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NCT00078247

Anti-HIV Drugs for Ugandan Patients With HIV and Tuberculosis

https://clinicaltrials.gov/study/NCT00078247

COMPLETED

This study is designed to determine whether 6 months of anti-HIV drugs given along with tuberculosis treatment will delay the onset of AIDS in HIV infected African patients.

NO

HIV Infections|Tuberculosis

DRUG: Abacavir|DRUG: Lamivudine|DRUG: Zidovudine|DRUG: Tuberculosis treatment

CD4+ decline (slope), Throughout study|Time to AIDS, Throughout study

Safety, Throughout study|Response to antituberculous therapy, Throughout study|Immune reconstitution, Throughout study|Viral drug resistance, Throughout study

National Institute of Allergy and Infectious Diseases (NIAID)

Makerere University

ALL

CHILD, ADULT

PHASE3

NIH

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT

1R01AI051219-01A2|1R01AI051219-01A2

2004-10

2004-02-23

2010-08-12

Makerere University Medical School, Kampala, Uganda

{ "Abacavir": [ { "intervention_type": "DRUG", "description": "Abacavir", "name": "Abacavir", "synonyms": [ "{(1S-cis)-4-[2-amino-6-(cyclopropylamino)-9H-purin-9-yl]cyclopent-2-en-1-yl}methanol", "Abacavir", "Ziagen", "ABC" ], "medline_plus_id": "a699012", "generic_names": [ "Abacavir" ], "drugbank_id": "DB01048" } ], "Lamivudine": [ { "intervention_type": "DRUG", "description": "Lamivudine", "name": "Lamivudine", "synonyms": [ "3'-Thia-2',3'-dideoxycytidine", "beta-L-2',3'-Dideoxy-3'-thiacytidine", "2',3'-Dideoxy-3'-thiacytidine", "GR109714X", "GR 109714X", "3TC Lamivudine", "Epivir", "Lamivudine, (2S-cis)-Isomer", "Lamivudina", "2',3' Dideoxy 3' thiacytidine", "(-)-1-((2R,5S)-2-(Hydroxymethyl)-1,3-oxathiolan-5-yl)cytosine", "Lamivudine, 3TC", "BCH189", "beta-L-3'-Thia-2',3'-dideoxycytidine", "BCH-189", "BCH 189", "(-)-2'-Deoxy-3'-thiacytidine", "Lamivudine", "Lamivudine, (+-)-trans-", "Lamivudin", "2(1H)-Pyrimidinone, 4-amino-1-(2-(hydroxymethyl)-1,3-oxathiolan-5-yl)-, (2R-cis)-", "GR-109714X", "Lamivudinum", "3TC", "Lamivudine, (+)-cis-" ], "medline_plus_id": "a696011", "generic_names": [ "Lamivudine" ], "mesh_id": "D019380", "drugbank_id": "DB00709" } ], "Zidovudine": [ { "intervention_type": "DRUG", "description": "Zidovudine", "name": "Zidovudine", "synonyms": [ "Azidothymidine", "ZDV", "3' Azido 2',3' Dideoxythymidine", "AZT, Antiviral", "Zidovudine", "BW A509U", "Antiviral AZT", "3'-Azido-2',3'-Dideoxythymidine", "BWA509U", "3'-Azido-3'-deoxythymidine", "Zidovudina", "AZT", "BWA-509U", "AZT Antiviral", "BWA 509U", "Zidovudinum", "Retrovir", "AZT (Antiviral)", "3' Azido 3' deoxythymidine" ], "medline_plus_id": "a601168", "generic_names": [ "Zidovudine" ], "mesh_id": "D019380", "drugbank_id": "DB00495" } ], "Tuberculosis treatment": [ { "intervention_type": "DRUG" } ] }

NCT05449847

Plasma MicroRNA for Prediction of Hepatocellular Carcinoma

https://clinicaltrials.gov/study/NCT05449847

COMPLETED

100 patients with diagnosed HCV were evaluated by clinical and ultrasound examination and were categorized as uncomplicated HCV (n=22) and complicated HCV (n=78). All patients were evaluated for hepatosteatosis and liver fibrosis using the computerized hepatorenal index, the hepatic steatosis index, aspartate aminotransferase (AST)/platelet count index (APRI) and the Fibrosis-4 (FIB-4) scores. Blood samples were obtained for estimation of serum levels of liver function tests and plasma levels of microRNA 21 and 126.

NO

Hepatitis C

BIOLOGICAL: Blood Sampling

Relation between MicroRNA and HCV, The ability of estimation of plasma microRNA 21 and 126 to differentiate between uncomplicated and complicated HCV patients, 12 months

Benha University

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

RC 1.7.2021

2021-05-13

2021-12-07

2022-03-20

2022-07-08

2022-07-08

Benha university, Banhā, El- Qalyobia, 13511, Egypt

{ "Blood Sampling": [ { "intervention_type": "BIOLOGICAL" } ] }

NCT00294047

Study to Evaluate the Efficacy of the Human Papillomavirus Vaccine in Healthy Adult Women of 26 Years of Age and Older

https://clinicaltrials.gov/study/NCT00294047

COMPLETED

This is a multicentre study in which women were planned to receive either the Human Papillomavirus Vaccine (HPV) vaccine or control. Under Protocol Amendment 3, study participation will last approximately 48 months and involves a total of eleven scheduled visits. Under Protocol Amendment 4, study participation will last up to 84 months and involves a maximum of seventeen scheduled visits.

YES

Infections, Papillomavirus|Papillomavirus Vaccines

BIOLOGICAL: Cervarix|BIOLOGICAL: Placebo control

Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection., CIN1+ = CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Persistent HPV infection = detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. * DNA- and sero-/+: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and 6 and seronegative/positive (sero-/+) at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) * Overall: subjects DNA- at Month 0 and 6 for the corresponding HPV-type, regardless of initial serostatus, Up to Month 48|Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA)., CIN1+ = CIN grades 1, 2 and 3, AIS and invasive cervical cancer. Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. * DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). * Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline., Up to Month 48|Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection., CIN1+ = CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Persistent HPV infection = detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. - DNA- and sero-/+: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and 6 and seronegative/positive (sero-/+) at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) - Overall: subjects DNA- at Month 0 and 6 for the corresponding HPV-type, regardless of initial serostatus, Up to Month 84|Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA)., CIN1+ = CIN grades 1, 2 and 3, AIS and invasive cervical cancer. Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. - DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline., Up to Month 84

Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18, Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Detection was done in: * DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). * Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline., Up to Month 48|Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18, Persistent cervical HPV infection (12-month definition) was defined as the detection of the same HPV type(s) PCR in cervical samples at all available time points over approximately a 12-month interval (evaluations are planned at approximately 6-month intervals). * DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). * Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline., Up to Month 48|Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations., Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Detection was done in subjects HPV DNA- for the corresponding HPV type at baseline (at month 0 and Month 6) regardless of initial serostatus. HPV-HRW=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18. HPV-HR=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68., Up to Month 48|Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations., Persistent HPV infection (12-month definition) = detection of the same HPV type(s) by PCR in cervical samples at available time points over approximately a 12-month interval (evaluations are planned at approximately 6-month intervals). Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. subjects HPV DNA- for the corresponding HPV type at Month 0 6, regardless of initial serostatus. HPV-HRW=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HPV-HR=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 , 68, Up to Month 48|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen, CIN2+ was defined as CIN grades 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done in: * DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). * Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline. Note: Results for seropositive status were not analysed., Up to Month 48|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen, CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done in: * DNA- and sero-/+: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). * Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline., Up to Month 48|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen, CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus., Up to Month 48|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Irrespective of HPV Cervical Infection and Irrespective of Baseline HPV DNA Status, CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done on all subjects irrespective of their baseline HPV DNA status., Up to Month 48|Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection, Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US). Detection was done in: * DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). * Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline. Results for seropositive status were not analysed., Up to Month 48|Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations, Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Detection was done in subjects who were HPV DNA negative for the corresponding HPV type at baseline (at month 0 and Month 6) regardless of initial serostatus. HRW-HPV= All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HPV-HR= High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68, Up to Month 48|Number of Subjects With Histopathologically Confirmed Reduction of Local Cervical Therapy, Detection was done on all subjects irrespective of their baseline HPV DNA status., Up to Month 48|Number of Subjects With First Colposcopy, Detection was done on all subjects irrespective of their baseline HPV DNA status., Up to Month 48|Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection, Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus., Up to Month 48|Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA)., Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus. The lesion was assigned to an HPV type found in the lesion if (1) the same HPV type was found in at least 1 of the 2 (closest) preceding cytology samples, or (2) none of the HPV types found in the lesion were found in any of the 2 preceding cytology samples (isolate HPV types), Up to Month 48|Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset., Seroconversion was defined as the appearance of antibodies (i.e.; titre greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. HPV-16 assay cut-off value was defined as greater than or equal to 8 ELISA units per millilitre (EL.U/mL). Seronegative (Sero-) subjects are subjects who had an antibody concentration below 8 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 8 EL.U/mL prior to vaccination. Immuno subset=subjects from selected sites N≥1000, at least 250 per region, At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84|Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset., Seroconversion was defined as the appearance of antibodies (i.e.; titre greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. HPV-18 assay cut-off value was defined as greater than or equal to 7 ELISA units per millilitre (EL.U/mL). Seronegative (Sero-) subjects are subjects who had an antibody concentration below 7 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 7 EL.U/mL prior to vaccination. Immuno subset=subjects from selected sites N≥1000, at least 250 per region, At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84|Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset., GMCs were expressed in ELISA units per milliliter (EL.U/mL). Seronegative (Sero-) subjects are subjects who had an antibody concentration below 8 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 8 EL.U/mL prior to vaccination. Immuno subset=subjects from selected sites (N≥1000, at least 250 per region), At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84|Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset., GMCs were expressed in ELISA units per milliliter (EL.U/mL). Seronegative (Sero-) subjects are subjects who had an antibody concentration below 7 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 7 EL.U/mL prior to vaccination. Immuno subset=subjects from selected sites (N≥1000, at least 250 per region), At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84|Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects., Seroconversion was defined as the appearance of antibodies (i.e.; titre greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. HPV-16/18 assay cut-off value was defined as greater than or equal to 40 Estimated dose 50% (ED50). Sero- subjects are subjects who had an antibody concentration below 40 ED50 prior to vaccination. Sero+ subjects are subjects who had an antibody concentration equal to or above 50 ED50 prior to vaccination. ED50 = the estimated serum dilution reducing the signal generated by viral infection by 50%, Prior to vaccination and at Months 7, 12, 18, 24, 48 and 84.|Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects., Titers are expressed as geometric mean antibody titers (GMTs). Seronegative (Sero-) subjects are subjects who had an antibody titer below 40 ED50 prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody titer equal to or above 40 ED50 prior to vaccination. ED50 = Estimated dose 50%, the estimated serum dilution reducing the signal generated by viral infection by 50%, Prior to vaccination and at Months 7, 12, 18, 24, 48 and 84.|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms., Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling was defined as redness/swelling above 50 millimeter (mm)., Within 7 days (Days 0-6) after vaccination|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms., Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (Fever = axillary temperature above 37.5 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = axillary temperature above 39.0°C., Within 7 days (Days 0-6) after vaccination|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)., An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 unsolicited AE = an event that prevented normal activity. A related AE = event assessed by the investigator as causally related to the study vaccination., Within 30 days (Days 0 - 29) post-vaccination period.|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)., SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. A related SAE was defined as an event assessed by the investigator as causally related to the study vaccination., Up to Month 48 and up to Month 84|Number of Subjects Reporting Related or Fatal Serious Adverse Event., Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity., Up to Month 84|Number of Subjects Reporting Any AE/SAE Leading to Premature Discontinuation of the Study., An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity., Up to Month 84|Number of Subjects Reporting New Onset of Chronic Disease (NOCDs)., NOCDs include autoimmune disorders, asthma and type I diabetes., Up to Month 48|Number of Subjects Reporting New Onset of Autoimmune Disease (NOADs)., Up to Month 48|Number of Subjects Reporting Medically Significant Conditions (MAEs)., Medically significant conditions were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury., Up to Month 48|Number of Subjects With Pregnancies and Their Outcomes., Pregnancy outcomes are live infant, premature live infant, elective termination, ectopic pregnancy, spontaneous abortion, lost to follow-up and pregnancy ongoing. For each category it was specified if the infant presents congenital anomaly (CA) or no apparent congenital anomaly (No ACA)., Up to Month 48|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the Type Assignment Algorithm (TAA), CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done on subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline. TAA: Type assignment algorithm. The lesion was assigned to an HPV type found in the lesion if 1. the same HPV type was found in at least one of the two (closest) preceding cytology samples, or 2. none of the HPV types found in the lesion were found in any of the two preceding cytology samples (isolate HPV types), Up to Month 48|Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18, Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Detection was done in: - DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline., Up to Month 84|Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18, Persistent cervical HPV infection (12-month definition) was defined as the detection of the same HPV type(s) PCR in cervical samples at all available time points over approximately a 12-month interval (evaluations are planned at approximately 6-month intervals). - DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline., Up to Month 84|Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations., Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Detection was done in subjects HPV DNA- for the corresponding HPV type at baseline (at month 0 and Month 6) regardless of initial serostatus. HPV-HRW=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18. HPV-HR=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68., Up to Month 84|Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations., Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. subjects HPV DNA- for the corresponding HPV type at Month 0 6, regardless of initial serostatus. HPV-HRW=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HPV-HR=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 , 68, Up to Month 84|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen, CIN2+ was defined as CIN grades 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done in: - DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline. Note: Results for seropositive status were not analysed., Up to Month 84|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen, CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done in: - DNA- and sero-/+: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline., Up to Month 84|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen, Up to Month 84|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Irrespective of HPV Cervical Infection and Irrespective of Baseline HPV DNA Status, CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done on all subjects irrespective of their baseline HPV DNA status., Up to Month 84|Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection, Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US). Detection was done in: - DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline. Results for seropositive status were not analysed., Up to Month 84|Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations, Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Detection was done in subjects who were HPV DNA negative for the corresponding HPV type at baseline (at month 0 and Month 6) regardless of initial serostatus. HRW-HPV= All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HPV-HR= High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68, Up to Month 48|Number of Subjects With Histopathologically Confirmed Reduction of Local Cervical Therapy, Detection was done on all subjects irrespective of their baseline HPV DNA status., Up to Month 84|Number of Subjects With First Colposcopy, Detection was done on all subjects irrespective of their baseline HPV DNA status., Up to Month 84|Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection, Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus., Up to Month 84|Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA)., Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus. The lesion was assigned to an HPV type found in the lesion if (1) the same HPV type was found in at least 1 of the 2 (closest) preceding cytology samples, or (2) none of the HPV types found in the lesion were found in any of the 2 preceding cytology samples (isolate HPV types), Up to Month 84

GlaxoSmithKline

FEMALE

ADULT, OLDER_ADULT

PHASE3

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION

104820|2005-002546-20

2006-02-16

2014-01-29

2014-01-29

2006-02-20

2012-03-27

2020-01-02

GSK Investigational Site, Fountain Valley, California, 92708, United States|GSK Investigational Site, Aurora, Colorado, 80045, United States|GSK Investigational Site, Golden, Colorado, 80401, United States|GSK Investigational Site, Coral Gables, Florida, 33134, United States|GSK Investigational Site, Miami, Florida, 33136, United States|GSK Investigational Site, Augusta, Georgia, 30912, United States|GSK Investigational Site, Iowa City, Iowa, 52242, United States|GSK Investigational Site, Wichita, Kansas, 67207, United States|GSK Investigational Site, Bardstown, Kentucky, 40004, United States|GSK Investigational Site, Louisville, Kentucky, 40202, United States|GSK Investigational Site, Chaska, Minnesota, 55318, United States|GSK Investigational Site, Omaha, Nebraska, 68131, United States|GSK Investigational Site, Lebanon, New Hampshire, 03756, United States|GSK Investigational Site, Albuquerque, New Mexico, 87131, United States|GSK Investigational Site, Syracuse, New York, 13057, United States|GSK Investigational Site, Chapel Hill, North Carolina, 27514, United States|GSK Investigational Site, New Bern, North Carolina, 28562, United States|GSK Investigational Site, Akron, Ohio, 44311, United States|GSK Investigational Site, Cleveland, Ohio, 44122, United States|GSK Investigational Site, Tulsa, Oklahoma, 74105, United States|GSK Investigational Site, Portland, Oregon, 97210, United States|GSK Investigational Site, Carnegie, Pennsylvania, 15106, United States|GSK Investigational Site, Erie, Pennsylvania, 16507, United States|GSK Investigational Site, Erie, Pennsylvania, 16508, United States|GSK Investigational Site, Philadelphia, Pennsylvania, 19107, United States|GSK Investigational Site, Pittsburgh, Pennsylvania, 15213, United States|GSK Investigational Site, Pittsburgh, Pennsylvania, 15236, United States|GSK Investigational Site, Wexford, Pennsylvania, 15090, United States|GSK Investigational Site, Austin, Texas, 78705, United States|GSK Investigational Site, Houston, Texas, 77004, United States|GSK Investigational Site, Houston, Texas, 77030, United States|GSK Investigational Site, Salt Lake City, Utah, 84109, United States|GSK Investigational Site, Salt Lake City, Utah, 84121, United States|GSK Investigational Site, South Jordan, Utah, 84095, United States|GSK Investigational Site, Wenatchee, Washington, 98801, United States|GSK Investigational Site, La Crosse, Wisconsin, 54601, United States|GSK Investigational Site, Parkville, Victoria, 3052, Australia|GSK Investigational Site, Perth, Western Australia, Australia|GSK Investigational Site, Edmonton, Alberta, T6G 2C8, Canada|GSK Investigational Site, Vancouver, British Columbia, V6H 3N1, Canada|GSK Investigational Site, Halifax, Nova Scotia, B3H 2Y9, Canada|GSK Investigational Site, Truro, Nova Scotia, B2N 1L2, Canada|GSK Investigational Site, Waterloo, Ontario, N2L 6H6, Canada|GSK Investigational Site, Sherbrooke, Quebec, J1H 1Z1, Canada|GSK Investigational Site, Quebec, G1S 2L6, Canada|GSK Investigational Site, Cuenavaca, Morelos, 62430, Mexico|GSK Investigational Site, Jojutla / Morelos, Mexico|GSK Investigational Site, Amsterdam, 1007 MB, Netherlands|GSK Investigational Site, Delft, 2625 AD, Netherlands|GSK Investigational Site, Rotterdam, 3015 CE, Netherlands|GSK Investigational Site, Lima, Peru|GSK Investigational Site, Laguna, Philippines|GSK Investigational Site, San Pablo City, Philippines|GSK Investigational Site, Taft Avenue, Manila, 1700, Philippines|GSK Investigational Site, Almada, 2805-267 Almada, Portugal|GSK Investigational Site, Coimbra, 3000-075 Coimbra, Portugal|GSK Investigational Site, Lisboa, 1200-831 Lisboa, Portugal|GSK Investigational Site, Porto, 4200-023 Porto, Portugal|GSK Investigational Site, Setúbal, 2910-446 Setúbal, Portugal|GSK Investigational Site, Ekaterinburg, 620073, Russian Federation|GSK Investigational Site, Moscow, 109263, Russian Federation|GSK Investigational Site, Moscow, 115 478, Russian Federation|GSK Investigational Site, Moscow, 117997, Russian Federation|GSK Investigational Site, Sankt-Petersburg, 190020, Russian Federation|GSK Investigational Site, Sankt-Petersburg, 199034, Russian Federation|GSK Investigational Site, Singapore, 119074, Singapore|GSK Investigational Site, Singapore, 229899, Singapore|GSK Investigational Site, Bangkok, 10400, Thailand|GSK Investigational Site, Bangkok, 10700, Thailand|GSK Investigational Site, Northwood, Middlesex, HA6 2RN, United Kingdom|GSK Investigational Site, Aberdeen, AB25 7ZD, United Kingdom|GSK Investigational Site, Cardiff, CF14 4XN, United Kingdom|GSK Investigational Site, Gateshead, NE9 6SX, United Kingdom|GSK Investigational Site, London, EC1M 6BQ, United Kingdom|GSK Investigational Site, Manchester, M13 9WL, United Kingdom

{ "Human Papillomavirus (HPV) Vaccine (Cervarix)": [ { "intervention_type": "BIOLOGICAL", "description": "Cervarix", "name": "Human Papillomavirus (HPV) Vaccine (Cervarix)", "synonyms": [ "Human Papillomavirus (HPV) Vaccine (Cervarix)", "Cervarix", "HPV", "Gardasil-9", "Human Papillomavirus (HPV) Vaccine", "HPV", "Human Papillomavirus (HPV) Vaccine " ], "medline_plus_id": "a610014", "generic_names": [ "Human Papillomavirus (HPV) Vaccine (Cervarix)", "Human Papillomavirus (HPV) Vaccine " ], "wikipedia_url": "https://en.wikipedia.org/wiki/Cervarix" } ], "Placebo control": [ { "intervention_type": "BIOLOGICAL" } ] }

NCT05283447

Manual Therapy and Gastroesophageal Reflux Disease in Patients With Hiatal Hernia

https://clinicaltrials.gov/study/NCT05283447

UNKNOWN

Introduction: Gastroesophageal reflux disease (GERD) is highly prevalent in our society. The association between GERD and hiatal hernia has been shown to be etiologically critical in the onset or worsening of these patients clinic. Pharmacological treatment with proton pump inhibitors (IBPs) and H2 blockers is commonly prescribed and will be followed for many patients for life. The cost of health care and the effects of prolonged consumption of PPIs are questionable, and other therapeutic alternatives are being considered. Only in exceptional cases and in patients with GERD and certain types of hiatal hernia is surgery the treatment of choice. Physiotherapy at the time proposed respiratory and diaphragmatic training as a therapeutic alternative that would improve the function of anti-reflux barriers. Recently, other studies evaluating the effectiveness of manual techniques on the crural diaphragm or osteopathic maneuvers on the cervical and thoracic region have obtained good results in the improvement of the MRGE clinic. In this context, the clinical trial presented specifically treats those with reflux disease associated with a Type I hiatal hernia with manual therapy. Material and methods: The aim of the clinical study is to evaluate the effects of a clinical intervention protocol on patients with GERD for type I hiatal hernia. The variables are assessed: GERD impact using the GIS MRG Impact Scale, and the EVA format scale for the Reflux Clinic (IEPT) used by the Surgery Service of the Parc Taulí Hospital in Sabadell . The productivity and quality of life of these patients is also assessed using the QOLRAD reflux and dyspepsia patient quality of life questionnaire. The randomized, double-blind clinical trial has a sample of 44 patients, divided into an intervention group treated with the protocol under study, and a control group undergoing treatment that does not affect the hernia. hiatus and reflux. A total of three treatment sessions are performed on each subject. The participants answer the different questionnaires, before the start of the treatment and for each session, one week after the treatment and one month later. In the protocol, maneuvers are performed on the epigastric region, thoracic diaphragm, mediastinum and anterior face of the neck.

NO

Gastroesophageal Reflux

OTHER: Osteopathic Medicine|OTHER: Control

Impact of GERD (Gastro-oesophageal Reflux Disease), Using The Gastro-oesophageal Reflux Disease Impact scale (GIS).The GIS impact assessment scale consists of 9 items that refer to the frequency during the last week of 5 possible symptoms of GERD, the impact on sleep, food or drink intake, work or activities of daily living and the need to use medications in addition to those prescribed by your doctor (from daily to never on a 4-point Likert-type scale). The Gis scale score ranges from 1 to 4, the higher the score, the better the patient s condition. The scale was validated in Spanish in 2008. (New, Tafalla et al, 2008)., 8 weeks

Impact of GERD (Gastro-oesophageal Reflux Disease), Using the Gastro-oesophageal Reflux Disease impact assessment scale used by gastroenterology team of the CSPT (Corporación Sanitaria Parc Taulí), aims to objectify GERD symptoms using a 0-10 range. The symptoms generated exclusively by the Reflux will be chosen: heartburn, regurgitation, cough, aphonia, epigastralgia. The maximum sum of the items on the scale is 50 points, indicating maximum severity. The value 0 points would indicate a minimal impact of the disease., 8 weeks|Quality of life in patients with GERD, For the collection of specific data on the quality of life of the patients, the QOLRAD scale will be used, this scale contains 25 items, in which the patient is asked about the effect of gastrointestinal symptoms on quality of life. Establishing the relationship with: emotional well-being, sleep, vitality, food and drink, and physical/social functioning. The patient answers the questionnaire about the frequency of these effects in relation to the last week, using a 7-point Likert scale ranging from all the time/very much to never/not at all . Low scores indicate significant impairment in daily functioning (Kulich KR et al, 2005), 8 weeks

Escoles Universitaries Gimbernat

Corporacion Parc Tauli

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

2018308

2018-11-15

2021-12-16

2023-06

2022-03-17

2022-03-17

Ricard Tutusaus Homs, Sant Cugat Del Vallès, Barcelona, 08174, Spain

{ "Osteopathic Medicine": [ { "intervention_type": "OTHER" } ], "Control": [ { "intervention_type": "OTHER" } ] }

NCT00594347

Immunogenicity and Safety of a Booster Dose of Pneumo 23® in 12 to 18 Months-Old Children Primed With Prevnar

https://clinicaltrials.gov/study/NCT00594347

COMPLETED

The present study intends to investigate the use as a booster of a dose of sanofi pasteur s Pneumo 23 vaccine in the second year of life following 3-dose priming with Wyeth s Prevnar vaccine. The researchers will use a cohort of subjects who have received 3 doses of Prevnar® at 2, 4, 6 months of age in the context of the clinical study A3L12 on Hexavalent combined vaccine (DTaP-IPV-HB-PRP~T)

NO

Streptococcus Pneumoniae

BIOLOGICAL: Pneumo 23|BIOLOGICAL: Prevnar

To provide information concerning the safety after booster administration of 23-valent polysaccharidic pneumococcal vaccine, 30 days post-vaccination

Sanofi Pasteur, a Sanofi Company

ALL

CHILD

PHASE3

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION

PNA19

2007-11

2008-03

2009-04

2008-01-15

2015-06-18

Bangkok, Thailand|KhonKaen, Thailand

{ "Pneumo 23": [ { "intervention_type": "BIOLOGICAL" } ], "Prevnar": [ { "intervention_type": "BIOLOGICAL" } ] }

NCT06093347

Central Apnoea Monitor Study

https://clinicaltrials.gov/study/NCT06093347

RECRUITING

An initial small study on 15 children that are already being investigated for central sleep apnoea in the sleep unit at Sheffield Children s Hospital. The central apnoea monitor will be placed around the child s abdomen overnight alongside the sensors already being used for the clinical sleep study and the signals from the two systems will be compared to evaluate the accuracy of the new device.

NO

Sleep Apnea

The accuracy of the system in 15 patients, when compared with the gold standard measurement system, 24 hours|The acceptability of the sensor to the child as viewed by the parent (and child), As measured by researcher designed questionnaire, End of study

Sheffield Children s NHS Foundation Trust

Sheffield Hallam University

ALL

CHILD

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

SCH-2708

2023-09-18

2024-06-30

2024-06-30

2023-10-23

2023-10-23

Clinical Research Facility, Sheffield Children s Hospital, Sheffield, United Kingdom

{}

NCT04138147

Superficial Cervical Plexus Versus Retrolaminar Block in Parotid Surgeries

https://clinicaltrials.gov/study/NCT04138147

UNKNOWN

The parotid gland receives sensory and autonomic innervation. Sensory innervation is supplied by the auriculotemporal nerve (gland) and the great auricular nerve (fascia). The parasympathetic innervation to the parotid gland begins with the glossopharyngeal nerve. This nerve synapses with the otic ganglion. The auriculotemporal nerve then carries parasympathetic fibers from the otic ganglion to the parotid gland. Parasympathetic stimulation increase saliva production. Sympathetic innervation from the superior cervical ganglion, part of the paravertebral chain

NO

Supportive Care

PROCEDURE: Superficial cervical plexus with auriculotemporal nerve blocks|PROCEDURE: Cervical retrolaminar with auriculotemporal nerve blocks

The time of first analgesic request post-operative., The time of first analgesic request in hours., 24 hours postoperative.

Total post-operative opioid requirement., Total post-operative morphine requirement in milligrams.., 24 hours postoperative.|The number of patients required rescue post-operative opioid analgesia.., in number., 24 hours postoperative.|Post-operative pain scale., by Visual analogue scale (VAS): (where 0 means no pain- while 100 mm is the worst pain) at 0, 1, 2, 6, 12 and 24 hours., 24 hours postoperative.|Intra-operative fentanyl consumption., in micro grams., Intraoperative (2 hours).|Heart rate (HR)., in beat/minutes, recorded basal, intraoperative: after the block 15 min and 30 min then every 30 minutes till the end of surgery, then postoperative at 0, 1, 2, 6, 12 and 24 hours., Intraoperative (2 hours), postoperative for 24 hours.|Mean arterial blood pressure (MAP)., Non invasive mean arterial pressure, in mmHg, recorded intraoperative: basal, after the block at 15 min and 30 min then every 30 minutes till the end of surgery, then postoperative at 0, 1, 2, 6, 12 and 24 hours., Intraoperative (2 hours), postoperative for 24 hours.|Intra-operative atracurium consumption, in milligrams., Intraoperative (2 hours).|The concentration of isoflurane., in percent, recorded after the block every 30 minutes till the end of surgery., Intraoperative (2 hours).|Sensory block assessment., Define the number of blocked dermatomes at post anesthesia care unit by skin pinprick. sensation at dermatomal distribution., 1 hour post-operative.|The block procedural duration., In minutes., 30 minutes.|Post-operative complication rate (nausea, vomiting and headache), In number., 24 hours postoperative.|Assessment of diaphragmatic dysfunction., Using ultrasound assessment,, 1 hour postoperative.

Mansoura University

ALL

ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE

MD/19.03.162

2019-11-20

2020-12

2020-12

2019-10-24

2020-09-18

Oncology Center, Mansoura University (OCMU), Mansoura, Dakahlia, 35516, Egypt

{ "Superficial cervical plexus with auriculotemporal nerve blocks": [ { "intervention_type": "PROCEDURE" } ], "Cervical retrolaminar with auriculotemporal nerve blocks": [ { "intervention_type": "PROCEDURE" } ] }

NCT05855447

Muscles Oxygenation During Exercise in Fibrosing Interstitial Lung Diseases

https://clinicaltrials.gov/study/NCT05855447

COMPLETED

The type of this study is an observational prospective study. It will be done to determine the oxygenation status of the intercostal muscles and quadriceps femoris muscle during exercise in patients with fibrosing lung and to examine its relationship with exercise capacity, respiratory functions and respiratory muscle strength. The main questions that the study aims to answer are: * Question 1: Do changes in muscle oxygenation during exercise affect respiratory functions in patients with Fibrosing Lung? * Question 2: Do changes in muscle oxygenation during exercise affect exercise capacity in patients with Fibrosing Lung? Participants; demographic information such as age, height, weight will be questioned. Respiratory functions will be evaluated with a desktop spirometer, peripheral muscle strength measurement will be evaluated with a digital myometer, and functional capacity will be evaluated with a 6-minute walk test (6MWT). The Moxy device, which is a non-invasive near-infrared spectroscopy (NIRS), will be attached to the upper leg (the vastus lateralis of the quadriceps muscle) and the rib (intercostal muscles) with a silk patch, and the oxygenation of the muscles here will be measured during the 6-minute walking test. In addition, fatigue status will be evaluated with the Modified Borg Scale.

NO

Lung Diseases, Interstitial|Exercise, Compulsive|Oxygen Deficiency

OTHER: NIRS device usage during 6MWT|OTHER: Peripheral Muscle Strength Measurement|OTHER: Pulmonary Function Test

Relative Muscle Oxygenation Changes with Moxy Muscle Oxygenation Monitor (SmO2), The measurement will be made in the dominant lower extremity, and the device will be measured by placing the device at a distance of 5 cm from the anterior superior reference point of the spina iliaca to the mid-thigh region of the midpoint of the patella, the intersection of the sixth and eighth intercostal spaces, and the anterior axillary line. Relative muscle oxygenation changes (SmO2) and total hemoglobin concentration according to the modified Beer-Lambert Law formula (SmO2 = (Hb +) by comparing the measured light intensities with a pre-computed data set obtained by a Monte Carlo (MC). O2Mb) ÷ [(O2Hb + O2Mb) + (HHb + HMb)]) percent SmO2 concentration is determined by the diffusion of light in tissue layers., Through study completion, an average of 1 year|Total Hemoglobin Concentration with Muscle Oxygenation Monitor (SmO2), The measurement will be made in the dominant lower extremity, and the device will be measured by placing the device at a distance of 5 cm from the anterior superior reference point of the spina iliaca to the mid-thigh region of the midpoint of the patella, the intersection of the sixth and eighth intercostal spaces, and the anterior axillary line. Relative muscle oxygenation changes (SmO2) and total hemoglobin concentration according to the modified Beer-Lambert Law formula (SmO2 = (Hb +) by comparing the measured light intensities with a pre-computed data set obtained by a Monte Carlo (MC). O2Mb) ÷ [(O2Hb + O2Mb) + (HHb + HMb)]) percent SmO2 concentration is determined by the diffusion of light in tissue layers., Through study completion, an average of 1 year

Digital Muscle Strength Measurement for Peripheral Muscle Strength, Muscle strength of shoulder flexors, abductors, elbow flexors, hip flexors, abductors, and knee extensors will be evaluated. The test will be done by Lafayette brand digital muscle strength meter., Before 6MWT|Pulmonary Function Test for FVC, Pulmonary function test will be performed with desktop type spirometry. The FVC value will be calculated., Before 6MWT|Pulmonary Function Test for FEV1, Pulmonary function test will be performed with desktop type spirometry. The FEV1 value will be calculated., Before 6MWT|Pulmonary Function Test for FEV1/FVC, Pulmonary function test will be performed with desktop type spirometry. The FEV1/FVC value will be calculated., Before 6MWT|Maximal Inspiratory Muscle Strength, Pulmonary function test will be performed with desktop type spirometry. The Maximal Inspiratory Pressure value will be calculated., Before 6MWT|Maximal Expiratory Muscle Strength, Pulmonary function test will be performed with desktop type spirometry. The Maximal Expiratory Pressure value will be calculated., Before 6MWT|Fatigue measured with the Modified Borg Scale, Fatigue severity will be measured with the Modified Borg Scale. In the scale, the severity of fatigue is measured with a score between 0 and 10 points. On this scale, 0 point defines the best condition in terms of fatigue, and 10 points the worst., Before 6MWT|Dyspnea measured with the Modified Borg Scale, Dyspnea severity will be measured with the Modified Borg Scale. In the scale, the severity of dyspnea is measured with a score between 0 and 10 points. On this scale, 0 point defines the best condition in terms of dyspnea, and 10 points the worst., Before 6MWT

Saglik Bilimleri Universitesi

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

Fibrozan_Moxy_1

2023-02-13

2023-10-01

2023-10-01

2023-05-11

2023-11-27

SBU Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital, Istanbul, Turkey

{ "NIRS device usage during 6MWT": [ { "intervention_type": "OTHER" } ], "Peripheral Muscle Strength Measurement": [ { "intervention_type": "OTHER" } ], "Pulmonary Function Test": [ { "intervention_type": "OTHER" } ] }

NCT01973647

A Behavioral Therapy for Insomnia Co-existing With COPD

https://clinicaltrials.gov/study/NCT01973647

COMPLETED

Difficulty falling asleep, staying asleep or poor quality sleep (insomnia) is common in people with chronic obstructive pulmonary disease. Insomnia is related to greater mortality, with four times the risk of mortality for sleep times < 300 minutes. Insomnia is also related to greater morbidity, with 75% greater health care costs than people without insomnia. However, insomnia medications are used with caution in COPD due to potential adverse effects. Common features of COPD such as dyspnea, chronic inflammation, anxiety and depression also affect insomnia and can interfere with therapy outcomes. While cognitive behavioral therapy for insomnia (CBT-I), a therapy that provides guidance on changing unhelpful sleep-related beliefs and behavior, is effective for people with primary insomnia and people with other chronic illnesses, the efficacy and mechanisms of action of such a therapy are yet unclear in people with both insomnia and COPD. The objective in this application is to rigorously test efficacy of two components of insomnia therapy - CBT-I and COPD education (COPD-ED) - in people with coexisting insomnia and COPD, and to identify mechanisms responsible for therapy outcomes. The central hypothesis is that both CBT-I and COPD-ED will have positive, lasting effects on objectively and subjectively measured insomnia and fatigue. The rationale for the proposed study is that once the efficacy and mechanisms of CBT-I and COPD-ED are known, new and innovative approaches for insomnia coexisting with COPD can be developed, thereby leading to longer, higher quality and more productive lives for people with COPD, and reduced societal cost due to the effects of insomnia. The investigators plan to test our central hypothesis by completing a randomized controlled comparison of CBT-I, COPD-ED and non-COPD, non-sleep health education attention control (AC) using a highly efficient 4-group design. Arm 1 comprises 6 weekly sessions of CBT-I+AC; Arm 2=6 sessions of COPD-ED+AC; Arm 3=CBT-I+COPD-ED; and Arm 4=AC. This design will allow completion of the following Specific Aims: 1. Determine the efficacy of individual treatment components, CBT-I and COPD-ED, on insomnia and fatigue. 2. Define mechanistic contributors to the outcomes after CBT-I and COPD-ED. The research proposed in this application is innovative because it represents a new and substantive departure from the usual insomnia therapy, namely by testing traditional CBT-I with education to enhance outcomes.

