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protocolSection identificationModule nctId: NCT06362759, orgStudyIdInfo id: TOUR006-C01, briefTitle: A Study to Evaluate TOUR006 in Patients With Chronic Kidney Disease and Elevated Hs-CRP, acronym: TRANQUILITY, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2026-02, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Tourmaline Bio, Inc., class: INDUSTRY, descriptionModule briefSummary: This study will evaluate the safety, tolerability, pharmacokinetics, and CRP-lowering effect of quarterly and monthly subcutaneous administration of TOUR006 in participants with chronic kidney disease and elevated hs-CRP., conditionsModule conditions: Chronic Kidney Diseases, conditions: Chronic Kidney Insufficiency, conditions: Chronic Renal Diseases, conditions: Chronic Renal Insufficiency, conditions: Kidney Insufficiency, Chronic, conditions: C-Reactive Protein, conditions: High Sensitivity C-Reactive Protein, conditions: Hs-CRP, conditions: hsCRP, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: TOUR006 - 50 MG, interventions name: TOUR006 - 25 MG, interventions name: TOUR006 - 15 MG, interventions name: Placebo, outcomesModule primaryOutcomes measure: Evaluate the effects of TOUR006 compared with placebo on hs-CRP, secondaryOutcomes measure: Evaluate the effects of TOUR006 compared with placebo on hs-CRP, secondaryOutcomes measure: Evaluate the pharmacokinetics by measuring serum concentrations of TOUR006, secondaryOutcomes measure: Evaluate the safety and tolerability of TOUR006 in participants with elevated cardiovascular risk and CKD, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06362746, orgStudyIdInfo id: FORPE-2, briefTitle: Non-immunogenic Recombinant Staphylokinase vs Placebo in Patients With Intermediate High-risk Pulmonary Embolism, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2028-06-01, completionDateStruct date: 2028-12-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Supergene, LLC, class: INDUSTRY, descriptionModule briefSummary: Objective: to evaluate the efficacy and safety of the non-immunogenic recombinant staphylokinase with its single bolus administration in comparison with placebo in normotensive patients with intermediate high-risk pulmonary embolism (PE), conditionsModule conditions: Pulmonary Embolism, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: At clinical sites patients will be equally randomized into two groups to receive non-immunogenic recombinant staphylokinase or placebo.Non-immunogenic recombinant staphylokinase or placebo will be administered intravenously at a dose of 15 mg as a single bolus for 10-15 seconds. All patients will be examined for 30 days., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Neither patient nor investigator knows treatment assignment. All eligible patients will be randomized in two equal groups for administration of non-immunogenic recombinant staphylokinase or placebo., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 486, type: ESTIMATED, armsInterventionsModule interventions name: Non-immunogenic recombinant staphylokinase, interventions name: Placebo, outcomesModule primaryOutcomes measure: Composite of death from any cause or hemodynamic collapse or recurrent PE, secondaryOutcomes measure: Right/left ventricular (RV/LV) end-diastolic diameter ratio, secondaryOutcomes measure: RV/LV end-diastolic diameter ratio, secondaryOutcomes measure: RV/LV end-diastolic diameter ratio, secondaryOutcomes measure: Right ventricular (RV) end-diastolic volume, secondaryOutcomes measure: Qanadli index, secondaryOutcomes measure: Systolic pulmonary artery pressure, secondaryOutcomes measure: In hospital death from all causes (assessed up to day 7), secondaryOutcomes measure: Death from all causes, secondaryOutcomes measure: Safety endpoint - hemorrhagic stroke, secondaryOutcomes measure: Safety endpoint - BARC type 3 and 5 bleeding, secondaryOutcomes measure: Safety endpoint - number and severity of adverse events (AEs) and serious AEs in organs and systems, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: V.F. Dolgopolov Vyselki Central District Hospital, city: Vyselki, state: Krasnodar Region, zip: 353100, country: Russian Federation, contacts name: Valerii V. Makukhin, PhD, role: CONTACT, phone: (86199) 123-53, phoneExt: +7, email: [email protected], contacts name: Valerii V. Makukhin, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.58128, lon: 39.66409, locations facility: I.P. Pavlov Ryazan State Medical University, city: Ryazan', state: Ryazan, zip: 390026, country: Russian Federation, contacts name: Denis S. Yunevich, PhD, role: CONTACT, phone: (4912) 46-63-90, phoneExt: +7, email: [email protected], contacts name: Denis S. Yunevich, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 54.6269, lon: 39.6916, locations facility: Belgorod Regional Clinical Hospital of St. Joseph, city: Belgorod, zip: 308007, country: Russian Federation, contacts name: Sergei L Konstantinov, MD, role: CONTACT, email: [email protected], contacts name: Sergei L Konstantinov, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.61074, lon: 36.58015, locations facility: Kuzbass Cardiology center, city: Kemerovo, zip: 650002, country: Russian Federation, contacts name: Vasilii V. Kashtalap, MD, PhD, role: CONTACT, phone: +7 (3842) 64-22-41, email: [email protected], contacts name: Vasilii V. Kashtalap, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.33333, lon: 86.08333, locations facility: City Clinical Hospital №1, city: Kirov, zip: 610035, country: Russian Federation, contacts name: Oleg V. Solovyev, PhD, role: CONTACT, phone: (8332) 56-35-74, phoneExt: +7, email: [email protected], contacts name: Oleg V. Solovyev, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 58.59665, lon: 49.66007, locations facility: Regional Clinical Hospital №2, city: Krasnodar, zip: 350012, country: Russian Federation, contacts name: Tamara A. Chirva, MD, role: CONTACT, phone: (861) 222-000-2, phoneExt: +7, email: [email protected], contacts name: Tamara A. Chirva, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.04484, lon: 38.97603, locations facility: S.S. Yudin City Clinical Hospital, city: Moscow, zip: 115446, country: Russian Federation, contacts name: Bogdan B Orlov, MD, PhD, role: CONTACT, phone: 7 (499) 612-45-66, email: [email protected], contacts name: Bogdan B Orlov, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.75222, lon: 37.61556, locations facility: V.V. Vinogradov City Clinical Hospital, city: Moscow, zip: 117292, country: Russian Federation, contacts name: Imad Merai, MD, PhD, role: CONTACT, phone: +7 (495) 103 46 66, email: [email protected], contacts name: Imad Merai, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.75222, lon: 37.61556, locations facility: S.P. Botkin City Clinical Hospital, city: Moscow, country: Russian Federation, contacts name: Yuri V. Karabach, PhD, role: CONTACT, phone: (499) 490-03-03, phoneExt: +7, email: [email protected], contacts name: Yuri V. Karabach, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.75222, lon: 37.61556, locations facility: N.N. Burdenko Penza Regional Clinical hospital, city: Penza, zip: 440026, country: Russian Federation, contacts name: Valentin E. Oleynikov, MD, PhD, role: CONTACT, phone: +7 (8412) 54-84-07, email: [email protected], contacts name: Valentin E. Oleynikov, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.20066, lon: 45.00464, locations facility: G.A. Zakharyin Clinical hospital №6, city: Penza, zip: 440071, country: Russian Federation, contacts name: Elena S. Panina, PhD, role: CONTACT, phone: (8412) 98-33-55, phoneExt: +7, email: [email protected], contacts name: Elena S. panina, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.20066, lon: 45.00464, locations facility: City Clinical Hospital №4, city: Perm, zip: 614107, country: Russian Federation, contacts name: Oleg M. Lapin, PhD, role: CONTACT, phone: 342-263-01-06, phoneExt: +7, email: [email protected], contacts name: Oleg M. Lapin, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 58.01046, lon: 56.25017, locations facility: V.P. Polyakov Samara Regional Clinical Cardiology Dispensary, city: Samara, zip: 443070, country: Russian Federation, contacts name: Dmitrii V Duplyakov, MD, PhD, role: CONTACT, phone: 8 (846) 373-70-63, email: [email protected], contacts name: Dmitrii V Duplyakov, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.20007, lon: 50.15, hasResults: False
protocolSection identificationModule nctId: NCT06362733, orgStudyIdInfo id: IRB-74165, briefTitle: Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2026-06-01, completionDateStruct date: 2026-06-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Stanford University, class: OTHER, descriptionModule briefSummary: The purpose of this open label trial is to examine the preliminary effectiveness of a 12-week behavioral intervention program (1 hour/week) to treat insistence on sameness (e.g., difficulty tolerating changes in routine) in youth with autism spectrum disorder (ASD). Treatment will be delivered via secure telemedicine platform and consist of a combination of parent-training and child-focused intervention., conditionsModule conditions: Autism Spectrum Disorder, conditions: Restricted Behavior, conditions: Autism, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 44, type: ESTIMATED, armsInterventionsModule interventions name: Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth, outcomesModule primaryOutcomes measure: Change from Baseline in Insistence on Sameness Subscale of the Dimensional Assessment of Restricted and Repetitive Behaviors (DARB)., secondaryOutcomes measure: Change from Baseline on Blinded Clinician Ratings of Clinical Global Impression Scale, Severity and Improvement Ratings., secondaryOutcomes measure: Change from Baseline in Parent-Rated Emotion Dysregulation on the Strengths and Difficulties Questionnaire Dysregulation Profile (SDQ-DP) during treatment., secondaryOutcomes measure: Change from Baseline in Parent-Rated Irritability as captured by the Aberrant Behavior Checklist (ABC), Irritability Subscale., secondaryOutcomes measure: Change from Baseline in Ritualistic/Sameness Subscale of Repetitive Behavior Scale-Revised (RBS-R)., secondaryOutcomes measure: Change from Baseline in Parent-Rated Challenging Behaviors on the Open-Source Challenging Behaviors Scale (OS-CBS)., secondaryOutcomes measure: Change from Baseline in Parent-Rated Anxiety as captured by the Anxiety Scale for Children with Autism Spectrum Disorder (ASC-ASD)., secondaryOutcomes measure: Change from Baseline in Caregiver Self-Report on the Caregiver Strain Questionnaire Short Form (CGSQ-SF7)., secondaryOutcomes measure: Change from Baseline in Caregiver Self-Report on the Warwick-Edinburg Mental Wellbeing Scales (WEMWS)., secondaryOutcomes measure: Change from Baseline in the Caregiver Self-Report Depression, Anxiety, and Stress Scale (DASS21)., secondaryOutcomes measure: Caregiver Report Autism Symptoms Dimension Questionnaire (ASDQ)., secondaryOutcomes measure: Caregiver Report Executive Functioning Scale (EFS)., secondaryOutcomes measure: Daily Living Skills Scale (DLSS)., eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06362720, orgStudyIdInfo id: 720/2566(IRB2), briefTitle: The Comparison the CMV Infection and Reactivation After Allogeneic Hematopoietic Stem Cell Transplantation Between Standard Regimen, Methotrexate Plus Cyclosporin A, and Post-transplant Cyclophosphamide-based Regimen, acronym: CMV, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Siriraj Hospital, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to compare the CMV infection and reactivation after allogeneic hematopoietic stem cell transplantation Between Standard Regimen, Methotrexate plus Cyclosporin A, and Post-transplant Cyclophosphamide-based Regimen. The main questions it aims to answer are:* How do CMV infection and reactivation differ between Allo-SCT patients who received a standard regimen versus those who received a Post-transplant Cyclophosphamide-based regimen?* progression-free survival, Median overall survival, cumulative incidence of relapse, non-relapsed mortality (NRM) and GvHD at 2 years after Allo-SCT* The impact of CMV infection and CMV reactivation on progression-free survival, overall survival, and NRM* Averse events of GVHD prophylaxis medication Participants will be collected the data of treatment and treatment response during transplant until 2 years after transplant from hospital medical record., conditionsModule conditions: CMV Infection or Reactivation After Allogenic HSCT, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 158, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Number of participants with CMV infection and reactivation, secondaryOutcomes measure: progression-free survival, secondaryOutcomes measure: Median overall survival, secondaryOutcomes measure: cumulative incidence of relapse, secondaryOutcomes measure: non-relapsed mortality, secondaryOutcomes measure: GvHD, secondaryOutcomes measure: Averse events, eligibilityModule sex: ALL, minimumAge: 15 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06362707, orgStudyIdInfo id: 2023161001, briefTitle: Fasudil Trial for Treatment of Early Alzheimer's Disease (FEAD), acronym: FEAD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-10-01, completionDateStruct date: 2026-10-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Helse Stavanger HF, class: OTHER_GOV, collaborators name: University of Exeter, descriptionModule briefSummary: The goal of this placebo-controlled double-blind Phase 2 clinical trial is to test in people with early Alzheimer's Disease.The main questions it aims to answer are:* Does treatment with fasudil, a ROCK-inhibitor, lead to significant improvement in working memory (based on computer-based working memory composite scores) compared to placebo in individuals with early Alzheimer's disease (AD) over 12 months?* What is the effect of fasudil treatment for 12 months on other cognitive functions, brain metabolism measured by Fluorodeoxyglucose Positron Emission Tomography (FDG-PET), and other relevant clinical functions and biomarkers in individuals with early Alzheimer's disease (AD)?* Treatment will be escalated to a maintenance dose of 120 mg total daily dose for up to 50 weeks, with regular clinic visits for efficacy and safety evaluations.* Assessments will include cognitive tests, FDG-PET scans, and biomarker analyses, with follow-up by the Data and Safety Monitoring Board for ongoing safety review.The study will compare participants receiving fasudil with those receiving placebo to see if fasudil treatment leads to improvements in cognitive functions, brain metabolism measured by FDG-PET., conditionsModule conditions: Cognitive Decline, Mild, conditions: Alzheimer Disease, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Fasudil, interventions name: Placebo, outcomesModule primaryOutcomes measure: Cognition, primaryOutcomes measure: Brain metabolism, secondaryOutcomes measure: Plasma levels of ptau217, secondaryOutcomes measure: Plasma levels of nfl, secondaryOutcomes measure: Levels of cerebrospinal Aβ1-40 and Aβ1-42, secondaryOutcomes measure: Levels of cerebrospinal tau and p-tau, secondaryOutcomes measure: Blood pressure (Safety assessments), secondaryOutcomes measure: Pulse (Safety assessments), secondaryOutcomes measure: Urine testing (Safety assessments), secondaryOutcomes measure: Blood urea nitrogen (BUN) (Safety assessments), secondaryOutcomes measure: Potassium (Safety assessments), secondaryOutcomes measure: Sodium (Safety assessments), secondaryOutcomes measure: Calcium (Safety assessments), secondaryOutcomes measure: Glucose (Safety assessments), secondaryOutcomes measure: Hemoglobin (Safety assessments), secondaryOutcomes measure: Creatinine (Safety assessments), secondaryOutcomes measure: Total and direct bilirubin (Safety assessments), secondaryOutcomes measure: CRP (C-reactive protein) (Safety assessments), secondaryOutcomes measure: Aspartate aminotransferase (AST) (Safety assessments), secondaryOutcomes measure: Serum glutamic-oxaloacetic transaminase (SGOT) (Safety assessments), secondaryOutcomes measure: Alanine aminotransferase (ALT) (Safety assessments), secondaryOutcomes measure: Serum glutamic-pyruvic transaminase (SGPT) (Safety assessments), secondaryOutcomes measure: Alkaline phosphatase (Safety assessments), secondaryOutcomes measure: Electrocardiogram (ECG) (Safety assessments), secondaryOutcomes measure: Columbia Suicide Severity Rating Scale (C-SSRS) (Safety assessments), eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06362694, orgStudyIdInfo id: 34, briefTitle: Study of the Rechallenge Concept in Patients With BRAF-positive Anaplastic Thyroid Cancer After Progression on Anti-BRAF Therapy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2026-03-25, completionDateStruct date: 2026-06-25, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Saint Petersburg State University, Russia, class: OTHER, descriptionModule briefSummary: This pilot phase 2 study evaluates the effectiveness and safety of the Rechallenge concept in patients with BRAF-positive anaplastic thyroid cancer after progression on anti-BRAF therapy. Patients with BRAF-positive anaplastic thyroid cancer who were previously treated with dabrafenib and trametinib (with a clinical or objective response at the start of treatment) and later with tumor progression during anti-BRAF therapy and subsequent lines of chemotherapy are scheduled to undergo targeted therapy (repeated administration of dabrafenib and trametinib in standard doses) and evaluate the outcomes according to the primary and secondary endpoints., conditionsModule conditions: Anaplastic Thyroid Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Dabrafenib + Trametinib, outcomesModule primaryOutcomes measure: Objective response rate, primaryOutcomes measure: Progression-Free Survival, primaryOutcomes measure: Safety and Tolerability assessment (Incidence of Treatment-Emergent Adverse Events), secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: The assessment of conversion to resectability, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Saint Petersburg State University Hospital, status: RECRUITING, city: Saint Petersburg, zip: 190020, country: Russian Federation, contacts name: Ernest Dzhelialov, role: CONTACT, phone: +7(911)134-50-44, email: [email protected], geoPoint lat: 59.93863, lon: 30.31413, hasResults: False
protocolSection identificationModule nctId: NCT06362681, orgStudyIdInfo id: CF-2023-I-13, briefTitle: Effects of Different Remineralization Agents on Molar Incisor Hypomineralization Defects: a Randomized Clinical Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2026-03-30, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Universidad Nacional Autonoma de Mexico, class: OTHER, descriptionModule briefSummary: The aim of this study was to present a comparative evaluation of the long-term efficacy of fluoride varnish( Flúor protector), Clinpro™ White Varnish and pastes containing CPP-ACP in the remineralization of creamy-white and yellow brown defects in incisors and permanent first molars with Molar Incisor Hypomineralization (MIH) in schoolchildren 6-12 years-old in Mexico., conditionsModule conditions: Molar Incisor Hypomineralization, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: The children will be randomly divided into the experiment groups: control (oral hygiene motivation only), fluoride varnish, clinpro white Varnish and pastes containing CPP-ACP and followed up for 24 months., primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, maskingDescription: using a block randomization technique in which a computer-generated sequence would be used to assign each participant to a particular group in the allocation ratio of 1:1., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Fluoride, outcomesModule primaryOutcomes measure: Mineral Density, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Alvaro Garcia Pérez, status: RECRUITING, city: San Pedro Apatlaco, state: Morelos, country: Mexico, geoPoint lat: 18.79306, lon: -98.95972, hasResults: False
protocolSection identificationModule nctId: NCT06362668, orgStudyIdInfo id: RCV-0006-EU, briefTitle: EU Sites: Fluid Management of Acute Decompensated Heart Failure With Reprieve Decongestion Management System (FASTR-EU), acronym: FASTR-EU, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-09, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Reprieve Cardiovascular, Inc, class: INDUSTRY, descriptionModule briefSummary: The objective of this study is to prospectively compare decongestive therapy administered by the Reprieve DMS system to Optimal Diuretic Therapy (ODT) in the treatment of patients diagnosed with acute decompensated heart failure (ADHF). The main objective is to determine if the Reprieve DMS is non-inferior to state-of-the-art urine sodium guided aggressive diuretic titration in two European HF centers of excellence., conditionsModule conditions: Acute Decompensated Heart Failure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Reprieve Decongestion Management System, interventions name: Diuretic (furosemide, bumetanide, torsemide, hydrochlorothiazide, and/or acetazolamide), outcomesModule primaryOutcomes measure: Total sodium loss (in mmol of sodium) per 24 hours, primaryOutcomes measure: Comparison of occurrence of composite endpoint comprised of clinically significant acute kidney injury, severe electrolyte abnormality, or symptomatic hypotension or hypertensive emergency., secondaryOutcomes measure: Total net fluid volume loss (difference between urine output volume and fluid input volume) per 24 hours, secondaryOutcomes measure: Weight loss per 24 hours at end of randomized therapy, secondaryOutcomes measure: Time on IV loop diuretic, secondaryOutcomes measure: Number of participants with ≥ 0.3 mg/dL increase in serum creatinine, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Medical Center Groningen, city: Groningen, country: Netherlands, contacts name: Kevin Damman, MD, role: CONTACT, geoPoint lat: 53.21917, lon: 6.56667, locations facility: Wroclaw Medical University, city: Wrocław, country: Poland, contacts name: Jan Biegus, MD, role: CONTACT, geoPoint lat: 51.1, lon: 17.03333, hasResults: False
protocolSection identificationModule nctId: NCT06362655, orgStudyIdInfo id: ANID/FONDECYT 2013/1230801, briefTitle: ACTIBESE Project - Active Behaviour in School Education, acronym: ACTIBESE, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-04-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Pontificia Universidad Catolica de Valparaiso, class: OTHER, collaborators name: Universidad de La Frontera, descriptionModule briefSummary: The ACtive BEhaviour in School Education (ACTIBESE) project aims to assess and intervene in Chilean schoolchildren's active behaviours by examining the influence of personal, interpersonal, and school factors. This study includes a cross-sectional and intervention study involving 152 schools in the Valparaíso and Araucanía Regions, representing urban and rural areas. Participants, divided into children (8-11 years old) and adolescents (12-17 years old), will undergo a comprehensive evaluation, including sociodemographic characteristics, physical activity (PA) levels, parental and peer support, teaching styles of the teachers, and school environment characteristics.For the cross-sectional study, questionnaires, interviews, accelerometry, and pedometry will be used to collect data on various factors influencing PA in schoolchildren. In the intervention study, a 5-month continuous training program for teachers will be implemented, focusing on improving teaching styles and enhancing teaching competencies related to physical education and health classes. The program aims to positively affect schoolchildren's PA indirectly through improved teaching practices.The research will use mixed models, ANCOVA (Analysis of Covariance), and logistic regressions for data analysis, incorporating multilevel logistic regressions to account for school-level dependencies. The study's outcomes will contribute valuable insights into the complex interactions between school, interpersonal, and personal factors influencing schoolchildren's PA, aiding the development of targeted interventions. This comprehensive approach aligns with the project's goal of fostering a physically active lifestyle among Chilean schoolchildren., conditionsModule conditions: Physical Inactivity, conditions: Child Behavior, conditions: Family Support, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Intervention Study, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, maskingDescription: No apply, enrollmentInfo count: 144, type: ESTIMATED, armsInterventionsModule interventions name: Intervention, outcomesModule primaryOutcomes measure: Physical activity levels, eligibilityModule sex: ALL, minimumAge: 9 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: IRyS Group, School of Physical Education, Pontificia Universidad Católica de Valparaíso, Valparaíso, Chile., city: Viña Del Mar, state: Valparaiso, zip: 2300000, country: Chile, geoPoint lat: -33.02457, lon: -71.55183, hasResults: False
protocolSection identificationModule nctId: NCT06362642, orgStudyIdInfo id: PMV-586-105, briefTitle: A Study to Investigate the Effects of Itraconazole on the Pharmacokinetics of PC14586 in Healthy Participants, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-28, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: PMV Pharmaceuticals, Inc, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to assess the effect of PC14586 pharmacokinetics when co administered with itraconazole in healthy participants., conditionsModule conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SEQUENTIAL, interventionModelDescription: The treatments will be: Day 1: single oral dose of PC14586, Day 20: oral dose of itraconazole BID, Day 21-22: single oral dose of itraconazole QD, Day 23: single oral dose of PC14586 and single oral dose of itraconazole, Day 24-27: single oral dose of itraconazole QD., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: PC14586, interventions name: Itraconazole, outcomesModule primaryOutcomes measure: Characterize the Maximum Plasma Concentration (Cmax) of PC14586 when co-administered with itraconazole in healthy participants., primaryOutcomes measure: Characterize the total drug exposure (AUC0-inf) of PC14586 when co-administered with itraconazole in healthy participants., primaryOutcomes measure: Characterize the time to peak drug concentration (Tmax) of PC14586 when co-administered with itraconazole in healthy participants., primaryOutcomes measure: Characterize the total drug exposure from time zero to 24 hours (AUC0-24) of PC14586 when co-administered with itraconazole in healthy participants., primaryOutcomes measure: Characterize the total drug exposure from time zero to the last timepoint (AUC0-t) of PC14586 when co-administered with itraconazole in healthy participants., primaryOutcomes measure: Characterize the half-life (t1/2) of PC14586 when co-administered with itraconazole in healthy participants., secondaryOutcomes measure: Characterize the Maximum Plasma Concentration (Cmax) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants., secondaryOutcomes measure: Characterize the total drug exposure (AUC0-inf) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants., secondaryOutcomes measure: Characterize the time to peak drug concentration (Tmax) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants., secondaryOutcomes measure: Characterize the total drug exposure from time zero to 24 hours (AUC0-24) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants., secondaryOutcomes measure: Characterize the total drug exposure from time zero to the last timepoint (AUC0-t) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants., secondaryOutcomes measure: Characterize the half-life (t1/2) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants., secondaryOutcomes measure: Identification of the incidence of treatment emergent adverse events (TEAE) of PC14586 when administered alone and co-administered with itraconazole in healthy participants., secondaryOutcomes measure: Identification of vital sign abnormalities after administration of PC14586 alone and when co-administered with itraconazole in healthy participants., secondaryOutcomes measure: Identification of 12-lead electrocardiogram (ECG) abnormalities after administration of PC14586 alone and when co-administered with itraconazole in healthy participants., secondaryOutcomes measure: Identification of laboratory abnormalities based on hematology and clinical chemistry after administration of PC14586 alone and when co-administered with itraconazole in healthy participants., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Fortrea, status: RECRUITING, city: Madison, state: Wisconsin, zip: 53704, country: United States, contacts name: Christine Hale, MD, role: CONTACT, email: [email protected], geoPoint lat: 43.07305, lon: -89.40123, hasResults: False
