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## A Study to Evaluate TOUR006 in Patients With Chronic Kidney Disease and Elevated Hs-CRP - NCT ID: NCT06362759 - Study ID: TOUR006-C01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-02 - Lead Sponsor: Tourmaline Bio, Inc. ### Study Description 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. ### Conditions - Chronic Kidney Diseases - Chronic Kidney Insufficiency - Chronic Renal Diseases - Chronic Renal Insufficiency - Kidney Insufficiency, Chronic - C-Reactive Protein - High Sensitivity C-Reactive Protein - Hs-CRP - hsCRP ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - TOUR006 - 50 MG - TOUR006 - 25 MG - TOUR006 - 15 MG - Placebo ### Outcomes Primary Outcomes - Evaluate the effects of TOUR006 compared with placebo on hs-CRP Secondary Outcomes - Evaluate the effects of TOUR006 compared with placebo on hs-CRP - Evaluate the pharmacokinetics by measuring serum concentrations of TOUR006 - Evaluate the safety and tolerability of TOUR006 in participants with elevated cardiovascular risk and CKD ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Non-immunogenic Recombinant Staphylokinase vs Placebo in Patients With Intermediate High-risk Pulmonary Embolism - NCT ID: NCT06362746 - Study ID: FORPE-2 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2028-12-01 - Lead Sponsor: Supergene, LLC ### Study Description 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) ### Conditions - Pulmonary Embolism ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Non-immunogenic recombinant staphylokinase - Placebo ### Outcomes Primary Outcomes - Composite of death from any cause or hemodynamic collapse or recurrent PE Secondary Outcomes - Right/left ventricular (RV/LV) end-diastolic diameter ratio - RV/LV end-diastolic diameter ratio - RV/LV end-diastolic diameter ratio - Right ventricular (RV) end-diastolic volume - Qanadli index - Systolic pulmonary artery pressure - In hospital death from all causes (assessed up to day 7) - Death from all causes - Safety endpoint - hemorrhagic stroke - Safety endpoint - BARC type 3 and 5 bleeding - Safety endpoint - number and severity of adverse events (AEs) and serious AEs in organs and systems ### Location - Facility: V.F. Dolgopolov Vyselki Central District Hospital, Vyselki, Krasnodar Region, 353100, Russian Federation @@
## Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth - NCT ID: NCT06362733 - Study ID: IRB-74165 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2026-06-01 - Lead Sponsor: Stanford University ### Study Description 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. ### Conditions - Autism Spectrum Disorder - Restricted Behavior - Autism ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth ### Outcomes Primary Outcomes - Change from Baseline in Insistence on Sameness Subscale of the Dimensional Assessment of Restricted and Repetitive Behaviors (DARB). Secondary Outcomes - Change from Baseline on Blinded Clinician Ratings of Clinical Global Impression Scale, Severity and Improvement Ratings. - Change from Baseline in Parent-Rated Emotion Dysregulation on the Strengths and Difficulties Questionnaire Dysregulation Profile (SDQ-DP) during treatment. - Change from Baseline in Parent-Rated Irritability as captured by the Aberrant Behavior Checklist (ABC), Irritability Subscale. - Change from Baseline in Ritualistic/Sameness Subscale of Repetitive Behavior Scale-Revised (RBS-R). - Change from Baseline in Parent-Rated Challenging Behaviors on the Open-Source Challenging Behaviors Scale (OS-CBS). - Change from Baseline in Parent-Rated Anxiety as captured by the Anxiety Scale for Children with Autism Spectrum Disorder (ASC-ASD). - Change from Baseline in Caregiver Self-Report on the Caregiver Strain Questionnaire Short Form (CGSQ-SF7). - Change from Baseline in Caregiver Self-Report on the Warwick-Edinburg Mental Wellbeing Scales (WEMWS). - Change from Baseline in the Caregiver Self-Report Depression, Anxiety, and Stress Scale (DASS21). - Caregiver Report Autism Symptoms Dimension Questionnaire (ASDQ). - Caregiver Report Executive Functioning Scale (EFS). - Daily Living Skills Scale (DLSS). ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## 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 - NCT ID: NCT06362720 - Study ID: 720/2566(IRB2) - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-12-31 - Lead Sponsor: Siriraj Hospital ### Study Description 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. ### Conditions - CMV Infection or Reactivation After Allogenic HSCT ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Number of participants with CMV infection and reactivation Secondary Outcomes - progression-free survival - Median overall survival - cumulative incidence of relapse - non-relapsed mortality - GvHD - Averse events ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Fasudil Trial for Treatment of Early Alzheimer's Disease (FEAD) - NCT ID: NCT06362707 - Study ID: 2023161001 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-10-01 - Lead Sponsor: Helse Stavanger HF ### Study Description 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. ### Conditions - Cognitive Decline, Mild - Alzheimer Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Fasudil - Placebo ### Outcomes Primary Outcomes - Cognition - Brain metabolism Secondary Outcomes - Plasma levels of ptau217 - Plasma levels of nfl - Levels of cerebrospinal Aβ1-40 and Aβ1-42 - Levels of cerebrospinal tau and p-tau - Blood pressure (Safety assessments) - Pulse (Safety assessments) - Urine testing (Safety assessments) - Blood urea nitrogen (BUN) (Safety assessments) - Potassium (Safety assessments) - Sodium (Safety assessments) - Calcium (Safety assessments) - Glucose (Safety assessments) - Hemoglobin (Safety assessments) - Creatinine (Safety assessments) - Total and direct bilirubin (Safety assessments) - CRP (C-reactive protein) (Safety assessments) - Aspartate aminotransferase (AST) (Safety assessments) - Serum glutamic-oxaloacetic transaminase (SGOT) (Safety assessments) - Alanine aminotransferase (ALT) (Safety assessments) - Serum glutamic-pyruvic transaminase (SGPT) (Safety assessments) - Alkaline phosphatase (Safety assessments) - Electrocardiogram (ECG) (Safety assessments) - Columbia Suicide Severity Rating Scale (C-SSRS) (Safety assessments) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Study of the Rechallenge Concept in Patients With BRAF-positive Anaplastic Thyroid Cancer After Progression on Anti-BRAF Therapy - NCT ID: NCT06362694 - Study ID: 34 - Status: RECRUITING - Start Date: 2024-03-25 - Completion Date: 2026-06-25 - Lead Sponsor: Saint Petersburg State University, Russia ### Study Description 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. ### Conditions - Anaplastic Thyroid Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Dabrafenib + Trametinib ### Outcomes Primary Outcomes - Objective response rate - Progression-Free Survival - Safety and Tolerability assessment (Incidence of Treatment-Emergent Adverse Events) Secondary Outcomes - Overall survival - The assessment of conversion to resectability ### Location - Facility: Saint Petersburg State University Hospital, Saint Petersburg, N/A, 190020, Russian Federation @@
## Effects of Different Remineralization Agents on Molar Incisor Hypomineralization Defects: a Randomized Clinical Study - NCT ID: NCT06362681 - Study ID: CF-2023-I-13 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-03-30 - Lead Sponsor: Universidad Nacional Autonoma de Mexico ### Study Description 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. ### Conditions - Molar Incisor Hypomineralization ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Fluoride ### Outcomes Primary Outcomes - Mineral Density Secondary Outcomes ### Location - Facility: Alvaro Garcia Pérez, San Pedro Apatlaco, Morelos, N/A, Mexico @@
## EU Sites: Fluid Management of Acute Decompensated Heart Failure With Reprieve Decongestion Management System (FASTR-EU) - NCT ID: NCT06362668 - Study ID: RCV-0006-EU - Status: NOT_YET_RECRUITING - Start Date: 2024-04-09 - Completion Date: 2024-12-31 - Lead Sponsor: Reprieve Cardiovascular, Inc ### Study Description 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. ### Conditions - Acute Decompensated Heart Failure ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Reprieve Decongestion Management System - Diuretic (furosemide, bumetanide, torsemide, hydrochlorothiazide, and/or acetazolamide) ### Outcomes Primary Outcomes - Total sodium loss (in mmol of sodium) per 24 hours - Comparison of occurrence of composite endpoint comprised of clinically significant acute kidney injury, severe electrolyte abnormality, or symptomatic hypotension or hypertensive emergency. Secondary Outcomes - Total net fluid volume loss (difference between urine output volume and fluid input volume) per 24 hours - Weight loss per 24 hours at end of randomized therapy - Time on IV loop diuretic - Number of participants with ≥ 0.3 mg/dL increase in serum creatinine ### Location - Facility: University Medical Center Groningen, Groningen, N/A, N/A, Netherlands @@
## ACTIBESE Project - Active Behaviour in School Education - NCT ID: NCT06362655 - Study ID: ANID/FONDECYT 2013/1230801 - Status: ENROLLING_BY_INVITATION - Start Date: 2023-04-01 - Completion Date: 2025-12-31 - Lead Sponsor: Pontificia Universidad Catolica de Valparaiso ### Study Description 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. ### Conditions - Physical Inactivity - Child Behavior - Family Support ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Intervention ### Outcomes Primary Outcomes - Physical activity levels Secondary Outcomes ### Location - Facility: IRyS Group, School of Physical Education, Pontificia Universidad Católica de Valparaíso, Valparaíso, Chile., Viña Del Mar, Valparaiso, 2300000, Chile @@
## A Study to Investigate the Effects of Itraconazole on the Pharmacokinetics of PC14586 in Healthy Participants - NCT ID: NCT06362642 - Study ID: PMV-586-105 - Status: RECRUITING - Start Date: 2024-03-28 - Completion Date: 2024-12 - Lead Sponsor: PMV Pharmaceuticals, Inc ### Study Description The purpose of this study is to assess the effect of PC14586 pharmacokinetics when co administered with itraconazole in healthy participants. ### Conditions - Healthy Volunteers ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: OTHER ### Interventions - PC14586 - Itraconazole ### Outcomes Primary Outcomes - Characterize the Maximum Plasma Concentration (Cmax) of PC14586 when co-administered with itraconazole in healthy participants. - Characterize the total drug exposure (AUC0-inf) of PC14586 when co-administered with itraconazole in healthy participants. - Characterize the time to peak drug concentration (Tmax) of PC14586 when co-administered with itraconazole in healthy participants. - Characterize the total drug exposure from time zero to 24 hours (AUC0-24) of PC14586 when co-administered with itraconazole in healthy participants. - Characterize the total drug exposure from time zero to the last timepoint (AUC0-t) of PC14586 when co-administered with itraconazole in healthy participants. - Characterize the half-life (t1/2) of PC14586 when co-administered with itraconazole in healthy participants. Secondary Outcomes - Characterize the Maximum Plasma Concentration (Cmax) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants. - Characterize the total drug exposure (AUC0-inf) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants. - Characterize the time to peak drug concentration (Tmax) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants. - 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. - 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. - Characterize the half-life (t1/2) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants. - Identification of the incidence of treatment emergent adverse events (TEAE) of PC14586 when administered alone and co-administered with itraconazole in healthy participants. - Identification of vital sign abnormalities after administration of PC14586 alone and when co-administered with itraconazole in healthy participants. - Identification of 12-lead electrocardiogram (ECG) abnormalities after administration of PC14586 alone and when co-administered with itraconazole in healthy participants. - Identification of laboratory abnormalities based on hematology and clinical chemistry after administration of PC14586 alone and when co-administered with itraconazole in healthy participants. ### Location - Facility: Fortrea, Madison, Wisconsin, 53704, United States @@
## AI App for Management of Atopic Dermatitis - NCT ID: NCT06362629 - Study ID: WCH240407 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-01 - Completion Date: 2029-08-31 - Lead Sponsor: West China Hospital ### Study Description 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. ### Conditions - Atopic Dermatitis - Artificial Intelligence ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Artificial Intelligence assistant decision-making system (AIADMS) App ### Outcomes Primary Outcomes - The overall efficiency rate of treating objectives including PP-NRS, EASI, SCORAD, POEM, and DLQI at 12 weeks after treatment Secondary Outcomes - The seperated efficiency rate of treating objectives including PP-NRS, EASI, SCORAD, POEM, and DLQI - The economic consumption - Satisfaction evaluation ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Preoperative Accelerated Partial Breast Irradiation in Patients With Locally Recurrent or Second Primary Breast Cancer - NCT ID: NCT06362616 - Study ID: N23PBD - Status: RECRUITING - Start Date: 2024-04-12 - Completion Date: 2027-04-11 - Lead Sponsor: The Netherlands Cancer Institute ### Study Description 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. ### Conditions - Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Preoperative