NO

Insomnia|COPD|Chronic Obstructive Pulmonary Disease|Fatigue

BEHAVIORAL: Cognitive Behavioral Therapy for Insomnia|BEHAVIORAL: COPD Education|BEHAVIORAL: Attention Control

Insomnia, Change in the level of insomnia will be assessed using actigraphy and the Sleep Impairment Index questionnaire., Up to 18 weeks

Fatigue, Change in the level of fatigue will be assessed using the Chronic Respiratory Disease Questionnaire Fatigue scale and the PROMIS Fatigue scale., Up to 18 weeks|Beliefs about sleep, Change in beliefs about sleep will be measured using the DBAS questionnaire, Up to 18 weeks|Sleep habits, Change in sleep habits will be measured using a Sleep Diary and Actigraphy, Up to 18 weeks|Self-efficacy for sleep, Change in self-efficacy for sleep will be measured using the Self-efficacy for Sleep Scale, Up to 18 weeks|Self-efficacy for COPD management, Change in self-efficacy for COPD management will be measured using the Self-efficacy for COPD scale., Up to 18 weeks|Emotional arousal, Change in emotional arousal will be measured using the PROMIS anxiety and depression scales, Up to 18 weeks|Inflammation, Change in inflammation will be measured using C-reactive protein., 6 weeks|Pulmonary function, Change in pulmonary function will be measured using pulmonary function tests., 6 weeks|Daytime functioning, Change in daytime functioning will be measured using actigraphy, the Chronic Respiratory Disease Questionnaire Dyspnea Scale and the PROMIS Physical Functioning Scale., Up to 18 weeks

University of Illinois at Chicago

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

2013-0626

2014-06

2019-07

2019-07

2013-10-31

2019-10-02

University of Illinois at Chicago, Chicago, Illinois, 60612, United States

{ "Cognitive Behavioral Therapy for Insomnia": [ { "intervention_type": "BEHAVIORAL" } ], "COPD Education": [ { "intervention_type": "BEHAVIORAL" } ], "Attention Control": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT05495347

Big Data Analysis of OSA Patients on Positive Airway Pressure (PAP) Treatment: Real-life Monitoring

https://clinicaltrials.gov/study/NCT05495347

TeleVAL

RECRUITING

The present study aims to determine to what extent remote monitoring of PAP related to patients clinical parameters is able to provide relevant data on predictors of compliance, subgroups of patients who may benefit from this technological tool, variations in AHI over time, occurrence of central events at the start of therapy and, in short, to shed new light on this disease and its treatment, all within the application of continuous positive pressure therapy in the real world. Among the intended objectives is the identification of phenotypes involved in the use and efficacy of PAP therapy: development of a predictive model, as well as the evaluation of the impact of long-term telemonitoring of patients with Obstructive Sleep Apnea (OSA). The study initially arose from the need to diagnose, treat and follow up patients with suspected OSA in compliance with the social distancing rules imposed by the COVID-19 pandemic. It is an ambispective cohort study, with retrospective data collection from the start date of the pandemic (March 2020) to December 2021, and prospective data collection from the approval of the protocol to December 2022.

NO

Obstructive Sleep Apnea|Positive Airway Pressure

OTHER: patients diagnosed with OSA

Characterize the phenotypes involved, Determine the emergent CSA appearance in relation to PAP treatment., pandemic start date March 2020 until December 2022.

Establish the percentage of patients who at the first connection to the TM achieved the optimal therapeutic pressure, According to Built in software (BIS) of the equipment, pandemic start date March 2020 until December 2022.|Establish the Profile of patients who at the first connection to the TM achieved the optimal therapeutic pressure, According to Built in software (BIS) of the equipment, pandemic start date March 2020 until December 2022.|Variations in AHI during the first year of follow-up and their relationship with patient characteristics., pandemic start date March 2020 until December 2022.|Time to achieve the optimal therapeutic pressure described after the first connection, Number of modifications required and their relationship with patient subgroups., pandemic start date March 2020 until December 2022.|Evaluation of the impact of long-term telemonitoring of patients with OSA, Number of acesses and interventions made to the telemonitoring platform/year and time invested, pandemic start date March 2020 until December 2022.

Instituto de Investigación Marqués de Valdecilla

ALL

CHILD, ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

TeleVAL

2022-07-01

2022-12-31

2022-12-31

2022-08-10

2022-08-10

Hospital Universitario Marques de Valdecilla, Santander, Cantabria, 39008, Spain

{ "patients diagnosed with OSA": [ { "intervention_type": "OTHER" } ] }

NCT03373747

Reliability and Physiological Analysis of an Isometric Test of Localized Muscular Fatigue

https://clinicaltrials.gov/study/NCT03373747

COMPLETED

Introduction: The isokinetic dynamometer, considered a gold standard tool for physical evaluation, is widely used in studies that aim to evaluate the reliability and reproducibility of localized muscular endurance (LME) tests. However, such tests may not represent full LME by fixing time or number of replicates. Therefore, it is relevant to construct a test that respects the actual capacity of each subject to withstand fatigue and to submit such a test to validation, as well as to physiological analysis. Research objectives: To assess the inter- and intra-rater reliability of a localized isometric endurance test (IET) on the isokinetic dynamometer and to establish the metabolic demand required during the test. Design: Reliability study with test-reteste dynamic. Participants and Setting: After fulfilling the eligibility criteria, eighty-eight male participants will participate in the study. Procedure: In phase 1 forty-eight participants will submitted to reliability of the IET within three sessions: familiarization session, test session and retest sessio. In phase 2 forty participants will be submitted the metabolic demand required during the IET will be analyzed by means of gas analysis, blood lactat concetrate and muscular activation percentage. Intervention: isometric endurance teste. Measurements: The measurements include time of execution of test, work of test, physiological and psychological outcomes.

NO

Healthy Volunteers

DIAGNOSTIC_TEST: Reliability of IET|DIAGNOSTIC_TEST: Physiological analysis of IET

The time of execution of the test, This outcome will be assessed in seconds during execution of the test, 45 seconds after the beginning of the test

The work of the test, This outcome will be assessed in Newton.meter (N.m) during execution of the test, day 2 and day 7|Oxygen consumption - gas analysis, Gas analysis will be measured during the test and after seven minutes of the same (VO2000, MedGraphics, Minnesota, USA)., Second phase during all the test|Blood lactate concentration, The blood lactate concentration will be collected in the 10 minutes of rest before the test and immediately after the test and in the third, fifth and seven minutes after the test, Second phase, 10 minutes of rest before the test and immediately after the test and in the third, fifth and seven minutes after the test|Muscular activation percentage, The muscular activation percentage will be assessed by means of twitch interpolation technique ( current generator - Quark), Day 2|Psychological Questionnaire, Participants will be instructed to mark with a dash, on a 10 centimeters analogical visual scale in between two extremes, in which zero means non-existent and 10 very intense to each classification, Day 2 and day 7|Work Ability Index Questionnaire, This questionnaire consists in seven indicators, which provide a score between seven and 49, in which the highest the scores the better. These indicators evaluate occupational wellness, providing subjective estimation about work capacity, including the ability to perform work tasks in relation to demands, health and mental resources, Day 1|Perceived Stress Scale, This scale is intended to document participants related stress on the previous month. Items evaluate the degree to which people find life unpredictable, uncontrollable or overloaded. This scale evaluates overall beliefs about perceived stress, without the providence of any specific event lists in life to the subjects, allowing these scores not to be biased by the event content or difference of previous life experience, Day 1|Bergen Insomnia Scale, This scale is intended to evaluate participants sleep and tiredness, which consists in six questions about sleep issues in the previous month. Questions are about (1) problems initiating sleep, (2) awakening from sleep, (3) early morning awakening, (4) not feeling adequately rested, (5) experiencing daytime impairment and (6) being dissatisfied with sleep. To each question participants will answer on a zero to seven days a week scale. The quantity of days will be calculated based on the average of the answers to these six questions, in order to obtain an overall sleep problems score, Day 1|Need for Recovery Scale, This is an 11 item scale which aims to evaluate work fatigue symptoms, related to a series of emotional, cognitive and behavioral aspects characterized as temporary overload feelings, irritability, social seclusion, lack of energy for new efforts and performance reduction, Day 7|Borg Scale, Participants physical effort perception will also be measured by the Borg Scale, which will be used to correlate with heart rate values. After the completion of IET participants willl answer the following question: How much exertion did you experience during the test? . This scale has 15 possible answers, ranging from six to 20, represented respectively from not exertion at all to maximal exertion ., Day 7|Borg CR10 Scale, Participants physical effort perception will be measured by The Borg CR10 Scale. After the IET application participants will answer the following question: How much exertion did you experience during the test? . This scale has 16 possible answers which vary from zero to 10 represented respectively from no effort to maximum effort., Day 7|Effort Perception Scale, The effort perception will be evaluated by the Effort Perception Scale, with values between 0 and 10, 0 being correspondent to no effort at all (rest) and 10, to maximum effort, Day 1, day 2 and day 7|Recovery Perception Scale, The perceived recovery of the dominant lower limb will be assessed by means of the Effort Perception Scale, which consists of a 10-point Likert Scale, in which 1 means no recovery and 10, completely recovered, Day 1, day 2 and day 7|Heart Rate, The heart rate caption will take place using a cardio frequency meter (Polar electro, Oy Kempele, Finland - V800 model), Day 2 and day 7

Universidade Estadual Paulista Júlio de Mesquita Filho

Fundação de Amparo à Pesquisa do Estado de São Paulo

MALE

ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER

2016/11785-7

2017-10-01

2018-07-01

2018-09-01

2017-12-14

2019-03-25

Larissa Rodrigues Larissa Rodrigues Souto, Presidente Prudente, SP, 19060-900, Brazil|Larissa Rodrigues Souto, Presidente Prudente, SP, 19060-900, Brazil

{ "Reliability of IET": [ { "intervention_type": "DIAGNOSTIC_TEST" } ], "Physiological analysis of IET": [ { "intervention_type": "DIAGNOSTIC_TEST" } ] }

NCT01091233

The Influence of Paracentesis on Intra-abdominal Pressure and Kidney Function in Critically Ill Patients With Liver Cirrhosis and Ascites: an Observational Study

https://clinicaltrials.gov/study/NCT01091233

WITHDRAWN

Patients with liver cirrhosis are at risk for development of renal failure, usually after a precipitating event such as infection or bleeding. This form of renal failure has a high morbidity and mortality and may be partly caused by increased intra-abdominal pressure secondary to ascites. Recent studies have shown that paracentesis (and the resulting decreased IAP) can increase urinary output and decrease renal arterial resistive index in patients with hepatorenal syndrome (a very pronounced form of renal failure in cirrhosis patients). The aim of this study is to evaluate the influence of Paracentesis on intra-abdominal pressure and kidney function in critically ill patients with liver cirrhosis and ascites across a wider range of kidney function. Kidney function will be evaluated using several estimates of glomerular filtration rate and measures of kidney injury i.e. cystatin C, serum NGAL, creatinine clearance, urinary output and renal arterial resistive index.

NO

Critically Ill|Liver Cirrhosis|Ascites

PROCEDURE: paracentesis

Intra-abdominal pressure and kidney function before, during, immediately after and 12-24h after Paracentesis, Kidney function parameters include 2h creatinine clearance, serum and urine creatinine, renal artery resistive index (measured via color Doppler), urinary output, serum cystatine C and NGAL measurement., 24h after paracentesis

The association between the change in IAP and kidney function, 24h after paracentesis|The relationship between the amount of fluid drained and any effect on IAP and kidney function, 24h after paracentesis|Cystatin C, NGAL, creatinine clearance, serum creatinine, urinary output and RI as measures of kidney injury in patients with liver cirrhosis and ascites, 24h after paracentesis

University Hospital, Ghent

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

2009/722

2010-03

2012-12

2012-12

2010-03-23

2021-07-08

University Hospital Ghent, Ghent, Belgium

{ "paracentesis": [ { "intervention_type": "PROCEDURE" } ] }

NCT01976533

Eisenmenger Syndrome in the Nordic Countries

https://clinicaltrials.gov/study/NCT01976533

UNKNOWN

This is a historical cohort study with retrospective collection of data comprising all Nordic patient s diagnosed with Eisenmengers syndrome in the period 1977 through 2011. The goal is to determine prognostic factors for mortality and morbidity.

NO

Eisenmenger Syndrome

All cause mortality, 10 years

Rigshospitalet, Denmark

Lund University Hospital|Rikshospitalet University Hospital|Hospital for Children and Adolescents, Finland|Actelion

ALL

CHILD, ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

3-3013-144/1/

2012-10

2015-12

2016-10

2013-11-06

2015-12-24

Dept. Cardiology B, Rigshospitalet, Copenhagen, Denmark|Centers for Adult Congenital Heart Disease, Various, Finland|Centers for Adult Congenital Heart Disease, Various, Norway|Centers for adult congenital heart disease, Various, Sweden

{}

NCT03190733

A Optimal Anti-Thymoglobuline (ATG) Dose Decrease cGVHD But Not Increase Leukemia Relapse for Haplo-HSCT

https://clinicaltrials.gov/study/NCT03190733

UNKNOWN

In this study, a randomized, prospective, multicenter, open cohort study was conducted to investigate patients with acute leukemia (14～60-year-old) with different ATG doses (10 mg / kg and 12.5 mg / kg ) in fludarabine, busulfan, cyclophosphamide and antilymphocyte globulin (FBCA) pretreatment protocol of Haploidentical hematopoietic stem cell transplantation (haplo-HSCT). The purpose is to compare the incidences of chronic graft vs host disease (cGVHD) in haplo-HSCT recipients receiving different dose ATG and one year leukemia relapse after transplantation. The main objective was to investigate the optimal dose of ATG for decrease cGVHD and not increase one year relapse leukemia after haplo-HSCT. Its significance is to provide evidence-based medical evidence to reduce the occurrence of cGVHD and to improve the quality of life of patients with haplo-HSCT.

NO

Chronic Graft-versus-host-disease|Leukemia Relapse

DRUG: ATG

occurrence of chronic GVHD, chronic GVHD diagnosis based on National Institutes of Health (NIH) criterion, from the day of stem cell transplantation to one year after stem cell transplantation

one year cumulative incidence of leukemia relapse, leukemia relapse base on morphology criterion, from the day of stem cell transplantation to one year after stem cell transplantation|The cumulative incidence rate of acute GVHD, acute GVHD diagnosis based on NIH criterion, from the day of stem cell transplantation to one year after stem cell transplantation|no relapse mortality one year, no relapse death, from the day of stem cell transplantation to one year after stem cell transplantation

Zhujiang Hospital

Nanfang Hospital, Southern Medical University|First Affiliated Hospital, Sun Yat-Sen University|Second Affiliated Hospital, Sun Yat-Sen University

ALL

CHILD, ADULT

PHASE4

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION

2016-XYNK-001

2017-08-30

2020-09-30

2021-09-30

2017-06-19

2017-06-19

{ "ATG": [ { "intervention_type": "DRUG" } ] }

NCT04741633

Multi Dimensional Precise Exploration of Immunoconsolidation Therapy for Locally Advanced NSCLC After Chemo-radiotherapy

https://clinicaltrials.gov/study/NCT04741633

NSCLC

UNKNOWN

The purpose of this study is to carry out a prospective observational study in patients with locally advanced NSCLC receiving radical concurrent chemoradiotherapy and follow-up immune consolidation therapy. By detecting ctDNA and TILs of the patients, we explored the value of blood dynamic monitoring of ctDNA in patients with prognosis stratification and treatment effect, and explored the patients before and after concurrent chemoradiotherapy and immune consolidation therapy The characteristics of DNA, RNA, T cells and other biomarkers were correlated with the efficacy and prognosis.

NO

NSCLC|Chemoradiotherapy|ctDNA

Correlation between ctDNA dynamic detection and 1-year PFS rate after chemoradiotherapy, The ctDNA dynamic detection will contain NGS test including mutations(both somatic and germline), copy number variations, gene fusions along with genetic interpretation for each and every mutation identified in each test(both blood and tissue) during the whole therapeutic process, Six months after consolidation treatment

PFS, Six months after consolidation treatment|OS, Six months after consolidation treatment

Fudan University

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

CID-001

2020-04-01

2022-12-31

2022-12-31

2021-02-05

2021-02-05

Fudan University Shanghai Cancer Center, Shanghai, Shanghai, 200032, China

{}

NCT03273933

DragONE Study: Acquisition and Maintenance of Paediatric Asthma Control: Usual Care vs Innovative Devices

https://clinicaltrials.gov/study/NCT03273933

DragONE

COMPLETED

Randomized clinical trial to assess acquisition and maintenance of paediatric asthma control through innovative devices supporting usual care. In the first study arm, a new application (DragONE) for iOS and Android will be only used for patient monitoring. In the second study arm, a small portable device (SmartONE) will also be connected to the DragONE APP, for daily assessment of the peak expiratory flow (PEF). The study duration is 12 weeks. The main outcome of the study is the Childhood Asthma Control Test (C-ACT) score, assessed once every 4 weeks for 12 weeks.

NO

Asthma

DEVICE: DragONE|DEVICE: SmartOne

Acquisition and maintenance of the control status, mean C-ACT score, Once every 4 weeks, for 12 weeks

Quality of life in asthma children, PAQLQ score, 12 weeks|Adherence to asthma treatment, MARS score, 12 weeks|Lung function: FEV1, Forced expiratory volume in the first second, 12 weeks|Lung function: FVC, Forced vital capacity, 12 weeks|Lung function: FEF 25-75, Forced expiratory flow at 25-75%, 12 weeks

Istituto per la Ricerca e l Innovazione Biomedica

ALL

CHILD

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE

7/2017_B

2018-03-08

2020-02-26

2020-02-26

2017-09-06

2020-06-09

Institute of Biomedicine and Molecular Immunology (IBIM) - National Research Council of Palermo, Palermo, 90146, Italy

{ "DragONE": [ { "intervention_type": "DEVICE" } ], "SmartOne": [ { "intervention_type": "DEVICE" } ] }

NCT04940533

Pharmacokinetics of CFTR Modulators in Pregnant Individuals and in Postpartum Breastfeeding Mothers

https://clinicaltrials.gov/study/NCT04940533

NOT_YET_RECRUITING

This study aims to evaluate the pharmacokinetic changes during pregnancy, postpartum, and in breast milk in cystic fibrosis patients receiving a cystic fibrosis transmembrane conductance regulator (CTFR) modulator, including Elexacaftor, Tezacaftor, Ivacaftor, or Lumacaftor.

NO

Cystic Fibrosis|Pregnancy

Change in levels of CTFR modulator in blood, Quantification of CTFR modulator in blood will be performed using Liquid Chromatography-Mass Spectrometry (LC-MS) and reported in units of ng/kg. Blood will be collected every 3 months during pregnancy and at the sampling of breast milk 0-4 days after giving birth., approximately 9 months|Change in levels of CTFR modulator in breast milk, Quantification of CTFR modulator in blood will be performed using Liquid Chromatography-Mass Spectrometry (LC-MS) and reported in units of ng/ml. Breast milk will be collected following feeding of the infant 0-4 days following birth of the infant., 4 days|Change in levels of CTFR modulator in umbilical cord blood, Quantification of CTFR modulator in blood will be performed using Liquid Chromatography-Mass Spectrometry (LC-MS) and reported in units of ng/kg. Umbilical cord blood will be collected once at the time the infant is born., at birth of the infant

University of Minnesota

FEMALE

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

PACCS-2020-28860-1

2024-12-01

2025-01

2025-01

2021-06-25

2024-04-01

University of Minnesota, Minneapolis, Minnesota, 55455, United States

{}

NCT00004033

Liposomal-Cisplatin Analogue (L-NDDP) in Treating Patients With Malignant Pleural Mesothelioma

https://clinicaltrials.gov/study/NCT00004033

COMPLETED

RATIONALE: Patient abstract not available PURPOSE: Patient abstract not available

NO

Malignant Mesothelioma

DRUG: liposomal NDDP|PROCEDURE: therapeutic thoracoscopy

NYU Langone Health

National Cancer Institute (NCI)

ALL

ADULT, OLDER_ADULT

PHASE2

OTHER

INTERVENTIONAL

Allocation: |Intervention Model: |Masking: |Primary Purpose: TREATMENT

CDR0000066141|P30CA016087|NYU-9850|MDA-FDR001234|MDA-ID-95209|NCI-G99-1575

1998-09

2001-05

2004-04-15

2011-03-28

NYU School of Medicine s Kaplan Comprehensive Cancer Center, New York, New York, 10016, United States|University of Texas - MD Anderson Cancer Center, Houston, Texas, 77030-4009, United States

{ "liposomal NDDP": [ { "intervention_type": "DRUG" } ], "therapeutic thoracoscopy": [ { "intervention_type": "PROCEDURE" } ] }

NCT03097133

54135419SUI3002: A Study to Evaluate the Efficacy and Safety of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Adult Participants Assessed to be at Imminent Risk for Suicide

https://clinicaltrials.gov/study/NCT03097133

Aspire II

COMPLETED

The purpose of this study is to evaluate the efficacy of intranasal esketamine 84 milligram (mg) compared with intranasal placebo in addition to comprehensive standard of care in reducing the symptoms of Major Depressive Disorder (MDD), including suicidal ideation, in participants who are assessed to be at imminent risk for suicide, as measured by the change from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) total score at 24 hours post first dose.

YES

Depressive Disorder, Major

DRUG: Esketamine|DRUG: Placebo|OTHER: Standard of Care

Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at 24 Hours Post First Dose (Last Observation Carried Forward [LOCF] Data): Double-blind (DB) Treatment Phase, MADRS is clinician-rated scale designed to be used in participants with Major Depressive Disorder (MDD) to measure depression severity and detect changes due to antidepressant treatment. It evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic and suicidal thoughts. Scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms), summed for total possible score of 0 to 60. Higher scores represent more severe condition. Negative change in score indicates improvement., Baseline (Day 1, predose) and 24 hours first post dose (Day 2)|Change From Baseline in Clinical Global Impression-Severity of Suicidality - Revised (CGI-SS-R) Scale at 24 Hours Post First Dose (LOCF Data): DB Treatment Phase, Clinical global impression-severity of suicidality-revised (CGI-SS-R) scale is revised version of the clinical global impression severity scale (CGI-S),a global rating scale that gives an overall measure of the severity of a participants illness. The CGI-SS-R summarizes the clinician s overall impression of severity of suicidality on a 7-point scale from 0 (normal, not at all suicidal) to 6 (among the most extremely suicidal participants), based on the totality of information available to the clinician. Higher score indicates a more severe condition. Negative change in score indicates improvement., Baseline (Day 1, predose) and 24 hours first post dose (Day 2)

Number of Participants With Remission of Major Depressive Disorder (MADRS Total Score Less Than or Equal to [<=] 12): DB Treatment Phase, MADRS is clinician-rated scale designed to be used in participants with Major Depressive Disorder (MDD) to measure depression severity and detect changes due to antidepressant treatment. It evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic and suicidal thoughts. Scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms), summed for total possible score of 0 to 60. Higher scores represent more severe condition. Negative change in score indicates improvement., Days 1 (4 hours [h] postdose), 2, 4, 8, 11, 15, 18, 22 and 25 (predose and 4 hours postdose)|Change From Baseline in MADRS Total Score at 4 Hours Post First Dose at Day 1 (4 Hours Post First Dose), and 2, 4, 8, 11, 15, 18, 22 and 25: DB Treatment Phase, MADRS is a clinician-rated scale designed to be used in participants with MDD to measure depression severity and detect changes due to antidepressant treatment. MADRS evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts. The instrument consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 0 to 60. Higher scores represent a more severe condition. Negative change in score indicates improvement., Baseline (Day 1, predose), Days 1 (4 hours postdose), 2, 4, 8, 11, 15, 18, 22 and 25 (predose and 4 hours postdose)|Change From Baseline in CGI-SS-R Score at 4 Hours Post First Dose at Day 1 (4 Hours Post First Dose), and 2, 4, 8, 11, 15, 18, 22 and 25: DB Treatment Phase, CGI-SS-R is revised version of the CGI-S. The CGI-SS-R summarizes the clinician s overall impression of severity of suicidality on a 7-point scale from 0 (normal, not at all suicidal) to 6 (among the most extremely suicidal participants), based on the totality of information available to the clinician. A higher score indicates a more severe condition. Negative change in score indicates improvement., Baseline (Day 1, predose), Days 1 (4 hours postdose), 2, 4, 8, 11, 15, 18, 22 and 25|Number of Participants Who Achieved Resolution of Suicidality (CGI-SS-R Score of 0 or 1): DB Treatment Phase, CGI-SS-R is revised version of the CGI-S. The CGI-SS-R summarizes the clinician s overall impression of severity of suicidality on a 7-point scale from 0 (normal, not at all suicidal) to 6 (among the most extremely suicidal participants), based on the totality of information available to the clinician. Higher score indicates a more severe condition. A participant was considered to have achieved resolution of suicidality at a given time point if the CGI-SS-R score was 0 (normal, not at all suicidal) or 1 (questionably suicidal). Participants who did not met such criterion or discontinued prior to the time point for any reason were not considered to have resolution of suicidality., Days 1 (4 hours postdose), 2, 4, 8, 11, 15, 18, 22 and 25|Change From Baseline in Clinical Global Impression of Imminent Suicide Risk (CGI-SR-I) at Days 1, 2, 4, 8, 11, 15, 18, 22 and 25: DB Treatment Phase, The CGI-SR-I is a scale summarizing the clinician s best assessment of the likelihood that the participant will attempt suicide in the next 7 days. The CGI-SR-I rating is scored on a 7-point scale: where 0 (no imminent suicide risk); 1 (minimal imminent suicide risk), 2 (mild imminent suicide risk), 3 (moderate imminent suicide risk), 4 (marked imminent suicide risk), 5 (severely imminent suicide risk), 6 (extreme imminent suicide risk). Higher score indicates a more severe condition. Negative change in score indicates improvement., Baseline (Day 1, predose), Days 1 (4 hours postdose), 2, 4, 8, 11, 15, 18, 22 and 25|Change From Baseline in Beck Hopelessness Scale (BHS) Total Score at Days 8 and 25 in DB Treatment Phase, BHS is a self-reported measure to assess one s level of negative expectations or pessimism regarding future. It consists of 20 true-false items that examine respondent s attitude over past week by either endorsing a pessimistic statement or denying an optimistic statement; 9 are keyed false and 11 are keyed true. For every statement, each response was assigned score of 0 or 1. Total BHS score is sum of item responses, ranged from 0-20, where higher score represented higher level of hopelessness., Baseline, Days 8 and 25|Change From Baseline in European Quality of Life Group, 5-Dimension, 5-Level (EQ-5D-5L) Sum Score at Days 2, 11 and 25 of the DB Treatment Phase, EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ-VAS). EQ-5D-5L descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (no problem, slight, moderate, severe and extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today . Responses were used to generate Health Status Index (HSI). HSI ranges from 0 (dead) to 1.00 (full health). EQ-VAS self-rating records respondent s own assessment of his/her overall health status at time of completion, on a scale of 0 (worst imaginable health)-100 (best imaginable health). Sum score ranges from 0 -100. Sum score=(sum of the scores from the 5 dimensions minus 5)*5. Higher score indicates worse health state. Negative change in score indicates improvement., Baseline, Days 2, 11 and 25|Change From Baseline in European Quality of Life Group, Visual Analogue Scale (EQ-VAS) Score at Days 2, 11 and 25 of the DB Treatment Phase, EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. The EQ VAS self-rating records the respondent s own assessment of his or her overall health status at the time of completion, on a scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). Positive change in score indicates improvement., Baseline, Days 2, 11 and 25|Change From Baseline in EQ-5D-5L Health Status Index at Days 2, 11 and 25 of the DB Treatment Phase, EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today . Responses were used to generate a HSI. HSI ranges from 0 (dead) to 1.00 (full health). Positive change in score indicates improvement., Baseline, Days 2, 11 and 25|Change From Baseline in Quality of Life in Depression Scale (QLDS) Total Score at Days 2, 11 and 25 of the DB Treatment Phase, The QLDS is a disease-specific patient-reported outcome designed to assess health-related quality of life in patients with MDD, it captures the impact of depression and its treatment from the participant s perspective. The instrument has a recall period of at the moment and contains 34 items with true / not true response options. The total score range is from 0 (good quality of life) to 34 (very poor quality of life). A higher score indicates a more severe condition. Negative change indicates improvement., Baseline, Days 2, 11 and 25|Treatment Satisfaction Questionnaire for Medication (TSQM-9) Domain Score at Days 15 and 25: DB Treatment Phase, The TSQM-9 is a 9-item generic patient-reported outcome instrument to assess participants satisfaction with medication. It covers domains of effectiveness, convenience, and global satisfaction. The TSQM-9 domain scores were calculated as recommended by the instrument authors. (i) Effectiveness = [(item 1 + item 2 + item 3) - 3]/18*100, (ii) Convenience = [(item 4 + item 5 + item 6) - 3]/18*100 and (iii) Global satisfaction = [(item 7 + item 8 + item 9) - 3]/14*100. Each domain score can be calculated only if all the three items considered in the calculation of that score are not missing. The TSQM-9 domain score ranges from 0 to 100, with higher scores representing higher satisfaction., Days 15 and 25|Change From Baseline in Suicide Ideation and Behavior Assessment Tool (SIBAT) Module 5 (My Risk) Question 3 (Participant-Reported Frequency of Suicidal Thinking) Score at Days 1, 2, 4, 8, 11, 15, 18, 22 and 25: DB Treatment Phase, SIBAT is an assessment tool that captures suicidal ideation, behavior, and risk. It permits assessment of change in suicidal ideation and behavior and documents clinician assessment of severity of suicidality and suicide risk. SIBAT is organized into 8 modules divided into 2 major divisions: patient-reported section (Modules 1-5) and clinician-rated section (Modules 6-8). Patient-reported section has modules of demographics and suicide history, risk/protective factors, suicidal thinking, suicide behavior, and suicide risk. Question 3 from Module 5 asks participants to describe their thinking about suicide right now from 5 response options ranging from 0 (I have no suicidal thoughts) to 4 (I have suicidal thoughts all of time)., Baseline, Days 1 (4h postdose), 2, 4, 8, 11, 15, 18, 22 and 25|Change From Baseline in Suicide Ideation and Behavior Assessment Tool (SIBAT) Module 7 (Clinician-rated Frequency of Suicidal Thinking [FoST]) Score at Days 1, 2, 4, 8, 11, 15, 18, 22 and 25: DB Treatment Phase, SIBAT is assessment tool that captures suicidal ideation, behavior, and risk. It permits assessment of change in suicidal ideation and behavior and documents clinician assessment of severity of suicidality and suicide risk. SIBAT has 8 modules divided into 2 major divisions: patient-reported section (Modules 1-5) and clinician-rated section (Modules 6-8). Clinician-rated section has modules for semi-structured interview, clinical global impressions of current severity of suicidality and imminent suicide risk, clinical global impression of long-term suicide risk, and clinical judgment of optimal suicide management. The score anchor point as in participant report frequency of suicidal thinking that is, response options from never to all the time. Module 7-FoST score ranges from 0-5; higher score indicates more severe condition. Negative change in score indicates improvement., Baseline, Days 1 (4 hours postdose), 2, 4, 8, 11, 15, 18, 22 and 25|Number of Participants With Treatment Emergent Adverse Events (TEAEs): DB Treatment Phase, An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. A TEAE is categorized as related if assessed by the investigator as possibly, probably, or very likely related to study agent., Up to Day 25|Number of Participants With Treatment Emergent Abnormal Laboratory Values: DB Treatment Phase, Low/high abnormal values are: Alanine aminotransferase (ALT)-high=200 Units per liter(U/L); ALP-high=250U/L; aspartate aminotransferase(AST)-high=250U/L; gamma glutamyl transferase(GGT)=300U/L; Albumin (low=24g/L,high=60 g/L); Bicarbonate(low=15.1, high=34.9mmol/L); Bilirubin(high=51.3micromol/L); calcium(low=1.5,high=3mmol/L);Chloride(low=94,high=112mmol/L); CK(High=990U/L); Creatinine (High=265.2micromol/L); Eosinophils(High=10%); Erythrocytes(low=3.0*1012/L,high=6.4*1012/L); Glucose(low=2.2,high=16.7mmol/L); Hemoglobin(low=80g/L,high=190g/L);Hematocrit(low=0.28, high=0.55 fraction); LD(high=500U/L); Leukocytes(low=2.5*109/L,high=15.5*109/L); Lymphocytes(low=10%,high=60%); Monocytes(high=20%); Neutrophils(low=30%,high=90%); Phosphate(low=0.7 mmol/L,high=2.6mmol/L); Platelet count(low=100*109/L,high=600*109/L]; Potassium(low=3.0mmol/L,high=5.8 mmol/L]; Protein(low=50 g/L); Sodium(low=125 mmol/L,high=155 mmol/L); Urate(low=89.2 micromol/L,high=594.8micromol/L); Urine(high=8.0 pH)., Up to Day 25|Number of Participants With Abnormal Nasal Examinations at Day 25: DB Treatment Phase, Number of participants with abnormal nasal examination were reported. Nasal examination of visual inspection of the epistaxis, nasal crusts, nasal discharge, and nasal erythema was performed., At Day 25|Number of Participants With Treatment Emergent Abnormal Electrocardiogram (ECG) Values at Any Time: DB Treatment Phase, Number of participants with treatment emergent abnormal ECG values for variables including heart rate (abnormally low refers to less than or equal to [<=] 50 beats per minute [bpm] , abnormally high refers greater than or equal to [>=] 100 bpm), pulse rate (PR) interval (abnormally high refers to >= 210 milliseconds [msec]), QRS interval (abnormally Low refers to <= 50, abnormally high refers to >= 120 msec) and QT interval (abnormally low refers to <= 200, abnormally high >= 500 msec) were reported., Up to Day 25|Number of Participants With Abnormal Arterial Oxygen Saturation (SpO2) Levels (Less Than [<] 93%) as Assessed by Pulse Oximetry at Any Time: DB Treatment Phase, Pulse oximetry was used to measure arterial SpO2 levels. On each dosing day, the device was attached to the finger, toe, or ear, and SpO2 was monitored and documented. If oxygen saturation levels were less than (<) 93% at any time during the 1.5 hours postdose interval, pulse oximetry was recorded every 5 minutes until levels return to >= 93% or until the participant is referred for appropriate medical care, if clinically indicated. Participants with at least 2 consecutive postdose oxygen saturation below 93% during the DB treatment phase were reported., Up to Day 25|Number of Participants With Treatment Emergent Vital Signs Abnormalities: DB Treatment Phase, Number of participants with treatment emergent vital signs abnormalities (pulse rate in bpm [abnormally low = a decrease from baseline of >= 15 to a value <= 50; abnormally high = an increase from baseline of >=15 to a value >=100] , systolic blood pressure [SBP] in mmHg [abnormally low = a decrease from baseline of >= 20 to a value <= 90; abnormally high = an increase from baseline of >= 20 to a value >= 180], and diastolic blood pressure [DBP] in mmHg [abnormally low= a decrease from baseline of >=15 to a value <= 50; abnormally high = an increase from baseline of >= 15 to a value >= 105) were reported., Up to Day 25|Number of Sedated Participants as Assessed by Modified Observer s Assessment of Alertness/Sedation (MOAA/S) Score at Any Time: DB Treatment Phase, MOAA/S was used to measure treatment-emergent sedation with correlation to levels of sedation defined by the American society of anesthesiologists (ASA) continuum. The MOAA/S scores range from 0 to 5 where,0 = no response to painful stimulus; ASA continuum = general anesthesia, 1 = responds to trapezius squeeze; ASA continuum = deep sedation, 2 = purposeful response to mild prodding or mild shaking; ASA continuum = moderate sedation, 3 = responds after name called loudly or repeatedly; ASA continuum = moderate sedation, 4 = lethargic response to name spoken in normal tone; ASA continuum = moderate sedation and 5 = readily responds to name spoken in normal tone (awake); ASA continuum = minimal sedation., Up to Day 25|Number of Participants With an Increase in Clinician-administered Dissociative States Scale (CADSS) Total Score Over Time: DB Treatment Phase, The CADSS used to measure present-state dissociative symptoms, and to assess treatment-emergent dissociative symptoms. It comprises 23 subjective items divided into 3 components: depersonalization (with score range from 0 to 28), derealization (with score range from 0 to 52), and amnesia (with score range from 0 to 8). Participants responses are coded on a 5-point scale (0 = Not at all , 1 = Mild , 2 = Moderate , 3 = Severe and 4 = Extreme ). The total score is sum of the 23 items and range from 0 to 92, where 0 (best) and 92 (worst). A higher score indicates a more severe condition. Number of participants with an increase in CADSS total score (increase based on maximum CADSS total score change from predose of > 0) was reported., Days 1, 4, 8, 11, 15, 18, 22 and 25

