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## Protocol Section ### Identification Module **NCT ID:** NCT06438445 **Brief Title:** Effects of Royal Jelly Supplementation in Chronic Kidney Disease **Official Title:** Effects of Royal Jelly Supplementation on Inflammation and Cellular Senescence in Chronic Kidney Disease Patients Under Hemodialysis #### Organization Study ID Info **ID:** Interventional #### Organization **Class:** OTHER **Full Name:** Universidade Federal Fluminense ### Status Module #### Completion Date **Date:** 2024-12-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-27 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-05-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Universidade Federal Fluminense #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The objective of this study is to evaluate the effects of royal jelly on inflammation and cellular senescence in patients with chronic kidney disease (CKD) on hemodialysis (HD). **Detailed Description:** Royal jelly is a substance produced in the hypopharyngeal glands of bees that operate young, and rich in bioactive compounds such as polyphenols, free fatty acids and exclusive peptides capable of mitigating inflammation and premature aging (genomic instability, mitochondrial dysfunction, shortening of telomeres) existing in patients with chronic kidney disease (CKD) on hemodialysis. However, to date there are no studies evaluating the effects of royal jelly on such complications in patients with RDC. Objectives: To evaluate the effects of royal jelly on inflammation and cellular senescence in patients with CKD. Methods: Clinical, longitudinal, randomized study, with washout and crossover period. Patients with CKD on HD received 140 mL bottles containing propolis and turmeric, and were instructed to take 10 mL/day (dosing cup), containing a dose equivalent to 110 mg/day of standardized green propolis extract (EPP-AF) plus 130 mg of curcuminoids/day or placebo for 8 weeks. After this supplementation, patients will enter the washout period (8 weeks) and after this period, the intervention group will receive placebo and vice versa. The collection of biological material (blood and feces) will be done before and after each study period. The mRNA expression of the transcription factors Nrf2 and NF-κB, as well as their target genes, antioxidant enzymes, inflammatory cytokines and the expression of genes and proteins that modulate the protein will be evaluated using rtPCR, western blotting and assay methods. multiplex. Uremic toxins from the intestinal microbiota such as indoxyl sulfate (IS), p-cresyl sulfate (p-CS) and Indole-3-acetic acid (IAA) will be confirmed by HPLC and plasma lipopolysaccharide (LPS) levels will be analyzed by ELISA. The determination of antioxidant capacity will be determined by the FRAP, ORAC AND DPPH methods. The analysis of the composition of the intestinal microbiota will be evaluated by high-throughput sequencing of the V4-V5 region of the 16S ribosomal RNA gene. Nutritional status and dietary intake will also be assessed. ### Conditions Module **Conditions:** - Kidney Failure, Chronic - Oxidative Stress - Hemodialysis **Keywords:** - Cellular Senescence - Renal Dialysis - Renal Insufficiency, Chronic - Oxidative Stress ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients with chronic kidney disease on hemodialysis will receive capsules containing 500mg of royal jelly/day for two months. **Intervention Names:** - Dietary Supplement: Real Jelly **Label:** Real Jelly Group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patients with chronic kidney disease on hemodialysis will receive capsules containing 500mg of placebo/ day for two months. **Intervention Names:** - Dietary Supplement: Placebo **Label:** Placebo group **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Real Jelly Group **Description:** Participants will receive 500mg of royal jelly capsules per day for two months. **Name:** Real Jelly **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - Placebo group **Description:** Participants will receive 500mg of placebo capsules per day for two months. **Name:** Placebo **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** The mRNA levels of Nrf2, Keap1, Bach1, NLPR3, NF-kB, HO-1, NQO1, p14, p16, p21 and p53 as well as VCAM, ICAM and E-selectin and TLR-4, TNFR and AhR receptors will be evaluated from peripheral blood mononuclear cells. **Measure:** Change in inflammatory biomarkers **Time Frame:** 6 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * patients with CKD undergoing hemodialysis for more than 6 months * patients with arteriovenous fistula (AVF) as vascular access. Exclusion Criteria: * pregnant, * lactating, * smoker * patients using antibiotics and antioxidant supplements in the last three months * patients with autoimmune and infectious diseases, * patients with cancer, liver disease, and AIDS **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** dmafra30@gmail.com **Name:** Denise Mafra **Phone:** 21985683003 **Role:** CONTACT #### Locations **Location 1:** **City:** Rio de Janeiro **Country:** Brazil **Facility:** Denise Mafra **State:** RJ **Zip:** 22260050 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014570 - Term: Urologic Diseases - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10698 - Name: Kidney Diseases - Relevance: HIGH - As Found: Kidney Disease - ID: M26717 - Name: Renal Insufficiency, Chronic - Relevance: HIGH - As Found: Chronic Kidney Disease - ID: M26718 - Name: Renal Insufficiency - Relevance: HIGH - As Found: Kidney Failure - ID: M10699 - Name: Kidney Failure, Chronic - Relevance: HIGH - As Found: Kidney Failure, Chronic - ID: M10293 - Name: Inflammation - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M6147 - Name: Chronic Disease - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: HIGH - As Found: Chronic ### Condition Browse Module - Meshes - ID: D000007674 - Term: Kidney Diseases - ID: D000051436 - Term: Renal Insufficiency, Chronic - ID: D000051437 - Term: Renal Insufficiency - ID: D000007676 - Term: Kidney Failure, Chronic ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M14295 - Name: Propolis - Relevance: LOW - As Found: Unknown - ID: T364 - Name: Bee Products - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06438432 **Acronym:** Activ'Tronc **Brief Title:** Trunk Activity Rehabilitation in Young Children With Cerebral Palsy **Official Title:** Trunk Activity Rehabilitation in Young Children With Cerebral Palsy #### Organization Study ID Info **ID:** RR-Flavigny-2023-2 #### Organization **Class:** OTHER **Full Name:** Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est ### Status Module #### Completion Date **Date:** 2024-10-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-27 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-10-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-25 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Children with CP exhibit trunk control issues from early childhood, affecting their balance and gait. These issues manifest as unstable walking, increased step width, and more pronounced anterior deceleration of the sternum. Previous studies have shown that early action of the triceps surae compensates for the deficit in trunk postural control. Rehabilitation targeting the trunk has shown significant improvements in postural control and gait. The main objective is to demonstrate that RAIT significantly reduces the peak anterior deceleration of the sternum at the beginning of the stance phase during barefoot spontaneous walking, with an enhanced effect from prolonged RAIT duration. Secondary objectives include reducing the downward deceleration of the fifth lumbar vertebra (L5), step width, gait variability index, and improving scores on the early clinical balance scale and the global motor function evaluation. Participants, children with spastic paraparesis or spastic hemiparesis capable of walking independently, are divided into two groups: one group continuing their usual rehabilitation for 3 months followed by RAIT for 9 months (RH-RAIT), and one group following RAIT for 12 months (RAIT-RAIT). RH involves rehabilitation exercises for lower limb muscles, while RAIT focuses on improving trunk postural control through activities involving intermediate postures. Functional motor assessments will be conducted initially, then at 3, 6, and 12 months. These include clinical evaluations, gait analysis (step width, gait variability index, anterior foot support), and an analysis of static standing displacement using an inertial sensor placed at L5. At M0, children with CP are expected to show higher values for deceleration peaks and gait variability indices, and lower scores on evaluation scales compared to typically developing (TD) children. After RAIT, an improvement in judgment criteria is expected: reduction in deceleration peaks, cycle width, gait variability index, anterior foot support, and an increase in scores on the ECPE and EMFG-66-SI. This study aims to confirm that rehabilitation through trunk-involving activities is more effective than usual rehabilitation in improving postural control and gait dynamics in young children with cerebral palsy, suggesting that this approach could become a standard rehabilitation practice from early childhood. ### Conditions Module **Conditions:** - Children With Cerebral Palsy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 32 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** A first group of children will continue their usual rehabilitation (RH) for the first 3 months and then have RAIT for the following 9 months. **Intervention Names:** - Other: RAIT **Label:** RH-RAIT **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The second group of children will have RAIT from the outset during the 12 months of the study. **Intervention Names:** - Other: RAIT **Label:** RAIT-RAIT **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - RAIT-RAIT - RH-RAIT **Description:** The RAIT program focuses on improving postural control and balance of the entire body, including the trunk and other affected muscles, through autonomous actions in intermediate postures. This approach uses fundamental automatic control of postural support and balance to enhance the use of affected muscles during all postural and locomotor tasks. The child controls their balance during various voluntary actions from intermediate postures like alternating between four-legged and cobra postures, or swinging from the camel posture. These actions, less difficult than standing and walking, are expected to benefit the latter. The child also performs more challenging trunk movements, requiring dissociation of scapular and pelvic girdle movements or reducing lumbar lordosis. **Name:** RAIT **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Varaible obtained via the analysis of walking on a zeno treadmill. A reduced value is expected after RAIT rehabilitation. **Measure:** Peak anterior deceleration of the sternum at the start of weight-bearing **Time Frame:** At inclusion, then 3, 6 and 12 months later #### Secondary Outcomes **Description:** The Evaluation Motrice Fonctionnelle Globale 66 (EMFG-66) is a standardized 66-item clinical score used to assess global motor function and its evolution over time in children with cerebral palsy. The EMFG-66-SI is a faster (approx. 20 to 30 minutes vs. 60 to 80 minutes), validated scoring method for the EMFG-66, using 15 to 39 items. The higher the score, the better. **Measure:** EMFG-66-SI **Time Frame:** At inclusion, then 3, 6 and 12 months later **Description:** This is a 13-item clinical scale for assessing postural stability (balance ability) in children with cerebral palsy, with two subscales: one dedicated to head and trunk postural control, the other to sitting and standing postural control.The scale has been validated for children aged 1.5 to 11, regardless of GMFCS level (40,47). The scale has been validated for children aged 1.5 to 11, regardless of GMFCS level.)The optimal score is 100. Administering the scale takes around 15 minutes. The higher the score, the better. **Measure:** The Early Clinical Balance Scale **Time Frame:** At inclusion, then 3, 6 and 12 months later **Description:** This questionnaire for parents, based on the child's voluntary movements for sitting, transferring and mobility, provides a 5-level classification of the severity of the child's cerebral palsy. Score between 1 and 5. The higher the score, the more severe the cerebral palsy. **Measure:** Global Motor Function Classification System family report questionnaire **Time Frame:** At inclusion **Description:** This is a questionnaire designed for parents to assess the upper limb and hand abilities in different functional situations of their child with CP. This questionnaire, validated for children with CP from the age of 2, will help to assess the expected improvement in hand and upper limb function linked to RAIT. The higher the score, the better. **Measure:** "Reach out" questionnaire **Time Frame:** At inclusion, then 3, 6 and 12 months later **Description:** This examination consists of measuring the amplitude of movement of the main joints in one or more planes, using a goniometer. Check against standards for each joint **Measure:** Neuro-orthopaedic assessment **Time Frame:** At inclusion, then 3, 6 and 12 months later **Description:** This examination consists of measuring spasticity of the main muscles, by mobilizing a joint at slow and then fast speed to elicit a stretch reflex. Score between 0 and 4. 4 indicates the highest level of spasticity. **Measure:** Neuro-orthopaedic assessment **Time Frame:** At inclusion, then 3, 6 and 12 months later **Description:** This examination consists of measuring the muscular strength of the main muscle groups, by asking the subject to mobilize a joint against resistance. Score between 0 and 5. The higher the score, the better. **Measure:** Neuro-orthopaedic assessment **Time Frame:** At inclusion, then 3, 6 and 12 months later **Description:** varaible obtained via the analysis of walking on a zeno treadmill. A reduced value is expected after RAIT rehabilitation. **Measure:** peak downward deceleration of L5 at the start of support **Time Frame:** At inclusion, then 3, 6 and 12 months later **Description:** Composite score based on 9 spatio-temporal parameters that quantifies the distance between the amount of variability observed in an asymptomatic reference group and the amount of variability observed in the patient. This index assesses gait instability and the risk of falling. It is usually high in children with CP. **Measure:** Gait variability index **Time Frame:** At inclusion, then 3, 6 and 12 months later **Description:** Varaible obtained via the analysis of walking on a zeno treadmill. A reduced value is expected after RAIT rehabilitation. **Measure:** Cycle width **Time Frame:** At inclusion, then 3, 6 and 12 months later **Description:** Ratio between the integrated pressure of the forefoot and the integrated pressure of the whole foot during the 1st double support. This variable will be higher the more the foot is supported on the ground by the forefoot, as in the PC child, and lower the more the foot is supported by the heel, as in the typically developing child. **Measure:** Anterior support of the foot during 1st double support **Time Frame:** At inclusion, then 3, 6 and 12 months later **Description:** Score developed for children with cerebral palsy, assessing the extent of kinematic deviations compared to typically developing children. (0 = normal, 1 = moderate or mild pathology, 2 = severe pathology). So 0 here means the best EVGS score. **Measure:** Edinburgh walk visual score **Time Frame:** At inclusion, then 3, 6 and 12 months later ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: For children with CP * Age between 18 months and 5 years 6 months * CP type: spastic paraparesis or spastic hemiparesis, GMFCS I to II * No or moderate retraction of the sural triceps (ankle dorsiflexion: \> 5° on clinical examination, knee straight) * Sufficient level of understanding to carry out activities involving the trunk in the form of self-exercises (rehabilitation protocol), as well as clinical assessments and functional explorations. * Acceptance by the physiotherapist in charge of the child's follow-up to collaborate in carrying out the RAIT. * Affiliated with a social security scheme For children with DT * Age between 18 months and 5 years 6 months * Walking acquired before age 18 months * Sufficient level of understanding to perform clinical assessments and functional explorations * Affiliated with a social security scheme Exclusion Criteria: For children with CP * Previous surgery on lower limbs less than 1 year ago * Botulinum toxin A injection less than 6 months ago * Any change in rehabilitative and/or orthopedic management in the last 2 months * Hip flessum \> 20 * Presence of subacute or chronic pain on standing or walking For children with DT - Neurological and/or orthopedic disorders that may influence gait **Healthy Volunteers:** True **Maximum Age:** 6 Years **Minimum Age:** 18 Months **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** jonathan.pierret@ugecam.assurance-maladie.fr **Name:** Jonathan Pierret, PhD **Phone:** +33 3 83 52 6761 **Role:** CONTACT **Contact 2:** **Name:** Christian Beyaert, PU-PH **Role:** CONTACT #### Locations **Location 1:** **City:** Nancy **Contacts:** ***Contact 1:*** - **Email:** jonathan.pierret@ugecam.assurance-maladie.fr - **Name:** Jonathan Pierret, PhD - **Phone:** +33 3 82 52 6761 - **Role:** CONTACT ***Contact 2:*** - **Name:** Christian Beyaert, PU-PH - **Role:** PRINCIPAL_INVESTIGATOR **Country:** France **Facility:** Institut Régional de Médecine Physique et de Réadaptation **Status:** RECRUITING **Zip:** 54000 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009422 - Term: Nervous System Diseases - ID: D000001925 - Term: Brain Damage, Chronic - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5796 - Name: Cerebral Palsy - Relevance: HIGH - As Found: Cerebral Palsy - ID: M13157 - Name: Paralysis - Relevance: LOW - As Found: Unknown - ID: M5207 - Name: Brain Injuries - Relevance: LOW - As Found: Unknown - ID: M5202 - Name: Brain Damage, Chronic - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002547 - Term: Cerebral Palsy ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06438419 **Acronym:** MOVOSCILLCBGT **Brief Title:** Parkinsonism-Related Oscillations in the Cortico-Basal Ganglia-Thalamic Network During Movement: Beyond the Frequency Range **Official Title:** Parkinsonism-Related Oscillations in the Cortico-Basal Ganglia-Thalamic Network During Movement: Beyond the Frequency Range #### Organization Study ID Info **ID:** CHUBX 2023/63 #### Organization **Class:** OTHER **Full Name:** University Hospital, Bordeaux ### Status Module #### Completion Date **Date:** 2026-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-27 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Université de Bordeaux, IMN, UMR CNRS 5293 #### Lead Sponsor **Class:** OTHER **Name:** University Hospital, Bordeaux #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Expression of hypokinetic and hyperkinetic motor symptoms in Parkinson's disease (PD) is associated with pathological synchronous oscillations of neuronal activity (local field potential/LFP) in the cortico-subcortical network with a wide frequency range. In the present project, we propose to study cortico-subcortical oscillations and their synchronization in patients operated for PD (subthalamic deep brain stimulation (STN-DBS)) during distinct pharmacological and stimulation conditions (hypokinetic and hyperkinetic), using a simple motor task. **Detailed Description:** To define the link between the characteristics of neuronal oscillations (frequency, amplitude, phase relationship) within the cortico-subcortical network and the movement, we designed a simple motor task of gripping/pulling a lever. The LFPs will be collected at the cortical and subcortical levels (STN) during the motor task using a high-resolution EEG (HR-EEG) and the Percept™ system (Medtronic). Recordings will be realized in four conditions: without pharmacological treatment and without stimulation (Off condition), without pharmacological treatment and during stimulation (DBS condition), during pharmacological treatment and without stimulation (DOPA condition) and during pharmacological treatment and stimulation (DOPA+DBS condition). ### Conditions Module **Conditions:** - Parkinson Disease - Hyperkinesis - Hypokinesia **Keywords:** - Parkinson disease - hypokinetic disorders - dyskinesia - networks - basal ganglia ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patient with idiopathic Parkinson's disease and having a STN DBS with a PERCEPT™ for less than a year or being candidate for subthalamic nucleus deep brain stimulation with the PERCEPT™ device (first-implantation) **Intervention Names:** - Other: Electrophysiological recordings **Label:** Recruited patient **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Recruited patient **Description:** Electrophysiological recordings will be made during a motor task in four different conditions: 1. without pharmacological treatment and without stimulation (Off condition), 2. without pharmacological treatment and during stimulation (DBS condition), 3. during pharmacological treatment and without stimulation (DOPA condition), 4. during pharmacological treatment and stimulation (DOPA+DBS condition). **Name:** Electrophysiological recordings **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Statistically significant difference in the cortico-subcortical electrophysiological coherence value between a movement performed in hypokinetic condition and a movement performed in hyperkinetic condition **Measure:** Cortico-subcortical electrophysiological coherence **Time Frame:** At inclusion (D0) #### Secondary Outcomes **Description:** Demonstration of a significant difference in spectral signal power between movement in hypokinetic and hyperkinetic conditions. **Measure:** Spectral signal power **Time Frame:** At inclusion (D0) **Description:** Demonstration of a significant effect of STN-DBS on spectral signal power and cortico-subcortical synchronization during movement in hypokinetic or hyperkinetic conditions **Measure:** Effect of STN-DBS on spectral signal power **Time Frame:** At inclusion (D0) **Description:** Demonstration of a statistical correlation between semiological characteristics (hypo- and hyperkinesia, movement parameters (reaction time and movement time)) and electrophysiological characteristics. **Measure:** Correlation between semiological characteristics **Time Frame:** At inclusion (D0) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Male or Female * 18 to 75 years-old * With idiopathic Parkinson's disease * Having a STN-DBS with a PERCEPT™ for less than a year or being candidate for STN-DBS with the PERCEPT™ device (first-implantation) * Able to perform the simple motor task * Patients covered by a health insurance scheme * Giving free, informed, written consent signed by the participant and the investigator. Exclusion Criteria: * Be incapable of giving consent personally. * Be subject to a legal protection measure (curatorship, guardianship) or be placed under judicial protection. * Being pregnant or breastfeeding * Present a serious and/or decompensated somatic or psychiatric illness. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** dominique.guehl@chu-bordeaux.fr **Name:** GUEHL Dominique, Pr **Phone:** 5 57 82 12 42 **Phone Ext:** +33 **Role:** CONTACT **Contact 2:** **Email:** claire.brandet@chu-bordeaux.fr **Name:** Claire BRANDET **Role:** CONTACT #### Locations **Location 1:** **City:** Bordeaux **Contacts:** ***Contact 1:*** - **Email:** dominique.guehl@chu-bordeaux.fr - **Name:** Dominique Guehl, Pr - **Role:** CONTACT ***Contact 2:*** - **Email:** claire.brandet@chu-bordeaux.fr - **Name:** Claire BRANDET - **Role:** CONTACT **Country:** France **Facility:** Bordeaux University Hospital ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001480 - Term: Basal Ganglia Diseases - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000009069 - Term: Movement Disorders - ID: D000080874 - Term: Synucleinopathies - ID: D000019636 - Term: Neurodegenerative Diseases - ID: D000003560 - Term: Cysts - ID: D000009369 - Term: Neoplasms - ID: D000017520 - Term: Mucinoses - ID: D000003240 - Term: Connective Tissue Diseases - ID: D000020820 - Term: Dyskinesias - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases ### Condition Browse Module - Browse Leaves - ID: M25603 - Name: Ganglion Cysts - Relevance: HIGH - As Found: Ganglion - ID: M13213 - Name: Parkinson Disease - Relevance: HIGH - As Found: Parkinson's Disease - ID: M22494 - Name: Parkinsonian Disorders - Relevance: HIGH - As Found: Parkinsonism - ID: M20582 - Name: Hypokinesia - Relevance: HIGH - As Found: Hypokinesia - ID: M9999 - Name: Hyperkinesis - Relevance: HIGH - As Found: Hyperkinesis - ID: M22574 - Name: Dyskinesias - Relevance: LOW - As Found: Unknown - ID: M16358 - Name: Synovial Cyst - Relevance: LOW - As Found: Unknown - ID: M6765 - Name: Cysts - Relevance: LOW - As Found: Unknown - ID: M4774 - Name: Basal Ganglia Diseases - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M12029 - Name: Movement Disorders - Relevance: LOW - As Found: Unknown - ID: M2217 - Name: Synucleinopathies - Relevance: LOW - As Found: Unknown - ID: M21558 - Name: Neurodegenerative Diseases - Relevance: LOW - As Found: Unknown - ID: M19781 - Name: Mucinoses - Relevance: LOW - As Found: Unknown - ID: M6464 - Name: Connective Tissue Diseases - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000045888 - Term: Ganglion Cysts - ID: D000010300 - Term: Parkinson Disease - ID: D000020734 - Term: Parkinsonian Disorders - ID: D000018476 - Term: Hypokinesia - ID: D000006948 - Term: Hyperkinesis ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M7471 - Name: Dihydroxyphenylalanine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06438406 **Brief Title:** Postural Assessment, Therapeutic Exercise and Orthotic Devices in the Prevention of Haemophilic Arthropathy **Official Title:** Postural Assessment, Therapeutic Exercise and Orthotic Devices in the Prevention of Haemophilic Arthropathy #### Organization Study ID Info **ID:** MFR052024 #### Organization **Class:** OTHER **Full Name:** University of Palermo ### Status Module #### Completion Date **Date:** 2024-05-27 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-27 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-10-30 **Type:** ACTUAL #### Start Date **Date:** 2023-04-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Palermo #### Responsible Party **Investigator Affiliation:** University of Palermo **Investigator Full Name:** Prof.ssa Giulia Letizia Mauro **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Haemophilic arthropathy (HA) is the most frequent complication of haemophilia and is often associated with a severe deterioration in quality of life. It is caused by repeated joint bleeding resulting in chronic proliferative synovitis and progressive destruction of articular cartilage. The most frequently affected joints are the knees, ankles and elbows. The aim of this study is to verify the use of lower limb orthoses in combination with postural rehabilitation, assessing the incidence of spontaneous haemarthroses and haematomas as the primary endpoint and pain and QoL as secondary endpoints. We conducted a prospective observational, randomised and controlled study on outpatients attending the UOC of Recovery and Functional Rehabilitation of the AOUP Paolo Giaccone of Palermo for haemophilic arthropathy sent by the UO of Haematology of the same hospital. The study period was between January 2017 and March 2023. The patients recruited were randomly divided into two groups by means of a computer-generated random number system: group A, consisting of patients who were prescribed orthoses and a 20-session rehabilitation programme; group B, consisting of patients who were only prescribed orthoses for the lower limbs. The rehabilitation programme was based on the Back School method. All patients were assessed at baseline (T0), at 3 months (T1) and after 6 months (T2). Two arthropathic-specific scales were used to assess outcomes, namely the Hemophilia Joint Health Score (HJHS), which reflects joint function and status, and the Functional Independence Score in Hemophilia (FISH), which relates to the patient\'s quality of life. We also used the Numerical Rating Scale (NRS) for joint pain. Finally, postural assessment was performed in static posture, observing the patient\'s alignment in different planes and using the APECS (AI Posture Evaluation and Correction System ®) mobile app. During the re-evaluations, any new haemarthroses and haematomas were also assessed. ### Conditions Module **Conditions:** - Haemophilic Arthropathy - Orthosis - Foot Malalignment **Keywords:** - haemophilic arthropathy - orthosis - postural assestment - foot malalignment - therapeutic exercise - haemarthroses - haematomas - HJHS - FISH ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 15 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Group A consisting of patients who were prescribed orthoses, to use gradually, and a 20-session rehabilitation programme, based on the Back School method **Intervention Names:** - Device: Orthotic devices and therapeutic exercise (Group A) - Device: Orthotic devices (Group B) **Label:** Orthotic devices and therapeutic exercise (Group A) **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Group B consisting of patients who were only prescribed orthoses for the lower limbs **Intervention Names:** - Device: Orthotic devices and therapeutic exercise (Group A) - Device: Orthotic devices (Group B) **Label:** Orthotic devices (Group B) **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Orthotic devices (Group B) - Orthotic devices and therapeutic exercise (Group A) **Description:** Group A consisting of patients who were prescribed orthoses, to use gradually, and a 20-session rehabilitation programme, based on the Back School method **Name:** Orthotic devices and therapeutic exercise (Group A) **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Orthotic devices (Group B) - Orthotic devices and therapeutic exercise (Group A) **Description:** Group B consisting of patients who were only prescribed orthoses for the lower limbs **Name:** Orthotic devices (Group B) **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** During re-evaluations, the possible appearance of new haemarthroses and haematomas was assessed ,which were absent at the baseline examination **Measure:** prevention of haemophilic arthropathy **Time Frame:** All patients were assessed at 3 months (T1) and after 6 months (T2). #### Secondary Outcomes **Description:** This score is a performance-based assessment tool used to measure the functional ability of patients. The maximum score is 32 (the greatest autonomy). **Measure:** Functional Independence Score in Hemophilia (FISH) **Time Frame:** All patients were assessed at baseline (T0), at 3 months (T1) and after 6 months (T2) **Description:** The Hemophilia Joint Health Score is a rating scale that measures joint health in the domains of anatomical structure and function (biomechanics) of the joints most frequently affected by haemorrhage in haemophilia: knees, ankles, elbows. **Measure:** Hemophilia Joint Health Score (HJHS) **Time Frame:** All patients were assessed at baseline (T0), at 3 months (T1) and after 6 months (T2) **Description:** The NRS scale is a one-dimensional 11-point scale that assesses pain intensity in adults, with a range from 0 to 10, corresponding to 'no pain' and 'worst pain imaginable' **Measure:** Numerical Rating Scale (NRS) **Time Frame:** All patients were assessed at baseline (T0), at 3 months (T1) and after 6 months (T2) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * diagnosis of severe haemophilia A or B; * age ≥ 6 years and ≤ 50 years; * presence of hindfoot and/or arch misalignment; * prophylaxis with factor deficient (VIII or IX). Exclusion Criteria: * patients with prosthetic implants/synthetic means * uncooperative patients **Gender Based:** True **Maximum Age:** 50 Years **Minimum Age:** 6 Years **Sex:** MALE **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Palermo **Country:** Italy **Facility:** A.O.U.P. Paolo Giaccone **Zip:** 90127 ### IPD Sharing Statement Module **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR - ANALYTIC_CODE **IPD Sharing:** YES **URL:** https://www.unipa.it/persone/docenti/l/giulia.letiziamauro/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009140 - Term: Musculoskeletal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10621 - Name: Joint Diseases - Relevance: HIGH - As Found: Arthropathy - ID: M9493 - Name: Hematoma - Relevance: LOW - As Found: Unknown - ID: M9483 - Name: Hemarthrosis - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: T2713 - Name: Hemophilic Arthropathy - Relevance: HIGH - As Found: Hemophilic Arthropathy ### Condition Browse Module - Meshes - ID: D000007592 - Term: Joint Diseases ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06438393 **Acronym:** SAFE-CT **Brief Title:** Screening Coronary Artery Disease Using artiFicial intelligencE in Non-contrast Computed Tomography **Official Title:** Screening Coronary Artery Disease Using artiFicial intelligencE in Non-contrast Computed Tomography #### Organization Study ID Info **ID:** SAFE-CT #### Organization **Class:** OTHER **Full Name:** Universidade do Porto ### Status Module #### Completion Date **Date:** 2027-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-27 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-02 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University of Oxford **Class:** OTHER **Name:** University of Edinburgh #### Lead Sponsor **Class:** OTHER **Name:** Universidade do Porto #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This project aims to improve direct patient care by reducing the risks of futile exposure to ionizing radiation and iodinated contrast in patients referred for coronary computed tomography angiography **Detailed Description:** Since the last NICE guidelines update recommending computed tomography coronary angiography (CTCA) as the first line of investigation for patients with suspected coronary artery disease (CAD), there has been a high burden in the healthcare system and unnecessary exposition to radiation and iodine-containing contrast medium, especially in the youngest. Around 35% of patients who currently undergo CTCA have normal coronaries which means those patients were unnecessary exposed to radiation and contrast. A CTCA screening strategy to rule out CAD is needed to comply with the ALARA ("As Low As Reasonable Achievable") principles preventing radiation risks, reducing unnecessary scans and directing healthcare resources to those who will benefit from a CTCA. We designed the SAFE-CT (Screening coronary Artery disease using artiFicial intelligencE in noncontrast Computed Tomography) study to develop a state-of-art artificial intelligence method to detect CAD as defined on CTCA using high-dimensional data (radiomics) extracted from the non-contrast cardiac computed tomography (CT). The model will be trained in 15,000 subjects scanned with paired non-contrast CT and CTCA and externally validated in an independent cohort of 1,000 subjects. In a preliminary analysis, non-contrast CT radiomics improved calcium score performance and discriminated CAD with an AUC of 0.91 (95% CI: 0.83-1.00). The algorithm will be converted into a user-friendly plugin to automatically decide whether the patient needs contrast. A real-world multicentre cohort study will be planned for software prospective validation and the creation of a large-scale proteomic biobank to support the translation of imaging biomarkers worldwide. SAFE-CT can change the current CT scanning workflow by creating software that accurately rules out any CAD in \>1/3 of patients referred for CTCA with low radiation and no contrast. This accurate machine learning model will be optimized to reach \>90% sensitivity and negative predictive value and will bring several advantages for patients and the healthcare system: * Prevention of radiation and contrast exposition. * Increased CTCA scanning capacity for complex cases. * Widespread use of CT for CAD exclusion in the emergency department and in outpatient clinics of centres with no CTCA. * Improved screening tool for CAD in asymptomatic subjects. * Up- and downstream cost reduction. The SAFE-CT project proposes a safer, low-cost, and personalized CTCA scanning strategy that fosters scientific and technological innovation with the potential to bring improvement to patient care and clinical practice, and, thereby, societal, and economic impact. ### Conditions Module **Conditions:** - Coronary Artery Disease - Coronary Atheroscleroses **Keywords:** - Artificial intelligence - Radiomics - Deep learning - Coronary artery disease - Non-contrast computed tomography ### Design Module #### Bio Spec **Description:** Peripheral blood samples for proteomics analysis **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** OTHER **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 1000 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** CAD: Presence of minimal coronary artery disease (i.e., coronary stenosis 0-25%) Normal coronary arteries: No visible coronary atherosclerosis **Intervention Names:** - Diagnostic Test: CT coronary angiography and non-contrast CT **Label:** Stable chest pain and unknown CAD who underwent CTCA and CCS in the same scanning session ### Interventions #### Intervention 1 **Arm Group Labels:** - Stable chest pain and unknown CAD who underwent CTCA and CCS in the same scanning session **Description:** A CTCA is an X-ray computed tomography of the coronary arteries that allows visualization of coronary plaques with high temporal and spatial resolution, however, it implies the use of iodine contrast and exposition to clinically significant ionizing radiation. Non-contrast ECG-gated CT ("calcium score" - CCS image). A non-contrast cardiac CT for CCS can be performed very quickly with significantly lower radiation (\~6 times lower) than CTCA and without the need for contrast. **Name:** CT coronary angiography and non-contrast CT **Other Names:** - Non-contrast computed tomography **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Measure:** Build a non-contrast CT radiomic signature of CAD **Time Frame:** 3 years **Measure:** Implement a machine learning model to discriminate patients with no CAD from patients with at least minimal disease (CAD-RADS=0 vs. CAD-RADS>0). **Time Frame:** 3 years **Measure:** Implement a machine learning model to detect coronary inflammation as defined using the Fat Attenuation Index (FAI ≥ -70.1 HU) in patients with no visible coronary plaque (CAD-RADS=0). **Time Frame:** 3 years **Measure:** Build a user-friendly plugin to facilitate users experience and distribution of our technology in clinical practice. **Time Frame:** 3 years **Measure:** Evaluate the real-world operationality and performance of the plugin in an international multicentre prospective cohort study. **Time Frame:** 3 years **Measure:** Create a national registry of cardiac CT **Time Frame:** 3 years #### Secondary Outcomes **Measure:** Setup a human blood biobank to identify the peripheral blood mononuclear cells (PBMCs) and plasma proteomics associated with CT data and clinical outcomes. **Time Frame:** 3 years **Measure:** Setup a public CT imaging repository **Time Frame:** 3 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: - Patient with stable chest pain who underwent a CTCA Exclusion Criteria: * Missing non-contrast CT image (coronary calcium score image) * Known coronary artery disease * Prior myocardial infarction * Prior PCI or CABG **Healthy Volunteers:** True **Maximum Age:** 100 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Stable chest pain patients with unknown CAD who underwent a CTCA with paired non-contrast CT ### Contacts Locations Module #### Locations **Location 1:** **City:** Porto **Country:** Portugal **Facility:** Faculty of Medicine of Porto ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000001161 - Term: Arteriosclerosis - ID: D000001157 - Term: Arterial Occlusive Diseases - ID: D000014652 - Term: Vascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M6546 - Name: Coronary Artery Disease - Relevance: HIGH - As Found: Coronary Artery Disease - ID: M19506 - Name: Myocardial Ischemia - Relevance: HIGH - As Found: Coronary Artery Disease - ID: M6549 - Name: Coronary Disease - Relevance: HIGH - As Found: Coronary Artery Disease - ID: M26188 - Name: Atherosclerosis - Relevance: HIGH - As Found: Atherosclerosis - ID: M10543 - Name: Ischemia - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M4469 - Name: Arteriosclerosis - Relevance: LOW - As Found: Unknown - ID: M4465 - Name: Arterial Occlusive Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003324 - Term: Coronary Artery Disease - ID: D000017202 - Term: Myocardial Ischemia - ID: D000003327 - Term: Coronary Disease - ID: D000050197 - Term: Atherosclerosis ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: BDCA - Name: Bone Density Conservation Agents - Abbrev: Micro - Name: Micronutrients - Abbrev: Infe - Name: Anti-Infective Agents ### Intervention Browse Module - Browse Leaves - ID: M5381 - Name: Calcium - Relevance: LOW - As Found: Unknown - ID: M5398 - Name: Calcium, Dietary - Relevance: LOW - As Found: Unknown - ID: M10488 - Name: Iodine - Relevance: LOW - As Found: Unknown - ID: M229695 - Name: Cadexomer iodine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06438380 **Brief Title:** User Experience of a Telemedicine Platform for the Follow-up of Post Intensive Care Syndrome (PICS) **Official Title:** Experience of Critically Ill Patients in the Use of a Telemedicine Platform for the Follow-up of Post Intensive Care Syndrome (PICS) After ICU Discharge #### Organization Study ID Info **ID:** 2023/5126 #### Organization **Class:** NETWORK **Full Name:** Parc Tauli Research and Innovation Institute Foundation ### Status Module #### Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-27 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** NETWORK **Name:** Parc Tauli Research and Innovation Institute Foundation #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Survivors of critical illness may present with a set of physical, emotional and cognitive sequelae, known as Post Intensive Care Syndrome (PICS). These alterations can become chronic over time and significantly affect patients' quality of life. Therefore, follow-up and monitoring of critically ill patients after ICU discharge, for example through telemedicine, could be essential for the prevention, early detection and management of PICS. Our main objective is to evaluate the suitability and user experience of a telemedicine platform from the perspective of critically ill patients. This study proposes the participation of ICU survivors in the design and improvement of a telemedicine platform for PICS follow-up through a qualitative approach. Participants will test the platform in person three months after discharge from the ICU and then undergo a semi-structured interview to assess their experience. The findings derived from this study may contribute to improve both the content and the format of the platform, optimizing resources and facilitating the management of post-ICU sequelae, which will have a positive impact on the patient's recovery process. ### Conditions Module **Conditions:** - Critical Illness **Keywords:** - Qualitative research - Post-Intensive Care Syndrome ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 14 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** To evaluate the user experience of a telemedicine platform for monitoring post-intensive care syndrome from the perspective of critically ill patients after ICU discharge through semi-structured interviews **Measure:** 1:1 semi-structured interviews **Time Frame:** 3 months after ICU discharge ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adult patients (≥18 years) * Admitted to a medical/surgical ICU * For respiratory failure, cardiogenic shock, or septic shock * With an expected ICU stay of ≥48 hours * Catalan and/or Spanish speakers * Who are able to give informed consent by themselves Exclusion Criteria: * History of intellectual disability or other neurodevelopmental disorders, such as autism spectrum disorder * History of neurological disorders, dementia or other neurodegenerative diseases, such as epilepsy, Alzheimer's disease, Parkinson's disease or multiple sclerosis * History of brain damage, such as traumatic brain injury or stroke * History of severe psychiatric illness, such as psychotic, bipolar, depressive, obsessive-compulsive, post-traumatic or personality disorder * Suspected or confirmed substance use disorder * Suspected or confirmed communicable disease in an isolated patient * Uncorrected hearing or visual impairment * Enrolled in another trial that does not allow co-enrollment **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Critically ill patients admitted to the ICU of the Parc Tauli Hospital (Sabadell, Spain). ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** mrgodoy@tauli.cat **Name:** Marta Godoy-González, PhD student **Phone:** +34937236673 **Role:** CONTACT **Contact 2:** **Email:** msfernandez@tauli.cat **Name:** Sol Fernández-Gonzalo, PhD **Phone:** +34937236673 **Role:** CONTACT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000020969 - Term: Disease Attributes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M19010 - Name: Critical Illness - Relevance: HIGH - As Found: Critical Illness - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000016638 - Term: Critical Illness ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06438367 **Brief Title:** TGRX-326 Pharmacokinetic Mass Balance **Official Title:** Mass Balance Study of [14C]TGRX-326 in Healthy Adult Chinese Male Participants #### Organization Study ID Info **ID:** TGRX-326-1004 #### Organization **Class:** INDUSTRY **Full Name:** Shenzhen TargetRx, Inc. ### Status Module #### Completion Date **Date:** 2024-10-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-27 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-08-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** The First Affiliated Hospital of Soochow University #### Lead Sponsor **Class:** INDUSTRY **Name:** Shenzhen TargetRx, Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This is a pharmacokinetic study for TGRX-326 on mass balance to evaluate distribution, metabolism and excretion of TGRX-326, an ALK inhibitor indicated for treatment of Non-small cell lung cancer. **Detailed Description:** This study is designed as a single-center, single-dose, non-randomized and open-label study. The study will be conducted in healthy male participants to evaluate distribution, metabolic pathways and route of excretion of TGRX-326 using the Carbon-14 labelled isotope of TGRX-326 compound. Safety evaluation will also be conducted. ### Conditions Module **Conditions:** - Non Small Cell Lung Cancer ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 6 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** healthy subjects will be given 60mg/100uCi\[14C\]TGRX-326 in suspension **Intervention Names:** - Drug: [14C]TGRX-326 **Label:** Experimental: TGRX-326 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental: TGRX-326 **Description:** Healthy subjects will be given TGRX-326 60 mg orally on day 1. **Name:** [14C]TGRX-326 **Other Names:** - TGRX-326 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** \[C14\]TGRX-326 radioactivity detected in urine **Measure:** Urine radioactivity **Time Frame:** Day-1 (day before dosing), Day 1 to Day 18 after dosing **Description:** \[C14\]TGRX-326 radioactivity detected in feces **Measure:** Fecal radioactivity **Time Frame:** Day-1 (day before dosing), Day 1 to Day 18 after dosing **Description:** percentage of \[C14\]TGRX-326 radioactivity in plasma **Measure:** Plasma AUC (Area under curve) percentage **Time Frame:** Day-1 (day before dosing), Day 1 to Day 18 after dosing **Description:** percentage of \[C14\]TGRX-326 radioactivity in urine **Measure:** Urine %Dose **Time Frame:** Day-1 (day before dosing), Day 1 to Day 18 after dosing **Description:** percentage of \[C14\]TGRX-326 radioactivity in feces **Measure:** Fecal %Dose **Time Frame:** Day-1 (day before dosing), Day 1 to Day 18 after dosing **Description:** Maximum concentration of \[C14\]TGRX-326 measured in plasma **Measure:** Plasma Cmax **Time Frame:** Day-1 (day before dosing), Day 1 to Day 18 after dosing **Description:** Time to maximum concentration of \[C14\]TGRX-326 measured in plasma **Measure:** Plasma Tmax **Time Frame:** Day-1 (day before dosing), Day 1 to Day 18 after dosing #### Secondary Outcomes **Description:** to record and analyse subjects with adverse events (AEs) and serious adverse events (SAEs) **Measure:** Adverse events/serious adverse events **Time Frame:** From screening through completion of study, an average of 1 to 1.5 months. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Healthy adult males * Age between 18 and 45 years old (both limits included) * Body weight index between 19.0 and 26.0 kg/m2 (both limits included), and body weight not less than 50.0kg * Willing to consent * Able to communicate with investigator and complete study according to study protocol Exclusion Criteria: * Clinically significant results from comprehensive physical and clinical examinations * Positive results on hepatitis, HIV or syphilis * Clinically significant results from eye examination * Usage of inducer or inhibitor drugs to drug metabolism with 30 days prior to screening * Usage of any prescription or non-prescription drug, Chinese herbal medicine or dietary supplements * Presence of any significant medical history or clinical conditions that could affect study results per investigators' judgement * Presence of any condition that could affect drug absorption * Reception of major surgery within 6 months before screening, or surgical wounds not completely healed * Presence of allergic reactions or may be allergic to ingredients in the investigational drug * Presence of hemorrhoids, or having history of or is having conditions that cause bloody feces * Habitual congestion or diarrhea * Alcohol abuse or excessive alcohol consumption within 6 months before screening * Excessive smoking within 3 months before screening * Substance abuse or positive results on urine substance test * Habits of grapefruit juice consumption or excessive caffeinated drinks consumption * History of long-term exposure under radiation; or significant radiation exposure 1 year before this study; or participation in other radioactive drug studies * Having difficulties to receive venous needle puncture, or cannot tolerate venous needle puncture, or history of hematophobia or needle sickness * Participation in any other clinical studies within 3 months before screening * Reception of vaccine within 1 months before screening, or planning to be vaccinated during the study * Planning to have children or donate sperms during the study and within 1 year after the study, or Not agreeing to take contraceptive measures during and within 1 year after study completion * Blood donation or blood loss of \> 400 ml within 3 months before screening; blood donation or blood loss of \> 200 ml within 1 month before screening; reception of blood transfusion within 1 months before screening, or planning to donate blood within 3 months after study completion * Having special dietary requirements and unable to follow the uniform dietary plan in the study * Any conditions that the investigator deemed unfit for the study **Healthy Volunteers:** True **Maximum Age:** 45 Years **Minimum Age:** 18 Years **Sex:** MALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** haifang.guo@tjrbiosciences.com **Name:** Haifang Guo, PhD **Phone:** +86-18762407693 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** The First Affiliated Hospital of Soochow University **Name:** Liyan Miao, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002283 - Term: Carcinoma, Bronchogenic - ID: D000001984 - Term: Bronchial Neoplasms - ID: D000008175 - Term: Lung Neoplasms - ID: D000012142 - Term: Respiratory Tract Neoplasms - ID: D000013899 - Term: Thoracic Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5546 - Name: Carcinoma, Non-Small-Cell Lung - Relevance: HIGH - As Found: Non-Small Cell Lung Cancer - ID: M11172 - Name: Lung Neoplasms - Relevance: LOW - As Found: Unknown - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M5540 - Name: Carcinoma, Bronchogenic - Relevance: LOW - As Found: Unknown - ID: M5260 - Name: Bronchial Neoplasms - Relevance: LOW - As Found: Unknown - ID: M14979 - Name: Respiratory Tract Neoplasms - Relevance: LOW - As Found: Unknown - ID: M16658 - Name: Thoracic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002289 - Term: Carcinoma, Non-Small-Cell Lung ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06438354 **Brief Title:** Non-surgical Step 3 Periodontal Treatment With/Without Adjunctive Protocol - Pilot RCT. **Official Title:** Non-surgical Treatment of Residual Periodontal Pockets Using Sodium Hypochlorite/Amino Acid Gel and Cross-linked Hyaluronic Acid - a 9-month Randomized Controlled Clinical Trial. #### Organization Study ID Info **ID:** 64/2022 #### Organization **Class:** OTHER **Full Name:** University of Witten/Herdecke ### Status Module #### Completion Date **Date:** 2024-02-29 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-27 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-10-30 **Type:** ACTUAL #### Start Date **Date:** 2022-08-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Witten/Herdecke #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Study conducted in patients recruited at private praxis setting after completed step 2 periodontal therapy. Residual pockets ≥4mm with positive bleeding or such \>5mm randomly allocated to either conventional subgingival re-instrumentation (controls) or to same mechanical treatment with adjectively applied hypochlorite/aminoacid gel for antiseptic reason followed by subginigival placement of cross linked hyaluronic acid gel for sealing the site after instrumentation. Re-evaluations at 3 and 9 months controlled for clinical parameters such as Periodontal Probing Depth (PPD) (CAL), Clinical Attachment Level, Gingival Recession (GR), Bleeding on Probing (BOP). The hypothesis is, sites treated with adjunctive protocol show greater PPD reduction and greater CAL gain at 9-month evaluation. ### Conditions Module **Conditions:** - Periodontal Pocket ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 52 **Type:** ACTUAL **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Test arm, patients undergo subgingival instrumentation of residual active site together with an adjunctive treatment protocol. **Intervention Names:** - Biological: subgingival instrumentation plus Perisolv / hyaDent BG **Label:** Group A **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Control arm, patients undergo subgingival instrumentation of residual active site only. **Intervention Names:** - Procedure: subgingival instrumentation **Label:** Group B **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Group A **Description:** Group A: Perisolv is applied prior to subgingival instrumentation for disinfecting purpose, hyaDent BG seals the site for accelerated blood clot stabilisation and support of cell proliferation. **Name:** subgingival instrumentation plus Perisolv / hyaDent BG **Type:** BIOLOGICAL #### Intervention 2 **Arm Group Labels:** - Group B **Description:** Group B: sites requiring re-treatment are subjected to subgingival scaling **Name:** subgingival instrumentation **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Greater amount of CAL gain in the test group A vs. control group B anticipated **Measure:** Clinical Attachment Level **Time Frame:** 9 month post-op #### Secondary Outcomes **Description:** Greater reduction in PPD for group A vs. Group B anticipated **Measure:** Periodontal Probing Depth **Time Frame:** 9 months post-op **Description:** Similar change in the GR depth anticipated for both groups **Measure:** Gingival Recession **Time Frame:** 9 months post-op **Description:** greater reduction in BOP anticipated for group A vs. group B patients. **Measure:** Bleeding on Probing **Time Frame:** 9 months post-op ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * systemically healthy individuals, smokers and non-smokers, HbA1c \<7.5%, compliant and adhering to systematic periodontal treatment protocol incl. SPT visits, patients willing to complete a 9-month post-op observation period Exclusion Criteria: * rheumatoid arthritis, HbA1c ≥7.5%, treatment of periodontitis within past 12 months, use of systemic antibiotics in past 6 months, pregnant and lactating individuals **Healthy Volunteers:** True **Maximum Age:** 80 Years **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Munich **Country:** Germany **Facility:** Implantat Competence Centrum München **Zip:** 80333 ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Ramanauskaite E, Machiulskiene V, Shirakata Y, Dvyliene UM, Nedzelskiene I, Sculean A. Clinical evaluation of sodium hypochlorite/amino acids and cross-linked hyaluronic acid adjunctive to non-surgical periodontal treatment: a randomized controlled clinical trial. Clin Oral Investig. 2023 Nov;27(11):6645-6656. doi: 10.1007/s00784-023-05271-0. Epub 2023 Sep 23. **PMID:** 37740107 **Citation:** Shirakata Y, Nakamura T, Setoguchi F, Imafuji T, Shinohara Y, Matsumura S, Iwata M, Noguchi K, Ramanauskaite E, Sculean A. Histological evaluation of nonsurgical periodontal treatment with and without the use of sodium hypochlorite / amino acids and cross-linked hyaluronic acid gels in dogs. Clin Oral Investig. 2024 Apr 27;28(5):281. doi: 10.1007/s00784-024-05674-7. **PMID:** 38676852 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010518 - Term: Periodontitis - ID: D000010510 - Term: Periodontal Diseases - ID: D000009059 - Term: Mouth Diseases - ID: D000009057 - Term: Stomatognathic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M13423 - Name: Periodontal Pocket - Relevance: HIGH - As Found: Periodontal Pocket - ID: M13427 - Name: Periodontitis - Relevance: LOW - As Found: Unknown - ID: M13419 - Name: Periodontal Diseases - Relevance: LOW - As Found: Unknown - ID: M12019 - Name: Mouth Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown - ID: T4202 - Name: Oculocerebral Syndrome With Hypopigmentation - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010514 - Term: Periodontal Pocket ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents ### Intervention Browse Module - Browse Leaves - ID: M9878 - Name: Hyaluronic Acid - Relevance: LOW - As Found: Unknown - ID: M15775 - Name: Sodium Hypochlorite - Relevance: LOW - As Found: Unknown - ID: M44557 - Name: Eusol - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06438341 **Brief Title:** Preliminary Evaluation of the Safety and Tolerability of SPOT-mRNA01 Subcutaneously Administered in Healthy Subjects **Official Title:** A Randomized, Double-blind, Placebo-controlled Exploratory Clinical Study to Evaluate the Safety and Tolerability of SPOT-mRNA01 Injection in Healthy Adult Subjects #### Organization Study ID Info **ID:** FM-T1-SH #### Organization **Class:** INDUSTRY **Full Name:** Spot Biosystems Ltd. ### Status Module #### Completion Date **Date:** 2025-12-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-30 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-09-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-30 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University #### Lead Sponsor **Class:** INDUSTRY **Name:** Spot Biosystems Ltd. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This is a first-in-human, randomized, double-blind, placebo-controlled clinical study to evaluate the Safety and Tolerability of SPOT-mRNA01 injection in healthy adult volunteers. **Detailed Description:** SPOT-mRNA01 (collagen 1 alpha 1 (COL1A1) mRNA-loaded EVs) can induce collagen protein grafts in dermal tissue, thereby supplementing collagen and reducing wrinkle formation in collagen-depleted skin. Therefore, SPOT-mRNA01 can provide a source of human collagen intradermally for cosmetic anti-aging use. This is a first-in-human randomized, double-blind, placebo-controlled, single-dose, dose ascending, exploratory clinical study to evaluate the Safety and Tolerability of SPOT-mRNA01 administered by subcutaneous injection to healthy adult volunteers. ### Conditions Module **Conditions:** - Skin Aging **Keywords:** - SPOT-mRNA01 - EVs - COL1A1 mRNA ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 10 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** SPOT-mRNA01 (COL1A1 mRNA-loaded EVs) **Intervention Names:** - Biological: SPOT-mRNA01 **Label:** SPOT-mRNA01 **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Sterile isotonic solution **Intervention Names:** - Other: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - SPOT-mRNA01 **Description:** SPOT-mRNA01 (COL1A1 mRNA-loaded EVs) ,single-dose subcutaneous injection **Name:** SPOT-mRNA01 **Type:** BIOLOGICAL #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** Sterile isotonic solution **Name:** Placebo **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The investigator will collect a description of the events, time of onset and resolution, assessment of severity and causal relationship to SPOT-mRNA01. **Measure:** Assessment of the safety and tolerability of SPOT-mRNA01 by recording adverse events **Time Frame:** 3 months #### Secondary Outcomes **Description:** Local collagen expression in injection area biopsy by ELISA detection **Measure:** Assessment of changes in collagen expression level after subcutaneous injection of SPOT-mRNA01 **Time Frame:** Days 4, 7 and 31 **Description:** Detecting local skin thickness in injection area biopsy by Masson trichrome stain **Measure:** Assessment of skin thickness after subcutaneous injection of SPOT-mRNA01 **Time Frame:** Days 4, 7 and 31 **Description:** Detecting local skin thickness by Skin ultrasound **Measure:** Assessment of skin thickness after subcutaneous injection of SPOT-mRNA01 **Time Frame:** Baseline and days 7, 15, 31, 61 and 91 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Aged 18 to 75 years inclusive at the time of informed consent. Exclusion Criteria: 1. Any transient or chronic skin condition, disorder, or infection within 20 cm of the target areas before treatment that, in the opinion of the investigator, may confound study results. 2. History of laser treatment or chemical peels or any cosmetic anti-aging treatments to the target areas within six months of the study treatment. 3. History of surgical procedures to target areas, including removal of benign or malignant skin cancers that, in the opinion of the investigator, may confound study results. 4. Participant with a history of heavy smoking, alcohol or drug abuse or steroid treatment. 5. Pregnant or breast-feeding females. 6. History of anaphylaxis or allergic reactions to any constituent of the study product and/or local anesthetics, and/or history of severe abnormal drug reaction. 7. Those who have participated in clinical trials of other investigational drugs within 3 months before the study treatment. 8. Those who are not suitable for subcutaneous injection and biopsy. 9. Any condition that the investigator or primary physician believes may not be appropriate for participating the study. - **Healthy Volunteers:** True **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ## Document Section ### Large Document Module #### Large Docs - Date: 2023-08-14 - Filename: Prot_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: False - Label: Study Protocol - Size: 687192 - Type Abbrev: Prot - Upload Date: 2024-05-24T07:36 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M8219 - Name: Exanthema - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06438328 **Brief Title:** Effectiveness of Scapular Muscle Training in Improving Grip Strength Among Lateral Epicondylitis Patients **Official Title:** Effectiveness of Scapular Muscle Training in Improving Grip Strength Among Lateral Epicondylitis Patients #### Organization Study ID Info **ID:** MSRSW/Batch-Fall22/710 #### Organization **Class:** OTHER **Full Name:** Superior University ### Status Module #### Completion Date **Date:** 2024-09-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-24 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-04-01 **Type:** ACTUAL #### Start Date **Date:** 2023-11-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Muhammad Naveed Babur #### Responsible Party **Investigator Affiliation:** Superior University **Investigator Full Name:** Muhammad Naveed Babur **Investigator Title:** Principal Investigator **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The effectiveness of scapular muscular training along with conventional physiotherapy on the improving the grip strength of the patients suffering with the lateral epicondylitis was assessed by diving 56 patinets in two grousp as Group A (n=28) was treated with conventional physiotherapy treatment and Group B (n=28) was treated with Scapular strengthening and conventional physiotherapy protocol. ### Conditions Module **Conditions:** - Lateral Epicondylitis ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 56 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Diagnostic Test: Left/ Right affected arm **Label:** Left/ Right affected arm **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Intervention Names:** - Other: Grip strength **Label:** Grip strength **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Left/ Right affected arm **Description:** Therapeutic exercises: eccentric and concentric exercises and wrist isometrics 10 repetitions of 3 sets with 10 seconds interval **Name:** Left/ Right affected arm **Type:** DIAGNOSTIC_TEST #### Intervention 2 **Arm Group Labels:** - Grip strength **Description:** assessed by using modified sphygmomanometer in which it first inflated to 100 mmHg with closed valve. The pressure was reduced to 20mmHg and the resisted wrist extension performed at baseline and at the 4th week. **Name:** Grip strength **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Measured by Patient-Rated Tennis Elbow Evaluation (PRTEE)from the scoring between 0-100 at baseline and at the 4th week. **Measure:** Severity of Disability **Time Frame:** 12 Months **Description:** assessed by using modified sphygmomanometer in which it first inflated to 100 mmHg with closed valve. The pressure was reduced to 20mmHg and the resisted wrist extension performed at baseline and at the 4th week. **Measure:** Grip strength: **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age: 20-50 years * Gender: Male and Female * Pain on the lateral epicondyle * VAS scoring more than 4 * Positive test: Tomson test, Mill's test , Cozen;s sign and Maudsley's test Exclusion Criteria: * Any neurological/ Radiculopathy signs in upper limb * Cervical pain * Bilateral elbow pain * History of elbow or wrist surgery * Receiving any corticosteroid injection within last 6 months **Maximum Age:** 50 Years **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Bhakkar **Country:** Pakistan **Facility:** Fatima medical center near green town **State:** Punjab ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000070639 - Term: Elbow Tendinopathy - ID: D000052256 - Term: Tendinopathy - ID: D000009135 - Term: Muscular Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000092464 - Term: Elbow Injuries - ID: D000001134 - Term: Arm Injuries - ID: D000014947 - Term: Wounds and Injuries - ID: D000013708 - Term: Tendon Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M16486 - Name: Tennis Elbow - Relevance: HIGH - As Found: Lateral Epicondylitis - ID: M10295 - Name: Influenza, Human - Relevance: LOW - As Found: Unknown - ID: M27013 - Name: Tendinopathy - Relevance: LOW - As Found: Unknown - ID: M627 - Name: Elbow Tendinopathy - Relevance: LOW - As Found: Unknown - ID: M12092 - Name: Muscular Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M2926 - Name: Elbow Injuries - Relevance: LOW - As Found: Unknown - ID: M4444 - Name: Arm Injuries - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M16479 - Name: Tendon Injuries - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000013716 - Term: Tennis Elbow ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06438315 **Acronym:** SSCORE **Brief Title:** SuperSaturated Oxygen Comprehensive Observational Registry **Official Title:** SuperSaturated Oxygen Comprehensive Observational Registry #### Organization Study ID Info **ID:** EDC-5731 #### Organization **Class:** INDUSTRY **Full Name:** TherOx ### Status Module #### Completion Date **Date:** 2029-03-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-24 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-03 **Type:** ESTIMATED #### Start Date **Date:** 2024-08-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** TherOx #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The SuperSaturated Oxygen Comprehensive Observational Registry (SSCORE) registry, a prospectively designed observational study, aims to evaluate the clinical utility and effectiveness of SSO2 Therapy versus PCI alone among patients with anterior AMI in routine clinical practice. The goal is to collect real-world data from patients treated with SSO2 Therapy to determine its impact on the overall HF burden on patients and healthcare systems compared with usual care for treatment of patients with AMI. The SSCORE Registry will generate effectiveness and healthcare resource utilization data that will be used in cost-effectiveness analysis modeling. ### Conditions Module **Conditions:** - STEMI - ST Elevation Myocardial Infarction - AMI ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 1000 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 2 Years ### Arms Interventions Module #### Arm Group 1 **Description:** Treated with SSO2 **Intervention Names:** - Other: No intervention **Label:** SSO2 #### Arm Group 2 **Description:** Not treated with SSO2 **Intervention Names:** - Other: No intervention **Label:** Control ### Interventions #### Intervention 1 **Arm Group Labels:** - Control - SSO2 **Description:** No intervention **Name:** No intervention **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Rate of composite of CV death, new onset HF, any new inpatient or outpatient treatment for HF, or worsening of HF **Measure:** CV death or Heart Failure burden at 1 year **Time Frame:** 1 year #### Secondary Outcomes **Description:** Days to the composite of CV death, new onset HF, any new inpatient or outpatient treatment for HF, or worsening of HF **Measure:** Time to CV death or HF burden **Time Frame:** 2 years **Description:** Rate of all cause mortality **Measure:** Rate of all cause mortality **Time Frame:** 2 years **Description:** Rate of All-cause Hospitalization **Measure:** Rate of All-cause Hospitalization **Time Frame:** 2 years **Description:** Rate of cardiovascular death **Measure:** Rate of cardiovascular death **Time Frame:** 2 years **Description:** Rate of Hospitalization for Heart Failure **Measure:** Rate of Hospitalization for Heart Failure **Time Frame:** 2 years **Description:** composite of rates of CV death, reinfarction, or HF hospitalization **Measure:** Major Adverse Cardiovascular Events (MACE) **Time Frame:** 2 years **Description:** Rate of Reinfarction **Measure:** Rate of Reinfarction **Time Frame:** 2 years **Description:** patient reported outcome, 0 to1, where 0 is death and 1 is perfect health **Measure:** Change in EQ5D-3L Score **Time Frame:** 2 years **Description:** heart related patient reported outcome, scaled from 0 to 100, with 0 representing the worst symptoms and function and 100 representing the best **Measure:** Change in KCCQ-23 Score **Time Frame:** 2 years **Description:** Rate of change of LVEF from baseline to time point **Measure:** Change in LVEF% **Time Frame:** 2 years **Description:** Rate of change of NHYA classification from baseline to time point **Measure:** Change in NYHA classification scale, I-IV **Time Frame:** 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Men or women aged 18 years or older * Presentation with AMI and successful revascularization of the infarct-related artery with PCI * The subject or their legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided and signed written informed consent, approved by the appropriate Institutional Review Board (IRB) Exclusion Criteria: * Life expectancy of less than 2 years * No access to medical records from either the index hospitalization or subsequent outpatient visits * Currently participating in an investigational drug or device trial **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The study will aim to prospectively enroll 500 subjects not treated with SSO2 Therapy (Prospective Control Cohort), 500 subjects who received SSO2 Therapy in accordance with the product label (SSO2 Treated On-Label) and any subjects that receive SSO2 at an institution that meet criteria IE criteria. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** jgardner@zoll.com **Name:** Jennifer Gardner **Phone:** 949-300-2811 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Henry Ford Hospital **Name:** William W O'Neill, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Stone GW, Martin JL, de Boer MJ, Margheri M, Bramucci E, Blankenship JC, Metzger DC, Gibbons RJ, Lindsay BS, Weiner BH, Lansky AJ, Krucoff MW, Fahy M, Boscardin WJ; AMIHOT-II Trial Investigators. Effect of supersaturated oxygen delivery on infarct size after percutaneous coronary intervention in acute myocardial infarction. Circ Cardiovasc Interv. 2009 Oct;2(5):366-75. doi: 10.1161/CIRCINTERVENTIONS.108.840066. Epub 2009 Sep 15. **PMID:** 20031745 **Citation:** David SW, Khan ZA, Patel NC, Metzger DC, Wood FO, Wasserman HS, Lotfi AS, Hanson ID, Dixon SR, LaLonde TA, Genereux P, Ozan MO, Maehara A, Stone GW. Evaluation of intracoronary hyperoxemic oxygen therapy in acute anterior myocardial infarction: The IC-HOT study. Catheter Cardiovasc Interv. 2019 Apr 1;93(5):882-890. doi: 10.1002/ccd.27905. Epub 2018 Sep 28. **PMID:** 30265429 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007511 - Term: Ischemia - ID: D000010335 - Term: Pathologic Processes - ID: D000009336 - Term: Necrosis - ID: D000017202 - Term: Myocardial Ischemia - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000014652 - Term: Vascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12155 - Name: Myocardial Infarction - Relevance: HIGH - As Found: Myocardial Infarction - ID: M1072 - Name: ST Elevation Myocardial Infarction - Relevance: HIGH - As Found: ST Elevation Myocardial Infarction - ID: M10282 - Name: Infarction - Relevance: HIGH - As Found: Infarction - ID: M10543 - Name: Ischemia - Relevance: LOW - As Found: Unknown - ID: M12284 - Name: Necrosis - Relevance: LOW - As Found: Unknown - ID: M6546 - Name: Coronary Artery Disease - Relevance: LOW - As Found: Unknown - ID: M19506 - Name: Myocardial Ischemia - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009203 - Term: Myocardial Infarction - ID: D000072657 - Term: ST Elevation Myocardial Infarction - ID: D000007238 - Term: Infarction ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06438302 **Acronym:** VENTINA **Brief Title:** Effects of Nasal Ventilation on Cerebral and Pulmonary Function in Orally Intubated Patients **Official Title:** Effects of Nasal Ventilation on Cerebral and Pulmonary Function in Orally Intubated Patients #### Organization Study ID Info **ID:** APHP240271 #### Organization **Class:** OTHER **Full Name:** Assistance Publique - Hôpitaux de Paris ### Status Module #### Completion Date **Date:** 2025-06-22 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06-22 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-21 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Assistance Publique - Hôpitaux de Paris #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The passage of air through the nasal cavity generates rhythmic oscillations transmitted by the olfactory bulb to the brain, which induces cerebral activation in functional areas and is associated with better cognitive performance compared to oral breathing. Consequently, the abolition of nasal ventilation in patients intubated via the orotracheal route could have deleterious effects on brain activity. Besides the loss of olfaction, the abolition of nasal ventilation could affect brain activity and respiratory control, consequently altering regional pulmonary ventilation. The hypothesis of the study is that nasal ventilation through the passage of humidified nasal airflow in patients intubated via the orotracheal route would be associated with modulation of cerebral electrical activity and tissue oxygenation and a modification of regional pulmonary ventilation. **Detailed Description:** The effects of nasal ventilation on cerebral activity will be studied on orally intubated and sedated patients in six experimental conditions. The first condition consists of nociceptive stimulation of the left upper limb as a negative control. In three conditions, the inspired fraction of oxygen (FiO2) will remain at 21% while applying three different rates of humidified nasal air at 0L/min, 30L/min and 60L/min respectively. The last two conditions consist of applying humidified nasal air at 30L/min and 60L/min with a FiO2 of 100%. The primary objective of this study is to evaluate the effects of high-flow humidified nasal air on electroencephalogram activity (root mean square gamma frequency) in sedated, orally intubated patients. The secondary objectives of the study are to evaluate the effects of high-flow humidified nasal air on cerebral perfusion and oxygenation, gas exchange and regional pulmonary ventilation in the same patients. ### Conditions Module **Conditions:** - Hypoxemic Acute Respiratory Failure **Keywords:** - nasal ventilation - orotracheal intubation - brain activity ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 22 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The study population will be adult patients with acute respiratory failure who are orally intubated and sedated. These patients should be free of neurological and psychiatric diseases prior to ICU admission. The choice of this particular population is justified by its exposure to mechanical ventilation and continuous sedation, which are recognized risk factors for brain damage. **Intervention Names:** - Device: EEG activity measurement **Label:** Major mechanically ventilated patients intubated orotracheally ### Interventions #### Intervention 1 **Arm Group Labels:** - Major mechanically ventilated patients intubated orotracheally **Description:** The nasal ventilation device (placed as part of the research) (AIRVO 2; Fisher and Paykel Healthcare, Auckland, New Zealand) will be positioned via nasal cannulas adapted to the patient's anatomy. The FiO2 will be set at 21% and the flow rate will be fixed at 0 L/min at the inclusion visit. The temperature of the humidified nasal oxygenator will be set at 37°C. Six 30-minute experimental conditions will be performed successively: 1) 0 L/min flow, FiO2 21%, 2) 30 L/min flow, FiO2 21%, 3) 30 L/min flow, FiO2 100%, 4) 60 L/min flow, FiO2 21%, 5) 60 L/min flow, FiO2 100%, 6) Negative control. At the end of each condition, a 10-minute thoracic electrical impedance tomography recording, a 10-minute EEG recording, a 10-minute cerebral NIRS recording and an instantaneous temporal Doppler velocity measurement will be performed. A blood gas (1.5 mL) will also be taken at the end of each condition. **Name:** EEG activity measurement **Other Names:** - Post-intubation nasal ventilation - Additional blood samples (from care catheter 1.5 mL) - Electrical impedance tomography **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** EEG spectral density spectrum of gamma frequency. **Measure:** Study the effects of nasal ventilation on brain electrical activity using electroencephalogram recording (EEG) in sedated orotracheally intubated patients. **Time Frame:** At inclusion (day 1) - step 1 to 6 #### Secondary Outcomes **Description:** This outcome will be assessed by the evaluation of the Index of Pulsatility (IP) (IP=(Vs-Vd)/Vm: Vs: Systolic velocity; Vd: Diastolic Velocity; Vm: Mean Velocity) **Measure:** Study the effects of nasal ventilation on cerebral perfusion **Time Frame:** At inclusion (day 1) - step 1 to 6 **Description:** Cerebral tissue oxygenation (% of O2) measured by NIRS (Near Infrared Spectroscopy) electrodes **Measure:** Study the effects of nasal ventilation on cerebral tissue oxygenation **Time Frame:** At inclusion (day 1) - step 1 to 6 **Description:** Ratio of PaO2 (partial pressure of O2) /FiO2 (inspired oxygen fraction) **Measure:** Study the effects of nasal ventilation on gas exchange **Time Frame:** At inclusion (day 1) - step 1 to 6 **Description:** Evaluation of PaCO2 (partial pressure of CO2) (mmHG) **Measure:** Study the effects of nasal ventilation on gas exchange **Time Frame:** At inclusion (day 1) - step 1 to 6 **Description:** Evaluation of impedance variation by thoracic electrical impedance tomography. **Measure:** Study the effects of nasal ventilation on regional lung ventilation distribution **Time Frame:** At inclusion (day 1) - step 1 to 6 **Description:** Evaluation of ventilation homogeneity by I thoracic electrical impedance tomography. **Measure:** Study the effects of nasal ventilation on regional lung ventilation distribution **Time Frame:** At inclusion (day 1) - step 1 to 6 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age ≥ 18 years old 2. Hypoxemic acute respiratory failure 3. Intubation and mechanical ventilation since less than 4 days 4. PaO2/FiO2 ratio less than 150 5. RASS\<-4 6. Consent obtained from next of kin 7. Patient with health insurance Exclusion Criteria: 1. Central nervous system diseases (stroke, MS, epilepsy) 2. Psychiatric illnesses (psychosis, depression) (indicated on patient's medical record) 3. Hemodynamic instability (noradrenalin\>2mg/h) 4. Patient on AME 5. Patients under legal protection (guardianship/curators) 6. Pregnant or breast-feeding women **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The study population will be adult patients with acute respiratory failure who are orally intubated and sedated. These patients should be free of neurological and psychiatric diseases prior to ICU admission. The choice of this particular population is justified by its exposure to mechanical ventilation and continuous sedation, which are recognized risk factors for brain damage. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** martin.dres@aphp.fr **Name:** Martin Dres **Phone:** 0142167809 **Role:** CONTACT ### IPD Sharing Statement Module **Access Criteria:** Researchers who provide a methodologically sound proposal. **Description:** The procedures carried out with the French data privacy authority (CNIL, "Commission nationale de l'informatique et des libertés") do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations **Info Types:** - STUDY_PROTOCOL - ICF **IPD Sharing:** YES **Time Frame:** Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012120 - Term: Respiration Disorders - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M14968 - Name: Respiratory Insufficiency - Relevance: HIGH - As Found: Hypoxemic Acute Respiratory Failure - ID: M14957 - Name: Respiration Disorders - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012131 - Term: Respiratory Insufficiency ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06438289 **Acronym:** DISLOTIP **Brief Title:** Ultrasound to Investigate Tip Dislodgment of Epicutaneous-caval Catheter. **Official Title:** Use of Ultrasound to Investigate Tip Dislodgment of Epicutaneous-caval Catheter: a Multicentric Study #### Organization Study ID Info **ID:** Protocol 335 #### Organization **Class:** OTHER **Full Name:** Federico II University ### Status Module #### Completion Date **Date:** 2025-01-17 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-29 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-01-17 **Type:** ESTIMATED #### Start Date **Date:** 2024-01-17 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-24 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Federico II University #### Responsible Party **Investigator Affiliation:** Federico II University **Investigator Full Name:** Francesco Raimondi **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Oversight Has DMC:** True ### Description Module **Brief Summary:** This is a non-pharmacological, non-profit, prospective, observational multicenter study. Primarily, the study aims to demonstrate the feasibility of ultrasound methodology to study the secondary malposition of epicutaneous-caval catheters (ECC) in neonates. After obtaining informed consent, the study involves performing ultrasound tip location on newborns who had an ECC placed. This will occur immediately after the placement and, if in a central position, subsequently at 60-120 minutes, 48-72 hours and 6-8 days post-placement. Data will be collected on various variables. Each Center will contribute at least 20 cases to the cohort and all data will be recorded in a database. The study is expected to last for 12 months **Detailed Description:** Epicutaneous-caval catheters (ECCs) are among the most common central venous catheters used in neonatology. It is known that they can experience malpositioning over time from the moment of placement, leading to complications. In all studies conducted so far, tip location has been performed using X-ray. Ultrasound would be the ideal method for serial, bedside and radiatIon-free evaluation of ECC tip location to intercept any migrations. The primary endpoint of the study is to demonstrate the feasibility of ultrasound method for the assessment of secondary ECC malposition. Secondary endpoints include validating the results of previous Investigators monocentric study on the feasibility of ultrasound tip location applied to ECC and establishing the incidence of secondary malpositioning and the optimal timing for reassessing tip position after ECC placement. All neonates undergoing placement of 28 Gauge/1 French ECCs with a standardized securement system are included in the study, while neonates with major malformation are excluded. The study includes: obtaining written informed consent; performing ultrasound tip location using a standardized protocol (high right parasternal, apical four-chamber, short-axis left parasternal and bicaval subcostal views); If the tip is in a central position, repeating ultrasound tip location (using the same protocol) at 60-120 minutes, 48-72 hours and 6-8 days post-placement; collecting variables including sex, site of ECC insertion, weight at placement and at each tip location, postmenstrual age at placement and at each tip location, days of life at placement and at each tip location, respiratory support at placement and at each tip location, feasibility of ultrasound tip location for each ECC and for each specified time, ultrasound tip location result for each ECC and for each specified time and any displacement relative to the time of placement, as wall as any reported complications associated with secondary malpositioning. All ultrasound will be performed with the newborn in a standardized position: limb adducted and elbow extended if the catheter is placed from the upper limb, limb adducted and knee extended if the catheter is placed from the lower limb, neutral position if the catheter is placed from the scalp. The records of the ultrasound exams at each time for the first five cases enrolled by each Center will be sent to the Coordinator Center for evaluation of protocol compliance. Using the exact binomial method and setting a margin of error of 4% for a 95% of confidence interval, the investigators calculated that the sample size should be 196. The collected data will be recorded anonymously in an Excel database. Continuous variables will be expressed as means with minimum and maximum ranges, while categorical variables will be expressed as frequencies with percentages. Each case will be identified with an alphanumeric code to ensure data confidentiality. The principal investigator is the only person able to link the code to the identity of the patient. Parents, relative or guardians of eligible patients will be provided with all explanations regarding the experimental protocol by the study staff before enrollment. Information will be provided and parents will be given up to 12 hours to give their consent. The principal investigator will be responsible for the overall monitoring of data and the safety of the study participants. No funding or additional costs beyond common current practice are anticipated. ### Conditions Module **Conditions:** - Migration of Implant or Internal Device **Keywords:** - tip location - ultrasound - epicutaneous-caval catheter - tip secondary migration - newborn - ECC ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 196 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** percentage, from 0% to 100% **Measure:** Percentage of cases in which ultrasound tip location is feasible to study ECC secondary malposition **Time Frame:** 8 days from the ECC placement ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * neonates undergoing placement of 28 G/1 Fr ECCs with a standardized securement system Exclusion Criteria: * neonates with major malformation **Healthy Volunteers:** True **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** neonates undergoing placement of 28G/1 Fr ECCs with a standardized securement system ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** raimondi@unina.it **Name:** Francesco Raimondi **Phone:** +393392683848 **Role:** CONTACT **Contact 2:** **Email:** fiorentino.grasso89@gmail.com **Name:** Fiorentino Grasso **Phone:** +393290710660 **Role:** CONTACT #### Locations **Location 1:** **City:** Naples **Contacts:** ***Contact 1:*** - **Email:** raimondi@unina.it - **Name:** Francesco Raimondi, Professor - **Phone:** +393392683848 - **Role:** CONTACT ***Contact 2:*** - **Email:** fiorentino.grasso89@gmail.com - **Name:** Fiorentino Grasso, MD - **Phone:** +393290710660 - **Role:** CONTACT **Country:** Italy **Facility:** AOU Federico II- Neonatal Intensive Care Unit **Status:** RECRUITING **Zip:** 80131 ### References Module #### References **Citation:** Practice Guidelines for Central Venous Access 2020: An Updated Report by the American Society of Anesthesiologists Task Force on Central Venous Access. Anesthesiology. 2020 Jan;132(1):8-43. doi: 10.1097/ALN.0000000000002864. No abstract available. **PMID:** 31821240 **Citation:** Barone G, Pittiruti M. Epicutaneo-caval catheters in neonates: New insights and new suggestions from the recent literature. J Vasc Access. 2020 Nov;21(6):805-809. doi: 10.1177/1129729819891546. Epub 2019 Dec 5. **PMID:** 31804149 **Citation:** Costello JM, Clapper TC, Wypij D. Minimizing complications associated with percutaneous central venous catheter placement in children: recent advances. Pediatr Crit Care Med. 2013 Mar;14(3):273-83. doi: 10.1097/PCC.0b013e318272009b. **PMID:** 23392365 **Citation:** de Jonge RC, Polderman KH, Gemke RJ. Central venous catheter use in the pediatric patient: mechanical and infectious complications. Pediatr Crit Care Med. 2005 May;6(3):329-39. doi: 10.1097/01.PCC.0000161074.94315.0A. **PMID:** 15857534 **Citation:** Acun C, Baker A, Brown LS, Iglesia KA, Sisman J. Peripherally inserted central cathether migration in neonates: Incidence, timing and risk factors. J Neonatal Perinatal Med. 2021;14(3):411-417. doi: 10.3233/NPM-200684. **PMID:** 33459671 **Citation:** Gupta R, Drendel AL, Hoffmann RG, Quijano CV, Uhing MR. Migration of Central Venous Catheters in Neonates: A Radiographic Assessment. Am J Perinatol. 2016 May;33(6):600-4. doi: 10.1055/s-0035-1570341. Epub 2016 Jan 5. **PMID:** 26731179 **Citation:** Srinivasan HB, Tjin-A-Tam A, Galang R, Hecht A, Srinivasan G. Migration patterns of peripherally inserted central venous catheters at 24 hours postinsertion in neonates. Am J Perinatol. 2013 Nov;30(10):871-4. doi: 10.1055/s-0033-1333672. Epub 2013 Feb 4. **PMID:** 23381907 **Citation:** Grasso F, Capasso A, Pacella D, Borgia F, Salome S, Capasso L, Raimondi F. Ultrasound Guided Catheter Tip Location in Neonates: A Prospective Cohort Study. J Pediatr. 2022 May;244:86-91.e2. doi: 10.1016/j.jpeds.2021.12.059. Epub 2021 Dec 28. **PMID:** 34971654 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12307 - Name: Neoplasm Metastasis - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06438276 **Acronym:** JAPSY **Brief Title:** Psychiatric Outreach Nurses Supporting Adolescent Mental Health **Official Title:** Supporting Adolescent Mental Health by Psychiatric Outreach Nurses: A Mixed Method Evaluation Study #### Organization Study ID Info **ID:** JAPSY_20230 #### Organization **Class:** OTHER **Full Name:** University of Eastern Finland ### Status Module #### Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-24 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-06 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-06 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Wellbeing Services County of North Savo **Class:** UNKNOWN **Name:** The Foundation for Municipal Development #### Lead Sponsor **Class:** OTHER **Name:** University of Eastern Finland #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The study evaluates the effectiveness and cost-effectiveness of the outreach work of psychiatric registered nurses (RN) and the experiences of professionals in the field. The service is provided in school environment. First, the study will assess the effectiveness of brief interventions provided by psychiatric outreach nurses on the perceived mental health and quality of life of adolescents (12-16 year old pupils) and their use of social and health services, compared to the support/treatment provided by conventional student welfare services at 6 and 12 months follow-up. The intervention is an outreach service provided by psychiatric nurses. In the intervention, the psychiatric registered nurse will implement interventions such as usual care, discussion, psychoeducation, substance abuse skills and various methods (such as interpersonal psychotherapy = IPT-N and Cool Kids) and motivational interviewing. Secondly, an economic evaluation of the service will be carried out at 6 and 12 months follow-up. The economic evaluation will be carried out from the perspective of the Wellbeing Services County, including the costs of implementing the intervention model and its effects on adolescents' use of student welfare services as well as other social and health services. Primarily, the economic evaluation will use quality-weighted life years as a measure of effectiveness. Also analysis using depression, anxiety and substance use measures will be conducted. Thirdly, the study will explore the experiences of psychiatric nurses implementing the service as well as the experiences of their collaborators in schools (public health nurses, school social workers, psychologists, doctors and teachers) about the service and its implementation. **Detailed Description:** Quantitative research data will be used to evaluate the effectiveness of the psychiatric outreach care compared to conventional care (TAU). Psychiatric outreach registered nurses are currently available in some schools in several municipalities in the North Savo region in Finland. In the other schools, support is provided by so-called "usual" counselling and other support/treatment, e.g. by public health nurses, school social workers, school psychologists and school doctors. The study design is a clustered controlled setting. The target sample size for quantitative data is 160 participants. The intervention group (n = 80) will consist of pupils receiving support/treatment from psychiatric outreach nurses. The control group (n = 80) will consist of pupils whose schools provide standard student welfare services and whose mental health status and support needs are similar to those of the intervention group. The data will be collected through questionnaires administered to secondary school pupils to assess their mental health status and quality of life. The adolescents' service use in terms of student welfare services as well as Wellbeing Services County's social and health care services will be collected through questionnaires. At baseline, the use of services will be surveyed retrospectively over a six-month period. The primary outcome variable of the intervention is the adolescent's perceived mental health status as assessed by the PHQ-9-A (Patient Health Questionnaire) measure of depression and the GAD-7 (generalized anxiety disorder) measure of anxiety. The secondary outcome variables are the adolescent's perceived quality of life (EQ-5D-Y, five dimensional quality of life measure) and substance use (ADSUME, Adolescents´ Substance Use Measurement). The study will primarily investigate the effect of psychiatric outreach nurses on treatment response. Secondarily, subgroups of at least 20 participants will be examined (e.g. controls for gender, age or other background variables). Participants are assigned to the intervention or control group based on whether the services of an psychiatric outreach nurse is available in their school (intervention) or not (control). For similarities and differences between the intervention and control groups, a descriptive analysis is performed using the chi-square test to compare categorical variables and the t-test or Mann-Whitney U-test to compare continuous variables. The effectiveness of the intervention will be analysed using statistical methods appropriate for panel data, taking into account the effects of possible correlation/multicollinearity on the results. Statistical methods will be used to control for the possible selection of a non-standardised design by including control variables in the models. The economic evaluation of the intervention will use data on the use of social and health services, student welfare services and the cost of the intervention. Data on the costs of the intervention will be obtained from the Wellbeing Services County of North Savo. The costs of health and social services and student welfare services are calculated on the basis of the number of services used and the unit costs. The cost-effectiveness of the intervention is analysed in relation to the treatment as usual provided by student welfare services using incremental net monetary benefit or incremental net health benefit evaluation to examine differences in costs and/or health benefits between groups and in the above-mentioned outcomes at 6-month and 12-month follow-up. Primarily, the economic evaluation will use the EQ-5D-Y measure to calculate quality-weighted life-years. In addition, the results of the PHQ-9-A, GAD-7 and ADSUME measures will be analysed. Eligibility Criteria: Pupils (12-16 years old) who seek help from a student welfare service due to mood disorders. In addition, a representative of the student welfare service (e.g. a public health nurse, school social worker, psychologist or doctor) or a representative of the student welfare service and an psychiatric outreach nurse assess together a person's eligibility for the study, taking into account the inclusion and exclusion criteria. Inclusion criteria for the intervention and control groups will be one or more of the following symptoms: prolonged and/or complicated anxiety, mood symptoms, obsessive-compulsive and/or eating disorder symptoms, mild to moderate self-harm (e.g. death wishes or cutting). In addition, the young person's motivation to receive the service is an admission criterion. Exclusion criteria: The psychiatric outreach nurse service is not suitable for persons with one or more of the following needs or life situations: pupils who need light support and guidance, young people with a single problem of low motivation for school, young people with a stressful life situation or relationship problems. On the other hand, the service is not intended for pupils who are in acute need of specialist care or for pupils with multidisciplinary problems for whom support measures have already been put in place, because of their mental health symptoms (e.g. severe depression, psychotic symptoms, severe and acute suicidal tendencies or a clear suicide plan). Exclusion criteria for the intervention and control groups also include situations where the young person has a long-lasting, already established mental health problem and/or a need for further treatment after a period of specialised hospital care. Exclusion criteria also include behavioural disorders where there is a clear underlying cause other than a mental disorder. The qualitative perspective of the study focuses on those implementing the service (psychiatric outreach nurses) and their collaborators in schools (e.g. school social workers, public health nurses, school psychologists, doctors and teachers). The total number of interviewees is estimated to be 15-20. Data collection consists of individual semi-structured interviews to describe the interviewees' experiences of applying the new service approach in the school setting. As the approach is new in the Wellbeing Services County of North Savo, it is necessary to explore the experiences of both those implementing as well as their collaborators in terms of introducing the service, operation of the service, the perceived needs for the service as well as the needs for development of the service. The interviews will be carried out at the beginning of the study and at 12-month follow-up. ### Conditions Module **Conditions:** - Depression - Anxiety **Keywords:** - mental health - mental disorders - adolescent - outreach service - school-based - effectiveness - economic evaluation ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 160 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Intervention group receiving psychiatric outreach nurse services: adolescents (12-16 years old) who seek help from student welfare services due to mood disorders and have access to psychiatric outreach nurse's service. Control group receiving TAU: adolescents (12-16 years old) who seek help from student welfare services due to mood disorders and have no access to psychiatric outreach nurse's service. **Intervention Names:** - Behavioral: Psychiatric outreach nurse service **Label:** Adolescents with mood disorders seeking help in student welfare services ### Interventions #### Intervention 1 **Arm Group Labels:** - Adolescents with mood disorders seeking help in student welfare services **Description:** Mental health service provided by psychiatric outreach nurses for 12-16 year old students in secondary schools **Name:** Psychiatric outreach nurse service **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The effects of the outreach psychiatric nurse service on adolescent's perceived mental health status assessed by the Patient Health Questionnaire modified for adolescent (PHQ-9-A) measure of depression in 6-month and 12-month follow-up. The minimum value of the measure is 0 and maximum value 27. Higher scores is worse outcome. **Measure:** Patient Health Questionnaire modified for adolescent to measure perceived mental health **Time Frame:** 6-month and 12-month follow-up **Description:** The effects of the outreach psychiatric nurse service on adolescent's perceived mental health status assessed by the Generalized Anxiety Disorder 7-item (GAD-7) measure of anxiety in 6-month and 12-month follow-up. The minimum value of the measure is 0 and maximum value 21. Higher scores is worse outcome. **Measure:** Generalized Anxiety Disorder 7-item to measure adolescent's perceived mental health **Time Frame:** 6-month and 12-month follow-up #### Secondary Outcomes **Description:** The effects of the outreach psychiatric nurse service on adolescent's perceived quality of life and substance use assessed by EuroQol- 5-Dimension 3-Level modified for adolescent (EQ-5D-Y-3L) measure in 6-month and 12-month follow-up. EQ-5D-Y will be converted to index-values \[theoretical range 0-1\] by using suitable value set. The higher value means better health related quality of life. **Measure:** EuroQol-5-Dimension 3-Level modified for adolescent to measure perceived quality of life **Time Frame:** 6-month and 12-month follow-up **Description:** The effects of the outreach psychiatric nurse service on adolescent's substance use assessed by Adolescents' Substance Use Measurement (ADSUME) measure in 6-month and 12-month follow-up.The minimum value of the measure is 0 and maximum value 90. Higher scores is worse outcome **Measure:** Adolescents' Substance Use Measurement to measure substance use **Time Frame:** 6-month and 12-month follow-up ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adolescents (12-16 years old) who seek help from student welfare services due to mood disorders and who have one or more of the following conditions: prolonged and/or complicated anxiety, mood symptoms, obsessive-compulsive and/or eating disorder symptoms, mild to moderate self-harm (e.g. death wishes or cutting). In addition, person's motivation to receive the service provided is an admission criterion. Exclusion Criteria: * Persons with one or more of the following needs or life situations: adolescents who need light support and guidance, young people with a single problem of low motivation for school, young people with a stressful life situation or relationship problems. On the other hand, adolescents who are in acute need of specialist care or for adolescents with multidisciplinary problems for whom support measures have already been put in place, because of their mental health symptoms (e.g. severe depression, psychotic symptoms, severe and acute suicidal tendencies or a clear suicide plan). * Exclusion criteria for the intervention and control groups also include situations where the adolescent has a long-lasting, already established mental health problem and/or a need for further treatment after a period of specialised hospital care. * Exclusion criteria also include behavioural disorders where there is a clear underlying cause other than a mental disorder. **Maximum Age:** 16 Years **Minimum Age:** 12 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD **Study Population:** Adolescent (12-16 year old) students of secondary schools in the municipalities of North Savo Wellbeing County who seek help from student welfare services due to mood disorders. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** anne.surakka@uef.fi **Name:** Anne Surakka, M.Soc.Sc, MHS (Health Econ.) **Phone:** +358505292553 **Role:** CONTACT #### Locations **Location 1:** **City:** Kuopio **Contacts:** ***Contact 1:*** - **Email:** sanna.kukkonen@pshyvinvointialue.fi - **Name:** Sanna Kukkonen, MHS - **Phone:** +35817173311 - **Role:** CONTACT ***Contact 2:*** - **Email:** sanna.voutilainen@pshyvinvointialue.fi - **Name:** Sanna Voutilainen - **Phone:** +35817173311 - **Role:** CONTACT **Country:** Finland **Facility:** Wellbeing Services County of North Savo **State:** North Savo **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** University of Eastern Finland **Name:** Johanna Lammintakanen, PhD, Professor **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001526 - Term: Behavioral Symptoms ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7058 - Name: Depression - Relevance: HIGH - As Found: Depression - ID: M4324 - Name: Anxiety Disorders - Relevance: LOW - As Found: Unknown - ID: M7061 - Name: Depressive Disorder - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003863 - Term: Depression ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06438263 **Brief Title:** A Study to Evaluate Bioavailability of Rocatinlimab Autoinjector and Vial in Healthy Participants **Official Title:** An Open-label, Phase 1, Single Dose, Randomized, Parallel-group Study to Assess the Relative Bioavailability of Rocatinlimab (AMG 451) Autoinjector and Vial in Healthy Subjects #### Organization Study ID Info **ID:** 20220014 #### Organization **Class:** INDUSTRY **Full Name:** Amgen ### Status Module #### Completion Date **Date:** 2025-01-16 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-27 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-01-16 **Type:** ESTIMATED #### Start Date **Date:** 2024-08-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Amgen #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True ### Description Module **Brief Summary:** The main objective of this study is to evaluate the pharmacokinetics (PK) of rocatinlimab given as a single subcutaneous (SC) autoinjector dose compared to vial in healthy participants. ### Conditions Module **Conditions:** - Atopic Dermatitis **Keywords:** - Rocatinlimab ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 230 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will be randomized to receive a single dose of rocatinlimab vial solution for SC injection. **Intervention Names:** - Drug: Rocatinlimab **Label:** Treatment A **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will be randomized to receive a single dose of rocatinlimab autoinjector for SC injection. **Intervention Names:** - Drug: Rocatinlimab **Label:** Treatment B **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Treatment A **Description:** Vial supplied as a single-use preservative free solution for SC injection. **Name:** Rocatinlimab **Other Names:** - AMG 451 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Treatment B **Description:** Autoinjector for SC injection. **Name:** Rocatinlimab **Other Names:** - AMG 451 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Maximum Plasma Concentration (Cmax) of Rocatinlimab **Time Frame:** Up to approximately 112 days **Measure:** Area Under the Serum Concentration-time Curve (AUC) From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Rocatinlimab **Time Frame:** Up to approximately 112 days **Measure:** AUC From Time Zero to Infinity (AUCinf) of Rocatinlimab **Time Frame:** Up to approximately 112 days #### Secondary Outcomes **Description:** TEAEs are any adverse events (AEs) that occurred after the participant received study treatment. Any clinically significant changes in vital signs, electrocardiograms (ECG), and clinical laboratory tests that occurred after study treatment administration will be recorded as TEAEs. A serious AE (SAE) is defined as any AE that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect or important medical events that do not meet the preceding criteria but based on appropriate medical judgment may jeopardize the participant or may require medical or surgical intervention to prevent any of the outcomes listed above. **Measure:** Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) **Time Frame:** Approximately 20 weeks **Measure:** Number of Participants with Anti-rocatinlimab Antibodies **Time Frame:** Up to approximately Day 112 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Participant has provided informed consent before initiation of any study-specific activities/procedures. 2. Healthy male or female participants, between 18 and 65 years of age (inclusive) 3. Body mass index between 18 and 32 kg/m2 (inclusive) Exclusion Criteria: 1. History or evidence, at Screening or Check-in, of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion. 2. History or evidence of clinically significant arrhythmia at Screening, including any clinically significant findings on the ECG taken at Check-in. 3. A QT interval corrected for heart rate using Fridericia's method (QTcF) \> 450 msec in male participants or \> 470 msec in female participants or history/evidence of long QT syndrome at Screening or Check-in. 4. Systolic blood pressure ≥ 140 mmHg or ≤ 90 mmHg, or diastolic blood pressure ≥ 90 mmHg or ≤ 50 mmHg, or pulse rate ≥ 100 bpm or ≤ 40 bpm 5. History of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee). Participants with seasonal allergies will be permitted. 6. Estimated glomerular filtration rate less than 70 mL/min/1.73 m2 7. Alanine aminotransferase or aspartate aminotransferase \> 1.5 times the upper limit of normal at Screening or Check-in. 8. Positive hepatitis B or hepatitis C panel (including positive hepatitis B surface antigen \[HBsAg\] and/or positive hepatitis C antibody) and/or positive human immunodeficiency virus test at Screening. Participants whose results are compatible with prior hepatitis B vaccination (positive hepatitis B surface antibody, negative hepatitis B core antibody, negative HBsAg) or prior infection (positive hepatitis B core antibody, positive hepatitis B surface antibody, negative HBsAg) may be included. 9. Participants who have received live vaccines within 5 weeks prior to Screening, or plan to receive live vaccines within 90 days after administration of an investigational product. Inactive vaccination (e.g., non-live or nonreplicating agent), including coronavirus-2019 (COVID-19) vaccination, is allowed. 10. History of latent tuberculosis or active chronic, recurrent, or acute infection requiring treatment with systemic antibiotics, antiviral, antiparasitic, antiprotozoal, or antifungals which has not completely resolved, or for which therapy has not been completed, within 4 weeks before Screening. 11. Use of any over-the-counter or prescription medications within 30 days or 5 half-lives (whichever is longer) before Check-in, excluding the following: 1. Acetaminophen (paracetamol) (up to 2 g per day) for analgesia will be allowed. 2. Hormonal contraception listed in Appendix 3 will be allowed. 3. Hormone replacement therapy (e.g., estrogen) and hormonal contraceptives will be allowed. 12. All herbal medicines (e.g., St. John's wort), vitamins, and supplements consumed by the participant within the 30 days prior to Check-in, unless deemed acceptable by the Investigator (or designee) and in consultation with the Sponsor. 13. Participant has received a dose of an investigational drug within the past 90 days or 5 half-lives, whichever is longer, prior to Check-in. 14. Have previously completed or withdrawn from this study or any other study investigating rocatinlimab or have previously received rocatinlimab. **Healthy Volunteers:** True **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** medinfo@amgen.com **Name:** Amgen Call Center **Phone:** 866-572-6436 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Amgen **Name:** MD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Access Criteria:** Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below. **Description:** De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request. **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR **IPD Sharing:** YES **Time Frame:** Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study. **URL:** http://www.amgen.com/datasharing ### References Module #### See Also Links **Label:** AmgenTrials clinical trials website **URL:** http://www.amgentrials.com ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M7067 - Name: Dermatitis - Relevance: HIGH - As Found: Dermatitis - ID: M7071 - Name: Dermatitis, Atopic - Relevance: LOW - As Found: Unknown - ID: M7655 - Name: Eczema - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003872 - Term: Dermatitis ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06438250 **Brief Title:** 68Ga-FAPI-JH04 PET/CT: Dosimetry and Biodistribution Studies **Official Title:** 68Ga-FAPI-JH04 PET/CT: Dosimetry and Biodistribution Study in Patients With Various Cancers #### Organization Study ID Info **ID:** FirstAHFujian-68Ga-FAPI-JH04 #### Organization **Class:** OTHER **Full Name:** First Affiliated Hospital of Fujian Medical University ### Status Module #### Completion Date **Date:** 2024-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-27 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-06-10 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-01 **Type:** ACTUAL **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** First Affiliated Hospital of Fujian Medical University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** 68Ga-FAPI-JH04 is a novel radiotracer targeting fibroblast activation protein (FAP). In this study, we observed the safety, biodistribution, and radiation dosimetry of 68Ga-JH040182 in patients with different types of cancer. **Detailed Description:** Carcinoma-associated fibroblasts (CAFs) are an integral part of the tumor microenvironment, and fibroblast activation protein (FAP), as a specific marker of CAFs, is overexpressed in more than 90% of epithelial malignant tumors' CAFs, with limited expression in normal tissues, making it an appropriate target for various tumors. Currently, several tracers targeting FAP for diagnostic purposes have been developed, such as 68Ga-FAPI-04, 68Ga-FAPI-02, and showed high efficacy in tumor staging and restaging. 68Ga-FAPI-JH04, a novel radiopharmaceutical targeting FAP, demostrated high stability in vitro and in vivo, and can accumulate specifically in tumors with high binding affinity, safety, and selectivity in preclinical studies. In this study, the safety, biodistribution, and radiation dosimetry of 68Ga-FAPI-JH04 in patients with different types of cancer were observed to evaluate the dosimetric characteristics of 68Ga-FAPI-JH04. ### Conditions Module **Conditions:** - Malignant Neoplasm ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Drug: 68Ga-FAPI-JH04 ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 5 **Type:** ESTIMATED **Phases:** - EARLY_PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** PET imaging will begin at 3 min (30s/bed), 15min (1min/bed), 30min (2 min/bed), 60min (2 min/bed) and 150min (2 min/bed) after injection **Intervention Names:** - Drug: 68Ga-FAPI-JH04 **Label:** dynamic PET scans **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - dynamic PET scans **Description:** The dose will be 148-222 MBq given intravenously. **Name:** 68Ga-FAPI-JH04 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The safety evaluation of 68Ga-FAPI-JH04 PET/CT was performed for all patients based on the Common Toxicity Criteria for Adverse Events 5.0 (CTCAE 5.0) from baseline to follow up, including vital signs, health conditions, and laboratory tests. **Measure:** safety and tolerability **Time Frame:** Up to 1 week #### Secondary Outcomes **Description:** reported as relative uptake values per organ at 3min, 15min, 30min, 60min and 150 min per individual subject and as a mean over all subjects **Measure:** Human biodistribution **Time Frame:** From right after tracer injection to 150 min at post-injection **Description:** radiation dose to individual organs and the equivalent dose for the whole body of each subject and as a mean over all subjects. Dosimetry will be calculated using the Hybrid-Dosimetry software. **Measure:** Human dosimetry **Time Frame:** From right after tracer injection to 150 min at post-injection ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Various solid tumors with available histopathological findings * Signed informed consent Exclusion Criteria: * pregnant or lactational women * who suffered from severe hepatic and renal insufficiency **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** miaoweibing@126.com **Name:** Weibing Miao, MD **Phone:** +86-0591-87981618 **Role:** CONTACT **Contact 2:** **Email:** guochang1007@163.com **Name:** Guochang Wang, PhD **Phone:** +86-0591-87981619 **Role:** CONTACT #### Locations **Location 1:** **City:** Fuzhou **Contacts:** ***Contact 1:*** - **Email:** miaoweibing@126.com - **Name:** Weibing Miao, MD - **Phone:** +86 591 87981618 - **Role:** CONTACT ***Contact 2:*** - **Email:** guochang1007@163.com - **Name:** Guochang Wang, MD - **Phone:** +86 591 87981619 - **Role:** CONTACT **Country:** China **Facility:** Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University **State:** Fujian **Status:** RECRUITING **Zip:** 350005 #### Overall Officials **Official 1:** **Affiliation:** The First Affiliated Hospital, Fujian Medical University **Name:** Weibing Miao, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Meshes - ID: D000009369 - Term: Neoplasms ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06438237 **Brief Title:** Validation of a Prediction Model for Inadequate Bowel Preparation **Official Title:** Validation of a Prediction Model for Inadequate Bowel Preparation Before Colonoscopy Based on a Systematic Review and Meta-analysis #### Organization Study ID Info **ID:** V-PMIBP #### Organization **Class:** OTHER **Full Name:** General Hospital of Shenyang Military Region ### Status Module #### Completion Date **Date:** 2024-12-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-27 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-09-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-06 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** General Hospital of Shenyang Military Region #### Responsible Party **Investigator Affiliation:** General Hospital of Shenyang Military Region **Investigator Full Name:** Xingshun Qi **Investigator Title:** Director of Gastroenterology **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** We have developed a novel inadequate bowel preparation prediction model based on a systematic review and meta-analysis. The goal of this observational study is to validate the accuracy of this model. **Detailed Description:** A total of 615 patients undergoing colonoscopy will be enrolled. The primary outcome is quality of bowel preparation. The secondary outcomes include polyp/adenoma detection rate, willingness of undergoing colonoscopy again and adverse events. ### Conditions Module **Conditions:** - Bowel Preparation - Colonoscopy **Keywords:** - Bowel preparation for colonoscopy ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 615 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients were informed to eat semi-liquid and non-slag diet for breakfast and lunch and full-liquid diet for dinner on the day before colonoscopy, and be fasting on the day of colonoscopy. A split-dose 3 L PEG regimen was used for all patients. **Intervention Names:** - Procedure: Bowel preparation before colonoscopy **Label:** Patients undergoing colonoscopy ### Interventions #### Intervention 1 **Arm Group Labels:** - Patients undergoing colonoscopy **Description:** Patients use purgative for bowel cleansing before colonoscopy. **Name:** Bowel preparation before colonoscopy **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** A total BBPS score ≥6 with BBPS score ≥2 for each colon segment was considered to have adequate bowel preparation. **Measure:** Quality of bowel preparation **Time Frame:** During the procedure of colonoscopy #### Secondary Outcomes **Description:** Proportion of patients with at least one adenoma and/or polyp detected during colonoscopy **Measure:** Adenoma and/or polyp detection rate **Time Frame:** During the procedure of colonoscopy **Description:** Number of polyps and/or adenomas detected during colonoscopy **Measure:** Number of polyps and/or adenomas **Time Frame:** During the procedure of colonoscopy **Description:** Incidence of abdominal pain, bloating, nausea/vomiting after intake of PEG. **Measure:** Adverse events **Time Frame:** Before the procedure of colonoscopy ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. adult patients (age is ≥18 years old); 2. patients undergoing colonoscopy; 3. written informed consent. Exclusion Criteria: 1. patients undergoing emergent colonoscopy; 2. patients with major psychiatric disorders; 3. pregnant or breast feeding patients; 4. patients with contraindications for colonoscopy (e.g., heart failure, renal insufficiency); 5. patients suspected to have intestinal obstruction, stenosis or perforation; 6. patients previously enrolled in this study. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Adult patients undergoing colonoscopy ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** xingshunqi@126.com **Name:** Xingshun Qi **Phone:** 18909881019 **Role:** CONTACT **Contact 2:** **Email:** 373302698@qq.com **Name:** Weiyi Wang **Phone:** 13019441024 **Role:** CONTACT #### Locations **Location 1:** **City:** Shenyang **Contacts:** ***Contact 1:*** - **Email:** xingshunqi@126.com - **Name:** Xingshun Qi - **Phone:** 18909881019 - **Role:** CONTACT ***Contact 2:*** - **Email:** 373302698@qq.com - **Name:** Weiyiy Wang - **Phone:** 13019441024 - **Role:** CONTACT **Country:** China **Facility:** Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area) **State:** Liaoning **Status:** RECRUITING **Zip:** 110840 #### Overall Officials **Official 1:** **Affiliation:** Department of Gastroenterology, General Hospital of Northern Theater Command **Name:** Xingshun Qi **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):620-5. doi: 10.1016/j.gie.2008.05.057. Epub 2009 Jan 10. **PMID:** 19136102 ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: Gast - Name: Gastrointestinal Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M27664 - Name: Laxatives - Relevance: LOW - As Found: Unknown - ID: M5651 - Name: Cathartics - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06438224 **Brief Title:** Clinical Utility of Extracorporeal Shock Wave Therapy in Restoring Hand Function of Patients With Nerve Injury and Hypertrophic Scars Due to Burns **Official Title:** Clinical Utility of Extracorporeal Shock Wave Therapy in Restoring Hand Function of Patients With Nerve Injury and Hypertrophic Scars Due to Burns #### Organization Study ID Info **ID:** HangangSHH-18 #### Organization **Class:** OTHER **Full Name:** Hangang Sacred Heart Hospital ### Status Module #### Completion Date **Date:** 2024-05-20 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-27 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-05-15 **Type:** ACTUAL #### Start Date **Date:** 2023-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Hangang Sacred Heart Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Joint contractures and nerve injuries are common after hand burns. Extracorporeal shock wave therapy (ESWT) is effective not only for the regeneration of various tissues, including scar tissues, but also for reducing pain and pruritus in patients with burns. Researchers have attempted to explore the effects of ESWT on hand dysfunction caused by nerve injury following burns. We planned to evaluate the effects of ESWT (compared to sham stimulation) on hands with nerve injury and hypertrophic scars and thereby on hand function. The ESWT parameters were as follows: energy flux density, 0.05-0.30 mJ/mm2; frequency, 4 Hz; 1000 to 2000 impulses per treatment; and 12 treatments, one/week for 12 weeks. Outcome measures were as follows: 10-point visual analog scale for pain, Jebsen-Taylor hand function test, grip strength, Purdue Pegboard test, ultrasound measurement of scar thickness, and skin characteristics before and immediately after 12 weeks of treatment. **Detailed Description:** Burns that occur in the hand cause early joint range-of-motion (ROM) limitations and hand muscle weakness that significantly affect quality of life. Hand burns, though restricted to a small total body surface area (TBSA), can have significant functional consequences. Joint contractures and nerve injuries are common after hand burns. Extracorporeal shock wave therapy (ESWT) is effective not only for the regeneration of various tissues, including scar tissues, but also for reducing pain and pruritus in patients with burns. Researchers have attempted to explore the effects of ESWT on hand dysfunction caused by nerve injury following burns. We planned to evaluate the effects of ESWT (compared to sham stimulation) on hands with nerve injury and hypertrophic scars and thereby on hand function. The ESWT parameters were as follows: energy flux density, 0.05-0.30 mJ/mm2; frequency, 4 Hz; 1000 to 2000 impulses per treatment; and 12 treatments, one/week for 12 weeks. Outcome measures were as follows: 10-point visual analog scale for pain, Jebsen-Taylor hand function test, grip strength, Purdue Pegboard test, ultrasound measurement of scar thickness, and skin characteristics before and immediately after 12 weeks of treatment. ### Conditions Module **Conditions:** - Hand Injuries - Extracorporeal Shock Wave Therapy - Burns **Keywords:** - Extracorporeal shock wave therapy - hypertrophic scar - burns - hand function - nerve injury ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** ESWT was conducted using the Duolith SD-1® device (StorzMedical, Tägerwilen, Switzerland), with an electromagnetic cylindrical coil source used to focus the shock wave. ESWT was performed around the primary treatment site, at an intensity of 100 impulses/cm2, an energy flux density (EFD) of 0.05 to 0.30 mJ/mm2, and frequency of 4 Hz. Regarding the volume of treatment, 1000-3000 impulses were administered per session for 12 sessions held at 1-week intervals. As in previous studies, the sham group was treated using an adapter that had the same shape but did not emit any energy ##### Masking Info **Masking:** DOUBLE **Masking Description:** The outcome measurements and data analyses were performed by a trained and blinded outcome assessor who was not involved in the intervention. **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 120 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Those in the ESWT group were asked to select the most hypertrophic and retracting scars for treatment. ESWT was conducted using the Duolith SD-1® device (StorzMedical, Tägerwilen, Switzerland), with an electromagnetic cylindrical coil source used to focus the shock wave. ESWT was performed around the primary treatment site, at an intensity of 100 impulses/cm2, an energy flux density (EFD) of 0.05 to 0.30 mJ/mm2, and frequency of 4 Hz. Regarding the volume of treatment, 1000-3000 impulses were administered per session for 12 sessions held at 1-week intervals. **Intervention Names:** - Other: Extracorporeal shock wave therapy (ESWT) **Label:** Extracorporeal shock wave therapy (ESWT) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** the sham group was treated using an adapter that had the same shape but did not emit any energy **Intervention Names:** - Other: sham stimulation **Label:** sham group **Type:** SHAM_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Extracorporeal shock wave therapy (ESWT) **Description:** Those in the ESWT group were asked to select the most hypertrophic and retracting scars for treatment. ESWT was conducted using the Duolith SD-1® device (StorzMedical, Tägerwilen, Switzerland), with an electromagnetic cylindrical coil source used to focus the shock wave. ESWT was performed around the primary treatment site, at an intensity of 100 impulses/cm2, an energy flux density (EFD) of 0.05 to 0.30 mJ/mm2, and frequency of 4 Hz. Regarding the volume of treatment, 1000-3000 impulses were administered per session for 12 sessions held at 1-week intervals. **Name:** Extracorporeal shock wave therapy (ESWT) **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - sham group **Description:** the sham group was treated using an adapter that had the same shape but did not emit any energy **Name:** sham stimulation **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** self-reported pain severity, ratings ranging from 0 (no pain) to 10 (unbearable pain **Measure:** 10-point visual analog scale (VAS) **Time Frame:** 12 weeks #### Secondary Outcomes **Description:** range of motion measurement **Measure:** the total active motion (TAM) scoring system **Time Frame:** 12 weeks **Description:** The JTT consists of seven subtests, each scored on a 0-15-point scale, with higher scores indicating better hand function **Measure:** Jebsen-Taylor hand function test (JTT) **Time Frame:** 12 weeks **Description:** quantified using a hand-held dynamometer (Lafayette Instrument, USA), with higher socres indicating more stronger **Measure:** Grip and pinch strengths **Time Frame:** 12 weeks **Description:** quantified using ultrasonography (128 BW1 US system, Medison, Korea) **Measure:** Scar thickness **Time Frame:** 12 weeks **Description:** Mexameter®(MX18, Courage-Khazaka Electronics GmbH, Germany) was used to measure the melanin levels and the severity of erythema. Higher values indicated darker and redder skin. **Measure:** erythema and pigementation **Time Frame:** 12 weeks **Description:** measured using a Tewameter® (Courage-Khazaka Electronic GmbH, Germany) to evaluate water evaporation. **Measure:** Trans-epidermal water loss (TEWL) **Time Frame:** 12 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * ≥ 18 years old * had sustained a deep partial-thickness (second-degree) or a full-thickness (third-degree) burn in the right dominant hand, which had been treated with a split-thickness skin graft (STSG) after the thermal injury * nerve injury to the hand was confirmed by electromyography * \< 6 months prior to the enrollment Exclusion Criteria: * musculoskeletal diseases (fracture, amputation, rheumatoid arthritis, and degenerative joint diseases) of the hands * acute infection * malignant tumors * coagulopathy * pregnancy * potential for additional skin damage if exposed to ESWT and conventional occupational therapy. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** sung6652@hallym.or.kr **Name:** Sung Rakyum **Phone:** 82-2-2639-5900 **Role:** CONTACT #### Locations **Location 1:** **City:** Seoul **Contacts:** ***Contact 1:*** - **Email:** sung6652@hallym.or.kr - **Name:** Ragyem Sung - **Phone:** 82-10-5939-2541 - **Role:** CONTACT **Country:** Korea, Republic of **Facility:** Hangang sacred heart hodpital **Status:** RECRUITING **Zip:** 07247 #### Overall Officials **Official 1:** **Affiliation:** handgang sacred heart hospital **Name:** SO YOUNG JOO **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Thiele S, Thiele R, Gerdesmeyer L. Lateral epicondylitis: This is still a main indication for extracorporeal shockwave therapy. Int J Surg. 2015 Dec;24(Pt B):165-70. doi: 10.1016/j.ijsu.2015.09.034. Epub 2015 Oct 9. **PMID:** 26455532 **Citation:** Cui HS, Hong AR, Kim JB, Yu JH, Cho YS, Joo SY, Seo CH. Extracorporeal Shock Wave Therapy Alters the Expression of Fibrosis-Related Molecules in Fibroblast Derived from Human Hypertrophic Scar. Int J Mol Sci. 2018 Jan 2;19(1):124. doi: 10.3390/ijms19010124. **PMID:** 29301325 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000020763 - Term: Pathological Conditions, Anatomical - ID: D000002921 - Term: Cicatrix - ID: D000005355 - Term: Fibrosis ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC26 - Name: Wounds and Injuries ### Condition Browse Module - Browse Leaves - ID: M15577 - Name: Shock - Relevance: HIGH - As Found: Shock - ID: M10035 - Name: Hypertrophy - Relevance: HIGH - As Found: Hypertrophic - ID: M19708 - Name: Cicatrix, Hypertrophic - Relevance: HIGH - As Found: Hypertrophic Scar - ID: M5326 - Name: Burns - Relevance: HIGH - As Found: Burn - ID: M9322 - Name: Hand Injuries - Relevance: HIGH - As Found: Hand Injuries - ID: M6160 - Name: Cicatrix - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: HIGH - As Found: Injury - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown - ID: M8485 - Name: Fibrosis - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012769 - Term: Shock - ID: D000006984 - Term: Hypertrophy - ID: D000017439 - Term: Cicatrix, Hypertrophic - ID: D000014947 - Term: Wounds and Injuries - ID: D000002056 - Term: Burns - ID: D000006230 - Term: Hand Injuries ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06438211 **Brief Title:** Comparison of Postoperative Analgesic Effectiveness of Superficial and Deep Serratus Plane Blocks for Mastectomy **Official Title:** Comparison of Postoperative Analgesic Effectiveness of Superficial and Deep Serratus Plane Blocks in Patients Undergoing Mastectomy #### Organization Study ID Info **ID:** 2024/58 #### Organization **Class:** OTHER **Full Name:** TC Erciyes University ### Status Module #### Completion Date **Date:** 2025-05-25 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-02-24 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-24 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** TC Erciyes University #### Responsible Party **Investigator Affiliation:** TC Erciyes University **Investigator Full Name:** Ayse Ulgey **Investigator Title:** Professor doctor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Pain after breast surgery can be quite severe and can significantly affect quality of life. By successfully treating acute pain, it is aimed to prevent the formation of pain memory and to ensure that chronic pain never occurs. It is known that by using regional techniques, the use of general anesthetics and opioids can be reduced and their harmful effects can be limited. In this study, it will be compared the analgesic effectiveness of superficial and deep serratus plane blocks in the postoperative acute and chronic periods. **Detailed Description:** Acute and chronic pain is a serious problem in patients undergoing breast surgery. Apart from the feeling of pain, it also causes psychological difficulties, increased hospital stays, delays or difficulties in mobilization, and so on. Due to all these reasons, postoperative pain control is very important. Although opioids are the gold standard in the treatment of pain, their side effect profiles (sedation, respiratory depression, constipation, tolerance development, etc.) limit their use and different searches are on the agenda. There are studies showing that superficial and deep serratus plane blocks are effective in mastectomy operations. In this study, patients who underwent mastectomy these two blocks will be compared to see which one is superior and to investigate the differences that may occur in the acute and chronic periods. After general anesthesia induction, a superficial serratus plane block will be performed on the first group of patients undergoing surgery by applying local anesthetic to the fascia between the serratus anterior and latissimus dorsi muscles at the level of the 4th and 5th ribs under ultrasound. then the patient will undergo surgical procedure. Likewise, for the second group of patients, after general anesthesia induction, a deep serratus plane block will be performed by applying local anesthetic between the rib and the serratus anterior muscle at the level of the 4th and 5th ribs, under ultrasound guidance, and the patient will be taken into surgery. Both groups of patients will be monitored for 24 hours after the operation with a patient-controlled analgesia device. Patients' pain scores, satisfaction scores, nausea and vomiting scores, and additional analgesic needs will be recorded 24 hours postoperatively. ### Conditions Module **Conditions:** - Mastectomy - Postoperative Pain - Analgesia **Keywords:** - serratus anterior plane block - local anesthetic - regional anesthesia - postoperative analgesia ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** OTHER #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Single-shot ultrasound (Esaote Mylab30) guided Superficial SAP block with 30 ml 0.25% bupivacain (Marcain 0.5%, Astra Zeneca, Turkey) at the T4- T5 ribs level (between the latissimus dorsi muscle and the serratus anterior muscle) was performed preoperatively to patients in the Superficial SAP group (Group I) **Intervention Names:** - Procedure: superficial or deep serratus anterior plane block for mastectomy **Label:** Group I (superficial serratus anterior plane block) **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Single- shot ultrasound (Esaote Mylab30) guided Deep SAP block with 30 ml 0.25% bupivacain (Marcain 0.5%, Astra Zeneca, Turkey) at the T4- T5 ribs level ( between the serratus anterior muscle and the ribs) was performed preoperatively to patients in the Deep SAP group (Group I) **Intervention Names:** - Procedure: superficial or deep serratus anterior plane block for mastectomy **Label:** Group II (deep serratus anterior plane block) **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Group I (superficial serratus anterior plane block) - Group II (deep serratus anterior plane block) **Description:** group I: superficial SAP Block for postoperative analgesia for mastectomy group II: deep SAP Block for postoperative analgesia for mastectomy **Name:** superficial or deep serratus anterior plane block for mastectomy **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** How much morphine the patient consumed in the first 24 hours postoperatively with a patient-controlled anesthesia device **Measure:** postoperative morphine consumption **Time Frame:** 24 hours #### Secondary Outcomes **Description:** Determining patients' pain levels with a visual analog scale (VAS) between the scale of 1-10 **Measure:** measuring pain scors **Time Frame:** 24 hours ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * patients who will undergo mastectomy surgery * patients who agreed to participate in the study * ASA I-II patients Exclusion Criteria: * Patients planned for bilateral breast surgery * Patients who have had previous breast surgery * Patients with existing neuropathic pain or receiving treatment for neuropathic pain * Patients with psychiatric disorders * Patients with opioid addiction * Patients allergic to local anesthetics **Gender Based:** True **Gender Description:** Since breast cancer is much more common in women than men and to ensure homogenization in the study, only female patients will be included. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** aulgey@erciyes.edu.tr **Name:** Ayşe Ülgey, MD **Phone:** 05378201751 **Role:** CONTACT #### Locations **Location 1:** **City:** Kayseri **Country:** Turkey **Facility:** University of Erciyes **State:** Talas **Zip:** 38100 #### Overall Officials **Official 1:** **Affiliation:** TC Erciyes University **Name:** Ayşe Ülgey, MD **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000011183 - Term: Postoperative Complications - ID: D000010335 - Term: Pathologic Processes - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M13069 - Name: Pain, Postoperative - Relevance: HIGH - As Found: Postoperative Pain - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M14065 - Name: Postoperative Complications - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010149 - Term: Pain, Postoperative ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Analg - Name: Analgesics ### Intervention Browse Module - Browse Leaves - ID: M5315 - Name: Bupivacaine - Relevance: LOW - As Found: Unknown - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown - ID: M4109 - Name: Anesthetics, Local - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06438198 **Acronym:** SWITCH-SAFE **Brief Title:** Early Switch From Controlled to Assisted Ventilation **Official Title:** Unraveling the (Patho)Physiological Mechanisms and Potential Clinical Benefits of an Early Switch From Controlled to Assisted Ventilation #### Organization Study ID Info **ID:** MEC-2024-0011 #### Organization **Class:** OTHER **Full Name:** Erasmus Medical Center ### Status Module #### Completion Date **Date:** 2026-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-04 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Erasmus Medical Center #### Responsible Party **Investigator Affiliation:** Erasmus Medical Center **Investigator Full Name:** Annemijn Jonkman **Investigator Title:** Assistant Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this physiological intervention study is to unravel the (patho)physiological mechanisms and potential clinical benefits of a pre-specified early switch from controlled to assisted ventilation in mechanically ventilated adult patients with acute hypoxemic respiratory failure (PaO2/FiO2 ratio \< 200 mmHg). The intervention is that participants will be switched from controlled to assisted ventilation when PaO2/FiO2 ratio \> 200 mmHg. The primary endpoint is the change in regional lung stress (as derived by electrical impedance tomography) when switching from controlled to assisted ventilation and until a successful or failed switch. **Detailed Description:** A crucial milestone in the trajectory of the mechanically ventilated patient is the switch from fully controlled mechanical ventilation to assisted ventilation. This switch should be made as early as feasible and safe, to limit the detrimental effects from prolonged controlled ventilation and sedation. However, there is also indirect evidence that excessive breathing effort during assisted ventilation may worsen lung injury (P-SILI). There are no guidelines that address this important switch moment. Therefore, the overall aim of this physiological intervention study is to unravel the (patho)physiological mechanisms and potential clinical benefits of a pre-specified early switch from controlled to assisted ventilation in mechanically ventilated adult patients with acute hypoxemic respiratory failure (PaO2/FiO2 ratio \< 200 mmHg). Participants will be switched from controlled to assisted ventilation switch when PaO2/FiO2 ratio \> 200 mmHg and will be monitored continuously using electrical impedance tomography, and oesophageal and gastric pressure until 4 hours post-switch and twice daily for 72 hours or until switch failure (switch back to controlled ventilation within 72 hours). The primary endpoint is the change in regional lung stress (as derived by electrical impedance tomography) when switching from controlled to assisted ventilation and until a successful or failed switch. ### Conditions Module **Conditions:** - Acute Hypoxemic Respiratory Failure - Mechanical Ventilation **Keywords:** - Electrical Impedance Tomography - Esophageal manometry - Controlled Mechanical Ventilation - Assisted Mechanical Ventilation - Respiratory Monitoring ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Switch from controlled to assisted mechanical ventilation when PaO2/FiO2-ratio \> 200 mmHg. Before switch (on controlled ventilation) participants will undergo an electrical impedance tomography (EIT) perfusion measurement as well as a photon-counting CT (PCCT) scan to assess lung perfusion and ventilation/perfusion mismatch. From 15 minutes before until 4 hours after switch and 30 minutes twice daily for 72 hours or until switch failure participants will be monitored continuously using EIT, esophageal pressure and gastric pressure. **Intervention Names:** - Other: Pre-specified switch from controlled to assisted ventilation when PaO2/FiO2-ratio > 200 mmHg **Label:** Mechanically ventilated adults **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Mechanically ventilated adults **Description:** A pre-specified switch from controlled to assisted ventilation will be initiated when PaO2/FiO2-ratio \> 200 mmHg. The moment of switch is pre-specified but patient management and ventilator settings are up to the clinical team. Switch is complete when the patient triggers all breaths spontaneously. Switch success is defined if patient reaches 72 hours on assisted ventilation. Switch failure is defined if patient switches back to controlled ventilation for more than 2 hours before 72 hours. **Name:** Pre-specified switch from controlled to assisted ventilation when PaO2/FiO2-ratio > 200 mmHg **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The change in regional lung stress as derived from EIT recordings by computing the regional ventilation distribution (ventral-to-dorsal ratio). **Measure:** Regional lung stress **Time Frame:** 72 hours #### Secondary Outcomes **Description:** Change in EIT parameters after transition from controlled to assisted ventilation (%) **Measure:** Electrical Impedance Tomography (EIT) parameters **Time Frame:** 72 hours **Description:** Ventilation/perfusion mismatch during controlled ventilation measured with photon-counting CT scan **Measure:** Photon-Counting Computed Tomography (PCCT)-derived ventilation/perfusion mismatch **Time Frame:** 30 minutes **Description:** Ventilation/perfusion mismatch during controlled ventilation measured with EIT **Measure:** Electrical Impedance Tomography (EIT)-derived ventilation/perfusion mismatch **Time Frame:** 30 minutes **Description:** Change in respiratory mechanics after transition from controlled to assisted ventilation (cmH2O) **Measure:** Respiratory mechanics **Time Frame:** 72 hours **Description:** Time-course of breathing effort during assisted ventilation as measured with esophageal manometry (cmH2O). **Measure:** Breathing effort **Time Frame:** 72 hours **Description:** Percentage of asynchronous breaths during assisted ventilation **Measure:** Patient-ventilator asynchrony **Time Frame:** 72 hours **Description:** Change in gas exchange after transition from controlled to assisted ventilation (%) **Measure:** Gas exchange **Time Frame:** 72 hours **Description:** Change in hemodynamics after transition from controlled to assisted ventilation (%) **Measure:** Hemodynamics **Time Frame:** 72 hours **Description:** Blood biomarkers concentrations including cytokines and chemokines (i.e., interleukins, TNF-alpha, MCP-1 and MIP-1beta, CD14) measured as the difference between baseline vs. 72h (%) **Measure:** Blood inflammatory biomarkers **Time Frame:** 72 hours **Description:** Swivel-derived exhaled-breath condensate biomarkers concentrations including cytokines and chemokines (i.e., interleukins, TNF-alpha, MCP-1 and MIP-1beta, CD14) measured as the difference between baseline vs. 72h (%) **Measure:** Breath condensate inflammatory biomarkers **Time Frame:** 72 hours **Description:** Ventilator-free days at day 28 **Measure:** Ventilator-free days **Time Frame:** 28 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18 years old * Written informed consent from a legal representative * Mechanical ventilation via an endotracheal tube * Acute hypoxemic respiratory failure with PaO2/FiO2 ratio \< 200 mmHg * Under continuous sedation with or without paralysis Exclusion Criteria: * Expected mechanical ventilation duration of \<48 hours * Pure chronic obstructive pulmonary disease exacerbation * Pre-existent respiratory muscle disease * Contraindication to EIT monitoring (as per clinical protocol, e.g. pacemaker, burns or thoracic wounds limiting electrode placement) * Contra-indications to oesophageal manometry (as per clinical protocol, e.g., recent oesophageal surgery, oesophageal varices, severe bleeding disorders) * Known pregnancy * Anticipating withdrawal of life support and/or shift to palliation as the goal of care **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** a.jonkman@erasmusmc.nl **Name:** Annemijn Jonkman, PhD **Phone:** +3110-7035142 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Erasmus Medical Center **Name:** Annemijn Jonkman, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012120 - Term: Respiration Disorders - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M14968 - Name: Respiratory Insufficiency - Relevance: HIGH - As Found: Acute Hypoxemic Respiratory Failure - ID: M14957 - Name: Respiration Disorders - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012131 - Term: Respiratory Insufficiency ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06438185 **Brief Title:** Efficacy And Safety of An IRE System For Treatment of Inferior Turbinate Hypertrophy **Official Title:** Evaluation of The Efficacy And Safety of An Irreversible Electroporation (IRE) System For Treatment of Inferior Turbinate Hypertrophy With Nasal Obstruction #### Organization Study ID Info **ID:** CLN 0157 #### Organization **Class:** INDUSTRY **Full Name:** ENTire Medical Ltd. ### Status Module #### Completion Date **Date:** 2026-03 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-29 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-09 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-07 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** ENTire Medical Ltd. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of the IRE System is to address the clinical need for reducing the volume of hypertrophic inferior turbinate(s) causing nasal obstruction while minimizing side effects and complications. Procedure time will also be reduced. The IRE System is designed to be more comfortable for patients, as it employs a noninvasive procedure using a high voltage pulsed electric field to create irreversible nanopores in the cell membrane, leading to cell death and the reduction of the inferior turbinate volume. **Detailed Description:** The purpose of the IRE System is to address the clinical need for reducing the volume of hypertrophic inferior turbinate(s) causing nasal obstruction while minimizing side effects and complications. Procedure time will also be reduced. The IRE System is designed to be more comfortable for patients, as it employs a noninvasive procedure using a high voltage pulsed electric field to create irreversible nanopores in the cell membrane, leading to cell death and the reduction of tonsil volume. On basis of these finding and in view of the known safety profile (refer to Chen et.al ) and efficacy of current technologies, the purpose of the current study is to prospectively determine the efficacy and safety of the IRE System in interior turbinate reduction. ### Conditions Module **Conditions:** - Inferior Turbinate Hypertrophy - Nasal Obstruction - Turbinate; Hypertrophy Mucous Membrane ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Irreversible Electroporation (IRE) System for Inferior Turbinate Hypertrophy with Nasal Obstruction ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The bi-polar IRE System locally applies short, high-voltage (HV) pulses, increasing the permeability of tissue cells, creating non-thermal irreversible electroporation (NTIRE). The energy is transferred via bipolar forceps and causes irreversible cell membrane perforation and apoptosis. This results in tissue reduction within 2-4 weeks after treatment. **Intervention Names:** - Device: IRE System **Label:** Enlarged Inferior Turbinate(s) will be reduced by ENTire IRE System. **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Enlarged Inferior Turbinate(s) will be reduced by ENTire IRE System. **Description:** Irreversible Electroporation (IRE) System for Inferior Turbinate Hypertrophy with Nasal Obstruction. **Name:** IRE System **Other Names:** - ENtire IRE System **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** A reduction of \> 20% in Nasal Obstruction Symptom Evaluation Scale scale and a \> 20% in the Nasal Obstruction VAS score as compared to screening visit. **Measure:** Reduction in Nasal Obstruction Symptom Evaluation Scale (NOSE) **Time Frame:** 3 months post treatment #### Secondary Outcomes **Description:** A Sinonasal Outcome Test (SNOT-22) score improvement 3 months post treatment. **Measure:** A Sinonasal Outcome Test (SNOT-22) score **Time Frame:** 3 months post treatment **Description:** Low to moderate Pain VAS (VAS/Pain VAS) score post treatment. **Measure:** Pain Visual Analog Scale (VAS) **Time Frame:** up to 1 week post treatment and through study subject completion ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age 18 - 70 years. * Nasal Obstruction Symptom Evaluation (NOSE) score of ≥ 60 at the Baseline. * Hypertrophy of the inferior turbinate is the primary cause of the patient's nasal obstruction based on vasoconstriction test. * Did not improve with medical treatment, including topical nasal steroids for nasal obstruction for at least three months. Exclusion Criteria: * Age below 18 years * Patients with a pacemaker or similar electro stimulator * Patients with caudal septal deviation that narrows the anterior nasal valve. * Patients with nasal polyps/tumors. * Patients with chronic rhinosinusitis. * Patients with Eosinophilia * Patients for whom the anesthesia involves high risk. * Patients with Epilepsy or other condition involving convulsions. * Patients with an inability to give informed consent and to complete self-reported questionnaires. * Patients with an inability to cooperate for treatment and follow-up. * Patients with severe heart disease. * Pregnancy or breastfeeding. * Previous inferior turbinate surgery. **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** Danielle@carbo-fix.com **Name:** Danielle Vales **Phone:** +972 0508881100 **Role:** CONTACT #### Locations **Location 1:** **City:** Tel Aviv **Contacts:** ***Contact 1:*** - **Email:** Navac@tlvmc.gov.il - **Phone:** +972 03-6974444 - **Role:** CONTACT **Country:** Israel **Facility:** Tel Aviv Sourasky Medical Center **Status:** RECRUITING **Location 2:** **City:** Vilnius **Contacts:** ***Contact 1:*** - **Email:** info@santa.lt - **Phone:** +370 852365010 - **Role:** CONTACT **Country:** Lithuania **Facility:** Vilnius University Hospital Santaros Klinikos **Status:** NOT_YET_RECRUITING **Zip:** 08661 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020763 - Term: Pathological Conditions, Anatomical - ID: D000009668 - Term: Nose Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000000402 - Term: Airway Obstruction - ID: D000012131 - Term: Respiratory Insufficiency - ID: D000012120 - Term: Respiration Disorders - ID: D000010038 - Term: Otorhinolaryngologic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC09 - Name: Ear, Nose, and Throat Diseases ### Condition Browse Module - Browse Leaves - ID: M10035 - Name: Hypertrophy - Relevance: HIGH - As Found: Hypertrophy - ID: M18157 - Name: Nasal Obstruction - Relevance: HIGH - As Found: Nasal Obstruction - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown - ID: M12604 - Name: Nose Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M3750 - Name: Airway Obstruction - Relevance: LOW - As Found: Unknown - ID: M14968 - Name: Respiratory Insufficiency - Relevance: LOW - As Found: Unknown - ID: M14957 - Name: Respiration Disorders - Relevance: LOW - As Found: Unknown - ID: M12961 - Name: Otorhinolaryngologic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000015508 - Term: Nasal Obstruction - ID: D000006984 - Term: Hypertrophy ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06438172 **Acronym:** HM_APOLLO **Brief Title:** A Study to Evaluate Efficacy and Safety of HCP1803 Compared to RLD2001-1 in Patients With Essential Hypertension **Official Title:** A Multicenter, Randomized, Double-blind, Phase III Study to Evaluate Efficacy and Safety of HCP1803 Compared to RLD2001-1 in Patients With Essential Hypertension #### Organization Study ID Info **ID:** HM-APOLLO-302 #### Organization **Class:** INDUSTRY **Full Name:** Hanmi Pharmaceutical Company Limited ### Status Module #### Completion Date **Date:** 2025-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-27 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-25 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Hanmi Pharmaceutical Company Limited #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** A multicenter, randomized, double-blind, phase 3 study to evaluate efficacy and safety of HCP1803 compared to RLD2001-1 in patients with essential hypertension ### Conditions Module **Conditions:** - Hypertension ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 220 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** HCP1803-3 **Intervention Names:** - Drug: HCP1803-3 - Drug: HPP2002-1 **Label:** Experimental **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** RLD2001-1 **Intervention Names:** - Drug: RLD2001-1 - Drug: HPP2003-3 **Label:** Active Comparator **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental **Description:** Take it once daily for 8 weeks orally. **Name:** HCP1803-3 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Active Comparator **Description:** Take it once daily for 8 weeks orally. **Name:** RLD2001-1 **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Active Comparator **Description:** Placebo drug. Take it once daily for 8 weeks orally. **Name:** HPP2003-3 **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - Experimental **Description:** Placebo drug. Take it once daily for 8 weeks orally. **Name:** HPP2002-1 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Change from baseline in sitting systolic blood pressure **Time Frame:** baseline, 8 weeks #### Secondary Outcomes **Measure:** Change from baseline in sitting systolic blood pressure **Time Frame:** baseline, 4 weeks **Measure:** Change from baseline in sitting distolic blood pressure **Time Frame:** baseline, 4 weeks, 8 weeks **Measure:** Proportion of subjects achieving blood pressure control **Time Frame:** 4 weeks, 8 weeks **Measure:** Blood pressure response rate **Time Frame:** 4 weeks, 8 weeks **Measure:** Treatment response rate **Time Frame:** 4 weeks, 8 weeks **Measure:** Change from baseline in pulse pressure **Time Frame:** baseline, 4 weeks, 8 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Patients with essential hypertension whose blood pressure measured in visit1 corresponds to the following conditions * mean sitSBP \<180 mmHg and mean sitDBP \< 110 mmHg for patients receiving any BP-lowering drug within 1 month prior to Visit 1 * 140 mmHg ≤ mean sitSBP \< 180 mmHg and 60 mmHg ≤ mean sitDBP \< 110 mmHg for patients not receiving BP-lowering drugs within 1 month prior to Visit 1 2. Patients with essential hypertension who meet 140 mmHg ≤ mean sitSBP \< 180 mmHg and 60 mmHg ≤ mean sitDBP \< 110 mmHg at Visit 2 Exclusion Criteria: 1. Difference between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP at Visit 1 2. Orthostatic hypotension with symptoms within 3 months prior to visit 1. 3. Secondary hypertensive patient or suspected to be 4. Uncontrolled diabetes mellitus(HbA1c \> 9%) or type I diabetes mellitus 5. Active gout or hyperuricemia (uric acid ≥ 9mg/dL) 6. Severe heart disease or severe neurovascular disease 7. Moderate or malignant retinopathy 8. Clinically significant hematological finding 9. Severe renal diseases (eGFR\<30mL/min/1.73m2) 10. Severe or active hepatopathy (AST or ALT ≥ 3 times of normal range) 11. Hypokalemia or Hyperkalemia(K\<3.5mmol/L or K ≥ 5.5mmol/L) 12. Hyponatremia or Hypernatremia(Na\<135mmol/L or Na ≥ 155mmol/L) 13. Hypercalcemia 14. History of malignancy tumor 15. History of autoimmune disease 16. History of alcohol or drug abuse 17. Positive to pregnancy test, nursing mother, intention on pregnancy 18. Considered by investigator as not appropriate to participate in the clinical study with other reason **Minimum Age:** 19 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** skyko7@hanmi.co.kr **Name:** Na Young Kim **Phone:** 82-2-410-9165 **Role:** CONTACT #### Locations **Location 1:** **City:** Goyang-si **Contacts:** ***Contact 1:*** - **Email:** mooyong.rhee@gmail.com - **Name:** Moo-Yong Rhee, M.D., Ph.D. - **Phone:** 82-31-961-5775 - **Role:** CONTACT **Country:** Korea, Republic of **Facility:** Donggguk University Ilsan Hospital **State:** Gyeonggi-do **Status:** RECRUITING **Zip:** 10326 #### Overall Officials **Official 1:** **Affiliation:** Donggguk University Ilsan Hospital **Name:** Moo-Yong Rhee, M.D., Ph.D. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M10024 - Name: Hypertension - Relevance: HIGH - As Found: Hypertension - ID: M1470 - Name: Essential Hypertension - Relevance: HIGH - As Found: Essential Hypertension - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006973 - Term: Hypertension - ID: D000075222 - Term: Essential Hypertension ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06438159 **Acronym:** CARDIO-MBSR **Brief Title:** Impact of Mindfulness-Based Stress Reduction Meditation Practice on Patients After Cardiac Rehabilitation. **Official Title:** Impact of Mindfulness-Based Stress Reduction Meditation Practice on Medium- and Long-term Follow-up of Cardiac Patients After Cardiac Rehabilitation. #### Organization Study ID Info **ID:** CARDIO-MBSR #### Organization **Class:** OTHER **Full Name:** Elsan ### Status Module #### Completion Date **Date:** 2026-09-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-09-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-09-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Elsan #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Cardiac rehabilitation is a major component of treatment for patients suffering from coronary pathology revealed by myocardial infarction or acute coronary syndrome warranting transluminal coronary angioplasty, as well as in the aftermath of cardiac surgery. A significant proportion of patients in this situation (40%) suffer from varying degrees of anxiety and depression, which are difficult to treat. These impair their quality of life and can make it more difficult for them to take part in the rehabilitation program, compromising the results that can be expected. Finally, they are often associated with lax compliance with medical treatment, less control of risk factors and less regular exercise. Cardiac rehabilitation teams are well aware of this anxiety-depressive picture, and various therapies such as sophrology, relaxation and yoga have been proposed as alternatives to conventional medical treatments to help patients through this period. Among these alternatives is the concept of "Mindfulness-Based Meditation", based on the Mindfulness-Based Stress Reduction (MBSR) protocol described by Dr. JKabat Zinn. It has been the subject of several prospective randomized studies, which have demonstrated that it is suitable for the management of patients in this situation, and that it has measurable beneficial effects on their sense of well-being. To our knowledge, the MBSR program used in cardiac rehabilitation has never been the subject of a randomized comparative study in France to assess its effectiveness on medium- and long-term anxiety-depressive disorders. This is the objective of this study. ### Conditions Module **Conditions:** - Cardiac Disease **Keywords:** - cardiac rehabilitation - MBSR ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 74 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Conventional cardiac rehabilitation over 4 weeks with the introduction of MBSR over 8 weeks **Intervention Names:** - Other: Cardiac rehabilitation with Mindfulness-Based Stress Reduction (MBSR) **Label:** Cardiac rehabilitation with Mindfulness-Based Stress Reduction (MBSR) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Conventional cardiac rehabilitation over 4 weeks **Intervention Names:** - Other: Conventional cardiac rehabilitation **Label:** Conventional cardiac rehabilitation **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Cardiac rehabilitation with Mindfulness-Based Stress Reduction (MBSR) **Description:** The MBSR program is as follows: * 8 weekly group sessions of 2h30 led by the mindfulness instructor, * Sessions of around 45 minutes a day to be carried out by the patient, at home, for personal training, * An intensive day between the 6th and 7th sessions to explore certain practices more intensively, in order to support participants in effectively integrating mindfulness meditation into various life situations. **Name:** Cardiac rehabilitation with Mindfulness-Based Stress Reduction (MBSR) **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Conventional cardiac rehabilitation **Description:** The usual cardiac rehabilitation program combines exercise training and therapeutic education workshops, with a daily session for four weeks. **Name:** Conventional cardiac rehabilitation **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** HADS (Hospital Anxiety and Depression Scale) is a self questionnaire including 14 items which identifies and quantifies the depression and anxiety from which a person suffers. **Measure:** Change from baseline of HADS anxiety and depression scores **Time Frame:** Baseline and 12 months #### Secondary Outcomes **Description:** The patients' quality of life will be measured by the MQOL-R questionnaire, which is a 14-point tool forming 4 subscales: physical, psychological, existential and social. **Measure:** To assess the quality of life **Time Frame:** Baseline, 1 month, 6 months and 12 months **Description:** The patients' compliance to their medical treatment will be measured by the GIRERD self-questionnaire including 6 questions, to assess compliance, i.e. whether treatment is taken regularly and as prescribed. **Measure:** Medical treatment compliance **Time Frame:** Baseline, 1 month, 6 months and 12 months **Description:** fasting blood glucose (in g/L) **Measure:** Changes from baseline of cardiac risk factor "fasting blood glucose" **Time Frame:** Baseline, 1 month, 6 months and 12 months **Description:** glycosylated hemoglobin (% of total hemoglobin) **Measure:** Changes from baseline of cardiac risk factor "glycosylated hemoglobin" **Time Frame:** Baseline, 1 month, 6 months and 12 months **Description:** Low Density Lipoprotein cholesterol (g/l) * Tobacco consumption (in packs.year) * BMI * Ricci Gagnon scale and 6-minute walk test **Measure:** Changes from baseline of cardiac risk factor "Lipid profile LDLc" **Time Frame:** Baseline, 1 month, 6 months and 12 months **Description:** High Density Lipoprotein cholesterol (g/l) **Measure:** Changes from baseline of cardiac risk factor "Lipid profile HDLc" **Time Frame:** Baseline, 1 month, 6 months and 12 months **Description:** BMI ( weight and height will be combined to report BMI in kg/m2) **Measure:** Changes from baseline of cardiac risk factor "BMI" **Time Frame:** Baseline, 1 month, 6 months and 12 months **Description:** 6-minute walk test **Measure:** Changes from baseline of cardiac risk factor "effort" **Time Frame:** Baseline, 1 month, 6 months and 12 months **Description:** Ricci Gagnon scale: self questionnaire including 9 questions to evaluate if the subject has an inactive, active or very active profile **Measure:** Changes from baseline of cardiac risk factor "activity" **Time Frame:** Baseline, 1 month, 6 months and 12 months **Description:** Tobacco consumption (in packs.year) **Measure:** Changes from baseline of cardiac risk factor "Tobacco consumption" **Time Frame:** Baseline, 1 month, 6 months and 12 months **Description:** Blood pressure **Measure:** Changes from baseline of cardiac risk factor "Blood pressure measurement" **Time Frame:** Baseline, 1 month, 6 months and 12 months **Description:** HADS anxiety score **Measure:** To assess the patient's anxiety **Time Frame:** Baseline, 1 months and 6 months **Description:** HADS depression score **Measure:** To assess the patient's depression **Time Frame:** Baseline, 1 months and 6 months **Description:** Patients of the MBSR group will be asked two questions : "Do you still do formal meditation practices?" "Do you still do informal meditation practices?" **Measure:** To evaluate the continuation of formal and informal mindfulness meditation practices in patients who have benefited from the MBSR program. **Time Frame:** 3 months, 6 months and 12 months **Description:** FFMQ (Five Facets Mindfulness Questionnaire) questionnaire, which includes 39 questions, which assess the 5 facets which constitute mindfulness as a construct: * Describe the experience: talk about the experience in words. * Acting mindfully: performing actions with active attention to each step. * Non-judgment: absence of positive or negative comments on the thoughts and emotions experienced. * Non-reactivity to private events: allowing thoughts and emotions to exist without responding to them automatically. * Observation: remaining aware and focused on the experience, even when it is aversive or painful. **Measure:** To evaluate the patient's "mindfulness" and its impact on vital aspects in patients who have benefited from the MBSR program. **Time Frame:** 3 months, 6 months and 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Cardiac patients eligible for cardiac rehabilitation, 2. Patient with a Hospital Anxiety and Depression Scale (HADS) score for the anxiety dimension (HADS-A) \>7 or a score for the depression dimension (HADS-D) \> 7 3. Age ≥ 18 years 4. Affiliated with a social security scheme or beneficiary of such a scheme 5. Patient signed free and informed consent form Exclusion Criteria: 1. Patients already treated for severe psychiatric disorders (major depression, psychosis, schizophrenia) 2. Inability to follow the 8-week MBSR program 3. Protected patient: minor, adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision 4. Medical conditions which may interfere with the conduct of the study and the investigator's judgment, and which may render the patient unfit to participate in the study. 5. Pregnant or breast-feeding patient 6. Refusal to participate in the study or inability to comply with the study protocol for any reason whatsoever **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** cardiotmkb@me.com **Name:** Bernard Truong, MD **Phone:** +33622079508 **Role:** CONTACT **Contact 2:** **Name:** Bernard Truong, MD **Role:** CONTACT #### Locations **Location 1:** **City:** Aressy **Contacts:** ***Contact 1:*** - **Email:** cardiotmk@me.com - **Name:** Bernard Truong, MD - **Phone:** +33622079508 - **Role:** CONTACT ***Contact 2:*** - **Name:** Bernard Truong, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** France **Facility:** Clinique d'Aressy **Zip:** 64320 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M9419 - Name: Heart Diseases - Relevance: HIGH - As Found: Cardiac Disease ### Condition Browse Module - Meshes - ID: D000006331 - Term: Heart Diseases ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06438146 **Acronym:** LIROH **Brief Title:** LIROH - Liraglutide for Obesity in HIV **Official Title:** Liraglutide for Management of Obesity in People Living With HIV on Dolutegravir-based Antiretroviral Therapy: a Single-arm Acceptability Study in South Africa #### Organization Study ID Info **ID:** 2023P002985 #### Organization **Class:** OTHER **Full Name:** Brigham and Women's Hospital #### Secondary ID Infos **ID:** K23DK125162 **Link:** https://reporter.nih.gov/quickSearch/K23DK125162 **Type:** NIH ### Status Module #### Completion Date **Date:** 2025-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-29 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-02 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-02 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) #### Lead Sponsor **Class:** OTHER **Name:** Brigham and Women's Hospital #### Responsible Party **Investigator Affiliation:** Brigham and Women's Hospital **Investigator Full Name:** Jennifer M. Manne-Goehler, MD, SCD **Investigator Title:** Assistant Professor of Medicine **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this single-arm, open label pilot study is to evaluate liraglutide at the recommended dosage administered subcutaneously + lifestyle counselling for the management of people living with HIV (PLWH) with obesity defined by a BMI ≥30 kg/m2 who are on dolutegravir-based ART. Following individual informed consent, all participants will undergo a series of basic cardiometabolic labs. They will then be initiated on liraglutide 0.6 mg administered subcutaneously, and this dose will be gradually increased over a period of 4 weeks to a dose of 3.0 mg daily. Alongside drug administration, participants will receive lifestyle counselling regarding diet and physical activity. Following completion of a 12-week "on treatment" period, liraglutide will be stopped and participants will be followed for an additional 12-weeks off treatment. Body weight, cardiometabolic risk parameters, and a suite of patient-reported outcomes regarding diet, physical activity, sleep, and quality of life will be assessed periodically over the course of the study. **Detailed Description:** South Africa has the largest population of PLWH globally, with a prevalence of 17% in adults or 7.2 million PLWH. The rapid scale-up of ART programs has resulted in \>6 million PLWH on treatment, significant gains in life expectancy, and a large population of aging PLWH. With increasing life expectancy, obesity and type 2 diabetes have become growing threats for PLWH in South Africa and globally. One recent study found that 63% of PLWH are overweight or obese, and 6% have diabetes in this setting. This elevated risk of obesity in PLWH in South Africa is likely due to a confluence of both general considerations and HIV-specific factors. First, South Africa has experienced an accelerated background epidemic of metabolic disease in the general population with a prevalence of overweight and obesity that is nearly equal to that of high-income countries. Additionally, the International Diabetes Federation estimates that approximately 15.5 million adults are living with diabetes in the African Region, and projects it to grow to 41 million by 2045. As part of this background epidemic of metabolic disease, South Africa is also experiencing a nutrition transition, with widespread availability of processed and refined foods as well as sugar-sweetened beverages. Regarding HIV-specific issues, in 2019 the first-line ART regimen for the South African national HIV treatment program transitioned to TLD. TLD is generally very safe and well-tolerated and has a high barrier to HIV resistance but this transition to this regimen has been associated with risk of excess weight gain at the population level. Both clinical trials and observational studies conducted in South Africa have shown substantial increases in body weight in those who are initiating this ART regimen newly and among those who are suppressed and switched, especially women. Given this, there is a growing risk of obesity in PLWH in this context and a need for management strategies to address this increasingly prevalent comorbidity. Preventing the metabolic complications of HIV in South Africa and worldwide requires urgent solutions. To date, obesity management and diabetes prevention have largely consisted of behavioural interventions such as the Diabetes Prevention Program and related lifestyle modification efforts, focused on improving diet and increasing physical activity. However, in the past several years, novel anti-obesity pharmacologic agents such as the glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have shown enormous promise for obesity management and diabetes prevention in people who are HIV-negative (8-10). However, this drug class has a very limited evidence base in PLWH and relatively scant data from sub-Saharan African populations. Currently, liraglutide is the only GLP-1 RA approved for obesity management in South Africa and this protocol proposes to use the drug for its labelled indication of "weight loss in addition to diet and exercise in adults aged 18 and above who have: (1) a BMI of 30 or greater (obese) or (2) a BMI of greater than 27 and less than 30 (overweight) and weight related health problems (such as diabetes, high blood pressure, hypercholesterolemia, or obstructive sleep apnoea). This evidence gap motivates further inquiry into GLP-1 RAs such as liraglutide as one potential approach to obesity management and prevention of diabetes in PLWH who have comorbid obesity in South Africa, with implications for PLWH in other contexts. In this proposal, the investigators seek to further this important area of inquiry by evaluating the acceptability of liraglutide along with lifestyle counselling in PLWH who have obesity and are stable on dolutegravir-based ART in South Africa. ### Conditions Module **Conditions:** - Obesity - HIV Infections **Keywords:** - HIV - Obesity - Liraglutide - Behavior - Exercise - Lifestyle counseling ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Following individual informed consent, all participants will undergo a series of basic cardiometabolic labs. They will then be initiated on liraglutide 0.6 mg administered subcutaneously, and this dose will be gradually increased over a period of 4 weeks to a dose of 3.0mg daily. Alongside drug administration, participants will receive lifestyle counselling regarding diet and physical activity. Following completion of a 12-week "on treatment" period, liraglutide will be stopped and participants will be followed for an additional 12-weeks off treatment. Body weight, cardiometabolic risk parameters, and a suite of patient-reported outcomes regarding diet, physical activity, sleep, and quality of life will be assessed periodically over the course of the study. **Intervention Names:** - Drug: Liraglutide **Label:** Lirgalutide **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Lirgalutide **Description:** Dosing regimen: In this study protocol, liraglutide dosing will be implemented as follows: Liraglutide will be started at a dose of 0.6 mg per day. Participants will be taught to use the injection pen and will be observed giving the first injection. The dose will then be increased by 0.6 mg each week to a maximum dosage of 3.0 mg per day at the end of 4 weeks. This corresponds to the following dosing schedule: Week 1: 0.6 mg per day for one week Week 2: 1.2 mg per day for one week Week 3: 1.8 mg per day for one week Week 4: 2.4 mg per day for one week Week 5-12: 3.0 mg per day for 8 weeks Week 13-24: No drug administration **Name:** Liraglutide **Other Names:** - Saxenda **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** Systolic blood pressure change in mm Hg **Measure:** Change in blood pressure following 12 weeks on treatment **Time Frame:** Measured at Visit 4 at 12 weeks **Description:** Blood pressure change in mm Hg **Measure:** Change in blood pressure over 24 weeks (12 weeks on + 12 weeks off treatment) **Time Frame:** Measured at End of Study at 24 weeks **Description:** Change in total cholesterol **Measure:** Change in lipids following 12 weeks on treatment **Time Frame:** Measured at Visit 4 at 12 weeks **Description:** Change in total cholesterol **Measure:** Change in lipids over 24 weeks (12 weeks on + 12 weeks off treatment) **Time Frame:** Measured at End of Study at 24 weeks **Description:** Change in waist circumference in cm **Measure:** Change in waist circumference following 12 weeks on treatment **Time Frame:** Measured at Visit 4 at 12 weeks **Description:** Change in waist circumference in cm **Measure:** Change in waist circumference over 24 weeks (12 weeks on + 12 weeks off treatment) **Time Frame:** Measured at End of Study at 24 weeks **Description:** Change in quality of life scale score (scale of 0 - 100) **Measure:** Change in quality of life following 12 weeks on treatment per the World Health Organization's Quality of Life Instrument in HIV Infection **Time Frame:** Measured at Visit 4 at 12 weeks **Description:** Change in quality of life scale score (scale of 0 - 100) **Measure:** Change in quality of life over 24 weeks (12 weeks on + 12 weeks off treatment) per the World Health Organization's Quality of Life Instrument in HIV Infection **Time Frame:** Measured at End of Study at 24 weeks **Description:** Change in sleep quality scale score (global score range of 0 to 21 where score of 5 or greater indicates poor sleep) **Measure:** Change in sleep quality following 12 weeks on treatment per the Pittsburgh Sleep Quality Index **Time Frame:** Measured at Visit 4 at 12 weeks **Description:** Change in sleep quality scale score (global score range of 0 to 21 where score of 5 or greater indicates poor sleep) **Measure:** Change in sleep quality over 24 weeks (12 weeks on + 12 weeks off treatment) per the Pittsburgh Sleep Quality Index **Time Frame:** Measured at End of Study at 24 weeks #### Primary Outcomes **Description:** This will be expressed in terms of the proportion of participants who attend screening and enrolment visits among the total number who are approached regarding interest in study participation. **Measure:** Proportion of participants who screen and enroll among those approached **Time Frame:** Measured at screening **Measure:** Time to reach study enrollment target **Time Frame:** Measured at enrollment **Description:** This will be expressed as a proportion of participants who remain in the study after the 12 week "on treatment" period among those enrolled. **Measure:** Study retention rate at 12 weeks **Time Frame:** Measured at Visit 4 at 12 weeks **Description:** This will be expressed as a proportion of participants who remain in the study after the full 24 weeks of study procedures are completed among those enrolled. **Measure:** Study retention rate at 24 weeks **Time Frame:** Measured at End of Study at 24 weeks **Description:** The investigators will assess volume remaining in the injector pens and provide a percentage of doses per participant that remained unused at the end of the 12-week period on treatment. **Measure:** Rate of adherence to treatment over 12 weeks **Time Frame:** Measured at Visit 4 at 12 weeks **Description:** This will be open-ended responses to a brief exit interview about acceptability and feasibility. **Measure:** Embedded qualitative interviews regarding the acceptability of liraglutide for obesity management **Time Frame:** Measured at End of Study at 24 weeks #### Secondary Outcomes **Description:** The investigators will report incidence of TEAEs up to 24 weeks (12 weeks on + 12 weeks off treatment) **Measure:** Incidence of treatment-emergent adverse events as defined in this protocol **Time Frame:** From the initiation of treatment until the date of a treatment-emergent adverse event, assessed up to 24 weeks. **Description:** The investigators will report incidence of SAEs up to 24 weeks (12 weeks on + 12 weeks off treatment) **Measure:** Incidence of serious adverse events (SAEs), as defined in this protocol **Time Frame:** From the initiation of treatment until the date of a serious adverse event, assessed up to 24 weeks. **Description:** Body weight will be measured in the study at both enrolment and after 12 weeks on treatment (Visit 4); these will be used to calculate a continuous change in kg. **Measure:** Change in body weight following 12 weeks on treatment **Time Frame:** Measured at Visit 4 at 12 weeks **Description:** Body weight will be measured in the study at both enrolment and after 24 weeks on treatment (EOS); these will be used to calculate a continuous change in kg. **Measure:** Change in body weight over 24 weeks (12 weeks on + 12 weeks off treatment) **Time Frame:** Measured at End of Study at 24 weeks **Description:** HbA1c will be measured at enrolment and at Visit 4; here investigators will calculate the difference between these measures (in %). **Measure:** Change in HbA1c following 12 weeks on treatment **Time Frame:** Measured at Visit 4 at 12 weeks **Description:** HbA1c will be measured at enrolment and at EOS; here investigators will calculate the difference between these measures (in %). **Measure:** Change in HbA1c over 24 weeks (12 weeks on + 12 weeks off treatment) **Time Frame:** Measured at End of Study at 24 weeks **Description:** Fasting glucose will be measured at enrolment and at Visit 4; investigators will calculate the difference between these measures (in mmol/L). **Measure:** Change in fasting plasma glucose following 12 weeks on treatment **Time Frame:** Measured at Visit 4 at 12 weeks **Description:** Fasting glucose will be measured at enrolment and at EOS; investigators will calculate the difference between these measures (in mmol/L). **Measure:** Change in fasting plasma glucose over 24 weeks (12 weeks on + 12 weeks off treatment) **Time Frame:** Measured at End of Study at 24 weeks **Description:** This will be defined as the difference in depression score per the Patient Health Questionnaire (PHQ-9) at enrolment and Visit 4. The minimum value is 1 and the maximum is 27, where the greater the total score, the greater severity of depression. **Measure:** Change in depressive symptoms following 12 weeks on treatment **Time Frame:** Measured at Visit 4 at 12 weeks **Description:** This will be defined as the difference in depression score per the Patient Health Questionnaire (PHQ-9) at enrolment and EOS. The minimum value is 1 and the maximum is 27, where the greater the total score, the greater severity of depression. **Measure:** Change in depressive symptoms over 24 weeks (12 weeks on + 12 weeks off treatment) **Time Frame:** Measured at End of Study at 24 weeks **Description:** This will be defined as the difference in physical activity expressed in MET-minutes per week, where MET minutes represent the amount of energy expended carrying out physical activity, per the International Physical Activity Questionnaire (IPAQ) at enrolment and Visit 4. **Measure:** Change in physical activity level following 12 weeks on treatment **Time Frame:** Measured at Visit 4 at 12 weeks **Description:** This will be defined as the difference in physical activity expressed in MET-minutes, where MET minutes represent the amount of energy expended carrying out physical activity, per week per the International Physical Activity Questionnaire (IPAQ) at enrolment and EOS. **Measure:** Change in physical activity level over 24 weeks (12 weeks on + 12 weeks off treatment) **Time Frame:** Measured at End of Study at 24 weeks **Description:** This will be defined as the difference in total servings of fruits and vegetables, change in frequency of sugar-sweetened beverage intake, and change frequency of fast food intake from enrolment to Visit 4. **Measure:** Change in dietary habits following 12 weeks on treatment **Time Frame:** Measured at Visit 4 at 12 weeks **Description:** This will be defined as the difference in total servings of fruits and vegetables, change in frequency of sugar-sweetened beverage intake, and change frequency of fast food intake from enrolment to EOS. **Measure:** Change in dietary habits over 24 weeks (12 weeks on + 12 weeks off treatment) **Time Frame:** Measured at End of Study at 24 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Able to give written informed consent to participate in the study 2. Able to comply with all study procedures, including daily subcutaneous injections 3. Adults ≥18 years old 4. PLWH on dolutegravir-based ART for ≥6 months 5. Documented HIV-1 viral load in the past 6 months confirming the participant is virologically suppressed 6. BMI ≥30 kg/m2 7. Desiring weight loss 8. Willing to undertake lifestyle change 9. Not on any weight loss agent for the duration of the study Exclusion Criteria: 1. Self-reported history of diabetes 2. Current use of medications for diabetes 3. Known contraindications to liraglutide, such as hypersensitivity to a component of the drug 4. Current pregnancy or desire to become pregnant 5. History of pancreatitis 6. History of thyroid disease 7. History of harmful use of alcohol 8. Clinically unstable in the opinion of the investigator **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** jmanne@bwh.harvard.edu **Name:** Jennifer Manne-Goehler, MD, ScD **Phone:** 7542246060 **Role:** CONTACT #### Locations **Location 1:** **City:** Mtubatuba **Contacts:** ***Contact 1:*** - **Email:** ngundu.behuhuma@ahri.org - **Name:** Ngundu Behuhuma, MBChB - **Phone:** 082 964 0652 - **Role:** CONTACT ***Contact 2:*** - **Name:** Ngundu Behuhuma, MBChB - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Mark Siedner, MD, MPH - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 4:*** - **Name:** Limakatso Lebina, MBChB - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 5:*** - **Name:** Jennifer Manne-Goehler, MD, ScD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** South Africa **Facility:** Africa Health Research Institute Clinical Trials Unit **Status:** RECRUITING **Zip:** 3935 #### Overall Officials **Official 1:** **Affiliation:** Brigham and Women's Hospital **Name:** Jennifer Manne-Goehler, MD, ScD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** Access to the IPD and the associated documents will require completion of the online data access application form accessible on the AHRI Data repository. AHRI bona fide data users are required to abide by the data use conditions stipulated on the application for access to the data. **Description:** Anonymized data as allowable **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR **IPD Sharing:** YES **Time Frame:** The IPD data will be shared in accordance with AHRI Data Access Policy and Data Management Plan within two years of completion. **URL:** https://data.ahri.org/ ### References Module #### References **Citation:** Venter WDF, Moorhouse M, Sokhela S, Fairlie L, Mashabane N, Masenya M, Serenata C, Akpomiemie G, Qavi A, Chandiwana N, Norris S, Chersich M, Clayden P, Abrams E, Arulappan N, Vos A, McCann K, Simmons B, Hill A. Dolutegravir plus Two Different Prodrugs of Tenofovir to Treat HIV. N Engl J Med. 2019 Aug 29;381(9):803-815. doi: 10.1056/NEJMoa1902824. Epub 2019 Jul 24. **PMID:** 31339677 **Citation:** Venter WDF, Sokhela S, Simmons B, Moorhouse M, Fairlie L, Mashabane N, Serenata C, Akpomiemie G, Masenya M, Qavi A, Chandiwana N, McCann K, Norris S, Chersich M, Maartens G, Lalla-Edward S, Vos A, Clayden P, Abrams E, Arulappan N, Hill A. Dolutegravir with emtricitabine and tenofovir alafenamide or tenofovir disoproxil fumarate versus efavirenz, emtricitabine, and tenofovir disoproxil fumarate for initial treatment of HIV-1 infection (ADVANCE): week 96 results from a randomised, phase 3, non-inferiority trial. Lancet HIV. 2020 Oct;7(10):e666-e676. doi: 10.1016/S2352-3018(20)30241-1. **PMID:** 33010240 **Citation:** Manne-Goehler J, Rahim N, van Empel E, de Vlieg R, Chamberlin G, Ihama A, Castle A, Mabweazara S, Venter WDF, Chandiwana N, Levitt NS, Siedner M. Perceptions of Health, Body Size, and Nutritional Risk Factors for Obesity in People with HIV in South Africa. AIDS Behav. 2024 Jan;28(1):367-375. doi: 10.1007/s10461-023-04152-7. Epub 2023 Aug 26. **PMID:** 37632604 **Citation:** Chandiwana NC, Siedner MJ, Marconi VC, Hill A, Ali MK, Batterham RL, Venter WDF. Weight Gain After HIV Therapy Initiation: Pathophysiology and Implications. J Clin Endocrinol Metab. 2024 Jan 18;109(2):e478-e487. doi: 10.1210/clinem/dgad411. **PMID:** 37437159 **Citation:** Magodoro IM, Olivier S, Gareta D, Koole O, Modise TH, Gunda R, Herbst K, Pillay D, Wong EB, Siedner MJ. Linkage to HIV care and hypertension and diabetes control in rural South Africa: Results from the population-based Vukuzazi Study. PLOS Glob Public Health. 2022 Nov 2;2(11):e0001221. doi: 10.1371/journal.pgph.0001221. eCollection 2022. **PMID:** 36962629 **Citation:** Rubino DM, Greenway FL, Khalid U, O'Neil PM, Rosenstock J, Sorrig R, Wadden TA, Wizert A, Garvey WT; STEP 8 Investigators. Effect of Weekly Subcutaneous Semaglutide vs Daily Liraglutide on Body Weight in Adults With Overweight or Obesity Without Diabetes: The STEP 8 Randomized Clinical Trial. JAMA. 2022 Jan 11;327(2):138-150. doi: 10.1001/jama.2021.23619. **PMID:** 35015037 **Citation:** Wadden TA, Bailey TS, Billings LK, Davies M, Frias JP, Koroleva A, Lingvay I, O'Neil PM, Rubino DM, Skovgaard D, Wallenstein SOR, Garvey WT; STEP 3 Investigators. Effect of Subcutaneous Semaglutide vs Placebo as an Adjunct to Intensive Behavioral Therapy on Body Weight in Adults With Overweight or Obesity: The STEP 3 Randomized Clinical Trial. JAMA. 2021 Apr 13;325(14):1403-1413. doi: 10.1001/jama.2021.1831. **PMID:** 33625476 **Citation:** Wilding JPH, Batterham RL, Calanna S, Davies M, Van Gaal LF, Lingvay I, McGowan BM, Rosenstock J, Tran MTD, Wadden TA, Wharton S, Yokote K, Zeuthen N, Kushner RF; STEP 1 Study Group. Once-Weekly Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2021 Mar 18;384(11):989-1002. doi: 10.1056/NEJMoa2032183. Epub 2021 Feb 10. **PMID:** 33567185 **Citation:** Hyle EP, Bekker LG, Martey EB, Huang M, Xu A, Parker RA, Walensky RP, Middelkoop K. Cardiovascular risk factors among ART-experienced people with HIV in South Africa. J Int AIDS Soc. 2019 Apr;22(4):e25274. doi: 10.1002/jia2.25274. **PMID:** 30990252 **Citation:** Bailin SS, Gabriel CL, Wanjalla CN, Koethe JR. Obesity and Weight Gain in Persons with HIV. Curr HIV/AIDS Rep. 2020 Apr;17(2):138-150. doi: 10.1007/s11904-020-00483-5. **PMID:** 32072466 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000050177 - Term: Overweight - ID: D000044343 - Term: Overnutrition - ID: D000009748 - Term: Nutrition Disorders - ID: D000001835 - Term: Body Weight ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC01 - Name: Infections - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M12701 - Name: Obesity - Relevance: HIGH - As Found: Obesity - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M3522 - Name: Acquired Immunodeficiency Syndrome - Relevance: LOW - As Found: Unknown - ID: M18250 - Name: HIV Infections - Relevance: LOW - As Found: Unknown - ID: M26186 - Name: Overweight - Relevance: LOW - As Found: Unknown - ID: M25307 - Name: Overnutrition - Relevance: LOW - As Found: Unknown - ID: M12684 - Name: Nutrition Disorders - Relevance: LOW - As Found: Unknown - ID: M5114 - Name: Body Weight - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009765 - Term: Obesity ### Intervention Browse Module - Ancestors - ID: D000097789 - Term: Glucagon-Like Peptide-1 Receptor Agonists - ID: D000007004 - Term: Hypoglycemic Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000054795 - Term: Incretins - ID: D000006728 - Term: Hormones - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: Gast - Name: Gastrointestinal Agents ### Intervention Browse Module - Browse Leaves - ID: M419 - Name: Liraglutide - Relevance: HIGH - As Found: Stable - ID: M347662 - Name: Dolutegravir - Relevance: LOW - As Found: Unknown - ID: M25428 - Name: Anti-Retroviral Agents - Relevance: LOW - As Found: Unknown - ID: M9043 - Name: Glucagon - Relevance: LOW - As Found: Unknown - ID: M3401 - Name: Glucagon-Like Peptide-1 Receptor Agonists - Relevance: LOW - As Found: Unknown - ID: M26997 - Name: Glucagon-Like Peptide 1 - Relevance: LOW - As Found: Unknown - ID: M10054 - Name: Hypoglycemic Agents - Relevance: LOW - As Found: Unknown - ID: M27905 - Name: Incretins - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M9788 - Name: Hormone Antagonists - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000069450 - Term: Liraglutide ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06438133 **Acronym:** CIMON **Brief Title:** Digital Supported Compression Bandaging in Patients With Chronic Edema in the Lower Limbs **Official Title:** Digital Supported Compression Bandaging in Patients With Chronic Edema in the Lower Limbs - Assessment of Measurement Properties of a Novel Sensor #### Organization Study ID Info **ID:** CIMON #### Organization **Class:** OTHER **Full Name:** Herlev and Gentofte Hospital ### Status Module #### Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-27 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Rigshospitalet, Denmark **Class:** OTHER **Name:** Hvidovre University Hospital **Class:** OTHER **Name:** Bispebjerg Hospital **Class:** OTHER **Name:** Odense University Hospital #### Lead Sponsor **Class:** OTHER **Name:** Carsten Bogh Juhl #### Responsible Party **Investigator Affiliation:** Herlev and Gentofte Hospital **Investigator Full Name:** Carsten Bogh Juhl **Investigator Title:** Professor **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Patients with chronic edema of the lower limb referred to compression bandaging in a hospital setting will be invited to participate in the validation study of a novel sensor (CIMON), which have been developed for assessing the effect of compression bandaging. Participants will have the sensor applied to the lower limb before initiation of compression bandaging and will receive usual compression treatment according to severity of the edema and usual practice at the treatment site. Duration of participation is 14 days. **Detailed Description:** The CIMON sensor is developed with the purpose of monitoring the effectiveness of compression bandaging (CB) in patients with chronic edema by application to the widest circumference of the calf. CIMON measures the difference in capacitance by stretching the circumferential sensor. Data from the sensor is transferred by Bluetooth technology to a secured webserver, where healthcare professionals can monitor the effect of compression bandaging. The study aims to assess the psychometric properties of the CIMON (reliability, validity and responsiveness) and assess the correlation between edema reduction and physical activity during compression bandaging. ### Conditions Module **Conditions:** - Compression; Vein - Venous Insufficiency - Lymphedema of Leg - Digital Technology **Keywords:** - Compression therapy - Compression bandaging - Chronic edema - Psychometrics ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients with chronic edema of the lower limbs referred to compression bandaging in a hospital setting. **Intervention Names:** - Other: CIMON - Other: Sens Motion **Label:** Patients with chronic edema of the lower limbs ### Interventions #### Intervention 1 **Arm Group Labels:** - Patients with chronic edema of the lower limbs **Description:** The sensor assess changes in the circumference of the limb and will be applied to the lower limb before compression bandaging is applied. **Name:** CIMON **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Patients with chronic edema of the lower limbs **Description:** The sensor assess physical activity and the amount of time spent at rest, standing, walking, running and count steps. **Name:** Sens Motion **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Assessed by Cimon sensor, tape measurement, tissue dielectic constant, perometry and dual xray energy absorptiometry (DXA) **Measure:** Edema reduction **Time Frame:** 14 days #### Secondary Outcomes **Description:** Self-reported pain, tension and heaviness **Measure:** Symptoms related to chronic edema **Time Frame:** 14 days **Description:** Assessed by Sens Motion sensor **Measure:** Physical Activity **Time Frame:** 14 days **Description:** Any adverse events related to compression bandaging and the application of sensors **Measure:** Adverse events **Time Frame:** 14 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Chronic edema of the lower limb * Referred to compression bandaging * Circumference of widest point of the lower leg between 35-75 cm Exclusion Criteria: * Wounds at the lower leg (at the widest circumference of the lower leg) * Acute deep venous thrombosis in the leg * Untreated cellulitis * Severe heart- or kidneyfailure * Severe peripheral neuropathy in the lower limbs **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients with chronic edema of the lower limbs referred to compression bandaging in a hospital setting. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** merete.celano.wittenkamp@regionh.dk **Name:** Merete Celano Wittenkamp, MPH **Phone:** +93911784 **Role:** CONTACT **Contact 2:** **Email:** carsten.bogh.juhl@regionh.dk **Name:** Carsten Bogh Juhl, Professor **Role:** CONTACT #### Locations **Location 1:** **City:** Bispebjerg **Contacts:** ***Contact 1:*** - **Name:** Mette L Joergensen, RN - **Role:** CONTACT **Country:** Denmark **Facility:** Department of Dermatology, Frederiksberg Bispebjerg Hospital **State:** Capital Region **Location 2:** **City:** Copenhagen **Contacts:** ***Contact 1:*** - **Name:** Jan Christensen, Phd - **Role:** CONTACT **Country:** Denmark **Facility:** Department of Physiotherapy and Occupational Therapy, Rigshospitalet **State:** Capital Region **Zip:** 2100 **Location 3:** **City:** Herlev **Contacts:** ***Contact 1:*** - **Email:** merete.celano.wittenkamp@regionh.dk - **Name:** Merete C Wittenkamp, MPH - **Phone:** +4593911784 - **Role:** CONTACT **Country:** Denmark **Facility:** Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte Hospital **State:** Capital Region **Zip:** 2730 **Location 4:** **City:** Hvidovre **Contacts:** ***Contact 1:*** - **Name:** Kira Marie Milandt Skibdal, Msc - **Role:** CONTACT **Country:** Denmark **Facility:** Department of Physiotherapy and Occupational Therapy, Amager Hvidovre Hospital **State:** Capital Region **Location 5:** **City:** Odense **Contacts:** ***Contact 1:*** - **Name:** Marianne Holt, Msc - **Role:** CONTACT **Country:** Denmark **Facility:** Department of Oncology, Unit of Lymphedema care, Odense University Hospital **State:** Region Of Southern Denmark #### Overall Officials **Official 1:** **Affiliation:** Herlev and Gentofte Hospital **Name:** Carsten Bogh Juhl, Professor **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000008206 - Term: Lymphatic Diseases - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M17435 - Name: Venous Insufficiency - Relevance: HIGH - As Found: Venous Insufficiency - ID: M11206 - Name: Lymphedema - Relevance: HIGH - As Found: Lymphedema - ID: M7657 - Name: Edema - Relevance: LOW - As Found: Unknown - ID: M11203 - Name: Lymphatic Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000014689 - Term: Venous Insufficiency - ID: D000008209 - Term: Lymphedema ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06438120 **Brief Title:** Chatbot-based Positive Psychology Intervention to Promote Well-being in Caregivers of Children With Autism Spectrum Disorder: a Pilot Feasibility Study **Official Title:** Chatbot-based Positive Psychology Intervention to Promote Well-being in Caregivers of Children With Autism Spectrum Disorder: A Pilot Feasibility Study #### Organization Study ID Info **ID:** RD/2023/1.20 #### Organization **Class:** OTHER **Full Name:** Hong Kong Metropolitan University ### Status Module #### Completion Date **Date:** 2025-07-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-27 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-07-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Hong Kong Metropolitan University #### Responsible Party **Investigator Affiliation:** Hong Kong Metropolitan University **Investigator Full Name:** Dr Wendy Zhang Wen **Investigator Title:** Assistant Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This project aims to evaluate the feasibility and preliminary effectiveness of chatbot-based positive psychology intervention. **Detailed Description:** According to a World Health Organization report, one in 100 children is diagnosed with Autism Spectrum Disorder (ASD), which is characterized by varying degrees of disability and deviation in social communication and interaction. Half of the parents of children with ASD have reported showing depression and high levels of anxiety. Lower well-being and poor quality-of-life have also been reported. Thus, there is an urgent need to find applicable interventions to reduce depressive symptoms and promote mental health in caregivers of children with ASD. Positive psychology intervention uses positive psychological skills, such as savoring, gratitude, forgiveness, optimism, personal strength, and attainable goals, to identify meaning and value in life events and to promote positive emotions, cognitions and behaviors. Considering the convenience, low cost and popularity of chatbot, chatbot-based positive psychology intervention will be applied in this study. A pilot feasibility study will be proposed to evaluate the feasibility of chatbot-based positive psychology intervention. The primary objective is to evaluate the feasibility and preliminary effectiveness of chatbot-based positive psychology intervention in promoting well-being in caregivers of children with ASD (Primary). The secondary objectives are: To test if the intervention reduces perceived stress in caregivers of children with ASD; To test if the intervention reduces depressive symptoms of caregivers of children with ASD; To test if the intervention improves quality of life in caregivers of children with ASD. ### Conditions Module **Conditions:** - Autism Spectrum Disorder ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Participants will receive chatbot-based positive psychology exercises including positive introduction, personal strengths, using strengths, three good things, gratitude letter/visit, hope and optimism, active/constructive responding, and savoring. ##### Masking Info **Masking:** NONE **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** In the intervention group, participants will receive chatbot-based positive psychology intervention. **Intervention Names:** - Behavioral: Chatbot-based positive psychology intervention **Label:** Intervention group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention group **Description:** Eight positive psychology exercises will be delivered, including positive introduction, personal strengths, using strengths, three good things, gratitude, hope and optimism, active/constructive responding, and savoring. **Name:** Chatbot-based positive psychology intervention **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Feasibility will be assessed by 2 items modified from the Feasibility of Intervention Measure and the semi-structured interview will be conducted after the intervention immediately (9-week follow-up). Barriers and facilitators to participant adherence, and retention will be discussed in order to collect feedback. **Measure:** The feasibility of chatbot-based positive psychology intervention **Time Frame:** Baseline and after the intervention immediately (8-week follow-up) **Description:** Well-being will be measured by the World Health Organization-5 Well-being **Measure:** The score of well-being **Time Frame:** Baseline and after the intervention immediately (8-week follow-up) #### Secondary Outcomes **Description:** Perceived Stress will be assessed by a 10-item Perceived Stress Scale (PSS-10) **Measure:** Perceived Stress **Time Frame:** Baseline and after the intervention immediately (8-week follow-up) **Description:** Depressive symptoms will be measured by the Patient Health Questionnaire-9 (PHQ-9) **Measure:** Depressive symptoms **Time Frame:** Baseline and after the intervention immediately (8-week follow-up) **Description:** Quality of life will be measured by the Chinese version of Short Form-8(SF-8) **Measure:** The score of Quality of life **Time Frame:** Baseline and after the intervention immediately (8-week follow-up) ### Eligibility Module **Eligibility Criteria:** Inclusion criteria: Primary caregivers * (i) providing long-term care for the primary-school-age child (6-11 years old) diagnosed with ASD; * (ii) who are over 18 years old; * (iii) who have the ability to communicate and read in Chinese; * (iv) who have at least one mobile phone with an internet connection. Exclusion criteria: Primary caregivers * (i) who participate in a similar psychological intervention within one year; * (ii) currently on regular psychotropic medications. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** wwzhang@hkmu.edu.hk **Name:** Wen Zhang, PhD **Phone:** +852-3970-2945 **Role:** CONTACT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000065886 - Term: Neurodevelopmental Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4623 - Name: Autistic Disorder - Relevance: HIGH - As Found: Autism - ID: M206 - Name: Autism Spectrum Disorder - Relevance: HIGH - As Found: Autism Spectrum Disorder - ID: M5903 - Name: Child Development Disorders, Pervasive - Relevance: HIGH - As Found: Autism Spectrum Disorder - ID: M5902 - Name: Developmental Disabilities - Relevance: LOW - As Found: Unknown - ID: M30644 - Name: Neurodevelopmental Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001321 - Term: Autistic Disorder - ID: D000067877 - Term: Autism Spectrum Disorder - ID: D000002659 - Term: Child Development Disorders, Pervasive ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06438107 **Brief Title:** Deep Phenotyping of the Renal Allograft to Prognosticate Clinical Outcomes **Official Title:** Deep Phenotyping of the Renal Allograft to Prognosticate Clinical Outcomes #### Organization Study ID Info **ID:** STUDY21090074 #### Organization **Class:** OTHER **Full Name:** University of Pittsburgh ### Status Module #### Completion Date **Date:** 2029-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-26 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-02-19 **Study First Submit QC Date:** 2024-05-26 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Pittsburgh #### Responsible Party **Investigator Affiliation:** University of Pittsburgh **Investigator Full Name:** Aravind Cherukuri **Investigator Title:** Assistant Professor of Medicine and Surgery **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this observational study is to determine phenotypic, transcriptional, and epigenetic underpinnings of renal allograft rejection in renal transplant rejection. The main questions it aims to answer are: * To determine the phenotype, frequency, location, and the inter-cellular interactions between the cells that constitute intra-graft inflammatory infiltrate in acute ejection. * To determine the phenotype, frequency, location, and the inter-cellular interactions between the cells that constitute intra-graft inflammatory infiltrate in recurrent/recalcitrant rejection vs. rejection that resolves with therapy. * To generate a scRNA sequencing (scRNAseq) map of the intra-graft immune cells and the renal parenchymal cells and compare the transcriptional and epigenetic changes within these cells in recurrent/recalcitrant rejection vs. rejection that resolves with therapy. * To determine phenotypic changes associated with chronic rejection. Participants will be asked to provide the following research specimens: * Renal biopsy specimens at the following timepoints: day of transplantation (pre-implantation and post-perfusion); routine protocol biopsies at 3 months and 12 months; and clinically indicated for-cause biopsies at any timepoint from time-0 to 1-yr post-transplantation. The 1st research core will be used for routine histopathological examination and left over tissue from this core will be used for deep phenotyping using multiparameter immunophenotyping, and digital spatial profiling. The second research core will be used for extraction of cells and nuclei for scRNAseq and snATACseq. * Blood samples will be processed to obtain plasma (for cytokine, chemokine and DSA measurements) and PBMC (for deep phenotyping and molecular analyses). For each collection timepoint, up to 75 mL (about 5 tablespoons) will be collected. * Prospective clinical data and outcomes will be collected from participant medical records. * Follow-Up Period: For-cause biopsies from 1-yr to 5-yr post-transplantation (by the transplant nephrologist): no additional cores will be obtained for research from these biopsies. The left-over tissue from the clinically indicated biopsy cores will be analyzed by deep phenotyping and digital spatial profiling. Blood samples will be processed to obtain plasma (for cytokine, chemokine and DSA measurements) and PBMC (for deep phenotyping and molecular analyses). **Detailed Description:** This study is exploratory in nature and aims to elucidate the phenotypic, transcriptional, and epigenetic underpinnings of renal transplant rejection. The study is designed to provide improved understanding of the regulation of intra-graft alloimmune response in the renal transplant recipients. In this single center, prospective, longitudinal, observational cohort study, sequential assessment of renal biopsies will be performed at baseline (pre-implantation), 3 months and at one-year post-transplantation in addition to any for-cause biopsies within the first five years post-transplantation. Blood samples will be also collected at the time of renal biopsies for comparison analyses. HYPOTHESIS It is proposed that unique phenotypic, transcriptional, and epigenetic changes within the parenchymal and the infiltrating nonparenchymal inflammatory cells dictate the evolution of renal allograft inflammation and rejection. The following research specimens will be obtained from each study participant: 1. The day of transplantation (by the UPMC operating surgeon): Pre-implantation core renal biopsy and post-perfusion core renal biopsy: Two research cores for each biopsy will be taken from the transplanted kidney. The pre-implantation biopsy specimens are obtained on the back table, and the post-perfusion cores are taken prior to closure of the surgical incision. The 1st research core will be used for routine histopathological examination and left over tissue from this core will be used for deep phenotyping using multiparameter immunophenotyping, and digital spatial profiling. The second research core will be used for extraction of cells and nuclei for scRNAseq and snATACseq. Blood samples will be processed to obtain plasma (for cytokine, chemokine and DSA measurements) and PBMC (for deep phenotyping and molecular analyses). For each collection timepoint, up to 75 mL (about 5 tablespoons) will be collected. 2. Protocol biopsies at 3 months and 12 months (by the transplant nephrologist): Renal transplant recipients at UPMC routinely undergo clinical post-transplant biopsies at 3 months and at 12 months. An additional research core will be collected along with the clinically indicated biopsy cores at both these time points (3 total passes of the biopsy needle for each collection). Left over tissue from the clinically indicated core will be used for deep phenotyping using multiparameter immunophenotyping, and digital spatial profiling. The research core will be used for extraction of cells and nuclei for scRNAseq and snATACseq. Blood samples will be processed to obtain plasma (for cytokine, chemokine and DSA measurements) and PBMC (for deep phenotyping and molecular analyses). 3. For-cause biopsies from time-0 to 1-yr post-transplantation (by the transplant nephrologist): Along with the protocol biopsies, UPMC renal transplant patients also undergo biopsies for clinical indication (for-cause biopsies). Again, an additional research core will be collected along with the clinically indicated biopsy cores whenever a patient undergoes any for-cause biopsy between time-0 and 1-year post-transplantation (3 total passes of the biopsy needle for each collection). Left over tissue from the clinically indicated core will be used for deep phenotyping using multiparameter immunophenotyping, and digital spatial profiling. The research core will be used for extraction of cells and nuclei for scRNAseq and snATACseq. Blood samples will be processed to obtain plasma (for cytokine, chemokine and DSA measurements) and PBMC (for deep phenotyping and molecular analyses). The investigators will review procedures associated with the consent with participants again at the time of each of these biopsies to confirm their continued interest in participation. As these procedures are a part of the standard of care biopsies that the patients undergo, no additional hospital visits are expected. The research specimens will be delivered to and processed by laboratory research members. Prospective clinical data and outcomes will be collected from participant medical records. The following clinical data will be collected from each research participant: 1. Demographic characteristics (e.g., age, gender, ethnicity, cause of renal disease) 2. Pre-transplant clinical variables (e.g., h/o prior transplant, HLA mismatches, panel reactive antibodies, prior use of immunosuppression, cold ischemia time, warm ischemia time) 3. De-identified donor data (e.g., donor age, gender, ethnicity, donor type, KDPI) as available at time of transplant 4. Immunosuppression details (e.g., induction and maintenance agents, trough CNI levels through the 1st post-transplant year) 5. Clinical outcomes (e.g., DGF; detection of DSA; biopsy clinical reports; Serum Creatinine and eGFR at 1, 3, 6, and 12 months, and then at 2, 3, 4, and 5 years; graft and patient survival at 5 years) Follow-Up Period For-cause biopsies from 1-yr to 5-yr post-transplantation (by the transplant nephrologist): These are the standard-of-care indication biopsies that are performed beyond the 1st post-transplant year, up to 5 years post-transplantation. While no additional cores will be obtained for research from these biopsies (about 2 passes of the biopsy needle per standard practices), we will analyze the left-over tissue from the clinically indicated biopsy cores by deep phenotyping (Marcus Clark Lab, University of Chicago; MTA in place) and digital spatial profiling (Randhawa Lab, University of Pittsburgh). Blood samples will be processed to obtain plasma (for cytokine, chemokine and DSA measurements) and PBMC (for deep phenotyping and molecular analyses). STUDY AIMS Aim 1. To determine phenotypic, transcriptional, and epigenetic underpinnings of renal allograft rejection. 1. A) To determine the phenotype, frequency, location, and the inter-cellular interactions between the cells that constitute intra-graft inflammatory infiltrate in acute ejection. (1B) To generate a scRNA sequencing (scRNAseq) map of the intra-graft immune cells and the renal parenchymal cells and determine the transcriptional and epigenetic changes within these cells at baseline, prior to the diagnosis, and at the diagnosis of acute rejection. Analysis of these changes longitudinally through the 1st post-transplant year will allow us to delineate the natural history of renal allograft rejection. Aim 2. To determine phenotypic, transcriptional, and epigenetic differences that underlie persistence vs. resolution of acute rejection after renal transplantation. 2. A) To determine the phenotype, frequency, location, and the inter-cellular interactions between the cells that constitute intra-graft inflammatory infiltrate in recurrent/recalcitrant rejection vs. rejection that resolves with therapy. (2B) To generate a scRNA sequencing (scRNAseq) map of the intra-graft immune cells and the renal parenchymal cells and compare the transcriptional and epigenetic changes within these cells in recurrent/recalcitrant rejection vs. rejection that resolves with therapy. Aim 3. To determine phenotypic changes associated with chronic rejection. In a subset of patient in whom for-cause transplant biopsies are available past the 1st year and up to 5 years after transplantation, we will perform multi-parameter immunophenotyping and spatial transcriptional analysis to explore cellular infiltrate and transcriptional changes associated with chronic rejection. Exploratory Endpoints: 1. To correlate the frequency and phenotype of the intra-graft inflammatory infiltrate with histological diagnosis within the 1st post-transplant year (acute rejection vs. borderline rejection vs. no acute rejection). 2. To determine the transcriptional and epigenetic changes within intra-graft immune cells and graft parenchymal cells at baseline, prior to and at the diagnosis of acute rejection or borderline rejection in comparison to no rejection. 3. To determine phenotypic, transcriptional, and epigenetic differences that underlie persistence vs. resolution of acute rejection in the 1st post-transplant year. 4. To determine the phenotypic and transcriptional changes associated with chronic rejection. 5. To correlate histological phenotypes with peripheral blood phenotypes. ### Conditions Module **Conditions:** - Renal Transplant Rejection **Keywords:** - Organ rejection - Acute rejection ### Design Module #### Bio Spec **Description:** Renal biopsy core tissue specimens, blood plasma and PBMC samples **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 24 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Living donor and deceased donor renal transplant recipients. There is no intervention to be administered. **Label:** Renal transplantation recipients ### Outcomes Module #### Primary Outcomes **Description:** Percentage biopsy proven acute rejection either on a surveillance biopsy or a for-cause biopsy in the First Post-Transplant Year **Measure:** Percentage of Participants with Biopsy Proven Acute Rejection at one year **Time Frame:** 1 year **Description:** Degree of Correlation of Transcriptional Changes Within the Infiltrating Inflammatory Cells Assessed by scRNA Sequencing in the First Post-Transplant Year **Measure:** Degree of Correlation of Acute Rejection Transcriptional Changes Within the Infiltrating Inflammatory Cells at one year **Time Frame:** 1 year **Description:** Percentage Correlation of Acute Rejection Transcriptional Changes Within the Renal Parenchymal Cells Assessed by scRNA Sequencing in the First Post-Transplant Year **Measure:** Percentage of Correlation of Transcriptional Changes Within the Renal Parenchymal Cells at one year **Time Frame:** 1 year #### Secondary Outcomes **Description:** Percentage Histological Persistence of Rejection in the First Post-Transplant Year **Measure:** Percentage of Histological Persistence of Rejection at one year **Time Frame:** 1 year **Description:** Degree of Correlation of Histological Transcriptional Changes Within the Infiltrating Inflammatory Cells in the First Post-Transplant Year **Measure:** Degree of Correlation of Histological Transcriptional Changes Within the Infiltrating Inflammatory Cells at one year **Time Frame:** 1 Year **Description:** Degree of Correlation of Histological Transcriptional Changes Within the Renal Parenchymal Cells in the First Post-Transplant Year **Measure:** Degree of Correlation of Histological Transcriptional Changes Within the Renal Parenchymal Cells at one year **Time Frame:** 1 Year **Description:** Percentage biopsy proven acute rejection either on a surveillance biopsy or a for-cause biopsy in the Third Post-Transplant Year **Measure:** Percentage of Participants with Biopsy Proven Acute Rejection at Year 3 **Time Frame:** 3 Years **Description:** Degree Correlation of Transcriptional Changes Within the Infiltrating Inflammatory Cells Assessed by scRNA Sequencing in the Third Post-Transplant Year **Measure:** Degree of Correlation of Acute Rejection Transcriptional Changes Within the Infiltrating Inflammatory Cells at Year 3 **Time Frame:** 3 Years **Description:** Degree of Correlation of Acute Rejection Transcriptional Changes Within the Renal Parenchymal Cells Assessed by scRNA Sequencing in the Third Post-Transplant Year **Measure:** Degree of Correlation of Transcriptional Changes Within the Renal Parenchymal Cells at Year 3 **Time Frame:** 3 Years **Description:** Degree of Correlation of Transcriptional Changes Within the Infiltrating Inflammatory Cells of Allograft Biopsy as Assessed by Digital Spatial Transcriptomic Analysis in the Third Post-Transplant Year **Measure:** Degree of Correlation of Acute Rejection Transcriptional Changes Within the Infiltrating Inflammatory Cells at year 3 **Time Frame:** 3 Years **Description:** Degree of Correlation of Transcriptional Changes Within the Renal Parenchymal Cells with Persistence or Resolution of Allograft Inflammation as Assessed by Digital Spatial Transcriptomic Analysis in the Third Post-Transplant Year **Measure:** Degree of Correlation of Acute Rejection Transcriptional Changes Within the Renal Parenchymal Cells **Time Frame:** 3 Years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. All adult living or deceased donor renal transplant recipients (age ≥ 18 years), irrespective of gender, race, or ethnic background. 2. Able to understand and provide inform consent. Exclusion Criteria: 1. Medical contraindications to undergo renal biopsy (use of long-term anticoagulation, low platelet count of \<100,000/uL) 2. Cause of ESRD likely to recur in transplant: Hemolytic uremic syndrome (HUS) 3. Not maintained on standard of care immunosuppression therapy (Thymoglobulin induction followed by tacrolimus and mycophenolate maintenance) **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Adult living donor or deceased donor renal transplant recipients ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** elinbd@upmc.edu **Name:** Beth Elinoff, RN **Phone:** 412-624-6611 **Role:** CONTACT **Contact 2:** **Email:** cherukuria@upmc.edu **Name:** Aravind Cherukuri, MD **Phone:** 4125250671 **Role:** CONTACT #### Locations **Location 1:** **City:** Pittsburgh **Contacts:** ***Contact 1:*** - **Email:** elinbd@upmc.edu - **Name:** Beth Elinoff, RN - **Phone:** 412-624-6611 - **Role:** CONTACT **Country:** United States **Facility:** UPMC **State:** Pennsylvania **Zip:** 15213 #### Overall Officials **Official 1:** **Affiliation:** University of Pittsburgh **Name:** Aravind Cherukuri, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** Subject research data/samples may be shared with investigators conducting other research; this information will be shared without identifiable information. Subjects will not be identified in any publication or in the sharing of data about this study. These samples and data will be under the control of the listed investigators. Researchers must present a scientifically valid written request to the PI of this study, who will then either approve or deny the request. **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: Rare - Name: Rare Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06438094 **Brief Title:** The Influence of Non-Carious Cervical Lesions on Root Coverage: A Prospective Cohort Study **Official Title:** The Influence of Non-Carious Cervical Lesions on Root Coverage by Means of Coronally Advanced Flap and a Connective Tissue Graft: A Prospective Cohort Study #### Organization Study ID Info **ID:** PER-ECL-2022-01 #### Organization **Class:** OTHER **Full Name:** Universitat Internacional de Catalunya ### Status Module #### Completion Date **Date:** 2026-05-25 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-30 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-05-25 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-26 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-26 **Study First Submit QC Date:** 2024-05-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Gonzalo Blasi #### Responsible Party **Investigator Affiliation:** Universitat Internacional de Catalunya **Investigator Full Name:** Gonzalo Blasi **Investigator Title:** DDS, MS, PhD **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The goal of this prospective cohort study is to evaluate the effect of non-carious cervical lesions (NCCLs) on the outcome of root coverage therapy. The main question it aims to answer is: In gingival recessions associated with NCCLs, characterized by an undetectable cemento-enamel junction (CEJ), reconstruction of the CEJ with a cervical composite restoration, prior to root coverage surgery by means of a coronally advanced flap combined with a connective tissue graft (CAF+CTG), provides similar clinical and patient-reported outcomes, as compared to the treatment of gingival recessions associated with NCCLs, characterized by a visible CEJ, with root coverage surgery only, by means of a CAF+CTG. In NCCLs where the CEJ is undetectable (B-type defect), the CEJ will be reconstructed before surgery with a cervical composite restoration mimicking the anatomic features of the contralateral, homologous tooth. CAF+CTG treatment will be performed in all cases. Participants will be assessed at 6 weeks, 3 months, and 6 months to evaluate clinical, volumetric, and patient-centred outcomes. **Detailed Description:** In this investigation, a prospective cohort study, several key outcomes will be assessed. First, we seek to determine whether restoring the cementoenamel junction (CEJ) in Class B GRs before root coverage therapy yields comparable clinical and volumetric outcomes to Class A GRs with detectable CEJ. In addition, the influence of the CEJ restoration on dentin sensitivity and aesthetic satisfaction of the patient will be investigated. To our knowledge, it will be the first clinical study to use Pini Prato et al.'s surface discrepancy classification as a decision-making tool to guide periodontal-restorative procedures. ### Conditions Module **Conditions:** - Gingival Recessions Associated With Non-carious Cervical Lesions ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** There are two treatments but they are based on the tooth-level ##### Masking Info **Masking:** DOUBLE **Who Masked:** - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 56 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Gingival recession defects that present with a visible CEJ. These defects will receive root coverage surgery only. **Intervention Names:** - Procedure: Root coverage surgery by means of a coronally advanced flap combined with a connective tissue graft **Label:** Type A gingival recession defects **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Gingival recession defects that do not present a visible CEJ. A cervical composite restoration will be done prior to root coverage surgery. **Intervention Names:** - Procedure: Reconstruction of the CEJ with a composite restoration followed by root coverage surgery by means of a coronally advanced flap combined with a connective tissue graft **Label:** Type B gingival recession defects **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Type A gingival recession defects **Description:** A root coverage surgery will be performed using Zucchelli et al.'s coronally advanced flap combined with a connective tissue graft from the palate. **Name:** Root coverage surgery by means of a coronally advanced flap combined with a connective tissue graft **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Type B gingival recession defects **Description:** Reconstruction of the CEJ with a composite restoration will be performed in B+ and B- defects prior to root coverage surgery. A root coverage surgery will be performed using Zucchelli et al.'s coronally advanced flap combined with a connective tissue graft from the palate. **Name:** Reconstruction of the CEJ with a composite restoration followed by root coverage surgery by means of a coronally advanced flap combined with a connective tissue graft **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Mean root coverage assesses in percentage **Measure:** Mean Root Coverage (MRC) **Time Frame:** 6 months #### Secondary Outcomes **Description:** Complete Root Coverage assessed in percentage **Measure:** Complete Root Coverage (CRC) **Time Frame:** 6 months **Description:** change in keratinized tissue width assessed digitally in mm **Measure:** change in keratinized tissue width (ΔKTW) **Time Frame:** 6 weeks, 3 months, 6 months **Description:** change in marginal gingival thickness assessed at 1,2, and 3 mm from the gingival margin in mm **Measure:** change in marginal gingival thickness (ΔMGT) **Time Frame:** 6 weeks, 3 months, 6 months **Description:** change in recession depth assessed digitally in mm **Measure:** change in recession depth (ΔRD) **Time Frame:** 6 weeks, 3 months, 6 months **Description:** change in recession area assessed digitally in mm\^2 **Measure:** change in recession area (ΔRA) **Time Frame:** 6 weeks, 3 months, 6 months **Description:** change in mucosal volume assessed digitally in mm\^3 **Measure:** change in mucosal volume (ΔMV) **Time Frame:** 6 weeks, 3 months, 6 months **Description:** probing pocket depth assessed clinically in mm using a periodontal probe **Measure:** probing pocket depth (PPD) **Time Frame:** 6 months **Description:** clinical attachment level assessed clinically in mm **Measure:** clinical attachment level (CAL) **Time Frame:** 6 months **Description:** dentin sensitivity assessed on each tooth using a Visual Analog Scale **Measure:** dentin sensitivity **Time Frame:** initial, 6 months **Description:** Patient aesthetic satisfaction assessed using a Visual Analog Scale **Measure:** Patient aesthetic satisfaction **Time Frame:** 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Systemically healthy individuals older than 18 years old; * Healthy periodontal status according to the AAP/EFP definition; * Full-mouth plaque (FMPS) and bleeding scores (FMBS) ≤ 20%; * At least one facial RT1 GR in single-rooted teeth with a minimum depth of 2 mm, associated with a NCCL; * No history of periodontal surgery at the experimental site(s). Exclusion Criteria: * Pregnancy or lactation; * Self-reported smoking ≥10 cigarettes/day; * Metabolic diseases that negatively affect soft tissue healing (i.e., diabetes mellitus); * Any medication that may interfere with wound healing; * Prosthetic crown at experimental teeth; * Ongoing orthodontic therapy. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** gonzaloblasi@uic.es **Name:** Gonzalo Blasi **Phone:** 620387688 **Role:** CONTACT **Contact 2:** **Email:** lory.abrahamian@uic.es **Name:** Lory Abrahamian **Phone:** 722528012 **Role:** CONTACT #### Locations **Location 1:** **City:** Barcelona **Contacts:** ***Contact 1:*** - **Email:** gonzaloblasi@uic.es - **Name:** Gonzalo Blasi - **Phone:** 620387688 - **Role:** CONTACT **Country:** Spain **Facility:** BLASI Clínica Dental Barcelona **Status:** RECRUITING **Zip:** 08021 #### Overall Officials **Official 1:** **Affiliation:** Universitat Internacional de Catalunya **Name:** Gonzalo Blasi **Role:** STUDY_DIRECTOR **Official 2:** **Affiliation:** Universitat Internacional de Catalunya **Name:** José Nart **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005882 - Term: Gingival Diseases - ID: D000010510 - Term: Periodontal Diseases - ID: D000009059 - Term: Mouth Diseases - ID: D000009057 - Term: Stomatognathic Diseases - ID: D000055093 - Term: Periodontal Atrophy - ID: D000014591 - Term: Uterine Diseases - ID: D000005831 - Term: Genital Diseases, Female - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000091662 - Term: Genital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M9001 - Name: Gingival Recession - Relevance: HIGH - As Found: Gingival Recession - ID: M5825 - Name: Uterine Cervical Diseases - Relevance: HIGH - As Found: Cervical Lesions - ID: M8994 - Name: Gingival Diseases - Relevance: LOW - As Found: Unknown - ID: M13419 - Name: Periodontal Diseases - Relevance: LOW - As Found: Unknown - ID: M12019 - Name: Mouth Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown - ID: M4589 - Name: Atrophy - Relevance: LOW - As Found: Unknown - ID: M28025 - Name: Periodontal Atrophy - Relevance: LOW - As Found: Unknown - ID: M17339 - Name: Uterine Diseases - Relevance: LOW - As Found: Unknown - ID: M8943 - Name: Genital Diseases, Female - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005889 - Term: Gingival Recession - ID: D000002577 - Term: Uterine Cervical Diseases ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06438081 **Brief Title:** Comparison Between Propess and Cook Double-balloon Catheter for Cervical Priming: a Randomized Controlled Trial **Official Title:** Comparison Between Propess (Dinoprostone Controlled Release Pessary) and Cook Double-balloon Catheter for Cervical Priming: a Randomized Controlled Trial #### Organization Study ID Info **ID:** UW 24-172 #### Organization **Class:** OTHER **Full Name:** The University of Hong Kong ### Status Module #### Completion Date **Date:** 2025-12-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-26 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-26 **Study First Submit QC Date:** 2024-05-26 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** The University of Hong Kong #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** True **Is US Export:** True ### Description Module **Brief Summary:** We aimed to compare efficacy and safety of Propess versus Cooks double-balloon catheter for cervical ripening with an unfavorable cervix in term pregnancy. **Detailed Description:** Previous studies focused on use of PGE2 instead of Propess, which is a preparation of PGE2 packaged in a hydrogel polymer matrix and release 10mg dinoprostone at 0.3mg per hour for 24 hours. Compared with PGE2, Propess can achieve a shorter induction-to-birth interval, a higher rate of vaginal delivery within 24 hours, and a smaller number of vaginal examinations during delivery. However local studies comparing the efficacy and satisfaction of cervical priming between Cook double-balloon catheter and Propess were lacking. We aimed to compare efficacy and safety of Propess versus Cooks double-balloon catheter for cervical ripening with an unfavorable cervix in term pregnancy. ### Conditions Module **Conditions:** - Delivery Problem ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** We did a pilot study to compare 5 patients using Cook double-catheter balloon priming and 5 patients using Propess. We found the mean priming to delivery interval was 1971.6 minutes in Propess group and 1212.0 minutes in Cook double-catheter balloon group. We assumed ratio of sample size in Propess and Cook double-catheter balloon was 1:1. In order to achieve 35% reduction of priming to delivery interval, a sample size of 28 is required for Type I error of 0.05, and Type II error of 0.2. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 28 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participant is placed in lithotomy position, then to clean vulval and vaginal area, followed by inserting vaginal speculum. Cook double-balloon catheter will be inserted under standard technique. Doctor or midwife guide the cervical ripening balloon with stylet to pass through the cervix. Uterine balloon should be place above level of internal os, then to remove the stylet before further advancing the catheter. Cook double-balloon catheter is further advancing through the cervix until both balloons entered cervical canal. Uterine and vaginal balloons are both inflated with up to 80ml normal saline according to manufacturer recommendation. Maximal duration of balloon placement will be 12 hours. If cervix remains unfavorable after Cook double-catheter balloons, she will be given another Cook double-catheter balloons priming the next day. If cervix remains unfavourable after two balloon priming, elective Caesarean section will be advised. **Intervention Names:** - Combination Product: Cook double-balloon catheter **Label:** Cook double-balloon catheter **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Participant will be firstly confirmed reactive tracing and without regular contraction by non-stress test for 20mins. Propess will be checked its integrity and applied with lubricating jelly before insertion. Propess is inserted to the posterior vaginal fornix. Woman should inform medical staff if they have leaking sensation. After insertion, woman will be advised to lie down and perform non-stress test for 2 hours. Propess will be removed after 24 hours post insertion. Cervical assessment is performed the next day after removal of Propess. Patient with favourable cervix, i.e. Bishop score \>= 7, will start artificial rupture of membrane and syntocinon infusion. Patient with unfavorable cervix, i.e. Bishop score \<7 is arranged another day of priming by PGE2. If the cervix remains unfavorable after 2 days of pharmacological priming, women will be given a rest day or continued priming by Cook double-balloon catheter. **Intervention Names:** - Combination Product: Cook double-balloon catheter **Label:** Propess **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Cook double-balloon catheter - Propess **Description:** To compare whether Cook double-balloon catheter or Propess able to achieve vaginal delivery with a shorter priming to delivery interval **Name:** Cook double-balloon catheter **Type:** COMBINATION_PRODUCT ### Outcomes Module #### Primary Outcomes **Description:** Time for priming (device placement) to delivery interval **Measure:** Priming to delivery interval **Time Frame:** 1 year #### Secondary Outcomes **Description:** delivery within 24 hours **Measure:** Vaginal delivery within 24 hours after priming **Time Frame:** 1 year **Description:** need of resort to Caesarean section and the corresponding indication **Measure:** Caesarean section rate **Time Frame:** 1 year **Description:** included instrumental delivery, e.g. vacuum extraction, forcep delivery **Measure:** Vaginal delivery rate **Time Frame:** 1 year **Description:** Time from priming to induction **Measure:** Priming to induction interval **Time Frame:** 1 year **Description:** Chance of going into spontaneous labor after priming **Measure:** Need of induction with oxytocin **Time Frame:** 1 year **Description:** calculate the amount of oxytocin use **Measure:** Amount of oxytocin use **Time Frame:** 1 year **Description:** to confirm if cephalic presentation before start of induction **Measure:** Malpresentation after priming **Time Frame:** 1 year **Description:** defined as cervix failed to dilate to more than 3cm after 12 hours use of oxytocin **Measure:** Failed induction rate **Time Frame:** 1 year **Description:** defined by a single contraction lasting for more than 2 minutes or more than 5 contractions in 10 minutes for 30 minutes **Measure:** Uterine hyperstimulation **Time Frame:** 1 year **Description:** infection rate that require antibiotics treatment **Measure:** Suspected intrauterine infection rate **Time Frame:** 1 year **Description:** Blood loss \>500ml within 24 hours of delivery **Measure:** Primary postpartum haemorrhage **Time Frame:** 1 year **Description:** calculate length of hospital stay after delivery **Measure:** Length of hospital stay **Time Frame:** 1 year **Description:** on a visual analogue scale of 0-10, 10 is most satisfactory **Measure:** Maternal satisfaction with the procedure **Time Frame:** 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Viable singleton pregnancy * Cephalic presentation * Bishop score \<7 * At term (\>=37+0 weeks of gestation) * Nulliparous women Exclusion Criteria: * Gestation \<37weeks * Multiple pregnancy * Bishop score \<7 * Malpresentation * Contraindication to vaginal delivery * Previous Caesarean section * History of myomectomy * Maternal fever * Suspected infection * Abnormal fetal heart-rate patterns * Rupture of membranes * Intrauterine growth restriction * Not fit for giving consent * Allergic to Propess or PGE2 **Maximum Age:** 50 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** lyf971@hku.hk **Name:** Yin Fong Leung, MBBS **Phone:** 852 22554517 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** The University of Hong Kong **Name:** Yin Fong Leung, MBBS **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007744 - Term: Obstetric Labor Complications - ID: D000011248 - Term: Pregnancy Complications - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7594 - Name: Dystocia - Relevance: HIGH - As Found: Delivery Problem - ID: M10764 - Name: Obstetric Labor Complications - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000004420 - Term: Dystocia ### Intervention Browse Module - Browse Branches - Abbrev: Repr - Name: Reproductive Control Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M13041 - Name: Oxytocin - Relevance: LOW - As Found: Unknown - ID: M17936 - Name: Dinoprostone - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06438068 **Brief Title:** Influence of Modern Colon Hydrotherapy on Intestinal Transit **Official Title:** Influence of Modern Colon Hydrotherapy on Intestinal Transit #### Organization Study ID Info **ID:** UComplutenseMadrid Fasisifer3 #### Organization **Class:** OTHER **Full Name:** Universidad Complutense de Madrid ### Status Module #### Completion Date **Date:** 2024-07-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-26 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-26 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-26 **Study First Submit QC Date:** 2024-05-26 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Universidad Complutense de Madrid #### Responsible Party **Investigator Affiliation:** Universidad Complutense de Madrid **Investigator Full Name:** Isidro Fernández López **Investigator Title:** PhD **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** A randomised and controlled trial, in which the effect of Modern Colon Hydrotherapy is evaluated in the gastrointestinal transit of subjects with functional constipation **Detailed Description:** The aim of the present randomized randomised and controlled trial is to evaluate the effect of Modern Colon Hydrotherapy in the gastrointestinal transit of subjects with functional constipation. Two intervention groups were used, to which this type of treatment was applied and to which the intake of a product with prebiotic and prebiotic properties or a placebo was added, depending on the assigned group. ### Conditions Module **Conditions:** - Constipation - Functional - Hydrotherapy - Functional Colonic Diseases **Keywords:** - constipation - internal hydrotherapy - Radiopaque Media - Functional Colonic Diseases ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Colonic cleansing through 3 interventions of Modern Colon Hydrotherapy. In addition, a daily intake of a product with prebiotic and prebiotic properties for 30 days. **Intervention Names:** - Other: Modern Colon Hydrotherapy plus probiotic product intake **Label:** Modern Colon Hydrotherapy plus probiotic product intake **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Colonic cleansing through 3 interventions of Modern Colon Hydrotherapy. In addition, a daily intake of a placebo for 30 days. **Intervention Names:** - Other: Modern Colon Hydrotherapy plus probiotic product intake **Label:** Modern Colon Hydrotherapy plus placebo intake **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Modern Colon Hydrotherapy plus placebo intake - Modern Colon Hydrotherapy plus probiotic product intake **Description:** Colonic cleansing through 3 interventions of Modern Colon Hydrotherapy separated by 48 hours. In addition, a daily intake of a product with prebiotic and prebiotic properties for 30 days. **Name:** Modern Colon Hydrotherapy plus probiotic product intake **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** intestinal transit using radiopaque markers **Measure:** intestinal transit **Time Frame:** 7 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients between 20 and 60 years of age with functional constipation of more than 5 years of evolution. Exclusion Criteria: * Taking any type of antibiotic in the last month * Taking prebiotics or probiotics products in the last month. * Taking laxatives in the last month. * Undergoing any medicinal treatment * Pregnancy * Subject with a history of current gastrointestinal pathology or disorder such as: acute colon pathology, acute haemorrhagic colitis, suspected digestive perforation, recent abdominal surgery, severe arterial hypertension, abdominal hernia, colon neoplasia, history of cardiac syncope, renal failure, liver cirrhosis, epilepsy, severe psychiatric illness (psychosis), necrosis due to abdominal irradiation, severe anaemia, severe neurovegetative lability. **Maximum Age:** 60 Years **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** isidrofe@ucm.es **Name:** Isidro Fernández-López, PhD. **Phone:** 34625598970 **Role:** CONTACT #### Locations **Location 1:** **City:** Madrid **Contacts:** ***Contact 1:*** - **Email:** isidro.fernandez.lopez@gmail.com - **Name:** Isidro Fernández-López, PhD. - **Phone:** +34625598970 - **Role:** CONTACT ***Contact 2:*** - **Name:** David Granizo-Bermejo, Mr. - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Spain **Facility:** Universidad Complutense de Madrid #### Overall Officials **Official 1:** **Affiliation:** Universidad Complutense de Madrid **Name:** Isidro Fernández-López, PhD. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012817 - Term: Signs and Symptoms, Digestive - ID: D000007410 - Term: Intestinal Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000004066 - Term: Digestive System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M6336 - Name: Colonic Diseases - Relevance: HIGH - As Found: Colonic Diseases - ID: M6337 - Name: Colonic Diseases, Functional - Relevance: HIGH - As Found: Functional Colonic Diseases - ID: M6472 - Name: Constipation - Relevance: HIGH - As Found: Constipation - ID: M15622 - Name: Signs and Symptoms, Digestive - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003108 - Term: Colonic Diseases - ID: D000003109 - Term: Colonic Diseases, Functional - ID: D000003248 - Term: Constipation ### Intervention Browse Module - Browse Branches - Abbrev: HB - Name: Herbal and Botanical - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: T120 - Name: Cola - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06438055 **Brief Title:** Clinical Treatment of Refractory Breast Cancer Based on Organoid Drug Sensitivity Results **Official Title:** Clinical Treatment of Refractory Breast Cancer Based on Organoid Drug Sensitivity Results #### Organization Study ID Info **ID:** TJBCPDO01 #### Organization **Class:** OTHER **Full Name:** Tianjin Medical University Cancer Institute and Hospital ### Status Module #### Completion Date **Date:** 2026-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-26 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-26 **Study First Submit QC Date:** 2024-05-26 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Kingbio Medical (Beijing) Co., Ltd. #### Lead Sponsor **Class:** OTHER **Name:** Tianjin Medical University Cancer Institute and Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study aims to enroll refractory breast cancer patients. Patient-derived organoid will be established, and drug sensitivity test will be conducted to intervene in the selection of clinical treatment plans. Efficacy evaluation and prognosis analysis will also be conducted. It is hoped that this study will provide a basis for the development of personalized treatment plans. **Detailed Description:** Forty patients with refractory breast cancer who met the inclusion criteria were enrolled in the study after signing an informed consent form. Tumor samples were obtained through clinical puncture, and qualified samples were subjected to organoid modeling. Perform drug sensitivity test on the established breast cancer organoids. The drugs used are all that have been marketed and applied in clinical practice. According to the results of organoid drug sensitivity analysis, the patient received a treatment plan with relatively sensitive drugs. Follow up prognostic data and relevant clinical information of enrolled patients, conduct statistical analysis on the consistency between drug sensitivity test results and patient treatment response, and evaluate the clinical effectiveness of treatment plans guided by organoid drug sensitivity results. ### Conditions Module **Conditions:** - Refractory Breast Cancer ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** All patients will be included in a single-arm. Participants will undergo biopsy of tumor tissue for subsequent organoid generation and drug sensitivity tests. **Intervention Names:** - Other: Chemotherapy and targeted-therapy guided by organoid drug sensitivity test **Label:** Organoid-Guided therapy **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Organoid-Guided therapy **Description:** This study conducts drug sensitivity tests on various clinically approved drugs. The most sensitive drug for the patient is selected for treatment. This study aims to evaluate the clinical effectiveness of treatment plans guided by organoid drug sensitivity tests. **Name:** Chemotherapy and targeted-therapy guided by organoid drug sensitivity test **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Percentage of patient's measurable disease who have achieved either complete response (CR) or partial response (PR) according to RECIST 1.1. **Measure:** Objective Response Rate **Time Frame:** 1-2 years #### Secondary Outcomes **Description:** The time from initiation of treatment to the occurrence of disease progression or death. **Measure:** Progressive free survival **Time Frame:** 1-2 years **Description:** The time from the date of randomization to the date of death for any cause. Patients will be followed until their date of death or until final database closure. **Measure:** Overall survival time **Time Frame:** 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Female, aged ≥ 18 years and ≤ 75 years old; 2. Breast cancer confirmed by histology or cytology; 3. One of the following two conditions shall be met: a) Operable breast cancer: Recurrent progression during adjuvant therapy; or the time from initial treatment to the onset of disease progression is less than or equal to 2 years; b) Non-operable breast cancer: patients who have changed two line treatment plans within 6 months; 4. Being able to obtain sufficient fresh tissue specimens for organoid establishment through puncture; 5. Expected survival time ≥ 3 months; 6. The patient voluntarily joined this study and signed an informed consent form (ICF), with good compliance and cooperation in follow-up. Exclusion Criteria: 1. Pregnant and lactating women; 2. Patients who have clinically significant (i.e. active) heart disease (such as congestive heart failure, symptomatic coronary artery disease, arrhythmia, etc.) or myocardial infarction within the past 12 months; 3. Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders; 4. The researchers believe that patients are not suitable for inclusion. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** shiyehui@tjmuch.com **Name:** Yehui Shi, PhD **Phone:** +8618622221183 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Tianjin Cancer Hospital **Name:** Yehui Shi, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Cao W, Chen HD, Yu YW, Li N, Chen WQ. Changing profiles of cancer burden worldwide and in China: a secondary analysis of the global cancer statistics 2020. Chin Med J (Engl). 2021 Mar 17;134(7):783-791. doi: 10.1097/CM9.0000000000001474. **PMID:** 33734139 **Citation:** Lei S, Zheng R, Zhang S, Chen R, Wang S, Sun K, Zeng H, Wei W, He J. Breast cancer incidence and mortality in women in China: temporal trends and projections to 2030. Cancer Biol Med. 2021 May 18;18(3):900-9. doi: 10.20892/j.issn.2095-3941.2020.0523. Online ahead of print. **PMID:** 34002584 **Citation:** Potter DA, Herrera-Ponzanelli CA, Hinojosa D, Castillo R, Hernandez-Cruz I, Arrieta VA, Franklin MJ, Yee D. Recent advances in neoadjuvant therapy for breast cancer. Fac Rev. 2021 Jan 4;10:2. doi: 10.12703/r/10-2. eCollection 2021. **PMID:** 33659921 **Citation:** Loibl S, Poortmans P, Morrow M, Denkert C, Curigliano G. Breast cancer. Lancet. 2021 May 8;397(10286):1750-1769. doi: 10.1016/S0140-6736(20)32381-3. Epub 2021 Apr 1. Erratum In: Lancet. 2021 May 8;397(10286):1710. **PMID:** 33812473 **Citation:** Gralow JR, Burstein HJ, Wood W, Hortobagyi GN, Gianni L, von Minckwitz G, Buzdar AU, Smith IE, Symmans WF, Singh B, Winer EP. Preoperative therapy in invasive breast cancer: pathologic assessment and systemic therapy issues in operable disease. J Clin Oncol. 2008 Feb 10;26(5):814-9. doi: 10.1200/JCO.2007.15.3510. **PMID:** 18258991 **Citation:** Seidlitz T, Merker SR, Rothe A, Zakrzewski F, von Neubeck C, Grutzmann K, Sommer U, Schweitzer C, Scholch S, Uhlemann H, Gaebler AM, Werner K, Krause M, Baretton GB, Welsch T, Koo BK, Aust DE, Klink B, Weitz J, Stange DE. Human gastric cancer modelling using organoids. Gut. 2019 Feb;68(2):207-217. doi: 10.1136/gutjnl-2017-314549. Epub 2018 Apr 27. **PMID:** 29703791 **Citation:** Eiraku M, Watanabe K, Matsuo-Takasaki M, Kawada M, Yonemura S, Matsumura M, Wataya T, Nishiyama A, Muguruma K, Sasai Y. Self-organized formation of polarized cortical tissues from ESCs and its active manipulation by extrinsic signals. Cell Stem Cell. 2008 Nov 6;3(5):519-32. doi: 10.1016/j.stem.2008.09.002. **PMID:** 18983967 **Citation:** Romero-Calvo I, Weber CR, Ray M, Brown M, Kirby K, Nandi RK, Long TM, Sparrow SM, Ugolkov A, Qiang W, Zhang Y, Brunetti T, Kindler H, Segal JP, Rzhetsky A, Mazar AP, Buschmann MM, Weichselbaum R, Roggin K, White KP. Human Organoids Share Structural and Genetic Features with Primary Pancreatic Adenocarcinoma Tumors. Mol Cancer Res. 2019 Jan;17(1):70-83. doi: 10.1158/1541-7786.MCR-18-0531. Epub 2018 Aug 31. **PMID:** 30171177 **Citation:** Li M, Izpisua Belmonte JC. Organoids - Preclinical Models of Human Disease. N Engl J Med. 2019 Feb 7;380(6):569-579. doi: 10.1056/NEJMra1806175. No abstract available. **PMID:** 30726695 **Citation:** Sachs N, de Ligt J, Kopper O, Gogola E, Bounova G, Weeber F, Balgobind AV, Wind K, Gracanin A, Begthel H, Korving J, van Boxtel R, Duarte AA, Lelieveld D, van Hoeck A, Ernst RF, Blokzijl F, Nijman IJ, Hoogstraat M, van de Ven M, Egan DA, Zinzalla V, Moll J, Boj SF, Voest EE, Wessels L, van Diest PJ, Rottenberg S, Vries RGJ, Cuppen E, Clevers H. A Living Biobank of Breast Cancer Organoids Captures Disease Heterogeneity. Cell. 2018 Jan 11;172(1-2):373-386.e10. doi: 10.1016/j.cell.2017.11.010. Epub 2017 Dec 7. **PMID:** 29224780 **Citation:** Dekkers JF, Whittle JR, Vaillant F, Chen HR, Dawson C, Liu K, Geurts MH, Herold MJ, Clevers H, Lindeman GJ, Visvader JE. Modeling Breast Cancer Using CRISPR-Cas9-Mediated Engineering of Human Breast Organoids. J Natl Cancer Inst. 2020 May 1;112(5):540-544. doi: 10.1093/jnci/djz196. **PMID:** 31589320 **Citation:** Chen P, Zhang X, Ding R, Yang L, Lyu X, Zeng J, Lei JH, Wang L, Bi J, Shao N, Shu D, Wu B, Wu J, Yang Z, Wang H, Wang B, Xiong K, Lu Y, Fu S, Choi TK, Lon NW, Zhang A, Tang D, Quan Y, Meng Y, Miao K, Sun H, Zhao M, Bao J, Zhang L, Xu X, Shi Y, Lin Y, Deng C. Patient-Derived Organoids Can Guide Personalized-Therapies for Patients with Advanced Breast Cancer. Adv Sci (Weinh). 2021 Nov;8(22):e2101176. doi: 10.1002/advs.202101176. Epub 2021 Oct 4. **PMID:** 34605222 **Citation:** Chica-Parrado MR, Godoy-Ortiz A, Jimenez B, Ribelles N, Barragan I, Alba E. Resistance to Neoadjuvant Treatment in Breast Cancer: Clinicopathological and Molecular Predictors. Cancers (Basel). 2020 Jul 22;12(8):2012. doi: 10.3390/cancers12082012. **PMID:** 32708049 **Citation:** Drost J, Clevers H. Organoids in cancer research. Nat Rev Cancer. 2018 Jul;18(7):407-418. doi: 10.1038/s41568-018-0007-6. **PMID:** 29692415 **Citation:** Norman M, Rivers C, Lee YB, Idris J, Uney J. The increasing diversity of functions attributed to the SAFB family of RNA-/DNA-binding proteins. Biochem J. 2016 Dec 1;473(23):4271-4288. doi: 10.1042/BCJ20160649. **PMID:** 27888239 **Citation:** Hashimoto T, Matsuda K, Kawata M. Scaffold attachment factor B (SAFB)1 and SAFB2 cooperatively inhibit the intranuclear mobility and function of ERalpha. J Cell Biochem. 2012 Sep;113(9):3039-50. doi: 10.1002/jcb.24182. **PMID:** 22566185 **Citation:** Hutter K, Lohmuller M, Jukic A, Eichin F, Avci S, Labi V, Szabo TG, Hoser SM, Huttenhofer A, Villunger A, Herzog S. SAFB2 Enables the Processing of Suboptimal Stem-Loop Structures in Clustered Primary miRNA Transcripts. Mol Cell. 2020 Jun 4;78(5):876-889.e6. doi: 10.1016/j.molcel.2020.05.011. **PMID:** 32502422 **Citation:** Hammerich-Hille S, Bardout VJ, Hilsenbeck SG, Osborne CK, Oesterreich S. Low SAFB levels are associated with worse outcome in breast cancer patients. Breast Cancer Res Treat. 2010 Jun;121(2):503-9. doi: 10.1007/s10549-008-0297-6. Epub 2009 Jan 10. **PMID:** 19137425 **Citation:** Zhen H, Yao Y, Yang H. SAFB2 Inhibits the Progression of Breast Cancer by Suppressing the Wnt/beta-Catenin Signaling Pathway via NFAT5. Mol Biotechnol. 2023 Sep;65(9):1465-1475. doi: 10.1007/s12033-022-00649-z. Epub 2023 Jan 18. **PMID:** 36652182 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000001941 - Term: Breast Diseases - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M5220 - Name: Breast Neoplasms - Relevance: HIGH - As Found: Breast Cancer - ID: M10018 - Name: Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M5218 - Name: Breast Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001943 - Term: Breast Neoplasms ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06438042 **Brief Title:** Prevention of Pressure Ulcers in Patients at High Risk of Developping Pressure Ulcers Using the Low-pressure Motorized Air Support Mattress With XTECH®25 Control Unit **Official Title:** Prevention of Pressure Ulcers in Patients at High Risk of Developping Pressure Ulcers Using the Low-pressure Motorized Air Support Mattress With XTECH®25 Control Unit #### Organization Study ID Info **ID:** 2023-A01556-39 #### Organization **Class:** INDUSTRY **Full Name:** SYSTAM ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-26 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-07 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-26 **Study First Submit QC Date:** 2024-05-26 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Clin-Experts #### Lead Sponsor **Class:** INDUSTRY **Name:** SYSTAM #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The aim of the study is to determine the clinical value of using a a low air pressure motorised therapeutic mattress in the prevention of pressure injury (PI) in patients at medium to high risk. This study is noncomparative, observational study. Patients older than 18 years of age, with a high risk of PI, without PI, lying more than 20 hours a day on a XTECH®25 mattress will be included. The study will be conducted in nursing homes, and in long-stay geriatrics department. Patients are followed up for 35 days. The use of the XTECH®25 mattress is associated with the usual PI prevention measures. The primary outcome is the percentage of patients who developed between day 0 and day 35 at least one PI of at least stage 2 on the sacrum, spine, or heel. Secondary endpoints are patient assessments of comfort, caregiver satisfaction, mattress noise level, and mattress safety. ### Conditions Module **Conditions:** - Pressure Ulcer **Keywords:** - Prevention - Pressure ulcer - Low air pressure motorised mattress ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 80 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Device: Use of a powered low air pressure motorised therapeutic mattress that combines the motorised and static technologies **Label:** Patients in nursing homes or long-stay geriatrics department ### Interventions #### Intervention 1 **Arm Group Labels:** - Patients in nursing homes or long-stay geriatrics department **Description:** Patients with a high risk of pressure injury, without pressure injury, lying more than 20 hours a day, will ly a on a XTECH®25 mattress **Name:** Use of a powered low air pressure motorised therapeutic mattress that combines the motorised and static technologies **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Percentage of patients who developed at least one stage 2 PI of the sacrum, backbone, or heel (areas of support when lying down) **Measure:** Percentage of patients who developed at least one stage 2 pressure injury **Time Frame:** 35 days after installation on the mattress (at day 35) #### Secondary Outcomes **Measure:** Percentage of patients who developed a o pressure injury (any stage), other than those of the sacrum, backbone, or heel between **Time Frame:** 35 days after installation on the mattress (at day 35) **Description:** On a scale from 0 (not satisfied at all) to 4 (very satisfied) **Measure:** Assessment by the patient (or family or staff in the case of incapacity) of the comfort of the mattress (general comfort, stability) **Time Frame:** 35 days after installation on the mattress (at day 35) **Description:** On a scale from 0 (not satisfied at all) to 4 (very satisfied) **Measure:** Assessment by the nursing staff with the use of the mattress (implementation, cleaning maintenance turning, changing to a sitting position) **Time Frame:** 35 days after installation on the mattress (at day 35) **Description:** On a scale from 1 (constantly moist) to 4 rarely moist **Measure:** Assessment of the degree of maceration **Time Frame:** On a scale from 1 (constantly moist) to 4 rarely moist **Description:** By collecting any adverse event or mattress malfunction during the follow up **Measure:** Assessment of mattress safety **Time Frame:** At day 35 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Patient over 18 years old Patient with high risk of developing pressure ulcers (clinical judgment and a score \<= 12 on the Braden scale (6 (maximum risk) to 23 (no risk)) Patient without pressure injury on the day of inclusion Patient up lying more than 20 hours a day on XTECH®25 mattress Patient with a weight \< 200 kg Patient (or a trusted third party) having been informed of the study and agreeing to participate Exclusion Criteria: * Patient at end of life (estimated life expectancy less than 6 months) * Patient discharge from the establishment expected within two months * Participants will be excluded from the study if they meet the following combination of criteria indicative of malnutrition according to the 2021 Haute Autorité de la Santé guidelines: One or more of the following phenotypic criteria: Significant unintentional weight loss: A weight loss of ≥ 5% within 1 month or ≥ 10% within 6 months. Low Body Mass Index (BMI): BMI \< 18.5 kg/m² for individuals under 70 years old. BMI \< 21 kg/m² for individuals aged 70 years and older. Reduced Muscle Mass: Evident reduction in muscle mass. AND One of the following etiological criteria: Inadequate nutritional intake: Nutritional intake less than 50% of the energy requirements for more than one week. Reduced food intake for more than two weeks. Presence of Disease or Stress Metabolism: Acute or chronic illness, or any condition causing metabolic stress that increases energy requirements. Participants must meet at least one phenotypic criterion and one etiological criterion to be considered malnourished and therefore ineligible for inclusion in the study. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients in nursing homes or long-stay geriatrics department ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** contact@clin-experts.fr **Name:** Renaud URBINELLI **Phone:** 0756882093 **Role:** CONTACT #### Locations **Location 1:** **City:** Multiple Locations **Country:** France **Facility:** Multiples locations #### Overall Officials **Official 1:** **Affiliation:** Hôpital ROSCHILD **Name:** Sylvie MEAUME **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000012883 - Term: Skin Ulcer - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M6870 - Name: Pressure Ulcer - Relevance: HIGH - As Found: Pressure Ulcer - ID: M17206 - Name: Ulcer - Relevance: HIGH - As Found: Ulcer - ID: M15686 - Name: Skin Ulcer - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003668 - Term: Pressure Ulcer - ID: D000014456 - Term: Ulcer ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06438029 **Brief Title:** The Effect of Disaster Training on the Perception of Disaster Response Competence **Official Title:** The Effect of Education Given to Nursing Students on Their Perceptions of Disaster Response Competence: A Randomized Controlled Trial #### Organization Study ID Info **ID:** FU-SBF-FU-02 #### Organization **Class:** OTHER **Full Name:** Firat University ### Status Module #### Completion Date **Date:** 2024-12-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-27 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-11-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-10-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** FATOŞ UNCU #### Responsible Party **Investigator Affiliation:** Firat University **Investigator Full Name:** FATOŞ UNCU **Investigator Title:** assistant professor **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Due to the increase in disasters, humanity is facing an increasing threat to life and property. Disasters occur with little warning and can last for hours or months. Existing literature reveals that most nurses are not prepared for a disaster in the community. Continuous preparedness requires the involvement of staff and nursing students in the development, review and implementation of the disaster plan. The development of ongoing, easily accessible, engaging and realistic educational programmes is best for the acquisition of skills and competence. An experimental study with pretest-posttest control group The project is planned to be conducted with the fourth grade students of the Department of Nursing, Faculty of Health Sciences, Fırat University in a randomised controlled study model with pre-test-post-test control group. The population of the study will consist of the fourth year students of the Department of Nursing, Faculty of Health Sciences, Fırat University. The sample will consist of 90 students with 0.05 error, 0.95 confidence interval, 0.95 confidence interval, 0.6 effect size and 0.80 representation power of the universe with the power analysis. These students will be divided into 45 experimental and 45 control groups. In the first stage of the study, the experimental and control group students were asked to complete the "Personal Information Form" and '' Disaster response self-efficacy scale" will be filled. In the second stage of the research, the students in the experimental group will be given a detailed and planned training programme. After the training, the students **Detailed Description:** Natural disasters, which cause a large number of casualties, increase the workload and lead to disability of individuals, have always been an important public health problem. Natural disasters are unpredictable and often sudden events that cause great destruction and loss of life and severe psychological symptoms for survivors. Disaster preparedness refers to all previous action plans and efforts to establish a disaster response system before a disaster occurs. To be prepared, nurses need to have sufficient knowledge and skills to minimise the negative effects of a disaster, including trauma, infectious diseases, physical and psychological distress. However, there is evidence that most nurses do not feel adequately prepared for a disaster in the community. In a study in which the general knowledge levels of nurses in developing countries about disaster preparedness were evaluated, the knowledge and skills of nurses especially in the Asia-Pacific Region about disasters were found to be inadequate. In another study, it was reported that Iranian nurses had inadequate knowledge about disaster preparedness. Despite the increasing number of disasters all over the world and the warnings of international nursing organisations and the World Health Organisation about the preparedness of nurses for disasters, it is seen that the training of nurses for disasters is inadequate and studies on this subject are limited. ### Conditions Module **Conditions:** - Public Health Nursing **Keywords:** - Natural disasters - Nursing students ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** This research is a randomised control study with pretest-posttest design. ##### Masking Info **Masking:** DOUBLE **Masking Description:** Randomisation method will be used to determine how the experimental and control groups will be separated at the beginning of the study (13). As the randomisation method, "simple randomisation method" was chosen in order to provide equal number of samples in two groups. Randomisation will be performed using https://www.randomizer.org/ website in computer environment. According to the randomisation outputs, the individuals to be included in the experimental and control groups will be listed. Columns between 1-90 will be created in the system. Patients will be randomly assigned to the groups by considering the numbers 1 and 2 in the columns (nursing education group 1 and control group 2). **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 90 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The forms used in the study were collected by the researcher through face-to-face interviews in seminar halls in schools. Firstly, the students in the experimental group will be trained on disaster and disaster response. The trainings were organised as a total of four sessions with a two-week interval of twenty minutes in each session. Personal Information Form and Disaster Intervention Self-Efficacy Scale were filled as pre-test in the seminar halls of the schools under the supervision of the researcher. **Intervention Names:** - Other: Education group - Other: No training was given **Label:** Education group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Personal Information Form and Disaster Response Self-Efficacy Scale will be applied to the students in the control group as a pre-test. No training will be given to the control group. In the last stage of the research, the Disaster Response Self-Efficacy Scale will be applied to the control group as a post-test and the data collection process will be terminated. After the last test was applied to the groups, training materials will be given to the people who demanded from the control group. **Label:** Control group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Education group **Description:** Students in the experimental group will be trained on disasters and disaster response competencies and nursing interventions will be carried out. The trainings will be held in a total of four sessions, with twenty minutes in each session, two weeks apart. **Name:** Education group **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Education group **Description:** No training was given **Name:** No training was given **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The scale is a 5-point Likert type and consists of a total of 19 items and 3 sub-dimensions (On-site rescue competence, Disaster psychological nursing competence, Nature of the role undertaken in disaster and adaptation competence). The scale is answered as having no self-confidence (1 point), basically no self-confidence (2 points), some self-confidence (3 points), basically self-confident (4 points) and full self-confidence (5 points). The scale score is calculated by summing the answers to the questions. A high score from the scale indicates high disaster response self-efficacy. In the Turkish validity and reliability study of the scale, the Cronbach alpha coefficient was found to be 0.96. **Measure:** Disaster response self-efficacy scale: **Time Frame:** 3 month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Being a 4th year Nursing Student • Want to participate in the research voluntarily Exclusion Criteria: * Student wants to leave the study • Incomplete filling of survey forms **Healthy Volunteers:** True **Maximum Age:** 25 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** funcu@firat.edu.tr **Name:** Fatoş Uncu, PhD **Phone:** 04242370000 **Phone Ext:** 4574 **Role:** CONTACT **Contact 2:** **Email:** tayyipcapkur6@gmail.com **Name:** Tayyip Çapkur, Lisans **Phone:** 04242370000 **Phone Ext:** 4574 **Role:** CONTACT #### Locations **Location 1:** **City:** Elazığ **Country:** Turkey **Facility:** Firat University **Zip:** 23119 ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06438016 **Brief Title:** Stress Management Training for Nursing Professionals in a Tertiary Care Center in Nepal **Official Title:** Exploring the Efficiency of Stress Management Training Programs in Reducing Stress Levels Within Nursing Professionals in a Tertiary Care Center in Nepal #### Organization Study ID Info **ID:** 205/2024 #### Organization **Class:** OTHER **Full Name:** Dhulikhel Hospital ### Status Module #### Completion Date **Date:** 2024-09-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-30 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-08-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Dhulikhel Hospital #### Responsible Party **Investigator Affiliation:** Dhulikhel Hospital **Investigator Full Name:** Rebecca Makaju Shrestha **Investigator Title:** Psychologist **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The goal of this clinical trial is to learn if stress management programs can help alleviate existing and prevent future symptoms of stress in nursing professionals working in a tertiary care center in Nepal. Researchers will compare the treatment group (exposed to stress management training) to the control group (not exposed to stress management training) to see if 1. Stress management sessions lead to reduction of levels of stress among nurses at tertiary level hospital in Nepal. 2. To compare the pre and post training stress levels among participants of intervention and control group Participants will Fill out the Depression, Anxiety and Stress Scale 21 and the Perceived Stress Scale before either being exposed to a 4-session stress management training (treatment group) or not being exposed to such training (control). All participants (both groups) will fill out the Depression, Anxiety and Stress Scale 21 and the Perceived Stress Scale for pre-post comparative measure. **Detailed Description:** This study will aim to explore the effectiveness of a stress management program in nursing professionals in a community teaching hospital in Nepal. A 4-day stress management training program will be conducted and pre and post-training stress levels will be measured using the Perceived Stress Scale (PSS) and the Stress-Subscale of the Depression, Anxiety and Stress Scale-21 (DASS-21) one week prior to and after the training program. This experimental pre-post double arm study will involve 86 participants - all nursing staff from the Dhulikhel Hospital. Participants will be divided into 2 groups - treatment and control. The treatment group will be further divided into 2 groups of 20-25. The stress management training program will be held across 4 weeks with both groups receiving one training course each week (eg. Week 1 - session 1; Week 2 - session 2). Both questionnaires will be distributed again to both groups, 1 month after the last stress management session (1 - month follow up) .The control group whilst not being subjected to the Stress management training during the study period, will obtain the training upon study completion. ### Conditions Module **Conditions:** - Mental Health **Keywords:** - Stress; Stress Management; Nursing; Nepal ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Treatment group will obtain stress management whilst the control will not. The control group will obtain stress management one month upon study completion ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 86 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants in this group will be provided with a demographic questionnaire, the DASS-21 and the PSS one week prior to and after the stress management training. The treatment group will be sub-divided into 2 groups of 20-25 participants and subjected to a 4-session stress management training program over the course of 4-weeks (one 40 minute session each week). The DASS and the PSS will be administered to this group one week and one month post completion of the final stress management training session. **Intervention Names:** - Other: Stress Management Training **Label:** Stress Management Group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** This control group will fill out the DASS-21 and PSS with the treatment group prior to the treatment group commencing stress management and will also fill out the DASS-21 and PSS upon completion of the treatment group's stress management training. This group will however not obtain stress management training during the study. Training will be provided upon study completion. **Label:** Control Group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Stress Management Group **Description:** The intervention will comprise of 4 sessions delivered over 4 weeks. The training session will be structured as follows: Session 1 - Psychoeducation relating to stress and its effects. Session 2 - Behavioral techniques to cope with stress 1, Session 3 - Cognitive techniques to cope with stress and Session 4- Behavioral techniques to cope with stress. Both verbal and written means will be used to provide this training. **Name:** Stress Management Training **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The DASS-21 is a 21-item tool measuring signs and symptoms of depression, anxiety and stress. The DASS-21 displays good to excellent internal consistency. Previous studies have reported a Cronbach's α ranging from 0.82 - 0.90 for Depression, .74 - .83 for Anxiety, and 82 - .87 for Stress. The DASS-21 has also been validated in Nepal with good reliability for each subscale, with Cronbach's alphas 0.79 for Anxiety, 0.91 for Stress, and 0.93 for Depression. **Measure:** Depression Anxiety Stress Scale - 21 **Time Frame:** One week prior to 4-week intervention, one week and one month post-intervention. **Description:** The PSS displays good internal consistency with a Cronbach's α ranging from 0.74 - 0.91. A Nepali version of the PSS has also been evaluated yielding validity, strong overall internal consistency (Cronbach's α = 0.95) and inter-rater reliability (ICC = 0.96). **Measure:** Perceived Stress Scale **Time Frame:** One week prior to 4-week intervention, one week and one month post-intervention. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Nurses employed at the Dhulikhel Hospital * Minimum one year work experience * Minimum qualification certificate level of nursing * Fluent in spoken and written English Exclusion Criteria: * Nurses with the post of nurse manager and above * Nursing Students * History having undergone stress management training in the past * Absent for one or more sessions * Incidence of a major stressful/critical life event during the study (e.g., divorce, death, and other critical events) **Maximum Age:** 65 Years **Minimum Age:** 8 Years **Sex:** FEMALE **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** rebecca.m.shrestha@gmail.com **Name:** Rebecca Makaju Shrestha, Psychology **Phone:** 9820114531 **Role:** CONTACT **Contact 2:** **Email:** subasnashrestha@gmail.com **Name:** Subasna Shrestha, MN **Phone:** 9849294785 **Role:** CONTACT #### Locations **Location 1:** **City:** Dhulikhel **Contacts:** ***Contact 1:*** - **Email:** rebecca.m.shrestha@gmail.com - **Name:** Rebecca Shrestha, MClinPsych - **Phone:** 9820114531 - **Role:** CONTACT ***Contact 2:*** - **Email:** subasnashrestha@gmail.com - **Name:** Subasna Shrestha, MN - **Phone:** 9849294785 - **Role:** CONTACT ***Contact 3:*** - **Name:** Rebecca Shrestha, MClinPsych - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 4:*** - **Name:** Subasna Shrestha, MN - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Nepal **Facility:** Dhulikhel Hospital **State:** Kavrepalanchowk **Zip:** 45200 ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Behzadi S, Alizadeh Z, Samani NK, Ghasemi A, Fereidouni Z, Rostami K. Effect of stress management on job stress of intensive care unit nurses in hospitals affiliated to the University of Medical Sciences. Archivos Venezolanos de Farmacología y Terapéutica. 2021;40(8):824-7. **Citation:** Hakim RM, Walton LM, Schwartz JJ, Futrell SM, Zaaeed N, Raigangar VL. Nepali Version of the Ten-Item Perceived Stress Scale: Translation and Validation Study for Bhutanese Refugees. In2023 Combined Sections Meeting (CSM) 2023 Feb 25. APTA. **Citation:** Lee EH. Review of the psychometric evidence of the perceived stress scale. Asian Nurs Res (Korean Soc Nurs Sci). 2012 Dec;6(4):121-7. doi: 10.1016/j.anr.2012.08.004. Epub 2012 Sep 18. **PMID:** 25031113 **Citation:** Thapa DK, Visentin D, Kornhaber R, Cleary M. Psychometric properties of the Nepali language version of the Depression Anxiety Stress Scales (DASS-21). Nurs Open. 2022 Nov;9(6):2608-2617. doi: 10.1002/nop2.959. Epub 2021 Jun 23. **PMID:** 34161668 **Citation:** Zanon C, Brenner RE, Baptista MN, Vogel DL, Rubin M, Al-Darmaki FR, Goncalves M, Heath PJ, Liao HY, Mackenzie CS, Topkaya N, Wade NG, Zlati A. Examining the Dimensionality, Reliability, and Invariance of the Depression, Anxiety, and Stress Scale-21 (DASS-21) Across Eight Countries. Assessment. 2021 Sep;28(6):1531-1544. doi: 10.1177/1073191119887449. Epub 2020 Jan 9. **PMID:** 31916468 **Citation:** Pahlavanzadeh S, Asgari Z, Alimohammadi N. Effects of stress management program on the quality of nursing care and intensive care unit nurses. Iran J Nurs Midwifery Res. 2016 May-Jun;21(3):213-8. doi: 10.4103/1735-9066.180376. **PMID:** 27186196 **Citation:** Chaabane S, Chaabna K, Bhagat S, Abraham A, Doraiswamy S, Mamtani R, Cheema S. Perceived stress, stressors, and coping strategies among nursing students in the Middle East and North Africa: an overview of systematic reviews. Syst Rev. 2021 May 5;10(1):136. doi: 10.1186/s13643-021-01691-9. **PMID:** 33952346 **Citation:** Dutton S, Kozachik SL. Evaluating the Outcomes of a Web-Based Stress Management Program for Nurses and Nursing Assistants. Worldviews Evid Based Nurs. 2020 Feb;17(1):32-38. doi: 10.1111/wvn.12417. Epub 2020 Jan 8. **PMID:** 31912984 **Citation:** Mimura C, Griffiths P. The effectiveness of current approaches to workplace stress management in the nursing profession: an evidence based literature review. Occup Environ Med. 2003 Jan;60(1):10-5. doi: 10.1136/oem.60.1.10. **PMID:** 12499451 **Citation:** Ducharme F, Dubé V, Lévesque L, Saulnier D, Giroux F. An online stress management training program as a supportive nursing intervention for family caregivers of an elderly person. Canadian Journal of Nursing Informatics. 2011 Jun;6(2):1-9. **Citation:** Edwards D, Burnard P. A systematic review of stress and stress management interventions for mental health nurses. J Adv Nurs. 2003 Apr;42(2):169-200. doi: 10.1046/j.1365-2648.2003.02600.x. **PMID:** 12670386 **Citation:** Sailaxmi G, Lalitha K. Impact of a stress management program on stress perception of nurses working with psychiatric patients. Asian J Psychiatr. 2015 Apr;14:42-5. doi: 10.1016/j.ajp.2015.01.002. Epub 2015 Feb 7. **PMID:** 25703040 **Citation:** Lary A, Borimnejad L, Mardani-Hamooleh M. The Impact of a Stress Management Program on the Stress Response of Nurses in Neonatal Intensive Care Units: A Quasi-Experimental Study. J Perinat Neonatal Nurs. 2019 Apr/Jun;33(2):189-195. doi: 10.1097/JPN.0000000000000396. **PMID:** 31021944 **Citation:** Alkhawaldeh JMA, Soh KL, Mukhtar FBM, Peng OC, Anshasi HA. Stress management interventions for intensive and critical care nurses: A systematic review. Nurs Crit Care. 2020 Mar;25(2):84-92. doi: 10.1111/nicc.12489. Epub 2019 Dec 15. **PMID:** 31840391 **Citation:** Izdebski Z, Kozakiewicz A, Bialorudzki M, Dec-Pietrowska J, Mazur J. Occupational Burnout in Healthcare Workers, Stress and Other Symptoms of Work Overload during the COVID-19 Pandemic in Poland. Int J Environ Res Public Health. 2023 Jan 30;20(3):2428. doi: 10.3390/ijerph20032428. **PMID:** 36767797 **Citation:** Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u. **PMID:** 7726811 **Citation:** Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available. **PMID:** 6668417 **Citation:** Yazdani M, Rezaei S, Pahlavanzadeh S. The effectiveness of stress management training program on depression, anxiety and stress of the nursing students. Iran J Nurs Midwifery Res. 2010 Fall;15(4):208-15. **PMID:** 22049282 **Citation:** Pahlevani M, Ebrahimi M, Radmehr S, Amini F, Bahraminasab M, Yazdani M. Effectiveness of stress management training on the psychological well-being of the nurses. J Med Life. 2015;8(Spec Iss 4):313-318. **PMID:** 28316750 **Citation:** Kumar N, Jin Y. Impact of nurses' emotional labour on job stress and emotional exhaustion amid COVID-19: The role of instrumental support and coaching leadership as moderators. J Nurs Manag. 2022 Oct;30(7):2620-2632. doi: 10.1111/jonm.13818. Epub 2022 Oct 11. **PMID:** 36181253 **Citation:** Woo T, Ho R, Tang A, Tam W. Global prevalence of burnout symptoms among nurses: A systematic review and meta-analysis. J Psychiatr Res. 2020 Apr;123:9-20. doi: 10.1016/j.jpsychires.2019.12.015. Epub 2020 Jan 22. **PMID:** 32007680 **Citation:** Hersch RK, Cook RF, Deitz DK, Kaplan S, Hughes D, Friesen MA, Vezina M. Reducing nurses' stress: A randomized controlled trial of a web-based stress management program for nurses. Appl Nurs Res. 2016 Nov;32:18-25. doi: 10.1016/j.apnr.2016.04.003. Epub 2016 Apr 9. **PMID:** 27969025 ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06438003 **Brief Title:** Improving Healthy Living Opportunities: Laurel HARVEST **Official Title:** Improving Healthy Living Opportunities: Laurel HARVEST #### Organization Study ID Info **ID:** 64602 #### Organization **Class:** OTHER **Full Name:** University of Kentucky #### Secondary ID Infos **Domain:** USDA NIFA **ID:** 2022-68015-36497 **Type:** OTHER_GRANT ### Status Module #### Completion Date **Date:** 2025-12-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-24 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2025-12-30 **Type:** ESTIMATED #### Start Date **Date:** 2023-01-27 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-24 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Makenzie Barr-Porter #### Responsible Party **Investigator Affiliation:** University of Kentucky **Investigator Full Name:** Makenzie Barr-Porter **Investigator Title:** Assistant Professor **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this pre-post intervention study is to understand how community-engaged approaches to policy, systems, and environmental approaches can work to improve fruit and vegetable consumption and food security status among an Appalachian Kentucky community. The main approaches taken will be to employ a Community Advisory Board to define our target population of need, and appropriate intervention strategies. The investigators aim to understand if nutrition-based programming and food system approaches for lower-income, single-parent households, and multi-generational households can improve health. Participants will engage in annual data collection to assess dietary quality and food security status. ### Conditions Module **Conditions:** - Health Knowledge, Attitudes, Practice - Obesity **Keywords:** - Health Equity - Food Insecurity - Rural ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 281 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Specialized services **Intervention Names:** - Behavioral: Special Services **Label:** Laurel County **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Extension services as usual **Intervention Names:** - Other: Services as Usual **Label:** Pike County **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Laurel County **Description:** Community members will complete data collection at the extension office or community partner location. Extension cooking classes and helping to make raised bed gardens along with other area happenings will be offered to participants throughout the year with check-ins and reminders. Data will be collected from study participants (regardless of the intervention decided) , at two time points, to include survey, dietary recall, and carotenoid scanner. **Name:** Special Services **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Pike County **Description:** Community members will receive extension services as usual with Data collection on participants at two time points to assess changes in rates of food insecurity, dietary quality, and overall health conditions. **Name:** Services as Usual **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Food Security Status will be measured at each time point by the 10-item United States Department of Agriculture (USDA) Household Food Security Module. The questionnaire includes ten questions pertaining to food security that were designed to assess an individual's ability to obtain food directly to ensure having enough healthy food to eat. The questions include items such as not having enough money to purchase food, inability to afford nutritious food, and skipping meals due to lack of sufficient money. Answer choices include often, sometimes, never, and don't know. Items will be scored Food security status is assigned as follows: raw score zero-High food security among adults, raw score 1-2-Marginal food security, raw score 3-5-Low food security, raw score 6-10-Very low food security. For some reporting purposes, the food security status of the first two categories in combination will be described as food secure and the latter two as food insecure. **Measure:** change in food security **Time Frame:** Baseline (year 1) and year 3 **Description:** The Healthy Eating Index is a measurement that can capture changes in the thirteen dietary components outlined in the Dietary Guidelines for Americans. A maximum score-5 or 10 points- can be reached for each dietary component, depending on the component. Points are awarded when the amounts consumed meets the standard for a particular dietary component. Amounts that do not meet the standard get fewer points, with zero being the minimum score, and the maximum total Healthy Eating Index score is 100. **Measure:** change in total Healthy Eating Index scores **Time Frame:** Baseline (year 1) and year 3 **Description:** 30 item questionnaire to collect self-reported behaviors pertaining to five domains: diet, physical activity, food safety, food security and food resource management. The response options for each question are based on a Likert scale. Each question is scored with higher scores indicating greater frequency of the behavior in question. **Measure:** Change in Food and Physical Activity Questionnaire (FPAQ) **Time Frame:** Baseline (year 1) and year 3 **Description:** the VEGGIE METER™ will be used to measure dermal carotenoids using non-invasive RS Spectroscopy. Carotenoids are a biological marker of fruit and vegetable consumption. This non-invasive measurement of dermal carotenoids has been validated against the standard of serum carotenoids in adults. To obtain the measurement, a subject places their pointer finger into the machine for 20 seconds while their finger is squeezed. Three replicates will be taken per person at 20 seconds per replicate. The VEGGIE METER™ scores dermal carotenoids on a scale of 0-850 with higher scores indicating higher intake. **Measure:** change in carotenoids **Time Frame:** Baseline (year 1) and year 3 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Resident of Laurel of Pike County * Over 18 years of age Exclusion Criteria: * Pregnancy * Non-English speaking * Plans to move out of the counties within the next three years **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Lexington **Country:** United States **Facility:** University of Kentucky **State:** Kentucky **Zip:** 40506 #### Overall Officials **Official 1:** **Affiliation:** University of Kentucky **Name:** Makenzie Barr-Porter, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12701 - Name: Obesity - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M5592 - Name: Carotenoids - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437990 **Brief Title:** Arteriovenous Loop Graft for Free Functional Gracilis Transfer in Brachial Plexus Surgery **Official Title:** Pilot Study of Arteriovenous Loop Graft for Free Functional Gracilis Transfer in Brachial Plexus Injured Patients With Insufficient Flow of Donor Artery #### Organization Study ID Info **ID:** 652/2556(EC4) #### Organization **Class:** OTHER **Full Name:** Siriraj Hospital ### Status Module #### Completion Date **Date:** 2024-07-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-26 **Overall Status:** ENROLLING_BY_INVITATION #### Primary Completion Date **Date:** 2024-04-30 **Type:** ACTUAL #### Start Date **Date:** 2015-11-19 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-26 **Study First Submit QC Date:** 2024-05-26 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Siriraj Hospital #### Responsible Party **Investigator Affiliation:** Siriraj Hospital **Investigator Full Name:** Panai Laohaprasitiporn, MD **Investigator Title:** Assistant Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Free functional muscle transfer (FFMT) using the gracilis muscle as a donor muscle has become a standard treatment for reconstructing late-onset brachial plexus injuries. Successful implementation of this procedure relies on the availability of functional donor vessels in the injured limb to supply the muscle flap. However, some brachial plexus injuries are accompanied by subclavian or axillary artery injuries, which compromise the viability of the muscle flap due to insufficient vascular supply. To address this, arteriovenous (AV) loop grafts have been employed to extend donor vessels to the flap and have been utilized in various body regions, including the upper extremity. Despite their widespread use, AV loop grafts have not been previously utilized in FFMT for late-onset brachial plexus injuries with concurrent subclavian or axillary artery injuries. This study aimed to assess the feasibility of this surgical approach and report the long-term outcomes of the procedure. ### Conditions Module **Conditions:** - Brachial Plexus Injury **Keywords:** - brachial plexus injury - brachial plexus palsy - free functional muscle transfer - arteriovenous loop graft - subclavian artery injury - axillary artery injury ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Late-onset brachial plexus injury patient with concomitant subclavian or axillary artery injury ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 10 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** A saphenous vein graft was used to create an arteriovenous loop from the common carotid artery to the external jugular vein, providing vascular supply for a free functional gracilis muscle flap in patients with late-onset brachial plexus injury. **Intervention Names:** - Procedure: Arteriovenous loop graft **Label:** Arteriovenous loop graft **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Arteriovenous loop graft **Description:** Using saphenous vein graft to create an arteriovenous loop from the common carotid artery to the external jugular vein, providing vascular supply for a free functional gracilis muscle flap in patients with late-onset brachial plexus injury with concomitant subclavian or axillary artery injury. **Name:** Arteriovenous loop graft **Other Names:** - AV loop graft **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Survival of the flap after the surgery **Measure:** Viability of the flap **Time Frame:** 1 month #### Secondary Outcomes **Description:** Medical Research Council (MRC) grading for motor power assessment **Measure:** Motor power **Time Frame:** 12 months, 18 months **Description:** Bleeding, infection, blood transfusion, stroke, embolism, thrombosis **Measure:** Complications **Time Frame:** 1 month **Description:** Total operative time including flap revision surgery or other related complications **Measure:** Operative time **Time Frame:** 1 month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age equal or more than 20 years old * Patients with brachial plexus injury with depletion of blood flow to the injured limb which confirmed by abnormal computed tomography arteriogram Exclusion Criteria: * Patients who had sufficient thoraco-acromial or thoraco-dorsal artery blood flow for standard free functional muscle transfer operation without the need of an AV loop graft **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Bangkoknoi **Country:** Thailand **Facility:** Faculty of Medicine Siriraj Hospital, Mahidol University **State:** Bangkok **Zip:** 10700 #### Overall Officials **Official 1:** **Affiliation:** Siriraj Hospital **Name:** Panai Laohaprasitiporn, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M13157 - Name: Paralysis - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437977 **Acronym:** neoR-TORCH **Brief Title:** Neoadjuvant Therapy of SBRT Sequencial With Toripalimab and Chemotherapy in Resectable Stage II-III NSCLC Patients(neoR-TORCH) **Official Title:** Neoadjuvant Therapy of SBRT Sequencial With Toripalimab and Chemotherapy in Resectable Stage II-III NSCLC Patients: A Multicenter, Openlabel, Randomized, Phase III Trial #### Organization Study ID Info **ID:** IS24056 #### Organization **Class:** OTHER **Full Name:** Shanghai Chest Hospital ### Status Module #### Completion Date **Date:** 2029-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-26 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-26 **Study First Submit QC Date:** 2024-05-26 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Shanghai Chest Hospital #### Responsible Party **Investigator Affiliation:** Shanghai Chest Hospital **Investigator Full Name:** Xuwei Cai **Investigator Title:** Director **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This is a randomized, controlled, multi-center, phase III clinical study to evaluate the efficacy and safety of SBRT sequencial with Toripalimab and chemotherapy versus Toripalimab and chemotherapy for subjects with resectable, stage II-III NSCLC. **Detailed Description:** Subjects who meet all the inclusion criteria but do not meet any exclusion criteria are randomized into two groups at a ratio of 1:1: according to the stratification factors as below: * Disease stage: II vs IIIA vs IIIB * PD-L1 status: PD-L1 expression ≥1% vs. PD-L1 \<1% or not evaluable * Pathological type: non-squamous cell carcinoma vs. squamous cell carcinoma Neoadjuvant therapy should be started within 1 week after randomization. Stereotactic body radiation therapy (SBRT) will be given for primary lung tumor, 24Gy/3fractions, sequential toripalimab IV 240 mg Q3W will be given combined with platinum-based doublet drug chemotherapy for three cycles in the preoperative neoadjuvant therapy period for trial group; the controlled group receive toripalimab IV 240 mg Q3W combined with platinum-based doublet drug chemotherapy for three cycles in the preoperative neoadjuvant therapy period. Every 3 weeks of treatment is regarded as one cycle, in which combined therapy is given in the first day of every cycle. All the subjects will receive preoperative radiological and surgical evaluation 4-6 weeks after neoadjuvant therapy. After 3 cycles of preoperative neoadjuvant therapy, all the subjects who still have surgical indications will receive radical excision based on the surgical operation criteria of the World Association for Lung Cancer Research within 4-6 weeks after 3 cycles of preoperative neoadjuvant therapy. The pTNM will be staged in accordance with AJCC Cancer Staging Manual (version 8). All the specimens taken during the operation will be evaluated by local pathologists for the surgical margin. The tumor tissue samples collected from subjects during the study will be submitted to the authorized central laboratory for blinded evaluation of pathological response and translational research. All the subjects who have completed the radical operation will receive one cycle of postoperative adjuvant therapy, i.e., Toripalimab IV 240 mg/placebo + platinum-based doublet drug chemotherapy in 30 days after the operation. Then it will proceed to consolidation treatment period three weeks after adjuvant therapy; In the consolidation treatment period, Toripalimab IV 240 mg/placebo is given in each cycle of every 3 weeks for a total of 13 cycles . Adverse events (AEs) will be monitored throughout the study, and the severity will be graded to the guidelines listed in National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) version 5.0 or above. The safety will be followed up in the subjects who have received study treatment and discontinued the drug prematurely. All the subjects will be followed up for overall survival, until death, withdrawal of informed consent or end of study ### Conditions Module **Conditions:** - Stage II-III Non-small Cell Lung Cancer ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Parallel ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 478 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants receive SBRT for primary lung tumor, sequential receive totally 4 cycles of Toripalimab combined with platinum doublet chemotherapy during perioperative period ; participants receive consolidation therapy of Toripalimab Intervention: SBRT: 24Gy/3fractions; Drug: 4cycles(Toripalimab IV 240mg + platinum-based doublet chemotherapy)+13 cycles(Toripalimab IV 240mg); Biological: Toripalimab **Intervention Names:** - Radiation: SBRT - Drug: Toripalimab **Label:** Experimental **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participantsreceive totally 4 cycles of Toripalimab combined with platinum doublet chemotherapy during perioperative period ; participants receive consolidation therapy of Toripalimab Intervention: Drug: 4cycles(Toripalimab IV 240mg + platinum-based doublet chemotherapy)+13 cycles(Toripalimab IV 240mg); Biological: Toripalimab **Intervention Names:** - Drug: Toripalimab **Label:** Active Comparator **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental **Description:** SBRT. 24Gy/3fractions Toripalimab 240 mg by IV infusion every 3 weeks (Q3W), given on cycle day 1;Drug: Cisplatin 75 mg/m\^2 by IV infusion Q3W, given on cycle day 1;Drug: Corboplatin AUC 5 by IV infusion Q3W, given on cycle day 1;Drug: Pemetrexed 500 mg/m\^2 by IV infusion Q3W, given on cycle day 1. Given only to participants with nonsquamous NSCLC.Drug:Paclitaxel 175 mg/m\^2 by IV infusion Q3W;Drug:Docetaxel 60-75 mg/m\^2 by IV infusion Q3W **Name:** SBRT **Type:** RADIATION #### Intervention 2 **Arm Group Labels:** - Active Comparator - Experimental **Description:** Toripalimab 240 mg by IV infusion every 3 weeks (Q3W), given on cycle day 1;Drug: Cisplatin 75 mg/m\^2 by IV infusion Q3W, given on cycle day 1;Drug: Corboplatin AUC 5 by IV infusion Q3W, given on cycle day 1;Drug: Pemetrexed 500 mg/m\^2 by IV infusion Q3W, given on cycle day 1. Given only to participants with nonsquamous NSCLC.Drug:Paclitaxel 175 mg/m\^2 by IV infusion Q3W;Drug:Docetaxel 60-75 mg/m\^2 by IV infusion Q3W **Name:** Toripalimab **Other Names:** - Toripalimab IV 240mg + platinum-based doublet chemotherapy **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Event Free Survival (EFS):EFS is defined as the time from randomization until radiographic disease progression, local progression precluding surgery, inability to resect the tumor, local or distant recurrence, or death due to any cause. EFS determined either by biopsy assessed by central pathologist or by imaging using RECIST 1.1 assessed by BICR. **Measure:** 2-year Event Free Survival Rate **Time Frame:** 2 years **Description:** Pathological Complete Response (pCR) Rate :pCR rate is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy. **Measure:** pCR rate **Time Frame:** up to 7 weeks after neoadjuvant #### Secondary Outcomes **Description:** Major Pathological Response (mPR) Rate.mPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes in neoadjuvant therapy **Measure:** Major Pathological Response **Time Frame:** up to 7 weeks after neoadjuvant **Measure:** Lymph node downstaging rate **Time Frame:** up to 7 weeks after neoadjuvant **Measure:** Perioperative complications **Time Frame:** 90 days after the last administration **Description:** Adverse event (AE), abnormal laboratory examination, serious adverse event (SAE) related with the study drug judged using NCI-CTCAE V5.0; surgical feasibility: percentage of procedure delay or cancellation, change of surgical approach, operation time **Measure:** Treatment associated adverse events **Time Frame:** 90 days after the last administration **Description:** EFS is defined as the time from randomization until radiographic disease progression, local progression precluding surgery, inability to resect the tumor, local or distant recurrence, or death due to any cause. EFS determined either by biopsy assessed by central pathologist or by imaging using RECIST 1.1 assessed by investigator **Measure:** EFS **Time Frame:** up to 3 years **Description:** DFS is defined as the time from postoperation until radiographic disease progression, , local or distant recurrence, or death due to any cause **Measure:** Disease-free survival (DFS) **Time Frame:** up to 3 years **Description:** OS is defined as the time from randomization until death from any cause. **Measure:** Overall survival (OS) **Time Frame:** up to 3 years **Measure:** R0 resection rate **Time Frame:** up to 7 weeks after neoadjuvant **Measure:** Surgical Completion Rate **Time Frame:** up to 7 weeks after neoadjuvant ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Aged 18 -75 years, regardless of gender； 2. ECOG score 0-1; 3. Treatment-naive, histologically confirmed resectable, stage II, IIIA, IIIB (N2) (AJCC staging system, version 8) NSCLC ; 4. Measurable lesions based on the response evaluation criteria in solid tumors version 1.1; 5. Tumor tissue specimens available for pathological diagnosis, detection of PD-L1 expression and biomarkers prior to randomization ; 6. According to the doctor's judgment, lung function can meet the requirements of pneumonectomy; 7. Confirming the absence of EGFR/ALK sensitive gene mutations through molecular pathological diagnosis of the organization; 8. Good organ function: Bone marrow function: absolute neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 80 × 109/L, hemoglobin ≥9 g/dL; Liver function: total bilirubin ≤ 1.5 × ULN, ALT and AST ≤ 1.5 × ULN; Renal function: serum creatinine ≤ 1.5 × ULN or serum creatinine clearance rate ≥ 60 mL/min; blood urea nitrogen ≤ 200mg/L; 9. Having sufficient understanding of this study and being willing to sign the informed consent form; 10. For female subjects of childbearing age, the serum pregnancy test should be negative within 3 days before receiving the first dose (cycle 1, day 1). Exclusion Criteria: 1. Have locally advanced unresectable or metastatic disease; unresectable includes unresectable stage III non-small cell lung cancer as defined by the Multidisciplinary Diagnosis and Treatment Consensus (2019 edition), including partial stages IIIA and IIIB and all stage IIIC, N2: single station mediastinal lymph nodes with short diameter≥3cm or N2: multi-station mediastinal metastasis with lymph node fusion and the short diameter of lymph node ≥2cm on CT, T4 invading esophagus, heart, aorta, pulmonary veins and all the N3; 2. NSCLC involving superior sulcus, large cell neuroendocrine carcinoma (LCNEC), sarcomatoid tumor; 3. Participants with known EGFR sensitive mutations or ALK translocation, EGFR and ALK mutation status needs to be identified for the subjects with non-squamous cell carcinoma; 4. Previous treatment with systemic antitumor therapy for early NSCLC, including investigational product; 5. History of (non-infectious) pneumonitis/interstitial lung disease requiring steroid treatment, or ongoing pneumonitis/interstitial lung disease requiring steroid treatment; 6. Active tuberculosis； 7. Active infection requiring systemic treatment； 8. Subjects with any known or suspected autoimmune disorder or immunodeficiency, with the following exceptions: hypothyroidism, hormone therapy is not needed, or well controlled at physiological dose; controlled type I diabetes; 9. Uncontrolled active hepatitis B (defined as positive hepatitis B surface antigen \[HBsAg\] in screening period with HBV-DNA detected higher than the upper limit of normal at the clinical laboratory of the study center); (the subjects with HBV-DNA assay \<500 IU/mL within 28 days prior to randomization who have received local standard antiviral therapy for at least 14 days and are willing to receive antiviral therapy continuously during the study can be enrolled); active hepatitis C (defined as positive hepatitis C surface antibody \[HCsAb\] in screening period and positive HCV-RNA); 10. Known human immunodeficiency virus (HIV) infection (known positive HIV antibody); 11. Vaccination of live vaccine within 30 days prior to the first dose. Including but not limited to the following: parotitis, rubella, measles, varicella/ herpes zoster (varicella), yellow fever, Rabies, Bacille Calmette-Guérin (BCG) and typhoid vaccine (inactivated virus vaccine allowed); 12. ≥ grade 2 peripheral neuropathy； 13. Previous use of PD-1/PD-L1 agent or the drug acting on another targeted T cell receptor (e.g., CTLA-4, OX-40); 14. Severe allergic reaction to other monoclonal antibodies; 15. History of serious allergy to Pemetrexed, paclitaxel or docetaxel, cisplatin, carboplatin or its preventive medications; 16. Known serious or uncontrolled pre-existing diseases; including but not limited to cardiovascular events with hemodynamic instability, symptomatic cerebrovascular events, and hepatic cirrhosis above Child-Pugh A within 6 months; 17. History or current evidence of any disease, therapy or abnormal laboratory examination that may confuse the study results, interfere with subject's participation in the full course of the study or not meet the best interest of subject's participation in the study, as judged by investigators; 18. Other malignant tumors within 5 years prior to the first dose, except non-small cell lung cancer. The malignant tumors with negligible risk of metastasis or death (e.g., expected disease-free survival \> 5 years) and expected to achieve radical outcomes after treatment (e.g., sufficiently treated carcinoma in situ of cervix, basal or squamous cell skin cancer, ductal carcinoma in situ treated for radical surgery) can be excluded. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** birdhome2000@163.com **Name:** Xuwei Cai **Phone:** 02122200000 **Role:** CONTACT ### IPD Sharing Statement Module **Description:** yes **IPD Sharing:** YES ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002283 - Term: Carcinoma, Bronchogenic - ID: D000001984 - Term: Bronchial Neoplasms - ID: D000008175 - Term: Lung Neoplasms - ID: D000012142 - Term: Respiratory Tract Neoplasms - ID: D000013899 - Term: Thoracic Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5546 - Name: Carcinoma, Non-Small-Cell Lung - Relevance: HIGH - As Found: Non-Small Cell Lung Cancer - ID: M11172 - Name: Lung Neoplasms - Relevance: LOW - As Found: Unknown - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M5540 - Name: Carcinoma, Bronchogenic - Relevance: LOW - As Found: Unknown - ID: M5260 - Name: Bronchial Neoplasms - Relevance: LOW - As Found: Unknown - ID: M14979 - Name: Respiratory Tract Neoplasms - Relevance: LOW - As Found: Unknown - ID: M16658 - Name: Thoracic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002289 - Term: Carcinoma, Non-Small-Cell Lung ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M19537 - Name: Paclitaxel - Relevance: LOW - As Found: Unknown - ID: M264 - Name: Pemetrexed - Relevance: LOW - As Found: Unknown - ID: M1668 - Name: Docetaxel - Relevance: LOW - As Found: Unknown - ID: M231 - Name: Albumin-Bound Paclitaxel - Relevance: LOW - As Found: Unknown - ID: M6182 - Name: Cisplatin - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437964 **Brief Title:** Prophylactic Antibiotics in Endoscopic Secondary Prevention of Gastroesophageal Variceal Bleeding **Official Title:** The Use of Prophylactic Antibiotics in the Endoscopic Secondary Prevention of Cirrhotic Patients With Gastroesophageal Variceal Bleeding #### Organization Study ID Info **ID:** 2024-0629 #### Organization **Class:** OTHER **Full Name:** Second Affiliated Hospital, School of Medicine, Zhejiang University ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-26 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-25 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-26 **Study First Submit QC Date:** 2024-05-26 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Second Affiliated Hospital, School of Medicine, Zhejiang University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Prophylactic antibiotics like third-generation cephalosporin is recommended for acute gastroesophageal variceal bleeding (GVB). Endoscopic sequential therapy is an option in the secondary prevention of acute gastroesophageal variceal bleeding (GVB). However, the value of prophylactic antibiotics in the endoscopic secondary prevention of GVB is still unclear. It's assumed that the procedure of needle puncture under endoscopy will cause iatrogenic variceal bleeding. Besides, the surface of intraluminal varices is nonsterile, and injection of sclerosing agent or tissue adhesive will put patients at a risk of bacteremia. As a result, it's rational to use antibiotics prophylactically in the endoscopic sequential therapy of GVB. While giving antibotics in all patients might cause abuse of antibiotics. In clinical practice now, the prophylactic administration of antibiotics is quite subjective. We observe that quite a lot of cirrhotic patients had no infection after endoscopic secondary prevention for gastroesophageal variceal bleeding, even they have not been administed prophylactic antibiotics. In this non-inferiority trial, we are aimed to evaluate whether no value of prophylactic antibiotics will increase the postoperative infection or not, in the endoscopic secondary prevention of cirrhotic patients with gastroesophageal variceal bleeding. ### Conditions Module **Conditions:** - Gastroesophageal Variceal Bleeding - Cirrhosis, Liver - Endoscopic Secondary Prevention - Prophylactic Antibiotics ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 224 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Other: No use of prophylactic antibiotics **Label:** Intravenous infusion of 2.0g ceftriaxone before endoscopic therapy **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Intervention Names:** - Other: No use of prophylactic antibiotics **Label:** No use of prophylactic antibiotics before endoscopic therapy **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Intravenous infusion of 2.0g ceftriaxone before endoscopic therapy - No use of prophylactic antibiotics before endoscopic therapy **Description:** In the endoscopic secondary prevention of cirrhotic patients with gastroesophageal variceal bleeding, do not use any antibiotics before the endoscopic operation. **Name:** No use of prophylactic antibiotics **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** have fever and increased inflammation marker within one day afer the endoscopic operation **Measure:** Post-operation infection **Time Frame:** 19 months #### Secondary Outcomes **Description:** have gastroesophageal variceal bleeding within 4 week after the endoscopic operation **Measure:** Post-operation 4-week rebleeding **Time Frame:** 19 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Cirrhotic patients with a history of gastroesophageal variceal bleeding that are readmitted for endoscopic secondary prevention, and are willing to sign an informed consent form. Exclusion Criteria: 1. Allergy to penicillin or cephalosporin. 2. The patient is unwilling to sign the informed consent form. 3. Already have concurrent infection before the endoscopic operation. 4. Already have fever (body temperature ≥ 37.5 ℃) before the endoscopic operation. 5. Have granulocyte deficiency (neutrophil count below 0.5 \* 10 \^ 9/L) before the endoscopic operation. 6. Have malignant tumors before the endoscopic operation. **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Hangzhou **Contacts:** ***Contact 1:*** - **Email:** xuemeng@zju.edu.cn - **Name:** Meng Xue, Ph.D - **Phone:** +86 13958123617 - **Role:** CONTACT **Country:** China **Facility:** The 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009385 - Term: Neoplastic Processes - ID: D000009369 - Term: Neoplasms - ID: D000010335 - Term: Pathologic Processes - ID: D000005355 - Term: Fibrosis - ID: D000008107 - Term: Liver Diseases - ID: D000004066 - Term: Digestive System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases ### Condition Browse Module - Browse Leaves - ID: M12307 - Name: Neoplasm Metastasis - Relevance: HIGH - As Found: Secondary - ID: M11103 - Name: Liver Cirrhosis - Relevance: HIGH - As Found: Cirrhosis, Liver - ID: M9556 - Name: Hemorrhage - Relevance: HIGH - As Found: Bleeding - ID: M12330 - Name: Neoplastic Processes - Relevance: LOW - As Found: Unknown - ID: M8485 - Name: Fibrosis - Relevance: LOW - As Found: Unknown - ID: M11107 - Name: Liver Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009362 - Term: Neoplasm Metastasis - ID: D000008103 - Term: Liver Cirrhosis - ID: D000006470 - Term: Hemorrhage ### Intervention Browse Module - Ancestors - ID: D000000890 - Term: Anti-Infective Agents ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: HIGH - As Found: Initial - ID: M5693 - Name: Ceftriaxone - Relevance: LOW - As Found: Unknown - ID: M4224 - Name: Antibiotics, Antitubercular - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000000900 - Term: Anti-Bacterial Agents ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437951 **Brief Title:** to Evaluate the Safety/Tolerability and Pharmacokinetics, and Pharmacodynamics of DWP14012 Injection **Official Title:** A Randomized, Double-blind, Placebo-controlled, Single/Multiple-dose, Phase 1 Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetics, and Pharmacodynamics After Intravenous DWP14012 Injection in Healthy Participants #### Organization Study ID Info **ID:** DW_DWJ1521104 #### Organization **Class:** INDUSTRY **Full Name:** Daewoong Pharmaceutical Co. LTD. ### Status Module #### Completion Date **Date:** 2025-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-07 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Daewoong Pharmaceutical Co. LTD. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** to evaluate the safety/tolerability and pharmacokinetics, and pharmacodynamics after intravenous DWP14012 injection in healthy participants ### Conditions Module **Conditions:** - Erosive Gastroesophageal Reflux Disease ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** IV injection of test drugs by dose group **Intervention Names:** - Drug: Fexuprazan Injection **Label:** Part1_test group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** IV injection of test drugs by dose group **Intervention Names:** - Drug: Fexuprazan Injection placebo **Label:** Part1_placebo group **Type:** PLACEBO_COMPARATOR #### Arm Group 3 **Description:** All Participants take IV injection of test drugs **Intervention Names:** - Drug: Fexuprazan Injection_part 2 **Label:** Part2 **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** In the case of test group, take IV injection in the period 1 and take a tablet in the period 2 **Intervention Names:** - Drug: Fexuprazan Injection_part 3 - Drug: Fexuprazan tablet **Label:** Part3_test group **Type:** EXPERIMENTAL #### Arm Group 5 **Description:** In the case of reference group, take a tablet in the period 1 and take IV injection in the period 2 **Intervention Names:** - Drug: Fexuprazan Injection_part 3 - Drug: Fexuprazan tablet **Label:** Part3_reference group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Part1_test group **Description:** 20/40/80 mg **Name:** Fexuprazan Injection **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Part1_placebo group **Description:** 20/40/80 mg **Name:** Fexuprazan Injection placebo **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Part2 **Description:** 20mg **Name:** Fexuprazan Injection_part 2 **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - Part3_reference group - Part3_test group **Description:** 40mg **Name:** Fexuprazan Injection_part 3 **Type:** DRUG #### Intervention 5 **Arm Group Labels:** - Part3_reference group - Part3_test group **Description:** 40mg **Name:** Fexuprazan tablet **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** 1. Blood and urinary concentrations of Fexuprazan by part **Measure:** PK of Fexuprazan **Time Frame:** 0 and 72hour **Description:** 1. Blood and urinary concentrations of metabolite by part **Measure:** PK of metabolite **Time Frame:** 0 and 72hour **Description:** pH monitoring **Measure:** PD of Fexuprazan **Time Frame:** up to 15days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Healthy adult volunteers aged 19 to 50 at the time of screening tests 2. Those who weigh more than 50.0 kg, 90.0 kg or less, and have a BMI of 18.5 or more and 29.9 or less at the time of screening inspection ☞ BMI (kg/m2) = Weight (kg) / {Height (m)}2 3. In the case of female volunteers, those who are not necessarily pregnant or lactating or who are in surgical infertility (bilateral ovarian obstruction, hysterectomy, bilateral ovarian resection, etc.) 4. A person who voluntarily decides to participate after hearing and fully understanding the detailed explanation of this clinical trial and agrees in writing before a screening procedure 5. A person who is suitable for this test when judging the tester by physical examination, clinical laboratory examination, questionnaire, etc Exclusion Criteria: 1. Clinically significant hepatomegaly (severe liver disorder, viral hepatitis, etc.), kidney (severe renal disorder, etc.), nervous system, immune system, respiratory system, digestive system, endocrine system, blood and tumor, cardiovascular system (heart failure, Torsades de points, etc.), urinary system, mental system (fever disorder, obsessive compulsive disorder, etc.), sexual dysfunction, etc 2. A person who has a history of gastrointestinal diseases (such as Crohn's disease, ulcers, gastritis, gastritis, gastroesophageal reflux disease, etc.) or surgery (except simple appendectomy or hernia) that may affect the safety, pharmacokinetics and pharmacodynamic evaluation of clinical medicines 3. Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 4. A person who has been tested positive for Helicobacter pylori 5. Those who have anatomical impairments in insertion and maintenance of the pH meter catheter etc **Healthy Volunteers:** True **Maximum Age:** 50 Years **Minimum Age:** 19 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** leesj0323@snu.ac.kr **Name:** Sujong Lee, Ph.D **Phone:** 027408910 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Seoul National University College of Medicine and Hospital **Name:** Injin zhang, Ph.D **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000015154 - Term: Esophageal Motility Disorders - ID: D000003680 - Term: Deglutition Disorders - ID: D000004935 - Term: Esophageal Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000004066 - Term: Digestive System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC09 - Name: Ear, Nose, and Throat Diseases ### Condition Browse Module - Browse Leaves - ID: M8880 - Name: Gastroesophageal Reflux - Relevance: HIGH - As Found: Gastroesophageal Reflux - ID: M17874 - Name: Esophageal Motility Disorders - Relevance: LOW - As Found: Unknown - ID: M17875 - Name: Esophageal Spasm, Diffuse - Relevance: LOW - As Found: Unknown - ID: M6882 - Name: Deglutition Disorders - Relevance: LOW - As Found: Unknown - ID: M8085 - Name: Esophageal Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005764 - Term: Gastroesophageal Reflux ### Intervention Browse Module - Ancestors - ID: D000005765 - Term: Gastrointestinal Agents ### Intervention Browse Module - Browse Branches - Abbrev: Gast - Name: Gastrointestinal Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M350719 - Name: Fexuprazan - Relevance: HIGH - As Found: Transverse abdominal - ID: M8881 - Name: Gastrointestinal Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000634065 - Term: Fexuprazan ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437938 **Brief Title:** The Effects of Dietary Supplements on Glycemic Control, Body Composition and Hepatic Fat Content in People With Prediabetes **Official Title:** The Effects of Dietary Supplements on Glycemic Control, Body Composition and Hepatic Fat Content in People With Prediabetes: a Randomized, Double-blind, Placebo-controlled Pilot Study #### Organization Study ID Info **ID:** 1543/2023 #### Organization **Class:** OTHER **Full Name:** Medical University of Vienna ### Status Module #### Completion Date **Date:** 2025-08-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-26 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-05-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-25 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-26 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** BIOGENA GmbH #### Lead Sponsor **Class:** OTHER **Name:** Medical University of Vienna #### Responsible Party **Investigator Affiliation:** Medical University of Vienna **Investigator Full Name:** Michael Leutner **Investigator Title:** Priv.Doz. Dr.med.univ. **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This clinical study aims to explore the effects of 3 dietary supplements on metabolic parameters, liver fat content, and body composition in individuals with prediabetes. Prediabetes refers to a condition where blood sugar levels are higher than normal but not high enough for a diabetes diagnosis. The study will last for three months, during which participants will either take a dietary supplement or a placebo. Five groups will be studied, including placebo groups. Blood tests will assess glucose and lipid metabolism parameters, adipokines, and liver and kidney function. Liver stiffness and fat content will also be measured using elastography. Additionally, body composition will be assessed, and participants' psychological state, quality of life, eating habits and sports habits will be evaluated using questionnaires. ### Conditions Module **Conditions:** - PreDiabetes **Keywords:** - Prediabetes - Dietary supplements ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Corresponding to dietary supplement groups B and C **Intervention Names:** - Other: Placebo group 1: Placebo capsules corresponding to DiaPhyt® Formula 3.0/Berberin Phytoactive Gold **Label:** Placebo group 1 **Type:** PLACEBO_COMPARATOR #### Arm Group 2 **Description:** Corresponding to dietary supplement A **Intervention Names:** - Other: Placebo group 2: Placebo powder corresponding to Wasabi leaf powder **Label:** Placebo group 2 **Type:** PLACEBO_COMPARATOR #### Arm Group 3 **Description:** Wasabi leaf powder **Intervention Names:** - Dietary Supplement: Dietary supplement A: Wasabi leaf powder (product of BIOGENA GmbH & Co KG) **Label:** Dietary supplement group A **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** Berberin Phytoactive Gold **Intervention Names:** - Dietary Supplement: Dietary supplement B: Berberin Phytoactive Gold (product of BIOGENA GmbH & Co KG) **Label:** Dietary supplement group B **Type:** PLACEBO_COMPARATOR #### Arm Group 5 **Description:** DiaPhyt® Formula 3.0 **Intervention Names:** - Dietary Supplement: Dietary supplement C: DiaPhyt® Formula 3.0 (product of BIOGENA GmbH & Co KG) **Label:** Dietary supplement group C **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Dietary supplement group A **Description:** To be taken according to the information in the study protocol/patient information leaflet. **Name:** Dietary supplement A: Wasabi leaf powder (product of BIOGENA GmbH & Co KG) **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - Dietary supplement group B **Description:** To be taken according to the information in the study protocol/patient information leaflet. **Name:** Dietary supplement B: Berberin Phytoactive Gold (product of BIOGENA GmbH & Co KG) **Type:** DIETARY_SUPPLEMENT #### Intervention 3 **Arm Group Labels:** - Dietary supplement group C **Description:** To be taken according to the information in the study protocol/patient information leaflet. **Name:** Dietary supplement C: DiaPhyt® Formula 3.0 (product of BIOGENA GmbH & Co KG) **Type:** DIETARY_SUPPLEMENT #### Intervention 4 **Arm Group Labels:** - Placebo group 1 **Description:** To be taken according to the information in the study protocol/patient information leaflet. **Name:** Placebo group 1: Placebo capsules corresponding to DiaPhyt® Formula 3.0/Berberin Phytoactive Gold **Type:** OTHER #### Intervention 5 **Arm Group Labels:** - Placebo group 2 **Description:** To be taken according to the information in the study protocol/patient information leaflet. **Name:** Placebo group 2: Placebo powder corresponding to Wasabi leaf powder **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** time in range measured with continuous glucose monitoring system **Measure:** changes in the time in range **Time Frame:** 2 weeks at baseline before start of the dietary supplement, 2 weeks during the last 2 weeks of the 3 month dietary supplement ingestion phase #### Secondary Outcomes **Description:** HbA1c (glycated haemoglobin) values **Measure:** changes in HbA1c values **Time Frame:** baseline, after 3 months **Description:** fasting glucose concentration **Measure:** changes in fasting glucose concentration **Time Frame:** baseline, after 3 months **Description:** fasting insulin concentration **Measure:** changes in fasting insulin concentration **Time Frame:** baseline, after 3 months **Description:** fasting c-peptide concentration **Measure:** changes in fasting c-peptide concentration **Time Frame:** baseline, after 3 months **Description:** HOMA-IR calculated as fasting insulin level (micro-units per milliliter) multiplied by the fasting blood glucose level (milligrams per deciliter), dividing the result by 405 **Measure:** changes in HOMA-IR **Time Frame:** baseline, after 3 months **Description:** HDL, LDL, triglycerides, total cholesterol, apolipoprotein B, chylomicrons **Measure:** changes in parameters of lipid metabolism **Time Frame:** baseline, after 3 months **Description:** hepatic fat content **Measure:** changes in the hepatic fat content **Time Frame:** baseline, after 3 months **Description:** hepatic fibrosis amount **Measure:** changes in the hepatic fibrosis amount **Time Frame:** baseline, after 3 months **Description:** GGT (gamma-glutamyltransferase), GOT (AST, aspartate transaminase), GPT (ALT, alanine transaminase), alkaline phosphatase **Measure:** changes in parameters of hepatic function **Time Frame:** baseline, after 3 months **Description:** bilirubin **Measure:** changes in bilirubin concentrations **Time Frame:** baseline, after 3 months **Description:** weight **Measure:** changes in the weight **Time Frame:** baseline, after 3 months **Description:** BMI calculated as weight in kilograms divided by the square of height in meters **Measure:** changes in the BMI **Time Frame:** baseline, after 3 months **Description:** fat free mass, fat mass **Measure:** changes in the anthropometric parameters **Time Frame:** baseline, after 3 months **Description:** adiponectin, leptin **Measure:** changes in adipokine levels **Time Frame:** baseline, after 3 months **Description:** depressive, anxiety and stress-related symptoms assessed using the Depression-Anxiety-Stress Scale **Measure:** changes in depressive, anxiety and stress-related symptoms **Time Frame:** baseline, after 3 months **Description:** quality of life assessed using the World Health Organization Quality of Life (WHOQOL-BREF) questionnaire **Measure:** changes in quality of life **Time Frame:** baseline, after 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * willingness and ability to provide written informed consent and comply with all study requirements, * age between 40 and 80 years * prediabetes with a HbA1c level between 5,7-6,4% * no antidiabetic treatment prior to the inclusion in the study * BMI between 25 and 35 kg/m2 * fasting glucose of 100-125mg/dl * in the case of women of childbearing potential, providing a negative pregnancy test at inclusion and once a month until the end of the study Exclusion Criteria: * failure to provide written informed consent and/or failure to comply with the study requirements * age \<40 years * HbA1c outside of the set range * significant impairments of hepatic and/or renal function * clinically significant abnormalities in medical history, routine laboratory screening, or in physical examination * allergies against any of the components of the dietary supplements or the placebo * type 1 diabetes mellitus, latent autoimmune diabetes in adults, maturity-onset diabetes of the young, gestational diabetes * pregnancy, lactation * concurrent treatment with any antidiabetic drug * concurrent treatment with drugs/dietary supplements that have proven interactions with dietary supplements included in our study **Maximum Age:** 80 Years **Minimum Age:** 40 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** michael.leutner@meduniwien.ac.at **Name:** Michael Leutner **Phone:** 0140400 **Phone Ext:** 20690 **Role:** CONTACT #### Locations **Location 1:** **City:** Vienna **Contacts:** ***Contact 1:*** - **Email:** michael.leutner@meduniwien.ac.at - **Name:** Michael Leutner, Priv.Doz. Dr.med.univ. - **Phone:** 0140400 - **Phone Ext:** 20690 - **Role:** CONTACT ***Contact 2:*** - **Name:** Dorota Sluková, Dr.med.univ. - **Role:** SUB_INVESTIGATOR **Country:** Austria **Facility:** Medical University of Vienna **Status:** RECRUITING **Zip:** 1090 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003920 - Term: Diabetes Mellitus - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases - ID: D000006943 - Term: Hyperglycemia ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M14117 - Name: Prediabetic State - Relevance: HIGH - As Found: Prediabetes - ID: M20295 - Name: Glucose Intolerance - Relevance: HIGH - As Found: Prediabetes - ID: M7115 - Name: Diabetes Mellitus - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M9994 - Name: Hyperglycemia - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011236 - Term: Prediabetic State - ID: D000018149 - Term: Glucose Intolerance ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437925 **Brief Title:** Effects of Probiotic Ayran on Gingivitis **Official Title:** Effects of the Use of Probiotics Ayran on Gingival Inflammation: An Experimental Gingivitis Study #### Organization Study ID Info **ID:** Cukurova University-1 #### Organization **Class:** OTHER **Full Name:** Cukurova University ### Status Module #### Completion Date **Date:** 2023-06-15 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-29 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-04-15 **Type:** ACTUAL #### Start Date **Date:** 2023-01-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Cukurova University #### Responsible Party **Investigator Affiliation:** Cukurova University **Investigator Full Name:** Cenk Haytac **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Objectives: This study investigates the effects of daily consumption of probiotic ayran drink on gingival inflammation and the development of experimental gingivitis. Methods: A total of 54volunteer students were included in the present randomized, double-blind, placebo-controlled trial.The participants were divided randomly into two groups; The Control group consisted of 27 participants who consumed placebo ayran, while the 27 participants of the Test group consumed probiotic ayran (containing Lactobacillus acidophilus and Bifidobacterium bifidum) for 42 days twice a day.After 42 days, mechanical plaque control was interrupted for 5 days. The clinical parameters of gingivitis; Plaque index (PI), gingival index (GI), probing bleeding (BOP), probing depth (PPD) were recorded at baseline, day 42 (beginning of experimental gingivitis) and day 47 (the end of experimental gingivitis). At the same time points, gingival crevicular fluid had been collected for analysis of matrix metalloproteinase - 8 (MMP-8). **Detailed Description:** The most used and studied probiotics in the periodontal literature are lactobacillus and bifidobacterium. The current study aims to observe the effects of daily ayran consumption containing a probiotic combination of Lactobacillus acidophilus and Bifidobacterium bifidum on plaque development and gingival inflammation in an experimental gingivitis model of healthy individuals. The null hypothesis of this study using of probiotics has no additional benefit for periodontal health. This study evaluates the effects of daily consumption of ayran containing a probiotic combination of Lactobacillus Acidophilus and Bifidobacterium Bifidum on plaque development and gingival status in healthy individuals with experimental gingivitis. ### Conditions Module **Conditions:** - Gingivitis - Probiotics - Inflamed Gums ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 54 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The participants in this experimental group will use probiotic containing ayran for 42 days and then will be subjected to 5 days of experimental gingivitis. **Intervention Names:** - Dietary Supplement: probiotic ayran drink **Label:** Probiotic ayran drink **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The participants in this control group will use control ayran without probiotics for 42 days and then will be subjected to 5 days of experimental gingivitis. **Intervention Names:** - Dietary Supplement: Placebo ayran drink **Label:** Placebo ayran drink **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Probiotic ayran drink **Description:** The test group has received probiotic ayran drink for 6 weeks **Name:** probiotic ayran drink **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - Placebo ayran drink **Description:** The control group has received placebo ayran drink for 6 weeks **Name:** Placebo ayran drink **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** PI was scored from 0 to 5 according to the color change obtained with the Mira-2 solution **Measure:** Plaque index **Time Frame:** Plaque index will be recorded at baseline, at day 42 and 47 **Description:** GI is graded by visual assessment and mechanical stimulation of the gingival tissues, scoring the gingival condition according to the criteria **Measure:** Gingival index **Time Frame:** Gingival index will be recorded at baseline, at day 42 and 47 **Description:** The probing bleeding (BOP) index was determined by the presence/absence of bleeding ≈30 seconds after probing **Measure:** Bleeding on probing **Time Frame:** BOP will be recorded at baseline, at day 42 and 47 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Systemic healthy * Subjects with gingivitis defined as a BOP sites ≥ 10% and PD ≤ 3 mm * No radiographic bone loss * Non-smoking participants Exclusion Criteria: * History of using antibiotics or anti-inflammatory drugs or probiotic preparations or food supplements in the last 6 months, * Undergoing orthodontic treatment, * Active carious lesions * Mouth breathing * History of allergy for milk or fermented milk products. * Taking medications affecting the gingiva and/or oral mucosa **Healthy Volunteers:** True **Maximum Age:** 25 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Adana **Country:** Turkey **Facility:** Cukurova University Faculty of Dentistry #### Overall Officials **Official 1:** **Affiliation:** Professor Doctor **Name:** Cenk Haytac, phd **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** The data will be shared upon request **Description:** The data will be shared upon request **Info Types:** - STUDY_PROTOCOL **IPD Sharing:** YES **Time Frame:** The data is ready and can be shared for two years ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007239 - Term: Infections - ID: D000005882 - Term: Gingival Diseases - ID: D000010510 - Term: Periodontal Diseases - ID: D000009059 - Term: Mouth Diseases - ID: D000009057 - Term: Stomatognathic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M9003 - Name: Gingivitis - Relevance: HIGH - As Found: Gingivitis - ID: M10293 - Name: Inflammation - Relevance: LOW - As Found: Unknown - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M8994 - Name: Gingival Diseases - Relevance: LOW - As Found: Unknown - ID: M13419 - Name: Periodontal Diseases - Relevance: LOW - As Found: Unknown - ID: M12019 - Name: Mouth Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005891 - Term: Gingivitis ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437912 **Brief Title:** Effectiveness of Botulinum Toxin A in Preventing Scar Formation and Initial Exploration of "Optimal Concentration" **Official Title:** Effectiveness of Botulinum Toxin A in Preventing Scar Formation and Initial Exploration of "Optimal #### Organization Study ID Info **ID:** MR-37-23-008382 #### Organization **Class:** OTHER **Full Name:** Dezhou Hospital Qilu Hospital of Shandong University ### Status Module #### Completion Date **Date:** 2024-03-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-27 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-10-10 **Type:** ACTUAL #### Start Date **Date:** 2023-03-23 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Dezhou Hospital Qilu Hospital of Shandong University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Each year, millions of burn, trauma, or surgical patients worldwide suffer from scarring that severely affects their quality of life and social functioning. In order to prevent and treat diseases related to abnormal scar hyperplasia, clinicians and researchers have adopted various methods, such as scar grinding, surgical resection, drug injection in scar tissue, cryotherapy, laser and so on. However, these methods can not effectively inhibit the abnormal proliferation of scars and improve the adverse effects of existing scars on patients. To date, there is no accepted gold standard for the effective treatment and improvement of abnormal scar tissue. **Detailed Description:** Through a large number of literature review and preliminary experiments, we summarized and found the following problems: a. The latest research on prevention of scar formation by botulinum toxin type A is only aimed at surgical wounds from the wound type, and there is no research on the scar prevention effect of trauma wounds. b. From the point of view of the study site, there is no study on the effect of scar prevention only on the head, neck, chest and other parts of the body. c. For the research results of botulinum toxin type A in the prevention of scarring, the current research focuses on the effectiveness of botulinum toxin type A at a certain concentration, and does not compare the effects of botulinum toxin type A at various concentrations.Therefore, in order to explore the "optimal concentration" of botulinum toxin type A to prevent scar formation; To explore the effect of botulinum toxin A on scar prevention of traumatic wounds and surgical incisions. To explore the effect of botulinum toxin A on scar prevention in other parts of the body in addition to effective prevention of head, neck and chest scar, We intend to focus on the effectiveness and "optimal concentration" of botulinum toxin type A to prevent scarring, to determine the effect of this means on scar prevention, to provide new ideas for botul ### Conditions Module **Conditions:** - Scar **Keywords:** - scar prevention - botulinum toxin type A ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 50 **Type:** ACTUAL **Phases:** - EARLY_PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Botulinum toxin type A (BTXA) was injected into both sides of the knife edge immediately after operation, the injection volume was 1U/0.1ml per point, the interval between the injection points on the same side of the knife edge was 1cm, and the distance of each injection point from the knife edge was 0.5cm. It was injected only once immediately after operation. **Intervention Names:** - Drug: Botulinum toxin type A **Label:** Injection 1 U / 0.1ml BTXA **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Botulinum toxin type A (BTXA) was injected into both sides of the knife edge immediately after operation, the injection volume was 2.5U/0.1ml per point, the interval between the injection points on the same side of the knife edge was 1cm, and the distance of each injection point from the knife edge was 0.5cm. It was injected only once immediately after operation. **Intervention Names:** - Drug: Botulinum toxin type A **Label:** Injection 2.5U / 0.1ml BTXA **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Botulinum toxin type A (BTXA) was injected into both sides of the knife edge immediately after operation, the injection volume was 5U/0.1ml per point, the interval between the injection points on the same side of the knife edge was 1cm, and the distance of each injection point from the knife edge was 0.5cm. It was injected only once immediately after operation. **Intervention Names:** - Drug: Botulinum toxin type A **Label:** Injection 5U / 0.1ml BTXA **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** Injection 0.9%Nacl Immediately after operation 0.9%Nacl was injected on both sides of the knife edge, the injection volume per point was 0.1ml, the interval between each injection point on the same side of the knife edge was 1cm, and each injection point was away from the knife edge 0.5cm. It was injected only once immediately after operation. **Intervention Names:** - Drug: Botulinum toxin type A **Label:** Injection 0.9%Nacl **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Injection 0.9%Nacl - Injection 1 U / 0.1ml BTXA - Injection 2.5U / 0.1ml BTXA - Injection 5U / 0.1ml BTXA **Description:** Eligible patients were randomly assigned to the experimental group and the control group. Patients in the experimental group will be randomized to receive injections of 1 U,2.5 U, and 5 U botulinum toxin type A,Patients in the control group received an injection of 0.9% Nacl **Name:** Botulinum toxin type A **Other Names:** - 0.9%Nacl **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The mSBSES included width (0 = scar enlargement prominent and \> 2 mm, 1 = presence of scar enlargement ≤ 2 mm, 2 = no scar widening), height (0 = marked scar uplift, 1 = presence of scar uplift, 2 = no scar uplift), color (0 = scar significantly redder than surrounding, 1 = scar redder than surrounding and 2 = scar the same color as or lighter than surrounding skin), The visibility of the incision line (0 = marked incision line, 1 = presence of incision line, 2 = absence of incision line) was objectively assessed separately in non-chronological order, with overall scar values varying from 0 to 8, with higher scores indicating better scar appearance. **Measure:** The modified Stony Brook Scar Evaluation Scale **Time Frame:** Postoperative 7 days, 15 days, 1 month, 3 months, 6 months #### Secondary Outcomes **Description:** Patient Satisfaction Scale (1=dissatisfied, 2=slightly satisfied, 3=satisfied, and 4=very satisfied). They were also asked to assess their levels of pain (0=no pain, 1=mild, 2=moderate, 3=severe, 4=very painful) and pruritus (0=no itch, 1=mild, 2=moderate, 3=severe, 4=very itchy) at the incision site. The totals varied between 0-8, where lower scores indicated more positive subjective patient perceptions. **Measure:** Patient satisfaction and perceptions represented secondary outcome measures in this study **Time Frame:** Postoperative 7 days, 15 days, 1 month, 3 months, 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Patients with emergency trauma and skin swellings, with clear consciousness, no mental retardation or cognitive difficulties, agree to participate in this study, 12≤ age ≤ 65 years old Exclusion Criteria: Allergic to botulinum toxin type A;Pregnant, lactating women, patients who plan to get pregnant in the near future;Patients taking retinoic acid, synthetic steroids, amino glycosides antibiotics, calcium channel blockers, cyclosporine and cholinesterase inhibitors; 4 Neuromuscular diseases: such as myasthenia gravis, Lambert-Eaton syndrome, multiple sclerosis;5. Patients with cardiovascular diseases, kidney diseases, liver and other basic diseases; 6 Patients with infection at the injection site; 7 Expect unrealistic patients. **Healthy Volunteers:** True **Maximum Age:** 65 Years **Minimum Age:** 12 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Dezhou **Country:** China **Facility:** Qilu Hospital of Shandong University Dezhou Hospital **State:** Shandong ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005355 - Term: Fibrosis - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M6160 - Name: Cicatrix - Relevance: HIGH - As Found: Scar - ID: M8485 - Name: Fibrosis - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002921 - Term: Cicatrix ### Intervention Browse Module - Ancestors - ID: D000065087 - Term: Acetylcholine Release Inhibitors - ID: D000049990 - Term: Membrane Transport Modulators - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000018678 - Term: Cholinergic Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000009465 - Term: Neuromuscular Agents - ID: D000018373 - Term: Peripheral Nervous System Agents ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: VaDiAg - Name: Vasodilator Agents ### Intervention Browse Module - Browse Leaves - ID: M5183 - Name: Botulinum Toxins - Relevance: HIGH - As Found: Light - ID: M21257 - Name: Botulinum Toxins, Type A - Relevance: HIGH - As Found: Pregnant - ID: M250193 - Name: abobotulinumtoxinA - Relevance: HIGH - As Found: Pregnant - ID: M3473 - Name: Acetylcholine - Relevance: LOW - As Found: Unknown - ID: M20758 - Name: Cholinergic Agents - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000001905 - Term: Botulinum Toxins - ID: D000019274 - Term: Botulinum Toxins, Type A - ID: C000542869 - Term: abobotulinumtoxinA ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437899 **Acronym:** LA vs SA **Brief Title:** Evaluation of Efficacy and Patient Satisfaction of Local Anaesthesia Versus Sedoanalgesia for Botox (R) Injection in the Urinary Bladder for the Treatment of Idiopathic Overactive Bladder **Official Title:** Evaluation of Efficacy and Patient Satisfaction Using Local Anaesthesia Versus Sedoanalgesia for Intradetrusor Botulinum-Toxin A Injection for the Treatment of Idiopathic Overactive Bladder: a Randomized Controlled Non-inferiority Trial #### Organization Study ID Info **ID:** 21346 #### Organization **Class:** OTHER **Full Name:** Hospital LKH Hochsteiermark - Leoben #### Secondary ID Infos **Domain:** AUB - Arbeitsgemeinschaft für Urogynäkologie Österreich **ID:** AUB **Type:** OTHER ### Status Module #### Completion Date **Date:** 2027-09 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-26 **Overall Status:** ENROLLING_BY_INVITATION #### Primary Completion Date **Date:** 2026-09 **Type:** ESTIMATED #### Start Date **Date:** 2023-09-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-03-30 **Study First Submit QC Date:** 2024-05-26 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Hospital LKH Hochsteiermark - Leoben #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Patients with symptoms of overactive bladder suffer from frequent micturition, urinary incontinence and recurrent urinary tract infections. Intravesical injections with botulinum toxin A can be used as a second-line therapy for this purpose. Intravesical botulinum toxin A injections can be performed under general anesthesia, regional anesthesia, sedoanalgesia and local anesthesia. Which form of anesthesia is used varies greatly from region to region. As these patients are often elderly and morbid, the lowest-risk and least stressful anesthesia method should be used. The lowest-risk anesthesia method that can be used is local anesthesia. Currently, there are no guidelines that describe the use of standardized protocols for local anesthesia. The aim of this study is to show that the use of local anesthesia in this context is not inferior to the use of sedoanalgesia. All patients with overactive bladder symptoms who fulfill the inclusion criteria and present at the Urogynecology Outpatient Clinic of the Department of Gynecology and Obstetrics at the LKH Hochsteiermark in Leoben within 24 months will be invited to participate in the study. The main outcome measure is pain, secondary outcome measures are quality of life, patient satisfaction, incontinence score, operation time and length of stay in the recovery room, acceptance of repeating the procedure under local anesthesia, satisfaction with the type of anesthesia method, side effects/complications and duration of inpatient stay. The study will be randomized into 2 arms (local anesthesia/sedoanalgesia) with a 1:1 ratio to carry out the intravesical injection with botulinum toxin A. **Detailed Description:** Urinary urgency symptoms with frequent micturition, urinary incontinence, nocturia and recurrent urinary tract infections are typical complaints of women with symptoms of an overactive bladder. The level of suffering is usually very high. Social withdrawal, depressive moods, frequent antibiotic use and financial burdens due to the increased need for incontinence products can be the result. In accordance with the guideline-based treatment of idiopathic overactive bladder, intravesical injection of botulinum toxin A can be offered after unsuccessful conservative first-line and second-line treatment. Intravesical injection of botulinum toxin A has been approved for the treatment of idiopathic overactive bladder in Austria since 2013. Botulinum toxin A is a registered drug in Austria and is used for injection into the detrusor with 100IE according to its approval indication. Intravesical botulinum toxin A injections can be performed under general anesthesia, regional anesthesia, sedoanalgesia and local anesthesia. Which form of anesthesia is used varies greatly from region to region. The effectiveness of botulinum toxin A is limited in time. Injections are repeated on average after 6-12 months. Patients are often older and often have comorbidities. Due to this and the potential need for repeated applications, the procedure should be performed under general and regional anesthesia. The use of local anesthesia, as one of the anesthesia methods mentioned, is considered to be very low-risk and the least stressful overall. Comparing the use of local anesthesia with the use of sedoanalgesia to perform the botulinum toxin A injection is equivalent to comparing two guideline-compliant standard treatments. The confirmation of our hypothesis, namely that performing the procedure under local anesthesia is equivalent to performing it under sedoanalgesia (non-inferiority study), could serve to optimize the treatment of overactive bladder patients and contribute to an increase in the level of health protection by strengthening the role of local anesthesia in the context of this procedure as an efficient option with the elimination of all anesthetic risks and as a first-choice procedure. All patients with overactive bladder symptoms who fulfill the inclusion criteria and present at the Urogynecology Outpatient Clinic of the Department of Gynecology and Obstetrics at the LKH Hochsteiermark in Leoben within 24 months will be invited to participate in the study. The following examinations are carried out on all patients before inclusion, in accordance with the examination standard of our department: * Medical history: age, micturition frequency day/night, urinary leakage, sexuality, amount drunk, frequency of urinary tract infections, previous treatments for incontinence, parity, secondary diseases (diabetes mellitus, obesity, arterial hypertension, central nervous diseases, etc), previous gynecological operations, medication * Urogynecological examination * Urinalysis (midstream urine) * Urodynamics with stress test * Micturition protocol (will be scanned) * Standardized questionnaires to assess incontinence symptoms and quality of life This is an open prospective randomized controlled non-inferiority study. Patients participating in the study will be randomized into 2 arms (local anesthesia/sedoanalgesia) with a 1:1 ratio. Randomization will be done electronically (www.randomizer.at). The sample design was calculated based on a non-inferiority study with pain score evaluation as the primary endpoint. A sample size of 39 per group, including expected drop-outs (approximately 3 per group) results in a required number of participants of 84. ### Conditions Module **Conditions:** - Overactive Bladder **Keywords:** - overactive bladder - botulinum toxin A - local anaesthesia ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 84 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: intravesical botulinum toxin A injection unter local anaesthesia **Label:** local anaesthesia **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Intervention Names:** - Drug: intravesical botulinum toxin A injection unter local anaesthesia **Label:** sedoanalagesia **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - local anaesthesia - sedoanalagesia **Description:** Arm1: Botulinum toxin A injection under local anesthesia according to standard protocol: Retrograde filling of the empty urinary bladder with a 1:1 mixture of 50 ml lidocaine 1% mixed with 50 ml sodium bicarbonate 8.4%, leave the local anesthetic mixture in the bladder for 15 minutes. Transurethral, intravesical injection of a total of 100IE botulinum toxin A dissolved in 10 ml NaCl 0.9% into the detrusor at 10 points using a rigid 70 degree cystoscope Arm 2: botulinum toxin A injection in sedoanalgesia according to the anesthesia standard protocol: Intravenous administration of remifentanil (0.05-0.15µg/kg/min) and propofol. Transurethral, intravesical injection of a total of 100IE botulinum toxin A dissolved in 10ml NaCl 0.9% into the detrusor. **Name:** intravesical botulinum toxin A injection unter local anaesthesia **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The numeric rating scale is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and ten meaning "the worst pain imaginable". **Measure:** pain assessed by numeric rating scale **Time Frame:** twentyfour hours #### Secondary Outcomes **Description:** The postoperative anaesthesia questionnaire is a tool used to assess a patient's experience with anesthesia following surgery. It aims to gather information about the patient's perceptions of anesthesia-related outcomes and any adverse effects they may have experienced. It collects direct feedback from patients about their subjective experiences, including satisfaction and any discomfort or complications. Common sections and questions are about preoperative information, intraoperative experience, postoperative symptoms and overall satisfaction. Questions are answered with "yes" or "no". **Measure:** patient satisfaction assessed with postoperative anaesthesia questionnaire **Time Frame:** twentyfour hours **Description:** The King's Health Questionnaire is a disease specific, self-administered questionnaire designed to assess the impact of urinary incontinence on quality of life in women. The questions in this questionnaire are to be answered using a 0-4 scale, with zero meaning "not applicable" and four meaning "very accurate". **Measure:** quality of life assessed with King's Health Questionnaire **Time Frame:** three and twelve months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Women with a minimum age of 18 years; no maximum age * Unsuccessful conservative first and second-line treatment of OAB (defined as: completed pelvic floor/bladder training, local estrogenization of the vagina, at least one anticholinergic or ß3-mimetic oral therapy) * Good German language skills Exclusion Criteria: * Pregnant women, breastfeeding women (no indication for approval) * Women unable to give informed consent * Refusal to participate in the study **Gender Based:** True **Gender Description:** All individuals with anatomical organs of a woman **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Leoben **Country:** Austria **Facility:** LKH Hochsteiermark **Zip:** 8700 ### IPD Sharing Statement Module **Description:** The important and interesting data are published in a journal as part of the publication. **IPD Sharing:** NO ### References Module #### References **Citation:** Subramanian B, Shastri N, Aziz L, Gopinath R, Karlekar A, Mehta Y, Sharma A, Bapat JS, Jain P, Jayant A, Samra T, Perera A, Agarwal A, Shetty V, Bhatnagar S, Pandya ST, Jain P. ASSIST - Patient satisfaction survey in postoperative pain management from Indian subcontinent. J Anaesthesiol Clin Pharmacol. 2017 Jan-Mar;33(1):40-47. doi: 10.4103/joacp.JOACP_245_16. **PMID:** 28413271 **Citation:** Smith I, Avramov MN, White PF. A comparison of propofol and remifentanil during monitored anesthesia care. J Clin Anesth. 1997 Mar;9(2):148-54. doi: 10.1016/S0952-8180(96)00240-1. **PMID:** 9075041 **Citation:** Barba M, Lazar T, Cola A, Marino G, Manodoro S, Frigerio M. Learning Curve of Botulinum Toxin Bladder Injection for the Treatment of Refractory Overactive Bladder. Int J Womens Health. 2022 Jan 4;14:1-7. doi: 10.2147/IJWH.S345454. eCollection 2022. **PMID:** 35018123 **Citation:** Schurch B, Reitz A, Tenti G. Electromotive drug administration of lidocaine to anesthetize the bladder before botulinum-A toxin injections into the detrusor. Spinal Cord. 2004 Jun;42(6):338-41. doi: 10.1038/sj.sc.3101593. **PMID:** 15007374 **Citation:** Faure Walker N, Macpherson F, Tasleem A, Rampal T. Interventions to improve tolerability of local anesthetic intradetrusor Botulinum toxin injections: A systematic review. Neurourol Urodyn. 2023 Jan;42(1):23-32. doi: 10.1002/nau.25061. Epub 2022 Oct 23. **PMID:** 36378811 **Citation:** Cox L, Cameron AP. OnabotulinumtoxinA for the treatment of overactive bladder. Res Rep Urol. 2014 Jul 21;6:79-89. doi: 10.2147/RRU.S43125. eCollection 2014. **PMID:** 25157339 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001745 - Term: Urinary Bladder Diseases - ID: D000014570 - Term: Urologic Diseases - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000059411 - Term: Lower Urinary Tract Symptoms - ID: D000020924 - Term: Urological Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M27167 - Name: Urinary Bladder, Overactive - Relevance: HIGH - As Found: Overactive Bladder - ID: M5026 - Name: Urinary Bladder Diseases - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M29464 - Name: Lower Urinary Tract Symptoms - Relevance: LOW - As Found: Unknown - ID: M22659 - Name: Urological Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000053201 - Term: Urinary Bladder, Overactive ### Intervention Browse Module - Ancestors - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000065087 - Term: Acetylcholine Release Inhibitors - ID: D000049990 - Term: Membrane Transport Modulators - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000018678 - Term: Cholinergic Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000009465 - Term: Neuromuscular Agents - ID: D000018373 - Term: Peripheral Nervous System Agents ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: AnArAg - Name: Anti-Arrhythmia Agents - Abbrev: ChanBlk - Name: Channel Blockers - Abbrev: Analg - Name: Analgesics - Abbrev: VaDiAg - Name: Vasodilator Agents ### Intervention Browse Module - Browse Leaves - ID: M5183 - Name: Botulinum Toxins - Relevance: HIGH - As Found: Light - ID: M21257 - Name: Botulinum Toxins, Type A - Relevance: HIGH - As Found: Neurocognitive - ID: M250193 - Name: abobotulinumtoxinA - Relevance: HIGH - As Found: Neurocognitive - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M11014 - Name: Lidocaine - Relevance: LOW - As Found: Unknown - ID: M18307 - Name: Propofol - Relevance: LOW - As Found: Unknown - ID: M4109 - Name: Anesthetics, Local - Relevance: LOW - As Found: Unknown - ID: M1696 - Name: Remifentanil - Relevance: LOW - As Found: Unknown - ID: M3473 - Name: Acetylcholine - Relevance: LOW - As Found: Unknown - ID: M20758 - Name: Cholinergic Agents - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000001905 - Term: Botulinum Toxins - ID: D000019274 - Term: Botulinum Toxins, Type A - ID: C000542869 - Term: abobotulinumtoxinA ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437886 **Brief Title:** High-dose Opioid Versus Opioid-sparing Anaesthesia in Cardiac Surgery **Official Title:** Postoperative Recovery After Cardiac Surgery A Randomised Controlled Trial of High-dose Opioid Versus Opioid-sparing Anaesthesia #### Organization Study ID Info **ID:** 2024-2323 #### Organization **Class:** OTHER **Full Name:** Chinese Academy of Medical Sciences, Fuwai Hospital ### Status Module #### Completion Date **Date:** 2024-07-22 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-29 **Overall Status:** ENROLLING_BY_INVITATION #### Primary Completion Date **Date:** 2024-07-22 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-22 **Type:** ACTUAL **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Chinese Academy of Medical Sciences, Fuwai Hospital #### Responsible Party **Investigator Affiliation:** Chinese Academy of Medical Sciences, Fuwai Hospital **Investigator Full Name:** Yan Fuxia **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** BACKGROUND In cardiac surgery, high-dose opioids contributes to adverse events associated with poor postoperative outcomes. There is growing evidence that nerve block-based opioid-sparing protocols may reduce perioperative opioid consumption with equally analgesia management and consequently improve patient's postoperative recovery. OBJECTIVE To determine whether opioid-sparing anaesthesia based on pecto-intercostal fascial block and rectus sheath block (PIFB and RSB) could improve early postoperative recovery after cardiac surgery. DESIGN A randomised controlled trial. SETTING A tertiary hospital. PATIENTS Eighty 45-70 years old patients undergoing cardiac surgery were enrolled. Key exclusion criteria included extubation failure within 24 hours postoperatively, contraindication to interventions or drugs and a history of chronic pain or chronic opioid use. INTERVENTIONS Eligible patients were randomised at a 1 : 1 ratio to receive either PIFB and RSB-based opioid-sapring anaesthesia (intervention group) or opioid-based anaesthesia (control group). MAIN OUTCOME MEASURES The primary outcome was the global score of the 15-item Quality of Recovery (QoR-15) questionnaire at 24 h after surgery. Secondary outcomes included recovery-related time, postoperative pain score and rescue analgesia, health-related quality of life, the incidence of postoperative adeverse events and chronic pain. ### Conditions Module **Conditions:** - Cardiac Surgery Patients ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 80 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Other: pecto-intercostal fascial block and rectus sheath block **Label:** pecto-intercostal fascial block and rectus sheath block-based opioid-sparing anesthesia **Type:** EXPERIMENTAL #### Arm Group 2 **Label:** high-dose opiod traditional anesthesia **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - pecto-intercostal fascial block and rectus sheath block-based opioid-sparing anesthesia **Description:** Bilateral PIFB and RSB was conducted after anesthetic induction in a supine position guided by ultrasound guidance. PIFB was conducted at the T2 to T5 levels under ultrasound guidance. The needle was inserted into the pecto-interfacial plane using an in-plane approach. Needle tip location was verified by ventral movement of the parietal pleura upon injection of 1-2 ml 0.9% saline. Each side received 20 ml 0.3% ropivacaine containing 2.5 mg dexamethasone. Bilateral RSB was conducted after the PIFB and the needle was inserted into the plane between the rectus abdominal muscle and its posterior sheath using an in-plane approach. Needle tip location was verified by ventral movement of the parietal pleura upon injection of 1-2 ml 0.9% saline. After verifying needle placement, 15 ml 0.3% ropivacaine containing 2.5 mg dexamethasone was delivered to each side. **Name:** pecto-intercostal fascial block and rectus sheath block **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Measure:** the global score of the 15-item Quality of Recovery (QoR-15) questionnaire **Time Frame:** at 24 hours postoperatively #### Secondary Outcomes **Description:** Postoperatvie pain was evaluated using an 11-point visual analogue scale (VAS) (0 = no pain, 10 = worst pain possible). **Measure:** QoR-15, postoperative pain assessment **Time Frame:** QoR-15 at 72 hours, postoperative pain assessment at 24 hours and 72 hours. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Male or female adult patients aged 45 to 70 years, awaiting elective cardiac surgery, and American Society of Anaesthesiologists physical status classes II or III were eligible. Exclusion Criteria: Patients with severe pulmonary, liver or renal dysfunction, contraindications to punctral or local anesthetic drugs, and inablity to communicate or refuse to enrollment. **Maximum Age:** 70 Years **Minimum Age:** 45 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Beijing **Country:** China **Facility:** Fuwai hospital ### IPD Sharing Statement Module **Description:** Data availuable by sending email to corresponding authors **IPD Sharing:** NO ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: AnEm - Name: Antiemetics - Abbrev: Gast - Name: Gastrointestinal Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: Analg - Name: Analgesics ### Intervention Browse Module - Browse Leaves - ID: M7102 - Name: Dexamethasone - Relevance: LOW - As Found: Unknown - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M1700 - Name: Ropivacaine - Relevance: LOW - As Found: Unknown - ID: M235549 - Name: Dexamethasone acetate - Relevance: LOW - As Found: Unknown - ID: M4033 - Name: Analgesics, Opioid - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437873 **Brief Title:** Long-term Survival Outcomes of Total Thyroidectomy and Radioactive Iodine Therapy in Unilateral T3/T4 FTC **Official Title:** Long-term Survival Outcomes of Total Thyroidectomy and Radioactive Iodine Therapy in Unilateral T3/T4 Follicular Thyroid Carcinoma:A Retrospective Propensity Score-Matched Study #### Organization Study ID Info **ID:** DezhouH_2024_001 #### Organization **Class:** OTHER **Full Name:** Dezhou Hospital Qilu Hospital of Shandong University ### Status Module #### Completion Date **Date:** 2024-05-25 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-27 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2020-12-31 **Type:** ACTUAL #### Start Date **Date:** 2000-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-25 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Dezhou Hospital Qilu Hospital of Shandong University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study aims to thoroughly examine survival disparities in patients with T3 or T4 stage follicular thyroid carcinoma (FTC) as classified by the AJCC staging system. It compares outcomes between those who underwent total thyroidectomy (TT) and those who did not, and assesses the influence of radioactive iodine therapy (RAIT) on the survival of patients without TT. Utilizing the SEER database, a retrospective study identified patients diagnosed with T3 or T4 FTC, categorizing them into two cohorts: those treated with TT and those who were not (No-TT). The No-TT group was further analyzed to determine the impact of RAIT on patient survival. Propensity score matching (PSM) was applied to adjust for confounding variables. Survival analysis, including Kaplan-Meier survival curves and Landmark analysis, was conducted to evaluate the effects of surgical intervention and RAIT on overall survival (OS) and cancer-specific survival (CSS). ### Conditions Module **Conditions:** - Follicular Thyroid Cancer - SEER Database Analysis **Keywords:** - Retrospective analysis, follicular thyroid carcinoma, total thyroidectomy, long-term survival outcomes. ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 2957 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients with T3 or T4 stage follicular thyroid carcinoma who underwent total thyroidectomy **Intervention Names:** - Procedure: Total Thyroidectomy (TT) **Label:** Total Thyroidectomy (TT) Group #### Arm Group 2 **Description:** Patients with T3 or T4 stage follicular thyroid carcinoma who did not undergo total thyroidectomy. **Label:** No Total Thyroidectomy (No-TT) Group #### Arm Group 3 **Description:** Patients in the No-TT group who received radioactive iodine therapy. **Intervention Names:** - Radiation: Radioactive iodine treatment(RAIT) **Label:** Radioactive Iodine Therapy (RAIT) Group #### Arm Group 4 **Description:** Patients in the No-TT group who did not receive radioactive iodine therapy. **Label:** No Radioactive Iodine Therapy (No-RAIT) Group ### Interventions #### Intervention 1 **Arm Group Labels:** - Total Thyroidectomy (TT) Group **Description:** TT:Surgical removal of the entire thyroid gland. **Name:** Total Thyroidectomy (TT) **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Radioactive Iodine Therapy (RAIT) Group **Description:** RAIT:Administration of radioactive iodine to eliminate remaining thyroid tissue or cancer cells. **Name:** Radioactive iodine treatment(RAIT) **Type:** RADIATION ### Outcomes Module #### Primary Outcomes **Description:** Time from diagnosis until death from any cause. **Measure:** Overall Survival (OS) **Time Frame:** Up to 10 years post-diagnosis **Description:** Time from diagnosis to death specifically from follicular thyroid carcinoma. **Measure:** Cancer-Specific Survival (CSS) **Time Frame:** Up to 10 years post-diagnosis ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria:1.The primary site code C73.9, denoting the thyroid gland;2.The International Classification of Diseases for Oncology, Third Edition (ICD-O-3) histology types comprising 8330 (Follicular adenocarcinoma, NOS), 8331 (Follicular adenocarcinoma well differentiated), 8332 (Follicular adenocarcinoma trabecular), 8335 (Follicular carcinoma, minimally invasive), and 8339 (Follicular thyroid carcinoma (FTC), encapsulated angioinvasive). Exclusion Criteria:(1). Absence of T stage information or designation as T1, T2; (2). Missing surgery codes; (3). Cases not verified by histopathological analysis; (4). FTC not being the initial malignancy diagnosed in the patient; (5). Unknown survival duration or survival less than one month; (6). Presence of bilateral tumors. **Healthy Volunteers:** True **Maximum Age:** 85 Years **Minimum Age:** 5 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** The SEER database was established in 1973, serves as a public database and research resource developed by the National Cancer Institute (NCI) of the United States. It encompasses data covering approximately 30% of the U.S. population. The dataset for this retrospective study was obtained from the SEER Research Data, encompassing information from 17 registries as of November 2022, which includes cases recorded between the years 2000 and 2020. ### Contacts Locations Module #### Overall Officials **Official 1:** **Affiliation:** Qilu hospital of Shandong University Dezhou hospital **Name:** Tao Zhang, MD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Access Criteria:** Researchers seeking access to the IPD must submit a methodologically sound proposal. Requests should be directed to the principal investigator and will be evaluated on the basis of scientific merit and ethical considerations. **Description:** De-identified individual participant data (IPD) will be shared with researchers upon reasonable request. **Info Types:** - STUDY_PROTOCOL - SAP **IPD Sharing:** YES **Time Frame:** Data will be available beginning 6 months after publication of the main study results and will be accessible for a period of 5 years. ### References Module #### References **Citation:** Daniels GH. Follicular Thyroid Carcinoma: A Perspective. Thyroid. 2018 Oct;28(10):1229-1242. doi: 10.1089/thy.2018.0306. Epub 2018 Aug 21. No abstract available. **PMID:** 30039751 **Citation:** Barbesino G, Goldfarb M, Parangi S, Yang J, Ross DS, Daniels GH. Thyroid lobe ablation with radioactive iodine as an alternative to completion thyroidectomy after hemithyroidectomy in patients with follicular thyroid carcinoma: long-term follow-up. Thyroid. 2012 Apr;22(4):369-76. doi: 10.1089/thy.2011.0198. Epub 2012 Mar 2. **PMID:** 22385290 **Citation:** Bal C, Satapathy S, Tupalli A, Ballal S. Propensity Score Matched Outcome Analysis of Lobar Ablation Versus Completion Thyroidectomy in Low-Risk Differentiated Thyroid Cancer Patients: Median Follow-Up of 11 Years. Thyroid. 2022 Oct;32(10):1220-1228. doi: 10.1089/thy.2022.0234. Epub 2022 Sep 22. **PMID:** 35983596 **Citation:** Choi JB, Lee SG, Kim MJ, Kim TH, Ban EJ, Lee CR, Lee J, Kang SW, Jeong JJ, Nam KH, Chung WY, Park CS. Oncologic outcomes in patients with 1-cm to 4-cm differentiated thyroid carcinoma according to extent of thyroidectomy. Head Neck. 2019 Jan;41(1):56-63. doi: 10.1002/hed.25356. Epub 2018 Dec 10. **PMID:** 30536465 **Citation:** Sugino K, Nagahama M, Kitagawa W, Ohkuwa K, Uruno T, Matsuzu K, Suzuki A, Tomoda C, Hames KY, Akaishi J, Masaki C, Ito K. Risk Stratification of Pediatric Patients with Differentiated Thyroid Cancer: Is Total Thyroidectomy Necessary for Patients at Any Risk? Thyroid. 2020 Apr;30(4):548-556. doi: 10.1089/thy.2019.0231. Epub 2020 Mar 11. **PMID:** 31910105 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004700 - Term: Endocrine System Diseases - ID: D000009369 - Term: Neoplasms - ID: D000000230 - Term: Adenocarcinoma - ID: D000002277 - Term: Carcinoma - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M20409 - Name: Adenocarcinoma, Follicular - Relevance: HIGH - As Found: Follicular Thyroid Cancer - ID: M16718 - Name: Thyroid Diseases - Relevance: HIGH - As Found: Thyroid - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M16723 - Name: Thyroid Neoplasms - Relevance: LOW - As Found: Unknown - ID: M3585 - Name: Adenocarcinoma - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: T5650 - Name: Thyroid Cancer, Follicular - Relevance: HIGH - As Found: Follicular Thyroid Cancer ### Condition Browse Module - Meshes - ID: D000018263 - Term: Adenocarcinoma, Follicular - ID: D000013959 - Term: Thyroid Diseases ### Intervention Browse Module - Browse Branches - Abbrev: Micro - Name: Micronutrients - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M10488 - Name: Iodine - Relevance: LOW - As Found: Unknown - ID: M229695 - Name: Cadexomer iodine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437860 **Brief Title:** Nutritional Intervention for Sustaining Health (NURISH) Trial **Official Title:** Nutritional Intervention for Sustaining Health (NURISH) Trial: Examining the Effects of the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) on Cognitive Performance, Metabolic Health, and Nutrient Status. #### Organization Study ID Info **ID:** NURISH #### Organization **Class:** OTHER **Full Name:** University of Illinois at Urbana-Champaign ### Status Module #### Completion Date **Date:** 2027-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-24 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-03 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-24 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Illinois at Urbana-Champaign #### Responsible Party **Investigator Affiliation:** University of Illinois at Urbana-Champaign **Investigator Full Name:** Naiman Khan **Investigator Title:** Associate Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this clinical trial is to learn if increasing adherence to a Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet pattern improves brain and heart health relative to a healthy control diet in middle-aged adults.The main questions it aims to answer are: Does the MIND diet improve cognitive performance and heart health relative to a control diet? Researchers will compare the MIND diet group to a control (a healthy diet that does not match the MIND diet) to see if the MIND provides more benefit to health. Participants will: Consume one meal that follows the MIND diet or a control meal every day for 3 months Visit the lab before and after the 3 months of meals for tests. Keep a record of the food they eat during the study. **Detailed Description:** The purpose of this study is to understand how a healthy diet is related to thinking ability and heart health. Participants will be asked to consume a microwaveable study meal or prepackaged smoothie every day for 12 weeks. These meals will be delivered to participant homes using Daily Harvest meal delivery service. The study meals and smoothies will follow either a dietary pattern thought to improve brain and heart health (MIND), or a control diet, and will include foods commonly found in grocery stores. Participants will not know which diet they are assigned to (active or control). Participants will also be asked to follow simple dietary guidance on a healthy diet in addition to the meals provided. Participants will complete a series of online forms or surveys. Additionally, participants will come to 4 in-person laboratory visits to complete several computer-based tests of memory and attention while wearing an EEG cap. Participants will also be asked to complete an eye test, a heart rate and blood pressure assessment, a bone and body scan called DXA, and a blood draw at the beginning of the study and again at the end of the 12-week diet period. ### Conditions Module **Conditions:** - Cognitive Change - Metabolic Syndrome, Protection Against - Diet, Healthy **Keywords:** - Executive function - MIND - Dietary pattern ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** OTHER #### Enrollment Info **Count:** 72 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants in the active MIND diet group will be asked to consume one ready-to-eat meal per day from Daily Harvest® meal delivery service. The treatment meals will follow MIND diet guidelines and include leafy green vegetables, nuts, legumes, whole grains, berries, and extra virgin olive oil. **Intervention Names:** - Other: MIND Diet **Label:** MIND Diet **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants in the control diet group will be asked to consume one ready-to-eat meal per day from Daily Harvest® meal delivery service. The Control group will receive daily meals that are isocaloric with the active/experimental meals but will follow a general diet based on the average American diet and Dietary Guidelines for Americans (i.e., vegetables, fruits, nuts, whole grains, and unsaturated fats). **Intervention Names:** - Other: Control Diet **Label:** Control Diet **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - MIND Diet **Description:** Daily meals designed to increase adherence to the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) dietary pattern. **Name:** MIND Diet **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Control Diet **Description:** Daily meals designed to increase fruit, vegetable, and whole grain intake consistent with a healthy American diet. **Name:** Control Diet **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Changes in accuracy (%) between groups using a computerized flanker task. **Measure:** Attentional Accuracy **Time Frame:** 12 weeks (Baseline vs Follow-Up) **Description:** Changes in reaction time (ms) between groups using a computerized flanker task. **Measure:** Attentional Reaction Time **Time Frame:** 12 weeks (Baseline vs Follow-Up) **Description:** Changes in P3 event related potential amplitude (microvolts) between groups using a computerized flanker task. **Measure:** Attentional Resource Allocation **Time Frame:** 12 weeks (Baseline vs Follow-Up) **Description:** Changes in P3 event related potential latency (ms) between groups using a computerized flanker task. **Measure:** Attentional Processing Speed **Time Frame:** 12 weeks (Baseline vs Follow-Up) **Description:** Changes in fasting blood glucose concentration (mg/dL) between groups. **Measure:** Fasting Blood Glucose **Time Frame:** 12 weeks (Baseline vs Follow-Up) **Description:** Changes in fasting blood triglyceride concentration (mg/dL) between groups. **Measure:** Fasting Blood Triglycerides **Time Frame:** 12 weeks (Baseline vs Follow-Up) **Description:** Changes in fasting blood HDL concentration (mg/dL) between groups. **Measure:** Fasting Blood HDL **Time Frame:** 12 weeks (Baseline vs Follow-Up) **Description:** Changes in systolic and diastolic blood pressure (mmHg) between groups. **Measure:** Blood Pressure **Time Frame:** 12 weeks (Baseline vs Follow-Up) **Description:** Changes in waist circumference (cm) between groups. **Measure:** Waist Circumference **Time Frame:** 12 weeks (Baseline vs Follow-Up) #### Secondary Outcomes **Description:** Changes in Macular Pigment Optical Density (log units) between groups using a macular densitometer. **Measure:** Macular Pigment Optical Density **Time Frame:** 12 weeks (Baseline vs Follow-Up) **Description:** Changes in visceral adipose tissue (g) between groups using Dual X-ray Absorptiometry. **Measure:** Visceral Adipose Tissue **Time Frame:** 12 weeks (Baseline vs Follow-Up) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 45-64 years of age * 20/20 or corrected vision * No food allergies or intolerances * Not pregnant, lactating, or have given birth in the past 12 months * Do not smoke, use tobacco, or abuse drugs * Absence of liver or gastrointestinal diseases (i.e., primary biliary cirrhosis or gallbladder disease, chronic constipation, diarrhea, Crohn's disease, celiac disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers), hepatitis, HIV, and cancer * Not currently taking oral hypoglycemic agents, or insulin * No history of malabsorptive or bariatric surgery * Cognitively intact with no prior diagnosis of neurological disease (i.e., mild cognitive impairment, Alzheimer's disease, vascular dementia, and/or Asperger's syndrome) * Able to consume the study meals * Not enrolled in another dietary, exercise, or medication study during the study Exclusion Criteria: * Non-consent of participant * Above 64 or below 45 years of age * Vision not 20/20 or corrected * Food allergies or intolerances * Pregnant, lactating, or have given birth in the past 12 months * Smoke, use tobacco, or abuse drugs * Prior diagnosis of liver or gastrointestinal disease (i.e., primary biliary cirrhosis or gallbladder disease, chronic constipation, diarrhea, Crohn's disease, celiac disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers), hepatitis, HIV, or cancer * Currently taking oral hypoglycemic agents or insulin * History of malabsorptive or bariatric surgery * Cognitively impaired and/or prior diagnosis of neurological disease (i.e., mild cognitive impairment, Alzheimer's disease, vascular dementia, and/or Asperger's syndrome) * Unable to consume the study meals * Concurrent enrollment in another dietary, exercise, or medication study **Healthy Volunteers:** True **Maximum Age:** 64 Years **Minimum Age:** 45 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** nakhan2@illinois.edu **Name:** Naiman Khan, PhD **Phone:** 217 300 1667 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** University of Illinois Urbana-Champaign **Name:** Naiman Khan, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007333 - Term: Insulin Resistance - ID: D000006946 - Term: Hyperinsulinism - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M23005 - Name: Metabolic Syndrome - Relevance: HIGH - As Found: Metabolic Syndrome - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M10370 - Name: Insulin Resistance - Relevance: LOW - As Found: Unknown - ID: M9997 - Name: Hyperinsulinism - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000024821 - Term: Metabolic Syndrome ### Intervention Browse Module - Browse Branches - Abbrev: HB - Name: Herbal and Botanical - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: T242 - Name: Olive - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437847 **Brief Title:** Assessment of the Need to Use Short Cognitive Tests for French General Practitioners/Family Doctors **Official Title:** Assessment of the Need to Use Short Cognitive Tests for French General Practitioners/Family Doctors #### Organization Study ID Info **ID:** IRBN632024/CHUSTE #### Organization **Class:** OTHER **Full Name:** Centre Hospitalier Universitaire de Saint Etienne ### Status Module #### Completion Date **Date:** 2024-11 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-27 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-11 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Centre Hospitalier Universitaire de Saint Etienne #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The prevalence of cognitive disorders is constantly increasing, with 1.2 million patients affected in France in 2016. Dementia is currently the seventh leading cause of death. In the absence of available treatment, systematic screening is not recommended. However, cognitive evaluation is recommended to maintain a level of autonomy for the patient at home. Targeted screening is the responsibility of the general practitioner. The latest recommendations from the HAS (2011) highlight the use of the MMSE as a first-line approach, there are no recommendations regarding short tests. Early cognitive assessment is limited by the time required to perform the tests and the knowledge about the available tools. The Codex is a short test, its sensitivity (92%) and specificity (85%) place it among the most discriminatory scores. It is underutilized in France. The objective of this thesis is to assess the training needs of general practitioners in short tests. ### Conditions Module **Conditions:** - Cognitive Disorder **Keywords:** - Cognitive evaluation - Short Test - General Practitioners - Codex, Training - Formation ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 120 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** Questionnaire assessing the use of cognitive tests. **Name:** Questionnaire **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Assessment of the need to use short cognitive tests **Measure:** Quantitative questionnaire 1 **Time Frame:** Month : 1, 3, 6 #### Secondary Outcomes **Description:** Assessment of the expectation regarding a project of training general practitioners to use the Codex tool **Measure:** Quantitative questionnaire 2 **Time Frame:** Month : 1, 3, 6 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * General practitioners of the AURA Region, in activity, university supervisor or not, trained or not trained in geriatrics. Exclusion Criteria: * General practitioners with exclusive practices in pediatrics, gynecology, aesthetics, rehabilitation, and homeopathy. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** General practitioners of the AURA Region will be included. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** angele-fournier@outlook.fr **Name:** Angèle FOURNIER, resident **Phone:** (0)6.95.37.34.22 **Phone Ext:** +33 **Role:** CONTACT #### Locations **Location 1:** **City:** Saint-Étienne **Contacts:** ***Contact 1:*** - **Email:** angele-fournier@outlook.fr - **Name:** Angèle FOURNIER, resident - **Role:** CONTACT ***Contact 2:*** - **Name:** Angèle FOURNIER, resident - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Antonin ZOUBIAN, MD - **Role:** SUB_INVESTIGATOR **Country:** France **Facility:** Chu de Saint-Etienne **Zip:** 42055 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000019965 - Term: Neurocognitive Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M6301 - Name: Cognition Disorders - Relevance: HIGH - As Found: Cognitive Disorders - ID: M29705 - Name: Cognitive Dysfunction - Relevance: HIGH - As Found: Cognitive Disorders - ID: M21836 - Name: Neurocognitive Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000060825 - Term: Cognitive Dysfunction - ID: D000003072 - Term: Cognition Disorders ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437834 **Brief Title:** Increasing Men's Engagement in Preventive Healthcare Through an Enhanced Cocoon Vaccination Strategy **Official Title:** Increasing Men's Engagement in Preventive Healthcare Through an Enhanced Cocoon Vaccination Strategy #### Organization Study ID Info **ID:** STUDY20240200 #### Organization **Class:** OTHER **Full Name:** University Hospitals Cleveland Medical Center ### Status Module #### Completion Date **Date:** 2025-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-24 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-10 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-24 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Randy Vince, MD #### Responsible Party **Investigator Affiliation:** University Hospitals Cleveland Medical Center **Investigator Full Name:** Randy Vince, MD **Investigator Title:** Physician **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this clinical trial is to understand if offering a high touch engagement with healthcare center catered to men and bedside vaccine access in a birthing center increases men's engagement in preventive healthcare. The main questions it aims to answer are: Does access to vaccinations and overall health education for men lead to increased uptake of vaccines? Does access to vaccinations and overall health education for men lead to increased engagement in overall healthcare of male identifying support persons. Researchers will compare three arms (one that receives information only, one that receives information and an offer of vaccines at bedside, and one that receives higher level of engagement from patient liaisons as well as the offer of vaccines at bedside) to see if there is a difference in vaccine uptake and engagement in healthcare Participants will complete two survey and one interview. **Detailed Description:** The goal of this project is to understand whether the combination of vaccination access and connection to services tailored for men improves vaccination rates among men and engagement in healthcare. Additionally, this project aims to understand variations in effectiveness between low-touch and high-touch approaches. To achieve these goals, the project has two specific aims: Aim 1: Assess the effectiveness of cocoon vaccination interventions on a continuum of minimum to high-touch in terms of vaccination completion and healthcare engagement. After refinement of the intervention materials and study materials based on engagement with community members, representatives of the priority population, interested parties including birthing parents, the initiative will roll out in three randomly timed clusters, one that includes low-touch information only, another that includes bedside vaccinations in addition to the low-touch information, and a third that includes bedside vaccinations and high-touch connection to the UH Cutler Center for Men through the Joe Team. Male-identifying individuals will be recruited and enrolled to complete two surveys, one at baseline and another four weeks after enrollment) to assess vaccination completion and healthcare engagement. Aim 2: Examine the factors that impact uptake of vaccination and healthcare engagement after a cocoon vaccination intervention. Factors that impact intervention uptake will be assessed through the two surveys and semi-structured interviews with a subsample of survey participants. Additionally, contextual factors related to the implementation of the intervention, such as hours of operation for high touch connections/vaccine distribution will be assessed. By understanding the factors that impact intervention uptake, we will assess the barriers and facilitators of this strategy. Hypothesis. This pilot study will examine whether implementing a cocoon vaccination strategy that provides access to vaccinations and overall health education for men leads to increased uptake of vaccines and engagement in overall healthcare of male identifying support persons. Additionally, it will assess the factors that impact intervention uptake. We anticipate that vaccination rates and engagement with healthcare will be highest among male visitors at the Ahuja Medical Center who receive the vaccination offer at bedside and the high-touch healthcare navigation information relative to those who are only offered information on health care or those who are offered bedside vaccines and information. ### Conditions Module **Conditions:** - Vaccines - Preventive Medicine **Keywords:** - cocoon vaccination - men's health ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 450 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** all male-identifying visitors in the birthing center will receive an information sheet about the importance of vaccinations and preventive healthcare for men. **Intervention Names:** - Other: Information Sheet **Label:** Information-Only **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** all male-identifying visitors in the birthing center at the birthing center will receive the information sheet about vaccinations and preventive healthcare, and the offer of influenza and Tdap vaccinations at bedside in the birthing center. **Intervention Names:** - Other: Information Sheet - Drug: Vaccines **Label:** Bedside Vaccines plus Information **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** all male-identifying visitors in the birthing center will receive the information sheet, the offer to receive influenza and Tdap vaccinations at bedside in the birthing center, as well as a high-touch connection to healthcare navigation supports. **Intervention Names:** - Other: Information Sheet - Other: High-touch connect - Drug: Vaccines **Label:** Bedside Vaccines plus High-touch connection **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Bedside Vaccines plus High-touch connection - Bedside Vaccines plus Information - Information-Only **Description:** Information sheet describing the importance of vaccines and preventive care as well as contact information for patient navigators. **Name:** Information Sheet **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Bedside Vaccines plus High-touch connection **Description:** Engagement with a patient navigator. **Name:** High-touch connect **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Bedside Vaccines plus High-touch connection - Bedside Vaccines plus Information **Description:** Offer of receiving TDap and Influenza vaccine **Name:** Vaccines **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Self-report of receipt of Influenza vaccine **Measure:** Number of participants who received Influenza Vaccine **Time Frame:** One-month post consent #### Secondary Outcomes **Description:** Self-report of receipt of TDap vaccine **Measure:** Number of participants who received TDap Vaccine **Time Frame:** One-month post consent **Description:** Self-report of enrollment in Men's Health Center that includes patient navigation **Measure:** Number of participant who enrolled in Patient Navigation **Time Frame:** One-month post consent ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: - Adult Partner of birthing person at a birthing center who identifies as male-identifying Exclusion Criteria: -Under the age of 18; does not identify as a man. **Gender Based:** True **Gender Description:** Identifies as Male **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** sjk98@case.edu **Name:** Sarah Koopman Gonzalez, PhD **Phone:** 216-368-5755 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** University Hospitals Cleveland Medical Center **Name:** Randy Vince, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M17360 - Name: Vaccines - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437821 **Brief Title:** Comparative Effect of Graston Technique and Petrissage Technique on Tight Trapezius Muscles in Young Adults **Official Title:** Comparative Effect of Graston Technique and Petrissage Technique on Tight Trapezius Muscles in Young Adults #### Organization Study ID Info **ID:** MSRSW/Batch-Fall22/717 #### Organization **Class:** OTHER **Full Name:** Superior University ### Status Module #### Completion Date **Date:** 2024-10-29 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-25 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-05-01 **Type:** ACTUAL #### Start Date **Date:** 2023-11-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-25 **Study First Submit QC Date:** 2024-05-25 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Superior University #### Responsible Party **Investigator Affiliation:** Superior University **Investigator Full Name:** Muhammad Naveed Babur **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This research aims to contribute valuable insights into the potential benefits of incorporating the portable wedge device into preventive or therapeutic interventions for calf-related musculoskeletal issues. By combining economical, ergonomic principles and user-friendly features, the proposed device offers individuals a convenient and efficient means to enhance their calf flexibility, ultimately mitigating strain and reducing spasms. **Detailed Description:** Developing and successfully integrating a portable wedge device could mark a significant breakthrough in preventive and rehabilitative care for musculoskeletal problems associated with the calf region. This innovative device can enhance the overall well-being and musculoskeletal health of individuals suffering from such issues, providing a more effective and convenient treatment solution. ### Conditions Module **Conditions:** - Trapezius Muscle Strain ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 46 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Diagnostic Test: Petrissage **Label:** Petrissage **Type:** OTHER #### Arm Group 2 **Intervention Names:** - Other: Graston Technique **Label:** Graston Technique **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Petrissage **Description:** The calf muscles will receive a firm, deep-circulation massage with fingertip pressure **Name:** Petrissage **Type:** DIAGNOSTIC_TEST #### Intervention 2 **Arm Group Labels:** - Graston Technique **Description:** The calf muscles will receive a firm, deep-circulation massage with fingertip pressure **Name:** Graston Technique **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** A pain scale is a method used to quantify the level of discomfort a person is experiencing. It assesses a person's level of pain intensity on a scale from 0 to 10. The scale rates a person's level of discomfort at a particular moment and goes from '0', indicating no pain, to '10,' representing the worst pain imaginable. This simple yet efficient method is widely used to help healthcare professionals evaluate and treat pain. **Measure:** Numeric Pain Rating Scale (NPRS) **Time Frame:** 12 Months **Description:** To evaluate a patient's functional status, ten questions are asked about their condition, including pain, personal care, lifting, reading, headaches, focus, job, driving, sleeping, and recreation. Each category is scored from 0 to 5, where 0 indicates "No pain" and 5 indicates "Worst imaginable pain." The score can be multiplied by two to get a percentage score, with a maximum score of fifty. **Measure:** Neck disability index (NDI) **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Male and female patients diagnosed with Trapezius tightness * Age above 18-30 * Presence of active trigger points in the upper trapezius muscle * Participants who are volunteer for the study * Patients who suffer from shoulder pain and stiffness due to bad posture Exclusion Criteria: * History of whiplash injury * History of head, neck, cervical spine or shoulder surgery * History of cervical radiculopathy * Diagnosed fibromyalgia and myopathy * History of cancer * Pregnancy Myofascial therapy within the past month * Contraindication of dry needling and instrument-assisted soft tissue mobilization technique **Maximum Age:** 30 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Lahore **Country:** Pakistan **Facility:** Faqraj Sharif Hospital (Trust) Physiotherapy and Orthopedic Department and Orian ABA Pakistan (Physiotherapy Department) **State:** Punjab ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437808 **Brief Title:** Optimizing Football Training: Integrating Portable Force Plates for Advanced Performance Analysis **Official Title:** Optimizing Football Training at Multan Sports Complex: Integrating Portable Force Plates for Advanced Performance Analysis #### Organization Study ID Info **ID:** MSRSW/Batch-Fall22/716 #### Organization **Class:** OTHER **Full Name:** Superior University ### Status Module #### Completion Date **Date:** 2024-09-29 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-25 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-05-01 **Type:** ACTUAL #### Start Date **Date:** 2023-10-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-25 **Study First Submit QC Date:** 2024-05-25 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Superior University #### Responsible Party **Investigator Affiliation:** Superior University **Investigator Full Name:** Muhammad Naveed Babur **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Optimizing Football Training at Multan Sports Complex: Integrating Portable Force Plates for Advanced Performance Analysis," aims to enhance football training through innovative technology. Under the supervision of Dr. Junaid Gondal, this MS Rehabilitation Science project explores the use of portable force plates to provide real-time data on players' biomechanics, enabling personalized training programs that improve performance and reduce injury risks. **Detailed Description:** The research adopts a randomized control trial design, involving 30 male football players aged 18-35. Participants are divided into intervention and control groups, with the former using portable force plates during training. Data analysis will be conducted using IBM SPSS. This study underscores the significance of advanced performance analysis in football training, advocating for the integration of cutting-edge technology to refine training methods and enhance athletic performance at the Multan Sports Complex. ### Conditions Module **Conditions:** - Injury;Sports ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 30 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Combination Product: Training with Portable Force Plates Integration **Label:** Training with Portable Force Plates Integration **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Other: Standard Training **Label:** Standard Training **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Training with Portable Force Plates Integration **Description:** This group will undergo football training sessions that incorporate the use of portable force plates. These devices will measure ground reaction forces and provide real-time data on players' movements, balance, and pressure points. The data collected will be used to create personalized training programs aimed at optimizing performance and reducing the risk of injuries. **Name:** Training with Portable Force Plates Integration **Type:** COMBINATION_PRODUCT #### Intervention 2 **Arm Group Labels:** - Standard Training **Description:** This group will continue with the existing football training regimen without the use of portable force plates. Training will follow the traditional methods used at the Multan Sports Complex, focusing on physical conditioning, technical skills, and tactical awareness without the advanced biomechanical analysis provided by the force plates. **Name:** Standard Training **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Rate of perceived exertion (RPE) is used to measure how hard your body works during physical activity. It runs from 0 - 10, using numbers to rate how much effort an activity takes **Measure:** RPE Scale **Time Frame:** 12 Months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Male football players at Multan Sports Complex * aged 18-35 * willing to consent. Exclusion Criteria: * Female players * unregistered players * those with unstable medical conditions. **Healthy Volunteers:** True **Maximum Age:** 35 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Multān **Country:** Pakistan **Facility:** Multan Sports Complex **State:** Punjab ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014947 - Term: Wounds and Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4570 - Name: Athletic Injuries - Relevance: HIGH - As Found: Injury;Sports - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001265 - Term: Athletic Injuries ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437795 **Brief Title:** Effectiveness of Dry Needling Versus Cupping Therapy for Pain in Piriformis Syndrome **Official Title:** Effectiveness of Dry Needling Versus Cupping Therapy for Pain in Piriformis Syndrome #### Organization Study ID Info **ID:** MSRSW/Batch-Fall22/715 #### Organization **Class:** OTHER **Full Name:** Superior University ### Status Module #### Completion Date **Date:** 2024-09-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-25 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-05-01 **Type:** ACTUAL #### Start Date **Date:** 2023-11-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-25 **Study First Submit QC Date:** 2024-05-25 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Superior University #### Responsible Party **Investigator Affiliation:** Superior University **Investigator Full Name:** Muhammad Naveed Babur **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This study aims to compare the effectiveness of two popular therapeutic interventions, dry needling and cupping therapy, in alleviating pain associated with Piriformis Syndrome. Piriformis Syndrome is a neuromuscular disorder caused by the compression or irritation of the sciatic nerve by the piriformis muscle, leading to buttock pain and radiating numbness. **Detailed Description:** The study will recruit participants diagnosed with Piriformis Syndrome and will randomly assign them to receive either dry needling or cupping therapy over a specific period. The primary outcome will be the reduction in pain intensity measured by standardized pain assessment tools. Secondary outcomes will include improvements in functional mobility and quality of life. By analyzing the efficacy and patient-reported outcomes of both therapies, the study aims to provide evidence-based recommendations for clinicians treating Piriformis Syndrome. ### Conditions Module **Conditions:** - Piriformis Syndrome ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 80 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Diagnostic Test: Dry Needling Group **Label:** Dry Needling Group **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Other: Cupping Therapy Group **Label:** Cupping Therapy Group **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Dry Needling Group **Description:** Participants in this group will receive dry needling therapy. This involves inserting thin needles into trigger points in the piriformis muscle to relieve pain and muscle tension. The therapy will be administered twice a week for 4 weeks, with each session lasting approximately 30 minutes. **Name:** Dry Needling Group **Type:** DIAGNOSTIC_TEST #### Intervention 2 **Arm Group Labels:** - Cupping Therapy Group **Description:** Participants in this group will receive cupping therapy. This involves placing cups on the skin to create suction, which is believed to improve blood flow and reduce muscle tension. The therapy will be administered twice a week for 4 weeks, with each session lasting approximately 30 minutes. **Name:** Cupping Therapy Group **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Participants will rate their pain on a scale from 0 (no pain) to 10 (worst possible pain) at the beginning and end of the study. **Measure:** Visual Analog Scale (VAS) **Time Frame:** 12 Months **Description:** This tool assesses the degree of disability in performing daily activities. Quality of life improvements measured by the SF-36 Health Survey, which evaluates physical and mental health status. **Measure:** Oswestry Disability Index (ODI) **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adults aged between 18 to 65 years. * Diagnosed with piriformis syndrome. * Experiencing chronic pain for at least 3 months. * Willingness to comply with the study protocol and attend all therapy sessions. Exclusion Criteria: * Recent surgery on the lower back or hip. * Presence of systemic diseases affecting muscle function (e.g., multiple sclerosis, rheumatoid arthritis). * Pregnant or breastfeeding women. * Use of anticoagulant medication or having a bleeding disorder. * Participating in another clinical trial simultaneously **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Lahore **Country:** Pakistan **Facility:** Ghurkee Hospital **State:** Punjab ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - ID: D000010335 - Term: Pathologic Processes - ID: D000020426 - Term: Sciatic Neuropathy - ID: D000020422 - Term: Mononeuropathies - ID: D000010523 - Term: Peripheral Nervous System Diseases - ID: D000009468 - Term: Neuromuscular Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000009408 - Term: Nerve Compression Syndromes - ID: D000009437 - Term: Neuralgia - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations - ID: D000017699 - Term: Pelvic Pain ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M28404 - Name: Piriformis Muscle Syndrome - Relevance: HIGH - As Found: Piriformis Syndrome - ID: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M22222 - Name: Sciatic Neuropathy - Relevance: LOW - As Found: Unknown - ID: M22218 - Name: Mononeuropathies - Relevance: LOW - As Found: Unknown - ID: M13432 - Name: Peripheral Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown - ID: M12352 - Name: Nerve Compression Syndromes - Relevance: LOW - As Found: Unknown - ID: M5853 - Name: Charcot-Marie-Tooth Disease - Relevance: LOW - As Found: Unknown - ID: M18092 - Name: Hereditary Sensory and Motor Neuropathy - Relevance: LOW - As Found: Unknown - ID: M12381 - Name: Neuralgia - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M19918 - Name: Pelvic Pain - Relevance: LOW - As Found: Unknown - ID: T4568 - Name: Piriformis Syndrome - Relevance: HIGH - As Found: Piriformis Syndrome - ID: T1081 - Name: Charcot-Marie-Tooth Disease - Relevance: LOW - As Found: Unknown - ID: T2761 - Name: Hereditary Motor and Sensory Neuropathy - Relevance: LOW - As Found: Unknown - ID: T2766 - Name: Hereditary Neuropathy With Liability to Pressure Palsies - Relevance: LOW - As Found: Unknown - ID: T5067 - Name: Roussy Levy Syndrome - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000055958 - Term: Piriformis Muscle Syndrome - ID: D000013577 - Term: Syndrome ### Intervention Browse Module - Browse Branches - Abbrev: Antipy - Name: Antipyretics - Abbrev: Analg - Name: Analgesics - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M2340 - Name: Acetaminophen - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437782 **Acronym:** HLQ-Diabete **Brief Title:** Exploration of Health Literacy in Diabetes in Reunion Island and France **Official Title:** Exploration of Health Literacy in Diabetes in Reunion Island and Metropolitan France #### Organization Study ID Info **ID:** 2017/CHU/13 #### Organization **Class:** OTHER **Full Name:** Centre Hospitalier Universitaire de la Réunion ### Status Module #### Completion Date **Date:** 2025-11 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-09 **Type:** ESTIMATED #### Start Date **Date:** 2024-09 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-22 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Centre Hospitalier Universitaire de la Réunion #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this observational study is to identify the health literacy profile of diabetic patients in Reunion Island and France in order to obtain information to improve access to information, therapeutic education and to health service. The main question\[s\] it aims to answer \[is/are\]: Participants will complete the Health Literacy Questionnaire (HLQ) once. ### Conditions Module **Conditions:** - Diabetes type1 - Diabetes Type 2 - Diabetes, Gestational ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 1350 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Other: Questionnaire completion **Label:** type 1 diabetes closed loop #### Arm Group 2 **Intervention Names:** - Other: Questionnaire completion **Label:** type 2 diabetes #### Arm Group 3 **Intervention Names:** - Other: Questionnaire completion **Label:** Gestational diabetes ### Interventions #### Intervention 1 **Arm Group Labels:** - Gestational diabetes - type 1 diabetes closed loop - type 2 diabetes **Description:** HLQ (Health Literacy questionnaire) will be completed by all included patients once. **Name:** Questionnaire completion **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** HLQ (Health literacy questionnaire) is completed once. The algorithm produces unweighted scores for each of the 9 scales of the HLQ. The final score for each scale is an average score across all the questions that form that scale. The HLQ does not provide one overall summative score; rather it gives you nine separate scores that indicate a person's strengths and needs in relation to their health literacy. **Measure:** Health literacy profiles in Reunion Island **Time Frame:** at inclusion #### Secondary Outcomes **Description:** HLQ (Health literacy questionnaire) is completed once. Health literacy profile in patients treated on Reunion Island et France will be described. The algorithm produces unweighted scores for each of the 9 scales of the HLQ. The final score for each scale is an average score across all the questions that form that scale. The HLQ does not provide one overall summative score; rather it gives you nine separate scores that indicate a person's strengths and needs in relation to their health literacy. **Measure:** Health literacy profiles in Reunion Island and France **Time Frame:** at inclusion ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Patient with type 1, 2 or gestational diabetes taken care in hospital Exclusion Criteria: * Patient unable to understand and respect study procedures * Patient with cognitive disorder * Patient with serious acute complication due to diabetes within 15 days before inclusion * Stroke history with neurologic consequences * Other specific types of diabetes : chronic calcific pancreatitis, iatrogenic, other secondary diabetes, rare monogenic or genetic diabetes due to insulin resistance **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients with type 1 diabetes (strict insulin dependence, or anti-GAD, anti-IA2, and/or anti-ZnT8 + antibodies) with a hybrid closed-loop insulin therapy system for at least 3 months , diabetes of type 2 (non-insulin-dependent or insulin-requiring, with negative anti-GAD, anti-IA2, and/or anti-ZnT8 Ab if diabetes has been diagnosed for less than 5 years at the time of insulin therapy), or diabetes during pregnancy: gestational diabetes (diabetes diagnosed during pregnancy according to the diagnostic criteria of French recommendations), or pre-existing diabetes (known or not) with pregnancy. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** anna.flaus-furmaniuk@chu-reunion.fr **Name:** Anna FLAUS **Phone:** +262262905610 **Role:** CONTACT **Contact 2:** **Email:** xavier.debussche@inserm.fr **Name:** Xavier DEBUSSCHE **Role:** CONTACT #### Locations **Location 1:** **City:** Saint-Denis **Contacts:** ***Contact 1:*** - **Email:** anna.flaus-furmaniuk@chu-reunion.fr - **Name:** Anna FLAUS - **Role:** CONTACT ***Contact 2:*** - **Name:** Anna FLAUS, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Réunion **Facility:** CHU de La Réunion **Zip:** 97400 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases - ID: D000011248 - Term: Pregnancy Complications - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M19012 - Name: Diabetes, Gestational - Relevance: HIGH - As Found: Diabetes, Gestational - ID: M7115 - Name: Diabetes Mellitus - Relevance: HIGH - As Found: Diabetes - ID: M7119 - Name: Diabetes Mellitus, Type 2 - Relevance: HIGH - As Found: Diabetes Type 2 - ID: M7117 - Name: Diabetes Mellitus, Type 1 - Relevance: HIGH - As Found: Diabetes Type 1 - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000016640 - Term: Diabetes, Gestational - ID: D000003920 - Term: Diabetes Mellitus - ID: D000003924 - Term: Diabetes Mellitus, Type 2 - ID: D000003922 - Term: Diabetes Mellitus, Type 1 ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437769 **Brief Title:** The Effect of Reiki on Cesarean During Hospitalization **Official Title:** The Effect of Reiki Applied to Women Who Have Been Hospitalized by Cesarean During the Hospitalization Process on Anxiety, Depression, Comfort and Breastfeeding #### Organization Study ID Info **ID:** 2024/236 #### Organization **Class:** OTHER **Full Name:** Ondokuz Mayıs University ### Status Module #### Completion Date **Date:** 2024-08-03 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-25 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-08-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-03 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-25 **Study First Submit QC Date:** 2024-05-25 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ondokuz Mayıs University #### Responsible Party **Investigator Affiliation:** Ondokuz Mayıs University **Investigator Full Name:** Sümeyye BAL **Investigator Title:** Director **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** To determine the effect of reiki applied to women who have been hospitalized by cesarean during the hospitalization process on anxiety, depression, comfort and breastfeeding Method: The study will be completed in a randomized controlled manner with a total of 60 women, 30 in the experimental group and 30 in the control group. Women in the experimental group Reiki therapy will be applied to the participants for 30 minutes while they lie down with their eyes closed. Research data will be collected with the Comfort Scale, Hospital anxiety and depression scale and bristol breastfeeding points and will be recorded **Detailed Description:** Design and Settings: This randomized controlled experimental study will conducted in the post operative room of the, Turkey between the dates of June 2024 and August 2024 ### Conditions Module **Conditions:** - Cesarean Section Complications ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** . Reiki therapy will be applied to the participants for 30 minutes while they lie down with their eyes closed. A total of 4 sessions of Reiki application will be applied to the intervention group at the 4th hour, 8th hour, 24th hour and 28th hour after the cesarean section. Reiki application will be applied at the 4th hour after the cesarean section. Comfort, anxiety, depression and breastfeeding symptoms after the 4th session will be recorded. **Intervention Names:** - Other: reiki **Label:** Reiki **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** will provided with standard midwifery care. **Label:** control group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Reiki **Description:** effect of reiki application to women who have been hospitalized by ceserean during the hospitlalization process on anxiety depression comfort and breastfeesing **Name:** reiki **Other Names:** - control group **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Hospital Anxiety and Depression Scale;Hospital anxiety depression scale, to screen anxiety and depression in people with physical illnesses. has been prepared. It consists of 14 items. **Measure:** anxiety and depression **Time Frame:** immediately after intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * volunteering * be over 18 years old * Not having a diagnosed psychiatric disease * no communication problems * No drug sensitivity or allergy * women who have had a cesarean section Exclusion Criteria: * Having a diagnosed psychiatric illness * no communication problems * Being under 18 years of age * not volunteering to participate in the research * drug sensitivity and allergy * women who gave birth normally **Healthy Volunteers:** True **Maximum Age:** 60 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** sumeyyebal@gmail.com **Name:** Sümeyye BAL, Ph.D **Phone:** 05434276696 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Ondokuz Mayıs University **Name:** Sümeyye BAL, Ph.D. **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7058 - Name: Depression - Relevance: LOW - As Found: Unknown - ID: M4324 - Name: Anxiety Disorders - Relevance: LOW - As Found: Unknown - ID: M7061 - Name: Depressive Disorder - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437756 **Brief Title:** Effects of Theraband Resistance Training on Muscle Strength in Coronary Artery Diseases **Official Title:** Effects of Theraband Resistance Training on Muscle Strength in Coronary Artery Diseases #### Organization Study ID Info **ID:** REC/01808 Zunaira Shaukat #### Organization **Class:** OTHER **Full Name:** Riphah International University ### Status Module #### Completion Date **Date:** 2024-07-10 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-27 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-07-10 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Riphah International University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** To compare the effects of Theraband Resistance Training with Conventional Resistance Training on muscle strength in coronary artery diseases ### Conditions Module **Conditions:** - Coronary Artery Disease ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 38 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Other: Theraband resistance training **Label:** Theraband resistance training **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Other: Conventional Resistance Training **Label:** Conventional Resistance Training **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Theraband resistance training **Description:** Three sessions of 30 minutes each was used to complete the intervention over the course of six weeks (two sets of 12 repetitions). The participants were warmed up by stretching for 10 minutes before each session Participants were advised to take 5 mins rest before moving to next movement if they would feel fatigued after one movement. Thera-Band was utilized in only three different colors for the workouts. **Name:** Theraband resistance training **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Conventional Resistance Training **Description:** The intervention was carried out over the course of six weeks in three sessions of 30 minutes each (two sets of 12 repetitions). The participants were warmed up by stretching for 10 minutes before each session. The resistance-training program was performed with Universal weights. **Name:** Conventional Resistance Training **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** If testing techniques are consistent, handheld dynamometry is a valid approach to assess the strength state and change in strength status. Hand-held dynamometry can be a reliable assessment technique when practiced by a single experienced tester **Measure:** Hand Held Dynamometer **Time Frame:** 6 week **Description:** The Modified Borg Dyspnea Scale is numerical rating scale ranging from 0 to 10 and is used to measure dyspnea that patient report during sub-maximal exercise and is regularly administered during six-minute walk test. Changes from the baseline will be measured **Measure:** Modified BORG Scale **Time Frame:** 6 week **Description:** It is a self-administered questionnaire for assessing the degree and severity of fatigue/tiredness in epidemiological populations, both clinical and non-clinical. The Chadler Fatigue Scale (CFS) was originally perceived as comprising two subscales that evaluate fatigue in the physical and mental domains. Items are rated on a 4-point Likert scale (0 = better than usual, 1 = no more than usual, 2 = worse than usual, 3 = much worse than usual), with higher scores indicating greater fatigue. Changes from the baseline are measured **Measure:** Chadler Fatigue Scale **Time Frame:** 6 week **Description:** Changes from the baseline, Body Mass Index can be define as statistical index utilizing an individuals height and weight to give an estimation of muscle versus fat in female and male of all ages. It is determined by taking an individual weight in kilograms, separated by their height in meters squared, or BMI = weight (in kg)/height (in m square). **Measure:** 6 Min walk test (Distance in meters) **Time Frame:** 6 week **Description:** The 30-Second Sit to Stand Test evaluates older people's leg strength and endurance using a foldable chair without arms. Participants stand with feet positioned back from knees, arms crossed, and arms crossed. The examiner counts stand within 30 seconds, determining the score. **Measure:** The 30 Second Sit to Stand Test(30SSST) for lower limb strength **Time Frame:** 6 week ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Participants having a documented diagnosis of CAD, confirmed by a medical professional. * Individuals with a history of myocardial infarction (heart attack), angina, or evidence of significant coronary artery stenosis. * Stable CAD who were not experiencing acute coronary events, such as recent heart attacks or unstable angina. * Patients who were able to perform exercises with TheraBand. * Reduced muscle strength of upper limb/lower limb Exclusion Criteria: * Patients over the age of 75 years. * Exclude individuals with a recent history of Theraband resistance training. * Severe cardiovascular complications such as heart failure with reduced ejection fraction, severe arrhythmias, or uncontrolled hypertension. * Patients with unstable conditions or cardiac episodes. * Individuals who had undergone major cardiovascular surgery (e.g., coronary artery bypass grafting) within the last six months. * Ejection fraction \< 40% **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** iqbal.tariq@riphah.edu.pk **Name:** Muhammad Iqbal Tariq, PhD* **Phone:** 03338236752 **Role:** CONTACT #### Locations **Location 1:** **City:** Islamabad **Contacts:** ***Contact 1:*** - **Email:** iqbal.tariq@riphah.edu.pk - **Name:** Muhammad Iqbal Tariq, PhD* - **Phone:** 03338236752 - **Role:** CONTACT ***Contact 2:*** - **Name:** Zunaira Shaukat - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Pakistan **Facility:** Al Nafees Medical Hospital **State:** Federal **Status:** RECRUITING **Zip:** 44000 #### Overall Officials **Official 1:** **Affiliation:** Riphah International University **Name:** Muhammad Iqbal Tariq, PhD* **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000001161 - Term: Arteriosclerosis - ID: D000001157 - Term: Arterial Occlusive Diseases - ID: D000014652 - Term: Vascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M6546 - Name: Coronary Artery Disease - Relevance: HIGH - As Found: Coronary Artery Disease - ID: M19506 - Name: Myocardial Ischemia - Relevance: HIGH - As Found: Coronary Artery Disease - ID: M6549 - Name: Coronary Disease - Relevance: HIGH - As Found: Coronary Artery Disease - ID: M10543 - Name: Ischemia - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M4469 - Name: Arteriosclerosis - Relevance: LOW - As Found: Unknown - ID: M4465 - Name: Arterial Occlusive Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003324 - Term: Coronary Artery Disease - ID: D000017202 - Term: Myocardial Ischemia - ID: D000003327 - Term: Coronary Disease ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437743 **Acronym:** SIMONE **Brief Title:** Monitoring Nociception Using NoL Index to Reduce Opioid-Related Complications in Laparoscopic Abdominal Surgery **Official Title:** Monitoring Nociception Using NoL Index and Its Implications in Reducing Opioid-Related Complications in Laparoscopic Abdominal Surgery #### Organization Study ID Info **ID:** SIMONE001 #### Organization **Class:** NETWORK **Full Name:** Investigation Group Anesthesia, Resuscitation, And Perioperative Medicine of Aragon ### Status Module #### Completion Date **Date:** 2025-06-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-25 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-25 **Study First Submit QC Date:** 2024-05-25 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** NETWORK **Name:** Investigation Group Anesthesia, Resuscitation, And Perioperative Medicine of Aragon #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study aims to determine if optimal intraoperative nociception monitoring using the NoL index can reduce postoperative complications related to opioid use in laparoscopic abdominal surgery. The hypothesis is that guided nociception monitoring decreases opioid-related complications and improves postoperative outcomes. **Detailed Description:** The study is a prospective, observational cohort study conducted across multiple centers. It aims to evaluate the impact of intraoperative nociception monitoring on postoperative opioid-related complications. The study will involve two groups of patients undergoing laparoscopic abdominal surgery: one group with visible NoL monitoring and another with non-visible NoL monitoring. ### Conditions Module **Conditions:** - Postoperative Opioid-related Complications **Keywords:** - Nociception, NoL Index, Opioids, Postoperative Complications, Laparoscopic Surgery ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 282 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients in this group will undergo laparoscopic abdominal surgery with the nociception level (NoL) monitor visible to the anesthesiologist. The NoL monitor provides an estimation of nociception through a multi-parameter sensor placed on the patient's finger. The anesthesiologist will adjust the doses of analgesic drugs based on the values observed on the NoL monitor, aiming to maintain the values between 10 and 25 during the surgery. **Intervention Names:** - Device: Nociception Level (NoL) Monitor **Label:** NoL Visible #### Arm Group 2 **Description:** Patients in this group will undergo laparoscopic abdominal surgery with the NoL monitor not visible to the anesthesiologist. The monitor will still be in place and collecting data, but its values will not be displayed during the surgery. The anesthesiologist will manage analgesia based on standard hemodynamic parameters such as heart rate and blood pressure, without access to the NoL values. The intervention includes the same standard anesthetic protocol as the NoL Visible group. **Intervention Names:** - Device: Nociception Level (NoL) Monitor **Label:** NoL Not Visible ### Interventions #### Intervention 1 **Arm Group Labels:** - NoL Not Visible - NoL Visible **Description:** The NoL Monitor (PMD-200) is a multi-parameter sensor device placed on the patient's finger to estimate nociception levels during surgery. It provides continuous, real-time feedback to the anesthesiologist on the patient's nociception, assisting in the optimization of analgesic drug administration. The monitor integrates parameters such as heart rate variability, skin conductance, and other physiological signals to compute the NoL index, which ranges from 0 to 100, with target values between 10 and 25 for optimal nociception management. **Name:** Nociception Level (NoL) Monitor **Other Names:** - PMD-200 **Type:** DEVICE ### Outcomes Module #### Other Outcomes **Description:** Patient satisfaction with pain management will be assessed using a standardized questionnaire. The goal is to compare satisfaction levels between the NoL visible group and the standard monitoring group. **Measure:** Patient Satisfaction with Pain Management **Time Frame:** At 48 hours postoperatively #### Primary Outcomes **Description:** The primary outcome measure will evaluate the incidence of postoperative opioid-related complications in patients undergoing laparoscopic abdominal surgery. Complications include nausea, vomiting, respiratory depression, and opioid-induced hyperalgesia. The study aims to determine if the use of the NoL monitor to guide intraoperative analgesia reduces these complications compared to standard hemodynamic monitoring. **Measure:** Reduction in Postoperative Opioid-Related Complications **Time Frame:** From the end of surgery up to 48 hours postoperatively #### Secondary Outcomes **Description:** This secondary outcome measure will assess the total amount of opioids administered during surgery. The comparison will be made between the group with visible NoL monitoring and the group with standard hemodynamic monitoring. **Measure:** Intraoperative Opioid Consumption **Time Frame:** During the surgical procedure **Description:** Postoperative pain levels will be measured using the Visual Analog Scale (VAS) at various time points post-surgery. The study will compare pain scores between the two groups to evaluate the effectiveness of NoL-guided analgesia. **Measure:** Postoperative Pain Scores **Time Frame:** At 1, 6, 12, 24, and 48 hours postoperatively **Description:** This secondary outcome will measure the duration of hospital stay from admission to discharge following surgery. The aim is to determine if NoL-guided analgesia affects the length of hospitalization. **Measure:** Length of Hospital Stay **Time Frame:** From admission to discharge, up to 7 days postoperatively ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age ≥ 18 years * Scheduled for laparoscopic abdominal surgery * Undergoing balanced general anesthesia * ASA physical status I-III * Signed informed consent Exclusion Criteria: * Refusal to participate * Communication barriers * Multimodal, opioid-free, or regional epidural anesthesia * ASA IV or V * Pregnant or breastfeeding women * Open or emergency abdominal surgery * Post-surgery transfer to ICU or Recovery Unit **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The study population includes adult patients scheduled for elective laparoscopic abdominal surgery at participating hospitals. The population will consist of individuals who meet the inclusion criteria and have consented to participate in the study. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** cristianaragon@outlook.com **Name:** Cristian Aragón-Benedí, M.D, Ph.D **Phone:** +34625408866 **Role:** CONTACT **Contact 2:** **Email:** anapascual689@gmail.com **Name:** Ana Pascual-Bellosta, M.D, Ph.D, Prof. **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Miguel Servet University Hospital **Name:** Ana Pascual-Bellosta, M.D, Ph.D, Prof. **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Miguel Servet University Hospital **Name:** Cristian Aragón-Benedí, M.D, Ph.D **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **Description:** There is no plan to make individual participant data (IPD) available to other researchers for this study. **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M14065 - Name: Postoperative Complications - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Analg - Name: Analgesics - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown - ID: M4033 - Name: Analgesics, Opioid - Relevance: LOW - As Found: Unknown - ID: M4854 - Name: Benzocaine - Relevance: LOW - As Found: Unknown - ID: T433 - Name: Tannic Acid - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437730 **Brief Title:** Comparison of INIT and Dry Needling on Trigger Points in Knee OA **Official Title:** Comparison of Integrated Neuromuscular Inhibition Technique and Dry Needling on Trigger Points in Patient With Knee Osteoarthritis #### Organization Study ID Info **ID:** RiphahIU Iqra Iftikhar #### Organization **Class:** OTHER **Full Name:** Riphah International University ### Status Module #### Completion Date **Date:** 2024-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-30 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-06-15 **Type:** ESTIMATED #### Start Date **Date:** 2023-10-12 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-26 **Study First Submit QC Date:** 2024-05-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Riphah International University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of the study is to compare the effects of Integrated Neuromuscular Inhibition Technique and Dry Needling on Functional Disability, Pain and Range of Motion. A randomized control trial will be conducted at Wah General Hospital Taxila. The sample size is 36 calculated through G-Power but I recruited 50. The participants were divided into two interventional groups each having 18 participants. Tools used in this study are Goniometer, NPRS, WOMAC, and Self structured Questionnaire. Data will be collected before and immediately after the application of interventions. Data will be analyzed through SPSS. **Detailed Description:** Knee osteoarthritis (OA) is also known as degenerative joint disease, in which there is progressive loss of articular cartilage due to wear and tear. Knee osteoarthritis can be classified into two types, primary and secondary. Primary osteoarthritis is defined as degeneration of articular cartilage without any underlying cause. Secondary osteoarthritis can be caused due to either an abnormal amount of forces placed across the joint in a result of post-traumatic cause or due to abnormal articular cartilage, for example Rheumatoid arthritis. The prevalence of knee OA is higher as compared to other types of OA. As with increasing age and longer lifetime and higher average weight of population the incidence of knee OA increases, particularly in obese women. Women have a greater prevalence (42.1%) than do men (31.2%). There are different grades of knee OA. In Grade 1 There is a swelling of articular cartilage along with mild fibrillation in superficial zone. In Grade 2 Small portion of cartilage is lost and fibrillation occurs in deeper zone and clusters of chondrocytes begun to form. In Grade 3 formation of chondrons occurs and vertical fissures have advanced into middle zone. Early OA changes affects the superficial and middle zone of cartilage. There are different risk factors for developing Knee OA that includes age, Female Gender, Menopause, heredity, repetitive micro and macro trauma, alcohol and tobacco use and joint surgery. Some risk factors are modifiable and some are non-modifiable. Modifiable factors include: any trauma, occupation, weight, muscle weakness or imbalance, Prolonged standing and repetitive knee bending. Non-modifiable risk factors include Gender - females, Age, Genetics and Race. There can be different causes of knee OA including family history, obesity, age, diabetes, systemic inflammatory mediators, lower limb alignment, trauma and inflammation by metabolic syndrome. Diagnosis of Knee OA is mainly based on symptoms and X-rays according to Kellgren and Lawrence system for classification of Osteoarthritis. The Knee OA most common symptom is pain around knee joint, Pain can be of different nature such as dull, intermittent or sharp. Pain intensity can also vary from mild to moderate to severe. The Range of motion can also be decreased in knee OA. Other symptoms include grinding and popping sounds. Swelling, locking and giving way of the knee can also be seen in later stages. Inconsistencies are observed, in which they explain presence of Myofascial trigger points in surrounding muscles around knee. Studies showed treatment of trigger points will cause reduction in pain and improvement in functional capacity in Knee OA patients. There are different techniques to treat trigger points e.g. Dry needling and Integrated neuromuscular inhibition technique. Study reported that there's significant reduction in pain and disability along with improved ROM in Knee Osteoarthritis patients who received Integrated Neuromuscular Inhibition Technique combined with Conventional treatment. Another study conducted on Effect of Integrated Neuromuscular Inhibition Technique on Iliotibial Band Tightness in Osteoarthritis of Knee and their study concluded that there is a significant effect of Integrated Neuromuscular Inhibition Technique on iliotibial band tightness in osteoarthritis of knee. Study was done to check effect of Dry needling in an exercise program for older adults with knee OA, The study concluded Despite the pain intensity and disability clinically relevant improvement for both DN and Sham-DN combined with exercise, 6 sessions of DN added to a therapeutic exercise program for older adults with KO did not seem to improve pain intensity and functionality. Study conducted on Dry needling versus INIT on upper trapezius myofascial trigger points. According to study findings DN was more effective than INIT on management of upper trapezius active myofascial trigger points. Proper evidence behind comparative effect of INIT and DN on trigger points in knee OA patient is sparse and there are less number of studies with limited methodological design on these techniques. This study will contribute to compare the ef-fects of INIT and Dry Needling on Functional Disability, Pain and ROM in patients with knee OA, and to check whether which technique is more effective in treating trigger points in Knee Osteoarthritis patients ### Conditions Module **Conditions:** - Knee Osteoarthritis **Keywords:** - Trigger Points, - Knee Osteoarthritis, - Dry Needling, - Integrated Neuromuscular Inhibition Technique, ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 36 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** MTrPs points will be released with ischemic compression, position of ease will be acquired, and in the last METs will be performed. Ischemic compression applied through thumb on trigger point present in any muscle around the knee joint. **Intervention Names:** - Other: Integrated Neuromuscular Inhibition Technique: **Label:** Group: 1 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Dry needle will be targeting trigger points (TrPs) using in-and-out techniques such as 'pistoning' or 'sparrow pecking'. 0.25x25mm needle is inserted. **Intervention Names:** - Other: Dry needling: **Label:** Group: 2 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Group: 1 **Description:** MTrPs points will be released with ischemic compression, position of ease will be acquired, and in the last METs will be performed. Ischemic compression applied through thumb on trigger point present in any muscle around the knee joint. Compression will be increased gradually until first resistance will feel and maintained until it resolves, further increases then until no tissue resistance will be felt under thumb. This process is maintained for 30sec and repeated 3-5 times per session. Positional release technique: after applying pressure on trigger point, patient will acquire position of ease that is maintained for 20 sec whether its extension or flexion of knee. This process is repeated 3-5 times per session. Muscle Energy Technique will be applied on the muscle in which isometric contraction is maintained for 7-10sec against 20-25% strength. After completion of muscular contraction, the limb is moved away for muscular stretch and then position is maintained for 30 seconds **Name:** Integrated Neuromuscular Inhibition Technique: **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Group: 2 **Description:** Dry needle will be targeting trigger points (TrPs) using in-and-out techniques such as 'pistoning' or 'sparrow pecking'. 0.25x25mm needle is inserted. For vastus laterals patient is supine line with knee extended performing an isometric quadriceps contraction, maintaining a clean technique by using gloves and performing an alcohol wipe down bracket the tissue to be treated and inserting needle with direct approach towards the femur, performing pistoning. For vastus medialis patient is supine line with 30 degrees of knee flexion. A headless 0.25x25mm needle fixed between the fingers of non-dominant hand and inserted perpendicularly to the MTrPs with metacarpophalangeal flexion extension of 1st and 2nd fingers of dominant hand. For Gastrocnemius patient is prone lying and bolstered supported slight knee bend, for the upper part anterior medial approach is used and center of muscle belly slight medial anterior approach is used. **Name:** Dry needling: **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The WOMAC pain score is a numerical score that measures pain, stiffness, and functional limitations. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for pain, 0-8 for stiffness, and 0-68 for physical function. **Measure:** Western Ontario and McMaster Universities Arthritis Index **Time Frame:** 6th day **Description:** The numeric pain rating scale is a scale for self-report of pain intensity. It is an 11-point scale, where 0 means no pain and 10 means the worst possible pain. **Measure:** Numeric Pain Rating Scale **Time Frame:** 6th day **Description:** A goniometer is a device used in physical therapy to measure a joint's range of motion. It is essentially a protractor with two arms extending from it, used to measure a joint's range of motion.. There are two "arms" one that is stationary and one that is movable-that are hinged together. Each is positioned at specific points on the body with the center of the goniometer aligned at the joint of interest. The goniometer can be used to measure many joints such as the knee, hip, shoulder, or wrist. **Measure:** Goniometer: **Time Frame:** 6th day **Description:** It is a common method of classifying the severity of Osteoarthritis using five grades The grades are as follows: Grade 0 (none): definite absence of x-ray changes of osteoarthritis Grade 1 (doubtful): doubtful joint space narrowing and possible osteophytic lipping Grade 2 (minimal): definite osteophytes and possible joint space narrowing Grade 3 (moderate): moderate multiple osteophytes, definite narrowing of joint space and some sclerosis and possible deformity of bone ends Grade 4 (severe): large osteophytes, marked narrowing of joint space, severe sclerosis and definite deformity of bone ends. **Measure:** Kellgren and Lawrence system for classification of Osteoarthritis: **Time Frame:** 6th day ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Osteoarthritis Grade-1 to 2 Positive jump sign Vastus medialis(75.43%), Vastus laterals(65.78%), Gastrocnemius Exclusion Criteria: * Patient with history of RA or any autoimmune disorder Any systematic Illness Patient with Varicose vein Post traumatic, Post-Surgical and Post fractured **Maximum Age:** 60 Years **Minimum Age:** 40 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** imran.amjad@riphah.edu.pk **Name:** Imran Amjad, PhD **Phone:** 03324390125 **Role:** CONTACT #### Locations **Location 1:** **City:** Rawalpindi **Contacts:** ***Contact 1:*** - **Email:** lalgul.khan@riphah.edu.pk - **Name:** Lal Gul Khan, MScPT - **Phone:** 03002146287 - **Role:** CONTACT ***Contact 2:*** - **Name:** Iqra Iftikhar, MSPT - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Pakistan **Facility:** Wah General Hospital, **State:** Punjab **Status:** RECRUITING **Zip:** 44000 #### Overall Officials **Official 1:** **Affiliation:** Riphah International University **Name:** Lal Gul Khan, MScPT **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Hsu H, Siwiec RM. Knee Osteoarthritis. 2023 Jun 26. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK507884/ **PMID:** 29939661 **Citation:** Lespasio MJ, Piuzzi NS, Husni ME, Muschler GF, Guarino A, Mont MA. Knee Osteoarthritis: A Primer. Perm J. 2017;21:16-183. doi: 10.7812/TPP/16-183. **PMID:** 29035179 **Citation:** Heidari B. Knee osteoarthritis diagnosis, treatment and associated factors of progression: part II. Caspian J Intern Med. 2011 Summer;2(3):249-55. **PMID:** 24049581 **Citation:** Favero M, Ramonda R, Goldring MB, Goldring SR, Punzi L. Early knee osteoarthritis. RMD Open. 2015 Aug 15;1(Suppl 1):e000062. doi: 10.1136/rmdopen-2015-000062. eCollection 2015. **PMID:** 26557380 **Citation:** Ejaz F, Safdar M, Ejaz H. Comparative Effectiveness of Integrated Neuromuscular Inhibition Technique Along with Conventional Treatment Vs Conventional Treatment Alone in Patients of Knee Osteoarthritis. Pakistan Journal of Medical & Health Sciences. 2023;17(01):859-. **Citation:** Albin SR, Koppenhaver SL, MacDonald CW, Capoccia S, Ngo D, Phippen S, Pineda R, Wendlandt A, Hoffman LR. The effect of dry needling on gastrocnemius muscle stiffness and strength in participants with latent trigger points. J Electromyogr Kinesiol. 2020 Dec;55:102479. doi: 10.1016/j.jelekin.2020.102479. Epub 2020 Oct 9. **PMID:** 33075711 **Citation:** Muraja S, Markulinčić B. FRI0597-HPR The effect of physical therapy on functional status and synovial perfusion in patients with knee osteoarthritis. Annals of the Rheumatic Diseases. 2013;72(Suppl 3):A578-A. **Citation:** Mayoral O, Salvat I, Martin MT, Martin S, Santiago J, Cotarelo J, Rodriguez C. Efficacy of myofascial trigger point dry needling in the prevention of pain after total knee arthroplasty: a randomized, double-blinded, placebo-controlled trial. Evid Based Complement Alternat Med. 2013;2013:694941. doi: 10.1155/2013/694941. Epub 2013 Mar 27. **PMID:** 23606888 **Citation:** Chavan SE, Shinde S. Effect of Integrated Neuromuscular Inhibition Technique on Iliotibial Band Tightness in Osteoarthritis of Knee **Citation:** Sanchez-Romero EA, Pecos-Martin D, Calvo-Lobo C, Ochoa-Saez V, Burgos-Caballero V, Fernandez-Carnero J. Effects of dry needling in an exercise program for older adults with knee osteoarthritis: A pilot clinical trial. Medicine (Baltimore). 2018 Jun;97(26):e11255. doi: 10.1097/MD.0000000000011255. **PMID:** 29952993 **Citation:** Abdelaziz YM, Abulkasem ST, Yamny AA. Dry Needling Versus Integrated Neuromuscular Inhibition Technique on Upper Trapezius Myofascial Trigger Points. Egypt J Appl Sci. 2020;35:45-56. ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001168 - Term: Arthritis - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000012216 - Term: Rheumatic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases ### Condition Browse Module - Browse Leaves - ID: M12926 - Name: Osteoarthritis - Relevance: HIGH - As Found: Osteoarthritis - ID: M22168 - Name: Osteoarthritis, Knee - Relevance: HIGH - As Found: Knee Osteoarthritis - ID: M4476 - Name: Arthritis - Relevance: LOW - As Found: Unknown - ID: M10621 - Name: Joint Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M15045 - Name: Rheumatic Diseases - Relevance: LOW - As Found: Unknown - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010003 - Term: Osteoarthritis - ID: D000020370 - Term: Osteoarthritis, Knee ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M3777 - Name: Ethanol - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437717 **Brief Title:** Role of Nanoemulsified Sesame Oil in Post-operative Care After Endoscopic Sinus Surgery **Official Title:** Role of Nanoemulsified Sesame Oil in Post-operative Care After Endoscopic Sinus Surgery #### Organization Study ID Info **ID:** MS.20.5.1134 #### Organization **Class:** OTHER **Full Name:** Mansoura University ### Status Module #### Completion Date **Date:** 2024-03-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-25 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-12-01 **Type:** ACTUAL #### Start Date **Date:** 2022-12-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-25 **Study First Submit QC Date:** 2024-05-25 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Mansoura University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The goal of our thesis is to design, develop and characterize a novel thermodynamically stable NE by spontaneous method intended for topical use. Subsequently, appraisal of nanoemulsified sesame oil formulation has been performed on the post-operative symptoms in CRS patients who have undergone ESS (endoscopic sinus surgery) combined with different types of nasal irrigation which may affect formulation efficacy. ### Conditions Module **Conditions:** - Chronic Rhinosinusitis (Diagnosis) ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Other: application of different topical nasal solutions **Label:** only normal saline as nasal irrigation **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Intervention Names:** - Other: application of different topical nasal solutions **Label:** normal saline as nasal irrigation followed by sesame oil nasal drops **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Intervention Names:** - Other: application of different topical nasal solutions **Label:** only Ringer's lactate solution as nasal irrigation **Type:** ACTIVE_COMPARATOR #### Arm Group 4 **Intervention Names:** - Other: application of different topical nasal solutions **Label:** Ringer's lactate solution as nasal irrigation followed by sesame oil nasal drops **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Ringer's lactate solution as nasal irrigation followed by sesame oil nasal drops - normal saline as nasal irrigation followed by sesame oil nasal drops - only Ringer's lactate solution as nasal irrigation - only normal saline as nasal irrigation **Description:** each group receives a type of nasal solution to detect if there is a difference in the outcomes in chronic rhinosinusitis patients **Name:** application of different topical nasal solutions **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Measure:** Sinonasal Outcome Test 22 (SNOT-22) **Time Frame:** weekly for three months **Measure:** Lund-Kennedy endoscopic grading system **Time Frame:** once monthly for three months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Patient age between 18 and 60 years old. 2. chronic rhinosinusitis patients who have undergone endoscopic sinus surgery. Exclusion Criteria: 1. Patients with history of allergy for sesame seed derivatives. 2. Patients with chronic diseases which affecting the process of healing (uncontrolled DM, renal failure and hepatic failure). 3. Patients with nasal granulomas. 4. Patients with invasive fungal rhinosinusitis. 5. Smokers. 6. Patients with history of radio and/or chemotherapy exposure. 7. Patients with systemic diseases affecting integrity of nasal mucosa (e.g. CF, scleroderma, Sjogren syndrome ...). **Maximum Age:** 60 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Mansoura **Country:** Egypt **Facility:** Mansoura University **State:** Dakahliya **Zip:** 35511 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012220 - Term: Rhinitis - ID: D000012141 - Term: Respiratory Tract Infections - ID: D000007239 - Term: Infections - ID: D000012852 - Term: Sinusitis - ID: D000010254 - Term: Paranasal Sinus Diseases - ID: D000009668 - Term: Nose Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000010038 - Term: Otorhinolaryngologic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC09 - Name: Ear, Nose, and Throat Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M3269 - Name: Rhinosinusitis - Relevance: HIGH - As Found: Rhinosinusitis - ID: M15049 - Name: Rhinitis - Relevance: LOW - As Found: Unknown - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown - ID: M15657 - Name: Sinusitis - Relevance: LOW - As Found: Unknown - ID: M13167 - Name: Paranasal Sinus Diseases - Relevance: LOW - As Found: Unknown - ID: M12604 - Name: Nose Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M12961 - Name: Otorhinolaryngologic Diseases - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown - ID: T5183 - Name: SeSAME Syndrome - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000096825 - Term: Rhinosinusitis ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437704 **Brief Title:** Effects of Brain Training Games on Cognitive Function and Quality of Life in MCI **Official Title:** The Effects of Brain Training Games on Cognitive Function and Quality of Life Among Older Adults With Mild Cognitive Impairment #### Organization Study ID Info **ID:** Lylas Ali #### Organization **Class:** OTHER **Full Name:** Riphah International University ### Status Module #### Completion Date **Date:** 2024-10-16 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-30 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-10-16 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-16 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-26 **Study First Submit QC Date:** 2024-05-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Riphah International University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The study aims to determine the effects of brain training games on cognitive function and Quality of life among older adults with MCI. **Detailed Description:** The study aims to determine the effects of brain training games on cognitive function and Quality of life among older adults with MCI.This study will assess the efficacy of Brain training games. Lumosity on the cognitive function and Quality of life among older adults with MCI .Beyond cognitive rehabilitation, this intervention holds promise as a cost-effective approach to delay, maintain, or even improve cognitive decline associated with the aging process. ### Conditions Module **Conditions:** - Mild Cognitive Impairment **Keywords:** - Cognition - Aging - Quality of life - Brain training games ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 44 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Brain training game (Lumosity) **Intervention Names:** - Other: Brain training game Lumosity **Label:** Experimental **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Simulation game (Simcity buildit) **Intervention Names:** - Other: Simulation game simcity buildit **Label:** Control **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental **Description:** . Group A, the experimental group will be trained using five selected games i.e. Speed Match, Memory Matrix, Tidal treasure, Ebb and Flow and Lost in Migration from Lumosity for a period of 30 sessions , 30 min/ day over the span of 6 weeks. **Name:** Brain training game Lumosity **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Control **Description:** Group B, the active control will be trained for the same number of sessions using a simulation game, SimCity Build it, for a period of 30 sessions , 30 min/ day over the span of 6 weeks. **Name:** Simulation game simcity buildit **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Brief cognitive function assessment is done using MoCA Questionnaire which consist of 12 items, that is to say visuospatial, executive functioning, short-term memory, attention or concentration, working memory, language, and lastly orientation. The total score of this Questionnaire is 30. As per grading system, the score of 26 to 30 represent normal cognition, score of 18 to 25 denotes mild cognitive impairment and score of 10-17 signifies moderate cognitive impairment. Lastly, score of less than 10 embodies severe cognitive impairment. The inter-rater reliability or ICC value is 0.96 (95% CI: 0.91-0.98). Cronbach's alpha is 0.79 and AUC of 0.89 (95% CI: 0.83-0.95). **Measure:** Montreal Cognitive Assessment Scale **Time Frame:** 6 weeks **Description:** Trail making test is a brief paper and pencil test used to screen for any cognitive impairment with the test scored by how long does it takes for a person to complete it. In part A of the test, the patient draw lines to join numbered circles from 1-to 25, connecting them in ascending order. The average score for completing this test is 29 seconds, whereas the rule of thumb suggests a typical score of 90 seconds. A score of greater than 78 seconds indicates deficiency. In part B of the test, the patient connect the circles alternating between numbers from 1 to 13 and letters from A to L. The average score is 75 seconds, with score of greater than 273 seconds representing deficiency. The rule of thumb for this test is a typical score of 3 minutes. The retest reliability for part A is between 0.76 and 0.89 and for part B it lies between 0.86 and 0.94. The Cronbach's alpha for this neuropsychological test is 0.90. **Measure:** Trail Making Test A and B **Time Frame:** 6 weeks **Description:** WHO-QOL BREIF questionnaire is a 26 items tool for measuring quality of life. It address four domains of quality of life which includes physical health comprising of 7 items, psychological health having 6 items, social relationships 3 items, and environmental health encompassing 8 items; it also contains QOL and general health items. Each item in the questionnaire is scored on a 5 point ordinal scale; from 1 to 5.The scores are then transformed linearly to a 0 to 100 scale where 0 score represents the worst of health and maximum score of 100 indicates best possible state of health. The Cronbach's alpha coefficient for this questionnaire is 0.86 and the ICC value is 0.74. The CVI score is within the range of 0.78 to 1.00 **Measure:** World Health Organization Quality of Life Brief Version (WHO-QOL BREF) Questionnaire: **Time Frame:** 6 weeks **Description:** IPAQ is a self-reported tool for the assessment of level of physical activity. It evaluates the duration of physical activity in the last 7 days in the domains of job related physical activity, transportation , house chores and house maintenance, caring for family, recreational activities, sport, and leisure-time physical activity as well as time spent sitting. The score is recorded in the form of MET minutes. The total minutes per week spent on each activity type, that is walking (3.3 METs), doing moderate (4.0 METs) or vigorous physical activity (8.0 METs) are calculated and converted into MET-minutes. The sum of total MET-minutes for each activity determine the level of total physical activity. The questionnaire has an excellent test-retest reliability for physical activity (ICC = 0.84-1.00) as well as an exceptional concurrent validity: ρ = 0.71 **Measure:** International Physical Activity Questionnaire (IPAQ); **Time Frame:** 6 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Older adults of age \>50 years and above * Both male and female * Education level matriculation at least * Mild cognitive impairment ( MOCA score of 18-25) * Active independent individuals with normal hearing and normal or corrected-to-normal vision. Exclusion Criteria: * Moderate to severe cognitive impairment * Diagnosed case of dementia, depression or other mental issues. * Current plans to move to another city. **Maximum Age:** 80 Years **Minimum Age:** 50 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** arshad.nawaz@riphah.edu.pk **Name:** Arshad Nawaz Malik, PhD **Phone:** 03334503754 **Role:** CONTACT #### Locations **Location 1:** **City:** Islamabad **Contacts:** ***Contact 1:*** - **Email:** arshad.nawaz@riphah.edu.pk - **Name:** Arshad Nawaz Malik, PhD - **Phone:** 03334503754 - **Role:** CONTACT ***Contact 2:*** - **Email:** lylasali.61@gmail.com - **Name:** Lylas Ali, MS-NMPT* - **Phone:** 03045195505 - **Role:** CONTACT ***Contact 3:*** - **Name:** Lylas Ali, MS-NMPT* - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Pakistan **Facility:** Riphah International University, Gulberg Green Campus **State:** Punjab **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Riphah International University Islamabad **Name:** Arshad Nawaz Malik, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003072 - Term: Cognition Disorders - ID: D000019965 - Term: Neurocognitive Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M29705 - Name: Cognitive Dysfunction - Relevance: HIGH - As Found: Mild Cognitive Impairment - ID: M6301 - Name: Cognition Disorders - Relevance: LOW - As Found: Unknown - ID: M21836 - Name: Neurocognitive Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: HIGH - As Found: Quality of Life ### Condition Browse Module - Meshes - ID: D000060825 - Term: Cognitive Dysfunction ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437691 **Brief Title:** Effect of Stent Placement on Short Term Survival of Left Sided Obstructive Colorectal Cancers Comparison of Bridge-To-Surgery Versus Emergency Surgery Approaches **Official Title:** Effect of Stent Placement on Short Term Survival of Left Sided Obstructive Colorectal Cancers. Comparison of Bridge-To-Surgery Versus Emergency Surgery Approaches #### Organization Study ID Info **ID:** StentSurv #### Organization **Class:** OTHER **Full Name:** Kanuni Sultan Suleyman Training and Research Hospital ### Status Module #### Completion Date **Date:** 2024-02-20 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-25 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-02-20 **Type:** ACTUAL #### Start Date **Date:** 2016-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-25 **Study First Submit QC Date:** 2024-05-25 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Yasir Musa Kesgin, MD #### Responsible Party **Investigator Affiliation:** Kanuni Sultan Suleyman Training and Research Hospital **Investigator Full Name:** Yasir Musa Kesgin, MD **Investigator Title:** MD **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The aim of this observational study is to determine effect of stent placement on survival results in first three years in a patient who applied to the emergency department with obstruction due to colorectal cancer. Eligible patients divided into two groups. Group A includes patients underwent emergency surgery directly. Patients underwent elective surgery following stent placement as bridge-to-surgery. Patients underwent elective surgery following bridge-to-surgery stent placement were accepted as Group B. **Detailed Description:** Patients who applied to emergency department of a single tertiary referral center between January 2016 and December 2020 and diagnosed as left sided obstructive colorectal cancer were included in this retrospective study. All patients were equal or older than 18 years and histopathologically found to have primary colorectal malignant neoplasms. Patients were excluded from the analysis if they met any of the following criteria: * Who underwent emergency surgery due to unsuccessful stent application intervention or stent-related complications developed, * Those with middle and lower rectum tumors or received neoadjuvant treatment, * Perforation, * Who underwent subtotal or total colectomy (as a result of colon ischemia in the cecum, microperforation, etc.), * Recurrent disease patients * Patients have metastasis ### Conditions Module **Conditions:** - Colorectal Cancer **Keywords:** - Obstructive Colorectal Cancer, Colorectal Emergencies, Self Expandable Metallic Stents ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 65 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients underwent emergency surgery directly after coming to emergency department due to left sided obstructive colorectal cancer **Label:** Group A - Emergency Surgery Group #### Arm Group 2 **Description:** Left sided obstructive colorectal cancer patients underwent elective surgery following decompression via self-expandable metallic stent placement. **Intervention Names:** - Procedure: Self-Expandable Metallic Stent Placement **Label:** Group B - Stent Group ### Interventions #### Intervention 1 **Arm Group Labels:** - Group B - Stent Group **Name:** Self-Expandable Metallic Stent Placement **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** The survival time of patient after being diagnosed as colorectal cancer after coming to emergency department **Measure:** Overall Survival **Time Frame:** 3 years **Description:** The local or systemic recurrence free time period of patient after being diagnosed as colorectal cancer after coming to emergency department **Measure:** Disease Free Survival **Time Frame:** 3 years #### Secondary Outcomes **Description:** Death of patient in postoperative first three months **Measure:** Mortality **Time Frame:** 90 days **Description:** Postoperative complications of patients that have a Clavien-Dindo Score greater than or equal to 3 **Measure:** Serious complications **Time Frame:** 90 days **Description:** Patients that found a chance for fully minimally invasive surgery for resection of colorectal cancer **Measure:** Minimally invasive surgery **Time Frame:** 90 days **Description:** Patients that have a end colostomy at the end of surgical resection of colorectal cancer **Measure:** End colostomy rate **Time Frame:** 90 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * All patients were equal or older than 18 years and histopathologically found to have primary colorectal malignant neoplasms and diagnosed as left sided (descending colon, sigmoid colon and upper rectum) obstructive colorectal cancer were included Exclusion Criteria: * Who underwent emergency surgery due to unsuccessful stent placement intervention * Who underwent emergency surgery due to stent-related complications * Those with middle and lower rectum tumors * Those received neoadjuvant treatment, * Patients have perforation, * Who underwent subtotal or total colectomy (as a result of colon ischemia in the cecum, microperforation, etc.), * Who has a recurrent disease or metastasis. **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients come to emergency department and diagnosed as left sided obstructive colorectal cancer ### Contacts Locations Module #### Overall Officials **Official 1:** **Affiliation:** Bakırköy Dr. Sadi Konuk Training and Research Hospital **Name:** Ahmet Sürek **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **Description:** The datasets generated and analysed during the current study are not publicly available due to institutional policies but are available from the contact person on reasonable request. **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007414 - Term: Intestinal Neoplasms - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000003108 - Term: Colonic Diseases - ID: D000007410 - Term: Intestinal Diseases - ID: D000012002 - Term: Rectal Diseases - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases ### Condition Browse Module - Browse Leaves - ID: M7796 - Name: Emergencies - Relevance: HIGH - As Found: Emergency - ID: M17890 - Name: Colorectal Neoplasms - Relevance: HIGH - As Found: Colorectal Cancer - ID: M10448 - Name: Intestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M6336 - Name: Colonic Diseases - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M14844 - Name: Rectal Diseases - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000015179 - Term: Colorectal Neoplasms - ID: D000004630 - Term: Emergencies ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437678 **Brief Title:** Phase II Study of Liposomal Irinotecan for Advanced Refractory Gastric Cancer **Official Title:** A Single-Center, Prospective Phase II Clinical Study of Liposomal Irinotecan Monotherapy for Third-Line and Beyond Recurrent/Refractory Advanced Gastric Cancer #### Organization Study ID Info **ID:** IRB-2024-498 #### Organization **Class:** OTHER **Full Name:** Zhejiang Cancer Hospital ### Status Module #### Completion Date **Date:** 2026-02-28 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-30 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-02-28 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-27 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-24 **Study First Submit QC Date:** 2024-05-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Zhejiang Cancer Hospital #### Responsible Party **Investigator Affiliation:** Zhejiang Cancer Hospital **Investigator Full Name:** Xiangdong Cheng **Investigator Title:** Chief physician **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** To evaluate the objective response rate (ORR) and disease control rate (DCR) of liposomal irinotecan monotherapy in the treatment of recurrent/refractory advanced gastric cancer. **Detailed Description:** This study is a single-arm, single-center, prospective clinical trial aimed at evaluating the efficacy and safety of liposomal irinotecan monotherapy in the treatment of recurrent/refractory advanced gastric cancer. The study targets patients with locally advanced, recurrent, or metastatic/previous treatment-refractory adenocarcinoma of the stomach or gastroesophageal junction. The primary endpoints of the study are objective response rate (ORR) and disease control rate (DCR). It plans to enroll 50 patients with locally advanced, recurrent, or metastatic/previous treatment-refractory adenocarcinoma of the stomach or gastroesophageal junction. Subjects will sign informed consent and undergo screening for eligibility before enrollment. Subjects will receive the following treatment: Liposomal Irinotecan Hydrochloride Injection (Ⅱ) 56.5mg/m2 every 2 weeks. Safety visits will be conducted on Day 1 of each treatment cycle, at the end of the study treatment, and 30 days (±7 days) after the end of the study treatment. Imaging assessments will be performed according to RECIST 1.1 criteria, including chest CT, enhanced CT scans of the abdomen and pelvis, or chest CT plain scan plus abdominal/pelvic MRI scan for patients allergic to contrast agents. Suspected cases of brain metastases will require brain enhanced MRI or enhanced CT. Bone scan examination will be conducted if bone metastases are suspected clinically or radiologically. Patients who discontinue treatment due to reasons other than radiological progression during the treatment period will undergo imaging examination at the end of treatment unless it has been conducted within 28 days. Subjects will undergo survival follow-up every 3 months after the end of treatment to collect and record survival status and subsequent anti-tumor treatment until death or loss to follow-up. ### Conditions Module **Conditions:** - Gastric Cancer ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: Liposomal Irinotecan Hydrochloride **Label:** Recurrent/Refractory Advanced Gastric Cancer **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Recurrent/Refractory Advanced Gastric Cancer **Description:** Liposomal Irinotecan Hydrochloride Injection (Ⅱ) 56.5mg/m2 every 2 weeks **Name:** Liposomal Irinotecan Hydrochloride **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** After treatment, the proportion of cancer patients whose tumors have shrunk to a predetermined value and can maintain the minimum time limit requirement is the sum of the complete response (CR) and partial response (PR) ratios. **Measure:** Objective response rate (ORR) **Time Frame:** through study completion, an average of 1 year **Description:** The percentage of evaluable cases in cancer patients who have improved their condition (CR+PR) and stabilized their condition (SD) after treatment. **Measure:** Disease Control Rate (DCR) **Time Frame:** through study completion, an average of 1 year #### Secondary Outcomes **Description:** The time between the date of enrollment and death caused by any reason. **Measure:** OS (Overall survival) **Time Frame:** Assessed up to 60 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients voluntarily join this study and sign an informed consent form; * Age ≥18 years and ≤75 years; * Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma; * CT or biopsy-confirmed recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma; * Previously received at least one line of standard first- and second-line therapy (e.g., chemotherapy, targeted therapy), and experienced disease progression or intolerance; * Interval of ≥4 weeks since previous chemotherapy, immunotherapy, or radiotherapy; * Expected survival of ≥12 weeks; * ECOG performance status score of 0-2; * Normal major organ function, meeting the following criteria: 1. Hematologic criteria: (No blood transfusion or blood products, and no use of G-CSF or other hematopoietic growth factors within 14 days) Absolute neutrophil count ≥1.5×10\^9/L; Platelets ≥80×10\^9/L; Hemoglobin ≥80 g/L. 2. Biochemical criteria: Total bilirubin \<1.5×ULN; ALT and AST ≤2.5×ULN (without liver metastasis) / ALT and AST ≤5×ULN (with liver metastasis); Serum creatinine ≤1.5×ULN or creatinine clearance \>50 ml/min (Male: creatinine clearance = ((140 - age) × weight) / (72 × serum creatinine); Female: creatinine clearance = ((140 - age) × weight) / (72 × serum creatinine) × 0.85; weight in kg; serum creatinine in mg/mL). 3. Urine protein (semi-quantitative method) less than 2+; 4. Normal coagulation function (including INR, APTT, PT, FIB). * Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose and agree to use effective contraception during the study and for 120 days after the last dose. Male participants with partners of childbearing potential must be surgically sterilized or agree to use effective contraception during the study and for 120 days after the last dose. Exclusion Criteria: * Having a history of or currently suffering from other malignant tumors; * Previous or current use of irinotecan drugs; * Having any chronic or significant disease deemed intolerable to treatment (e.g., severe heart disease, uncontrolled hypertension, significant liver or kidney dysfunction, etc.); * History of gastrointestinal perforation, abdominal abscess, or recent (within 3 months) bowel obstruction, or imaging or clinical symptoms indicating the presence of bowel obstruction; * Significant clinically relevant bleeding symptoms or a clear tendency to bleed within 3 months before the first dose of the study drug, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, or vasculitis; if fecal occult blood is positive at baseline, retesting is allowed. If retesting remains positive, a gastroscopy is required (unless gastroscopy has been performed within the past 3 months to exclude these conditions); * Currently undergoing treatment for an active infection (e.g., requiring antibacterial, antiviral, or antifungal therapy); * Active hepatitis (Hepatitis B: HBsAg positive and HBV DNA ≥500 IU/ml; Hepatitis C: HCV antibody positive and HCV RNA \> upper limit of normal); * Congenital or acquired immunodeficiency (e.g., HIV infection); * Suffering from a mental illness that could interfere with consent or follow-up; * Having any active autoimmune disease or a history of autoimmune disease with a risk of recurrence; * Planned or previous organ or allogeneic bone marrow transplantation; * Currently having interstitial pneumonia or interstitial lung disease, a history of interstitial pneumonia or interstitial lung disease requiring steroid treatment, or a screening CT showing active pneumonia or severe lung dysfunction; active tuberculosis; * Currently using or recently used immunosuppressive drugs or systemic corticosteroids for immunosuppressive purposes; * Received an attenuated live vaccine within 28 days before the first dose of the study drug, or requires such a vaccine during the treatment period or within 60 days after the last dose; * Known allergy to any study drug or excipients; * Breastfeeding women. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** chengxd@zjcc.org.cn **Name:** Xiangdong Cheng **Phone:** 13968032995 **Role:** CONTACT **Contact 2:** **Email:** yuanli2768@zjcc.org.cn **Name:** Li Yuan **Phone:** 15558103169 **Role:** CONTACT #### Locations **Location 1:** **City:** Hangzhou **Country:** China **Facility:** Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital) **State:** Zhejiang #### Overall Officials **Official 1:** **Affiliation:** Zhejiang Cancer Hospital **Name:** Xiangdong Cheng **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000013272 - Term: Stomach Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16064 - Name: Stomach Neoplasms - Relevance: HIGH - As Found: Gastric Cancer - ID: M14850 - Name: Recurrence - Relevance: LOW - As Found: Unknown - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M16062 - Name: Stomach Diseases - Relevance: LOW - As Found: Unknown - ID: T5486 - Name: Stomach Cancer - Relevance: HIGH - As Found: Gastric Cancer ### Condition Browse Module - Meshes - ID: D000013274 - Term: Stomach Neoplasms ### Intervention Browse Module - Ancestors - ID: D000059004 - Term: Topoisomerase I Inhibitors - ID: D000059003 - Term: Topoisomerase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000970 - Term: Antineoplastic Agents ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M1671 - Name: Irinotecan - Relevance: HIGH - As Found: International - ID: M29349 - Name: Topoisomerase I Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000077146 - Term: Irinotecan ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437665 **Brief Title:** Tech-wise Driver (Technology Acceptance of Targeted ADAS for Older Adults) **Official Title:** The Tech-wise Driver: Exploring the Sustained Efficacy and Technology Acceptance of Targeted ADAS for Older Drivers #### Organization Study ID Info **ID:** R5570A12 #### Organization **Class:** OTHER **Full Name:** Western University, Canada ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-30 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-05-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-24 **Study First Submit QC Date:** 2024-05-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Western University, Canada #### Responsible Party **Investigator Affiliation:** Western University, Canada **Investigator Full Name:** Liliana Alvarez Jaramillo **Investigator Title:** Associate Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The tech-wise driver: Exploring the sustained efficacy and technology acceptance of targeted ADAS for older drivers A significant percentage of road traffic fatalities registered in Canada occurred among older adults. According to the studies, the Advanced Driver Assistance Systems (ADAS) can enhance the safety and mitigate the age-related declines of older drivers. Whether sustained use results in declines in driving performance in older drivers relying on ADAS remains largely unexplored. This is problematic given emerging evidence on ADAS use by older drivers. Furthermore, exploring changes in ADAS technology acceptance in relation to sustained use can inform the correlation between perceived safety and intention to use. The investigators hypothesize that, compared to driving simulator training alone, lane departure warning (LDW), cruise control (CC), and forward proximity warning (FPW) technology will result in a sustained decrease of critical driving errors in this population; and that exposure to the technology will increase participants' perceived usability and ease of use. To achieve this goal, the investigators will explore the determination of sustained efficacy, establish the impact of technology exposure, evaluate the concurrent validity of a computerized model of driving error type and severity using trained occupational therapy in-vehicle evaluation as the criterion, when evaluating older drivers 'performance. Our findings may significantly impact the ability of older drivers to choose in-vehicle technologies, and our study will be the first to assess the criterion validity of a simulator-derived computerized model against the findings of an evaluator-based functional assessment. **Detailed Description:** The driving simulator will be used to collect data on drivers in driving scenarios that include situations that may be more challenging for some drivers, e.g., pedestrian stepping into a crosswalk, a vehicle pulling out of a parking spot, a vehicle suddenly changing lanes. Vehicle data and gaze data will be collected for drivers along with images from the simulated environment. The simulator will measure driving performance through metrics generated from the simulator, e.g. pedal (i.e., gas and brake) reaction time, vehicle velocity, headway distance/time, etc. Participants: Licensed older drivers (≥65 years of age) will be included in this study. Participants will be excluded if they have neurological or psychiatric conditions that would preclude full participation in driving activity, or if they take medications that may have a sustained negative impact on their mental and/or physical functioning during driving. Sample Size: A sample size of n=68 will be recruited to achieve 80% power to detect a medium effect size of .50 based on a two-sided significance test with a significance level of 0.05. Procedure: 1. Interested potential participants will reach to the team, using the information distributed during recruitment. 2. Upon confirm eligibility criteria, the first session will be scheduled. 3. Participants will receive a parking pass to park on the premises. 4. The first session will take approximately 1 hr to complete. 5. The objective of the study will be reviewed with each participant and they will be shown the simulator. 2.b. Participants will complete a battery of paper and pencil and computer tests. Of these tests, the first will be vision screening testing to make sure they meet inclusion criteria. Visual acuity (monocular and binocular) will be assessed via Snellen vision charts; visual acuity, peripheral fields, contrast sensitivity, color discrimination, depth perception, lateral phorias and vertical phorias will be assessed via the Optec 5000® Visual Analyzer (Stereo Optical Company, Inc., Chicago, IL). After vision screening, participants will complete an intake form. This is a standardized intake form adapted by the research team which will collect the following information: age, gender, preferred method of contact information for scheduling purposes, self-identified ethnicity, level of education, occupation, and medications. The questions regarding ethnic origin and population group are based on Statistics Canada updated standards. 2.c. Driving History and Habits: The participants will complete several tests germane to their driving history. First, participants will complete a driving history form adapted by the research team (based on Ali et al., 2014). The form will collect information in three sections. Section one will include age at which participants obtained their first license, type of vehicle participants normally drive, whether participants have been involved in a motor vehicle crash and previous use of ADAS technology. Second, participants will complete the computer-based Useful Field of View (UFOV). The UFOV is a standardized test which assesses visual perception and attention (Edwards et al., 2005). This test has shown to be correlated with driving performance among older drivers. The UFOV consists of three subtests that assess attention, divided attention, and selective attention. Finally, the participants will complete the Comprehensive Trail Making Test (CTMT), a normed test in which participants are presented with a standardized set of five visual search and sequencing tasks using pen and paper (Reynolds, 2002). Rapid Pace Walk Administration: A physical assessment involving walking at a brisk pace, potentially used to evaluate gait and mobility, which can impact a person's ability to operate pedals and controls in a vehicle. Finger to Nose Administration: A motor coordination test where the participant touches their nose with their finger, assessing fine motor skills and coordination relevant for tasks like steering and operating switches while driving. Adelaide Self-Efficacy Driving Scale: A self-report questionnaire assessing the participant's confidence and perceived ability in various driving situations, helping to understand their subjective assessment of their driving skills. Modified Simulator Sickness Questionnaire: A questionnaire measuring symptoms of simulator sickness or discomfort experienced during driving simulation sessions, important for evaluating the usability and comfort of simulation-based assessments. Driving Simulation Evaluation Form: A structured form or checklist used to evaluate the participant's performance and behavior during driving simulation scenarios, providing objective data on driving skills and behaviors. Manchester Driving Behavior Questionnaire: A questionnaire assessing self-reported driving behaviors and attitudes, offering insights into the participant's driving style, risk perception, and adherence to traffic rules. The post-assessment tests generally involve reassessing specific aspects measured during the baseline assessment or evaluating any changes or improvements following interventions or training. 2.d. Following these tests, participants will complete their simulation drives. The investigators will employ a clinical driving simulator (DriveSafety Inc., Salt Lake City, UT). Prior to each drive, participants will be exposed to an acclimation drive. Acclimation drives are part of a mitigation protocol aimed at reducing the likelihood of participants experiencing discomfort caused by simulation. Such drives last no longer than 7 minutes, and slowly introduce the participant to the simulation, starting with simple maneuvers (e.g., accelerate ad stop) and progressively introducing more complex maneuvers (e.g. turning). 2.e. Each Participants will then complete a randomized 15-minute drive. Participants will then take part in three sets of four training sessions in which the ADAS will be simulated (experimental group) or a training script will be provided (control). After each set of four drives, a simulator assessment post-test will be completed with the final post-test also including the battery of clinical assessments. Available routes will be randomly allocated and counterbalanced across participants. All drives will be recorded (frontal view of the driver as well as simulated drive). Once a participant has completed all drives, the recordings will be sent to a blinded trained evaluator (occupational therapist and driving rehabilitation specialist). The study will use a high-fidelity clinical driving simulator (DriveSafety Inc) configured with three 19 inch flat-panel displays; 110-degree field of view; 1920 x 1080 pixels/screen. Raw files will be used to develop and compute the model for comparison. The drive using the simulator will be recorded (mp4). This will allow the post-drive evaluation of the number and type of driving errors conducted by the research team. In addition to recording the simulation drive, a camera located in the simulator records the face of the driver to enable scoring of visual scanning errors. All video files are stored in the password protected research drive connected to the simulator computer in the research lab, and only accessible to members of this research team. There will also be a stereo camera attached to the simulator for collecting gaze information of the driver. This camera is connected to a computer running gaze analysis software and records only the gaze directions (as vector in the 3D space of the camera) and head direction (also a vector in the 3D space of the camera). This data is numeric and will be stored using the identifier assigned to the participant; no images are collected from this camera. Prior to and after each drive, the Adapted Motion Sickness Questionnaire will be used to monitor for any signs of simulator sickness. If a participant scores over 5 in any of the items, the session will be suspended, the participants remunerated and provided with access to water, ginger ale, crackers, and cool room. No further drives will be attempted to avoid any risk of increasing simulator sickness. 2.f. After the driving session, the research team will thank the participant and provide remuneration. 3.In order to give the team access to the driving simulator metrics of each drive, a password protected One Drive folder within Western's license will be used. Only deidentified driving simulator data will be uploaded to the One Drive. ### Conditions Module **Conditions:** - Older Adults - Driving - Simulator **Keywords:** - Simulator driving, ADAS, Older Adults ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** The parallel model involves comparing two distinct groups, in this case, older drivers (≥65 years of age), who are randomly assigned to either receive ADAS-integrated driver simulation training or driving-simulator training alone. This model allows for a direct comparison between the two groups regarding the effectiveness of the targeted ADAS intervention on driving performance. ##### Masking Info **Masking:** NONE **Masking Description:** Masking, also known as blinding, refers to the practice of concealing information about the intervention assignment from certain parties involved in a study to reduce bias. In the described study, the masking applies to the Outcomes Assessor, who is an independent blinded occupational therapist responsible for evaluating the driving performance of participants. This means that the Outcomes Assessor will not be aware of which group (ADAS-integrated driver simulation training or driving-simulator training alone) each participant belongs to during the assessment process, helping to ensure an unbiased evaluation of the study outcomes. **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 68 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The intervention administered in this study is ADAS-integrated driver simulation training. Participants in this arm will undergo training sessions using a high-fidelity driving simulator equipped with Lane Departure Warning (LDW), Cruise Control (CC), and Forward Proximity Warning (FPW) technologies. These technologies are designed to assist older drivers (≥65 years of age) in improving their driving performance and reducing critical driving errors. The training will simulate real-world driving scenarios to help participants become familiar with and effectively use these ADAS features. **Intervention Names:** - Behavioral: The intervention name in this study is ADAS-integrated driver simulation training. **Label:** ADAS-integrated driver simulation training **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - ADAS-integrated driver simulation training **Description:** The intervention involves providing older drivers (≥65 years of age) with training sessions utilizing a high-fidelity driving simulator. This training focuses on the integration and use of Lane Departure Warning (LDW), Cruise Control (CC), and Forward Proximity Warning (FPW) technologies, collectively referred to as ADAS. The training is designed to familiarize participants with these advanced driver assistance systems, enabling them to effectively utilize these features while driving. **Name:** The intervention name in this study is ADAS-integrated driver simulation training. **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** This outcome aims to assess the sustained efficacy of a targeted Advanced Driver Assistance Systems (ADAS) intervention comprising Lane Departure Warning (LDW), Cruise Control (CC), and Forward Proximity Warning (FPW) technologies on the driving performance of older drivers (≥65 years). The study compares the performance of participants who receive ADAS-integrated driver simulation training against those who undergo driving-simulator training alone. The primary focus is on measuring the decrease in critical driving errors, as evaluated by an independent blinded occupational therapist, across post-test intervals. **Measure:** Number of driving errors **Time Frame:** The study will span over a 12-week period, encompassing pre-test, post-test 1, and post-test 2 assessments. **Description:** The blinded evaluator will record type pf driving errors, to establish if there is a decrease in the number of critical driving errors (i.e. those requiring physical intervention from an instructor). **Measure:** Type of driving errors **Time Frame:** The study will span over a 12-week period, encompassing pre-test, post-test 1, and post-test 2 assessments. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Must be 65 years of age or older. * Must hold a valid driver's license. Exclusion Criteria: * Neurological or psychiatric conditions that would preclude driving * Use of psychotropic medications that may have a sustained negative impact on mental and/or physical functioning **Healthy Volunteers:** True **Minimum Age:** 65 Years **Sex:** ALL **Standard Ages:** - OLDER_ADULT ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437652 **Brief Title:** An AI Algorithm for Lymphocyte Focus Score of Minor Salivary Gland Biopsy Samples for Diagnosing Sjogren's Syndrome **Official Title:** An Artificial Intelligence Algorithm for Lymphocyte Focus Score in Whole Slide Images of Minor Salivary Gland Biopsy Samples for Diagnosing Sjogren's Syndrome : a Blinded Clinical Validation and Deployment Study #### Organization Study ID Info **ID:** SYSKY-2023-915-01 #### Organization **Class:** OTHER **Full Name:** Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ### Status Module #### Completion Date **Date:** 2024-09-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-30 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-09-30 **Type:** ESTIMATED #### Start Date **Date:** 2023-10-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-11 **Study First Submit QC Date:** 2024-05-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University #### Responsible Party **Investigator Affiliation:** Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University **Investigator Full Name:** Moyingqian **Investigator Title:** Director **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The aim of this research is to discover an artificial intelligence (AI) algorithm for lymphocyte focus score in whole slide images of labial minor salivary gland (SG) biopsy samples for diagnosing Sjogren's Syndrome, in order to enhance the precision of pathological interpretation of labial minor SG biopsy samples in patients with suspected Sjogren's syndrome and aid clinicians make an accurate diagnose. A remote AI-assisted pathological interpretation platform for lymphocyte focus score in labial SG will be built for the global based on the research results. The research will propose the AI-assisted pathological interpretation of lymphocyte focus score in labial minor SG biopsy samples in the future guidelines for the diagnosis and treatment of Sjogren's syndrome. The research will： 1. Develop and debug the AI algorithm for lymphocyte focus score in whole slide images of labial minor SG biopsy samples for diagnosing Sjogren's Syndrome; 2. Internal test of the AI algorithm; 3. Clinical validation of the AI algorithm with blind method in multiple centers; 4）Built a remote AI-assisted pathological interpretation platform for lymphocyte focus score in labial SG for the global and Explore its clinical application. **Detailed Description:** 1. Develop and debug the AI algorithm for lymphocyte focus score in whole slide images of labial minor SG biopsy samples for diagnosing Sjogren's Syndrome; A total of 200 H\&E staining slides of labial minor SG biopsy samples are collected from Sun Yat-sen Memorial Hospital of Sun Yat-sen University and scanned into digital pathological images. The ground truth of gland tissue area and lymphocyte foci numbers in each image is interpreted by three senior pathologists with over 5 years of related experience. 2. Internal test of the AI algorithm; A total of 500 additional digital pathological images of labial gland biopsy tissues are collected from Sun Yat-sen Memorial Hospital of Sun Yat-sen University. The ground truth of gland tissue area and lymphocyte foci numbers in each images is interpreted by three senior pathologists with over 5 years of related experience. The AI algorithm's accuracy, specificity, sensitivity, positive predictive value and negative predictive value in evaluating the area of labial gland and the number of lymphocyte foci are calculated. Comparison of whether the image meets the criteria for Sjögren's syndrome (focus score greater than 1) is also conducted between the AI algorithm and the ground truth. 3. Clinical validation of the AI algorithm with blind method in multiple centers; A total of 600 additional digital pathological images of labial gland biopsy tissues are collected from six external centers. The ground truth of gland tissue area and lymphocyte foci numbers in each images is interpreted by three senior pathologists with over 5 years of related experience. The AI algorithm's accuracy, specificity, sensitivity, positive predictive value and negative predictive value in evaluating the area of labial gland and the number of lymphocyte foci are calculated. Comparison of whether the image meets the criteria for Sjögren's syndrome (focus score greater than 1) is also conducted between the AI algorithm and the ground truth. 4）Built a remote AI-assisted pathological interpretation platform for lymphocyte focus score in labial SG for the global and Explore its clinical application. Digital pathological images of labial gland biopsy tissue can be uploaded to the Labial Gland Pathological Focus Score Remoting platform. AI-assisted pathological interpretation on gland tissue area, lymphocyte foci numbers, and whether meeting the criteria for Sjögren's syndrome (focus score greater than 1) is compared with the ground truth. ### Conditions Module **Conditions:** - Sjogren's Syndrome ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 1000 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** The ground truth of gland tissue area and lymphocyte foci numbers in consecutive images is interpreted by three senior pathologists with over 5 years of related experience. The focal score is determined by the gland tissue area and the number of lymphocyte foci. AI-assisted interpretation is compared with ground truth. **Measure:** The accuracy of pathological interpretation of focal index of labial gland tissue **Time Frame:** during the procedure #### Secondary Outcomes **Description:** AI-assisted interpretation is compared with ground truth. **Measure:** The precision of pathological interpretation regarding the area of glandular tissue and the count of lymphocyte foci in labial gland tissue. **Time Frame:** during the procedure ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * The original format of digital pathological images of labial gland biopsy tissue from patients with suspected Sjögren's Syndrome uploaded to the designated platform. Exclusion Criteria: 1. Overlapping layers of cells due to excessively thick sections; 2. Excessive tissue defects caused by incomplete sectioning or poor staining on slides; 3. Absence of labial gland; 4. Insufficient clarity in the image. **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The suspected SjS patients presenting with ocular dryness and/or oral dryness, as determined by the American-European Consensus Group (AECG) questions ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** moyingq@mail.sysu.edu.cn **Name:** Ying-Qian Mo, Dr. **Phone:** 00861356497192 **Role:** CONTACT #### Locations **Location 1:** **City:** Guangzhou **Country:** China **Facility:** Ying-Qian Mo **State:** Guangdong **Status:** RECRUITING **Zip:** 510120 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - ID: D000010335 - Term: Pathologic Processes - ID: D000001172 - Term: Arthritis, Rheumatoid - ID: D000001168 - Term: Arthritis - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000012216 - Term: Rheumatic Diseases - ID: D000014987 - Term: Xerostomia - ID: D000012466 - Term: Salivary Gland Diseases - ID: D000009059 - Term: Mouth Diseases - ID: D000009057 - Term: Stomatognathic Diseases - ID: D000015352 - Term: Dry Eye Syndromes - ID: D000007766 - Term: Lacrimal Apparatus Diseases - ID: D000005128 - Term: Eye Diseases - ID: D000003240 - Term: Connective Tissue Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: BC11 - Name: Eye Diseases - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - ID: M15664 - Name: Sjogren's Syndrome - Relevance: HIGH - As Found: Sjogren's Syndrome - ID: M4476 - Name: Arthritis - Relevance: LOW - As Found: Unknown - ID: M4480 - Name: Arthritis, Rheumatoid - Relevance: LOW - As Found: Unknown - ID: M10621 - Name: Joint Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M15045 - Name: Rheumatic Diseases - Relevance: LOW - As Found: Unknown - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown - ID: M17724 - Name: Xerostomia - Relevance: LOW - As Found: Unknown - ID: M15285 - Name: Salivary Gland Diseases - Relevance: LOW - As Found: Unknown - ID: M12019 - Name: Mouth Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown - ID: M18040 - Name: Dry Eye Syndromes - Relevance: LOW - As Found: Unknown - ID: M10664 - Name: Keratoconjunctivitis Sicca - Relevance: LOW - As Found: Unknown - ID: M10786 - Name: Lacrimal Apparatus Diseases - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown - ID: M6464 - Name: Connective Tissue Diseases - Relevance: LOW - As Found: Unknown - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012859 - Term: Sjogren's Syndrome - ID: D000013577 - Term: Syndrome ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437639 **Brief Title:** MEXIDOL® Sequential Therapy of Patients With Primary Open-angle Glaucoma (POAG) **Official Title:** Prospective, Open, Comparative, Randomized Study of the Efficacy and Safety Evaluation of the Mexidol® Sequential Therapy of Patients With Primary Open-angle Glaucoma (POAG) #### Organization Study ID Info **ID:** MexidolPOAG2024 #### Organization **Class:** INDUSTRY **Full Name:** Pharmasoft ### Status Module #### Completion Date **Date:** 2024-02-02 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-30 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-11-29 **Type:** ACTUAL #### Start Date **Date:** 2023-09-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-24 **Study First Submit QC Date:** 2024-05-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Pharmasoft #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Hypothesis: The use of neurocytoprotectors helps restore the functional activity of mitochondria, improve the nervous activity of the retina and optic nerve, and stabilize the glaucomatous process. **Detailed Description:** Hypothesis: Mexidol® allows to optimize POAG therapy by reducing mitochondrial dysfunction and stabilizing glaucomatous optic neuropathy by improving the functional activity of mitochondria and its energy-producing function ### Conditions Module **Conditions:** - Primary Open-Angle Glaucoma (POAG) **Keywords:** - Glaucoma - Primary Open-Angle Glaucoma (POAG) - Glaucomatous Optic Neuropathy (GON) - Mitochondrial Dysfunction - Neuroprotection - Mexidol - Ethylmethylhydroxypyridine Succinate ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 80 **Type:** ACTUAL **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Mexidol IV 300 mg for 14 days, then Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 8 weeks **Intervention Names:** - Drug: Mexidol **Label:** Main (Mexidol and standard therapy) **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** IOP normalizing therapy **Label:** Control (standard therapy) **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Main (Mexidol and standard therapy) **Description:** Neurocytoprotector **Name:** Mexidol **Other Names:** - Ethylmethylhydroxypyridine Succinate **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Enzyme status of lymphocytes (Succinate dehydrogenase and Glycerophosphate dehydrogenase) **Measure:** Degree of expression of mitochondrial dysfunction **Time Frame:** 90 days **Description:** Cytomorphodensitometry (number of mitochondria, their optical density, number of granules and deposits in the mitochondria of lymphocytes) **Measure:** Dynamics of the structural and functional characteristics of mitochondria **Time Frame:** 90 days #### Secondary Outcomes **Description:** Dynamics of index of mean deviation (MD) of retinal photosensitivity \[Static Automated Perimetry (SAP)\] **Measure:** Аssessment of differential light sensitivity of the retina **Time Frame:** 90 days **Description:** The average thickness of retinal nerve fibers (RNFL) of the peripapillary zone in four quadrants was studied using the Fast RNFL Thickness program and the thickness of the retinal ganglion cell complex (GCC-Ganglion Cell Complex protocol) **Measure:** Structural and topographic changes in the layer of nerve fibers and the retinal ganglion [Optical Coherence Tomography (OCT) parameters] **Time Frame:** 90 days **Description:** Adverse events related to Mexidol **Measure:** Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] **Time Frame:** 90 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * An advanced stage of POAG in one or two eyes * Hypotonic-compensated intraocular pressure (IOP) Exclusion Criteria: * Degenerative diseases of the central nervous system, diabetes mellitus * Primary mitochondrial dysfunction * A history of surgical interventions and damage to the organ of vision * Acute or chronic inflammatory or hereditary degenerative eye diseases (anterior and posterior sections) * Decompensation of concomitant somatic diseases * Taking antioxidants/nootropic drugs 6 months before inclusion in the study * Hypersensitivity to ethylmethylhydroxypyridine succinate or to any of the excipients **Maximum Age:** 65 Years **Minimum Age:** 50 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Tyumen **Country:** Russian Federation **Facility:** Tyumen Scientific Center of the Russian Academy of Sciences **Zip:** 625026 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009798 - Term: Ocular Hypertension - ID: D000005128 - Term: Eye Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC11 - Name: Eye Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC14 - Name: Heart and Blood Diseases ### Condition Browse Module - Browse Leaves - ID: M9013 - Name: Glaucoma - Relevance: HIGH - As Found: Glaucoma - ID: M9014 - Name: Glaucoma, Open-Angle - Relevance: HIGH - As Found: Primary Open Angle Glaucoma - ID: M12832 - Name: Optic Nerve Diseases - Relevance: LOW - As Found: Unknown - ID: M10024 - Name: Hypertension - Relevance: LOW - As Found: Unknown - ID: M12731 - Name: Ocular Hypertension - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005901 - Term: Glaucoma - ID: D000005902 - Term: Glaucoma, Open-Angle ### Intervention Browse Module - Ancestors - ID: D000000975 - Term: Antioxidants - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000020011 - Term: Protective Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000010975 - Term: Platelet Aggregation Inhibitors - ID: D000011619 - Term: Psychotropic Drugs ### Intervention Browse Module - Browse Branches - Abbrev: PsychDr - Name: Psychotropic Drugs - Abbrev: PlAggInh - Name: Platelet Aggregation Inhibitors - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M249938 - Name: Emoxypine succinate - Relevance: HIGH - As Found: Gene analysis - ID: M4292 - Name: Antioxidants - Relevance: LOW - As Found: Unknown - ID: M21869 - Name: Protective Agents - Relevance: LOW - As Found: Unknown - ID: M13865 - Name: Platelet Aggregation Inhibitors - Relevance: LOW - As Found: Unknown - ID: M14474 - Name: Psychotropic Drugs - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000070020 - Term: Emoxypine succinate ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437626 **Acronym:** MIR **Brief Title:** MEXIDOL® Sequential Therapy of Patients With Acute Cerebral Failure **Official Title:** Prospective International Multicenter Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety Evaluation of the Mexidol® Sequential Therapy of Patients in the Acute and Early Recovery Periods of Ischemic Stroke #### Organization Study ID Info **ID:** MexidolMIR2023 #### Organization **Class:** INDUSTRY **Full Name:** Pharmasoft #### Secondary ID Infos **Domain:** Ministry of Health, Russian Federation **ID:** PHS-APIS-004-MEX-SOL-TAB **Type:** OTHER ### Status Module #### Completion Date **Date:** 2023-08-18 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-30 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-08-18 **Type:** ACTUAL #### Start Date **Date:** 2019-11-18 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-24 **Study First Submit QC Date:** 2024-05-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Pharmasoft #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Cerebral stroke is one of the most pressing clinical and social problems of modern medicine. According to WHO estimates, acute cerebral failure rank second among all causes of death. Optimizing the treatment of such conditions remains an urgent problem in neurology and rehabilitation. **Detailed Description:** Hypothesis: The addition of neurocytoprotectors to standard therapy in the acute and early recovery periods of Ischemic Stroke helps improve the results of further rehabilitation and reduce the severity of neurological deficit. The multimodal mechanism of action allows Mexidol® to realize a whole range of clinical effects, primarily such as anti-ischemic, vegetotropic, anti-amnestic, nootropic, anxiolytic, anticonvulsant, etc.). ### Conditions Module **Conditions:** - Ischemic Stroke, Acute **Keywords:** - Ischemic Stroke - Acute Stroke - Cerebral stroke - Acute Cerebrovascular Accident - ACVA - Acute cerebral failure - Neuroprotection - Mexidol - Ethylmethylhydroxypyridine Succinate ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 304 **Type:** ACTUAL **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Mexidol IV 500 mg 2 times a day for 10 days, then Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days **Intervention Names:** - Drug: Mexidol **Label:** Main (Mexidol and standard therapy) **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Placebo and standard therapy according to a scheme similar to the main group **Intervention Names:** - Other: Placebo **Label:** Control (Placebo and standard therapy) **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Main (Mexidol and standard therapy) **Description:** Neurocytoprotector **Name:** Mexidol **Other Names:** - Ethylmethylhydroxypyridine Succinate **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Control (Placebo and standard therapy) **Description:** Placebo therapy **Name:** Placebo **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The Modified Rankin Scale (mRS) \[6 point scale: min value 0, max value 5, higher scores mean a worse outcome\] **Measure:** Measures the degree of disability or dependence in the daily activities **Time Frame:** 71 days #### Secondary Outcomes **Description:** The National Institutes of Health Stroke Scale (NIHSS) \[43 point scale: min value 0, max value 42, higher scores mean a worse outcome\] **Measure:** Quantifying stroke severity **Time Frame:** 71 days **Description:** The Rivermead index \[16 point scale: min value 0, max value 15, higher scores mean a better outcome\] **Measure:** Dynamics of level of mobility **Time Frame:** 71 days **Description:** The Montreal Cognitive Assessment (MoCA test) \[31 point scale: min value 0, max value 30, higher scores mean a better outcome\] **Measure:** Dynamics of cognitive status **Time Frame:** 71 days **Description:** The Hospital Anxiety and Depression Scale (HADS) \[43 point scale: min value 0, max value 42, higher scores mean a worse outcome\] **Measure:** Reduction in anxiety **Time Frame:** 71 days **Description:** Adverse events related to Mexidol **Measure:** Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] **Time Frame:** 71 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Acute Ischemic Stroke confirmed by neuroimaging methods (CT, MRI) * Modified Rankin Scale, mRS ≥ 3 * National Institutes of Health Stroke Scale: 9 ≤ NIHSS ≤ 15 Exclusion Criteria: * Repeated or hemorrhagic stroke; * Traumatic brain injury with severe neurological symptoms and cognitive impairment; * Patients who have undergone thrombolytic therapy or thrombectomy; * History of clinically significant allergic reactions, hypersensitivity and/or intolerance to any component of the study drug or placebo; * Parkinson's disease, parkinsonism, multiple sclerosis, epilepsy, degenerative diseases of the central nervous system (CNS), history of dementia of the Alzheimer's type; * BMI (Body Mass Index) \> 35 * Systemic autoimmune diseases or vascular collagenoses requiring previous or current treatment with systemic corticosteroid drugs, cytostatics; * Malignant neoplasms within the last 5 years; * Need to use drugs prohibited in this study; * Having a positive result of a rapid test for IgM antibodies to the SARS-CoV-2 virus; * Need for surgical intervention; * History of alcohol or drug addiction; * Positive result of at least one of the following tests: blood test for HIV, syphilis, hepatitis B and C; * Pregnancy or lactation period; * Participation of the patient in any clinical trial less than 3 months before the start of the present one. **Maximum Age:** 75 Years **Minimum Age:** 40 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Almaty **Country:** Kazakhstan **Facility:** Almaty City Hospital № 7 **Zip:** 050006 **Location 2:** **City:** Kazan **Country:** Russian Federation **Facility:** Tatarstan Republican Clinical Hospital **Zip:** 410064 **Location 3:** **City:** Kazan **Country:** Russian Federation **Facility:** Interregional Clinical Diagnostic Center **Zip:** 420101 **Location 4:** **City:** Kazan **Country:** Russian Federation **Facility:** Kazan City Hospital № 7 **Zip:** 420103 **Location 5:** **City:** Kemerovo **Country:** Russian Federation **Facility:** Kemerovo City Clinical Hospital № 11 **Zip:** 650014 **Location 6:** **City:** Krasnodar **Country:** Russian Federation **Facility:** Research Institute - Regional Clinical Hospital № 1 **Zip:** 350086 **Location 7:** **City:** Moscow **Country:** Russian Federation **Facility:** Federal Center for Brain and Neurotechnology **Zip:** 117997 **Location 8:** **City:** Moscow **Country:** Russian Federation **Facility:** Russian National Research Medical University n.a. N. I. Pirogov **Zip:** 117997 **Location 9:** **City:** Rostov-on-Don **Country:** Russian Federation **Facility:** Rostov State Medical University **Zip:** 344022 **Location 10:** **City:** Saint Petersburg **Country:** Russian Federation **Facility:** Alexandrovskaya Hospital **Zip:** 193312 **Location 11:** **City:** Saint Petersburg **Country:** Russian Federation **Facility:** St. Petersburg Clinical Hospital № 26 **Zip:** 196247 **Location 12:** **City:** Saint Petersburg **Country:** Russian Federation **Facility:** National Medical Research Center n.a. V. A. Almazov **Zip:** 197341 **Location 13:** **City:** Saint Petersburg **Country:** Russian Federation **Facility:** City Hospital № 40 of Kurortny District **Zip:** 197706 **Location 14:** **City:** Samara **Country:** Russian Federation **Facility:** Samara Regional Clinical Hospital n.a. V. D. Seredavin **Zip:** 443095 **Location 15:** **City:** Ulyanovsk **Country:** Russian Federation **Facility:** Central Clinical Medical and Sanitary Unit n.a. V. A. Egorov **Zip:** 432026 **Location 16:** **City:** Voronezh **Country:** Russian Federation **Facility:** Voronezh Regional Clinical Hospital № 1 **Zip:** 394066 **Location 17:** **City:** Vsevolozhsk **Country:** Russian Federation **Facility:** Vsevolozhsk Clinical Interdistrict Hospital **Zip:** 188643 **Location 18:** **City:** Yaroslavl **Country:** Russian Federation **Facility:** Yaroslavl Clinical Hospital № 2 **Zip:** 150030 **Location 19:** **City:** Tashkent **Country:** Uzbekistan **Facility:** The first clinic of the Tashkent Medical Academy **Zip:** 100109 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002561 - Term: Cerebrovascular Disorders - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M22306 - Name: Stroke - Relevance: HIGH - As Found: Stroke - ID: M2400 - Name: Ischemic Stroke - Relevance: HIGH - As Found: Ischemic Stroke - ID: M10543 - Name: Ischemia - Relevance: HIGH - As Found: Ischemic - ID: M5810 - Name: Cerebrovascular Disorders - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000020521 - Term: Stroke - ID: D000083242 - Term: Ischemic Stroke - ID: D000007511 - Term: Ischemia ### Intervention Browse Module - Ancestors - ID: D000000975 - Term: Antioxidants - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000020011 - Term: Protective Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000010975 - Term: Platelet Aggregation Inhibitors - ID: D000011619 - Term: Psychotropic Drugs ### Intervention Browse Module - Browse Branches - Abbrev: PsychDr - Name: Psychotropic Drugs - Abbrev: PlAggInh - Name: Platelet Aggregation Inhibitors - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M249938 - Name: Emoxypine succinate - Relevance: HIGH - As Found: Gene analysis - ID: M4292 - Name: Antioxidants - Relevance: LOW - As Found: Unknown - ID: M21869 - Name: Protective Agents - Relevance: LOW - As Found: Unknown - ID: M13865 - Name: Platelet Aggregation Inhibitors - Relevance: LOW - As Found: Unknown - ID: M14474 - Name: Psychotropic Drugs - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000070020 - Term: Emoxypine succinate ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437613 **Brief Title:** "Effects of Passive Static Stretching of 30 Seconds Versus 60 Seconds on the Hamstring Flexibility in Adults With Hamstring Tightness. **Official Title:** "Effects of Passive Static Stretching of 30 Seconds Versus 60 Seconds on the Hamstring Flexibility in Adults With Hamstring Tightness. #### Organization Study ID Info **ID:** FUI/CTR/2024/9 #### Organization **Class:** OTHER **Full Name:** Foundation University Islamabad ### Status Module #### Completion Date **Date:** 2024-06-20 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-27 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2023-11-20 **Type:** ACTUAL #### Start Date **Date:** 2023-07-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Foundation University Islamabad #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study is a randomised controlled trial and the purpose of this study is to determine the effects of Passive Static Stretching of 30 seconds versus 60 seconds on the Hamstring Flexibility in adults with Hamstring Tightness. The study is conducted in Rehabilitation department of Fauji Foundation Hospital on the sample of 38 participants. Hamstring flexibility will be evaluated at the beginning by Active knee extension test. The subjects will be randomized into two group by sealed envelope method. Baseline assessment would be done by using tools of SLR and modified knee extension test and then final assessment will be done after 4 weeks. **Detailed Description:** The purpose of this study is to determine the effects of passive static stretching on hamstring flexibility in adults with hamstring tightness" adults (age : 18-45 years ) by using 1. Goniometer 2. Straight leg raise (SLR) 3. Passive Hip Flexion Test(PHFT) 4. Active Knee Extension Test( AKET) 5. Modified Knee Extension Test(MKET) Data will be collected before and after the intervention protocol for each participant. Data collection procedure:The subjects will be advised of the training session schedule following the baseline assessment. Pre and post intervention scores will be recorded. ### Conditions Module **Conditions:** - Hamstring Flexibility ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Randomized Controlled Trial ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 32 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Week 1 Passive Hip Flexion Test Straight leg Raise Modified Knee Extension Test Passive Static Stretching 3-4 reps 3-5 second hold in each activity Week 2 Passive Hip Flexion Test Straight leg Raise Modified Knee Extension Test Passive Static Stretching 3-4 reps 3-5 second hold in each activity Week 3 Passive Hip Flexion Test Straight leg Raise Modified Knee Extension Test Passive Static Stretching 3-4 reps 3-5 second hold in each activity Week 4 Passive Hip Flexion Test Straight leg Raise Modified Knee Extension Test Passive Static Stretching 3-4 reps 3-5 second hold in each activity **Intervention Names:** - Procedure: Passive Static Stretching exercises for 30 seconds **Label:** Group 1 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Week 1 Passive Hip Flexion Test Straight leg Raise Modified Knee Extension Test Passive Static Stretching 3-4 reps 3-5 second hold in each activity Week 2 Passive Hip Flexion Test Straight leg Raise Modified Knee Extension Test Passive Static Stretching 3-4 reps 3-5 second hold in each activity Week 3 Passive Hip Flexion Test Straight leg Raise Modified Knee Extension Test Passive Static Stretching 3-4 reps 3-5 second hold in each activity Week 4 Passive Hip Flexion Test Straight leg Raise Modified Knee Extension Test Passive Static Stretching 3-4 reps 3-5 second hold in each activity **Intervention Names:** - Procedure: Passive Static Stretching exercises for 60 seconds **Label:** Group 2 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Group 1 **Description:** Intervention includes Following Tests 1. Passive Hip Flexion Test(PHFT) 2. Straight Leg Raises(SLR) 3. Modified Knee Extension Test(MKET) **Name:** Passive Static Stretching exercises for 30 seconds **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Group 2 **Description:** Intervention includes Following Tests 1. Passive Hip Flexion Test(PHFT) 2. Straight Leg Raises(SLR) 3. Modified Knee Extension Test(MKET) **Name:** Passive Static Stretching exercises for 60 seconds **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Numeric Pain Rating Scale has a scale of 0-10 or 0-100 points and can be given verbally or in writing. **Measure:** Pain intensity **Time Frame:** 4 weeks **Description:** Goniometer will be used **Measure:** Range of motion **Time Frame:** 4 weeks **Description:** Physical Function will be assessed using Oswestry disability Questionairre **Measure:** Physical Function **Time Frame:** 4 weeks **Description:** Using Inclinometer **Measure:** Lumbar range of motion **Time Frame:** 4 Weeks ### Eligibility Module **Eligibility Criteria:** Inclusion criteria: * Adults age ranging from 18-45 years * Both males and females are included in the study * Individuals with 90 degree hip flexion having a minimum reduction of 15 degrees in knee extension position. Exclusion criteria : * Old adults * Individuals suffering from any acute or chronic co-morbidities of musculoskeletal, neurologic, cardiovascular or systemic origin * Post-surgical cases * Hamstring strain or any other dysfunction in past two years. **Maximum Age:** 45 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** Imranmalik109558@gmail.com **Name:** Imran Malik, MS-MSKPT* **Phone:** +92 355877619 **Role:** CONTACT #### Locations **Location 1:** **City:** Rawalpindi **Contacts:** ***Contact 1:*** - **Email:** sana.khalid@fui.edu.pk - **Name:** Sana Khalid, DPT,MSNMPT,PHD* - **Phone:** 03444218174 - **Role:** CONTACT **Country:** Pakistan **Facility:** Foundation University College of Physical Therapy **State:** Punjab **Status:** RECRUITING **Zip:** 4000 ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437600 **Acronym:** MAGIC **Brief Title:** Immediate Angioplasty For Acute Ischemic Stroke With Severe Intracranial Atherosclerotic Stenosis **Official Title:** Immediate Angioplasty For Acute Ischemic Stroke With Severe Intracranial Atherosclerotic Stenosis (MAGIC): A Multicenter, Prospective, Open-label, Blinded Endpoint, Randomized Controlled Trial #### Organization Study ID Info **ID:** SYSKY-2024-337-01 #### Organization **Class:** OTHER **Full Name:** Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ### Status Module #### Completion Date **Date:** 2029-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-30 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2029-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-10 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-30 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Shenzhen Hospital of Southern Medical University #### Lead Sponsor **Class:** OTHER **Name:** Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** A multicenter, prospective, open-label, blinded endpoint, randomized controlled trial that aims to evaluate the effect of immediate angioplasty (with or without stenting) for acute ischemic stroke (AIS) with severe intracranial atherosclerotic stenosis (ICAS) in improving the 90-day functional outcome. **Detailed Description:** This study is a multicenter, prospective, open-label, blinded endpoint, randomized controlled trial designed to evaluate the effect of immediate angioplasty (with or without stenting) for AIS with severe ICAS. The primary outcome is the proportion of patients with a 90-day modified Rankin scale (mRS) of 0-2. Study intervention: (1) Participants in the experimental group will undergo immediate angioplasty (with or without stenting), and will receive the best medical treatment (BMM) after the procedure. (2) Participants in the control group will receive BMM alone. This study is anticipated to enroll 418 participants, with 209 participants in each group (1:1 ratio). ### Conditions Module **Conditions:** - Stroke, Acute Ischemic ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 418 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive immediate angioplasty (with or without stenting) for the culprit vessel and the target residual stenosis should be less than 30%. All participants will receive the best medical management (BMM). **Intervention Names:** - Procedure: Immediate angioplasty **Label:** The experimental group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will receive BMM alone. **Label:** The control group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - The experimental group **Description:** See arm/group descriptions. **Name:** Immediate angioplasty **Type:** PROCEDURE ### Outcomes Module #### Other Outcomes **Description:** Symptomatic intracranial hemorrhage within 36 hours (according to Heidelberg criteria). **Measure:** SAFETY OUTCOME: Symptomatic intracranial hemorrhage **Time Frame:** 24 (±12) hours **Description:** Mortality at 90 days. **Measure:** SAFETY OUTCOME: Mortality **Time Frame:** 90(±7) days **Description:** Any intracranial hemorrhage within 36 hours (according to Heidelberg criteria). **Measure:** SAFETY OUTCOME: Any intracranial hemorrhage **Time Frame:** 24 (±12) hours #### Primary Outcomes **Description:** The proportion of the mRS 0-2 at 90 days. **Measure:** The modified Rankin Scale (mRS) 0-2 **Time Frame:** 90(±7) days #### Secondary Outcomes **Description:** The proportion of the mRS of 0-1 at 90 days. **Measure:** The mRS 0-1 **Time Frame:** 90(±7) days **Description:** The proportion of the mRS of 0-3 at 90 days. **Measure:** The mRS 0-3 **Time Frame:** 90(±7) days **Description:** The distribution of the mRS at 90 days. **Measure:** The shift analysis of the mRS distribution **Time Frame:** 90(±7) days **Description:** The change of NIHSS from baseline to 7 days or discharge (whichever comes first). **Measure:** The change of National Institute of Health Stroke Scale (NIHSS) **Time Frame:** 7(±1) days or discharge, whichever came first **Description:** The value of quality of life (EQ-5D-5L) at 90 days. **Measure:** The quality of life **Time Frame:** 90(±7) days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Aged 18 years or older. 