protocolSection identificationModule nctId: NCT06362629, orgStudyIdInfo id: WCH240407, briefTitle: AI App for Management of Atopic Dermatitis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2028-12-31, completionDateStruct date: 2029-08-31, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: West China Hospital, class: OTHER, descriptionModule briefSummary: Background: Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by recurrent rashes and itching, which seriously affects the quality of life of patients and brings heavy economic burden to society. The Treat to Target (T2T) strategy was proposed to guide optimal use of systemic therapies in patients with moderate to severe AD, and it is emphasized patients' adherence and combined evaluation from both health providers and patients. While effective treatments for AD are available, non-adherence of treatment is common in clinical practice due to the patients' unawareness of self-evaluation and lack of concern about the specific follow-up time points in clinics, which leads to the treatment failure and repeated relapse of AD.Hypothesis: An Artificial Intelligence assistant decision-making system (AIADMS) with implementation of the T2T framework could help control the disease progression and improve the clinical outcomes for AD.Overall objectives:We aim to develop an AIADMS in the form of smartphone app to integrate T2T approach for both clinicians and patients, and design clinical trials to verify the effectiveness and safety of the app. Methods: This project consists of three parts, AI training model for diagnosis and severity grading of AD based on deep learning, development of Artificial Intelligence assistant decision-making system (AIADMS) in the form of app, and design of a randomized controlled trial to verify the effectiveness and safety of AIADMS App for improvement of the clinical outcomes in AD patients.Expected results: With application of AIADMS based app, the goal of T2T for patients with AD could be realized better, the prognosis could be improved, and more satisfaction could be achieved for both patients and clinicians.Impact: This is the first AIADMS based app for AD management running through thediagnosis, patients' self-participation, medical follow-up, and evaluation of achievement of goal of T2T., conditionsModule conditions: Atopic Dermatitis, conditions: Artificial Intelligence, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 232, type: ESTIMATED, armsInterventionsModule interventions name: Artificial Intelligence assistant decision-making system (AIADMS) App, outcomesModule primaryOutcomes measure: The overall efficiency rate of treating objectives including PP-NRS, EASI, SCORAD, POEM, and DLQI at 12 weeks after treatment, secondaryOutcomes measure: The seperated efficiency rate of treating objectives including PP-NRS, EASI, SCORAD, POEM, and DLQI, secondaryOutcomes measure: The economic consumption, secondaryOutcomes measure: Satisfaction evaluation, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 75 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06362616, orgStudyIdInfo id: N23PBD, briefTitle: Preoperative Accelerated Partial Breast Irradiation in Patients With Locally Recurrent or Second Primary Breast Cancer, acronym: PAPBI-3, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-12, primaryCompletionDateStruct date: 2026-10-11, completionDateStruct date: 2027-04-11, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: The Netherlands Cancer Institute, class: OTHER, descriptionModule briefSummary: This study evaluates the acute toxicity and feasibility of repeat breast conserving therapy with preoperative accelerated partial breast re-irradiation (PAPBI) in female patients aged 51 years or older with ipsilateral recurrent or second primary low-risk breast cancer., conditionsModule conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 31, type: ESTIMATED, armsInterventionsModule interventions name: Preoperative accelerated partial breast irradiation, interventions name: Breast conserving surgery, interventions name: Sentinel node procedure, interventions name: Biopsy track removal, outcomesModule primaryOutcomes measure: Acute post-treatment toxicity, secondaryOutcomes measure: Fibrosis/induration, secondaryOutcomes measure: Patient-reported Outcome Measures (PROMS): EORTC Quality of Life Questionnaire (QLQ)-C30, secondaryOutcomes measure: Patient-reported Outcome Measures (PROMS): EORTC QLQ-BR23, secondaryOutcomes measure: Patient-reported Outcome Measures (PROMS): Patient's Questionnaire Cosmesis, secondaryOutcomes measure: Cosmetic outcome according to the BCCT.core software program, eligibilityModule sex: FEMALE, minimumAge: 51 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Netherlands Cancer Institute, status: RECRUITING, city: Amsterdam, zip: 1066CX, country: Netherlands, contacts name: Astrid Scholten, MD PhD, role: CONTACT, phone: +31205129111, email: [email protected], geoPoint lat: 52.37403, lon: 4.88969, hasResults: False
protocolSection identificationModule nctId: NCT06362603, orgStudyIdInfo id: FB2022NIH, briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA], statusModule overallStatus: WITHHELD, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: [Redacted], hasResults: False
protocolSection identificationModule nctId: NCT06362590, orgStudyIdInfo id: LV-SPIND-001, briefTitle: Expanded Access Use of Ladiratuzumab Vedotin in Advanced Solid Tumors, statusModule overallStatus: AVAILABLE, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Seagen Inc., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to provide the option of Ladiratuzumab Vedotin treatment to eligible patients in studies SGNLVA-005., designModule studyType: EXPANDED_ACCESS, armsInterventionsModule interventions name: ladiratuzumab vedotin, eligibilityModule stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06362577, orgStudyIdInfo id: TSC202202, briefTitle: Clinical Study of HIFU for Localized Prostate Cancer, acronym: HIFU, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-11-30, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: RenJi Hospital, class: OTHER, descriptionModule briefSummary: In this study, the safety and effectiveness data of Sonablate system, a transrectal high-intensity focused ultrasound therapeutic instrument, in the treatment of localized prostate cancer were collected, and the treatment conditions of patients with other methods (such as radical prostatectomy) were compared and analyzed. Observe the differences in treatment effect, survival rate, postoperative PSA, recurrence and complications.To analyze and compare the clinical outcome, postoperative complications and tumor control of HIFU and robot-assisted laparoscopic radical prostatectomy for localized prostate cancer, and to explore the effectiveness and safety of HIFU in the treatment of localized prostate cancer, so as to provide an alternative treatment for localized prostate cancer., conditionsModule conditions: Localized Prostate Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: EQ-5D-5L IPSS IIEF-5 EPIC-26 ECOG, outcomesModule primaryOutcomes measure: Incidence of postoperative complications, secondaryOutcomes measure: The time to reach the lowest point of PSA, secondaryOutcomes measure: Assessment of quality of life and sexual function spontaneously reported at 2, 6, and 12 months after surgery, secondaryOutcomes measure: The negative rate of tumor exclusion was evaluated by imaging (mainly mp-MRI) at 2 and 12 months after surgery, secondaryOutcomes measure: The incidence of biochemical recurrence that requires remedial or systemic treatment 12 months after surgery, secondaryOutcomes measure: Postoperative overall survival rate, eligibilityModule sex: MALE, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06362564, orgStudyIdInfo id: CIPL-LBE-0101, briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA], statusModule overallStatus: WITHHELD, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: [Redacted], hasResults: False
protocolSection identificationModule nctId: NCT06362551, orgStudyIdInfo id: INC-GS-2024-002, briefTitle: Oocyte Donor Application Discrepancies, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Inception Fertility, LLC, class: INDUSTRY, collaborators name: GeneScreen Counseling, LLC, descriptionModule briefSummary: Retrospective observational study comparing information received on Inception Central Donor Recruitment's standardized online egg donor application compared to information reported during a genetic risk assessment consultation with a certified genetic counselor with contracted third party genetic counseling service, GeneScreen. All donor applicants completing a full application with Inception's Central Donor Recruitment and a GRA consultation with GeneScreen will be included., conditionsModule conditions: Infertility, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Rate of additional information, primaryOutcomes measure: Rate of applicant decline, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Inception Fertility LLC, city: Houston, state: Texas, zip: 77081, country: United States, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False
protocolSection identificationModule nctId: NCT06362538, orgStudyIdInfo id: MCH-ProCardioPrev, briefTitle: The Cardiovascular Prevention Program, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2027-04-15, completionDateStruct date: 2027-04-15, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Maria Cecilia Hospital, class: OTHER, descriptionModule briefSummary: Cardiovascular diseases represent one of the main public health problems being the leading cause of morbidity, disability and mortality. In recent decades, the global prevalence and cardiovascular disease mortality has increased, with 23.6 million annual deaths expected by 2030. In Europe, mortality per year is equal to 2.2 million women and 1.9 million men, representing 47% and 37% of all deaths respectively. In Italy, the situation in terms of deaths due to cardiovascular diseases it is in line with the world ranking and European, being responsible for 44% of all deaths. The only interventional or pharmacological approach is neither effective nor sustainable. The most deaths from cardiovascular diseases are due to atherothrombotic events, which are attributable to a series of risk factors, most of which are modifiable. Turns out itself as a targeted action on these factors with the aim of safeguarding the state of health cardiovascular, may represent the best applicable strategy. It is therefore necessary structure and activate prevention programs aimed at the general population and groups of subjects at higher risk., conditionsModule conditions: Cardiovascular Prevention, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: International Physical Activity Questionnaire, interventions name: Six minute walking test, interventions name: SF-36, Euro-Qol 5D-5L, Perceived stress scale-10, Pittsburgh Sleep Quality Index, Depression Anxiety Stress scale- 21., interventions name: MEDAS, interventions name: Intima-media thickness (IMT), interventions name: Blood sampling, interventions name: Stool Sample Culture Test, outcomesModule primaryOutcomes measure: measure of body mass index, primaryOutcomes measure: Adherence to the Mediterranean diet, primaryOutcomes measure: blood test to check cholesterol levels, primaryOutcomes measure: blood pressure measurement, primaryOutcomes measure: blood glucose test, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06362525, orgStudyIdInfo id: 2022-389, briefTitle: Incidence of Episodes of (Dis)Connected Consciousness Among Emergency Patients Admitted in the Resuscitation Room, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-09, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2027-09-30, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: University of Liege, class: OTHER, collaborators name: Centre Hospitalier Universitaire de Liege, descriptionModule briefSummary: This observational study aims to describe the incidence of episodes of disconnected consciousness (including near-death experience (NDE)) and episodes of connected consciousness in patients admitted to the resuscitation room, who survived a critical condition and who meet at least one of these criteria during their stay in the resuscitation room: (1) deep sedation, (2) intubation, (3) cardiopulmonary resuscitation, or (4) (non-drug-induced) Glasgow Coma Scale score = 3. We also investigate the potential (neuro)physiological markers and biomarkers. In order to help determine the potential risk factors of such episodes, cognitive factors such as dissociative propensity are also investigated. Unexpected visual and auditory stimuli will be displayed. In addition, we assess the evolution of memory, as well as short- and long-term consequences on quality of life, anxiety, and attitudes towards care.Memory of patients who did not meet the above-mentioned criteria are also investigated. A group of 15 healthy participants will be invited to test the stimuli display.Finally, (neuro)physiological parameters of a subsample of dying patients are also investigated., conditionsModule conditions: Critical Illness, conditions: Near-Death Experience, conditions: Consciousness, Loss of, conditions: Quality of Life, conditions: Emergencies, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, outcomesModule primaryOutcomes measure: Detection of potential episodes of disconnected consciousness, primaryOutcomes measure: Detection of potential episodes of connected consciousness, secondaryOutcomes measure: Risk factors, secondaryOutcomes measure: Quality of life assessment, secondaryOutcomes measure: Memory content and evolution assessment, secondaryOutcomes measure: Detection of post-traumatic stress disorder (PTSD), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU of Liège, status: RECRUITING, city: Liège, zip: 4000, country: Belgium, geoPoint lat: 50.63373, lon: 5.56749, hasResults: False
protocolSection identificationModule nctId: NCT06362512, orgStudyIdInfo id: Marco_PANG_2024, briefTitle: Cognitive-motor Exercise for Stroke Patients in Function, Cognition and Related Brain Changes., acronym: COGMOTION, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: The Hong Kong Polytechnic University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to evaluate a cognitive-motor exercise on dual-task interference during dual-task ankle movement and the corresponding alterations of brain activity., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: After stratification according to gender and walking speed, the participants will be randomly allocated to one of three groups: (1) dual-task training, (2) single-task training, and (3) control intervention, using a 1:1:1 allocation ratio., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: This will be a single-blinded randomized controlled trial . The assessor will be blinded during assessments. The participants and investigators (trainers) are not possible to be blinded as it is an exercise intervention., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 84, type: ESTIMATED, armsInterventionsModule interventions name: Dual-task training, interventions name: Single-task training, interventions name: Upper limb strengthening exercise, outcomesModule primaryOutcomes measure: Dual-task step frequency, primaryOutcomes measure: Dual-task cognitive performance accuracy, secondaryOutcomes measure: Blood oxygenation level changes of the brain, otherOutcomes measure: Single-task walking speed, otherOutcomes measure: Dual-task walking performance, otherOutcomes measure: Mini Balance Evaluation Systems Test, otherOutcomes measure: Activities-specific Balance Confidence Scale, otherOutcomes measure: Trail Making Test, otherOutcomes measure: Digit Span Test, otherOutcomes measure: Montreal Cognitive Assessment, otherOutcomes measure: Fall incidence, otherOutcomes measure: Dual-task ankle movement degree, otherOutcomes measure: Dual-task cognitive performance time, eligibilityModule sex: ALL, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Hong Kong Polytechnic University, status: RECRUITING, city: Hong Kong, zip: 000000, country: China, contacts name: Marco Yiu Chung Pang, PhD, role: CONTACT, geoPoint lat: 22.39407, lon: 114.13737, hasResults: False
protocolSection identificationModule nctId: NCT06362499, orgStudyIdInfo id: 01, briefTitle: Effects of Unsupervised Inspiratory Muscle Training on Ventilation Variability in Post-covid-19 Patients., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-07-31, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Universidade Federal do Rio Grande do Norte, class: OTHER, descriptionModule briefSummary: Dysfunctional breathing and persistent hypocapnia can be associated with many of the symptoms experienced by patients such as dyspnea, fatigue, chest pain and palpitations. The identification of dysfunctional breathing and hypocapnia in these patients is important as it may represent a target for treatment.In many of these patients, tachypnea at low levels of exertion suggests increased respiratory muscle activity, which can lead to the sensation of dyspnea. Sympathetic hyperactivity leads to excessive and irregular ventilation during exercise. In this way, inspiratory muscle training can improve symptoms (dysfunctional breathing), possibly by attenuating the metaboreflex (vagal modulation-attenuation of the sympathetic response) of the inspiratory muscle in post-covid-19 subjects, reducing ventilatory variability., conditionsModule conditions: COVID-19, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Experimental Group, outcomesModule primaryOutcomes measure: Ventilation variability and ventilation efficiency, secondaryOutcomes measure: Respiratory muscle strength, secondaryOutcomes measure: Pulmonary function, secondaryOutcomes measure: Quality of life - Medical Outcomes Study 36-Item Short Health Form Survey (SF-36), secondaryOutcomes measure: Peripheral muscle strength, secondaryOutcomes measure: Functional capacity, secondaryOutcomes measure: Adverse effects and adherence, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Federal University of Rio Grande do Norte, status: RECRUITING, city: Natal, state: Rio Grande Do Norte, zip: 59082-100, country: Brazil, contacts name: Gabriely Azevêdo, role: CONTACT, phone: 84999390004, email: [email protected], contacts name: Patrícia Nogueira, role: CONTACT, geoPoint lat: -5.795, lon: -35.20944, locations facility: Patrícia Nogueira, status: RECRUITING, city: Natal, state: Rio Grande Do Norte, country: Brazil, contacts name: Patrícia Nogueira, role: CONTACT, contacts name: Gabriely Azevêdo, role: CONTACT, phone: 5584999390004, email: [email protected], geoPoint lat: -5.795, lon: -35.20944, hasResults: False
protocolSection identificationModule nctId: NCT06362486, orgStudyIdInfo id: SIGNATURE, briefTitle: Stress in Pregnancy During the Covid19 Pandemic and Impact on the Newborn Neurodevelopment, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2021-08-01, primaryCompletionDateStruct date: 2023-08-01, completionDateStruct date: 2024-08-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla, class: OTHER, descriptionModule briefSummary: The Covid19 pandemic, paradoxically, represents a valuable opportunity to carry out cohort studies that allow us to advance our knowledge about the relationship between inflammation, brain development and an increased risk of suffering from neuropsychiatric disorders or alterations. In addition, the current availability of sophisticated biological techniques and evaluation procedures represents an unique option for this purpose.Here, we propose a cohort study of sars-cov-2 (type 2 coronavirus causing severe acute respiratory syndrome) infected pregnant women and newborns. We will try to answer the following questions: (i) what is the inflammatory / immune status of newborns (NBs) of mothers infected by Covid19 like?; (ii) is there a relationship between the clinical characteristics of the maternal infection (severity / moment / of infection) and the inflammatory status of the newborn?; (iii) could these features increase the vulnerability to developing central nervous system (CNS) alterations at an early age, and at some point during adult life ?; (iv) How is the Covid19 infected mother's placenta altered? Do the placental alterations Covid19 mediated contribute to develop CNS alterations?; (v) is the infection associated with phenotypes obtained through neurological and neurodevelopmental clinical evaluation (hypotonia, clumsiness, impaired communication and sociability) in children at 6 months and 12 months?Our main objective is to explore how the presence of stressors and prenatal sars-cov-2 infection generates an abnormal inflammatory activity in the newborn, which is associated with neurodevelopmental disorders and which confers a greater risk of developing neuropsychiatric disorders. The biological information of the umbilical cord (fetus blood) and peripheral blood of the mother obtained after childbirth was provided by the cohort of women during the Covid19 pandemic monitored during their pregnancy, delivery, childbirth and postpartum. These samples and the clinical characterisation of the cohort of mothers and newborns, of which we will be able to do an exhaustive longitudinal follow-up, are tremendously valuable at this time. There is a need to establish new research strategies to understand the pathophysiology of neuropsychiatric diseases, and to discover new molecular and cellular mechanisms involved in the development of the CNS., conditionsModule conditions: Covid19 and Pregnancy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Severity of infection, time of infection., interventions name: Mental health assessment, interventions name: biological, outcomesModule primaryOutcomes measure: explore how the presence of stressors and prenatal sars-cov-2 infection generates an abnormal inflammatory activity in the newborn, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Universitario Virgen del Rocío, city: Sevilla, zip: 41013, country: Spain, geoPoint lat: 37.38283, lon: -5.97317, hasResults: False
protocolSection identificationModule nctId: NCT06362473, orgStudyIdInfo id: LIPIGEN-001, briefTitle: Lipid Transport Disorder Italian Genetic Record (LIPIGEN), acronym: LIPIGEN, statusModule overallStatus: RECRUITING, startDateStruct date: 2015-08-04, primaryCompletionDateStruct date: 2026-09-30, completionDateStruct date: 2026-09-30, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Fondazione SISA (Societa Italiana per lo Studio della Arteriosclerosi), class: OTHER, descriptionModule briefSummary: LIPIGEN is an observational study involving Italian physicians and researchers in the field of diseases related to blood lipid levels. This study aims to improve the diagnosis and treatment of people with familial dyslipidaemias, including very common conditions such as familial hypercholesterolaemia (FH) and less common ones such as familial chylomicronidaemic syndrome (FCS).What does the study do?It collects information on Italian patients with Familial Hypercholesterolaemia (FH), following them in their normal clinical examination without adding extra procedures.It uses the data collected to further our understanding of diseases such as familial hypercholesterolaemia, examining how it is diagnosed clinically and by genetic testing, and evaluating the effectiveness of different treatments.It seeks to identify the genetic mutations that cause familial hypercholesterolaemia and other dyslipidaemias, helping to choose the most effective treatments.It evaluates the impact of long-term treatments and patient adherence to medication, as well as monitoring the incidence of cardiovascular events and other important outcomes.Who can participate?The study is aimed at people of all ages, from children to adults, with familial hypercholesterolaemia or other genetic dyslipidaemia.More than 50 centres throughout Italy are involved, making the study accessible to many.What does participation entail?Participants will continue with their normal clinical practice.Data such as family history, personal clinical findings and genetic information will be collected, without additional procedures.For some, further evaluations, such as ultrasounds, may be required to better study their condition.The LIPIGEN study not only helps to better understand diseases related to high cholesterol but also aims to improve patients\' lives through more precise diagnosis and personalised treatments., conditionsModule conditions: Familial Hypercholesterolemia, conditions: Genetic Disorder, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 10000, type: ESTIMATED, armsInterventionsModule interventions name: Lipid-lowering treatments, outcomesModule primaryOutcomes measure: Lipid profile of patients with genetic dyslipidemia, primaryOutcomes measure: Genetic profile of patients with genetic dyslipidemia, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Multimedica, status: RECRUITING, city: Sesto san Giovanni, state: Milano, zip: 20099, country: Italy, contacts name: Fabio Pellegatta, MD, role: CONTACT, phone: 00390224209593, email: [email protected], contacts name: Fabio Pellegatta, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.53329, lon: 9.22585, hasResults: False
protocolSection identificationModule nctId: NCT06362460, orgStudyIdInfo id: RAY1216-23-03, briefTitle: Mass Balance Study of [14C]RAY1216 in Healthy Adult Male Subjects in China, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-09-18, primaryCompletionDateStruct date: 2023-11-01, completionDateStruct date: 2023-11-15, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Guangdong Raynovent Biotech Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: This study is a single-center, open-label, and single-dose clinical study to evaluate the mass balance, biotransformation and pharmacokinetics of \[14C\]RAY1216 in healthy Chinese male participants, revealing the overall pharmacokinetic characteristics of RAY1216., conditionsModule conditions: Pharmacokinetics, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 6, type: ACTUAL, armsInterventionsModule interventions name: [14C] RAY1216, outcomesModule primaryOutcomes measure: Total radioactivity in plasma PK, primaryOutcomes measure: Total radioactivity in plasma PK, primaryOutcomes measure: Total radioactivity in plasma PK, primaryOutcomes measure: Total radioactivity in plasma PK, primaryOutcomes measure: Mass balance recovery of total radioactivity in all (urine, faeces) amount excreted (Ae) expressed as a percentage of the administered dose (%Ae), secondaryOutcomes measure: Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Bengbu Medical College, city: Bengbu, country: China, geoPoint lat: 32.94083, lon: 117.36083, hasResults: False
protocolSection identificationModule nctId: NCT06362447, orgStudyIdInfo id: RC31/22/0320, briefTitle: Efficacy of Injectable Gentamicin in Hereditary Ichthyosis, acronym: GENTIC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-23, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2027-04-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: University Hospital, Toulouse, class: OTHER, descriptionModule briefSummary: This study will evaluate the efficacy and safety of intravenous gentamicin in congenital ichthyosis due to a non-sens mutation. The primary objective is the severity of scales and erythema at the third month, compared to baseline. Secondary objectives will include: the importance of itching, trans epidermal water loss, cutaneous expression of the targeted protein, the security of the drug and patients' satisfaction., conditionsModule conditions: Ichthyosis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 26, type: ESTIMATED, armsInterventionsModule interventions name: Gentamicin Injectable Solution, outcomesModule primaryOutcomes measure: Gentamicin efficacity, secondaryOutcomes measure: Gentamicin efficacity, secondaryOutcomes measure: Gentamicin efficacity on quality of life, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hôpital Saint-Louis APHP, city: Paris, zip: 75010, country: France, contacts name: BOURRAT Emmanuelle, MD, role: CONTACT, phone: 01 42 49 90 90, phoneExt: 33, email: [email protected], geoPoint lat: 48.85341, lon: 2.3488, locations facility: CHU de Toulouse, city: Toulouse, zip: 31059, country: France, contacts name: SEVERINO-FREIRE Maella, MD, role: CONTACT, phone: 05 67 77 81 41, phoneExt: 33, email: [email protected], contacts name: TEXIER Hélène, role: CONTACT, phone: 05 67 77 81 80, phoneExt: 33, email: [email protected], contacts name: MAZEREEUW-HAUTIER Juliette, MD, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 43.60426, lon: 1.44367, hasResults: False