Janssen Research & Development, LLC

ALL

ADULT

PHASE3

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT

CR108285|2016-003992-23|54135419SUI3002

2017-06-15

2019-04-11

2019-04-11

2017-03-31

2020-09-25

2021-08-30

University of California San Diego/Psychiatry, San Diego, California, 92103-8229, United States|Sharp Mesa Vista Hospital, San Diego, California, 92123, United States|University of Conneticut School of Medicine, Farmington, Connecticut, 06030, United States|University of Miami Health System, Miami, Florida, 33136, United States|Innovative Clinical Research, Inc., North Miami, Florida, 33161, United States|University of South Florida, Tampa, Florida, 33613, United States|Atlanta Behavioral Research, LLC, Atlanta, Georgia, 30338, United States|Memorial Medical Center, Springfield, Illinois, 62702, United States|Neuroscience Research Institute, Winfield, Illinois, 60190, United States|Lake Charles Clinical Trials, Lake Charles, Louisiana, 70629, United States|John Hopkins Hospital, Baltimore, Maryland, 21287, United States|Altea Research Institute, Las Vegas, Nevada, 89102, United States|The Zucker Hillside Hospital, Glen Oaks, New York, 11004, United States|Stony Brook University Medical Center, Stony Brook, New York, 11794, United States|University of North Carolina, Chapel Hill, North Carolina, 27599, United States|University of Cincinnati, Dept of Psychiatry & Behavioral Neuroscience, Cincinnati, Ohio, 45219, United States|East Tennessee State University, Johnson City, Tennessee, 37604, United States|University of Wisconsin Medical Center, Madison, Wisconsin, 53705, United States|Clínica Privada Banfield S.A, Banfield, B1828CKR, Argentina|Hospital Fleni, Ciudad de Buenos Aires, C1428AQK, Argentina|Sanatorio Prof. Leon S. Morra, Cordoba, X5009BIN, Argentina|Clinica Privada de Salud Mental Santa Teresa de Ávila, La Plata, B1904ADM, Argentina|Medical University Vienna, MUV, Vienna, 1090, Austria|Klinikum Wels-Grieskirchen, Wels, 4600, Austria|AZ Sint-Jan Brugge-Oostende AV, Brugge, 8000, Belgium|UZ Gent, Gent, 9000, Belgium|ARIADNE, Lede, 9340, Belgium|Hospital Universitario Professor Edgar Santos, Bahia, 40110-060, Brazil|Hospital Das Clinicas Da Universidade Federal De Minas Gerais, Belo Horizonte, 301301, Brazil|Universidade Federal Do Ceara, Fortaleza, 60430-370, Brazil|Instituto Bairral de Psiquiatria, Itapira, 13970-905, Brazil|CEMEC - Centro Multidisciplinar de Estudos Clínicos, Santo Andre, 09190-510, Brazil|Instituto de Psiquiatria - Hcfmusp, Sao Paulo, 05403-903, Brazil|St. Michael s Hospital, Toronto, Ontario, M5B 1W8, Canada|Institut universitaire en sante mentale de Montreal, Montréal, Quebec, H1N 3M5, Canada|Fakultni nemocnice Brno, Brno, 62500, Czechia|Nemocnice s pol. Havirov, p.o., Havirov, 73601, Czechia|Narodni ustav dusevniho zdravi, Klecany, 25067, Czechia|Vseobecna Fakultní Nemocnice, Praha, 12000, Czechia|Úst?ední vojenské nemocnice Praha, Praha, 16902, Czechia|Hôpital de Bohars, Bohars, 29820, France|CHRU Montpellier - Hôpital Lapeyronie, Montpellier, 34090, France|CHU Caremeau, Nimes, 30029, France|Hopital Sainte Anne, Paris, 75014, France|CHU Saint-Etienne - Hôpital Nord, Saint-Priest en Jarez, 42270, France|CHU Toulouse, Toulouse, 31059, France|Republic Kaunas Hospital, Kaunas County, Lithuania|Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Kaunas, LT-50009, Lithuania|Vilnius Mental Health Center, Vilnius, 10309, Lithuania|Uniwersyteckie Centrum Kliniczne, Gdansk, 80-952, Poland|Szpital Specjalistyczny im. H. Klimontowicza, Oddzial Psychiatryczny, Gorlice, 38-300, Poland|SPZOZ CSK UM w Lodzi Klinika Zaburzen Afektywnych i Psychotycznych, Lodz, 92-216, Poland|Klinika Psychiatryczna WUM Mazowieckie Specjalistyczne Centrum Zdrowia im prof Jana Mazurkiewicza, Pruszkow, 05-802, Poland|Hosp. Univ. Vall D Hebron, Barcelona, 08035, Spain|Inst. Internac. Neurociencias Aplicadas, Barcelona, 8006, Spain|Hosp. Univ. de Basurto, Bilbao, 48013, Spain|Clinica Univ. de Navarra, Pamplona, 31008, Spain|Bursa Sevket Yilmaz Research and Training Hospital, Bursa, 16240, Turkey|Uludag University Medical Faculty, Bursa, 16285, Turkey|Şişli Etfal Research Training Hospital, Istanbul, 34360, Turkey|Samsun Psychiatric Hospital, Samsun, 55070, Turkey

Study Protocol, https://cdn.clinicaltrials.gov/large-docs/33/NCT03097133/Prot_000.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/33/NCT03097133/SAP_001.pdf

{ "Esketamine": [ { "intervention_type": "DRUG", "description": "Esketamine", "name": "Esketamine", "synonyms": [ "(\u2212)-ketamine", "(S)-(\u2212)-ketamine", "(-)-Ketamine", "Esketamine", "(S)-2-(o-chlorophenyl)-2-(methylamino)cyclohexanone", "(S)-ketamine", "S-(-)-Ketamine", "Ketanest", "Spravato", "S-ketamine", "L-ketamine", "CI 581", "Ketanest", "2-(2-Chlorophenyl)-2-(methylamino)cyclohexanone", "Calipsol", "2-(o-chlorophenyl)-2-(methylamino)-cyclohexanone", "2-(methylamino)-2-(2-chlorophenyl)cyclohexanone", "DL-ketamine", "Ketamine", "NMDA", "CI-581", "Ketaset", "Special K", "(\u00b1)-ketamine", "Ketamina", "Calypsol", "Ketamine Hydrochloride", "K\u00e9tamine", "Kalipsol", "Ketaminum", "Ketalar", "(+-)-Ketamine", "CI581", "2-(2-Chloro-phenyl)-2-methylamino-cyclohexanone", "CI 581", "Ketanest", "2-(2-Chlorophenyl)-2-(methylamino)cyclohexanone", "Calipsol", "2-(o-chlorophenyl)-2-(methylamino)-cyclohexanone", "2-(methylamino)-2-(2-chlorophenyl)cyclohexanone", "DL-ketamine", "Ketamine", "NMDA", "CI-581", "Ketaset", "Special K", "(\u00b1)-ketamine", "Ketamina", "Calypsol", "Ketamine Hydrochloride", "K\u00e9tamine", "Kalipsol", "Ketaminum", "Ketalar", "(+-)-Ketamine", "CI581", "2-(2-Chloro-phenyl)-2-methylamino-cyclohexanone" ], "medline_plus_id": "a619017", "generic_names": [ "Esketamine", "Ketamine", "Ketamine" ], "drugbank_id": "DB11823", "wikipedia_url": "https://en.wikipedia.org/wiki/Esketamine" } ], "Placebo": [ { "intervention_type": "DRUG" } ], "Standard of Care": [ { "intervention_type": "OTHER" } ] }

NCT02350933

Endoscopic Evaluation of the Paediatric Airway After Prior Prolonged (>24 h) Tracheal Intubation

https://clinicaltrials.gov/study/NCT02350933

COMPLETED

The purpose of this study is to determine whether possible damages of the trachea caused by a prior prolonged intubation (> 24h) can be observed by rigid endoscopy of the trachea and if cuffed tracheal tubes cause less damages than cuffed tubes.

NO

Intubation|Endoscopy

PROCEDURE: Endoscopy

Number of patients with evidence of subglottic stenosis after longterm intubation with cuffed versus uncuffed tracheal tubes, An International Study Board Committee (assessor board) will assess the endoscopic records in a blinded manner using a systematic grading system., After an average induction period of 10 min of an anesthesia with a planned intubation after the endoscopy

Numbers of prior intubations, Numbers of shortterm and prolonged (>24h) and numbers of intubations with cuffed and uncuffed tubes are listed, Retrospective data analysis of former intubations is performed within two years after the endoscopy|Duration of prior longterm intubation, Retrospective data analysis of former intubations is performed within two years after the endoscopy|Reason for prior longterm intubation, Reason for prior longterm intubation is look up in patient s medical records., Retrospective data analysis of former intubations is performed within two years after the endoscopy|Route of prior longterm intubation, Route of prior longterm intubation (nasal or oral) is look up in patient s medical records., Retrospective data analysis of former intubations is performed within two years after the endoscopy|Tube type used for prior longterm intubation, Tube type used for prior longterm intubation (cuffed or uncuffed) is look up in patient s medical records., Retrospective data analysis of former intubations is performed within two years after the endoscopy|Tube brand used for prior longterm intubation, Tube brand used for prior longterm intubation is look up in patient s medical records., Retrospective data analysis of former intubations is performed within two years after the endoscopy|Tube size used for prior longterm intubation, Tube size (inner diameter) used for prior longterm intubation is look up in patient s medical records., Retrospective data analysis of former intubations is performed within two years after the endoscopy|Site of prior longterm intubation, Site of prior longterm intubation is look up in patient s medical records., Retrospective data analysis of former intubations is performed within two years after the endoscopy|Maximal cuff pressure during prior longterm intubation, Maximal cuff pressure in cmH2O during longterm intubation is look up in patient s medical records., Retrospective data analysis of former intubations is performed within two years after the endoscopy|Number of patients with a stridor event after extubation of prior longterm intubation, Retrospective data analysis of former intubations is performed within two years after the endoscopy

University Children s Hospital, Zurich

Great Ormond Street Hospital for Children NHS Foundation Trust|Asklepios-Klinik Sankt Augustin|Kinderkrankenhaus Amsterdamer Straße|Erasmus Medical Center

ALL

CHILD

OTHER

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC

Endostudy

2011-09

2017-12

2017-12

2015-01-30

2018-05-09

Kinderkrankenhaus Amsterdamer Straße, Köln, Nordrhein-Westfalen, 50735, Germany|Asklepios Kinderklinik Sankt Augustin, Sankt Augustin, Nordrhein-Westfalen, 53757, Germany|Erasmus Medical Center, Sophia Children s Hospital, Rotterdam, 3015, Netherlands|University Children s Hospital, Zurich, 8032, Switzerland|Great Ormond Street Hospital for Children NHS Foundation Trust, London, WC1N 3JH, United Kingdom

{ "Endoscopy": [ { "intervention_type": "PROCEDURE" } ] }

NCT06062433

A Study of Remote Asthma Management Using an Integrated Artificial Intelligence-assisted EHR Dashboard and Mobile Device Compared With Usual Asthma Care to Treat 6-17 Year Old Patients

https://clinicaltrials.gov/study/NCT06062433

ENROLLING_BY_INVITATION

The main purpose of this study is to look at whether clinicians and their patients with asthma can satisfactorily perform remote asthma management at home (not visiting clinic) by using an artificial intelligence tool called Asthma-Guidance and Prediction System combined with a home monitoring device called AsthmaTuner.

NO

Asthma in Children

DEVICE: AsthmaTuner|OTHER: Asthma-Guidance and Prediction System

Change in satisfaction of asthma care, Measured by single question to assess satisfaction about asthma care using a Likert scale where 1=strongly disagree and 5=strongly agree. Higher score indicates greater satisfaction., Baseline, 6 months

Time allocated to asthma visits, Total time allocated to asthma visits which includes time spent with pediatric participant, EHR review, and completion of timed clinical task., 6 months|Number of on-site visits, Total number of on-site visits for related asthma care, 6 months|Frequency of poorly controlled asthma, Number of subjects to have poorly controlled asthma defined as Asthma Control Test or Childhood Asthma Control Test score less than 20., Baseline, 6 months

Mayo Clinic

ALL

CHILD

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE

22-001438

2023-12-05

2024-12

2024-12

2023-10-02

2024-03-12

Mayo Clinic, Rochester, Minnesota, 55905, United States

{ "AsthmaTuner": [ { "intervention_type": "DEVICE" } ], "Asthma-Guidance and Prediction System": [ { "intervention_type": "OTHER" } ] }

NCT01106833

Chronic Graft-versus-Host Disease Treatment (BMT CTN 0801)

https://clinicaltrials.gov/study/NCT01106833

COMPLETED

This study is designed as a combined Phase II/III, randomized, open label, multicenter, prospective comparative study of sirolimus plus prednisone versus sirolimus/calcineurin-inhibitor plus prednisone for the treatment of chronic GVHD. Patients will be stratified by transplant center and will be randomized to an experimental arm of one of the two pre-specified experimental arms (sirolimus + prednisone or the comparator arm of sirolimus + calcineurin inhibitor + prednisone) in a 1:1 ratio.

YES

Chronic GVHD

DRUG: Sirolimus + calcineurin inhibitor + prednisone|DRUG: Sirolimus + prednisone

Proportion of Participants With Treatment Success, Treatment success was evaluated at 6 months in Phase II and is defined as a complete or partial response without secondary systemic immunosuppressive therapy and no recurrent malignancy or death. In Phase III, treatment success was evaluated at 24 months and is defined as a complete response without secondary systemic immunosuppressive therapy and no recurrent malignancy or death., 6 months and 24 months post-randomization

Percentage of Participants With Overall Survival, Overall survival is defined as survival of death from any cause., 6 months and 24 months post-randomization|Percentage of Participants With Progression-free Survival, Progression-free Survival is defined as survival without malignancy relapse. Relapse and death are considered failures for this endpoint., 6 months and 24 months post-randomization|Percentage of Participants With Failure-free Survival, Failure-free Survival is defined as survival without malignancy progression or initiation of secondary therapy for chronic GVHD. Progression, initiation of secondary therapy for chronic GVHD, and death are considered failures for this endpoint., 6 months and 24 months post-randomization|Percentage of Participants With Relapse, Relapse is defined as recurrence of the primary malignancy. Death is considered a competing risk for this endpoint., 6 months and 24 months post-randomization|Percentage of Participants With Secondary Immunosuppressive Therapy Initiated, The percentage of participants initiating secondary immunosuppressive therapy for chronic GVHD is described. Death is considered a competing risk for this endpoint., 6 months and 24 months post-randomization|Percentage of Participants With Discontinuation of Systemic Immunosuppressive Therapy at Two Years, The percentage of participants discontinuing all systemic immunosuppressive therapy by two years post-randomization is described. Death is considered a competing risk for this endpoint., 2 years post-randomization|Prednisone Dose, Daily dose of prednisone is described by treatment arm at baseline, 6 months, and 1 year post-randomization., Baseline, 6 months, and 1 year post-randomization|Change in Prednisone Dose From Baseline, Change in the daily dose of prednisone from baseline, the time of randomization, is described by treatment arm at 6 months and 1 year post-randomization., 6 months and 1 year post-randomization|Serum Creatinine Level, Creatinine level is described by treatment arm at baseline, 6 months, and 1 year post-randomization., Baseline, 6 months, and 1 year post-randomization|Change in Serum Creatinine Level From Baseline, Change in creatinine level from baseline, the time of randomization, is described by treatment arm at 6 months and 1 year post-randomization., 6 months and 1 year post-randomization|Patient-reported Chronic GVHD Severity, Each patient s perception of the severity of the chronic GVHD was collected at baseline and at 6 months, 1 year, and 2 years post-randomization. Severity is categorized as none, mild, moderate, and severe., Baseline, 6 months, 1 year, and 2 years post-randomization|Provider-reported Chronic GVHD Severity, Each patient s care provider s perception of the severity of the chronic GVHD was collected at baseline and at 6 months, 1 year, and 2 years post-randomization. Severity is categorized as none, mild, moderate, and severe., Baseline, 6 months, 1 year, and 2 years post-randomization|NIH Consensus Criteria Chronic GVHD Severity, Chronic GVHD severity was determined at baseline and at 6 months, 1 year, and 2 years post-randomization per the 2005 NIH Consensus Criteria (Filipovich et al. 2005). Severity is categorized as none, mild, moderate, and severe., Baseline, 6 months, 1 year, and 2 years post-randomization|SF-36 Physical Component Summary, The Medical Outcome Study SF-36 Physical Component Summary (PCS) is a subscale of the SF-36 intended to measure physical well-being. It is scored on a scale of 0-100, with higher scores indicating higher levels of well-being., Baseline, 2 months, 6 months, 1 year, and 2 years post-randomization|SF-36 Mental Component Summary, The Medical Outcome Study SF-36 Mental Component Summary (MCS) is a subscale of the SF-36 intended to measure mental well-being. It is scored on a scale of 0-100, with higher scores indicating higher levels of well-being., Baseline, 2 months, 6 months, 1 year, and 2 years post-randomization|FACT-BMT Score, The Functional Assessment of Cancer Therapy-Bone Marrow Transplant scale (FACT-BMT) is a quality of life instrument that assesses the effects of bone marrow transplantation (BMT) on a patient s physical, social/family, emotional, and functional well-being while taking into consideration BMT-specific concerns. The assessment has 37 questions, each scored on a Likert scale from 0-4. The overall score is computed by adding scores of the questions and falls in the range 0-148, with higher scores indicating higher levels of overall well-being., Baseline, 2 months, 6 months, 1 year, and 2 years post-randomization

Medical College of Wisconsin

National Heart, Lung, and Blood Institute (NHLBI)|National Cancer Institute (NCI)|Blood and Marrow Transplant Clinical Trials Network|National Marrow Donor Program

ALL

CHILD, ADULT, OLDER_ADULT

PHASE2|PHASE3

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT

BMTCTN0801|U01HL069294|BMT CTN 0801|U01HL06929406|5U24CA076518

2010-04

2017-02-14

2018-06

2010-04-20

2018-08-14

2018-12-05

City of Hope National Medical Center, Duarte, California, 91010-3000, United States|University of California San Diego Medical Center, La Jolla, California, 92093, United States|Stanford Hospital and Clinics, Stanford, California, 94305, United States|University of Florida College of Medicine (Shands), Gainesville, Florida, 32610-0277, United States|Emory University, Atlanta, Georgia, 30322, United States|Blood & Marrow Transplant Program at Northside Hospital, Atlanta, Georgia, 30342, United States|University of Chicago, Chicago, Illinois, 60637-1470, United States|University of Kansas Hospital, Kansas City, Kansas, 66160, United States|Johns Hopkins University, Baltimore, Maryland, 21231, United States|University of Michigan Medical Center, Ann Arbor, Michigan, 48105-2967, United States|University of Minnesota, Minneapolis, Minnesota, 55455, United States|Washington University, Barnes Jewish Hospital, Saint Louis, Missouri, 63110, United States|University of Nebraska Medical Center, Omaha, Nebraska, 68198-7680, United States|Hackensack University Medical Center, Hackensack, New Jersey, 07601, United States|Roswell Park Cancer Institute, Buffalo, New York, 14263, United States|Memorial Sloan-Kettering Cancer Center, New York, New York, 10174, United States|Mayo Clinic, Rochester, New York, 55905, United States|University of North Carolina Hospital at Chapel Hill, Chapel Hill, North Carolina, 27599-7305, United States|Duke University Medical Center, Durham, North Carolina, 27705, United States|Jewish Hospital BMT Program, Cincinnati, Ohio, 45236, United States|University Hospitals of Cleveland/ Case Western, Cleveland, Ohio, 44106-5061, United States|University of Oklahoma Medical Center, Oklahoma City, Oklahoma, 73104, United States|Oregon Health & Science University (A) and (P), Portland, Oregon, 97239-3098, United States|University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania, 19104, United States|Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, 15224, United States|Medical University of South Carolina, Charleston, South Carolina, 29425, United States|University of Texas/MD Anderson CRC, Houston, Texas, 77030, United States|Texas Transplant Institute, San Antonio, Texas, 78229, United States|Virginia Commonwealth University/MCV Hospitals, Richmond, Virginia, 23298, United States|Fred Hutchinson Cancer Research Center, Seattle, Washington, 98109-1024, United States|University of Wisconsin Hospital and Clinics, Madison, Wisconsin, 53792-5156, United States

Study Protocol, https://cdn.clinicaltrials.gov/large-docs/33/NCT01106833/Prot_000.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/33/NCT01106833/SAP_001.pdf

{ "Sirolimus": [ { "intervention_type": "DRUG", "description": "Sirolimus + calcineurin inhibitor + prednisone", "name": "Sirolimus", "synonyms": [ "AY 22-989", "AY 22989", "Rapamune", "Rapamycin", "I2190A", "I-2190A", "Sirolimus", "Fyarro", "I 2190A", "Sirolimusum", "Sirolim\u00fas", "AY 22 989", "(-)-Rapamycin", "Fyarro", "Sirolimus (with albumin)", "Fyarro", "Sirolimus (with albumin)" ], "medline_plus_id": "a602026", "generic_names": [ "Sirolimus", "Sirolimus (with albumin)", "Sirolimus (with albumin)" ], "mesh_id": "D007166", "drugbank_id": "DB00877", "wikipedia_url": "https://en.wikipedia.org/wiki/Sirolimus" }, { "intervention_type": "DRUG", "description": "Sirolimus + prednisone", "name": "Sirolimus", "synonyms": [ "AY 22-989", "AY 22989", "Rapamune", "Rapamycin", "I2190A", "I-2190A", "Sirolimus", "Fyarro", "I 2190A", "Sirolimusum", "Sirolim\u00fas", "AY 22 989", "(-)-Rapamycin", "Fyarro", "Sirolimus (with albumin)", "Fyarro", "Sirolimus (with albumin)" ], "medline_plus_id": "a602026", "generic_names": [ "Sirolimus", "Sirolimus (with albumin)", "Sirolimus (with albumin)" ], "mesh_id": "D007166", "drugbank_id": "DB00877", "wikipedia_url": "https://en.wikipedia.org/wiki/Sirolimus" } ], "Prednisone": [ { "intervention_type": "DRUG", "description": "Sirolimus + calcineurin inhibitor + prednisone", "name": "Prednisone", "synonyms": [ "Apo-Prednisone", "Sone", "Acsis, Prednison", "Prednison Acsis", "Ultracorten", "Prednisona", "Kortancyl", "Cortan", "Encortone", "Prednisone Intensol", "Predni Tablinen", "17,21-Dihydroxypregna-1,4-diene-3,11,20-trione", "Sterapred", "Panafcort", "Predniment", "Cutason", "Deltasone", "1,4-Pregnadiene-17\u03b1,21-diol-3,11,20-trione", "Prednison Hexal", "Prednidib", "Encorton", "1,2-Dehydrocortisone", "Dehydrocortisone", "Liquid Pred", "delta-Cortisone", "Prednisonum", "Enkortolon", "Dacortin", "Decortisyl", "Meticorten", "Panasol", "Cortancyl", "Prednison Galen", "Rectodelt", "Orasone", "Decortin", "Pronisone", "Rayos", "Winpred", "Prednisone", "delta1-Cortisone-21-acetate", "Cortancyl", "Prednisone-21-acetate", "Prednisone 21-acetate", "Prednisone acetate", "21-Acetoxy-17alpha-hydroxypregna-1,4-diene-3,11,20-trione", "1,4-Pregnadien-17\u03b1,21-diol-3,11,20-trione-21-acetate", "delta'-Dehydrocortisone acetate", "delta1-Cortisone-21-acetate", "Cortancyl", "Prednisone-21-acetate", "Prednisone 21-acetate", "Prednisone acetate", "21-Acetoxy-17alpha-hydroxypregna-1,4-diene-3,11,20-trione", "1,4-Pregnadien-17\u03b1,21-diol-3,11,20-trione-21-acetate", "delta'-Dehydrocortisone acetate" ], "medline_plus_id": "a601102", "generic_names": [ "Prednisone", "Prednisone acetate", "Prednisone acetate" ], "mesh_id": "D018931", "drugbank_id": "DB00635" }, { "intervention_type": "DRUG", "description": "Sirolimus + prednisone", "name": "Prednisone", "synonyms": [ "Apo-Prednisone", "Sone", "Acsis, Prednison", "Prednison Acsis", "Ultracorten", "Prednisona", "Kortancyl", "Cortan", "Encortone", "Prednisone Intensol", "Predni Tablinen", "17,21-Dihydroxypregna-1,4-diene-3,11,20-trione", "Sterapred", "Panafcort", "Predniment", "Cutason", "Deltasone", "1,4-Pregnadiene-17\u03b1,21-diol-3,11,20-trione", "Prednison Hexal", "Prednidib", "Encorton", "1,2-Dehydrocortisone", "Dehydrocortisone", "Liquid Pred", "delta-Cortisone", "Prednisonum", "Enkortolon", "Dacortin", "Decortisyl", "Meticorten", "Panasol", "Cortancyl", "Prednison Galen", "Rectodelt", "Orasone", "Decortin", "Pronisone", "Rayos", "Winpred", "Prednisone", "delta1-Cortisone-21-acetate", "Cortancyl", "Prednisone-21-acetate", "Prednisone 21-acetate", "Prednisone acetate", "21-Acetoxy-17alpha-hydroxypregna-1,4-diene-3,11,20-trione", "1,4-Pregnadien-17\u03b1,21-diol-3,11,20-trione-21-acetate", "delta'-Dehydrocortisone acetate", "delta1-Cortisone-21-acetate", "Cortancyl", "Prednisone-21-acetate", "Prednisone 21-acetate", "Prednisone acetate", "21-Acetoxy-17alpha-hydroxypregna-1,4-diene-3,11,20-trione", "1,4-Pregnadien-17\u03b1,21-diol-3,11,20-trione-21-acetate", "delta'-Dehydrocortisone acetate" ], "medline_plus_id": "a601102", "generic_names": [ "Prednisone", "Prednisone acetate", "Prednisone acetate" ], "mesh_id": "D018931", "drugbank_id": "DB00635" } ] }

NCT00266487

The Norwegian Vitamin Trial (NORVIT)

https://clinicaltrials.gov/study/NCT00266487

COMPLETED

The purpose of this study is to examine whether the lowering of blood homocysteine levels by treatment with B vitamins can prevent cardiovascular disease

NO

Acute Myocardial Infarction

DRUG: Folic acid|DRUG: Vitamin B12|DRUG: Vitamin B6

The primary end point was a composite of|nonfatal myocardial infarction,|fatal myocardial infarction,|nonfatal stroke,|fatal stroke, and|sudden death attributed to coronary heart disease.

Individual components of the primary end point, i.e.|Nonfatal myocardial infarction|Fatal myocardial infarction|Nonfatal stroke|Fatal stroke|In addition the following secondary outcomes:|Unstable angina pectoris requiring hospitalization|Percutaneous coronary revascularization|Coronary-artery bypass grafting|Death from any cause|Cancer|Pulmonary embolus|Transitoric ischemic attack|Surgery for abdominal aortic aneurysm|Plasma homocysteine levels|Plasma levels of B vitamins

University of Tromso

The Research Council of Norway|The Council on Health and Rehabilitation, Norway|The Norwegian Council on Cardiovascular Disease|The Royal Norwegian Ministry of Health|The International Federation of Red Cross and Red Crescent Societies|Foundation to Promote Research into Functional Vitamin B12 Deficiency, Bergen, Norway

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: DOUBLE|Primary Purpose: TREATMENT

NRC 112812/320|NRC 138859/320

1998-12

2004-03

2005-12-16

2017-05-08

Institute of Community Medicine, University of Tromsø, Tromsø, N-9037, Norway

{ "Folic Acid": [ { "intervention_type": "DRUG", "description": "Folic acid", "name": "Folic Acid", "synonyms": [ "Folic Acid", "Folicet", "Folvite", "Folicet", "Folate", "Folvite", "Folicet", "Folate" ], "medline_plus_id": "a682591", "generic_names": [ "Folic Acid" ] } ], "Vitamin B12": [ { "intervention_type": "DRUG" } ], "Vitamin B6": [ { "intervention_type": "DRUG" } ] }

NCT02349633

Study For Patients With NSCLC EGFR Mutations (Del 19 or L858R +/- T790M)

https://clinicaltrials.gov/study/NCT02349633

TERMINATED

This is a Phase 1/2 study of PF-06747775 as a single agent and in combination with other cancer treatments in patients with advanced EGFRm NSCLC. The overall clinical study consists of a Phase 1 single agent dose-escalation and expansion part to determine the RP2D of PF-06747775 single agent in patients with previously-treated EGFRm NSCLC followed by sequential evaluations of PF-06747775 at the RP2D in 3 different clinical scenarios as detailed below: * Cohort 1: Phase 2 evaluation of PF-06747775 as a single agent in previously untreated patients with advanced EGFRm NSCLC, * Cohort 2: Phase 1b single arm evaluation of PF-06747775 in combination with palbociclib (Cohort 2A) followed by Phase 2 randomized evaluation of PF 06747775 in combination with palbociclib vs PF-06747775 single agent (Cohort 2B) in previously-treated patients with EGFRm NSCLC with a secondary T790M mutation (del 19 and T790M or L858R and T790M), and * Cohort 3: Phase 1b evaluation of PF-06747775 in combination with avelumab in previously-treated patients with EGFRm NSCLC with a secondary T790M mutation (del 19 and T790M or L858R and T790M).