2. Diagnosed with AIS and baseline NIHSS ≥6. 3. Pre-stroke mRS ≤2, or mRS \>2 but not related to neurological disease (e.g., amputation, blindness). 4. Time from symptom onset to randomization within 24 hours; the onset time refers to "Last Known Well" (LKW). 5. NCCT/DWI-MRI ASPECTS ≥6. 6. CTA, MRA, or DSA confirmed severe ICAS (70-99%) of the intracranial segment of the internal carotid artery, or M1 or M2 segment of the middle cerebral artery, and is presumed to be responsible for the stroke. 7. Signed informed consent. Exclusion Criteria: 1. Normal diameter of the culprit vessel \<2.0 mm. 2. Hemorrhagic stroke within the past 90 days. 3. Stroke is caused by cerebral vasculitis, arterial inflammatory stenosis, vasospasm, dissection, perforating arteriopathy, and internal capsule warning syndrome. 4. Severe calcification at the site of stenosis, where target residual stenosis \<30% could not be achieved. 5. Stroke caused by cardioembolic origin, but those with only atrial fibrillation but no clear evidence of cardiac thrombosis could still be included in the study. 6. Coagulation disorder with INR\>1.7, use of new oral anticoagulants within the last 48 hours from screening, or use of low molecular weight heparin within the last 24 hours from screening. 7. Known genetic or acquired bleeding disposition with anticoagulation factor deficiency. 8. Platelet count \<50×10\^9/L. 9. Intracranial hemorrhage confirmed by CT or MRI. 10. Women who are pregnant or breastfeeding. 11. Participation in other clinical trials. 12. Known severe renal insufficiency with glomerular filtration rate \<30 ml/min or blood creatinine \>220 μmol/L (2.5 mg/dl). 13. Severe allergy to contrast (non-mild rash allergy) or absolute contraindication to iodine contrast. 14. Aortic dissection. 15. Intracranial tumors or arteriovenous malformations. 16. Previous parenchymal organ surgery or biopsy in the last 1 month. 17. Any active bleeding or recent bleeding (gastrointestinal, urinary tract bleeding, etc.) in the last 1 month. 18. SBP\>185 mmHg or DBP\>110 mmHg refractory to treatment. 19. Anticipated life expectancy \<3 months (e.g., malignancy, severe cardiopulmonary disease, etc.). 20. Any condition that, in the judgment of the investigator, makes the patient unsuitable for this study or where this study may impose a significant risk to the patient (e.g., inability to understand and/or comply with study procedures and/or follow-up due to psychiatric disorders, cognitive or emotional impairment). **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** yangxinguang0926@163.com **Name:** Xinguang Yang, MD **Phone:** 86-20-81332619 **Role:** CONTACT **Contact 2:** **Email:** drxjhe@163.com **Name:** Xiongjun He, MD, PhD **Role:** CONTACT #### Locations **Location 1:** **City:** Guangzhou **Contacts:** ***Contact 1:*** - **Name:** Yang Xinguang, Ph.D - **Phone:** 86-20-81332619 - **Role:** CONTACT ***Contact 2:*** - **Name:** Yamei Tang, M.D., PhD. - **Role:** PRINCIPAL_INVESTIGATOR **Country:** China **Facility:** Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University **State:** Guangdong **Zip:** 510120 **Location 2:** **City:** Shenzhen **Country:** China **Facility:** Shenzhen Hospital of Southern Medical University **State:** Guangdong ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002561 - Term: Cerebrovascular Disorders - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M22306 - Name: Stroke - Relevance: HIGH - As Found: Stroke - ID: M2400 - Name: Ischemic Stroke - Relevance: HIGH - As Found: Stroke, Acute Ischemic - ID: M10543 - Name: Ischemia - Relevance: HIGH - As Found: Ischemic - ID: M6475 - Name: Constriction, Pathologic - Relevance: LOW - As Found: Unknown - ID: M5810 - Name: Cerebrovascular Disorders - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000020521 - Term: Stroke - ID: D000083242 - Term: Ischemic Stroke - ID: D000007511 - Term: Ischemia ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437587 **Brief Title:** Effects of Appropriate Technology for Home-based Rehabilitation in Patients With Post-stroke Physical Dysfunction **Official Title:** Effects of Appropriate Technology for Home-based Rehabilitation in Patients With Post-stroke Physical Dysfunction #### Organization Study ID Info **ID:** HMUDQ20231116205 #### Organization **Class:** OTHER **Full Name:** Harbin Medical University ### Status Module #### Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-25 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-10 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-25 **Study First Submit QC Date:** 2024-05-25 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Harbin Medical University #### Lead Sponsor **Class:** OTHER **Name:** Xi Chen #### Responsible Party **Investigator Affiliation:** Harbin Medical University **Investigator Full Name:** Xi Chen **Investigator Title:** researcher **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The goal of this clinical trial is to assess the effect of S-HRAT to improve patients' motor function and activities of daily living. **Detailed Description:** Limb dysfunction is the primary disability factor among stroke patients. However, due to various factors, most stroke survivors do not receive sufficient rehabilitation training after discharge. Home-based rehabilitation appropriate technology (S-HRAT） training could be a strategy to meet the patients' requirements for rehabilitation after hospital discharge. This study aims to assess the effect of a nursing intervention based on Cox's Interaction Model of Client Health Behavior (IMCHB) with the application of S-HRAT to improve patients' motor function and activities of daily living. In this pilot trial, 36 stroke survivors with limb dysfunction will be screened for inclusion before hospital discharge and randomly assigned to the experimental or control group with their informed consent. The control group(n=18) will receive the usual care provided by the hospital. The experimental group(n=18) will receive usual care and an 8-week S-HRAT training program. This nursing interventions use Cox's IMCHB as a theoretical framework that consists of rehabilitation exercises and the provision of health information. Baseline assessments will be conducted on the day before hospital discharge, and outcomes will be assessed at 8 weeks and 12 weeks after discharge. The primary outcome is change in motor function 8 weeks after discharge, and the secondary outcomes include the activities of daily living, anxiety, depression, exercise adherence, and patient satisfaction. This study is the first of its kind conducted in China to use Cox's IMCHB as a framework to guide the development of the S-HRAT training program. Our pilot will determine if such an approach is feasible and effective in enhancing motor function and improving the activities of daily living post-stroke after discharge. ### Conditions Module **Conditions:** - Stroke **Keywords:** - home-based rehabilitation - appropriate technology ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Masking Description:** Due to the nature of the intervention, it is impossible to blind the researcher of the intervention who will deliver the intervention. Therefore, the participants and the outcome assessor will be blinded. The outcome assessor will be blinded to the allocation throughout the study and will independently assess all outcomes at T0, T1, and T2 for both groups. **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 36 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Home-based rehabilitation appropriate technology (S-HRAT) training **Intervention Names:** - Other: Home-based rehabilitation appropriate technology (S-HRAT) training **Label:** intervention group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Routine discharge instructions **Label:** control group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - intervention group **Description:** The S-HRAT training instruction consists of two phases: in-hospital training and post-discharge remote home training. Based on the S-HRAT list, we select individualized home rehabilitation training exercises for the participants and conduct five offline training instruction sessions one week before discharge to ensure that the participants master the correct method for each exercise and clarify precautions. At discharge, participants will receive an S-HRAT brochures, which will include detailed text, pictures and video demonstrations of exercises, to visualize the rehabilitation instructions and make them easy to understand. Participants learn how to use the S-HRAT booklet and follow a daily training program to complete the prescribed content. They will be asked to record a video of their training and send it to the researcher via WeChat for monitoring purposes and feedback. **Name:** Home-based rehabilitation appropriate technology (S-HRAT) training **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The motor function of the patients is measured using the Motor Assessment Scale (MAS) for stroke. MAS is methodologically simple, targeted, and easily generalizable for motor function assessment in stroke patients, as well as reliable and valid. The scale consists of nine items, each of which is scored from 0 to 6 out of 48, with the ninth item not scoring. Higher scores indicate better motor function. **Measure:** Motor Function **Time Frame:** baseline (T0), 8-week post-intervention (T1), and 12-week follow-up (T2). **Description:** Balance was measured using the Berg Balance Scale (BBS). The scale consists of 14 items, including sitting to standing, standing independently, walking independently, and standing to sit, and each item is scored on five functional levels: 0, 1, 2, 3, and 4. A score of 4 indicates that the action under examination can be performed normally. In contrast, a score of 0 indicates that it cannot be performed or requires significant assistance. The total possible score is 56, with higher scores indicating better balance. **Measure:** Balance **Time Frame:** baseline (T0), 8-week post-intervention (T1), and 12-week follow-up (T2). #### Secondary Outcomes **Description:** The Modified Barthel Index(MBI) is used to measure the activity of daily living. The scale consists of ten items, including eating, bathing, grooming, dressing, toileting, bed and chair transfers, walking on level ground, walking up and downstairs, bowel control, and urinary control. The possible score ranges from 0 to 100, and a higher score means greater independence **Measure:** Activity of Daily Living **Time Frame:** baseline (T0), 8-week post-intervention (T1), and 12-week follow-up (T2). **Description:** The Functional Exercise Adherence Scale for Stroke Patients (questionnaire of exercise adherence, EAQ) developed by Chinese author Beilei Lin in 2013 was used to assess patients' adherence to rehabilitation exercises. The scale consists of three dimensions: physical participation in exercise, monitoring of exercise effects, and active adherence to seeking exercise advice. Each item is scored using a Likert scale ranging from 0 to 4, with a total score ranging from 14 to 56. A higher score indicates a higher level of exercise adherence. **Measure:** Exercise Adherence **Time Frame:** baseline (T0), 8-week post-intervention (T1), and 12-week follow-up (T2). **Description:** The Nursing Job Satisfaction Questionnaire (Client Satisfaction Test, CST) was developed by Bear Bowers based on the IMCHB model and comprises 12 items across six domains: emotional support, health information, decision control, professional skills, service accessibility, and overall satisfaction. The rating method employs a scale of 1 to 5 points, representing five options "very satisfied," "quite satisfied," "not sure," "not too satisfied," and "very dissatisfied." The total scale thus ranges from 12 to 60 points. A higher score on the scale indicates a higher level of patient satisfaction. **Measure:** Patient Satisfaction **Time Frame:** baseline (T0), 8-week post-intervention (T1), and 12-week follow-up (T2). **Description:** The Chinese version of the Hospital Anxiety and Depression Scale (HADS) is employed to assess the anxiety and depression levels of patients. The HADS is a frequently used instrument for assessing the severity of anxiety and depression in patients. It is a 14-item instrument comprising two subscales: anxiety (HADS-A, 7 items) and depression (HADS-D, 7 items). Each item is rated on a 4-point Likert scale, ranging from 0 for "no problem" to 3 for "severe problem," with higher scores indicating higher levels of anxiety and depression. **Measure:** Anxiety and Depression **Time Frame:** baseline (T0), 8-week post-intervention (T1), and 12-week follow-up (T2). ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: ①Age≥18; ②Patients diagnosed with cerebrovascular disease who have cerebral infarction or cerebral hemorrhage based on cranial CT or MRI and meet the diagnostic criteria; ③Patients are in the non-acute phase, meaning between two weeks and six months after the onset of the disease; ④Patients with limb dysfunction. Exclusion Criteria: ①Return to a hospital or rehabilitation facility after discharge; ②The patient has a history of mental illness and dyslexia; ③Patients have a combination of serious, life-threatening conditions. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002561 - Term: Cerebrovascular Disorders - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M22306 - Name: Stroke - Relevance: HIGH - As Found: Stroke - ID: M5810 - Name: Cerebrovascular Disorders - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000020521 - Term: Stroke ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437574 **Brief Title:** Intensive Cholesterol-Lowering and CD8+ T Cells in Prostate Cancer **Official Title:** Lowering Cholesterol in Prostate Cancer to Target Rapamycin-Insensitive Companion Of MTOR (TORC2) in T-Cell Surface Glycoprotein CD8 Alpha Chain (CD8+) Lymphocytes #### Organization Study ID Info **ID:** STUDY00003290 #### Organization **Class:** OTHER **Full Name:** Cedars-Sinai Medical Center #### Secondary ID Infos **ID:** R01CA280060 **Link:** https://reporter.nih.gov/quickSearch/R01CA280060 **Type:** NIH ### Status Module #### Completion Date **Date:** 2028-05-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2028-02-29 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Cancer Institute (NCI) #### Lead Sponsor **Class:** OTHER **Name:** Cedars-Sinai Medical Center #### Responsible Party **Investigator Affiliation:** Cedars-Sinai Medical Center **Investigator Full Name:** Hyung L. Kim, MD **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** To test the hypothesis that intensive cholesterol lowering (iCL) therapy has anti-tumor immune modulating activity, the investigators will conduct an open-label, single-arm phase II trial in prostate cancer patients who are in active surveillance and undergoing a planned surveillance biopsy in 3-6 months. Eligible patients will initiate iCL with Vytorin®(group 1, 2, and 3), an FDA-approved combination of ezetimibe and simvastatin used to lower atherogenic low density lipoprotein cholesterol (LDL-C) or Ezetimibe (group 4). Starting dose will be determined by current statin use and LDL-C levels. Dose modifications of VYTORIN will be employed with the goal of achieving LDL-C \<70 mg/dl. Dose adjustment is not allowed for ezetimibe. ### Conditions Module **Conditions:** - Prostate Cancer ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 140 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Single arm with dual agents (ezetimibe and simvastatin) target the two primary sources of cholesterol, absorption in the gut and synthesis in the liver. These 2 agents are available in a single pill that is FDA approved and sold under the trade name, Vytorin. **Intervention Names:** - Drug: Vytorin **Label:** Intensive Lipid Lowering **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Intensive Lipid Lowering **Description:** Vytorin is a drug combination (Ezetimibe and Simvastatin) that targets the two primary sources of cholesterol, absorption in the gut and synthesis in the liver. **Name:** Vytorin **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Our primary hypothesis is that maximum cholesterol lowering will increase CD8+ memory T cells and increase CD8+ T cell infiltration into prostate tissue. Change in CD8+ T cells in the prostate from baseline to 3 to 6 months is the primary endpoint. **Measure:** Pre/Post-change in % prostate infiltrating CD8+ T lymphocytes. **Time Frame:** 3 to 6 months of cholesterol-lowering intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Provision of signed and dated informed consent form. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. At least one Atherosclerotic Cardiovascular Disease (ASCVD) risk factor, such as: 1. ≥ 50 years of age 2. Hypertension 3. Hypercholesterolemia 4. Diabetes 5. Current or former smoker 6. First-degree family history of any cardiovascular heart disease 7. BMI \> 25 8. On hypertension treatment, statin, and/or aspirin therapy 4. Patients with clinically localized prostate cancer. That is Low or intermediate risk prostate cancer defined as: 1. Pre-operative PSA (Prostate Specific Antigen) 20.0 ng/ml 2. Clinical stage T1c or cT2 3. Gleason score 3+3 or 3+4 or 4+3 5. Patients on AS with plans for surveillance biopsy 6. No previous treatment for prostate cancer with radiotherapy, chemotherapy, or hormonal therapy 7. Ability to take oral medication and be willing to adhere to once daily, oral Vytorin or ezetimibe. 8. Agree to avoid consumption of grapefruit and grapefruit juice ≥ one quart per day throughout study duration. Exclusion Criteria: 1. Current use of medications contraindicated for use with a statin such as strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, and nefazodone). 2. Current use of medications contraindicated for use with ezetimibe (i.e., gemfibrozil, cyclosporine, or danazol). 3. History of allergic or severe reaction to a either study agent. 4. History of moderate or severe myalgia with statin use. 5. Acute liver failure or decompensated cirrhosis 6. Already on maximum VYTORIN dose (10/80) 7. Already on a PCSK9 inhibitor **Minimum Age:** 18 Years **Sex:** MALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** Amy.Hoang@cshs.org **Name:** Amy Hoang **Phone:** 310-423-1542 **Role:** CONTACT **Contact 2:** **Email:** Laura.Sarmiento@cshs.org **Name:** Laura Sarmiento **Phone:** 310-423-4295 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Cedars-Sinai Medical Center **Name:** Hyung Kim, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005834 - Term: Genital Neoplasms, Male - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000005832 - Term: Genital Diseases, Male - ID: D000091662 - Term: Genital Diseases - ID: D000091642 - Term: Urogenital Diseases - ID: D000011469 - Term: Prostatic Diseases - ID: D000052801 - Term: Male Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M14335 - Name: Prostatic Neoplasms - Relevance: HIGH - As Found: Prostate Cancer - ID: M8946 - Name: Genital Neoplasms, Male - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M8944 - Name: Genital Diseases, Male - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14333 - Name: Prostatic Diseases - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011471 - Term: Prostatic Neoplasms ### Intervention Browse Module - Ancestors - ID: D000000924 - Term: Anticholesteremic Agents - ID: D000000960 - Term: Hypolipidemic Agents - ID: D000000963 - Term: Antimetabolites - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000057847 - Term: Lipid Regulating Agents ### Intervention Browse Module - Browse Branches - Abbrev: Lipd - Name: Lipid Regulating Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: Hemat - Name: Hematinics ### Intervention Browse Module - Browse Leaves - ID: M450 - Name: Ezetimibe, Simvastatin Drug Combination - Relevance: HIGH - As Found: Remdesivir - ID: M21713 - Name: Simvastatin - Relevance: LOW - As Found: Unknown - ID: M21960 - Name: Sirolimus - Relevance: LOW - As Found: Unknown - ID: M11110 - Name: Liver Extracts - Relevance: LOW - As Found: Unknown - ID: M409 - Name: Ezetimibe - Relevance: LOW - As Found: Unknown - ID: M353695 - Name: Temsirolimus - Relevance: LOW - As Found: Unknown - ID: M2827 - Name: MTOR Inhibitors - Relevance: LOW - As Found: Unknown - ID: M340819 - Name: polysaccharide-K - Relevance: LOW - As Found: Unknown - ID: M4243 - Name: Anticholesteremic Agents - Relevance: LOW - As Found: Unknown - ID: M4278 - Name: Hypolipidemic Agents - Relevance: LOW - As Found: Unknown - ID: M4281 - Name: Antimetabolites - Relevance: LOW - As Found: Unknown - ID: M28883 - Name: Lipid Regulating Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000069499 - Term: Ezetimibe, Simvastatin Drug Combination ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437561 **Brief Title:** Report of Ten Cases of Venous Aneurysm in Extremities **Official Title:** Venous Aneurysm: a Case Series and Review of Literature #### Organization Study ID Info **ID:** 114099 #### Organization **Class:** OTHER **Full Name:** Golestan University of Medical sciences ### Status Module #### Completion Date **Date:** 2024-03-15 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-25 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-03-11 **Type:** ACTUAL #### Start Date **Date:** 2024-02-13 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-25 **Study First Submit QC Date:** 2024-05-25 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Golestan University of Medical sciences #### Responsible Party **Investigator Affiliation:** Golestan University of Medical sciences **Investigator Full Name:** Pezhman Kharazm, MD **Investigator Title:** Vascular Surgeon **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Venous aneurysms are not common in general, but because of the inherent risk of thrombosis in aneurysms, their timely diagnosis and treatment are recommended in most of the current sources. Ten cases of venous aneurysms were diagnosed and managed in our vascular surgery department from October 2018 to January 2024. Patient information was extracted from their files retrospectively. **Detailed Description:** A vascular aneurysm is defined as the focal dilatation of a vessel. Aneurysm is classically used for arterial dilatations, although dilatations can occur in any part of the vascular system including veins. Venous aneurysms are not common in general, but with the increase in the use of duplex ultrasound, the number of cases diagnosed with venous aneurysms has recently increased. Venous aneurysms are more common in the lower limbs, and in the lower limbs, the involvement of the deep venous system is much more than the superficial venous system. According to reports, 77% of venous aneurysms are present in the lower limbs, of which 57% are in the deep venous system and 1.5% in the superficial venous system. Considering their rarity, venous aneurysms may cause diagnostic challenges in some cases. The importance of these aneurysms, especially in the lower limbs, which inherently have relative stasis due to the opposite flow direction of gravity, is that by creating venous stasis and whirlwind blood flow inside the aneurysm, they increase the susceptibility to clotting. Also, due to dysfunction of the pigeon nest valves, they cause chronic venous insufficiency. Although clot formation and subsequent pulmonary embolism are more common in deep venous aneurysms, cases of pulmonary embolism secondary to superficial venous aneurysms of the lower limbs have also been reported. Complications caused by chronic venous insufficiency are more common in aneurysms that occur at the main junctions of superficial and deep veins, including saphenous femoral and saphenous popliteal junctions. Considering the possible complications mentioned about venous aneurysms, these aneurysms need treatment, regardless of their location, and although in the superficial system, surgical resection is the most commonly recommended method, other surgical methods such as aneurysmectomy and primary repair, resection, and graft interposition, and also endovascular methods have been used. Of course, in case of insufficiency in the venous system, specific treatment of the cause of insufficiency (such as stripping of the large saphenous vein) is necessary in addition to the treatment of the aneurysm. Regarding the follow-up after the treatment of aneurysms of the superficial system, most articles have recommended short-term treatment with anticoagulants and control of the superficial and deep systems through color doppler. In this case series, we present 10 cases of venous aneurysms and discuss their presentation, diagnosis, and management. ### Conditions Module **Conditions:** - Venous Aneurysm Nos - Arteriovenous Malformations - Vascular Diseases **Keywords:** - aneurysm - venous malformation - vascular surgery ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 10 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** different clinical presentations of extremity venous aneurysms and their prevalence **Measure:** clinical presentation of extremity venous aneurysms **Time Frame:** 6 years **Description:** prevalence of extremity venous aneurysms in different ages **Measure:** age distribution of extremity venous aneurysms **Time Frame:** 6 years **Description:** prevalence of extremity venous aneurysms in upper vs. lower limbs as well as left side vs. right side **Measure:** location distribution of extremity venous aneurysms **Time Frame:** 6 years **Description:** prevalence of extremity venous aneurysms in both sexes **Measure:** sex distribution of extremity venous aneurysms **Time Frame:** 6 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: - Presence of extremity venous aneurysm Exclusion Criteria: - **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** all patients with extremity venous aneurysm since 2018 to 2024 ### Contacts Locations Module #### Locations **Location 1:** **City:** Gorgan **Country:** Iran, Islamic Republic of **Facility:** Pezhman Kharazm, MD **State:** Golestan **Zip:** 4917956808 ### IPD Sharing Statement Module **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR - ANALYTIC_CODE **IPD Sharing:** YES ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000054079 - Term: Vascular Malformations - ID: D000018376 - Term: Cardiovascular Abnormalities ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth ### Condition Browse Module - Browse Leaves - ID: M4113 - Name: Aneurysm - Relevance: HIGH - As Found: Aneurysm - ID: M17400 - Name: Vascular Diseases - Relevance: HIGH - As Found: Vascular Disease - ID: M4473 - Name: Arteriovenous Malformations - Relevance: HIGH - As Found: Arteriovenous Malformations - ID: M12 - Name: Congenital Abnormalities - Relevance: HIGH - As Found: Malformations - ID: M27558 - Name: Vascular Malformations - Relevance: LOW - As Found: Unknown - ID: M20503 - Name: Cardiovascular Abnormalities - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000783 - Term: Aneurysm - ID: D000014652 - Term: Vascular Diseases - ID: D000001165 - Term: Arteriovenous Malformations - ID: D000000013 - Term: Congenital Abnormalities ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437548 **Brief Title:** Epidural Stimulation for Upper Extremity Function **Official Title:** Spinal Cord Stimulation for Reanimation After Nervous System Injury #### Organization Study ID Info **ID:** 2024P000185 #### Organization **Class:** OTHER **Full Name:** Brigham and Women's Hospital ### Status Module #### Completion Date **Date:** 2027-09 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-30 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-09 **Type:** ESTIMATED #### Start Date **Date:** 2024-09 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-25 **Study First Submit QC Date:** 2024-05-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Brigham and Women's Hospital #### Responsible Party **Investigator Affiliation:** Brigham and Women's Hospital **Investigator Full Name:** Yi Lu, MD PhD **Investigator Title:** Director of Neurosurgical Trauma, Associate Professor of Neurosurgery **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Restoring upper extremity function in patients with cervical spinal cord injury is extremely important for patients' independence and quality of life. At present, there are limited options for hand or arm reanimation in this patient population. Nerve transfer is one such option that can partially restore the natural movement of hand or arm function in select patients. The investigators are interested in understanding whether recovery of hand or arm motor function after nerve transfer can be augmented by cervical epidural spinal cord stimulation. **Detailed Description:** The study will enroll up to 20 participants in a single arm prospective clinical study. Potential participants will have already had a nerve transfer surgery more than 6 months prior to enrollment and will have also completed post-nerve transfer physical /occupational neurorehabilitation. At baseline, upper extremity muscle strength, muscle force and nerve health with needle electromyography and neuroimaging will be tested. Patients will undergo percutaneous (temporary) spinal cord stimulator leads placement in the cervical supralesional spine region. Week 0-4: Weekly testing of motor function and muscle contraction force with the stimulation turned on versus turned off will be performed. Stimulation parameters for each target upper extremity muscle will also be documented. Temporary leads will be removed after approximately 4 weeks. At the last research visit at approximately 6-7 weeks post leads placement muscle strength/force will be assessed to determine the duration of the stimulation effect (if it is sustained). To assess any improvement of nerve health, neuroimaging and electromyography will also be performed. ### Conditions Module **Conditions:** - Spinal Cord Injury Cervical - Tetraplegia **Keywords:** - spinal - cord - stimulation - percutaneous - peripheral - nerve - transfer ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Percutaneous temporary spinal cord stimulator. Parameters for upper extremity motor function will be assessed with the stimulation turned on and off. Muscle strength and force will be assessed with the stim turned on and off. ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** All participants will undergo baseline muscle strength and force assessments. Participants will also answer questionnaires on pain and quality of life. An optional nerve health assessment with needle electromyography and neuroimaging may be performed. Participants will undergo clinically indicated percutaneous (temporal) cervical epidural leads placement. Weeks 0-4 post-leads placement: during weekly visits upper extremity muscle strength and force will be assessed, pain and quality of life questionnaires will be completed (1 research visit per week) At approximately 28 days temporary leads will be removed. At the last visit, muscle strength and force in upper extremity muscle groups will be assessed, participants will complete pain and quality of life questionnaires. Participants may choose to undergo an optional nerve health assessment with needle electromyography and neuroimaging. **Intervention Names:** - Device: Percutaneous spinal cord stimulation **Label:** Percutaneous spinal cord stimulation **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Percutaneous spinal cord stimulation **Description:** The parameters of percutaneous cervical spinal cord stimulation leads will be adjusted for optimal upper extremity motor function. **Name:** Percutaneous spinal cord stimulation **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Change in Medical Research Council (MRC) grade of recipient nerve transfer muscle group with spinal cord stimulation activated. MRC ranges from 0 (no visible muscle contraction) to 5 (normal muscle strength against full resistance). A larger number represents a better outcome. **Measure:** Nerve transfer recipient muscle strength **Time Frame:** 0-6 weeks #### Secondary Outcomes **Description:** Change in muscle force generated by recipient nerve transfer muscle group with spinal cord stimulation activated. Muscle force is measured with a hand-held dynamometer. This is measured in Newtons, with a larger number meaning greater force and a better outcome. **Measure:** Nerve transfer recipient muscle force **Time Frame:** 0-6 weeks **Description:** Change in neck and upper extremity pain measured with the Numeric Rating Scale (NRS). NRS scale ranges from 0 (No pain) to 10 (worst possible pain), with a lower number representing a better outcome. A positive change in NRS from baseline to follow-up visits suggests improvement of pain. **Measure:** Neck and upper extremity pain **Time Frame:** 0-6 weeks **Description:** Optimized amplitude of percutaneous stimulation for each upper extremity muscle for voluntary hand/arm motor function will be documented. Amplitude is measured in miliAmperes. **Measure:** Amplitude of percutaneous stimulation **Time Frame:** 0-4 weeks **Description:** Optimized frequency of percutaneous stimulation for each upper extremity muscle for voluntary hand/arm motor function will be documented. Frequency is measured in Hz (Hertz). **Measure:** Frequency of percutaneous stimulation **Time Frame:** 0-4 weeks **Description:** Optimized pulse width of percutaneous stimulation for each upper extremity muscle for voluntary hand/arm motor function will be documented. Pulse width is measured in microseconds. **Measure:** Pulse width of percutaneous stimulation **Time Frame:** 0-4 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age ≥18 years and ≤65 * Provides informed consent * History of upper extremity nerve transfer \> 6 months prior to enrollment * Completion of standard post-nerve transfer occupational therapy * Baseline upper extremity strength of \< 5/5 grade with the MRC * Scheduled to undergo a cervical spinal cord stimulation procedure for chronic pain refractory to first line therapy * Willing and able to adhere to the study protocol Exclusion Criteria: * Central nervous system (CNS) malignancy * A contraindication to the SCS procedure * Diagnosis that precludes the patient from full participation in the protocol * A functional implanted device (pacemaker, vagus nerve device, baclofen pump) * Botulinum toxin injection in upper extremity muscles \< 6 months prior to enrollment * For female participants, current/planned pregnancy (females of childbearing age will be asked to take a pregnancy test on the day of the intervention) * Other factors that prevent participation in the opinion of the surgeon-principal investigator **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** bjohnston2@mgb.org **Name:** Benjamin R. Johnston, MD PhD **Phone:** (617) 525-7378 **Role:** CONTACT **Contact 2:** **Email:** jchalif@bwh.harvard.edu **Name:** Joshua I. Chalif, MD PhD **Phone:** (617) 525-7378 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Brigham and Women's Hospital **Name:** Yi Lu, MD PhD **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **Description:** Individual participant data will not be shared with researchers outside of the study, except as required de-identified data for publication purposes. **IPD Sharing:** NO ### References Module #### References **Citation:** Bertelli JA, Ghizoni MF. Nerve transfers for restoration of finger flexion in patients with tetraplegia. J Neurosurg Spine. 2017 Jan;26(1):55-61. doi: 10.3171/2016.5.SPINE151544. Epub 2016 Aug 5. **PMID:** 27494781 **Citation:** Fox IK. Nerve Transfers in Tetraplegia. Hand Clin. 2016 May;32(2):227-42. doi: 10.1016/j.hcl.2015.12.013. Epub 2016 Mar 10. **PMID:** 27094894 **Citation:** Lu DC, Edgerton VR, Modaber M, AuYong N, Morikawa E, Zdunowski S, Sarino ME, Sarrafzadeh M, Nuwer MR, Roy RR, Gerasimenko Y. Engaging Cervical Spinal Cord Networks to Reenable Volitional Control of Hand Function in Tetraplegic Patients. Neurorehabil Neural Repair. 2016 Nov;30(10):951-962. doi: 10.1177/1545968316644344. Epub 2016 May 18. **PMID:** 27198185 **Citation:** Barra B, Conti S, Perich MG, Zhuang K, Schiavone G, Fallegger F, Galan K, James ND, Barraud Q, Delacombaz M, Kaeser M, Rouiller EM, Milekovic T, Lacour S, Bloch J, Courtine G, Capogrosso M. Epidural electrical stimulation of the cervical dorsal roots restores voluntary upper limb control in paralyzed monkeys. Nat Neurosci. 2022 Jul;25(7):924-934. doi: 10.1038/s41593-022-01106-5. Epub 2022 Jun 30. **PMID:** 35773543 **Citation:** Greiner N, Barra B, Schiavone G, Lorach H, James N, Conti S, Kaeser M, Fallegger F, Borgognon S, Lacour S, Bloch J, Courtine G, Capogrosso M. Recruitment of upper-limb motoneurons with epidural electrical stimulation of the cervical spinal cord. Nat Commun. 2021 Jan 19;12(1):435. doi: 10.1038/s41467-020-20703-1. **PMID:** 33469022 **Citation:** Powell MP, Verma N, Sorensen E, Carranza E, Boos A, Fields DP, Roy S, Ensel S, Barra B, Balzer J, Goldsmith J, Friedlander RM, Wittenberg GF, Fisher LE, Krakauer JW, Gerszten PC, Pirondini E, Weber DJ, Capogrosso M. Epidural stimulation of the cervical spinal cord for post-stroke upper-limb paresis. Nat Med. 2023 Mar;29(3):689-699. doi: 10.1038/s41591-022-02202-6. Epub 2023 Feb 20. **PMID:** 36807682 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000013118 - Term: Spinal Cord Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000020196 - Term: Trauma, Nervous System - ID: D000014947 - Term: Wounds and Injuries - ID: D000010243 - Term: Paralysis - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M15916 - Name: Spinal Cord Injuries - Relevance: HIGH - As Found: Spinal Cord Injury - ID: M14632 - Name: Quadriplegia - Relevance: HIGH - As Found: Tetraplegia - ID: M22023 - Name: Trauma, Nervous System - Relevance: LOW - As Found: Unknown - ID: M15915 - Name: Spinal Cord Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M13157 - Name: Paralysis - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000013119 - Term: Spinal Cord Injuries - ID: D000011782 - Term: Quadriplegia ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437535 **Brief Title:** Role of Vaspin in Pathophysiology of Pre-eclampsia **Official Title:** The Pathophysiological Role of Vaspin and Apoptosis in Pre-eclamptic Obese Women #### Organization Study ID Info **ID:** vaspin and pre-eclampsia #### Organization **Class:** OTHER **Full Name:** Assiut University ### Status Module #### Completion Date **Date:** 2025-08 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Assiut University #### Responsible Party **Investigator Affiliation:** Assiut University **Investigator Full Name:** Aya Ali Ibrahim Sayed **Investigator Title:** principal investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** * To investigate the possible role of vaspin and apoptosis in pre-eclamptic obese women . * To compare the serum as well as placental level of vaspin in normotensive and severe pre-eclamptic obese women. * To compare the serum as well as placental level of vaspin in normotensive normal body weight and severe pre-eclamptic obese women women . * To compare placental apoptosis marker Bcl2 in normotensive and severe pre-eclamptic obese women . * To compare placental apoptosis marker Bcl2 in normotensive normal body weight and severe pre-eclamptic obese women . * Correlation between vaspin and apoptosis in pre-eclamptic obese women . * Correlation between vaspin level and apoptosis marker with patient demographic data(Age -parity). **Detailed Description:** • Pre-eclampsia(PE) is defined as new onset hypertension after 20 weeks gestation with evidence of maternal organ or uteroplacental dysfunction or proteinuria. The majority of maternal deaths related to PE can be avoided by providing timely and effective care and delivery to high-risk women. Thus, optimization of health care for women during pregnancy to prevent and treat PE . PE classified clinically to mild and severe sub types as Pregnant women with BP≥160/110 mmHg and proteinuria ≥3+ reading on dipstick are classified as having severe PE while pregnant women with systolic blood pressure of 140 -159 mmHg, diastolic blood pressure of 90-109 mmHg, and proteinuria ≥1+ reading on dipstick are classified as having mild PE.. Vaspin, a member of adipokines was first isolated from the visceral adipose tissue of the rat abdominal obesity model (OLETF). It belongs to the serine protease inhibitors and acts through a protein G-coupled receptor - GRP78. Vaspin has also found in the liver, pancreas, cerebrospinal fluid, hypothalamus, intestine, and lungs.it has pleiotropic functions that include regulating inflammatory response, insulin resistance and the development of obesity. Vaspin like other adipokines including leptin and adiponectin can affect the female reproduction system like ovary. Vaspin expression was detected in another reproductive component, the placenta. In humans, vaspin was localized in cytotrophoblasts and syncytiotrophoblasts in first-trimester placentas, but only in syncytiotrophoblasts in third-trimester placentas. Apoptosis plays a critical role in the homeostasis regulation of normal placental development. However, excessive placental apoptosis leads to placental dysfunction, which may consequence in pregnancy disorders such as preeclampsia. vaspin acts as an antiapoptotic agent in ovary by attenuating the tumor necrosis factor (TNF-α)-induced apoptosis by promoting autophagy also has been shown to inhibit macrophage apoptosisAnti apoptotic effects of vaspin have also been described in human osteoblast cells by upregulation of the expression of BCL2 and downregulation of BAX through the Mitogen-activated kinase (MAP3/1)pathway and Protein kinase B(AKT) pathway. ### Conditions Module **Conditions:** - Pre-Eclampsia ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 75 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** will include 25 women with normal weight and normal blood pressure . **Label:** Group 1 #### Arm Group 2 **Description:** :will include 25 obsese women with normal blood pressure. **Label:** Group2 #### Arm Group 3 **Description:** : will include 25 obese women with confirmed diagnosis of severe preeclampsia . **Label:** Group 3 ### Outcomes Module #### Primary Outcomes **Description:** - measure level of vaspin in serum as well as its level in placenta in patients with pre-eclampsia and women with normal pregnancy **Measure:** vaspin level in serum and placenta **Time Frame:** one year **Description:** measure level of gene expression of apoptotic marker bcl2 by PCR in placenta in patients with preeclampsia and women with normal pregnancy **Measure:** level of bcl2 expression in placenta **Time Frame:** one year **Description:** correlation between level of vaspin and bcl2 gene expression in patients of preeclamsia and women with normal pregnancy **Measure:** vaspin and bcl2 **Time Frame:** one year #### Secondary Outcomes **Description:** Correlation between vaspin level and bcl2 level with patient demographic data(Age -parity). **Measure:** vapin level and bcl2 level and patient demographic data **Time Frame:** one year ### Eligibility Module **Eligibility Criteria:** Inclusion criteria: * Pregnant women who will come to hospital for termination of pregnancy . * Confirmed diagnosis of preeclampsia for study groups. * Control group will include Normotensive pregnant women. * Age group 18-35 years. * gestional age at termination of pregnancy : group 1\&2 : from 38 to 40 weeks group 3:terminatin of pregnancy regardless of gestional age Exclusion Criteria: * Pregnant women who do not consent to participate. * Diabeteic patients . * History of pre-gestional hypertension. * History of chronic renal disease. **Gender Based:** True **Maximum Age:** 35 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT **Study Population:** Pregnant women who will come for termination of pregnancy ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** ayaa.alii2468@gmail.com **Name:** Aya ali ibrahim sayed, master **Phone:** +20 010096908832 **Role:** CONTACT **Contact 2:** **Email:** mrafadeil@gmail.com **Name:** Mahmoud Raafat Abdel-fadeil, professor **Phone:** +20 01001644429 **Role:** CONTACT ### References Module #### References **Citation:** Bergman L, Torres-Vergara P, Penny J, Wikstrom J, Nelander M, Leon J, Tolcher M, Roberts JM, Wikstrom AK, Escudero C. Investigating Maternal Brain Alterations in Preeclampsia: the Need for a Multidisciplinary Effort. Curr Hypertens Rep. 2019 Aug 2;21(9):72. doi: 10.1007/s11906-019-0977-0. **PMID:** 31375930 **Citation:** Fondjo LA, Sarpong D, Owiredu WKBA, Opoku S, Adu-Bonsaffoh K, Teviu E. Effect of magnesium sulfate treatment on mediators of endothelial dysfunction and electrolytes in mild and severe preeclampsia: A case-control study. Health Sci Rep. 2023 Apr 26;6(5):e1232. doi: 10.1002/hsr2.1232. eCollection 2023 May. **PMID:** 37123551 **Citation:** Kurowska P, Mlyczynska E, Dawid M, Jurek M, Klimczyk D, Dupont J, Rak A. Review: Vaspin (SERPINA12) Expression and Function in Endocrine Cells. Cells. 2021 Jul 6;10(7):1710. doi: 10.3390/cells10071710. **PMID:** 34359881 **Citation:** Kurowska P, Mlyczynska E, Dawid M, Opydo-Chanek M, Dupont J, Rak A. In Vitro Effects of Vaspin on Porcine Granulosa Cell Proliferation, Cell Cycle Progression, and Apoptosis by Activation of GRP78 Receptor and Several Kinase Signaling Pathways Including MAP3/1, AKT, and STAT3. Int J Mol Sci. 2019 Nov 19;20(22):5816. doi: 10.3390/ijms20225816. **PMID:** 31752432 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000046110 - Term: Hypertension, Pregnancy-Induced - ID: D000011248 - Term: Pregnancy Complications - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M12701 - Name: Obesity - Relevance: LOW - As Found: Unknown - ID: M7633 - Name: Eclampsia - Relevance: HIGH - As Found: Eclampsia - ID: M14106 - Name: Pre-Eclampsia - Relevance: HIGH - As Found: Pre-Eclampsia - ID: M10024 - Name: Hypertension - Relevance: LOW - As Found: Unknown - ID: M25635 - Name: Hypertension, Pregnancy-Induced - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: T2019 - Name: Eclampsia - Relevance: HIGH - As Found: Eclampsia ### Condition Browse Module - Meshes - ID: D000004461 - Term: Eclampsia - ID: D000011225 - Term: Pre-Eclampsia ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437522 **Brief Title:** A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors **Official Title:** A Phase II Clinical Trial To Evaluate the Efficacy and Safety of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (Non-nasopharyngeal Carcinoma) and Other Solid Tumors #### Organization Study ID Info **ID:** BL-B01D1-204-02 #### Organization **Class:** INDUSTRY **Full Name:** Sichuan Baili Pharmaceutical Co., Ltd. ### Status Module #### Completion Date **Date:** 2026-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-27 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Baili-Bio (Chengdu) Pharmaceutical Co., Ltd. #### Lead Sponsor **Class:** INDUSTRY **Name:** Sichuan Baili Pharmaceutical Co., Ltd. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study is a phase II clinical study to explore the efficacy and safety of BL-B01D1 + PD-1 monoclonal antibody combination therapy in patients with recurrent or metastatic head and neck squamous cell carcinoma (non-nasopharyngeal carcinoma) and other solid tumors. ### Conditions Module **Conditions:** - Head and Neck Squamous Cell Carcinoma ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 52 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants receive BL-B01D1 + PD-1 monoclonal antibody as intravenous infusion for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons. **Intervention Names:** - Drug: BL-B01D1 - Drug: PD-1 monoclonal antibody **Label:** Study treatment **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Study treatment **Description:** Administration by intravenous infusion for a cycle of 3 weeks. **Name:** BL-B01D1 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Study treatment **Description:** Administration by intravenous infusion for a cycle of 3 weeks. **Name:** PD-1 monoclonal antibody **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS). **Measure:** Objective Response Rate (ORR) **Time Frame:** Up to approximately 24 months **Description:** The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of BL-B01D1. **Measure:** Recommended Phase II Dose (RP2D) **Time Frame:** Up to approximately 24 months #### Secondary Outcomes **Description:** Progression-free survival (PFS) as assessed by BIRC is defined as the time between the date subjects are randomized and the first observation of disease progression (based on BICR's image-based assessment) or death. **Measure:** Progression-free survival (PFS) **Time Frame:** Up to approximately 24 months **Description:** Disease Control Rate (DCR) : Percentage of all randomized subjects who rated the best overall response (BOR) as complete response (CR), partial response (PR), and disease stabilization (SD) according to RECIST 1.1 criteria. **Measure:** Disease Control Rate (DCR) **Time Frame:** Up to approximately 24 months **Description:** Duration of Response (DOR) : defined as the period from the date when tumor response is first recorded to the date when objective tumor progression is first recorded or the date of death. **Measure:** Duration of Response (DOR) **Time Frame:** Up to approximately 24 months **Description:** TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-B01D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-B01D1. **Measure:** Treatment Emergent Adverse Event (TEAE) **Time Frame:** Up to approximately 24 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Subject volunteered to participate in the study and signed an informed consent; 2. Male or female aged ≥18 years and ≤75 years; 3. Expected survival time ≥3 months; 4. ECOG score 0-1; 5. Patients with recurrent or metastatic head and neck squamous cell carcinoma (non-nasopharyngeal carcinoma) and other solid tumors confirmed by histopathology and/or cytology; 6. Patients must provide a documented tumor tissue specimen of the primary or metastatic tumor within 3 years for PD-L1 testing and other testing; 7. At least one measurable lesion meeting the RECIST v1.1 definition was required; 8. No blood transfusion and no use of cell growth factors and/or platelet-raising drugs within 14 days before screening, and the organ function level must meet the requirements; 9. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0; 10. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, a serum or urine pregnancy test must be negative, and the patient must not be lactating; All enrolled patients should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment. Exclusion Criteria: 1. Prior treatment with an ADC drug with TOP I inhibitors as a toxin; 2. Before the first delivery within four weeks or five half-life used anti-tumor treatment; Palliative radiotherapy was given within 2 weeks before the first dose; 3. Received any previous systemic antitumor regimen for solid tumors such as recurrent or metastatic head and neck squamous cell carcinoma; 4. Had received immunotherapy and developed ≥ grade 3 irAE or ≥ grade 2 immune-related myocarditis; 5. Use of an immunomodulatory drug within 14 days before the first dose of study drug; 6. Systemic corticosteroids were required within 2 weeks before the first dose of the study; 7. Has a history of severe disease of heart head blood-vessel; 8. Active autoimmune and inflammatory diseases; 9. Other malignant tumors that progressed or required treatment within 3 years before the first dose; 10. With ILD requiring steroid treatment, current ILD, or suspected ILD at screening; 11. Presence of: a) poorly controlled diabetes mellitus before study treatment; b) poorly controlled hypertension; c) history of hypertensive crisis or hypertensive encephalopathy; 12. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; 13. Patients with active central nervous system metastasis; 14. Patients with pleural effusion, pericardial effusion or ascites with clinical symptoms or requiring repeated drainage; 15. Had allergic history to recombinant humanized antibody or human-mouse chimeric antibody or to any of BL-B01D1's excipients; 16. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT); 17. Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or active hepatitis C virus infection; 18. Active infection requiring systemic therapy; 19. Had participated in another clinical trial within 4 weeks before the first dose; 20. Who have a history of psychotropic drug abuse and cannot abstain from it or have mental disorders; 21. Other circumstances that the investigator deemed inappropriate for participation in the trial. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** xiaosa@baili-pharm.com **Name:** Sa Xiao, PHD **Phone:** 15013238943 **Role:** CONTACT #### Locations **Location 1:** **City:** Shanghai **Contacts:** ***Contact 1:*** - **Name:** Chaosu Hu - **Role:** CONTACT ***Contact 2:*** - **Name:** Chaosu Hu - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Dongmei Ji - **Role:** PRINCIPAL_INVESTIGATOR **Country:** China **Facility:** Fudan University Shanghai Cancer Center **State:** Shanghai #### Overall Officials **Official 1:** **Affiliation:** Fudan University **Name:** Chaosu Hu **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Fudan University **Name:** Dongmei Ji **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000018307 - Term: Neoplasms, Squamous Cell - ID: D000006258 - Term: Head and Neck Neoplasms - ID: D000009371 - Term: Neoplasms by Site ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: HIGH - As Found: Carcinoma - ID: M5550 - Name: Carcinoma, Squamous Cell - Relevance: HIGH - As Found: Squamous Cell Carcinoma - ID: M14850 - Name: Recurrence - Relevance: LOW - As Found: Unknown - ID: M1689 - Name: Squamous Cell Carcinoma of Head and Neck - Relevance: HIGH - As Found: Head and Neck Squamous Cell Carcinoma - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M20451 - Name: Neoplasms, Squamous Cell - Relevance: LOW - As Found: Unknown - ID: M9348 - Name: Head and Neck Neoplasms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002277 - Term: Carcinoma - ID: D000002294 - Term: Carcinoma, Squamous Cell - ID: D000077195 - Term: Squamous Cell Carcinoma of Head and Neck ### Intervention Browse Module - Ancestors - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4225 - Name: Antibodies - Relevance: HIGH - As Found: Given - ID: M4230 - Name: Antibodies, Monoclonal - Relevance: HIGH - As Found: Chemotherapy - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000000906 - Term: Antibodies - ID: D000000911 - Term: Antibodies, Monoclonal ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437509 **Brief Title:** A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Extensive-stage Small Cell Lung Cancer **Official Title:** A Phase II Clinical Trial to Evaluate the Efficacy and Safety of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Extensive-stage Small Cell Lung Cancer #### Organization Study ID Info **ID:** BL-B01D1-204-01 #### Organization **Class:** INDUSTRY **Full Name:** Sichuan Baili Pharmaceutical Co., Ltd. ### Status Module #### Completion Date **Date:** 2026-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-27 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Baili-Bio (Chengdu) Pharmaceutical Co., Ltd. #### Lead Sponsor **Class:** INDUSTRY **Name:** Sichuan Baili Pharmaceutical Co., Ltd. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study is a phase II clinical study to explore the efficacy and safety of BL-B01D1 + PD-1 monoclonal antibody combination therapy in patients with extensive-stage small cell lung cancer. ### Conditions Module **Conditions:** - Extensive-stage Small-cell Lung Cancer ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants receive BL-B01D1 + PD-1 monoclonal antibody as intravenous infusion for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons. **Intervention Names:** - Drug: BL-B01D1 - Drug: PD-1 monoclonal antibody **Label:** Study treatment **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Study treatment **Description:** Administration by intravenous infusion for a cycle of 3 weeks. **Name:** BL-B01D1 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Study treatment **Description:** Administration by intravenous infusion for a cycle of 3 weeks. **Name:** PD-1 monoclonal antibody **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS). **Measure:** Objective Response Rate (ORR) **Time Frame:** Up to approximately 24 months **Description:** The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of BL-B01D1. **Measure:** Recommended Phase II Dose (RP2D) **Time Frame:** Up to approximately 24 months #### Secondary Outcomes **Description:** Progression-free survival (PFS) as assessed by BIRC is defined as the time between the date subjects are randomized and the first observation of disease progression (based on BICR's image-based assessment) or death. **Measure:** Progression-free survival (PFS) **Time Frame:** Up to approximately 24 months **Description:** Disease Control Rate (DCR) : Percentage of all randomized subjects who rated the best overall response (BOR) as complete response (CR), partial response (PR), and disease stabilization (SD) according to RECIST 1.1 criteria. **Measure:** Disease Control Rate (DCR) **Time Frame:** Up to approximately 24 months **Description:** Duration of Response (DOR) : defined as the period from the date when tumor response is first recorded to the date when objective tumor progression is first recorded or the date of death. **Measure:** Duration of Response (DOR) **Time Frame:** Up to approximately 24 months **Description:** TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-B01D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-B01D1. **Measure:** Treatment Emergent Adverse Event (TEAE) **Time Frame:** Up to approximately 24 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Subject volunteered to participate in the study and signed an informed consent; 2. Male or female aged ≥18 years and ≤75 years; 3. Expected survival time ≥3 months; 4. ECOG score 0-1; 5. Newly diagnosed patients with extensive-stage small cell lung cancer confirmed by histopathology and / or cytology; 6. A archived tumor tissue sample or fresh tissue sample of the primary or metastatic lesion must be provided within 3 years; 7. At least one measurable lesion meeting the RECIST v1.1 definition was required; 8. No blood transfusion and no use of cell growth factors and/or platelet-raising drugs within 14 days before screening, and the organ function level must meet the requirements; 9. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0; 10. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, a serum or urine pregnancy test must be negative, and the patient must not be lactating; All enrolled patients should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment. Exclusion Criteria: 1. Prior use of ADC drug therapy with small molecule toxins as topoisomerase I inhibitors; 2. Prior treatment with any systemic anti-tumor regimen for extensive-stage small cell lung cancer; 3. Pathology suggested small cell carcinoma containing non-small cell carcinoma components; 4. Subjects had used immunomodulatory drugs within 14 days before the first use of the study drug ; 5. Screening the history of severe cardiovascular and cerebrovascular diseases in the first half of the year ; 6. QT interval prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia ; 7. Active autoimmune diseases and inflammatory diseases ; 8. Receiving long-term systemic corticosteroid therapy or equivalent anti-inflammatory active drugs or any form of immunosuppressive therapy prior to the first dose; 9. Other malignancies that have progressed or require treatment within 5 years prior to the first dose; 10. Have ILD requiring steroid therapy, or currently have ILD, or suspected ILD at screening; 11. Prior to initiation of study treatment, there were: a) poorly controlled diabetes mellitus; b) with severe complications of diabetes; c) glycosylated hemoglobin levels of 8% or more; d) hypertension that is poorly controlled by two antihypertensive drugs; e) history of hypertensive crisis or hypertensive encephalopathy; 12. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to screening; Except for infusion set-related thrombosis; 13. Concurrent pulmonary disease leading to severe clinical impairment of respiratory function; 14. Patients with active central nervous system metastases; 15. Patients with large serosal effusions, or symptomatic serosal effusions, or poorly controlled serosal effusions; 16. History of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any excipient component of the experimental drug; 17. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation; 18. Positive human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection; 19. Severe infection within 4 weeks prior to first dose of study drug; Lung infection or active lung inflammation within 4 weeks; 20. Have participated in another clinical trial within 4 weeks prior to the first dose; 21. Have a history of psychotropic substance abuse and cannot be abstained from or have a history of severe neurological or psychiatric disorders; 22. Imaging examination showed that the tumor had invaded or encapsulated the large blood vessels in the chest; 23. Severe and non-healing wounds, ulcers, or fractures within 4 weeks prior to signing the informed policy; 24. Clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing the informed policy; 25. Subjects who are scheduled to receive or receive a live vaccine within 28 days prior to the first dose; 26. Other conditions that the investigator considers unsuitable to participate in this clinical trial. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** xiaosa@baili-pharm.com **Name:** Sa Xiao, PHD **Phone:** 15013238943 **Role:** CONTACT #### Locations **Location 1:** **City:** Shanghai **Contacts:** ***Contact 1:*** - **Name:** Caicun Zhou - **Role:** CONTACT **Country:** China **Facility:** Shanghai East Hospital **State:** Shanghai #### Overall Officials **Official 1:** **Affiliation:** Shanghai East Hospital **Name:** Caicun Zhou, PHD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012142 - Term: Respiratory Tract Neoplasms - ID: D000013899 - Term: Thoracic Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000002283 - Term: Carcinoma, Bronchogenic - ID: D000001984 - Term: Bronchial Neoplasms ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11172 - Name: Lung Neoplasms - Relevance: HIGH - As Found: Lung Cancer - ID: M28323 - Name: Small Cell Lung Carcinoma - Relevance: HIGH - As Found: Small Cell Lung Cancer - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M14979 - Name: Respiratory Tract Neoplasms - Relevance: LOW - As Found: Unknown - ID: M16658 - Name: Thoracic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M5540 - Name: Carcinoma, Bronchogenic - Relevance: LOW - As Found: Unknown - ID: M5260 - Name: Bronchial Neoplasms - Relevance: LOW - As Found: Unknown - ID: T5271 - Name: Small Cell Lung Cancer - Relevance: HIGH - As Found: Small Cell Lung Cancer ### Condition Browse Module - Meshes - ID: D000008175 - Term: Lung Neoplasms - ID: D000055752 - Term: Small Cell Lung Carcinoma ### Intervention Browse Module - Ancestors - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4225 - Name: Antibodies - Relevance: HIGH - As Found: Given - ID: M4230 - Name: Antibodies, Monoclonal - Relevance: HIGH - As Found: Chemotherapy - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000000906 - Term: Antibodies - ID: D000000911 - Term: Antibodies, Monoclonal ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437496 **Brief Title:** 68Ga-AAZTA-093 PET/CT: First-in-human Study **Official Title:** 68Ga-AAZTA-093 PET/CT: First-in-human Study in Patients With Prostate Cancer #### Organization Study ID Info **ID:** FirstAHFujian-68Ga-AAZTA-093 #### Organization **Class:** OTHER **Full Name:** First Affiliated Hospital of Fujian Medical University ### Status Module #### Completion Date **Date:** 2024-10-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-27 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** First Affiliated Hospital of Fujian Medical University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** 68Ga-AAZTA-093 is a novel radiotracer targeting prostate-specific membrane antigen (PSMA). In this study, we observed the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-AAZTA-093 PET/CT in patients with prostate cancer. **Detailed Description:** Prostate cancer (PCa) is one of the most common malignancies worldwide in men. Prostate specific membrane antigen (PSMA), as known as folate hydrolase I or glutamate carboxypeptidase II, is overexpressed on the cells of prostatic adenocarcinoma. Various low molecular weight radiopharmaceuticals targeting PSMA such as PSMA-11, PSMA-617 for 68Ga- or 177Lu- labeling have been developed. 68Ga-AAZTA-093, a novel radiopharmaceutical targeting PSMA, with the urea fragment of a conjugate that employs the AAZTA chelator for labeling with 68Ga(III). This pilot study was prospectively designed to evaluate the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-AAZTA-093 PET/CT and compared with 68Ga-PSMA-11 and 68Ga-PSMA-617 PET/CT in the same group of prostate cancer patients. ### Conditions Module **Conditions:** - Malignant Neoplasm of Prostate ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - EARLY_PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Drug: 68Ga-AAZTA-093 Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-AAZTA-093. Tracer doses of 68Ga-AAZTA-093 will be used to image lesions of prostate cancer by PET/CT. **Intervention Names:** - Drug: 68Ga-AAZTA-093 **Label:** 68Ga-AAZTA-093 PET/ CT **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Drug: 68Ga-PSMA-11/68Ga-PSMA-617 Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-PSMA-11/68Ga-PSMA-617. Tracer doses of 68Ga-PSMA-11/68Ga-PSMA-617 will be used to image lesions of prostate cancer by PET/CT. **Intervention Names:** - Drug: 68Ga-PSMA-11//68Ga-PSMA-617 **Label:** 68Ga-PSMA-11/68Ga-PSMA-617 PET/ CT **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - 68Ga-AAZTA-093 PET/ CT **Description:** Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-AAZTA-093. Tracer doses of 68Ga-AAZTA-093 will be used to image lesions of prostate cancer by PET/CT. **Name:** 68Ga-AAZTA-093 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - 68Ga-PSMA-11/68Ga-PSMA-617 PET/ CT **Description:** Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-PSMA-11//68Ga-PSMA-617. Tracer doses of 68Ga-PSMA-11/68Ga-PSMA-617 will be used to image lesions of prostate cancer by PET/CT. **Name:** 68Ga-PSMA-11//68Ga-PSMA-617 **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** Sensitivity and Specificity of 68Ga-AAZTA-093 for prostate cancer in comparison with 68Ga-PSMA-11/68Ga-PSMA-617 PET/CT. **Measure:** Diagnostic value **Time Frame:** through study completion, an average of 3 months **Description:** Compare the SUV of tumors between 68Ga-AAZTA-093 PET/CT and 68Ga-PSMA-11/68Ga-PSMA-617 PET/CT. **Measure:** SUV of tumors **Time Frame:** through study completion, an average of 3 months #### Primary Outcomes **Description:** The safety will be assessed by the number and percentage of patients with adverse events; Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0. **Measure:** Safety evaluation **Time Frame:** Within 7 days following PET/CT #### Secondary Outcomes **Description:** Calculate the absorbed dose of 68Ga-AAZTA-093 in normal organs. **Measure:** Dosimetry data **Time Frame:** through study completion, an average of 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * confirmed treated or untreated prostate cancer patients; * 68Ga-AAZTA-093 and 68Ga-PSMA-11/68Ga-PSMA-617 PET/CT within 1 week; * signed written consent. Exclusion Criteria: * known allergy against PSMA; * any medical condition that in the opinion of the investigator may significantly interfere with study compliance. **Maximum Age:** 90 Years **Minimum Age:** 18 Years **Sex:** MALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** miaoweibing@126.com **Name:** Weibing Miao, MD **Phone:** 86-0591-87981618 **Role:** CONTACT **Contact 2:** **Email:** guochang1007@163.com **Name:** Guochang Wang, MD **Phone:** 86-0591-87981619 **Role:** CONTACT #### Locations **Location 1:** **City:** Fuzhou **Contacts:** ***Contact 1:*** - **Email:** guochang1007@163.com - **Name:** Guochang Wang, MD - **Phone:** 86-0591-87981619 - **Role:** CONTACT **Country:** China **Facility:** Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University **State:** Fujian **Status:** RECRUITING **Zip:** 350005 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005834 - Term: Genital Neoplasms, Male - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000005832 - Term: Genital Diseases, Male - ID: D000091662 - Term: Genital Diseases - ID: D000091642 - Term: Urogenital Diseases - ID: D000011469 - Term: Prostatic Diseases - ID: D000052801 - Term: Male Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M14335 - Name: Prostatic Neoplasms - Relevance: HIGH - As Found: Malignant Neoplasm of Prostate - ID: M8946 - Name: Genital Neoplasms, Male - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M8944 - Name: Genital Diseases, Male - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14333 - Name: Prostatic Diseases - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009369 - Term: Neoplasms - ID: D000011471 - Term: Prostatic Neoplasms ### Intervention Browse Module - Ancestors - ID: D000019275 - Term: Radiopharmaceuticals - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M352637 - Name: Gallium 68 PSMA-11 - Relevance: HIGH - As Found: Noise - ID: M21258 - Name: Radiopharmaceuticals - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000718244 - Term: Gallium 68 PSMA-11 ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437483 **Brief Title:** Effects of Sustained Natural Apophyseal Glides Combined With Kinesiotaping in Patients With Chronic Mechanical Neck Pain: A Randomised Controlled Trial **Official Title:** Effects of Sustained Natural Apophyseal Glides Combined With Kinesiotaping in Patients With Chronic Mechanical Neck Pain: A Randomised Controlled Trial #### Organization Study ID Info **ID:** FUI/CTR/2024/7 #### Organization **Class:** OTHER **Full Name:** Foundation University Islamabad ### Status Module #### Completion Date **Date:** 2024-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-27 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-05-30 **Type:** ESTIMATED #### Start Date **Date:** 2023-11-10 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Foundation University Islamabad #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study is a randomized controlled trial and its purpose is to determine the combined effects of sustained natural apophyseal glides and kinesiotaping on pain, range of motion and neck disability in patients with chronic mechanical neck pain. **Detailed Description:** This study aims to determine the combined effects of sustained natural apophyseal glides and kinesiotaping in chronic mechanical neck pain patients of age range 18-40. Outcome variables are pain, range of motion and functional disability of neck which will be determined by using the following respective data collection tools: 1. Numeric pain rating scale 2. Inclinometer 3. Neck Disability Index Participants of interest will be approached and explained about the research. They will be randomly allocated in to two groups. Informed written consent will be taken. The intervention protocol will be comprised of six sessions over a 2-week period (3 sessions per week on alternate days). Outcome measures will be assessed at baseline and after 2 weeks. Data will be analyzed and interpreted using SPSS. ### Conditions Module **Conditions:** - Neck Pain ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Randomized Controlled Trial ##### Masking Info **Masking:** SINGLE **Masking Description:** In this study, participants are blinded to their assigned treatment groups. **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 42 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants in this group will receive Sustained Natural Apophyseal Glides followed by Kinesiotaping in addition to the conventional treatment. This arm of the study will assess the synergistic effects of SNAGs and kinesiotape. **Intervention Names:** - Procedure: Sustained Natural Apophyseal Glides - Procedure: Kinesiotaping - Procedure: Conventional Treatment **Label:** Group A **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants in group B will receive Sustained Natural Apophyseal Glides along with the conventional treatment. **Intervention Names:** - Procedure: Sustained Natural Apophyseal Glides - Procedure: Conventional Treatment **Label:** Group B **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Group A - Group B **Description:** SNAGs: Therapist will apply an antero-superior accessory glide to the superior spinous process of the involved motion segment (between C3 to C7) by pushing it towards the direction of eyeball at approximately a 45 degree angle, using the thumb. The other thumb will reinforce the glide. Painless accessory glide will be maintained and subject will slowly turn their head towards the painful or restricted side (that elicited symptoms) and sustain the position for a few seconds. In case of symptom-free, the subject will apply overpressure at the end of restricted range of motion. The glide will be maintained till the head returns to the midline. Each session will consist of three sets of six to ten repetitions. **Name:** Sustained Natural Apophyseal Glides **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Group A **Description:** Kinesiotaping (KT): Subject will be in comfortable sitting position. Neck of the subject will be thoroughly cleaned with alcohol and sterile gauze pads before the application of Kinesiotape.The layers of KT will be applied in the form of two strips i.e. "Y strip" and "I strip". and applied over the neck in a position of cervical flexion and contralateral rotation and, pasted up and over either ridge of the spine covering the cervical muscles.It extends from T1-T2 to either side of C1-C2.The second layer is I-strip:The overlaying I-strip will be placed perpendicular to the Y-strip, It will be stretched from the both ends, and the middle portion of the tape will be applied first after which tension is released and ends are applied without tension. **Name:** Kinesiotaping **Type:** PROCEDURE #### Intervention 3 **Arm Group Labels:** - Group A - Group B **Description:** Hot pack (moist heat) and TENS will be applied, each for 10 minutes. **Name:** Conventional Treatment **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** It will be documented by using Numeric Pain Rating Scale (NPRS) which is a self- rated scale of 0-10 points where the participants rate their pain verbally or in writing."0" shows no pain whereas "10" represents worst pain. According to guidelines, NPRS scale categorizes pain into no pain (0), mild pain (1-3), moderate pain (4-7) and severe pain (8-10). **Measure:** Pain intensity **Time Frame:** 2 weeks **Description:** The range of motion for flexion, extension, and side bending will be documented using a Inclinometer, positioned on the vertex of the head. For rotation, it will be placed on the forehead. Inclinometer demonstrates good Intraclass Correlation Coeffecient (ICC) value of 0.770-0.982. **Measure:** Cervical Range of Motion **Time Frame:** 2 weeks **Description:** It will be documented by using Neck Disability Index (NDI) which consists of 10 questions addressing various aspects of neck functions to assess the impact of neck pain on a person's daily life. A total score ranges between 0 and 50 with higher scores indicating a high level of disability. Each question contains six answer choices, scored from 0 (no disability) to 5 (complete disability). All sections are then totaled.The scores on NDI are typically classified as: 0-4 (no disability), 5-14 (mild disability), 15-24 (moderate disability), 25-34 (severe disability), above 34 (complete disability). **Measure:** Functional Disability of Neck **Time Frame:** 2 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Mechanical Neck Pain * Age range: 18-40 years * Both males and females * Having pain from at least last 3 months (chronic) * Pain score greater than 3 on NPRS * Pain and limitation on neck moverment Exclusion criteria : * Recent surgery of spine, Temporomandibular joint or shoulder in the previous 12 months. * Open wound around neck. * History of traumatic injuries or fractures in the cervical spine. * History of neurological and cardiac pathologies. * History of some serious pathologies (e.g., malignancy, inflammatory disorder etc.). * History of cervical or shoulder neurological movement disorder. * Cervical spondylolisthesis, cervical radiculopathy, and spinal stenosis. * Vascular syndromes such as basilar insufficiency. * Diagnosed psychiatric disorders such as anxiety and depression. * Interventions including medications, exercise or physical therapy in the last 3 months. * Any other condition that contraindicates kinesiotaping such as skin sensitivity. **Maximum Age:** 40 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** fatimah.riazf16@gmail.com **Name:** Fatima Riaz, MS-MSKPT **Phone:** 0347-0051283 **Role:** CONTACT #### Locations **Location 1:** **City:** Rawalpindi **Contacts:** ***Contact 1:*** - **Email:** ali.asim@fui.edu.pk - **Name:** Ali Bin Asim, MS-OMPT - **Phone:** 03135088144 - **Role:** CONTACT **Country:** Pakistan **Facility:** Foundation University College of Physical Therapy **State:** Punjab **Status:** RECRUITING **Zip:** 460000 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M21485 - Name: Neck Pain - Relevance: HIGH - As Found: Neck Pain - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000019547 - Term: Neck Pain ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M3777 - Name: Ethanol - Relevance: LOW - As Found: Unknown - ID: M16204 - Name: Sulfamethazine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437470 **Brief Title:** Effect of Blood Flow Restriction Technique After Anterior Cruciate Ligament Reconstruction **Official Title:** Combined Effect Of Blood Flow Restriction Technique And Conventional Physical Therapy Program After Anterior Cruciate Ligament Reconstruction #### Organization Study ID Info **ID:** P.T.REC/012/005176 #### Organization **Class:** OTHER **Full Name:** Cairo University ### Status Module #### Completion Date **Date:** 2025-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-25 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-25 **Study First Submit QC Date:** 2024-05-25 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Cairo University #### Responsible Party **Investigator Affiliation:** Cairo University **Investigator Full Name:** Mostafa Ahmed Ali Abed **Investigator Title:** Assistant Lecturer of Physical Therapy for Musculoskeletal System Disorders and its Surgery, Faculty of Physical Therapy, Cairo University **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The purpose of this study will be to evaluate the effect of adding BFR (using 80% of LOP) to the conventional physical therapy program on knee function, functional test, balance, quadriceps and hamstrings muscles strength, thigh muscle girth and knee effusion in rehabilitation after ACLR. **Detailed Description:** Anterior cruciate ligament (ACL) injury is one of the most common knee injuries especially in the age range 20 to 29 years. It is commonly seen during sport activities including jumping, pivoting or during contact with the other players (Khalil et al., 2023). Quadriceps and hamstrings muscle weakness and atrophy are commonly seen after Anterior cruciate ligament reconstruction (ACLR) mainly due to weight bearing limitation in the early stage of rehabilitation (Barber-Westin and Noyes 2019 and Hughes et al., 2019). Recent rehabilitation protocols focused on range of motion (ROM) exercises and increased muscle activation in the early post-operative phase to minimize complications such as joint stiffness and muscle weakness (Myer et al., 2006 and Patterson et al., 2019a). It is recommended by the American College of Sports Medicine to use 60% to 70% of one repetition maximum (1 RM) to increase muscle strength and 70% to 80% of 1 RM to increase muscle size. However, using these percentage of loads in the early post-operative phase after ACLR may not be applicable (Barber-Westin and Noyes 2019). Therefore, therapists considered it is necessary to find a safe exercise protocol designed to increase muscle strength and mass to be used in the early post-operative phase. One of these protocols is the blood flow restriction training (BFRT) (Patterson et al., 2019a). The BFRT is a technique that restricts arterial and venous circulation in the working muscles during exercise (Scott et al., 2015). This technique uses a pneumatic tourniquet system that applies external pressure to the most proximal part of the arm or the thigh. Cuff inflation causes compression on the vascular structures under the cuff leading to occlusion of the venous return and restriction of the arterial blood flow to the distal part of the limb. This intentionally induced ischemic environment results in a state of hypoxia within the distal muscles (Manini and Clark 2009). In such environment, muscle strength and hypertrophy can be reached by smaller external loads such as 20% or 30% of 1RM (Loenneke et al., 2012a). This makes the BFRT applicable in the early post-operative phase of rehabilitation without stressing the knee joint, thus protecting the graft and minimizing the risk of increasing any associated injuries in cartilage or meniscus (Loenneke et al., 2012b and Arve et al., 2020). The BFRT is beneficial for many groups such as geriatrics and those with degenerative joint diseases, ligamentous injury and inflammatory diseases (Hughes et al., 2017). Early BFRT research designs used general measures to calculate cuff pressures, such as setting pressure relative to systolic blood pressure, thigh circumference, or random pressures which is probably inaccurate especially with change in limb circumference or body position (Takano et al., 2005 and Loenneke et al., 2015). A study performed by (Khalil et al., 2023) used the portable doppler ultrasound device to calculate limb occlusion pressure (LOP) of dorsalis pedis artery while manually inflating the restriction cuff. This procedure is operator dependent and may lead to some errors, especially in determining the exact location of the artery. Recent research recommends the use of individualized BFRT where the percentage of occlusion of the vascular structures is determined automatically for each individual separately (Scott et al., 2015). Previous studies concluded that BFRT after ACLR was effective in improving knee extension and flexion torques, pain, and balance (Spada et al., 2022, Bobes et al., 2020 and Jung et al., 2022) A recent systematic review performed by (Colapietro et al., 2023) found that limited studies included functional testing of the knee joint after BFRT which will be covered in this study using the latest wireless version of AirBands produced by VALD performance company which possesses the ability to automatically calculate LOP for each participant alone as recommended by the guidelines of Australian Institute of Sport. Up to the authors' knowledge, there was no study has investigated the effect of blood flow restriction (BFR) using 80% of LOP combined with the conventional physical therapy program on knee function and balance compared to the conventional physical therapy program alone after ACLR. ### Conditions Module **Conditions:** - Anterior Cruciate Ligament Injuries ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Masking Description:** A triple-blinded randomized controlled trial will be conducted, ensuring that participants, the research assistant (who serves as the examiner for all participants) and the statistician are blinded to the treatment group. **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** participants will receive the conventional physical therapy program while using non-inflated cuff as a sham treatment during exercising. **Intervention Names:** - Other: blood flow restriction technique **Label:** conventional physical therapy program **Type:** SHAM_COMPARATOR #### Arm Group 2 **Description:** participants will receive the conventional physical therapy program with the use of BFR cuff which will be inflated to reach 80% of limb occlusive pressure **Intervention Names:** - Other: blood flow restriction technique **Label:** blood flow restriction combined to conventional physical therapy program **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - blood flow restriction combined to conventional physical therapy program - conventional physical therapy program **Description:** All participants in the control group will receive the conventional physical therapy program with the use non-inflated cuff as a sham treatment during exercising. All participants in the intervention group will receive the conventional physical therapy program combined to blood flow restriction to 80% of limb occlusive pressure by using blood flow restriction cuff. **Name:** blood flow restriction technique **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** will be assessed by the Arabic version of the knee outcome survey-activities for daily living scale **Measure:** knee function **Time Frame:** after 3 months of intervention **Description:** will be assessed by the single leg hop test **Measure:** knee functional test **Time Frame:** after 3 months of intervention **Description:** will be assessed by the Y balance test for the lower quarter **Measure:** balance **Time Frame:** after 3 months of intervention **Description:** will be assessed by the hand held dynamometer **Measure:** quadriceps and hamstring muscles strength **Time Frame:** after 3 months of intervention #### Secondary Outcomes **Description:** will be assessed by a non-elastic measuring tape **Measure:** Thigh muscle girth **Time Frame:** baseline then 3 months after intervention **Description:** will be assessed by a non-elastic measuring tape **Measure:** Knee effusion **Time Frame:** baseline then 3 months after intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Aged from 18-35 years. 2. Underwent an ACLR semitendinosus autograft one-week post-operative 3. Willingness to participate in the intervention and subsequent assessment. 4. BMI from 18.5 to 29.9 kg/m2. Exclusion Criteria: 1. Insecure graft fixation (due to bone quality, suspension). 2. Active infection. 3. Postsurgical excess knee swelling that may limit exercise performance. 4. ACLR using bone tendon bone (BTB) graft. 5. Any cardiovascular disease such as hypertension. 6. Any lower limb trauma. 7. Hip and ankle pathology. 8. BMI more than 30 kg/m2 **Maximum Age:** 35 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** dr.mostafaabed@cu.edu.eg **Name:** Mostafa A Abed, asst. lec. **Phone:** 00201062051106 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Prof. of PT for Musculoskeletal System Disorders and its Surgery, Faculty of PT, Cairo University **Name:** Enas F Youssef, Professor **Role:** STUDY_CHAIR **Official 2:** **Affiliation:** Lec. of PT for Musculoskeletal System Disorders and its Surgery, Faculty of PT, Cairo University **Name:** Dina S Abd Allah, lecturer **Role:** STUDY_DIRECTOR **Official 3:** **Affiliation:** Asst. prof. of orthopedic surgery, Cairo University **Name:** Ahmed S Elkalyoby, Asst. prof **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007718 - Term: Knee Injuries - ID: D000007869 - Term: Leg Injuries - ID: D000014947 - Term: Wounds and Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M601 - Name: Anterior Cruciate Ligament Injuries - Relevance: HIGH - As Found: Anterior Cruciate Ligament Injuries - ID: M10738 - Name: Knee Injuries - Relevance: LOW - As Found: Unknown - ID: M10881 - Name: Leg Injuries - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000070598 - Term: Anterior Cruciate Ligament Injuries ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437457 **Brief Title:** Comparison of Gd-EOB-DTPA-enhanced MRI and Contrast-enhanced Ultrasound for Measuring Tumor Size of Solitary Hepatocellular Carcinoma ≤ 5cm:A Retrospective Study **Official Title:** Comparison of CE-MRI and CEUS for Measuring Tumor Size of HCC #### Organization Study ID Info **ID:** 2023-RE-117 #### Organization **Class:** OTHER **Full Name:** Anhui Medical University ### Status Module #### Completion Date **Date:** 2024-05-20 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-25 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-05-01 **Type:** ACTUAL #### Start Date **Date:** 2019-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-25 **Study First Submit QC Date:** 2024-05-25 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Anhui Medical University #### Responsible Party **Investigator Affiliation:** Anhui Medical University **Investigator Full Name:** Kunyuan Jiang **Investigator Title:** Anhui Medical University **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Knowing the tumor size before operation is of great significance to the choice of treatment methods of surgeons and the prognosis of patients. In this study, two commonly used imaging methods( CE-MRI/CEUS) were selected to measure and compare the tumor size before operation, in order to determine which measurement method is more accurate. **Detailed Description:** A total of 194 patients who met the inclusion criteria from January 2019 through May 2024 were included. Taken pathological results as the gold standard, Paired T-test and Bland-Altman analisis were conducted to assess the correlation and mean absolute error between the measured tumor sizes obtained from CE-MRI/CEUS and pathological results. ### Conditions Module **Conditions:** - HCC - Hepatocellular Carcinoma ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 194 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The patients who underwent CEUS before liver resection **Intervention Names:** - Radiation: ceus **Label:** CEUS #### Arm Group 2 **Description:** The patients who underwent CE-MRI before liver resection **Intervention Names:** - Radiation: ceus **Label:** CE-MRI ### Interventions #### Intervention 1 **Arm Group Labels:** - CE-MRI - CEUS **Description:** MRI was performed by using a superconducting magnet scanner operated at 3.0 T (GE discovery MR750w, USA) and the CEUS examination (Mindray, China), ultrasound was performed first in B-mode to identify the suspicious lesions and then switched to contrast mode prior to the injection of the contrast medium. **Name:** ceus **Type:** RADIATION ### Outcomes Module #### Primary Outcomes **Description:** the performance of Gd-EOB-DTPA-enhanced MRI (CE-MRI) and Contrast-enhanced Ultrasound (CEUS) in measuring tumor size of solitary hepatocellular carcinoma (HCC) ≤5cm. **Measure:** measuring HCC diameter **Time Frame:** Jaunary 2019 - May 2024 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. had no anti-HCC therapy before imaging examinations. 2. at least had one examination of Gd-EOB-DTPA-enhanced MRI and CEUS 2 weeks before surgery and confirmed as one single HCC. 3. If the patient had both imaging tests, the time interval between two examinations was less than 1 weeks. 4. both radiological and pathological results recorded the maximum tumor diameter. Exclusion Criteria: 1. had anti-HCC therapy before imaging examinations. 2. had no examination of Gd-EOB-DTPA-enhanced MRI or CEUS 2 weeks before surgery . 3. had no radiological or pathological results recorded the maximum tumor diameter. **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** The patients who underwent liver resection from January 2019 to May 2024 were included. ### Contacts Locations Module #### Locations **Location 1:** **City:** Hefei **Country:** China **Facility:** Anhui Provincial Hospital **State:** Anhui **Zip:** 230001 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000000230 - Term: Adenocarcinoma - ID: D000008113 - Term: Liver Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000004066 - Term: Digestive System Diseases - ID: D000008107 - Term: Liver Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: HIGH - As Found: Carcinoma - ID: M9613 - Name: Carcinoma, Hepatocellular - Relevance: HIGH - As Found: Hepatocellular Carcinoma - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M3585 - Name: Adenocarcinoma - Relevance: LOW - As Found: Unknown - ID: M11113 - Name: Liver Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M11107 - Name: Liver Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002277 - Term: Carcinoma - ID: D000006528 - Term: Carcinoma, Hepatocellular ### Intervention Browse Module - Browse Branches - Abbrev: Hemat - Name: Hematinics - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M11110 - Name: Liver Extracts - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437444 **Brief Title:** Asthma Crisis in Paediatrics: Impact of a Care Pathway in Primary and Hospital Care **Official Title:** Asthma Crisis in Paediatrics: Impact of a Care Pathway in Primary and Hospital Care #### Organization Study ID Info **ID:** 2021111010 #### Organization **Class:** OTHER_GOV **Full Name:** Basque Health Service ### Status Module #### Completion Date **Date:** 2026-05-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-26 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-05-07 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-07 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-26 **Study First Submit QC Date:** 2024-05-26 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Health Department of the Basque Government #### Lead Sponsor **Class:** OTHER_GOV **Name:** Basque Health Service #### Responsible Party **Investigator Affiliation:** Basque Health Service **Investigator Full Name:** Marta Montejo Fernandez **Investigator Title:** Pediatrician **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study aims to evaluate the effect of the implementation of the new Asthma Care Pathway in the Basque Healthcare Service for the improvement of care for children with asthma attacks and the reduction of variability between professionals and care settings in this care practice. Asthma is the most common chronic disease in children and has a major impact on people's quality of life. The Asthma Care Pathway is a structured multidisciplinary care plan that details the essential steps in the care of patients with mild-moderate asthma attacks and the coordinated practice of the agents involved as dictated by the evidence. This pathway will include quality indicators of compliance with diagnostic criteria, assessment of severity and prescription of drugs, as well as the experience of families and professionals, which have been collected in meetings designed for this purpose. The study consists in a mixed methods implementation trial with two phases: 1. Phase I: a quantitative evaluation will be carried out to assess implementation outcomes at the professional level through a pretest-posttest quasi-experimental study with paired control group, with a ratio of 1:2. The primary outcome variable will be the overall percentage of bronchodilator treatment with a spacer chamber in children diagnosed with mild-moderate asthma attacks. We will also include as outcomes to be measured the registration rate of the Pulmonary Score, the recording rate of the assessment of persistent asthma symptoms, and the rate of initiation of background treatment in children with persistent asthma symptoms. These variables will be analysed using differences in pre- and post-intervention outcome measures between the intervention and control groups. 