protocolSection identificationModule nctId: NCT06362434, orgStudyIdInfo id: UHN-HHREHAB-24-xxxx, briefTitle: Visual Telerehabilitation in Children, Adolescents and Young Adults With Hemianopsia Consecutive to a Brain Tumour, acronym: HHREHAB, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2027-06-01, completionDateStruct date: 2027-06-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: University Health Network, Toronto, class: OTHER, collaborators name: Alberta Children's Hospital, collaborators name: St. Justine's Hospital, collaborators name: The Hospital for Sick Children, collaborators name: British Columbia Children's Hospital, descriptionModule briefSummary: Brain malignancies are the most common cause of death from cancer in the pediatric population and a major source of morbidity amongst survivors. Many children with a brain tumour often suffer from visual field defects (hemianopia) dramatically impacting their daily life with poorer social interaction, difficulties learning, playing sports and engaging with peers. Practically, they bump into people and objects and have problems in finding their way in unfamiliar places and in detecting incoming objects in their blind field. There is growing recognition of the diverse and deep impact of hemianopia on physical and mental health, quality of life, and social outcomes of the affected individuals and their family. However, despite the frequent impact of brain tumours on the visual function and functional vision, ophthalmologic evaluations are not standard of care for all brain tumour patients and there are no standardized protocols of vision loss management in the pediatric population with hemianopia. There is an unmet need of restoring perception in the blind field in individuals with hemianopia consecutive to pediatric brain tumor.Our laboratory has developed a visual rehabilitation procedure based on the combination of adaptative audio and visual target tracking in a 3D environment in virtual reality. Participants perform audiovisual stimulation at home in a headset, with remote control from the laboratory. Preliminary on data on paediatric patients with hemianopia consecutive to a brain tumour indicate feasibility and potential effectiveness of a 6-week Re:Vision program on visual fields, visual perception and quality of life.Our objective is to evaluate the effectiveness of Re:Vision, an 8-week visual telerehabilitation program, on visual perception in 50 individuals aged 10-40 years old with hemianopia consecutive to a pediatric brain tumor in a phase IIa/b multi-centric clinical study across Canada.This intervention provides more equitable access to individuals, with the ability to receive rehabilitation therapy at home without supervision by a healthcare professional, meaning that Canadians living outside urban centres could take advantage of specialized therapies with remote supervision. This is the first study that could lead to a major change in the management of these patients. It could open the door for visual rehabilitation strategies to other population of visually impaired children, significantly impacting public health strategies., conditionsModule conditions: Hemianopsia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Audiovisual stimulation, outcomesModule primaryOutcomes measure: Binocular Visual Field, secondaryOutcomes measure: Patient-related Outcome Measures - National Eye Institute - Visual Function Questionnaire - 25, secondaryOutcomes measure: Patient-related Outcome Measures - World Health Organization - Quality of Life questionnaire - BREF, secondaryOutcomes measure: Reading Speed, secondaryOutcomes measure: Fixation Stability, secondaryOutcomes measure: Contrast Sensitivity, otherOutcomes measure: Brain Activity - Visually-evoked potentials, otherOutcomes measure: Retinal Integrity, otherOutcomes measure: Brain imaging - Tractography, otherOutcomes measure: Brain imaging - Retinotopy, otherOutcomes measure: Head tracking, otherOutcomes measure: Eye tracking, eligibilityModule sex: ALL, minimumAge: 10 Years, maximumAge: 40 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Alberta Children's Hospital, city: Calgary, state: Alberta, zip: T3B 6A8, country: Canada, contacts name: Lucie Lafay-Cousin, MD, role: CONTACT, phone: 403-955-7272, email: [email protected], contacts name: Lucie Lafay-Cousin, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.05011, lon: -114.08529, locations facility: British Columbia Children's Hospital, city: Vancouver, state: British Columbia, zip: V6H 3N1, country: Canada, contacts name: Sylvia Cheng, MD, role: CONTACT, phone: 604-875-2406, email: [email protected], contacts name: Sylvia Cheng, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.24966, lon: -123.11934, locations facility: The Hospital for Sick Children, city: Toronto, state: Ontario, zip: M5G 1E8, country: Canada, contacts name: Eric Bouffet, MD, role: CONTACT, phone: 416-813-7500, email: [email protected], contacts name: Eric Bouffet, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Uri Tabori, MD, role: SUB_INVESTIGATOR, contacts name: Inci Yaman Bajin, MD, role: SUB_INVESTIGATOR, geoPoint lat: 43.70011, lon: -79.4163, locations facility: Centre Hospitalier Universitaire Sainte-Justine, city: Montreal, state: Quebec, zip: H3T 1C5, country: Canada, contacts name: Sebastien Perreault, MD, role: CONTACT, phone: 514-345-2372, email: [email protected], contacts name: Sebastien Perreault, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.50884, lon: -73.58781, locations facility: CHU de Québec, city: Québec, state: Quebec, zip: G1J 1Z4, country: Canada, contacts name: Valerie Larouche, MD, role: CONTACT, phone: 418-654-2282, email: [email protected], contacts name: Valerie Larouche, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.81228, lon: -71.21454, hasResults: False
protocolSection identificationModule nctId: NCT06362421, orgStudyIdInfo id: ONC-HN-2402, briefTitle: Saliva Testing for High-Risk Human Papillomavirus Infection Oral Cavity and Pharynx Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2026-07, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Wake Forest University Health Sciences, class: OTHER, collaborators name: InnoTech Precision Medicine, descriptionModule briefSummary: The purpose of this research study is to determine if saliva and oral swab samples can be used to detect human papillomavirus in patients with cancer. In this study, the methods required to detect human papillomavirus will be developed and tested in samples collected from patients with oropharyngeal squamous cell carcinoma and compared to samples collected from participants without cancer., conditionsModule conditions: Oropharyngeal Squamous Cell Carcinoma, conditions: Human Papillomavirus Infection, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Pre-Radiation Dental Evaluation/Sample Collection, interventions name: Pre-Study Visit, interventions name: Oral Medicine Consultation Visit/Sample Collection, outcomesModule primaryOutcomes measure: Number of Participants with Sensitivity for Detection of HPV 16, 18 and gene ACTB, primaryOutcomes measure: Number of Participants with Specificity Detection of HPV 16, 18 and gene ACTB, primaryOutcomes measure: Overall Accuracy - All Participants, eligibilityModule sex: ALL, minimumAge: 39 Years, maximumAge: 59 Years, stdAges: ADULT, contactsLocationsModule locations facility: Hayworth Cancer Center, city: High Point, state: North Carolina, zip: 27262, country: United States, contacts name: Study Coordinator, role: CONTACT, phone: 336-713-1790, email: [email protected], geoPoint lat: 35.95569, lon: -80.00532, locations facility: Atrium Health Wake Forest Baptist Comprehensive Cancer Center, city: Winston-Salem, state: North Carolina, zip: 27157, country: United States, contacts name: Study Coordinator, role: CONTACT, phone: 336-713-1790, email: [email protected], contacts name: Muhammad A Shazib, DMD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.09986, lon: -80.24422, hasResults: False
protocolSection identificationModule nctId: NCT06362408, orgStudyIdInfo id: PLAGH-DEX-PSM/IPTW-001, briefTitle: Effect of Dexmedetomidine on Postoperative Mental Disorders and Long-term Survival in Elderly Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-06-01, primaryCompletionDateStruct date: 2023-05-25, completionDateStruct date: 2023-06-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Chinese PLA General Hospital, class: OTHER, collaborators name: Beijing Tiantan Hospital, collaborators name: First Affiliated Hospital of Guangxi Medical University, collaborators name: The Affiliated Hospital Of Guizhou Medical University, collaborators name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, collaborators name: Wuhan Union Hospital, China, collaborators name: Fudan University, descriptionModule briefSummary: China's aging population is causing an increase in the number of senior persons undergoing surgery. More and more clinicians are paying attention to the postoperative survival and mental health of elderly surgical patients.Dexmedetomidine (DEX) is an alpha-2 adrenergic agonist that works by inhibiting norepinephrine releasing renaline, which reduces inflammation and thus plays a protective role in the central nervous system. DEX has the potential to prevent and treat postoperative anxiety and depression in elderly patients undergoing non-cardiac surgery.Further exploration of evidence for evidence-based medicine is needed. Based on the above research background, this hypothesis is proposed: in elderly patients undergoing noncardiac surgery, intraoperative DEX is associated with a reduction in short-term postoperative mental disorders and a reduction in long-term postoperative mortality., conditionsModule conditions: Cohort Studies, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 6000, type: ACTUAL, armsInterventionsModule interventions name: Dexmedetomidine, outcomesModule primaryOutcomes measure: Postoperative mortality rate, secondaryOutcomes measure: The incidence of postoperative delirium, secondaryOutcomes measure: The incidence of postoperative anxiety, secondaryOutcomes measure: The incidence of postoperative depression, secondaryOutcomes measure: Postoperative sleep disorders, secondaryOutcomes measure: Surgical related complications, secondaryOutcomes measure: Postoperative quality of life evaluation, eligibilityModule sex: ALL, minimumAge: 65 Years, maximumAge: 110 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chinese PLA General Hospital, city: Beijing, state: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
protocolSection identificationModule nctId: NCT06362395, orgStudyIdInfo id: 24-5022, briefTitle: Ultra-high Dose Radiation for Liver Metastasis Using MR-guided TReatment With Stereotactic Ablative Single-fraction, acronym: ULTRAS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2030-06, completionDateStruct date: 2030-06, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: University Health Network, Toronto, class: OTHER, descriptionModule briefSummary: This international multi-centre phase 3 randomized control trial investigates whether giving a very high dose of radiation in a single treatment session (ultra-high dose: experimental) using advanced technology called MR-Linac is more effective than a high dose (control) for treating liver tumors that have spread from other parts of the body (liver metastases). This study also aims to identify predictors of treatment response and side effects by analyzing various factors such as imaging markers and genetic profiles.Liver metastases are common in several cancers, but surgery is often not feasible for many patients. Stereotactic body radiotherapy (SBRT), which delivers focused radiation to tumors, is an alternative treatment option. Previous studies have shown promising results with SBRT, but the optimal radiation dose for liver metastases is still uncertain.This study will look at patients with specific types of primary cancers known to respond well to SBRT. Treatment effectiveness will be assessed by monitoring tumor control, overall survival, and quality of life.By comparing ultra-high dose SBRT with standard high dose, the study aims to determine if the former can provide better tumor control with fewer side effects. If successful, this approach could offer a significant advancement in the treatment of liver metastases, potentially improving outcomes and quality of life for patients., conditionsModule conditions: Liver Metastases, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 114, type: ESTIMATED, armsInterventionsModule interventions name: Magnetic resonance (MR)-guided stereotactic ablative single-fraction (SBRT), outcomesModule primaryOutcomes measure: Local control (LC) of treated target lesion compared to high dose MR-guided stereotactic single-fraction radiation., secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Progression free survival (PFS), secondaryOutcomes measure: Intra-hepatic progression, secondaryOutcomes measure: Widespread progression., secondaryOutcomes measure: Physician-assessed toxicities: National Cancer Institute (NCI) Common Terminology Criteria of Adverse Events (CTCAE) V.5., secondaryOutcomes measure: Patients-reported toxicity: Patient Reported Outcomes - Common Terminology Criteria of Adverse Events (PRO CTCAE) V.1., secondaryOutcomes measure: Quality of life (QOL): European Organization for Research and Treatment of Cancer Quality of Life Questionnaires, Core 15 for Palliative Care (EORTC QLQ-C15-PAL), secondaryOutcomes measure: Quality of life (QOL): European Organization for Research and Treatment of Cancer Quality of Life Questionnaires, liver metastases (EORTC QOQ-LM21)., otherOutcomes measure: Changes in the levels of circulating biomarkers (cell-free tumor DNA) in response to SBRT., otherOutcomes measure: Changes in the levels of circulating biomarkers (cytokines) in response to SBRT., otherOutcomes measure: Changes in the levels of circulating biomarkers (metabolites) in response to SBRT., otherOutcomes measure: Changes in the levels of circulating biomarkers (immune cell populations) in response to SBRT., otherOutcomes measure: Identification of MR imaging biomarkers in response to SBRT., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06362382, orgStudyIdInfo id: 2024-zxm-01, briefTitle: Mobile Internet-based Remote Home Rehabilitation Improves Prognostic Function and Life Quality in Pulmonary Hypertension, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2026-04-22, completionDateStruct date: 2026-05-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: China-Japan Friendship Hospital, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to learn the effectiveness of remote home-based exercise rehabilitation using mobile Internet technology for patients with pulmonary hypertension，especically providing early and mid-term results of its effectiveness. The main questions it aims to answer are:Dose tele-rehabilitation training improves prognostic function and quality of life in patients with pulmonary hypertension？ Researchers will compare tele-rehabilitation training group to a control group (receive health propaganda and education, and then follow their daily routine after discharge from the hospital) to see if tele-rehabilitation training works to improve prognosis.Participants will:During their stay in the hospital, the patients of tele-rehabilitation training group were accompanied by a rehabilitation trainer and a psychotherapist for a complete cycle of (7 days ± 3 days 1 week/times) standardized training. The scheme of rehabilitation is impedance training. A specialized professional team including cardiologists, rehabilitation trainers, psychotherapists and radiologists were involved. After discharge from the hospital, patients in the rehabilitation group underwent 3-5 weekly daily training sessions and intensive supervision and management by the online community at least once a week.Visit the clinic at the 3rd month of the study. Extended follow-up up to 6 months may be considered if patients are cooperative and could complete the training program in the first 3 months., conditionsModule conditions: Pulmonary Hypertension, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: tele-rehabilitation training, interventions name: health propaganda and education, outcomesModule primaryOutcomes measure: changes in 6MWD after 3 months, primaryOutcomes measure: changes in muscle mass after 3 months, secondaryOutcomes measure: peak VO2, secondaryOutcomes measure: VO2peak%, secondaryOutcomes measure: VE/VCO2 slope, secondaryOutcomes measure: PET CO2, secondaryOutcomes measure: Changes in muscle mass evaluated by CT, secondaryOutcomes measure: Changes in grip strength, secondaryOutcomes measure: the time for 5 sit-to-stand test, secondaryOutcomes measure: Quality of life measured by SF-36 after 3 months, secondaryOutcomes measure: Quality of life measured by SF-36 after 6 months, secondaryOutcomes measure: Quality of life measured by emPHasis-10 after 3 months, secondaryOutcomes measure: Quality of life measured by emPHasis-10 after 6 months, secondaryOutcomes measure: Changes in WHO Cardiac Function Classification, secondaryOutcomes measure: Change in NT-proBNP, secondaryOutcomes measure: Change in TAPSE by cardiac doppler ultrasound, secondaryOutcomes measure: Changes in hemodynamic indice after 6 months, secondaryOutcomes measure: Changes in sleep quality score after 3 months, secondaryOutcomes measure: Changes in sleep quality score after 6 months, secondaryOutcomes measure: Changes in psychosocial score after 3 months, secondaryOutcomes measure: Changes in psychosocial score after 6 months, secondaryOutcomes measure: All-cause mortality in 3 months, secondaryOutcomes measure: All-cause mortality in 6 months, secondaryOutcomes measure: The occurrence rate of primary events in pulmonary hypertension in 3 months, secondaryOutcomes measure: The occurrence rate of primary events in pulmonary hypertension in 6 months, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Fuwai Hospital, city: Beijing, state: Beijing, zip: 100037, country: China, contacts name: Xiaoming Zhou, MD, role: CONTACT, phone: +86 88396992, email: [email protected], contacts name: Xiaoming Zhou, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
protocolSection identificationModule nctId: NCT06362369, orgStudyIdInfo id: 7HP-111, briefTitle: A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: 7 Hills Pharma, LLC, class: INDUSTRY, descriptionModule briefSummary: This study is an open-label Phase Ib (Part A) dose escalation followed by a blinded, randomized, multi cohort Phase 2a (Part B) comparison of combination vs. reference regimens.Currently study will only be enrolling the Phase 1b and the Phase 2a protocol requirements will be added to the study near completion of the Phase 1b, conditionsModule conditions: Advanced Cancer, conditions: Advanced Solid Tumor, conditions: Melanoma, conditions: Metastasis, conditions: Pleural Mesothelioma, conditions: Renal Cell Carcinoma, conditions: MSI-High, conditions: Mismatch Repair Deficiency, conditions: Colorectal Cancer, conditions: Hepatocellular Carcinoma, conditions: Hepatocellular Cancer, conditions: Renal Cell Cancer, conditions: Kidney Cancer, conditions: Skin Cancer, conditions: Non Small Cell Lung Cancer, conditions: NSCLC, conditions: Anaplastic Lymphoma Kinase Genomic Tumor Aberrations, conditions: ALK Genomic Tumor Aberrations, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Phase 1b - Open Label, enrollmentInfo count: 126, type: ESTIMATED, armsInterventionsModule interventions name: Alintegimod, interventions name: Ipilimumab, interventions name: Nivolumab, outcomesModule primaryOutcomes measure: Number of participants treated with Alintegimod monotherapy with treatment related adverse events as assessed by CTCAEv5.0, primaryOutcomes measure: Number of participants treated with Alintegimod in combination with treatment related adverse events as assessed by CTCAEv5.0, primaryOutcomes measure: Define RPTDs for Alintegimod, secondaryOutcomes measure: Characterize Pharmacokinetics of Alintegimod monotherapy by measuring Maximum Plasma Concentration (Cmax), secondaryOutcomes measure: Characterize Pharmacokinetics of Alintegimod monotherapy by measuring Area Under the Curve (AUC), secondaryOutcomes measure: Characterize Pharmacokinetics of Alintegimod plus ipilimumab by measuring Maximum Plasma Concentration (Cmax), secondaryOutcomes measure: Characterize Pharmacokinetics of Alintegimod plus ipilimumab by measuring Area Under the Curve (AUC), secondaryOutcomes measure: Determine Progression Free Survival (PFS) response in patients treated with Alintegimod plus ipilimumab followed by nivolumab using RECIST v1.1 tumor assessment criteria., secondaryOutcomes measure: Determine Overall Response Rate (ORR) in patients treated with Alintegimod plus ipilimumab followed by nivolumab using RECIST v1.1 response assessment criteria., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Florida Cancer Specialists, city: Lake Mary, state: Florida, zip: 32746, country: United States, contacts name: Study Coordinator, role: CONTACT, phone: 407-804-6133, contacts name: Alexander Philipovskiy, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.75888, lon: -81.31784, locations facility: Dartmouth Hitchcock, city: Lebanon, state: New Hampshire, zip: 03756, country: United States, contacts name: Study Coordinator, role: CONTACT, phone: 603-650-6345, contacts name: Konstantin H Dragnev, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.64229, lon: -72.25176, locations facility: MD Anderson Cancer Center, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Study Coordinator, role: CONTACT, phone: 713-792-4259, contacts name: Apostolia-Maria Tsimberidou, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False
protocolSection identificationModule nctId: NCT06362356, orgStudyIdInfo id: 24-106, briefTitle: Microbial Metabolites and Outcomes of Pregnancy Study, acronym: MMOPS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-05, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: The Cleveland Clinic, class: OTHER, descriptionModule briefSummary: Emerging data connect diet, the gut microbiota and its metabolites in cardiometabolic disease. Hypertensive disorders of pregnancy (HDP) are common and are a leading cause of maternal and neonatal morbidity. HDP likely share similar pathophysiology as cardiometabolic disease in non-pregnant people with a yet unrevealed role of diet and the gut microbiota, including systemic inflammation and endothelial dysfunction.Despite high biological plausibility that nutrition, the gut microbiota and its metabolites may play a role in health and disease in pregnancy, there is a paucity of data regarding these associations, thus limiting advancement of the field. Similar to the proposed pathogenesis for diet, gut microbiota and the microbial metabolite trimethylamine-N-oxide (TMAO) in cardiovascular disease, we hypothesize that the interplay between maternal diet, the gut microbiota and its associated microbial metabolites play a mechanistic role in HDP. We propose to test this hypothesis in a racially-diverse US cohort to determine association with adverse pregnancy outcomes, specifically future development of HDP. We propose to prospectively collect plasma and urine TMAO throughout pregnancy from a cohort of 200 pregnant participants.Through 1) characterizing plasma and urine TMAO levels across each trimester of pregnancy, and 2) assessment of this microbial metabolite as a predictor of development of HDP, we have the potential to identify a biomarker that would allow us to identify people at risk of HDP early in pregnancy and provide new opportunities for therapeutic interventions to improve maternal and neonatal outcomes., conditionsModule conditions: Hypertensive Disorder of Pregnancy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: TMAO level, primaryOutcomes measure: TMAO level, primaryOutcomes measure: TMAO level, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Cleveland Clinic, status: RECRUITING, city: Cleveland, state: Ohio, zip: 44195, country: United States, contacts name: Cara Dolin, M.D., role: CONTACT, phone: 440-312-2229, email: [email protected], geoPoint lat: 41.4995, lon: -81.69541, hasResults: False
protocolSection identificationModule nctId: NCT06362343, orgStudyIdInfo id: PUMCH-Rivaroxaban-Monitoring, briefTitle: The Study of Monitoring and Dosing Guidance of Direct Oral Anticoagulants Based on Pharmacokinetics, Pharmacodynamics, and Pharmacogenomics, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2026-10-30, completionDateStruct date: 2027-01-30, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Peking Union Medical College Hospital, class: OTHER, collaborators name: Ruijin Hospital, collaborators name: Xiangya Hospital of Central South University, collaborators name: China-Japan Friendship Hospital, descriptionModule briefSummary: 1. Integrate pharmacokinetic-pharmacodynamic (PK-PD) modeling and pharmacogenomics techniques to develop a population PK-PD model, aiming to explore monitoring and dose guidance schemes for Direct Oral Anticoagulants (DOACs).2. Investigate the factors influencing PK-PD of DOACs in the pulmonary embolism population, clarifying the correlation between genotype characteristics and clinical outcomes.3. Explore the correlation between drug concentrations, coagulation indices, and clinical outcomes of DOACs, defining the indications for DOACs testing and the overall monitoring process., conditionsModule conditions: Pulmonary Embolism, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Rivaroxaban, outcomesModule primaryOutcomes measure: Bleeding events, primaryOutcomes measure: Recurrent thromboembolic events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 120 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking Union Medical College Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100730, country: China, contacts name: Juhong Shi, M.D, role: CONTACT, phone: +8613701178492, email: [email protected], contacts name: Min Peng, M.D, role: CONTACT, phone: +8613581888792, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
protocolSection identificationModule nctId: NCT06362330, orgStudyIdInfo id: 2022-SR-471, briefTitle: Multi-parametric MRI in Patients of Bladder Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-07-01, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital with Nanjing Medical University, class: OTHER, descriptionModule briefSummary: Accurate preoperative detection of muscle-invasive bladder cancer remains a clinical challenge. The investigators aimed to develop and validate a knowledge-guided causal diagnostic network for the detection of muscle-invasive bladder cancer with multiparametric magnetic resonance imaging(MRI)., conditionsModule conditions: Muscle-invasive Bladder Cancer, conditions: Artificial Intelligence, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: magnetic resonance imaging, outcomesModule primaryOutcomes measure: Muscle-invasive bladder cancer, primaryOutcomes measure: Non-muscle-invasive bladder cancer, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Yu-Dong Zhang, status: RECRUITING, city: Nanjing, zip: 210029, country: China, contacts name: Yu-Dong Zhang, MD;PHD, role: CONTACT, phone: 15805151704, email: [email protected], geoPoint lat: 32.06167, lon: 118.77778, hasResults: False
protocolSection identificationModule nctId: NCT06362317, orgStudyIdInfo id: K5247, briefTitle: Toripalimab With or Without Lenvatinib or Chemotherapy in First-Line Treatment of Advanced Biliary Tract Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-06, primaryCompletionDateStruct date: 2025-03-06, completionDateStruct date: 2026-03-06, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Peking Union Medical College Hospital, class: OTHER, descriptionModule briefSummary: Explore the impact of the first-line application of Toripalimab with or without Lenvatinib or chemotherapy, on the survival, disease progression, and drug safety of patients with advanced biliary tract cancers, conditionsModule conditions: Biliary Tract Neoplasms Immunotherapy, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Toripalimab, interventions name: Lenvatinib, interventions name: Gemox Chemotherapy（Gemox or GC）, outcomesModule primaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Duration of response, secondaryOutcomes measure: Clinical benefit rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chinese Academy of Medical Sciences & Peking Union Medical College Hospital (CAMS&PUMCH), status: RECRUITING, city: Beijing, state: Beijing, zip: 100005, country: China, contacts name: Haitao Zhao, Professor, role: CONTACT, phone: +861069156042, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