YES

Non-Small Cell Lung Cancer

DRUG: PF-06747775|DRUG: Palbociclib|DRUG: Avelumab

Number of Participants With Dose Limiting Toxicities (DLTs) During the First Cycle in Phase 1 Dose-escalation Cohorts, Japan LIC and Phase 1b Cohort 3, and First 2 Cycles in Phase 1b Cohort 2A, DLT was defined as any of the following adverse events (AEs) occurring during the first cycle for Phase 1 dose-escalation cohorts, Japan LIC and Phase 1b Cohort 3, or the first 2 cycles for Phase 1b Cohort 2A of treatment, and considered attributable to study intervention: Grade 4 neutropenia >7 days; febrile neutropenia; Grade >=3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia; Grade >=3 non-hematologic toxicities; Grade 4 rash, mucositis, or diarrhea; failure to receive at least 70% of planned doses; Grade 3 QTcF prolongation in asymptomatic participants; treatment-related AEs attributable to PF-06747775, palbociclib or both that caused palbociclib treatment delay >= 10 days or omission of at least 12 doses of the combination. Grade of AE was defined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03., 21 days for Phase 1 dose-escalation cohorts and Japan LIC; 42 days for Phase 1b Cohort 2A; 28 days for Phase 1b Cohort 3|Number of Participants With Confirmed Objective Response (OR) in PF-06747775 200 mg QD Group, Number of participants with confirmed OR according to Response Evaluation Criteria in Solid Tumor (RECIST) v1.1. Complete response (CR) was defined as complete disappearance of all target lesions with the exception of nodal disease. Partial response (PR) was defined as Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions., Baseline up to end of treatment (maximum of 165 weeks)|Progression-free Survival (PFS) in Phase 2 Cohort 2B, PFS was based on Kaplan-Meier estimates. PFS was defined as the time from Cycle 1 Day 1 to the date of the first documentation of objective progression (PD) or death due to any cause. PD was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm., Cycle 1 Day 1 up to the end of study (maximum of 5 years)

Number of Participants With Treatment-emergent AEs (TEAEs) in All Cohorts All Phases (All-causality), AE = any untoward medical occurrence in participant who received study treatment without regard to possibility of causal relationship. Grade 3 (Severe) events = unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. Grade 5 (Death) events = death related to an AE. Treatment-emergent events = between first dose of study treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state., Baseline up to 28 days after last dose of study treatment (maximum of 199 weeks)|Number of Participants With TEAEs in All Cohorts All Phases (Treatment-related), Treatment-related AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. Grade 3 (Severe) events = unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. Grade 5 (Death) events = death related to an AE. Treatment-emergent events = between first dose of study treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Treatment-related AEs were determined by the investigator., Baseline up to 28 days after last dose of study treatment (maximum of 199 weeks)|Number of Participants With Serious Adverse Events (SAEs) in All Cohorts All Phases, An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-related SAEs were determined by the investigator., Baseline up to 28 days after last dose of study treatment (maximum of 199 weeks)|Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases, Laboratory values included hemoglobin, platelets, white blood cell count (WBC), absolute (abs) neutrophils, abs lymphocytes, abs monocytes, abs eosinophils, abs basophils, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (Alk Phos), sodium, potassium, magnesium, chloride, total calcium, total bilirubin, blood urea nitrogen (BUN) or urea, creatinine, uric acid, glucose, albumin, phosphorous or phosphate, prothrombin time (PT) or international normalized ratio (INR), partial thromboplastin time (PTT), urinalysis and pregnancy test. Grades of laboratory results were defined by NCI CTCAE version 4.03. Grade 3 (Severe) events = unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death., Baseline up to the end of treatment (maximum of 195 weeks)|Number of Participants Meeting Categorical Criteria of QTcF Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab., Number of participants meeting categorical criteria of QTcF values when PF-06747775 was given as a single agent in Phase 1 dose-escalation cohorts, PF-06747775 200 mg QD group (only participants in Phase 2 Cohort 1 and Japan LIC were eligible for QTcF within this combined group), and in combination with palbociclib and avelumab in Phase 1b/2 Cohorts 2A, 2B and 3. Criteria for categorization of QTcF were defined as: maximum values 450 - <480 msec, 480 - <500 msec and >=500 msec., Baseline up to Cycle 4 Day 1 (maximum of 10 weeks)|Number of Participants Meeting Categorical Criteria of QTcB Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab., Number of participants meeting categorical criteria of QTcB values when PF-06747775 was given as a single agent in Phase 1 dose-escalation cohorts, PF-06747775 200 mg QD group (only participants in Phase 2 Cohort 1 and Japan LIC were eligible for QTcB within this combined group), and in combination with palbociclib and avelumab in Phase 1b/2 Cohorts 2A, 2B and 3. Criteria for categorization of QTcB were defined as: maximum values 450 - <480 msec, 480 - <500 msec and >=500 msec., Baseline up to Cycle 4 Day 1 (maximum of 10 weeks)|Number of Participants With Confirmed and Unconfirmed OR in Phase 1 Cohorts, Number of participants in Phase 1 cohorts with confirmed and unconfirmed OR according to RECIST v1.1. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. PR was defined as Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. Stable was defined as not qualifying for CR, PR or PD. PD was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm. Indeterminate was defined as progression not documented., Baseline up to end of treatment (maximum of 195 weeks)|Objective Response Rate (ORR) in Phase 1b/2 Cohorts 2A, 2B and 3, ORR was defined as percentage of participants with OR based assessment of CR or PR according to RECIST v1.1 that must have been confirmed ≥4 weeks later. Participants who did not have an on treatment radiographic tumor assessment due to early progression, who received anti tumor treatment other than the study medication prior to reaching a CR or PR, or who died, progressed, or dropped out for any reason prior to reaching a CR or PR were counted as non responders in the assessment of ORR. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. PR was defined as Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions., Baseline up to end of treatment (maximum of 108 weeks)|PFS in PF-06747775 200 mg QD Group, Phase 1b Cohorts 2A and 3, PFS was based on Kaplan-Meier estimates. PFS was defined as the time from Cycle 1 Day 1 to the date of the first documentation of PD or death due to any cause. PD was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm., Cycle 1 Day 1 up to the end of study (maximum of 5 years)|Duration of Objective Response (DOR) in Phase 1b/2 Cohorts, DOR was the time from the date of first documentation of confirmed CR or PR to the date of first documentation of PD or death due to any cause. If tumor progression data included more than 1 date, the first date was used. DOR (months) = [progression/death date - first date of OR + 1]/30.4. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. PR was defined as Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. Stable was defined as not qualifying for CR, PR or PD. PD was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm., Baseline up to the end of study (maximum of 5 years)|Overall Survival (OS) Probability at 12 Months in Phase 1b/2 Cohorts, OS probability was based on Kaplan-Meier method. OS was defined as the time from the start date to date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive., Baseline up to the end of study (maximum of 5 years)|Plasma Area Under the Curve From Zero to Infinite Time (AUCinf) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1, Plasma area under the curve from zero to infinite time (AUCinf) of PF-06747775 as a single agent after single dose on Day -8 lead-in period in Phase 1 dose-escalation cohorts and on Day -4 lead-in period in Phase 2 Cohort 1. AUCinf was area under the plasma concentration versus time curve (AUC) from zero to extrapolated infinite time., 1, 2, 4, 6, 8, 24, 48 and 72 hours post-dose on Day -8 (+/- 3 days) in lead-in period for Phase 1 dose-escalation cohorts and on Day -4 in lead-in period for Phase 2 Cohort 1|Maximum Concentration Observed After Dose Administration (Cmax) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1, Cmax of PF-06747775 as a single agent after single dose on Day -8 lead-in period in Phase 1 dose-escalation cohorts and on Day -4 lead-in period in Phase 2 Cohort 1. Cmax was the maximum concentration after dose administration observed directly from the data., 1, 2, 4, 6, 8, 24, 48 and 72 hours post-dose on Day -8 (+/- 3 days) in lead-in period for Phase 1 dose-escalation cohorts and on Day -4 in lead-in period for Phase 2 Cohort 1|Half-life (t1/2) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1, Half-life (t1/2) of PF-06747775 as a single agent after single dose on Day -8 lead-in period in Phase 1 dose-escalation cohorts and on Day -4 lead-in period in Phase 2 Cohort 1. t1/2 was defined as the time measured for the plasma concentration to decrease by one half., 1, 2, 4, 6, 8, 24, 48 and 72 hours post-dose on Day -8 (+/- 3 days) in lead-in period for Phase 1 dose-escalation cohorts and on Day -4 in lead-in period for Phase 2 Cohort 1|Apparent Clearance (CL/F) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1, Apparent clearance (CL/F) of PF-06747775 as a single agent after single dose on Day -8 lead-in period in Phase 1 dose-escalation cohorts and on Day -4 lead-in period in Phase 2 Cohort 1. CL/F was calculated as: CL/F = dose / AUCinf. AUCinf was area under the plasma concentration versus time curve (AUC) from zero to extrapolated infinite time., 1, 2, 4, 6, 8, 24, 48 and 72 hours post-dose on Day -8 (+/- 3 days) in lead-in period for Phase 1 dose-escalation cohorts and on Day -4 in lead-in period for Phase 2 Cohort 1|Volume of Distribution (Vz/F) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1, Vz/F was defined as apparent volume of distribution. Vz/F was calculated as: Vz/F = dose / (AUCinf * kel). kel was defined as terminal phase rate constant and calculated by a linear regression of the log-linear concentration-time curve. AUCinf was area under the plasma concentration versus time curve (AUC) from zero to extrapolated infinite time., 1, 2, 4, 6, 8, 24, 48 and 72 hours post-dose on Day -8 (+/- 3 days) in lead-in period for Phase 1 dose-escalation cohorts and on Day -4 in lead-in period for Phase 2 Cohort 1|Pre-dose Concentration at Steady State (Ctrough) of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B, Pre-dose concentration at steady state (Ctrough) of PF-06747775 as a single agent after multiple doses on Cycle 1 Day 11 in Phase 1 dose-escalation cohorts, Phase 2 Cohorts 1 and 2B. Ctrough was defined as pre-dose concentration during multiple dosing and observed directly from data., Pre-dose on Cycle 1 Day 11|Area Under the Curve at Steady State (AUCtau) of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B, AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCtau was calculated using Linear/Log trapezoidal method., 0 (pre-dose), 1, 2, 4, 6, 8, 24 hours post-dose on Cycle 1 Day 11 for Phase 1 dose-escalation cohorts; 0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose on Cycle 1 Day 11 for Phase 2 Cohorts 1 and 2B|CL/F of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B, CL/F of PF-06747775 as a single agent after multiple doses on Cycle 1 Day 11 in Phase 1 dose-escalation cohorts, Phase 2 Cohorts 1 and 2B. CL/F was calculated as: CL/F = dose / AUCtau. AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCtau was calculated using Linear/Log trapezoidal method., 0 (pre-dose), 1, 2, 4, 6, 8, 24 hours post-dose on Cycle 1 Day 11 for Phase 1 dose-escalation cohorts; 0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose for Phase 2 Cohorts 1 and 2B|Observed Accumulation Ratio (Rac) of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B, Rac was calculated as: Rac = (steady state AUCtau) / (single dose AUC24). AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCtau was calculated using Linear/Log trapezoidal method. AUC24 was defined as area under the plasma concentration-time curve from time 0 to 24 hours., 1, 2, 4, 6, 8 and 24 hours post dose on Lead-in Day -8 (dose-escalation cohorts) or -4 (Cohort 1); 0 (pre-dose), 1, 2, 4, 6, 8 (except for Cohort 1) and 24 hours post dose on Cycle 1 Day 11 for dose-escalation cohorts, Cohorts 1 and 2B|Steady State Accumulation Ratio (Rss) of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B, Steady state accumulation ratio (Rss) of PF-06747775 as a single agent after multiple doses on Cycle 1 Day 11 in Phase 1 dose-escalation cohorts, Phase 2 Cohorts 1 and 2B. Rss was calculated as: Rss = (steady state AUCtau) / (single dose AUCinf). AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCtau was calculated using Linear/Log trapezoidal method. AUCinf was area under the plasma concentration versus time curve (AUC) from zero to extrapolated infinite time., 1, 2, 4, 6, 8, 24, 48 and 72 hours post dose on Lead-in Day -8 (dose-escalation cohorts) or Day -4 (Cohort 1); 0 (pre-dose), 1, 2, 4, 6, 8 (except for Cohort 1) and 24 hours post dose on Cycle 1 Day 11|AUCinf of Sildenafil Dosed Alone on Day -8 lead-in Period in Phase 1 Sildenafil Sub-study, AUCinf of sildenafil dosed alone and in combination with PF-06747775 200 mg or 300 mg on Day -8 lead-in period in Phase 1 Sildenafil sub-study. AUCinf was defined as area under the plasma concentration versus time curve from zero to extrapolated infinite time., 0.5, 1, 2, 3, 4, 6, 8 and 24 hours post-dose on Day -8 (+/- 3 days) in lead-in period|Cmax of Sildenafil Dosed Alone on Day -8 lead-in Period in Phase 1 Sildenafil Sub-study, Cmax values for sildenafil were analyzed using a mixed effects model with treatment as fixed effect and participant as random effect to estimate the effect of steady state PF-06747775 on sildenafil exposure. Cmax was the maximum concentration after dose administration observed directly from the data., 0.5, 1, 2, 3, 4, 6, 8 and 24 hours post dose on Day -8 (+/- 3 days) in lead-in period|CL/F of Sildenafil Dosed Alone on Day -8 lead-in Period in Phase 1 Sildenafil Sub-study, CL/F of sildenafil dosed alone on Day -8 lead-in period in Phase 1 Sildenafil sub-study. CL/F was calculated as: CL/F = dose / AUCinf. AUCinf was area under the plasma concentration versus time curve (AUC) from zero to extrapolated infinite time., 0.5, 1, 2, 3, 4, 6, 8 and 24 hours post dose on Day -8 (+/- 3 days) in lead-in period|AUCinf of Sildenafil Dosed in Combination With PF-06747775 200 mg or 300 mg on Cycle 1 Day 11 in Phase 1 Sildenafil Sub-study, AUCinf of sildenafil dosed alone and in combination with PF-06747775 200 mg or 300 mg on Day -8 lead-in period in Phase 1 Sildenafil sub-study. AUCinf was defined as area under the plasma concentration versus time curve from zero to extrapolated infinite time., 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 11 (+/- 4 days)|Cmax of Sildenafil Dosed in Combination With PF-06747775 200 mg or 300 mg on Cycle 1 Day 11 in Phase 1 Sildenafil Sub-study, Cmax values for sildenafil were analyzed using a mixed effects model with treatment as fixed effect and participant as random effect to estimate the effect of steady state PF-06747775 on sildenafil exposure., 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 11 (+/- 4 days)|CL/F of Sildenafil Dosed in Combination With PF-06747775 200 mg or 300 mg on Cycle 1 Day 11 in Phase 1 Sildenafil Sub-study, CL/F of sildenafil dosed alone and in combination with PF-06747775 200 mg or 300 mg on Day -8 lead-in period and Cycle 1 Day 11 in Phase 1 Sildenafil sub-study. CL/F was calculated as: CL/F = dose / AUCinf. AUCinf was area under the plasma concentration versus time curve (AUC) from zero to extrapolated infinite time., 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 11 (+/- 4 days)|AUCtau of PF-06747775 at RP2D Under Fed and Overnight Fasted Conditions in Phase 1 Food Effect and Rifampin DDI Sub-study, AUCtau of PF-06747775 at the RP2D under fed and overnight fasted conditions in Phase 1 Food Effect and Rifampin DDI sub-study. AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCtau was calculated using Linear/Log trapezoidal method., Pre-dose, 1, 2, 4, 6, 8 and 24 hours post dose of PF-06747775 on Cycle 1 Days 8 and 9|Cmax of PF-06747775 at RP2D Under Fed and Overnight Fasted Conditions in Phase 1 Food Effect and Rifampin DDI Sub-study, Cmax of PF-06747775 at the RP2D under fed and overnight fasted conditions in Phase 1 Food Effect and Rifampin DDI sub-study. Cmax was the maximum concentration after dose administration observed directly from the data., Pre-dose, 1, 2, 4, 6, 8 and 24 hours post dose of PF-06747775 on Cycle 1 Days 8 and 9|AUCtau of PF-06747775 at RP2D When Dosed Alone and After Esomeprazole/Itraconazole Treatment in Phase 1 Esomeprazole-Itraconazole DDI Sub-study, AUCtau of PF-06747775 at the RP2D when dosed alone and after esomeprazole/itraconazole treatment in Phase 1 Esomeprazole-Itraconazole DDI sub-study. AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCtau was calculated using Linear/Log trapezoidal method., 0 (pre-dose), 1, 2, 4, 6, 8 and 24 hours post dose of PF-06747775 on Cycle 1 Days 8, 13 and 21|Cmax of PF-06747775 at RP2D When Dosed Alone and After Esomeprazole/Itraconazole Treatment in Phase 1 Esomeprazole-Itraconazole DDI Sub-study, Cmax of PF-06747775 at RP2D when dosed alone and after esomeprazole/itraconazole treatment in Phase 1 Esomeprazole-Itraconazole DDI sub-study. Cmax was the maximum concentration after dose administration observed directly from the data., 0 (pre-dose), 1, 2, 4, 6, 8 and 24 hours post dose of PF-06747775 on Cycle 1 Days 8, 13 and 21|AUCtau of PF-06747775 at RP2D Dosed Alone and After Rifampin Treatment in Phase 1 Food Effect and Rifampin DDI Sub-study, AUCtau of PF-06747775 at RP2D dosed alone and after rifampin treatment in Phase 1 Food Effect and Rifampin DDI sub-study. AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCtau was calculated using Linear/Log trapezoidal method., Pre-dose, 1, 2, 4, 6, 8 and 24 hours post dose of PF-06747775 on Cycle 1 Day 21|Cmax of PF-06747775 at RP2D Dosed Alone and After Rifampin Treatment in Phase 1 Food Effect and Rifampin DDI Sub-study, Cmax of PF-06747775 at RP2D dosed alone and after rifampin treatment in Phase 1 Food Effect and Rifampin DDI sub-study. Cmax was the maximum concentration after dose administration observed directly from the data., Pre-dose, 1, 2, 4, 6, 8 and 24 hours post dose of PF-06747775 on Cycle 1 Day 21|AUCtau of PF-06747775 Following Multiple Doses When Given in Combination With Palbociclib on Cycle 1 Day 15 in Phase 1b Cohort 2A and Phase 2 Cohort 2B, AUCtau of PF-06747775 following multiple doses when given in combination with palbociclib on Cycle 1 Day 15 in Phase 1b Cohort 2A and Phase 2 Cohort 2B. AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCtau was calculated using Linear/Log trapezoidal method., 0 (pre-dose), 1, 2, 4, 6 and 24 hours post dose on Cycle 1 Day 15|Cmax of PF-06747775 Following Multiple Doses When Given in Combination With Palbociclib on Cycle 1 Day 15 in Phase 1b Cohort 2A and Phase 2 Cohort 2B, Cmax of PF-06747775 following multiple doses when given in combination with palbociclib on Cycle 1 Day 15 in Phase 1b Cohort 2A and Phase 2 Cohort 2B. Cmax was the maximum concentration after dose administration observed directly from the data., 0 (pre-dose), 1, 2, 4, 6 and 24 hours post dose on Cycle 1 Day 15|CL/F of PF-06747775 Following Multiple Doses When Given in Combination With Palbociclib on Cycle 1 Day 15 in Phase 1b Cohort 2A and Phase 2 Cohort 2B, CL/F of PF-06747775 following multiple doses when given in combination with palbociclib on Cycle 1 Day 15 in Phase 1b Cohort 2A and Phase 2 Cohort 2B. CL/F was calculated as: CL/F = dose / AUCtau. AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCtau was calculated using Linear/Log trapezoidal method., 0 (pre-dose), 1, 2, 4, 6 and 24 hours post dose on Cycle 1 Day 15|Ctrough of PF-06747775 Following Multiple Doses When Given in Combination With Palbociclib on Day 15 of Cycles 1-2 and Day 1 of Cycles 2-4 in Phase 1b Cohort 2A and Phase 2 Cohort 2B, Ctrough of PF-06747775 following multiple doses when given in combination with palbociclib on Day 15 of Cycles 1-2 and Day 1 of Cycles 2-4 in Phase 1b Cohort 2A and Phase 2 Cohort 2B. Ctrough was defined as pre-dose concentration during multiple dosing and observed directly from data., Pre-dose on Day 15 of Cycles 1-2 and Day 1 of Cycles 2-4|Ctrough of PF-06747775 Following Multiple Doses When Given in Combination With Avelumab on Cycle 1 Day 15 in Phase 1b Cohort 3, Ctrough of PF-06747775 following multiple doses when given in combination with avelumab on Cycle 1 Day 15 in Phase 1b Cohort 3. Ctrough was defined as pre-dose concentration during multiple dosing and observed directly from data., Pre-dose on Cycle 1 Day 15|AUCtau of Palbociclib Following Multiple Doses When Given in Combination With PF-06747775 on Cycle 1 Day 15 in Phase 1b Cohort 2A and Phase 2 Cohort 2B, AUCtau of palbociclib following multiple doses when given in combination with PF-06747775 on Cycle 1 Day 15 in Phase 1b Cohort 2A and Phase 2 Cohort 2B. AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCtau was calculated using Linear/Log trapezoidal method., 0 (pre-dose), 1, 2, 4, 6 and 24 hours post dose on Cycle 1 Day 15|Cmax of Palbociclib Following Multiple Doses When Given in Combination With PF-06747775 on Cycle 1 Day 15 in Phase 1b Cohort 2A and Phase 2 Cohort 2B, Cmax of palbociclib following multiple doses when given in combination with PF-06747775 on Cycle 1 Day 15 in Phase 1b Cohort 2A and Phase 2 Cohort 2B. Cmax was the maximum concentration after dose administration observed directly from the data., 0 (pre-dose), 1, 2, 4, 6 and 24 hours post dose on Cycle 1 Day 15|Ctrough of Palbociclib Following Multiple Doses When Given in Combination With PF-06747775 on Day 15 of Cycles 1-2 and Day 1 of Cycles 2-4 in Phase 1b Cohort 2A and Phase 2 Cohort 2B, Ctrough of palbociclib following multiple doses when given in combination with PF-06747775 on Day 15 of Cycles 1-2 and Day 1 of Cycles 2-4 in Phase 1b/2 Cohorts 2A and 2B. Ctrough was defined as pre-dose concentration during multiple dosing and observed directly from data., Pre-dose on Day 15 of Cycles 1-2 and Day 1 of Cycles 2-4|Ctrough of Avelumab When Given in Combination With PF-06747775 on Day 1 of Cycles 1-3 and Cycle 1 Day 15 in Phase 1b Cohort 3, Ctrough of avelumab when given in combination with PF-06747775 on Day 1 of Cycles 1-3 and Cycle 1 Day 15 in Phase 1b Cohort 3. Ctrough was defined as pre-dose concentration during multiple dosing and observed directly from data., Pre-dose on Day 1 of Cycles 1-3 and Cycle 1 Day 15|Cmax of Avelumab When Given in Combination With PF-06747775 on Day 1 of Cycles 1-3 and Cycle 1 Day 15 in Phase 1b Cohort 3, Cmax of avelumab when given in combination with PF-06747775 on Day 1 of Cycles 1-3 and Cycle 1 Day 15 in Phase 1b Cohort 3. Cmax was the end of infusion peak concentration observed directly from data., End of infusion of avelumab on Day 1 of Cycles 1-3 and Cycle 1 Day 15|Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases, Number of participants with EGFR mutations in tumor tissue in all cohorts all phases. EGFR mutation assessments in tumor tissue included the mutations statuses of exon 19 deletion (del 19), exon 21 (L858R), G719X, L861Q, S768I, exon 20 insertions and T790M., Baseline|Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases, Number of participants with EGFR mutations in plasma in all cohorts all phases. EGFR mutation assessments in plasma included the mutations statuses of exon 19 deletion (del 19), exon 21 (L858R) and T790M., Baseline|Number of Participants With Positive Serum Anti-drug Antibody (ADA) of Avelumab in Phase 1b Cohort 3, Number of participants with positive serum ADA of avelumab at pre-dose on Day 1 of Cycles 1-3 and Cycle 1 Day 15 in Phase 1b Cohort 3., Pre-dose on Day 1 of Cycles 1-3 and Cycle 1 Day 15|AUCinf of PF-06747775 Following Single Dose on Lead-in Day -4 in Japan LIC RP2D Cohort, Lead-in Day -7 and Cycle 1 Day 1 in Japan LIC PK Cohort, AUCinf of PF-06747775 following a 200 mg single dose on Lead-in Day -4 in Japan LIC RP2D cohort and Cycle 1 Day 1 in Japan LIC PK cohort, and following a 100 mg single dose on Lead-in Day -7 in Japan LIC PK cohort. AUCinf was defined as area under the plasma concentration versus time curve from zero to extrapolated infinite time., 0 (pre-dose), 1, 2, 4, 6, 8 and 24 hours post dose on Lead-in Day -4 for Japan LIC RP2D cohort, Lead-in Day -7 and Cycle 1 Day 1 for Japan LIC PK cohort|Cmax of PF-06747775 Following Single Dose on Lead-in Day -4 in Japan LIC RP2D Cohort, Lead-in Day -7 and Cycle 1 Day 1 in Japan LIC PK Cohort, Cmax of PF-06747775 following a 200 mg single dose on Lead-in Day -4 in Japan LIC RP2D cohort and Cycle 1 Day 1 in Japan LIC PK cohort, and following a 100 mg single dose on Lead-in Day -7 in Japan LIC PK cohort. Cmax was the maximum concentration observed from data., 0 (pre-dose), 1, 2, 4, 6, 8 and 24 hours post dose on Lead-in Day -4 for Japan LIC RP2D cohort, Lead-in Day -7 and Cycle 1 Day 1 for Japan LIC PK cohort|Vz/F of PF-06747775 Following Single Dose on Lead-in Day -4 in Japan LIC RP2D Cohort, Lead-in Day -7 and Cycle 1 Day 1 in Japan LIC PK Cohort, Vz/F of PF-06747775 following a 200 mg single dose on Lead-in Day -4 in Japan LIC RP2D cohort and Cycle 1 Day 1 in Japan LIC PK cohort, and following a 100 mg single dose on Lead-in Day -7 in Japan LIC PK cohort. Vz/F was defined as apparent volume of distribution. Vz/F was calculated as: Vz/F = dose / (AUCinf * kel). kel was defined as terminal phase rate constant and calculated by a linear regression of the log-linear concentration-time curve. AUCinf was area under the plasma concentration versus time curve (AUC) from zero to extrapolated infinite time., 0 (pre-dose), 1, 2, 4, 6, 8 and 24 hours post dose on Lead-in Day -4 for Japan LIC RP2D cohort, Lead-in Day -7 and Cycle 1 Day 1 for Japan LIC PK cohort|t1/2 of PF-06747775 Following Single Dose on Lead-in Day -4 in Japan LIC RP2D Cohort, Lead-in Day -7 and Cycle 1 Day 1 in Japan LIC PK Cohort, t1/2 of PF-06747775 following a 200 mg single dose on Lead-in Day -4 in Japan LIC RP2D cohort and Cycle 1 Day 1 in Japan LIC PK cohort, and following a 100 mg single dose on Lead-in Day -7 in Japan LIC PK cohort. t1/2 was defined as the time measured for the plasma concentration to decrease by one half., 0 (pre-dose), 1, 2, 4, 6, 8 and 24 hours post dose on Lead-in Day -4 for Japan LIC RP2D cohort, Lead-in Day -7 and Cycle 1 Day 1 for Japan LIC PK cohort|AUCtau of PF-06747775 Following Multiple Doses in Japan LIC RP2D and PK Cohorts, AUCtau of PF-06747775 following multiple doses on Cycle 1 Day 11 in Japan LIC RP2D cohort and Cycle 1 Day 15 in Japan LIC PK cohort. AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCtau was calculated using Linear/Log trapezoidal method., 0 (pre-dose), 1, 2, 4, 6, 8 and 24 hours post dose on Cycle 1 Day 11 (Japan LIC RP2D cohort) and Day 15 (Japan LIC PK cohort)|Ctrough of PF-06747775 Following Multiple Doses in Japan LIC RP2D and PK Cohorts, Ctrough of PF-06747775 following multiple doses on Cycle 1 Day 11 in Japan LIC RP2D cohort and Cycle 1 Day 15 in Japan LIC PK cohort. Ctrough was defined as pre-dose concentration during multiple dosing and observed directly from data., Pre-dose on Cycle 1 Day 11 (Japan LIC RP2D cohort) and Day 15 (Japan LIC PK cohort)|Rac of PF-06747775 Following Multiple Doses in Japan LIC RP2D and PK Cohorts, Rac of PF-06747775 following multiple doses on Cycle 1 Day 11 in Japan LIC RP2D cohort and Cycle 1 Day 15 in Japan LIC PK cohort. Rac was calculated as: Rac = (steady state AUCtau) / (single dose AUC24). AUC24 was defined as area under the plasma concentration-time curve from time 0 to 24 hours following single dose. AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours., 0 (pre-dose), 1, 2, 4, 6, 8 and 24 hours post dose on Lead-in Day -4, Cycle 1 Day 11 for Japan LIC RP2D cohort, Cycle 1 Days 1 and 15 for Japan LIC PK cohort|Rss of PF-06747775 Following Multiple Doses in Japan LIC RP2D and PK Cohorts, Rss of PF-06747775 following multiple doses on Cycle 1 Day 11 in Japan RP2D cohort and Cycle 1 Day 15 in Japan PK cohort. Rss was calculated as: Rss = (steady state AUCtau) / (single dose AUCinf). AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCinf was area under the plasma concentration versus time curve (AUC) from zero to extrapolated infinite time., 0 (pre-dose), 1, 2, 4, 6, 8 and 24 hours post dose on Lead-in Day -4, Cycle 1 Day 11 for Japan LIC RP2D cohort, Cycle 1 Days 1 and 15 for Japan LIC PK cohort|CL/F of PF-06747775 Following Single and Multiple Doses in Japan LIC RP2D and PK Cohorts, CL/F of PF-06747775 following single dose on Lead-in Day -4 in Japan LIC RP2D cohort, Lead-in Day -7 and Cycle 1 Day 1 in Japan LIC PK cohort, and following multiple doses on Cycle 1 Day 11 in Japan LIC RP2D cohort and on Cycle 1 Day 15 in Japan LIC PK cohort. CL/F was calculated as: CL/F = dose/AUCinf for single dose or dose/AUCtau for multiple doses. AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCinf was area under the plasma concentration versus time curve (AUC) from zero to extrapolated infinite time., 0 (pre-dose), 1, 2, 4, 6, 8 and 24 hours post dose on Lead-in Day -4, Cycle 1 Day 11 for Japan LIC RP2D cohort, Lead-in Day-7, Days 1 and 15 for Japan LIC PK cohort

Pfizer

ALL

ADULT, OLDER_ADULT

PHASE1|PHASE2

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT

B7971001

2015-05-14

2020-05-28

2020-05-28

2015-01-29

2021-06-10

2021-06-10

UC San Diego Medical Center - La Jolla, La Jolla, California, 92037, United States|UC San Diego Moores Cancer Center, La Jolla, California, 92093, United States|UC San Diego Medical Center - Hillcrest, San Diego, California, 92103, United States|Smilow Cancer Hospital at Yale-New Haven, New Haven, Connecticut, 06510, United States|UPMC Cancer Pavilion, Pittsburgh, Pennsylvania, 15232, United States|UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, 15232, United States|Seattle Cancer Care Alliance, Seattle, Washington, 98109, United States|Chris O Brien Lifehouse, Camperdown, New South Wales, 2050, Australia|Royal Prince Alfred Hospital, Camperdown, New South Wales, 2050, Australia|Prince Charles Hospital, Cancer Care Services, Chermside, Queensland, 4032, Australia|National Hospital Organization Shikoku Cancer Center, Matsuyama, Ehime, 791-0280, Japan|The Cancer Institute Hospital of JFCR, Koto-ku, Tokyo, 135-8550, Japan|Seoul National University Hospital / Department of Internal Medicine, Seoul, 03080, Korea, Republic of|Severance Hospital, Yonsei University Health System, Seoul, 03722, Korea, Republic of|Asan Medical Center, Seoul, 05505, Korea, Republic of

Study Protocol, https://cdn.clinicaltrials.gov/large-docs/33/NCT02349633/Prot_000.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/33/NCT02349633/SAP_001.pdf

{ "PF-06747775": [ { "intervention_type": "DRUG" } ], "Palbociclib": [ { "intervention_type": "DRUG", "description": "Palbociclib", "name": "Palbociclib", "synonyms": [ "6-acetyl-8-cyclopentyl-5-methyl-2-{[5-(piperazin-1-yl)pyridin-2-yl]amino}pyrido[2,3-d]pyrimidin-7(8H)-one", "Ibrance", "Palbociclib" ], "medline_plus_id": "a615013", "generic_names": [ "Palbociclib" ], "drugbank_id": "DB09073" } ], "Avelumab": [ { "intervention_type": "DRUG", "description": "Avelumab", "name": "Avelumab", "synonyms": [ "Bavencio", "Avelumab" ], "medline_plus_id": "a617006", "generic_names": [ "Avelumab" ], "drugbank_id": "DB11945", "wikipedia_url": "https://en.wikipedia.org/wiki/Avelumab" } ] }

NCT03758287

Ningetinib (CT053PTSA) Plus Gefitinib in Stage IIIB or IV NSCLC Patients With EGFR Mutation and T790M Negative

https://clinicaltrials.gov/study/NCT03758287

UNKNOWN

This is a phase Ib, multi-center, open label study evaluating the safety and efficacy of CT053PTSA in combination with gefitinib in patients with EGFR mutation, T790M negative NSCLC who have progressed after EGFR TKI treatment.

NO

Non-small Cell Lung Cancer

DRUG: CT053PTSA|DRUG: Gefitinib

Part 1（dose-escalation part）: Maximum Tolerated Dose (MTD), The maximum tolerated dose (MTD) of the CT053PTSA and gefitinib combination will be determined according to incidence of dose-limiting toxicity (DLT) assessed by NCI CTCAE v4.03, Cycle 1 Day 1 to Cycle 1 Day 28|Part 2（expansion part）: Overall Response Rate, Overall response rate (ORR), defined as a partial response (PR) or complete response (CR) occurring at any point post-treatment according to Response Evaluation Criteria in Solid Tumors as assessed by RECIST v1.1, up to approximately 36 months

Number of patients with adverse events (AEs) as a measure of safety and tolerability, Safety and tolerability will be assessed through AEs, via monitoring changes in physical examination, clinical laboratory parameters, vital signs and ECGs, up to approximately 36 months|Disease Control Rate (DCR), DCR, proportion of patients with best overall response of CR, PR or SD, up to approximately 36 months|Progression-free Survival (PFS), PFS, defined as time from date of treatment to disease progression or death due to any cause, up to approximately 36 months|Duration of Response (DOR), DOR, defined as time from the first documented CR or PR to first documented progression or death due to any cause, up to approximately 36 months|Overall Survival (OS), OS, defined as time from date of treatment to death due to any cause, up to approximately 60 months|Maximum observed plasma concentration (Cmax), to assess the pharmacokinetic profile, Cycle 1 Day1 and Day 28|Time of maximum observed plasma concentration (Tmax), to assess the pharmacokinetic profile, Cycle 1 Day1 and Day 28|Area under the plasma concentration time curve (AUC), to assess the pharmacokinetic profile, Cycle 1 Day1 and Day 28

Sunshine Lake Pharma Co., Ltd.

