision measurements predict improvements in visual acuity?) 3. Explore agreement between the OKKO Space Academy measures of visual acuity against in-clinic measurements (usual standard of care), including an exploration of intra- and inter-session repeatability. Inclusion Criteria: - Age 3.01 - 8.99 years with amblyopia - Currently undergoing or at first visit to start amblyopia patching treatment - Vision is fully corrected in glasses - Visual acuity between -0.02 and 0.98 logMAR - Have daily access to an approved smartphone or tablet - Parent/child able to read and understand English - Patient (child) able to understand spoken English Exclusion Criteria: - Parent not able to read and understand English - Patient (child) not able to understand spoken English - Parent/child not willing to participate - Parent unable to give consent - Any other ocular comorbidities - Child has cognitive impairment or intellectual disability

NCT0531xxxx/NCT05313529.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313529</url> </required_header> <id_info> <org_study_id>ZZ2022</org_study_id> <nct_id>NCT05313529</nct_id> </id_info> <brief_title>Effects of Liraglutide, Empagliflozin and Linagliptin on the Cognitive Function in T2DM Patients With Mild Cognitive Impairment: a Multicenter, Randomized, Parallel Controlled Clinical Trial</brief_title> <official_title>A Prospective, Randomized, Open Label, Parallel, 12-month Study to Explore and Evaluate the Therapeutic Effects ofLiraglutide, Empagliflozin and Linagliptin on the Cognitive Function, Olfactory Function, and Odor-induced Brain Activation in T2DM Patients With Mild Cognitive Impairment.</official_title> <sponsors> <lead_sponsor> <agency>The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Wuxi People's Hospital</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>The First Affiliated Hospital with Nanjing Medical University</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> This is a prospective, randomized, open label, parallel, 12-month study to explore and evaluate the therapeutic effects of Liraglutide, Empagliflozin and Linagliptin on the cognitive function, olfactory function, and odor-induced brain activation in T2DM patients with mild cognitive impairment(MCI). </textblock> </brief_summary> <detailed_description> <textblock> This is a prospective, randomized, open label, parallel, 12-month study to explore and evaluate the therapeutic effects of Liraglutide, Empagliflozin and Linagliptin on the cognitive function, olfactory function, and odor-induced brain activation in T2DM patients with MCI inadequately controlled with metformin monotherapy. We have 1 principle investigator, 6 sub-investigators and 1 nurse in research centre. The sub-investigators will screen in the outpatient and inpatient departments to enroll 324 patients (108 for each arm) totally with the inclusion and exclusion criteria in 12 months. The patients will be randomized at a 1:1:1 ratio into Liraglutide, Empagliflozin and Linagliptin treatment group with a computer-generated random order. All patients will also continue on their existing dose and regimen of metformin throughout the study. At the baseline, clinical information collection, 100g-steamed bread meal test, biochemical measurement, body composition analysis, cognitive assessment, olfactory test and functional magnetic resonance imaging(fMRI) scan will be conducted for all patients. During the treatment period, visits at 8-week intervals will be performed to evaluate the safety of drugs and adjust the dose of metformin if hypoglycaemia occurs; meanwhile, fasting and 2-hour postprandial plasma glucose assayed by fingerstick, physical examination, and olfactory test will be conducted. At the end of the study, all of the assessments will be performed again for all recruited subjects, including early withdrawal patients. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">October 8, 2022</start_date> <completion_date type="Anticipated">August 31, 2027</completion_date> <primary_completion_date type="Anticipated">August 31, 2026</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Change of cognitive function</measure> <time_frame>from baseline to 1 year's follow-up</time_frame> <description>Type 2 diabetes mellitus patients with MCI were relieved of mild cognitive impairment , which means MoCA scores were not less than 26 points after treatment, or improved referring to the MoCA score or the RBANS total score increased by 0.5 standard deviation compared with baseline after treatment.</description> </primary_outcome> <secondary_outcome> <measure>Change of other cognitive function</measure> <time_frame>from baseline to 1 year's follow-up</time_frame> <description>whether there are differences in memory scores between the three groups before and after treatment and the difference of changes between the three groups. Memory testing was performed to let patients remember some words and stories, with a total score of 0-64. Higher scores indicated better ability.</description> </secondary_outcome> <secondary_outcome> <measure>Change of olfactory brain activation by fMRI</measure> <time_frame>from baseline to 1 year's follow-up</time_frame> <description>Whether the activation degree of olfactory task fMRI brain area in the three groups after intervention was different from that before treatment and the difference of changes between the three groups. All patients underwent odor-induced task fMRI on a 3.0T MR scanner with 222 volumes for task fMRI and 230 volumes for resting-state fMRI. The odor-induced task consisted of "fresh air" "rest" and "scent". Odor-induced brain activation was assessed by a general linear model using Statistical Parametric Mapping 12 (SPM12) software. Following extraction of the three separate conditions "fresh air," "scent," and "rest" from the whole sequence, contrasts were made for each participant between "fresh air > rest" and "scent > rest." Odor-induced fMRI data were analyzed in the mask of the olfactory network, including the regions of bilateral parahippocampus, amygdala, piriform cortex, insula, orbitofrontal cortex, hippocampus, and entorhinal cortices.</description> </secondary_outcome> <secondary_outcome> <measure>Olfactory threshold test</measure> <time_frame>from baseline to 1 year's follow-up</time_frame> <description>Whether the olfactory threshold scores of the three groups after intervention were higher than those before treatment and the difference of changes between the three groups. Olfactory testing was performed using Olfactory Function Assessment by Computerized Testing (OLFACT) (Osmic Enterprises, Inc.). Based on the University of Pennsylvania Smell Identification Test (UPSIT), OLFACT tests were computerized, standardized, and self-administered. Higher scores indicated better ability to detect odors. Threshold testing was performed by a series of binary dilutions of n-butanol solution in light mineral oil, and scores ranged from 1 to 13.5.</description> </secondary_outcome> <secondary_outcome> <measure>Change of metabolism</measure> <time_frame>every two months from baseline to 1 year's follow-up</time_frame> <description>The changes of glycosylated hemoglobin among the three groups before and after intervention. The level of glycosylated hemoglobin <7% means better glucose metabolism.</description> </secondary_outcome> <number_of_arms>3</number_of_arms> <enrollment type="Anticipated">324</enrollment> <condition>Type 2 Diabetes Mellitus</condition> <condition>Mild Cognitive Impairment</condition> <arm_group> <arm_group_label>Liraglutide</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Liraglutide will be titrated from 0.6mg/day to a final dose 1.8mg/day during the first 2 weeks, if well tolerated. Meanwhile, All patients will also continue on their existing dose and regimen of metformin throughout the study. Visits at 8-week intervals will be performed to evaluate the safety of drugs. Metformin dose can be reduced in response to hypoglycaemia, but liraglutide could not be adjusted. If the plasma glucose still not achieve the target at the maximum dose, the maximum dose will be maintained until the completion of the study.</description> </arm_group> <arm_group> <arm_group_label>Empagliflozin</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Empagliflozin will be initiated and maintained at 10mg/ day every morning until the completion of the study. Meanwhile, All patients will also continue on their existing dose and regimen of metformin throughout the study. Visits at 8-week intervals will be performed to evaluate the safety of drugs. Metformin dose can be reduced in response to hypoglycaemia, but Empagliflozin could not be adjusted. If the plasma glucose still not achieve the target at the maximum dose, the maximum dose will be maintained until the completion of the study.</description> </arm_group> <arm_group> <arm_group_label>linagliptin</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>linagliptin will be initiated at 5mg/ day every morning. Meanwhile, All patients will also continue on their existing dose and regimen of metformin throughout the study. Visits at 8-week intervals will be performed to evaluate the safety of drugs. Metformin dose can be reduced in response to hypoglycaemia, but linagliptin could not be adjusted. If the plasma glucose still not achieve the target at the maximum dose, the maximum dose will be maintained until the completion of the study.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Liraglutide</intervention_name> <description>Liraglutide will be titrated from 0.6mg/day to 1.8mg/day during the first 2 weeks, if well tolerated. All patients will also continue on their existing dose and regimen of metformin throughout the study</description> <arm_group_label>Liraglutide</arm_group_label> <other_name>metformin</other_name> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Empagliflozin</intervention_name> <description>Empagliflozin will be initiated and maintained at 10mg/ day every morning until the completion of the study. All patients will also continue on their existing dose and regimen of metformin throughout the study.</description> <arm_group_label>Empagliflozin</arm_group_label> <other_name>metformin</other_name> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Linagliptin</intervention_name> <description>Iinagliptin will be initiated at 5mg/ day every morning until the completion of the study. All patients will also continue on their existing dose and regimen of metformin throughout the study.</description> <arm_group_label>linagliptin</arm_group_label> <other_name>metformin</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - patients with type 2 diabetes mellitus ;  - Aged:40 -75 years ;  - Cognitive function assessment suggests mild cognitive impairment;  - A stable glucose-lowering regimen include Metformin alone or in combination with sulfonylureas , glinides , glycosidase inhibitors, thiazolidinediones or basic insulin for more than 3 months, and the dose of metformin≥1.0g/d;  - HbA1c 7 - 10%;  - ≥6 years education;  - Right-handed.  Exclusion Criteria:  - Cognitive function assessment suggests normal cognition or dementia;  - Other dementia related neurological diseases or depression, Mental dysplasia, mania, schizophrenia, etc in the past 2 years; Central nervous system diseases, including brain trauma, intracranial hemorrhage, acute cerebral infarction, etc;  - Severe sinusitis, nasal cavity and sinus polyps, skull base or nasopharyngeal tumors and other space occupying lesions;  - Congenital diseases and traumatic history of nose, maxillofacial and skull base affecting olfaction. · With symptoms of upper respiratory tract infection, including nasal congestion, runny nose, fever, etc. on the day of MR examination;  - Diabetic Acute and chronic complications, including diabetic ketoacidosis, diabetic ketoacidosis; a hyperglycemic hyperosmolar state or severe hypoglycemic coma, etc.  - Severe impairment of heart, liver, kidney and other organs;  - Contraindications of MRI examination, such as implantation of metal prosthesis in vivo, claustrophobia, etc;  - Pregnant and lactating women;  - Receive other test drugs currently or within 6 months before participating in the project;  - Known or suspected allergic history to the test drug or similar drugs; GLP-1 receptor agonist, SGLT2 inhibitor and DPP4 inhibitor were used in recent 3 months. </textblock> </criteria> <gender>All</gender> <minimum_age>40 Years</minimum_age> <maximum_age>75 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <location> <facility> <name>Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University</name> <address> <city>Nanjing</city> <state>Jiangsu</state> <zip>210000</zip> <country>China</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Jindan Wu, MD,PhD</last_name> <phone>86-025-52271000</phone> <email>wujindandan@sina.com</email> </contact> <investigator> <last_name>Jindan Wu, MD,PhD</last_name> <role>Principal Investigator</role> </investigator> <investigator> <last_name>Rong Huang, PhD</last_name> <role>Sub-Investigator</role> </investigator> </location> <location> <facility> <name>Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University</name> <address> <city>Nanjing</city> <state>Jiangsu</state> <zip>210008</zip> <country>China</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Yan Bi, MD,PhD</last_name> <phone>86-25-83-105302</phone> <email>biyan@nju.edu.cn</email> </contact> <contact_backup> <last_name>PhD</last_name> </contact_backup> <investigator> <last_name>YAN BI, MD,PhD</last_name> <role>Principal Investigator</role> </investigator> <investigator> <last_name>ZHOU ZHANG, MD,PhD</last_name> <role>Sub-Investigator</role> </investigator> </location> <location> <facility> <name>Department of Endocrinology, The Affiliated Wuxi People's Hospital of Nanjing Medical University</name> <address> <city>Wuxi</city> <state>Jiangsu</state> <zip>214000</zip> <country>China</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Lan Xu, MD</last_name> <phone>86-0510-82700775</phone> <email>xulan126@126.com</email> </contact> <investigator> <last_name>Lan Xu, MD</last_name> <role>Principal Investigator</role> </investigator> <investigator> <last_name>Haiyan Cheng, PhD</last_name> <role>Sub-Investigator</role> </investigator> <investigator> <last_name>Xiang Xu, PhD</last_name> <role>Sub-Investigator</role> </investigator> </location> <location_countries> <country>China</country> </location_countries> <results_reference> <citation>Zhang Z, Zhang B, Wang X, Zhang X, Yang QX, Qing Z, Zhang W, Zhu D, Bi Y. Olfactory Dysfunction Mediates Adiposity in Cognitive Impairment of Type 2 Diabetes: Insights From Clinical and Functional Neuroimaging Studies. Diabetes Care. 2019 Jul;42(7):1274-1283. doi: 10.2337/dc18-2584. Epub 2019 May 21.</citation> <PMID>31221697</PMID> </results_reference> <results_reference> <citation>Zhang Z, Zhang B, Wang X, Zhang X, Yang QX, Qing Z, Lu J, Bi Y, Zhu D. Altered Odor-Induced Brain Activity as an Early Manifestation of Cognitive Decline in Patients With Type 2 Diabetes. Diabetes. 2018 May;67(5):994-1006. doi: 10.2337/db17-1274. Epub 2018 Mar 2.</citation> <PMID>29500313</PMID> </results_reference> <results_reference> <citation>Cheng H, Zhang Z, Zhang B, Zhang W, Wang J, Ni W, Miao Y, Liu J, Bi Y. Enhancement of Impaired Olfactory Neural Activation and Cognitive Capacity by Liraglutide, but Not Dapagliflozin or Acarbose, in Patients With Type 2 Diabetes: A 16-Week Randomized Parallel Comparative Study. Diabetes Care. 2022 May 1;45(5):1201-1210. doi: 10.2337/dc21-2064.</citation> <PMID>35263425</PMID> </results_reference> <verification_date>May 2023</verification_date> <study_first_submitted>March 19, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>May 15, 2023</last_update_submitted> <last_update_submitted_qc>May 15, 2023</last_update_submitted_qc> <last_update_posted type="Actual">May 16, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School</investigator_affiliation> <investigator_full_name>Yan Bi</investigator_full_name> <investigator_title>Chief Physician</investigator_title> </responsible_party> <keyword>Functional MRI</keyword> <keyword>cognition</keyword> <keyword>Olfactory function</keyword> <keyword>Liraglutide, Empagliflozin and Linagliptin</keyword> <condition_browse>  <mesh_term>Diabetes Mellitus, Type 2</mesh_term> <mesh_term>Cognitive Dysfunction</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Metformin</mesh_term> <mesh_term>Liraglutide</mesh_term> <mesh_term>Empagliflozin</mesh_term> <mesh_term>Linagliptin</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>Undecided</sharing_ipd> </patient_data>  </clinical_study>

This is a prospective, randomized, open label, parallel, 12-month study to explore and evaluate the therapeutic effects of Liraglutide, Empagliflozin and Linagliptin on the cognitive function, olfactory function, and odor-induced brain activation in T2DM patients with mild cognitive impairment(MCI). This is a prospective, randomized, open label, parallel, 12-month study to explore and evaluate the therapeutic effects of Liraglutide, Empagliflozin and Linagliptin on the cognitive function, olfactory function, and odor-induced brain activation in T2DM patients with MCI inadequately controlled with metformin monotherapy. We have 1 principle investigator, 6 sub-investigators and 1 nurse in research centre. The sub-investigators will screen in the outpatient and inpatient departments to enroll 324 patients (108 for each arm) totally with the inclusion and exclusion criteria in 12 months. The patients will be randomized at a 1:1:1 ratio into Liraglutide, Empagliflozin and Linagliptin treatment group with a computer-generated random order. All patients will also continue on their existing dose and regimen of metformin throughout the study. At the baseline, clinical information collection, 100g-steamed bread meal test, biochemical measurement, body composition analysis, cognitive assessment, olfactory test and functional magnetic resonance imaging(fMRI) scan will be conducted for all patients. During the treatment period, visits at 8-week intervals will be performed to evaluate the safety of drugs and adjust the dose of metformin if hypoglycaemia occurs; meanwhile, fasting and 2-hour postprandial plasma glucose assayed by fingerstick, physical examination, and olfactory test will be conducted. At the end of the study, all of the assessments will be performed again for all recruited subjects, including early withdrawal patients. Inclusion Criteria: - patients with type 2 diabetes mellitus ; - Aged:40 -75 years ; - Cognitive function assessment suggests mild cognitive impairment; - A stable glucose-lowering regimen include Metformin alone or in combination with sulfonylureas , glinides , glycosidase inhibitors, thiazolidinediones or basic insulin for more than 3 months, and the dose of metformin≥1.0g/d; - HbA1c 7 - 10%; - ≥6 years education; - Right-handed. Exclusion Criteria: - Cognitive function assessment suggests normal cognition or dementia; - Other dementia related neurological diseases or depression, Mental dysplasia, mania, schizophrenia, etc in the past 2 years; Central nervous system diseases, including brain trauma, intracranial hemorrhage, acute cerebral infarction, etc; - Severe sinusitis, nasal cavity and sinus polyps, skull base or nasopharyngeal tumors and other space occupying lesions; - Congenital diseases and traumatic history of nose, maxillofacial and skull base affecting olfaction. · With symptoms of upper respiratory tract infection, including nasal congestion, runny nose, fever, etc. on the day of MR examination; - Diabetic Acute and chronic complications, including diabetic ketoacidosis, diabetic ketoacidosis; a hyperglycemic hyperosmolar state or severe hypoglycemic coma, etc. - Severe impairment of heart, liver, kidney and other organs; - Contraindications of MRI examination, such as implantation of metal prosthesis in vivo, claustrophobia, etc; - Pregnant and lactating women; - Receive other test drugs currently or within 6 months before participating in the project; - Known or suspected allergic history to the test drug or similar drugs; GLP-1 receptor agonist, SGLT2 inhibitor and DPP4 inhibitor were used in recent 3 months.

NCT0531xxxx/NCT05313542.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313542</url> </required_header> <id_info> <org_study_id>PSY021</org_study_id> <nct_id>NCT05313542</nct_id> </id_info> <brief_title>Physical Activity in the Format of Self-defence Training for Depressive Symptoms</brief_title> <official_title>Effect of Physical Activity in the Format of Self-defence Training for Depressive Symptoms - A Pilot Randomised Controlled Trial</official_title> <sponsors> <lead_sponsor> <agency>Chinese University of Hong Kong</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Chinese University of Hong Kong</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Inadequate mental health care capacity is a long-standing issue in Hong Kong (Yang & Mak, 2020). For example, a recent study predicts an additional 12% service need for specialist psychiatric care (Ni et al., 2020). It would be helpful to develop interventions that would ease the high demand of the health care system. Physical activity has been shown to reduce depressive symptoms in a number of studies (Bellón et al., 2021; Josefsson et al., 2014; Kvam et al., 2018; Schuch et al., 2016). Its flexibility and low-cost nature make physical activity a good intervention option for depressed individuals to do it anytime and anywhere.  This study aims to investigate the effect of physical activity intervention in the format of self-defence training on depressive symptoms. Around 40 eligible participants with at least moderate level of depressive symptoms will be randomly assigned to the physical activity (PA) group and waitlist (WL) control group. The PA group will receive a 6-week home-based self-defence training programme consisting of 120 min video training (including daily practice time) per week. Self-report questionnaires will be collected at baseline, immediate post-intervention, and 4-week follow up assessments. The primary outcome measure will be the Patient Health Questionnaire-9 to evaluate depression severity. Secondary outcomes will include psychological health symptoms, sleep quality, lifestyle, and quality of life. This research will provide new perspectives on the application of physical activity in the form of self-defence training as an intervention for depressive individuals. </textblock> </brief_summary> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">September 1, 2022</start_date> <completion_date type="Anticipated">August 31, 2023</completion_date> <primary_completion_date type="Anticipated">June 30, 2023</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>Single (Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Change in the Patient Health Questionnaire (PHQ-9)</measure> <time_frame>Baseline, immediately post-intervention, 4-week follow-up</time_frame> <description>The PHQ-9, a 20-item questionnaire used for screening, diagnosing, monitoring and measuring the severity of depression, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day).</description> </primary_outcome> <secondary_outcome> <measure>Change in the Short Form (Six-Dimension) Health Survey (SF-6D)</measure> <time_frame>Baseline, immediately post-intervention, 4-week follow-up</time_frame> <description>SF-6D is a preference-based single index measure of health. A six-digit number represents each SF-6D health state, each digit denotes the level of one of six SF-6D dimensions: physical functioning, role limitation, social functioning, bodily pain, mental health, and vitality.</description> </secondary_outcome> <secondary_outcome> <measure>Change in the International Physical Activities Questionnaire - Chinese version (IPAQ-C)</measure> <time_frame>Baseline, immediately post-intervention, 4-week follow-up</time_frame> <description>Participants' sitting time, walking time and moderate and vigorous physical activity are assessed by 5 questions from the short form of the International Physical Activity Questionnaire - Chinese version. Participants' engagement in brief strength and stamina-enhancing activity were assessed by asking the number of days they engaged in physical activity while seated and standing in the last seven days.</description> </secondary_outcome> <secondary_outcome> <measure>Change in the Insomnia Severity Index (ISI)</measure> <time_frame>Baseline, immediately post-intervention, 4-week follow-up</time_frame> <description>The ISI is a 7-item scale designed to evaluate perceived insomnia severity. Ratings on the 5-point Likert scale are obtained on the perceived severity of sleep-onset, sleep-maintenance, early morning awakening problems, satisfaction with current sleep pattern, interference with daily functioning, noticeably of impairment attributed to the sleep problem, and level of distress caused by the sleep problem.</description> </secondary_outcome> <secondary_outcome> <measure>Change in Hospital Anxiety and Depression Scale (HADS-14)</measure> <time_frame>Baseline, immediately post-intervention, 4-week follow-up</time_frame> <description>HADS is a 14-item self-rated questionnaire which consists of two 7-item subscales that measure the presence of anxiety and depression symptoms respectively. Each item is rated on a 4-point-scale (0-3) by the participant. The greater the score, the more psychologically distressed the respondent is.</description> </secondary_outcome> <secondary_outcome> <measure>Change in Multidimensional Fatigue Inventory (MFI-20)</measure> <time_frame>Baseline, immediately post-intervention, 4-week follow-up</time_frame> <description>The MFI-20 assesses the severity of fatigue covering the following dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation and reduced activity.</description> </secondary_outcome> <secondary_outcome> <measure>Change in Credibility-Expectancy Questionnaire (CEQ)</measure> <time_frame>Baseline, immediately post-intervention, 4-week follow-up</time_frame> <description>The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success.</description> </secondary_outcome> <secondary_outcome> <measure>Change in Treatment Adherence Survey (TAS)</measure> <time_frame>Baseline, immediately post-intervention</time_frame> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">40</enrollment> <condition>Depressive Symptoms</condition> <arm_group> <arm_group_label>Physical Activity Group (PA group)</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>The PA group will receive a 6-week home-based self-defence training programme consisting of 120 min video training (including daily practice time) per week. Self-report questionnaires will be collected at baseline, immediate post-intervention, and 4-week follow up assessments.</description> </arm_group> <arm_group> <arm_group_label>Waitlist Group (WL group)</arm_group_label> <arm_group_type>Other</arm_group_type> <description>The waitlist group will receive access to the programme at the end of study.</description> </arm_group> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>Physical Activity</intervention_name> <description>Physical Activity in the format of Self-defence Training</description> <arm_group_label>Physical Activity Group (PA group)</arm_group_label> <arm_group_label>Waitlist Group (WL group)</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - 18 to 65 years old  - Hong Kong Residents  - Patient Health Questionnaire (PHQ-9) score ≥ 10; and  - Willingness to provide informed consent and comply with the trial protocol.  Exclusion Criteria:  - Patients with any cardiovascular diseases  - Receiving psychological treatment or medication for psychiatric disorders  - Participated in self defence training in the past 6 months </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>65 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_contact> <last_name>Angel Lee</last_name> <phone>39436575</phone> <email>angellyy@link.cuhk.edu.hk</email> </overall_contact> <location> <facility> <name>The Chinese University of Hong Kong</name> <address> <city>Sha Tin</city> <country>Hong Kong</country> </address> </facility> </location> <location_countries> <country>Hong Kong</country> </location_countries> <verification_date>July 2022</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>July 18, 2022</last_update_submitted> <last_update_submitted_qc>July 18, 2022</last_update_submitted_qc> <last_update_posted type="Actual">July 20, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation> <investigator_full_name>Fiona YY Ho</investigator_full_name> <investigator_title>Assistant Professor</investigator_title> </responsible_party> <keyword>Self Defence Training</keyword> <keyword>Physical Activity</keyword> <condition_browse>  <mesh_term>Depression</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Undecided</sharing_ipd> </patient_data>  </clinical_study>

Inadequate mental health care capacity is a long-standing issue in Hong Kong (Yang & Mak, 2020). For example, a recent study predicts an additional 12% service need for specialist psychiatric care (Ni et al., 2020). It would be helpful to develop interventions that would ease the high demand of the health care system. Physical activity has been shown to reduce depressive symptoms in a number of studies (Bellón et al., 2021; Josefsson et al., 2014; Kvam et al., 2018; Schuch et al., 2016). Its flexibility and low-cost nature make physical activity a good intervention option for depressed individuals to do it anytime and anywhere. This study aims to investigate the effect of physical activity intervention in the format of self-defence training on depressive symptoms. Around 40 eligible participants with at least moderate level of depressive symptoms will be randomly assigned to the physical activity (PA) group and waitlist (WL) control group. The PA group will receive a 6-week home-based self-defence training programme consisting of 120 min video training (including daily practice time) per week. Self-report questionnaires will be collected at baseline, immediate post-intervention, and 4-week follow up assessments. The primary outcome measure will be the Patient Health Questionnaire-9 to evaluate depression severity. Secondary outcomes will include psychological health symptoms, sleep quality, lifestyle, and quality of life. This research will provide new perspectives on the application of physical activity in the form of self-defence training as an intervention for depressive individuals. Inclusion Criteria: - 18 to 65 years old - Hong Kong Residents - Patient Health Questionnaire (PHQ-9) score ≥ 10; and - Willingness to provide informed consent and comply with the trial protocol. Exclusion Criteria: - Patients with any cardiovascular diseases - Receiving psychological treatment or medication for psychiatric disorders - Participated in self defence training in the past 6 months

NCT0531xxxx/NCT05313555.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313555</url> </required_header> <id_info> <org_study_id>HUM00198624</org_study_id> <nct_id>NCT05313555</nct_id> </id_info> <brief_title>The Effect of Violet Device Dosed Ultra Violet-C Light (UV-C) Exposure on Healthy Hand Skin</brief_title> <official_title>The Effect of Violet Device Dosed UV-C Exposure on Healthy Hand Skin</official_title> <sponsors> <lead_sponsor> <agency>University of Michigan</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Archimedes Innovations, Pbc</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>University of Michigan</source> <oversight_info> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>Yes</is_fda_regulated_device> <is_unapproved_device>Yes</is_unapproved_device> <is_us_export>No</is_us_export> </oversight_info> <brief_summary> <textblock> The purpose of this trial is to determine the safety of ultraviolet light (UV-C) irradiation as a method to sanitize hands instead of chemical-based sanitizers.  Eligible participants will be enrolled and receive treatment with the Violet UV-C device or UV-B. Punch biopsies will be performed following UV exposure to quantify any changes in cellular and molecular properties of the tissue. </textblock> </brief_summary> <overall_status>Active, not recruiting</overall_status> <start_date type="Actual">April 19, 2022</start_date> <completion_date type="Anticipated">April 2024</completion_date> <primary_completion_date type="Anticipated">April 2024</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Deoxyribonucleic acid (DNA) damage in the form of DNA base pair dimers measured by immunohistochemistry microscopy with statistical analysis.</measure> <time_frame>Day 1 (visit 1 after light therapy)</time_frame> </primary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">30</enrollment> <condition>Healthy Volunteers</condition> <arm_group> <arm_group_label>Ultraviolet lights (UV-B)</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> </arm_group> <arm_group> <arm_group_label>Ultraviolet lights (UV-C)</arm_group_label> <arm_group_type>Experimental</arm_group_type> </arm_group> <intervention> <intervention_type>Device</intervention_type> <intervention_name>Ultraviolet Light (UV-B)</intervention_name> <description>This control group will receive a UV-B exposure as a positive control. Participants will have punch biopsies after exposure.</description> <arm_group_label>Ultraviolet lights (UV-B)</arm_group_label> </intervention> <intervention> <intervention_type>Device</intervention_type> <intervention_name>Ultraviolet lights (UV-C)</intervention_name> <description>Violet is tabletop device that emits filtered UV-C (200nm-230nm; peak at 222nm). Participants will choose, based on availability, to be in groups that deliver 1 cycle, 10 cycles, 15 cycles or 25 cycles of the Violet. The subject will be exposed for no more than 5 minutes and 20 seconds in total. Participants will have punch biopsies after exposure.</description> <arm_group_label>Ultraviolet lights (UV-C)</arm_group_label> <other_name>Violet UV-C Light</other_name> <other_name>Care222</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria  - Good general health  - Type 1 or type 2 skin (lightly colored skin)  - No history of skin disorders, disease states or physical conditions which would impair evaluation of the test sites  - Willingness and ability to follow the protocol  - No use of lotion or hand sanitizer 3 hours before the experiment  Exclusion Criteria:  - Has received an experimental drug or used an experimental device in the 30 days prior to admission to the study  - Undergoing treatment or taking medication that increases sun sensitivity  - History of keloids  - History of sensitivity to lidocaine or epinephrine  - Pregnant or nursing women, pregnancy status will be self-reported, women unsure of their pregnancy status will be excluded </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>55 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Gary Fisher, PhD</last_name> <role>Principal Investigator</role> <affiliation>University of Michigan</affiliation> </overall_official> <location> <facility> <name>University of Michigan</name> <address> <city>Ann Arbor</city> <state>Michigan</state> <zip>48109</zip> <country>United States</country> </address> </facility> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>March 2023</verification_date> <study_first_submitted>March 28, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>March 22, 2023</last_update_submitted> <last_update_submitted_qc>March 22, 2023</last_update_submitted_qc> <last_update_posted type="Actual">March 24, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>University of Michigan</investigator_affiliation> <investigator_full_name>Gary Fisher</investigator_full_name> <investigator_title>Professor</investigator_title> </responsible_party> <keyword>ultraviolet light</keyword> <keyword>light skin</keyword> <keyword>skin changes</keyword> <keyword>healthy volunteers</keyword> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

The purpose of this trial is to determine the safety of ultraviolet light (UV-C) irradiation as a method to sanitize hands instead of chemical-based sanitizers. Eligible participants will be enrolled and receive treatment with the Violet UV-C device or UV-B. Punch biopsies will be performed following UV exposure to quantify any changes in cellular and molecular properties of the tissue. Inclusion Criteria - Good general health - Type 1 or type 2 skin (lightly colored skin) - No history of skin disorders, disease states or physical conditions which would impair evaluation of the test sites - Willingness and ability to follow the protocol - No use of lotion or hand sanitizer 3 hours before the experiment Exclusion Criteria: - Has received an experimental drug or used an experimental device in the 30 days prior to admission to the study - Undergoing treatment or taking medication that increases sun sensitivity - History of keloids - History of sensitivity to lidocaine or epinephrine - Pregnant or nursing women, pregnancy status will be self-reported, women unsure of their pregnancy status will be excluded

NCT0531xxxx/NCT05313568.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313568</url> </required_header> <id_info> <org_study_id>Foot.Balance.ReactionTime.</org_study_id> <nct_id>NCT05313568</nct_id> </id_info> <brief_title>Self Stretching, Plantar Self Massage and Manual Stimulation on Balance and Reaction Time</brief_title> <official_title>Instant Effect of Self Stretching, Plantar Self Massage and Manual Stimulation on Balance and Reaction Time in Healthy Individuals</official_title> <sponsors> <lead_sponsor> <agency>Istanbul Medipol University Hospital</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Istanbul Medipol University Hospital</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The aim of this study is to investigate the instantaneous effects of self-stretching, plantar self-massage and manual stimulation on balance and reaction time in healthy individuals. 102 individuals meeting the inclusion criteria will be included in the study. Individuals will be randomly divided into 3 groups: static stretching group (n=34), self-massage group (n=34) and manual stimulation group (n=34). Static stretching will be applied to all individuals (n=102). In addition to static stretching, self-massage will be applied to individuals in the self-massage group (n=34). Individuals in the manual stimulation group (n=34) will receive manual stimulation in addition to static stretching. Individuals will be evaluated in terms of static balance, dynamic balance, reaction time and foot functionality before and immediately after the applications. </textblock> </brief_summary> <overall_status>Active, not recruiting</overall_status> <start_date type="Actual">June 28, 2021</start_date> <completion_date type="Anticipated">June 2022</completion_date> <primary_completion_date type="Anticipated">May 2022</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Prevention</primary_purpose> <masking>Single (Participant)</masking> </study_design_info> <primary_outcome> <measure>One Leg Standing Test</measure> <time_frame>change in static balance immediately after application</time_frame> <description>It will be used to evaluate static balance. If the cut-off value is <10 seconds, there is a balance disorder, if it is <5 seconds, there is a risk of falling.</description> </primary_outcome> <primary_outcome> <measure>Functional Reach Test</measure> <time_frame>change in dynamic balance immediately after application</time_frame> <description>It will be used to evaluate dynamic balance. The distance that the person can reach is measured. Higher scores mean better performance.</description> </primary_outcome> <primary_outcome> <measure>Y Balance Test</measure> <time_frame>change in dynamic balance immediately after application</time_frame> <description>It will be used to evaluate dynamic balance. The distance that the person can reach is measured. Higher scores mean better performance.</description> </primary_outcome> <primary_outcome> <measure>Nelson's Foot Reaction Time Test</measure> <time_frame>change in reaction time immediately after application</time_frame> <description>It will be used to evaluate reaction time. The time that the person can react is measured. Higher scores mean worse performance.</description> </primary_outcome> <secondary_outcome> <measure>Active-passive Limb Matching Test</measure> <time_frame>change in proprioception immediately after application</time_frame> <description>It will be used to evaluate proprioception. Same position mean better performance.</description> </secondary_outcome> <secondary_outcome> <measure>Goniometer</measure> <time_frame>change in range of motion immediately after application</time_frame> <description>It will be used to evaluate range of motion of ankle. Dorsiflexion range of motion is 20 degree. Plantar flexion range of motion is 50 degree. Eversion range of motion is 15 degree. Inversion range of motion is 35 degree. Higher score means better performance.</description> </secondary_outcome> <secondary_outcome> <measure>Foot Posture Index</measure> <time_frame>change in foot posture immediately after application</time_frame> <description>It will be used to evaluate foot posture. Palpation of the talus head in the hindfoot, inclination under and over the lateral malleolus, pronation/supination of the calcaneus, ballooning in the talonavicular joint region in the forefoot, medial longitudinal arch structure, and abduction/adduction of the forefoot relative to the hindfoot are evaluated. Each of these criteria takes values between -2 and +2. 0 means the foot is in neutral position, positive values are interpreted as pronation, and negative values are interpreted as supination.</description> </secondary_outcome> <secondary_outcome> <measure>Thomas test</measure> <time_frame>change in hip flexor shortness immediately after application</time_frame> <description>It will be used to evaluate hip flexor shortness. If the other leg raise, it is positive.</description> </secondary_outcome> <secondary_outcome> <measure>Pointed-blunt Test</measure> <time_frame>change in sensory immediately after application</time_frame> <description>It will be used to evaluate presence of sensory problems. Higher scores mean worse performance. Scoring: Normal <6mm Fair 6-10mm Poor 11-15mm</description> </secondary_outcome> <number_of_arms>3</number_of_arms> <enrollment type="Anticipated">102</enrollment> <condition>Healthy</condition> <condition>Stretch</condition> <arm_group> <arm_group_label>static stretching group</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>The stretch will be done by placing both feet on a raised platform, lowering the heel off the platform without touching the ground, and held in this position to perform a static stretch. They will perform 5 repetitions, 15 seconds of rest and 1 minute of stretching.</description> </arm_group> <arm_group> <arm_group_label>self massage group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>In addition to the self-stretching application, plantar self-massage will be applied. Plantar self massage will be shown to the participants by the physiotherapist with a 7 cm spiky massage ball. Then, participants will be asked to self-massage the plantar sole of the foot for 5 minutes with a 7 cm spiky massage ball.</description> </arm_group> <arm_group> <arm_group_label>Manual Stimulation Group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>In addition to the self-stretching application, manual stimulation will be applied. Manual protocol: A) Pressure will be applied in each interdigital space and on the longitudinal arch with shear in the longitudinal direction (5 repetitions of 10 seconds each). B) Pressure with transverse shear on the metatarsal heads (5 repetitions of 5 seconds each) C) Static pressure will be applied to the first and fifth metatarsal head, center of the midfoot, and heel (5 repetitions per 10-second period each).</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>static stretching</intervention_name> <description>The stretch will be done by placing both feet on a raised platform, lowering the heel off the platform without touching the ground, and held in this position to perform a static stretch. They will perform 5 repetitions, 15 seconds of rest and 1 minute of stretching.</description> <arm_group_label>Manual Stimulation Group</arm_group_label> <arm_group_label>self massage group</arm_group_label> <arm_group_label>static stretching group</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>self massage</intervention_name> <description>In addition to the self-stretching application, plantar self-massage will be applied. Plantar self massage will be shown to the participants by the physiotherapist with a 7 cm spiky massage ball. Then, participants will be asked to self-massage the plantar sole of the foot for 5 minutes with a 7 cm spiky massage ball.</description> <arm_group_label>self massage group</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Manual Stimulation</intervention_name> <description>In addition to the self-stretching application, manual stimulation will be applied. Manual protocol: A) Pressure will be applied in each interdigital space and on the longitudinal arch with shear in the longitudinal direction (5 repetitions of 10 seconds each). B) Pressure with transverse shear on the metatarsal heads (5 repetitions of 5 seconds each) C) Static pressure will be applied to the first and fifth metatarsal head, center of the midfoot, and heel (5 repetitions per 10-second period each).</description> <arm_group_label>Manual Stimulation Group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - being between 18 and 50 years old  - having Body Mass Index (BMI) limit to be 20-25  - having Normal range of motion of the ankle joint  - having the score of the foot is between 0 and +5 according to the foot posture index,  - having the score 3+ on ankle muscle strength  Exclusion Criteria:  - being pregnant  - having undergone surgery on the foot and ankle in the last 6 months  - history of lower extremity injury with residual symptoms in the past year  - having diseases that affect the balance such as rheumatic disease, osteoarthritis, multiple sclerosis  - being professional athlete  - presence of vestibular disease (Meniere, Vertigo etc.), diabetes, neuropathy Being in  - being in the menopausal period  - having hip flexor muscle shortening  - having basal ganglia disorders such as Parkinson's disease, Huntington's disease  - having sensory problems on the sole of the foot </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>50 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Miray BUDAK, PhD</last_name> <role>Principal Investigator</role> <affiliation>Medipol University</affiliation> </overall_official> <location> <facility> <name>Istanbul Medipol University</name> <address> <city>Istanbul</city> <state>Beykoz</state> <zip>34815</zip> <country>Turkey</country> </address> </facility> </location> <location_countries> <country>Turkey</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>October 14, 2021</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>March 29, 2022</last_update_submitted> <last_update_submitted_qc>March 29, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Istanbul Medipol University Hospital</investigator_affiliation> <investigator_full_name>Miray Budak</investigator_full_name> <investigator_title>Principal Investigator</investigator_title> </responsible_party> <keyword>Self Stretching, Self Massage, Manual Stimulation, Balance, Reaction Time, Healthy</keyword>  </clinical_study>