protocolSection identificationModule nctId: NCT06362304, orgStudyIdInfo id: 2024-DG-01, briefTitle: 99mTc-CNDG SPECT/CT in Brain Tumors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Peking Union Medical College Hospital, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the value of 99mTc-CNDG for diagnosis of brain tumors by comparing it with 18F-FDG-PET. The main questions it aims to answer are:1. What is the diagnostic consistency between 99mTc-CNDG and 18F-FDG?2. What is the correlation between the SUVmax value of 99mTc-CNDG and tumor type?Participants will:Receive18F-FDG-PET and 99mTc-CNDG examination within 2 weeks before surgery. Obtain pathological diagnosis by surgery or biopsy as the gold standard., conditionsModule conditions: Intracranial Tumor, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: 99mTc-CNDG SPECT/CT, outcomesModule primaryOutcomes measure: SUVmax, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06362291, orgStudyIdInfo id: 2023IR27, briefTitle: Comparison of MRI AI-cTB Versus Routine cTB in Prostate Cancer Diagnosis: a Prospective Randomized Controlled Trial, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-01, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Peking University First Hospital, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare the cancer detection rates of MRI artificial intelligence-guided cTB (AI-cTB) and routine cTB, and explore the added value of using AI for the guidance of cTB. The main questions it aims to answer are:Does AI-cTB promote the accurate diagnosis and treatment of prostate cancer? What's the value of prostate MRI artificial intelligence assistant diagnosis system in developing the best scheme of prostate biopsy? What's the value of prostate MRI artificial intelligence assistant diagnosis system in predicting the pathological results of prostate targeted biopsy?Researchers will compare the cancer detection rates of AI-cTB and routine cTB to explore the added value of using AI for the guidance of cTB.Participants will:Receive AI-cTB or routine cTB., conditionsModule conditions: Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 340, type: ESTIMATED, armsInterventionsModule interventions name: MRI-AI guided cognitive prostate targeted biopsy, interventions name: Routine cognitive prostate targeted biopsy, outcomesModule primaryOutcomes measure: The clinically significant prostate cancer (csPCa) detection rate for targeted biopsy (TB) and TB combined with systematic biopsy (SB), secondaryOutcomes measure: The PCa detection rate, secondaryOutcomes measure: The Gleason score (GS) of the biopsy sample, secondaryOutcomes measure: The GS of radical prostatectomy (RP) specimens, eligibilityModule sex: MALE, minimumAge: 45 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking University First Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100034, country: China, contacts name: Baowei Zhang, role: CONTACT, phone: +86 83572466, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
protocolSection identificationModule nctId: NCT06362278, orgStudyIdInfo id: 026, briefTitle: A Multi-omics Study of "Healthy" Premature CAD Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital with Nanjing Medical University, class: OTHER, descriptionModule briefSummary: The goal of this multi-center observational clinical trial is to investigate the genetic risk factors of patients with premature CAD and none traditional CAD risk factors through a multi-omics approach.The main questions it aims to answer are:* Genetic risk factors \& metabolic fingerprints of patients with premature CAD and none traditional CAD risk factors remain unknown.* How to optimize current primary prevention strategy for this rare CAD subgroup？, conditionsModule conditions: Coronary Artery Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: multi-omics studies, outcomesModule primaryOutcomes measure: common & rare variants associated with "healthy" pre-mature CAD phenotype, primaryOutcomes measure: Unique metabolomic fingerprints associated with "healthy" pre-mature CAD phenotype, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: First Affiliated Hospital of Nanjing Medical University, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210000, country: China, contacts name: Chunjian Li, Phd、MD, role: CONTACT, phone: +86 13701465229, email: [email protected], geoPoint lat: 32.06167, lon: 118.77778, locations facility: Qilu Hospital of Shangdong University, status: ACTIVE_NOT_RECRUITING, city: Jinan, state: Shandong, zip: 250012, country: China, geoPoint lat: 36.66833, lon: 116.99722, locations facility: The Second Affiliated Hospital of Zhejiang University Medical College, status: ACTIVE_NOT_RECRUITING, city: Hangzhou, state: Zhejiang, zip: 310009, country: China, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False
protocolSection identificationModule nctId: NCT06362265, orgStudyIdInfo id: 18437, secondaryIdInfos id: I8H-MC-BDDB, type: OTHER, domain: Eli Lilly and Company, briefTitle: A Study to Evaluate Pharmacokinetics of LY3209590 in Pediatric Participants With Type 2 Diabetes Mellitus, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-11, completionDateStruct date: 2026-11, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Eli Lilly and Company, class: INDUSTRY, descriptionModule briefSummary: The main purpose of this study is to evaluate how much of LY3209590 gets into the blood stream after a single dose and how long it takes the body to remove it in pediatric participants with Type 2 Diabetes Mellitus (T2DM). The study will last for approximately 100 days., conditionsModule conditions: Type 2 Diabetes Mellitus, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 22, type: ESTIMATED, armsInterventionsModule interventions name: LY3209590, outcomesModule primaryOutcomes measure: Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve (AUC) of LY3209590, primaryOutcomes measure: PK: Maximum Observed Plasma Concentration (Cmax) of LY3209590, secondaryOutcomes measure: Change from Baseline in Fasting Glucose, eligibilityModule sex: ALL, minimumAge: 10 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Honor Health Research Institute, city: Scottsdale, state: Arizona, zip: 85258, country: United States, geoPoint lat: 33.50921, lon: -111.89903, locations facility: Children's Hospital Los Angeles, city: Los Angeles, state: California, zip: 90027, country: United States, geoPoint lat: 34.05223, lon: -118.24368, locations facility: Children's Healthcare of Atlanta - Center for Advanced Pediatrics, city: Atlanta, state: Georgia, zip: 30329, country: United States, geoPoint lat: 33.749, lon: -84.38798, locations facility: University of Louisville, Norton Children's Research Institute, city: Louisville, state: Kentucky, zip: 40202, country: United States, geoPoint lat: 38.25424, lon: -85.75941, locations facility: Johns Hopkins University School of Medicine, city: Baltimore, state: Maryland, zip: 21287, country: United States, geoPoint lat: 39.29038, lon: -76.61219, locations facility: Joslin Diabetes Center, city: Boston, state: Massachusetts, zip: 02215, country: United States, geoPoint lat: 42.35843, lon: -71.05977, locations facility: UBMD Pediatrics, city: Buffalo, state: New York, zip: 14203, country: United States, geoPoint lat: 42.88645, lon: -78.87837, locations facility: NYU Langone, city: New York, state: New York, zip: 10016, country: United States, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Cincinnati Children's Hospital Medical Center, city: Cincinnati, state: Ohio, zip: 45229, country: United States, geoPoint lat: 39.12713, lon: -84.51435, locations facility: Children's Hospital of Philadelphia, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, geoPoint lat: 39.95233, lon: -75.16379, hasResults: False
protocolSection identificationModule nctId: NCT06362252, orgStudyIdInfo id: DS7300-189, secondaryIdInfos id: 2023-509629-36, type: OTHER, domain: EU CT, briefTitle: A Study of I-DXd in Combination With Atezolizumab With or Without Carboplatin as First-Line Induction or Maintenance in Subjects With Extensive Stage-Small Cell Lung Cancer (IDeate-Lung03), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-17, primaryCompletionDateStruct date: 2026-11-30, completionDateStruct date: 2026-12-30, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Daiichi Sankyo, class: INDUSTRY, collaborators name: Merck Sharp & Dohme LLC, descriptionModule briefSummary: This study is designed to evaluate the safety and efficacy of ifinatamab deruxtecan (I-DXd) in combination with immune checkpoint inhibitor (ICI) atezolizumab with or without carboplatin in participants with extensive stage-small cell lung cancer (ES-SCLC) in the first-line (1L) setting., conditionsModule conditions: Extensive Stage-small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 149, type: ESTIMATED, armsInterventionsModule interventions name: Ifinatamab deruxtecan, interventions name: Atezolizumab, interventions name: Carboplatin, interventions name: Etoposide, outcomesModule primaryOutcomes measure: Number of Participants Reporting Dose-limiting Toxicities Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A), primaryOutcomes measure: Overall Number of Participants With Treatment-emergent Adverse Events Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B), secondaryOutcomes measure: Progression-free Survival As Assessed by Blinded Independent Central Review and Investigator Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B), secondaryOutcomes measure: Number of Participants With Objective Response Rate Assessed by Blinded Independent Central Review and Investigator Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B), secondaryOutcomes measure: Duration of Response As Assessed by Blinded Independent Central Review and Investigator Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B), secondaryOutcomes measure: Disease Control Rate As Assessed by Blinded Independent Central Review and Investigator Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B), secondaryOutcomes measure: Clinical Benefit Rate as Assessed by Blinded Independent Central Review and Investigator Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B), secondaryOutcomes measure: Time to Response As Assessed by Blinded Independent Central Review and Investigator Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B), secondaryOutcomes measure: Best Percentage Change in the Sum of Diameters (SoD) of Measurable Tumors As Assessed by Blinded Independent Central Review and Investigator Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B), secondaryOutcomes measure: Overall Survival Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B), secondaryOutcomes measure: Pharmacokinetic Parameter Maximum Serum Concentration of I-DXd, secondaryOutcomes measure: Pharmacokinetic Parameter Time to Maximum Serum Concentration of I-DXd, secondaryOutcomes measure: Pharmacokinetic Parameter Area Under the Concentration Curve of I-DXd, secondaryOutcomes measure: The Number of Participants Who Are Anti-Drug Antibody (ADA)-Positive At Any Time and Who Have A Treatment-emergent Anti-Drug Antibody, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06362239, orgStudyIdInfo id: STUDY00003853, briefTitle: Prospective Home-Based Palliative Care and Hospice Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-10, completionDateStruct date: 2027-10, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Steven Smith, class: OTHER, collaborators name: Akron Children's Hospital, collaborators name: Medical University of South Carolina, collaborators name: Nemours Children's Hospital, collaborators name: Baylor College of Medicine, descriptionModule briefSummary: The purpose of this study is to test the hypothesis that the addition of home-based hospice and palliative care (HBHPC) will provide a reduction in health care utilization, improve quality of life, and facilitate goal-concordant care that is superior to inpatient and clinic pediatric palliative care (PPC) alone., conditionsModule conditions: Pediatric Palliative Care, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: Study Surveys, outcomesModule primaryOutcomes measure: Hospital Utilization Differences, secondaryOutcomes measure: Demographic Differences, secondaryOutcomes measure: Location of death differences, eligibilityModule sex: ALL, maximumAge: 19 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06362226, orgStudyIdInfo id: HM20029491, briefTitle: OPTIMIZING OCULAR OUTCOMES: A DUAL-ARMED STUDY FOR PERIORBITAL BURN MANAGEMENT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-08, completionDateStruct date: 2026-10, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Virginia Commonwealth University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to evaluate the effectiveness in using subcutaneous 5-FU/Kenalog \& antibiotic ointment with vitamin E as different therapeutic adjuncts in the prevention of pathologic remodeling after periorbital burns., conditionsModule conditions: Periorbital Burns, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Steroid/Antibiotic, interventions name: 5-FU/Kenalog, outcomesModule primaryOutcomes measure: Comparison of wound healing time, primaryOutcomes measure: Comparison of infection rate, primaryOutcomes measure: Comparison of complication rates, secondaryOutcomes measure: Comparison of pain level, secondaryOutcomes measure: Comparison of quality of life, secondaryOutcomes measure: Comparison of cosmetic outcome through the Vancouver scar scale (VSS), secondaryOutcomes measure: Comparison of cosmetic outcome through the Patient Observer Scar Assessment Scale (POSAS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06362213, orgStudyIdInfo id: NL76924.029.22, briefTitle: Gaining Insight Into Dual Sensory Loss, acronym: DSL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Amsterdam UMC, location VUmc, class: OTHER, collaborators name: Royal Dutch Visio, descriptionModule briefSummary: The goal of this observational study is to explore difficulties in information access, mobility, communication and fatigue in people with combined vision and hearing impairments. The main question it aims to answer is:• What influence do varying severities of vision and hearing loss have on information access, mobility, communication and fatigue.Participants will fill out questionnaires and the researchers will measure their vision and hearing functions., conditionsModule conditions: Dual Sensory Impairment of Vision and Hearing, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: information access, primaryOutcomes measure: mobility, primaryOutcomes measure: communication, primaryOutcomes measure: fatigue, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Amsterdam UMC, location VUmc, city: Amsterdam, state: Noord Holland, zip: 1081 HV, country: Netherlands, geoPoint lat: 52.37403, lon: 4.88969, hasResults: False
protocolSection identificationModule nctId: NCT06362200, orgStudyIdInfo id: LYG20230083, briefTitle: The Validation and Biological Index Studies on the Improved Social Function of ASD by 40 Hz tACS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2028-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Central South University, class: OTHER, descriptionModule briefSummary: In this proposed study, tACS will be used to intervene in the autism spectrum disorders of children and adolescents, and the efficacy of this intervention method will be evaluated, as well as the internal mechanism of adolescents' autism spectrum disorders will be discussed., conditionsModule conditions: Autism Spectrum Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: 40 Hz tACS intervention, outcomesModule primaryOutcomes measure: Autism assessment assessment index, secondaryOutcomes measure: EEG physiological detection index, secondaryOutcomes measure: Magnetic resonance detection index, secondaryOutcomes measure: Eye movement index, secondaryOutcomes measure: Emotion recognition index, secondaryOutcomes measure: Understanding of social interaction index, secondaryOutcomes measure: Understanding of thoughts and intentions index, secondaryOutcomes measure: Social Communication Changes index, secondaryOutcomes measure: Stereotyped behavior index, secondaryOutcomes measure: Sensory index, secondaryOutcomes measure: Abnormal behavior indicator, secondaryOutcomes measure: Sleep index, otherOutcomes measure: Plasma Metabolite Levels Assessment, otherOutcomes measure: Safety evaluation SAFTEE indicator, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06362187, orgStudyIdInfo id: STUDY00003238, briefTitle: VR Pilot for Pancreatitis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Cedars-Sinai Medical Center, class: OTHER, descriptionModule briefSummary: The purpose of the research is to test the feasibility and preliminary impact of a home-based, standardized, gut-directed, virtual reality cognitive behavioral therapy (VR CBT) on clinical and functional outcomes of patients with chronic pancreatitis (CP) and recurrent acute pancreatitis (RAP) pain. The primary research procedures are questionnaires and biometric Fitbit data. The study will enroll adult patients with CP or RAP., conditionsModule conditions: Chronic Pancreatitis, conditions: Recurrent Pancreatitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, double-blind, controlled, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Gut Directed VR, interventions name: Sham Control VR, outcomesModule primaryOutcomes measure: Feasibility of home-based VR, secondaryOutcomes measure: Impact of home-based VR, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Marissa Podell, city: Los Angeles, state: California, zip: 90048, country: United States, geoPoint lat: 34.05223, lon: -118.24368, hasResults: False
protocolSection identificationModule nctId: NCT06362174, orgStudyIdInfo id: SHEBA-22-9902-SBH-CTIL, briefTitle: Capsule & Omics for pRedicting Exacerbation of Crohn's Disease, acronym: CORE-CD, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-02-07, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Sheba Medical Center, class: OTHER_GOV, descriptionModule briefSummary: The research group have previously evaluated the benefit of serial consecutive capsule endoscopy as monitoring tool for Crohn's disease in remission, demonstrating its superior accuracy for disclosing inflammation and for prediction of flares in comparison to other diagnostic modalities such as magnetic resonance enterography and inflammatory biomarkers. Subsequently, deep learning algorithms had developed to provide excellent accuracy for identification and grading of ulcers and intestinal strictures on capsule endoscopy still images. The investigators will advance this knowledge using a parallel two-parts approach., conditionsModule conditions: Crohn's Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 62, type: ACTUAL, outcomesModule primaryOutcomes measure: Crohn's Disease Activity Index score (CDAI), primaryOutcomes measure: Disease related complications, primaryOutcomes measure: disease related hospitalization, primaryOutcomes measure: Change of crohn's disease medications, primaryOutcomes measure: opinion of the principle investigator (PI) or the treating physician, secondaryOutcomes measure: The rate of clinical flare accompanied by objective signs of mucosal inflammation., secondaryOutcomes measure: The rate of inflammatory worsening with/without accompanying clinical symptoms, eligibilityModule sex: ALL, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sheba Medical Center, city: Tel-Hashomer, country: Israel, geoPoint lat: 32.04195, lon: 34.85623, hasResults: False
protocolSection identificationModule nctId: NCT06362161, orgStudyIdInfo id: IRB-300011066, briefTitle: Establishment of an Interdisciplinary Functional Neurological Disorder (FND) Treatment Program and Development of a Clinical Care Pathway for FND, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2028-05-01, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: University of Alabama at Birmingham, class: OTHER, descriptionModule briefSummary: The purpose of this study is to help providers develop an interdisciplinary treatment pathway for functional neurological disorder (FND) at University of Alabama at Birmingham (UAB), and will involve psychiatry, speech therapy, physical therapy, and occupational therapy. The study will also help providers to evaluate the treatment pathway and publish results regarding the process and outcomes., conditionsModule conditions: Functional Neurological Disorder, conditions: Convulsion, Non-Epileptic, conditions: Functional Seizure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 1100, type: ESTIMATED, outcomesModule primaryOutcomes measure: Patient Demographic Information, primaryOutcomes measure: Hospital Anxiety and Depression Scale (HADS), primaryOutcomes measure: ASM 121 functional assessment definitions, primaryOutcomes measure: SF-36 (subjective health and wellbeing), primaryOutcomes measure: Work and Social Adjustment Scale (WSAS), primaryOutcomes measure: Patient Health Questionnaire 15, primaryOutcomes measure: Dizziness Handicap Inventory, primaryOutcomes measure: Dizziness Symptom Profile, primaryOutcomes measure: Adult Tic Questionnaire (ATQ), primaryOutcomes measure: Child Self-Report Tic Questionnaire, primaryOutcomes measure: Parent Tic Questionnaire (PTQ), primaryOutcomes measure: Seizure Questionnaire, primaryOutcomes measure: Level 2-Somatic Symptom report, primaryOutcomes measure: Revised Children's Anxiety and Depression Scale (RCADS), primaryOutcomes measure: Functional Disability Inventory (FDI), primaryOutcomes measure: Impact on the Family Scale, primaryOutcomes measure: Pediatric Quality of Life (Peds-QL), primaryOutcomes measure: Healthcare Utility Questionnaire, primaryOutcomes measure: Assessment of control over symptoms, eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 89 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Alabama at Birmingham, city: Birmingham, state: Alabama, zip: 35294, country: United States, contacts name: Michelle Bumpers, role: CONTACT, geoPoint lat: 33.52066, lon: -86.80249, hasResults: False
protocolSection identificationModule nctId: NCT06362148, orgStudyIdInfo id: 1-10-72-134-23, briefTitle: Circulating Tumor DNA in Peripheral T-cell Lymphomas, acronym: CIRCULATE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2030-12, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University of Aarhus, class: OTHER, collaborators name: Aarhus University Hospital, descriptionModule briefSummary: The aim of this study is to evaluate the feasibility of circulating tumor DNA (ctDNA) measurement in blood plasma for the applicability in prognostication, treatment evaluation and measurable residual disease (MRD) surveillance in a cohort of patients with newly diagnosed or relapsed/refractory peripheral T-cell lymphomas (PTCL)., conditionsModule conditions: Peripheral T-cell Lymphoma, conditions: NK/T-Cell Lymphoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Tumor- and plasma-informed, next-generation sequencing (NGS)-based patient-specific droplet digital (dd)PCR assay, interventions name: 18F-fludeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT), outcomesModule primaryOutcomes measure: ctDNA occurrence, primaryOutcomes measure: ctDNA quantification, secondaryOutcomes measure: Progression free survival, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Radiographic assessment by PET/CT, secondaryOutcomes measure: Comparison of molecular and radiographic response, secondaryOutcomes measure: Spatial and temporal mutational homo- or heterogeneity, secondaryOutcomes measure: Fragment pattern analysis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Hematology, Aarhus University Hospital, status: RECRUITING, city: Aarhus, state: Central Denmark Region, zip: 8200, country: Denmark, contacts name: Patrick R Noerhave, MD, role: CONTACT, phone: +4551543715, email: [email protected], contacts name: Francesco A d'Amore, MD, DMSc, role: CONTACT, phone: +4523708527, email: [email protected], contacts name: Patrick R Noerhave, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Martin B Pedersen, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Francesco A d'Amore, MD, DMSc, role: SUB_INVESTIGATOR, geoPoint lat: 56.15674, lon: 10.21076, hasResults: False
protocolSection identificationModule nctId: NCT06362135, orgStudyIdInfo id: 0733, briefTitle: Virtual Home Visits for Stroke Patients and Their Caregivers, acronym: INHABASAEV, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: The Scientific and Technological Research Council of Turkey, class: OTHER, descriptionModule briefSummary: The primary aim of this study is to evaluate the effectiveness of virtual home care for stroke patients and their caregivers. The secondary purpose is to evaluate the usability of the application by developing a mobile application for use in virtual home visits.The study will be carried out using the mixed research model, in which quantitative and qualitative methods are used together. The population of the research will consist of patients and caregivers with the diagnosis of hemorrhage, infarction, cerebrovascular accident and cerebral infarction, who applied to the Antalya Provincial Health Directorate Antalya Training and Research Hospital Home Health Unit, where the study is planned to be conducted. The sample of the study will consist of stroke patients and caregivers who meet the criteria for inclusion in the study. The first phase of the study was designed as a parallel group, single center and single blind randomized controlled trial to evaluate the effectiveness of virtual home visits in terms of time, cost and caregiver competence. The experimental group was the patient/patient relative group who made a virtual home visit, the control group will consist of 48 patients/patient relatives who have been visited face-to-face. In the second phase of the study, semi-structured interview method will be used to determine the views of patients/patient relatives about virtual home visits. In order to evaluate the usability of the developed application, a usability survey will be applied to the group that has visited the virtual home.With the results of this study, telemedicine applications in home care services will help to increase accessibility to home care services and reduce health care costs.considered to contribute. At the same time, it is expected that the results of the study will contribute to the scientific literature in the field of design and application of telemedicine services, which are developing and spreading, conditionsModule conditions: Stroke, conditions: Caregiver, conditions: Virtual, conditions: Home Visit, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel Assignment Virtual visit with stroke patient and their caregiver, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, maskingDescription: Telephone support or virtual meeting during the research process will be provided by an independent interviewer., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 96, type: ESTIMATED, armsInterventionsModule interventions name: Virtual Home Visit, interventions name: Control Group, outcomesModule primaryOutcomes measure: Effect of Virtual and Face to face to home visit, primaryOutcomes measure: Level of competence of stroke caregiver, primaryOutcomes measure: Frequency of unplanned hospital readmission, secondaryOutcomes measure: Effect of the virtual home visit, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Yasemin Demi̇r Avci̇, status: RECRUITING, city: Antalya, zip: 07058, country: Turkey, contacts name: Yasemin Demir Avcı, PhD, role: CONTACT, phone: +905514028492, email: [email protected], geoPoint lat: 36.90812, lon: 30.69556, hasResults: False
protocolSection identificationModule nctId: NCT06362122, orgStudyIdInfo id: PREDICTO-POLYP, briefTitle: Anatomo-clinico-biological Profiles in Severe Nasal Polyps, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2026-10-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Poitiers University Hospital, class: OTHER, descriptionModule briefSummary: Nasal sinus polyposis is a chronic inflammatory pathology of the nasal cavity and sinus cavities that causes bilateral and multifocal polyp development and has a prevalence of 2 to 4% in the general population.Therapeutic management consists of first-line medical treatment for anti-inflammatory purposes. Local corticosteroid therapy, using nasal sprays, is the background treatment. Surgical management is offered to patients in case of failure of medical treatment. Although effective, surgery does not protect patients from recurrence of symptoms related to regrowth of polyps. Recently, biologics have appeared, which despite its effectiveness, about 20% of patients have a partial or no response to these treatments. There is currently no possibility of determining the probability of response to treatments in patients.It is therefore essential to determine an anatomo-clinico-biological correlation associating the anatomopathological profile, the clinical characteristics and the cytokine signature in order to best guide the patient's management, including the initiation of biotherapy. Indeed, patients, according to their clinical, biological characteristics and the cytokine signature of their polyps will react differently to different treatments, including surgery and biotherapy. This correlation will serve as a predictor of treatment response., conditionsModule conditions: NASAL POLYPS, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: identification anatomo-clinico-biological profiles, outcomesModule primaryOutcomes measure: Identify anatomical profiles present in nasal sinus polyposis resistant to medical treatment., primaryOutcomes measure: Evaluation of symptoms related to nasal sinus polyposis by visual analogue scale, primaryOutcomes measure: Evaluation to quality of life by Sino-Nasal Outcome Test, primaryOutcomes measure: Identify biological profiles for patients with nasal sinus polyposis, primaryOutcomes measure: Evaluation to cytokine concentration in serum for patients with nasal sinus polyposis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06362109, orgStudyIdInfo id: Once tubefeeding, briefTitle: The Impact of Intermittent Nutritional Tube Supplementation in Elderly Patients With Dysphagia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Zhao Song Ling, class: OTHER_GOV, descriptionModule briefSummary: This is a prospective, randomized controlled clinical trail involved Elderly Patients With Dysphagia.The goal of this clinical trial is to compare the clinical effect of Intermittent Oro-esophageal Tube Feeding in Elderly Patients With Dysphagia. The main questions it aims to answer:Can Intermittent Nutritional Tube Supplementation help improve the nutritional status in Elderly Patients With Dysphagia.Participants will be divided into two groups randomly. All patients are given routine rehabilitation and the intervention group is given Intermittent Oro-esophageal Tube Feeding once a day., conditionsModule conditions: Dysphagia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Routine rehabilitation, interventions name: Intermittent Oro-esophageal Tube Feeding, outcomesModule primaryOutcomes measure: Nutritional status-prealbumin, secondaryOutcomes measure: Nutritional status-albumin, secondaryOutcomes measure: Nutritional status-hemoglobin, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06362096, orgStudyIdInfo id: pyrotinib diarrhra, briefTitle: A Multicenter, Prospective Study of Diarrhea Tolerance of Pyrotinib Combined With Trastumab and Taxane in the First-line Treatment of HER2-positive Advanced Breast Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Huihua Xiong, class: OTHER, descriptionModule briefSummary: To explore a reasonable and effective way to reduce the incidence of grade 3 or above diarrhea caused by pyrotinib, conditionsModule conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: Trastuzumab+pyrotinib+taxene, outcomesModule primaryOutcomes measure: Incidence of ≥ grade 3 diarrhea, eligibilityModule sex: ALL, minimumAge: 17 Years, maximumAge: 75 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06362083, orgStudyIdInfo id: 34-317 ex 21/22, briefTitle: Urethral Stricture Database, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-15, primaryCompletionDateStruct date: 2034-01-15, completionDateStruct date: 2034-03-15, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Medical University of Graz, class: OTHER, descriptionModule briefSummary: Establishment of a clinical urethral stricture database for a prospective longitudinal cohort study., conditionsModule conditions: Urethral Stricture, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Questionnaires and data collection, outcomesModule primaryOutcomes measure: Success rate of urethral reconstructive surgeries, secondaryOutcomes measure: Complications of urethral reconstructive surgeries, secondaryOutcomes measure: Sexual function after urethral reconstructive surgeries, secondaryOutcomes measure: Health status after urethral reconstructive surgeries, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Röthl Martina Anna, status: RECRUITING, city: Graz, state: Styria, zip: 8036, country: Austria, contacts name: Marianne Leitsmann, Prof. Dr., role: CONTACT, phone: +43 316 385 80550, email: [email protected], contacts name: Marianne Leitsmann, Prof. Dr., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.06667, lon: 15.45, hasResults: False