2. Phase II: A qualitative evaluation will be carried out through a structured process with discussion groups focused on the identification of the main barriers and facilitators for the provision of recommended clinical practice related to asthmatic crisis in mild-moderate cases established by the Asthma Care Pathway. A purposive sample of paediatricians stratified by level of care and service organisations will be recruited to ensure that all views are represented in the discussion groups. The structured script will be designed with questions to explore each of the domains of the Theoretical Domains Framework (TDF). The study will be carried out mainly in two integrated healthcare organizations (IHO), which are made up of two primary care areas and the paediatric reference hospital emergency department of both areas, as well as the hospitalisation, intensive care and paediatric pneumology departments of said hospital, to extend in the future the Asthma Care Pathway to the rest of the Basque Health Service IHOs. ### Conditions Module **Conditions:** - Asthma in Children - Implementation Science - Inappropriate Prescribing ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Quasi-experimental pre-post cluster trial with control group ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 249 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** All the primary care and hospital pediatricians of the two Integrated Hospital Organizations (IHO) (Barakaldo-Sestao and Ezkerraldea-Enkarterri-Cruces) where the care pathway will be implemented. 83 participants in total. **Intervention Names:** - Behavioral: The implementation strategy to encourage the adoption of the Care Pathway **Label:** Asthma Care Pathway group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Primary care and hospital pediatricians of other IHOs where the care pathway is not implemented, but with similar characteristics to those in the experimental group, and with a proportion of 1:2. 166 participants in total. **Label:** Control **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Asthma Care Pathway group **Description:** 1. Dissemination of the most novel aspects of the agreed Care Pathway via corporate mail. 2. Audit \& Feedback (A\&F) data reports, sent every two weeks, to each paediatrician on the rate of prescription of bronchodilators administered with a spacer chamber, together with the rates of the other indicators established in the pathway, in their health centre and in the rest of the centres in the participating health areas. 3. Interactive training sessions, in which epidemiological data and data on the health, economic and social impact of asthma attacks were presented, together with data on other indicators associated with the care pathway, and key messages on current treatment recommendations based on the latest clinical practice. 4. Distribution of reminder posters in paediatrics consultations, PEDs and health centers. **Name:** The implementation strategy to encourage the adoption of the Care Pathway **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The overall percentage of bronchodilator treatment with a spacer chamber in children diagnosed with mild-moderate asthma attacks. **Measure:** Percentage of bronchodilator treatment **Time Frame:** from baseline to 12 months and 24 months #### Secondary Outcomes **Description:** Rate of Pulmonary Score registration in children diagnosed with mild-moderate asthma attacks, at all levels of care. **Measure:** Pulmonary Score registration **Time Frame:** from baseline to 12 months and 24 months **Description:** Rate of assessment and recording of persistent asthma symptoms in children diagnosed with mild-moderate asthma attacks by ussing the PACT form (Pediatric Asthma Control Tool). **Measure:** Assessment and recording of persistent asthma symptoms. **Time Frame:** from baseline to 12 months and 24 months **Description:** Rate of initiation of background treatment in children who have been assessed and registered with persistent asthma symptoms. **Measure:** Initiation of background treatment in children with persistent asthma symptoms **Time Frame:** from baseline to 12 months and 24 months ### Eligibility Module **Eligibility Criteria:** Eligibility for professionals: * Primary Care paediatricians and nurses * Paediatricians and nurses in the Paediatric Emergency Department * Paediatricians and nurses on the inpatient ward * Paediatric Intensive Care paediatricians and nurses * Paediatric Pneumology paediatricians and nurses Eligibility for patients: - Patients between 2 and 14 years with an acute episode of asthma; defined as an episode of wheezing and a previous diagnosis of asthma or with a previous episode of wheezing, or a first episode in a child older than 2 years with a personal/family history of atopy and/or with an objective response to bronchodilators as assessed by the Pulmonary Score, that have being attended between the 05/07/2024 and the 05/07/2025. **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** ALVARO.SANCHEZPEREZ@osakidetza.eus **Name:** Alvaro Sanchez Perez **Phone:** (+34)946006673 **Role:** CONTACT #### Locations **Location 1:** **City:** Barakaldo **Contacts:** ***Contact 1:*** - **Email:** ALVARO.SANCHEZPEREZ@osakidetza.eus - **Name:** Alvaro Sanchez Perez - **Phone:** (+34)946006673 - **Role:** CONTACT **Country:** Spain **Facility:** Primary Care Research Unit of Bizkaia **State:** Bizkaia **Status:** RECRUITING **Zip:** 48903 ### IPD Sharing Statement Module **Access Criteria:** Since data supporting the present study will mostly concern routine data retrieved from the electronic health record of the Basque Health Service-Osakidetza, it will be only shared on justified request to the study guarantors (proposals should be directed to the Responsible Party). It will only be shared with researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose. **Description:** Individual participant data will be shared that underlie results reported in the publication, after deidentification. **Info Types:** - STUDY_PROTOCOL **IPD Sharing:** YES **Time Frame:** Starting 6 months after the publication of results ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001982 - Term: Bronchial Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000008173 - Term: Lung Diseases, Obstructive - ID: D000008171 - Term: Lung Diseases - ID: D000012130 - Term: Respiratory Hypersensitivity - ID: D000006969 - Term: Hypersensitivity, Immediate - ID: D000006967 - Term: Hypersensitivity - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4556 - Name: Asthma - Relevance: HIGH - As Found: Asthma - ID: M5258 - Name: Bronchial Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M11170 - Name: Lung Diseases, Obstructive - Relevance: LOW - As Found: Unknown - ID: M10018 - Name: Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M14967 - Name: Respiratory Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M10020 - Name: Hypersensitivity, Immediate - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001249 - Term: Asthma ### Intervention Browse Module - Browse Branches - Abbrev: Resp - Name: Respiratory System Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M5269 - Name: Bronchodilator Agents - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437431 **Acronym:** GALICE **Brief Title:** Glenzocimab in Anterior Stroke With Large Ischemic Core Eligible for Endovascular Therapy **Official Title:** Glenzocimab in Anterior Stroke With Large Ischemic Core Eligible for Endovascular Therapy #### Organization Study ID Info **ID:** JDS_2023_13 #### Organization **Class:** NETWORK **Full Name:** Fondation Ophtalmologique Adolphe de Rothschild ### Status Module #### Completion Date **Date:** 2028-10 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-27 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2028-10 **Type:** ESTIMATED #### Start Date **Date:** 2024-09 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** NETWORK **Name:** Fondation Ophtalmologique Adolphe de Rothschild #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Until recently, acute ischemic stroke (AIS) patients with a baseline large infarct core have been generally excluded from clinical trials of endovascular therapy (EVT). A first multicenter randomized trial (Rescue Japan Limit trial) found a significant benefit of EVT in AIS patients with large infarct core (DWI-ASPECTS of 3-5). Another non-randomized multicenter prospective study found a positive association of EVT with 3-month outcome in AIS patients with a baseline CTP ischemic core volume \>70mL. More recently, 2 additional randomized trials were published. They both confirmed a strong efficacy of EVT in patients with large infarct core. However, even with EVT, the proportion of good outcome (3-month mRS score of 0-3), remains low in these highly severe AIS patients ranging from 8-30%. Almost 75% of EVT-treated patients are still severely disabled or dead at 3 months. In experimental studies, we and others described the pathophysiological features of the downstream microvascular thrombosis (DMT) in AIS setting highlighting its immediate occurrence and the pivotal role of platelet activation and aggregation. In recent clinical studies, it has been shown that, even with a complete angiographic recanalization after EVT, up to 40% of patients presented no-reflow (NR), a failure of downstream microvascular reperfusion, visible on perfusion imaging performed after EVT. Some clinical studies reported the clinical impact of NR after successful EVT. We found that DMT participated to the development of neurovascular lesions in AIS with both an early ischemic lesion growth risk evolving towards a delayed hemorrhagic transformation (HT) and vasogenic edema risks and therefore worse outcome. Our results suggested that an antiplatelet therapy infused early in AIS patients could reduce both the ischemic lesion but also the risk of delayed vasogenic edema and HT. Platelet glycoprotein VI (GPVI) is a key receptor for collagen and fibrin and plays a major role in platelet activation, platelet recruitment and thrombosis. Furthermore, inhibition of the GPVI does not impair haemostasis and subjects with a genetic or acquired GPVI deficiency are not prone to excessively bleed. Glenzocimab is a monoclonal antibody directed against the GPVI. It has been developed as an immediate antiplatelet agent with minimal bleeding risk for treating AIS. The ACTIMIS trial, a phase IB/IIA clinical study that assessed for the first time the glenzocimab IV infusion in AIS patients found very promising safety data including a significant reduce of symptomatic HT (1% vs. 7.8%) and mortality rates (7.8% vs. 18.7%), especially in severe AIS patients. Our hypothesis is that IV glenzocimab infusion would improve good functional outcome in large ischemic core AIS patients treated with EVT by reducing the DMT, ischemic lesion growth, and the HT rate. ### Conditions Module **Conditions:** - Acute Ischemic Stroke ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 304 **Type:** ESTIMATED **Phases:** - PHASE2 - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: glenzocimab **Label:** glenzocimab **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: placebo **Label:** placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - glenzocimab **Description:** Two vials (2x500 mg) of glenzocimab should be administered concomitantly for eligible patients for a total dose of 1g of glenzocimab as an IV infusion over 6 hours, with 1/4 of the dose administered by a 15-minutes bolus and 3/4 of the dose administered by 5h45minutes continuous infusion. **Name:** glenzocimab **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - placebo **Description:** Placebo of glenzocimab is 0.9% NaCl for IV administration. It is supplied for clinical trial use in vials of 50 mL. Two vials of placebo should be administered concomitantly for eligible patients. The administration scheme will be the same as in the experimental arm. **Name:** placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Functional outcome at 3 months will be assessed with the modified Rankin Scale (mRS) score dichotomized 0 to 3 versus 4 to 6, collected by phone by trained certified professionals and blinded to the treatment allocation and centralized. In case of loss of follow-up and impossibility to obtain mRS from the patient or his family at three month, a mRS score from the patient medical record (e.g. follow-up neurologist consultation, report of the rehabilitation hospitalization etc...) will be used if it is more or less 1 month from the 3-month protocol follow-up date. **Measure:** proportion of good functional outcome at 3 months. **Time Frame:** Month 3 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age \>18 years old * Acute ischemic stroke due to an isolated proximal anterior large vessel occlusion (M1 and M2 segment of the middle cerebral artery, terminal internal carotid artery (TICA)) * Indication of EVT within the time window of 0 to 24 hours in participants treated with or without intravenous thrombolysis. * Presenting with a baseline infarct core volume assessed on the MRI (DWI sequence) or CT scan with an ASPECTS\<6 * Woman \<49 years old must have a negative serum/urine pregnancy test at baseline Exclusion Criteria: * Possible tandem occlusion on the baseline imaging, potentially requiring stenting * Significant pre-stroke disability (mRS\>2) * Patients under or needing immediate dual anti-platelet therapy (DAPT) within the first 24 hours after the cessation of glenzocimab or placebo infusion * Significant mass effect with midline shift as confirmed on CT/MRI * Gastrointestinal or urinary tract haemorrhage in previous 21 days * Patient with intracranial haemorrhage * Platelet count \<100 000 mm3 * Known hypersensitivity to glenzocimab or to any of the excipients * Known hypersensitivity to the gadolinium used for the brain MRI perfusion, or one of its excipients * Known Severe renal insufficiency (Grades 4-5) with a glomerular filtration rate \< 30mL/Min/1.73m2 * Patients receiving anticoagulants within the last 24 hours and: * For heparin, an elevated aPTT -greater than upper limit of normal for laboratory * For vitamin K antagonists (ex: warfarin), an INR \>1.7; * For direct thrombin inhibitors or direct factor Xa inhibitors, a plasmatic dosage of the drug greater than upper limit of normal for laboratory * Pregnant or breastfeeding woman * Participation in another interventional clinical investigational drug or medical device trial within 30 days prior to the inclusion. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002561 - Term: Cerebrovascular Disorders - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M22306 - Name: Stroke - Relevance: HIGH - As Found: Stroke - ID: M2400 - Name: Ischemic Stroke - Relevance: HIGH - As Found: Acute Ischemic Stroke - ID: M10543 - Name: Ischemia - Relevance: HIGH - As Found: Ischemic - ID: M5810 - Name: Cerebrovascular Disorders - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000020521 - Term: Stroke - ID: D000083242 - Term: Ischemic Stroke - ID: D000007511 - Term: Ischemia ### Intervention Browse Module - Ancestors - ID: D000000925 - Term: Anticoagulants ### Intervention Browse Module - Browse Branches - Abbrev: AnCoag - Name: Anticoagulants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M266316 - Name: Glenzocimab - Relevance: HIGH - As Found: GSK2245035 - ID: M4244 - Name: Anticoagulants - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000711868 - Term: Glenzocimab ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437418 **Brief Title:** Association of Biliary Tract Disorders in Chronic Kidney Disease Patients and Its Related Risk Factors **Official Title:** Association of Biliary Tract Disorders in Chronic Kidney Disease Patients and Its Related Risk Factors #### Organization Study ID Info **ID:** Gallbladder dysfunction in CKD #### Organization **Class:** OTHER **Full Name:** Assiut University ### Status Module #### Completion Date **Date:** 2025-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-30 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-26 **Study First Submit QC Date:** 2024-05-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Assiut University #### Responsible Party **Investigator Affiliation:** Assiut University **Investigator Full Name:** rehab Mohamed Mohamed **Investigator Title:** resident doctor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Our aim in this cross-sectional study is to determine the frequency and aspects of gallbladder dysfunction and the related risk factors in pre-ESRD and hemodialysis patients. **Detailed Description:** Biliary tract disorders including cholelithiasis, cholecystitis, and other diseases of the biliary tract, are one of the most prevalent medical issues in the digestive system, posing a myriad of challenges for health workers and patients. Gallbladder dysfunction is the most frequent cause of symptomatic and complicated biliary tract disorders. Although gallbladder dysfunction is a common condition in Middle East countries, data on the incidence of end-stage renal disease (ESRD) are limited. The occurrence of gallbladder dysfunction in patients fed with low-protein diets suggests that gallbladder stones formation is affected by dietary protein content. Also the lithogenic composition changes of bile, increased nucleation tendency, and impaired motility of gallbladder are important factors in ESRD patients. It has been reported that chronic kidney disease (CKD) patients on regular hemodialysis (HD) have increased bile cholesterol levels and an increased bile saturation index. In addition, the gallbladder is innervated by the autonomic nervous system, which malfunctions in uremia, and it has been shown that gallbladder stasis might cause increased stone formation. In some studies, the prevalence of gallbladder dysfunction has been shown to increase in patients undergoing hemodialysis (HD) treatment for ESRD. So, we focused in this study to try to find association of gallbladder dysfunction in pre-dialysis ESRD and HD patient in comparison to normal renal function individuals. ### Conditions Module **Conditions:** - CKD - Gall Bladder Dysfunction **Keywords:** - CKD - gall bladder dysfunction - gall bladder ejection fraction - hemodialysis ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 108 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Gallbladder dysfunction in pre-dialysis CKD patients. **Intervention Names:** - Diagnostic Test: abdominal ultrasonography. **Label:** Group I #### Arm Group 2 **Description:** Gallbladder dysfunction in end stage CKD patients on dialysis. **Intervention Names:** - Diagnostic Test: abdominal ultrasonography. **Label:** Group II #### Arm Group 3 **Description:** Gallbladder dysfunction in normal renal function participants (control group). **Intervention Names:** - Diagnostic Test: abdominal ultrasonography. **Label:** Control Group ### Interventions #### Intervention 1 **Arm Group Labels:** - Control Group - Group I - Group II **Description:** Evaluate the gallbladder ejection fraction (EF) **Name:** abdominal ultrasonography. **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** Evaluate the gallbladder ejection fraction (EF) which will be calculated by following formula. (EF = (fasting gallbladder volume (FV) - residual gallbladder volume (RV)) / fasting gallbladder volume (FV)x 100) EF = (FV - RV) / FV x 100 **Measure:** Gallbladder dysfunction in CKD patients **Time Frame:** measuring fasting gallbladder volume (FV) after 10 overnight hours fasting and the residual gallbladder volume (RV) after 30 minutes after standard fixed meal ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients who are diagnosed as CKD with eGFR according to Cockcroft-Gault Equation, whatever they are on regular hemodialysis or pre-dialysis without history of previous gallbladder dysfunction with normal renal function individuals. Exclusion Criteria: * Patients who are younger than 18 years. * Patients who are diabetic. * Patients who have body mass index (BMI) more than 30. * Patients who have family history of gallbladder disorder. **Maximum Age:** 85 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** individuals visiting outpatient clinics of nephrology, GIT and internal medicine in Assiut hospitals. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** rehab.eltaib@med.aun.edu.eg **Name:** Rehab Mohamed Mohamed Eltayeb, M.B.B.CH. **Phone:** 01016644593 **Role:** CONTACT #### Locations **Location 1:** **City:** Assiut **Contacts:** ***Contact 1:*** - **Email:** rehab.eltaib@med.aun.edu.eg - **Name:** Rehab Mohamed Mohamed Eltayeb Ahmed, M.B.B.CH. - **Phone:** 01016644593 - **Role:** CONTACT **Country:** Egypt **Facility:** faculty of medicine Assiut university ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014570 - Term: Urologic Diseases - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000051437 - Term: Renal Insufficiency - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000004066 - Term: Digestive System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10698 - Name: Kidney Diseases - Relevance: HIGH - As Found: Kidney Disease - ID: M4946 - Name: Biliary Tract Diseases - Relevance: HIGH - As Found: Biliary Tract Disorders - ID: M26717 - Name: Renal Insufficiency, Chronic - Relevance: HIGH - As Found: Chronic Kidney Disease - ID: M26718 - Name: Renal Insufficiency - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M6147 - Name: Chronic Disease - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001660 - Term: Biliary Tract Diseases - ID: D000007674 - Term: Kidney Diseases - ID: D000051436 - Term: Renal Insufficiency, Chronic ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437405 **Brief Title:** Resistance Exercise Plus Vinegar Ingestion on Biomarkers in Healthy Adults **Official Title:** The Effects of a 12-Week Resistance Exercise Program Plus Vinegar Ingestion on Biomarkers of Intestinal Permeability, Cognition, and Mood State in Healthy Adults #### Organization Study ID Info **ID:** STUDY00019774 #### Organization **Class:** OTHER **Full Name:** Arizona State University ### Status Module #### Completion Date **Date:** 2024-12-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-26 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-10-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-22 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-26 **Study First Submit QC Date:** 2024-05-26 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Arizona State University #### Responsible Party **Investigator Affiliation:** Arizona State University **Investigator Full Name:** Carol Johnston **Investigator Title:** Professor and Associate Dean **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Given its capacity to stimulate exercise-induced neuroplasticity at lower doses compared to aerobic exercise, resistance exercise has become the top-recommended rehabilitation approach for individuals with neurocognitive impairments. Despite a large body of evidence supporting its application in the context of cognition, little work has been done to investigate the role of resistance exercise in modifying the structure and function of the microbiota-gut-brain axis. Likewise, despite a general understanding of the benefits of short chain fatty acids such as acetate for the gut-brain axis, the impact of exogenous acetic acid has not been sufficiently examined in the context of the intestinal barrier. While self-reported mood disturbance responds favorably to vinegar ingestion, it is currently unknown if these effects are also associated with changes in intestinal permeability. **Detailed Description:** Existing resistance exercise interventions have produced promising outcomes indicating favorable shifts in microbial composition, intestinal barrier integrity, and serum biomarkers of inflammation. These changes appear to be particularly pronounced in individuals experiencing greater enhancements in lean mass, implying a crucial role for the hypertrophic effects of the exercise protocol. Given the current knowledge surrounding age-related cognitive decline and the pathophysiology of neurological and psychiatric disorders, it seems that many of the mechanisms significantly influenced by resistance exercise could contribute to reducing the risk or, at the very least, delaying the onset of these conditions. Considering the observed neuroplastic and neuroprotective effects of resistance exercise on the brain, it is plausible to hypothesize that the mitigation of excessive intestinal permeability and subsequent neuroinflammation may further support overall brain function. Given the potential for vinegar to enhance these outcomes, investigating the combined effects of exercise and vinegar ingestion may provide valuable insights into how lifestyle interventions can effectively promote cognitive and mental health. Therefore, the purpose of this work is to assess whether the combination of resistance exercise and vinegar ingestion elicits more favorable shifts in gut barrier function, cognition, and mental health compared to resistance exercise alone. This investigation aims to demonstrate the potential efficacy of this integrated approach in fostering long-team health outcomes. ### Conditions Module **Conditions:** - LPS - Mood Disorders - Cognitive Change **Keywords:** - vinegar - resistance training - strength - depression ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** 12-week randomized controlled trial preceded by a 3-week control period ##### Masking Info **Masking:** SINGLE **Masking Description:** participants will be randomly assigned to the liquid vinegar group or the vinegar pill group (control) **Who Masked:** - PARTICIPANT **Primary Purpose:** OTHER #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 2 tablespoons of liquid apple cider vinegar (5% acidity) diluted in one cup of water twice daily with meals providing 1.5g acetic acid. **Intervention Names:** - Dietary Supplement: Vinegar liquid **Label:** Liquid vinegar **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** one apple cider vinegar tablet (0.022g acetic acid) daily. **Intervention Names:** - Dietary Supplement: vinegar pill **Label:** Vinegar pill **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Liquid vinegar **Description:** one pill daily **Name:** Vinegar liquid **Other Names:** - Vinegar pill **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - Vinegar pill **Description:** One pill daily **Name:** vinegar pill **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** measured indirectly via LPS binding protein **Measure:** Lipopolysaccharide **Time Frame:** 12 weeks **Description:** measured via Profile of Mood States (POMS) questionnaire **Measure:** Depression **Time Frame:** 12 weeks **Description:** measured using Trail Making Test **Measure:** Cognitive change **Time Frame:** 12 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. premenopausal (for those assigned female at birth) 2. willing and able to participate in moderate to vigorous exercise as determined by the ACSM Health/Fitness Facility Preparticipation Screening Questionnaire 3. sedentary (defined as a score \<14 on the Godin-Shepard Leisure Time Physical Activity Questionnaire (GSLTQ)) 4. equipped with access to a complete gym 5. available for all lab visits (at weeks 0, 3, 9, and 15) Exclusion Criteria: 1. antibiotic use within the past three months 2. prebiotic, probiotic, or high-dose antioxidant supplementation within the past month 3. regular engagement in moderate to vigorous exercise 4. following a vegetarian diet 5. presence of any medical/psychiatric disease 6. presence of any gastrointestinal disorder such as irritable bowel syndrome, inflammatory bowel disease, Crohn's disease, diverticulitis/diverticulosis, etc. 7. actively pregnant or breastfeeding **Healthy Volunteers:** True **Maximum Age:** 60 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** carol.johnston@asu.edu **Name:** Carol Johnston, PhD **Phone:** 6024962539 **Role:** CONTACT #### Locations **Location 1:** **City:** Phoenix **Contacts:** ***Contact 1:*** - **Email:** carol.johnston@asu.edu - **Name:** Carol S Johnston, PhD - **Phone:** 602-965-2539 - **Role:** CONTACT **Country:** United States **Facility:** 850 PBC **State:** Arizona **Status:** RECRUITING **Zip:** 85004 ### IPD Sharing Statement Module **Description:** There is no plan to share data beyond study investigators. **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7058 - Name: Depression - Relevance: LOW - As Found: Unknown - ID: M21835 - Name: Mood Disorders - Relevance: HIGH - As Found: Mood Disorders - ID: M7061 - Name: Depressive Disorder - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000019964 - Term: Mood Disorders ### Intervention Browse Module - Ancestors - ID: D000000900 - Term: Anti-Bacterial Agents - ID: D000000890 - Term: Anti-Infective Agents ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: Vi - Name: Vitamins ### Intervention Browse Module - Browse Leaves - ID: M21319 - Name: Acetic Acid - Relevance: HIGH - As Found: Anorectal - ID: M303111 - Name: Retinol acetate - Relevance: LOW - As Found: Unknown - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: T436 - Name: Acetic Acid - Relevance: HIGH - As Found: Anorectal ### Intervention Browse Module - Meshes - ID: D000019342 - Term: Acetic Acid ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437392 **Brief Title:** Evaluation of Sarcopenia and Related Factors in Patients Diagnosed With Psoriatic Arthritis **Official Title:** Evaluation of Sarcopenia and Related Factors in Patients Diagnosed With Psoriatic Arthritis #### Organization Study ID Info **ID:** 10026356 #### Organization **Class:** OTHER **Full Name:** Ankara City Hospital Bilkent ### Status Module #### Completion Date **Date:** 2024-08-20 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-26 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-08-20 **Type:** ESTIMATED #### Start Date **Date:** 2023-06-20 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-19 **Study First Submit QC Date:** 2024-05-26 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ankara City Hospital Bilkent #### Responsible Party **Investigator Affiliation:** Ankara City Hospital Bilkent **Investigator Full Name:** Gonca Canan Doğan Tosun **Investigator Title:** Medical Doctor (Physical Medicine and Rehabilitation) **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of the study is identify the prevalence of sarcopenia and its associated factors in patients with psoriatic arthritis. Furthermore, we aimed to investigate the predictive contribution of USG in diagnosing sarcopenia by assessing the thickness of the rectus femoris, vastus intermedius, and quadriceps muscles in patients with psoriatic arthritis. **Detailed Description:** After being informed about study and potential risk, all patient and giving written informed consent will undergo screnneing determite eligibility for study entire. Participants who agree to take part in the study and sign the informed consent form will be divided into two groups: patients and healthy volunteers. The patients will undergo a rheumatological examination, and sarcopenia screening will be conducted for both groups. Additionally, the quadriceps muscle thickness of both groups will be measured. ### Conditions Module **Conditions:** - Psoriatic Arthritis **Keywords:** - rheumatic disease - sarcopenia - ultrasonography ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 102 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Psoriatic arthritis patient **Label:** Psoriatic arthritis #### Arm Group 2 **Description:** Healthy Volunteer **Label:** Healthy volunteer ### Outcomes Module #### Primary Outcomes **Description:** muscle strength measurement:Hand grip strength is a parameter used to assess sarcopenia. Therefore, the hand grip strength of participants will be measured. A Jamar hydraulic hand dynamometer (FEI®, model 5030J1, USA) will be used for measuring muscle strength.For the hand grip strength measurement, participants will be seated with back support, with the shoulder in adduction, the elbow at 90 degrees flexion, the forearm and wrist in neutral and supported **Measure:** Grip strength **Time Frame:** 1 day **Description:** Participants are instructed to walk at a normal pace on a flat 6-meter surface (including the first 1 meter for acceleration, 4 meters for the walking test area, and the last 1 meter for deceleration). Those who take longer than 5 seconds to complete the 4 meters (walking speed \<0.8 m/s) are evaluated as having low physical performance. **Measure:** 4 m gait speed test **Time Frame:** 1 day **Description:** The SARQoL (Sarcopenia Quality of Life) questionnaire consists of 55 items and 22 questions, organized into seven different domains of quality of life: physical and mental health, locomotion, body composition, functionality, daily living activities, leisure activities, and fears. **Measure:** Quality of life in sarcopenia scale (SARQoL) **Time Frame:** 1 day **Description:** It is a test that assesses the participants' balance and walking. It includes 9 questions for balance and 7 questions for walking. Each response is scored between 0 and 2 points. **Measure:** Tinetti balance and walking test **Time Frame:** 1 day **Description:** It is a scale developed to identify cases of anxiety disorders and depression in patients in non-psychiatric hospital clinics. Both contain seven intertwined items. **Measure:** Hospital Anxiety and Depression Scale **Time Frame:** 1 day **Description:** This is a questionnaire that assesses the quality of life of patients diagnosed with psoriatic arthritis. It addresses pain, fatigue, skin problems, ability to perform work and/or leisure activities, functional capacity, discomfort, sleep disturbances, embarrassment from appearance, social participation, and depression.In this test, patients receive a score between 0 and 10. **Measure:** PSAID12 **Time Frame:** 1 day **Description:** In the method where tenderness and swelling in 28 joints are recorded, known as the Disease Activity Score (DAS 28), global pain assessment score is used along with CRP (C-Reactive Protein) or ESR (Erythrocyte Sedimentation Rate) values. Scores of 2.6 or lower are considered remission, while scores between 2.6 and 3.2 indicate low disease activity, scores between 3.2 and 5.1 indicate moderate disease activity, and scores above 5.1 indicate high disease activity. **Measure:** DAS 28 **Time Frame:** 1 day **Description:** The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score consists of six questions in the form of a visual analog scale (VAS) related to the five main symptoms of Ankylosing Spondylitis over the past week: fatigue, spinal pain, peripheral joint pain/swelling, localized tenderness, and morning stiffness. A final score between 0 and 10 is obtained. A BASDAI score of 4 or higher is considered indicative of active disease. **Measure:** BASDAI **Time Frame:** 1 day **Description:** The Disease Activity Index for Psoriatic Arthritis (DAPSA) score involves a joint examination of the patient. 68 joints are assessed for tenderness, and 66 joints for swelling. The numbers of tender and swollen joints are determined. The physician evaluates the patient's overall pain during examination and scores it out of 10. The patient's Visual Analog Scale (VAS) value is also recorded. The CRP value is noted. The score is then calculated simply by summing up all these values (number of tender joints + number of swollen joints + physician's assessment of overall pain + VAS + CRP). A score between 0 and 4 indicates remission, 5 to 14 indicates low disease activity, 15 to 27 indicates moderate disease activity, and a score greater than 28 indicates high disease activity. **Measure:** DAPSA **Time Frame:** 1 day **Description:** The Psoriasis Area Severity Index (PASI) evaluates both the severity and extent of psoriasis lesions on four body regions: the scalp, arms, trunk, and legs. It assesses the percentage of body surface area affected by lesions (A=area score; 1=\<10%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89%, 6=90-100%) and the severity of erythema (E), induration (I), and desquamation (D), each scored from 0 to 4. PASI scores range from 0 to 72, with higher scores indicating more severe disease. **Measure:** PASI **Time Frame:** 1 day **Description:** All participants included in the study will undergo sonographic examination using the Logiq 9 (GE, USA) ultrasound device and a high-frequency 7-12 MHz linear probe available in our clinic. The distance between the bilateral spina iliaca anterior superior and the upper pole of the patella of the participants' dominant and non-dominant extremities will be measured, and the distal 1/3 will be marked. The measurement will be taken in a seated upright position. Care will be taken to avoid compression during the measurement. After ensuring there is no compression in the subcutaneous fat tissue and muscle, an axial image will be recorded. The thickness of the subcutaneous fat tissue, vastus intermedius, rectus femoris, and total quadriceps will be measured three times, and the average of these measurements will be recorded. **Measure:** ultrasonography **Time Frame:** 1 day ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Diagnosed with psoriatic arthritis according to CASPAR criteria at least 1 year ago * Between 18 and 65 years old * Normal cognitive functions * Agrees to participate in the study * No changes in medical treatment for psoriatic arthritis in the last 3 months Exclusion Criteria: * Those with neurological diseases * Those with hip dysplasia * Those with upper and lower extremity deformities * Those with upper and lower extremity joint arthroplasty * Those with arthritis and deformities in the hands * Those with lumbar stabilization * Those with cognitive impairment preventing participation in the study * Those with body weight beyond the device\&#39;s measurement capacity * Those who do not agree to participate in the study **Healthy Volunteers:** True **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients between the ages of 18-65, who were diagnosed with psoriatic arthritis at least one year ago according to the CASPAR criteria, and healthy controls, who visited Ankara Bilkent City Hospital Physical Medicine and Rehabilitation Department, were included. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** tubakulu@yahoo.com **Name:** Tuba Güler, Assoc Prof **Phone:** +905052841036 **Role:** CONTACT **Contact 2:** **Email:** gcdogan92@gmail.com **Name:** Gonca Canan Dogan Tosun, Medical Doctor **Phone:** +905383760095 **Role:** CONTACT #### Locations **Location 1:** **City:** Ankara **Contacts:** ***Contact 1:*** - **Email:** gcdogan92@gmail.com - **Name:** Gonca Canan DOGAN TOSUN, Medical Dovtor - **Phone:** 05383760095 - **Role:** CONTACT **Country:** Turkey **Facility:** Ankara Bilkent City Hospital Physical Therapy an Rehabilitation Hospital **State:** Bilkent-Cankaya **Status:** RECRUITING **Zip:** 06800 #### Overall Officials **Official 1:** **Affiliation:** Ankara Bilkent City Hospital **Name:** Gonca Canan Dogan Tosun, Medical Doctor **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Ankara City Hospital Bilkent **Name:** Tuba Güler, Assoc Prof **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169. Erratum In: Age Ageing. 2019 Jul 1;48(4):601. **PMID:** 30312372 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000009133 - Term: Muscular Atrophy - ID: D000020879 - Term: Neuromuscular Manifestations - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases - ID: D000001284 - Term: Atrophy - ID: D000020763 - Term: Pathological Conditions, Anatomical - ID: D000025242 - Term: Spondylarthropathies - ID: D000025241 - Term: Spondylarthritis - ID: D000013166 - Term: Spondylitis - ID: D000013122 - Term: Spinal Diseases - ID: D000001847 - Term: Bone Diseases - ID: D000011565 - Term: Psoriasis - ID: D000017444 - Term: Skin Diseases, Papulosquamous - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC01 - Name: Infections - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M4476 - Name: Arthritis - Relevance: HIGH - As Found: Arthritis - ID: M18178 - Name: Arthritis, Psoriatic - Relevance: HIGH - As Found: Psoriatic Arthritis - ID: M28396 - Name: Sarcopenia - Relevance: HIGH - As Found: Sarcopenia - ID: M15045 - Name: Rheumatic Diseases - Relevance: LOW - As Found: Unknown - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown - ID: M10621 - Name: Joint Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M4589 - Name: Atrophy - Relevance: LOW - As Found: Unknown - ID: M12090 - Name: Muscular Atrophy - Relevance: LOW - As Found: Unknown - ID: M22619 - Name: Neuromuscular Manifestations - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown - ID: M23036 - Name: Spondylarthropathies - Relevance: LOW - As Found: Unknown - ID: M15961 - Name: Spondylitis - Relevance: LOW - As Found: Unknown - ID: M23035 - Name: Spondylarthritis - Relevance: LOW - As Found: Unknown - ID: M15919 - Name: Spinal Diseases - Relevance: LOW - As Found: Unknown - ID: M5126 - Name: Bone Diseases - Relevance: LOW - As Found: Unknown - ID: M14422 - Name: Psoriasis - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M19713 - Name: Skin Diseases, Papulosquamous - Relevance: LOW - As Found: Unknown - ID: T5412 - Name: Spondylarthropathy - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001168 - Term: Arthritis - ID: D000015535 - Term: Arthritis, Psoriatic - ID: D000055948 - Term: Sarcopenia ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437379 **Brief Title:** Infection Control Measures for Patients Undergoing Percutaneous Nephrolithotomy **Official Title:** Effect of Teaching Protocol on Nurse's Knowledge and Practice Regarding Infection Control Measures for Patients Undergoing Percutaneous Nephrolithotomy #### Organization Study ID Info **ID:** Infection Control Measures #### Organization **Class:** OTHER **Full Name:** Assiut University ### Status Module #### Completion Date **Date:** 2025-01-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-26 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-12-01 **Type:** ESTIMATED #### Start Date **Date:** 2023-09-01 **Type:** ACTUAL **Status Verified Date:** 2024-03 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-03-17 **Study First Submit QC Date:** 2024-05-26 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Assiut University #### Responsible Party **Investigator Affiliation:** Assiut University **Investigator Full Name:** Kamilia Farouk Abdel Fattah Osman **Investigator Title:** Nursing specialist **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** To evaluate the effect of implementing teaching protocol on nurse's knowledge and practice regarding infection control measures for patients undergoing Percutaneous Nephrolithotomy. **Detailed Description:** Percutaneous Nephrolithotomy (PCNL) is a surgery to remove kidney stones that are too large to pass on their own. Percutaneous" means that the procedure occurs through the skin. "Nephrolithotomy" means the removal of a calculus (kidney stone) from a kidney . Percutaneous Nephrolithotomy is typically recommended when kidney stones are larger than 0.8 inch (2 centimeters) in diameter. . Percutaneous Nephrolithotomy (PCNL) has altered dramatically the management of urolithiasis. In fact, these treatment modalities have nearly 99% success rates for treatment of upper urinary tract stones. . There were several complications related to Percutaneous Nephrolithotomy such as fever (23%) and bleeding necessitating transfusion (12%). Extravasation was seen in 7% of patients and transient ureteral obstruction in 6%. The complications limit surgical outcome of PCNL. Infection remains the most common complication arising from this procedure and some patients develop septicemia and septic shock, resulting in increased mortality and morbidity. So, the success of the Percutaneous Nephrolithotomy depends on the maintenance of infection control precautions. This is why investigator looked at this study. Knowledge of the nurse of percutaneous nephrolithotomy care was of crucial importance and had an impact on nurse's practice. The main goal of care was to prevent infection undergoing the percutaneous nephrolithotomy The nurses' role preventing infection for patient undergoing (PCNL) and mainly maintain the sterile field and after operation safety removing (PPE), washing instruments used during operation all of that resulting in positive surgical outcomes Infection control is an important concern for health care professionals specially nurses. Nurses have higher risk for both self-acquiring and transmitting infections to other patients infection control practices form the backbone of nurse's. Nurses has the distinctive opportunity to reduce hospital - acquired infections by utilizing the skills and knowledge about infection control measures, they can facilitate patient recovery while minimizing complications related to infections. Compliance with infection control and sterile technique principles will be prevent nosocomial infections in the operating room, and the patient's hospital stay being shorter and a reduced cost for the medical aids and hospitals . the investigators searched for this topic in many sites such as PubMed Central, Research Gate, and Science.gov.The current topic was not covered in the previous studies. Previous studies did not include specific point about this topic but include general point about PCNL and this strong rational for this study. This study will be carried out to evaluate the knowledge and practice about standard precautions and infection control measures and to explore education needs of nurses. Generally, programs of healthcare education vary greatly in their contents and approaches .Various forms of visual aids are currently used in healthcare education including illustrations such as photographs and animations such as computer -generated clips and video clips. ### Conditions Module **Conditions:** - Urological Nursing - Kidney Stone **Keywords:** - PCNL - infection control - nurses ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** To evaluate the effect of implementing teaching protocol on nurse's knowledge and practice regarding infection control measures for patients undergoing Percutaneous Nephrolithotomy. ##### Masking Info **Masking:** NONE **Masking Description:** nurse working in urology department **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 30 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Effect of Teaching Protocol on Nurse's Knowledge and Practice regarding Infection Control Measures for Patients undergoing Percutaneous Nephrolithotomy **Intervention Names:** - Behavioral: Infection control **Label:** effect of infection control on patient outcomes undergoing PCNL **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - effect of infection control on patient outcomes undergoing PCNL **Description:** To evaluate the effect of implementing teaching protocol on nurse's knowledge and practice regarding infection control measures for patients undergoing Percutaneous Nephrolithotomy. **Name:** Infection control **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** use infection control technique to reduce infection in patient undergoing PCNL **Measure:** teach nurses new measures to reduce infection in patient undergoing PCNL by applying infection control measure **Time Frame:** one year #### Secondary Outcomes **Description:** reduce patient length of hospital stay **Measure:** reduce the patients hospital stay postoperative **Time Frame:** one year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1- Nursing Staff providing nursing care services for patient undergoing PNL (pre-intra-post) operative care. Exclusion Criteria: 1. Head nurses 2. Nurses refused to participate in the study **Maximum Age:** 65 Years **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Assiut **Country:** Egypt **Facility:** Faculty of Nursing **Zip:** 088 ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Babjuk M, Burger M, Capoun O, Cohen D, Comperat EM, Dominguez Escrig JL, Gontero P, Liedberg F, Masson-Lecomte A, Mostafid AH, Palou J, van Rhijn BWG, Roupret M, Shariat SF, Seisen T, Soukup V, Sylvester RJ. European Association of Urology Guidelines on Non-muscle-invasive Bladder Cancer (Ta, T1, and Carcinoma in Situ). Eur Urol. 2022 Jan;81(1):75-94. doi: 10.1016/j.eururo.2021.08.010. Epub 2021 Sep 10. **PMID:** 34511303 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000053040 - Term: Nephrolithiasis - ID: D000007674 - Term: Kidney Diseases - ID: D000014570 - Term: Urologic Diseases - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000052878 - Term: Urolithiasis - ID: D000014545 - Term: Urinary Calculi - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000002137 - Term: Calculi - ID: D000020763 - Term: Pathological Conditions, Anatomical ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: HIGH - As Found: Infection - ID: M10693 - Name: Kidney Calculi - Relevance: HIGH - As Found: Kidney Stone - ID: M27126 - Name: Nephrolithiasis - Relevance: LOW - As Found: Unknown - ID: M5399 - Name: Calculi - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M10698 - Name: Kidney Diseases - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M27103 - Name: Urolithiasis - Relevance: LOW - As Found: Unknown - ID: M17295 - Name: Urinary Calculi - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007239 - Term: Infections - ID: D000007669 - Term: Kidney Calculi ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437366 **Acronym:** HeartMathsub **Brief Title:** Nurse-Led Heart Math Training Program With Substance Use Disorder **Official Title:** Effectiveness of a Nurse-Led Heart Math Training Program on Resilience , Sense of Coherence, and Emotional Adjustment in Patients With Substance Use Disorder #### Organization Study ID Info **ID:** 100.a #### Organization **Class:** OTHER **Full Name:** Alexandria University ### Status Module #### Completion Date **Date:** 2024-08-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-25 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-07-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-25 **Study First Submit QC Date:** 2024-05-25 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Alexandria University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Substance use disorders (SUDs) pose significant challenges to individuals' psychological well-being, resilience, and emotional adjustment. These disorders often lead to detrimental effects on physical health, mental health, and overall quality of life, creating a critical need for effective interventions that can support recovery and enhance emotional resilience. One promising approach is the implementation of nurse-led HeartMath training programs. These programs utilize evidence-based techniques to improve emotional regulation, increase resilience, and foster a sense of coherence, which is the ability to perceive life as comprehensible, manageable, and meaningful. **Detailed Description:** The HeartMath training program, developed by the HeartMath Institute, focuses on teaching individuals self-regulation skills that promote heart-brain coherence. This state of coherence has been associated with improved cognitive function, emotional stability, and physical health. By integrating this training into the care of patients with SUDs, nurses can play a pivotal role in addressing the complex emotional and psychological needs of this population. Brief About the Training Program The nurse-led HeartMath training program consists of several key components designed to enhance resilience, sense of coherence, and emotional adjustment: Heart-Focused Breathing Techniques: Patients are taught specific breathing techniques that help synchronize heart and brain activity, leading to a state of physiological coherence. Emotional Regulation Skills: The training includes exercises that help individuals recognize and shift from negative to positive emotional states, thereby improving emotional stability and reducing stress. Biofeedback Technology: Participants use HeartMath biofeedback devices that provide real-time feedback on their heart rhythm patterns, enabling them to monitor and improve their coherence levels. Resilience-Building Exercises: The program incorporates activities and practices aimed at enhancing personal resilience, such as positive visualization and the cultivation of gratitude and appreciation. Individual and Group Sessions: The training is delivered through a combination of individual coaching and group workshops, providing both personalized support and a sense of community. ### Conditions Module **Conditions:** - Substance Abuse ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 120 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The HeartMath training program, developed by the HeartMath Institute, focuses on teaching individuals self-regulation skills that promote heart-brain coherence. This state of coherence has been associated with improved cognitive function, emotional stability, and physical health. By integrating this training into the care of patients with SUDs, nurses can play a pivotal role in addressing the complex emotional and psychological needs of this population. **Intervention Names:** - Behavioral: Nurse-Led Heart Math Training Program **Label:** nurse-led HeartMath training program on patients with substance use disorder **Type:** EXPERIMENTAL #### Arm Group 2 **Label:** Non-experimental patients with substance use disorder **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - nurse-led HeartMath training program on patients with substance use disorder **Description:** he nurse-led HeartMath training program consists of several key components designed to enhance resilience, sense of coherence, and emotional adjustment: Heart-Focused Breathing Techniques: Patients are taught specific breathing techniques that help synchronize heart and brain activity, leading to a state of physiological coherence. Emotional Regulation Skills: The training includes exercises that help individuals recognize and shift from negative to positive emotional states, thereby improving emotional stability and reducing stress. **Name:** Nurse-Led Heart Math Training Program **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Patients with substance use disorder who participate in a nurse-led HeartMath training program will show a statistically significant increase in resilience, as measured by the Connor-Davidson Resilience Scale (CD-RISC), compared to those who do not participate in the program. **Measure:** Patients with substance use disorder who participate in a nurse-led HeartMath training program **Time Frame:** three months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * substance abuse for at least one month Exclusion Criteria: * out side hospital **Maximum Age:** 60 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Alexandria **Contacts:** ***Contact 1:*** - **Email:** mohamed-hussein@alexu.edu.com - **Name:** mohamed H atta - **Phone:** 2026609088 - **Role:** CONTACT **Country:** Egypt **Facility:** Alexandria university **State:** Al Iskandariyah **Status:** RECRUITING **Zip:** 21913 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000064419 - Term: Chemically-Induced Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC25 - Name: Substance Related Disorders - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M21837 - Name: Substance-Related Disorders - Relevance: HIGH - As Found: Substance Use Disorders - ID: M30302 - Name: Chemically-Induced Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000019966 - Term: Substance-Related Disorders ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437353 **Brief Title:** Surufatinib Combined With Carboplatin/Paclitaxel and Surufatinib Combined With Olaparib as First-line and Maintenance Therapy for Newly Diagnosed High-risk Ovarian Cancer **Official Title:** Sorafenib Combined With Carboplatin/Paclitaxel and Sorafenib Combined With Olaparib as First-line and Maintenance Therapy for Newly Diagnosed High-risk Ovarian Cancer: a Single-arm, Multicenter, Exploratory Clinical Study #### Organization Study ID Info **ID:** 2024 No. 047 #### Organization **Class:** OTHER **Full Name:** Anhui Provincial Cancer Hospital ### Status Module #### Completion Date **Date:** 2027-10-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-26 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-10-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-25 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-26 **Study First Submit QC Date:** 2024-05-26 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Hutchison Medipharma Limited #### Lead Sponsor **Class:** OTHER **Name:** Anhui Provincial Cancer Hospital #### Responsible Party **Investigator Affiliation:** Anhui Provincial Cancer Hospital **Investigator Full Name:** Bai-Rong Xia **Investigator Title:** Director of Gynecological Surgery **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this type of clinical trial study is to evaluate the safety and efficacy of Surufatinib combined with Carboplatin/Paclitaxel and Surufatinib combined with Olaparib as first-line and maintenance therapy for newly diagnosed high-risk ovarian cancer **Detailed Description:** Patients will have tests and exams to see if they are eligible for the clinical trial. First-line chemotherapy regimen: Paclitaxel/Carboplatin(repeat every 3 weeks, total of 6 cycles): * Paclitaxel: 175 mg/m², intravenous infusion, on day 1. * Carboplatin: AUC 5, intravenous infusion, on day 1. * For patients aged ≥70 years or those with comorbidities, the paclitaxel dose can be adjusted to 135 mg/m². Surufatinib(repeat every 3 weeks, total of 5 cycles): * Surufatinib is not used during the first postoperative cycle. * Starting from the second postoperative cycle, surufatinib is administered at a dose of 250 mg once daily, taken continuously. Maintenance Therapy Regimen: HRD-positive Patients: * Surufatinib: 250 mg once daily, taken continuously. * Olaparib: 300 mg twice daily, with doses taken 12 hours apart. Olaparib can be used for a maximum of 2 years. HRD-negative or HRD Status Unknown Patients: * Surufatinib: 250 mg once daily, taken continuously. Treatment continues until the patient experiences disease progression or meets other criteria for discontinuation of the study treatment as specified in the protocol. ### Conditions Module **Conditions:** - Ovarian Cancer **Keywords:** - Antiangiogenic ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** First-line chemotherapy regimen: * Paclitaxel: 175 mg/m², intravenous infusion, on day 1. * Carboplatin: AUC 5, intravenous infusion, on day 1. * Surufatinib：250 mg once daily, taken continuously. Maintenance Therapy Regimen: * Surufatinib: 250 mg once daily, taken continuously. * Olaparib: 300 mg twice daily. **Intervention Names:** - Drug: Paclitaxel **Label:** First-line and maintenance therapy regimen **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - First-line and maintenance therapy regimen **Description:** First-line chemotherapy regimen: * Paclitaxel: 175 mg/m², intravenous infusion, on day 1. * Carboplatin: AUC 5, intravenous infusion, on day 1. * Surufatinib：250 mg once daily, taken continuously. Maintenance Therapy Regimen: * Surufatinib: 250 mg once daily, taken continuously. * Olaparib: 300 mg twice daily. **Name:** Paclitaxel **Other Names:** - Surufatinib - Carboplatin **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Progression-free survival on first-line and maintenance therapy with Surufatinib Combined With Carboplatin/Paclitaxel and Surufatinib Combined With Olaparib **Measure:** Progression free survival **Time Frame:** 12-month #### Secondary Outcomes **Description:** ORR is defined as the proportion of participants achieving Complete Response (CR) or Partial Response (PR) as assessed by the investigator per RECIST (v.1.1). Per RECIST 1.1, CR is defined as the disappearance of all target lesions; PR is defined as at least a 30% decrease in the sum of diameters (SoD) of target lesions **Measure:** Overall Response Rate (ORR **Time Frame:** 3-month **Description:** the percentage of patients with complete response, partial response, and stable disease for more than 4 weeks in which response can be evaluated **Measure:** Disease control rate **Time Frame:** 3-month **Description:** the date of enrollment to the date of death from any cause **Measure:** Overall survival **Time Frame:** 3-years **Description:** Adverse medical events in clinical trial subjects treated with Surufatinib Combined With Carboplatin/Paclitaxel and Surufatinib Combined With Olaparib **Measure:** Adverse event **Time Frame:** 3-month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age: 18-75 years old (≥18, ≤75) 2. Patients with newly diagnosed FIGO stage III or IV high-grade serous ovarian cancer, high-grade endometrioid carcinoma, primary peritoneal cancer, and/or fallopian tube cancer with high-risk factors for recurrence. High-risk recurrence is defined as follows: * FIGO stage III with non-R0 resection; * FIGO stage IV; * Presence of ascites at initial diagnosis. 3. Patients who have undergone primary debulking surgery (PDS) for ovarian cancer. 4. ECOG performance status score: 0-2. 5. Postoperative administration time ≤12 weeks. 6. Expected survival of at least 3 months. 7. Major organ function within 7 days prior to treatment meets the following criteria: * Hemoglobin (HB) ≥90 g/L; * Absolute neutrophil count (ANC) ≥1.5×10⁹/L; * Platelets (PLT) ≥100×10⁹/L. 8. Biochemical parameters must meet the following standards: * Total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN); * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN, or ≤5×ULN if liver metastases are present; * Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CCr) ≥60 ml/min. 9. Women of childbearing potential must use effective contraception. 10. Subjects must voluntarily join the study and sign the informed consent form (ICF). 11. Subjects are expected to have good compliance and the ability to follow up on efficacy and adverse reactions as required by the protocol. Exclusion Criteria: 1. Previous treatment with anti-angiogenic drugs such as apatinib, sorafenib, anlotinib, bevacizumab, or other anti-angiogenic therapies. 2. Pregnant or breastfeeding women. 3. Patients who have previously participated in other clinical trials that have not yet concluded. 4. Patients with evidence or history of significant bleeding tendencies or events within 3 months before enrollment (bleeding \>30 mL, accompanied by hematemesis, melena, or hematochezia), hemoptysis (≥5 mL of fresh blood within 4 weeks), or thromboembolic events (including stroke and/or transient ischemic attack) within 12 months. 5. Patients with uncontrolled hypertension (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg). 6. Patients with grade I or higher myocardial ischemia or infarction, arrhythmias (including QTc ≥480 ms), or ≥ grade 2 congestive heart failure (New York Heart Association (NYHA) classification). 7. Patients with active or uncontrolled severe infections (≥CTC AE grade 2). 8. Patients with renal failure requiring hemodialysis or peritoneal dialysis. 9. Patients with a history of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases, or those with a history of organ transplantation. 10. Patients with persistent proteinuria (≥++) on two consecutive urine tests, and confirmed 24-hour urine protein \>1.0 g. 11. Patients with psychiatric disorders, including epilepsy, dementia, severe depression, mania, etc. 12. Patients with any signs or history of bleeding disorders, regardless of severity; patients who experienced any bleeding or hemorrhagic event ≥CTCAE grade 3 within 4 weeks before enrollment; patients with unhealed wounds, ulcers, or fractures. 13. Patients who had arterial or venous thrombotic events, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism, within the past 6 months. 14. Patients with symptomatic brain metastases or those whose symptoms have been controlled for less than 2 months. 15. Patients with a history of substance abuse that cannot be relinquished or those with psychiatric disorders. 16. Patients with difficulty swallowing or known absorption disorders affecting drug intake. 17. Patients allergic to treatment drugs sorafenib or paclitaxel/carboplatin. 18. Any other condition that the researcher deems unsuitable for enrollment. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** xiabairong9999@126.com **Name:** Bai-Rong Xia, Doctor **Phone:** 18604516165 **Role:** CONTACT #### Locations **Location 1:** **City:** Hefei **Contacts:** ***Contact 1:*** - **Email:** xiabairong9999@126.com - **Name:** Bai-Rong Xia, MD - **Phone:** 18604516165 - **Role:** CONTACT **Country:** China **Facility:** Anhui Cancer Hospital **State:** Anhui **Status:** RECRUITING **Zip:** 230001 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004701 - Term: Endocrine Gland Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000010049 - Term: Ovarian Diseases - ID: D000000291 - Term: Adnexal Diseases - ID: D000005831 - Term: Genital Diseases, Female - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000005833 - Term: Genital Neoplasms, Female - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000091662 - Term: Genital Diseases - ID: D000004700 - Term: Endocrine System Diseases - ID: D000006058 - Term: Gonadal Disorders - ID: D000002277 - Term: Carcinoma - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M12974 - Name: Ovarian Neoplasms - Relevance: HIGH - As Found: Ovarian Cancer - ID: M1704 - Name: Carcinoma, Ovarian Epithelial - Relevance: HIGH - As Found: Ovarian Cancer - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M7863 - Name: Endocrine Gland Neoplasms - Relevance: LOW - As Found: Unknown - ID: M12972 - Name: Ovarian Diseases - Relevance: LOW - As Found: Unknown - ID: M3643 - Name: Adnexal Diseases - Relevance: LOW - As Found: Unknown - ID: M8943 - Name: Genital Diseases, Female - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8945 - Name: Genital Neoplasms, Female - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M9163 - Name: Gonadal Disorders - Relevance: LOW - As Found: Unknown - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: T4352 - Name: Ovarian Cancer - Relevance: HIGH - As Found: Ovarian Cancer - ID: T4354 - Name: Ovarian Epithelial Cancer - Relevance: HIGH - As Found: Ovarian Cancer ### Condition Browse Module - Meshes - ID: D000010051 - Term: Ovarian Neoplasms - ID: D000077216 - Term: Carcinoma, Ovarian Epithelial ### Intervention Browse Module - Ancestors - ID: D000000972 - Term: Antineoplastic Agents, Phytogenic - ID: D000000970 - Term: Antineoplastic Agents - ID: D000050257 - Term: Tubulin Modulators - ID: D000050256 - Term: Antimitotic Agents - ID: D000050258 - Term: Mitosis Modulators - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M19537 - Name: Paclitaxel - Relevance: HIGH - As Found: Surgery - ID: M18650 - Name: Carboplatin - Relevance: HIGH - As Found: System - ID: M231 - Name: Albumin-Bound Paclitaxel - Relevance: LOW - As Found: Unknown - ID: M22318 - Name: Angiogenesis Inhibitors - Relevance: LOW - As Found: Unknown - ID: M233003 - Name: Olaparib - Relevance: LOW - As Found: Unknown - ID: M1680 - Name: Sorafenib - Relevance: LOW - As Found: Unknown - ID: M26197 - Name: Tubulin Modulators - Relevance: LOW - As Found: Unknown - ID: M26196 - Name: Antimitotic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000017239 - Term: Paclitaxel - ID: D000016190 - Term: Carboplatin ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437340 **Brief Title:** Life Satisfaction of Fathers of Children With Cerebral Palsy **Official Title:** Determinants of Life Satisfaction Levels of Fathers of Children With Cerebral Palsy #### Organization Study ID Info **ID:** KAEU-T.ATAHAN-003 #### Organization **Class:** OTHER **Full Name:** Kirsehir Ahi Evran Universitesi ### Status Module #### Completion Date **Date:** 2024-05-15 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-25 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-05-10 **Type:** ACTUAL #### Start Date **Date:** 2023-06-06 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-25 **Study First Submit QC Date:** 2024-05-25 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Kirsehir Ahi Evran Universitesi #### Responsible Party **Investigator Affiliation:** Kirsehir Ahi Evran Universitesi **Investigator Full Name:** Atahan TURHAN **Investigator Title:** Dr. Lecturer **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to examine the determinants of life satisfaction among fathers of children diagnosed with Cerebral Palsy. ### Conditions Module **Conditions:** - Cerebral Palsy - Father-Child Relations - Life Satisfaction ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 122 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Sociodemographic information included gender, age, height, and weight of the children and their fathers. In addition, clinical information about the children, such as duration of physical therapy and type of disability, was recorded. **Measure:** Sociodemographic Data **Time Frame:** 20week **Description:** Life satisfaction level was assessed using the Satisfaction with Life Scale. The scale has a total of 5 items. Participants are asked to rate each item from 1 to 7. The scores obtained from each item can range from 1 to 7, and the total score can range from 1 to 35. The higher the score obtained from the scale, the higher the life satisfaction. **Measure:** Satisfaction with Life **Time Frame:** 20week **Description:** The Gross Motor Function Classification System (GMFCS) was used to assess the level of gross motor function in children with Cerebral Palsy (CP). GMFCS is a system that classifies the gross motor function levels of children with CP in the same age groups from 1 to 5. Level 1 represents the highest level of function and level 5 represents the lowest level. A higher level represents a lower level of function. **Measure:** Gross Motor Function **Time Frame:** 20week ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * to be literate and to have no communication problems * to be the father of a child with Cerebral Palsiy (CP) and no other medical diagnosis (aged between 1-18 years) * to have a child with CP who regularly receives physiotherapy and rehabilitation * to live in the same house with his wife and child/children * to be willing to participate in the study Exclusion Criteria: * to care for individuals in need of care (such as disabled, elderly, chronically ill) additionally to the child with CP * to have a chronic disorder (such as neurological, rheumatologic, psychiatric disorder) that would affect life satisfaction. **Healthy Volunteers:** True **Sampling Method:** PROBABILITY_SAMPLE **Sex:** MALE **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Patients admitted to the Physical Medicine and Rehabilitation Outpatient Clinic with a diagnosis of cerebral palsy were examined by a physiatrist. Children diagnosed with cerebral palsy and their fathers who met the inclusion criteria and agreed to participate in the study were included. ### Contacts Locations Module #### Locations **Location 1:** **City:** Kirsehir **Country:** Turkey **Facility:** Atahan TURHAN **State:** Merkez **Zip:** 40100 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009422 - Term: Nervous System Diseases - ID: D000001925 - Term: Brain Damage, Chronic - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5796 - Name: Cerebral Palsy - Relevance: HIGH - As Found: Cerebral Palsy - ID: M13157 - Name: Paralysis - Relevance: LOW - As Found: Unknown - ID: M5207 - Name: Brain Injuries - Relevance: LOW - As Found: Unknown - ID: M5202 - Name: Brain Damage, Chronic - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002547 - Term: Cerebral Palsy ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437327 **Brief Title:** Comparison of Effectiveness Between Active Release Technique and Hold Relax Technique in Patients With Piriformis Syndrome **Official Title:** Comparison of Effectiveness Between Active Release Technique and Hold Relax Technique in Patients With Piriformis Syndrome #### Organization Study ID Info **ID:** FUI/CTR/2024/10 #### Organization **Class:** OTHER **Full Name:** Foundation University Islamabad ### Status Module #### Completion Date **Date:** 2024-06-20 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-27 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2023-11-20 **Type:** ACTUAL #### Start Date **Date:** 2023-07-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-27 **Study First Submit QC Date:** 2024-05-27 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Foundation University Islamabad #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study is a randomized controlled trial and the purpose of this study is to compare the effects between active release technique and hold relax technique in patients with Piriformis syndrome. **Detailed Description:** The purpose of this study is to compare the effects between active release technique and hold relax technique in patients with piriformis syndrome pain, range of motion, and functional disability, in adults (age: 25-55 years) 1. Numeric pain rating scale 2. Goniometer 3. Oswestry Disability Questionairre Data will be collected before and after the intervention protocol for each participant. Data collection procedure: Participants of interest would be approached and explained about the research. Informed written consent will be taken. Pre and post-intervention scores will be recorded. ### Conditions Module **Conditions:** - Piriformis Syndrome ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Randomized Controlled Trial ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Hot pack for 10 minutes Interferential Current (IFC) for 10 minutes Active release technique is applied (patient is prone lying with knee flexed, Pressure is applied on taut band and patient is asked to move the leg in internal rotation to achieve maximal lengthening) Repetitions 5 to 7 times hold for 5 to 20 seconds **Intervention Names:** - Procedure: Electrotherapy - Procedure: Active release technique **Label:** Experimiental Group 1 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Hot pack for 10 minutes Interferential Current (IFC) for 10 minutes Hold relax technique This technique is applied while the patient is in supine lying with one leg crossed over the other Patient is instructed to contract the piriformis against the manual resistance for 5 to 10 secs Then 15 secs of passive stretch is given repetitions x 5 times **Intervention Names:** - Procedure: Electrotherapy - Procedure: Hold relax technique **Label:** Experimental Group 2 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental Group 2 - Experimiental Group 1 **Description:** Hot pack for 10 minutes Interferential Current (IFC) for 10 minutes **Name:** Electrotherapy **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Experimiental Group 1 **Description:** Active release technique is applied (patient is prone lying with knee flexed, Pressure is applied on taut band and patient is asked to move the leg in internal rotation to achieve maximal lengthening) Repetitions 5 to 7 times hold for 5 to 20 seconds **Name:** Active release technique **Type:** PROCEDURE #### Intervention 3 **Arm Group Labels:** - Experimental Group 2 **Description:** This technique is applied while the patient is in supine lying with one leg crossed over the other Patient is instructed to contract the piriformis against the manual resistance for 5 to 10 secs Then 15 secs of passive stretch is given repetitions x 5 times **Name:** Hold relax technique **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Numeric Pain Rating Scale (NPRS): ICC (0.93-0.96).It has a scale of 0-10 or 0-100 points and can be given verbally or in writing. **Measure:** Pain intensity **Time Frame:** 2 weeks **Description:** Physical Function will be measured using Oswestry disability Questionnaire **Measure:** Physical Function using Oswestry disability Questionnaire **Time Frame:** 2 weeks **Description:** Hip internal rotation using Goniometer **Measure:** Hip internal rotation range of motion **Time Frame:** 2 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion criteria: * Gender: Both male and female * Individuals aged 25-55 years * Tenderness to palpation over sciatic foramen * Positive FAIR Test. Exclusion criteria : * History of hip, pelvic, or Femoral fractures. * Malignancies. * Avascular necrosis of Femoral head. * Inflammatory conditions (e.g. Rheumatoid Arthritis) **Maximum Age:** 55 Years **Minimum Age:** 25 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** qasim111298@gmail.com **Name:** Mohammad Ali, MS-MSKPT* **Phone:** 03415161695 **Role:** CONTACT #### Locations **Location 1:** **City:** Rawalpindi **Contacts:** ***Contact 1:*** - **Email:** furqan.hassan@fui.edu.pk - **Name:** Furqan Hassan, MS-OMPT,PHD* - **Phone:** 03334056768 - **Role:** CONTACT **Country:** Pakistan **Facility:** Foundation University College of Physical Therapy **State:** Punjab **Status:** RECRUITING **Zip:** 46000 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - ID: D000010335 - Term: Pathologic Processes - ID: D000020426 - Term: Sciatic Neuropathy - ID: D000020422 - Term: Mononeuropathies - ID: D000010523 - Term: Peripheral Nervous System Diseases - ID: D000009468 - Term: Neuromuscular Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000009408 - Term: Nerve Compression Syndromes - ID: D000009437 - Term: Neuralgia - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations - ID: D000017699 - Term: Pelvic Pain ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M28404 - Name: Piriformis Muscle Syndrome - Relevance: HIGH - As Found: Piriformis Syndrome - ID: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - ID: M22222 - Name: Sciatic Neuropathy - Relevance: LOW - As Found: Unknown - ID: M22218 - Name: Mononeuropathies - Relevance: LOW - As Found: Unknown - ID: M13432 - Name: Peripheral Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown - ID: M12352 - Name: Nerve Compression Syndromes - Relevance: LOW - As Found: Unknown - ID: M5853 - Name: Charcot-Marie-Tooth Disease - Relevance: LOW - As Found: Unknown - ID: M18092 - Name: Hereditary Sensory and Motor Neuropathy - Relevance: LOW - As Found: Unknown - ID: M12381 - Name: Neuralgia - Relevance: LOW - As Found: Unknown - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M19918 - Name: Pelvic Pain - Relevance: LOW - As Found: Unknown - ID: T4568 - Name: Piriformis Syndrome - Relevance: HIGH - As Found: Piriformis Syndrome - ID: T1081 - Name: Charcot-Marie-Tooth Disease - Relevance: LOW - As Found: Unknown - ID: T2761 - Name: Hereditary Motor and Sensory Neuropathy - Relevance: LOW - As Found: Unknown - ID: T2766 - Name: Hereditary Neuropathy With Liability to Pressure Palsies - Relevance: LOW - As Found: Unknown - ID: T5067 - Name: Roussy Levy Syndrome - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000055958 - Term: Piriformis Muscle Syndrome - ID: D000013577 - Term: Syndrome ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437314 **Brief Title:** Effect of an Intervention Based on Back School in an Aquatic Environment on Non-specific Low Back Pain **Official Title:** Effect of an Intervention Based on Back School in an Aquatic Environment on Non-specific Low Back Pain: Randomized Controlled Trial #### Organization Study ID Info **ID:** EE acuático #### Organization **Class:** OTHER **Full Name:** University of Vigo ### Status Module #### Completion Date **Date:** 2025-01-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-30 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-10 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-25 **Study First Submit QC Date:** 2024-05-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Vigo #### Responsible Party **Investigator Affiliation:** University of Vigo **Investigator Full Name:** Pablo Hernandez-Lucas **Investigator Title:** PhD **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** A controlled and randomized clinical trial will be conducted, in which scores on dependent variable measures will be compared before and after the intervention, both in the experimental group (EG) (individuals who will attend the in an aquatic program based on the back school) and in the control group (CG) (individuals who will not attend the in an aquatic program based on the back school). The experimental procedure will follow the recommendations of the CONSORT and TidIER guidelines. The study protocol will be approved by the Research Ethics Committee of the University of Vigo. This study will be conducted under the Declaration of Helsinki (2013 version). Participants will sign a written informed consent after being informed of the benefits and risks of the research. Participants in the EG will participate in an aquatic program based on the back school. This program will follow the recommendations of the biopsychosocial model of chronic pain and will be conducted in an aquatic environment. The intervention will be carried out by physiotherapists in a sports center. The duration of the intervention will be six weeks, with a frequency of two sessions per week, totaling 12 sessions of 45 minutes each. Of all the sessions, 10 will have a practical focus and the other two will have a theoretical focus. ### Conditions Module **Conditions:** - Low Back Pain - Exercise - Healthy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 65 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will undertake a back school-based program. This program will follow the recommendations of the biopsychosocial model of chronic pain and will be conducted in an aquatic environment. The intervention will be carried out by physiotherapists in a sports center. The duration of the intervention will be six weeks, with a frequency of two sessions per week, totaling 12 sessions of 45 minutes each. Of all the sessions, 10 will have a practical focus (centered on trunk exercises) and the other two will have a theoretical focus (providing education on pain and risk factors for low back pain). **Intervention Names:** - Behavioral: Aquatic program based on the back school **Label:** Aquatic program based on the back school **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** They will continue with their usual lifestyle. **Label:** Control **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Aquatic program based on the back school **Description:** Participants will undertake a back school-based program. This program will follow the recommendations of the biopsychosocial model of chronic pain and will be conducted in an aquatic environment. The intervention will be carried out by physiotherapists in a sports center. The duration of the intervention will be six weeks, with a frequency of two sessions per week, totaling 12 sessions of 45 minutes each. Of all the sessions, 10 will have a practical focus (centered on trunk exercises) and the other two will have a theoretical focus (providing education on pain and risk factors for low back pain). **Name:** Aquatic program based on the back school **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The visual analog scale (VAS) is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). **Measure:** Visual Analogue Scale. **Time Frame:** Through study completion, an average of 2 months. **Description:** The Roland Morris Disability Questionnaire Scoring (RMQ) is a 24-item patient-reported outcome measure that inquires about pain-related disability resulting from LBP. Items are scored 0 if left blank or 1 if endorsed, for a total RMQ score ranging from 0 to 24; higher scores represent higher levels of pain-related disability. **Measure:** Roland Morris Disability Questionnaire. **Time Frame:** Through study completion, an average of 2 months. **Description:** Short-Form Health Survey (SF-36) was used to measure quality of life.The SF-36 explores people's physical and mental health. It consists of 36 items that assessed eight dimensions of health status: social function, physical function, emotional role, physical role, mental health, vitality, physical pain, and general health. Scores ranged from 0 (worst health status) to 100 (best health status). **Measure:** Short-Form Health Survey-36. **Time Frame:** Through study completion, an average of 2 months. **Description:** This scale measures kinesiophobia. The total scale score ranges from 11 to 44, where 11 means no kinesiophobia and 44 means severe kinesiophobia. **Measure:** Tampa Scale Of Kinesiophobia. **Time Frame:** Through study completion, an average of 2 months. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18-65 years of age. With non-specific low back pain for at least three months, with pain intensity (30-70 on a VAS). Exclusion Criteria: * History of cancer, spine infection, rheumatologic diseases, history of spine fracture, history of trauma, red flag signs including unwanted weight loss (exceeding 10 percent of the total body weight) in the past six months and fever, history of psychological disease and history of spine surgery, radiculopathy, anatomical and congenital disturbance. * Missing more than two Back School sessions. * Not being able to attend the measurement sessions. **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Pontevedra **Country:** Spain **Facility:** Beone Sport center **Zip:** 36003 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M4714 - Name: Back Pain - Relevance: HIGH - As Found: Back Pain - ID: M19433 - Name: Low Back Pain - Relevance: HIGH - As Found: Low Back Pain - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001416 - Term: Back Pain - ID: D000017116 - Term: Low Back Pain ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437301 **Brief Title:** End Tidal CO2 and Masks: Is There a Correlation? **Official Title:** End Tidal CO2 and Masks: Is There a Correlation? #### Organization Study ID Info **ID:** 2021-057 #### Organization **Class:** OTHER **Full Name:** CHRISTUS Health ### Status Module #### Completion Date **Date:** 2022-03-16 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-24 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2021-12-31 **Type:** ACTUAL #### Start Date **Date:** 2021-07-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-03-07 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** CHRISTUS Health #### Responsible Party **Investigator Affiliation:** CHRISTUS Health **Investigator Full Name:** Peter Richman, MD **Investigator Title:** Professor and Research Director **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** In light of the ongoing COVID-19 pandemic, wearing a mask has become a universal standard as an attempt to reduce the spread of COVID-19. As of 2020, more than half of all U.S. states have implemented a state wide mandated mask policy. There are many schools of thought regarding the benefits and risks of donning a mask to prevent the spread of COVID-19. There is an unproven theory among some that wearing a mask interferes with our natural respiratory function, causing hypoxia, altered mental status and other various health issues. This dangerous perception has led some to believe wearing a mask is harmful, and encourages against wearing a mask in public. This theory, recently refuted by a study investigating oxygen levels while participants wore masks, performed in 2020 encouraged increased compliance with wearing masks. Another study, preformed by evaluated whether gas exchange abnormalities occurred with the use of surgical masks in subjects with and without lung function impairment. The conclusions of the study showed that regardless of lung function impairment, the presence of surgical masks did not impact gas exchange. Additionally, a more recent study concluded that the presence of a facemask did not have a significant change in physiologic parameters while during exercise. Although there is evidentiary support that facemasks do not negatively affect oxygen status and physiologic capacity, there is not strong evidence examining the relationship between ETCO2 and facemasks. The relationship between ETCO2 and facemasks is one of importance because mild decreases in oxygen have much less dangerous effects compared to the effects of rapid accumulations of carbon dioxide. Increases in end tidal carbon dioxide lead to confusion, acidosis and in severe cases, respiratory distress and failure. A study performed in 1989 showed that hypercapnia has greater increases in blood pressure, minute ventilation and sympathetic nerve activity than hypoxia. In this newly proposed study, healthy volunteers will all wear the same type of three layer surgical mask. Their end tidal carbon dioxide will be measured while at rest without a mask, while resting with a mask and then after walking 100 meters in the mask. While previous studies have focused on changes in oxygen, there is a lack of research dedicated to analyzing end tidal carbon dioxide. This study will hope to show evidence supporting that there is no increase in end tidal carbon dioxide while wearing a mask. ### Conditions Module **Conditions:** - End Tidal Carbon Dioxide (ETCO2) **Keywords:** - Hypoxia - Respiratory Disease - Surgical Mask - Physiologic Capacity - Oxygen - Sympathetic Nerve Activity ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** This study is a prospective, controlled study involving healthy adult volunteers all of whom are resident and faculty physicians, or other medical staff. There will be no financial compensation. ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 31 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Subjects will have their baseline end tidal carbon dioxide measured while at rest and without a mask. **Intervention Names:** - Other: Baseline measure of ETCO2 without mask **Label:** Baseline ETCO2 without mask **Type:** OTHER #### Arm Group 2 **Description:** The second measurement will also occur at rest, but while subjects are wearing a mask. **Intervention Names:** - Other: Baseline ETCO2 with mask **Label:** Baseline ETCO2 with mask **Type:** OTHER #### Arm Group 3 **Description:** Lastly, end tidal carbon dioxide will be measured after each participant walks 200 meters, with a surgical mask. **Intervention Names:** - Other: ETCO2 after 200 meter walk with mask **Label:** ETCO2 after 200 meter walk with mask **Type:** OTHER #### Arm Group 4 **Description:** Lastly, end tidal carbon dioxide will be measured after each participant walks 200 meters, without a surgical mask. **Intervention Names:** - Other: ETCO2 after 200 meter walk without mask **Label:** ETCO2 after 200 meter walk without mask **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Baseline ETCO2 without mask **Description:** Baseline **Name:** Baseline measure of ETCO2 without mask **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Baseline ETCO2 with mask **Description:** Mask **Name:** Baseline ETCO2 with mask **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - ETCO2 after 200 meter walk with mask **Description:** 200 meter walk and mask **Name:** ETCO2 after 200 meter walk with mask **Type:** OTHER #### Intervention 4 **Arm Group Labels:** - ETCO2 after 200 meter walk without mask **Description:** 200 meter walk **Name:** ETCO2 after 200 meter walk without mask **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The primary objective of this study is to evaluate if there are changes present with non-invasive end tidal carbon dioxide measurement while wearing a mask. **Measure:** Change in end tidal carbon dioxide while wearing a mask. **Time Frame:** Measured immediately after mask was put on. #### Secondary Outcomes **Description:** The secondary objective is to assess possible changes in end tidal carbon dioxide while walking moderate distances (200 meters) while wearing a mask. **Measure:** Change in end tidal carbon dioxide while wearing a mask and walking a moderate distance. **Time Frame:** Measured a time = 0 seconds after walk was completed. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Healthy individuals between the ages of 18 and 75 * Consent to participate in this study * Resident and ancillary staff Exclusion Criteria: * Patients * Inability or refusal consent * Inability to walk the predetermined distance * History of lung disease * History of significant cardiac disease * People under the age of 18 and over the age of 75 **Healthy Volunteers:** True **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Corpus Christi **Country:** United States **Facility:** CHRISTUS Health-Texas A&M Spohn Emergency Medicine Residency **State:** Texas **Zip:** 78405 ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Chan NC, Li K, Hirsh J. Peripheral Oxygen Saturation in Older Persons Wearing Nonmedical Face Masks in Community Settings. JAMA. 2020 Dec 8;324(22):2323-2324. doi: 10.1001/jama.2020.21905. **PMID:** 33125030 **Citation:** Barbeito-Caamano C, Bouzas-Mosquera A, Peteiro J, Lopez-Vazquez D, Quintas-Guzman M, Varela-Cancelo A, Martinez-Ruiz D, Yanez-Wonenburger JC, Pineiro-Portela M, Vazquez-Rodriguez JM. Exercise testing in COVID-19 era: Clinical profile, results and feasibility wearing a facemask. Eur J Clin Invest. 2021 Apr;51(4):e13509. doi: 10.1111/eci.13509. Epub 2021 Feb 15. **PMID:** 33548060 **Citation:** Samannan R, Holt G, Calderon-Candelario R, Mirsaeidi M, Campos M. Effect of Face Masks on Gas Exchange in Healthy Persons and Patients with Chronic Obstructive Pulmonary Disease. Ann Am Thorac Soc. 2021 Mar;18(3):541-544. doi: 10.1513/AnnalsATS.202007-812RL. No abstract available. **PMID:** 33003954 #### See Also Links **Label:** What U.S. States Require Masks In Public? **URL:** https://masks4all.co/what-states-require-masks/ **Label:** Adverse Effects of Prolonged Mask Use among Healthcare Professionals during COVID-19 **URL:** https://clinmedjournals.org/articles/jide/journal-of-infectious-diseases-and-epidemiology-jide-6-130.php?jid=jide ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases ### Condition Browse Module - Browse Leaves - ID: M4185 - Name: Hypoxia - Relevance: LOW - As Found: Unknown - ID: M14957 - Name: Respiration Disorders - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437288 **Brief Title:** Hematoporphyrin Photodynamic Therapy for Esophageal Cancer **Official Title:** Therapeutic Effectiveness of Hematoporphyrin Injection Based Photodynamic Therapy in Post-Treatment Recurrent or Residual Superficial Esophageal Cancer: A Prospective, Single-Arm, Multicentric Study #### Organization Study ID Info **ID:** 2024-FXY-183 #### Organization **Class:** OTHER **Full Name:** Sun Yat-sen University ### Status Module #### Completion Date **Date:** 2027-12-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-26 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-04-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-31 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-26 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Sun Yat-sen University #### Responsible Party **Investigator Affiliation:** Sun Yat-sen University **Investigator Full Name:** Jian-jun Li **Investigator Title:** Prefessor, Endoscopy Department Administrative Director **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The goal of this clinical trial is to evaluate the effectiveness of photodynamic therapy using hematoporphyrin injection in treating recurrent or residual superficial esophageal cancer. The primary purpose is to assess the ability of this intervention to achieve complete response in these patients. The main question it aims to answer is: - What is the complete response rate at day 28 post-treatment with PDT using hematoporphyrin injection in patients with recurrent or residual superficial esophageal cancer? There is no comparison group in this single-arm study. Participants will: * Be adults aged 18-80 with recurrent or residual superficial esophageal cancer after prior treatment. * Receive an intravenous infusion of hematoporphyrin injection at a dose of 3mg/kg over 60 minutes. * Undergo 630nm laser irradiation 48-72 hours after the infusion. * Be assessed for complete response at day 28 post-treatment, as well as progression-free survival, overall survival, swallowing function, quality of life, and adverse events throughout the study. ### Conditions Module **Conditions:** - Esophageal Cancer - Photodynamic Therapy ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Single-Stage Phase II Clinical Trials ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 198 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Receive an intravenous infusion of hematoporphyrin injection at a dose of 3mg/kg over 60 minutes. Undergo 630nm laser irradiation 48-72 hours after the infusion. **Intervention Names:** - Drug: photodynamic therapy **Label:** photodynamic therapy **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - photodynamic therapy **Description:** Receive an intravenous infusion of hematoporphyrin injection **Name:** photodynamic therapy **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The proportion of patients showing a complete disappearance of the tumor following the treatment, as assessed by EUS on day 28 **Measure:** The complete response rate evaluated by endoscopic ultrasound (EUS) **Time Frame:** 28 days after the treatment. #### Secondary Outcomes **Description:** Length of time during and after the treatment of a disease, in which a patient lives with the disease but it does not get worse. **Measure:** Progression free survival **Time Frame:** 3 years **Description:** length of time from the start of the treatment until the death of the patient, regardless of the cause. **Measure:** Overall survival **Time Frame:** 3 years **Description:** Adverse events of the treatment. **Measure:** Adverse events **Time Frame:** 1 month after the treatment **Description:** EORTC QLQ-C30 () is a 30-item questionnaire that assesses the quality of life of cancer patients. **Measure:** Quality of life evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30(EORTC QLQ-C30) **Time Frame:** 0.5 year; 1 year; 3 year **Description:** Stooler's dysphagia grading is a clinical method used to categorize the severity of swallowing difficulties in patients with esophageal disorders, including esophageal cancer. It is based on the patient's ability to swallow liquids, semi-solids, and solids. **Measure:** Stooler's dysphagia grading **Time Frame:** 0.5 year; 1 year; 3 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adult patients aged 18-80 with recurrent or residual superficial esophageal cancer after prior treatment. Exclusion Criteria: * Known hypersensitivity, severe comorbidities, pregnancy, etc. **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** lijj@sysucc.org.cn **Name:** Jianjun Li, Doctor **Phone:** 02087343009 **Phone Ext:** 02087343009 **Role:** CONTACT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000006258 - Term: Head and Neck Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000004935 - Term: Esophageal Diseases - ID: D000005767 - Term: Gastrointestinal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M8088 - Name: Esophageal Neoplasms - Relevance: HIGH - As Found: Esophageal Cancer - ID: M14850 - Name: Recurrence - Relevance: LOW - As Found: Unknown - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M9348 - Name: Head and Neck Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M8085 - Name: Esophageal Diseases - Relevance: LOW - As Found: Unknown - ID: T2141 - Name: Esophageal Cancer - Relevance: HIGH - As Found: Esophageal Cancer ### Condition Browse Module - Meshes - ID: D000004938 - Term: Esophageal Neoplasms ### Intervention Browse Module - Browse Branches - Abbrev: Derm - Name: Dermatologic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M9502 - Name: Hematoporphyrins - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437275 **Brief Title:** The Degree of Knowledge and Attitude of Egyptian Physicians Regarding Emergency Treatment of Traumatic Dental Injuries **Official Title:** The Degree of Knowledge and Attitude of Egyptian Physicians Regarding Emergency Treatment of Traumatic Dental Injuries: Cross Sectional Study #### Organization Study ID Info **ID:** knowloedge and attitude #### Organization **Class:** OTHER **Full Name:** Cairo University ### Status Module #### Completion Date **Date:** 2025-02 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-24 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-24 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Cairo University #### Responsible Party **Investigator Affiliation:** Cairo University **Investigator Full Name:** Nour Ziad Al-Tabbaa **Investigator Title:** Principal investigator - Dr. Nour Ziad Al-Tabbaa **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study intends to evaluate physicians' fundamental knowledge and attitude regarding the management of TDIs in Egypt. A convenience sample of physicians will be enrolled in this cross-sectional study, and they will be asked to complete a validated questionnaire. The questionnaire includes demographic questions, two case scenarios involving crown fractures and the avulsion of permanent teeth, and self-evaluation questions. **Detailed Description:** Several epidemiological studies continue to show significant levels of dental trauma in many countries. In industrialized countries, about one in five children experience a traumatic dental injury (TDI) to permanent teeth before leaving school. Primary care providers (e.g., family physicians, pediatricians, emergency medicine physicians and nurses) can play an important role in offering primary care following dentofacial trauma, especially for rural populations with limited access to dentists. Several global studies indicate that physicians and even pediatricians lacked the emergency management knowledge to deal with traumatic dental injuries (TDIs). Emphasizing the fact that medical students are not well educated or trained to manage TDIs. To the best of our knowledge, no study has been conducted in Egypt to investigate physicians' knowledge and attitudes addressing traumatic dental injury. ### Conditions Module **Conditions:** - Traumatic Dental Injuries **Keywords:** - Traumatic dental injuries - awareness - knowledge - attitude ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 290 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** Questionnaire for the degree of knowledge and attitude of Egyptian physicians regarding emergency treatment of traumatic dental injuries. **Name:** Questionnaire for the degree of knowledge and attitude **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Evaluate Egyptian physicians knowledge and attitude regarding the management of dental trauma using questionnaire **Measure:** The degree of knowledge and attitude of Egyptian physicians. **Time Frame:** 2 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Physicians who accept to participate. Exclusion Criteria: Physicians who refuse to participate. **Healthy Volunteers:** True **Minimum Age:** 25 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Participants are family medicine, pediatricians, emergency doctors and other specialties in Cairo and Ain Shams University in Egypt. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** n.z.tabbaa@hotmail.com **Name:** Nour Al-Tabbaa, Master **Phone:** +966551970003 **Role:** CONTACT #### Locations **Location 1:** **City:** Cairo **Contacts:** ***Contact 1:*** - **Name:** Rasha Adel, phd - **Phone:** 00201111511145 - **Role:** CONTACT **Country:** Egypt **Facility:** Cairo University **State:** Al Manial #### Overall Officials **Official 1:** **Affiliation:** Cairo University **Name:** Sherien Badr, Professor **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Description:** evaluate physicians' fundamental knowledge and attitude regarding the management of TDIs in Egypt. **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Al-Haj Ali SN, Farah RI, Alhariqi S. Knowledge and Attitudes of Saudi Medical Students about Emergency Management of Traumatic Dental Injuries. Int J Environ Res Public Health. 2022 Oct 31;19(21):14249. doi: 10.3390/ijerph192114249. **PMID:** 36361130 **Citation:** Al Barkhati S, Al Mullahi A. Knowledge and Awareness of Emergency Medical Physicians on the Management of Traumatic Dental Avulsion at Sultan Qaboos University Hospital. Sultan Qaboos Univ Med J. 2023 Nov;23(4):479-484. doi: 10.18295/squmj.5.2023.030. Epub 2023 Nov 30. **PMID:** 38090234 **Citation:** Sari MBD, Sari E, Bal C, Aksoy M. Evaluation of the knowledge level of pediatricians on dental trauma and their awareness of the ToothSOS mobile application: A cross sectional study. Dent Traumatol. 