ALL

ADULT, OLDER_ADULT

PHASE1|PHASE2

INDUSTRY

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT

PCD-DCT053-16-001

2016-11

2023-07-17

2023-07-17

2018-11-29

2022-06-22

Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, China

{ "CT053PTSA": [ { "intervention_type": "DRUG" } ], "Gefitinib": [ { "intervention_type": "DRUG", "description": "Gefitinib", "name": "Gefitinib", "synonyms": [ "Gefitinib", "Iressa", "ZD 1839", "N-(3-Chloro-4-fluorophenyl)-7-methoxy-6-(3-(4-morpholinyl)propoxy)-4-quinazolinamide", "ZD1839", "N-(3-chloro-4-fluorophenyl)-7-methoxy-6-(3-(4-morpholinyl)propoxy)-4-quinazolinamine", "4-(3'-chloro-4'-fluoroanilino)-7-methoxy-6-(3-morpholinopropoxy)quinazoline" ], "medline_plus_id": "a607002", "generic_names": [ "Gefitinib" ], "mesh_id": "D000092004", "drugbank_id": "DB00317" } ] }

NCT04835987

Evaluation of the Autonomic Nervous System in Patients Undergoing Esophagectomy for Cancer

https://clinicaltrials.gov/study/NCT04835987

PROSNACO

WITHDRAWN

Esophageal surgery is a complex surgery, with high post-operative morbidity and mortality. The incidence of complications associated with esophagectomy varies from 17% to 74%, in the literature. A section of vagus nerves is conventionally performed during esophagectomy for cancer, because of oncological margins. The vagus nerve is responsible for the parasympathetic innervation at the gastrointestinal level, but also at the cardiac and pulmonary level. The post-operative morbidity of these procedures could be linked in part to the bilateral section of the vagus nerves, because of their impact on the autonomous regulation of this vital functions. The main objective of the study is to find a modification of the sympathomimetic balance pre and post operatively, in patients undergoing esophagectomy.

NO

Esophageal Cancer

DIAGNOSTIC_TEST: Holter ECG|BEHAVIORAL: Questionary|DIAGNOSTIC_TEST: Pupillometry

Analysis of Standard deviation of all NN (SDNN) (ms), Analysis of Standard deviation of all NN (SDNN) intervals, over the entire registration period, provides information on global variability. Measured by Holter results. Day 0 = surgery, before surgery|Analysis of Standard deviation of all NN (SDNN) (ms), Analysis of Standard deviation of all NN (SDNN) intervals, over the entire registration period, provides information on global variability. Measured by Holter results. Day 0 = surgery, day 7 to day 90

HF activity, Day 0 = surgery measured with the Holter Electrocardiogram, before surgery : Day -82, Day -30, Day -1|LF activity, Day 0 = surgery measured with the Holter Electrocardiogram, before surgery : Day -82, Day -30, Day -1|LF/HF ratio, Day 0 = surgery measured with the Holter Electrocardiogram, before surgery : Day -82, Day -30, Day -1|HF activity, Day 0 = surgery measured with the Holter Electrocardiogram, after surgery : day 7, day 60, day 90|LF activity, Day 0 = surgery measured with the Holter Electrocardiogram, after surgery : day 7, day 60, day 90|LF/HF ratio, Day 0 = surgery measured with the Holter Electrocardiogram, after surgery : day 7, day 60, day 90|change in baroreflex, baroreflex sensitivity : ms/mmHg Day 0 = surgery, Day -1, Day 7, day discharge, day 90|modify the respiratory functional exploration, Peak expiratory volume per second : L Day 0 = surgery, Day -30, Day 30, Day 60|intraoperative pupillometry, pupillary diameter : mm, during surgery|physical capacity, walking distance in 6 minutes Day 0 = surgery, Day-30, Day 30, Day 90

Centre Hospitalier Universitaire de Saint Etienne

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

20CH250|2020-A03326-33

2023-12

2024-03

2024-09

2021-04-08

2023-11-24

Centre Hospitalier Universitaire de Saint-Etienne, Saint-Étienne, 42055, France

{ "Holter ECG": [ { "intervention_type": "DIAGNOSTIC_TEST" } ], "Questionary": [ { "intervention_type": "BEHAVIORAL" } ], "Pupillometry": [ { "intervention_type": "DIAGNOSTIC_TEST" } ] }

NCT04638387

PB125, Osteoarthritis, Pain, Mobility, and Energetics

https://clinicaltrials.gov/study/NCT04638387

TERMINATED

Nuclear factor erythroid 2-related factor 2 (Nrf2) is an important regulator in the body. It controls how well cells protect themselves against stress. PB125 (Pathways Bioscience) is a plant based activator of this important regulator Nrf2. PB125 is made up of three plant extracts (rosemary, ashwagandha, and Sophora japonica) so that it contains these things; 1. Carnosol, 2. Withaferin A, and 3. Luteolin. Carnosol comes from rosemary leaves. Rosemary is a spice often used in Italian foods and grown in many herb gardens all around Fort Collins. Withaferin A comes from the medicinal plant Withania somnifera, also called ashwagandha. Ashwaganda is commonly known as Indian Winter cherry or Indian Ginseng and it is one of the most important herbs of Ayurveda (the traditional system of medicine in India) used for millennia. Finally, luteolin is found widely in plants including those present in the diet (peppers, onions, celery, herbs/spices). Some people purchase these herbs commercially, and take them on their own for a variety of purposes. Typically, when you buy them, they will be in much higher doses than they are in PB125. What makes PB125 different is that very low doses of each of the 3 components work together-synergistically-to activate Nrf2 and increase the ability of cells to respond to stress. It is unknown if there are any benefits to taking PB125 and the risks are currently unknown. The purpose of this study is to examine changes in muscle, in joint pain, in mobility (standing and walking) and in leg strength that occur after consuming PB125 every day for 3 months. We want to make these measurements in people who have been diagnosed with mild to moderate osteoarthritis-a degenerative joint disease-in their knees.

NO

Osteoarthritis, Knee|Muscle Weakness|Pain, Joint

DIETARY_SUPPLEMENT: PB125|DIETARY_SUPPLEMENT: Placebo

Mobility-6 min self-paced walk, Change in Distance walked, Change from baseline at 12 weeks|Mobility-sit to stand, Change in Time for 5 sit to stand repetitions, Change from baseline at 12 weeks|Mobility-static balance, Yes/No ability to complete 30 sec trials with eyes open or closed on firm and foam surfaces, Change from baseline at 12 weeks|Mobility-6 min fast-paced walk, Change in Distance walked, Change from baseline at 12 weeks|Intermittent and Constant Knee Pain, Weekly change in Intermittent and Constant Pain Score (ICOAP) 11 question survey of pain on a 0-4 scale, Change weekly for 12 weeks|Energetics-Submaximal Oxygen Consumption, Change in oxygen (O2) flux in permeabilized muscle fibers at submaximal adenosine diphosphate (ADP) concentrations, Change from baseline at 12 weeks|Energetics-Maximal Oxygen Consumption, Change in O2 flux in permeabilized muscle fibers at maximal ADP concentrations, Change from baseline at 12 weeks

Energetics-hydrogen peroxide emission, Change in Hydrogen peroxide emission in permeabilized muscle fibers, Change from baseline at 12 weeks|Bone Mineral Density, Bone mineral density via dual x-ray absorptiometry (DEXA), Change from baseline at 12 weeks|Knee Range of Motion, Change in active and passive bilateral knee range of motion, Change from baseline at 12 weeks|Leg extensor strength, Change in maximal force generated during knee extension, Change from baseline at 12 weeks

Colorado State University

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

19-9100H

2020-11-03

2021-09-01

2021-09-01

2020-11-20

2022-09-14

Colorado State University, Fort Collins, Colorado, 80523-1582, United States

{ "PB125": [ { "intervention_type": "DIETARY_SUPPLEMENT" } ], "Placebo": [ { "intervention_type": "DIETARY_SUPPLEMENT" } ] }

NCT00189787

Dose Response of Inhaled Tacrolimus in Patients With Moderate Persistent Asthma

https://clinicaltrials.gov/study/NCT00189787

COMPLETED

This study will evaluate the efficacy and safety of tacrolimus in patients with asthma.

NO

Asthma, Bronchial|Bronchial Asthma

DRUG: tacrolimus

Astellas Pharma Inc

Astellas Pharma Europe B.V.

ALL

ADULT, OLDER_ADULT

PHASE2

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT

FG-506-17-07

2005-08

2005-08

2005-09-19

2008-04-17

Pleven, 5800, Bulgaria|Rousse, 7000, Bulgaria|Sofia, 1431, Bulgaria|Varna, 9010, Bulgaria|Brno, 656 91, Czech Republic|Krhanice, 257 42, Czech Republic|Olomouc, 775 20, Czech Republic|Sumperk, 787 52, Czech Republic|Berlin, 10365, Germany|Berlin, 10717, Germany|Berlin, 10969, Germany|Berlin, 12203, Germany|Berlin, 12687, Germany|Berlin, 13357, Germany|Berlin, 13597, Germany|Berlin, 14050, Germany|Bonn, 53119, Germany|Deggendorf, 94469, Germany|Dusseldorf, 40217, Germany|Hannover, 30159, Germany|Munchen, 80802, Germany|Potsdam, 14469, Germany|Rudersdorf, 15562, Germany|Solingen, 42651, Germany|Wiesbaden, 65187, Germany|Budapest, 1125, Hungary|Csorna, 9300, Hungary|Fuzesabony, 3390, Hungary|Nyiregyhaza, 4400, Hungary|Szombathely, 9700, Hungary|Bialystok, 15-025, Poland|Krakow, 31-133, Poland|Lodz, 90-153, Poland|Lodz, 91-520, Poland|Lublin, 20-718, Poland|Tarnow, 33-100, Poland|Wroclaw, 50-434, Poland|Ekaterinburg, 620142, Russian Federation|Moscow, 107066, Russian Federation|Moscow, 143420, Russian Federation|Rostov-na-Donu, 344015, Russian Federation|Smolensk, 214018, Russian Federation|St. Petersburg, 194291, Russian Federation|St. Petersburg, 194354, Russian Federation|St. Petersburg, 197022, Russian Federation|St. Petersburg, 197291, Russian Federation|Dnepropetrovsk, 49044, Ukraine|Donetsk, 83003, Ukraine|Kiev, 03680, Ukraine

{ "Tacrolimus": [ { "intervention_type": "DRUG", "description": "tacrolimus", "name": "Tacrolimus", "synonyms": [ "Anhydrous Tacrolimus", "Tacrolimus, anhydrous", "FR900506", "Astagraf XL", "FR 900506", "Tacrolimus", "Prograft", "FK506", "Anhydrous, Tacrolimus", "FR-900506", "Advagraf", "Tacrolimus Anhydrous", "Protopic", "Prograf", "FK-506", "Tacrolimus, Anhydrous", "Anhydrous tacrolimus", "FK 506", "Tacrolimus anhydrous" ], "medline_plus_id": "a602020", "generic_names": [ "Tacrolimus" ], "mesh_id": "D065095", "drugbank_id": "DB00864", "wikipedia_url": "https://en.wikipedia.org/wiki/Tacrolimus" } ] }

NCT05420987

Effect of Jing Si Herbal Tea on Inflammation in Patients With Cardiovascular Disease

https://clinicaltrials.gov/study/NCT05420987

NOT_YET_RECRUITING

Jing Si herbal tea includes eight Chinese herbs: such as mugwort leaves, fish needle grass, Ophiopogon japonicus, platycodon, perilla leaves, chrysanthemum, and licorice. In vitro, these ingredients were found to be able to block the binding of SARS-CoV-2 and human ACE2 receptor, and further reduce the penetration ability of the virus. Now, Jing Si herbal tea liquid packets have obtained the special license for export from the Ministry of Health and Welfare in Taiwan. The aim of the study is to investigate (1) the effect of Jing Si herbal tea liquid on blood pressure, blood sugar, and cholesterol in patients with cardiovascular diseases. (2)The human gut microbiota change which is associated with TMAO production (3) The proinflammatory and inflammatory biomarkers change. We are going to recruit 100 participants from cardiovascular clinics, including patients with hypertension, hyperlipidemia, ischemic heart disease and diabetes, aged 20-75 years old. We exclude those who are cancer patients, have comorbidities with poor control, patients with eGFR< 40 ml/min/1.73m2, those who are pregnant, breastfeeding, and in their menstrual period when recruiting. The study has two parts. The first part is a pilot study with 20 subjects all take active Jing Si herbal tea. The second part is a double-blind randomized controlled study with 40 subjects in each arm.

NO

Inflammatory Response|Gut Microbiome|Life Quality|Trimethylamine N-oxide|Cardiovascular Diseases|Herbal Medicine

DIETARY_SUPPLEMENT: Jing Si herbal tea liquid packet

inflammatory biomarkers, IL-1b (pg/mL), IL-4(pg/mL), IL-6(pg/mL), IL-10(pg/mL), TNF-gamma(pg/mL),TNF-alpha (pg/mL), 3 months|inflammatory biomarkers, GlycA (umol/L), 3 months|lipid profile , Glu-AC, hs_CRP, Total cholesterol(mg/dL), TG(mg/dL), HDL-C(mg/dL), LDL-C(mg/dL), uric acid (mg/dL) and Glu-AC (mg/dL),hs_CRP(mg/dL), 3 months|diabetes control index, HbA1c (%), insulin (mU/L), HOMA-IR, HOMA-beta, 3 months|biomarkers for congestive heart failure, Nt-proBNP (pg/ mL), 3 months|heart function measurement for congestive heart failure, LVEF(%), 3 months|kidney function 1, BUN (mg/dL),Cre (mg/dL), 3 months|kidney function 2, eGFR (mL/min), 3 months|kidney function 3, Urine Albumin to Creatinine Ratio(mg/g), 3 months|Gut microbiome, TMAO (uM), 3 months|immune composition analysis 1, CD3(%), CD4(%), CD8(%), CD56(%), CD11b(%), Foxp3(%), NK,HLA-DR(%), 3 months|immune composition analysis 2, WBC (10^3/uL), 3 months|immune function analysis, IFN-gamma (IU/mL), 3 months

Buddhist Tzu Chi General Hospital

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE

IRB111-025-A

2022-06

2024-12

2024-12

2022-06-16

2022-06-16

{ "Jing Si herbal tea liquid packet": [ { "intervention_type": "DIETARY_SUPPLEMENT" } ] }

NCT02502487

Dorsal Penile Nerve Block for Rigid Cystoscopy in Men

https://clinicaltrials.gov/study/NCT02502487

COMPLETED

This study will determine the effectiveness and safety of dorsal penile nerve block (DPNB) in men undergoing rigid cystoscopy.

YES

Pain

PROCEDURE: Dorsal Penile Nerve Block|DRUG: Ropivacaine|DRUG: Tetracaine

Visual Analog Scale (VAS) for Pain, A visual analog scale (VAS) ranging from 0 to 10 was used to assess the patients pain during the procedure. 0 means no pain, 1 to 3 means mild pain, 4 to 7 means moderate pain, and 8 to 10 means severe pain. Patients were asked the VAS score to express the degree of pain at each time point., at cystoscopic inspection of external sphincter

Visual Analog Scale (VAS) for Pain, A visual analog scale (VAS) ranging from 0 to 10 was used to assess the patients pain during the procedure. 0 means no pain, 1 to 3 means mild pain, 4 to 7 means moderate pain, and 8 to 10 means severe pain. Patients were asked the VAS score to express the degree of pain at each time point., before gel administration|Visual Analog Scale (VAS) for Pain, A visual analog scale (VAS) ranging from 0 to 10 was used to assess the patients pain during the procedure. 0 means no pain, 1 to 3 means mild pain, 4 to 7 means moderate pain, and 8 to 10 means severe pain. Patients were asked the VAS score to express the degree of pain at each time point., at cystoscopic inspection of penile and bulbar urethra|Visual Analog Scale (VAS) for Pain, A visual analog scale (VAS) ranging from 0 to 10 was used to assess the patients pain during the procedure. 0 means no pain, 1 to 3 means mild pain, 4 to 7 means moderate pain, and 8 to 10 means severe pain. Patients were asked the VAS score to express the degree of pain at each time point., at cystoscopic inspection of prostate and bladder|Visual Analog Scale (VAS) for Pain, A visual analog scale (VAS) ranging from 0 to 10 was used to assess the patients pain during the procedure. 0 means no pain, 1 to 3 means mild pain, 4 to 7 means moderate pain, and 8 to 10 means severe pain. Patients were asked the VAS score to express the degree of pain at each time point., after withdrawal of cystoscope|Heart Rate Before Gel Administration, before gel administration|Heart Rate at Cystoscopic Inspection of Penile and Bulbar Urthra, at cystoscopic inspection of penile and bulbar urethra|Heart Rate at Cystoscopic Inspection of External Sphincter, at cystoscopic inspection of external sphincter|Heart Rate After Withdrawal of Cystoscope, after withdrawal of cystoscope|Mean Arterial Pressure Before Gel Administration, before gel administration|Mean Arterial Pressure at Cystoscopic Inspection of Penile and Bulbar Urthra, at cystoscopic inspection of penile and bulbar urthra|Mean Arterial Pressure at Cystoscopic Inspection of External Sphincter, at cystoscopic inspection of external sphincter|Mean Arterial Pressure After Withdrawal of Cystoscope, after withdrawal of cystoscope|Oxygen Saturation by Pulse Before Gel Administration, before gel administration|Oxygen Saturation by Pulse at Cystoscopic Inspection of Penile and Bulbar Urthra, at cystoscopic inspection of penile and bulbar urthra|Oxygen Saturation by Pulse at Cystoscopic Inspection of External Sphincter, at cystoscopic inspection of external sphincter|Oxygen Saturation by Pulse After Withdrawal of Cystoscope, after withdrawal of cystoscope|Breath Rate Before Gel Administration, before gel administration|Breath Rate at Cystoscopic Inspection of Penile and Bulbar Urthra, at cystoscopic inspection of penile and bulbar Urthra|Breath Rate at Cystoscopic Inspection of External Sphincter, at cystoscopic inspection of external sphincter|Breath Rate After Withdrawal of Cystoscope, after withdrawal of cystoscope

West China Hospital

MALE

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION

WestChinaHAesthesia-1

2015-06

2016-03

2016-03

2015-07-20

2016-07-11

2020-03-31

West China Hospital of Sichuan University, Department of Anesthesiology, Chengdu, Sichuan, 610041, China

{ "Dorsal Penile Nerve Block": [ { "intervention_type": "PROCEDURE" } ], "Ropivacaine": [ { "intervention_type": "DRUG", "description": "Ropivacaine", "name": "Ropivacaine", "synonyms": [ "Ropivacaina", "1-Propyl-2',6'-pipecoloxylidide", "(S)-(\u2212)-1-propyl-2',6'-pipecoloxylidide", "Naropeine", "Ropivacaine Hydrochloride", "L-N-n-propylpipecolic acid-2,6-xylidide", "AL-381", "Ropivacaine", "Ropivacainum", "Naropin", "1 Propyl 2',6' pipecoloxylidide", "Ropivacaine Monohydrochloride", "LEA 103", "Ropivacaine Monohydrochloride, (S)-isomer", "LEA103", "AL381", "LEA-103", "(S)-ropivacaine", "AL 381" ], "mesh_id": "D000779", "generic_names": [ "Ropivacaine" ], "drugbank_id": "DB00296" } ], "Tetracaine": [ { "intervention_type": "DRUG", "description": "Tetracaine", "name": "Tetracaine", "synonyms": [ "Amethocaine", "Tetrracaine Hydrochloride", "Amethocaine HCl", "Tetracaine HCl", "Di\u00e4thylamino\u00e4thanol ester der p-butylaminobenz\u00f6s\u00e4ure", "2-(Dimethylamino)ethyl p-(butylamino)benzoate", "p-Butylaminobenzoyl-2-dimethylaminoethanol", "Pontocaine", "Ametop", "2-(dimethylamino)ethyl 4-(butylamino)benzoate", "Pantocaine", "Hydrochloride, Tetrracaine", "Metraspray", "Tetraca\u00edna", "Tetrakain", "T\u00e9traca\u00efne", "Medihaler-Tetracaine", "Tetracaine Monohydrochloride", "p-(butylamino)benzoic acid \u03b2-(dimethylamino)ethyl ester", "Tetracaine", "Dicaine" ], "mesh_id": "D000779", "generic_names": [ "Tetracaine" ], "drugbank_id": "DB09085" } ] }

NCT06238687

A Study of STRO-002 in Chinese Adults With Epithelial Ovarian Cancer and Other Advanced Malignant Solid Tumors

https://clinicaltrials.gov/study/NCT06238687

RECRUITING

This is a multi-center, open-label, monotherapy dose escalation, PK bridging, and dose expansion Phase I/IIa study in Chinese adult subjects to evaluate the safety, tolerability, Pharmacokinetics (PK) profiles, immunogenicity, and preliminary efficacy of STRO-002 in patients with advanced malignant solid tumors.

NO

Neoplasm Malignant

BIOLOGICAL: STRO-002

DLT Assessment, Toxicity associated with the treatment of the investigational drug STRO-002., From Day1 to Day21 after first dose of STRO-002|AE Assessment, The frequency of AE, From first dose of STRO-002 until 28 days after the last dose of STRO-002|AUC, PK parameter：area under the concentration-time curve (AUC), From first dose of STRO-002 until 28 days after the last dose of STRO-002.|Cmax, PK parameter：Cmax, From first dose of STRO-002 until 28 days after the last dose of STRO-002.|Half life (t1/2), PK parameter：half life (t1/2), From first dose of STRO-002 until 28 days after the last dose of STRO-002.|Overall response rate (ORR), ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) per RECIST v 1.1, From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months|Determine the recommended phase II dose (RP2D), From first dose of STRO-002 until 28 days after the last dose of STRO-002.

Occurrence of positive anti-drug antibodies (ADAs) and changes over time., Occurrence of positive anti-drug antibodies (ADAs), From first dose of STRO-002 until 28 days after the last dose of STRO-002.|Duration of response (DOR), DOR is defined as the time from the first documented response (CR or PR evaluated by RECIST v1.1) until the time of first documentation of disease progression by RECIST v1.1., From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months|Progression-free survival (PFS), PFS is defined as a time from the first dose of STRO-002 to documented disease progression or death from any cause., From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months|FolRα and cancer antigen 125 (CA-125) levels measured in tumor tissue, A CA-125 response is defined as at least a 50% reduction in CA-125 levels from a pretreatment sample, and the response must be confirmed and maintained for at least 28 days., From first dose of STRO-002 until 28 days after the last dose of STRO-002.

Tasly Pharmaceutical Group Co., Ltd

Sutro Biopharma, Inc.

ALL

ADULT, OLDER_ADULT

PHASE1|PHASE2

INDUSTRY

INTERVENTIONAL

Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT

TSL-B2276-1-01

2023-11-08

2026-12-30

2027-12-30

2024-02-02

2024-02-02

West China Hospital of Sichuan University, Chengdu, Sichuan, China

{ "STRO-002": [ { "intervention_type": "BIOLOGICAL" } ] }

NCT05370287

Adaptive Optics Retinal Imaging

https://clinicaltrials.gov/study/NCT05370287

RECRUITING

The objective of the study is to collect and assess adaptive optics (AO) retinal images from human subjects in support of projects to demonstrate, advance, and enhance clinical use of AO technology.

NO

Glaucoma, Primary Open Angle

OTHER: oxygen inhalation|DEVICE: Adaptive optics imaging

Change in Retinal blood flow (RBF) with oxygen inhalation, RBF [uL/min] will be measured from ensemble RBC velocity [mm/s] measurements from line-scan AOSLO videos and vessel diameter [mm] measurements from average AO-OCT volumes., RBF will be measured in all subjects twice during a single AO imaging session - once before and once during pure oxygen inhalation. Subjects will be imaged only once; there is no longitudinal component to this outcome measure.|Retinal ganglion cell (RGC) density, RGC density will be calculated at specific retinal eccentricities from cells counted in average AO-OCT volumes., RGC density will be calculated once at the AO imaging session in which RGCs are the target. For the reproducibility/longitudinal study portion, RGC density will be quantified three times over 1.5 years (visits separated by 6 months).|RGC soma diameter, RGC soma diameter will be calculated at specific retinal eccentricities from cells segmented in average AO-OCT volumes., RGC diameter will be calculated once at the AO imaging session in which RGCs are the target. For the reproducibility/longitudinal portion of the study, RGC soma diameter will be quantified three times over 1.5 years (visits separated by 6 months).|Retinal pigment epithelium (RPE) cell organelle motility, RPE cell organelle motility will be calculated from the decorrelation time constant for cells segmented from a sequence of AO-OCT volumes., RPE organelle motility will be calculated once at the AO imaging session in which RPE cells are the target. For the reproducibility portion of the study, RPE organelle motility will be quantified three times over six weeks (visits separated by 2 weeks).|Photoreceptor (PR) cell function, Photoreceptor cell (cone) function will be measured from phase changes between inner segment - outer segment junction and cone outer segment tip signals in a sequence of AO-OCT volumes collected during visible light stimulation., PR function will be calculated once at the AO imaging session in which photoreceptors are stimulated. For the reproducibility portion of the study, PR function will be quantified three times over six weeks (visits separated by 2 weeks).

Food and Drug Administration (FDA)

University of Maryland, Baltimore

ALL

ADULT, OLDER_ADULT

FED

INTERVENTIONAL

Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE

17-062R

2018-01-22

2026-09-30

2026-09-30

2022-05-11

2024-01-02

Food and Drug Administration, Silver Spring, Maryland, 20993, United States

Study Protocol, https://cdn.clinicaltrials.gov/large-docs/87/NCT05370287/Prot_002.pdf|Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/87/NCT05370287/ICF_003.pdf

{ "oxygen inhalation": [ { "intervention_type": "OTHER" } ], "Adaptive optics imaging": [ { "intervention_type": "DEVICE" } ] }

NCT05214287

Multiple N-of-1 Trials of (Intermittent) Hypoxia Therapy in Parkinson s Disease

https://clinicaltrials.gov/study/NCT05214287

TALISMAN

COMPLETED

In recent years, mitochondrial dysfunction and oxidative stress have been implicated in PD pathophysiology. Intermittent hypoxia therapy (IHT) is an upcoming treatment used by elite athletes as well as fragile individuals in clinical settings that works by improving exercise tolerance, neuroplasticity and inducing hypoxic preconditioning (HPC). HPC might improve the oxidative stress response in PD on the long-term. In addition, preclinical evidence suggests beneficial short-term effects such as influence on dopamine and noradrenalin release. Anecdotal evidence indeed suggests that visiting high-altitude areas improves PD symptoms and it is hypothesized that this effect results from decreased oxygen pressure at high altitudes. The safety and feasibility of (intermittent) hypoxia therapy on PD symptoms will be assessed in an exploratory phase I randomized-controlled trial.

NO

Parkinson Disease|Effect of Drug

DRUG: Hypoxic Gas Mixture

Nature and number of adverse events, Actively reported during intervention and passively for up to 3 days after the intervention, adverse events will be collected., Until 3 days post-intervention|Self-reported dizziness, discomfort and stress on a ten-point scale, Every 10 minutes up to one hour post-intervention, one time next morning post-intervention, 10-point Likert scale, lower is better., Until 3 days post-intervention|Blood pressure, Systolic and diastolic blood pressure, Baseline and every 5 mins until 30 mins post-intervention|Heartrate, Beats/min, Baseline and every 5 mins until 30 mins post-intervention|Respiratory rate, Breaths/min, Baseline and every 5 mins until 30 mins post-intervention|Oxygen saturation, Percentage, Baseline and every 5 mins until 30 mins post-intervention|Feasibility questionnaire, 17-item scale, scored 1-10, lower is better. Subscores and total score, After 1st, 5th, 10th post-intervention test

Participant-selected motor symptom, Change from (pre-treatment) baseline in the symptom that improved most during previous positive altitude effect (if applicable), or other symptom of choice. Self-reported severity scores on a Likert-scale. 10-point Likert scale allowing half points. Lower is better., Directly after, as well as 30 and 60 minutes after the intervention and four times once every hour after that. In addition, these will be measured once every morning (i.e. in OFF) for the next three mornings after the intervention.|General impression of PD symptoms, Change from (pre-treatment) baseline on 10-point Likert scale allowing half points. Lower is better., Directly after, as well as 30 and 60 minutes after the intervention and four times once every hour after that. In addition, these will be measured once every morning (i.e. in OFF) for the next three mornings after the intervention.|Urge to take dopaminergic medication, Change from (pre-treatment) baseline on 10-point Likert scale allowing half points. Lower is better., Directly after, as well as 30 and 60 minutes after the intervention and four times once every hour after that. In addition, these will be measured once every morning (i.e. in OFF) for the next three mornings after the intervention.|Timed Up & Go Test, Change from (pre-treatment) baseline in total time and steps. The Timed Up & Go Test is a test that evaluates primarily gait functioning. Lower is better., 30 minutes|MiniBESTest, Change from (pre-treatment) baseline in item subscores and total score. The MiniBESTest is a concise balance test. Higher is better., 30 minutes|Movement Disorder Society-Unified Parkinson s Disease Rating Scale (MDS-UPDRS) part III, The MDS-UPDRS part III is the gold standard for motor assessment in Parkinson s disease. Change form (pre-treatment) baseline in item subscores and total scores. Lower is better., 30 minutes|Finger tapping, Change from (pre-treatment) baseline in number of taps during 10-second trials on both hands, one session each. Finger tapping is considered a measure of bradykinesia. Higher is better., 30 minutes|MDS Non-Motor Symptoms Scale (only items related to stress, fatigue, mood, anxiety, pain), The most important potentially adaptive non-motor symptoms mentioned in this gold standard for non-motor symptom screening are selected. Likert scale 1-10 (allowing half points). Change from (pre-treatment) baseline. Lower is better., 30 minutes|Accelerometry during MDS-UPDRS part III, items on pronation-supination and tremor, During the MDS-UPDRS part III, accelerometry allows for quantification of therapeutic effects in addition to the MDS-UPDRS part III. Lower amplitude is better in tremor, higher frequency and rotational power is better in pronation-supination. Change from (pre-treatment) baseline., 30 minutes|Heart Rate Variability (HRV), Average HRV during intervention and post intervention. HRV is a marker of cardiovascular stress. Change form (pre-treatment) baseline. Lower equals more stress., 30 minutes|Modified Purdue pegboard test, Change from (pre-treatment) baseline in number of pins per side. The Purdue pegboard test is primarily a measure of bradykinesia, hypokinesia and fine motor skills. Higher is better., 30 minutes

Serum platelet-derived growth factor receptor β (PDGFRβ), PDGFRβ is a pericyte-released marker of hypoxia and blood-brain barrier integrity. Change from (pre-treatment) baseline. Higher equals more hypoxic-induced adaptive response, 60 minutes after intervention|Serum cortisol, Cortisol is a molecular marker of systemic stress. Change from (pre-treatment) baseline. Lower equals less stress., Directly after intervention, 30 minutes, 60 minutes|Serum erythropoietin (EPO), Erythropoietin is a marker of cellular hypoxia. Change from (pre-treatment) baseline. Higher equals more hypoxic-induced adaptive response., 60 minutes after intervention

Radboud University Medical Center

Michael J. Fox Foundation for Parkinson s Research

ALL

ADULT, OLDER_ADULT

PHASE1|PHASE2

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

112203|NL.77891.091.21|2021-005480-41|2021-12410

2022-02-22

2023-07-12

2023-07-12

2022-01-28

2023-07-21

Dpt. of Physiology, Radboud University Medical Center, Nijmegen, 6525EX, Netherlands

{ "Hypoxic Gas Mixture": [ { "intervention_type": "DRUG" } ] }

NCT00456287

Platelet Activation and Circadian Rhythms of Clotting-Fibrinolysis Factors in Patients With Sleep Apnea Syndrome

https://clinicaltrials.gov/study/NCT00456287

UNKNOWN

The objective of the study is to define and compare clotting- fibrinolysis patterns, platelet function markers and endothelial dysfunction in patients with SAHS before and after treatment and normal controls age and weight matched.

NO

Sleep Apnea|Cardiovascular Diseases

DEVICE: CPAP (Continuous Positive Airway Pressure)

To define and compare clotting- fibrinolysis patterns, platelet function markers and endothelial dysfunction

CPAP (Continuous Positive Airway Pressure) effect on studied variables

Sociedad Española de Neumología y Cirugía Torácica

Fondo de Investigacion Sanitaria|Fundacion Caubet-Cimera Islas Baleares

MALE

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION

PR-109

2007-02

2007-04-04

2007-04-04

Hospital Universitario Son Dureta, Palma de Mallorca, Baleares, 07014, Spain

{ "CPAP (Continuous Positive Airway Pressure)": [ { "intervention_type": "DEVICE" } ] }

NCT04318587

Assessment of Donor Derived Cell Free DNA and Utility in Lung Transplantation

https://clinicaltrials.gov/study/NCT04318587

TERMINATED

The use of Allosure to identify and quantify circulating donor-derived cell-free DNA to quantitate allograft injury in the early post-transplant period and determine its relationship to allograft failure.