The aim of this study is to investigate the instantaneous effects of self-stretching, plantar self-massage and manual stimulation on balance and reaction time in healthy individuals. 102 individuals meeting the inclusion criteria will be included in the study. Individuals will be randomly divided into 3 groups: static stretching group (n=34), self-massage group (n=34) and manual stimulation group (n=34). Static stretching will be applied to all individuals (n=102). In addition to static stretching, self-massage will be applied to individuals in the self-massage group (n=34). Individuals in the manual stimulation group (n=34) will receive manual stimulation in addition to static stretching. Individuals will be evaluated in terms of static balance, dynamic balance, reaction time and foot functionality before and immediately after the applications. Inclusion Criteria: - being between 18 and 50 years old - having Body Mass Index (BMI) limit to be 20-25 - having Normal range of motion of the ankle joint - having the score of the foot is between 0 and +5 according to the foot posture index, - having the score 3+ on ankle muscle strength Exclusion Criteria: - being pregnant - having undergone surgery on the foot and ankle in the last 6 months - history of lower extremity injury with residual symptoms in the past year - having diseases that affect the balance such as rheumatic disease, osteoarthritis, multiple sclerosis - being professional athlete - presence of vestibular disease (Meniere, Vertigo etc.), diabetes, neuropathy Being in - being in the menopausal period - having hip flexor muscle shortening - having basal ganglia disorders such as Parkinson's disease, Huntington's disease - having sensory problems on the sole of the foot

NCT0531xxxx/NCT05313581.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313581</url> </required_header> <id_info> <org_study_id>2022-00108</org_study_id> <nct_id>NCT05313581</nct_id> </id_info> <brief_title>START NOW: Web-based Training to Promote Mental Health</brief_title> <official_title>Implementation of an E-version of the Skills Training START NOW for Promoting Emotion Regulation and Resilience in Residential Youth Care and Correctional Institutions</official_title> <sponsors> <lead_sponsor> <agency>Prof. Christina Stadler</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>University Psychiatric Clinics Basel</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Almost every young person has experienced difficult situations, crises and stress in his or her life. It is difficult to cope with such situations and it is not uncommon for mental health to be affected. At the same time, those affected often do not get any help. There are too few offers of help. That is why the investigators have developed the START NOW training and the corresponding WebAPP. With this training, young people can train their resilience, i.e. their psychological resistance. Resilient people cope better with difficult situations and remain psychologically healthy for longer. Because the START NOW training is now also available as a WebAPP, users can apply it practically, playfully and at any time. Furthermore, the WebAPP can be used as a prevention and treatment option in a resource-saving and cost-efficient way in institutions. The aim is to find out in a randomized study design with two treatment conditions and a waiting group whether START NOW is effective as a newly developed WebAPP. Specifically, the investigators will investigate whether a digital web-based self-help training can already achieve positive effects or whether a format in which accompanying guidance by a coach and social learning is possible (support by a trainer who guides young people during the training) is better for achieving sustainable changes.The project is funded by the Federal Office of Justice as part of a pilot project. </textblock> </brief_summary> <detailed_description> <textblock> Psychological Flexibility (PF) is associated with improved mental health across a multitude of contexts and populations, while psychological inflexibility is associated with mental health problems, in particular depression and anxiety. Taking into consideration that prevalence rates of clinically significant anxiety and depression in large youth cohorts are high and even increased especially due to Covid-19, interventions aiming to enhance psychological flexibility are of particular importance. START NOW represents one approach that is well equipped to promote PF. It is an evidence-based, integrative skills training program, which offers a broad scope of applicability to different populations and contexts by promoting general psychological health and resilience.  Web-based health approaches are well established across settings, populations and a range of mental health outcomes and offer benefits such as cost-effectiveness, high accessibility and flexibility, direct and convenient use of resources, anonymity, decreased stigmatization and a feasible way to ensure continuity of care in transitional phases. Our project aims to develop and evaluate a web-based translation of the existing START NOW skills training that promotes PF in institutionalized youth.  The investigatorss will investigate the efficacy of web-based START NOW on PF in a randomized controlled trial comparing the following conditions: 1) Web-based group training guided by a trained START NOW facilitator (either face-to-face or through videoconferencing) 2) Web-based self-help without guidance 3) Treatment as usual (TAU) </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">April 1, 2022</start_date> <completion_date type="Anticipated">April 2024</completion_date> <primary_completion_date type="Anticipated">April 2024</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <intervention_model_description>1) Web-based group training guided by a trained START NOW facilitator(either face-to-face or through videoconferencing)2) Web-based self-help without guidance 3) Treatment as usual (TAU)</intervention_model_description> <primary_purpose>Prevention</primary_purpose> <masking>None (Open Label)</masking> <masking_description>open</masking_description> </study_design_info> <primary_outcome> <measure>Response to web-based training: pre-post participation CHANGE in psychological inflexibility as measured by scores on the AFQ-Y questionnaire</measure> <time_frame>Primary endpoint is the CHANGE in total score between baseline (T1) and follow-up (T3, 12 +/- 2 weeks after the end of the intervention)</time_frame> <description>The AFQ-Y is a widely used and validated self-rating questionnaire for assessing Psychological Flexibility in youth and young adults. Participants answer 17 items indicating how true each item is for them on a 5-point Likert scale (0 = not at all true; 4 = very true). Higher total scores indicate lower PF. Items are based on ACT models of human suffering representing the theoretical concept of psychological inflexibility due to high cognitive fusion and experiential avoidance. Data will be assessed within 2 weeks before start of skills training (baseline, T1), within 2 weeks after end of skills training (post-treatment assessment, T2), as well as at 12 weeks (+/- 2 weeks) (T3) and 24 weeks (+/- 2 weeks) (T4) post skills training. Primary endpoint is the change in total score between baseline (T1) and follow-up (T3). Total scores can range between 0 and 68. Accordingly, a change in score can range between -68 to +68.</description> </primary_outcome> <secondary_outcome> <measure>change in resilience (all 3 conditions)</measure> <time_frame>- between baseline (T1) and post-training (T2, ≤2 weeks after end of intervention ) - between baseline (T1) and 12-week follow-up (T3, after the end of intervention) - between baseline (T1) and 24-week follow-up (T4)</time_frame> <description>Increase in total score on the German version of the Connor-Davidson Resilience Scale (CD-RISC) in the 10-items version both in self-rating by participant and self-rating by caretaker. The CD-RISC refers to an individual's ability to endure difficult experiences. Answers are given on a 5-point Likert-Scale (0= not true at all; 4= true nearly all of the time). Total scores can range from 0 to 50, with change scores ranging from -50 to +50.</description> </secondary_outcome> <secondary_outcome> <measure>change in self-reported psychological well-being (all 3 conditions)</measure> <time_frame>- between baseline (T1) and post-training (T2, ≤2 weeks after end of intervention ) - between baseline (T1) and 12-week follow-up (T3, after the end of intervention) - between baseline (T1) and 24-week follow-up (T4)</time_frame> <description>Increase in total score on the World Health Organization - Five Well-Being Index (WHO-5) in self-rating by participant. The self-report questionnaire contains five items on a 6-point Likert-Scale (5= all of the time; 0= none of the time). Respondents are asked to indicate how often they felt well during the last two weeks. Total scores can range from 0 to 25, with higher scores indicating greater well-being. Accordingly, change scores range from -25 to +25.</description> </secondary_outcome> <secondary_outcome> <measure>change in self-reported self-efficacy (all 3 conditions)</measure> <time_frame>- between baseline (T1) and post-training (T2, ≤2 weeks after end of intervention ) - between baseline (T1) and 12-week follow-up (T3, after the end of intervention) - between baseline (T1) and 24-week follow-up (T4)</time_frame> <description>Increase in total score on the German 'General Self-Efficacy Scale - Skala zur Allgemeinen Selbstwirksamkeitserwartung' (SWE) in self-rating by participant. The questionnaire includes 10 Items and a 4-point Likert Scale (1= not true; 4= completely true). The scale reflects one's convictions on subjective controllability or competence expectations in different demand situations, with higher scores indicating a greater sense of self-efficacy. Total scores can range from 10 to 40, with change scores ranging from -40 to +40.</description> </secondary_outcome> <secondary_outcome> <measure>change in general impairment (all 3 conditions)</measure> <time_frame>- between baseline (T1) and post-training (T2, ≤2 weeks after end of intervention ) - between baseline (T1) and 12-week follow-up (T3, after the end of intervention) - between baseline (T1) and 24-week follow-up (T4)</time_frame> <description>Reduction of all sub scores and total score on the Columbia Impairment Scale (CIS) both in self-rating by participant and external rating by caretaker. The 13-item questionnaire captures functional impairment in four domains: interpersonal relations, broad psychopathological domains, functioning in school or at work, and use of leisure time. It will be answered both by the participant as a self-report questionnaire, and by the caretakers as external raters. Items are answered on a 5-point Likert-Scale (0= no problem; 4= a very big problem). Total score can range from 0 to 52, with change scores ranging from -52 to +52.</description> </secondary_outcome> <secondary_outcome> <measure>change in depression and anxiety (all 3 conditions)</measure> <time_frame>- between baseline (T1) and post-training (T2, ≤2 weeks after end of intervention ) - between baseline (T1) and 12-week follow-up (T3, after the end of intervention) - between baseline (T1) and 24-week follow-up (T4)</time_frame> <description>Reduction of total score on the Patient Health Questionnaire 4 (PHQ-4) in self-rating by participants. The PHQ-4 is a ultra- short questionnaire with the two subscales depression and anxiety, and was evaluated a s a reliable, valid and precise screening tools for self reported depression, anxiety and general psychological distress. Answers are given on 4-point Likert-Scale (0=not at all, 3= nearly every day). Total score is determined by adding together the scores of each of the 4 items. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12). Total score ≥3 for first 2 questions suggests anxiety. Total score ≥3 for last 2 questions suggests depression.</description> </secondary_outcome> <secondary_outcome> <measure>change in anger-irritability (all 3 conditions)</measure> <time_frame>- between baseline (T1) and post-training (T2, ≤2 weeks after end of intervention ) - between baseline (T1) and 12-week follow-up (T3, after the end of intervention) - between baseline (T1) and 24-week follow-up (T4)</time_frame> <description>Reduction of total score on Affective Reactivity Scale (ARI) both in self-rating by participant and external rating by caretaker. The ARI contains seven items to be scored on a 3-point Likert-Scale (0= not true, 1= somewhat true, 2= certainly true). As just the first six items are summed to the total score, it can range from 0 to 12, with change scores ranging from -12 to +12. The seventh item is analysed separately.</description> </secondary_outcome> <secondary_outcome> <measure>change in substance use (all 3 conditions)</measure> <time_frame>between screening (T0) and 12 week follow-up (T3, 12 weeks after the end of the intervention)</time_frame> <description>Reduction of total score on the Alcohol/Drug Use subscale of the MAYSI-2 in self-rating by participants. The MAYSI-2 is a brief screening tool designed for youth between the ages of 12-17 years, but it has been suggested that the screening tool may also be adequate for young adults as long as results are interpreted with caution. The MAISY-2 contains 52 items across seven subscales: Alcohol/Drug Use, Anger-Irritability, Depression-Anxiety, Somatic Complaints, Suicide Ideation, Traumatic Experiences and Thought Disturbance. Respondents are asked about the presence of various thoughts, feelings or behaviours in the past few months, in a yes or no format. Each subscale contains different caution cut-offs.</description> </secondary_outcome> <other_outcome> <measure>Client Training Satisfaction (2 intervention conditions)</measure> <time_frame>T2 (post intervention, ≤2 weeks after end of intervention)</time_frame> <description>Participants within the two intervention conditions can indicate their satisfaction with the training using the Client Satisfaction Questionnaire (CSQ) at T2 (post intervention). The CSQ was specifically developed to assess participants' experiences and satisfaction with START NOW. It contains eight items on a 4-point Likert-Scale (ranging from 0 to 3; response options are provided with smileys) and two open questions about what participants liked or would want to be changed within the training. Total scores can range from 0 to 24.</description> </other_outcome> <other_outcome> <measure>Trainer Satisfaction (facilitators of the group training)</measure> <time_frame>T2 (post intervention, ≤2 weeks after end of intervention)</time_frame> <description>Satisfaction of facilitators of the group training guided by a facilitator condition will be assessed with the Trainer Satisfaction Questionnaire (TSQ) at T2 (post intervention), a 5 Min self-rating questionnaire. After the end of the intervention, focused group discussions are planned for all interested institutions regarding implementation and experiences with START NOW. The group discussions will be conducted as guided interviews for 1 hour with a maximum of 3 institute employees and recorded for later transcription (audio and video; destroyed after transcription; text anonymized) and qualitative analyses.</description> </other_outcome> <other_outcome> <measure>Social Atmosphere</measure> <time_frame>T1 and all following time points</time_frame> <description>Social Atmosphere will be assessed by the German version of the Essen Climate Evaluation Schema (EssenCES). It is a short self-rating questionnaire, containing 17 items across three subscales: Therapeutic Hold, Patients' Cohesion and Mutual Support, and Experienced Safety. Responses are given on a 5-point Likert Scale (0= not at all, 1= little, 2= somewhat, 3= quite a lot, 4= very much). Total scores can range from 0 to 68 with higher scores indicating a better social climate. Accordingly, change scores can range between -68 to +68.</description> </other_outcome> <other_outcome> <measure>Checklist Baseline T1 and Checklist Monitoring</measure> <time_frame>T1 and all following time points. NOTE: Monitoring purpose (Data Control), no aggregation of data</time_frame> <description>Inclusion/exclusion criteria throughout the course of the study (i.e., participation in concurrent CBT based skills training similar to START NOW., internet access, external placements/discharge, unauthorized leaves) will be screened/monitored with two specially designed Checklists.</description> </other_outcome> <other_outcome> <measure>Prior Experiences of Caretakers and Facilitator</measure> <time_frame>For caretakers at baseline (T1), for facilitators at post-treatment assessment (T2, ≤2 weeks after end of intervention).</time_frame> <description>The professional qualification of involved caretakers and facilitators, their experiences with START NOW or other forms of resilience trainings will be assessed with a short questionnaire.</description> </other_outcome> <other_outcome> <measure>Adherence</measure> <time_frame>during one session (either live or via online connection)</time_frame> <description>For each institution, the quality of the group training guided by a facilitator will be rated by a START NOW facilitator during one session (either live or via online connection) using a Quality Assurance Form.</description> </other_outcome> <number_of_arms>3</number_of_arms> <enrollment type="Anticipated">244</enrollment> <condition>Resilience</condition> <condition>Emotion Regulation</condition> <condition>Social Competence</condition> <condition>Stress</condition> <arm_group> <arm_group_label>START NOW as web-based group training guided by a facilitator</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>In condition 1, participants will be required to attend weekly sessions of the group training (period of 9 weeks; 3 double sessions;4 to12 participants) guided by a facilitator, either face-to-face or via videoconferencing. Facilitation will be provided either by a staff member (caretaker) of the institution who has received a 1.5 days training in START NOW (face-to-face setting), or by a member of the START NOW facilitator team of Universitäre Psychiatrische Kliniken (UPK) Basel (videoconference setting). All participants will have access to the START NOW Web application (WebApp) during the entire intervention and follow-up phase to complete additional exercises or review content. Institutions randomized to group training guided by a facilitator condition will receive the complete pretraining (12 hours à 3 blocks: Theoretical Background; WebApp and Facilitator Material; Running Sessions) with individual coaching. Supervision will be provided twice during the intervention phase.</description> </arm_group> <arm_group> <arm_group_label>START NOW as web-based pure self-help training</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Participants in condition 2 will use the START NOW web-based pure self-help training. Using the same session contents as in the group training guided by a facilitator, sessions have been adjusted so that participants can complete them individually and participants receive one session each week (session 1+2, 9+10 and 11+12 as double sessions). Institutions randomized to pure self-help training will receive the first block of the pretraining and the material from the second block (facilitator training material) prior to interventions start.</description> </arm_group> <arm_group> <arm_group_label>Treatment as usual (TAU)</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>Participants in condition 3 will not receive any health promotion services during the skills training or follow-up period beyond what is offered at their respective institution. They will also be excluded from any group trainings similar to START NOW. For ethical reasons and to increase study-related commitment, they will be provided with the web-based pure self-help training after completion of the study. Institution staff will receive the first block of the pretraining and material from the second block after the end of the intervention. Supervision for participating caretakers and facilitators will not be provided during the intervention phase.</description> </arm_group> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>START NOW WebApp</intervention_name> <description>The WebApp is based on the existing manualized START NOW skills training. START NOW aims to improve emotion- and stress regulation, social competence, effective management of encountered problems/crises, subjective well-being and resilience through improving an individual's level of psychological flexibility. It primarily employs a cognitive behaviourally oriented group skills training with integrated components from Dialectical Behavioural Therapy (DBT), Acceptance and Commitment Therapy (ACT), trauma-informed care and Motivational Interview (MI) techniques. During the training, participants will encounter different exercises to help them train their skills. There are several mindfulness exercises in the form of audio tracks, containing, e.g., instructions on a breathing exercise. The skills training phase takes place over a period of 9 weeks (sessions 1+2, 9+10 and 11+12 are double session).</description> <arm_group_label>START NOW as web-based group training guided by a facilitator</arm_group_label> <arm_group_label>START NOW as web-based pure self-help training</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Youth and young adults in Residential Youth Care (RYC) or Correctional Institutions (CI)  - Age between 14-24 at time of screening  - Need for improvement: Avoidance and Fusion Questionnaire for Youth (AFQ-Y) equal or higher than 34.05, or  - Massachusetts Youth Screening Instrument-2 (MAYSI-2) subscale Angry-Irritable equal or higher than 5, or  - MAYSI-2 subscale Depressed-Anxious equal or higher than 3.  - Sufficient speaking, writing and reading skills in German or French  - (Written) informed consent  - No planned discharge before end of intervention phase; Exception: Self-Help condition  Exclusion Criteria:  - Suicidality: MAYSI-2 subscale Suicide Ideation equal or higher than 2  - Acute psychotic symptoms or mania: MAYSI-2 subscale Thought Disturbance equal or higher than 1  - Concurrent Cognitive Behavioral Therapy (CBT) based skills training similar to START NOW </textblock> </criteria> <gender>All</gender> <minimum_age>14 Years</minimum_age> <maximum_age>24 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Christina Stadler, Prof. Dr.</last_name> <role>Principal Investigator</role> <affiliation>University Psychiatric Clinics Basel</affiliation> </overall_official> <overall_contact> <last_name>Christina Stadler, Prof. Dr.</last_name> <phone>+41 61 265 8970</phone> <email>christina.stadler@upk.ch</email> </overall_contact> <overall_contact_backup> <last_name>Donja Brunner, Dr.</last_name> <email>donja.brunner@upk.ch</email> </overall_contact_backup> <location> <facility> <name>University Psychiatric Clinic</name> <address> <city>Basel</city> <state>Basel-Stadt</state> <zip>4002</zip> <country>Switzerland</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Christina Stadler, Prof.</last_name> <phone>+41 61 325 8279</phone> <email>christina.stadler@upk.ch</email> </contact> </location> <location_countries> <country>Switzerland</country> </location_countries> <reference> <citation>Kersten L, Pratzlich M, Mannstadt S, Ackermann K, Kohls G, Oldenhof H, Saure D, Krieger K, Herpertz-Dahlmann B, Popma A, Freitag CM, Trestman RL, Stadler C. START NOW - a comprehensive skills training programme for female adolescents with oppositional defiant and conduct disorders: study protocol for a cluster-randomised controlled trial. Trials. 2016 Dec 1;17(1):568. doi: 10.1186/s13063-016-1705-6. Erratum In: Trials. 2017 Mar 2;18(1):95.</citation> <PMID>27903282</PMID> </reference> <reference> <citation>Kersten L, Cislo AM, Lynch M, Shea K, Trestman RL. Evaluating START NOW: A Skills-Based Psychotherapy for Inmates of Correctional Systems. Psychiatr Serv. 2016 Jan;67(1):37-42. doi: 10.1176/appi.ps.201400471. Epub 2015 Aug 17.</citation> <PMID>26278230</PMID> </reference> <verification_date>December 2022</verification_date> <study_first_submitted>March 16, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>December 21, 2022</last_update_submitted> <last_update_submitted_qc>December 21, 2022</last_update_submitted_qc> <last_update_posted type="Actual">December 23, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor-Investigator</responsible_party_type> <investigator_affiliation>University Psychiatric Clinics Basel</investigator_affiliation> <investigator_full_name>Prof. Christina Stadler</investigator_full_name> <investigator_title>Principal Investigator, Professor for Developmental Psychopathology (Full professorship), Department of Child and Adolescent Psychiatry (UPK-KJ), Psychiatric University Clinics Basel (UPK)</investigator_title> </responsible_party> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Almost every young person has experienced difficult situations, crises and stress in his or her life. It is difficult to cope with such situations and it is not uncommon for mental health to be affected. At the same time, those affected often do not get any help. There are too few offers of help. That is why the investigators have developed the START NOW training and the corresponding WebAPP. With this training, young people can train their resilience, i.e. their psychological resistance. Resilient people cope better with difficult situations and remain psychologically healthy for longer. Because the START NOW training is now also available as a WebAPP, users can apply it practically, playfully and at any time. Furthermore, the WebAPP can be used as a prevention and treatment option in a resource-saving and cost-efficient way in institutions. The aim is to find out in a randomized study design with two treatment conditions and a waiting group whether START NOW is effective as a newly developed WebAPP. Specifically, the investigators will investigate whether a digital web-based self-help training can already achieve positive effects or whether a format in which accompanying guidance by a coach and social learning is possible (support by a trainer who guides young people during the training) is better for achieving sustainable changes.The project is funded by the Federal Office of Justice as part of a pilot project. Psychological Flexibility (PF) is associated with improved mental health across a multitude of contexts and populations, while psychological inflexibility is associated with mental health problems, in particular depression and anxiety. Taking into consideration that prevalence rates of clinically significant anxiety and depression in large youth cohorts are high and even increased especially due to Covid-19, interventions aiming to enhance psychological flexibility are of particular importance. START NOW represents one approach that is well equipped to promote PF. It is an evidence-based, integrative skills training program, which offers a broad scope of applicability to different populations and contexts by promoting general psychological health and resilience. Web-based health approaches are well established across settings, populations and a range of mental health outcomes and offer benefits such as cost-effectiveness, high accessibility and flexibility, direct and convenient use of resources, anonymity, decreased stigmatization and a feasible way to ensure continuity of care in transitional phases. Our project aims to develop and evaluate a web-based translation of the existing START NOW skills training that promotes PF in institutionalized youth. The investigatorss will investigate the efficacy of web-based START NOW on PF in a randomized controlled trial comparing the following conditions: 1) Web-based group training guided by a trained START NOW facilitator (either face-to-face or through videoconferencing) 2) Web-based self-help without guidance 3) Treatment as usual (TAU) Inclusion Criteria: - Youth and young adults in Residential Youth Care (RYC) or Correctional Institutions (CI) - Age between 14-24 at time of screening - Need for improvement: Avoidance and Fusion Questionnaire for Youth (AFQ-Y) equal or higher than 34.05, or - Massachusetts Youth Screening Instrument-2 (MAYSI-2) subscale Angry-Irritable equal or higher than 5, or - MAYSI-2 subscale Depressed-Anxious equal or higher than 3. - Sufficient speaking, writing and reading skills in German or French - (Written) informed consent - No planned discharge before end of intervention phase; Exception: Self-Help condition Exclusion Criteria: - Suicidality: MAYSI-2 subscale Suicide Ideation equal or higher than 2 - Acute psychotic symptoms or mania: MAYSI-2 subscale Thought Disturbance equal or higher than 1 - Concurrent Cognitive Behavioral Therapy (CBT) based skills training similar to START NOW

NCT0531xxxx/NCT05313594.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313594</url> </required_header> <id_info> <org_study_id>NL79685.091.21</org_study_id> <nct_id>NCT05313594</nct_id> </id_info> <brief_title>Digital Twin - Modelling Postprandial Triglyceride and Glucose Responses</brief_title> <official_title>Digital Twin - Modelling Postprandial Triglyceride and Glucose Responses</official_title> <sponsors> <lead_sponsor> <agency>Wageningen University and Research</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Wageningen University and Research</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Giving personalised dietary advice will help mitigate the postprandial increases in TG and glucose levels, and will assist in the battle against the increase in nutrition-related diseases, such as cardiovascular diseases. Being able to predict postprandial responses, will be a first step to personalised dietary advice.  The primary objective of this study is to validate the prediction model on the effect of a standardized mixed meal challenge on postprandial TG levels in a heterogenous group of middle-aged, overweight to obese individuals. The secondary objectives are 1) to improve the accuracy of the predicted postprandial TG responses by increasing the number of postprandial TG measurements, 2) to determine which parameters can improve the accuracy of the predicted postprandial TG responses, 3) to determine if we can predict the effect of a standardized mixed meal challenge on postprandial glucose levels in a heterogenous group of middle-aged, overweight to obese individuals, and 4) to determine which parameters can improve the accuracy of the predicted postprandial glucose responses. Another objective is to validate dried blood spots postprandial triglyceride concentrations against venous blood concentrations.  There are minor risks for the research subjects of this study. Research subjects will invest approximately 13.5 hours in the study. They will visit the Wageningen University research facility three times and Hospital Gelderse Vallei once. </textblock> </brief_summary> <detailed_description> <textblock> Elevated triglyceride (TG) and glucose levels are major risk factors for cardiovascular diseases. Therefore, mitigating the postprandial increase in TG and glucose levels may help curb a person's risk of developing cardiovascular diseases. Current strategies to stimulate people to adopt a healthy lifestyle, however, are still insufficient. This is partly due to the fact that nutritional advice is nowadays still given at the population level via general nutrition guidelines, while nutritionist have long been aware that what works for one person may not work for another. Giving personalised dietary advice will help mitigate the postprandial increases in TG and glucose levels, and will assist in the battle against the increase in nutrition-related diseases, such as cardiovascular diseases. Being able to predict postprandial responses, will be a first step to personalised dietary advice.  The primary objective of this study is to validate the prediction model on the effect of a standardized mixed meal challenge on postprandial TG levels in a heterogenous group of middle-aged, overweight to obese individuals. The secondary objectives are 1) to improve the accuracy of the predicted postprandial TG responses by increasing the number of postprandial TG measurements, 2) to determine which parameters can improve the accuracy of the predicted postprandial TG responses, 3) to determine if we can predict the effect of a standardized mixed meal challenge on postprandial glucose levels in a heterogenous group of middle-aged, overweight to obese individuals, and 4) to determine which parameters can improve the accuracy of the predicted postprandial glucose responses. Another objective is to validate dried blood spots postprandial triglyceride concentrations against venous blood concentrations.  Digital twin is an observational study with three visits, including one mixed meal challenge test day.  Study population consists of 38 volunteers, 45-75 year old, BMI between 25-35 kg/m2.  The primary study parameter is the postprandial triglyceride responses in blood upon a mixed meal challenge. The secondary study parameters are: postprandial responses in the blood upon a mixed meal challenge, and extensive phenotyping of the subjects by collecting data on fasting blood profiles of micronutrients, metabolites, and proteins, continuous blood glucose levels (Freestyle Libre), body fat composition (DEXA), liver fat percentage (MRI), habitual dietary intake (FFQ), and physical activity (ActivPAL3).  This study is related to a broad general population. There are minor risks for the research subjects of this study. Consumption of the liquid mixed meal may cause some gastro-intestinal discomfort. Blood sampling will be performed via a cannula and the insertion can be a bit painful and may cause a bruise. The amount of blood that is drawn from subjects is within acceptable limits (total amount collected = 186mL). The radiation dose received during the DEXA scan for measuring body composition, is negligible compared to the average dose each person in the Netherlands receives per year. Research subjects will invest approximately 13.5 hours in the study. They will visit the Wageningen University research facility three times: once for a short screening, once to collect phenotyping data, and once for a mixed-meal challenge test day. In addition, they will visit Hospital Gelderse Vallei once for an MRI measurement. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">March 28, 2022</start_date> <completion_date type="Actual">June 29, 2022</completion_date> <primary_completion_date type="Actual">June 14, 2022</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Case-Only</observational_model> <time_perspective>Cross-Sectional</time_perspective> </study_design_info> <primary_outcome> <measure>Postprandial triglycerides blood levels</measure> <time_frame>Baseline</time_frame> <description>Postprandial triglyceride responses in blood upon a mixed meal challenge</description> </primary_outcome> <primary_outcome> <measure>Postprandial triglycerides blood levels</measure> <time_frame>15 minutes post-ingestion</time_frame> <description>Postprandial triglyceride responses in blood upon a mixed meal challenge</description> </primary_outcome> <primary_outcome> <measure>Postprandial triglycerides blood levels</measure> <time_frame>30 minutes post-ingestion</time_frame> <description>Postprandial triglyceride responses in blood upon a mixed meal challenge</description> </primary_outcome> <primary_outcome> <measure>Postprandial triglycerides blood levels</measure> <time_frame>45 minutes post-ingestion</time_frame> <description>Postprandial triglyceride responses in blood upon a mixed meal challenge</description> </primary_outcome> <primary_outcome> <measure>Postprandial triglycerides blood levels</measure> <time_frame>60 minutes post-ingestion</time_frame> <description>Postprandial triglyceride responses in blood upon a mixed meal challenge</description> </primary_outcome> <primary_outcome> <measure>Postprandial triglycerides blood levels</measure> <time_frame>90 minutes post-ingestion</time_frame> <description>Postprandial triglyceride responses in blood upon a mixed meal challenge</description> </primary_outcome> <primary_outcome> <measure>Postprandial triglycerides blood levels</measure> <time_frame>120 minutes post-ingestion</time_frame> <description>Postprandial triglyceride responses in blood upon a mixed meal challenge</description> </primary_outcome> <primary_outcome> <measure>Postprandial triglycerides blood levels</measure> <time_frame>150 minutes post-ingestion</time_frame> <description>Postprandial triglyceride responses in blood upon a mixed meal challenge</description> </primary_outcome> <primary_outcome> <measure>Postprandial triglycerides blood levels</measure> <time_frame>180 minutes post-ingestion</time_frame> <description>Postprandial triglyceride responses in blood upon a mixed meal challenge</description> </primary_outcome> <primary_outcome> <measure>Postprandial triglycerides blood levels</measure> <time_frame>210 minutes post-ingestion</time_frame> <description>Postprandial triglyceride responses in blood upon a mixed meal challenge</description> </primary_outcome> <primary_outcome> <measure>Postprandial triglycerides blood levels</measure> <time_frame>240 minutes post-ingestion</time_frame> <description>Postprandial triglyceride responses in blood upon a mixed meal challenge</description> </primary_outcome> <primary_outcome> <measure>Postprandial triglycerides blood levels</measure> <time_frame>270 minutes post-ingestion</time_frame> <description>Postprandial triglyceride responses in blood upon a mixed meal challenge</description> </primary_outcome> <primary_outcome> <measure>Postprandial triglycerides blood levels</measure> <time_frame>300 minutes post-ingestion</time_frame> <description>Postprandial triglyceride responses in blood upon a mixed meal challenge</description> </primary_outcome> <primary_outcome> <measure>Postprandial triglycerides blood levels</measure> <time_frame>330 minutes post-ingestion</time_frame> <description>Postprandial triglyceride responses in blood upon a mixed meal challenge</description> </primary_outcome> <primary_outcome> <measure>Postprandial triglycerides blood levels</measure> <time_frame>360 minutes post-ingestion</time_frame> <description>Postprandial triglyceride responses in blood upon a mixed meal challenge</description> </primary_outcome> <primary_outcome> <measure>Postprandial triglycerides blood levels</measure> <time_frame>390 minutes post-ingestion</time_frame> <description>Postprandial triglyceride responses in blood upon a mixed meal challenge</description> </primary_outcome> <primary_outcome> <measure>Postprandial triglycerides blood levels</measure> <time_frame>420 minutes post-ingestion</time_frame> <description>Postprandial triglyceride responses in blood upon a mixed meal challenge</description> </primary_outcome> <primary_outcome> <measure>Postprandial triglycerides blood levels</measure> <time_frame>450 minutes post-ingestion</time_frame> <description>Postprandial triglyceride responses in blood upon a mixed meal challenge</description> </primary_outcome> <primary_outcome> <measure>Postprandial triglycerides blood levels</measure> <time_frame>480 minutes post-ingestion</time_frame> <description>Postprandial triglyceride responses in blood upon a mixed meal challenge</description> </primary_outcome> <secondary_outcome> <measure>Postprandial glucose blood levels</measure> <time_frame>Baseline</time_frame> <description>Postprandial glucose responses in blood upon a mixed meal challenge</description> </secondary_outcome> <secondary_outcome> <measure>Postprandial glucose blood levels</measure> <time_frame>15 minutes post-ingestion</time_frame> <description>Postprandial glucose responses in blood upon a mixed meal challenge</description> </secondary_outcome> <secondary_outcome> <measure>Postprandial glucose blood levels</measure> <time_frame>30 minutes post-ingestion</time_frame> <description>Postprandial glucose responses in blood upon a mixed meal challenge</description> </secondary_outcome> <secondary_outcome> <measure>Postprandial glucose blood levels</measure> <time_frame>45 minutes post-ingestion</time_frame> <description>Postprandial glucose responses in blood upon a mixed meal challenge</description> </secondary_outcome> <secondary_outcome> <measure>Postprandial glucose blood levels</measure> <time_frame>60 minutes post-ingestion</time_frame> <description>Postprandial glucose responses in blood upon a mixed meal challenge</description> </secondary_outcome> <secondary_outcome> <measure>Postprandial glucose blood levels</measure> <time_frame>90 minutes post-ingestion</time_frame> <description>Postprandial glucose responses in blood upon a mixed meal challenge</description> </secondary_outcome> <secondary_outcome> <measure>Postprandial glucose blood levels</measure> <time_frame>120 minutes post-ingestion</time_frame> <description>Postprandial glucose responses in blood upon a mixed meal challenge</description> </secondary_outcome> <secondary_outcome> <measure>Postprandial glucose blood levels</measure> <time_frame>150 minutes post-ingestion</time_frame> <description>Postprandial glucose responses in blood upon a mixed meal challenge</description> </secondary_outcome> <secondary_outcome> <measure>Postprandial glucose blood levels</measure> <time_frame>180 minutes post-ingestion</time_frame> <description>Postprandial glucose responses in blood upon a mixed meal challenge</description> </secondary_outcome> <secondary_outcome> <measure>Postprandial glucose blood levels</measure> <time_frame>210 minutes post-ingestion</time_frame> <description>Postprandial glucose responses in blood upon a mixed meal challenge</description> </secondary_outcome> <secondary_outcome> <measure>Postprandial glucose blood levels</measure> <time_frame>240 minutes post-ingestion</time_frame> <description>Postprandial glucose responses in blood upon a mixed meal challenge</description> </secondary_outcome> <secondary_outcome> <measure>Postprandial glucose blood levels</measure> <time_frame>480 minutes post-ingestion</time_frame> <description>Postprandial glucose responses in blood upon a mixed meal challenge</description> </secondary_outcome> <secondary_outcome> <measure>Postprandial insulin blood levels</measure> <time_frame>Baseline</time_frame> <description>Postprandial insulin responses in blood upon a mixed meal challenge</description> </secondary_outcome> <secondary_outcome> <measure>Postprandial insulin blood levels</measure> <time_frame>15 minutes post-ingestion</time_frame> <description>Postprandial insulin responses in blood upon a mixed meal challenge</description> </secondary_outcome> <secondary_outcome> <measure>Postprandial insulin blood levels</measure> <time_frame>30 minutes post-ingestion</time_frame> <description>Postprandial insulin responses in blood upon a mixed meal challenge</description> </secondary_outcome> <secondary_outcome> <measure>Postprandial insulin blood levels</measure> <time_frame>60 minutes post-ingestion</time_frame> <description>Postprandial insulin responses in blood upon a mixed meal challenge</description> </secondary_outcome> <secondary_outcome> <measure>Postprandial insulin blood levels</measure> <time_frame>90 minutes post-ingestion</time_frame> <description>Postprandial insulin responses in blood upon a mixed meal challenge</description> </secondary_outcome> <secondary_outcome> <measure>Postprandial insulin blood levels</measure> <time_frame>120 minutes post-ingestion</time_frame> <description>Postprandial insulin responses in blood upon a mixed meal challenge</description> </secondary_outcome> <secondary_outcome> <measure>Postprandial insulin blood levels</measure> <time_frame>150 minutes post-ingestion</time_frame> <description>Postprandial insulin responses in blood upon a mixed meal challenge</description> </secondary_outcome> <secondary_outcome> <measure>Postprandial insulin blood levels</measure> <time_frame>180 minutes post-ingestion</time_frame> <description>Postprandial insulin responses in blood upon a mixed meal challenge</description> </secondary_outcome> <secondary_outcome> <measure>Postprandial insulin blood levels</measure> <time_frame>210 minutes post-ingestion</time_frame> <description>Postprandial insulin responses in blood upon a mixed meal challenge</description> </secondary_outcome> <secondary_outcome> <measure>Postprandial insulin blood levels</measure> <time_frame>240 minutes post-ingestion</time_frame> <description>Postprandial insulin responses in blood upon a mixed meal challenge</description> </secondary_outcome> <secondary_outcome> <measure>Postprandial insulin blood levels</measure> <time_frame>480 minutes post-ingestion</time_frame> <description>Postprandial insulin responses in blood upon a mixed meal challenge</description> </secondary_outcome> <other_outcome> <measure>Blood glucose profile</measure> <time_frame>Continuous for 5 days</time_frame> <description>Continuous blood glucose levels</description> </other_outcome> <other_outcome> <measure>Physical activity</measure> <time_frame>Continuous for 5 days</time_frame> <description>Continuous physical activity levels</description> </other_outcome> <other_outcome> <measure>Anthropometrics</measure> <time_frame>Baseline</time_frame> <description>Waist-to-hip ratio</description> </other_outcome> <other_outcome> <measure>Body composition</measure> <time_frame>Baseline</time_frame> <description>Body composition measurement with Dexa scan</description> </other_outcome> <other_outcome> <measure>Habitual dietary intake</measure> <time_frame>Baseline</time_frame> <description>Habitual dietary intake assessment with FFQ</description> </other_outcome> <other_outcome> <measure>Liver fat</measure> <time_frame>Baseline</time_frame> <description>Liver fat percentage assessment with MRI</description> </other_outcome> <other_outcome> <measure>Micronutrient levels in blood</measure> <time_frame>Baseline</time_frame> <description>Micronutrient levels</description> </other_outcome> <other_outcome> <measure>Metabolite levels in blood (full profile)</measure> <time_frame>Baseline</time_frame> <description>Metabolomics</description> </other_outcome> <other_outcome> <measure>Protein levels in blood (full profile)</measure> <time_frame>Baseline</time_frame> <description>Proteomics</description> </other_outcome> <other_outcome> <measure>Triglyceride blood levels</measure> <time_frame>Baseline</time_frame> <description>Triglyceride measurement in dried blood spots in fingerprick blood upon a mixed meal challenge</description> </other_outcome> <other_outcome> <measure>Triglyceride blood levels</measure> <time_frame>120 minutes post-ingestion</time_frame> <description>Triglyceride measurement in dried blood spots in fingerprick blood upon a mixed meal challenge</description> </other_outcome> <other_outcome> <measure>Triglyceride blood levels</measure> <time_frame>240 minutes post-ingestion</time_frame> <description>Triglyceride measurement in dried blood spots in fingerprick blood upon a mixed meal challenge</description> </other_outcome> <other_outcome> <measure>Triglyceride blood levels</measure> <time_frame>480 minutes post-ingestion</time_frame> <description>Triglyceride measurement in dried blood spots in fingerprick blood upon a mixed meal challenge</description> </other_outcome> <enrollment type="Actual">38</enrollment> <condition>Lipid Metabolism</condition> <condition>Glucose Metabolism</condition> <intervention> <intervention_type>Diagnostic Test</intervention_type> <intervention_name>Mixed meal challenge test</intervention_name> <description>Mixed meal consumption followed by postprandial blood sampling</description> </intervention> <intervention> <intervention_type>Diagnostic Test</intervention_type> <intervention_name>MRI</intervention_name> <description>MRI imaging</description> </intervention> <intervention> <intervention_type>Diagnostic Test</intervention_type> <intervention_name>DEXA</intervention_name> <description>DEXA scan</description> </intervention> <intervention> <intervention_type>Device</intervention_type> <intervention_name>Freestyle Libre</intervention_name> <description>Continuous blood glucose measurement</description> </intervention> <intervention> <intervention_type>Device</intervention_type> <intervention_name>ActivPAL3</intervention_name> <description>Continuous physical activity measurement</description> </intervention> <biospec_retention>Samples Without DNA</biospec_retention> <biospec_descr> <textblock> Blood plasma and serum </textblock> </biospec_descr> <eligibility> <study_pop> <textblock> The population of the study will consist of generally healthy males and females aged 45-75, with a BMI ranging from 25 to 35 kg/m2. For this study, we will include 38 research subjects (aiming at 50% females). </textblock> </study_pop> <sampling_method>Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Male or female  - Age 45-75 y  - BMI 25-35 kg/m2  - Suitable veins for insertion of cannula  Exclusion Criteria:  - Having a gastro-intestinal disease, such as celiac disease, Crohn's disease, or Ulcerative colitis  - Having a history of intestinal surgery that might interfere with study outcomes, as determined by the medical supervisor. This does not include an appendectomy or cholecystectomy  - Presence of significant systemic diseases, such as diabetes mellitus, cancer, cardiovascular disease or respiratory disease, as determined by the medical supervisor  - Use of medications known to interfere with glucose or lipid homeostasis (e.g. corticosteroids, cholesterol-lowering medication, insulin, metformin), as determined by medical supervisor  - Blood clotting disorders  - Unstable body weight (weight gain or loss >3 kg in the past three months)  - Reported slimming, medically prescribed or other extreme diets  - Alcohol consumption >21 glasses a week  - Anaemia (Hb values <7.5 mmol/L for women and <8.5 mmol/L for men; checked at screening)  - Pregnant, lactating or wishing to become pregnant in the period of the study (self-reported)  - Having a pacemaker, implantable cardioverter-defibrillator, hearing implant, internal insulin pump, neurostimulator, aneurysm clips placed before 1990, or metal splinter in the eye  - Having claustrophobia  - Not willing to give up blood donation during the study  - Food allergies or intolerances for products that we use in the study  - Unwilling to consume non-vegan test meal  - Recent use of antibiotics (<3 months prior to study start)  - Current smokers  - Abuse of soft and/or hard drugs  - Participation in another clinical trial at the same time  - Being an employee of the Food, Health & Consumer Research group of Wageningen Food & Biobased Research or Human Nutrition and Health Department of Wageningen University </textblock> </criteria> <gender>All</gender> <minimum_age>45 Years</minimum_age> <maximum_age>75 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Diederik J Esser, PhD</last_name> <role>Principal Investigator</role> <affiliation>Wageningen University & Research</affiliation> </overall_official> <location> <facility> <name>Stichting Wageningen Research</name> <address> <city>Wageningen</city> <state>Gelderland</state> <zip>6708 WG</zip> <country>Netherlands</country> </address> </facility> </location> <location_countries> <country>Netherlands</country> </location_countries> <verification_date>July 2022</verification_date> <study_first_submitted>March 15, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>July 4, 2022</last_update_submitted> <last_update_submitted_qc>July 4, 2022</last_update_submitted_qc> <last_update_posted type="Actual">July 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Wageningen University and Research</investigator_affiliation> <investigator_full_name>Diederik Esser</investigator_full_name> <investigator_title>Clinical Trial Coordinator</investigator_title> </responsible_party> <keyword>postprandial</keyword> <keyword>lipids</keyword> <keyword>glucose</keyword> <keyword>dried blood spot</keyword> <keyword>prediction model</keyword> <keyword>metabolic responses</keyword> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Giving personalised dietary advice will help mitigate the postprandial increases in TG and glucose levels, and will assist in the battle against the increase in nutrition-related diseases, such as cardiovascular diseases. Being able to predict postprandial responses, will be a first step to personalised dietary advice. The primary objective of this study is to validate the prediction model on the effect of a standardized mixed meal challenge on postprandial TG levels in a heterogenous group of middle-aged, overweight to obese individuals. The secondary objectives are 1) to improve the accuracy of the predicted postprandial TG responses by increasing the number of postprandial TG measurements, 2) to determine which parameters can improve the accuracy of the predicted postprandial TG responses, 3) to determine if we can predict the effect of a standardized mixed meal challenge on postprandial glucose levels in a heterogenous group of middle-aged, overweight to obese individuals, and 4) to determine which parameters can improve the accuracy of the predicted postprandial glucose responses. Another objective is to validate dried blood spots postprandial triglyceride concentrations against venous blood concentrations. There are minor risks for the research subjects of this study. Research subjects will invest approximately 13.5 hours in the study. They will visit the Wageningen University research facility three times and Hospital Gelderse Vallei once. Elevated triglyceride (TG) and glucose levels are major risk factors for cardiovascular diseases. Therefore, mitigating the postprandial increase in TG and glucose levels may help curb a person's risk of developing cardiovascular diseases. Current strategies to stimulate people to adopt a healthy lifestyle, however, are still insufficient. This is partly due to the fact that nutritional advice is nowadays still given at the population level via general nutrition guidelines, while nutritionist have long been aware that what works for one person may not work for another. Giving personalised dietary advice will help mitigate the postprandial increases in TG and glucose levels, and will assist in the battle against the increase in nutrition-related diseases, such as cardiovascular diseases. Being able to predict postprandial responses, will be a first step to personalised dietary advice. The primary objective of this study is to validate the prediction model on the effect of a standardized mixed meal challenge on postprandial TG levels in a heterogenous group of middle-aged, overweight to obese individuals. The secondary objectives are 1) to improve the accuracy of the predicted postprandial TG responses by increasing the number of postprandial TG measurements, 2) to determine which parameters can improve the accuracy of the predicted postprandial TG responses, 3) to determine if we can predict the effect of a standardized mixed meal challenge on postprandial glucose levels in a heterogenous group of middle-aged, overweight to obese individuals, and 4) to determine which parameters can improve the accuracy of the predicted postprandial glucose responses. Another objective is to validate dried blood spots postprandial triglyceride concentrations against venous blood concentrations. Digital twin is an observational study with three visits, including one mixed meal challenge test day. Study population consists of 38 volunteers, 45-75 year old, BMI between 25-35 kg/m2. The primary study parameter is the postprandial triglyceride responses in blood upon a mixed meal challenge. The secondary study parameters are: postprandial responses in the blood upon a mixed meal challenge, and extensive phenotyping of the subjects by collecting data on fasting blood profiles of micronutrients, metabolites, and proteins, continuous blood glucose levels (Freestyle Libre), body fat composition (DEXA), liver fat percentage (MRI), habitual dietary intake (FFQ), and physical activity (ActivPAL3). This study is related to a broad general population. There are minor risks for the research subjects of this study. Consumption of the liquid mixed meal may cause some gastro-intestinal discomfort. Blood sampling will be performed via a cannula and the insertion can be a bit painful and may cause a bruise. The amount of blood that is drawn from subjects is within acceptable limits (total amount collected = 186mL). The radiation dose received during the DEXA scan for measuring body composition, is negligible compared to the average dose each person in the Netherlands receives per year. Research subjects will invest approximately 13.5 hours in the study. They will visit the Wageningen University research facility three times: once for a short screening, once to collect phenotyping data, and once for a mixed-meal challenge test day. In addition, they will visit Hospital Gelderse Vallei once for an MRI measurement. Blood plasma and serum The population of the study will consist of generally healthy males and females aged 45-75, with a BMI ranging from 25 to 35 kg/m2. For this study, we will include 38 research subjects (aiming at 50% females). Inclusion Criteria: - Male or female - Age 45-75 y - BMI 25-35 kg/m2 - Suitable veins for insertion of cannula Exclusion Criteria: - Having a gastro-intestinal disease, such as celiac disease, Crohn's disease, or Ulcerative colitis - Having a history of intestinal surgery that might interfere with study outcomes, as determined by the medical supervisor. This does not include an appendectomy or cholecystectomy - Presence of significant systemic diseases, such as diabetes mellitus, cancer, cardiovascular disease or respiratory disease, as determined by the medical supervisor - Use of medications known to interfere with glucose or lipid homeostasis (e.g. corticosteroids, cholesterol-lowering medication, insulin, metformin), as determined by medical supervisor - Blood clotting disorders - Unstable body weight (weight gain or loss >3 kg in the past three months) - Reported slimming, medically prescribed or other extreme diets - Alcohol consumption >21 glasses a week - Anaemia (Hb values <7.5 mmol/L for women and <8.5 mmol/L for men; checked at screening) - Pregnant, lactating or wishing to become pregnant in the period of the study (self-reported) - Having a pacemaker, implantable cardioverter-defibrillator, hearing implant, internal insulin pump, neurostimulator, aneurysm clips placed before 1990, or metal splinter in the eye - Having claustrophobia - Not willing to give up blood donation during the study - Food allergies or intolerances for products that we use in the study - Unwilling to consume non-vegan test meal - Recent use of antibiotics (<3 months prior to study start) - Current smokers - Abuse of soft and/or hard drugs - Participation in another clinical trial at the same time - Being an employee of the Food, Health & Consumer Research group of Wageningen Food & Biobased Research or Human Nutrition and Health Department of Wageningen University