accelerated partial breast irradiation - Breast conserving surgery - Sentinel node procedure - Biopsy track removal ### Outcomes Primary Outcomes - Acute post-treatment toxicity Secondary Outcomes - Fibrosis/induration - Patient-reported Outcome Measures (PROMS): EORTC Quality of Life Questionnaire (QLQ)-C30 - Patient-reported Outcome Measures (PROMS): EORTC QLQ-BR23 - Patient-reported Outcome Measures (PROMS): Patient's Questionnaire Cosmesis - Cosmetic outcome according to the BCCT.core software program ### Location - Facility: The Netherlands Cancer Institute, Amsterdam, N/A, 1066CX, Netherlands @@
## [Trial of device that is not approved or cleared by the U.S. FDA] - NCT ID: NCT06362603 - Study ID: FB2022NIH - Status: WITHHELD - Start Date: N/A - Completion Date: N/A - Lead Sponsor: [Redacted] ### Study Description No description available. ### Conditions - No conditions listed. ### Study Design - Type: N/A - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Expanded Access Use of Ladiratuzumab Vedotin in Advanced Solid Tumors - NCT ID: NCT06362590 - Study ID: LV-SPIND-001 - Status: AVAILABLE - Start Date: N/A - Completion Date: N/A - Lead Sponsor: Seagen Inc. ### Study Description The purpose of this study is to provide the option of Ladiratuzumab Vedotin treatment to eligible patients in studies SGNLVA-005. ### Conditions - No conditions listed. ### Study Design - Type: EXPANDED_ACCESS - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - ladiratuzumab vedotin ### Outcomes Primary Outcomes Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Clinical Study of HIFU for Localized Prostate Cancer - NCT ID: NCT06362577 - Study ID: TSC202202 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2026-12-31 - Lead Sponsor: RenJi Hospital ### Study Description 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. ### Conditions - Localized Prostate Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - EQ-5D-5L IPSS IIEF-5 EPIC-26 ECOG ### Outcomes Primary Outcomes - Incidence of postoperative complications Secondary Outcomes - The time to reach the lowest point of PSA - Assessment of quality of life and sexual function spontaneously reported at 2, 6, and 12 months after surgery - The negative rate of tumor exclusion was evaluated by imaging (mainly mp-MRI) at 2 and 12 months after surgery - The incidence of biochemical recurrence that requires remedial or systemic treatment 12 months after surgery - Postoperative overall survival rate ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## [Trial of device that is not approved or cleared by the U.S. FDA] - NCT ID: NCT06362564 - Study ID: CIPL-LBE-0101 - Status: WITHHELD - Start Date: N/A - Completion Date: N/A - Lead Sponsor: [Redacted] ### Study Description No description available. ### Conditions - No conditions listed. ### Study Design - Type: N/A - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Oocyte Donor Application Discrepancies - NCT ID: NCT06362551 - Study ID: INC-GS-2024-002 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-25 - Completion Date: 2025-05 - Lead Sponsor: Inception Fertility, LLC ### Study Description 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. ### Conditions - Infertility ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Rate of additional information - Rate of applicant decline Secondary Outcomes ### Location - Facility: Inception Fertility LLC, Houston, Texas, 77081, United States @@
## The Cardiovascular Prevention Program - NCT ID: NCT06362538 - Study ID: MCH-ProCardioPrev - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2027-04-15 - Lead Sponsor: Maria Cecilia Hospital ### Study Description 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. ### Conditions - Cardiovascular Prevention ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: PREVENTION ### Interventions - International Physical Activity Questionnaire - Six minute walking test - SF-36, Euro-Qol 5D-5L, Perceived stress scale-10, Pittsburgh Sleep Quality Index, Depression Anxiety Stress scale- 21. - MEDAS - Intima-media thickness (IMT) - Blood sampling - Stool Sample Culture Test ### Outcomes Primary Outcomes - measure of body mass index - Adherence to the Mediterranean diet - blood test to check cholesterol levels - blood pressure measurement - blood glucose test Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Incidence of Episodes of (Dis)Connected Consciousness Among Emergency Patients Admitted in the Resuscitation Room - NCT ID: NCT06362525 - Study ID: 2022-389 - Status: RECRUITING - Start Date: 2023-10-09 - Completion Date: 2027-09-30 - Lead Sponsor: University of Liege ### Study