protocolSection identificationModule nctId: NCT06362070, orgStudyIdInfo id: COMPAR-G, briefTitle: Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Gastrectomy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-31, primaryCompletionDateStruct date: 2024-03-30, completionDateStruct date: 2025-07-31, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Azienda Ospedaliera Universitaria Integrata Verona, class: OTHER, descriptionModule briefSummary: The object of this exploratory clinical trial is to evaluate intra and post-operative complications in a population that underwent Robotic Gastrectomy, with multiple platforms:* DaVinci;* Hugo;* Versius.This study is divided into two phases: in the first phase, gastrectomy will be performed using both the new platforms (Hugo and Versius) and the standard platform (Da Vinci), to evaluate the feasibility of the surgical procedure. In the second phase, the three platforms will be compared to evaluate any differences in the learning curve for an upper-GI surgeon, expert in laparoscopic surgery but not with robotic one.The questions it aims to answer are:* Are differences (intra-operative, post-operative, oncological, functional, technical, and economic) among the three different platforms observable?* Are there any differences between the three platforms related to the learning curve for surgeons?Participants will be enrolled, after obtaining informed consent, in one of the following cohorts:1. surgery with the daVinci platform;2. surgery with the Hugo platform;3. surgery with the Versius platform., conditionsModule conditions: Gastric Cancer, conditions: Gastrointestinal Cancer, conditions: Neoplasms, conditions: Gastric Diffuse Adenocarcinoma, conditions: Gastric Neoplasm, conditions: Stomach Adenocarcinoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule interventions name: DaVinci® Surgical System, interventions name: Hugo™ RAS System, interventions name: Versius® Robotic Surgery System, outcomesModule primaryOutcomes measure: Conversion rate to open or laparoscopic approach (Phase 1), primaryOutcomes measure: Number of participants with major intraoperative complications (Phase 1), primaryOutcomes measure: Evaluation of surgical times of the standardized procedures (Phase 2), primaryOutcomes measure: Analysis of video of surgical procedures (Phase 2), secondaryOutcomes measure: Estimated Blood Loss, secondaryOutcomes measure: Overall duration of the surgery, secondaryOutcomes measure: Anesthesia, Lymphadenectomy, Gastrectomy (10 different surgical steps), secondaryOutcomes measure: Number of participants with major postoperative complications, secondaryOutcomes measure: Compliance rate to ERAS protocol, secondaryOutcomes measure: Postoperative hospitalization, secondaryOutcomes measure: Postoperative pain, secondaryOutcomes measure: Re-admission rate to hospitalization, secondaryOutcomes measure: Damage due to positioning, secondaryOutcomes measure: Positive Surgical Margin, secondaryOutcomes measure: Lymph nodes resection, secondaryOutcomes measure: Quality of Life Evaluation, secondaryOutcomes measure: Time taken for platform-related technical steps, secondaryOutcomes measure: Possible malfunction of the platform, secondaryOutcomes measure: Non-Technical Skills Assessment (NTS) demonstrated by members of the surgical team during the intraoperative phase., secondaryOutcomes measure: Procedure-related costs, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: General and Upper GI Unit, status: RECRUITING, city: Verona, zip: 37126, country: Italy, contacts name: Simone SG Giacopuzzi, MD, Prof, role: CONTACT, phone: +39 0458127510, email: [email protected], contacts name: Simone Giacopuzzi, MD, Prof, role: PRINCIPAL_INVESTIGATOR, contacts name: Maria Bencivenga, MD, Prof, role: SUB_INVESTIGATOR, geoPoint lat: 45.4299, lon: 10.98444, hasResults: False
protocolSection identificationModule nctId: NCT06362057, orgStudyIdInfo id: ADMNF-0020324, briefTitle: Biomechanical Effects of Digitally Constructed Subperiosteal Implants, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-04, primaryCompletionDateStruct date: 2024-06-20, completionDateStruct date: 2024-07-27, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Menoufia University, class: OTHER, descriptionModule briefSummary: Subperiosteal implants were first introduced in 1940 and then used worldwide for the treatment of edentulous maxilla or mandible with advanced bone atrophy., conditionsModule conditions: Bone Loss, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: OTHER, enrollmentInfo count: 9, type: ESTIMATED, armsInterventionsModule interventions name: Subperiosteal implant framework, outcomesModule primaryOutcomes measure: bone loss under the implants, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mohammed A. El-Sawy, status: RECRUITING, city: Mansoura, zip: 12345, country: Egypt, contacts name: Mohammed A. El-Sawy, PhD, role: CONTACT, phone: 161314522, email: [email protected], contacts name: PhD, role: CONTACT, geoPoint lat: 31.03637, lon: 31.38069, hasResults: False
protocolSection identificationModule nctId: NCT06362044, orgStudyIdInfo id: P24-120, briefTitle: A Study to Assess Frequency of Undetectable Minimal Residual Disease (uMRD) in Adult Participants With Chronic Lymphocytic Leukemia (CLL) Receiving Oral Venetoclax Tablets ± Intravenously (IV) Infused Rituximab in Routine Clinical Practice in Japan, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-07, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: AbbVie, class: INDUSTRY, descriptionModule briefSummary: Most cases of Chronic lymphocytic leukemia (CLL) remain an incurable disease with the goal of therapy being to improve quality of life and to prolong survival. This study will evaluate the participant's related outcomes and experience of CLL in adult participants who are treated in the Japan.Study participants will receive oral treatments of Venetoclax±Rituximab for CLL as prescribed by their study doctor in accordance with approved local label. Adult participants prescribed various treatments Venetoclax±Rituximab will be enrolled. Around 89 participants will be enrolled in the study in sites in Japan.Participants will receive oral venetoclax tablets ± intravenously (IV) infused rituximab treatments for CLL according to the approved local label. The overall study duration will be 27 months.There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice., conditionsModule conditions: Chronic Lymphocytic Leukemia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 89, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Percentage of Participants with Undetectable Minimal Residual Disease (uMRD), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Cancer Center Hospital East /ID# 265970, status: RECRUITING, city: Kashiwa, state: Chiba, zip: 277-8577, country: Japan, geoPoint lat: 35.86224, lon: 139.97732, hasResults: False
protocolSection identificationModule nctId: NCT06362031, orgStudyIdInfo id: H18.Oncology.12-SR1812, briefTitle: A Study to Explore Treatment Patterns, Treatment Outcomes, Healthcare Resource Utilization in Adult Participants With Acute Myeloid Leukemia (AML) Receiving Venetoclax Through Chart Review, statusModule overallStatus: WITHDRAWN, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: AbbVie, class: INDUSTRY, descriptionModule briefSummary: Acute myeloid leukemia (AML), also referred to as acute myelogenous leukemia or acute non-lymphocytic leukemia, is a relatively rare, yet aggressive, type of cancer. This study will evaluate treatment patterns, treatment outcomes, healthcare resource utilization in adult participants with AML receiving venetoclax.Data from up to 700 participants will be collected. No participants will be enrolled in this study.Participants' charts will be reviewed. No drug will be administered as a part of this study. The duration of the observation period is up to 10 months.There is no additional burden for participants in this trial. All visits must be completed prior to data extraction and participants will be followed for up to 10 months., conditionsModule conditions: Acute Myeloid Leukemia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 0, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Overall Survival (OS), primaryOutcomes measure: Event-free survival (EFS), primaryOutcomes measure: Percentage of Participants Achieving Best Overall Response, primaryOutcomes measure: Duration of Response (DoR), primaryOutcomes measure: Percentage of Participants with Transfusion Independence (TI), secondaryOutcomes measure: Number of Participants with Healthcare Resource Utilization (HRU), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 89 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06362018, orgStudyIdInfo id: MHC/CT/23-24/055, secondaryIdInfos id: MHC/CT/23-24/055, Version No.:, type: OTHER, domain: Mprex Healthcare Pvt. Ltd., briefTitle: Bioavailability of Three Mitopure Formulations, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-09, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Amazentis SA, class: INDUSTRY, collaborators name: Mprex Healthcare Pvt. Ltd., descriptionModule briefSummary: This study's design as an open-label, single-dose, randomized trial that aligns with the objective of characterizing the concentration-time profiles of three Urolithin A (Mitopure) formulations in a controlled setting. The inclusion criteria, stringent fasting requirements, standardized fluid intake and strict dietary restriction protocols ensure homogeneity among the study participants, enhancing the reliability of the outcomes.Ultimately, this clinical trial aims to contribute valuable insights into the pharmacokinetic behavior of the different Urolithin A formulations, facilitating informed decisions for future developments and applications in the realm of health and wellness., conditionsModule conditions: Healthy Adults, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Mitopure (Urolithin A), outcomesModule primaryOutcomes measure: Plasma concentrations of Urolithin A over time and maximal plasma concentration (Cmax), primaryOutcomes measure: Exposure to Urolithin A over time measured as area under the curve (AUC), secondaryOutcomes measure: Number of adverse events and serious adverse events throughout the study., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Lokmanya Medical Research Centre and Hospital, city: Pune, zip: 411033, country: India, contacts name: Dr Ramshyam Agarwal, MD, role: CONTACT, geoPoint lat: 18.51957, lon: 73.85535, hasResults: False
protocolSection identificationModule nctId: NCT06362005, orgStudyIdInfo id: AUAREC2023011-1, briefTitle: The Efficacy of Selenium as an Alternative or Complementary Topical Treatment of Oral Lichen Planus, acronym: RCT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Al-Azhar University, class: OTHER, collaborators name: Sphinx university, descriptionModule briefSummary: evaluate clinically and biochemically the efficacy of topically applied selenium as complementary or alternative to triamcinolone acetonide 0.1% and tacrolimus 0.1% in patients with oral lichen planus., conditionsModule conditions: Lichen Planus, Oral, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Triamcinolone Acetonide 0.1% Oint, interventions name: Tacrollimus Topical, interventions name: Selenium, interventions name: Selenium & Triamcinolone Acetonide 0.1% Oint, interventions name: Selenium& Tacrollimus topical, outcomesModule primaryOutcomes measure: to assess a visual analog scale (VAS)of the oral lichen planus lesion, secondaryOutcomes measure: to assess The associated Oral Disease Severity Score 3- Glutathione biomarker level as an antioxidant enzyme in saliva by ELISA analysis, secondaryOutcomes measure: Biochemical evaluation of salivary Glutathione level using (ELISA), eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Alazhar university ,faculty of Dental Medicine, city: Assiut, zip: 0000, country: Egypt, geoPoint lat: 27.18096, lon: 31.18368, hasResults: False
protocolSection identificationModule nctId: NCT06361992, orgStudyIdInfo id: BC_SERBIA_2022, briefTitle: Efficacy and Safety of Blue Cap for the Treatment of Atopic Dermatitis in Children, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-03-15, primaryCompletionDateStruct date: 2023-09-15, completionDateStruct date: 2024-02-13, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Catalysis SL, class: INDUSTRY, descriptionModule briefSummary: To verify the efficacy and tolerability of Activated Piroctone Olamine (Blue Cap Foam, label volume 100 ml) by CATALYSIS, S. L. Madrid, applied in the management of all types of dermatitis (atopic, seborrheic, eczema) in patients with significant manifestations of the disease in varying areas of the body of varying extent and to assess differences in individual tolerability and the final effect in a group of selected patients aged 3 to 18 years., conditionsModule conditions: Atopic Dermatitis, conditions: Atopic Dermatitis and Related Conditions, conditions: Atopic Dermatitis Eczema, conditions: Atopic Dermatitis \(AD\), designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 58, type: ACTUAL, armsInterventionsModule interventions name: Blue Cap Foam, outcomesModule primaryOutcomes measure: Grade of Patient Tolerability to the investigation product, primaryOutcomes measure: Clinical Improvement of Patients with Dermatitis, primaryOutcomes measure: Clinical assessment of symptoms and sings associated with Dermatitis, secondaryOutcomes measure: Evaluation of the therapeutic effect of Blue Cap in paediatric patients with dermatitis., secondaryOutcomes measure: Evaluation of the therapeutic effect of Blue Cap on healing of the skin at the patients, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: University of Niš Faculty of Medicine, Department of Dermatology and Venereology, University Clinical Center of Niš, city: Niš, state: Nišava, zip: 18108, country: Serbia, geoPoint lat: 43.32472, lon: 21.90333, locations facility: City Institute for Skin and Venereal Diseases Belgrade, city: Belgrade, zip: 11000, country: Serbia, geoPoint lat: 44.80401, lon: 20.46513, locations facility: University of Belgrade Faculty of Medicine, University Clinical Center of Serbia, city: Belgrade, zip: 11000, country: Serbia, geoPoint lat: 44.80401, lon: 20.46513, hasResults: False
protocolSection identificationModule nctId: NCT06361979, orgStudyIdInfo id: A1811, briefTitle: SHR-A1811 Combined With Bevacizumab in HER2-positive Breast Cancer With Brain Metastases, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Huihua Xiong, class: OTHER, descriptionModule briefSummary: This study aimed to evaluate the use of SHR-A1811 and bevacizumab in HER2-positive Breast Cancer with brain metastases, conditionsModule conditions: Breasr Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: SHR-A1811, interventions name: Bevacizumab, outcomesModule primaryOutcomes measure: CNS-ORR, secondaryOutcomes measure: PFS, secondaryOutcomes measure: ORR, secondaryOutcomes measure: AE, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06361966, orgStudyIdInfo id: 2021/00638, briefTitle: Evaluating User Satisfaction and Feasibility of a Remote Model for 3d Scanned and Printed Transtibial Prosthetic Sockets, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-11, primaryCompletionDateStruct date: 2023-01-09, completionDateStruct date: 2023-01-09, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Tan Tock Seng Hospital, class: OTHER, collaborators name: Prosfit Technologies JSC, collaborators name: Centre for Allied Health and Pharmacy Excellence (CAPE), descriptionModule briefSummary: The goal of this clinical trial is to investigate the repeatability of application of a fully remote method of manufacturing 3D printing of prosthetic sockets for transtibial amputees, and determine user satisfaction of sockets produced through these methods. The study also aims to evaluate the time and cost effectiveness of this production model.The main question\[s\] it aims to answer are:1. To determine the repeatability and user satisfaction with transtibial sockets produced using a remote-digital method as compared to conventional manufacturing methods.2. To determine if transtibial prosthetic users have greater prosthetic satisfaction scores across the 4 Prosthesis Evaluation Questionnaire (PEQ) subscales of Utility (UT), Appearance (AP), Sounds (SO) and Residual Limb Health (RL) with the 3D printed socket fabricated through the remote-digital method compared to the laminate socket made using the conventional method.3. To determine if transtibial prosthetic users experience greater socket comfort with the 3D printed socket compared to the laminate socket.Participants will receive a 3D printed socket (trial intervention) and a laminate socket (control intervention) and will use each socket for a period of 4 weeks.The order of socket use will be randomised. At the end of each 4 week period, participants will rate their comfort and satisfaction with the socket. At the end of the trial, participants will indicate their preferred socket, which will be fitted to their prosthesis.Participants will attend 6 visits across a total duration of 11 weeks during the course of the study., conditionsModule conditions: Amputation, conditions: Prosthesis User, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 16, type: ACTUAL, armsInterventionsModule interventions name: 3d printed prosthetic socket, outcomesModule primaryOutcomes measure: Prosthesis Evaluation Questionnaire, primaryOutcomes measure: Socket Comfort Score, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tan Tock Seng Hospital, city: Singapore, zip: 308433, country: Singapore, geoPoint lat: 1.28967, lon: 103.85007, hasResults: False
protocolSection identificationModule nctId: NCT06361953, orgStudyIdInfo id: IR.SBMU.MSP.REC. 1401. 161, briefTitle: Comparing the Efficacy of Two Neurofeedback Protocols for Generalized Anxiety Disorder, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-06-01, primaryCompletionDateStruct date: 2023-07-01, completionDateStruct date: 2023-07-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Shahid Beheshti University of Medical Sciences, class: OTHER, descriptionModule briefSummary: Generalized anxiety disorder (GAD) is one of the most prevalent mental disorders in adults, marked by excessive and uncontrollable worry about various events or activities. It is accompanied by symptoms such as restlessness, irritability, fatigue, difficulty concentrating, problems with sleep, and somatic symptoms.In addition, a critical and up-to-date comparison of different treatments for GAD is crucial due to their high costs and unsatisfactory outcomes. EEG neurofeedback training has not reached the same level of evidence as more extensively validated non-pharmacological treatments, such as cognitive behavioral therapy.This study aimed to compare the efficacy of two protocols: one targeting alpha-theta amplitude increase and the other concentrating on SMR., conditionsModule conditions: Generalized Anxiety Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: EEG Neurofeedback, outcomesModule primaryOutcomes measure: The Beck Anxiety Inventory, primaryOutcomes measure: The Perceived Stress Questionnaire, primaryOutcomes measure: Spielberger's state-trait anxiety test, eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shahid Beheshti University of Medical Science, city: Tehran, zip: 4739-19395, country: Iran, Islamic Republic of, geoPoint lat: 35.69439, lon: 51.42151, hasResults: False
protocolSection identificationModule nctId: NCT06361940, orgStudyIdInfo id: IIT-CHAUDHARY-ENDOCRINE2-OPP, briefTitle: Molecular Analyses to Identify Pathways of Endocrine Resistance Following Short Term Neoadjuvant Endocrine Treatment in Patients With Hormone Receptor-Positive HER2-negative Breast Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2028-12, completionDateStruct date: 2029-12, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Medical College of Wisconsin, class: OTHER, descriptionModule briefSummary: This is an exploratory phase II interventional study that initiates standard-of-care anti-estrogen treatment preoperatively for 4-12 weeks (+/- 2 weeks)., conditionsModule conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Aromatase inhibitors or tamoxifen, outcomesModule primaryOutcomes measure: Change from baseline in the number of subjects with increased HER-1 receptor tyrosine kinases protein expression in tumors., primaryOutcomes measure: Change from baseline in the number of subjects with increased HER-2 receptor tyrosine kinases protein expression in tumors., primaryOutcomes measure: Change from baseline in the number of subjects with increased HER-3 receptor tyrosine kinases protein expression in tumors., primaryOutcomes measure: Change from baseline in the number of subjects with increased HER-4 receptor tyrosine kinases protein expression in tumors., eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Froedtert Hospital and the Medical College of Wisconsin, city: Milwaukee, state: Wisconsin, zip: 53226, country: United States, contacts name: Lubna N Chaudhary, MD, role: CONTACT, email: [email protected], geoPoint lat: 43.0389, lon: -87.90647, hasResults: False
protocolSection identificationModule nctId: NCT06361927, orgStudyIdInfo id: SSGJ-707-NSCLC-II-01, briefTitle: A Phase II Study of SSGJ-707 Monotherapy in First-line PD-L1 Positive Advanced NSCLC Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This study includes two cohorts, cohort A is for non-squamous NSCLC and cohort B is for squamous NSCLC., conditionsModule conditions: NSCLC, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: SSGJ-707, outcomesModule primaryOutcomes measure: ORR, secondaryOutcomes measure: Safety and tolerability, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Hunan Cancer Hospital, status: RECRUITING, city: Changsha, state: Hunan, country: China, contacts name: Lin Wu, MD,Ph.D, role: CONTACT, phone: 0731-89762302, email: [email protected], geoPoint lat: 28.19874, lon: 112.97087, hasResults: False
protocolSection identificationModule nctId: NCT06361914, orgStudyIdInfo id: 2314393, briefTitle: Digital CBT-I for Patients With Chronic Pain and Insomnia, acronym: Back2Sleep, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-12, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2026-09-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Odense University Hospital, class: OTHER, collaborators name: Aarhus University Hospital, collaborators name: University of Southern Denmark, collaborators name: University of Aarhus, collaborators name: Odense Patient Data Explorative Network, collaborators name: T&W Engineering A/S, descriptionModule briefSummary: Chronic pain constitutes an increasing health and social burden. More than 50% of patients with chronic pain report insomnia, and patients with comorbid insomnia often report stronger and widespread pain, compared to those who are sleeping well. Sleep disturbances are often considered a consequence to chronic pain. This means that insomnia is often overlooked or ineffectively managed with hypnotics or advice on sleep hygiene. Therefore, efficacious, easily accessible, and safe alternatives to the current pharmacological treatments for patients with chronic pain and insomnia are needed. Cognitive behavioral therapy for insomnia (CBT-I) is a cost-effective and safe treatment for insomnia and is recommended as first-line treatment. While highly efficacious, the challenge is to deliver CBT-I to those in need. The main barriers of face-to-face delivered CBT-I are availability of trained therapists, costs, as well as physical and geographical constraints.The primary aim of this randomized controlled clinical superiority trial is to investigate whether digitally-delivered CBT-I has a greater effect on insomnia and pain than digitally-delivered sleep hygiene education in patients with chronic pain and comorbid insomnia.Secondary objectives are to a) explore whether the pain-relieving effect is mediated by a change in physiological markers of sleep quality, b) whether health care cost and use of medications at 12 months are reduced after digital CBT-I, and c) to explore the effectiveness of digital CBT-I compared with sleep hygiene education on:1. Physiological sleep metrics (recorded with ear EEG in subsample of 60 patients).2. Self-reported sleep quality.3. Quality of life.4. Physical and mental health.5. Thoughts and beliefs about sleep and pain., conditionsModule conditions: Chronic Pain, conditions: Insomnia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: Digital CBT-I, interventions name: Digital Sleep hygiene education, outcomesModule primaryOutcomes measure: Insomnia severity, primaryOutcomes measure: Average pain intensity during the last 7 days, secondaryOutcomes measure: The trajectory of ISI severity scores, secondaryOutcomes measure: 30% ISI responders, secondaryOutcomes measure: 50% ISI responders, secondaryOutcomes measure: Weekly pain intensity score trajectory, secondaryOutcomes measure: 30% pain intensity responders, secondaryOutcomes measure: 50% pain intensity responders, secondaryOutcomes measure: Global Perceived Effect (GPE) for sleep, secondaryOutcomes measure: Global Perceived Effect (GPE) for pain, secondaryOutcomes measure: Sleep Quality, secondaryOutcomes measure: Physical and Mental Health, secondaryOutcomes measure: Sleep diary, secondaryOutcomes measure: Thoughts about sleep and pain, secondaryOutcomes measure: Thoughts about sleep, secondaryOutcomes measure: Treatment compliance, secondaryOutcomes measure: Health-related quality of life - mobility, secondaryOutcomes measure: Health-related quality of life - self care, secondaryOutcomes measure: Health-related quality of life - usual activities, secondaryOutcomes measure: Health-related quality of life - pain/discomfort, secondaryOutcomes measure: Health-related quality of life - anxiety/depression, secondaryOutcomes measure: Health-related quality of life - global, otherOutcomes measure: Age, otherOutcomes measure: Sex, otherOutcomes measure: Chronic pain, otherOutcomes measure: Ethnicity, otherOutcomes measure: Height, otherOutcomes measure: Weight, otherOutcomes measure: Marital status, otherOutcomes measure: Level of education, otherOutcomes measure: Pain distribution, otherOutcomes measure: Medical history and concomitant illnesses, otherOutcomes measure: Concomitant medication, otherOutcomes measure: Health-related quality of life - mobility, otherOutcomes measure: Health-related quality of life - self care, otherOutcomes measure: Health-related quality of life - usual activities, otherOutcomes measure: Health-related quality of life - pain/discomfort, otherOutcomes measure: Health-related quality of life - anxiety/depression, otherOutcomes measure: Health-related quality of life - global, otherOutcomes measure: Insomnia Severity, otherOutcomes measure: Average pain intensity during the last 7 days, otherOutcomes measure: Medication use, otherOutcomes measure: Economical evaluation, otherOutcomes measure: Time from sleep onset until final awakening (TST) from Ear EEG in subgroup of 60 patients, otherOutcomes measure: Sleep efficiency (SE) from Ear EEG in subgroup of 60 patients, otherOutcomes measure: Sleep onset latency (SOL) from Ear EEG in subgroup of 60 patients, otherOutcomes measure: Wake after sleep onset (WASO) from Ear EEG in subgroup of 60 patients, otherOutcomes measure: REM sleep latency from Ear EEG in subgroup of 60 patients, otherOutcomes measure: Time from sleep onset until first epoch of REM stage sleep from Ear EEG, otherOutcomes measure: Amount of wake and stage N1, N2, N3, and R sleep as a percentage of SPT from Ear EEG, otherOutcomes measure: Number of awakenings within TST from Ear EEG, otherOutcomes measure: Arousal index which is number of arousals per hour from Ear EEG, otherOutcomes measure: Ease-of-use and Comfort with ear EEG, otherOutcomes measure: Ear EEG adverse device effects, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pain Center, Department of Anesthesiology and Intensive Care Medicine, University Hospital Odense, status: RECRUITING, city: Odense, zip: 5000, country: Denmark, contacts name: Henrik B Vaegter, PhD, role: CONTACT, phone: 004565413869, email: [email protected], contacts name: Louise S Olsen, MSc, role: CONTACT, phone: 004565413869, email: [email protected], contacts name: Henrik B Vægter, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Louise S Olsen, MSc, role: SUB_INVESTIGATOR, geoPoint lat: 55.39594, lon: 10.38831, hasResults: False