NCT0531xxxx/NCT05313607.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313607</url> </required_header> <id_info> <org_study_id>cerebral palsy</org_study_id> <nct_id>NCT05313607</nct_id> </id_info> <brief_title>Effect of Plyometric Exercises on Upper Extremity Function in Children With Unilateral Cerebral Palsy</brief_title> <official_title>Effect of Plyometric Exercises on Upper Extremity Function in Children With Unilateral Cerebral Palsy</official_title> <sponsors> <lead_sponsor> <agency>Cairo University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Cairo University</source> <oversight_info> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Plyometric training includes muscle contraction that moves rapidly from the eccentric to the concentric phase of movement while using proper biomechanics. It is an effective neuromuscular stimulus that can improve motor functions of children with CP. In plyometric training, muscles exert maximum force in short intervals of time, with the goal of increasing power. </textblock> </brief_summary> <detailed_description> <textblock> This is a prospective double-masked randomized controlled trial. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">November 30, 2021</start_date> <completion_date type="Actual">June 30, 2023</completion_date> <primary_completion_date type="Actual">December 30, 2022</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Other</primary_purpose> <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Upper extremity function</measure> <time_frame>after 3 successive months</time_frame> <description>The quality of upper extremity skill test is used to measure the motor function with maximum score 100% with higher score reflects better performance.</description> </primary_outcome> <primary_outcome> <measure>Hand grip strength</measure> <time_frame>after 3 successive months</time_frame> <description>The hand held dynamometer was used to assess grip strength and recorded in kilogram.</description> </primary_outcome> <secondary_outcome> <measure>Selective motor control</measure> <time_frame>after 3 successive months</time_frame> <description>Test of arm selective control was used to measure selectivity of upper extremitywith total score for each upper extremity is 16.</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">40</enrollment> <condition>Sports Physical Therapy</condition> <arm_group> <arm_group_label>conventional group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>received conventional physical therapy program</description> </arm_group> <arm_group> <arm_group_label>plyometric group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>received a plyometric physical therapy program</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Designed physical therapy</intervention_name> <description>Attention is given to improve motor function, conducted for 30 minutes</description> <arm_group_label>conventional group</arm_group_label> <arm_group_label>plyometric group</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Occupational therapy</intervention_name> <description>included exercises facilitating hand skills, conducted for 30 minutes</description> <arm_group_label>conventional group</arm_group_label> <arm_group_label>plyometric group</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Conventional Therapy</intervention_name> <description>aimed to improve the affected upper extremity function, conducted for 30 minutes</description> <arm_group_label>conventional group</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Plyometric training</intervention_name> <description>basically focuses on upper extremity strength training conducted for 30 minutes</description> <arm_group_label>plyometric group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - spastic hemiplegia  Exclusion Criteria:  - fixed deformities </textblock> </criteria> <gender>All</gender> <minimum_age>8 Years</minimum_age> <maximum_age>12 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>walaa A El-nabie, Phd</last_name> <role>Study Chair</role> <affiliation>Cairo university, faculty of physical therapy</affiliation> </overall_official> <overall_official> <last_name>Hazem A Ali, Phd</last_name> <role>Study Director</role> <affiliation>Cairo university, faculty of physical therapy</affiliation> </overall_official> <location> <facility> <name>Amira Mahmoud Abd-elmonem</name> <address> <city>Giza</city> <zip>12662</zip> <country>Egypt</country> </address> </facility> </location> <location_countries> <country>Egypt</country> </location_countries> <verification_date>September 2023</verification_date> <study_first_submitted>March 7, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>September 14, 2023</last_update_submitted> <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc> <last_update_posted type="Actual">September 15, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Cairo University</investigator_affiliation> <investigator_full_name>Amira Mahmoud Abd-elmonem</investigator_full_name> <investigator_title>Amira Abd-elmonem, assist Prof. Physiacl therapy for pediatric department, faculty of physical therapy , Cairo university</investigator_title> </responsible_party> <keyword>plyometric exercises</keyword> <keyword>Unilateral Cerebral Palsy</keyword> <keyword>cerebral pslay</keyword> <keyword>hand grip strength</keyword> <keyword>upper extremity function</keyword> <keyword>selective motor control</keyword> <condition_browse>  <mesh_term>Cerebral Palsy</mesh_term> </condition_browse>  </clinical_study>

Plyometric training includes muscle contraction that moves rapidly from the eccentric to the concentric phase of movement while using proper biomechanics. It is an effective neuromuscular stimulus that can improve motor functions of children with CP. In plyometric training, muscles exert maximum force in short intervals of time, with the goal of increasing power. This is a prospective double-masked randomized controlled trial. Inclusion Criteria: - spastic hemiplegia Exclusion Criteria: - fixed deformities

NCT0531xxxx/NCT05313620.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313620</url> </required_header> <id_info> <org_study_id>GIS-2021-JAKihemo</org_study_id> <nct_id>NCT05313620</nct_id> </id_info> <brief_title>Effect of Tofacitinib on Coagulation and Platelet Function, and Its Role in Thromboembolic Events</brief_title> <official_title>Effect of Tofacitinib on Coagulation and Platelet Function, and Its Role in Thromboembolic Events</official_title> <sponsors> <lead_sponsor> <agency>Fundación de Investigación Biomédica - Hospital Universitario de La Princesa</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Fundación de Investigación Biomédica - Hospital Universitario de La Princesa</source> <oversight_info> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Post-authorization, prospective and unicenter clinical trial, in which patients with UC will be included. The treatment with anti-TNFα (infliximab, adalimumab or golimumab) or JAK-inhibitors (tofacitinib) will be initiated by clinical practice and the choice will be made at the discretion of the investigator at the center where the patients will be recruited (Hospital Universitario de La Princesa). In the case of the group of patients treated with tofacitinib, the selection will be made following the action protocol implemented in our center, in which this drug is usually reserved for those cases refractory to anti-TNFα and/or vedolizumab. There will be no random assignment of treatment. The drugs will be used in the approved indications and conditions of use. </textblock> </brief_summary> <detailed_description> <textblock> BACKGROUND  Ulcerative colitis (UC) is a chronic pathology that causes inflammation of the colonic mucosa (1, 2). The most common symptoms include bloody diarrhea, abdominal pain, and urgent bowel movements, which has a great impact on the quality of life (3). The chronic course of this disease is characterized by alternating periods of relapse and remission (4). The prevalence of UC is relatively high, with a rate of 505 cases per 100,000 population in Europe and 249 cases per 100,000 population in North America (5). In terms of incidence, it is increasing rapidly due to industrialization and westernization of lifestyles (6). The EpiCOM study recorded an overall incidence of 8.2 cases/100,000 person-years of UC (7). In Spain, a recent multicenter study coordinated from our center, which includes 17 Autonomous Communities of the country, confirmed that the current incidence of UC is higher than previously described, with rates of 8 new cases per 100,000 person-years, approximately (8,9). The complexity, the social burden and the costs of treatment make this disease very relevant for health systems. Specifically, in Europe, the annual direct cost is estimated at 9,000 euros per patient (regardless of severity) and 10,000 euros for those cases with moderate to severe UC. The total economic burden of UC has been estimated at 8-15 billion dollars in the US and 12-29 billion euros in Europe (10). All of this underscores the strategic importance of UC to society, including patients and health systems.  The goal of drug treatment is to control inflammation to prevent the development of progressive intestinal damage and the onset of complications, so patients can achieve an optimal quality of life. Biological drugs are effective in maintaining clinical remission (11-13). However, approximately half of the patients treated do not reach remission with biological treatment (14-16). The reason for this reduced effectiveness is because therapies are administered based on empirical approaches due to the lack of prognostic biomarkers, adapting them according to the clinical evolution and complications of each case (17).  A novel treatment for these refractory cases is tofacitinib (Xeljanz®), a synthetic small molecule inhibitor of JAK kinases, which has been shown to be effective in treating UC (18). Tofacitinib has been recently approved by the European Medicines Agency (EMA) and the Food and Drug Administration (FDA). It is indicated for the treatment of rheumatoid arthritis and active psoriatic arthritis, as well as in the treatment of adult patients with moderate to severe UC who have had an insufficient response, a loss of response or have been intolerant to conventional treatment or biological therapy. The recommended dose for UC is 10 mg twice daily for induction for 8 weeks, followed by 5 mg twice daily for maintenance (19). A relevant aspect to consider of this drug is its oral administration, unlike biological therapies, which are prescribed intravenously or subcutaneously.  Despite these advantages, it has been observed that some patients treated with tofacitinib have a higher incidence of severe thromboembolic events, including dose dependent pulmonary embolism and deep vein thrombosis. Recent data from a randomized, post-authorization safety trial (A3921133) in patients with rheumatoid arthritis over 50 years of age and at least one cardiovascular risk factor, treated with tofacitinib 10 mg twice daily, have shown an increased risk of pulmonary embolism and overall mortality. The increased risk of pulmonary embolism was 5 times higher compared to patients treated with anti-TNFα. The incidence rates of pulmonary embolism for tofacitinib 10 mg twice daily, tofacitinib 5 mg twice daily, and anti- TNFα were 0.54 (95% CI, 0.32-0.87), 0.27 (0.12-0.52), and 0.09 (0.02-0.26) per 100 patient-years treated, respectively. Furthermore, mortality due to any cause in the tofacitinib 10 mg every 12-hour group was 2 times higher than the mortality of the groups treated with tofacitinib 5 mg twice daily and anti-TNFα. The incidence rates of deep vein thrombosis for tofacitinib 10 mg twice daily, tofacitinib 5 mg twice daily, and anti-TNFα were 0.38 (0.20-0.67), 0.30 (0.14-0.55), and 0.18 (0.07-0.39) per 100 patient-years, respectively (20). These results support the current recommendation for cautious use of tofacitinib in patients with high thromboembolic risk.  As a result of the serious consequences associated with pulmonary embolism and the uncertainty about the underlying mechanism, the "Advisory Committee for Risk Assessment in Pharmacovigilance" decided to evaluate the impact of these findings on the benefit-risk balance of tofacitinib in all authorized indications, as well as the dose of administration. Both FDA and EMA have recently issued new warnings recommending "against" prescribing tofacitinib 10 mg twice daily for maintenance treatment in patients with UC who have one or more of the following known risk factors for venous thromboembolism (advanced age, obesity, diabetes, hypertension smoking, medical history of deep vein thrombosis and pulmonary embolism, immobilization of myocardial infarction in the previous three months, heart failure, use of combined hormonal contraceptives or hormone replacement therapy, inherited clotting disorders, neoplasia), unless appropriate alternative treatment is not available (21,22). In addition, the recommendations established by AEMPS to health professionals include monitoring all patients undergoing treatment with tofacitinib for signs and symptoms suggestive of pulmonary embolism, instructing them to request medical assistance immediately if they experience such symptoms (23).  Regarding thromboembolic risk specifically in UC patients treated with tofacitinib, the results of a recent post-hoc analysis showed that during tofacitinib treatment one patient had venous thromboembolism [incidence rate, patients with events/100 patient-years: 0.04; (0.00-0.23)] and four had pulmonary embolism [0.16 (0.04- 0.41)] at a dose of 10 mg predominantly, with risk factors for venous thromboembolism (24). Although data concerning UC patients are still limited, the results of the above-mentioned clinical trial in rheumatoid arthritis are relevant for any therapeutic indication.  Other drugs that inhibit the JAK-STAT pathway, such as baricitinib, ruxolitinib, and upadacitinib, have also been associated with an increased incidence of venous thromboembolism. However, the mechanism leading to these events is not known (25). Therefore, a possible class effect of JAK inhibitors in the development of these events cannot be ruled out. Moreover, other JAK inhibitors (pefacitinib, filgotinib and pacritinib) are currently being studied in phase 3 clinical trials in rheumatoid arthritis, atopic dermatitis, Crohn's disease and myelofibrosis (26-28). Because safety data on these new drugs are very limited, both regulatory agencies and clinical researchers have shown great concern about their thromboembolic risk. Therefore, it is clear that new studies are required to evaluate the safety of these new drugs.  This is an utmost need is order to offer these drugs to patients under the safest circumstances.  In summary, the pathophysiological mechanism that leads to an increased thromboembolic event in patients treated with tofacitinib or other JAK inhibitors is not currently known. Therefore, despite being effective and rapid drugs, their use has been restricted, since it is not known what would be the effective preventive antiplatelet or anticoagulation treatment, for example, to avoid thromboembolic events in these patients. This not only affects tofacitinib but may also involve the other JAK inhibitor drugs that will be approved for inflammatory bowel disease (or for other diseases) in the future. In this line, our project has an ambitious objective: to characterize in-depth this adverse event by studying the alterations in haemostasis. To that aim, the effect of tofacitinib on the general haemostatic profile (i.e., coagulation, platelet aggregation and activation) will be studied in vivo in patients with UC in the short and long term (baseline, 3 and 12 month follow-up).  Finally, it is highly probable that from the results obtained in the present project significant advances will be achieved in the knowledge of the molecular mechanisms involved in the appearance of venous thromboembolism caused by exposure to tofacitinib. Therefore, this will allow, in clinical practice, to adopt effective pharmacological measures and facilitate prevention strategies to reduce the onset of these complications. Furthermore, it is expected that the results obtained can be extrapolated to other JAK inhibitor drugs of the same family, due to the possible class effect. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">April 1, 2022</start_date> <completion_date type="Anticipated">October 2024</completion_date> <primary_completion_date type="Anticipated">October 2023</primary_completion_date> <phase>Phase 4</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Non-Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>platelet activation</measure> <time_frame>1 year</time_frame> <description>Platelet activation status will be assessed ex vivo in platelet-rich plasma (PRP) samples from UC patients (active and quiescent) and healthy controls incubated in the absence or presence of drug (tofacitinib or anti-TNFα). Regarding the in vivo study, platelet activation will be analyzed in samples from patients with active UC before and after initiating treatment with tofacitinib or anti-TNFα. It will be mesured by rate of platelet agregation</description> </primary_outcome> <secondary_outcome> <measure>Endoscopic activity</measure> <time_frame>1 year</time_frame> <description>It will be evaluated by the Mayo endoscopic sub-score; endoscopic activity will be considered as ≥ 2.</description> </secondary_outcome> <secondary_outcome> <measure>Endoscopic response</measure> <time_frame>1 year</time_frame> <description>It will be defined as a decrease of ≥ 1 point in the Mayo endoscopic sub-score 3 months after starting treatment.</description> </secondary_outcome> <secondary_outcome> <measure>Endoscopic remission</measure> <time_frame>1 year</time_frame> <description>It will be defined as an endoscopic subscore ≤1, 3 months after starting treatment.</description> </secondary_outcome> <number_of_arms>3</number_of_arms> <enrollment type="Anticipated">30</enrollment> <condition>Ulcerative Colitis</condition> <condition>Thromboembolism</condition> <arm_group> <arm_group_label>Ulcerative colitis patients treated with tofacitinib</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Tofacitinib 5 mg/day oral per clinical practice</description> </arm_group> <arm_group> <arm_group_label>Ulcerative colitis patients treated with an anti-TNFα drug</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Infliximab (Infusion 5mg/kg milligram(s)/Kilogram-Intravenous use) per clinical practice, or adalimumab (Subcutaneus 40 mg milligram(s)-subcutaneus) per clinical practice, or golimumab (subcutaneus 50 mg milligram(s)-subcutaneus) per clinical practice</description> </arm_group> <arm_group> <arm_group_label>healthy controls</arm_group_label> <arm_group_type>No Intervention</arm_group_type> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Tofacitinib</intervention_name> <description>Tofacitinib 5 MG/day per clinical practice</description> <arm_group_label>Ulcerative colitis patients treated with tofacitinib</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Infliximab Adalimumab y Golimumab</intervention_name> <description>Infliximab (Infusion 5mg/kg milligram(s)/Kilogram-Intravenous use) per clinical practice or adalimumab (Subcutaneus 40 mg milligram(s)-subcutaneus) per clinical practice or or golimumab (subcutaneus 50 mg milligram(s)-subcutaneus) per clinical practice.</description> <arm_group_label>Ulcerative colitis patients treated with an anti-TNFα drug</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  EX VIVO STUDY IN PATIENTS WITH UC  PATIENTS WITH UC:  - Over 18 years old.  - Diagnosis of UC according to the criteria of the European Crohn's and Colitis Organisation (ECCO).  - Previous treatments are allowed, provided they have remained stable for the past 3 months.  - In the case of patients with active UC, they should have endoscopic activity within 1 month of starting the treatment (Mayo endoscopic sub-index of ≥ 2).  - Women of childbearing age using contraceptive methods with an error rate <1% per year. Examples of contraceptive methods whose error rate is <1% per year are:  1. Intrauterine device (IUD).  2. Bilateral tubal occlusion.  3. Couple with vasectomy.  4. Sexual abstinence.  INDIVIDUALS WITHOUT UC:  - Over 18 years old.  - Subjects not diagnosed with UC, or other inflammatory allergic, malignant or autoimmune diseases.  - Women of childbearing age using contraceptive methods with an error rate <1% per year. Examples of contraceptive methods whose error rate is <1% per year are:  1. Intrauterine device (IUD).  2. Bilateral tubal occlusion.  3. Couple with vasectomy.  4. Sexual abstinence.  IN VIVO STUDY IN PATIENTS WITH UC  PATIENTS WITH UC:  - Over 18 years old.  - Diagnosis of UC according to the criteria of the European Crohn's and Colitis Organisation (ECCO).  - Have indication of treatment with anti-TNFα (infliximab, adalimumab or golimumab) o tofacitinib.  - Be the first received JAK-inhibitor or anti-TNFα with a given mechanism of action.  - Have endoscopic activity of UC within 1 month of starting the treatment (Mayo endoscopic sub-index of ≥ 2).  - Previous treatments (including corticosteroids and immunosuppressants) are allowed provided that they have been stable for the last 3 months before beginning treatment with JAK-inhibitor or anti-TNFα and that they are maintained at a stable dose for the duration of the study  - Women of childbearing age using contraceptive methods with an error rate <1% per year. Examples of contraceptive methods whose error rate is <1% per year are:  1. Intrauterine device (IUD).  2. Bilateral tubal occlusion.  3. Couple with vasectomy.  4. Sexual abstinence.  INDIVIDUALS WITHOUT UC:  - Over 18 years old.  - Subjects not diagnosed with UC, or other inflammatory, allergic, malignant or autoimmune diseases.  - Women of childbearing age using contraceptive methods with an error rate <1% per year. Examples of contraceptive methods whose error rate is <1% per year are:  1. Intrauterine device (IUD).  2. Bilateral tubal occlusion.  3. Couple with vasectomy.  4. Sexual abstinence.  Exclusion Criteria:  EX VIVO STUDY IN PATIENTS WITH UC  PATIENTS WITH UC:  - Under 18 years old.  - Immune-mediated disease, neoplasm or active infection.  - Pregnancy or lactation.  - Alcohol or drug abuse.  - Ostomy.  - Abdominal surgery in the last 6 months.  - Colectomy.  - Active infection with hepatitis B, C or HIV virus.  - Medical history of thromboembolic events.  - Treatment with anticoagulants, antiplatelets or other drugs that alter the coagulation.  - Use of combined hormonal contraceptives or hormone replacement therapy.  - Hereditary coagulation disorders.  - Refusal to give consent for participation in the study.  INDIVIDUALS WITHOUT UC:  - Under 18 years of age.  - Advanced chronic disease or any other pathology that prevents the monitoring of the protocol of this study.  - Pregnancy or lactation.  - Alcohol or drug abuse.  - Ostomy.  - Abdominal surgery in the last 6 months.  - Colectomy.  - Active infection with hepatitis B, C or HIV virus.  - Medical history of thromboembolic events.  - Treatment with anticoagulants, antiplatelets or other drugs that alter the coagulation.  - Use of combined hormonal contraceptives or hormone replacement therapy.  - Hereditary coagulation disorders.  - Refusal to give consent for participation in the study.  IN VIVO STUDY IN PATIENTS WITH UC  PATIENTS WITH UC:  - Under 18 years old.  - Immune-mediated disease.  - Neoplasm or active infection.  - Pregnancy or lactation.  - Alcohol or drug abuse.  - Ostomy.  - Colectomy.  - Active infection with hepatitis B, C or HIV virus.  - Indication of anti-TNFα or JAK-inhibitors treatment for a cause other than UC.  - Have previously received a drug with the same mechanism of action (anti-TNFα or JAK-inhibitors)  - Medical history of thromboembolic events.  - Treatment with anticoagulants, antiplatelets or other drugs that alter the coagulation.  - Use of combined hormonal contraceptives or hormone replacement therapy.  - Hereditary coagulation disorders.  - Refusal to give consent for participation in the study.  INDIVIDUALS WITHOUT UC:  - Under 18 years of age.  - Advanced chronic disease or any other pathology that prevents the monitoring of the protocol of this study.  - Pregnancy or lactation.  - Alcohol or drug abuse.  - Active infection with hepatitis B, C or HIV virus.  - Finding of macroscopic alterations during the colonoscopy or finding of relevant inflammatory alterations in the biopsies obtained during the colonoscopy.  - Treatment with immunomodulators, immunosuppressants, corticosteroids or other drugs that alter the immune system.  - Medical history of thromboembolic events.  - Treatment with anticoagulants, antiplatelets or other drugs that alter the coagulation.  - Use of combined hormonal contraceptives or hormone replacement therapy.  - Hereditary coagulation disorders.  - Refusal to give consent for participation in the study.  - Abdominal surgery in the last 6 months. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_contact> <last_name>Sandra Hermida</last_name> <phone>913093911</phone> <email>sandra.hermida.hlp@gmail.com</email> </overall_contact> <location> <facility> <name>Hospital Universitario de La Princesa</name> <address> <city>Madrid</city> <zip>28006</zip> <country>Spain</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Javier P. 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Effects of preoperative aspirin on perioperative platelet activation and dysfunction in patients undergoing off-pump coronary artery bypass graft surgery: A prospective randomized study. PLoS One. 2017 Jul 17;12(7):e0180466. doi: 10.1371/journal.pone.0180466. eCollection 2017.</citation> <PMID>28715503</PMID> </reference> <reference> <citation>Vrigkou E, Tsangaris I, Bonovas S, Kopterides P, Kyriakou E, Konstantonis D, Pappas A, Anthi A, Gialeraki A, Orfanos SE, Armaganidis A, Tsantes A. Platelet and coagulation disorders in newly diagnosed patients with pulmonary arterial hypertension. Platelets. 2019;30(5):646-651. doi: 10.1080/09537104.2018.1499890. Epub 2018 Jul 26.</citation> <PMID>30047809</PMID> </reference> <reference> <citation>Peyrin-Biroulet L, Sandborn W, Sands BE, Reinisch W, Bemelman W, Bryant RV, D'Haens G, Dotan I, Dubinsky M, Feagan B, Fiorino G, Gearry R, Krishnareddy S, Lakatos PL, Loftus EV Jr, Marteau P, Munkholm P, Murdoch TB, Ordas I, Panaccione R, Riddell RH, Ruel J, Rubin DT, Samaan M, Siegel CA, Silverberg MS, Stoker J, Schreiber S, Travis S, Van Assche G, Danese S, Panes J, Bouguen G, O'Donnell S, Pariente B, Winer S, Hanauer S, Colombel JF. Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE): Determining Therapeutic Goals for Treat-to-Target. Am J Gastroenterol. 2015 Sep;110(9):1324-38. doi: 10.1038/ajg.2015.233. Epub 2015 Aug 25.</citation> <PMID>26303131</PMID> </reference> <reference> <citation>Kamm MA, Sandborn WJ, Gassull M, Schreiber S, Jackowski L, Butler T, Lyne A, Stephenson D, Palmen M, Joseph RE. Once-daily, high-concentration MMX mesalamine in active ulcerative colitis. Gastroenterology. 2007 Jan;132(1):66-75; quiz 432-3. doi: 10.1053/j.gastro.2006.10.011. Epub 2006 Oct 12.</citation> <PMID>17241860</PMID> </reference> <reference> <citation>Van Assche G, Sandborn WJ, Feagan BG, Salzberg BA, Silvers D, Monroe PS, Pandak WM, Anderson FH, Valentine JF, Wild GE, Geenen DJ, Sprague R, Targan SR, Rutgeerts P, Vexler V, Young D, Shames RS. Daclizumab, a humanised monoclonal antibody to the interleukin 2 receptor (CD25), for the treatment of moderately to severely active ulcerative colitis: a randomised, double blind, placebo controlled, dose ranging trial. Gut. 2006 Nov;55(11):1568-74. doi: 10.1136/gut.2005.089854. Epub 2006 Apr 7.</citation> <PMID>16603634</PMID> </reference> <reference> <citation>D'Haens G, Feagan B, Colombel JF, Sandborn WJ, Reinisch W, Rutgeerts P, Carbonnel F, Mary JY, Danese S, Fedorak RN, Hanauer S, Lemann M; International Organization for Inflammatory Bowel Diseases (IOIBD) and the Clinical Trial Committee Clincom of the European Crohn's and Colitis Organisation (ECCO). Challenges to the design, execution, and analysis of randomized controlled trials for inflammatory bowel disease. Gastroenterology. 2012 Dec;143(6):1461-9. doi: 10.1053/j.gastro.2012.09.031. Epub 2012 Sep 20.</citation> <PMID>23000597</PMID> </reference> <reference> <citation>Nunes T, Barreiro-de Acosta M, Nos P, Marin-Jimenez I, Bermejo F, Ceballos D, Iglesias E, Gomez-Senent S, Torres Y, Ponferrada A, Arevalo JA, Hernandez V, Calvet X, Ginard D, Monfort D, Chaparro M, Mancenido N, Dominguez-Antonaya M, Villalon C, Perez-Calle JL, Munoz C, Nunez H, Carpio D, Aramendiz R, Bujanda L, Estrada-Oncins S, Hermida C, Barrio J, Casis MB, Duenas-Sadornil MC, Fernandez L, Calvo-Cenizo MM, Botella B, de Francisco R, Ayala E, Sans M; RECLICU Study Group of GETECCU. Usefulness of oral beclometasone dipropionate in the treatment of active ulcerative colitis in clinical practice: the RECLICU Study. J Crohns Colitis. 2010 Dec;4(6):629-36. doi: 10.1016/j.crohns.2010.07.003.</citation> <PMID>21122572</PMID> </reference> <verification_date>August 2022</verification_date> <study_first_submitted>September 2, 2021</study_first_submitted> <study_first_submitted_qc>April 5, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>August 2, 2022</last_update_submitted> <last_update_submitted_qc>August 2, 2022</last_update_submitted_qc> <last_update_posted type="Actual">August 3, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>ulcerative colitis</keyword> <keyword>Tromboembolism</keyword> <keyword>Coagulation</keyword> <keyword>Platelet Function</keyword> <keyword>Tofacitinib</keyword> <keyword>JAK inhibitors</keyword> <keyword>anti-TNF</keyword> <keyword>Infliximab</keyword> <keyword>Adalimumab</keyword> <keyword>Golimumab</keyword> <condition_browse>  <mesh_term>Colitis</mesh_term> <mesh_term>Colitis, Ulcerative</mesh_term> <mesh_term>Thromboembolism</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Adalimumab</mesh_term> <mesh_term>Infliximab</mesh_term> <mesh_term>Golimumab</mesh_term> <mesh_term>Tofacitinib</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Post-authorization, prospective and unicenter clinical trial, in which patients with UC will be included. The treatment with anti-TNFα (infliximab, adalimumab or golimumab) or JAK-inhibitors (tofacitinib) will be initiated by clinical practice and the choice will be made at the discretion of the investigator at the center where the patients will be recruited (Hospital Universitario de La Princesa). In the case of the group of patients treated with tofacitinib, the selection will be made following the action protocol implemented in our center, in which this drug is usually reserved for those cases refractory to anti-TNFα and/or vedolizumab. There will be no random assignment of treatment. The drugs will be used in the approved indications and conditions of use. BACKGROUND Ulcerative colitis (UC) is a chronic pathology that causes inflammation of the colonic mucosa (1, 2). The most common symptoms include bloody diarrhea, abdominal pain, and urgent bowel movements, which has a great impact on the quality of life (3). The chronic course of this disease is characterized by alternating periods of relapse and remission (4). The prevalence of UC is relatively high, with a rate of 505 cases per 100,000 population in Europe and 249 cases per 100,000 population in North America (5). In terms of incidence, it is increasing rapidly due to industrialization and westernization of lifestyles (6). The EpiCOM study recorded an overall incidence of 8.2 cases/100,000 person-years of UC (7). In Spain, a recent multicenter study coordinated from our center, which includes 17 Autonomous Communities of the country, confirmed that the current incidence of UC is higher than previously described, with rates of 8 new cases per 100,000 person-years, approximately (8,9). The complexity, the social burden and the costs of treatment make this disease very relevant for health systems. Specifically, in Europe, the annual direct cost is estimated at 9,000 euros per patient (regardless of severity) and 10,000 euros for those cases with moderate to severe UC. The total economic burden of UC has been estimated at 8-15 billion dollars in the US and 12-29 billion euros in Europe (10). All of this underscores the strategic importance of UC to society, including patients and health systems. The goal of drug treatment is to control inflammation to prevent the development of progressive intestinal damage and the onset of complications, so patients can achieve an optimal quality of life. Biological drugs are effective in maintaining clinical remission (11-13). However, approximately half of the patients treated do not reach remission with biological treatment (14-16). The reason for this reduced effectiveness is because therapies are administered based on empirical approaches due to the lack of prognostic biomarkers, adapting them according to the clinical evolution and complications of each case (17). A novel treatment for these refractory cases is tofacitinib (Xeljanz®), a synthetic small molecule inhibitor of JAK kinases, which has been shown to be effective in treating UC (18). Tofacitinib has been recently approved by the European Medicines Agency (EMA) and the Food and Drug Administration (FDA). It is indicated for the treatment of rheumatoid arthritis and active psoriatic arthritis, as well as in the treatment of adult patients with moderate to severe UC who have had an insufficient response, a loss of response or have been intolerant to conventional treatment or biological therapy. The recommended dose for UC is 10 mg twice daily for induction for 8 weeks, followed by 5 mg twice daily for maintenance (19). A relevant aspect to consider of this drug is its oral administration, unlike biological therapies, which are prescribed intravenously or subcutaneously. Despite these advantages, it has been observed that some patients treated with tofacitinib have a higher incidence of severe thromboembolic events, including dose dependent pulmonary embolism and deep vein thrombosis. Recent data from a randomized, post-authorization safety trial (A3921133) in patients with rheumatoid arthritis over 50 years of age and at least one cardiovascular risk factor, treated with tofacitinib 10 mg twice daily, have shown an increased risk of pulmonary embolism and overall mortality. The increased risk of pulmonary embolism was 5 times higher compared to patients treated with anti-TNFα. The incidence rates of pulmonary embolism for tofacitinib 10 mg twice daily, tofacitinib 5 mg twice daily, and anti- TNFα were 0.54 (95% CI, 0.32-0.87), 0.27 (0.12-0.52), and 0.09 (0.02-0.26) per 100 patient-years treated, respectively. Furthermore, mortality due to any cause in the tofacitinib 10 mg every 12-hour group was 2 times higher than the mortality of the groups treated with tofacitinib 5 mg twice daily and anti-TNFα. The incidence rates of deep vein thrombosis for tofacitinib 10 mg twice daily, tofacitinib 5 mg twice daily, and anti-TNFα were 0.38 (0.20-0.67), 0.30 (0.14-0.55), and 0.18 (0.07-0.39) per 100 patient-years, respectively (20). These results support the current recommendation for cautious use of tofacitinib in patients with high thromboembolic risk. As a result of the serious consequences associated with pulmonary embolism and the uncertainty about the underlying mechanism, the "Advisory Committee for Risk Assessment in Pharmacovigilance" decided to evaluate the impact of these findings on the benefit-risk balance of tofacitinib in all authorized indications, as well as the dose of administration. Both FDA and EMA have recently issued new warnings recommending "against" prescribing tofacitinib 10 mg twice daily for maintenance treatment in patients with UC who have one or more of the following known risk factors for venous thromboembolism (advanced age, obesity, diabetes, hypertension smoking, medical history of deep vein thrombosis and pulmonary embolism, immobilization of myocardial infarction in the previous three months, heart failure, use of combined hormonal contraceptives or hormone replacement therapy, inherited clotting disorders, neoplasia), unless appropriate alternative treatment is not available (21,22). In addition, the recommendations established by AEMPS to health professionals include monitoring all patients undergoing treatment with tofacitinib for signs and symptoms suggestive of pulmonary embolism, instructing them to request medical assistance immediately if they experience such symptoms (23). Regarding thromboembolic risk specifically in UC patients treated with tofacitinib, the results of a recent post-hoc analysis showed that during tofacitinib treatment one patient had venous thromboembolism [incidence rate, patients with events/100 patient-years: 0.04; (0.00-0.23)] and four had pulmonary embolism [0.16 (0.04- 0.41)] at a dose of 10 mg predominantly, with risk factors for venous thromboembolism (24). Although data concerning UC patients are still limited, the results of the above-mentioned clinical trial in rheumatoid arthritis are relevant for any therapeutic indication. Other drugs that inhibit the JAK-STAT pathway, such as baricitinib, ruxolitinib, and upadacitinib, have also been associated with an increased incidence of venous thromboembolism. However, the mechanism leading to these events is not known (25). Therefore, a possible class effect of JAK inhibitors in the development of these events cannot be ruled out. Moreover, other JAK inhibitors (pefacitinib, filgotinib and pacritinib) are currently being studied in phase 3 clinical trials in rheumatoid arthritis, atopic dermatitis, Crohn's disease and myelofibrosis (26-28). Because safety data on these new drugs are very limited, both regulatory agencies and clinical researchers have shown great concern about their thromboembolic risk. Therefore, it is clear that new studies are required to evaluate the safety of these new drugs. This is an utmost need is order to offer these drugs to patients under the safest circumstances. In summary, the pathophysiological mechanism that leads to an increased thromboembolic event in patients treated with tofacitinib or other JAK inhibitors is not currently known. Therefore, despite being effective and rapid drugs, their use has been restricted, since it is not known what would be the effective preventive antiplatelet or anticoagulation treatment, for example, to avoid thromboembolic events in these patients. This not only affects tofacitinib but may also involve the other JAK inhibitor drugs that will be approved for inflammatory bowel disease (or for other diseases) in the future. In this line, our project has an ambitious objective: to characterize in-depth this adverse event by studying the alterations in haemostasis. To that aim, the effect of tofacitinib on the general haemostatic profile (i.e., coagulation, platelet aggregation and activation) will be studied in vivo in patients with UC in the short and long term (baseline, 3 and 12 month follow-up). Finally, it is highly probable that from the results obtained in the present project significant advances will be achieved in the knowledge of the molecular mechanisms involved in the appearance of venous thromboembolism caused by exposure to tofacitinib. Therefore, this will allow, in clinical practice, to adopt effective pharmacological measures and facilitate prevention strategies to reduce the onset of these complications. Furthermore, it is expected that the results obtained can be extrapolated to other JAK inhibitor drugs of the same family, due to the possible class effect. Inclusion Criteria: EX VIVO STUDY IN PATIENTS WITH UC PATIENTS WITH UC: - Over 18 years old. - Diagnosis of UC according to the criteria of the European Crohn's and Colitis Organisation (ECCO). - Previous treatments are allowed, provided they have remained stable for the past 3 months. - In the case of patients with active UC, they should have endoscopic activity within 1 month of starting the treatment (Mayo endoscopic sub-index of ≥ 2). - Women of childbearing age using contraceptive methods with an error rate <1% per year. Examples of contraceptive methods whose error rate is <1% per year are: 1. Intrauterine device (IUD). 2. Bilateral tubal occlusion. 3. Couple with vasectomy. 4. Sexual abstinence. INDIVIDUALS WITHOUT UC: - Over 18 years old. - Subjects not diagnosed with UC, or other inflammatory allergic, malignant or autoimmune diseases. - Women of childbearing age using contraceptive methods with an error rate <1% per year. Examples of contraceptive methods whose error rate is <1% per year are: 1. Intrauterine device (IUD). 2. Bilateral tubal occlusion. 3. Couple with vasectomy. 4. Sexual abstinence. IN VIVO STUDY IN PATIENTS WITH UC PATIENTS WITH UC: - Over 18 years old. - Diagnosis of UC according to the criteria of the European Crohn's and Colitis Organisation (ECCO). - Have indication of treatment with anti-TNFα (infliximab, adalimumab or golimumab) o tofacitinib. - Be the first received JAK-inhibitor or anti-TNFα with a given mechanism of action. - Have endoscopic activity of UC within 1 month of starting the treatment (Mayo endoscopic sub-index of ≥ 2). - Previous treatments (including corticosteroids and immunosuppressants) are allowed provided that they have been stable for the last 3 months before beginning treatment with JAK-inhibitor or anti-TNFα and that they are maintained at a stable dose for the duration of the study - Women of childbearing age using contraceptive methods with an error rate <1% per year. Examples of contraceptive methods whose error rate is <1% per year are: 1. Intrauterine device (IUD). 2. Bilateral tubal occlusion. 3. Couple with vasectomy. 4. Sexual abstinence. INDIVIDUALS WITHOUT UC: - Over 18 years old. - Subjects not diagnosed with UC, or other inflammatory, allergic, malignant or autoimmune diseases. - Women of childbearing age using contraceptive methods with an error rate <1% per year. Examples of contraceptive methods whose error rate is <1% per year are: 1. Intrauterine device (IUD). 2. Bilateral tubal occlusion. 3. Couple with vasectomy. 4. Sexual abstinence. Exclusion Criteria: EX VIVO STUDY IN PATIENTS WITH UC PATIENTS WITH UC: - Under 18 years old. - Immune-mediated disease, neoplasm or active infection. - Pregnancy or lactation. - Alcohol or drug abuse. - Ostomy. - Abdominal surgery in the last 6 months. - Colectomy. - Active infection with hepatitis B, C or HIV virus. - Medical history of thromboembolic events. - Treatment with anticoagulants, antiplatelets or other drugs that alter the coagulation. - Use of combined hormonal contraceptives or hormone replacement therapy. - Hereditary coagulation disorders. - Refusal to give consent for participation in the study. INDIVIDUALS WITHOUT UC: - Under 18 years of age. - Advanced chronic disease or any other pathology that prevents the monitoring of the protocol of this study. - Pregnancy or lactation. - Alcohol or drug abuse. - Ostomy. - Abdominal surgery in the last 6 months. - Colectomy. - Active infection with hepatitis B, C or HIV virus. - Medical history of thromboembolic events. - Treatment with anticoagulants, antiplatelets or other drugs that alter the coagulation. - Use of combined hormonal contraceptives or hormone replacement therapy. - Hereditary coagulation disorders. - Refusal to give consent for participation in the study. IN VIVO STUDY IN PATIENTS WITH UC PATIENTS WITH UC: - Under 18 years old. - Immune-mediated disease. - Neoplasm or active infection. - Pregnancy or lactation. - Alcohol or drug abuse. - Ostomy. - Colectomy. - Active infection with hepatitis B, C or HIV virus. - Indication of anti-TNFα or JAK-inhibitors treatment for a cause other than UC. - Have previously received a drug with the same mechanism of action (anti-TNFα or JAK-inhibitors) - Medical history of thromboembolic events. - Treatment with anticoagulants, antiplatelets or other drugs that alter the coagulation. - Use of combined hormonal contraceptives or hormone replacement therapy. - Hereditary coagulation disorders. - Refusal to give consent for participation in the study. INDIVIDUALS WITHOUT UC: - Under 18 years of age. - Advanced chronic disease or any other pathology that prevents the monitoring of the protocol of this study. - Pregnancy or lactation. - Alcohol or drug abuse. - Active infection with hepatitis B, C or HIV virus. - Finding of macroscopic alterations during the colonoscopy or finding of relevant inflammatory alterations in the biopsies obtained during the colonoscopy. - Treatment with immunomodulators, immunosuppressants, corticosteroids or other drugs that alter the immune system. - Medical history of thromboembolic events. - Treatment with anticoagulants, antiplatelets or other drugs that alter the coagulation. - Use of combined hormonal contraceptives or hormone replacement therapy. - Hereditary coagulation disorders. - Refusal to give consent for participation in the study. - Abdominal surgery in the last 6 months.