YES

Lung Transplant Failure and Rejection

DIAGNOSTIC_TEST: Allosure

Number of Participants With Primary Graft Dysfunction/Allograft Rejection 24 Hours Post Transplant, Primary Graft Dysfunction is measured using a combination of radiographic opacification and P:F ratio (ratio of partial pressure of oxygen related to fraction of inhaled oxygen). Grade 0: No opacifications on CXR Grade 1: Opacifications and P:F > 300 Grade 2: Opacifications and P:F >200, < 300 Grade 3: Opacifications and P:F < 200 If someone requires ECMO, they are automatically a grade 3., 24 hours post transplant|Number of Participants With Primary Graft Dysfunction/Allograft Rejection 48 Hours Post Transplant, Primary Graft Dysfunction is measured using a combination of radiographic opacification and P:F ratio (ratio of partial pressure of oxygen related to fraction of inhaled oxygen). Grade 0: No opacifications on CXR Grade 1: Opacifications and P:F > 300 Grade 2: Opacifications and P:F >200, < 300 Grade 3: Opacifications and P:F < 200 If someone requires ECMO, they are automatically a grade 3., 48 hours post transplant|Number of Participants With Primary Graft Dysfunction/Allograft Rejection 72 Hours Post Transplant, Primary Graft Dysfunction is measured using a combination of radiographic opacification and P:F ratio (ratio of partial pressure of oxygen related to fraction of inhaled oxygen). Grade 0: No opacifications on CXR Grade 1: Opacifications and P:F > 300 Grade 2: Opacifications and P:F >200, < 300 Grade 3: Opacifications and P:F < 200 If someone requires ECMO, they are automatically a grade 3., 72 hours post transplant|Number of Participants With Allograft Rejection 3 Months Post Transplant, Number of participants that experienced allograft rejection determined by evaluation of biopsy taken during bronchoscopy., 3 months post transplant|Number of Participants With Allograft Rejection 6 Months Post Transplant, Number of participants that experienced allograft rejection determined by evaluation of biopsy taken during bronchoscopy., 6 months post transplant|Number of Participants With Allograft Rejection 9 Months Post Transplant, Number of participants that experienced allograft rejection determined by evaluation of biopsy taken during bronchoscopy., 9 months post transplant|Number of Participants With Allograft Rejection 12 Months Post Transplant, Number of participants that experienced allograft rejection determined by evaluation of biopsy taken during bronchoscopy., 12 months post transplant|Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) Pre-Transplant, dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells. Amount of Allosure Donor Derived Cell Free DNA (dd-cDNA) Pre-Transplant, pre-transplant|Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 24 Hours Post Transplant, dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells., 24 hours post-transplant|Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 48 Hours Post Transplant, dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells., 48 hours post-transplant|Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 72 Hours Post Transplant, dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells., 72 hours post-transplant|Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 1 Week Post Transplant, dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells., 1 week post-transplant|Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 2 Weeks Post Transplant, dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells. Amount of Allosure Donor Derived Cell Free DNA (dd-cDNA) 2 Weeks Post Transplant, 2 weeks post-transplant|Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 3 Weeks Post Transplant, dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells., 3 weeks post-transplant|Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 4 Weeks Post Transplant, dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells., 4 weeks post-transplant|Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 5 Weeks Post Transplant, dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells., 5 weeks post-transplant|Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 6 Weeks Post Transplant, dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells., 6 weeks post-transplant|Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 7 Weeks Post Transplant, dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells., 7 weeks post-transplant|Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 8 Weeks Post Transplant, dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells., 8 weeks post-transplant|Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 9 Weeks Post Transplant, dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells., 9 weeks post-transplant|Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 10 Weeks Post Transplant, dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells., 10 weeks post-transplant|Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 11 Weeks Post Transplant, dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells., 11 weeks post-transplant|Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 12 Weeks Post Transplant, dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells., 12 weeks post-transplant|Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 4 Months Post Transplant, dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells., 4 months post transplant|Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 5 Months Post Transplant, dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells., 5 months post transplant|Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 6 Months Post Transplant, dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells., 6 months post-transplant|Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 7 Months Post Transplant, dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells., 7 months post-transplant|Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 8 Months Post Transplant, dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells., 8 months post-transplant|Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 9 Months Post Transplant, dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells., 9 months post-transplant|Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 10 Months Post Transplant, dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells., 10 months post-transplant|Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 11 Months Post Transplant, dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells., 11 months post-transplant|Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 12 Months Post Transplant, dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells., 12 months post-transplant

Number of Participants That Experienced Graft Failure or Death Within One Year Post Transplant, The number of participants that were diagnosed as having chronic lung allograft dysfunction (CLAD), needed re-transplanted or died before 1 year post transplant., one year post transplant

Pablo Sanchez

CareDx

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SCREENING

STUDY19090098

2020-06-29

2022-12-31

2023-12-30

2020-03-24

2024-03-25

2024-03-25

UPMC Presbyterian, Pittsburgh, Pennsylvania, 15213, United States

Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/87/NCT04318587/Prot_SAP_000.pdf

{ "Allosure": [ { "intervention_type": "DIAGNOSTIC_TEST" } ] }

NCT04794387

The Lymphoma and Leukemia Society Amended COVID-19 Registry

https://clinicaltrials.gov/study/NCT04794387

COMPLETED

The LLS COVID-19 Registry is being amended to invite people who participated in the LLS COVID-19 Registry and did not develop antibodies after receiving a complete COVID-19 vaccination, as well as people with blood cancer who did not participate in the initial LLS COVID-19 Registry and also did not develop antibodies after receiving a complete COVID-19 vaccination, to participate in this amended LLS COVID-19 Registry.

NO

Covid19

BIOLOGICAL: Amended LLS COVID-19 Registry

A SARS antibody test will be paired with surveys to measure the response people with blood cancer, who did not develop antibodes after a complete COVID-19 vaccination, have to the COVID-19 booster., Observational Study, 10 years

Lymphoma and Leukemia Society

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

LLSC19-001-Amendment 1

2021-08-27

2022-12-13

2022-12-13

2021-03-12

2023-03-02

Lymphoma and Leukemia Society, Rye Brook, New York, 10573, United States

{ "Amended LLS COVID-19 Registry": [ { "intervention_type": "BIOLOGICAL" } ] }

NCT05012787

Safety and Immunogenicity of Adjuvanted SARS-CoV-2 (SCB-2019) Vaccine in Adults With Chronic Immune-Mediated Diseases

https://clinicaltrials.gov/study/NCT05012787

COVID-19

TERMINATED

The purpose of the study is to evaluate the safety and immunogenicity of the investigational CpG 1018/Alum-adjuvanted recombinant SARS-CoV-2 trimeric spike (S)-protein subunit vaccine (SCB-2019) in adult participants with stable chronic inflammatory immune-mediated diseases (IMDs), compared to control vaccine.

NO

COVID-19

BIOLOGICAL: CpG 1018/Alum-adjuvanted SCB-2019 vaccine|BIOLOGICAL: Havrix|OTHER: Placebo; 0.9% saline

Percentage of Participants With Unsolicited Adverse Events (AEs), Day 1 through Day 43|Percentage of Participants With Medically Attended AEs (MAAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI), Day 1 through Day 205|Percentage of Participants With Any Confirmed Relapse of Immune-mediated Disease (RA, IBD, or RRMS), Day 1 through Day 205

Geometric Mean Titer (GMT) of SARS-CoV-2 Neutralizing Antibody (nAb), Day 1, 22, 36 and 205|Geometric Mean Fold Rise (GMFRs) of SARS-CoV-2 nAb, Day 22, 36 and 205|Number of Participants With Seroconversion for SARS-CoV-2 nAb, Day 22, 36 and 205|Geometric Mean Titer (GMT) of SCB-2019 Binding Antibody, Day 1, 22, 36 and 205|Geometric Mean Fold Rise (GMFRs) of SCB-2019 Binding Antibody, Day 22, 36 and 205|Number of Participants With Seroconversion for SCB-2019 Binding Antibody, Day 22, 36 and 205|Geometric Mean Titer (GMT) of SARS-CoV-2 Neutralizing Antibody (nAb) in Participants With RA, IBD, and RRMS, Day 1, 22, 36 and 205|Geometric Mean Fold Rise (GMFRs) of SARS-CoV-2 nAb in Participants With RA, IBD, and RRMS, Day 22, 36 and 205|Number of Participants With Seroconversion for SARS-CoV-2 nAb in Participants With RA, IBD and RRMS, Day 22, 36 and 205|Geometric Mean Titer (GMT) of SCB-2019 Binding Antibody in Participants With RA, IBD, and RRMS, Day 1, 22, 36 and 205|Geometric Mean Fold Rise (GMFRs) of SCB-2019 Binding Antibody in Participants With RA, IBD, and RRMS, Day 22, 36 and 205|Number of Participants With Seroconversion for SCB-2019 Binding Antibody in Participants With RA, IBD, and RRMS, Day 22, 36 and 205|Geometric Mean Titer (GMT) of SARS-CoV-2 Neutralizing Antibody (nAb) in Participants Who Receive Corticosteroids, Day 1, 22, 36 and 205|Geometric Mean Fold Rise (GMFRs) of SARS-CoV-2 nAb in Participants Who Receive Corticosteroids, Day 22, 36 and 205|Number of Participants With Seroconversion for SARS-CoV-2 nAb in Participants Who Receive Corticosteroids, Day 22, 36 and 205|Geometric Mean Titer (GMT) of SCB-2019 Binding Antibody in Participants Who Receive Corticosteroids, Day 1, 22, 36 and 205|Geometric Mean Fold Rise (GMFRs) of SCB-2019 Binding Antibody in Participants Who Receive Corticosteroids, Day 22, 36 and 205|Number of Participants With Seroconversion for SCB-2019 Binding Antibody in Participants Who Receive Corticosteroids, Day 22, 36 and 205|Geometric Mean Titer (GMT) of SARS-CoV-2 Neutralizing Antibody (nAb) in Participants Who Receive Tumor Necrosis Factor (TNF)-alpha Inhibitors, Day 1, 22, 36 and 205|Geometric Mean Fold Rise (GMFRs) of SARS-CoV-2 nAb in Participants Who Receive TNF-alpha Inhibitors, Day 22, 36 and 205|Number of Participants With Seroconversion for SARS-CoV-2 nAb in Participants who Received TNF-alpha Inhibitors, Day 22, 36 and 205|Geometric Mean Titer (GMT) of SCB-2019 Binding Antibody in Participants Who Receive TNF-alpha Inhibitors, Day 1, 22, 36 and 205|Geometric Mean Fold Rise (GMFRs) of SCB-2019 Binding Antibody in Participants Who Receive TNF-alpha Inhibitors, Day 22, 36 and 205|Number of Participants With Seroconversion for SCB-2019 Binding Antibody in Participants Who Receive TNF-alpha Inhibitors, Day 22, 36 and 205|Geometric Mean Titer (GMT) of SARS-CoV-2 Neutralizing Antibody (nAb) in Participants Who Receive Immunomodulators, Day 1, 22, 36 and 205|Geometric Mean Fold Rise (GMFRs) of SARS-CoV-2 nAb in Participants Who Receive Immunomodulators, Day 22, 36 and 205|Number of Participants With Seroconversion for SARS-CoV-2 nAb in Participants who Receive Immunomodulators, Day 22, 36 and 205|Geometric Mean Titer (GMT) of SCB-2019 Binding Antibody in Participants Who Receive Immunomodulators, Day 1, 22, 36 and 205|Geometric Mean Fold Rise (GMFRs) of SCB-2019 Binding Antibody in Participants Who Receive Immunomodulators, Day 22, 36 and 205|Number of Participants With Seroconversion for SCB-2019 Binding Antibody in Participants Who Receive Immunomodulators, Day 22, 36 and 205|Geometric Mean Titer (GMT) of SARS-CoV-2 Neutralizing Antibody (nAb) in Participants Who Receive Other Treatment Regimens, Day 1, 22, 36 and 205|Geometric Mean Fold Rise (GMFRs) of SARS-CoV-2 nAb in Participants Who Receive Other Treatment Regimens, Day 22, 36 and 205|Number of Participants With Seroconversion for SARS-CoV-2 nAb in Participants Who Receive Other Treatment Regimens, Day 22, 36 and 205|Geometric Mean Titer (GMT) of SCB-2019 Binding Antibody in Participants Who Receive Other Treatment Regimens, Day 1, 22, 36 and 205|Geometric Mean Fold Rise (GMFRs) of SCB-2019 Binding Antibody in Participants Who Receive Other Treatment Regimens, Day 22, 36 and 205|Number of Participants With Seroconversion for SCB-2019 Binding Antibody in Participants Who Receive Other Treatment Regimens, Day 22, 36 and 205|Number of Participants With Local and Systemic Solicited AEs, Day 1 to 7 and Day 22 to 29

Clover Biopharmaceuticals AUS Pty Ltd

ALL

ADULT, OLDER_ADULT

PHASE3

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION

CLO-SCB-2019-005

2021-11-12

2022-03-30

2022-05-04

2021-08-19

2023-03-24

Medical Centre of Edelweiss Medics LLC, Kyiv, 2002, Ukraine|Medical Center of Medbud-Clinic LLC, Kyiv, 3037, Ukraine|Center of Family Medicine Plus, LLC, Kyiv, 4210, Ukraine|Medical Center Salutem LLC, Vinnitsa, 21009, Ukraine

{ "SCB-2019": [ { "intervention_type": "BIOLOGICAL", "description": "CpG 1018/Alum-adjuvanted SCB-2019 vaccine", "name": "SCB-2019", "synonyms": [ "SCB-2019", "" ], "drugbank_id": "DB15805", "generic_names": [ "SCB-2019" ], "wikipedia_url": "https://en.wikipedia.org/wiki/SCB-2019" } ], "Hepatitis A Vaccine": [ { "intervention_type": "BIOLOGICAL", "description": "Havrix", "name": "Hepatitis A Vaccine", "synonyms": [ "Hepatitis A Vaccine", "Hepatitis A vaccine, inactivated", "Havrix", "Biovac A", "Havrix", "Hepatitis A vaccine", "Vaqta", "Biovac A", "Havrix", "Hepatitis A vaccine", "Vaqta", "Biovac A", "Havrix", "Hepatitis A vaccine", "Vaqta" ], "medline_plus_id": "a695003", "generic_names": [ "Hepatitis A Vaccine" ], "drugbank_id": "DB10989" } ], "Placebo; 0.9% saline": [ { "intervention_type": "OTHER" } ] }

NCT01089387

Intracavernous Bone Marrow Stem-cell Injection for Post Prostatectomy Erectile Dysfunction

https://clinicaltrials.gov/study/NCT01089387

INSTIN

COMPLETED

Erectile dysfunction is a frequent adverse event after radical prostatectomy for prostate cancer. It is the consequence of penile vascular damage, mainly arterial insufficiency and venous leakage associated with fibrosis of the corpus cavernous. Apoptosis of penile cells, including mesenchymal cells, smooth muscle cells and endothelial is believed to play an important role in the pathophysiology of post prostatectomy erectile dysfunction. Bone marrow mononucleated cells (BMMNC) contain different cell types that may replace the damaged penile cells after radical prostatectomy. These are mainly: mesenchymal stem cells, endothelial progenitor cells and hematopoietic stem cell. Intracavernous injection of BMMNC may therefore find application in the treatment of post prostatectomy erectile dysfunction. The aims of this phase I-II study is to test the safety of autologous intracavernous BMMNC injection and to evaluate benefit for the patient concerning recovery of natural erection. Patients with penile vascular abnormality (echo-doppler) and localized prostate cancer (considered as cured by radical prostatectomy) will be included in this study. Four different doses of BMMNC will be tested.

NO

Prostate Cancer|Erectile Dysfunction

BIOLOGICAL: injection of bone marrow mononucleated cells

Absence of serious adverse event (general or local), Side effects envisaged: priapism, local inflammation after cell injection, 6 months

Recovery of natural erection, improvement of penile doppler parameters, Evaluation of erectile recovery using validated quesitonnaires (IIEF15, EHS, UCLA-PCI), 6 month

Institut National de la Santé Et de la Recherche Médicale, France

MALE

ADULT, OLDER_ADULT

PHASE1|PHASE2

OTHER_GOV

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT

BT06-07|2008-A01248-47

2010-05

2012-05

2015-03

2010-03-18

2016-11-18

CHU Henri Mondor-Albert Chenevier-Centre Intercommunal de Créteil, Créteil, 94101, France

{ "injection of bone marrow mononucleated cells": [ { "intervention_type": "BIOLOGICAL" } ] }

NCT01435187

Prematurity and Respiratory Outcomes Program (PROP)

https://clinicaltrials.gov/study/NCT01435187

PROP

COMPLETED

In survivors of extreme prematurity to 36 weeks Post Menstrual Age (PMA), specific biologic, physiologic and clinical data obtained during the initial hospitalization will predict respiratory morbidity as defined by respiratory health care utilization and respiratory symptoms, between discharge and 1 year corrected age. This protocol describes a collaboratively developed multicenter study of very preterm infants from birth through the time of discharge from the Neonatal Intensive Care Unit (NICU) and up to 1 year of age, corrected for the degree of prematurity.

NO

Prematurity|Respiratory Disease

Respiratory morbidity, The primary goal of the PROP studies (single center and multicenter protocols) is to identify biomarkers (biochemical, physiological and genetic) and clinical variables that are associated with and thus potentially predictive of pulmonary status in preterm infants up to 1 year corrected age., 1 year (corrected age)

University of Pennsylvania

National Heart, Lung, and Blood Institute (NHLBI)

ALL

CHILD

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

813839|U01HL101794-02

2011-08

2015-04

2016-03

2011-09-16

2016-11-06

Alta Bates Summit Medical Center, Oakland, California, 94609, United States|University of California, San Francisco, San Francisco, California, 94143, United States|Indiana University Health/Riley Hospital for Children, Indianapolis, Indiana, 46202, United States|Washington Universitiy, St Louis, Missouri, 63130, United States|University of Buffalo, Buffalo, New York, 14260, United States|University of Rochester, Rochester, New York, 14642, United States|Duke University Medical Center, Durham, North Carolina, 27710, United States|Cincinnati University Hospital, Cincinnati, Ohio, 45219, United States|Good Samaritan Hospital, Cincinnati, Ohio, 45220, United States|Cincinnati Children s Hospital, Cincinnati, Ohio, 45229, United States|Jackson-Madison County General Hospital, Jackson, Tennessee, 38301, United States|Monroe Carell Jr Children s Hospital at Vanderbilt, Nashville, Tennessee, 37232, United States|University of Texas, Houston, Houston, Texas, 77030, United States

{}

NCT00738387

A Study of ASA404 or Placebo in Combination With Docetaxel in Second-line Treatment for (Stage IIIb/IV) Non-small Cell Lung Cancer

https://clinicaltrials.gov/study/NCT00738387

ATTRACT-2

TERMINATED

The purpose of this study is to determine if adding ASA404 to docetaxel chemotherapy makes the cancer treatment more effective in patients with locally advanced or metastatic non-small cell lung cancer

NO

Non-Small Cell Lung Cancer

DRUG: ASA404|DRUG: Placebo|DRUG: docetaxel

Overall survival, Every 6 weeks from study treatment discontinuation until death or loss to follow-up

Progression free survival, Every 6 weeks from study treatment discontinuation until documented PD, death or loss to follow-up|Overall response rate, Every 42 days (=/- 7 days) from date of randomization until PD|Quality of life, At every odd cycle and at end of treatment|Biomarker assessments, 1 hr post-study drug at cycles 1, 2, 4, 6 and End of Treatment|Pharmacokinetic assessments, 1 hr post-study drug, optional 3-5 hr post-study drug at cycles 1, 2, 3, 4, 5 and 6

Novartis Pharmaceuticals

ALL

ADULT, OLDER_ADULT

PHASE3

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT

CASA404A2302|EUDRACT number: 2008-002309-38

2008-12

2010-12

2008-08-20

2020-12-24

Oncology Specialist, P.c., Huntsville, Alabama, 35805, United States|Arizona Oncology, Tucson, Arizona, 85704, United States|Highlands Oncology Group, Bentonville, Arkansas, 72712, United States|Central Hematology Oncology Medical Group, Alhambra, California, 91801, United States|Comprehensive Blood and Cancer Center, Bakersfield, California, 93309, United States|Compassionate Cancer Care Medical Group, Corona, California, 92879, United States|Compassionate Cancer Care Medical Group, Fountain Valley, California, 92708, United States|St. Jude Heritage Healthcare, Fullerton, California, 92835, United States|Beaver Medical Group, L.P., Highland, California, 92346, United States|Scripps Clinic, La Jolla, California, 92037, United States|University of Southern Californa, Los Angeles, California, 90033-0800, United States|Cedars-Sinai Medical Center, Los Angeles, California, 90048, United States|UCLA, Los Angeles, California, 90095, United States|North Valley Hematology/Oncology Medical Group, Northridge, California, 91325, United States|University of California Irvine Medical Center, Orange, California, 92868, United States|Ventura County Hematology/Oncology Specialists, Oxnard, California, 93030, United States|Palo Alto Medical Foundation - Camino Div., Palo Alto, California, 94301, United States|Bay Area Cancer Research Group, Pleasant Hill, California, 94523, United States|Loma Linda Oncology Medical Group, Inc., Redlands, California, 92374, United States|Compassionate Cancer Care Medical Group, Riverside, California, 92501, United States|California Pacific Medical Research Institute, San Francisco, California, 94115, United States|University of California - SF, San Francisco, California, 94115, United States|Stanford Cancer Center, Stanford, California, 94305, United States|Rocky Mountain Cancer Center, Denver, Colorado, 80218, United States|Georgetown University Hospital, Washington, District of Columbia, 21113, United States|Advanced Medical Specialties, Miami, Florida, 33176, United States|Florida Cancer Institute, New Port Richey, Florida, 34655, United States|Ocala Oncology Center, Ocala, Florida, 34474, United States|Florida Hospital Cancer Institute, Orlando, Florida, 32804, United States|Cancer Centers of Florida, PA, Orlando, Florida, 32806, United States|Hematology/Oncology Associates of Treasure Coast, Port Saint Lucie, Florida, 34952, United States|Suburban Hematology-Oncology, Lawrenceville, Georgia, 30045, United States|Cancer Care Specialists of Central Illinois, Decatur, Illinois, 62526, United States|Comprehensive Cancer Program, Harvey, Illinois, 60426, United States|Cancer Care & Hematology Specialists of Chicagoland, Niles, Illinois, 60714, United States|OSF Center for Cancer Care, Rockford, Illinois, 61108-2472, United States|Loyola Cancer Care and Research Center, Winfield, Illinois, 60190, United States|Central Indiana Cancer Centers, Indianapolis, Indiana, 46219, United States|Horizon Oncology Center, Lafayette, Indiana, 47905, United States|Providence Medical Group, Terre Haute, Indiana, 47802, United States|Siouxland Hematology-Oncology Associates, Sioux City, Iowa, 51101, United States|Kansas City Cancer care, Southwest, Overland Park, Kansas, 66210, United States|University of Kansas Medical Center, Westwood, Kansas, 66205, United States|Cancer Center of Texas, Wichita, Kansas, 67214, United States|James Graham Brown Cancer Center, Louisville, Kentucky, 40202, United States|Western Kentucky Hematology & Oncology, Paducah, Kentucky, 42003, United States|Harry & Jeannette Weinberg Cancer Institute, Baltimore, Maryland, 21237, United States|Missouri Cancer Associates, Columbia, Missouri, 65201, United States|St. John s Mercy Medical Center, Saint Louis, Missouri, 63141, United States|Comprehensive Cancer Centers of Nevada, Henderson, Nevada, 89074, United States|Nevada Cancer Institute, Las Vegas, Nevada, 89135, United States|New Mexico Cancer Center, Albuquerque, New Mexico, 87109, United States|Advanced Oncology Associates, Armonk, New York, 10504, United States|Arena Oncology Associates, P.C., Lake Success, New York, 11042, United States|NY Oncology/Hematology - Latham, Latham, New York, 12110, United States|Winthrop Hematology/Oncology, Mineola, New York, 11501, United States|SUNY Upstate Medical University, Syracuse, New York, 13210, United States|Duke University Medical Center, Durham, North Carolina, 27710, United States|Cancer Center of North Carolina, Raleigh, North Carolina, 27606, United States|MetroHealth Medical Center, Cleveland, Ohio, 44109, United States|Hematology Oncology Consultants, Inc., Columbus, Ohio, 43235, United States|Signal Point Hematology/Oncology, Inc., Middletown, Ohio, 45042, United States|Kaiser Permanante, Northwest Region, Portland, Oregon, 97227, United States|St. Luke s Hospital & Healtth Network, Bethlehem, Pennsylvania, 18015, United States|Temple University Hospital, Philadelphia, Pennsylvania, 19140, United States|Hollings Cancer Center, Charleston, South Carolina, 29425, United States|Sarah Cannon Research Institute, Nashville, Tennessee, 37203, United States|Texas Cancer center - Abilene, Abilene, Texas, 79606, United States|Texas Oncology - Arlington South, Arlington, Texas, 76014-2084, United States|Mamie McFadden Ward Cancer Ctr, Texas Oncology, Beaumont, Texas, 77702-1449, United States|Texas Cancer Center at Medical City, Dallas, Texas, 75230, United States|Texas Oncology at Presbyterian Hospital, Dallas, Texas, 75231, United States|Methodist Charlton Cancer Center, Dallas, Texas, 75237, United States|UT Southwester Med Ctr at Dallas, Dallas, Texas, 75390, United States|Texas Cancer Center - Denton, Denton, Texas, 76210, United States|Longview Cancer Center, Longview, Texas, 75601, United States|Texas Oncology - Allison Cancer Center, Midland, Texas, 79701, United States|Paris Regional Cancer Center, Paris, Texas, 75460, United States|Texas Cancer Center - Sherman, Sherman, Texas, 75090, United States|Tyler Cancer Center, Tyler, Texas, 75702, United States|Blood and Cancer Center of East Texas, Tyler, Texas, 75791, United States|Texas Oncology Cancer Care Center & Research Center, Waco, Texas, 76712, United States|Puget Sound Cancer Centers, Edmonds, Washington, 98026, United States|Fred Hutchinson Cancer Reseach Center, Seattle, Washington, 98109, United States|Puget Sound Cancer Center, Seattle, Washington, 98133, United States|Evergreen Hematology and Oncology, Spokane, Washington, 99218, United States|MultiCare Health System, Tacoma, Washington, 98405, United States|Northwest Cancer Specialists, Vancouver, Washington, 98684, United States|Novartis Investigative Site, Antwerpen, Belgium|Novartis Investigative Site, Arlon, Belgium|Novartis Investigative Site, Bruxelles, Belgium|Novartis Investigative Site, Genk, Belgium|Novartis Investigative Site, Gent, Belgium|Novartis Investigative Site, Leuven, Belgium|Novartis Investigative Site, Liege, Belgium|Novartis Investigative Site, Namur, Belgium|Novartis Investigative Site, Edmonton, Canada|Novartis Investigative Site, Greenfield Park, Canada|Novartis Investigative Site, Laval, Canada|Novartis Investigative Site, Montreal, Canada|Novartis Investigative Site, Toronto, Canada|Novartis Investigative Site, Trois-Rivieres, Canada|Novartis Investigative Site, Vancouver, Canada|Novartis Investigative Site, Weston, Canada|Novartis Investigative Site, Winnepeg, Canada|Novartis Investigative Site, Avignon, France|Novartis Investigative Site, Brest, France|Novartis Investigative Site, Caen Cedex 5, France|Novartis Investigative Site, Caen Cedex 9, France|Novartis Investigative Site, La Chaussée Saint Victor, France|Novartis Investigative Site, Le mans Cedex, France|Novartis Investigative Site, Lille Cedex, France|Novartis Investigative Site, Nimes, France|Novartis Investigative Site, Paris, France|Novartis Investigative Site, Perpignan, France|Novartis Investigative Site, Rennes cedex 5, France|Novartis Investigative Site, Vandoeuvre-les-Nancy, France|Novartis Investigative site, Bamberg, Germany|Novartis Investigative Site, Berlin, Germany|Novartis Investigative Site, Coswig, Germany|Novartis Investigative Site, Eschweiler, Germany|Novartis Investigative Site, Essen, Germany|Novartis Investigative Site, Freiburg, Germany|Novartis Investigative Site, Grosshansdorf, Germany|Novartis Investigative Site, Guestrow, Germany|Novartis Investigative Site, Halle, Germany|Novartis Investigative Site, Hamburg, Germany|Novartis Investigative Site, Hannover, Germany|Novartis Investigative Site, Hemer, Germany|Novartis Investigative Site, Koeln, Germany|Novartis Investigative Site, Leipzig, Germany|Novartis Investigative Site, Magdeburg, Germany|Novartis Investigative Site, Muenchen, Germany|Novartis Investigative Site, Muenster, Germany|Novartis Investigative Site, Oldenburg, Germany|Novartis Investigative Site, Ulm, Germany|Novartis Investigative site, Deszk, Hungary|Novartis Investigative Site, Gyula, Hungary|Novartis Investigative Site, Szekesfehervar, Hungary|Novartis Investigative Site, Torokbalint, Hungary|Novartis Investigative Site, Zalaegerszeg-Pozva, Hungary|Novartis Investigative Site, Ancona, Italy|Novartis Investigative Site, Aviano, Italy|Novartis Investigative Site, Bologna, Italy|Novartis Investigative Site, Cosenza, Italy|Novartis Investigative Site, Cremona, Italy|Novartis Investigative Site, Milano, Italy|Novartis Investigative Site, Mirano, Italy|Novartis Investigative Site, Monza, Italy|Novartis Investigative Site, Napoli, Italy|Novartis Investigative Site, Palermo, Italy|Novartis Investigative Site, Reggio Emilia, Italy|Novartis Investigative Site, Sassari, Italy|Novartis InvestigativeSite, Udine, Italy|Novartis Investigative Site, Bialystok, Poland|Novartis Investigative Site, Lonza, Poland|Novartis Investigative Site, Szczecin, Poland|Novartis Investigative Site, Warszawa, Poland|Novartis Investigative Site, Mataro, Spain|Novartis investigative Site, Sabadell, Spain|Novartis Investigative Site, Santander, Spain|Novartis Investigative Site, Geneve, Switzerland|Novartis Investigative site, St. Gallen, Switzerland

{ "ASA404": [ { "intervention_type": "DRUG" } ], "Placebo": [ { "intervention_type": "DRUG" } ], "Docetaxel": [ { "intervention_type": "DRUG", "description": "docetaxel", "name": "Docetaxel", "synonyms": [ "Docetaxel Hydrate", "N-Debenzoyl-N-(tert-butoxycarbonyl)-10-deacetyltaxol", "Taxotere", "Docefrez", "Taxoltere Metro", "Docetaxol", "RP-56976", "RP56976", "Docetaxel anhydrous", "TXL", "Docetaxel Trihydrate", "N-Debenzoyl-N-(tert-butoxycarbonyl)-10-deacetylpaclitaxel", "Docetaxel", "RP 56976", "N-Debenzoyl-N-tert-butoxycarbonyl-10-deacetyltaxol", "N Debenzoyl N tert butoxycarbonyl 10 deacetyltaxol", "Docetaxel Anhydrous", "NSC 628503" ], "medline_plus_id": "a696031", "generic_names": [ "Docetaxel" ], "mesh_id": "D050257", "drugbank_id": "DB01248" } ] }

NCT02906787

Behavioral Activation for Smoking Cessation and the Prevention of Post-Cessation Weight Gain

https://clinicaltrials.gov/study/NCT02906787

COMPLETED

The purpose of this research study is to better understand (1) why people gain weight when they quit smoking and (2) whether certain types of smoking cessation (i.e. quit smoking) counseling combined with the nicotine patch help people quit smoking and gain less weight.

YES

Smoking Cessation|Weight Loss

BEHAVIORAL: BAS+|BEHAVIORAL: SC

Smoking Cessation, Smoking abstinence (primary outcome) will be assessed and biochemically verified at the End of Treatment Visit (week 8), at 12 and 26 weeks after the target quit date. The primary smoking outcome variable will be 7-day point prevalence abstinence (no smoking, not even a puff, for at least 7 days prior to the assessment) biochemically verified by CO < 5 ppm at End of Treatment (week 8), and by saliva cotinine < 15ng/ml at the 12- and 26-week follow-up., Through Study Completion (End of Treatment Visit, 12-Week Follow-Up Visit, and 26-Week Follow-Up Visit)|Weight Change, Weight will be measured by a physician s scale (pounds) at the beginning of every in-person visit through study completion. Participants will be wearing light clothing without shoes. Pre-cessation weight will be computed as the average of weights at the Intake and Baseline Visits prior to any change in smoking behavior. Weight change from Baseline to the 26-week follow-up will serve as a primary weight outcome variable., Through Study Completion (Intake Visit, Baseline Visit, Pre-Quit Visit , Target Quit Date Visit, Mid-Tx. 1 Visit, Mid-Tx 2 Visit, Mid-Tx 3 Visit, Mid-Tx 4 Visit , End of Treatment, 12-Week Follow-Up Visit, and 26-Week Follow-Up Visit)|Sub-Study: Seven-day Point Prevalence Abstinence (Carbon Monoxide) at 12 Weeks Post Target Quit Date, Smoking abstinence was assessed and biochemically verified at the 12-week Follow-Up Visit (12 weeks post target quit date). Seven-day point prevalence abstinence (no smoking, not even a puff for the last 7 days prior to the assessment) was biochemically verified by a carbon monoxide (CO) reading <8 parts per million., 12-Week Follow-Up Visit

Food Intake, Food intake (secondary outcome) will be assessed via 3 telephone-administered, 24-hour dietary recalls during the week after (or near) the Baseline Visit, Mid-Treatment 3 Visit (week 4), End of Treatment Visit (week 8) and the 12-week and 26-week follow-up Visits (n=15). A trained member of the research staff will use a multi-pass method with an interactive computerized software program, the Automated Self-Administered 24-hour Recall (ASA24®), to determine total kcal/day (outcome variable)., Through Study Completion (Baseline Visit, Mid-Tx 3 Visit, End of Treatment Visit, 12-Week Follow-Up Visit, and 26-Week Follow-Up Visit)|Sub-Study: fMRI BOLD Signal Change, T2*-weighted Blood Oxygen-Level-Dependent (BOLD) images will be acquired using a wholebrain, single-shot gradient-echo (GE) echo-planar imaging (EPI) sequence. BOLD images were captured (and subsequently analyzed) while participants complete a Food Cue-Induced Craving, Relative Reinforcing Value of Food, and Working Memory task inside the MRI Scanner., Pre-Treatment fMRI Scan (~week 2), End of Treatment MRI Scan (~week 8)

Abramson Cancer Center at Penn Medicine

National Cancer Institute (NCI)

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT

825425|R01CA206058

2016-09-13

2021-02-28

2021-02-28

2016-09-20

2023-02-16

2024-05-29

Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States

Study Protocol and Statistical Analysis Plan: Full Study and Sub-Study, https://cdn.clinicaltrials.gov/large-docs/87/NCT02906787/Prot_SAP_000.pdf|Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/87/NCT02906787/ICF_001.pdf

{ "BAS+": [ { "intervention_type": "BEHAVIORAL" } ], "SC": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT05167487

Pathological Response After Neoadjuvant Treatment on NSCLC

https://clinicaltrials.gov/study/NCT05167487

PLANET

RECRUITING

This is a non-interventional, observational, multicenter and retrospective study. Being limited to the collection of patient data already filled in the Tumor Thoracic Registry data base and the data from stage IIIA clinical trials case report forms.