protocolSection identificationModule nctId: NCT06361901, orgStudyIdInfo id: 2023GR0452, briefTitle: Comparison of Therapeutic Effect Between Speech Rehabilitation Program and Speech Therapy in Stroke Patients With Aphasia, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-17, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Korea University Guro Hospital, class: OTHER, descriptionModule briefSummary: Our study will provide precise and intensive speech rehabilitation treatment program to patients with speech disorders after stroke, and compare clinical evaluations with the conventional speech therapy patient group.Clinical evaluation tools will be performed before and after the treatment for all patients* K-Western Aphasia Battery for aphasia assessment tools* Cerebral blood flow changes with near-infrared spectroscopy, conditionsModule conditions: Stroke, conditions: Aphasia, conditions: Speech Therapy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Zenicog;language rehabilitation program, interventions name: Conventional language rehabilitation, outcomesModule primaryOutcomes measure: Aphasic quatient, secondaryOutcomes measure: Change of cerebral blood flow, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Rehabilitation Medicine, Korea University Guro Hospital, status: RECRUITING, city: Seoul, zip: 08308, country: Korea, Republic of, contacts name: Seung Nam Yang, MD, PhD, role: CONTACT, phone: 82-2-2626-1500, email: [email protected], geoPoint lat: 37.566, lon: 126.9784, hasResults: False
protocolSection identificationModule nctId: NCT06361888, orgStudyIdInfo id: 2023-012-00CH1, briefTitle: A Phase II/III Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine in Metastatic Pancreatic Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-31, primaryCompletionDateStruct date: 2027-08-31, completionDateStruct date: 2027-08-31, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Hutchmed, class: INDUSTRY, descriptionModule briefSummary: To evaluate the efficacy of Surufatnib combined withcamrelizumab, nab-paclitaxel, and gemcitabine versus nab-paclitaxel plus gemcitabine as the first-line treatment in metastatic pancreatic cancer, conditionsModule conditions: Metastatic Pancreatic Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 482, type: ESTIMATED, armsInterventionsModule interventions name: Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine, interventions name: Nab-paclitaxel Plus Gemcitabine, interventions name: Surufatinib with Nab-paclitaxel, and Gemcitabine, outcomesModule primaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Progression-free Survival (PFS) (RECIST1.1), secondaryOutcomes measure: Objective response rate (ORR)(RECIST1.1), secondaryOutcomes measure: Duration of response (DoR)(RECIST1.1), secondaryOutcomes measure: Disease control rate (DCR)(RECIST1.1), secondaryOutcomes measure: Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30), secondaryOutcomes measure: Cancer Quality of Life Questionnaire - PAN26(EORTC QLQ-PAN26), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nanjing Tianyinshan Hospital, city: Nanjing, state: Jiang Su, zip: 210000, country: China, contacts name: Shukui Qin, Prof., role: CONTACT, geoPoint lat: 32.06167, lon: 118.77778, locations facility: Tianjin Cancer Hospital, city: Tianjin, state: Tianjin, zip: 300000, country: China, contacts name: Jihui Hao, Prof., role: CONTACT, geoPoint lat: 39.14222, lon: 117.17667, hasResults: False
protocolSection identificationModule nctId: NCT06361875, orgStudyIdInfo id: VAV00045, secondaryIdInfos id: U1111-1295-2852, type: REGISTRY, domain: ICTRP, briefTitle: A Study to Investigate the Safety and Immunogenicity of the Quadrivalent Influenza mRNA Vaccines in Adults Aged 18 Years and Above, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-05-22, completionDateStruct date: 2025-05-22, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Sanofi Pasteur, a Sanofi Company, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular (IM) injection of different formulations of Quadrivalent Influenza Vaccine (QIV) messenger ribonucleic acid (mRNA) (MRT5421, MRT5424, and MRT5429) compared to an active control (QIV- standard dose (SD), QIV- high dose (HD) \[adults ≥ 65 years of age only\], or quadrivalent recombinant influenza vaccine (RIV4)) in adults 18 years of age and older., conditionsModule conditions: Influenza Immunization, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel with dose escalation for sentinel cohort, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, maskingDescription: Modified double-blind (Participants; Sites except for those preparing/administering study intervention; Sponsor's except Sponsor unblinded internal safety review committee), whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 1002, type: ESTIMATED, armsInterventionsModule interventions name: Quadrivalent Influenza mRNA Vaccine MRT5421, interventions name: Quadrivalent Influenza mRNA Vaccine MRT5424, interventions name: Quadrivalent Influenza mRNA Vaccine MRT5429, interventions name: Quadrivalent Influenza Standard Dose Vaccine, interventions name: Quadrivalent Influenza High-Dose Vaccine, interventions name: Quadrivalent Recombinant Influenza Vaccine, outcomesModule primaryOutcomes measure: Number of participants with immediate unsolicited systemic adverse events (AEs), primaryOutcomes measure: Number of participants with solicited injection site reactions, primaryOutcomes measure: Number of participants with solicited systemic reactions, primaryOutcomes measure: Number of participants with unsolicited AEs, primaryOutcomes measure: Number of participants with medically attended adverse events (MAAEs), primaryOutcomes measure: Number of participants with serious adverse events (SAEs), primaryOutcomes measure: AESIs reported throughout the study, primaryOutcomes measure: Number of participants with adverse events of special interests (AESIs), primaryOutcomes measure: Number of participants with out-of-range biological test results, primaryOutcomes measure: Geometric Mean Titer (GMT), primaryOutcomes measure: Geometric Mean of individual Titer Ratio (GMTR), primaryOutcomes measure: Seroconversion, primaryOutcomes measure: HAI Ab titer ≥ 40 (1/dil), secondaryOutcomes measure: Neutralizing Ab titers at D01 and D29, secondaryOutcomes measure: Individual neutralizing antibodies titer ratio, secondaryOutcomes measure: 2-fold and 4-fold increase in neutralizing titers, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Velocity Clinical Research Site Number : 8400048, status: RECRUITING, city: La Mesa, state: California, zip: 91942, country: United States, geoPoint lat: 32.76783, lon: -117.02308, locations facility: California Research Foundation Site Number : 8400038, status: RECRUITING, city: San Diego, state: California, zip: 92123-1881, country: United States, geoPoint lat: 32.71533, lon: -117.15726, locations facility: Accel Clinical Research-Deland Clinical Research Unit Site Number : 8400001, status: RECRUITING, city: DeLand, state: Florida, zip: 32720-0834, country: United States, geoPoint lat: 29.02832, lon: -81.30312, locations facility: Indago Research and Health Center Site Number : 8400032, status: RECRUITING, city: Hialeah, state: Florida, zip: 33012, country: United States, geoPoint lat: 25.8576, lon: -80.27811, locations facility: Research Centers of America Site Number : 8400037, status: RECRUITING, city: Hollywood, state: Florida, zip: 33024, country: United States, geoPoint lat: 26.0112, lon: -80.14949, locations facility: Suncoast Research Group, LLC Site Number : 8400015, status: RECRUITING, city: Miami, state: Florida, zip: 33135, country: United States, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Brengle Family Medicine Site Number : 8400045, status: RECRUITING, city: Indianapolis, state: Indiana, zip: 46260, country: United States, geoPoint lat: 39.76838, lon: -86.15804, locations facility: AMR Lexington Site Number : 8400042, status: RECRUITING, city: Lexington, state: Kentucky, zip: 40509, country: United States, geoPoint lat: 37.98869, lon: -84.47772, locations facility: Velocity Clinical Research Site Number : 8400053, status: RECRUITING, city: Metairie, state: Louisiana, zip: 70006, country: United States, geoPoint lat: 29.98409, lon: -90.15285, locations facility: Optimal Research, LLC Rockville Site Number : 8400025, status: RECRUITING, city: Rockville, state: Maryland, zip: 20850, country: United States, geoPoint lat: 39.084, lon: -77.15276, locations facility: The Alliance for Multispecialty Research - KCM, LLC Site Number : 8400034, status: RECRUITING, city: Kansas City, state: Missouri, zip: 64114, country: United States, geoPoint lat: 39.09973, lon: -94.57857, locations facility: Velocity Clinical Research Norfolk Site Number : 8400046, status: RECRUITING, city: Norfolk, state: Nebraska, zip: 68701, country: United States, geoPoint lat: 42.02834, lon: -97.417, locations facility: Velocity Clinical Research, Omaha Site Number : 8400008, status: RECRUITING, city: Omaha, state: Nebraska, zip: 68134, country: United States, geoPoint lat: 41.25626, lon: -95.94043, locations facility: Rochester Clinical Research. Inc. Site Number : 8400005, status: RECRUITING, city: Rochester, state: New York, zip: 14609, country: United States, geoPoint lat: 43.15478, lon: -77.61556, locations facility: Aventiv Research Columbus Site Number : 8400020, status: RECRUITING, city: Columbus, state: Ohio, zip: 43213, country: United States, geoPoint lat: 39.96118, lon: -82.99879, locations facility: Coastal Carolina Research Center Site Number : 8400014, status: RECRUITING, city: North Charleston, state: South Carolina, zip: 29405, country: United States, geoPoint lat: 32.85462, lon: -79.97481, locations facility: AMR Knoxville Site Number : 8400043, status: RECRUITING, city: Knoxville, state: Tennessee, zip: 37909, country: United States, geoPoint lat: 35.96064, lon: -83.92074, locations facility: Clinical Trials of Texas, Inc. - PPDS Site Number : 8400029, status: RECRUITING, city: San Antonio, state: Texas, zip: 78229, country: United States, geoPoint lat: 29.42412, lon: -98.49363, locations facility: DM Clinical Research/Pediatric Healthcare of Northwest Houston Site Number : 8400056, status: RECRUITING, city: Tomball, state: Texas, zip: 77375, country: United States, geoPoint lat: 30.09716, lon: -95.61605, locations facility: JBR Clinical Research Site Number : 8400051, status: RECRUITING, city: Salt Lake City, state: Utah, zip: 84107, country: United States, geoPoint lat: 40.76078, lon: -111.89105, locations facility: Investigational Site Number : 6300002, status: RECRUITING, city: Barrio Sabana, zip: 00694, country: Puerto Rico, hasResults: False
protocolSection identificationModule nctId: NCT06361862, orgStudyIdInfo id: WARD - Overtreatment, briefTitle: Does Continuous Vital Sign Monitoring Increase Investigations and Interventions in Complication-free Patients?, acronym: WARD-OT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Rigshospitalet, Denmark, class: OTHER, collaborators name: Bispebjerg Hospital, descriptionModule briefSummary: This aim of this study is to investigate whether active alerts during CVSM result in an increased number of diagnostic tests and treatments in complication free patients, hypothesizing that more interventions are performed in the CVSM-group than standard of care (EWS) group., conditionsModule conditions: Cancer, conditions: Chronic Obstructive Pulmonary Disease, conditions: Surgery-Complications, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 700, type: ESTIMATED, armsInterventionsModule interventions name: Active alarms from WARD software, outcomesModule primaryOutcomes measure: Frequency of patients having at least one of the following tests/treatments:, secondaryOutcomes measure: The frequency of individual treatments and diagnostics:, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Eske Kvanner Aasvang, status: RECRUITING, city: Copenhagen, zip: 2100, country: Denmark, contacts name: Eske K Aasvang, M.D., DMSci, role: CONTACT, phone: +4526232076, email: [email protected], geoPoint lat: 55.67594, lon: 12.56553, hasResults: False
protocolSection identificationModule nctId: NCT06361849, orgStudyIdInfo id: 55013, briefTitle: TauTona Pneumoperitoneum Assist Device (TPAD), acronym: TPAD, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Stanford University, class: OTHER, collaborators name: TauTona Group, descriptionModule briefSummary: The purpose of this study is to assess the safety and ease of use of a trocar placement access device (TPAD) to assist with obtaining peritoneal access with a Veress needle, and for placing a primary trocar, during laparoscopic surgery., conditionsModule conditions: Laparoscopic Surgery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: DEVICE_FEASIBILITY, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Trocar Placement Assist Device (TPAD), outcomesModule primaryOutcomes measure: Surgeon satisfaction survey, secondaryOutcomes measure: Time required to obtain peritoneal access and place primary trocar during laparoscopic surgery, secondaryOutcomes measure: Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Stanford Hospital & Clinics, city: Palo Alto, state: California, zip: 94305, country: United States, geoPoint lat: 37.44188, lon: -122.14302, hasResults: False
protocolSection identificationModule nctId: NCT06361836, orgStudyIdInfo id: SBT777101-02, briefTitle: Study of Single Doses of SBT777101 in Subjects With Hidradenitis Suppurativa, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Sonoma Biotherapeutics, Inc., class: INDUSTRY, descriptionModule briefSummary: This study will test the safety and effects of SBT777101 when given as a single dose to subjects with hidradenitis suppurativa. Increasing dose levels will be given after the safety at lower dose levels is shown., conditionsModule conditions: Hidradenitis Suppurativa, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Sequential escalating dose cohorts, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: SBT777101, outcomesModule primaryOutcomes measure: Incidence, nature, and severity of adverse events [Safety and Tolerability], primaryOutcomes measure: Incidence and nature of Dose Limiting Toxicities [DLTs], eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Brigham and Women's Hospital, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02115, country: United States, contacts name: Oliva Gabriel, role: CONTACT, phone: 617-525-8250, email: [email protected], geoPoint lat: 42.35843, lon: -71.05977, hasResults: False
protocolSection identificationModule nctId: NCT06361823, orgStudyIdInfo id: IIH-Semaglutide, briefTitle: Exploratory Study on the Efficacy and Safety of Semaglutide for Idiopathic Intracranial Hypertension Treatment, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2025-01-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Capital Medical University, class: OTHER, descriptionModule briefSummary: This study aims to investigate the safety and efficacy of semaglutide in patients with Idiopathic intracranial hypertension., conditionsModule conditions: Idiopathic Intracranial Hypertension, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The researchers are tasked with adhering to the protocol requirements when selecting participants, and consistently enrolling eligible patients who are then randomly assigned to either the experimental or control group in a 1:1 ratio. The randomization process is overseen by expert statisticians and executed by specialized clinical researchers in an independent manner., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 74, type: ESTIMATED, armsInterventionsModule interventions name: Semaglutide, interventions name: Low calorie diet, outcomesModule primaryOutcomes measure: Intracranial pressure, primaryOutcomes measure: Adverse reactions, secondaryOutcomes measure: Headache severity, secondaryOutcomes measure: Degree of papilledema, secondaryOutcomes measure: Perimetric mean deviation, secondaryOutcomes measure: Optic nerve sheath diameter, secondaryOutcomes measure: Body mass index, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06361810, orgStudyIdInfo id: IRB00430008, briefTitle: PSMA Therapy and Immunotherapy in Kidney Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2030-07, completionDateStruct date: 2031-07, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, class: OTHER, collaborators name: Merck Sharp & Dohme LLC, collaborators name: Lantheus Medical Imaging, descriptionModule briefSummary: This is a multi-center, single arm open label phase 1b/2 study of pembrolizumab in combination with 177Lu-PNT2002 (also known as 177Lu-PSMA I\&T) radiopharmaceutical therapy in patients with metastatic clear cell renal cell carcinoma (RCC) who have progressed after prior treatment with anti-programmed cell death protein 1 (PD1) or PD-L1 immune-checkpoint inhibitors (ICIs). The study comprises 2 phases: an open-label Phase 1b dose escalation portion followed by a Phase 2 dose expansion portion. Investigators hypothesize that pembrolizumab in combination with 177Lu-PNT2002 in in patients with metastatic clear cell RCC at a biologically active dose will result in tolerable safety profile and it will lead to improved radiological objective responses in patients who have progressed after prior treatment with standard anti-PD1 or anti- Programmed Cell Death Ligand 1 (PDL1) immune-checkpoint inhibitor containing regimen when compared to historic controls. Patients in both phases will have prostate-specific membrane antigen (PSMA), positron emission tomography (PET) imaging with the radiotracer (F-18)-DCFPyl, to help detect any spread of the cancer., conditionsModule conditions: Metastatic Renal Cell Carcinoma, conditions: Metastatic Clear Cell Renal Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 37, type: ESTIMATED, armsInterventionsModule interventions name: Pembrolizumab, interventions name: 177Lu-PNT2002, interventions name: (F-18)-DCFPyL, outcomesModule primaryOutcomes measure: Safety assessed by the incidence of dose limiting toxicities., primaryOutcomes measure: Objective response rate by RECIST 1.1 criteria, secondaryOutcomes measure: Progression free survival, secondaryOutcomes measure: Safety as assessed by number of participants experiencing adverse events, secondaryOutcomes measure: Disease control rates, secondaryOutcomes measure: Duration of response to study therapy, secondaryOutcomes measure: Overall survival rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06361797, orgStudyIdInfo id: IRB00415412, briefTitle: Varying Bone Marrow-Derived Mesenchymal Stem Cells Concentrations' Impact on Rotator Cuff Repair Outcomes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2027-10, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Johns Hopkins University, class: OTHER, collaborators name: ON Foundation, descriptionModule briefSummary: Randomized controlled trial comparing benefits of varying amounts of proximal humerus-derived bone marrow aspirate and bone marrow concentrate in rotator cuff repair., conditionsModule conditions: Rotator Cuff Tears, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study is designed as a parallel group 1:1:1 randomized controlled trial., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Patients and research assistants collecting data will be unaware of assigned treatment until study completion., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Rotator cuff repair augmented with whole bone marrow, interventions name: Rotator cuff repair augmented with concentrated bone marrow, outcomesModule primaryOutcomes measure: Number of Rotator cuff re-tears as assessed by magnetic resonance imaging, secondaryOutcomes measure: American Shoulder and Elbow Surgeons Score, secondaryOutcomes measure: Visual Analogue Pain Score, secondaryOutcomes measure: Subjective Shoulder Value score, secondaryOutcomes measure: Comprehensive Shoulder Assessment, secondaryOutcomes measure: Revision surgery rate, secondaryOutcomes measure: Rate of oral and/or intra-articular corticosteroid required, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Johns Hopkins Howard County General Hospital, city: Columbia, state: Maryland, zip: 21230, country: United States, contacts name: Study Director, role: CONTACT, contacts name: Principal Investigator, role: CONTACT, geoPoint lat: 39.24038, lon: -76.83942, locations facility: Johns Hopkins Medicine - Green Spring Station, city: Lutherville, state: Maryland, zip: 21093, country: United States, contacts name: Matthew J Best, MD, role: CONTACT, phone: 443-997-2663, email: [email protected], contacts name: Uma Srikumaran, MD, MBA, MPH, role: CONTACT, phone: 410-546-1550, email: [email protected], geoPoint lat: 39.42122, lon: -76.62608, hasResults: False
protocolSection identificationModule nctId: NCT06361784, orgStudyIdInfo id: INT216-23, secondaryIdInfos id: MFAG27480, type: OTHER_GRANT, domain: AIRC Foundation for Cancer Research in Italy, briefTitle: Improving the Success Rate for Thoracic Radiotherapy Through Specific Cardiac Substructure Dosimetry: Location Matters. (LOCATION MATTERS), acronym: LM, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-29, primaryCompletionDateStruct date: 2029-03-29, completionDateStruct date: 2029-03-29, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, class: OTHER, collaborators name: Politecnico di Milano, descriptionModule briefSummary: The prospective study LOCATION MATTERS aims to investigate the radiation-induced damage to the heart and the cardiovascular system in patients treated with thoracic radiotherapy. Patients enrolled in the study will complete a set of extensive measures at the baseline, end of RT, and 9 months after treatment. Ultrasound exams, CT scans, pulmonary tests and wearable devices will assess functional and morphological parameters and the association with their variation and the dose delivered to the heart substructures and to the normal lung., conditionsModule conditions: Locally Advanced Lung Non-Small Cell Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, outcomesModule primaryOutcomes measure: Variation in eco-cardio and eco-vascular parameters after thoracic radiotherapy, secondaryOutcomes measure: Major adverse cardiac events post-RT, secondaryOutcomes measure: Increase in cardiac calcification after RT, otherOutcomes measure: Longitudinal variation of cardiopulmonary functional parameters, otherOutcomes measure: Texture variation in the heart substructures, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione IRCCS Istituto Nazionale dei Tumori, status: RECRUITING, city: Milan, zip: 20133, country: Italy, contacts name: Alessandro Cicchetti, PhD, role: CONTACT, phone: 0223903858, email: [email protected], contacts name: Chiara Casati, role: CONTACT, email: [email protected], contacts name: Alessandro Cicchetti, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
protocolSection identificationModule nctId: NCT06361771, orgStudyIdInfo id: 29BRC24.0079 - PRICELESS, briefTitle: Evaluation of Invisible Preparation Behaviors of Middle and High School Students in Sports Facilities (PRICELESS), acronym: PRICELESS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-08, primaryCompletionDateStruct date: 2024-12-20, completionDateStruct date: 2024-12-20, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: University Hospital, Brest, class: OTHER, descriptionModule briefSummary: The investigators define the Invisible Preparation (IP) as the set of health behaviors that young athletes implement, on their own, to optimize their health and performances. This includes sleep, nutrition and hydration, physical well-being (injuries prevention) and mental well-being. If some studies have reported a lack of compliance in young athletes regarding sleep and hydration recommendations, the literature is poor in this field.The CMS (Brest Metropolitan Area Sports Medicine Centre, France) aims at preserving the health of young athletes. Prior to their medical examination, the patients will be asked, all along the year 2024, to fill out a form that question them about their health behaviors in the four areas of the IP.Under the direction of the Brest University Hospital, PRICELESS (Invisible Preparation of Middle and High School Students in Sports Institutions) study will try, based on their answers, to estimate the proportion of young athletes who declare adopting the health behaviors recommended in the IP., conditionsModule conditions: Sports Injury, conditions: Prevention, conditions: Training, conditions: Hydration, conditions: Nutrition, conditions: Sleep, conditions: Mental Health, conditions: Physical Well-Being, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 1500, type: ESTIMATED, outcomesModule primaryOutcomes measure: The proportion of teenagers who declare adopting the health behaviors recommended in the four areas of the Invisible Preparation., secondaryOutcomes measure: The proportion of girls who declare adopting these behaviors, compared to the proportion in boys., secondaryOutcomes measure: The proportion of Middle School students who declare adopting these behaviors, compared to the proportion in High School students., secondaryOutcomes measure: The proportion of young athletes practicing an intensive sporting activity (10 hours or more per week), compared to the proportion in young athletes practicing a non-intensive sporting activity (less than 10 hours per week)., secondaryOutcomes measure: The proportion of young athletes with disabilities who declare adopting these behaviors, compared to the proportion in young athletes without disabilities., eligibilityModule sex: ALL, minimumAge: 9 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Chu Brest, status: RECRUITING, city: Brest, zip: 29609, country: France, contacts name: Marie-Agnès GIROUX-METGES, PhD, role: CONTACT, phone: 0298347366, phoneExt: +33, email: [email protected], contacts name: Florent GUIMARD, Resident, role: CONTACT, phone: 02 98 33 53 40, phoneExt: +33, email: [email protected], geoPoint lat: 48.3903, lon: -4.48628, hasResults: False
protocolSection identificationModule nctId: NCT06361758, orgStudyIdInfo id: B2023-326(2), briefTitle: Second-line Treatment With CAdonilimab and LEnvatinib for Unresectable HCC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-31, primaryCompletionDateStruct date: 2026-05-31, completionDateStruct date: 2027-05-31, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Shanghai Zhongshan Hospital, class: OTHER, collaborators name: Sun Yat-sen University, collaborators name: Eastern Hepatobiliary Surgery Hospital, descriptionModule briefSummary: This is an open-label, multi-center, single-arm, phase II study to evaluate the efficacy and safety of lenvatinib in combination with cadonilimab as second-line therapy in subjects with advanced hepatocellular carcinoma (HCC) who failed first-line standard therapy of immunotheray and antiangiogenic therapy., conditionsModule conditions: Hepatocellular Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Cadonilimab+Lenvatinib, outcomesModule primaryOutcomes measure: Objective Response Rate (ORR) per RECIST v1.1, secondaryOutcomes measure: Objective Response Rate (ORR) per mRECIST, secondaryOutcomes measure: Disease control Rate (DCR), secondaryOutcomes measure: Duration of response (DoR), secondaryOutcomes measure: Progression-Free-Survival (PFS), secondaryOutcomes measure: Overall survival Overall survival (OS), secondaryOutcomes measure: Incidence of Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zhongshan Hospital, Fudan University, city: Shanghai, state: Shanghai, zip: 200032, country: China, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Sun Yat-sen University Cancer Center), city: Guangzhou, country: China, contacts name: Li Xu, role: CONTACT, contacts name: Li Xu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.11667, lon: 113.25, locations facility: Eastern Hepatobiliary Surgery Hospital, city: Shanghai, country: China, contacts name: Kui Wang, role: CONTACT, contacts name: Jun Xue, role: CONTACT, contacts name: Kui Wang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