NCT0531xxxx/NCT05313633.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313633</url> </required_header> <id_info> <org_study_id>plyometric training</org_study_id> <nct_id>NCT05313633</nct_id> </id_info> <brief_title>Plyometric Exercises Versus Wii Training In Children With Unilateral Cerebral Palsy</brief_title> <official_title>Efficacy Of Plyometric Exercises Versus Wii Training On Upper Extremity Function In Children With Unilateral Cerebral Palsy: A Randomized Controlled Trial</official_title> <sponsors> <lead_sponsor> <agency>Cairo University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Cairo University</source> <oversight_info> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Plyometric training includes muscle contraction that moves rapidly from the eccentric to the concentric phase of movement while using proper biomechanics. It is an effective neuromuscular stimulus that can improve motor functions of children with cerebral palsy. In plyometric training, muscles exert maximum force in short intervals of time, with the goal of increasing power.  Commercially available video games have been used for a wide range of clinical populations with generally positive clinical outcomes. They have been shown to be active enough to provide an increase in energy expenditure and physical activity in children with cerebral palsy. Furthermore, an early case study showed improvements in visual-perceptual processing, balance, and mobility in a child with cerebral palsy. </textblock> </brief_summary> <detailed_description> <textblock> Ethics Statement This study was approved by the Institutional Review Board of the Faculty of Physical Therapy, Cairo University, Egypt and strictly adhered to the criteria proclaimed in the latest version of the Declaration of Helsinki code of ethics. Children's participation will be commissioned by asking their legal guardian to sign a consent form prior to data collection.  A convenient sample of ambulant children with unilateral CP will be recruited from the Out-patient Clinic Faculty of physical therapy, Cairo University and outpatient physical therapy clinics.  Sample size estimation To avoid a type II error, a preliminary power analysis (power =0.8, α=0.05, effect size =0.5) determined a sample size of 28 for this study. Accordingly, 35 children who met the eligible criteria will be included in the current study for possible dropouts.  Randomization The randomization process will be performed using sealed envelopes. The investigator will prepare 35 sealed envelopes that contain a piece of paper indicating whether each participant was in the Wii group (receive Wii training for 45 minutes) or plyometric group (receive plyometric exercises for 45 minutes). The randomization process will be carried out by a registration clerk who was not involved in any part of the study. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">April 1, 2022</start_date> <completion_date type="Anticipated">March 30, 2023</completion_date> <primary_completion_date type="Anticipated">March 30, 2023</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Other</primary_purpose> <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Upper extremity function</measure> <time_frame>after 3 months of treatment</time_frame> <description>The quality of upper extremity skill test is a reliable and valid tool used to measure the motor function in children with cerebral palsy ages of 18 months to 8 years in four basic domains representing dissociated movement; grasp; protective extension; and weight bearing. The total scores for each domain percentage score are calculated as total score which range from zero to 100% with higher score reflects better performance.</description> </primary_outcome> <primary_outcome> <measure>Hand grip strength</measure> <time_frame>after 3 months of treatment</time_frame> <description>The hand held dynamometer (Patterson Medical, Warrenville, IL, USA) is a valid and reliable tool to assess grip strength in typically developing and disabled children recorded in kilogram. The assessment will be carried out with the child sitting on a chair with back support with suitable height to maintain the hips and knees at right angles and feet maintained on the supporting surface in neutral position. The tested upper extremity is aligned beside the body forearm and wrist in neutral positions with 90o elbow flexion. Then, each child is instructed to maximally compress the handle of the dynamometer. Each child performs three trials and the mean will be recorded in kilogram for statistical analysis.</description> </primary_outcome> <secondary_outcome> <measure>Range of motion</measure> <time_frame>after 3 months of treatment</time_frame> <description>An electronic goniometer will be used for the measurements of ROM of the affected upper limb in order to accurately track progress in a rehabilitation program. Shoulder flexion and abduction, elbow extension, forearm supination and wrist extension will be measured for all children before and after treatment</description> </secondary_outcome> <secondary_outcome> <measure>Selective motor control</measure> <time_frame>after 3 months of treatment</time_frame> <description>Test of arm selective control, a valid and reliable tool, will be used to measure selectivity of upper extremity of shoulder; elbow; wrist; fingers movements and thumb extension (key grip) as described in in the illustrated guide for administration and scoring. For each movement, the examiner passively moves the tested upper extremity to assess the full range of motion and demonstrate the desired movement. Then, he/she is instructed to actively move the test upper extremity using a three-second verbal count. Each position is scored as unable (0); impaired (1) or intact SVMC (2) with total score for each upper extremity is 16 and 32 for both tested upper extremities.</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">35</enrollment> <condition>Sports Physical Therapy</condition> <arm_group> <arm_group_label>Wii group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Children in this group will receive a designed physical therapy and occupational therapy programs prescribed individually for each child based on the functional capacity of each child (each program lasted for 30 minutes). Additionally, a 30- minute rest period will be implemented before receiving the allocated intervention. This group will receive a Wii training program for 45 minutes The treatment will be implemented three sessions a week for three months period.</description> </arm_group> <arm_group> <arm_group_label>plyometric group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Children in this group will receive a designed physical therapy and occupational therapy programs prescribed individually for each child based on the functional capacity of each child (each program lasted for 30 minutes). Additionally, a 30- minute rest period will be implemented before receiving the allocated intervention. This group will receive a plyometric training program for 45 minutes The treatment will be implemented three sessions a week for three months period.</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Designed physical therapy</intervention_name> <description>Attention was given to improve strength, enhance postural control, promote normal walking-pattern, and optimize function. The program incorporated manual passive and functional flexibility, progressive strengthening, postural and advanced balance exercises, and functional walking exercises</description> <arm_group_label>Wii group</arm_group_label> <arm_group_label>plyometric group</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Occupational therapy</intervention_name> <description>Both groups received a designed occupational therapy program for 30 minutes that included exercises facilitating hand skills, such as reaching, grasping, carrying, releasing, in-hand manipulation, and bilateral hand use. The children performed these exercises while they sat on a chair, with the therapist sitting beside to guide and assist them in performing the exercises correctly</description> <arm_group_label>Wii group</arm_group_label> <arm_group_label>plyometric group</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Plyometric training</intervention_name> <description>The designed plyometric training program basically focuses on upper extremity strength training and is developed according to the guidelines of the National Strength and Conditioning Association. The exercise load is progressively increased and conducted in two phases; each phase lasted for six weeks. To ensure safety and optimal performance, every child performed a pre-workout warming up before each session for five minutes including static and dynamic stretching and moving through the exercises planned for each day's workout at a lower intensity. Another set of cool down exercises for five minutes is considered to stretch and relax the entire body after each session. The exercises include: Two-hand chest pass Downward slam throw Push-ups against wall Clap push-ups against wall Bench push-ups Two-hand overhead throw Two-hand underhand side throw Single-Arm Throw</description> <arm_group_label>plyometric group</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Wii training</intervention_name> <description>The dose of Wii training was 40 minutes, three times a week for 12 weeks which is an interactive motion-based device. The Wii has a multiplayer mode and different levels of difficulty. The content of Wii training consisted of practicing four Wii games: (1) tennis; (2) boxing; (3) bowling; and (4) basketball. These games are chosen because they target the upper limbs, are fun, provide immediate feedback, and are easy to learn and play, and progression is built into the game. Also, fine motor coordination and sensory deficits are targeted through pressing buttons and vibration feedback from the Wii Remote. The children are instructed that they could stop at any point if discomfort or undue fatigue is experienced. The therapist randomly presented the games to eliminate any effect of order</description> <arm_group_label>Wii group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - aged 8-12 years;  - both sexes;  - had a diagnosis of spastic hemiplegia obtained from medical records;  - level I-III on the Manual Ability Classification System (MACS)  - able to understand and follow simple commands.  Exclusion Criteria:  - Botox injection/surgery in the affected upper extremity within the past 6 months;  - severe uncontrolled seizures;  - fixed deformities in the affected side  - attention deficit disorders </textblock> </criteria> <gender>All</gender> <minimum_age>8 Years</minimum_age> <maximum_age>12 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>walaa A El-nabie, Phd</last_name> <role>Study Chair</role> <affiliation>Cairo university, faculty of physical therapy</affiliation> </overall_official> <overall_official> <last_name>Hazem A Ali, Phd</last_name> <role>Study Director</role> <affiliation>Cairo university, faculty of physical therapy</affiliation> </overall_official> <overall_contact> <last_name>Amira M Abd-elmonem, PhD</last_name> <phone>01155553316</phone> <email>Dramira.salim2020@gmail.com</email> </overall_contact> <overall_contact_backup> <last_name>Amira M Abd-elmonem, PhD</last_name> <phone>01155553316</phone> <email>amira.mahmoud@cu.edu.eg</email> </overall_contact_backup> <location> <facility> <name>faculty of physical therapy, Cairo university</name> <address> <city>Giza</city> <country>Egypt</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>amira M Abd-elmonem</last_name> <email>Dramira.salim2020@gmail.com</email> </contact> </location> <location_countries> <country>Egypt</country> </location_countries> <verification_date>December 2022</verification_date> <study_first_submitted>March 7, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>December 6, 2022</last_update_submitted> <last_update_submitted_qc>December 6, 2022</last_update_submitted_qc> <last_update_posted type="Actual">December 7, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Cairo University</investigator_affiliation> <investigator_full_name>Amira Mahmoud Abd-elmonem</investigator_full_name> <investigator_title>principle investigator</investigator_title> </responsible_party> <keyword>Cerebral palsy</keyword> <keyword>Unilateral Cerebral Palsy</keyword> <keyword>hand grip strength</keyword> <keyword>upper extremity function</keyword> <keyword>range of motion</keyword> <keyword>Wii training</keyword> <keyword>plyometric exercises</keyword> <condition_browse>  <mesh_term>Cerebral Palsy</mesh_term> </condition_browse>  </clinical_study>

Plyometric training includes muscle contraction that moves rapidly from the eccentric to the concentric phase of movement while using proper biomechanics. It is an effective neuromuscular stimulus that can improve motor functions of children with cerebral palsy. In plyometric training, muscles exert maximum force in short intervals of time, with the goal of increasing power. Commercially available video games have been used for a wide range of clinical populations with generally positive clinical outcomes. They have been shown to be active enough to provide an increase in energy expenditure and physical activity in children with cerebral palsy. Furthermore, an early case study showed improvements in visual-perceptual processing, balance, and mobility in a child with cerebral palsy. Ethics Statement This study was approved by the Institutional Review Board of the Faculty of Physical Therapy, Cairo University, Egypt and strictly adhered to the criteria proclaimed in the latest version of the Declaration of Helsinki code of ethics. Children's participation will be commissioned by asking their legal guardian to sign a consent form prior to data collection. A convenient sample of ambulant children with unilateral CP will be recruited from the Out-patient Clinic Faculty of physical therapy, Cairo University and outpatient physical therapy clinics. Sample size estimation To avoid a type II error, a preliminary power analysis (power =0.8, α=0.05, effect size =0.5) determined a sample size of 28 for this study. Accordingly, 35 children who met the eligible criteria will be included in the current study for possible dropouts. Randomization The randomization process will be performed using sealed envelopes. The investigator will prepare 35 sealed envelopes that contain a piece of paper indicating whether each participant was in the Wii group (receive Wii training for 45 minutes) or plyometric group (receive plyometric exercises for 45 minutes). The randomization process will be carried out by a registration clerk who was not involved in any part of the study. Inclusion Criteria: - aged 8-12 years; - both sexes; - had a diagnosis of spastic hemiplegia obtained from medical records; - level I-III on the Manual Ability Classification System (MACS) - able to understand and follow simple commands. Exclusion Criteria: - Botox injection/surgery in the affected upper extremity within the past 6 months; - severe uncontrolled seizures; - fixed deformities in the affected side - attention deficit disorders

NCT0531xxxx/NCT05313646.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313646</url> </required_header> <id_info> <org_study_id>JSVCT111</org_study_id> <nct_id>NCT05313646</nct_id> </id_info> <brief_title>Clinical Evaluation for Batch Consistency of Ad5-nCoV in Chinese Healthy Adults</brief_title> <official_title>Safety, Immunogenicity, and Batch Consistency of a Single Dose of a Recombinant Adenovirus Type-5-vectored COVID-19 Vaccine in Chinese Healthy Adults Aged 18 Years and Above: a Randomized, Double-blind, Parallel-controlled Clinical Trial</official_title> <sponsors> <lead_sponsor> <agency>Jiangsu Province Centers for Disease Control and Prevention</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Jiangsu Province Centers for Disease Control and Prevention</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> This is a randomized, double-blind, parallel-controlled, equivalence trial, for evaluation of safety and immunogenicity, and batch-to-batch consistency of a recombinant adenovirus type-5-vectored Covid-19 vaccine Convidecia in one shot schedule in Chinese healthy adults aged 18 years and above. In total 1050 healthy adults will be recruited in this study. Subjects in both cohort will be randomized stratified into two cohort by age(18~59 years and≥60 years) in a 1:1:1 ratio to receive one of three consecutive batches of Convidecia. The primary objective is to test the equivalence of the immune responses to three consecutive manufacturing lots of Convidecia in healthy adults. The secondary objectives were to evaluate the immunogenicity and safety of Convidecia for each lot and the pooled data of three lots) </textblock> </brief_summary> <overall_status>Completed</overall_status> <start_date type="Actual">March 8, 2021</start_date> <completion_date type="Actual">September 8, 2021</completion_date> <primary_completion_date type="Actual">April 8, 2021</primary_completion_date> <phase>Phase 4</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <intervention_model_description>Subjects in adults cohort and elderly cohort will be randomized in a 1:1:1 ratio to receive one of three consecutive batches of Convidecia, respectively.</intervention_model_description> <primary_purpose>Prevention</primary_purpose> <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking> <masking_description>Participants and investigators will be kept blinded.</masking_description> </study_design_info> <primary_outcome> <measure>GMTs of SARS-CoV-2 RBD-specific binding IgG on day 28 after vaccination.</measure> <time_frame>On day 28 after vaccination</time_frame> <description>GMTs of SARS-CoV-2 RBD-specific binding IgG on day 28 after vaccination.</description> </primary_outcome> <secondary_outcome> <measure>GMFIs of SARS-CoV-2 RBD-specific binding IgG on day 28 after vaccination.</measure> <time_frame>On day 28 after vaccination</time_frame> <description>GMFIs of SARS-CoV-2 RBD-specific binding IgG on day 28 after vaccination.</description> </secondary_outcome> <secondary_outcome> <measure>Propotion of participants with at least four-fold increase of post-vaccination antibody level against SARS-CoV-2 RBD-specific binding IgG compared to that at baseline on day 28 after vaccination.</measure> <time_frame>On day 28 after vaccination</time_frame> <description>Propotion of participants with at least four-fold increase of post-vaccination antibody level against SARS-CoV-2 RBD-specific binding IgG compared to that at baseline on day 28 after vaccination.</description> </secondary_outcome> <secondary_outcome> <measure>GMTs of SARS-CoV-2 RBD-specific binding IgG on day 28 after vaccination stratified by neutralizing antibody levels against Ad5 at baseline.</measure> <time_frame>On day 28 after vaccination</time_frame> <description>GMTs of SARS-CoV-2 RBD-specific binding IgG on day 28 after vaccination stratified by neutralizing antibody</description> </secondary_outcome> <secondary_outcome> <measure>Incidence of solicited adverse events within 7 days after vaccination.</measure> <time_frame>Within 7 days after vaccination</time_frame> <description>Incidence of solicited adverse events within 7 days after vaccination.</description> </secondary_outcome> <secondary_outcome> <measure>Incidence of adverse reactions within 28 days after vaccination.</measure> <time_frame>Within 28 days after vaccination</time_frame> <description>Incidence of adverse reactions within 28 days after vaccination.</description> </secondary_outcome> <secondary_outcome> <measure>Incidence of unsolicited adverse events within 28 days after vaccination.</measure> <time_frame>Within 28 days after vaccination</time_frame> <description>Incidence of unsolicited adverse events within 28 days after vaccination.</description> </secondary_outcome> <secondary_outcome> <measure>Incidence of serious adverse events (SAE) within the 6 months after vaccination.</measure> <time_frame>Within the 6 months after vaccination</time_frame> <description>Incidence of serious adverse events (SAE) within the 6 months after vaccination.</description> </secondary_outcome> <number_of_arms>3</number_of_arms> <enrollment type="Actual">1050</enrollment> <condition>COVID-19</condition> <arm_group> <arm_group_label>batch 1 of Ad5-nCoV</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Eligible subjects in both cohort were vaccinated with one injection of Ad5-nCoV, lot NCOV202101001.</description> </arm_group> <arm_group> <arm_group_label>batch 2 of Ad5-nCoV</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Eligible subjects in both cohort were vaccinated with one injection of Ad5-nCoV, lot NCOV202101002.</description> </arm_group> <arm_group> <arm_group_label>batch 3 of Ad5-nCoV</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Eligible subjects in both cohort were vaccinated with one injection of Ad5-nCoV, lot NCOV202102003.</description> </arm_group> <intervention> <intervention_type>Biological</intervention_type> <intervention_name>batch 1 of Ad5-nCoV</intervention_name> <description>The vaccine is a replication defective Ad5 vectored vaccine expressing the full-length spike glycoprotein of SARS-CoV-2 produced by CanSino, lot NCOV202101001. It contains 5×10^10 viral particles per 0.5 mL in a vial.</description> <arm_group_label>batch 1 of Ad5-nCoV</arm_group_label> <other_name>Convidecia</other_name> </intervention> <intervention> <intervention_type>Biological</intervention_type> <intervention_name>batch 2 of Ad5-nCoV</intervention_name> <description>The vaccine is a replication defective Ad5 vectored vaccine expressing the full-length spike glycoprotein of SARS-CoV-2 produced by CanSino, lot NCOV202101002. It contains 5×10^10 viral particles per 0.5 mL in a vial.</description> <arm_group_label>batch 2 of Ad5-nCoV</arm_group_label> <other_name>Convidecia</other_name> </intervention> <intervention> <intervention_type>Biological</intervention_type> <intervention_name>batch 3 of Ad5-nCoV</intervention_name> <description>The vaccine is a replication defective Ad5 vectored vaccine expressing the full-length spike glycoprotein of SARS-CoV-2 produced by CanSino, lot NCOV202102003. It contains 5×10^10 viral particles per 0.5 mL in a vial.</description> <arm_group_label>batch 3 of Ad5-nCoV</arm_group_label> <other_name>Convidecia</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. healthy participants aged 18 years and above who have not received COVID-19 vaccine.  2. The subjects can provide with informed consent and sign informed consent form (ICF).  4. The subjects are able to and willing to comply with the requirements of the clinical trial program and could complete the follow-up of the study.  5. Axillary temperature ≤ 37.0℃. 6. negative IgM and IgG against SARS-CoV-2 7. with BMI between18.5 to 30.0 8. No history of epidemiological contact with COVID-2019 9. have not been to medium or high risk areas in the past 21 days and have no history of departure.  10. be determined to be healthy by medical history, physical examination and clinical examination and meet the requirements for immunization of this product.  Exclusion criteria:  1. Medical history or family history of convulsion, epilepsy, encephalopathy and psychosis.  2. Allergic to any component of the research vaccines, or a history of hypersensitivity or serious reactions to vaccination.  3. Women with positive urine pregnancy test, pregnant or breast-feeding, or have a pregnancy plan in this study.  4. Suffering from acute febrile disease, infectious disease, or SARS infection history  5. Serious cardiovascular disease, such as arrhythmia, conduction block, myocardial infarction, severe hypertension, which cannot be controlled by medication (systolic blood pressure ≥180mmHg, diastolic blood pressure ≥110mmHg)  6. Have severe chronic diseases or unstable condition ( Grade 3 or higher as defined in the guidelines for the classification of adverse events in clinical trials for prophylactic vaccines), Such as diabetes, thyroid disease and so on.  7. Congenital or acquired angioedema / neuroedema.  8. had urticaria one year before this vaccination.  9. Asplenia or functional asplenia.  10. Thrombocytopenia or other clotting disorder (this may contraindicate intramuscular injection).  11. Faintng during acupuncture treatment  12. Received immunosuppressant therapy, antiallergic therapy, cytotoxic therapy, high dose inhaled corticosteroid over the past 6 months (excluding corticosteroid spray for allergic rhinitis, surface corticosteroid for acute non-complicated dermatitis, and corticosteroid with dose less than 20mg/ day)  13. Received blood products within 4 months before vaccination.  14. Received other investigational drugs within 1 month prior to receiving the investigational vaccines.  15. Received other live attenuated vaccines within 1 month prior to receiving the investigational vaccines.  16. Received subunit or inactivated vaccine within 14 days prior to receiving investigational vaccine.  17. Be receiving anti-tuberculosis treatment  18. Have the history of SARS-CoV-2 infection or COVID-19  19. Any medical, psychological, social or other conditions that, in the investigator's judgment, are inconsistent with the study protocol or affect the subjects' informed consent </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Fengcai Zhu, MSc</last_name> <role>Principal Investigator</role> <affiliation>Jiangsu Provincial Center for Diseases Control and Prevention</affiliation> </overall_official> <location> <facility> <name>Guanyun Center for Disease Control and Prevention</name> <address> <city>Lianyungang</city> <state>Jiangsu</state> <zip>222000</zip> <country>China</country> </address> </facility> </location> <location_countries> <country>China</country> </location_countries> <verification_date>December 2021</verification_date> <study_first_submitted>March 28, 2022</study_first_submitted> <study_first_submitted_qc>April 5, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>April 5, 2022</last_update_submitted> <last_update_submitted_qc>April 5, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>SARS-CoV-2 Vaccine</keyword> <keyword>Batches consistency</keyword> <keyword>Adenovirus type-5-vectored</keyword> <keyword>Safety</keyword> <keyword>Immunogenicity</keyword> <condition_browse>  <mesh_term>COVID-19</mesh_term> </condition_browse>  </clinical_study>

This is a randomized, double-blind, parallel-controlled, equivalence trial, for evaluation of safety and immunogenicity, and batch-to-batch consistency of a recombinant adenovirus type-5-vectored Covid-19 vaccine Convidecia in one shot schedule in Chinese healthy adults aged 18 years and above. In total 1050 healthy adults will be recruited in this study. Subjects in both cohort will be randomized stratified into two cohort by age(18~59 years and≥60 years) in a 1:1:1 ratio to receive one of three consecutive batches of Convidecia. The primary objective is to test the equivalence of the immune responses to three consecutive manufacturing lots of Convidecia in healthy adults. The secondary objectives were to evaluate the immunogenicity and safety of Convidecia for each lot and the pooled data of three lots) Inclusion Criteria: 1. healthy participants aged 18 years and above who have not received COVID-19 vaccine. 2. The subjects can provide with informed consent and sign informed consent form (ICF). 4. The subjects are able to and willing to comply with the requirements of the clinical trial program and could complete the follow-up of the study. 5. Axillary temperature ≤ 37.0℃. 6. negative IgM and IgG against SARS-CoV-2 7. with BMI between18.5 to 30.0 8. No history of epidemiological contact with COVID-2019 9. have not been to medium or high risk areas in the past 21 days and have no history of departure. 10. be determined to be healthy by medical history, physical examination and clinical examination and meet the requirements for immunization of this product. Exclusion criteria: 1. Medical history or family history of convulsion, epilepsy, encephalopathy and psychosis. 2. Allergic to any component of the research vaccines, or a history of hypersensitivity or serious reactions to vaccination. 3. Women with positive urine pregnancy test, pregnant or breast-feeding, or have a pregnancy plan in this study. 4. Suffering from acute febrile disease, infectious disease, or SARS infection history 5. Serious cardiovascular disease, such as arrhythmia, conduction block, myocardial infarction, severe hypertension, which cannot be controlled by medication (systolic blood pressure ≥180mmHg, diastolic blood pressure ≥110mmHg) 6. Have severe chronic diseases or unstable condition ( Grade 3 or higher as defined in the guidelines for the classification of adverse events in clinical trials for prophylactic vaccines), Such as diabetes, thyroid disease and so on. 7. Congenital or acquired angioedema / neuroedema. 8. had urticaria one year before this vaccination. 9. Asplenia or functional asplenia. 10. Thrombocytopenia or other clotting disorder (this may contraindicate intramuscular injection). 11. Faintng during acupuncture treatment 12. Received immunosuppressant therapy, antiallergic therapy, cytotoxic therapy, high dose inhaled corticosteroid over the past 6 months (excluding corticosteroid spray for allergic rhinitis, surface corticosteroid for acute non-complicated dermatitis, and corticosteroid with dose less than 20mg/ day) 13. Received blood products within 4 months before vaccination. 14. Received other investigational drugs within 1 month prior to receiving the investigational vaccines. 15. Received other live attenuated vaccines within 1 month prior to receiving the investigational vaccines. 16. Received subunit or inactivated vaccine within 14 days prior to receiving investigational vaccine. 17. Be receiving anti-tuberculosis treatment 18. Have the history of SARS-CoV-2 infection or COVID-19 19. Any medical, psychological, social or other conditions that, in the investigator's judgment, are inconsistent with the study protocol or affect the subjects' informed consent