NO

Stage IIIA Non-small Cell Lung Cancer

DRUG: Cisplatin|DRUG: Carboplatin

To assess pathological response after neoadjuvant treatment as a subrogate endpoint for overall survival and disease-free survival in resectable stage IIIA non-small cell lung cancer patients., Pathological response will be assessed as complete pathological response, major pathological response (defined as ≤10% of viable tumor cells) and incomplete pathological response., From the end of neoadjuvant treatment until the last follow up or death, assessed up to 45 months

To describe the percentage of residual viable tumor in this population of patients under common criteria, A) No response or more than 70% of viable tumor: Lymph node major pathological response negative (LN-MPR)- B) ≤70% of viable tumor cells: Lymph node major pathological response positive (LN-MPR)+ C) No evidence of any viable tumor (including primary tumor): Complete pathological response, From the end of neoadjuvant treatment until the last follow up or death,assessed up to 45 months|To describe the histopathological changes within tumor bed associated to tumor response, Types of histopathological changes within tumor bed: fibrosis, lymphoid aggregates and others, From the end of neoadjuvant treatment until the last follow up or death, assessed up to 45 months|To correlate pathological response and post-surgical complications, Pathological response will be assessed as complete pathological response, major pathological response (defined as ≤10% of viable tumor cells) and incomplete pathological response., From the end of neoadjuvant treatment until the last follow up or death, assessed up to 45 months|To describe the relation between nodal downstaging after neoadjuvant treatment and overall survival, Downstaging after surgery is a reduction in the stage of a cancer. Overall Survival defined as the length of time from either the date of diagnosis or the start of the treatment that patients diagnosed with the disease are still alive., From the end of neoadjuvant treatment until the last follow up or death, assessed up to 45 months

Fundación GECP

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

GECP 21/03_PLANET

2021-12-13

2024-03-30

2024-04-01

2021-12-22

2023-06-23

ICO Badalona, Hospital Germans Trias i Pujol, Badalona, Barcelona, 08916, Spain|ICO Hospitalet, Hospitalet de Llobregat, Barcelona, 08908, Spain|Hospital Universitario Insular de Gran canaria, Las Palmas De Gran Canaria, Gran Canaria, 35016, Spain|Hospital Dr. Negrín, Las Palmas de Gran Canaria, Las Palmas, 35010, Spain|Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, 28222, Spain|Complejo Hospitalario Universitario de Vigo, Vigo, Pontevedra, 36036, Spain|Hospital Universitario Cruces, Barakaldo, Vizcaya, 48903, Spain|Hospital Universitario De A Coruna, A Coruña, 15006, Spain|Hospital General Universitario de Alicante, Alicante, 03010, Spain|Hospital Vall d Hebron, Barcelona, 08035, Spain|Hospital de la Santa Creu i Sant Pau, Barcelona, 08041, Spain|Hospital Clínico San Carlos, Madrid, 28040, Spain|Hospital Universitario Fundación Jiménez Díaz, Madrid, 28040, Spain|Hospital 12 De Octubre, Madrid, 28041, Spain|Hospital Universitario la Paz, Madrid, 28046, Spain|Hospital Universitario Regional de Málaga, Málaga, 29010, Spain|Hospital Universitario La Fe, Valencia, 46026, Spain

{ "Cisplatin": [ { "intervention_type": "DRUG", "description": "Cisplatin", "name": "Cisplatin", "synonyms": [ "CDDP", "Platinol", "PLATINUM, DIAMMINEDICHLORO-, (SP-4-2)-", "cis-DDP", "CIS-DIAMMINEDICHLOROPLATINUM", "INT-230-6 COMPONENT CISPLATIN", "CIS-DIAMMINEDICHLOROPLATINUM II", "cis-diamminedichloroplatinum(II)", "(SP-4-2)-DIAMMINEDICHLOROPLATINUM", "Cisplatin", "INT230-6 COMPONENT CISPLATIN", "Cis-DDP", "cis-Platinum II", "cisplatino" ], "medline_plus_id": "a684036", "generic_names": [ "Cisplatin" ], "drugbank_id": "DB00515" } ], "Carboplatin": [ { "intervention_type": "DRUG", "description": "Carboplatin", "name": "Carboplatin", "synonyms": [ "Carboplatino", "Carboplatin", "cis-diammine(1,1-cyclobutanedicarboxylato)platinum", "cis-diammine(1,1-cyclobutanedicarboxylato)platinum(II)", "Paraplatin", "Carboplatine", "cis-(1,1-cyclobutanedicarboxylato)diammineplatinum(II)", "CBDCA" ], "medline_plus_id": "a695017", "generic_names": [ "Carboplatin" ], "drugbank_id": "DB00958" } ] }

NCT01218087

Cranial Cup Use for the Prevention of Positional Head Shape Deformity in the NICU

https://clinicaltrials.gov/study/NCT01218087

TERMINATED

Many hospitalized infants can develop a flattening of the back or sides of their head. This condition develops gradually when an infant s head rests on a firm or semi-firm surface for a prolonged period of time. Premature infants are more likely to have a positional head shape deformity because they may spend longer periods of time in a crib. Infants participating in this study will be randomly assigned to either standard treatment, which is a moldable positioner device, or to a cranial cup device and moldable positioner for positioning. The purpose of this prospective single-blinded randomized clinical trial will be to evaluate the effectiveness of the cranial cup in preventing positional head shape deformity in the NICU patient population.

YES

Plagiocephaly|Scaphocephaly|Brachycephaly

DEVICE: Cranial cup device and Moldable positioner|DEVICE: Moldable positioner device

Cranial Abnormalities Were Measured at Hospital Discharge, Cranial abnormality measurements were obtained at hospital discharge by orthotists blinded to the study group assignment. Cranial abnormalities include both cranial index measures and cranial symmetry measures. Cranial index (normal measurement between 73%-85%) was obtained dividing the head width (M-L) by length (A-P) then multiplying it by 100%. Cranial symmetry (normal measurement of<8mm) was obtained by calculating the difference in the right and left anterior-posterior measures., up to 120 days

Incidence of Cardiorespiratory, daily log of cardiorespiratory events (apnea, bradycardia, oxygen desaturation) collected on a daily positioning log at the infant s bedside, daily up to 120 days

Boston Children s Hospital

Boston Orthotics & Prosthetics

ALL

CHILD

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION

8120584

2010-04

2012-07

2012-07

2010-10-11

2015-08-26

2017-02-03

Children s Hospital Boston, Boston, Massachusetts, 02115, United States

{ "Cranial cup device and Moldable positioner": [ { "intervention_type": "DEVICE" } ], "Moldable positioner device": [ { "intervention_type": "DEVICE" } ] }

NCT05297487

Evaluation of the Early Use of the Pressure Relaxer in the Respiratory Impairment of Patients With Amyotrophic Lateral Sclerosis: Multicenter Randomized Controlled Study.

https://clinicaltrials.gov/study/NCT05297487

RELAX SLA

NOT_YET_RECRUITING

Amyotrophic lateral sclerosis (ALS) is a rare and serious neurodegenerative disease causing degeneration of motor neurons. . It leads to a progressive paralysis of the muscles involved in voluntary motricity. In France, its incidence is 2.5/100,000 inhabitants per year. The death of patients is mainly caused by a progressive attack of the respiratory muscles. Indeed, the thorax is no longer actively mobilized to the maximum amplitude, it will lose its flexibility. A restrictive syndrome sets in followed by alveolar hypoventilation. Bronchial congestion may be concomitant. Management is then based on non-invasive ventilation (NIV). This step, which is difficult for patients to accept psychologically, must be delayed as much as possible. However, to date, there are no precise recommendations on preventing the appearance of this restrictive syndrome and on slowing down the deterioration of lung function in patients. The pressure relaxer (RLX) is an instrumental aid allowing on the one hand to mobilize the thorax thanks to hyper insufflations, and on the other hand to increase the effectiveness of the cough. The use of this device in physiotherapy is part of the HAS recommendations to promote decluttering. However, we believe that RLX in patients with ALS, through the pulmonary alveolar recruitment it induces, could be relevant at an earlier phase, for the prevention of the decline in pulmonary functions: the restrictive syndrome, bronchial congestion and alveolar hypoventilation. So ultimately, the quality of life and survival of these patients would be improved. It is in this context that this multicenter randomized controlled study RELAX SLA takes place in order to evaluate the effects of the early use of the pressure relaxer on the respiratory impairment of patients with ALS.

NO

Amyotrophic Lateral Sclerosis

DEVICE: early use of intermittent positive pressure breathing

assess the early use of the intermittent positive pressure breathing combined with standard management slows down the deterioration of lung volumes in patients with ALS, Comparison of changes in lung volumes between the two groups based on Forced Vital Capacity (FVC), measured by spirometry during a Functional Respiratory Test (LFE), EVERY 3 MONTHS DURING 24 MONTHS

Centre Hospitalier Universitaire de la Réunion

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER

2021/CHU/08

2025-07-01

2028-07-01

2028-07-01

2022-03-28

2023-09-21

{ "early use of intermittent positive pressure breathing": [ { "intervention_type": "DEVICE" } ] }

NCT04390087

Effect of Upper-body Rowing on Cardiometabolic Risk in Spinal Cord Injured Wheelchair Users

https://clinicaltrials.gov/study/NCT04390087

COMPLETED

This randomized controlled trial will determine the effects of 12-weeks of wheelchair user-modified upper-body rowing on both traditional cardiometabolic risk factors in SCI manual wheelchair users.

NO

Spinal Cord Injuries|Exercise Training

OTHER: Exercise

fasting insulin, Serum fasting insulin concentration will be measured from approximately 20 mL blood drawn from a peripheral vein, The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)

Arterial blood pressure, Resting systolic and diastolic BP will be measured with an automated blood pressure monitoring device, The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)|Body mass, Body mass (kg), The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)|Heart rate variability (HRV), HRV will be derived from spectral analysis of the R-R interval obtained from the ECG., The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)|Vascular structure, Intima media thickness (mm), The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)|Fasting blood glucose, Venous blood sampling, The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)|Cardiorespiratory fitness level, Peak oxygen consumption, The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)|Shoulder pain, the Wheelchair Users Shoulder Pain Index (WUSPI)). Consist of 15 items each consisting og a visual analog scales (pain from 0-10, with 10 representing maximum pain)., The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)|Free-living physical activity, Wrist-worn accelerometer, The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)|Health-related quality of life (HRQOL), Short-form 36 (SF-36). 0-100, with 100 representing the best possible health., The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)|body mass index, BMI (kg/m2), The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)|Waist Circumference, Measured in cm, The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)|Conduit artery function, Flow-mediated dilation (percent change from baseline), The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)|Resistance vessel function, Reactive hyperemia (blood flow area under the curve), The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)|Vascular function, Blood flow (ml/min), The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)|Long-term blood glucose, HbA1c (percent), The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)|HDL cholesterol, Concentration (mmol/l), The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)|LDL cholesterol, concentration (mmol/l), The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)|Triglyceride, concentration (mmol/l), The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)|C-reactive protein, mg/l, The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)|Alanin-aminotransferase, U/L, The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)|Interleukin 6, Anti and pro-inflammatory cytokine, The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)|Tumor necrosis factor-alpha, Pro-inflammatory cytokine, The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)|Interleukin-10, Antoinflammatory cytokine, The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)|Interleukin-1 receptor antagonist, Anti-inflammatory cytokine, The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)

Aalborg University

Aage og Johanne Louis-Hansens Fond

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE

N-20190053

2021-01-11

2021-11-25

2021-11-25

2020-05-15

2024-05-31

Aalborg University, Aalborg, 9220, Denmark

{ "Exercise": [ { "intervention_type": "OTHER" } ] }

NCT03182387

Key to Improve DiagNosis in Aspiration Pneumonia

https://clinicaltrials.gov/study/NCT03182387

KIDNAP

COMPLETED

To evaluate the diagnostic performance of amylase assay performed from bronchial alveolar fluid to differentiate aseptic chemical inhalation pneumonitis from an infectious inhalation pneumonitis in comatose patients with intubated ventilation for less than 24 hours.

NO

Infectious Pneumonia|Coma

Sensitivity and specificityof amylase test., Amylase culture in bronchoalveolar fluid is compared to gold standard culture, 5 days after inclusion day

University Hospital, Bordeaux

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

CHUBX 2015/38

2017-08-21

2020-11-19

2020-11-19

2017-06-09

2021-06-07

Hôpital Pellegrin, Bordeaux, 33000, France

{}

NCT02666287

GSK961081 Alone and With Fluticasone Furoate (FF), Phase 1 (Ph1), Single Dose Regimen (SD), Repeat Dose Regimen (RD), Pharmacokinetic (PK) Study in Healthy Volunteer (HV)

https://clinicaltrials.gov/study/NCT02666287

COMPLETED

Batefenterol (BAT) is a novel bifunctional molecule that combines muscarinic antagonism and beta2-agonism in a single molecule and is in development for the treatment of chronic obstructive pulmonary disease (COPD). FF is a corticosteroid approved as the inhaled corticosteroid (ICS) component of a combination product, with vilanterol (VI), a long-acting beta2-agonist for COPD. In the current study FF will be investigated as an inhaled product in combination with BAT, for treatment of COPD. This study is an open-label, six-way crossover, single and repeat dose study to evaluate the systemic pharmacokinetics, safety and tolerability of FF and BAT when administered via the ELLIPTA™ alone, in combination, or concurrently at 3 times the clinical dose, following a single dose, and at the proposed clinical dose, following repeat doses. This study will consist of screening period, 6 treatment periods, and a follow-up visit. Each subject will have 3 periods in which they receive a single dose treatment regimen (3 inhalations on Day 1 of each single dose study period) and 3 periods in which they receive a single dose treatment regimen followed by a 7-day, once-daily, repeated dose. On Day 1 of those periods, subjects will receive their single dose as 3 inhalations. On Days 2-8, subjects will receive 1 inhalation per day for the repeated dose regimen. There will be a minimum of 7-day washout between each treatment periods. All subjects will receive 9 treatments and follow-up procedures will be done 7 14 days after the last dose. Forty eight healthy subjects will be enrolled into the study, such that approximately 40 subjects complete dosing and PK assessments. The total duration of participation for each subject in this study will be up to 15 weeks. ELLIPTA is a registered trademark of the GlaxoSmithKline [GSK] group of companies.

NO

Pulmonary Disease, Chronic Obstructive

DRUG: BAT/FF|DRUG: BAT|DRUG: FF|DRUG: FF (MgSt)|DRUG: FF/Vilanterol

Area under the plasma concentration-time curve (AUC) of FF in plasma on Day 7 of repeat dosing, The following PK parameter will be measured: AUC, Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dosing on Day 7 of each repeat dose regimen|Maximum observed plasma concentration (Cmax) of FF in plasma on Day 7 of repeat dosing, The following PK parameter will be measured: Cmax, Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dosing on Day 7 of each repeat dose regimen

AUC of BAT in plasma on Day 7 of repeat dosing, Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dosing on Day 7 of each repeat dose regimen|Cmax of BAT in plasma on Day 7 of repeat dosing, Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dosing on Day 7 of each repeat dose regimen|AUC of FF in plasma on Day 1 of study period, Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dosing on Day 1 of each treatment period|Cmax of FF in plasma on Day 1 of study period, Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dosing on Day 1 of each treatment period|AUC of BAT in plasma on Day 1 of study period, Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dosing on Day 1 of each treatment period|Cmax of BAT in plasma on Day 1 of study period, Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dosing on Day 1 of each treatment period|Number of participants with adverse events (AEs), An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product., Up to 15 weeks|Safety as assessed by 12-lead Electrocardiogram (ECG), A single 12-lead ECG will be obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and corrected QT (QTc) intervals., Up to 15 weeks|Safety as assessed by systolic and diastolic blood pressure measurements, Three readings of systolic and diastolic pressure will be taken at screening and Day -1. Single measurements will be taken at all other specified timepoints, Up to 15 weeks|Safety as assessed by oral temperature measurements, Oral temperature measurements will be recorded at pre-dose on dosing days, Up to 15 weeks|Safety as assessed by heart rate measurements, Three readings of heart rate will be taken at screening and Day -1. Single measurements will be taken at all other timepoints, Up to 15 weeks|Safety as assessed by respiratory rate measurements, Respiratory rate measurements will be recorded at pre-dose on dosing days, Up to 15 weeks|Composite of Haematology parameters as a measure of safety, The following hematology parameters will be measured: Platelet Count, red blood cell (RBC) count, Hemoglobin, Hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), white blood cell (WBC) count, Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils, Up to 15 weeks|Composite of Clinical Chemistry parameters as a measure of safety, The following clinical chemistry parameters will be measured: Urea, Creatinine, Glucose (fasting), Uric acid, Potassium, Sodium, Calcium, Chloride, Phosphate, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase, Gamma-glutamyl transferase (GGT), Cholesterol, Triglycerides, Total Bilirubin, Total Protein, Albumin, and Globulin., Up to 15 weeks|Composite of Urinalysis parameters as a measure of safety, The following urinalysis parameters will be measured by dip stick test: protein, blood, ketones, glucose, bilirubin, urobilinogen, leukocyte esterase, specific gravity, nitrites, power of hydrogen (pH). If urine dipstick is abnormal for leukocyte esterase, nitrites, blood or protein, microscopic examination will be performed., Up to 15 weeks

GlaxoSmithKline

Hammersmith Medicines Research

ALL

ADULT

PHASE1

INDUSTRY

INTERVENTIONAL

Allocation: NON_RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT

201958

2016-01-27

2016-06-03

2016-06-03

2016-01-28

2017-05-15

GSK Investigational Site, London, NW10 7EW, United Kingdom

{ "BAT/FF": [ { "intervention_type": "DRUG" } ], "BAT": [ { "intervention_type": "DRUG" } ], "FF": [ { "intervention_type": "DRUG" } ], "FF (MgSt)": [ { "intervention_type": "DRUG" } ], "FF/Vilanterol": [ { "intervention_type": "DRUG" } ] }

NCT00453687

A Single Centre Randomized Study Evaluating The Safety And Tolerability Of GSK233705 In Healthy Volunteers.

https://clinicaltrials.gov/study/NCT00453687

COMPLETED

This study will investigate the safety and tolerability of inhaled doses of GSK233705 with a new formulation.

NO

Pulmonary Disease, Chronic Obstructive

DRUG: GSK233705

General safety and tolerability endpoints: adverse events, blood pressure, heart rate, 12-lead electrocardiogram (ECG), Holter and Lead II ECG monitoring, lung function (FEV1, FVC) and clinical laboratory safety tests over 24 hours., over 24 hours.

Plasma and urine concentrations of GSK233705 and derived pharmacokinetic parameters from 0 to 24 hours. Serial Specific airway conductance (sGaw) and Forced Expiratory Volume in 1 second (FEV1) measurements over 24 hours post-dose., over 24 hours

GlaxoSmithKline

MALE

ADULT

PHASE1

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT

AC2108380

2007-03-09

2007-05-16

2007-05-16

2007-03-29

2017-08-07

GSK Investigational Site, Baltimore, Maryland, 21225, United States

{ "GSK233705": [ { "intervention_type": "DRUG" } ] }

NCT05953987

Effects of Aerobic Combined With Diaphragmatic Breathing Exercise in Smokers

https://clinicaltrials.gov/study/NCT05953987

COMPLETED

This study aimed to evaluate the effectiveness of aerobic exercise combined with diaphragmatic breathing exercise on pulmonary function and smoking cessation among smokers.

NO

Smoker Lung|Smoking Cessation

OTHER: aerobic combined with diaphragmatic breathing exercise (EXDB)|OTHER: aerobic exercise (EX)|OTHER: sedentary control (CON)

Pulmonary function, The anticipated value and liters of FVC, FEV1, and MVV maneuver were measured using a computerized spirometer (SpirobankG) in accordance with the pulmonary function test criteria of the American Thoracic Society. Participants were asked to sit on a chair with a nasal clip on. Before demonstrating forced inspiration and expiration and returning to normal breathing, three cycles of slow normal breathing were performed. Participants were instructed to inhale and exhale quickly and strongly for 15 seconds during the MVV maneuver., Change from Baseline pulmonary function at 8 weeks.|Smoking cessation, The Quit Smoking Questionnaire was utilized to evaluate the smoking status of each participant by posing the following question: Did you refrain from smoking continuously for a minimum of 7 days after your designated quit date? If the response was affirmative, the participants were further inquired about their continuous abstinence for either 30 days after the training. Four items within the questionnaire yielded a Cronbach s alpha coefficient of 0.93, Change from Baseline Smoking cessation at 8 weeks, and 12 weeks|Urine cotinine, The Direct Barbituric Acid (DBA) reaction method was utilized to measure urine cotinine. The results were interpreted based on the color change observed in the urine sample. Each morning, a urine sample of 30-50 ml was collected and added to the urinary cotinine measurement kit by participants. The color of the sample was then com-pared to the standard color band for urinary cotinine, and pictures were taken to be sent to the researchers. Assessment was conducted at 30 days after training, and the results were categorized as either found or not found based on the color change observed in the test tabs, Change from Baseline Urine cotinine at 8 weeks, and 12 weeks

Respiratory muscle strength, A portable handheld mouth pressure meter (Micro RPM England) was used to test respiratory muscle strength. For the MIP assessment, participants were told to exhale until they felt no air remaining in their lungs (starting at the functional residual capacity [FRC]). They then inhaled for 1-2 seconds while holding the item in their mouth. For the MEP measurement, participants were told to inhale until their lungs were completely filled with air (beginning with the total lung capacity [TLC] point). They then exhaled strongly while holding the device in their lips for 1-2 seconds., Change from Baseline Respiratory muscle strength at 8 weeks.

Chulalongkorn University

ALL

ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

EX PHYSIO SPSC 7

2022-06-01

2023-02-25

2023-02-25

2023-07-20

2023-07-20

Faculty of Sports Science, Chulalongkorn University, Pathum Wan, Bangkok, 10330, Thailand

{ "aerobic combined with diaphragmatic breathing exercise (EXDB)": [ { "intervention_type": "OTHER" } ], "aerobic exercise (EX)": [ { "intervention_type": "OTHER" } ], "sedentary control (CON)": [ { "intervention_type": "OTHER" } ] }

NCT01310387

Prospective Study of Active Pain Management in Lung Cancer Outpatients (APM)

https://clinicaltrials.gov/study/NCT01310387

APM

COMPLETED

This study is: * A single-center, randomized, prospective controlled trial. * To prove superiority of active pain management group compared to control group by the percent of pain intensity difference of outpatients with lung cancer pain. * 204 patients will be recruited.

NO

Lung Cancer

BEHAVIORAL: Active pain management

The percent of pain intensity difference, The percent of pain intensity difference (%PID) %PID = (NRS of visit 1 - NRS of visit 3)/NRS of visit 1, visit 3 (6 to 8 weeks)

Patients satisfaction score about pain management, Qustionnaire of 5-point scale, visit 3 (6 to 8 weeks)|Eastern Cooperative Oncology Group (ECOG) Performance score, ECOG performance status: 0,1,2,3,4, visit 3 (6 to 8 weeks)|Assessment of Korean Brief Pain Inventory score, Qustionnaire; K-BPI(Korean Brief Pain Inventory), visit 3 (6 to 8 weeks)|Investigator s global assessment score, Qustionnaire of 5-point scale, visit 3 (6 to 8 weeks)

Chonnam National University Hospital

Janssen Korea, Ltd., Korea

ALL

ADULT, OLDER_ADULT

PHASE3

OTHER

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE

PAIN_LCA_2011

2011-01

2012-01

2012-06

2011-03-08

2016-02-05

Chonnam National University Hwasun Hospital, Jeonnam, Korea, Republic of

{ "Active pain management": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT02850887

Patient Positioning and Airway Management During ERCP

https://clinicaltrials.gov/study/NCT02850887

COMPLETED

The aim of this study is to determine the effect of airway management (a set of medical procedures performed to prevent airway blockage and thus ensure an open path between a patient s lungs and the atmosphere) during endoscopic retrograde cholangiopancreatography [(ERCP), a procedure commonly used to treat conditions of the bile ducts and pancreas] and the effect on airway complications (problems), time to biliary cannulation (access into bile duct) and total procedure duration (length of time). Two methods are being compared and studied: 1) general endotracheal anesthesia: an inhalation anesthetic (substance that blocks pain) technique in which anesthetic and respiratory gases pass through a tube placed in the trachea (throat) via the mouth or nose vs 2) deep sedation without endotracheal intubation: local anesthesia together with sedation (drug that produces sleep) and analgesia (drug that treats pain) only.

NO

Airway Management

OTHER: general endotracheal anesthesia|OTHER: deep sedation without endotracheal intubation

Incidence of sedation related adverse events or the need for airway maneuvers, approximately one year

Procedure duration, intraoperative|Time to cannulation of intended duct system, during the procedure|Technical success of ERCP, approximately one year|Immediate ERCP adverse events, Adverse events within 24 hours of ERCP|Delayed adverse events, Adverse events occurring within 7 days

Washington University School of Medicine

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE

201605151

2016-07-25

2017-11-29

2018-01-04

2016-08-01

2018-02-06

Washington University School of Medicine in St Louis, Saint Louis, Missouri, 63010, United States

{ "general endotracheal anesthesia": [ { "intervention_type": "OTHER" } ], "deep sedation without endotracheal intubation": [ { "intervention_type": "OTHER" } ] }

NCT05186987

Visa-versa! Breaking Instead of Pushing the Pedals-A

https://clinicaltrials.gov/study/NCT05186987

COMPLETED

Eccentric muscle work is defined as lengthening of a muscle while applying force. It was shown that with eccentric work, muscles are able to perform four times as much power compared to usual concentric work, which results in huge training gain with a highly decreased oxygen demand and thus lower cardiovascular load. Pulmonary hypertension (PH) is a chronic condition associated with significant reduced exercise capacity and increased morbidity and mortality, resulting in reduced quality of life. Physical training has been shown to be beneficial in PH, even in severely limited patients. However, due to cardiopulmonary constraints in PH, training intensities may be very low, so that many patients are physically almost unable to perform exercise on a high enough level to maintain muscle mass. A low body muscle not only feeds the vicious cycle of decreasing exercise capacity, but also has many deleterious metabolic and immunological consequences which further increase disability and decrease quality of life in PH. Thus, eccentric training, which allows to gain muscle mass with a low stress to the cardiopulmonary unit may to be highly beneficial for patients with PH and allied cardiopulmonary disease, such as chronic obstructive pulmonary disease (COPD) and heart failure. Therefore, the objective of the trial is, to compare differences in oxygen uptake (peak VO2 [l/min]) and other physiological measures during similar cardiopulmonary exercise test protocols of eccentric- vs. concentric cycling in PH- patients and comparators with or without other cardiopulmonary diseases.

NO

Pulmonary Hypertension

PROCEDURE: 15 minutes eccentric cycling|PROCEDURE: 15 minutes concentric (normal) cycling

Oxygen uptake (peak VO2 [l/min]), Difference in oxygen uptake (peak VO2 [l/min]) of eccentric vs. concentric cycling exercise., 1 Day

Respiratory exchange ratio (RER), Volume carbon dioxide devided by the volume of oxygen( VCO2/VO2), 1 day|Breathing equivalent for carbon dioxide, Minute ventilation divided by volume carbon dioxide (VE/VCO2), 1 day|Pulmonary end tidal carbon dioxide (PET CO2), The level of carbon dioxide that is released at the end of an exhaled breath, 1 day|Arterial oxygen saturation (SpO2), Noninvasively measured oxygenation of the hemoglobin by pulse oximetry (Light Sensors), 1 day|Borg Scale for dyspnea, Patient reported level of dyspnea from 0 to 10 while 10 is the worst, 1 day|Borg Scale for leg fatigue, Patient reported level of leg fatigue from 0 to 10 while 10 is the worst, 1 day|Cardiac output, How many liters blood is the heart able to move in one minute. Assessed by echocardiography., 1 day|Pulmonary Artery Pressure, Right ventricle pressure divided by the right atrium pressure gradient (RV/RA pressure gradient) to assess the systolic pulmonary artery pressure by echocardiography, 1 day|Blood pressure, Systolic and diastolic blood pressure assessed by arm cuff measurement, 1 day|Brain tissue oxygenation, Oxygenation of the brain tissue assessed by light sensors on the forehead, 1 day|Muscle tissue oxygenation, Oxygenation of the muscle tissue assessed by light sensors on the quadriceps muscle, 1 day|Arterial blood gases: PH, Arterial blood gases: PH, assessed by arterial blood sample, 1 day|Arterial blood gases: Partialpressure for oxygen (PaO2), Arterial blood gases: Partialpressure for oxygen (PaO2), assessed by arterial blood sample, 1 day|Arterial blood gases: Bicarbonate (HCO3), Arterial blood gases: Bicarbonate (HCO3), assessed by arterial blood sample, 1 day|Arterial blood gases: lactate, Arterial blood gases: lactate, assessed by arterial blood sample, 1 day

University of Zurich

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT

Visa-Versa!-A

2022-02-15

2023-08-31

2023-09-30

2022-01-11

2024-01-30

Respiratory Clinic, University Hospital of Zurich, Zurich, 8091, Switzerland

{ "15 minutes eccentric cycling": [ { "intervention_type": "PROCEDURE" } ], "15 minutes concentric (normal) cycling": [ { "intervention_type": "PROCEDURE" } ] }

NCT02325687

A Pilot Study of Biomarkers in Obstructive Sleep Apnea

https://clinicaltrials.gov/study/NCT02325687

Cytokine OSA

COMPLETED

Obstructive sleep apnea (OSA) is common and is a risk factor for postoperative complications, including respiratory and cardiac events and delirium. Despite this risk, however, there are currently no accepted biomarkers that can predict poor outcomes, making it unclear to see which patients will have complications after surgery, and who might need prolonged monitoring or an extended hospital stay. An improved understanding of the pathophysiology of OSA is required to identify potential biomarkers for outcomes after surgery, as well as to develop new treatments. The aim of this pilot study is to identify serum and cerebrospinal (CSF) biomarkers associated with obstructive sleep apnea (OSA). The presence of cytokines and neurotrophins will be determined and quantified in both patients with OSA and in controls. The CSF samples will additionally be analyzed by proteomic methods to identify potential biomarkers with significantly different levels present in patients with and without OSA. The working hypothesis is that OSA patients who are non-CPAP-compliant will have higher levels of circulating cytokines and lower levels of circulating neurotrophins in serum and CSF, compared to patients who are CPAP-compliant and/or controls.

YES

Obstructive Sleep Apnea

PROCEDURE: Lumbar Puncture (Standard-of-Care)

Serum IL-6 (Interleukin 6) Levels, The primary outcome, the levels of cytokine IL-6 in serum of OSA-treated, OSA-untreated and control patients presenting for knee replacement surgery with planned spinal or combined spinal-epidural anesthesia., Intraoperatively - Pre-Incision

Serum and CSF (Cerebrospinal Fluid) Levels of the Cytokines TNF-alpha (Tumor Necrosis Factor) , IL-6, IL-8, IL-10 (Interleukin), Biological samples were collected, but not analyzed for the presence and levels of particular cytokines (TNF-alpha, IL-6, IL-8, IL-10) and neurotrophins (BDNF(brain-derived neurotrophic factor), β-NGF (nerve growth factor)) due to the integrity of the samples., Intraoperatively - Pre-Incision|Serum and CSF Levels of the Neurotrophins BDNF, IFN-gamma (Interferon Gamma), CSF (cerebrospinal fluid) was planned to be screened for the differential expression of proteins.The samples have been collected, but the assays have not been performed due to the integrity of the samples., Intraoperatively - Pre-Incision|Number of Participants With Respiratory, Cardiac, and/or CNS (Central Nervous System) Complications, We will look at the incidence of respiratory complications (hypoxia; need for respiratory intervention), cardiac complications (MI/ACS or arrhythmias) and CNS (central nervous system) complications (delirium, TIA or CVA). Parameters will be scored for presence or absence over the entire length of stay., Throughout hospital stay, or an average of 1 week.|Incidence of Intraoperative Obstructive Respiratory Events, Incidences of intraoperative obstructive respiratory events will be collected perioperatively in the operating room by the anesthesiologist, Throughout hospital stay, or an average of 1 week.|Levels of Blood Oxygen Saturation, Levels of blood oxygen saturation will be measured via arterial blood gas levels. These will be drawn as standard-of-care., Throughout stay in the recovery unit, or an average of 1-2 days.|Length of Stay in the Recovery Unit, Levels of blood oxygen saturation throughout the length of stay in the recovery unit will be measured via arterial blood gas levels, found in the patient s electronic medical record, Throughout stay in the recovery unit, or an average of 1-2 days.

Hospital for Special Surgery, New York

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC

2014-100

2015-01

2016-11

2016-11

2014-12-25

2020-04-21

2020-04-21

Hospital for Special Surgery, New York, New York, 10021, United States

{ "Lumbar Puncture (Standard-of-Care)": [ { "intervention_type": "PROCEDURE" } ] }

NCT03110887

Monitoring Outcome in Neonatal Thrombocytopenia

https://clinicaltrials.gov/study/NCT03110887

MONET

COMPLETED

Rationale: Approximately 10% of neonates admitted to neonatal intensive care units develop a major hemorrhage. In an attempt to avert this severe complication various preventive measures have been implemented. One of these is the transfusion of platelets to premature neonates with low platelet counts. However, this practice is not supported by scientific evidence. Most neonates with low platelet counts never experience a major bleeding and platelet transfusions may carry risks of volume overload or infection. Therefore, it is important to treat only those patients that truly benefit from this intervention. We urgently need a scientifically based tool to predict which premature neonates are at risk for major bleeding. A few prediction models do exist, but these only allow assessment of bleeding risk at baseline, and do not correct for changes in clinical status during the admission period. We believe that adding this feature to our prediction model will significantly improve our ability to predict bleeding. The prediction model will also be helpful in developing individualized transfusion guidelines as it helps us to predict which neonates would benefit from prophylactic platelet transfusions. Main objective: to develop a dynamic prediction model for bleeding in preterm neonates with low platelet counts. Study design: retrospective observational cohort study. Study population: neonates with a gestational age at birth of < 34 weeks admitted to a neonatal intensive care unit (NICU), with a thrombocyte count of less than 50x109/L will be included. Assessments: only data generated through standard care will be collected. This includes platelet counts, cerebral ultrasounds, information about bleeding and transfusions, and multiple clinical variables. Main study endpoint: major bleeding during admission Statistical analyses: dynamic prediction model using landmarking.

NO

Neonatal Thrombocytopenia|Intraventricular Hemorrhage|Platelet Transfusion

Major hemorrhage, Any type of major bleeding (IVH, pulmonary hemorrhage, gastro-intestinal hemorrhage, etc, according to prespecified definitions), T0 = time of first platelet count <50. End of study = major bleed, death or discharge. Datacollection between 01-01-2010 and 31-12-2014

Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research

Leiden University Medical Center|Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

ALL

CHILD, ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

PPOC 12-012027

2015-11-20

2016-10-21

2016-11-09

2017-04-12

2017-08-15

{}

NCT02862587

Precision Cell Immunotherapy Combined With TACE in Advanced Liver Cancer

https://clinicaltrials.gov/study/NCT02862587

UNKNOWN

Objectives: To evaluate the safety and effectiveness of cell therapy using precision cells to treat Advanced Lung Cancer. Eligibility: Individuals greater than or equal to 18 years of age and less than or equal to 65 years of age who have been diagnosed with Advanced Lung Cancer.

NO

Precision Cells|Chemotherapy|Advanced Lung Cancer

DRUG: Chemotherapy|BIOLOGICAL: precision cells

Overall survival, 2 years|Progress-free survival, 2 years

Quality of life, Questionnaire will be used., 2 years

Shanghai International Medical Center

ALL

ADULT

PHASE1|PHASE2

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT

SIMC-20160104

2016-08

2018-03

2018-08

2016-08-11

2016-09-02

Shanghai International Medical Center, Shanghai, Shanghai, 201318, China

{ "Chemotherapy": [ { "intervention_type": "DRUG" } ], "precision cells": [ { "intervention_type": "BIOLOGICAL" } ] }

NCT01892787

Effects of Particle Size in Small Airways Dysfunction

https://clinicaltrials.gov/study/NCT01892787

MAN03

COMPLETED

The airways in the lungs get smaller the further into the lungs they go. Most simple measurements of lung function only reflect the larger central airways and do not provide information on the smaller peripheral airways. Newer measurements have been developed that can now give us accurate information on how the smaller airways are working. Indeed the small airways seem to play a significant role in asthma in terms of inflammation and airway narrowing. Recently, new types of inhaler formulations have been developed that have a much smaller particle size than other standard formulations. These formulations have been shown to go further into the lungs, thus getting into the smaller airways. In this study we aim to compare the two extremes of available long acting beta agonists in terms of particle size i.e. extra fine formoterol (Atimos) versus coarse particle salmeterol (Serevent)in asthmatics with abnormal small airway function using a breathing test called impulse oscillometry. By using this test we will be able to find out whether using an extrafine particle inhaler improves small airway function.