protocolSection identificationModule nctId: NCT06361745, orgStudyIdInfo id: PG-005-6, briefTitle: Early Clinical Study of UTAA09 Injection in the Treatment of Relapsed/Refractory Autoimmune Diseases, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-02, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: PersonGen BioTherapeutics (Suzhou) Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: Main purpose:To evaluate the safety of UTAA09 injection in the treatment of relapsed/refractory (R/R) autoimmune disease (AID).Secondary purpose:To evaluate the pharmacokinetic (PK) profile of UTAA09 injection in patients with R/R AID.To evaluate the pharmacodynamic (PD) characteristics of UTAA09 injection in patients with R/R AID.To evaluate the initial efficacy of UTAA09 injection in the treatment of R/R AID subjects.To evaluate the immunogenicity of UTAA09 injection in R/R AID subjects., conditionsModule conditions: Systemic Lupus Erythematosus, conditions: Idiopathic Inflammatory Myopathies, conditions: Systemic Sclerosis, conditions: IgG4 Related Disease, conditions: Primary Sjögren Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: UTAA09 injection, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: T cell injection targeting CD19 chimeric antigen receptor, outcomesModule primaryOutcomes measure: AE, secondaryOutcomes measure: Cmax, secondaryOutcomes measure: CD19-positive cells, secondaryOutcomes measure: Disease remission/response/improvement rates, secondaryOutcomes measure: anti-CAR antibody, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: PersonGen.Anke Cellular Therapeutice Co., Ltd, status: RECRUITING, city: Hefei, country: China, contacts name: Huimin Meng, Doctor, role: CONTACT, phone: +86-18015580390, email: [email protected], geoPoint lat: 31.86389, lon: 117.28083, hasResults: False
protocolSection identificationModule nctId: NCT06361732, orgStudyIdInfo id: ILBS-liver Transplant-03, briefTitle: Prevalence of CYP3A5 Polymorphisms in the Donors and ABCB1 Polymorphisms in the Recipients Undergoing Pediatric Liver Transplant and Their Influence on Tacrolimus Levels and Graft Function., statusModule overallStatus: RECRUITING, startDateStruct date: 2022-12-17, primaryCompletionDateStruct date: 2024-10-30, completionDateStruct date: 2024-10-30, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Institute of Liver and Biliary Sciences, India, class: OTHER, descriptionModule briefSummary: It is known that Immunosuppression post-Liver transplant is central to achieving optimal outcomes in liver transplant recipients. It is required to maintain an adequate balance between reducing rejection and toxicities. Mainstay drugs for maintenance therapy are Calcinuerin inhibitors - Tacrolimus versus cyclosporine. Tacrolimus is preferred, as it has less rejection and better graft survival. However, there is risk of renal and metabolic toxicities. Tacrolimus is bound mainly to alpha1-acid-glycoprotein (encoded by the ABCB1gene) expressed on various epithelial and endothelial cells and lymphocytes. Elimination occurs by metabolizing enzymes of cytochrome P450 system, with biliary excretion (95%) of metabolites (majority) with minority through urine (2.4%). Demethylation and hydroxylation of tacrolimus occurs by hepatic and intestinal CYP3A isoforms (CYP3A4 and CYP3A5). Among the factors that play an important role in the pharmacokinetics of tacrolimus, thus affecting the tacrolimus trough levels in the body and in turn influencing the dosing of the drug required to maintain an adequate balance between reducing rejection and toxicities, genetics plays an important role. Increased expression of CYP3A5 causes more metabolism of tacrolimus and hence affecting the tacrolimus concentration/weight-adjusted dose (C/W-D) ratio in the body. The wild type (CYP3A5\*3) are slow metabolizers and mutant ones (CYP3A5 \*1/\*1 and CYP3A5 \*1/\*3) are fast metabolizers. Fastmetabolizers have a low C/W-D ratio and require higher Tacrolimus dosing and are thus susceptible to renal and metabolic toxicities, EBV viremia and post transplant lymphoproliferative disorder. Polymorphisms in ABCB1 (c.3435C\>T) are also known to influence tacrolimus dosage in the first week of transplant (C/D ratio was lower in ABCB1 3435CC in comparison to CT and TT). There is no such data in pediatric liver transplant setting from Indian subcontinent. The aim of the study is to study the prevalence of CYP3A5 polymorphisms in the donors and ABCB1 polymorphisms in the recipients undergoing Paediatric liver transplant and their influence on Tacrolimus levels and graft function., conditionsModule conditions: Pediatric Liver Transplant, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: OTHER, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: No intervention, outcomesModule primaryOutcomes measure: Time (in days) to achieve transaminases within 1.5 times ULN (60 IU/L) in the pediatric Liver transplant recipients with grafts from slow metabolizer (CYP3A5*3/3 allele) versus fast metabolizer (CYP3A5*1/3 and 1/1 alleles) donors., secondaryOutcomes measure: Prevalence of CYP3A5 alleles in the donors of pediatric liver transplant recipients., secondaryOutcomes measure: Influence of donor CYP3A5 alleles (slow versus fast metabolizers) on tacrolimus concentration-weight adjusted dose ratio at 1 week, 4 weeks, 3 months & 6 months and 1 year after liver transplantation., secondaryOutcomes measure: Prevalence of ABCB1 3435 C/T alleles in the recipients of pediatric liver transplant., secondaryOutcomes measure: Influence of recipient ABCB1 3435 C/T on tacrolimus concentration-weight adjusted dose ratio at 1 week, 4 weeks, 3 months and 6 months and 1 year after liver transplantation., secondaryOutcomes measure: Comparison of the Number of Rejection episodes 1 year from LT., secondaryOutcomes measure: Comparison of proportion of patients who were withdrawn from Mycophenolate or required addition of Mycophenolate 1 year from LT., secondaryOutcomes measure: Comparison of proportion of patients with renal toxicity 1 year from LT., secondaryOutcomes measure: Comparison of proportion of patients with Neurological toxicity 1 year from LT., secondaryOutcomes measure: Comparison of e-GFRand cystatin-C levels in the two cohorts of pediatric liver transplant recipients with grafts from slow metabolizer (CYP3A5*3/3 allele) versus fast metabolizer (CYP3A5*1/3 and 1/1 alleles) donors., eligibilityModule sex: ALL, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Institute of Liver and Biliary Sciences, status: RECRUITING, city: New Delhi, zip: 110070, country: India, contacts name: Dr Snigdha Verma, MD, role: CONTACT, phone: 01146300000, email: [email protected], contacts name: Dr Rajeev Khanna, MD, role: CONTACT, phone: 01146300000, email: [email protected], geoPoint lat: 28.63576, lon: 77.22445, hasResults: False
protocolSection identificationModule nctId: NCT06361719, orgStudyIdInfo id: 2312INF, briefTitle: Efficacy of Two HMOs in Chinese Infants, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-31, primaryCompletionDateStruct date: 2026-11, completionDateStruct date: 2027-06, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Société des Produits Nestlé (SPN), class: INDUSTRY, descriptionModule briefSummary: This is a randomized, controlled, double-blind, intervention trial of healthy male and female term infants to evaluate the efficacy of the 2 HMOs on beneficially modulating the gut microbiota, gut maturation, gut barrier integrity, immune response, and other developmental outcomes in healthy Chinese infants. The trial consists of 2 randomized formula-fed groups, and a non-randomized breastfed reference group., conditionsModule conditions: Healthy Infants, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 262, type: ESTIMATED, armsInterventionsModule interventions name: Experimental Group (EG), interventions name: Control Group (CG), outcomesModule primaryOutcomes measure: Bifidobacteria abundance in fecal samples, secondaryOutcomes measure: Gut microbiota composition, secondaryOutcomes measure: Fecal metabolism, secondaryOutcomes measure: Fecal metabolism, secondaryOutcomes measure: Fecal markers of intestinal immune health, secondaryOutcomes measure: Fecal markers of gut barrier function, secondaryOutcomes measure: Fecal markers of gut barrier function, secondaryOutcomes measure: Fecal markers of gut barrier function, secondaryOutcomes measure: Fecal markers of inflammation, secondaryOutcomes measure: Fecal markers of inflammation, secondaryOutcomes measure: Fecal markers of inflammation, secondaryOutcomes measure: Stool patterns, secondaryOutcomes measure: Stool patterns, secondaryOutcomes measure: GI symptoms and behaviors, secondaryOutcomes measure: Immune competence, secondaryOutcomes measure: Infant sleep duration and night-time wakings per 24 hours, secondaryOutcomes measure: Infant Health Related Quality of Life, secondaryOutcomes measure: Growth, secondaryOutcomes measure: Growth, secondaryOutcomes measure: Growth, secondaryOutcomes measure: Growth, secondaryOutcomes measure: Growth, secondaryOutcomes measure: Physical Examination, secondaryOutcomes measure: Infant Illness, secondaryOutcomes measure: Infant illness, infections and medication usage, secondaryOutcomes measure: Medication use (type and duration), otherOutcomes measure: Formula feeding, otherOutcomes measure: Breastfeeding, otherOutcomes measure: Infant dietary pattern, eligibilityModule sex: ALL, minimumAge: 3 Days, maximumAge: 14 Days, stdAges: CHILD, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06361706, orgStudyIdInfo id: 24/047-P, briefTitle: VR-Enhanced Psychoeducation for Chronic Pain: A Primary Care Pilot Study, acronym: REDOCVR, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-04, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Badalona Serveis Assistencials, class: OTHER, collaborators name: Department of Health, Generalitat de Catalunya, descriptionModule briefSummary: This pilot study aims to evaluate the integration of virtual reality (VR) with a psychoeducational program for individuals experiencing chronic pain and central sensitization. Chronic pain significantly hampers daily life, and the condition of central sensitization intensifies this challenge by making the pain more acute. Our research is grounded in the hypothesis that VR, when used to complement conventional psychoeducational methods, can enhance engagement and understanding of pain management strategies, thus potentially improving patient outcomes.Key objectives and related measured variables include:Usability and Feasibility: Evaluated through the System Usability Scale (SUS) responses from both participants and healthcare professionals, assessing the ease of use and integration of VR into the psychoeducational program.Participant Engagement and Program Adherence: Determined by participants\' satisfaction with the VR system, using Likert scale questionnaires, and tracked through session attendance and program completion rates.Impact on Chronic Pain Management and Emotional Well-being: Assessed through changes in the Warwick-Edinburgh Mental Well-being Scale (WEMWBS), and the Hospital Anxiety and Depression Scale (HADS) collected at baseline, post-intervention, and 4-8 weeks follow-up Self-management of Chronic Pain: Monitored through the Central Sensitization Inventory (CSI) and changes in patient functionality and mobility using the EuroQol-5D-5L scale, measured at baseline, post-intervention, and 4-8 weeks follow-up.Healthcare Professionals\' Perceptions: Investigated using SUS scores and qualitative feedback on the applicability and benefits of VR in clinical practice for chronic pain management.Participants will complete eight 90-minute sessions, engaging with VR to supplement the program\'s content. This approach aims to provide immersive experiences that deepen the understanding and management of chronic pain. Participant feedback on the VR experience, alongside observed changes in pain management and overall well-being, will be critically examined.By targeting individuals suffering from chronic pain, this research aims to offer healthcare professionals an innovative tool for enhancing pain management strategies. Integrating VR into psychoeducational content, the study seeks to promote more engaging and effective learning experiences, potentially leading to improved outcomes in chronic pain management., conditionsModule conditions: Chronic Pain, conditions: Central Sensitization, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: The REDOCVR study utilizes a Single-Group Interventional Model, where all participants receive the same VR-enhanced psychoeducational intervention for chronic pain management. This model facilitates a focused evaluation of VR's effectiveness and usability within a structured psychoeducational framework, allowing for direct assessment of participant experiences and outcomes., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, maskingDescription: The statisticians and researchers involved in data analysis will be masked to the identity of participants, using a random code for each participant., enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: VR-Enhanced Psychoeducational Program for Chronic Pain, outcomesModule primaryOutcomes measure: Participant Satisfaction with the VR-enhanced Psychoeducational Program as measured by the Participants Satisfaction Questionnaire, primaryOutcomes measure: Participants´ System Usability and VR Headset Comfort as assessed by the SUS for participants, primaryOutcomes measure: Professionals System Usability as measured by the SUS for Professionals, secondaryOutcomes measure: Mental Well-being as assessed by the WEMWBS-7, secondaryOutcomes measure: Anxiety and Depression Severity as measured by the HADS, secondaryOutcomes measure: Central Sensitization as measured by the CSI, secondaryOutcomes measure: Changes in Functionality and Mobility as assessed by the EuroQol-5D-5L Scale, secondaryOutcomes measure: Adherence to the VR-enhanced Psychoeducational Program as indicated by session attendance and program completion rates, otherOutcomes measure: Participant Feedback as recorded on the Participant Comment Sheet, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Primary Care Progrès-Raval, status: RECRUITING, city: Badalona, state: Barcelona, zip: 08912, country: Spain, contacts name: Jose Ferrer Costa, MD, role: CONTACT, phone: 0034933951779, email: [email protected], contacts name: Elena Villabona López, MSc, role: CONTACT, phone: 0034933890695, email: [email protected], contacts name: Elena Villabona Lopez, MSc, role: SUB_INVESTIGATOR, contacts name: Jose Ferrer Costa, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Melanie Rodriguez Belloso, BSc, role: SUB_INVESTIGATOR, geoPoint lat: 41.45004, lon: 2.24741, locations facility: Primary Care Center Apenins-Montigalà, status: RECRUITING, city: Badalona, state: Barcelona, zip: 08917, country: Spain, contacts name: José Ferrer Costa, MD, role: CONTACT, phone: 0034933951779, email: [email protected], contacts name: Christian Torrecillas Camacho, BSc, role: CONTACT, phone: 0034933951779, email: [email protected], contacts name: José Ferrer Costa, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Christian Torrecillas Camacho, BSc, role: SUB_INVESTIGATOR, contacts name: Alexandra Fernandez Brusco, BSc, role: SUB_INVESTIGATOR, geoPoint lat: 41.45004, lon: 2.24741, locations facility: Primary Care Center Morera-Pomar, status: RECRUITING, city: Badalona, state: Barcelona, country: Spain, contacts name: Nuria Moran Blanco, MD, role: CONTACT, phone: 0034934655200, email: [email protected], contacts name: Laura Villares Urgell, MSc, role: CONTACT, phone: 0034934655200, email: [email protected], contacts name: Jose Ferrer Costa, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Nuria Moran Blanco, MD, role: SUB_INVESTIGATOR, contacts name: Laura Villare Urgel, MSc, role: SUB_INVESTIGATOR, geoPoint lat: 41.45004, lon: 2.24741, hasResults: False
protocolSection identificationModule nctId: NCT06361693, orgStudyIdInfo id: APHP240147, secondaryIdInfos id: 2024-A00143-44, type: OTHER, domain: France : Ministry of Health, briefTitle: Descriptive Observational Study of Patient-performed Pre-oxygenation, acronym: ApréOx, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: The aim of this research would be to determine the efficacy and effects of preoxygenation when performed by the patient (mask held by the patient).This is the concept of "self-preoxygenation"., conditionsModule conditions: Anesthesia, conditions: Anxiety, conditions: ASA Physical Status I, conditions: ASA Physical Status II, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: Auto-preoxygenation, interventions name: APAIS scale, interventions name: Visual analog anxiety scale (VAS-A), interventions name: Visual analog comfort scale (VAS-C), outcomesModule primaryOutcomes measure: FeO2>90%, secondaryOutcomes measure: APAIS anxiety score, secondaryOutcomes measure: Visual analog anxiety scale (VAS-A) score, secondaryOutcomes measure: Visual analog anxiety scale (VAS-A) score, secondaryOutcomes measure: Visual analog comfort scale (VAS-C) score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Anesthesia-intensive care department - Cochin - Port-Royal hospital - APHP, city: Paris, state: Ile De France, zip: 75014, country: France, contacts name: Sophie TOUSSAINT, Nurse anesthetist, role: CONTACT, phone: 00 33 1 58 41 45 17, email: [email protected], contacts name: Claude LE STANG, Nurse anesthetist, role: CONTACT, email: [email protected], contacts name: Christophe BAILLARD, PUPH, role: SUB_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False
protocolSection identificationModule nctId: NCT06361680, orgStudyIdInfo id: Coenzyme Q10 on diabetic child, briefTitle: Effect of Coenzyme Q10 on Diabetic Children, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10-30, primaryCompletionDateStruct date: 2025-10-30, completionDateStruct date: 2025-11-30, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Determine the effect of Coenzyme Q10 on random blood sugar and glycosylated haemoglobin, conditionsModule conditions: Type 1 Diabetes Mellitus, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Coenzyme Q10 Cap/Tab as natural factors capsules or kirkman tablets, outcomesModule primaryOutcomes measure: Assess the effect of Coenzyme Q10 on glycated haemoglobin in type 1 diabetes mellitus, secondaryOutcomes measure: Control of random blood sugar and glycated haemoglobin in children with type 1 diabetes mellitus ., eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06361667, orgStudyIdInfo id: 1/02.02.2024, briefTitle: Culture and Well-being: Art as Prescription Therapy ("Art on Prescription"), acronym: AoP, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-12-15, completionDateStruct date: 2025-01-15, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: KAVADIA ELENI, class: OTHER, descriptionModule briefSummary: Cluster randomised controlled trial with two arms: arts intervention (any of the arts interventions, see list), which we call here Active Group (AG) vs waitlist control (WL)., conditionsModule conditions: Mental Health Issue, conditions: Anxiety Disorders, conditions: Depressive Disorder, conditions: Emotional Disorder, conditions: Schizophrenia, conditions: Autism, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: We will follow standard practice for RCTs and apply an ANCOVA model to estimate the effects of treatment. The formalism is:y \~ b0 + b1xtreatment_group + b2xtime + b3xtreatment_groupxtime + covariates (1)Where, y is each outcome, b1-b3 are the regression coefficients and covariates denotes covariates at randomisation (DETERMINE)The inference of interest for the model concerns b3, the interaction term, as we posit that there will be a difference in slopes between the treatment groups.The inference is going to happen via an estimation of the t-statistic, defined as follows"t = b3/SE (2)Where SE is the standard error for coefficient b3t \> 1.96 (3)And 1.96 is the critical value for statistical significance at alpha = 0.05., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 384, type: ESTIMATED, armsInterventionsModule interventions name: Arts, outcomesModule primaryOutcomes measure: The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS), secondaryOutcomes measure: Generalised Anxiety Disorder Assessment (GAD-7), secondaryOutcomes measure: The Patient Health Questionnaire-9 (PHQ-9), secondaryOutcomes measure: UCLA 3-item Loneliness Scale, secondaryOutcomes measure: The Strengths and Difficulties Questionnaire (SDQ), eligibilityModule sex: ALL, minimumAge: 10 Years, maximumAge: 99 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Eleni Kavadia, status: RECRUITING, city: Athens, country: Greece, contacts name: Eleni Kavadia, role: CONTACT, phone: +30 210 6170804, email: [email protected], contacts name: Nikos Stefanis, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.97945, lon: 23.71622, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2024-03-10, uploadDate: 2024-03-26T12:19, filename: Prot_000.pdf, size: 390364, hasResults: False
protocolSection identificationModule nctId: NCT06361654, orgStudyIdInfo id: 2023/0135/OB, briefTitle: Effect of Muscular Imbalance Between Flexors and Extensors of the Fingers and Wrist on Upper Limb Injuries in Climbers, acronym: CRIMPER, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2025-03-25, completionDateStruct date: 2025-09-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: University Hospital, Rouen, class: OTHER, descriptionModule briefSummary: Climbing is a booming sport with an increasing number of participants. When practicing this sport, there is a muscular imbalance between the flexor and extensor systems (especially in the fingers), with the flexors of the fingers exerting greater force than the extensors. In addition, upper limb injuries, particularly the fingers, are very common.The study will be carried out on club-licensed climbers, as they are better supervised. They will be recruited through requests sent to various clubs. The measurements will be taken during different climbing sessions, after the warm-up.The study will include measurements on different climbers. Informed consent and personal data will be collected from the climbers before the measurements are taken. The strength values of the flexors and extensors of the fingers and wrist will be measured using a dynamometer. The climbers will then continue their usual training for 1 year. For 1 year after the measurements, the climbers will be contacted every month by telephone to collect the different injuries they may have suffered in relation to climbing, as well as the number of hours they have spent climbing in the past month. After 1 year, the annual number of hours of climbing and the annual number of injuries can be calculated for each climber. Injury is defined as any medically diagnosed lesion of the musculoskeletal system of the upper limb or pain that prevents the practice of a sport whose aetiology is climbing. These data are used to calculate the "athlete exposure" (A-E), i.e. the incidence of injury per 1000 hours of practice. As the study population is large, this allows for variations in exposure between subjects., conditionsModule conditions: Climber, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 47, type: ESTIMATED, armsInterventionsModule interventions name: The strength values of the flexors and extensors of the fingers and wrist will be measured using a dynamometer, outcomesModule primaryOutcomes measure: Athlete exposure, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rouen, University Hospital, status: RECRUITING, city: Rouen, state: Normandie, zip: 76031, country: France, contacts name: timothee gillot, phd, role: CONTACT, phone: 0232880671, phoneExt: +33, email: [email protected], geoPoint lat: 49.44313, lon: 1.09932, hasResults: False
protocolSection identificationModule nctId: NCT06361641, orgStudyIdInfo id: 49RC23_0259, secondaryIdInfos id: AO2721-44, type: OTHER, domain: ANSM, briefTitle: Functional and Phenotypic Characterization of Monocytes in Myeloproliferative Syndromes, acronym: PHEMOP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2025-10-19, completionDateStruct date: 2027-10-19, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: University Hospital, Angers, class: OTHER_GOV, descriptionModule briefSummary: Prospective study for functional and phenotypic characterization of monocytes in philadelphia-negative myeloproliferative neoplasms, conditionsModule conditions: Myeloproliferative Neoplasm, conditions: Polycythemia Vera, conditions: Essential Thrombocythemia, conditions: Primary Myelofibrosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Monocytes signatures in myeloproliferative neoplasms at diagnosis, outcomesModule primaryOutcomes measure: WHO 2016 criteria for polycythemia vera, prefibrotic myelofibrosis, essential thrombocytosis and overt myelofibrosis diagnosis, secondaryOutcomes measure: Identify correlation between the monocytic signature and driver mutations (mutation in JAK2, CALR or MPL gene)., secondaryOutcomes measure: Identify correlation between the monocytic signature and the grade of fibrosis, secondaryOutcomes measure: prognostic value of the monocytic signature using a principal component analysis Response criteria according to Barosi et al., Leukemia, vol. 29,1 (2015): 20-6, secondaryOutcomes measure: Prognostic value of the monocyte signature for disease worsening according to Sureau et al., Blood Cancer Journal, vol. 12,4, 56. 8 Apr. 2022, secondaryOutcomes measure: leukemia-free survival, secondaryOutcomes measure: myelofibrosis-free survival, secondaryOutcomes measure: Monocytes parameters for hematological progression, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: GOUBAND Agathe, city: Angers, state: Maine Et Loire, zip: 49933, country: France, contacts name: Agathe GOUBAND, PharmD, role: CONTACT, phone: 02 41 35 55 96, phoneExt: 33, email: [email protected], contacts name: Damien LUQUE PAZ, PharmD, role: CONTACT, phone: 02 41 35 53 53, phoneExt: 33, email: [email protected], geoPoint lat: 47.46667, lon: -0.55, locations facility: BESCOND Charles, city: Cholet, state: Maine Et Loire, zip: 49325, country: France, contacts name: Charles BESCOND, MD, role: CONTACT, phone: 0241355880, email: [email protected], geoPoint lat: 47.06667, lon: -0.88333, locations facility: TRUCHAN-GRACZYK Malgorzata, city: Saumur, state: Maine Et Loire, zip: 49400, country: France, geoPoint lat: 47.26667, lon: -0.08333, hasResults: False
protocolSection identificationModule nctId: NCT06361628, orgStudyIdInfo id: RIVER-EU WP4, briefTitle: Implementation and Evaluation of Tailored Interventions to Increase MMR and/or HPV Vaccine, acronym: RIVER-EU, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: University Medical Center Groningen, class: OTHER, collaborators name: Prolepsis Institute for Preventive, Environmental and Occupational Medicine, collaborators name: University in Zielona Góra, collaborators name: Pavol Jozef Safarik University, descriptionModule briefSummary: The goal of the study is to monitor and evaluate the implementation of interventions that aim to increase HPV \& MMR vaccines among underserved communities across four European countries: Greece, Netherlands, Poland, and Slovakia. The interventions will target identified health systems barriers in an earlier phase of the project. The interventions that will be implemented employ trusted community members as health promotors whom will provide educational sessions on HPV and MMR vaccination to the target groups. In addition, the cost-effectiveness of vaccine uptake strategies for the target groups is being evaluated.The main research question is: to what extent is the multicomponent tailored intervention effective to increase MMR/HPV intention and vaccine uptake in the target population in Greece, Netherlands, Poland and Slovakia?, conditionsModule conditions: Vaccination, conditions: Health Systems, conditions: Knowledge, Attitudes, Practice, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: multicomponent intervention on vaccination awareness, outcomesModule primaryOutcomes measure: Intention to vaccinate MMR and/or HPV by questionnaire, secondaryOutcomes measure: Uptake of MMR and/or HPV vaccinations by questionnaire, secondaryOutcomes measure: Knowledge concerning MMR and/or HPV vaccinations in the target group using a questionnaire, secondaryOutcomes measure: Communication skills of health care professionals using a questionnaire, secondaryOutcomes measure: Satisfaction of the stakeholders as measured by a questionnaire, otherOutcomes measure: Improved access to vaccinations by addressing identified health system barriers - number of barriers addressed, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 100 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Prolepsis, city: Athens, state: Athene, zip: 151 25, country: Greece, contacts name: Pania Karnaki, role: CONTACT, phone: +30 210 6255700, email: [email protected], contacts name: Nikole Papaevgeniou, PhD, role: CONTACT, email: [email protected], geoPoint lat: 37.97945, lon: 23.71622, locations facility: University Medical Center Groningen, city: Groningen, zip: 9713 GZ, country: Netherlands, contacts name: Janine de Zeeuw, PhD, role: CONTACT, phone: +31 6 45552994, email: [email protected], geoPoint lat: 53.21917, lon: 6.56667, locations facility: University of Zielona Gora, city: Zielona Góra, state: Lubusz, zip: 65 417, country: Poland, contacts name: Maria Ganczak, MD PhD, role: CONTACT, email: [email protected], geoPoint lat: 51.93548, lon: 15.50643, locations facility: PJ Šafárik University, city: Košice, state: Košice Region, zip: 04180, country: Slovakia, contacts name: Daniela Fiľakovská, PhD, role: CONTACT, phone: +421 55 234 3390, email: [email protected], geoPoint lat: 48.71395, lon: 21.25808, hasResults: False