NCT0531xxxx/NCT05313659.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313659</url> </required_header> <id_info> <org_study_id>postoperative agitation</org_study_id> <nct_id>NCT05313659</nct_id> </id_info> <brief_title>Intramuscular Ketamine Effect on Postnasal Surgery Agitation</brief_title> <official_title>Intramuscular Ketamine Effect on Postnasal Surgery Agitation: a Double Blinded Randomized Controlled Trial.</official_title> <sponsors> <lead_sponsor> <agency>Jordanian Royal Medical Services</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Jordanian Royal Medical Services</source> <oversight_info> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Emergence agitation (EA) is a common complication after nasal surgery. In this study, we aimed to investigate the effect of intramuscular ketamine on EA following septoplasty and open septorhinoplasty (OSRP) when administered at subanesthetic doses at the end of surgery. Sedation and Agitation scores were recorded using The Richmond agitation-sedation score after extubation. </textblock> </brief_summary> <detailed_description> <textblock> At the end of surgery and immediately after the inhalational agent was discontinued, 2mL of normal saline containing 0.7 mg/kg racemic ketamine was administered intramuscularly to Group-K, whereas 2 mL of normal saline was administered intramuscularly to Group-S using a 3 ml syringe. The injection site of both groups was at the lateral thigh. For postoperative analgesia, 0.07 mg/kg morphine was also given when turning off the inhalational agent. A nasal pack was used in all of the patients. The patients were ventilated with 100% oxygen at a flow rate of 7 L/min. Once the patients met the extubation criteria, they were extubated.  The EA level of the patients was evaluated immediately after extubation till the patient was handed over to the PACU using Richmond Agitation-Sedation Scale (RASS), Table 1, and the highest score was documented by the main investigators. In this study patients with a RASS score of +2 or more were considered to have EA. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">May 11, 2022</start_date> <completion_date type="Actual">October 20, 2022</completion_date> <primary_completion_date type="Actual">October 20, 2022</primary_completion_date> <phase>Phase 2</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Prevention</primary_purpose> <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Development of Agitation</measure> <time_frame>immediately After extubation.</time_frame> <description>Using The Richmond agitation-sedation score. The score being from(-5) to (+4) ; 2 and more being agitated patients and less than 2 not agitated.</description> </primary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">193</enrollment> <condition>Agitation, Emergence</condition> <arm_group> <arm_group_label>group-K</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>At the end of surgery and immediately after the inhalational agent was discontinued, 2mL of normal saline containing 0.7 mg/kg racemic ketamine was administered intramuscularly to Group-K</description> </arm_group> <arm_group> <arm_group_label>group-S</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>At the end of surgery and immediately after the inhalational agent was discontinued, 2 mL of normal saline was administered intramuscularly.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Ketamine Hydrochloride</intervention_name> <description>intramuscular ketamine hydrochloride at dose of 0.7 mg/kg at the time of turning the inhalational agent off</description> <arm_group_label>group-K</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. Age group 18-64 years old  2. ASA I-II  3. BMI 20-29.9  4. Patients accepting the study and consenting  5. Undergoing general anesthesia for scheduled septoplasty or open septorhinoplasty.  Exclusion Criteria:  1. ketamine allergy  2. Morphine allergy  3. History of cardiac, neurological, or psychiatric disease, glaucoma,  4. Patients with a body mass index of less than 20 or more than 30 kg/m2 </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>64 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Husam A. Almajali, MD</last_name> <role>Principal Investigator</role> <affiliation>Jordanian Royal Medical Services</affiliation> </overall_official> <overall_official> <last_name>Ali M. Abu Dalo, MD</last_name> <role>Principal Investigator</role> <affiliation>Jordanian Royal Medical Services</affiliation> </overall_official> <location> <facility> <name>Jordanian Royal Medical Services</name> <address> <city>Amman</city> <zip>11855</zip> <country>Jordan</country> </address> </facility> </location> <location_countries> <country>Jordan</country> </location_countries> <verification_date>January 2023</verification_date> <study_first_submitted>March 20, 2022</study_first_submitted> <study_first_submitted_qc>April 5, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>January 23, 2023</last_update_submitted> <last_update_submitted_qc>January 23, 2023</last_update_submitted_qc> <last_update_posted type="Actual">January 25, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Jordanian Royal Medical Services</investigator_affiliation> <investigator_full_name>Husam A. Almajali</investigator_full_name> <investigator_title>anesthesia specialist</investigator_title> </responsible_party> <keyword>Agitation</keyword> <keyword>Emergence</keyword> <keyword>Ketamine</keyword> <keyword>Intramuscular</keyword> <keyword>Nasal surgery</keyword> <condition_browse>  <mesh_term>Psychomotor Agitation</mesh_term> <mesh_term>Emergence Delirium</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Ketamine</mesh_term> </intervention_browse>  </clinical_study>

Emergence agitation (EA) is a common complication after nasal surgery. In this study, we aimed to investigate the effect of intramuscular ketamine on EA following septoplasty and open septorhinoplasty (OSRP) when administered at subanesthetic doses at the end of surgery. Sedation and Agitation scores were recorded using The Richmond agitation-sedation score after extubation. At the end of surgery and immediately after the inhalational agent was discontinued, 2mL of normal saline containing 0.7 mg/kg racemic ketamine was administered intramuscularly to Group-K, whereas 2 mL of normal saline was administered intramuscularly to Group-S using a 3 ml syringe. The injection site of both groups was at the lateral thigh. For postoperative analgesia, 0.07 mg/kg morphine was also given when turning off the inhalational agent. A nasal pack was used in all of the patients. The patients were ventilated with 100% oxygen at a flow rate of 7 L/min. Once the patients met the extubation criteria, they were extubated. The EA level of the patients was evaluated immediately after extubation till the patient was handed over to the PACU using Richmond Agitation-Sedation Scale (RASS), Table 1, and the highest score was documented by the main investigators. In this study patients with a RASS score of +2 or more were considered to have EA. Inclusion Criteria: 1. Age group 18-64 years old 2. ASA I-II 3. BMI 20-29.9 4. Patients accepting the study and consenting 5. Undergoing general anesthesia for scheduled septoplasty or open septorhinoplasty. Exclusion Criteria: 1. ketamine allergy 2. Morphine allergy 3. History of cardiac, neurological, or psychiatric disease, glaucoma, 4. Patients with a body mass index of less than 20 or more than 30 kg/m2

NCT0531xxxx/NCT05313672.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313672</url> </required_header> <id_info> <org_study_id>UModenaReggio21</org_study_id> <nct_id>NCT05313672</nct_id> </id_info> <brief_title>Inspiratory Effort and Respiratory Mechanics in Spontaneously Breathing Patients With Acute Exacerbation of Idiopathic Pulmonary Fibrosis: a Matched Control Study</brief_title> <acronym>IERATIC</acronym> <official_title>Inspiratory Effort and Respiratory Mechanics in Spontaneously Breathing Patients With Acute Exacerbation of Idiopathic Pulmonary Fibrosis: a Matched Control Study</official_title> <sponsors> <lead_sponsor> <agency>Roberto Tonelli</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>University of Modena and Reggio Emilia</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Idiopathic pulmonary fibrosis is a life-threatening lung disease characterized by progressive deterioration of lung function and a median survival time of 3-5 years from diagnosis. The onset of an acute deterioration (AE) of respiratory function, the so called acute exacerbation of IPF (AE-IPF), may lead to severe hypoxemia, further worsening prognosis. During these events, the typical usual interstitial pneumonia pattern (UIP) - the radiologic and histologic hallmark of IPF- is overlapped with diffuse alveolar damage (DAD), sharing similarities with the acute respiratory distress syndrome (ARDS) and often requiring respiratory assistance. Several studies show that the need for mechanical ventilation (MV) is associated with high mortality in IPF patients, probably due to the pathophysiological properties of UIP-like fibrotic lung (i.e. collapse induration areas, elevated lung elastance, high inhomogeneity) that make it more susceptible to ventilatory-induced lung injury (VILI). It has been theorized that the application of PEEP on a UIP-like lung pattern can determine the protrusion of the most distensible areas through a dense anelastic fibrotic tissue circles, causing increased rigidity, worsening compliance, and thus enabling tissue breakdown. In this scenario, non-invasive mechanical ventilation (NIV) may therefore represent an alternative option to assist these patients, although no specific recommendations have been made so far. In patients with ARDS, the efficacy of NIV in reducing the patient's inspiratory effort early after its application has been related to a favorable clinical outcome. Indeed, the mitigation of respiratory drive might have resulted in a lower risk for the self-inflicted lung injury (SILI) during spontaneous breathing, whose onset is very likely to worse outcomes of patients undergoing acute respiratory failure (ARF).  To date no data available on the inspiratory effort and the lung mechanics in patients with AE-IPF either during unassisted of assisted spontaneous breathing. Aim of this study was then to compare respiratory mechanics, at baseline and 2-h following NIV application, in AE-IPF and ARDS patients matched for severity. </textblock> </brief_summary> <overall_status>Active, not recruiting</overall_status> <start_date type="Actual">August 1, 2016</start_date> <completion_date type="Anticipated">August 1, 2026</completion_date> <primary_completion_date type="Actual">April 1, 2022</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Case-Control</observational_model> <time_perspective>Retrospective</time_perspective> </study_design_info> <primary_outcome> <measure>Inspiratory effort in IPF patients</measure> <time_frame>On respiratory intensive care unit admission</time_frame> <description>Assessment of esophageal pressure swing in IPF patients during acute exacerbation of disease as compared to ARDS</description> </primary_outcome> <secondary_outcome> <measure>Respiratory mechanics change after NIV application in IPF patients acute exacerbation</measure> <time_frame>2 hours</time_frame> <description>Respiratory mechanics change after NIV application in IPF patients acute exacerbation as compared to ARDS</description> </secondary_outcome> <number_of_groups>2</number_of_groups> <enrollment type="Actual">20</enrollment> <condition>Idiopathic Pulmonary Fibrosis</condition> <arm_group> <arm_group_label>IPF patients with UIP pattern requiring NIV</arm_group_label> </arm_group> <arm_group> <arm_group_label>ARDS patients requiring NIV</arm_group_label> </arm_group> <eligibility> <study_pop> <textblock> Patients with IPF developing AE consecutively admitted to the Respiratory Intensive Care Unit and the Intensive Care Unit of the University Hospital of Modena over the period August 1st, 2016 to January 1th, 2022 were prospectively considered eligible for enrollment. </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  previously established diagnosis of IPF; occurring acute exacerbation of IPF as defined by an acute, clinically significant respiratory deterioration characterized by evidence of new widespread alveolar abnormality on chest CT scan (12); age >18 years; presence of ARF with PaO2/FiO2 ratio <200 mmHg despite HFNC (set with at least 60 L/min and FiO2 higher than 0.6); suitability for a NIV trial according to the attending staff; consent to measure esophageal pressure.  Exclusion Criteria:  - acute cardiogenic pulmonary edema,  - concomitant hypercapnic respiratory failure (PaCO2 >45 mmHg) of any etiology,  - neuromuscular disease or chest wall deformities,  - home long-term oxygen therapy,  - intolerance or contraindication to NIV, such as the need for immediate endotracheal intubation </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> </eligibility> <verification_date>April 2022</verification_date> <study_first_submitted>March 28, 2022</study_first_submitted> <study_first_submitted_qc>March 28, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>April 5, 2022</last_update_submitted> <last_update_submitted_qc>April 5, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 13, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor-Investigator</responsible_party_type> <investigator_affiliation>University of Modena and Reggio Emilia</investigator_affiliation> <investigator_full_name>Roberto Tonelli</investigator_full_name> <investigator_title>Principal investigator</investigator_title> </responsible_party> <keyword>Inspiratory effort</keyword> <keyword>Esophageal manometry</keyword> <keyword>Non-invasive mechanical ventilation</keyword> <condition_browse>  <mesh_term>Pulmonary Fibrosis</mesh_term> <mesh_term>Idiopathic Pulmonary Fibrosis</mesh_term> <mesh_term>Respiratory Aspiration</mesh_term> <mesh_term>Fibrosis</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Undecided</sharing_ipd> </patient_data>  </clinical_study>

Idiopathic pulmonary fibrosis is a life-threatening lung disease characterized by progressive deterioration of lung function and a median survival time of 3-5 years from diagnosis. The onset of an acute deterioration (AE) of respiratory function, the so called acute exacerbation of IPF (AE-IPF), may lead to severe hypoxemia, further worsening prognosis. During these events, the typical usual interstitial pneumonia pattern (UIP) - the radiologic and histologic hallmark of IPF- is overlapped with diffuse alveolar damage (DAD), sharing similarities with the acute respiratory distress syndrome (ARDS) and often requiring respiratory assistance. Several studies show that the need for mechanical ventilation (MV) is associated with high mortality in IPF patients, probably due to the pathophysiological properties of UIP-like fibrotic lung (i.e. collapse induration areas, elevated lung elastance, high inhomogeneity) that make it more susceptible to ventilatory-induced lung injury (VILI). It has been theorized that the application of PEEP on a UIP-like lung pattern can determine the protrusion of the most distensible areas through a dense anelastic fibrotic tissue circles, causing increased rigidity, worsening compliance, and thus enabling tissue breakdown. In this scenario, non-invasive mechanical ventilation (NIV) may therefore represent an alternative option to assist these patients, although no specific recommendations have been made so far. In patients with ARDS, the efficacy of NIV in reducing the patient's inspiratory effort early after its application has been related to a favorable clinical outcome. Indeed, the mitigation of respiratory drive might have resulted in a lower risk for the self-inflicted lung injury (SILI) during spontaneous breathing, whose onset is very likely to worse outcomes of patients undergoing acute respiratory failure (ARF). To date no data available on the inspiratory effort and the lung mechanics in patients with AE-IPF either during unassisted of assisted spontaneous breathing. Aim of this study was then to compare respiratory mechanics, at baseline and 2-h following NIV application, in AE-IPF and ARDS patients matched for severity. Patients with IPF developing AE consecutively admitted to the Respiratory Intensive Care Unit and the Intensive Care Unit of the University Hospital of Modena over the period August 1st, 2016 to January 1th, 2022 were prospectively considered eligible for enrollment. Inclusion Criteria: previously established diagnosis of IPF; occurring acute exacerbation of IPF as defined by an acute, clinically significant respiratory deterioration characterized by evidence of new widespread alveolar abnormality on chest CT scan (12); age >18 years; presence of ARF with PaO2/FiO2 ratio <200 mmHg despite HFNC (set with at least 60 L/min and FiO2 higher than 0.6); suitability for a NIV trial according to the attending staff; consent to measure esophageal pressure. Exclusion Criteria: - acute cardiogenic pulmonary edema, - concomitant hypercapnic respiratory failure (PaCO2 >45 mmHg) of any etiology, - neuromuscular disease or chest wall deformities, - home long-term oxygen therapy, - intolerance or contraindication to NIV, such as the need for immediate endotracheal intubation

NCT0531xxxx/NCT05313685.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313685</url> </required_header> <id_info> <org_study_id>21-012057</org_study_id> <nct_id>NCT05313685</nct_id> </id_info> <brief_title>Educational Materials for Hiccups</brief_title> <official_title>A Feasibility Double-Blinded, Randomized Study of Educational Materials for Hiccups</official_title> <sponsors> <lead_sponsor> <agency>Mayo Clinic</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Mayo Clinic</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> This is a research study about hiccup educational materials. The purpose of this study is to learn whether this type of research can be done. </textblock> </brief_summary> <overall_status>Completed</overall_status> <start_date type="Actual">December 6, 2021</start_date> <completion_date type="Actual">March 25, 2022</completion_date> <primary_completion_date type="Actual">February 23, 2022</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Cohort</observational_model> <time_perspective>Prospective</time_perspective> </study_design_info> <primary_outcome> <measure>Feasibility of enrollment</measure> <time_frame>5 months</time_frame> <description>This is a feasibility study that seeks to enroll 20 patients with hiccups in 5 months from the start of trial recruitment.</description> </primary_outcome> <number_of_groups>2</number_of_groups> <enrollment type="Actual">50</enrollment> <condition>Hiccup</condition> <arm_group> <arm_group_label>Mayo Clinic hiccup educational materials</arm_group_label> </arm_group> <arm_group> <arm_group_label>Mayo Clinic hiccup educational materials + updated supplementary content</arm_group_label> </arm_group> <eligibility> <study_pop> <textblock> Patients who have had hiccups in the preceding four weeks or patients who might be at risk for hiccups based on drug exposure (for example, recent dexamethasone exposure). </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Age ≥ 18 years of age.  - Hiccups in the 4 weeks prior to phone contact (patient must confirm).  - Able to speak and read English.  - Has an e-mail address.  Exclusion Criteria:  - Individuals < 18 years of age. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Aminah Jatoi, MD</last_name> <role>Principal Investigator</role> <affiliation>Mayo Clinic</affiliation> </overall_official> <location> <facility> <name>Mayo Clinic Rochester</name> <address> <city>Rochester</city> <state>Minnesota</state> <zip>55905</zip> <country>United States</country> </address> </facility> </location> <location_countries> <country>United States</country> </location_countries> <link> <url>https://www.mayo.edu/research/clinical-trials</url> <description>Mayo Clinic Clinical Trials</description> </link> <verification_date>June 2022</verification_date> <study_first_submitted>March 28, 2022</study_first_submitted> <study_first_submitted_qc>April 5, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>June 20, 2022</last_update_submitted> <last_update_submitted_qc>June 20, 2022</last_update_submitted_qc> <last_update_posted type="Actual">June 22, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Mayo Clinic</investigator_affiliation> <investigator_full_name>Aminah Jatoi, M.D.</investigator_full_name> <investigator_title>Principal Investigator</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Hiccup</mesh_term> </condition_browse>  </clinical_study>

This is a research study about hiccup educational materials. The purpose of this study is to learn whether this type of research can be done. Patients who have had hiccups in the preceding four weeks or patients who might be at risk for hiccups based on drug exposure (for example, recent dexamethasone exposure). Inclusion Criteria: - Age ≥ 18 years of age. - Hiccups in the 4 weeks prior to phone contact (patient must confirm). - Able to speak and read English. - Has an e-mail address. Exclusion Criteria: - Individuals < 18 years of age.

NCT0531xxxx/NCT05313698.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313698</url> </required_header> <id_info> <org_study_id>16969557-2167</org_study_id> <nct_id>NCT05313698</nct_id> </id_info> <brief_title>Validity and Reliability of The Turkish Version of The Kidscreen-27</brief_title> <official_title>Validity and Reliability of The Turkish Version of The Kidscreen-27 Questionnaires in Individuals With Cerebral Palsy</official_title> <sponsors> <lead_sponsor> <agency>Muş Alparlan University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Muş Alparlan University</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Functional impairment of the upper extremities can impair the health-related quality of life (HRQOL) of persons with Cerebral Palsy CP. Health-related quality of life (HRQOL) measures several subjective dimensions dealing with the impact of health or illness on physical and psychosocial functioning. Quality of life (QOL) measures for children and adolescents have been developed in recent years, initially for children with specific chronic conditions, but more recently generic and health-related QOL (HRQOL) measures have been developed . The early assessments of children's quality of life were mostly disease-specific, and this trend has continued. Generic HRQOL measurements for children and adolescents can help identify subgroups of children and adolescents who are at risk of developing health problems. KIDSCREEN-27 is a generic HRQOL measure derived from KIDSCREEN-52. The KIDSCREEN-27 is a subset of the KIDSCREEN-52 that includes 27 items for assessing HRQOL across five dimensions: Physical Well-Being (5 items) examines a child's or adolescent's level of physical activity, energy, and fitness. Although the psychometric properties of the Turkish version of the KIDSCREEN forms have been studied previously; however, its psychometric characteristics in children with CP have yet to be determined. Accordingly, the aim of this study is to provide an overview of the psychometric results of the KIDSCREEN-27 HRQOL questionnaire </textblock> </brief_summary> <detailed_description> <textblock> Children with CP generally report a lower QOL than their normally developing peers. Quality of life (QOL) is now recognized as an important outcome of interventions because it relates to a person's individual cognition or well-being in a range of domains (e.g., physical, social, emotional, spiritual). Health-related quality of life (HRQOL) is a subdomain of the more global construct of QOL, including domains such as physical, mental, and social well-being Recently, there has been a surge in interest in assessing the quality of life (QOL) of children with cerebral palsy (CP). QOL instruments are increasingly used to assess the effectiveness of interventions for children with CP. To assess QOL, there are both generic and condition-specific scales available. The Cerebral Palsy Quality of Life Questionnaire for Children (CP QOL-Child), the Child Health Questionnaire (CHQ), European generic health related quality of life questionnaire (KIDSCREEN), and the Pediatric Quality of Life Inventory are some of the most used instruments. Out of these QOL instruments, European generic health related quality of life questionnaire (KIDSCREEN) is a generic QOL questionnaire and KIDSCREEN-27 is a shorter version of the KIDSCREEN-52 questionnaire to evaluate HRQOL outcomes of children and adolescents between the ages of 8-18 years. . Generic scales are useful for comparing groups since they are designed to be relevant to all subgroups of the population. Because they do not include domains that are relevant to the sickness or disability, they are less useful for evaluating the effectiveness of an intervention for children with that illness or disability. Condition-specific scales are useful for detecting changes in QOL for a given condition and are designed to be applicable to a group. Instruments that are condition-specific can capture the domains of QOL that are significant to children and adolescents with CP. Although the psychometric properties of KIDSCREEN-27 tests have been extensively studied in healthy children and adolescents, there has been no research to date on the psychometric features of KIDSCREEN-27 instruments in cerebral palsy children and adolescents. Thus, the aims of this study were to examine and determine the construct-concurrent validity and reliability of the Turkish version of the self and proxy versions of KIDSCREEN-27 questionnaire in individuals with cerebral palsy </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">January 1, 2022</start_date> <completion_date type="Actual">May 1, 2022</completion_date> <primary_completion_date type="Actual">April 1, 2022</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Case-Only</observational_model> <time_perspective>Prospective</time_perspective> </study_design_info> <primary_outcome> <measure>Consistency from baseline in mean scores of KIDSCREEN-27 at week 2</measure> <time_frame>Change from Baseline KIDCREEN-27 mean scores at 2 weeks</time_frame> <description>The KIDSCREEN-27 is a 27-item variation of the KIDSCREEN-52 questionnaire that includes five dimensions of health-related quality of life (HRQOL). It is a valid and reliable tool for assessing children's and adolescents' HRQOL outcomes</description> </primary_outcome> <enrollment type="Actual">135</enrollment> <condition>Cerebral Palsy</condition> <intervention> <intervention_type>Diagnostic Test</intervention_type> <intervention_name>No intervention</intervention_name> <description>cross-sectional study/psychometric study</description> </intervention> <eligibility> <study_pop> <textblock> Children with all typologies of cerebral palsy and their parents/caregivers </textblock> </study_pop> <sampling_method>Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  Children with cerebral palsy who have sufficient intellectual level to answer KIDSCREEN-27' items  Exclusion Criteria:  children with severe intellectual disability </textblock> </criteria> <gender>All</gender> <minimum_age>8 Years</minimum_age> <maximum_age>18 Years</maximum_age> </eligibility> <overall_official> <last_name>Mintaze KEREM GUNLE</last_name> <role>Study Chair</role> <affiliation>Hacettepe University</affiliation> </overall_official> <location> <facility> <name>Hacettepe University</name> <address> <city>Ankara</city> <zip>06100</zip> <country>Turkey</country> </address> </facility> </location> <location_countries> <country>Turkey</country> </location_countries> <verification_date>May 2022</verification_date> <study_first_submitted>March 22, 2022</study_first_submitted> <study_first_submitted_qc>April 5, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>May 31, 2022</last_update_submitted> <last_update_submitted_qc>May 31, 2022</last_update_submitted_qc> <last_update_posted type="Actual">June 3, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Muş Alparlan University</investigator_affiliation> <investigator_full_name>Hasan Bingöl</investigator_full_name> <investigator_title>Dr</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Cerebral Palsy</mesh_term> </condition_browse>  </clinical_study>

Functional impairment of the upper extremities can impair the health-related quality of life (HRQOL) of persons with Cerebral Palsy CP. Health-related quality of life (HRQOL) measures several subjective dimensions dealing with the impact of health or illness on physical and psychosocial functioning. Quality of life (QOL) measures for children and adolescents have been developed in recent years, initially for children with specific chronic conditions, but more recently generic and health-related QOL (HRQOL) measures have been developed . The early assessments of children's quality of life were mostly disease-specific, and this trend has continued. Generic HRQOL measurements for children and adolescents can help identify subgroups of children and adolescents who are at risk of developing health problems. KIDSCREEN-27 is a generic HRQOL measure derived from KIDSCREEN-52. The KIDSCREEN-27 is a subset of the KIDSCREEN-52 that includes 27 items for assessing HRQOL across five dimensions: Physical Well-Being (5 items) examines a child's or adolescent's level of physical activity, energy, and fitness. Although the psychometric properties of the Turkish version of the KIDSCREEN forms have been studied previously; however, its psychometric characteristics in children with CP have yet to be determined. Accordingly, the aim of this study is to provide an overview of the psychometric results of the KIDSCREEN-27 HRQOL questionnaire Children with CP generally report a lower QOL than their normally developing peers. Quality of life (QOL) is now recognized as an important outcome of interventions because it relates to a person's individual cognition or well-being in a range of domains (e.g., physical, social, emotional, spiritual). Health-related quality of life (HRQOL) is a subdomain of the more global construct of QOL, including domains such as physical, mental, and social well-being Recently, there has been a surge in interest in assessing the quality of life (QOL) of children with cerebral palsy (CP). QOL instruments are increasingly used to assess the effectiveness of interventions for children with CP. To assess QOL, there are both generic and condition-specific scales available. The Cerebral Palsy Quality of Life Questionnaire for Children (CP QOL-Child), the Child Health Questionnaire (CHQ), European generic health related quality of life questionnaire (KIDSCREEN), and the Pediatric Quality of Life Inventory are some of the most used instruments. Out of these QOL instruments, European generic health related quality of life questionnaire (KIDSCREEN) is a generic QOL questionnaire and KIDSCREEN-27 is a shorter version of the KIDSCREEN-52 questionnaire to evaluate HRQOL outcomes of children and adolescents between the ages of 8-18 years. . Generic scales are useful for comparing groups since they are designed to be relevant to all subgroups of the population. Because they do not include domains that are relevant to the sickness or disability, they are less useful for evaluating the effectiveness of an intervention for children with that illness or disability. Condition-specific scales are useful for detecting changes in QOL for a given condition and are designed to be applicable to a group. Instruments that are condition-specific can capture the domains of QOL that are significant to children and adolescents with CP. Although the psychometric properties of KIDSCREEN-27 tests have been extensively studied in healthy children and adolescents, there has been no research to date on the psychometric features of KIDSCREEN-27 instruments in cerebral palsy children and adolescents. Thus, the aims of this study were to examine and determine the construct-concurrent validity and reliability of the Turkish version of the self and proxy versions of KIDSCREEN-27 questionnaire in individuals with cerebral palsy Children with all typologies of cerebral palsy and their parents/caregivers Inclusion Criteria: Children with cerebral palsy who have sufficient intellectual level to answer KIDSCREEN-27' items Exclusion Criteria: children with severe intellectual disability

NCT0531xxxx/NCT05313711.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313711</url> </required_header> <id_info> <org_study_id>1-075-21</org_study_id> <nct_id>NCT05313711</nct_id> </id_info> <brief_title>Photographic Rhinometry Following Derm/Mohs Surgery for Skin Cancers</brief_title> <official_title>Study of Use of 'Photographic Rhinometry' Following Derm and Mohs Micrographic Surgery for Skin Cancers: A Follow-up Study</official_title> <sponsors> <lead_sponsor> <agency>NHS Grampian</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>NHS Grampian</source> <oversight_info> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Dermatological surgeons and patients routinely notice alterations in nasal shape and size following surgery and reconstruction. There is no uniform approach to objectively measure these changes. Anthropometric measurements are routinely used in rhinoplasty to assess outcomes, but they are time consuming and have not been reported as being used by dermatological surgeons. Soft-tissue measurements in profile photographs have been demonstrated to be useful for objective measurement of nasal change following surgery. This is a follow up study of the pilot study to assess the feasibility of photographic rhinometry as an objective tool, and (ii) to quantify changes following common dermatological surgical procedures on the nose. This follow-up study will aim to recruit a larger population sample to better quantify some of the changes occurring post-operatively. </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">November 17, 2021</start_date> <completion_date type="Anticipated">September 2023</completion_date> <primary_completion_date type="Anticipated">September 2023</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Cohort</observational_model> <time_perspective>Prospective</time_perspective> </study_design_info> <primary_outcome> <measure>The primary outcome is to quantify changes following common dermatological surgical procedures on the nose.</measure> <time_frame>"baseline, pre-intervention/procedure/surgery" and "immediately after the intervention/procedure/surgery"</time_frame> <description>Photographs will be taken with a camera in fixed zoom setting with a ruler placed in different anatomical sites before and after surgery.</description> </primary_outcome> <enrollment type="Anticipated">68</enrollment> <condition>Skin Cancer</condition> <eligibility> <study_pop> <textblock> 68 participants undergoing surgery for removal of Basal Cell Carcinoma (BCC), Squamous Cell Carcinoma (SCC). </textblock> </study_pop> <sampling_method>Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Gender: Male and female participants  - Type of cancer: Undergoing surgery for removal of Basal Cell Carcinoma (BCC), Squamous Cell Carcinoma (SCC))  Exclusion Criteria:  - Cases unable to consent to participation in the study  - Patients who are unable to complete the study assessments  - Patients below 18 years of age  - Patients undergoing surgery for other types of skin cancer </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>100 Years</maximum_age> </eligibility> <overall_official> <last_name>Sanjay Rajpara, MD</last_name> <role>Principal Investigator</role> <affiliation>NHS Grampian</affiliation> </overall_official> <overall_contact> <last_name>Sanjay Rajpara, MD</last_name> <phone>07916259270</phone> <email>sanjay.rajpara@nhs.scot</email> </overall_contact> <location> <facility> <name>Burnside House, Foresterhill Health Campus, Cornhill Road,</name> <address> <city>Aberdeen</city> <zip>AB25 2ZR</zip> <country>United Kingdom</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Sanjay Rajpara, MD</last_name> </contact> </location> <location> <facility> <name>The Hillingdon Hospitals NHS Foundation Trust</name> <address> <city>Uxbridge</city> <zip>UB8 3NN</zip> <country>United Kingdom</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Sanjay Rajpara, MD</last_name> </contact> </location> <location_countries> <country>United Kingdom</country> </location_countries> <verification_date>April 2022</verification_date> <study_first_submitted>November 3, 2021</study_first_submitted> <study_first_submitted_qc>April 5, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>April 5, 2022</last_update_submitted> <last_update_submitted_qc>April 5, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Skin Neoplasms</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Dermatological surgeons and patients routinely notice alterations in nasal shape and size following surgery and reconstruction. There is no uniform approach to objectively measure these changes. Anthropometric measurements are routinely used in rhinoplasty to assess outcomes, but they are time consuming and have not been reported as being used by dermatological surgeons. Soft-tissue measurements in profile photographs have been demonstrated to be useful for objective measurement of nasal change following surgery. This is a follow up study of the pilot study to assess the feasibility of photographic rhinometry as an objective tool, and (ii) to quantify changes following common dermatological surgical procedures on the nose. This follow-up study will aim to recruit a larger population sample to better quantify some of the changes occurring post-operatively. 68 participants undergoing surgery for removal of Basal Cell Carcinoma (BCC), Squamous Cell Carcinoma (SCC). Inclusion Criteria: - Gender: Male and female participants - Type of cancer: Undergoing surgery for removal of Basal Cell Carcinoma (BCC), Squamous Cell Carcinoma (SCC)) Exclusion Criteria: - Cases unable to consent to participation in the study - Patients who are unable to complete the study assessments - Patients below 18 years of age - Patients undergoing surgery for other types of skin cancer

NCT0531xxxx/NCT05313724.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313724</url> </required_header> <id_info> <org_study_id>2022-00174</org_study_id> <nct_id>NCT05313724</nct_id> </id_info> <brief_title>Mind-body Online Therapy in Gynecological Oncology</brief_title> <official_title>Mind-body Online Therapy in a Somatic Setting - a Randomized-controlled, Two-arm, Monocentric Study in Gynecological Oncology</official_title> <sponsors> <lead_sponsor> <agency>Katja Haemmerli Keller</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>University of Bern</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Cantonal Hospital of St. Gallen</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> In this randomized-controlled two-arm monocentric study with three measurement time points, the effectiveness and feasibility of an internet-based, therapist-guided mind-body self-help intervention for gynecological cancer patients with primary diagnoses is examined. Different modules (e.g., relaxation, mindfulness, stress management, disease management, nutrition and exercise behaviors) with a mind-body focus are available for the patients. The goal of the intervention is to improve or maintain the quality of life. </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">July 1, 2022</start_date> <completion_date type="Anticipated">August 31, 2024</completion_date> <primary_completion_date type="Anticipated">June 30, 2024</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Crossover Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Anxiety and depression</measure> <time_frame>Changes between week 0, 8, 16</time_frame> <description>German version of the questionnaire "Hospital Anxiety and Depression Scale" (HADS; (Herrmann et al., 1995; Herrmann-Lingen et al., 2011)</description> </primary_outcome> <primary_outcome> <measure>Depression (external assessment)</measure> <time_frame>Changes between week 0, 8, 16</time_frame> <description>German version of the questionnaire "Hamilton Depression Scale" (HAM-D17; Hamilton, 1960; Hamilton, 1986)</description> </primary_outcome> <primary_outcome> <measure>Somatization</measure> <time_frame>Changes between week 0, 8, 16</time_frame> <description>German version of the questionnaire "Patient Health Questionnaire" (PHQ-9; Gräfe et al., 2004; Kroenke et al., 2010)</description> </primary_outcome> <primary_outcome> <measure>General distress</measure> <time_frame>Week 0, Week 8, Week 16</time_frame> <description>German version of the questionnaire "Distress Thermometer" (BTH; Mehnert et al., 2006)</description> </primary_outcome> <primary_outcome> <measure>Psychological stress</measure> <time_frame>Changes between week 0, 8, 16</time_frame> <description>German version of the questionnaire "Symptom Checklist" (SCL-K11; Franke, 2001; Franke, 2002)</description> </primary_outcome> <primary_outcome> <measure>Impairment from cancer therapy</measure> <time_frame>Changes between week 0, 8, 16</time_frame> <description>German version of the questionnaire "Functional Assessment of Cancer Therapy" (FACT-G; Cella & Bonomi, 1996; Cella et al., 1993)</description> </primary_outcome> <primary_outcome> <measure>Insomnia (Severity)</measure> <time_frame>Changes between week 0, 8, 16</time_frame> <description>German version of the questionnaire "Insomnia Severity Index" (ISI; Morin, 1993)</description> </primary_outcome> <primary_outcome> <measure>Sleep quality</measure> <time_frame>Changes between week 0, 8, 16</time_frame> <description>German version of the questionnaire "Pittsburgh Sleep Quality Index" (PSQI; Buysse et al., 1989; Carpenter & Andrykowski, 1998)</description> </primary_outcome> <primary_outcome> <measure>Health-related quality of life</measure> <time_frame>Changes between week 0, 8, 16</time_frame> <description>German version of the questionnaire "Short Form 12" (SF-12; Morfeld et al., 2012)</description> </primary_outcome> <primary_outcome> <measure>SpO2 [%]</measure> <time_frame>Changes between week 0, 8, 16</time_frame> <description>Sleep diagnostic system "WatchPAT" (Neumedpro, Neuwirth Medical Products, 2021)</description> </primary_outcome> <primary_outcome> <measure>Peripheral arterial tone (PAT) [mmHG]</measure> <time_frame>Changes between week 0, 8, 16</time_frame> <description>Sleep diagnostic system "WatchPAT" (Neumedpro, Neuwirth Medical Products, 2021)</description> </primary_outcome> <secondary_outcome> <measure>Feasibility of the intervention (Patient-therapist relationship)</measure> <time_frame>Changes between week 8, 16</time_frame> <description>German version of the questionnaire "Working Alliance Inventory - Short Revised" (WAI-SR; Wilmers et al., 2008)</description> </secondary_outcome> <secondary_outcome> <measure>Feasibility of the intervention (Usability)</measure> <time_frame>Changes between week 8, 16</time_frame> <description>German version of the questionnaire "System Usability Scale" (SUS; Brooke, 1996)</description> </secondary_outcome> <secondary_outcome> <measure>Feasibility of the intervention (Patient satisfaction)</measure> <time_frame>Changes between week 8, 16</time_frame> <description>German questionnaire "Patient Satisfaction" (ZUF-8; Schmidt & Wittmann, 2002)</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">120</enrollment> <condition>Gynecologic Cancer</condition> <arm_group> <arm_group_label>Mind-Body Online Therapy</arm_group_label> <arm_group_type>Experimental</arm_group_type> </arm_group> <arm_group> <arm_group_label>TAU (treatment as usual)</arm_group_label> <arm_group_type>No Intervention</arm_group_type> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Mind-Body Online Therapy</intervention_name> <description>There are 8 different modules (e.g. relaxation, mindfulness, stress management, disease management, nutrition and exercise behavior) with a mind-body focus available for the patients to independently (time, location) work on.</description> <arm_group_label>Mind-Body Online Therapy</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - At least 18 years old  - Oncologic disease: first diagnosed; within the first 12 weeks of diagnosis, first-line treatment (either systemic treatment - including chemotherapy, hormonal therapy or targeted therapy - or radiotherapy), Notes: (1) Patients treated for first recurrence of a tumor previously treated with curative intent are also eligible. (2) Psychological distress is taken into account by stratification according to the stress thermometer. In research, this procedure corresponds to the current state-of-the-art. Individual subgroups (e.g. cancer stages) can then be studied post-hoc.  - Sufficient computer skills and internet access  - Availability of an emergency address  - Written informed consent by signing the informed consent form  Exclusion Criteria:  - Patient unable to provide written informed consent by signing informed consent form  - Insufficient knowledge of German  - Moderate to severe depressive symptomatology (BDI > 18; HAM-D17 ≥ 17) during T1 survey  - Suicidality (BDI suicidality item > 1; HAM-D17 suicidality item ≥ 2) in the context of the T1 survey  - Diagnosis of psychotic, bipolar, or other serious mental or somatic disorder requiring immediate treatment  - Male breast cancer patients </textblock> </criteria> <gender>Female</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <location> <facility> <name>Clinic for Psychosomatic Medicine and Consultation-Liaison Psychiatry</name> <address> <city>St.Gallen</city> <zip>9007</zip> <country>Switzerland</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Katja H H Keller</last_name> <phone>+41714941727</phone> <email>katja.haemmerlikeller@kssg.ch</email> </contact> </location> <location_countries> <country>Switzerland</country> </location_countries> <verification_date>September 2023</verification_date> <study_first_submitted>March 11, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>September 2, 2023</last_update_submitted> <last_update_submitted_qc>September 2, 2023</last_update_submitted_qc> <last_update_posted type="Actual">September 6, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor-Investigator</responsible_party_type> <investigator_affiliation>Cantonal Hospital of St. Gallen</investigator_affiliation> <investigator_full_name>Katja Haemmerli Keller</investigator_full_name> <investigator_title>Principal Investigator</investigator_title> </responsible_party> <keyword>Mind</keyword> <keyword>Body</keyword> <keyword>MBM</keyword> <keyword>Mind Body Medicin</keyword> <keyword>Online Therapy</keyword> <keyword>Online-Therapie</keyword> <keyword>Internettherapie</keyword> <keyword>Internet Therapy</keyword> <keyword>Selbsthilfeintervention</keyword> <keyword>Onkologie</keyword> <keyword>Oncology</keyword> <keyword>Krebs</keyword> <keyword>Cancer</keyword> <keyword>Gynäkologie</keyword> <keyword>Gynecology</keyword> <keyword>Frauenklinik</keyword> <keyword>Frauenheilkunde</keyword> <keyword>Psychosomatik</keyword> <keyword>Psychosomatics</keyword> <keyword>Psychotherapie</keyword> <keyword>Psychotherapy</keyword> <condition_browse>  <mesh_term>Neoplasms</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