2024 Apr;40(2):195-203. doi: 10.1111/edt.12895. Epub 2023 Oct 18. **PMID:** 37849392 **Citation:** Raoof M, Vakilian A, Kakoei S, Manochehrifar H, Mohammadalizadeh S. Should medical students be educated about dental trauma emergency management? A study of physicians and dentists in Kerman Province, Iran. J Dent Educ. 2013 Apr;77(4):494-501. **PMID:** 23576595 **Citation:** Iyer SS, Panigrahi A, Sharma S. Knowledge and Awareness of First Aid of Avulsed Tooth among Physicians and Nurses of Hospital Emergency Department. J Pharm Bioallied Sci. 2017 Apr-Jun;9(2):94-98. doi: 10.4103/jpbs.JPBS_343_16. **PMID:** 28717331 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M7796 - Name: Emergencies - Relevance: HIGH - As Found: Emergency - ID: M17685 - Name: Wounds and Injuries - Relevance: HIGH - As Found: Injury - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: T4202 - Name: Oculocerebral Syndrome With Hypopigmentation - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000004630 - Term: Emergencies - ID: D000014947 - Term: Wounds and Injuries ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437262 **Brief Title:** Antibacterial Effect and Substantivity of a New Chlorhexidine and Cymenol Gel on Oral Biofilm and Saliva **Official Title:** Randomized Clinical Trial on the Immediate Antibacterial Effect and Substantivity of a Single Application of a New Chlorhexidine Gel on Oral Biofilm and Saliva #### Organization Study ID Info **ID:** 2021-CE161 #### Organization **Class:** OTHER **Full Name:** University of Santiago de Compostela ### Status Module #### Completion Date **Date:** 2023-07-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-25 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-06-30 **Type:** ACTUAL #### Start Date **Date:** 2022-09-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-25 **Study First Submit QC Date:** 2024-05-25 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Lacer, S.A. #### Lead Sponsor **Class:** OTHER **Name:** University of Santiago de Compostela #### Responsible Party **Investigator Affiliation:** University of Santiago de Compostela **Investigator Full Name:** Inmaculada Tomás **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The objective of this project was to compare the immediate antimicrobial effect and in situ substantivity of a new 0.20% chlorhexidine (CHX) gel and cymenol with the current CHX gel formulation on dental plaque biofilm and salivary flora up to 7 hours after a single application. ### Conditions Module **Conditions:** - Healthy - Saliva - Biofilms ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 30 **Type:** ACTUAL **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants underwent a single application of the 0.20% CHX gel. Samples were collected in basal conditions (i.e., before application) and at 5 minutes, 1 hour, 3 hours, 5 hours and 7 hours after application. **Intervention Names:** - Drug: 0.20% CHX gel on saliva - Drug: 0.20% CHX gel on oral biofilm **Label:** 0.20% CHX gel **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Participants underwent a single application of the 0.20% CHX + Cymenol gel. Samples were collected in basal conditions (i.e., before application) and at 5 minutes, 1 hour, 3 hours, 5 hours and 7 hours after application. **Intervention Names:** - Drug: 0.20% CHX and Cymenol gel on saliva - Drug: 0.20% CHX and Cymenol gel on oral biofilm **Label:** 0.20% CHX and Cymenol gel **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - 0.20% CHX gel **Description:** In vivo application of a gel on the vestibular and palatal/lingual gingival mucosa of both arches at minute 0 for posterior saliva collection at different time-points. **Name:** 0.20% CHX gel on saliva **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - 0.20% CHX and Cymenol gel **Description:** In vivo application of a gel on the vestibular and palatal/lingual gingival mucosa of both arches at minute 0 for posterior saliva collection at different time-points. **Name:** 0.20% CHX and Cymenol gel on saliva **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - 0.20% CHX gel **Description:** Ex vivo application of a gel on the glass disks of the removable intraoral appliance at minute 0 for subsequent one-by-one disk removal from the device at different time-points. **Name:** 0.20% CHX gel on oral biofilm **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - 0.20% CHX and Cymenol gel **Description:** Ex vivo application of a gel on the glass disks of the removable intraoral appliance at minute 0 for subsequent one-by-one disk removal from the device at different time-points. **Name:** 0.20% CHX and Cymenol gel on oral biofilm **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: baseline vs 5 minutes **Measure:** Intragel bacterial viability: baseline vs 5 minutes **Time Frame:** Baseline vs 5 minutes **Description:** Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: baseline vs 1 hour **Measure:** Intragel bacterial viability: baseline vs 1 hour **Time Frame:** Baseline vs 1 hour **Description:** Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: baseline vs 3 hours **Measure:** Intragel bacterial viability: baseline vs 3 hours **Time Frame:** Baseline vs 3 hours **Description:** Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: baseline vs 5 hours **Measure:** Intragel bacterial viability: baseline vs 5 hours **Time Frame:** Baseline vs 5 hours **Description:** Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: baseline vs 7 hours **Measure:** Intragel bacterial viability: baseline vs 7 hours **Time Frame:** Baseline vs 7 hours **Description:** Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: 5 minutes vs 1 hour **Measure:** Intragel bacterial viability: 5 minutes vs 1 hour **Time Frame:** 5 minutes vs 1 hour **Description:** Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: 5 minutes vs 3 hours **Measure:** Intragel bacterial viability: 5 minutes vs 3 hours **Time Frame:** 5 minutes vs 3 hours **Description:** Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: 5 minutes vs 5 hours **Measure:** Intragel bacterial viability: 5 minutes vs 5 hours **Time Frame:** 5 minutes vs 5 hours **Description:** Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) with either 0.20% CHX gel or 0.20% CHX and cymenol gel: 5 minutes vs 7 hours **Measure:** Intragel bacterial viability: 5 minutes vs 7 hours **Time Frame:** 5 minutes vs 7 hours **Description:** Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) at baseline: 0.20% CHX gel vs 0.20% CHX and cymenol gel. **Measure:** Intergel bacterial viability at baseline: 0.20% CHX gel vs 0.20% CHX and cymenol gel **Time Frame:** Baseline **Description:** Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) after 5 minutes: 0.20% CHX gel vs 0.20% CHX and cymenol gel. **Measure:** Intergel bacterial viability after 5 min: 0.20% CHX gel vs 0.20% CHX and cymenol gel **Time Frame:** 5 minutes **Description:** Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) after 1 hour: 0.20% CHX gel vs 0.20% CHX and cymenol gel. **Measure:** Intergel bacterial viability after 1 hour: 0.20% CHX gel vs 0.20% CHX and cymenol gel **Time Frame:** 1 hour **Description:** Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) after 3 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel. **Measure:** Intergel bacterial viability after 3 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel **Time Frame:** 3 hours **Description:** Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) after 5 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel. **Measure:** Intergel bacterial viability after 5 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel **Time Frame:** 5 hours **Description:** Percentage of bacterial viability (Ratio of viable bacteria to total bacteria -viable + non-viable- multiplied by 100) after 7 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel. **Measure:** Intergel bacterial viability after 7 hours: 0.20% CHX gel vs 0.20% CHX and cymenol gel **Time Frame:** 7 hours ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Systemically healthy volunteers * Age between 20-45 years * Presence of minimum 24 permanent teeth * No evidence of gingivitis or periodontitis (CPITN= 0) * No presence of untreated caries at the start of the study Exclusion Criteria: * Smoker or ex-smoker * Presence of dental protheses or orthodontic appliances * Antibiotic treatment and/or routine use of oral antiseptics in the previous three months * Presence of any systemic disease that could alter saliva production or composition **Healthy Volunteers:** True **Maximum Age:** 45 Years **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Santiago de Compostela **Country:** Spain **Facility:** University of Santiago de Compostela **State:** A Coruña **Zip:** 15782 #### Overall Officials **Official 1:** **Affiliation:** University of Santiago de Compostela, Spain **Name:** Inmaculada Tomás, Prof **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Derm - Name: Dermatologic Agents ### Intervention Browse Module - Browse Leaves - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M5953 - Name: Chlorhexidine - Relevance: LOW - As Found: Unknown - ID: M344731 - Name: Chlorhexidine gluconate - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437249 **Brief Title:** Children's Dental Anxiety in Relation to Parental Dental Anxiety, Child's Age and Gender and Caries Experience **Official Title:** Children's Dental Anxiety in Relation to Parental Dental Anxiety, Child's Age and Gender and Caries Experience (Cross Sectional Study) #### Organization Study ID Info **ID:** children dental anxiety #### Organization **Class:** OTHER **Full Name:** Cairo University ### Status Module #### Completion Date **Date:** 2025-02 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-30 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Cairo University #### Responsible Party **Investigator Affiliation:** Cairo University **Investigator Full Name:** Ghadeer Jaafar Ali Jawad **Investigator Title:** Principal Investigator Ghadeer Jaafar Ali **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Determine the relation of of Children's dental anxiety to Parental Dental anxiety, child's age and gender and caries experience will be obtained through written questionnaires (ACDAS) and (CDAS) to the child and parents of children aged 6-8 years old in the clinic. **Detailed Description:** 1. Soft copies of the Abeer children dental anxiety SCALE (ACDAS) Questionnaire and Corah Dental Anxiety Scale (CDAS) Questionnaire. 2. The child's age and gender will be recorded first. 3. Level of anxiety will be recorded by using Heart rate using fingertip pulse oximeter. 4. Dental caries experiences will record by using Dental caries indices (DMF and def) 5. Child dental anxiety will be evaluated from (ACDAS) Questionnaire: The first part is child self-report part, the operator will be answered by ticking the box that corresponds to child dental anxiety, 1 (happy), 2 (Ok), 3 (Scared). The second part about the cognitive part with five questions: three of them answered with (Yes, No) and the other two questions answered with score, 1 (happy), 2 (Ok), 3 (Scared) 6. Parents dental anxiety will be evaluated from (CDAS) Questionnaire. the parents will answer by ticking the answer. The final scores, \&amp;gt;9 (Mild anxiety), 9-12 (Moderate anxiety), 13-14 (High anxiety), 15-20 (Sever anxiety). 7. Results will be analyzed by the statistician. 8. Data handling will be supervised by the supervisors. ### Conditions Module **Conditions:** - Child Dental Anxiety **Keywords:** - Parental dental anxiety - Child dental anxiety ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 74 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 1 Month ### Outcomes Module #### Primary Outcomes **Description:** Using Abeer children dental anxiety SCALE Questionnaire Score score 1 happy 2 Ok 3 Scared **Measure:** Child dental anxiety **Time Frame:** Two months **Description:** record Heart rate number using fingertip pulse oximeter **Measure:** Level of anxiety **Time Frame:** Two months **Description:** Using dental caries indices ( Decayed Missed Filling and Decayed Exposed to extraction Filling ) in mixed dentition **Measure:** Caries experience **Time Frame:** Two months #### Secondary Outcomes **Description:** Using Corah Dental Anxiety Scale Questionnaire Score a = 1, b = 2, c = 3, d = 4, e = 5 Total possible = 20 * \< 9 = mild * 9 - 12 = moderate anxiety * 13 - 14 = high anxiety * 15 - 20 = severe anxiety (or phobia) higher score means worse **Measure:** Parental dental anxiety **Time Frame:** Two months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Children range in age from 6-8 years old. 2. First dental visit. 3. Accompanied by their parents. 4. Both male and female included. Exclusion Criteria: 1. Children with Physical or mental disabilities. 2. Children who refuse to participate. **Healthy Volunteers:** True **Maximum Age:** 8 Years **Minimum Age:** 6 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD **Study Population:** 1. Gender: Male and Female. 2. Age: 6-8 years old * in Pediatric Clinic in Pediatric Dentistry and Dental Public Health Department-faculty of Dentistry, Cairo University, Egypt. * parents will be interviewed by the examiner and the questionnaire will be filled. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** ghadeerja08558@gmail.com **Name:** Ghadeer Jawad, Master **Phone:** 00201220262599 **Phone Ext:** +97333323874 **Role:** CONTACT #### Locations **Location 1:** **City:** Cairo **Contacts:** ***Contact 1:*** - **Email:** rasha.adel@dentistry.cu.edu.eg - **Name:** Rasha l Adel, PHD - **Phone:** 00201111511145 - **Role:** CONTACT **Country:** Egypt **Facility:** Cairo University **State:** Almanial **Zip:** Egypt #### Overall Officials **Official 1:** **Affiliation:** Cairo University **Name:** Ola Mustafa, professor **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Description:** evaluate the relation between the parental dental anxiety, child age and gender and caries experience on child dental anxiety in a group of Egyptian children. **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Coric A, Banozic A, Klaric M, Vukojevic K, Puljak L. Dental fear and anxiety in older children: an association with parental dental anxiety and effective pain coping strategies. J Pain Res. 2014 Aug 20;7:515-21. doi: 10.2147/JPR.S67692. eCollection 2014. **PMID:** 25187737 **Citation:** Corah NL, Gale EN, Illig SJ. Assessment of a dental anxiety scale. J Am Dent Assoc. 1978 Nov;97(5):816-9. doi: 10.14219/jada.archive.1978.0394. **PMID:** 31377 **Citation:** Al-Namankany A, Ashley P, Petrie A. The development of a dental anxiety scale with a cognitive component for children and adolescents. Pediatr Dent. 2012 Nov-Dec;34(7):e219-24. **PMID:** 23265158 **Citation:** Aditya PVA, Prasad MG, Nagaradhakrishna A, Raju NS, Babu DN. Comparison of effectiveness of three distraction techniques to allay dental anxiety during inferior alveolar nerve block in children: A randomized controlled clinical trial. Heliyon. 2021 Sep 29;7(9):e08092. doi: 10.1016/j.heliyon.2021.e08092. eCollection 2021 Sep. **PMID:** 34632153 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M4324 - Name: Anxiety Disorders - Relevance: HIGH - As Found: Anxiety - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: T4202 - Name: Oculocerebral Syndrome With Hypopigmentation - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001008 - Term: Anxiety Disorders ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437236 **Brief Title:** Comparative Study Between Intravenous Granisetron and Ondansetron on Their Effect on Hemodynamics and Shivering After Spinal Anesthesia in Elective Cesarean Delivery **Official Title:** Comparative Study Between Intravenous Granisetron and Ondansetron on Their Effect on Hemodynamics and Shivering After Spinal Anesthesia in Elective Cesarean Delivery : A Randomized Double-Blind Study #### Organization Study ID Info **ID:** soh-Med-24-04-012MS #### Organization **Class:** OTHER **Full Name:** Sohag University ### Status Module #### Completion Date **Date:** 2024-12-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-30 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-10 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Sohag University #### Responsible Party **Investigator Affiliation:** Sohag University **Investigator Full Name:** Mohamed Abdelrady Abdelaziz **Investigator Title:** resident at Anesthesiology, Surgical Intensive Care and Pain Medicine department **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Spinal anesthesia is commonly used in cesarean section surgeries . The most important adverse effects of spinal anesthesia are hypotension and bradycardia caused by sympathetic blockade, with an incidence of about 55-100% . However, blocking the venous return by the gravid uterus increases the risk of hypotension. Spinal anesthesia-induced hypotension is commonly associated with uncomfortable symptoms, such as shivering , nausea and vomiting, in the mother. Prolonged maternal hypotension may lead to serious maternal adverse effects, such as cardiovascular collapse, loss of consciousness, apnea, and aspiration of gastric contents. In addition, uteroplacental blood flow decreases in cases of sustained hypotension and detrimental neonatal effects, such as fetal acidosis and fetal death, may occur. Preventing spinal anesthesia-induced hypotension during cesarean section is essential for the well-being of both the mother and neonate. Also, Shivering often happens after spinal anesthesia. Shivering is an unconscious and rhythmic movement involving several groups of muscles. The increase of muscle activity generates the elevation of oxygen consumption, lactic acidosis, and carbon dioxide production In recent years, researchers have focused on the effects of the Bezold-Jarisch reflex (BJR) . This reflex includes a triad of bradycardia, hypotension, and apnea. Researchers have suggested that serotonin and 5-hydroxytryptamine 3 (5-HT3) receptors play an important role in the occurrence of the BJR after spinal anesthesia . The 5-HT3 receptors are present in the heart, lung, and spine. Diminished venous return caused by spinal anesthesia stimulates the cardiac chemoreceptors, and parasympathetic activity increases, which results in bradycardia and hypotension . Studies have suggested that the use of 5-HT3 antagonists may attenuate spinal anesthesia-induced hypotension, thus inhibiting peripheral vasodilatation, alleviating the BJR, and increasing venous return to the heart . Ondansetron is a commonly used 5-HT3 receptor antagonist, and its peak plasma concentration occurs within 30 min following IV injection. Granisetron is a new 5-HT3 receptor antagonist, and the onset of action occurs 30 min following its IV administration \[ ### Conditions Module **Conditions:** - Hemodynamic Instability and Shivering ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** will receive ondansetron 4mg diluted in normal saline,The total volume of the solution infused will kept at 10 mL. After preloading, patients in the respective group will receive the infusion of the study drug over 1 minute just 5 minutes before performing the subarachnoid block. **Intervention Names:** - Drug: ondansetron **Label:** Group A **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** will receive granisetron 1mg diluted in normal saline.The total volume of the solution infused will kept at 10 mL. After preloading, patients in the respective group will receive the infusion of the study drug over 1 minute just 5 minutes before performing the subarachnoid block. **Intervention Names:** - Drug: granisetron **Label:** group B **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Group A **Description:** Group A will receive ondansetron 4mg diluted in normal saline,The total volume of the solution infused will kept at 10 mL. After preloading, patients in the respective group will receive the infusion of the study drug over 1 minute just 5 minutes before performing the subarachnoid block **Name:** ondansetron **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - group B **Description:** Group B will receive granisetron 1mg diluted in normal saline.The total volume of the solution infused will kept at 10 mL. After preloading, patients in the respective group will receive the infusion of the study drug over 1 minute just 5 minutes before performing the subarachnoid block **Name:** granisetron **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** a comparison of change in Blood pressure among groups **Measure:** Blood pressure mesurment in mmhg **Time Frame:** 6 months #### Secondary Outcomes **Description:** will include detect difference among groups incidece of shivering or not **Measure:** incidece of shivering or not **Time Frame:** 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * All parturient who underwent elective caesarean delivery under spinal anesthesia will be included in this study Exclusion Criteria: * 1. Patient refusal 2. Patient with significant neurological , psychological disease 3. patient known allergy to ondansetron or granisetron, 4. patients receiving serotonin agonists or antagonists, 5. patient ischemic heart disease, chronic hypertension or pregnancy induced hypertension **Gender Based:** True **Healthy Volunteers:** True **Sex:** FEMALE **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** mohamedreshwan@med.sohag.edu.eg **Name:** mohamed A A, resident **Phone:** 01030026022 **Role:** CONTACT **Contact 2:** **Name:** fawzy A B, assistant professor **Role:** CONTACT #### Locations **Location 1:** **City:** Sohag **Country:** Egypt **Facility:** Sohag university Hospital **Status:** RECRUITING ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Lee JE, George RB, Habib AS. Spinal-induced hypotension: Incidence, mechanisms, prophylaxis, and management: Summarizing 20 years of research. Best Pract Res Clin Anaesthesiol. 2017 Mar;31(1):57-68. doi: 10.1016/j.bpa.2017.01.001. Epub 2017 Jan 8. **PMID:** 28625306 **Citation:** Kinsella SM, Tuckey JP. Perioperative bradycardia and asystole: relationship to vasovagal syncope and the Bezold-Jarisch reflex. Br J Anaesth. 2001 Jun;86(6):859-68. doi: 10.1093/bja/86.6.859. **PMID:** 11573596 **Citation:** Ortiz-Gomez JR, Palacio-Abizanda FJ, Morillas-Ramirez F, Fornet-Ruiz I, Lorenzo-Jimenez A, Bermejo-Albares ML. The effect of intravenous ondansetron on maternal haemodynamics during elective caesarean delivery under spinal anaesthesia: a double-blind, randomised, placebo-controlled trial. Int J Obstet Anesth. 2014 May;23(2):138-43. doi: 10.1016/j.ijoa.2014.01.005. Epub 2014 Feb 4. **PMID:** 24631057 **Citation:** Yeoh SB, Leong SB, Heng AS. Anaesthesia for lower-segment caesarean section: Changing perspectives. Indian J Anaesth. 2010 Sep;54(5):409-14. doi: 10.4103/0019-5049.71037. **PMID:** 21189878 ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000000932 - Term: Antiemetics - ID: D000001337 - Term: Autonomic Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000005765 - Term: Gastrointestinal Agents - ID: D000000982 - Term: Antipruritics - ID: D000003879 - Term: Dermatologic Agents - ID: D000058831 - Term: Serotonin 5-HT3 Receptor Antagonists - ID: D000012702 - Term: Serotonin Antagonists - ID: D000018490 - Term: Serotonin Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: AnEm - Name: Antiemetics - Abbrev: Derm - Name: Dermatologic Agents - Abbrev: Gast - Name: Gastrointestinal Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: PhSol - Name: Pharmaceutical Solutions ### Intervention Browse Module - Browse Leaves - ID: M19588 - Name: Ondansetron - Relevance: HIGH - As Found: Dual - ID: M20020 - Name: Granisetron - Relevance: HIGH - As Found: Per os - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown - ID: M4251 - Name: Antiemetics - Relevance: LOW - As Found: Unknown - ID: M8881 - Name: Gastrointestinal Agents - Relevance: LOW - As Found: Unknown - ID: M7074 - Name: Dermatologic Agents - Relevance: LOW - As Found: Unknown - ID: M15512 - Name: Serotonin - Relevance: LOW - As Found: Unknown - ID: M29246 - Name: Serotonin 5-HT3 Receptor Antagonists - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000017294 - Term: Ondansetron - ID: D000017829 - Term: Granisetron ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437223 **Brief Title:** Study of Xiflam™ Treatment in Patients Post COVID-19 Infection Suffering From What is Known as Long COVID (LC) **Official Title:** A Phase 2 Study to Compare the Efficacy and Safety of Orally Administered Xiflam™ Therapy With Orally Administered Placebo in Patients With Ocular and Systemic Manifestations of Post COVID Sequelae Known as "Long" COVID #### Organization Study ID Info **ID:** IFX-LC001 #### Organization **Class:** INDUSTRY **Full Name:** Inflammx Therapeutics Inc ### Status Module #### Completion Date **Date:** 2025-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-29 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-03 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-12 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-29 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Inflammx Therapeutics Inc #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** The primary objective of this study is to evaluate the safety and efficacy of Xiflam versus Placebo in patients who present with signs and symptoms of Long COVID. Xiflam (n=10) or placebo (n=5) will be administered orally once a day (QD) for 12 weeks. **Detailed Description:** This is a Phase 2a randomized, masked, placebo-controlled clinical trial to evaluate the safety and efficacy of Xiflam for use in patients with signs/symptoms of Long COVID. Patients will be randomized to Xiflam the study drug (n=10) or Placebo (n=5). Both Xiflam and Placebo will be taken once daily by mouth for 12 weeks. I. Baseline Screening Visit After obtaining informed consent and before treatment is initiated, an initial study visit will be conducted in person to confirm subject eligibility. Subjects will be asked complete a baseline questionnaire to assess signs and symptom severity. During this screening visit, a baseline blood sample will be obtained to determine any changes over time in any of the measured parameters. These include biomarkers of inflammation. Additional study procedures occurring during the baseline/screening phase of this study are outlined in the protocol. Patients who are found not to meet inclusion criteria, will not be entered into the treatment Phase of the study. ### Conditions Module **Conditions:** - Long COVID ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Masking Description:** Phase 2 randomized, masked, placebo-controlled clinical trial **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 15 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** IFX-LC001 Tonabersat tablets 40mg tablets or placebo Take two tablets once per day **Intervention Names:** - Drug: Tonabersat **Label:** Experimental **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** IFX-LC001Tonabersat tablets 40mg tablets or placebo Take two tablets once per day **Intervention Names:** - Drug: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental **Description:** Tonabersat 40mg. Two tablets per day **Name:** Tonabersat **Other Names:** - Xiflam **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** Placebo 40mg, Two tablets per day **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** Incidence and severity of ocular and systemic treatment emergent adverse events (TEAE) **Measure:** Safety Endpoint **Time Frame:** 12 weeks #### Primary Outcomes **Description:** Primary outcomes are change from baseline for signs and symptoms measured by a Visual Analogue Scale (VAS) instrument. Reporting done by the patient on a 0-100 scale. Scale measures severity from none (0) to severe (100) for multiple signs and symptoms, for the different systems involved in this disease state (see below) 1. General health 2. Neurological signs/symptoms 3. Ocular signs/symptoms 4. Respiratory signs/symptoms 5. Gastrointestinal signs/symptoms 6. Cardiovascular signs/symptoms 7. Musculoskeletal signs/symptoms 8. Dermatological signs/symptoms 9. Mental Health signs/symptoms 10. Miscellaneous signs/symptoms which may not be captured above. Since Long COVID is a multi-system disease, patients will only score on the severity scale of the signs/symptoms which are of clinical significance to that particular patient. **Measure:** Primary Endpoint **Time Frame:** 12 weeks #### Secondary Outcomes **Description:** Complete Blood Count (CBC) including biomarkers of inflammation Physical Examination including electrocardiogram (EKG) Change in laboratory values including inflammatory markers, e.g., C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), Antinuclear Antibody (ANA) **Measure:** Secondary Endpoint **Time Frame:** 12 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Have tested positive for COVID-19 irrespective of variant or timeframe. 2. Developed signs and symptoms of the disease as described by the Centers for Disease Control and Prevention (CDC) and World Health Organization (WHO). 3. Have recovered from the infection (tested negative for COVID-19). 4. Following negative COVID-19 testing, continued to demonstrate signs/symptoms which were not pre-existing. The signs/symptoms must have persisted for 12 weeks or more. 5. Have had a persistent recurrence of a disease state (e.g., posterior uveitis, extreme fatigue etc.) that occurred following COVID-19 infection. 6. Female subjects must be: 1. Women of non-child-bearing potential, or 2. Women of child-bearing potential with a negative pregnancy test at screening, must agree to use approved methods of contraception for the duration of the study and refrain from breastfeeding for the duration of the study. 7. Males with female partners of child-bearing potential must agree to use approved methods of contraception and agree to refrain from donating sperm for the duration of the study. 8. Willing and able to give informed consent and to comply with the study procedures and assessments. Exclusion Criteria: A subject will not be eligible for inclusion in this study if any of the following exclusion criteria apply: 1. No proof of having tested positive for COVID-19 infection at any time. 2. Presence of an active ocular/systemic disease that in the opinion of the Investigator existed prior to COVID-19 infection and is not likely a LC related condition. 3. Intraocular surgery (including lens replacement surgery) within 3 months prior to randomization. 4. History of laser therapy in the macular region. 5. Any ocular or systemic condition that in the opinion of the Investigator is not LC related (e.g., pre-existing cataract) that may require surgery or medical intervention during the study period. 6. Participation in any systemic experimental treatment or any other systemic investigational new drug within 90 days prior to the start of study treatment. 7. Any screening laboratory value (hematology, serum chemistry or urinalysis) that in the opinion of the Investigator is clinically significant and not suitable for study participation. 8. Known hypersensitivity to Xiflam™ or excipients. 9. Known history of alcohol and/or drug abuse within 12 months prior to Visit 1 Screening that, in the opinion of the Investigator, may interfere with study compliance, outcome measures, safety parameters, and/or the general medical condition of the subject. **Minimum Age:** 21 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** ymassoudi@mersi.com **Name:** Yasmin Massoudi **Phone:** (781) 647-1431 **Role:** CONTACT **Contact 2:** **Email:** tvalerio@mersi.com **Name:** Tate Valerio **Phone:** (781) 647-1431 **Role:** CONTACT #### Locations **Location 1:** **City:** Waltham **Contacts:** ***Contact 1:*** - **Email:** ymassoudi@mersi.com - **Name:** Yasmin Massoudi - **Phone:** 781-647-1431 - **Role:** CONTACT ***Contact 2:*** - **Email:** tvalerio@mersi.com - **Name:** Tate Valerio - **Phone:** (781) 647-1431 - **Role:** CONTACT ***Contact 3:*** - **Name:** Peter Chang, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Massachusetts Eye Research and Surgery Institution (MERSI) **State:** Massachusetts **Status:** RECRUITING **Zip:** 02451 #### Overall Officials **Official 1:** **Affiliation:** Massachusetts Eye Research and Surgery Institution (MERSI) **Name:** Peter Chang, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000086382 - Term: COVID-19 - ID: D000011024 - Term: Pneumonia, Viral - ID: D000011014 - Term: Pneumonia - ID: D000012141 - Term: Respiratory Tract Infections - ID: D000007239 - Term: Infections - ID: D000014777 - Term: Virus Diseases - ID: D000018352 - Term: Coronavirus Infections - ID: D000003333 - Term: Coronaviridae Infections - ID: D000030341 - Term: Nidovirales Infections - ID: D000012327 - Term: RNA Virus Infections - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000094025 - Term: Post-Infectious Disorders - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M3013 - Name: Post-Acute COVID-19 Syndrome - Relevance: HIGH - As Found: Long COVID - ID: M2561 - Name: COVID-19 - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M13904 - Name: Pneumonia - Relevance: LOW - As Found: Unknown - ID: M13914 - Name: Pneumonia, Viral - Relevance: LOW - As Found: Unknown - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M20490 - Name: Coronavirus Infections - Relevance: LOW - As Found: Unknown - ID: M6555 - Name: Coronaviridae Infections - Relevance: LOW - As Found: Unknown - ID: M23685 - Name: Nidovirales Infections - Relevance: LOW - As Found: Unknown - ID: M15149 - Name: RNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M3014 - Name: Post-Infectious Disorders - Relevance: LOW - As Found: Unknown - ID: M6147 - Name: Chronic Disease - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000094024 - Term: Post-Acute COVID-19 Syndrome ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437210 **Brief Title:** Evaluation of Treatment With Viusid in Post-COVID Syndrome **Official Title:** Evaluation of Treatment With Viusid in Post-COVID Syndrome #### Organization Study ID Info **ID:** VIUSID_POSTCOVID_CO_2022 #### Organization **Class:** INDUSTRY **Full Name:** Catalysis SL ### Status Module #### Completion Date **Date:** 2024-03-15 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-30 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-12-15 **Type:** ACTUAL #### Start Date **Date:** 2022-02-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-30 **Study First Submit QC Date:** 2024-05-30 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Catalysis SL #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Reports of long-lasting symptoms of COVID-19 are increasing, but little is known about the prevalence of risk factors or whether it is possible to predict a prolonged course at disease onset. Prolonged COVID is characterized on the basis of symptoms such as fatigue, headache, dyspnea, and anosmia present for weeks, with older age, high body mass index, and female sex being more susceptible. Accordingly, and in the absence of specific treatments, the present study seeks to establish a treatment protocol for Post-COVID syndrome through the application of the dietary supplement VIUSID, due to its anti-inflammatory and immunomodulatory effect, thus helping to reduce and/or control the symptoms of the syndrome. **Detailed Description:** Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2e) is the pathogen responsible for the 2019 coronavirus disease pandemic (COVID-19), which has caused global health care crises and overstretched health care resources, Scientific and clinical evidence is evolving on the subacute and long-term effects of COVID-19, which can affect multiple organ systems. As the population of patients recovering from COVID-19 grows, it is critical to establish an understanding of the healthcare issues surrounding them. COVID-19 is now recognized as a multi-organ disease with a broad spectrum of manifestations. Early reports suggest residual effects of SARS-CoV-2c infection, such as fatigue, dyspnea, chest pain, cognitive impairment, arthralgia and impaired quality of life. Cellular damage, a robust innate immune response with inflammatory cytokine production and a procoagulant state induced by SARS-CoV-2 infection may contribute to these sequelae. Survivors of previous coronavirus infections, including the 2003 SARS epidemic and the 2012 Middle East Respiratory Syndrome (MERS) outbreak, have demonstrated a similar set of persistent symptoms, reinforcing concerns about clinically significant sequelae of COVID-19. Some countries use several drugs to treat coronavirus. In one of its documents, the Spanish Society of Medicine mentions the recommendations of the protocol developed for the treatment of COVID-19. Specific antiviral treatment requires drugs such as lopinavir/ritonavir administered orally. This drug is indicated to help control human immunodeficiency virus (HIV) infection. It is only administered orally 0 in concomitant treatment with interferon beta-lb. In this case Betaferon is recommended, which is indicated for the treatment of multiple sclerosis. Interferons are proteins produced by the body that help fight against attacks on the immune system, such as viral infections. Lopinavir / ritonavir can also be used in combination with an alpha-2B interferon, such as Intron A, which modifies the immune system response of the patient. the body's immune system to help fight infections and serious illnesses. Viusid (Catalysis Laboratories, Madrid, Spain) is a nutritional supplement with recognized antioxidant and immunomodulatory properties that have beneficial effects on clinical outcomes related to cirrhosis, such as survival, disease progression and the development of hepatocellular carcinoma (HCC). It contains different molecules (ascorbic acid, zinc and glycyrrhizic acid) with recognized antioxidant and immunomodulatory properties. Glycyrrhizin (0.033g), the most important active ingredient of the supplement, is known to have an immunomodulatory, antiviral and biological effect, and has also demonstrated various anti-inflammatory properties (such as increased production of IL-10: a potent anti-inflammatory cytokine that inhibits the synthesis of many proinflammatory proteins), as well as an anti-apoptotic effect, hepatocyte proliferation and stabilization of cell membranes in the liver. Recent data suggest that Viusid ameliorates oxidative stress through the reduction of 105 lipid peroxidation products and that it has an immunomodulatory effect on cytokine secretion through increased cytokine secretion by the liver. cytokines through increased production of IFN-y and IL-l0, decreased production of IL-ly, stabilized tumor necrosis factor and secretion in HCV patients who have failed previous antiviral treatments. Taking into account the benefits of Viusid, such as the reduction of inflammation and the immunomodulatory effect, a randomized double-blind study is proposed to evaluate the treatment with this food supplement in 200 patients with post-COVID syndrome diagnosed, assessing the improvement of their symptoms before and after treatment for 1 month, through clinical and paraclfnical examinations. ### Conditions Module **Conditions:** - Post-COVID-19 Syndrome - COVID-19 - Dyspnea - Fatigue - Cough - Inflammation **Keywords:** - COVID-19 - Antioxidants - Post-COVID-19 Syndrome - Fatigue - Immunomodulator ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 200 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Oral administration of viusid oral solution 30 mL 3 times a day with the main meals (breakfast, lunch and dinner) for 30 days. **Intervention Names:** - Dietary Supplement: Viusid Oral Solution **Label:** Viusid Group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Oral administration of placebo 30 mL 3 times a day with the main meals (breakfast, lunch and dinner) for 30 days. **Intervention Names:** - Dietary Supplement: Placebo **Label:** Placebo Group **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Viusid Group **Description:** Patients in the experimental intervention group will be administered Viusid Oral Solution (CATALYSIS S.L., Madrid, Spain) 30 mL orally 3 times a day with the main meals (breakfast, lunch and dinner) for 30 days. **Name:** Viusid Oral Solution **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - Placebo Group **Description:** Patients in the experimental intervention group will be administered Placebo (CATALYSIS S.L., Madrid, Spain) 30 mL orally 3 times a day with the main meals (breakfast, lunch and dinner) for 30 days. **Name:** Placebo **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** To evaluate treatment with Viusid (Oral administration of 30 mL 3 times daily for 30 days) in symptomatic patients diagnosed with Post-COVID syndrome by improvement or non-improvement of symptoms associated with Post-COVID syndrome compared to baseline symptom assessment and placebo group. Symptom assessment will be performed using the visual analog fatigue scale (VASf) **Measure:** Evaluation of the symptoms associated with post-COVID syndrome. **Time Frame:** 30 days **Description:** Evaluation of inflammation associated with Post-COVID syndrome by analysis of IL-6 in venous blood samples before and after treatment, compared to the placebo group. **Measure:** Evaluation of inflammation associated with Post-COVID syndrome. **Time Frame:** 30 days **Description:** Evaluation of oxidative stress associated with Post-COVID syndrome by analysis of glutathione peroxidase in venous blood samples before and after treatment, compared to the placebo group. **Measure:** Evaluation of oxidative stress associated with Post-COVID syndrome **Time Frame:** 30 days **Description:** To evaluate the effect of Viusid on the recovery of respiratory symptoms associated with Post-COVID syndrome by thoracic CT imaging analysis before and after treatment and in comparison with the placebo group. For the CT assessment, image analysis will be performed through digital processing, where different grayscale image data will be extracted in order to obtain numerical information about the evident pulmonary fibrosis, taking into account the intensity of the targets in the region of interest (i.e. lung tissue), comparing it with control images of healthy lungs. In addition, radiomic analysis and segmentation of the affected areas will be applied to obtain quantitative data on the severity of fibrosis. In addition, the images of interest will be visually analyzed by the project's medical staff, so that fibrosis can be directly diagnosed. **Measure:** Evaluation of pulmonar fibrosis associated with Post-COVID syndrome **Time Frame:** 30 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Patients with one or more of the following symptoms, persistent after suffering COVID-19: * Extreme tiredness (Fatigue). * Shortness of breath * Chest pain * Problems with memory or concentration ("Brain fog") * Insomnia * Palpitations * Dizziness * Tingling * Joint pain * Depression and anxiety * Tinnitus or ear pain * Malaise, diarrhea, stomach pain, loss of appetite * Fever, cough, headache, dry throat, changes in sense of smell or taste * Rash Exclusion Criteria: * Patients with a positive diagnosis of COVID-19 in the last 14 days. * Patients who have presented symptoms similar to Post-COVID syndrome prior to the onset of COVID-19 due to a concomitant disease. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Bogotá **Country:** Colombia **Facility:** Fundación CR INVESTIGATION INSTITUTE **State:** Bogotá DC **Zip:** 110131 ### IPD Sharing Statement Module **Info Types:** - STUDY_PROTOCOL - SAP - CSR **IPD Sharing:** YES ### References Module #### References **Citation:** Montani D, Savale L, Noel N, Meyrignac O, Colle R, Gasnier M, Corruble E, Beurnier A, Jutant EM, Pham T, Lecoq AL, Papon JF, Figueiredo S, Harrois A, Humbert M, Monnet X; COMEBAC Study Group. Post-acute COVID-19 syndrome. Eur Respir Rev. 2022 Mar 9;31(163):210185. doi: 10.1183/16000617.0185-2021. Print 2022 Mar 31. **PMID:** 35264409 **Citation:** Silvagno F, Vernone A, Pescarmona GP. The Role of Glutathione in Protecting against the Severe Inflammatory Response Triggered by COVID-19. Antioxidants (Basel). 2020 Jul 16;9(7):624. doi: 10.3390/antiox9070624. **PMID:** 32708578 **Citation:** Sudre CH, Murray B, Varsavsky T, Graham MS, Penfold RS, Bowyer RC, Pujol JC, Klaser K, Antonelli M, Canas LS, Molteni E, Modat M, Jorge Cardoso M, May A, Ganesh S, Davies R, Nguyen LH, Drew DA, Astley CM, Joshi AD, Merino J, Tsereteli N, Fall T, Gomez MF, Duncan EL, Menni C, Williams FMK, Franks PW, Chan AT, Wolf J, Ourselin S, Spector T, Steves CJ. Attributes and predictors of long COVID. Nat Med. 2021 Apr;27(4):626-631. doi: 10.1038/s41591-021-01292-y. Epub 2021 Mar 10. Erratum In: Nat Med. 2021 Jun;27(6):1116. **PMID:** 33692530 **Citation:** Vilar Gomez E, Gra Oramas B, Soler E, Llanio Navarro R, Ruenes Domech C. Viusid, a nutritional supplement, in combination with interferon alpha-2b and ribavirin in patients with chronic hepatitis C. Liver Int. 2007 Mar;27(2):247-59. doi: 10.1111/j.1478-3231.2006.01411.x. **PMID:** 17311621 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - ID: D000010335 - Term: Pathologic Processes - ID: D000011024 - Term: Pneumonia, Viral - ID: D000011014 - Term: Pneumonia - ID: D000012141 - Term: Respiratory Tract Infections - ID: D000007239 - Term: Infections - ID: D000014777 - Term: Virus Diseases - ID: D000018352 - Term: Coronavirus Infections - ID: D000003333 - Term: Coronaviridae Infections - ID: D000030341 - Term: Nidovirales Infections - ID: D000012327 - Term: RNA Virus Infections - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000012120 - Term: Respiration Disorders - ID: D000012818 - Term: Signs and Symptoms, Respiratory ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - ID: M2561 - Name: COVID-19 - Relevance: HIGH - As Found: COVID-19 - ID: M7591 - Name: Dyspnea - Relevance: HIGH - As Found: Dyspnea - ID: M10293 - Name: Inflammation - Relevance: HIGH - As Found: Inflammation - ID: M8364 - Name: Fatigue - Relevance: HIGH - As Found: Fatigue - ID: M6590 - Name: Cough - Relevance: LOW - As Found: Unknown - ID: M13904 - Name: Pneumonia - Relevance: LOW - As Found: Unknown - ID: M13914 - Name: Pneumonia, Viral - Relevance: LOW - As Found: Unknown - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M20490 - Name: Coronavirus Infections - Relevance: LOW - As Found: Unknown - ID: M6555 - Name: Coronaviridae Infections - Relevance: LOW - As Found: Unknown - ID: M23685 - Name: Nidovirales Infections - Relevance: LOW - As Found: Unknown - ID: M15149 - Name: RNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M14957 - Name: Respiration Disorders - Relevance: LOW - As Found: Unknown - ID: M15623 - Name: Signs and Symptoms, Respiratory - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000086382 - Term: COVID-19 - ID: D000004417 - Term: Dyspnea - ID: D000013577 - Term: Syndrome - ID: D000007249 - Term: Inflammation - ID: D000005221 - Term: Fatigue ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown - ID: M2853 - Name: Immunomodulating Agents - Relevance: LOW - As Found: Unknown - ID: M4292 - Name: Antioxidants - Relevance: LOW - As Found: Unknown - ID: M3628 - Name: Adjuvants, Immunologic - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437197 **Brief Title:** Evaluation of Using Platelet-Rich Fibrin in Adult Pulpotomy **Official Title:** Clinical and Radiographic Evaluation of Platelets Rich Fibrin in Adult Pulpotomy: Randomized Clinical Trial #### Organization Study ID Info **ID:** 867/2992 #### Organization **Class:** OTHER **Full Name:** Al-Azhar University ### Status Module #### Completion Date **Date:** 2024-03-23 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-26 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-03-18 **Type:** ACTUAL #### Start Date **Date:** 2023-03-12 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2023-02-09 **Study First Submit QC Date:** 2024-05-26 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Al-Azhar University #### Responsible Party **Investigator Affiliation:** Al-Azhar University **Investigator Full Name:** Ahmed Ibrahim Ahmed Qandeel **Investigator Title:** Demonstrator of Endodontics, Faculty of Dental Medicine **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this interventional randomized clinical trial is to evaluate the use of platelet rich fibrin in full pulpotomy in mature adult teeth. The main questions it aims to answer are: 1. Does the use of platelet rich fibrin in complete pulpotomy in mature permanent teeth will raise the success rate of full pulpotomy of adult teeth? 2. Does the use of cone beam computed tomography scans will be more effective in early detection of apical periodontitis than periapical radiographs? Participants will be asked to do the following: * Receive the pulpotomy treatment of their target tooth. * Record the pain score in the pain assessment chart. * Attend the follow-up visits. They'll receive a full pulpotomy treatment of their target tooth. Researchers will evaluate the usage of platelet rich fibrin in performing the pulpotomy procedure of adult teeth and if cone beam computed tomography scans will be more effective in early detection of apical periodontitis than periapical radiographs. ### Conditions Module **Conditions:** - Irreversible Pulpitis **Keywords:** - Pulpotomy - Platelet Rich Fibrin ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 20 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Pulpotomy of adult teeth using Hydraulic Calcium Silicate Cement. **Intervention Names:** - Procedure: Pulpotomy **Label:** Hydraulic Calcium Silicate Cement **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Pulpotomy of adult teeth using platelet Rich fibrin. **Intervention Names:** - Procedure: Pulpotomy **Label:** platelet rich fibrin (PRF) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Hydraulic Calcium Silicate Cement - platelet rich fibrin (PRF) **Description:** Removal of the coronal pulp chamber in an adult teeth **Name:** Pulpotomy **Other Names:** - Pulp amputation **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** The radiographic changes was evaluated using periapical radiographs. the outcome was measured using the periapical index scoring 1,2,3,4 or 5 with 1 indicating normal and 5 indicates severe periodontitis with exacerbating features. **Measure:** Radiographic changes in periapical area using periapical radiographs. **Time Frame:** 6 and 12 months. #### Secondary Outcomes **Description:** The postoperative pain was measured by modified modified Visual analog scale VAS which is is segmented into ten levels according to severity of pain, no pain (0), mild pain (1-3), moderate pain (4-6), or severe pain (7-10). **Measure:** Postoperative pain **Time Frame:** Immediately, 24, 48, 72 hours and 7 days. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Patient age: 25-35 years 2. Mature permanent premolar teeth with two separate roots. 3. Clinical diagnosis of irreversible pulpitis. 4. Patients without existing medical condition. Exclusion criteria: 1. Immature teeth. 2. Non-restorable teeth. 3. Non-vital Teeth. 4. Uncontrolled pulpal bleeding. 5. Periodontally affected teeth. **Healthy Volunteers:** True **Maximum Age:** 35 Years **Minimum Age:** 25 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Cairo **Country:** Egypt **Facility:** Faculty of Dental Medicine, Al-Azhar university **Zip:** 11651 ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Iaculli F, Rodriguez-Lozano FJ, Briseno-Marroquin B, Wolf TG, Spagnuolo G, Rengo S. Vital Pulp Therapy of Permanent Teeth with Reversible or Irreversible Pulpitis: An Overview of the Literature. J Clin Med. 2022 Jul 11;11(14):4016. doi: 10.3390/jcm11144016. **PMID:** 35887779 **Citation:** Hanna SN, Perez Alfayate R, Prichard J. Vital Pulp Therapy an Insight Over the Available Literature and Future Expectations. Eur Endod J. 2020 Mar 1;5(1):46-53. doi: 10.14744/eej.2019.44154. eCollection 2020. **PMID:** 32342038 **Citation:** Guideline on Pulp Therapy for Primary and Immature Permanent Teeth. Pediatr Dent. 2016 Oct;38(6):280-288. No abstract available. **PMID:** 27931467 **Citation:** AAE Position Statement on Vital Pulp Therapy. J Endod. 2021 Sep;47(9):1340-1344. doi: 10.1016/j.joen.2021.07.015. Epub 2021 Aug 3. No abstract available. **PMID:** 34352305 **Citation:** Cervino G, Laino L, D'Amico C, Russo D, Nucci L, Amoroso G, Gorassini F, Tepedino M, Terranova A, Gambino D, Mastroieni R, Tozum MD, Fiorillo L. Mineral Trioxide Aggregate Applications in Endodontics: A Review. Eur J Dent. 2020 Oct;14(4):683-691. doi: 10.1055/s-0040-1713073. Epub 2020 Jul 29. **PMID:** 32726858 **Citation:** Cushley S, Duncan HF, Lappin MJ, Tomson PL, Lundy FT, Cooper P, Clarke M, El Karim IA. Pulpotomy for mature carious teeth with symptoms of irreversible pulpitis: A systematic review. J Dent. 2019 Sep;88:103158. doi: 10.1016/j.jdent.2019.06.005. Epub 2019 Jun 20. **PMID:** 31229496 **Citation:** Linsuwanont P, Wimonsutthikul K, Pothimoke U, Santiwong B. Treatment Outcomes of Mineral Trioxide Aggregate Pulpotomy in Vital Permanent Teeth with Carious Pulp Exposure: The Retrospective Study. J Endod. 2017 Feb;43(2):225-230. doi: 10.1016/j.joen.2016.10.027. Epub 2016 Dec 29. **PMID:** 28041685 **Citation:** Qudeimat MA, Alyahya A, Hasan AA. Mineral trioxide aggregate pulpotomy for permanent molars with clinical signs indicative of irreversible pulpitis: a preliminary study. Int Endod J. 2017 Feb;50(2):126-134. doi: 10.1111/iej.12614. Epub 2016 Feb 22. **PMID:** 26841969 **Citation:** Taha NA, Khazali MA. Partial Pulpotomy in Mature Permanent Teeth with Clinical Signs Indicative of Irreversible Pulpitis: A Randomized Clinical Trial. J Endod. 2017 Sep;43(9):1417-1421. doi: 10.1016/j.joen.2017.03.033. Epub 2017 Jun 30. **PMID:** 28673494 **Citation:** Awawdeh L, Al-Qudah A, Hamouri H, Chakra RJ. Outcomes of Vital Pulp Therapy Using Mineral Trioxide Aggregate or Biodentine: A Prospective Randomized Clinical Trial. J Endod. 2018 Nov;44(11):1603-1609. doi: 10.1016/j.joen.2018.08.004. Epub 2018 Oct 3. **PMID:** 30292451 **Citation:** Asgary S, Eghbal MJ, Shahravan A, Saberi E, Baghban AA, Parhizkar A. Outcomes of root canal therapy or full pulpotomy using two endodontic biomaterials in mature permanent teeth: a randomized controlled trial. Clin Oral Investig. 2022 Mar;26(3):3287-3297. doi: 10.1007/s00784-021-04310-y. Epub 2021 Dec 2. **PMID:** 34854987 **Citation:** Choukroun J, Diss A, Simonpieri A, Girard MO, Schoeffler C, Dohan SL, Dohan AJ, Mouhyi J, Dohan DM. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part IV: clinical effects on tissue healing. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e56-60. doi: 10.1016/j.tripleo.2005.07.011. **PMID:** 16504852 **Citation:** Borie E, Olivi DG, Orsi IA, Garlet K, Weber B, Beltran V, Fuentes R. Platelet-rich fibrin application in dentistry: a literature review. Int J Clin Exp Med. 2015 May 15;8(5):7922-9. eCollection 2015. **PMID:** 26221349 **Citation:** Patidar S, Kalra N, Khatri A, Tyagi R. Clinical and radiographic comparison of platelet-rich fibrin and mineral trioxide aggregate as pulpotomy agents in primary molars. J Indian Soc Pedod Prev Dent. 2017 Oct-Dec;35(4):367-373. doi: 10.4103/JISPPD.JISPPD_178_17. **PMID:** 28914251 **Citation:** Eid A, Mancino D, Rekab MS, Haikel Y, Kharouf N. Effectiveness of Three Agents in Pulpotomy Treatment of Permanent Molars with Incomplete Root Development: A Randomized Controlled Trial. Healthcare (Basel). 2022 Feb 25;10(3):431. doi: 10.3390/healthcare10030431. **PMID:** 35326909 **Citation:** Keswani D, Pandey RK, Ansari A, Gupta S. Comparative evaluation of platelet-rich fibrin and mineral trioxide aggregate as pulpotomy agents in permanent teeth with incomplete root development: a randomized controlled trial. J Endod. 2014 May;40(5):599-605. doi: 10.1016/j.joen.2014.01.009. Epub 2014 Mar 6. **PMID:** 24767550 **Citation:** Noor Mohamed R, Basha S, Al-Thomali Y. Efficacy of platelet concentrates in pulpotomy - a systematic review. Platelets. 2018 Jul;29(5):440-445. doi: 10.1080/09537104.2018.1445844. Epub 2018 Mar 14. **PMID:** 29537945 **Citation:** Kumar V, Juneja R, Duhan J, Sangwan P, Tewari S. Comparative evaluation of platelet-rich fibrin, mineral trioxide aggregate, and calcium hydroxide as pulpotomy agents in permanent molars with irreversible pulpitis: A randomized controlled trial. Contemp Clin Dent. 2016 Oct-Dec;7(4):512-518. doi: 10.4103/0976-237X.194107. **PMID:** 27994420 **Citation:** Charan J, Biswas T. How to calculate sample size for different study designs in medical research? Indian J Psychol Med. 2013 Apr;35(2):121-6. doi: 10.4103/0253-7176.116232. **PMID:** 24049221 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003788 - Term: Dental Pulp Diseases - ID: D000014076 - Term: Tooth Diseases - ID: D000009057 - Term: Stomatognathic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M14525 - Name: Pulpitis - Relevance: HIGH - As Found: Pulpitis - ID: M6984 - Name: Dental Pulp Diseases - Relevance: LOW - As Found: Unknown - ID: M16831 - Name: Tooth Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011671 - Term: Pulpitis ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: BDCA - Name: Bone Density Conservation Agents ### Intervention Browse Module - Browse Leaves - ID: M5381 - Name: Calcium - Relevance: LOW - As Found: Unknown - ID: M5398 - Name: Calcium, Dietary - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437184 **Acronym:** DiOpTB **Brief Title:** Increased Tuberculosis Case Detection - a Cluster-randomized Trial Combining Available Resources and Novel Strategies for High Endemic Areas **Official Title:** Increased Tuberculosis Case Detection - a Cluster-randomized Trial Combining Available Resources and Novel Strategies for High Endemic Areas #### Organization Study ID Info **ID:** DiOpTB - Version 17 230424 #### Organization **Class:** OTHER **Full Name:** Aarhus University Hospital ### Status Module #### Completion Date **Date:** 2026-03-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-26 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-09-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-03 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-26 **Study First Submit QC Date:** 2024-05-26 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** Linkoeping University **Class:** OTHER **Name:** University of Gondar #### Lead Sponsor **Class:** OTHER **Name:** Aarhus University Hospital #### Responsible Party **Investigator Affiliation:** Aarhus University Hospital **Investigator Full Name:** Frauke Rudolf **Investigator Title:** MD, PhD, Clinical Associated Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** As estimated by the WHO 10.6 million new Tuberculosis (TB) cases were identified in 2022- while more than three million went undetected and untreated. The low detection rate illustrates the failure to recognise and diagnose TB in the current cascade of healthcare and is a major obstacle to effective TB control programs. This multi-centre cluster-randomised clinical trial will evaluate the effect (i.e., diagnostic yield) of improving the point-of-care diagnostics already in place in most primary health-care centres in low-resource settings. The present study will be conducted in two different geographical settings in the Western and Eastern African countries of Guinea Bissau and Ethiopia. This improved clinical diagnostic pathway may improve case detection rates at primary healthcare level, ensuring prompt commencement of treatment, thereby diminishing transmission risk in the community and improving treatment outcomes. The Optimized Diagnostic Procedure (ODP) will utilize instructed sputum sampling and pooling as well as computer-aided detection (CAD) chest X-ray (CXR) and additional pooled sputum sample as well as non-sputum sampling (faecal and a buccal/tongue swab and saliva) for GeneXpert Ultra PCR (Xpert) as state-of-the-art add-ons to the routine diagnostic pathway for TB. This adds to the key components of the WHO "End TB" strategy - early diagnosis - and if successful, may be rapidly approved by the WHO and implemented by governments globally with potentially major public health benefits. The study will be conducted in close liaison with the national Ministries of Health and TB programs in Guinea-Bissau and Ethiopia. This will facilitate any relevant findings to be taken forward for implementation into policy and practice. Capacity development, training and educational activities will be closely aligned to this study. **Detailed Description:** 2 Objectives 2.1 Primary objective 1. Diagnostic yield of active TB within ten days, comparing Enhanced Usual Diagnostic Procedure (EUDP) to Optimized Diagnostic Procedure (ODP). 2.2 Secondary objectives 1. Number of patients treated for TB within two weeks comparing EUDP to ODP. 2. The additional diagnostic yield of CAD CXR compared to Xpert and culture. 3. Improved follow-up (FU) rates in the cascade of care (i.e., one week and six months FU for all included and treatment start and outcome for all TB diagnosed). 4. Differences in diagnostic yield of active TB between routine sputum samples, instructed sputum samples and non-sputum samples (faecal and saliva combined with buccal/tongue swabs). 5. Feasibility of including Oxford Nanopore sequencing for detection and molecular resistance patterns measured as rate of analysed samples within two weeks. 3 Background In 2022, the WHO estimated that of a total 10.6 million new TB cases, more than three million went undiagnosed and of the remaining seven million only 57% were bacteriologically confirmed (1). In sub-Saharan African settings such as Ethiopia and Guinea Bissau, smear microscopy remains the major diagnostic tool in most areas despite the rollout of rapid diagnostic tests such as Xpert. In a multi-centre trial by Theron et al, the implementation of Xpert in African settings did indeed reduce diagnostic delay but unfortunately without any effect on the numbers who were initiated on TB treatment nor on mortality (2). The trial showed that Xpert rollout was not superior to enhanced, well-equipped, microscopy-based diagnostic facilities. In an editorial to the Lancet written by our group, it was concluded that TB elimination could be better advanced by improving currently available tools than by expanding Xpert testing to peripheral health facilities (2, 3). Nevertheless, when TB is diagnosed with a point of care test, there is a need to ensure that correct treatment is provided. However, culture-based drug susceptibility testing is very scarce in high endemic areas and often takes several weeks or months to perform (4). Recently, the Cryptic study (5) has shown that genotypic drug susceptibility testing (gDST) may guide treatment with a sensitivity and specificity well above 90% for key drugs. New techniques such as MinION (Oxford Nanopore Technologies) have also made it possible to perform sequencing and gDST directly from sputum samples. Such point-of-care-based sequencing technology is comparable in size to a USB flash drive (6) and may be attached to a laptop computer at a health centre in a high endemic area. A cluster-randomised trial implementing the TBscore recently showed a fourfold increase in case detection rate in Ethiopia but not in Guinea-Bissau (7). It identified that factors such as laboratory capacity and routines in collecting and examining sputum smear samples may have a high impact on case detection rate and could be optimized based on the available resources. Surprisingly, the sensitivity of sputum smear microscopy ranges from 20-80% with an average of about 50% (8), which may partly be due to patient selection but also depend on considerable variability in sputum collection strategies and/or laboratory procedures. In a comparison of sputum collection methods by Datta et al (9), pooling of sputum and structured instructions before sampling on average led to a twofold higher diagnostic yield whereas a spot versus morning sample showed no difference. A multi-centre study including Ethiopia, comparing fluorescence microscopy to conventional light microscopy showed a small but significant increase in sensitivity (72.8 vs 65.8%)(10). Further, recent research has shown that buccal and tongue swabs, that are easily obtained, can hold valuable diagnostic potential. (11) In smear-negative patients with presumed TB, the available diagnostic tools in high endemic countries include CXR but standardized procedures for evaluation of CXR have been scarce. Recently, CAD software based on artificial intelligence algorithms such as qXR (Qure.ai, India) have improved detection of microbiologically confirmed TB from 50-60% by experienced radiologists to 70-84% with a specificity of 80% by CAD (12). However, a recent systematic review concluded as did the WHO that there are too few high-quality studies to fully assess its diagnostic accuracy (13). We now propose to conduct a multi-centre cluster-randomised clinical trial to evaluate whether improvements on available diagnostic resources can increase the diagnostic yield of active TB and decrease mortality for patients diagnosed with TB. 4 Methods 4.1 Location and nature of sites The present study will be conducted in two African countries: Guinea-Bissau and Ethiopia. In Bissau, the capital of Guinea-Bissau, The Bandim Health Project has been a Health and Demographic Surveillance Site (HDSS) for 45 years and has a well-defined study population of approximately 100,000 under continued surveillance. Within the study area there are two health centres (HCs) from where patients with presumed TB will be enrolled (Bandim HC, Belem HC). In Ethiopia the study will be conducted in collaboration with the University of Gondar in the region of North-Gondar, which has a population of more than two million. Two health centres located in North Gondar Zone, namely Azezo HC and Gondar HC will participate. The Gondar University Hospital is a teaching and referral hospital and will be used for further management of severe TB cases during this study. 4.2 Epidemiology and study population 4.2.1 Guinea-Bissau The epidemiology of TB in the Bissau study population has been extensively described (14-18). The overall incidence of TB has declined only slightly since 2004 and was estimated at 273/100,000 population in 2020, while TB/HIV co-infection declined from 108 per 100.000 to 14 per 100,000 over the period (19). Smear negative cases and case fatality rate likewise declined over the period. The incidence of smear positive TB remained stable at 188 per 100,000 between 2004 and 2011 (20). All HCs have basic laboratory facilities to carry out sputum smear microscopy and all provide TB treatment. The national referral hospital for TB, Hospital Raoul Follereau, is located adjacent to the study area and is a close collaborating partner. The incidence rate of TB in Guinea-Bissau as a whole is 361 per 100,000 with a case detection rate estimated at 35% (21, 22). 4.2.2 Ethiopia TB continues to be a major public health concern in Ethiopia fuelled by the expansion of the HIV epidemic since the 1990s. According to the 2022 WHO TB report (1), Ethiopia is among high-burden countries for both TB and TB/HIV and has an estimated incidence rate of 119 per 100,000, and a TB mortality of 17.7 per 100,000 (21). HIV-positive TB incidence is 6.2 per 100,000 and case detection rate is currently estimated at 73% (21, 22). These figures are high considering that Ethiopia is the second most populous country in Africa with an estimated total population size of more than 100 million. HIV screening is carried out as a routine. 4.3 Design The present study is designed as an open-label, stepped-wedge cluster-randomised controlled trial (23) to investigate an optimized diagnostic procedure for active TB in healthcare centres in Guinea-Bissau and Ethiopia. Applying the stepped-wedge design ensures that all participating HCs will implement the intervention during the study period. This design is particularly useful for evaluating the population-level impact of an intervention, which is of interest in this study. All clusters (i.e., HCs) start with Enhanced Usual Diagnostic Procedure (EUDP) and are then randomized to switch to the intervention phase at predefined time points (see table 1). See below for detailed description of sample size calculations. 4.4 Bandim TBscore The Bandim TBscore (TBscore) (Table 2) consists of five symptoms (cough, haemoptysis, dyspnoea, chest pain, and night sweats) and six signs (pale inferior conjunctivae, pulse \>100 per minute, positive finding at lung auscultation, temperature \>37°C (axillary), body mass index (BMI) \<18/\<16, and mid-upper-arm circumference (MUAC) \<220 mm/\<200 mm) (24). Each variable contributes one point while BMI and MUAC contribute an additional point if BMI\<16/MUAC\<200 mm; hence, the maximum score is 13. The score divides patients into three severity classes (SC): SC-I, TBscore 0-5; SC-II, TBscore 6-7, and SC-III, TBscore≥8. A simplified version of the score - TBscoreII - with a maximum score of 8 points has also been developed (25). The advantage of the latter score is that it can be performed without a physician present. The TBscore has been assessed in both Gondar and Bissau and found to be a useful add on in the diagnostic cascade of care.(7) 4.5 Buccal, tongue swap and saliva sample Buccal and tongue samples will be collected using the Omniswab (Whatman, catalogue #WB100035) and added to a container where patients leave a saliva sample. Samples will be collected by trained laboratory staff, who gently brush the inside of each cheek and then the tongue of the participant for 10 seconds with the OmniSwab. The OmniSwab has a breakpoint and the head will be ejected into 500 µl buffer containing 50 mM Tris pH 8.0, 50 mM EDTA, 50 mM sucrose, 100 mM NaCl, and 1% SDS, and transported to the laboratory at 4˚C. (11) There, the OmniSwab-collected samples will be vortexed in the saliva, and the swabs heads removed. One part of the sample will be analyzed using Xpert Ultrawhile the other part will be stored at - 80 °C until further processing. 4.6 Computer-aided detection chest X-ray (CAD CXR) applying artificial intelligence (AI) A preliminary study using an AI based CAD CXR software (qXR, Qure) compared to two Ethiopian radiologists included 498 CXRs from a previously performed randomized controlled trial on the TBscore. Of those, the less experienced radiologist found 50, the more experienced radiologist found 100 and CAD CXR found 83 to be indicative of TB. Using Xpert PCR as the gold standard for TB diagnosis, the overall AUC for the CAD CXR was 0.84 while the less experienced radiologist performed at a sensitivity of 41.4% and a specificity of 94.1% and the experienced radiologist's assessments were 55.2% sensitive and 85.0% specific. The agreement between the radiologists was moderate (kappa=0.45), as was the agreement between each radiologist and the software (kappa=0.36, kappa=0.59). In the present study we will include a mobile phone app to guide photographing analog X-ray films. These photographs will then be uploaded to a locally placed box (qbox) and analyzed on site. 4.7 Enrolment At all sites adult patients will be screened during consultations carried out at primary healthcare centres. All patients presenting with cough of any duration, sputum production, or weight loss will have their TBscore assessed. All participating health centres have previous experience collecting the symptoms and signs necessary for the TBscore and completing a score chart from which the TBscore can be calculated. All patients with a TBscore≥4 will be referred for TB diagnostics. Patients with 4≤TBscore\<6 will be referred to fluorescence microscopy while patients with TBscore≥6 will be referred to Xpert PCR. The staff at the sites will receive general training in TB diagnosis and then the healthcare facilities will, following a random sequence, switch from Enhanced Usual Diagnostic Procedure (EUDP), consisting of standard TB program diagnostics but ensuring availability of all reagents, to intervention (i.e., OPD). 4.7.1 Enhanced Usual Diagnostic Procedure (EUDP) The standard TB diagnostics in both settings consist of performing the sputum smear analysis by the clinical routine. Smear-negative cases will be followed as per standard routine (Figure 1A). 4.7.2 The Optimized Diagnostic Procedure (ODP) intervention A three-step package which involves (Figure 1B): 1. Oral and mobile phone-guided instructions by study staff Patients will be instructed to take several deep breaths, hold their breath for a moment, and repeat this several times until coughing is induced including instructions to cough deeply and vigorously whilst breathing out (26). Instructions will be presented to the participating patients on a mobile phone to ensure consistent instructions to all participants. 2. Pooling of two spot sputum samples (9) Two instructed pooled spot samples will be split into two parts (27) and investigated by fluorescence microscopy (28). The other part of the pooled sputum sample will be frozen for later confirmation with batch-wise BACTEC 960 MGIT as a gold standard for microbiological diagnosis. As an add on, we will analyze a subgroup of samples with the MinION to assess applicability in a low resource setting. 3. Smear-negative cases at the first visit will be assessed for persisting symptoms and referred to a CXR unit Those with a CXR CAD result suggestive of active TB will be treated for TB. The smear negative cases will also leave an additional instructed spot sputum sample which will be pooled and one part analyzed by Xpert Ultra and the other part by BACTEC 960 MGIT culture. Additionally, non-sputum sampling will be performed and analyzed by Xpert Ultra including saliva combined with buccal and tongue sample using the same swab as well as a faecal sample Xpert Ultra using the WHO-recommended direct procedure. (29) In a feasibility study, on the basis of intention to treat (either by smear microscopy or CXR/clinical grounds) the participants will be asked for an additional instructed sputum sample which will extracted using EZ1 and sequenced using nanopore sequencing and the EPI2ME bioinformatic platform as previously described. (6) 4.7.3 Implementation of the ODP and EUDP Upon commencement of the intervention arm, the staff will be trained in applying optimized diagnostic procedures. For all included patients (both in the EUDP and the ODP) a follow-up visit one week from first encounter will take place, to ensure initiation of treatment (for smear positive cases) or to screen for persisting symptoms and carry out a second clinical evaluation (smear negative cases). Diagnosis will be according to local standards and based on smear microscopy, CXR, and WHO clinical criteria including for extrapulmonary cases (30, 31). During the intervention, the physician can overrule the TBscore if needed. At all clinics, both in the EUDP and ODP (i.e. intervention) phase, all included patients will be referred to HIV testing at adjacent HIV-treatment clinics, where pre- and post-testing counselling will be carried out. 4.7.4 Inclusion criteria At the participating healthcare facilities, all patients ≥15 years old with presumed TB with cough, sputum production, and/or weight loss of any duration are eligible to participate. Healthcare facilities (n=4, two in each of the countries) will switch from Enhanced Usual Diagnostic Procedure (EUDP) to Optimized Diagnostic Procedure (ODP) following a random sequence. 4.7.5 Exclusion criteria 1. TB treatment within the past year. 2. Cerebral disturbances impairing the ability to give informed consent or follow the treatment regime. 5 Outcomes 5.1 Primary outcomes 1. Number of smear positive, Xpert PCR positive, or CXR positive patients comparing EUDP to ODP. 5.2 Secondary outcomes 1. Number of patients on active TB treatment comparing EUDP clinics to ODP clinics. 2. Diagnostic yield of CAD CXR compared to smear microscopy, Xpert PCR, and culture. 3. Follow-up rates in the cascade of care (i.e. one-week and six-months follow-up for all included and treatment start and outcome for all diagnosed with TB) 4. Differences in diagnostic yield between instructed sampling, buccal samples, fecal samples and routine sputum sample. 6 Sample size and statistical analyses Based on a previous study in the same setting, we found that among patients with a TBscore≥3 there were a total of 5% smear positive cases both in Guinea-Bissau and Ethiopia. Using a higher cut-off value at TBscore≥4 increases specificity and is estimated to increase the case detection yield to 6% (based on previous data) using routine sputum collection and sputum smear analysis. Increasing the TBscore cut-off value thus leads to a lower referral rate of 54% of all screened (instead of 73%) while increasing the number of smear positive cases in the sample (from 5% to 6%). As both settings now use Xpert MTB/RIF Ultra as the primary diagnostic method, initial case rate is estimated at 8% (32). Based on systematic reviews, it is estimated that the diagnostic yield of an instructed sputum where two spot-samples are pooled and processed using LED microscopy will lead to an at least twofold increase in sensitivity (9, 10, 27, 33). Adding CAD CXR onto those that are smear negative by the optimized sputum smear strategy is estimated to increase the number of patients diagnosed with TB 2.5-fold. To show an increase in diagnostic yield using ODP from a conservative estimate of 7% to 14% with a power of 80% and a significance level of 0.05, two clusters in each country are needed, including 132 patients per time interval (of 22 weeks). The estimated inclusion rate per cluster per week is 6 patients, which means that it should take 66 weeks to reach a target of 1584 inclusions. Sample size was calculated using the "steppedwedge" function in Stata (34). The diagnostic yield, time to diagnosis, and treatment outcomes will be calculated. Detection rates will be compared between control (EUDP) and intervention (ODP) in a generalized linear mixed effects model taking into account time and center effect and allowing for intra-cluster correlation, i.e., a mixed effect logistic regression for longitudinal data. A similar repeated measurements model will be used to analyze and compare groups on patient characteristics. 7 Timeframe Study preparations will start August 2023 with establishment of enrolment procedures and training of staff. Enrolment will take place for 68 weeks (from June 2024 to September 2025). End of follow-up will be April 2026. For details, please see Table 3. Overall responsible body for activities planned is the PI in collaboration with local VIP and TAP personnel. 8 Public health importance 8.1 Major advances TB case-finding remains a challenge, particularly in overburdened healthcare facilities with limited access to diagnostics (35-37). A simple disease management strategy combined with improved utilization of available diagnostics may ensure that more patients with TB are treated and earlier and that those at high risk of dying are targeted appropriately with a rational use of limited resources. The major advance of adding a standardized approach to patients with presumed TB will be to decrease the substantial burden of undiagnosed TB with simple means, which makes it a sustainable, affordable, and practicable tool. 8.2. New approach The strength of the Bandim TBscore strategy is that it guides the health care professional through a structured interview and uses the existing laboratory set-up, which is of great benefit compared to other more advanced diagnostic tools. The diagnostic algorithm simply utilizes what is already part of the primary healthcare setup, thereby increasing the chance of being applicable in similar settings worldwide. Similarly, the novel technologies employed in the ODP can easily be integrated into clinical settings worldwide. 8.3. Generalizability of trial results This trial will test implementation of a cheap, readily available, practical point-of-care package which requires only minor additional training of staff. If shown to be effective in identifying additional TB cases, use of the Bandim TBscore and improved diagnostics may be expected to be endorsed with little delay by the WHO and national governments as a standard part of TB diagnosis and management. 8.4. Contribution to improved disease management and public health In under-funded over-burdened healthcare facilities with a large patient load presenting with co-morbidities, many patients with TB remain undiagnosed and untreated (35-37). Simple clinical tools at points of care which can identify up patients with active TB may have great potential for diagnosing patients with TB early and thereby preventing TB-associated morbidity and mortality. Targeting delayed TB diagnosis and TB-related mortality will add to the agenda of reducing poverty-related diseases. The resources used to combat TB and the productive years lost to TB inflict a punishing toll on the economies of TB-endemic countries and helps perpetuate the cycle of poverty. The majority of TB is now concentrated in the World's poorest countries, thus effective and practicable programs to detect and cure TB early is the most feasible method of controlling the disease. 8.5 Improvements in patient care A major strength of the Bandim TBscore is its ability to continually assess disease severity during treatment as has previously been shown by our group (25, 38, 39). Thus, the score may be used both to enhance the number of confirmed TB cases among patients with presumed TB and serve as an easily adaptable monitoring tool during the treatment or re-evaluation of these. 9 Ethical considerations Consultative approval is expected to be granted from the Regional Ethics Committee in the Central Denmark Region, Denmark and permission to carry out the study will likewise be sought from the national ethics committees in Guinea-Bissau and Ethiopia. Written information will be provided in the official language Portuguese/Amharic and oral information will be provided to all eligible patients in the widely spoken language Portuguese Creole/Amharic. Informed written consent or a fingerprint if illiterate will be kept together with case report forms. 10 Capacity Building and future implications The present study will serve as a platform for relevant capacity building for good clinical practice and good clinical laboratory practice in the two African sites as well as promote a stronger linkage within Africa, building on the existing links with Institutions in the EU. In addition, the capacity building and networking activities planned for this project aim to integrate African partners into the rapidly developing global network of TB trial sites; in particular it will build a resource of patients with presumed TB with detailed clinical data which is rare among TB studies in Africa(1). We have built a well-functioning infrastructure to carry out trials at the primary healthcare level, which is seldom done in TB research. We now aim to utilize this solid basis and our experience to improve TB case detection further. 11 The Nordic collaboration and study group The Nordic collaborators in this trial have been working together since 2016. The main aim of the collaboration is to improve case finding of TB using applicable interventions in high endemic settings. Capacity building is an essential part of the collaboration and all trials make efforts to involve existing structures and political elements in the settings in which they are carried out. Workshops will be held throughout the trial period. Christian Morberg Wejse (CW), MD, PhD is a consultant at the Department of Infectious Diseases, Aarhus University Hospital and Professor of Cross-Cultural Medicine and Global Health at the Department of Public Health, Aarhus University. He has supervised more than 20 research projects in Guinea-Bissau. Thomas Schön (TS), MD, PhD is a consultant of clinical microbiology and infectious diseases and a professor at the Department of Biomedical and Clinical Sciences Linköping University. He has undertaken multiple research projects in Ethiopia and Sweden. Both CW and TS have been involved in the development of the present research project and act as supervisors during the trial. Frauke Rudolf (FR), MD, PhD is senior registrar at the Department of Infectious Diseases, Aarhus University Hospital where she is responsible for TB patients, and clinical associate professor at Aarhus University. She has completed her PhD in Guinea-Bissau, evaluating a clinical score for TB. In recent years her research has focused on improving TB case detection and assessing gender differences in TB. Anita Zalisz, will be working on the project in the capacity of PhD-student. Anita will be responsible for supervising procedures in Bissau including data collection, data entry, as well as disseminating results. Mulugeta Aemero (MA), professor, Head, Tropical \& Infectious Diseases Research Centre, CMHSCSH, University of Gondar, Ethiopia, will be working on the project in the capacity of project collaborator in Gondar, Ethiopia. Temesgen Tadesse (TT), MD, is a physician, who will be working on the project in the capacity of radiologist in Gondar, Ethiopia. Segenet Bizuneh (SB), MD, is a physician, who will be working on the project in the capacity of internist in Gondar, Ethiopia. Dessie Abebaw Angaw, Assistant Professor of Epidemiology and Biostatistics, will be working on the project in the capacity of project collaborator and supervisor in Gondar, Ethiopia. Masresha Seyoum, BSc, MSc, Diagnostic Coordinator at UoGCSH, will be working on the project in the capacity of microbiologist in Gondar, Ethiopia. Lilica Sanca (LS), BSc, and Ebba Abate (EA), PhD, are key personnel in Guinea-Bissau and Ethiopia respectively. LS is responsible for the national refence laboratory for TB in Guinea-Bissau while EA has completed his PhD in Gondar, has formerly worked as Director General, Ethiopian Public Health Institute (EPHI), Ethiopia and is now Project Director for the North Africa Saving Lives and Livelihood Initiative, Project Hope Namibia, Namibia. Armando Sifna (AS), MD, is a physician with extensive experience in TB and is part of the TB program under the ministry of health in Guinea-Bissau. 12 Exploiting and disseminating the project results The standardised approach to TB management resulting from implementing the Bandim TBscore and improving available diagnostics is simple to communicate and translate into policy and WHO guidelines. The national partners in this project work within the national TB programs and may disseminate project results rapidly into policy changes at the national level. There are no intellectual property rights issues preventing a global dissemination of the Bandim TBscore which will be attempted through peer-reviewed publications and conference ### Conditions Module **Conditions:** - Tuberculosis ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SEQUENTIAL ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 1584 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The standard TB diagnostics in both settings consist of performing the sputum smear analysis by the clinical routine. Smear-negative cases will be followed as per standard routine (Figure 1A). **Label:** Enhanced Usual Diagnostic Procedure (EUDP) **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** 1. Oral and mobile phone-guided instructions by study staff 2. Pooling of two spot sputum samples (9) 3. Smear-negative cases at the first visit will be assessed for persisting symptoms and referred to a CXR unit. **Intervention Names:** - Diagnostic Test: ODP **Label:** The Optimized Diagnostic Procedure (ODP) intervention **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - The Optimized Diagnostic Procedure (ODP) intervention **Description:** se previously **Name:** ODP **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** 1. Number of smear positive, Xpert PCR positive, or CXR positive patients comparing EUDP to ODP. **Measure:** 1. Number of smear positive, Xpert PCR positive, or CXR positive patients comparing EUDP to ODP. **Time Frame:** 1.5 years #### Secondary Outcomes **Measure:** 1. Number of patients on active TB treatment comparing EUDP clinics to ODP clinics. **Time Frame:** 1.5 years **Measure:** 2. Diagnostic yield of CAD CXR compared to smear microscopy, Xpert PCR, and culture. **Time Frame:** 1.5 years **Measure:** 3. Follow-up rates in the cascade of care (i.e. one-week and six-months follow-up for all included and treatment start and outcome for all diagnosed with TB) **Time Frame:** 1.5 years **Measure:** 4. Differences in diagnostic yield between instructed sampling, buccal samples, fecal samples and routine sputum sample. **Time Frame:** 1.5 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * patients ≥15 years old with presumed TB with cough, sputum production, and/or weight loss of any duration are eligible to participate Exclusion Criteria: * 1. TB treatment within the past year. 2. Cerebral disturbances impairing the ability to give informed consent or follow the treatment regime. **Maximum Age:** 120 Years **Minimum Age:** 15 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** frauke.rudolf@au.dk **Name:** Frauke Rudolf **Phone:** 51372359 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009164 - Term: Mycobacterium Infections - ID: D000000193 - Term: Actinomycetales Infections - ID: D000016908 - Term: Gram-Positive Bacterial Infections - ID: D000001424 - Term: Bacterial Infections - ID: D000001423 - Term: Bacterial Infections and Mycoses - ID: D000007239 - Term: Infections ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M17127 - Name: Tuberculosis - Relevance: HIGH - As Found: Tuberculosis - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M12119 - Name: Mycobacterium Infections - Relevance: LOW - As Found: Unknown - ID: M4722 - Name: Bacterial Infections - Relevance: LOW - As Found: Unknown - ID: M19252 - Name: Gram-Positive Bacterial Infections - Relevance: LOW - As Found: Unknown - ID: M12136 - Name: Mycoses - Relevance: LOW - As Found: Unknown - ID: M4721 - Name: Bacterial Infections and Mycoses - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000014376 - Term: Tuberculosis ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437171 **Brief Title:** FeNO as a Marker of Allergic Reactions to OFC and Response of OMA Treatment in Multiple FA **Official Title:** The Use of Exhaled Nitric Oxide as a Predictive Marker of Allergic Reactions to Oral Food Challenge and Clinical Response of Omalizumab Treatment in Subjects With Multiple Food Allergies #### Organization Study ID Info **ID:** ML45389 #### Organization **Class:** OTHER **Full Name:** AAADRS Clinical Research Center ### Status Module #### Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-26 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-07 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-26 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** AAADRS Clinical Research Center #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** True ### Description Module **Brief Summary:** This is a Phase IV, open-label, single-center study to evaluate the change in FeNO as a marker of clinical response to OMA in participants with multiple FA. **Detailed Description:** This is a Phase IV, open-label, single-center study to evaluate the change in FeNO as a marker of clinical response to OMA in participants with multiple FA. Twenty (20) participants will be enrolled over a 9-month enrollment period from an allergy and asthma medical specialty clinic. Should the participant meet all eligibility criteria, then following the Screening Period, the participant will be dosed with OMA and asked to continue to follow their food avoidance regimen. Participants will return to the clinic every two weeks for 16-weeks, and then every 2 or 4-weeks (depending on dosing) for the remaining 36-weeks, for a total of 52-weeks. Primary endpoint analyses will occur at Week 16 and Week 52. Description of XOLAIR treatment schedule: Omalizumab will be dosed according to the OUtMATCH Study dosing. Patients will be monitored for acute hypersensitivity reactions for at least 61 minutes after the end of the injection. Epinephrine and parenteral diphenhydramine must be readily available for immediate use if required to treat a hypersensitivity reaction; site personnel must be able to detect and treat such reactions. Patients with severe hypersensitivity reactions (e.g., stridor, angioedema, life-threatening change in vital signs) must be withdrawn from study treatment. All adverse events of systemic hypersensitivity reactions or anaphylactoid or anaphylaxis reactions must be reported within 24 hours to the Sponsor. ### Conditions Module **Conditions:** - Food Allergy **Keywords:** - Food Allergy - Multiple Food Allergies - Biomarker ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Omalizumab dose and frequency based on baseline patient weight and total IgE **Intervention Names:** - Biological: Omalizumab **Label:** Open Label Injection of Omalizumab **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Open Label Injection of Omalizumab **Description:** Omalizumab dose and frequency based on baseline subject weight and total IgE **Name:** Omalizumab **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** biomarker **Measure:** FeNO change from baseline to week 52 **Time Frame:** 1 year #### Secondary Outcomes **Description:** biomarker **Measure:** Time to change from baseline FeNO during OFC **Time Frame:** at baseline and at week 16 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients must meet the following criteria for study entry: * Able and willing to provide written informed consent from patient and parent or guardian and to comply with the study protocol. * Age 6 years of age or older at Visit 1 * Documented history of food allergy to one or more of the following foods based on SPT performed at baseline visit: * peanut * milk * egg * tree nuts (Walnut/Pecan, Cashew/Pistachio, Almond, Hazelnut, Brazil nut) Exclusion Criteria: * Patients who meet any of the following criteria will be excluded from study entry: * Diagnosis of asthma requiring maintenance medication, including inhaled steroids, leukotriene modifiers, LABA/ICS, biologics medications (Intermittent asthma \[Step 1\] is allowed and defined according to the 2020 NAEPP guidelines (as 'asthma requiring only prn SABA use) and FEV1 \< 80% of predicted normal. * Diagnosis of nasal polyps, cystic fibrosis or any respiratory condition that will skew normally occurring FeNO levels * FeNO (measured in ppb) is lower than a value expected for the age, height, and gender of the participant or inability to perform respiratory collection maneuver * Systemic steroids, leukotriene modifiers, or nasal steroids for any cause/diagnosis within 4 weeks of baseline * Biologic use, for any diagnosis, within five half-lives of Screening * Antibiotic use, systemic/oral/intramuscular, for any cause/diagnosis within 2 weeks of baseline * Active smoker, cigarette, cigar, vape, recreational, and/or prior 10 pack year history * Participant weight or IgE levels outside of the dosing table for OMA * Known history of anaphylaxis/hypersensitivity to OMA * Any medical condition that is serious or unstable that in the opinion of the PI could confound the study results and/or interfere with subject participation or adherence * Pregnant or breastfeeding, or intending to become pregnant during the study or within 60 days after the last dose of OMA * Women of childbearing potential must have a negative serum pregnancy test result during the screening period **Minimum Age:** 6 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** MJLANZMD@gmail.com **Name:** Miguel Lanz, MD **Phone:** 3054440441 **Role:** CONTACT **Contact 2:** **Email:** claudia.eisenlohr@gmail.com **Name:** Claudia Eisenlohr, MIB **Phone:** 3054440441 **Role:** CONTACT #### Locations **Location 1:** **City:** Coral Gables **Contacts:** ***Contact 1:*** - **Email:** mjlanzmd@gmail.com - **Name:** Miguel J Lanz, MD - **Phone:** 305-444-0441 - **Role:** CONTACT ***Contact 2:*** - **Email:** claudia.eisenlohr@gmail.com - **Name:** Claudia P Eisenlohr, MIB - **Phone:** 305 444-0441 - **Role:** CONTACT ***Contact 3:*** - **Name:** Miguel J Lanz, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** AAADRS Clinical Research Center **State:** Florida **Status:** RECRUITING **Zip:** 33134 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007154 - Term: Immune System Diseases - ID: D000006969 - Term: Hypersensitivity, Immediate ### Condition Browse Module - Browse Branches - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M10018 - Name: Hypersensitivity - Relevance: HIGH - As Found: Allergy - ID: M8636 - Name: Food Hypersensitivity - Relevance: HIGH - As Found: Food Allergy - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: M10020 - Name: Hypersensitivity, Immediate - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006967 - Term: Hypersensitivity - ID: D000005512 - Term: Food Hypersensitivity ### Intervention Browse Module - Ancestors - ID: D000018926 - Term: Anti-Allergic Agents - ID: D000018927 - Term: Anti-Asthmatic Agents - ID: D000019141 - Term: Respiratory System Agents ### Intervention Browse Module - Browse Branches - Abbrev: AAll - Name: Anti-Allergic Agents - Abbrev: Resp - Name: Respiratory System Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: VaDiAg - Name: Vasodilator Agents ### Intervention Browse Module - Browse Leaves - ID: M413 - Name: Omalizumab - Relevance: HIGH - As Found: Stool - ID: M12507 - Name: Nitric Oxide - Relevance: LOW - As Found: Unknown - ID: M20962 - Name: Anti-Allergic Agents - Relevance: LOW - As Found: Unknown - ID: M20963 - Name: Anti-Asthmatic Agents - Relevance: LOW - As Found: Unknown - ID: M21137 - Name: Respiratory System Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000069444 - Term: Omalizumab ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06437158 **Brief Title:** Efficacy and Safety of Different Concentrations of Bleomycin in the Sclerotherapy of Lymphatic Malformations **Official Title:** Efficacy and Safety of Different Concentrations of Bleomycin in the Sclerotherapy of Lymphatic Malformations #### Organization Study ID Info **ID:** 2023-12-19 #### Organization **Class:** OTHER **Full Name:** West China Hospital ### Status Module #### Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-25 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-03-08 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Study First Submit Date:** 2023-12-19 **Study First Submit QC Date:** 2024-05-25 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** West China Hospital #### Responsible Party **Investigator Affiliation:** West China Hospital **Investigator Full Name:** Yi Ji **Investigator Title:** Clinical Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Bleomycin has nowadays been more and more widely used in the sclerotherapy of LMs, which has been proven to be primarily dose dependent. We aim to compare the efficacy and safety of different concentrations of Bleomycin in the sclerotherapy of LMs for pediatric patients. **Detailed Description:** Lymphatic malformations (LMs) are vascular anomalies that arise from abnormal embryonic development of the lymphatic system and might present as dilated lymphatic channels or cysts lined by lymphatic endothelial cells. With an estimated incidence of approximately 1/4000-1/2000, LMs can occur at any site in the lymphatic system, in which head, neck and axilla were mostly detected and have been reported to account for over 75%. Based on the location and size of the lesion and the extent of involvement, LMs may be asymptomatic with incidental detection, or chronic abdominal pain and distension due to their compression of surrounding structures, or critical and even fatal secondary to their volvulus, hemorrhage, infection and rupture. Surgical excision is a definitive treatment for LMs, while it may be difficult at times because of the infiltrative nature of the lesions, leading to a high incidence of complications like vital organ injuries, nerve injuries, bleeding, infection scar formation, and recurrences. Sclerotherapy is a simpler alternative to tedious surgical excision treatment for LMs and avoids the complications related to surgery. As an anticancer drug extracted from Streptomyces verticillus, Bleomycin has been more and more widely used in the sclerotherapy of LMs for pediatric patients, which has been proven to be primarily dose dependent. However, the optimum concentration of Bleomycin in the sclerotherapy of LMs for pediatric patients has not been strictly validated, due to the lack of high-quality RCT studies. We aim to compare the efficacy and safety of different concentrations of Bleomycin in the sclerotherapy of LMs for pediatric patients. ### Conditions Module **Conditions:** - Lymphatic Malformation **Keywords:** - Lymphatic Malformation - Bleomycin - Sclerotherapy - Intracystic injection - High-dose concentrations - Low-dose concentrations ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** We aim to compare the efficacy and safety of different concentrations of Bleomycin in the sclerotherapy of lymphatic malformations for pediatric patients. ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 200 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** In this arm, patients with lymphatic malformations were treated by intracapsular injection with low-dose concentrations (1mg/ml) of Bleomycin. **Intervention Names:** - Drug: Bleomycin **Label:** Low-dose Concentrations (1mg/ml) of Bleomycin **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** In this arm, patients with lymphatic malformations were treated by intracapsular injection with high-dose concentrations (2mg/ml) of Bleomycin. **Intervention Names:** - Drug: Bleomycin **Label:** High-dose Concentrations (2mg/ml) of Bleomycin **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - High-dose Concentrations (2mg/ml) of Bleomycin - Low-dose Concentrations (1mg/ml) of Bleomycin **Description:** To validated the efficacy and safety of different concentrations of Bleomycin in the sclerotherapy of lymphatic malformations for pediatric patients **Name:** Bleomycin **Other Names:** - Zeocin **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Changes of Volume is defined as follows: a complete (90%-100% reduction in LMs volume), substantial (60%-89% reduction in LMs volume), intermediate (20%-59% reduction in LMs volume), or no (\< 20% reduction in LMs volume) response 3 to 6 months post-therapy as assessed by imaging. **Measure:** Changes of Volume **Time Frame:** 3 to 6 months post-therapy #### Secondary Outcomes **Description:** Score of Pain is selfassessed at each visit on a 0 to 10 visual analog scale (where 0 indicates no pain and 10 indicates the worst pain imaginable), reported along with period duration. **Measure:** Score of Pain **Time Frame:** 3 to 6 months post-therapy **Description:** Global efficacy is assessed at each visit beginning at MS by the physician and self-assessed by the participant and proxy (parents) on a 0 to 10 visual analog scale (where 0 indicates no efficacy and 10 indicates complete resolution). **Measure:** Global Efficacy **Time Frame:** 3 to 6 months post-therapy **Description:** Score of Quality of Life is assessed by the validated Children-Dermatological Life Quality Index (C-DLQI). **Measure:** Score of Quality of Life **Time Frame:** 3 to 6 months post-therapy **Description:** Number of Participants with Efficacy was assessed by 2 independent experts. **Measure:** Number of Participants with Efficacy **Time Frame:** 3 to 6 months post-therapy **Description:** Number of Participants with Safety was assessed based on physical signs and monitoring of imaging examinations or laboratory test. **Measure:** Number of Participants with Safety **Time Frame:** 3 to 6 months post-therapy ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Male or female participants less than 14 years of age at the time of informed consent/assent form was signed. * Participants whose parents have voluntarily given written consent and participants who provided assent (if applicable) after the study has been explained to them. * Participants with LMs of all sites measured and confirmed via imaging at screening, with rapid progression, resluting in obvious symptoms or dysfunction, which could not be radically resected and could be treated by sclerotherapy. Exclusion Criteria: * Penicillin allergy. * Vascular tumors or combined vascular malformations. * Participants who may have had surgical or sclerotherapy treatment by other hardeners. * LMs growing slowly, without obvious symptoms or dysfunction, which does not need to be treated prematurely. **Maximum Age:** 14 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** jijiyuanyuan@163.com **Name:** Yi Ji, Ph.D. **Phone:** +8618980606865 **Role:** CONTACT **Contact 2:** **Email:** hx2014bsym@163.com **Name:** Min Yang, M.D. **Phone:** +8615928411140 **Role:** CONTACT #### Locations **Location 1:** **City:** Chengdu **Contacts:** ***Contact 1:*** - **Email:** jijiyuanyuan@163.com - **Name:** Yi Ji, Ph.D. - **Phone:** +8618980606865 - **Role:** CONTACT ***Contact 2:*** - **Email:** hx2014bsym@163.com - **Name:** Min Yang, M.D. - **Phone:** +8615928411140 - **Role:** CONTACT **Country:** China **Facility:** West China Hospital of Sichuan University **State:** Sichuan **Status:** RECRUITING **Zip:** 610041 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Sun J, Wang C, Li J, Song D, Guo L. The efficacy of bleomycin sclerotherapy in the treatment of lymphatic malformations: a review and meta-analysis. Braz J Otorhinolaryngol. 2023 Jul-Aug;89(4):101285. doi: 10.1016/j.bjorl.2023.101285. Epub 2023 Jun 29. **PMID:** 37423005 **Citation:** De Maria L, De Sanctis P, Balakrishnan K, Tollefson M, Brinjikji W. Sclerotherapy for lymphatic malformations of head and neck: Systematic review and meta-analysis. J Vasc Surg Venous Lymphat Disord. 2020 Jan;8(1):154-164. doi: 10.1016/j.jvsv.2019.09.007. Epub 2019 Nov 14. **PMID:** 31734224 **Citation:** Wu Z, Zou Y, Fu R, Jin P, Yuan H. A nomogram for predicting sclerotherapy response for treatment of lymphatic malformations in children. Eur J Med Res. 2022 Oct 21;27(1):209. doi: 10.1186/s40001-022-00844-3. **PMID:** 36271467 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000018190 - Term: Lymphatic Vessel Tumors - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000008206 - Term: Lymphatic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M12 - Name: Congenital Abnormalities - Relevance: HIGH - As Found: Malformations - ID: M11199 - Name: Lymphangioma - Relevance: HIGH - As Found: Lymphatic Malformations - ID: M25277 - Name: Lymphatic Abnormalities - Relevance: HIGH - As Found: Lymphatic Malformations - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M11203 - Name: Lymphatic Diseases - Relevance: LOW - As Found: Unknown - ID: T3529 - Name: Lymphatic Malformations - Relevance: HIGH - As Found: Lymphatic Malformations ### Condition Browse Module - Meshes - ID: D000008202 - Term: Lymphangioma - ID: D000044148 - Term: Lymphatic Abnormalities - ID: D000000013 - Term: Congenital Abnormalities ### Intervention Browse Module - Ancestors - ID: D000000903 - Term: Antibiotics, Antineoplastic - ID: D000000970 - Term: Antineoplastic Agents ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents ### Intervention Browse Module - Browse Leaves - ID: M5042 - Name: Bleomycin - Relevance: HIGH - As Found: Intravenous injection - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M4224 - Name: Antibiotics, Antitubercular - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000001761 - Term: Bleomycin ### Misc Info Module - Version Holder: 2024-05-31