NO

Asthma

DRUG: Formoterol|DRUG: Salmeterol

Change in R5-R20 as change from baseline after first and last dose, R5 - Resistance at 5Hz, R20 - Resistance at 20Hz, At baseline & after 1-2 weeks

Change in remaining impulse oscillometry variables (R5,R20,X5,AX,RF) after first and last dose, R5 - Resistance at 5Hz, R20 - Resistance at 20Hz, X5 - Reactance at 5Hz, RF - Frequency of resonance, AX - Area under reactance curve, Baseline and after 1-2 weeks|Area under the curve from 0 to 60 min, Baseline and 1-2 weeks|Spirometry, Forced expiratory volume in 1 second (FEV1); forced vital capacity (FVC); forced expriatory flow between 25-75% of vital capacity., Baseline & 1-2 weeks|Domiciliary peak expiratory flow, 1-2 weeks|Asthma Control Questionnaire, 1-2 weeks|Exhaled nitirc oxide, 2 weeks

University of Dundee

Chiesi Farmaceutici S.p.A.

ALL

CHILD, ADULT, OLDER_ADULT

PHASE4

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT

2013RC01|2013-001103-36|13/ES/0050

2013-07

2014-12

2014-12

2013-07-04

2019-04-12

Brian Lipworth, Dundee, DD1 3AU, United Kingdom

{ "Formoterol": [ { "intervention_type": "DRUG", "description": "Formoterol", "name": "Formoterol", "synonyms": [ "Formoterol", "Foradil", "N-[2-hydroxy-5-(1-hydroxy-2-{[2-(4-methoxyphenyl)-1-methylethyl]amino}ethyl)phenyl]formamide", "Oxeze", "Formoterolum", "2'-hydroxy-5'-(1-hydroxy-2-((p-methoxy-\u03b1-methylphenethyl)amino)ethyl)formanilide", "2'-hydroxy-5'-{1-hydroxy-2-[(p-methoxy-\u03b1-methylphenethyl)amino]ethyl}formanilide" ], "medline_plus_id": "a602023", "generic_names": [ "Formoterol" ], "drugbank_id": "DB00983", "wikipedia_url": "https://en.wikipedia.org/wiki/Formoterol" } ], "Salmeterol": [ { "intervention_type": "DRUG", "description": "Salmeterol", "name": "Salmeterol", "synonyms": [ "Salmeterolum", "Serevent", "Aeromax", "Salmaterol", "Salmeterol" ], "medline_plus_id": "a695001", "generic_names": [ "Salmeterol" ], "drugbank_id": "DB00938", "wikipedia_url": "https://en.wikipedia.org/wiki/Salmeterol" } ] }

NCT00185887

Nitroglycerin Versus Terbutaline for Intrapartum Fetal Resuscitation

https://clinicaltrials.gov/study/NCT00185887

COMPLETED

To compare nitroglycerin and terbutaline for intrapartum fetal heart rate resuscitation

NO

Fetal Distress

DRUG: Terbutaline

resolution of abnormal fetal heart tracing, Administration of study medication to resolution of abnormal fetal heart tracing or operative delivery.

cesarean section rate, Data analysis|operative vaginal delivery rate, Data analysis|neonatal outcomes, time of delivery to time of discharge

Stanford University

FEMALE

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

79504

2003-10

2006-07

2007-10

2005-09-16

2011-03-08

Stanford University School of Medicine, Stanford, California, 94305, United States

{ "Terbutaline": [ { "intervention_type": "DRUG", "description": "Terbutaline", "name": "Terbutaline", "synonyms": [ "terbutalin von ct", "Terbutalin ratiopharm", "Asthmoprotect", "KWD2019", "Terbutalin-ratiopharm", "KWD-2019", "Terbuturmant", "Terbutalinum", "Bricanyl SA", "Terbutalin Stada", "Arubendol", "Brethine", "Butaliret", "KWD 2019", "Butalitab", "Bricanyl", "Terbutaline", "Terbutalin", "Tedipulmo", "Monovent", "Contimit", "Brethaire", "Taziken", "Terbutalin AL", "Terbul", "Terbasmin", "Terbutalina", "Terbutaline Sulfate" ], "medline_plus_id": "a611026", "generic_names": [ "Terbutaline" ], "mesh_id": "D058666", "drugbank_id": "DB00871" } ] }

NCT05935787

Cytoflavin in the Complex Rehabilitation of Stroke Patients

https://clinicaltrials.gov/study/NCT05935787

RECRUITING

It is known that the acute period of stroke occurs is accompanied by oxidative stress, when intense generation of reactive oxygen species (ROS) have a toxic effect, which causes oxidative degradation of proteins, lipids, nucleic acids. Antioxidants may have a positive effect on the processes of reparation, remodeling and neuroplasticity, thus improving the effectiveness of post-stroke rehabilitation. The adjunctive use of drug therapy that improves neuroplasticity may promote accelerated motor learning, which underlies the effects of exercise therapy and physical therapy, speech therapy, and sessions with a psychologist or occupational therapist. CYTOFLAVIN® is a combination of succinic acid, riboflavin, nicotinamide and inosine (riboxin) which has antihypoxic and antioxidant effects. The study hypothetizes that this neurometabolic drug will facilitate learning in stroke survivors and help to acquire new cognitive or motor skills necessary for daily living. The study will be conducted in two parallel groups of stroke survivors: the experimental group will be treated with Cytoflavin along with ohysical rehabilitation, the control group will receive standard rehabilitation course.

NO

Stroke

DRUG: Cytoflavin (Inosine + Nicotinamide + Riboflavin + Succinic Acid)|DRUG: Placebo

Change of performance, Change at the performance subscale (range 0-10, higher=better) of Canadian Occupational Performance Measure (COPM) score after completion of therapy compared to baseline, 40 days

POLYSAN Scientific & Technological Pharmaceutical Company

ALL

ADULT, OLDER_ADULT

PHASE3

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT

CTF-III-SR-2022

2023-03-23

2024-09-01

2024-12-01

2023-07-07

2023-07-11

City General Hospital №2, Saint Petersburg, Russian Federation|City Hospital №40 of the Kurortny District, Saint Petersburg, Russian Federation|Saint-Petersburg I.I.Dzanelidze Research Institute of Emergency Medicine, Saint Petersburg, Russian Federation

{ "Cytoflavin (Inosine + Nicotinamide + Riboflavin + Succinic Acid)": [ { "intervention_type": "DRUG" } ], "Placebo": [ { "intervention_type": "DRUG" } ] }

NCT00023387

TBTC Study 25PK: Intensive Pharmacokinetic Study of Three Doses of Rifapentine and 25-Desacetyl Rifapentine

https://clinicaltrials.gov/study/NCT00023387

COMPLETED

Primary objective: To compare the pharmacokinetics of rifapentine and 25-desacetyl rifapentine at three different doses: 600 mg, 900 mg, and 1200 mg. Secondary objective: To describe any correlation between pharmacokinetic parameters of three different doses of rifapentine plus a standard dose of isoniazid and the occurrence of toxicity attributed to anti-tuberculosis treatment.

NO

Tuberculosis

DRUG: Rifapentine|DRUG: 25-desacetyl Rifapentine|DRUG: Isoniazid

Compare the pharmacokinetics of rifapentine and 25-desacetyl rifapentine at three difference doses: 600 mg, 900 mg, and 1200 mg

Describe any correlation between pharmacokinetic parameters of three different doses of rifapentine plus a standard dose of isoniazid and the occurrence of toxicity attributed to anti-tuberculosis treatment.

Centers for Disease Control and Prevention

US Department of Veterans Affairs

ALL

ADULT, OLDER_ADULT

FED

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT

CDC-NCHSTP-2558|TBTC Study 25PK

2000-03

2001-05

2001-09-10

2005-09-13

Central Arkansas Veterans Health System, Little Rock, Arkansas, 72205, United States|LA County/USC Medical Center, Los Angeles, California, 90033, United States|University of California, San Francisco, San Francisco, California, 94110, United States|Denver Department of Public Health and Hospitals, Denver, Colorado, 80204, United States|Washington, D.C. VAMC, Washington, District of Columbia, 20422, United States|Chicago VA Medical Center (Lakeside), Chicago, Illinois, 60611, United States|Hines VA Medical Center, Hines, Illinois, 60141, United States|Johns Hopkins University School of Medicine, Baltimore, Maryland, 21287-0003, United States|Boston Medical Center, Boston, Massachusetts, 02118, United States|New Jersey Medical School, Newark, New Jersey, 07107-3001, United States|New York University School of Medicine, New York, New York, 10016, United States|Columbia University/Presbyterian Medical Center, New York, New York, 10032, United States|Harlem Hospital Center, New York, New York, 10037, United States|Carolinas Medical Center, Charlotte, North Carolina, 28203, United States|Duke University Medical Center, Durham, North Carolina, 34222, United States|Nashville VA Medical Center, Nashville, Tennessee, 37212-2637, United States|University of North Texas Health Science Center, Fort Worth, Texas, 76107-2699, United States|Thomas Street Clinic, Houston, Texas, 77009, United States|Audi L. Murphy VA Hospital, San Antonio, Texas, 78284, United States|Seattle King County Health Department, Seattle, Washington, 98104, United States|University of British Columbia, Vancouver, British Columbia, Canada V5Z 4R4, Canada|University of Manitoba, Winnipeg, Manitoba, CANADA R3A 1R8, Canada|Montreal Chest Institute McGill University, Montreal, Quebec, H2X 2P4Pq Canada, Canada

{ "Rifapentine": [ { "intervention_type": "DRUG", "description": "Rifapentine", "name": "Rifapentine", "synonyms": [ "Priftin", "3-(((4-Cyclopentyl-1-piperazinyl)imino)methyl)rifamycin", "Cyclopentylrifampicin", "Rifapentin", "Rifapentine" ], "medline_plus_id": "a616011", "generic_names": [ "Rifapentine" ], "drugbank_id": "DB01201", "wikipedia_url": "https://en.wikipedia.org/wiki/Rifapentine" } ], "25-desacetylrifapentine": [ { "intervention_type": "DRUG", "description": "25-desacetyl Rifapentine", "name": "25-desacetylrifapentine", "synonyms": [ "25-desacetylrifapentine", "25-DESACETYL RIFAPENTINE" ], "drugbank_id": "DB15213", "generic_names": [ "25-desacetylrifapentine" ] } ], "Isoniazid": [ { "intervention_type": "DRUG", "description": "Isoniazid", "name": "Isoniazid", "synonyms": [ "Rimifon", "Isonicotins\u00e4urehydrazid", "Hyzyd", "Tubizid", "Isoniazid", "Isonicotinic acid hydrazide", "Laniazid", "Isonicotinylhydrazine", "Isonicotinic hydrazide", "Isonicotinohydrazide", "INH", "Isoniazida", "4-pyridinecarbohydrazide", "Pyridine-4-carboxylic acid hydrazide", "Isonicotinoylhydrazide" ], "medline_plus_id": "a682401", "generic_names": [ "Isoniazid" ], "drugbank_id": "DB00951" } ] }

NCT04525287

Prediction Models for Diagnosis and Prognosis of Severe COVID-19

https://clinicaltrials.gov/study/NCT04525287

COMPLETED

Clinical observation has found that COVID-19 patients often present inconsistency of clinical features, nucleic acid of the SARS-CoV-2 and imaging findings, which brings challenges to the management of patients.The quantitative assessment of patients pulmonary lesions of chest CT, combined with the basic information, epidemiological history, clinical symptoms, basic diseases and other information of patients, will quickly establish a reliable prediction model for the severe COVID-19. This model will greatly contribute to the effective diagnosis and treatment of COVID-19.

NO

Coronavirus Infection|COVID19

Chest CT and clinical features, chest CT imaging data of the patient, basic patient information, epidemiological history, clinical symptoms, and underlying diseases, 2020-1-1 to 2020-6-1

Second Affiliated Hospital, School of Medicine, Zhejiang University

ALL

CHILD, ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

2020-12020001231

2020-02-20

2020-08-20

2020-08-20

2020-08-25

2021-08-06

Department of radiology, The Second People s Hospital, Fuyang, Anhui, China, Fuyang, Zhejiang, China|2nd Affiliated Hospital, School of Medicine, Zhejiang University, China, Hangzhou, Zhejiang, 310009, China|Department of Radiology, The First Hospital of Jiaxing, Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang, China, Jiaxing, Zhejiang, China|Department of Radiology, Taizhou Hospital of Zhejiang Province, Taizhou, Zhejiang, China, Taizhou, Zhejiang, China|Department of Radiology, Ruian People s Hospital, The Third Affiliated Hospital of Wenzhou Medical University, Ruian, Zhejiang, China, Wenzhou, Zhejiang, China|Department of Radiology, Yueqing People s Hospital, Yueqing, Wenzhou, Zhejiang, China, Wenzhou, Zhejiang, China

{}

NCT00382187

Safety and Immunogenicity of Two Adjuvanted and One Non-adjuvanted H5N1 Influenza Vaccine in Adults

https://clinicaltrials.gov/study/NCT00382187

COMPLETED

The present study aims to evaluate safety and immunogenicity of two doses, administered three weeks apart, and a 6 month booster dose, of two influenza vaccines containing 7.5 micrograms or 15 micrograms of H5N1 influenza antigen, and of a non-adjuvanted influenza vaccine containing 15 micrograms of H5N1 influenza antigen, in adults

NO

Influenza

BIOLOGICAL: MF59 adjuvanted H5N1 influenza vaccine

CPMP criteria for evaluation of flu vaccines e.g. Seroprotection, GMT s and Seroconversion rate at day 0 and day 22 and day 43 following vaccination., day 1 to day 43

Solicited Local and Systemic Reactions Within 6 Days Following Each Vaccination And Adverse Events Throughout the Study., Day 1 to Day 382

Novartis Vaccines

ALL

ADULT

PHASE2

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: PREVENTION

V87P2|Eudract number 2006-004063-66

2006-11

2008-01

2008-01

2006-09-28

2016-12-01

Presidio Distrettuale N. 8, Azienda USL 7 di Siena, Via Savina Petrilli, 3, Siena, 53100, Italy

{ "Influenza vaccine": [ { "intervention_type": "BIOLOGICAL", "description": "MF59 adjuvanted H5N1 influenza vaccine", "name": "Influenza vaccine", "synonyms": [ "Afluria", "Influenza vaccine", "Fluarix", "Fluzone", "Afluria", "Influenza Vaccine, Inactivated or Recombinant", "Flucelvax", "Fluarix", "Fluzone", "Flu Vaccine", "Afluria", "Influenza Vaccine, Inactivated or Recombinant", "Flucelvax", "Fluarix", "Fluzone", "Flu Vaccine", "Afluria", "Influenza Vaccine, Inactivated or Recombinant", "Flucelvax", "Fluarix", "Fluzone", "Flu Vaccine", "Afluria", "Influenza Vaccine, Inactivated or Recombinant", "Flucelvax", "Fluarix", "Fluzone", "Flu Vaccine", "Afluria", "Influenza Vaccine, Inactivated or Recombinant", "Flucelvax", "Fluarix", "Fluzone", "Flu Vaccine", "Afluria", "Influenza Vaccine, Inactivated or Recombinant", "Flucelvax", "Fluarix", "Fluzone", "Flu Vaccine" ], "wikipedia_url": "https://en.wikipedia.org/wiki/Influenza%20vaccine", "generic_names": [ "Influenza Vaccine, Inactivated or Recombinant", "Influenza Vaccine, Inactivated or Recombinant", "Influenza Vaccine, Inactivated or Recombinant", "Influenza Vaccine, Inactivated or Recombinant", "Influenza Vaccine, Inactivated or Recombinant", "Influenza Vaccine, Inactivated or Recombinant" ] } ] }

NCT00265187

The Prevalence and Clinical Manifestations of Human Metapneumovirus Among Children With Bronchiolitis.

https://clinicaltrials.gov/study/NCT00265187

COMPLETED

Sputum specimens will be obtained from children < 2 years of age and processed by different mode for the HMPV, RSV, Pertussis, Influenza A, B, Parainfluenza 1,2,3, Adenovirus. Clinical and epidemiological data will also be obtained.

NO

Respiratory Tract Infection|Children

HaEmek Medical Center, Israel

ALL

CHILD

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

3350105

2005-12

2006-03

2006-03

2005-12-14

2013-01-03

Pediatric department A, HaEmek Medical Center, Afula, Israel|Maier Hospital, Haifa, Israel|Pediatric Depart ment , Bnai Zion Hospital, Haifa, Israel

{}

NCT01701687

Biomarkers for the Prognosis of Decompensated Alcoholic Liver Disease

https://clinicaltrials.gov/study/NCT01701687

BANDED

COMPLETED

Fibroscan is a non invasive imaging investigation which measures liver stiffness, known to correlate well with liver scarring and cirrhosis on liver biopsy. Indocyanine green is an inert dye which is purely extracted from the blood by liver cells, and is hence an excellent marker of both liver cell function and overall liver blood flow. There is little data for either of these biomarkers regarding outcomes in alcoholic liver disease. We aim to establish the accuracy of these liver biomarkers in predicting important liver related outcomes (death, transplantation and hospital readmission with cirrhosis related consequences) in patients with severe (decompensated) alcoholic liver disease. Moreover, we will assess whether the serial measurement of biomarkers has any impact on alcohol abstinence, motivation or quality of life. Over an 18 month period, 125 consecutive hospital inpatients with decompensated alcoholic liver disease will undergo baseline biomarker measurement, routine blood and urine tests and qualitative questionnaires. These will be measured during their initial hospital admission (0 months) with subsequent repeat measurement during follow up visits at 1, 2, 4 and 6 months. Each study visit time will be in the region of 30-40 minutes to complete these investigations. The end of the study for individual patients will be patient death, liver transplantation or 6 month from study enrolment; whichever occurs first.

NO

Alcoholic Liver Diseases|Decompensated Cirrhosis

Liver Related Death, The proportion of deaths up to 6 months from the baseline visit directly attributable to consequences of cirrhosis, 6 months

Non-Liver related death, Mortality unrelated to liver disease up to 6 months from baseline study visit, 6 months|Hospital Readmission, Hospital readmission secondary to complications of cirrhosis, 6 months|Alcohol abstinence, Proportion of patients abstinent from alcohol at the 6 month timepoint, 6 months

University of Nottingham

National Institute for Health Research, United Kingdom

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

12050

2012-09

2015-07

2015-07

2012-10-05

2015-08-03

Nottingham University Hospitals NHS Trust, Nottingham, Notts, NG7 2UH, United Kingdom

{}

NCT02317887

Study of RS1 Ocular Gene Transfer for X-linked Retinoschisis

https://clinicaltrials.gov/study/NCT02317887

ACTIVE_NOT_RECRUITING

Background: - X-linked juvenile retinoschisis (XLRS) is caused by changes in the RS1 gene. These changes cause abnormal function of the eye protein retinoschisin. Without normal retinoschisin, the layers of the retina split and vision is lost. Researchers want to try to introduce a healthy RS1 gene into eye cells, to see if this helps retinal cells make healthy retinoschisin. They will put the gene in a virus. The gene and virus package is known as a gene transfer vector (AAV-RS1 vector). Objectives: - To see if the AAV-RS1 vector is safe to use in people. Eligibility: - Adults 18 and older with a mutation of the RS1 gene, 20/63 vision or worse in one eye, and XLRS. Design: * Participants will be screened with genetic tests to confirm XLRS. They will have a medical history and physical and eye exams. * At visits 1-2, participants will have some or all of the following: * Medical history * Physical exam * Blood and urine tests * Tuberculosis skin test * Eye exam * Vision tests (for one test an intravenous line will be placed in the arm. A dye will be injected that will travel to the blood vessels in the eye). * At visit 3, the AAV-RS1 vector will be injected with a needle in the study eye. Participants pupils will be dilated. They will get numbing eye drops. * Visits 4-13 will occur in the 18 months after gene transfer. Many of the above tests will be repeated. Participants will discuss any side effects. * Visits 14-17 will occur yearly between years 2 and 5. * After year 5, participants will be contacted yearly by phone for up to 15 years.

NO

Retinoschisis|X-Linked

BIOLOGICAL: RS1 AAV Vector

Retinal function, maintenance of retinal function, Day 1, Day 7, Day 14, Month 1, Month 2, Month 3, Month 4, Month 6, Month 9, Month12, Month 18, Year 2, Year 3, Year 4, Year 5|Ocular Structure, maintenance of ocular structure, Day 1, Day 7, Day 14, Month 1, Month 2, Month 3, Month 4, Month 6, Month 9, Month12, Month 18, Year 2, Year 3, Year 4, Year 5|Occurrence of AEs, number and severity of adverse events that differ clinically from the normal progression of XLRS, Day 1, Day 7, Day 14, Month 1, Month 2, Month 3, Month 4, Month 6, Month 9, Month12, Month 18, Year 2, Year 3, Year 4, Year 5

ERG, Change in ERG combined response amplitudes from average of baseline 1 and 2, Months 1, 3, 6, 12, 18, and annually at years 2-5|OCT imaging, Change in retinal structure compared to average of baseline 1 and 2, Months 1, 2, 3, 4, 6, 9, 18 and annually at years 2-5|Anti-AAV antibodies, formation of circulating systemic anti-AAV or anti-RS1 antibodies, Day 7, Day 14, Months 1, 2, 3, 6, 9, 12, 18 and annually at years 2-5|Visual function, Mean median and distribution of change in BCVA compared to average of baseline 1 and 2, Days 1, 7, 14, Months 1, 2, 3, 4, 6, 9, 12, 18 and annually at years 2-5

VegaVect, Inc.

National Eye Institute (NEI)

MALE

ADULT, OLDER_ADULT

PHASE1|PHASE2

INDUSTRY

INTERVENTIONAL

Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT

15EI0038|15-EI-0038

2015-02-11

2025-07-31

2025-07-31

2014-12-17

2024-04-26

National Institutes of Health Clinical Center, Bethesda, Maryland, 20892, United States

{ "RS1 AAV Vector": [ { "intervention_type": "BIOLOGICAL" } ] }

NCT04302987

Vitamin D Intervention in Infants - 6 Years Follow-up (VIDI2)

https://clinicaltrials.gov/study/NCT04302987

VIDI2

COMPLETED

Exposure to vitamin D intervention in early life may have permanent effects on physiology and metabolism. Bone growth and mineralization, development of immunity, body composition and brain structure and functioning may be affected. The importance of a long-term surveillance includes follow-up of both beneficial but also harmful effects of vitamin D. Vitamin D intervention in infants (VIDI) study was conducted in 2013-2016. VIDI study was a large randomized trial that aimed to evaluate effects of two vitamin D supplemental doses of daily 10 ug and 30 ug from the age 2 weeks until 2 years on bone strength, infections, immunity, allergy, atopy and asthma, neurologic and cognitive development, and genetic regulation of mineral homeostasis. Current study is a 6 Years Follow-up (VIDI2) study of the original VIDI trial. Our focuses of interest in the follow-up are: bone strength, growth pattern, body composition, and morbidity due to infections and allergic diseases, and the development of immunity. Further, in addition to more classical associates of vitamin D, our aim is to continue to follow-up children s neurocognitive development and mental health. We will also focus on the effect of vitamin D supplementation on occurrence of molar-incisor hypomineralization, dental caries, and oral immunity.

NO

Bone Strength|Growth|Body Composition|Infection|Allergic Diseases|Dental Health

Areal bone mineral quantity, Bone mineral quantity in milligrams per millimeter is measured by peripheral quantitative computed tomography (pQCT)., 6.5 years|Volumetric bone mineral density, Bone mineral density in milligrams per cubic centimeter is measured by pQCT., 6.5 years|Cross-sectional area of the bone, Cross-sectional area of the bone in square millimeters is measured by pQCT., 6.5 years|Bone mineral quantity, Bone mineral quantity in grams is measured by dual-energy X-ray absorptiometry (DXA)., 6.5 years|Bone mineral density, Bone mineral density in grams per centimeter squared is measured by DXA., 6.5 years|Serum intact parathyroid hormone, Serum intact parathyroid hormone concentration is measured from blood samples with the blood gas analyzer ABL 90 FLEX or ABL 835 FLEX., 6.5 years|Plasma ionized calcium, Plasma ionized calcium concentration is measured from blood samples with the blood gas analyzer ABL 90 FLEX or ABL 835 FLEX., 6.5 years|Plasma alkaline phosphatase, Plasma alkaline phosphatase concentration is measured from blood samples with photometric methods., 6.5 years|Serum C-telopeptide of type I collagen, Serum C-telopeptide of type I collagen is measured with competitive polyclonal antibody assay., 6.5 years|Plasma fibroblast growth factor 23, Plasma intact and C-terminal fibroblast growth factor 23 is determined with enzyme-linked immunosorbent assay., 6.5 years|Morbidity due to infectious diseases, Morbidity due to infectious diseases in frequencies and type are to be collected via questionnaires filled in by parents., 6.5 years|Morbidity due to allergic diseases, Morbidity due to allergic diseases and symptoms are to be collected via questionnaires filled in by parents., 6.5 years|Weight, Weight in kilograms is measured with a Seca 285 digital measuring station., 6.5 years|Height, .Height in centimeters is measured with a Seca 285 digital measuring station, 6.5 years|Fat mass, Fat mass in kilograms based on ohms is measured by InBody bioelectrical impedance analysis., 6.5 years|Fat-free mass, Fat-free mass in kilograms based on ohms is measured with InBody., 6.5 years

High sensitivity C-reactive protein, High sensitivity C-reactive protein is measured with enzyme immunoassay., 6.5 years|Plasma matrix metalloproteinase 8, Plasma matrix metalloproteinase 8 is analysed with time-resolved immunofluorometric assay., 6.5 years|Gene variants, Gene variants associated with vitamin D metabolism and primary outcomes are performed using Sanger-sequencing, Taqman and genome-wide SNP-arrays., 6.5 years|Epigenetic changes, Epigenetic changes associated with vitamin D metabolism and primary outcomes are performed using methylation assays., 6.5 years|Cognitive abilities, Cognitive abilities are measured with Wechsler Intelligence Scale for Children-IV. Scales are scored according to the manual and standardized total scores vary between 10 and 159. Higher scores present better performance., 6.5 years|Executive functioning, Executive functions are measured with performance based test called NEPSY-II. Scales are scored according to the manual. Higher scores represent better performance., 6.5 years|Psychiatric disorders and symptoms, Psychiatric disorders and symptoms are measured with parent-rated questionnaire: the Child behavioral checklist. Scales are scored according to the manual. Maximum and minimum values very between subscales scales. Higher scores represent worse outcomes, i.e. more psychiatric symptoms., 6.5 years|Attention deficient and hyperactivity symptoms, Attention deficient and hyperactivity symptoms are measured with parent rated ADHD Rating Scale IV -questionnaire. Scales are scored according to the published guidelines and higher scores reflect more problems., 6.5 years|Autism spectrum disorders and symptoms, Parent-rated Autism Spectrum Screening Questionnaire is used to measure Autism spectrum disorders and symptoms. Scales are scored according to the published guidelines and higher scores reflect more problems., 6.5 years|Sleep, Sleep is measured using a parent rated Sleep Disturbance Scale for Children. Questionnaire is scored according to publishers guidelines and the minimum and maximum scores vary. Higher scores in disturbance scales present worse outcome whereas a longer time at sleep represents a better outcome., 6.5 years|Temperament, Temperament is measured using parent rated questionnaire The Children s Behavior Questionnaire . Questionnaire is scored according to manual and the minimum and maximum scores vary by temperament dimension. Higher scores do not as such mean better or worse outcome., 6.5 years|Prevalence of molar-incisor hypomineralization, Clinical evaluation by dentist of tooth enamel opacities, posteruptive enamel breakdown, atypical restorations, and/or extractions of molars according to the European Academy of Paediatric Dentistry criteria, 6.5 years|Prevalence of caries, Clinical evaluation by dentist as decayed or filled tooth surfaces., 6.5 years|Salivary matrix metalloproteinase 8 level, Salivary matrix metalloproteinase 8 is analysed with salivary sample test., 6.5 years|SARS-CoV-2 virus antibodies, SARS-CoV-2 virus antibodies are measured from blood samples, 6,.5 years|SARS-CoV-2 virus, SARS-CoV-2 virus PCR is analyzed from saliva, 6.5 years

University of Helsinki

ALL

CHILD

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

Helsinki University

2019-11-01

2021-12-15

2022-05-27

2020-03-10

2022-11-03

Children s Hospital, Helsinki, Finland

{}

NCT03379987

Analgesic Efficacy of Paravertebral Morphine

https://clinicaltrials.gov/study/NCT03379987

UNKNOWN

The investigator will test the analgesic efficacy of paravertebral morphine as an adjuvant to local anesthetics for acute postoperative pain following breast surgery and renal surgery

NO

Acute Pain

DRUG: PVB morphine|DRUG: PVB bupivacaine

24 hour postoperative morphine consumption, the quantity of analgesic (morphine) consumed by the patient in the first postoperative 24 hour, the first postoperative 24 hour

VAS pain score (visual analogue pain score), a scle in which 0 = no pain and 10 = maximum tolerable pain, we will assess every 4 hour in the first postoperative 24 hour

Assiut University

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

SECI-IRB-IORG0006563-404

2018-01-01

2019-07

2019-08

2017-12-20

2019-02-11

Diab, Assiut, Assuit, 71515, Egypt

{ "Morphine": [ { "intervention_type": "DRUG", "description": "PVB morphine", "name": "Morphine", "synonyms": [ "Anhydrous morphine", "Morphium", "MXL", "Morphine Chloride", "SDZ 202250", "Arymo", "Morphin", "(5\u03b1,6\u03b1)-didehydro-4,5-epoxy-17-methylmorphinan-3,6-diol", "Contin, MS", "Morfina", "SDZ 202 250", "(5R,6S,9R,13S,14R)-4,5-epoxy-N-methyl-7-morphinen-3,6-diol", "(7R,7AS,12bs)-3-methyl-2,3,4,4a,7,7a-hexahydro-1H-4,12-methano[1]benzofuro[3,2-e]isoquinoline-7,9-diol", "(5\u03b1,6\u03b1)-17-methyl-7,8-didehydro-4,5-epoxymorphinan-3,6-diol", "Sevredol", "Oramorph", "SDZ202-250", "Morphine Sulfate (2:1), Anhydrous", "Chloride, Morphine", "Morphine", "Roxanol-T", "Morphgesic", "Oramorph SR", "Morphine Sulfate", "Morphia", "Astramorph", "Zomorph", "(5alpha,6alpha)-17-methyl-7,8-didehydro-4,5-epoxymorphinan-3,6-diol", "Infumorph", "MS Contin", "Sulfate, Morphine", "Morphine Sulfate (2:1), Pentahydrate", "Morphinum", "RMS", "MST", "Kadian", "Duramorph", "SDZ 202-250", "SDZ202250", "SDZ202 250", "(5alpha,6alpha)-didehydro-4,5-epoxy-17-methylmorphinan-3,6-diol", "(\u2212)-morphine" ], "medline_plus_id": "a606006", "generic_names": [ "Morphine" ], "nhs_url": "https://www.nhs.uk/medicines/morphine", "mesh_id": "D009294", "drugbank_id": "DB00295" } ], "Bupivacaine": [ { "intervention_type": "DRUG", "description": "PVB bupivacaine", "name": "Bupivacaine", "synonyms": [ "Buvacaina", "Svedocain Sin Vasoconstr", "DL-Bupivacaine", "Marcaine", "Carbostesin", "Bupivacain-RPR", "Bupivacaine Carbonate", "Bupivacaina Braun", "Posimir", "Marcain", "1-Butyl-2',6'-pipecoloxylidide", "Bupivacain RPR", "Bupivacaina", "Bupivacaine Anhydrous", "Bupivacaine Hydrochloride", "Bupivacaine Monohydrochloride, Monohydrate", "1-Butyl-N-(2,6-dimethylphenyl)-2-piperidinecarboxamide", "dl-1-Butyl-2',6'-pipecoloxylidide", "Bupivacain Janapharm", "Bupivacaine", "(RS)-bupivacaine", "Dolanaest", "Bupivacainum", "Racemic bupivacaine", "(\u00b1)-bupivacaine", "Sensorcaine" ], "mesh_id": "D000779", "generic_names": [ "Bupivacaine" ], "drugbank_id": "DB00297", "wikipedia_url": "https://en.wikipedia.org/wiki/Bupivacaine" } ] }

NCT03706287

Efficacy and Safety of Anlotinib Plus Platinum Plus Pemetrexed in T790M-negative NSCLC

https://clinicaltrials.gov/study/NCT03706287

UNKNOWN

This study is conducted to explore the safety and efficacy of anlotinib, a tyrosine kinase inhibitors of vascular endothelial growth factor receptor 2（VEGFR）、FGFR（fibroblast growth factor receptor）, platelet-derived growth factor receptor（PDGFR） and tumor cell proliferation related kinase c-Kit, combined with platinum plus pemetrexed in T790M mutation negative metastatic non-squamous non-small cell lung cancer(NSCLC) after the failure of EGFR-TKI.

NO

Lung Cancer Metastatic

DRUG: anlotinib 8mg + AP/PC|DRUG: anlotinib 10mg + AP/PC|DRUG: anlotinib 12mg + AP/PC|DRUG: anlotinib + AP/PC

Progression-free survival (PFS), PFS defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause., Up to 24 months|Dose limiting toxicity (DLT), Dose Limiting Toxicity (DLT) is referred to grade 3 non-hematological toxicity or grade 4 hematological toxicity according to NCI CTCAE 4.03 criteria, Estimated about 6 months|Maximum tolerance dose (MTD), Maximum Tolerance Dose (MTD) is the dose of treatment in the cohort where there are 2 cases of DLT reported., Estimated about 6 months

Objective response rate(ORR), To determine ORR of Anlotinib Anlotinib combined with Platinum-based Pemetrexed in T790M mutation negative Advanced NSCLC. ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1., Up to 24months|Disease Control Rate (DCR), Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1., Up to 24months|Duration of Response (DOR), Defined as the the time from first confirmed CR or PR until the first date of either objective disease progression or death due to any cause., Up to 24months|Safety (Number of Participants with Adverse Events as a Measure of Safety and Tolerability), Number of Participants with Adverse Events as a Measure of Safety and Tolerability, Until 21 day safety follow-up visit

Sichuan Cancer Hospital and Research Institute

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

ALL

ADULT, OLDER_ADULT

PHASE1|PHASE2

OTHER

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT

ALTER-L022

2018-12-06

2021-03-10