In this randomized-controlled two-arm monocentric study with three measurement time points, the effectiveness and feasibility of an internet-based, therapist-guided mind-body self-help intervention for gynecological cancer patients with primary diagnoses is examined. Different modules (e.g., relaxation, mindfulness, stress management, disease management, nutrition and exercise behaviors) with a mind-body focus are available for the patients. The goal of the intervention is to improve or maintain the quality of life. Inclusion Criteria: - At least 18 years old - Oncologic disease: first diagnosed; within the first 12 weeks of diagnosis, first-line treatment (either systemic treatment - including chemotherapy, hormonal therapy or targeted therapy - or radiotherapy), Notes: (1) Patients treated for first recurrence of a tumor previously treated with curative intent are also eligible. (2) Psychological distress is taken into account by stratification according to the stress thermometer. In research, this procedure corresponds to the current state-of-the-art. Individual subgroups (e.g. cancer stages) can then be studied post-hoc. - Sufficient computer skills and internet access - Availability of an emergency address - Written informed consent by signing the informed consent form Exclusion Criteria: - Patient unable to provide written informed consent by signing informed consent form - Insufficient knowledge of German - Moderate to severe depressive symptomatology (BDI > 18; HAM-D17 ≥ 17) during T1 survey - Suicidality (BDI suicidality item > 1; HAM-D17 suicidality item ≥ 2) in the context of the T1 survey - Diagnosis of psychotic, bipolar, or other serious mental or somatic disorder requiring immediate treatment - Male breast cancer patients

NCT0531xxxx/NCT05313737.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313737</url> </required_header> <id_info> <org_study_id>MAMMoutreach</org_study_id> <nct_id>NCT05313737</nct_id> </id_info> <brief_title>Opt-in vs. Opt-out for Breast Cancer Screening</brief_title> <official_title>Opt-in vs. Opt-out Mammography Screening Outreach: a Randomized Controlled Trial</official_title> <sponsors> <lead_sponsor> <agency>VA Puget Sound Health Care System</agency> <agency_class>U.S. Fed</agency_class> </lead_sponsor> </sponsors> <source>VA Puget Sound Health Care System</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> This is a randomized controlled trial that will evaluate the effectiveness two different outreach strategies for a population-based breast cancer screening program at the VA Puget Sound among average risk female Veterans who are due for breast cancer screening. </textblock> </brief_summary> <detailed_description> <textblock> This is a prospective, randomized controlled trial that will evaluate the effectiveness of two different outreach strategies in improving adherence to breast cancer screening via mammography.  Average risk female Veterans who are due for breast cancer screening (defined as aged 45-75 with no previous history of bilateral mastectomy, not under hospice care, and alive at the time of screening) will be identified through administrative data.  Veterans eligible for enrollment into the trial will be randomized in a 1:1 allocation using permuted block randomization (with random block sizes of 2 and 4) to the following interventions:  Arm 1: Automated phone opt-in message Intervention Type: Audiocare message requiring Veteran to confirm that they would like to participate in screening and have consult sent Arm 2: Opt-out scheduling Intervention Type: Consult automatically sent and Veteran called to schedule screening  Randomization will be stratified within arms by prior screening status (prior screener vs. never screener).  The study's primary outcome of interest is screening completion at 100 days post randomization. The study's secondary outcome of interest is screening scheduling at 100 days post randomization. Subgroup analysis aim 1 will explore whether the differences in breast cancer screening completion between investigational groups varies according to the Veterans' race/ethnicity. Subgroup analysis aim 2 will explore whether the differences in breast cancer screening scheduling between investigational groups varies according to the Veterans' race/ethnicity. Enrollment in the trial will occur between March 1, 2022 and August 31, 2022. </textblock> </detailed_description> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">April 18, 2022</start_date> <completion_date type="Anticipated">August 31, 2022</completion_date> <primary_completion_date type="Anticipated">August 31, 2022</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Screening</primary_purpose> <masking>Triple (Participant, Care Provider, Investigator)</masking> </study_design_info> <primary_outcome> <measure>Percentage of mammograms completed at 100 days post randomization</measure> <time_frame>100 days post randomization</time_frame> <description>Percent of mammograms completed</description> </primary_outcome> <secondary_outcome> <measure>Percentage of mammograms scheduled at 100 days post randomization</measure> <time_frame>100 days post randomization</time_frame> <description>Percent of mammograms scheduled</description> </secondary_outcome> <other_outcome> <measure>Percentage of mammograms cancelled at 100 days post randomization</measure> <time_frame>100 days post randomization</time_frame> <description>Percent of mammograms cancelled</description> </other_outcome> <other_outcome> <measure>Percentage of mammograms active at 100 days post randomization</measure> <time_frame>100 days post randomization</time_frame> <description>Percent of mammograms active</description> </other_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">871</enrollment> <condition>Breast Cancer</condition> <arm_group> <arm_group_label>Automated phone opt-in message</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Audiocare message requiring Veteran to confirm that they would like to participate in screening and have consult sent</description> </arm_group> <arm_group> <arm_group_label>Opt-out scheduling</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Consult automatically sent and Veteran called to schedule screening</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Automated message</intervention_name> <description>Automated message via phone call (audiocare)</description> <arm_group_label>Automated phone opt-in message</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Opt-out scheduling</intervention_name> <description>Scheduling via non-automated phone call</description> <arm_group_label>Opt-out scheduling</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - female Veterans aged 45-75  - assigned to a primary care provider at the VA Puget Sound as of January 1, 2022 with at least 1 year of prior data available  - due for breast cancer screening (have not had a mammogram in the last 12 months)  Exclusion Criteria:  - must not be any indication of current receipt of hospice care  - no record of recent death in the administrative data  - not scheduled for either a screening or diagnostic mammogram within the following 12 weeks from assessment.  - not have a personal history of bilateral mastectomy. </textblock> </criteria> <gender>Female</gender> <gender_based>Yes</gender_based> <gender_description>female only</gender_description> <minimum_age>45 Years</minimum_age> <maximum_age>75 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Ashok Reddy, MD</last_name> <role>Principal Investigator</role> <affiliation>VA Puget Sound Health Care System</affiliation> </overall_official> <overall_official> <last_name>Stefanie Deeds, MD</last_name> <role>Principal Investigator</role> <affiliation>VA Puget Sound Health Care System</affiliation> </overall_official> <overall_contact> <last_name>Stefanie Deeds, MD</last_name> <phone>206-314-0507</phone> <email>Stefanie.Deeds@va.gov</email> </overall_contact> <overall_contact_backup> <last_name>Alaina Mori, MS</last_name> <phone>206-247-6782</phone> <email>Alaina.Mori@va.gov</email> </overall_contact_backup> <location> <facility> <name>VA Puget Sound Health Care System</name> <address> <city>Seattle</city> <state>Washington</state> <zip>98108</zip> <country>United States</country> </address> </facility> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>April 2022</verification_date> <study_first_submitted>February 1, 2022</study_first_submitted> <study_first_submitted_qc>April 5, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>April 5, 2022</last_update_submitted> <last_update_submitted_qc>April 5, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>VA Puget Sound Health Care System</investigator_affiliation> <investigator_full_name>Alaina Mori</investigator_full_name> <investigator_title>Staff Physician</investigator_title> </responsible_party> <keyword>Cancer Screening</keyword> <keyword>Adherence</keyword> <condition_browse>  <mesh_term>Breast Neoplasms</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

This is a randomized controlled trial that will evaluate the effectiveness two different outreach strategies for a population-based breast cancer screening program at the VA Puget Sound among average risk female Veterans who are due for breast cancer screening. This is a prospective, randomized controlled trial that will evaluate the effectiveness of two different outreach strategies in improving adherence to breast cancer screening via mammography. Average risk female Veterans who are due for breast cancer screening (defined as aged 45-75 with no previous history of bilateral mastectomy, not under hospice care, and alive at the time of screening) will be identified through administrative data. Veterans eligible for enrollment into the trial will be randomized in a 1:1 allocation using permuted block randomization (with random block sizes of 2 and 4) to the following interventions: Arm 1: Automated phone opt-in message Intervention Type: Audiocare message requiring Veteran to confirm that they would like to participate in screening and have consult sent Arm 2: Opt-out scheduling Intervention Type: Consult automatically sent and Veteran called to schedule screening Randomization will be stratified within arms by prior screening status (prior screener vs. never screener). The study's primary outcome of interest is screening completion at 100 days post randomization. The study's secondary outcome of interest is screening scheduling at 100 days post randomization. Subgroup analysis aim 1 will explore whether the differences in breast cancer screening completion between investigational groups varies according to the Veterans' race/ethnicity. Subgroup analysis aim 2 will explore whether the differences in breast cancer screening scheduling between investigational groups varies according to the Veterans' race/ethnicity. Enrollment in the trial will occur between March 1, 2022 and August 31, 2022. Inclusion Criteria: - female Veterans aged 45-75 - assigned to a primary care provider at the VA Puget Sound as of January 1, 2022 with at least 1 year of prior data available - due for breast cancer screening (have not had a mammogram in the last 12 months) Exclusion Criteria: - must not be any indication of current receipt of hospice care - no record of recent death in the administrative data - not scheduled for either a screening or diagnostic mammogram within the following 12 weeks from assessment. - not have a personal history of bilateral mastectomy.

NCT0531xxxx/NCT05313750.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313750</url> </required_header> <id_info> <org_study_id>20211112</org_study_id> <nct_id>NCT05313750</nct_id> </id_info> <brief_title>Efficacy and Safety of Sitafloxacin in the Treatment of Acute Exacerbation of Bronchiectasis in Adults</brief_title> <official_title>Efficacy and Safety of Sitafloxacin in the Treatment of Acute Exacerbation of Bronchiectasis in Adults :A Multi-center, Randomized, Evaluator-blinded, Levofloxacin Parallel-controlled Clinical Study</official_title> <sponsors> <lead_sponsor> <agency>Shanghai Pulmonary Hospital, Shanghai, China</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Shanghai Pulmonary Hospital, Shanghai, China</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The treatment of acute exacerbation of bronchiectasis requires comprehensive treatment, and antibacterial drug therapy is the key. The study is a multicenter, randomized, evaluator-blinded, levofloxacin parallel-controlled clinical study designed to evaluate the efficacy and safety of sitafloxacin in the treatment of acute exacerbations of bronchiectasis in adults. </textblock> </brief_summary> <detailed_description> <textblock> Acute exacerbation of bronchiectasis refers to changes in three or more ofthe following six symptoms in patients with bronchiectasis, including cough frequency, increased sputum volume or nature change, increased purulent sputum with or without wheezing, dyspnea, hemoptysis, and (or) general malaise, lasting for 48 hours or more, and clinicians consider that it is necessary to change the current therapeutic regimen for the condition. The treatment of acute exacerbation of bronchiectasis requires comprehensive treatment, and antibacterial drug therapy is the key. Sitafloxacin has a broad antibacterial spectrum. It has good in vivo and in vitro activities against gram-positive bacteria, gram-negative bacteria, anaerobic bacteria and atypical pathogens and it has excellent pharmacokinetic properties, rapid oral absorption, strong tissue permeability and no liver retention, and no inhibition to main liver drug enzymes of human and it shows good activity against many fluoroquinolone-resistant bacteria. The study aims to evaluate efficacy and safety of sitafloxacin in the treatment of acute exacerbations of bronchiectasis in adults. </textblock> </detailed_description> <overall_status>Active, not recruiting</overall_status> <start_date type="Actual">June 30, 2021</start_date> <completion_date type="Anticipated">June 30, 2024</completion_date> <primary_completion_date type="Anticipated">December 30, 2023</primary_completion_date> <phase>Phase 4</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Clinical effectiveness</measure> <time_frame>24days</time_frame> <description>The clinical effective rate was the percentage of improved cases in the analysis set cases.</description> </primary_outcome> <secondary_outcome> <measure>microbiological discontinuation of Administration</measure> <time_frame>10days</time_frame> <description>The effective rate of microbiology is the percentage of cases of clearance, hypothetical clearance, replacement and reinfection in the number of evaluable cases in the analysis set.</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">256</enrollment> <condition>Acute Exacerbation of Bronchiectasis</condition> <arm_group> <arm_group_label>sitafloxacin group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Oral sitafloxacin (0.1g one time daily) for 10 days</description> </arm_group> <arm_group> <arm_group_label>levofloxacin group</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Oral levofloxacin (0.4g one time daily) for 10 days</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>anti-infective therapy sitafloxacin</intervention_name> <description>anti-infective therapy</description> <arm_group_label>sitafloxacin group</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>anti-infective therapy levofloxacin</intervention_name> <description>anti-infective therapy</description> <arm_group_label>levofloxacin group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. Patients who older than 18 years old and are diagnosed with acute exacerbations of bronchiectasis Acute exacerbation of bronchiectasis refers to changes in three or more ofthe following six symptoms in patients, including cough frequency, increased sputum volume or nature change, increased purulent sputum with or without wheezing, dyspnea, hemoptysis, and (or) general malaise, lasting for 48 hours or more, and clinicians consider that it is necessary to change the current therapeutic regimen for the condition; It should also be noted that left and right cardiac insufficiency, arrhythmia, pleural effusion, pulmonary embolism, pneumothorax and pneumonia should be noted.  2. Patients who have not accepted antibacterial drug therapy within 48 hours before initiation of administration or who have accepted other antibacterial drug therapy within 48 hours before initiation of administration but not more than 24 hours (excluding use of quinolones), and still present with apparent symptoms of infection  Exclusion Criteria:  Patients complying with any of the following exclusion criteria cannot be enrolled into this trail:  1. Bronchiectaticpatientswith previous sputum examinations suggesting the presence of bronchiectasis of pathogenic  - Page 3 of 5 - microorganisms resistant to quinolone drugscomplicated with chronic respiratory failure  2. Patients with a previous stable phase BSI score greater than 9  3. Inhaled, oral or intravenous quinolone antibiotics have been used within 1 week before enrollment.  4. Patients who have a history of allergy to any quinolone or fluoroquinolone  5. Patients who have a medical history of pathological changes in the muscle tendon caused by quinolones or fluoroquinolones;  6. Complicatingbronchial asthma, allergic bronchopulmonary aspergillosis, or active tuberculosis, or active non-tuberculous mycobacterial infection that requires standardized treatment;  7. A history of complicating serious cardiovascular diseases, hematopoietic system diseases, etc. (such as: congestive heart failure, clinically significant coronary heart disease, stroke, myocardial infarction and/or stroke that occurred within half a year, clinically significant arrhythmia, known aortic aneurysm, poorly controlled hypertension (systolic blood pressure> 160mmHg, or diastolic blood pressure> 100mmHg, etc.in two or more consecutive detections);  8. Moderate hemoptysis (>30ml in 24h);  9. Complicatingserious systemic diseases and mental disorders;  10. Complicatingdiabetic patients with poor control or fasting blood glucose> 10mmol/L;  11. Complicatingmalignant tumor;  12. Complicating myasthenia gravis and Parkinson's disease;  13. Patients with abnormal liver function test, withAST (GOT) and/or ALT (GPT) higher than 3 times the upper limit of normal, and/or total bilirubin higher than twice the upper limit of normal;  14. Patients with moderate or severe renal hypofunction, withendogenous creatinine clearance rate <50 ml/min (if the examination is not performed, the clearance rate may be calculated from the serum creatinine value using a formula)*;  15. *Cockcroft-Gault Formula i. Male:eCcr(ml/min)=[(140 - age)  ×weight(kg)]/[72 ×serum creatinine(mg/dl)] ii. Female:eCcr(ml/ min)=[(140 - age) ×weight(kg) × 0.85]/[72 ×serum creatinine(mg/ dl)] or, iii. Male: eCcr(ml/min)= [(140 - age)×weight(kg)×1.23]/serum creatinine(µmol/l) iv. Male:eCcr(ml/min)= [(140 - age)×weight× 1.04]/serum creatinine(µmol/l)  16. Patients with a medical history of prolonged QTc interval,or requiring use of drugs to treat prolonged QTc interval (e.g., Class I or III anti-arrhythmic, as detailed in Appendix 1), or suffering serious cardiac insufficiency (NYHA Functional Class ≥ III, as detailed in Appendix 2);  17. Patients with a medical history of epileptic seizures, or mental disease that may influence the compliance withthe protocol, or with suicide risk, or a history of alcohol or illicit drug abuse;  18. Immunocompromised patients usingglucocorticoids (with the total dose equivalent to prednisone daily or acourse of treatment of more than 2 weeks) or immunosuppressants, etc.;  19. Pregnant or lactating women or women of childbearing age who are preparing to conceive;  20. Those who have participatedin other clinical trials within 3 months prior to screening. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <location> <facility> <name>Shanghai pulmonary hospital</name> <address> <city>Shanghai</city> <state>Shanghai</state> <zip>200433</zip> <country>China</country> </address> </facility> </location> <location_countries> <country>China</country> </location_countries> <verification_date>April 2022</verification_date> <study_first_submitted>November 12, 2021</study_first_submitted> <study_first_submitted_qc>April 5, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>April 5, 2022</last_update_submitted> <last_update_submitted_qc>April 5, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Shanghai Pulmonary Hospital, Shanghai, China</investigator_affiliation> <investigator_full_name>Jin-Fu Xu</investigator_full_name> <investigator_title>Chief of Department of Pulmonary and Critical Care Medicine</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Bronchiectasis</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Levofloxacin</mesh_term> <mesh_term>Sitafloxacin</mesh_term> <mesh_term>Anti-Infective Agents</mesh_term> </intervention_browse>  </clinical_study>

The treatment of acute exacerbation of bronchiectasis requires comprehensive treatment, and antibacterial drug therapy is the key. The study is a multicenter, randomized, evaluator-blinded, levofloxacin parallel-controlled clinical study designed to evaluate the efficacy and safety of sitafloxacin in the treatment of acute exacerbations of bronchiectasis in adults. Acute exacerbation of bronchiectasis refers to changes in three or more ofthe following six symptoms in patients with bronchiectasis, including cough frequency, increased sputum volume or nature change, increased purulent sputum with or without wheezing, dyspnea, hemoptysis, and (or) general malaise, lasting for 48 hours or more, and clinicians consider that it is necessary to change the current therapeutic regimen for the condition. The treatment of acute exacerbation of bronchiectasis requires comprehensive treatment, and antibacterial drug therapy is the key. Sitafloxacin has a broad antibacterial spectrum. It has good in vivo and in vitro activities against gram-positive bacteria, gram-negative bacteria, anaerobic bacteria and atypical pathogens and it has excellent pharmacokinetic properties, rapid oral absorption, strong tissue permeability and no liver retention, and no inhibition to main liver drug enzymes of human and it shows good activity against many fluoroquinolone-resistant bacteria. The study aims to evaluate efficacy and safety of sitafloxacin in the treatment of acute exacerbations of bronchiectasis in adults. Inclusion Criteria: 1. Patients who older than 18 years old and are diagnosed with acute exacerbations of bronchiectasis Acute exacerbation of bronchiectasis refers to changes in three or more ofthe following six symptoms in patients, including cough frequency, increased sputum volume or nature change, increased purulent sputum with or without wheezing, dyspnea, hemoptysis, and (or) general malaise, lasting for 48 hours or more, and clinicians consider that it is necessary to change the current therapeutic regimen for the condition; It should also be noted that left and right cardiac insufficiency, arrhythmia, pleural effusion, pulmonary embolism, pneumothorax and pneumonia should be noted. 2. Patients who have not accepted antibacterial drug therapy within 48 hours before initiation of administration or who have accepted other antibacterial drug therapy within 48 hours before initiation of administration but not more than 24 hours (excluding use of quinolones), and still present with apparent symptoms of infection Exclusion Criteria: Patients complying with any of the following exclusion criteria cannot be enrolled into this trail: 1. Bronchiectaticpatientswith previous sputum examinations suggesting the presence of bronchiectasis of pathogenic - Page 3 of 5 - microorganisms resistant to quinolone drugscomplicated with chronic respiratory failure 2. Patients with a previous stable phase BSI score greater than 9 3. Inhaled, oral or intravenous quinolone antibiotics have been used within 1 week before enrollment. 4. Patients who have a history of allergy to any quinolone or fluoroquinolone 5. Patients who have a medical history of pathological changes in the muscle tendon caused by quinolones or fluoroquinolones; 6. Complicatingbronchial asthma, allergic bronchopulmonary aspergillosis, or active tuberculosis, or active non-tuberculous mycobacterial infection that requires standardized treatment; 7. A history of complicating serious cardiovascular diseases, hematopoietic system diseases, etc. (such as: congestive heart failure, clinically significant coronary heart disease, stroke, myocardial infarction and/or stroke that occurred within half a year, clinically significant arrhythmia, known aortic aneurysm, poorly controlled hypertension (systolic blood pressure> 160mmHg, or diastolic blood pressure> 100mmHg, etc.in two or more consecutive detections); 8. Moderate hemoptysis (>30ml in 24h); 9. Complicatingserious systemic diseases and mental disorders; 10. Complicatingdiabetic patients with poor control or fasting blood glucose> 10mmol/L; 11. Complicatingmalignant tumor; 12. Complicating myasthenia gravis and Parkinson's disease; 13. Patients with abnormal liver function test, withAST (GOT) and/or ALT (GPT) higher than 3 times the upper limit of normal, and/or total bilirubin higher than twice the upper limit of normal; 14. Patients with moderate or severe renal hypofunction, withendogenous creatinine clearance rate <50 ml/min (if the examination is not performed, the clearance rate may be calculated from the serum creatinine value using a formula)*; 15. *Cockcroft-Gault Formula i. Male:eCcr(ml/min)=[(140 - age) ×weight(kg)]/[72 ×serum creatinine(mg/dl)] ii. Female:eCcr(ml/ min)=[(140 - age) ×weight(kg) × 0.85]/[72 ×serum creatinine(mg/ dl)] or, iii. Male: eCcr(ml/min)= [(140 - age)×weight(kg)×1.23]/serum creatinine(µmol/l) iv. Male:eCcr(ml/min)= [(140 - age)×weight× 1.04]/serum creatinine(µmol/l) 16. Patients with a medical history of prolonged QTc interval,or requiring use of drugs to treat prolonged QTc interval (e.g., Class I or III anti-arrhythmic, as detailed in Appendix 1), or suffering serious cardiac insufficiency (NYHA Functional Class ≥ III, as detailed in Appendix 2); 17. Patients with a medical history of epileptic seizures, or mental disease that may influence the compliance withthe protocol, or with suicide risk, or a history of alcohol or illicit drug abuse; 18. Immunocompromised patients usingglucocorticoids (with the total dose equivalent to prednisone daily or acourse of treatment of more than 2 weeks) or immunosuppressants, etc.; 19. Pregnant or lactating women or women of childbearing age who are preparing to conceive; 20. Those who have participatedin other clinical trials within 3 months prior to screening.

NCT0531xxxx/NCT05313763.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313763</url> </required_header> <id_info> <org_study_id>2194</org_study_id> <nct_id>NCT05313763</nct_id> </id_info> <brief_title>The Effect of Kinesio Taping With Cervical Spondylosis</brief_title> <official_title>The Effect of Kinesio Taping on Cervical Proprioception Sense, Pain, Disability and Quality of Life in Patients With Cervical Spondylosis</official_title> <sponsors> <lead_sponsor> <agency>Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The investigators aimed to evaluate the effect of kinesio tape application on the sense of proprioception in patients with cervical spondylosis.This research aims to determine the relationship between the sense of cervical proprioception and neck pain intensity, neck disability and quality of life, and to determine the relationship between cervical spinal MRI findings and cervical proprioception. Studies conducted to date are limited to the evaluation of patients who underwent kinesio tape for neck pain in terms of joint range of motion, pain, and disability. In a study examining the relationship between cervical kinesio-tape application and cervical proprioception sense; The patient group consists of the young population and the patient evaluation was made immediately after the end of the treatment. The aim of this study is to evaluate the relationship of kinesio tape applied to the elderly patient group with cervical spondylosis, where the cervical proprioception sense is more affected, with cervical proprioception sense in the mid-term and to examine its relationship with cervical spinal MRI phenotypes. The possible relationship between proprioceptive sensory deficit and joint degeneration is based on a combination of neuromuscular control dysfunction and periarticular degeneration. Thus, the investigators aimed to improve the proprioceptive sense, reduce pain and increase functionality in the elderly patient group with kinesio-tape in the study. </textblock> </brief_summary> <detailed_description> <textblock> Cervical spondylosis is the aging of the cervical spine as a result of degeneration of the intervertebral discs. In this process, shortening of the disc distance in the cervical spine, thickening of the ligaments, development of ligamentous and segmental instability, arthrosis and loss of lordosis in the facet joints are observed. Degenerative disc changes are often seen as bulging, protrusion, extrusion, and sequestration. Cervical discs are thicker anteriorly than posteriorly, resulting in normal lordosis. In the degenerative process, first of all, the height decreases in the anterior of the disc and loss of lordosis occurs. The process progresses with aging and causes axial neck pain and/or disc herniations due to degenerative changes, intraspinal canal and foraminal stenosis, secondary radiculopathy or myelopathy symptoms.  Although there is no complete consensus about the pathophysiological mechanism that causes cervical degenerative disc disease, several hypotheses have been developed. Although spondylosis is seen as a normal part of aging according to the current approach, certain occupations, repetitive movements and traumas can accelerate the process. Only a single factor has no chance to trigger the degenerative process. In other words, many factors of the normal aging process affect cervical spondylolysis. Although age-related degeneration is the primary cause, cervical disc injuries may affect this degenerative process in younger patients.  Degeneration in the cervical spine may only present with neck pain if there is no compression on the spinal cord or nerve root. This degeneration causes radicular pain in the occipital region, posterior neck, shoulder or arm due to inflammation due to extrinsic compression in the nerve root. Patients with cervical spondylosis usually present with complaints of pain, tingling, numbness, and weakness in the upper extremities, resulting in significant disability and functional limitations.  Proprioception is a sense of bodily movement position that includes a sense of joint position and a sense of movement (kinesthesia). Proprioceptive information reaches the central nervous system via the afferent pathway, which contributes to movement and postural neuromuscular control. The cervical muscles have an abundant muscle spindle density reflecting a rich proprioceptive system, which contributes to enhanced sensorimotor function and therefore plays an important role in maintaining effective motor control and static and dynamic postures.  Studies have shown that sense of cervical position is vital in maintaining joint stability under static and dynamic conditions, and impaired proprioception may predispose to the development of pain. Cervical proprioception is measured by joint position error in degrees. In cervical spondylosis, impaired cervical proprioception is the result of position sensitivity being affected primarily by impairment in the muscles, joints, or capsules and secondarily by changes in afferent proprioceptive adjustment and integration. Impaired position sense impairs both neuronal and muscular control of normal cervical joint function, resulting in unbalanced muscle strength and placing the joint at risk for trauma.  Conservative treatment of spondylosis includes transcutaneous electrical nerve stimulation (TENS), heat, traction, exercise, postural training, massage, kinesiotaping, and numerous manual therapy and mobilization techniques. Recent studies investigating treatment modalities for neck pain associated with cervical spondylosis have shown that combined treatments are more effective than exercise alone.  The kinesio-tape technique has been developed with the philosophy that positive results can be obtained with a taping method similar to the structural properties and flexibility of human skin, without limiting the joint movements of the kinesio tape. Latex-free kinesio-tape is composed of 100% cotton and elastic polymer fibers. Dr. According to Kase, muscle dysfunction is one of the leading problems originating from the musculoskeletal system. Dr. Kase argues that taping the muscle is more effective than immobilizing the joint circumference with tape. After injury or overuse, the elastic properties of the muscle deteriorate. For this reason, kinesiology tapes are designed to be similar to the elastic properties of the muscle, to be adhesive, to have a lifting effect on the skin to which kinesiology tapes are applied, and to allow air circulation between the skin and the external environment. The technique is based on 3 basic concepts. These are space, motion, and cooling. As painful and inflamed muscles swell due to edema, the area where muscles are located narrows. When kinesio-taping is applied, the skin and subcutaneous interstitial area are increased by lifting the skin, thus increasing circulation and movement. This reduces pain and improves performance. The neuromuscular system is retrained. Injuries are prevented, circulation is accelerated and tissue healing is ensured.  The idea that kinesiotaping can regulate proprioception by affecting cutaneous mechanoreceptors has been put forward by some researchers. Kinesiolo-tape affects mechanoreceptors sensitive to tension, loading, pressure and shear forces by changing the length of the skin and superficial fascia and the tension of the muscle fibers. This can lead to significant changes in muscle movement and tone. Slow pressure stimulation, particularly on connective tissue, alters the effect on mechanoreceptors and may affect gamma motor neuron firing and muscle tone regulation. Kinesiotape can be particularly effective in increasing proprioceptive ability only in the middle of the movement. In this range, ligament mechanoreceptors are inactive, whereas muscle receptors are active. Understanding joint movement and position can be effective in the development of proprioception by stimulating sensory afferent transmission. Cutaneous afferent stimuli interact with the motor cortex and thus affect the muscle excitability of the central nervous system. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">December 2, 2021</start_date> <completion_date type="Actual">November 30, 2022</completion_date> <primary_completion_date type="Actual">November 30, 2022</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>Double (Participant, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>change in cervical proprioception after treatment</measure> <time_frame>change in cervical proprioception will be evaluated 1 month after treatment</time_frame> <description>It is measured by the cervical joint position error test. This test assesses whether the patient can return to the previous neutral position after maximum rotation of the head in the coronal and sagittal planes. A headlamp with a laser light source in the middle, an eye patch, a 40 cm diameter target with trigonometric segments, a metal and magnetic apparatus used to adjust the target according to its neutral position are used as equipment.The patient is seated in a chair with his eyes closed in a neutral position; The target is positioned at a distance of 90 cm. The target is a 40 cm diameter circle and contains five separate small circles to which the grading is applied. These small circles are called 1 degree, 2 degrees, 3 degrees, 4.5 degrees, and 6 degrees, which allows to evaluate the deviation. The target is adjusted according to the patient's height.</description> </primary_outcome> <secondary_outcome> <measure>cervical joint range of motion</measure> <time_frame>Evaluations will be made before treatment, immediately after treatment, and 1 month after treatment.</time_frame> <description>It is measured with a goniometer. While all movements of the neck are evaluated as active and passive, they are evaluated in terms of limitation and pain. Normal joint ranges of motion in the cervical region are: 80-90 degrees of flexion, 20-45 degrees of lateral flexion, 70 degrees of extension and 90 degrees of rotation.</description> </secondary_outcome> <secondary_outcome> <measure>Hand grip strength</measure> <time_frame>Evaluations will be made before treatment, immediately after treatment, and 1 month after treatment.</time_frame> <description>It will be evaluated with the Jamar hydraulic hand dynamometer.The purpose of this test is to test the maximum isometric contraction strength of the hand and forearm muscles. A hand grip dynamometer is required to perform the test (such as Jamar™, Camry™, Smedley™). Dynamometer Examples Grip strength should be evaluated while the patient is sitting in the chair. The elbows are kept close to the body and at 90° flexion. The wrist is in neutral. The person to be measured is asked to grasp the dynamometer and squeeze it as hard as he can. The test result is determined by calculating the average of the three measurements. Norm values for measurement: 47-40kg for men aged 20-69 (left hand 2 kg less) 30-24kg for women (1.5-2kg less for left hand),</description> </secondary_outcome> <secondary_outcome> <measure>Upper extremity functionality</measure> <time_frame>Evaluations will be made before treatment, immediately after treatment, and 1 month after treatment.</time_frame> <description>Upper extremity functionality to be measured by upper extremity functional index (UEFI).The Upper Extremity Functional Index was developed in 2001 to evaluate the functional disability of the upper extremity (50). The first version consists of 20 questions. There is also a version of the scale that was reduced to 15 questions after Rasch analysis (51.52). Aytar et al. In 2015, Turkish cultural adaptation, validity and reliability study was carried out. Scoring is calculated based on Likert scoring (0: extremely difficult/not able to do at all, 4: no difficulty). The scoring of the version consisting of 15 questions is between 0-100 points, and a high score indicates a high level of activity. This scale, which is specific to the region, is completed in about 5 minutes.</description> </secondary_outcome> <secondary_outcome> <measure>Neck pain</measure> <time_frame>Evaluations will be made before treatment, immediately after treatment, and 1 month after treatment.</time_frame> <description>Neck pain will be measured with the Visual Analog Scale (VAS).The Visual Analog Scale (VAS) is used to convert some values that cannot be measured numerically. Two end definitions of the parameter to be evaluated are written at the two ends of a 100 mm line, and the patient is asked to indicate where on this line their situation is appropriate by drawing a line or by placing a dot or pointing. For example, for pain, I have no pain at one end and very severe pain at the other end and the patient marks his/her current state on this line. The length of the distance from the point where there is no pain to the point marked by the patient indicates the patient's pain.</description> </secondary_outcome> <secondary_outcome> <measure>Neuropathic pain</measure> <time_frame>Evaluations will be made before treatment, immediately after treatment, and 1 month after treatment.</time_frame> <description>Neuropathic pain will be measured with the Douleur Neuropathique 4 Questions (DN4).Douleur neuropathique en 4 questions (DN4) asks 7 questions about symptoms and 3 questions about clinical management. The DN4 scoring is an easy tool and a total score of 4 or more out of 10 indicates neuropathic pain. With the same results, 7 sensory discriminators can be used as a self-report tool. DN4 has been shown to have 83% sensitivity and 90% specificity.</description> </secondary_outcome> <secondary_outcome> <measure>Neck disability</measure> <time_frame>Evaluations will be made before treatment, immediately after treatment, and 1 month after treatment.</time_frame> <description>Neck disability will be measured with the Neck Disability Index (NDI).This form consists of 10 questions. The intensity of pain in the neck, the difficulty in personal care, the ability to lift a load, the interaction of reading with neck pain, headaches, difficulty in doing work, driving, difficulty in sleeping and leisure activities are questioned. Each question scores between 0 and 5 points, and an increased score is associated with increased disability. If the volunteer does not drive, does not do leisure time activities and does not work in a job, these questions are calculated by subtracting them from the scoring. The neck disability rate of the patient is calculated by multiplying the score the volunteers get with the maximum score they can get, multiplied by 100. As this rate increases, it is accepted that the patient's neck-related disability increases.</description> </secondary_outcome> <secondary_outcome> <measure>SF-36</measure> <time_frame>Evaluations will be made before treatment, immediately after treatment, and 1 month after treatment.</time_frame> <description>Quality of life will be measured with the 36-Item Short Form Survey (SF-36).The primary feature of the SF-36 is that it is a self-assessment scale. It is considered among the advantages of the scale that it can be filled in as little as five minutes, and that it can evaluate the positive as well as the negative aspects of the health status. The scale consists of 36 items and they provide the measurement of 8 dimensions; physical function (10 items), social function (2 items), role limitations due to physical functions (4 items), role limitations due to emotional problems (3 items), mental health (5 items), energy/vitality (4 items), pain (2 items) and general perception of health (5 items). The scale is evaluated considering the last 4 weeks. In order to create the acute form, a form evaluating the last 1 week was also applied.</description> </secondary_outcome> <secondary_outcome> <measure>Mood</measure> <time_frame>Evaluations will be made before treatment, immediately after treatment, and 1 month after treatment.</time_frame> <description>Mood will be measured with the Hospital Anxiety and Depression Scale (HAD).It is a self-assessment scale developed to determine the risk of anxiety and depression in patients with physical illness and those applying to primary health care services, and to measure its level and change in severity (Zigmond and Snaith 1983). It was translated into Turkish by Aydemir et al. and its validity and reliability study was conducted. It has anxiety and depression subscales. The internal consistency (Cronbach alpha) of the scale was 0.8525 for the anxiety subscale and 0.7784 for the depression subscale. The item-total score correlation coefficients ranged between 0.8161-0.8547 in the anxiety subscale and between 0.7374-0.7795 in the depression subscale. In two-half reliability, r=0.8532 for anxiety subscale and 0.8069 for depression subscale. It consists of 14 questions in total. The minimum score for the anxiety and depression subscales is 0, and the maximum score is 21.</description> </secondary_outcome> <secondary_outcome> <measure>Cervical spinal MRI</measure> <time_frame>Evaluations will be made before treatment</time_frame> <description>Cervical spinal MRI will be evaluated with Cervical Phenotype Index (CPI).It is an index that comprehensively evaluates degenerative cervical spine findings, and it has been found to be associated with patient-reported NDI and VAS, and is predictive of prognosis for operated patients. This index scores C2-T1 vertebrae on disc degeneration, disc space narrowing, disc displacement, Modic changes, end plate abnormalities (e.g. schmorl's nodules), high-density regions (HIZs), osteophytes.</description> </secondary_outcome> <number_of_arms>3</number_of_arms> <enrollment type="Actual">69</enrollment> <condition>Cervical Spondylosis</condition> <arm_group> <arm_group_label>Conventional physical therapy group</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Conventional physical therapy is the first line of treatment in cervical spondylosis.</description> </arm_group> <arm_group> <arm_group_label>Kinesio-tape Group</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Conventional rehabilitation program will be applied five days a week, 3 weeks, a total of 15 sessions. Kinesio-tape applications will be applied in 6 sessions during conventional physical therapy, twice a week at four-day intervals.</description> </arm_group> <arm_group> <arm_group_label>Sham kinesio-tape Group</arm_group_label> <arm_group_type>Sham Comparator</arm_group_type> <description>Conventional rehabilitation program will be applied five days a week, 3 weeks, a total of 15 sessions. Sham kinesio-tape applications will be applied twice a week at four-day intervals, 6 sessions during conventional physical therapy.</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>conventional physical therapy</intervention_name> <description>A hotpack will be applied to the neck area for 15 minutes in the prone position of the patients. Conventional type Tens with a frequency of 50 Hz and a pulse duration of <150 microseconds will be applied for 20 minutes, taking the painful area to the center. Ultrasound will be applied to the patients for 5 minutes with a dosage of 1-1.5 watts/cm2. Cervical joint range of motion exercises, stretching exercises for trapezius, scalenia, rhomboid, levator scapulae, pectoral and suboccipital muscles will be applied, then cervical isometric strengthening exercises and stabilization exercises will be carried out in a controlled manner. Conventional physical therapy will be applied by the same physiotherapist 5 days a week for 3 weeks.</description> <arm_group_label>Conventional physical therapy group</arm_group_label> <arm_group_label>Kinesio-tape Group</arm_group_label> <arm_group_label>Sham kinesio-tape Group</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Active Kinesiotaping</intervention_name> <description>For kinesio-tape application, a 20 cm long Y strip and a 15 cm long I strip tape will be prepared. The patient will flex his neck, and the application will be started from the midline of the upper thoracic vertebrae. Initially, 4-5 cm stretching will be applied, and the arms of the Y strip will be adhered to the cervical paravertebral muscles without stretching. I strip will be applied to the painful area with the area correction technique, with maximum stretching in the middle and without stretching the ends. The applications will be made by the same physiatrist with 7 years of clinical experience.</description> <arm_group_label>Kinesio-tape Group</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Sham Kinesiotaping</intervention_name> <description>For Sham kinesio-tape application, a 20 cm long Y strip and a 15 cm long I strip tape will be prepared. The patient will flex his neck, the application will be started from the midline of the upper thoracic vertebrae, and the Y and I bands will be applied without stretching. The applications will be made by the same physiatrist with 7 years of clinical experience.</description> <arm_group_label>Sham kinesio-tape Group</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Being over 50 and under 70  - Moderate to severe neck pain and limitation in neck movements according to the Visual Analogue Scale, which has been present for at least 3 months  - Presence of cervical degeneration radiologically  - being literate  - Giving consent by agreeing to participate in the study  - Having an MRI registered in the system in the last 1 (one) year  Exclusion Criteria:  - Being under 50 and over 70  - Neck pain that has been present for less than 3 months  - Patients with positive Spurling test and radiculopathy  - Patients with nerve root compression and stenosis in the evaluation with cervical MRI within the last 1 year  - History of neurological disease, history of neck trauma, cervical myelopathy, any inflammatory arthritis, tumor, infection involving the cervical spine, and vertebrobasilar artery insufficiency  - Cervical spinal surgery history  - Vestibular disorder  - vision problems  - cognitive impairment  - polyneuropathy  - B12 and vitamin D deficiency (Patients with abnormal values for B12 and vitamin D in the last three months through the hospital examination result system will not be included in the study)  - No known diagnosis of psychotic disorder  - Active skin infection, cellulitis, open wounds, presence of cancerous tissue, extreme obesity and allergy to adhesives containing polyacrylate  - not being literate  - Patients who received physical therapy, injection, manual therapy, kinesio-tape treatment from the neck region in the last 3 months. </textblock> </criteria> <gender>All</gender> <minimum_age>50 Years</minimum_age> <maximum_age>70 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Emre Ata, Ass.Prof.</last_name> <role>Principal Investigator</role> <affiliation>Sultan II. Abdulhamidhan Training and Research Hospital</affiliation> </overall_official> <location> <facility> <name>Sultan 2. Abdulhamid Han Training and Research Hospital</name> <address> <city>Istanbul</city> <country>Turkey</country> </address> </facility> </location> <location_countries> <country>Turkey</country> </location_countries> <verification_date>December 2022</verification_date> <study_first_submitted>March 23, 2022</study_first_submitted> <study_first_submitted_qc>April 5, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>December 5, 2022</last_update_submitted> <last_update_submitted_qc>December 5, 2022</last_update_submitted_qc> <last_update_posted type="Actual">December 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey</investigator_affiliation> <investigator_full_name>Emre Ata, Assoc Prof</investigator_full_name> <investigator_title>Associate Proffesor</investigator_title> </responsible_party> <keyword>Cervical Spondylosis</keyword> <keyword>kinesio-tape</keyword> <keyword>cervical proprioception</keyword> <condition_browse>  <mesh_term>Spondylosis</mesh_term> </condition_browse>  </clinical_study>