protocolSection identificationModule nctId: NCT06361615, orgStudyIdInfo id: CEC_FP_2023042, briefTitle: Effect of a Dual-task Intervention Program on Physical and Cognitive Function, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-11-08, primaryCompletionDateStruct date: 2024-03-05, completionDateStruct date: 2024-04-05, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: University of Americas, class: OTHER, descriptionModule briefSummary: Aim: to compare the effects of single-task (ST) and dual-task (DT) training on physical and cognitive function in institutionalized older adults in 1 month.Methods: Participants were assigned randomly into two groups, ST (multicomponent physical exercise) and DT training (multicomponent physical exercise + cognitive tasks). Both groups performed the exercise three times per week for 1 month. Short Physical Performance Battery (SPPB), handgrip strength, Barthel Index and Montreal Cognitive Assessment (MoCA) were used to assess physical and cognitive performance, respectively. Variables were measured at the beginning (V1),at the end of the exercise (V2), as well as one month later (V3). Paired Student's t-test and lineal logistic regressions models were used to explore the effect of the exercise interventions., conditionsModule conditions: Functional Movement Disorder, conditions: Fragility, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel Assignment, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Although blinding is not possible for participants in exercise-intervention research, the outcome assessors and data analysts were masked to group assignments. The study was unblinded after the statistical analyses were completed., whoMasked: PARTICIPANT, enrollmentInfo count: 24, type: ACTUAL, armsInterventionsModule interventions name: Single-Task, interventions name: Dual-Task, outcomesModule primaryOutcomes measure: Short Physical Performance Battery (SPPB), secondaryOutcomes measure: Montreal Cognitive Assessment (MoCA), secondaryOutcomes measure: Barthel Index, secondaryOutcomes measure: Isometric Handgrip Strength (IHS), secondaryOutcomes measure: Immobility Syndrome Scale, eligibilityModule sex: ALL, minimumAge: 65 Years, maximumAge: 75 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Universidad de las Americas, city: Santiago de Chile, state: Santiago, zip: 7750495, country: Chile, geoPoint lat: -33.45694, lon: -70.64827, hasResults: False
protocolSection identificationModule nctId: NCT06361602, orgStudyIdInfo id: SYSKY-2023-1015-01, briefTitle: Exploring the Effectiveness and Factors Affecting the Collection of Single Nucleated Cells From Different Volunteers, acronym: SYX-AN-01, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-05-01, completionDateStruct date: 2027-05-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, class: OTHER, descriptionModule briefSummary: 1. 80 cases of healthy donors were subjected to peripheral blood single nucleated cells (PBMC) collection and analyzed the effects of age, body mass index (BMI), blood routine indexes before collection, collection of circulating blood volume, volume of processed blood and the number of circulations, etc., on the PBMC obtained from both men and women, and explored the effects of PBMC collection in different volunteers and the factors affecting the collection. and the influencing factors.2. The data obtained will provide a reference for the MNC threshold for the subsequent clinical trials of immunocell therapy in hospitals.3. From the screening of volunteers, PBMC collection and transportation conditions and other specific details of the operation, risk assessment and the establishment of a safe operation standard process, for the hospital to carry out subsequent clinical trials of immune cell therapy to provide an effective reference., conditionsModule conditions: Observational Study, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: inapplicable, outcomesModule primaryOutcomes measure: Exploring the effectiveness and factors affecting the collection of single nucleated cells from different volunteers, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06361589, orgStudyIdInfo id: EK2023003-1, briefTitle: Real World Study of Lolatinib for Advanced ALK+ NSCLC Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-11-01, completionDateStruct date: 2028-11-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Sichuan Cancer Hospital and Research Institute, class: OTHER, descriptionModule briefSummary: This study was a multicenter, prospective, non-interventional clinical study that included first-line and late-line patients with advanced non-small cell lung cancer with ALK fusions treated with the third generation ALK-TKI lorlatinib until disease progression, intolerable toxicity, investigator or subject decision to withdraw, lost to follow-up, initiation of other antineoplastic therapy, or death. Clinical pathology including sex, age, ALK mutation status at diagnosis, and clinical stage at diagnosis were collected from medical records. Physical condition as assessed by ECOG-PS before administration of lorlatinib was also recorded. Treatment information was obtained from the records, including dose and timing of ALK-TKI therapy and tumor response, number of prior systemic lines of therapy, and local treatment modalities such as radiotherapy and surgery. Quality of life based on the EORTC QLQ C30+LC29 scale (plus the EORTC QLQ BN20 scale in patients with brain/meningeal metastases) was performed at baseline and at each follow-up point. This study will use REDCap platform to collect and manage the study data information of multi-center patients., conditionsModule conditions: ALK-positive Non-small Cell Lung Cancer, conditions: Real World Study, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Lorlatinib, outcomesModule primaryOutcomes measure: PFS, secondaryOutcomes measure: OS, secondaryOutcomes measure: ORR, secondaryOutcomes measure: AE, secondaryOutcomes measure: PRO1, secondaryOutcomes measure: PRO2, secondaryOutcomes measure: PRO3, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sichuan cancer hospital, status: RECRUITING, city: Chengdu, state: Sichuan, zip: 610000, country: China, contacts name: Juan Li, MD, role: CONTACT, phone: 13880276636, email: [email protected], geoPoint lat: 30.66667, lon: 104.06667, hasResults: False
protocolSection identificationModule nctId: NCT06361576, orgStudyIdInfo id: CA209-1443, briefTitle: Real-World Use of Nivolumab for the Treatment of Patients With Metastatic Upper Gastrointestinal Cancer in Canada, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-09-05, primaryCompletionDateStruct date: 2024-01-25, completionDateStruct date: 2024-01-25, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Bristol-Myers Squibb, class: INDUSTRY, descriptionModule briefSummary: The purpose of this observational study is to describe the demographics, and disease characteristics of participants with metastatic upper gastrointestinal cancer, along with the treatment characteristics of these patients when treated with nivolumab., conditionsModule conditions: Upper Gastrointestinal Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 700, type: ACTUAL, armsInterventionsModule interventions name: Nivolumab, outcomesModule primaryOutcomes measure: Particpant sociodemographics, primaryOutcomes measure: Participant Eastern Cooperative Oncology Group (ECOG) score, primaryOutcomes measure: Participant HER2 status, primaryOutcomes measure: Participant comorbidities, primaryOutcomes measure: Participant tumour location, primaryOutcomes measure: Participant treatment history, secondaryOutcomes measure: Initial nivolumab dosage prescribed to participants, secondaryOutcomes measure: Number of nivolumab treatments received by participants, secondaryOutcomes measure: Planned combination chemotherapy treatment, secondaryOutcomes measure: Nivolumab treatment initiation date, secondaryOutcomes measure: Nivolumab dosage modification, secondaryOutcomes measure: Participant treatment duration, secondaryOutcomes measure: Reason for participant discharge, secondaryOutcomes measure: Participant adverse events (AEs), secondaryOutcomes measure: Management of participant adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bayshore Specialty Rx Ltd., city: Mississauga, state: Ontario, zip: L5K 2L3, country: Canada, geoPoint lat: 43.5789, lon: -79.6583, hasResults: False
protocolSection identificationModule nctId: NCT06361563, orgStudyIdInfo id: CA209-1442, briefTitle: Real-World Use of Adjuvant Nivolumab in Patients With Upper Gastrointestinal Cancer in Canada, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-09-05, primaryCompletionDateStruct date: 2024-01-25, completionDateStruct date: 2024-01-25, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Bristol-Myers Squibb, class: INDUSTRY, descriptionModule briefSummary: The purpose of this observational study is to describe the patient, disease and treatment characteristics of eligible participants with upper gastrointestinal cancer treated with adjuvant nivolumab., conditionsModule conditions: Upper Gastrointestinal Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 250, type: ACTUAL, armsInterventionsModule interventions name: Nivolumab, outcomesModule primaryOutcomes measure: Participant sociodemographics, primaryOutcomes measure: Participant Eastern Cooperative Oncology Group (ECOG) score, primaryOutcomes measure: Participant histology results, primaryOutcomes measure: Participant comorbidities, primaryOutcomes measure: Participant tumour location, primaryOutcomes measure: Date of tumour resection, primaryOutcomes measure: Participant primary upper gastrointestinal cancer diagnosis, secondaryOutcomes measure: Initial nivolumab dosage prescribed to participants, secondaryOutcomes measure: Number of nivolumab treatments received, secondaryOutcomes measure: Nivolumab dosage modification, secondaryOutcomes measure: Nivolumab treatment duration, secondaryOutcomes measure: Reason for participant discharge, secondaryOutcomes measure: Participant adverse events (AEs), secondaryOutcomes measure: Management of participant adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bayshore Specialty Rx Ltd., city: Mississauga, state: Ontario, zip: L5K 2L3, country: Canada, geoPoint lat: 43.5789, lon: -79.6583, hasResults: False
protocolSection identificationModule nctId: NCT06361550, orgStudyIdInfo id: AYTO_SALAMANCA_001, briefTitle: Nutritional Status Assessment and Dietary Recommendations Program (VENREDI), statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-02, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-12-30, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: University of Salamanca, class: OTHER, collaborators name: Ayuntamiento de Salamanca, descriptionModule briefSummary: Introduction: The Mediterranean diet has been related to beneficial effects in the prevention of cardiovascular diseases and other chronic pathologies related to diet, including some types of cancer. Specifically in the elderly population, it has been observed that the Mediterranean diet is inversely associated with all causes of mortality and that the greater the adherence to this type of diet, the lower the mortality in elderly adults.Objective: To evaluate the effect of a multifactorial intervention (seminar on shopping basket and food labeling, workshop on healthy cooking and subsequent tasting of the prepared products) in improving adherence to the Mediterranean diet in older adults.Methodology: Randomized controlled clinical trial with two parallel groups: an intervention group (IG) and a control group (CG). The study population will be adults over 60 years of age, retired or pre-retired. A sample size of 200 participants has been estimated, 100 in each group to detect a difference of 0.83 points or more in the MEDAS questionnaire.All participants will receive an educational talk on healthy nutrition, with an estimated duration of 2 hours. The GI, in addition to this educational workshop, will receive a practical seminar on how to properly carry out the shopping cart. This will take place both in a market and later in a supermarket in Salamanca. In addition, a workshop will be held where participants will prepare a menu consisting of three dishes (starter, main and dessert) and will later taste them.An initial and post-intervention evaluation will be carried out after 3 months so that both groups can study the change variables related to Adherence to the Mediterranean Diet \[Mediterranean Diet Adherence Questionnaire (MEDAS)\], physical activity \[Short physical performance battery (SPPB)\], sleep quality (ATENAS questionnaire) and assessment of cognitive function (MOCA questionnaire)., conditionsModule conditions: Adherence to the Mediterranean Diet, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: VENREDI group, interventions name: Health education, outcomesModule primaryOutcomes measure: Adherence to the Mediterranean Diet, secondaryOutcomes measure: Physical activity, secondaryOutcomes measure: Sleep Quality, secondaryOutcomes measure: Cognitive function, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rosario Alonso Domínguez, status: RECRUITING, city: Salamanca, zip: 37007, country: Spain, contacts name: Rosario Alonso Domínguez, PhD, role: CONTACT, phone: 0034923294500, phoneExt: 3280, email: [email protected], geoPoint lat: 40.96882, lon: -5.66388, hasResults: False
protocolSection identificationModule nctId: NCT06361537, orgStudyIdInfo id: CONE-02, briefTitle: Phase 3 Study of IV Human Plasma-derived C1 Esterase Inhibitor Concentrate in Patients With Congenital C1-INH Deficiency for Treatment and Pre-procedure Preventing of Acute Hereditary Angioedema Attacks, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Octapharma, class: INDUSTRY, descriptionModule briefSummary: Prospective, multicenter, randomized, double-blind, parallel group, placebo- controlled, efficacy and safety phase 3 study of an intravenous human plasma- derived C1 esterase inhibitor (C1-INH) concentrate in participants with congenital C1-INH deficiency for the treatment and pre-procedure prevention of acute hereditary angioedema attacks, conditionsModule conditions: Acute Hereditary Angio Edema, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 124, type: ESTIMATED, armsInterventionsModule interventions name: OCTA-C1-INH, interventions name: Placebo, outcomesModule primaryOutcomes measure: Time (h) to beginning of unequivocal symptom relief at the defining site in blinded participants., secondaryOutcomes measure: Percentage of participants responding to treatment, secondaryOutcomes measure: Time to beginning of unequivocal symptom relief at all sites involved, secondaryOutcomes measure: Changes in symptom severity at the defining site by VAS severity rating, eligibilityModule sex: ALL, minimumAge: 2 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06361524, orgStudyIdInfo id: 44967, secondaryIdInfos id: 5F32HL143916, type: NIH, link: https://reporter.nih.gov/quickSearch/5F32HL143916, secondaryIdInfos id: 856341, type: OTHER_GRANT, domain: American Heart Association, briefTitle: Gut Microbiome Profiling in Patients With Chronic Heart Failure, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2018-08-01, primaryCompletionDateStruct date: 2028-12, completionDateStruct date: 2028-12, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Stanford University, class: OTHER, collaborators name: National Heart, Lung, and Blood Institute (NHLBI), collaborators name: American Heart Association, descriptionModule briefSummary: The goal of this observational study is to learn about the composition and function of the gut microbiome in adults with chronic heart failure with reduced ejection fraction. The main questions the study aims to answer are:1. How does the gut microbiome and its interactions with the host change over time in adults with chronic heart failure?2. How do these changes relate to heart failure disease severity and complications?, conditionsModule conditions: Heart Failure With Reduced Ejection Fraction, conditions: Nonischemic Cardiomyopathy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Advanced heart failure-associated microbiome signatures, primaryOutcomes measure: Temporal changes in the gut microbiome community composition in chronic heart failure, secondaryOutcomes measure: Comprehensive longitudinal metabolome profile in chronic heart failure, secondaryOutcomes measure: Comprehensive longitudinal cytokine profile in chronic heart failure, secondaryOutcomes measure: Longitudinal change in New York Heart Association (NYHA) functional class, secondaryOutcomes measure: Longitudinal change in the self-reported functional status, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Stanford University, city: Stanford, state: California, zip: 94305-5210, country: United States, geoPoint lat: 37.42411, lon: -122.16608, hasResults: False
protocolSection identificationModule nctId: NCT06361511, orgStudyIdInfo id: 2023H0284, briefTitle: The Foods & Oil to Repair, Correct and Enhance Strength (FORCES) Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2029-05-01, completionDateStruct date: 2030-05-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Ohio State University, class: OTHER, collaborators name: National Institutes of Health (NIH), descriptionModule briefSummary: The proposed research is a parallel arm, randomized placebo-controlled clinical trial designed to assess changes in muscle strength, volume, fatigue resistance, and mobility in older adults after daily consumption of 12g of linoleic acid-rich oil., conditionsModule conditions: Sarcopenia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: High Linoleic Acid Foods, interventions name: High Oleic Acid Foods, outcomesModule primaryOutcomes measure: Changes is leg extensor muscle strength, secondaryOutcomes measure: Changes in quadriceps muscle volume, secondaryOutcomes measure: Change in maximum leg press strength, secondaryOutcomes measure: Change in leg fatiguability, secondaryOutcomes measure: Change in muscle mitochondria function, secondaryOutcomes measure: Changes in cardiolipin species, secondaryOutcomes measure: Changes in grip strength, secondaryOutcomes measure: Changes in gait speed, secondaryOutcomes measure: Changes in chair rise time, secondaryOutcomes measure: Changes in stair climb power, secondaryOutcomes measure: Change in short physical performance battery score, secondaryOutcomes measure: change in blood fatty acids, otherOutcomes measure: Association of changes in plasma linoleic acid with muscle function, otherOutcomes measure: Association of changes in plasma linoleic acid with muscle strength, otherOutcomes measure: Association of changes in plasma linoleic acid with muscle volume, otherOutcomes measure: Association of changes 4-LA-cardiolipin with muscle function, otherOutcomes measure: Association of changes 4-LA-cardiolipin with muscle strength, otherOutcomes measure: Association of changes 4-LA-cardiolipin with muscle volume, otherOutcomes measure: Association of changes mitochondria function with muscle volume., otherOutcomes measure: Association of changes mitochondria function with muscle function, otherOutcomes measure: Association of changes mitochondria function with muscle strength., eligibilityModule sex: ALL, minimumAge: 65 Years, maximumAge: 80 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Ohio State University, city: Columbus, state: Ohio, zip: 43210, country: United States, geoPoint lat: 39.96118, lon: -82.99879, hasResults: False
protocolSection identificationModule nctId: NCT06361498, orgStudyIdInfo id: 23-3115, briefTitle: Ultrasound for Evaluation of Percutaneous G-tube Position, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: University of North Carolina, Chapel Hill, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare using ultrasound imaging to look at the position of the gastrostomy tube (GT) against fluoroscopic imaging in pediatric patients who had a recent GT tube replacement.The main questions it aims to answer are:* If ultrasound is just as accurate as fluoroscopy to assess the GT position.* If ultrasound takes less time than fluoroscopy to assessing the GT position.Participants will be imaging using ultrasound to assess GT positioning before their standard of care fluoroscopic imaging., conditionsModule conditions: Gastrostomy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Ultrasound Imaging, outcomesModule primaryOutcomes measure: Proportion of Ultrasound that Agree with Fluoroscopy with Respect to Identifying the GT Location, secondaryOutcomes measure: Sensitivity of ultrasound (US) to determine the visualization of GT leakage, secondaryOutcomes measure: Specificity of ultrasound (US) to determine the visualization of GT leakage, secondaryOutcomes measure: Duration of ultrasound (US) to complete evaluation of GT position, eligibilityModule sex: ALL, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: University of North Carolina at Chapel Hill, city: Chapel Hill, state: North Carolina, zip: 27599, country: United States, contacts name: Hannah P Mignosa-Martin, role: CONTACT, phone: 919-843-1670, email: [email protected], contacts name: Desma Jones, role: CONTACT, phone: 9198439463, email: [email protected], contacts name: William Pryor, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.9132, lon: -79.05584, hasResults: False
protocolSection identificationModule nctId: NCT06361485, orgStudyIdInfo id: 011624, briefTitle: Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Lumbar Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2027-03-31, completionDateStruct date: 2028-04-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: R3 Stem Cell, class: INDUSTRY, collaborators name: R3 Medical Research, descriptionModule briefSummary: This is a Pilot Study that is an open label, prospective, non-controlled study in which the safety and feasibility of Wharton's Jelly (WJ) allograft will be evaluated in 100 participants suffering with low back pain., conditionsModule conditions: Low Back Pain, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Prospective, open label, non-controlled Pilot study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Open Label, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Lumbar Injections with 10cc's of Wharton's Jelly Allograft, outcomesModule primaryOutcomes measure: C-reactive protein, primaryOutcomes measure: Erythrocyte sedimentation rate, primaryOutcomes measure: Alanine transaminase (ALT), primaryOutcomes measure: Aspartate transaminase (AST), primaryOutcomes measure: Alkaline phosphatase (ALP), primaryOutcomes measure: Albumin, primaryOutcomes measure: Creatinine, primaryOutcomes measure: Blood Urea Nitrogen (BUN), secondaryOutcomes measure: 36-Item Short Form Survey (SF-36), secondaryOutcomes measure: Numerical Pain Rating Scale (NPRS), secondaryOutcomes measure: Oswestry disability index (ODI), secondaryOutcomes measure: Roland Morris disability questionnaire (RMQ), secondaryOutcomes measure: The Patient-specific functional scale (PSFS), eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: R3 Anti Aging Scottsdale, status: RECRUITING, city: Scottsdale, state: Arizona, zip: 85262, country: United States, contacts name: David Greene, MD, PhD, MBA, role: CONTACT, phone: 480-306-6256, email: [email protected], contacts name: Sabrina Solt, NMD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.50921, lon: -111.89903, locations facility: R3 Anti Aging Beverly Hills, status: RECRUITING, city: Beverly Hills, state: California, zip: 90210, country: United States, contacts name: Kathleen Francesca, BA, role: CONTACT, phone: 424-382-1074, email: [email protected], contacts name: Neville Campbell, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.07362, lon: -118.40036, locations facility: Scheer Medical Wellness, status: RECRUITING, city: New York, state: New York, zip: 10036, country: United States, contacts name: Alexandre Scheer, MD, role: CONTACT, phone: 646-762-9499, email: [email protected], contacts name: Alexandre Scheer, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Dr. Duc (Steve) Le, MD, status: RECRUITING, city: Cleveland, state: Texas, zip: 77327, country: United States, contacts name: Steve Le, MD, role: CONTACT, phone: 281-593-1500, email: [email protected], contacts name: Steve Le, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.67682, lon: -99.25367, hasResults: False
protocolSection identificationModule nctId: NCT06361472, orgStudyIdInfo id: 11695, briefTitle: Contextual Factors-Enriched Standard Care on Mechanical Neck Pain, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-08-31, completionDateStruct date: 2025-11-30, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Universidad Nacional de la Matanza, class: OTHER, descriptionModule briefSummary: The primary purpose of this study will be to determine if a CFs-Enriched Standard Care approach is an effective treatment for mechanical neck pain in terms of reducing pain and improving function. We hypothesize that a 4-week CFs-Enriched Standard Care approach will be superior to Standard Care alone in terms of patient-reported disability and pain, with measurements conducted using the Northwick Park Neck Pain Questionnaire and the Numeric Pain Rating Scale, respectively.This will be an assessor-blinded, 2-group (1:1) randomized clinical trial aiming to enroll 94 participants with neck pain persisting for more than 4 weeks. Both groups will undergo 4 weeks of standard care twice weekly, following established clinical practice guidelines. In the intervention group, CFs will be enhanced, encompassing the physical, psychological, and social elements inherent in the clinical encounter, based on existing evidence.The primary outcomes will encompass changes in Pain and Disability after 4 weeks of treatment, with a follow-up reassessment at week 12 post-treatment. Secondary outcomes will include changes in Active Range of Motion, Global Rating of Change, and Satisfaction with treatment. The change between groups after treatment and at the 12-week follow-up will be reported for all outcomes, considering the difference from scores recorded at baseline., conditionsModule conditions: Neck Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The ContextualizAR trial is designed as a two-arm, randomized, controlled, and blinded assessor superiority trial conducted at a single center. Patients will be allocated to one of two groups: a CFs+SC group and the SC group., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Due to the nature of the study, blinding of both therapists and patients will not be feasible. However, to uphold the scientific validity of the study, specific descriptors and methodological details, such as terms like "placebo" or "CFs," have been intentionally excluded from the consent disclosure. To prevent any potential bias in participants' perceptions, information regarding the potential involvement of CFs in outcomes will not be provided. Instead, participants will be informed that the study aims to assess changes resulting from standard treatment for MNP. The person in charge of data statistical analysis (FV) and the evaluators who will assess all participants' pre- and post-intervention assessments (MLL and AR) will be blinded to the allocated intervention., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 94, type: ESTIMATED, armsInterventionsModule interventions name: Standard Care, interventions name: Contextual Factors, outcomesModule primaryOutcomes measure: Neck Pain Intensity, primaryOutcomes measure: Neck Disability, secondaryOutcomes measure: Active Range of Movement, secondaryOutcomes measure: Global Rating of Change, secondaryOutcomes measure: Satisfaction with treatment, secondaryOutcomes measure: Expectations, secondaryOutcomes measure: Credibility, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False