The investigators aimed to evaluate the effect of kinesio tape application on the sense of proprioception in patients with cervical spondylosis.This research aims to determine the relationship between the sense of cervical proprioception and neck pain intensity, neck disability and quality of life, and to determine the relationship between cervical spinal MRI findings and cervical proprioception. Studies conducted to date are limited to the evaluation of patients who underwent kinesio tape for neck pain in terms of joint range of motion, pain, and disability. In a study examining the relationship between cervical kinesio-tape application and cervical proprioception sense; The patient group consists of the young population and the patient evaluation was made immediately after the end of the treatment. The aim of this study is to evaluate the relationship of kinesio tape applied to the elderly patient group with cervical spondylosis, where the cervical proprioception sense is more affected, with cervical proprioception sense in the mid-term and to examine its relationship with cervical spinal MRI phenotypes. The possible relationship between proprioceptive sensory deficit and joint degeneration is based on a combination of neuromuscular control dysfunction and periarticular degeneration. Thus, the investigators aimed to improve the proprioceptive sense, reduce pain and increase functionality in the elderly patient group with kinesio-tape in the study. Cervical spondylosis is the aging of the cervical spine as a result of degeneration of the intervertebral discs. In this process, shortening of the disc distance in the cervical spine, thickening of the ligaments, development of ligamentous and segmental instability, arthrosis and loss of lordosis in the facet joints are observed. Degenerative disc changes are often seen as bulging, protrusion, extrusion, and sequestration. Cervical discs are thicker anteriorly than posteriorly, resulting in normal lordosis. In the degenerative process, first of all, the height decreases in the anterior of the disc and loss of lordosis occurs. The process progresses with aging and causes axial neck pain and/or disc herniations due to degenerative changes, intraspinal canal and foraminal stenosis, secondary radiculopathy or myelopathy symptoms. Although there is no complete consensus about the pathophysiological mechanism that causes cervical degenerative disc disease, several hypotheses have been developed. Although spondylosis is seen as a normal part of aging according to the current approach, certain occupations, repetitive movements and traumas can accelerate the process. Only a single factor has no chance to trigger the degenerative process. In other words, many factors of the normal aging process affect cervical spondylolysis. Although age-related degeneration is the primary cause, cervical disc injuries may affect this degenerative process in younger patients. Degeneration in the cervical spine may only present with neck pain if there is no compression on the spinal cord or nerve root. This degeneration causes radicular pain in the occipital region, posterior neck, shoulder or arm due to inflammation due to extrinsic compression in the nerve root. Patients with cervical spondylosis usually present with complaints of pain, tingling, numbness, and weakness in the upper extremities, resulting in significant disability and functional limitations. Proprioception is a sense of bodily movement position that includes a sense of joint position and a sense of movement (kinesthesia). Proprioceptive information reaches the central nervous system via the afferent pathway, which contributes to movement and postural neuromuscular control. The cervical muscles have an abundant muscle spindle density reflecting a rich proprioceptive system, which contributes to enhanced sensorimotor function and therefore plays an important role in maintaining effective motor control and static and dynamic postures. Studies have shown that sense of cervical position is vital in maintaining joint stability under static and dynamic conditions, and impaired proprioception may predispose to the development of pain. Cervical proprioception is measured by joint position error in degrees. In cervical spondylosis, impaired cervical proprioception is the result of position sensitivity being affected primarily by impairment in the muscles, joints, or capsules and secondarily by changes in afferent proprioceptive adjustment and integration. Impaired position sense impairs both neuronal and muscular control of normal cervical joint function, resulting in unbalanced muscle strength and placing the joint at risk for trauma. Conservative treatment of spondylosis includes transcutaneous electrical nerve stimulation (TENS), heat, traction, exercise, postural training, massage, kinesiotaping, and numerous manual therapy and mobilization techniques. Recent studies investigating treatment modalities for neck pain associated with cervical spondylosis have shown that combined treatments are more effective than exercise alone. The kinesio-tape technique has been developed with the philosophy that positive results can be obtained with a taping method similar to the structural properties and flexibility of human skin, without limiting the joint movements of the kinesio tape. Latex-free kinesio-tape is composed of 100% cotton and elastic polymer fibers. Dr. According to Kase, muscle dysfunction is one of the leading problems originating from the musculoskeletal system. Dr. Kase argues that taping the muscle is more effective than immobilizing the joint circumference with tape. After injury or overuse, the elastic properties of the muscle deteriorate. For this reason, kinesiology tapes are designed to be similar to the elastic properties of the muscle, to be adhesive, to have a lifting effect on the skin to which kinesiology tapes are applied, and to allow air circulation between the skin and the external environment. The technique is based on 3 basic concepts. These are space, motion, and cooling. As painful and inflamed muscles swell due to edema, the area where muscles are located narrows. When kinesio-taping is applied, the skin and subcutaneous interstitial area are increased by lifting the skin, thus increasing circulation and movement. This reduces pain and improves performance. The neuromuscular system is retrained. Injuries are prevented, circulation is accelerated and tissue healing is ensured. The idea that kinesiotaping can regulate proprioception by affecting cutaneous mechanoreceptors has been put forward by some researchers. Kinesiolo-tape affects mechanoreceptors sensitive to tension, loading, pressure and shear forces by changing the length of the skin and superficial fascia and the tension of the muscle fibers. This can lead to significant changes in muscle movement and tone. Slow pressure stimulation, particularly on connective tissue, alters the effect on mechanoreceptors and may affect gamma motor neuron firing and muscle tone regulation. Kinesiotape can be particularly effective in increasing proprioceptive ability only in the middle of the movement. In this range, ligament mechanoreceptors are inactive, whereas muscle receptors are active. Understanding joint movement and position can be effective in the development of proprioception by stimulating sensory afferent transmission. Cutaneous afferent stimuli interact with the motor cortex and thus affect the muscle excitability of the central nervous system. Inclusion Criteria: - Being over 50 and under 70 - Moderate to severe neck pain and limitation in neck movements according to the Visual Analogue Scale, which has been present for at least 3 months - Presence of cervical degeneration radiologically - being literate - Giving consent by agreeing to participate in the study - Having an MRI registered in the system in the last 1 (one) year Exclusion Criteria: - Being under 50 and over 70 - Neck pain that has been present for less than 3 months - Patients with positive Spurling test and radiculopathy - Patients with nerve root compression and stenosis in the evaluation with cervical MRI within the last 1 year - History of neurological disease, history of neck trauma, cervical myelopathy, any inflammatory arthritis, tumor, infection involving the cervical spine, and vertebrobasilar artery insufficiency - Cervical spinal surgery history - Vestibular disorder - vision problems - cognitive impairment - polyneuropathy - B12 and vitamin D deficiency (Patients with abnormal values for B12 and vitamin D in the last three months through the hospital examination result system will not be included in the study) - No known diagnosis of psychotic disorder - Active skin infection, cellulitis, open wounds, presence of cancerous tissue, extreme obesity and allergy to adhesives containing polyacrylate - not being literate - Patients who received physical therapy, injection, manual therapy, kinesio-tape treatment from the neck region in the last 3 months.

NCT0531xxxx/NCT05313776.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313776</url> </required_header> <id_info> <org_study_id>RECHMPL20_0431</org_study_id> <nct_id>NCT05313776</nct_id> </id_info> <brief_title>Identification of Non-motor Brain Areas Involved in Upper Limb Motor Recovery After Stroke</brief_title> <acronym>NOMO-Stroke</acronym> <official_title>Identification of Non-motor Brain Areas Involved in Upper Limb Motor Recovery After Stroke</official_title> <sponsors> <lead_sponsor> <agency>University Hospital, Montpellier</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Centre Hospitalier Universitaire de Nīmes</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Euromov, Université Montpellier</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>IMT Mines Ales</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>University Hospital, Montpellier</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Why: Upper-limb recovery post-stroke is challenging. Rehabilitation, aiming to induce plasticity takes an important place in patients' treatment. The last years, non-invasive brain stimulation of the primary motor cortex has gained the communities' interest, allowing direct modification of neural excitability and thus impacting plasticity. Yet, research outcomes remain inconclusive to date. It's expected this to be related to patient heterogeneity including mild to severe motor deficits, and suboptimal site of stimulation. It might be questioned whether M1 stimulation is preferable over that of higher association areas like the parietal or premotor cortex.  What: The aim of the study is to identify alternative brain regions to stimulate, related to improved motor quality after a severe initial deficit. How: by following motor recovery over time, by co-recording movement kinematics and brain activity.  Because: Stimulation of the novel identified regions may improve motor recovery after stroke. </textblock> </brief_summary> <detailed_description> <textblock> Patients' brain activity and connectivity during an elbow flexion/extension task will be evaluated at 2 weeks (V0), 3 months (V1) and 6 months (V2) post-stroke. Between V0 and V1, patients will receive standard in-care rehabilitation at the physical and rehabilitation medicine department (PMR) of Montpellier's University Hospital: 120 minutes a day, for 5 days/week (orthopedic training, sitting/standing balance, walking, sensorimotor training - including 2 and 3 dimensional reach to grasp exercises with and without vision, functional electrical stimulation of the upper-limb, finger pinching exercises). On the day of imaging, a clinical evaluation will be performed to evaluate patients upper-limb function (Fugl-Meyer Upper Extremity scale) and capacity (WOLF motor function test & Box and Block test). The imaging protocol includes a 3DT1 for anatomical reference, a functional task-based MRI with block-design (30s rest alternated with 30s of activity) and diffusion tensor imaging (DTI) to quantify anatomical connectivity. During imaging, participants will lay on their back with their arm stretched along their body. A short auditory signal will inform patient when to start/stop moving. During movement, only the elbow will be rhythmically flexed and extended at a self-selected comfortable pace in the vertical plane. The motor task will be performed with both the paretic and ipsilesional upper-limb, in random order. Patients that are unable to move, will be asked to keep trying to move during the activity block.  Material: 3.0T whole-body magnet MRI (Prisma Siemens, Germany), MRI compatible 3D motion camera's (Qualisys, France).  Imaging data will be acquired by the I2FH research platform at the Montpellier University Hospital Data treatment: functional Imaging data will be preprocessed following standard procedures, including reorientation to the anterior commissure, slice-time correction, realignment, co-registering & normalization to 3DT1 anatomical template, smoothing. Subsequent group analyses using general linear models, will be corrected for multiple comparisons. Imaging data will be analyzed by the I2FH research platform. 3D-Movement time-series of upper-limb displacement will be analyzed by Euromov, using matlab the mathworks. The movement will be quantified by its shaping (e.g. Amplitude/Frequency) and structure (e.g. Fluency/Directness). Clinical testing will be performed as part of standard care evaluations at the physical rehabilitation medicine department of the hospital of Montpellier and Nimes.  Schedule visit:  Patients: V0: ~10 post-stroke, V1: ~3 months post-stroke, V2: ~6 months post stroke. Clinical testing will be performed on the day (+/- 1) of the MRI session.  Healthy subjects will be evaluated once </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">February 7, 2022</start_date> <completion_date type="Anticipated">June 2024</completion_date> <primary_completion_date type="Anticipated">December 2023</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Case-Control</observational_model> <time_perspective>Prospective</time_perspective> </study_design_info> <primary_outcome> <measure>Change of brain activity during motor task during post-stroke recovery</measure> <time_frame>~10days, 3 months and 6 months post-stroke.</time_frame> <description>Functional MRI imaging with upper-limb elbow flexion in a blocked-design. Analysis with integrated movement kinematics that are registered simulateously.</description> </primary_outcome> <secondary_outcome> <measure>fMRI task-based and resting state brain connectivity</measure> <time_frame>at ~10days, 3 months and 6 months post-stroke.</time_frame> <description>Resting-state and functional MRI with upper-limb elbow flexion</description> </secondary_outcome> <secondary_outcome> <measure>Diffusion Tensor Imaging anatomical brain connectivity</measure> <time_frame>at ~10days, 3 months and 6 months post-stroke.</time_frame> <description>DTI imaging</description> </secondary_outcome> <number_of_groups>2</number_of_groups> <enrollment type="Anticipated">50</enrollment> <condition>Upper Limb Ischemia</condition> <condition>Stroke</condition> <arm_group> <arm_group_label>Post-stroke</arm_group_label> <description>People with a first ever ischemic stroke of the middle cerebral artery presenting severe motor deficits of the upper-limb at onset. The patients</description> </arm_group> <arm_group> <arm_group_label>Controls</arm_group_label> <description>Age and sexe matched healthy subjects without known neurological and or psychological deficits.</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Magnetic Resonance Imaging</intervention_name> <description>IMR is a non-invasive imaging technology that produces three dimensional detailed anatomical images. It is often used for disease detection, diagnosis, and treatment monitoring. It is based on sophisticated technology that excites and detects the change in the direction of the rotational axis of protons found in the water that makes up living tissues.</description> <arm_group_label>Controls</arm_group_label> <arm_group_label>Post-stroke</arm_group_label> </intervention> <eligibility> <study_pop> <textblock> All patients admitted at the University hospital of Montpellier with an ischemic stroke that are meeting the inclusion criteria. </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria patients post-stroke:  - 18-85 yrs,  - First ever ischemic stroke of the middle cerebral artery,  - Initial severe motor deficit (fugl-Upper limb assessment score <30/66),  - Written consent.  Exclusion criteria patients post-stroke:  - The presence of secondary neurological or psychiatric deficits,  - Strong hemineglect (bell-test);  - Aphasie >3/5 on the Boston scale,  - Bilateral stroke,  - Hemorraghic stroke,  - MRI contra-indications,  - Pregnancy/breastfeading,  - Patient under curatele,  - Medical urgency.  Inclusion criteria healthy subjects:  - Age matching (+/- 5 yrs),  - Sexe matching,  - Written consent.  Exclusion criteria healthy subjets:  - Neurological or psychological deficits;  - MRI contra-indations;  - Pregnancy/breastfeeding,  - Personunder curatele. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>85 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Isabelle LAFFONT, PHD,MD</last_name> <role>Principal Investigator</role> <affiliation>Montpellier University Hospital</affiliation> </overall_official> <overall_contact> <last_name>Isabelle LAFFONT, PHD,MD</last_name> <phone>0467338664</phone> <email>I-laffont@chu-montpellier.fr</email> </overall_contact> <location> <facility> <name>Montpellier University Hospital</name> <address> <city>Montpellier</city> <zip>34090</zip> <country>France</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Isabelle LAFFONT, PHD,MD</last_name> <phone>0467338664</phone> <email>i-laffont@chu-montpellier.fr</email> </contact> </location> <location_countries> <country>France</country> </location_countries> <verification_date>March 2023</verification_date> <study_first_submitted>February 23, 2022</study_first_submitted> <study_first_submitted_qc>April 5, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>March 8, 2023</last_update_submitted> <last_update_submitted_qc>March 8, 2023</last_update_submitted_qc> <last_update_posted type="Actual">March 9, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Ischemic stroke</keyword> <keyword>Motor recovery</keyword> <keyword>Upper-limb</keyword> <keyword>Functional MRI</keyword> <keyword>Neuroplasticity</keyword> <condition_browse>  <mesh_term>Stroke</mesh_term> <mesh_term>Ischemia</mesh_term> </condition_browse>  </clinical_study>

Why: Upper-limb recovery post-stroke is challenging. Rehabilitation, aiming to induce plasticity takes an important place in patients' treatment. The last years, non-invasive brain stimulation of the primary motor cortex has gained the communities' interest, allowing direct modification of neural excitability and thus impacting plasticity. Yet, research outcomes remain inconclusive to date. It's expected this to be related to patient heterogeneity including mild to severe motor deficits, and suboptimal site of stimulation. It might be questioned whether M1 stimulation is preferable over that of higher association areas like the parietal or premotor cortex. What: The aim of the study is to identify alternative brain regions to stimulate, related to improved motor quality after a severe initial deficit. How: by following motor recovery over time, by co-recording movement kinematics and brain activity. Because: Stimulation of the novel identified regions may improve motor recovery after stroke. Patients' brain activity and connectivity during an elbow flexion/extension task will be evaluated at 2 weeks (V0), 3 months (V1) and 6 months (V2) post-stroke. Between V0 and V1, patients will receive standard in-care rehabilitation at the physical and rehabilitation medicine department (PMR) of Montpellier's University Hospital: 120 minutes a day, for 5 days/week (orthopedic training, sitting/standing balance, walking, sensorimotor training - including 2 and 3 dimensional reach to grasp exercises with and without vision, functional electrical stimulation of the upper-limb, finger pinching exercises). On the day of imaging, a clinical evaluation will be performed to evaluate patients upper-limb function (Fugl-Meyer Upper Extremity scale) and capacity (WOLF motor function test & Box and Block test). The imaging protocol includes a 3DT1 for anatomical reference, a functional task-based MRI with block-design (30s rest alternated with 30s of activity) and diffusion tensor imaging (DTI) to quantify anatomical connectivity. During imaging, participants will lay on their back with their arm stretched along their body. A short auditory signal will inform patient when to start/stop moving. During movement, only the elbow will be rhythmically flexed and extended at a self-selected comfortable pace in the vertical plane. The motor task will be performed with both the paretic and ipsilesional upper-limb, in random order. Patients that are unable to move, will be asked to keep trying to move during the activity block. Material: 3.0T whole-body magnet MRI (Prisma Siemens, Germany), MRI compatible 3D motion camera's (Qualisys, France). Imaging data will be acquired by the I2FH research platform at the Montpellier University Hospital Data treatment: functional Imaging data will be preprocessed following standard procedures, including reorientation to the anterior commissure, slice-time correction, realignment, co-registering & normalization to 3DT1 anatomical template, smoothing. Subsequent group analyses using general linear models, will be corrected for multiple comparisons. Imaging data will be analyzed by the I2FH research platform. 3D-Movement time-series of upper-limb displacement will be analyzed by Euromov, using matlab the mathworks. The movement will be quantified by its shaping (e.g. Amplitude/Frequency) and structure (e.g. Fluency/Directness). Clinical testing will be performed as part of standard care evaluations at the physical rehabilitation medicine department of the hospital of Montpellier and Nimes. Schedule visit: Patients: V0: ~10 post-stroke, V1: ~3 months post-stroke, V2: ~6 months post stroke. Clinical testing will be performed on the day (+/- 1) of the MRI session. Healthy subjects will be evaluated once All patients admitted at the University hospital of Montpellier with an ischemic stroke that are meeting the inclusion criteria. Inclusion Criteria patients post-stroke: - 18-85 yrs, - First ever ischemic stroke of the middle cerebral artery, - Initial severe motor deficit (fugl-Upper limb assessment score <30/66), - Written consent. Exclusion criteria patients post-stroke: - The presence of secondary neurological or psychiatric deficits, - Strong hemineglect (bell-test); - Aphasie >3/5 on the Boston scale, - Bilateral stroke, - Hemorraghic stroke, - MRI contra-indications, - Pregnancy/breastfeading, - Patient under curatele, - Medical urgency. Inclusion criteria healthy subjects: - Age matching (+/- 5 yrs), - Sexe matching, - Written consent. Exclusion criteria healthy subjets: - Neurological or psychological deficits; - MRI contra-indations; - Pregnancy/breastfeeding, - Personunder curatele.

NCT0531xxxx/NCT05313789.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313789</url> </required_header> <id_info> <org_study_id>20180413.2018/04-2</org_study_id> <nct_id>NCT05313789</nct_id> </id_info> <brief_title>Analgesia Nociception Index for Pain Monitoring in Intensive Care Units</brief_title> <official_title>Analgesia Nociception Index for Pain Monitoring in Intensive Care Units</official_title> <sponsors> <lead_sponsor> <agency>İstanbul Yeni Yüzyıl Üniversitesi</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>İstanbul Yeni Yüzyıl Üniversitesi</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The aim of this study is to examine the usability of ANI in patients who will be treated in intensive care unit. </textblock> </brief_summary> <detailed_description> <textblock> The aim of this study is to examine the usability of Analgesia Nociception Index in patients who will be treated in intensive care unit ( a- Cardiovascular b- surgical c- internal diseases), mechanically ventilated and lacking communication. The investigators will examine whether the positive inotropic/vasoconstrictor agents will have any effect on Analgesia Nociception Index. </textblock> </detailed_description> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">April 11, 2022</start_date> <completion_date type="Anticipated">June 6, 2022</completion_date> <primary_completion_date type="Anticipated">May 10, 2022</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Case-Only</observational_model> <time_perspective>Prospective</time_perspective> </study_design_info> <primary_outcome> <measure>Analgesia Nociception Index for pain monitorization</measure> <time_frame>3 Months</time_frame> <description>The duration between two R waves within heart rate variations (filtering the variations in respiratory cycles). A numeric measure of parasympathetic tonus will be obtained. This variation is between (pΣ) 0 and 100.</description> </primary_outcome> <number_of_groups>3</number_of_groups> <enrollment type="Anticipated">180</enrollment> <condition>Stress Related Disorder</condition> <condition>Pain</condition> <condition>Intensive Care Unit Syndrome</condition> <arm_group> <arm_group_label>Intensive Care Patients (Cardiovascular)</arm_group_label> <description>Intensive care unit patients, mechanically ventilated and lacking communication. Will examine whether the positive inotropic/vasoconstrictor agents will have any effect on Analgesia Nociception Index.</description> </arm_group> <arm_group> <arm_group_label>Intensive Care Patients (Internal diseases)</arm_group_label> <description>Intensive care unit patients, both mechanically ventilated and lacking communication and mechanically ventilated and conscious. Will examine whether the positive inotropic/vasoconstrictor agents will have any effect on Analgesia Nociception Index.</description> </arm_group> <arm_group> <arm_group_label>Intensive Care Patients (Obese)</arm_group_label> <description>Intensive care unit patients. Will examine whether the positive inotropic/vasoconstrictor agents will have any effect on Analgesia Nociception Index.</description> </arm_group> <intervention> <intervention_type>Device</intervention_type> <intervention_name>Analgesia Nociception Index (ANI)</intervention_name> <description>Monitorization of Analgesia Nociception Index in Intensive Care Patients</description> <arm_group_label>Intensive Care Patients (Cardiovascular)</arm_group_label> <arm_group_label>Intensive Care Patients (Internal diseases)</arm_group_label> <arm_group_label>Intensive Care Patients (Obese)</arm_group_label> </intervention> <eligibility> <study_pop> <textblock> Intensive care patients between 18 and 80 years old. White Turkish Population. </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Intensive Care Cardiovascular Patients Group 1 - Patients aged from 18 to 80 years, scheduled for elective isolated coronary bypass graft (CABG) for 2-4 vessel disease, without any perioperative complications, and who were postoperatively monitored via the analgesia nociception index in the cardiovascular intensive care will be included.  - Intensive Care Internal Diseases Group 2 - Patients aged from 18 to 80 years, intubated or tracheostomized, In mechanical ventilation with Pressure-Controlled Ventilation mode, under perfusion neuromuscular blocker, Normothermic, non-cooperative and/or sedated and neuromuscular blocker  - Intensive Care Patients (Obese) Group 3 - Post Bariatric surgery, over 40 BMI  Exclusion Criteria:  - Intensive Care Cardiovascular Patients Group 1 Patients who required emergency surgery, had significant preoperative chronic pain, had autonomic nervous system anomalies and patients with rhythm will be excluded from the study.  - Intensive Care Internal Diseases Group 2 Ramsey sedation scale under 5, cooperative, with spontaneous breathing effort and extremity movement, non sinusal cardiac rhythm  - Intensive Care Patients (Obese) Group 3 - patients under 40 BMI </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>80 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_contact> <last_name>Ali Sefik Koprulu, MD</last_name> <phone>+905322677226</phone> <email>sefik.koprulu@yeniyuzyil.edu.tr</email> </overall_contact> <overall_contact_backup> <last_name>Ersi Kalfoglou, PhD</last_name> <phone>+905323500656</phone> <email>ersi.kalfoglu@yeniyuzyil.edu.tr</email> </overall_contact_backup> <reference> <citation>Le Guen M, Jeanne M, Sievert K, Al Moubarik M, Chazot T, Laloe PA, Dreyfus JF, Fischler M. The Analgesia Nociception Index: a pilot study to evaluation of a new pain parameter during labor. Int J Obstet Anesth. 2012 Apr;21(2):146-51. doi: 10.1016/j.ijoa.2012.01.001. Epub 2012 Feb 21.</citation> <PMID>22360936</PMID> </reference> <reference> <citation>Jeanne M, Clement C, De Jonckheere J, Logier R, Tavernier B. Variations of the analgesia nociception index during general anaesthesia for laparoscopic abdominal surgery. J Clin Monit Comput. 2012 Aug;26(4):289-94. doi: 10.1007/s10877-012-9354-0. Epub 2012 Mar 28.</citation> <PMID>22454275</PMID> </reference> <reference> <citation>Dias Dde S, Resende MV, Diniz Gdo C. Patient stress in intensive care: comparison between a coronary care unit and a general postoperative unit. Rev Bras Ter Intensiva. 2015 Jan-Mar;27(1):18-25. doi: 10.5935/0103-507X.20150005. Epub 2015 Mar 1.</citation> <PMID>25909309</PMID> </reference> <reference> <citation>Soral M, Altun GT, Dincer PC, Arslantas MK, Aykac Z. Effectiveness of the Analgesia Nociception Index Monitoring in Patients Who Undergo Colonoscopy with Sedo-Analgesia. Turk J Anaesthesiol Reanim. 2020 Feb;48(1):50-57. doi: 10.5152/TJAR.2019.45077. Epub 2019 Sep 24.</citation> <PMID>32076680</PMID> </reference> <reference> <citation>Jendoubi A, Abbes A, Ghedira S, Houissa M. Pain Measurement in Mechanically Ventilated Patients with Traumatic Brain Injury: Behavioral Pain Tools Versus Analgesia Nociception Index. Indian J Crit Care Med. 2017 Sep;21(9):585-588. doi: 10.4103/ijccm.IJCCM_419_16.</citation> <PMID>28970658</PMID> </reference> <reference> <citation>Broucqsault-Dedrie C, De Jonckheere J, Jeanne M, Nseir S. Measurement of Heart Rate Variability to Assess Pain in Sedated Critically Ill Patients: A Prospective Observational Study. PLoS One. 2016 Jan 25;11(1):e0147720. doi: 10.1371/journal.pone.0147720. eCollection 2016.</citation> <PMID>26808971</PMID> </reference> <verification_date>March 2022</verification_date> <study_first_submitted>March 16, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>March 29, 2022</last_update_submitted> <last_update_submitted_qc>March 29, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>İstanbul Yeni Yüzyıl Üniversitesi</investigator_affiliation> <investigator_full_name>Ali Sefik Koprulu, MD, Ass. Prof.</investigator_full_name> <investigator_title>Ass. Prof.</investigator_title> </responsible_party> <keyword>Analgesia Nociception Index</keyword> <keyword>Intensive Care Unit</keyword> <keyword>Pain Monitoring</keyword> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

The aim of this study is to examine the usability of ANI in patients who will be treated in intensive care unit. The aim of this study is to examine the usability of Analgesia Nociception Index in patients who will be treated in intensive care unit ( a- Cardiovascular b- surgical c- internal diseases), mechanically ventilated and lacking communication. The investigators will examine whether the positive inotropic/vasoconstrictor agents will have any effect on Analgesia Nociception Index. Intensive care patients between 18 and 80 years old. White Turkish Population. Inclusion Criteria: - Intensive Care Cardiovascular Patients Group 1 - Patients aged from 18 to 80 years, scheduled for elective isolated coronary bypass graft (CABG) for 2-4 vessel disease, without any perioperative complications, and who were postoperatively monitored via the analgesia nociception index in the cardiovascular intensive care will be included. - Intensive Care Internal Diseases Group 2 - Patients aged from 18 to 80 years, intubated or tracheostomized, In mechanical ventilation with Pressure-Controlled Ventilation mode, under perfusion neuromuscular blocker, Normothermic, non-cooperative and/or sedated and neuromuscular blocker - Intensive Care Patients (Obese) Group 3 - Post Bariatric surgery, over 40 BMI Exclusion Criteria: - Intensive Care Cardiovascular Patients Group 1 Patients who required emergency surgery, had significant preoperative chronic pain, had autonomic nervous system anomalies and patients with rhythm will be excluded from the study. - Intensive Care Internal Diseases Group 2 Ramsey sedation scale under 5, cooperative, with spontaneous breathing effort and extremity movement, non sinusal cardiac rhythm - Intensive Care Patients (Obese) Group 3 - patients under 40 BMI

NCT0531xxxx/NCT05313802.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313802</url> </required_header> <id_info> <org_study_id>18453</org_study_id> <secondary_id>J2A-MC-GZGK</secondary_id> <nct_id>NCT05313802</nct_id> </id_info> <brief_title>A Study of LY3502970 in Healthy Overweight and Obese Participants</brief_title> <official_title>A Multiple Dose Study in Healthy Overweight and Obese Participants to Investigate the Safety, Tolerability, and Pharmacokinetics of LY3502970</official_title> <sponsors> <lead_sponsor> <agency>Eli Lilly and Company</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Eli Lilly and Company</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>Yes</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The main purpose of this study is to evaluate the safety and tolerability of LY3502970 in healthy overweight and obese participants. The blood tests will be conducted to measure how much LY3502970 is in the bloodstream and how the body handles and eliminates LY3502970 in these participants. The study will last up to 42 days excluding the screening period. </textblock> </brief_summary> <overall_status>Completed</overall_status> <start_date type="Actual">May 26, 2022</start_date> <completion_date type="Actual">September 9, 2022</completion_date> <primary_completion_date type="Actual">September 9, 2022</primary_completion_date> <phase>Phase 1</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Parallel Assignment</intervention_model> <primary_purpose>Basic Science</primary_purpose> <masking>Double (Participant, Investigator)</masking> </study_design_info> <primary_outcome> <measure>Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration</measure> <time_frame>Predose up to 42 days</time_frame> <description>A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module</description> </primary_outcome> <secondary_outcome> <measure>Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3502970</measure> <time_frame>Predose up to 29 days postdose</time_frame> <description>PK: AUC of LY3502970</description> </secondary_outcome> <secondary_outcome> <measure>PK: Maximum Observed Concentration (Cmax) of LY3502970</measure> <time_frame>Predose up to 29 days postdose</time_frame> <description>PK: Cmax of LY3502970</description> </secondary_outcome> <secondary_outcome> <measure>PK: Time to Maximum Observed Concentration (Tmax) of LY3502970</measure> <time_frame>Predose up to 29 days postdose</time_frame> <description>PK: Tmax of LY3502970</description> </secondary_outcome> <secondary_outcome> <measure>Pharmacodynamics (PD): Change From Baseline in Body Weight</measure> <time_frame>Predose through Day 28</time_frame> <description>PD: Change From Baseline in Body Weight</description> </secondary_outcome> <number_of_arms>3</number_of_arms> <enrollment type="Actual">72</enrollment> <condition>Healthy</condition> <condition>Obese</condition> <arm_group> <arm_group_label>LY3502970 (Dose Level 1)</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>LY3502970 administered orally.</description> </arm_group> <arm_group> <arm_group_label>LY3502970 (Dose Level 2)</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>LY3502970 administered orally.</description> </arm_group> <arm_group> <arm_group_label>LY3502970 (Dose Level 3)</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>LY3502970 administered orally.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>LY3502970</intervention_name> <description>Administered orally.</description> <arm_group_label>LY3502970 (Dose Level 1)</arm_group_label> <arm_group_label>LY3502970 (Dose Level 2)</arm_group_label> <arm_group_label>LY3502970 (Dose Level 3)</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Participants with stable body weight for at least one month prior to randomization.  - Participants with body mass index (BMI) of greater than or equal to (≥) 27.0 kilograms per meter squared (kg/m²)  - Male participants who agree to use highly effective/effective methods of contraception and female participants not of childbearing potential  Exclusion Criteria:  - Have known allergies to LY3502970 or other glucagon-like peptide-1 Receptor Agonists (GLP-1 RA) analogs  - Significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders  - Have any type of diabetes with hemoglobin A1c (HbA1c) ≥6.5 % </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>70 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)</last_name> <role>Study Director</role> <affiliation>Eli Lilly and Company</affiliation> </overall_official> <location> <facility> <name>Qps-Mra, Llc</name> <address> <city>Miami</city> <state>Florida</state> <zip>33143</zip> <country>United States</country> </address> </facility> </location> <location> <facility> <name>ICON Early Phase Services Lenexa Center</name> <address> <city>Lenexa</city> <state>Kansas</state> <zip>66219</zip> <country>United States</country> </address> </facility> </location> <location> <facility> <name>ICON Early Phase Services</name> <address> <city>San Antonio</city> <state>Texas</state> <zip>78209</zip> <country>United States</country> </address> </facility> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>October 1, 2022</verification_date> <study_first_submitted>April 4, 2022</study_first_submitted> <study_first_submitted_qc>April 4, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>October 17, 2022</last_update_submitted> <last_update_submitted_qc>October 17, 2022</last_update_submitted_qc> <last_update_posted type="Actual">October 18, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Pharmacokinetics</keyword> <keyword>Safety and Tolerability</keyword> <keyword>LY3502970</keyword> <condition_browse>  <mesh_term>Overweight</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

The main purpose of this study is to evaluate the safety and tolerability of LY3502970 in healthy overweight and obese participants. The blood tests will be conducted to measure how much LY3502970 is in the bloodstream and how the body handles and eliminates LY3502970 in these participants. The study will last up to 42 days excluding the screening period. Inclusion Criteria: - Participants with stable body weight for at least one month prior to randomization. - Participants with body mass index (BMI) of greater than or equal to (≥) 27.0 kilograms per meter squared (kg/m²) - Male participants who agree to use highly effective/effective methods of contraception and female participants not of childbearing potential Exclusion Criteria: - Have known allergies to LY3502970 or other glucagon-like peptide-1 Receptor Agonists (GLP-1 RA) analogs - Significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders - Have any type of diabetes with hemoglobin A1c (HbA1c) ≥6.5 %

NCT0531xxxx/NCT05313815.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313815</url> </required_header> <id_info> <org_study_id>22-5218</org_study_id> <nct_id>NCT05313815</nct_id> </id_info> <brief_title>Moderate Hypofractionated Boost to the Prostate With Pelvic RT in High Risk Prostate Cancer</brief_title> <acronym>MOB-RT</acronym> <official_title>Moderate Hypofractionated Boost to the Prostate With Pelvic RT in High Risk Prostate Cancer</official_title> <sponsors> <lead_sponsor> <agency>University Health Network, Toronto</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>University Health Network, Toronto</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> This is a single-arm phase II prospective trials that is recruiting 100 participants. The study population that is being investigated are patients with localized high-risk or node-positive prostate cancer. Participants will receive external beam radiotherapy as a moderately hypofractionated boost to the prostate with pelvic radiation therapy. Androgen deprivation therapy will be prescribed at the discretion of the treating physician as per standard of care. </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">July 18, 2022</start_date> <completion_date type="Anticipated">July 2030</completion_date> <primary_completion_date type="Anticipated">July 2025</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>N/A</allocation> <intervention_model>Single Group Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Acute Grade >2 Gastrointestinal Toxicity</measure> <time_frame>Baseline to 5-year follow-up</time_frame> <description>Acute (less than or equal to 90 days) toxicity will be evaluated by using prospective follow-up and grading according to the latest version of the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.</description> </primary_outcome> <secondary_outcome> <measure>Patient-reported quality-of-life assessed by EPIC-26</measure> <time_frame>Baseline to 5-year Follow-up</time_frame> <description>Patient-Reported Quality of Life will be assessed at baseline and at each follow-up visit (3-weeks post intervention then every 6 months until 5 years, or more frequently if clinically necessary) using the following assessment questionnaires: 26-Item Expanded Prostate Cancer Index Composite (EPIC-26)</description> </secondary_outcome> <secondary_outcome> <measure>Measure the severity of lower urinary tract symptoms during the study</measure> <time_frame>Baseline to 5-year Follow-up</time_frame> <description>Patient-Reported symptoms will be assessed at baseline and at each follow-up visit (3-weeks post intervention then every 6 months until 5 years, or more frequently if clinically necessary) using the following assessment questionnaires: International Prostate Symptom Score (IPSS)</description> </secondary_outcome> <secondary_outcome> <measure>Graded criteria based on CTCAE version 5.0 for acute genitourinary toxicity and late genitourinary and gastrointestinal toxicity</measure> <time_frame>Baseline to 5-year Follow-up</time_frame> <description>Acute (less than or equal to 90 days) and long-term (greater than 90 days) toxicity will be evaluated by using prospective follow-up and grading according to the latest version of the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.</description> </secondary_outcome> <secondary_outcome> <measure>Measure of oncologic outcomes</measure> <time_frame>Baseline to 5-year Follow-up</time_frame> <description>Time to development of castrate-resistant prostate cancer (biochemmical or ardiographic progression while having castrate levels of testosterone)</description> </secondary_outcome> <secondary_outcome> <measure>Measure of oncologic outcomes</measure> <time_frame>Baseline to 5-year Follow-up</time_frame> <description>Biochemical control rate will be assessed at baseline and at each follow-up visit (3 weeks after treatment then every 6 months until 5 years or more frequently if clinically necessary) by the blood level of prostate-specific antigen (PSA) levels</description> </secondary_outcome> <secondary_outcome> <measure>Measure of onocologic outcomes</measure> <time_frame>Baseline to 5-year Follow-up</time_frame> <description>Radiographic control rate will be assess at baseline and weekly during the radiotherapy intervention using cone beam CT or bone scan.</description> </secondary_outcome> <secondary_outcome> <measure>Prostate cancer specific survival based on death from prostate cancer</measure> <time_frame>Baseline to 5-year Follow-up</time_frame> <description>Safety will be evaluated by recording prostate cancer mortality at follow-up visits (3-weeks post intervention then every 6 months until 5 years, or more frequently if clinically necessary)</description> </secondary_outcome> <secondary_outcome> <measure>Overall survival</measure> <time_frame>Baseline to 5-year Follow-up</time_frame> <description>Safety will be evaluated by recording overall mortality at follow-up visits (3-weeks post intervention then every 6 months until 5 years, or more frequently if clinically necessary).</description> </secondary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Anticipated">100</enrollment> <condition>Prostate Cancer</condition> <arm_group> <arm_group_label>Moderate Hypofracitonated Boost to the Prostate with Pelvic Radiation Therapy</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>External beam radiotherapy- 60 Gy in 20 fractions to the prostate, 48 Gy in 20 fractions to the pelvis, 68 Gy in 20 fraction optional boost to prostatic dominant intraprostatic lesion, 55 Gy in 20 fraction optional boost to involved pelvic lymph nodes</description> </arm_group> <intervention> <intervention_type>Radiation</intervention_type> <intervention_name>Moderate hypofractionated boost to the prostate with pelvic RT (external beam radiotherapy)</intervention_name> <description>External beam radiotherapy- 60 Gy in 20 fractions to the prostate, 48 Gy in 20 fractions to the pelvis, 68 Gy in 20 fraction optional boost to prostatic dominant intraprostatic lesion, 55 Gy in 20 fraction optional boost to involved pelvic lymph nodes</description> <arm_group_label>Moderate Hypofracitonated Boost to the Prostate with Pelvic Radiation Therapy</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Age > 18 years.  - Able to provide informed consent.  - Histologic diagnosis of prostate adenocarcinoma.  - ECOG performance status 0-1.  - High-risk localized disease by NCCN criteria (>cT3, Grade group >4, or PSA >20 ng/mL) or clinical N1 disease.  - Clinical M0 by conventional imaging (computed tomography (CT) and bone scan (BS)) and/or molecular imaging (prostate specific membrane antigen (PSMA)- positron emission tomography (PET))  Exclusion Criteria:  - Prior pelvic radiotherapy.  - Contraindications to radiotherapy </textblock> </criteria> <gender>Male</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_contact> <last_name>Rachel Glicksman, MD</last_name> <phone>416-946-4486</phone> <email>rachel.glicksman@rmp.uhn.ca</email> </overall_contact> <location> <facility> <name>Princess Margaret Cancer Center</name> <address> <city>Toronto</city> <state>Ontario</state> <zip>M5G 2M9</zip> <country>Canada</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Rachel Glicksman, MD</last_name> <phone>416-946-4483</phone> <email>rachel.glicksman@rmp.uhn.ca</email> </contact> </location> <location_countries> <country>Canada</country> </location_countries> <verification_date>May 2023</verification_date> <study_first_submitted>March 15, 2022</study_first_submitted> <study_first_submitted_qc>April 5, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>May 7, 2023</last_update_submitted> <last_update_submitted_qc>May 7, 2023</last_update_submitted_qc> <last_update_posted type="Actual">May 9, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>prostate cancer</keyword> <keyword>high risk prostate cancer</keyword> <keyword>high-risk prostate cancer</keyword> <keyword>node positive prostate cancer</keyword> <keyword>nod-positive prostate cancer</keyword> <keyword>hypofractionation</keyword> <condition_browse>  <mesh_term>Prostatic Neoplasms</mesh_term> </condition_browse>  </clinical_study>

This is a single-arm phase II prospective trials that is recruiting 100 participants. The study population that is being investigated are patients with localized high-risk or node-positive prostate cancer. Participants will receive external beam radiotherapy as a moderately hypofractionated boost to the prostate with pelvic radiation therapy. Androgen deprivation therapy will be prescribed at the discretion of the treating physician as per standard of care. Inclusion Criteria: - Age > 18 years. - Able to provide informed consent. - Histologic diagnosis of prostate adenocarcinoma. - ECOG performance status 0-1. - High-risk localized disease by NCCN criteria (>cT3, Grade group >4, or PSA >20 ng/mL) or clinical N1 disease. - Clinical M0 by conventional imaging (computed tomography (CT) and bone scan (BS)) and/or molecular imaging (prostate specific membrane antigen (PSMA)- positron emission tomography (PET)) Exclusion Criteria: - Prior pelvic radiotherapy. - Contraindications to radiotherapy

NCT0531xxxx/NCT05313828.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313828</url> </required_header> <id_info> <org_study_id>soh-med-22-02-28</org_study_id> <nct_id>NCT05313828</nct_id> </id_info> <brief_title>Effect of Various Treatment Modalities on Dendritic Vial Ulcer</brief_title> <official_title>Effect of Various Treatment Modalities on Dendritic Vial Ulcer</official_title> <sponsors> <lead_sponsor> <agency>Sohag University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Sohag University</source> <oversight_info> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Eye infection is a prevalent problem in primary care and remains a crucial healthcare concern. According to the American Academy of Ophthalmology (AAO), herpes simplex virus (HSV) keratitis (HSK) is the leading cause of infectious blindness worldwide . HSK is defined as a corneal inflammatory condition caused by the HSV infection . The global incidence of herpetic keratitis is estimated at 1.5 million per year, resulting in 40,000 new cases of severe visual impairment associated with corneal scarring and opacification . HSV type I (HSV-1) is by far the most predominant causative pathogen of eye infections]. HSV-1 is also known for causing orolabial herpes, HSV folliculitis, herpes gladiatorum, herpetic whitlow, and eczema herpeticum . HSV can be transferred to the eye by touching an active lesion and then the eye. The National Health and Nutrition Evaluation revealed a seroprevalence of HSV-1 in 53.9% of 14-49 year olds, and 90% of adults 50 years or older , indicating that the majority of the population has been exposed to this virus thus are at risk of developing HSK.  In this study we evaluate the efficacy of different treatment modalities on viral keratitis HSK. </textblock> </brief_summary> <overall_status>Recruiting</overall_status> <start_date type="Actual">March 18, 2022</start_date> <completion_date type="Anticipated">July 20, 2022</completion_date> <primary_completion_date type="Anticipated">June 28, 2022</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Case-Control</observational_model> <time_perspective>Prospective</time_perspective> </study_design_info> <primary_outcome> <measure>healing of the epithelium</measure> <time_frame>10 days follow up</time_frame> <description>the epithelial healing assessed with flourescin stain and measured by slit lamp scale in millimetres and compared with pre treatment epithelial defect</description> </primary_outcome> <number_of_groups>4</number_of_groups> <enrollment type="Anticipated">40</enrollment> <condition>Corneal Ulcer</condition> <arm_group> <arm_group_label>group 1'</arm_group_label> <description>patients with viral ulcers will receive antiviral medication with antibiotics</description> </arm_group> <arm_group> <arm_group_label>group 2</arm_group_label> <description>patients with viral ulcers will receive antiviral medication, tear substitutes with antibiotics</description> </arm_group> <arm_group> <arm_group_label>group 3</arm_group_label> <description>patients with viral ulcers will receive antiviral medication, weak steroids(at the same time) with antibiotics</description> </arm_group> <arm_group> <arm_group_label>group 4</arm_group_label> <description>patients with viral ulcers will receive antiviral medication with antibiotics followed by weak steroid after epithelial healing</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Acyclovir</intervention_name> <description>acyclovir 4 times /day</description> <arm_group_label>group 1'</arm_group_label> <arm_group_label>group 2</arm_group_label> <arm_group_label>group 3</arm_group_label> <arm_group_label>group 4</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Tobramycin</intervention_name> <description>tobramycin 4 times /day</description> <arm_group_label>group 1'</arm_group_label> <arm_group_label>group 2</arm_group_label> <arm_group_label>group 3</arm_group_label> <arm_group_label>group 4</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Fluorometholone</intervention_name> <description>Fluorometholone 4 times/ day</description> <arm_group_label>group 3</arm_group_label> <arm_group_label>group 4</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Sodium Hyaluronate</intervention_name> <description>Sodium Hyaluronate 4 times/day</description> <arm_group_label>group 2</arm_group_label> </intervention> <eligibility> <study_pop> <textblock> patients suffering from epithelial viral keratitis </textblock> </study_pop> <sampling_method>Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  patients with epithelial viral ulcers  -  Exclusion Criteria:  - patients with stromal keratitis patients with corneal opacity </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_contact> <last_name>Hany Mahmoud</last_name> <phone>00201024368111</phone> <email>drhanymahmoud@gmail.com</email> </overall_contact> <location> <facility> <name>Sohag University</name> <address> <city>Sohag</city> <zip>82524</zip> <country>Egypt</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Hany Mahmoud</last_name> <phone>01024368111</phone> <email>drhanymahmoud@gmail.com</email> </contact> </location> <location_countries> <country>Egypt</country> </location_countries> <verification_date>April 2022</verification_date> <study_first_submitted>March 26, 2022</study_first_submitted> <study_first_submitted_qc>April 4, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>April 4, 2022</last_update_submitted> <last_update_submitted_qc>April 4, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Sohag University</investigator_affiliation> <investigator_full_name>Hany Mahmoud,MD</investigator_full_name> <investigator_title>principal investigator</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Corneal Ulcer</mesh_term> <mesh_term>Ulcer</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Fluorometholone</mesh_term> <mesh_term>Tobramycin</mesh_term> <mesh_term>Acyclovir</mesh_term> <mesh_term>Hyaluronic Acid</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>Yes</sharing_ipd> <ipd_info_type>Study Protocol</ipd_info_type> <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type> <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type> <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type> <ipd_info_type>Analytic Code</ipd_info_type> </patient_data>  </clinical_study>

Eye infection is a prevalent problem in primary care and remains a crucial healthcare concern. According to the American Academy of Ophthalmology (AAO), herpes simplex virus (HSV) keratitis (HSK) is the leading cause of infectious blindness worldwide . HSK is defined as a corneal inflammatory condition caused by the HSV infection . The global incidence of herpetic keratitis is estimated at 1.5 million per year, resulting in 40,000 new cases of severe visual impairment associated with corneal scarring and opacification . HSV type I (HSV-1) is by far the most predominant causative pathogen of eye infections]. HSV-1 is also known for causing orolabial herpes, HSV folliculitis, herpes gladiatorum, herpetic whitlow, and eczema herpeticum . HSV can be transferred to the eye by touching an active lesion and then the eye. The National Health and Nutrition Evaluation revealed a seroprevalence of HSV-1 in 53.9% of 14-49 year olds, and 90% of adults 50 years or older , indicating that the majority of the population has been exposed to this virus thus are at risk of developing HSK. In this study we evaluate the efficacy of different treatment modalities on viral keratitis HSK. patients suffering from epithelial viral keratitis Inclusion Criteria: patients with epithelial viral ulcers - Exclusion Criteria: - patients with stromal keratitis patients with corneal opacity

NCT0531xxxx/NCT05313841.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313841</url> </required_header> <id_info> <org_study_id>IPP equation</org_study_id> <nct_id>NCT05313841</nct_id> </id_info> <brief_title>Novel Equation for Estimating Intraperitoneal Pressure</brief_title> <official_title>Novel Equation for Estimating Intraperitoneal Pressure in Patients on Peritoneal Dialysis Patients</official_title> <sponsors> <lead_sponsor> <agency>Peking University First Hospital</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Peking University First Hospital</source> <oversight_info> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Intraperitoneal Pressure is associated with the complications of increased intra-abdominal pressure in peritoneal dialysis patients. Due to the complicated operations, routine measurement of hydrostatic intraperitoneal pressure is not used routinely in adult peritoneal dialysis patients. There ars some limitions in equations from previous studies, such as the sample size was small , and the study population was limited. In the study, we aim to develop and validate an equation for estimating intraperitoneal pressure in peritoneal patients. </textblock> </brief_summary> <overall_status>Completed</overall_status> <start_date type="Actual">July 17, 2021</start_date> <completion_date type="Actual">October 31, 2021</completion_date> <primary_completion_date type="Actual">October 31, 2021</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Case-Only</observational_model> <time_perspective>Cross-Sectional</time_perspective> </study_design_info> <primary_outcome> <measure>Novel equation development</measure> <time_frame>July 17, 2021 to September 30, 2021</time_frame> <description>Developed equation for estimating intraperitoneal pressure in peritoneal dialysis patients</description> </primary_outcome> <primary_outcome> <measure>Novel equation validation</measure> <time_frame>October 1,2021 to October 31,2021</time_frame> <description>Validate the novel equation with intraperitoneal pressure obtained by Durand method</description> </primary_outcome> <enrollment type="Actual">200</enrollment> <condition>Intraperitoneal Pressure</condition> <condition>Peritoneal Dialysis</condition> <condition>Equation</condition> <eligibility> <study_pop> <textblock> All peritoneal dialysis patients meet the inclusion and exclusion criteria in a single center </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Peritoneal dialysis patients  - Dialysis length >1 month  - Aged 18-80 years  - Injection volume of peritoneal dialysis solution>1500ml  Exclusion Criteria:  - Acute complications （ peritonities, cardiovascular and cerebrovascular diseases) to hospitalization 1 month prior to the study  - History of abdominal surgery and trauma 1 month prior to the study  - Previous history of hernia, leakage, or thoracoabdominal fistula  - Can't come for a follow-up visit </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>80 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <location> <facility> <name>Jie Dong</name> <address> <city>Beijing</city> <state>Beijing</state> <zip>100034</zip> <country>China</country> </address> </facility> </location> <location_countries> <country>China</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>March 29, 2022</last_update_submitted> <last_update_submitted_qc>March 29, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Peking University First Hospital</investigator_affiliation> <investigator_full_name>Dong Jie</investigator_full_name> <investigator_title>Clinical Professor in Renal Division, Department of Medicine</investigator_title> </responsible_party>  </clinical_study>

Intraperitoneal Pressure is associated with the complications of increased intra-abdominal pressure in peritoneal dialysis patients. Due to the complicated operations, routine measurement of hydrostatic intraperitoneal pressure is not used routinely in adult peritoneal dialysis patients. There ars some limitions in equations from previous studies, such as the sample size was small , and the study population was limited. In the study, we aim to develop and validate an equation for estimating intraperitoneal pressure in peritoneal patients. All peritoneal dialysis patients meet the inclusion and exclusion criteria in a single center Inclusion Criteria: - Peritoneal dialysis patients - Dialysis length >1 month - Aged 18-80 years - Injection volume of peritoneal dialysis solution>1500ml Exclusion Criteria: - Acute complications （ peritonities, cardiovascular and cerebrovascular diseases) to hospitalization 1 month prior to the study - History of abdominal surgery and trauma 1 month prior to the study - Previous history of hernia, leakage, or thoracoabdominal fistula - Can't come for a follow-up visit

NCT0531xxxx/NCT05313854.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313854</url> </required_header> <id_info> <org_study_id>RA-2020-455</org_study_id> <nct_id>NCT05313854</nct_id> </id_info> <brief_title>Diagnosis and Survival Prediction of Pancreatic Cancer by Machine Learning of Image Data</brief_title> <official_title>Diagnosis and Survival Prediction of Pancreatic Cancer by Machine Learning of Image Data</official_title> <sponsors> <lead_sponsor> <agency>RenJi Hospital</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>RenJi Hospital</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> This prospective cohort study is designed to investigate the diagnostic ability and prediction accuracy of pancreatic cancer by radiomics data and clinical data. </textblock> </brief_summary> <detailed_description> <textblock> In this study, investigators aimed to investigate the diagnostic performance and prediction accuracy of pancreatic cancer by radiomics data and clinical data, which include CT scan, MRI, PET-CT, PET-MR, ultrasound, and clinical data. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">January 1, 2021</start_date> <completion_date type="Anticipated">December 31, 2023</completion_date> <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Cohort</observational_model> <time_perspective>Prospective</time_perspective> </study_design_info> <primary_outcome> <measure>Patient overall survival</measure> <time_frame>up to 3 years</time_frame> <description>Patient overall survival, from the time of diagnosis of pancreatic tumor to the death of the patient.</description> </primary_outcome> <secondary_outcome> <measure>Pathology diagnosis</measure> <time_frame>intraoperative</time_frame> <description>Pathology diagnosis of the patient, such as adenocarcinoma, pancreatic neuroendocrine tumors, intraductal Papillary Mucinous Neoplasm, et al.</description> </secondary_outcome> <other_outcome> <measure>Progression-free Survival</measure> <time_frame>up to 3 years</time_frame> <description>Patient progression-free survival, the length of time during and after the treatment of the tumor, that a patient lives with the disease but it does not get worse.</description> </other_outcome> <enrollment type="Anticipated">1000</enrollment> <condition>Pancreatic Cancer</condition> <eligibility> <study_pop> <textblock> hospitalized patients with radiology conformed pancreatic tumor </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  Clinical diagnosis of pancreatic tumor; Must have CT / MRI / ultrasound data and pathology diagnosis  Exclusion Criteria:  Have other tumors along with pancreatic tumor; Clinical information missing </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>90 Years</maximum_age> </eligibility> <overall_official> <last_name>Tao Chen, Dr</last_name> <role>Principal Investigator</role> <affiliation>Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University</affiliation> </overall_official> <overall_contact> <last_name>Xinsen Xu, Dr</last_name> <phone>+86-21-68383713</phone> <email>xuxinsen@gmail.com</email> </overall_contact> <overall_contact_backup> <last_name>Tao Chen, Dr</last_name> <phone>+86-21-68383713</phone> <email>dr_chentao78@163.com</email> </overall_contact_backup> <location> <facility> <name>Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University</name> <address> <city>Shanghai</city> <country>China</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Tao Chen, MD.</last_name> <email>dr_chentao78@163.com</email> </contact> </location> <location_countries> <country>China</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>March 16, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>March 29, 2022</last_update_submitted> <last_update_submitted_qc>March 29, 2022</last_update_submitted_qc> <last_update_posted type="Actual">April 6, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Pancreatic Cancer</keyword> <keyword>Machine Learning</keyword> <keyword>Radiomics</keyword> <keyword>CT</keyword> <keyword>MRI</keyword> <keyword>Ultrasound</keyword> <condition_browse>  <mesh_term>Pancreatic Neoplasms</mesh_term> </condition_browse>  </clinical_study>

This prospective cohort study is designed to investigate the diagnostic ability and prediction accuracy of pancreatic cancer by radiomics data and clinical data. In this study, investigators aimed to investigate the diagnostic performance and prediction accuracy of pancreatic cancer by radiomics data and clinical data, which include CT scan, MRI, PET-CT, PET-MR, ultrasound, and clinical data. hospitalized patients with radiology conformed pancreatic tumor Inclusion Criteria: Clinical diagnosis of pancreatic tumor; Must have CT / MRI / ultrasound data and pathology diagnosis Exclusion Criteria: Have other tumors along with pancreatic tumor; Clinical information missing

NCT0531xxxx/NCT05313867.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313867</url> </required_header> <id_info> <org_study_id>2021-A02571-40</org_study_id> <nct_id>NCT05313867</nct_id> </id_info> <brief_title>Effects of Dietary Supplements Based on Trace Elements on Voice Parameters and Some Psychological and Physiological Parameters Related to Stress - Single-center, Comparative, Cross-over, Randomized, Double-blind Study Versus Placebo, in Healthy Subjects</brief_title> <official_title>Effects of Dietary Supplements Based on Trace Elements on Voice Parameters and Some Psychological and Physiological Parameters Related to Stress - Single-center, Comparative, Cross-over, Randomized, Double-blind Study Versus Placebo, in Healthy Subjects</official_title> <sponsors> <lead_sponsor> <agency>Laboratoires Pronutri</agency> <agency_class>Industry</agency_class> </lead_sponsor> <collaborator> <agency>Clin-Experts</agency> <agency_class>Industry</agency_class> </collaborator> <collaborator> <agency>Plateforme Cocolab</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Laboratoires Pronutri</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Preliminary data obtained by the company Pronutri, which produces food supplements based on trace metals, suggests that food supplements containing trace metal compounds could act by reducing stress, which could result in effects on various physiological parameters.  Trace elements are pure minerals essential to the functioning of our body, present in very small quantities. They have a precise and fundamental role in biological and information processes: a deficiency can lead to dysfunctions, often at the origin of our daily ailments.  No scientific study has so far been carried out to measure the effects of these molecules on physiological and psychological parameters related to stress in healthy volunteers. The present study therefore aims to test the effects of these tablets containing metals and trace metals on the reduction of stress. </textblock> </brief_summary> <overall_status>Completed</overall_status> <start_date type="Actual">March 15, 2022</start_date> <completion_date type="Actual">June 10, 2022</completion_date> <primary_completion_date type="Actual">June 10, 2022</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Crossover Assignment</intervention_model> <primary_purpose>Other</primary_purpose> <masking>Double (Participant, Investigator)</masking> </study_design_info> <primary_outcome> <measure>F0 voice frequency</measure> <time_frame>Change from baseline at 5 minutes after the intake</time_frame> <description>The vocal parameters will be evaluated using the Praat software (duration of sound in sec, average duration of pauses in sec, average vocal frequency expressed in Hz (F0), standard deviation of F0 expressed in Hz, minimum and maximum of F0, "jitter " and "shimmer"</description> </primary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">43</enrollment> <condition>Stress</condition> <arm_group> <arm_group_label>Placebo</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> <description>1 sequence of 10 tablets containing only excipients</description> </arm_group> <arm_group> <arm_group_label>Trace elements</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Nutri VX1 in a single dose (1 sequence of 10 tablets). Nutri VX1 is a complex of trace elements with the status of a food supplement.</description> </arm_group> <intervention> <intervention_type>Dietary Supplement</intervention_type> <intervention_name>Nutri VX 1</intervention_name> <description>1 sequence of 10 tablets (one intake)</description> <arm_group_label>Trace elements</arm_group_label> </intervention> <intervention> <intervention_type>Dietary Supplement</intervention_type> <intervention_name>Placebo</intervention_name> <description>1 sequence of 10 tablets (one intake)</description> <arm_group_label>Placebo</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Male or female over 18 years of age  - Healthy (healthy volunteers) (no current treatment except contraception and no acute illness within 3 months)  - Affiliated to the social security system  - Signed consent  Exclusion Criteria:  - Voice disorders: aphasia, dysphonia, aphonia...  - Presence of a cardiac pacemaker  - Person intolerant to lactose, or to any excipient present in the VX 1 product  - Person under legal protection or unable to give consent  - Minor  - Pregnant or post-pregnant woman under 6 months or of childbearing age without effective contraception  - Person deprived of liberty by a judicial or administrative decision or under psychiatric care </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Alice GUYON</last_name> <role>Principal Investigator</role> <affiliation>Plateforme Cocolab - Maison des Sciences de l'Homme et de la Société Sud-Est</affiliation> </overall_official> <location> <facility> <name>Plateforme Cocolab - Maison des Sciences de l'Homme et de la Société Sud-Est, 24, avenue des Diables Bleus, Campus Saint Jean d'Angély</name> <address> <city>Nice</city> <zip>06100</zip> <country>France</country> </address> </facility> </location> <location_countries> <country>France</country> </location_countries> <verification_date>February 2023</verification_date> <study_first_submitted>March 20, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>February 19, 2023</last_update_submitted> <last_update_submitted_qc>February 19, 2023</last_update_submitted_qc> <last_update_posted type="Actual">February 21, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Stress</keyword> <keyword>trace elements</keyword> <keyword>voice parameters</keyword> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Preliminary data obtained by the company Pronutri, which produces food supplements based on trace metals, suggests that food supplements containing trace metal compounds could act by reducing stress, which could result in effects on various physiological parameters. Trace elements are pure minerals essential to the functioning of our body, present in very small quantities. They have a precise and fundamental role in biological and information processes: a deficiency can lead to dysfunctions, often at the origin of our daily ailments. No scientific study has so far been carried out to measure the effects of these molecules on physiological and psychological parameters related to stress in healthy volunteers. The present study therefore aims to test the effects of these tablets containing metals and trace metals on the reduction of stress. Inclusion Criteria: - Male or female over 18 years of age - Healthy (healthy volunteers) (no current treatment except contraception and no acute illness within 3 months) - Affiliated to the social security system - Signed consent Exclusion Criteria: - Voice disorders: aphasia, dysphonia, aphonia... - Presence of a cardiac pacemaker - Person intolerant to lactose, or to any excipient present in the VX 1 product - Person under legal protection or unable to give consent - Minor - Pregnant or post-pregnant woman under 6 months or of childbearing age without effective contraception - Person deprived of liberty by a judicial or administrative decision or under psychiatric care

NCT0531xxxx/NCT05313880.xml

<clinical_study>  <required_header> <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date> <link_text>Link to the current ClinicalTrials.gov record.</link_text> <url>https://clinicaltrials.gov/ct2/show/NCT05313880</url> </required_header> <id_info> <org_study_id>307636</org_study_id> <nct_id>NCT05313880</nct_id> </id_info> <brief_title>DIGITAL-HF - Digital Tools in Heart Failure - a Survey of Patient Usage (DIGITAL-HF)</brief_title> <acronym>DIGITAL-HF</acronym> <official_title>Digital Tools in Heart Failure - a Survey of Patient Usage (DIGITAL-HF)</official_title> <sponsors> <lead_sponsor> <agency>Royal Brompton & Harefield NHS Foundation Trust</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Royal Brompton & Harefield NHS Foundation Trust</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Heart failure is a chronic health condition associated with significant symptoms, an increased need of support from the NHS, and typically is associated with a reduction in life expectancy. The covid pandemic has made it more difficult for the NHS to deliver high quality care to the 1 million patients living with heart failure in the UK. NHS England plans that digitalisation of services will help, increasing efficiency and improving ability of patients to self-care and manage their conditions. "Digitalisation" includes the use of digital tools for health, such as Apps and online resources & support. But the typical heart failure patient does not receive a diagnosis of heart failure until their 70s or 80s, creating a significant risk of digital exclusion. The heart failure failure community doesn't have any information about which tools (if any) heart failure patients are using, or why.  Patients who attend the heart failure clinic at the Royal Brompton, either face-to-face or virtually, will be eligible for our study. They will be provided an information sheet and asked for informed consent. The study consists of 4 short questionnaires (30 questions total) which only takes between 10-15 minutes to complete, this consists of 3 previously validated questionnaires and one bespoke questionnaire related to their digital tool use.  The investigators aim to recruit 130 patients to help us better understand how many NHS patients with heart failure access digital tools, which ones are most often used, and how this relates to their health literacy, digital health literacy and overall attitude to their health condition and management. The investigators aim to describe different digital subgroups of patients and will use this information to help inform local and national policy around digital support for people living with heart failure. </textblock> </brief_summary> <overall_status>Completed</overall_status> <start_date type="Actual">January 4, 2022</start_date> <completion_date type="Actual">March 28, 2023</completion_date> <primary_completion_date type="Actual">December 1, 2022</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Cohort</observational_model> <time_perspective>Cross-Sectional</time_perspective> </study_design_info> <primary_outcome> <measure>Proportions of digital tool use</measure> <time_frame>6 months</time_frame> <description>Proportions of study participants using a variety of digital tools to access information about heart failure including websites, mobile applications and social media. The frequency of use and reasons for use.</description> </primary_outcome> <primary_outcome> <measure>Correlation of digital tool use with demographics</measure> <time_frame>6 months</time_frame> <description>The correlation between digital tool use and several patient demographics including age in years, gender, highest educational level in grade, estimated income in British pounds and ethnic group.</description> </primary_outcome> <primary_outcome> <measure>Correlation of digital tool use with measures of patients' heart failure</measure> <time_frame>6 months</time_frame> <description>The correlation between digital tool use and left ventricular ejection fraction in percentage, time from diagnosis of heart failure in months, New York Heart Association classification of heart failure (NYHA) and number of comorbidities.</description> </primary_outcome> <primary_outcome> <measure>Correlation of digital tool use with validated questionnaires</measure> <time_frame>6 months</time_frame> <description>The correlation between digital tool use and health literacy (as measured by the validated AAHLS questionnaire - All aspects of health literacy scale). The correlation between digital tool use and digital health literacy (as measured by the validated eHEALS questionnaire). The correlation between digital tool use and patient activation (as measured by the validated PAM®). Patient activation is the knowledge, skills and confidence to manage one's health and healthcare.</description> </primary_outcome> <number_of_groups>1</number_of_groups> <enrollment type="Actual">254</enrollment> <condition>Heart Failure</condition> <arm_group> <arm_group_label>Digital tool Survey</arm_group_label> <description>Sequential patients from the 4 heart failure clinics at our institution will be offered to take part in the study.</description> </arm_group> <eligibility> <study_pop> <textblock> This is a study of outpatients with a diagnosis of heart failure, regardless of ejection fraction. </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Any patient who attends one of the heart failure clinics at the Royal Brompton hospital with a diagnosis of heart failure will be considered for the study.  Exclusion Criteria:  - Unable to complete a questionnaire </textblock> </criteria> <gender>All</gender> <minimum_age>N/A</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Martin Cowie</last_name> <role>Principal Investigator</role> <affiliation>Royal Brompton hospital, part of Guys and St Thomas' hospital</affiliation> </overall_official> <location> <facility> <name>Royal Brompton Hospital</name> <address> <city>London</city> <zip>SW3 6NP</zip> <country>United Kingdom</country> </address> </facility> </location> <location> <facility> <name>Guy's and St Thomas' foundation NHS trust</name> <address> <city>London</city> <country>United Kingdom</country> </address> </facility> </location> <location> <facility> <name>King's college NHS foundation trust</name> <address> <city>London</city> <country>United Kingdom</country> </address> </facility> </location> <location_countries> <country>United Kingdom</country> </location_countries> <verification_date>March 2023</verification_date> <study_first_submitted>March 29, 2022</study_first_submitted> <study_first_submitted_qc>March 29, 2022</study_first_submitted_qc> <study_first_posted type="Actual">April 6, 2022</study_first_posted> <last_update_submitted>March 28, 2023</last_update_submitted> <last_update_submitted_qc>March 28, 2023</last_update_submitted_qc> <last_update_posted type="Actual">March 31, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Digital technology</keyword> <keyword>Digital literacy</keyword> <keyword>Patient activation measures</keyword> <condition_browse>  <mesh_term>Heart Failure</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Yes</sharing_ipd> <ipd_info_type>Study Protocol</ipd_info_type> <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type> <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type> </patient_data>  </clinical_study>

Heart failure is a chronic health condition associated with significant symptoms, an increased need of support from the NHS, and typically is associated with a reduction in life expectancy. The covid pandemic has made it more difficult for the NHS to deliver high quality care to the 1 million patients living with heart failure in the UK. NHS England plans that digitalisation of services will help, increasing efficiency and improving ability of patients to self-care and manage their conditions. "Digitalisation" includes the use of digital tools for health, such as Apps and online resources & support. But the typical heart failure patient does not receive a diagnosis of heart failure until their 70s or 80s, creating a significant risk of digital exclusion. The heart failure failure community doesn't have any information about which tools (if any) heart failure patients are using, or why. Patients who attend the heart failure clinic at the Royal Brompton, either face-to-face or virtually, will be eligible for our study. They will be provided an information sheet and asked for informed consent. The study consists of 4 short questionnaires (30 questions total) which only takes between 10-15 minutes to complete, this consists of 3 previously validated questionnaires and one bespoke questionnaire related to their digital tool use. The investigators aim to recruit 130 patients to help us better understand how many NHS patients with heart failure access digital tools, which ones are most often used, and how this relates to their health literacy, digital health literacy and overall attitude to their health condition and management. The investigators aim to describe different digital subgroups of patients and will use this information to help inform local and national policy around digital support for people living with heart failure. This is a study of outpatients with a diagnosis of heart failure, regardless of ejection fraction. Inclusion Criteria: - Any patient who attends one of the heart failure clinics at the Royal Brompton hospital with a diagnosis of heart failure will be considered for the study. Exclusion Criteria: - Unable to complete a questionnaire