Description 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. ### Conditions - Critical Illness - Near-Death Experience - Consciousness, Loss of - Quality of Life - Emergencies ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Detection of potential episodes of disconnected consciousness - Detection of potential episodes of connected consciousness Secondary Outcomes - Risk factors - Quality of life assessment - Memory content and evolution assessment - Detection of post-traumatic stress disorder (PTSD) ### Location - Facility: CHU of Liège, Liège, N/A, 4000, Belgium @@
## Cognitive-motor Exercise for Stroke Patients in Function, Cognition and Related Brain Changes. - NCT ID: NCT06362512 - Study ID: Marco_PANG_2024 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2026-04 - Lead Sponsor: The Hong Kong Polytechnic University ### Study Description 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. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Dual-task training - Single-task training - Upper limb strengthening exercise ### Outcomes Primary Outcomes - Dual-task step frequency - Dual-task cognitive performance accuracy Secondary Outcomes - Blood oxygenation level changes of the brain ### Location - Facility: The Hong Kong Polytechnic University, Hong Kong, N/A, 000000, China @@
## Effects of Unsupervised Inspiratory Muscle Training on Ventilation Variability in Post-covid-19 Patients. - NCT ID: NCT06362499 - Study ID: 01 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-07-31 - Lead Sponsor: Universidade Federal do Rio Grande do Norte ### Study Description 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. ### Conditions - COVID-19 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Experimental Group ### Outcomes Primary Outcomes - Ventilation variability and ventilation efficiency Secondary Outcomes - Respiratory muscle strength - Pulmonary function - Quality of life - Medical Outcomes Study 36-Item Short Health Form Survey (SF-36) - Peripheral muscle strength - Functional capacity - Adverse effects and adherence ### Location - Facility: Federal University of Rio Grande do Norte, Natal, Rio Grande Do Norte, 59082-100, Brazil @@
## Stress in Pregnancy During the Covid19 Pandemic and Impact on the Newborn Neurodevelopment - NCT ID: NCT06362486 - Study ID: SIGNATURE - Status: ACTIVE_NOT_RECRUITING - Start Date: 2021-08-01 - Completion Date: 2024-08-01 - Lead Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla ### Study Description 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. ### Conditions - Covid19 and Pregnancy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Severity of infection, time of infection. - Mental health assessment - biological ### Outcomes Primary Outcomes - explore how the presence of stressors and prenatal sars-cov-2 infection generates an abnormal inflammatory activity in the newborn Secondary Outcomes ### Location - Facility: Hospital Universitario Virgen del Rocío, Sevilla, N/A, 41013, Spain @@
## Lipid Transport Disorder Italian Genetic Record (LIPIGEN) - NCT ID: NCT06362473 - Study ID: LIPIGEN-001 - Status: RECRUITING - Start Date: 2015-08-04 - Completion Date: 2026-09-30 - Lead Sponsor: Fondazione SISA (Societa Italiana per lo Studio della Arteriosclerosi) ### Study Description 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. ### Conditions - Familial Hypercholesterolemia - Genetic Disorder ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Lipid-lowering treatments ### Outcomes Primary Outcomes - Lipid profile of patients with genetic dyslipidemia - Genetic profile of patients with genetic dyslipidemia Secondary Outcomes ### Location - Facility: IRCCS Multimedica, Sesto san Giovanni, Milano, 20099, Italy @@
## Mass Balance Study of [14C]RAY1216 in Healthy Adult Male Subjects in China - NCT ID: NCT06362460 - Study ID: RAY1216-23-03 - Status: COMPLETED - Start Date: 2023-09-18 - Completion Date: 2023-11-15 - Lead Sponsor: Guangdong Raynovent Biotech Co., Ltd ### Study Description 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. ### Conditions - Pharmacokinetics ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - [14C] RAY1216 ### Outcomes Primary Outcomes - Total radioactivity in plasma PK - Total radioactivity in plasma PK - Total radioactivity in plasma PK - Total radioactivity in plasma PK - Mass balance recovery of total radioactivity in all (urine, faeces) amount excreted (Ae) expressed as a percentage of the administered dose (%Ae) Secondary Outcomes - Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0 ### Location - Facility: The First Affiliated Hospital of Bengbu Medical College, Bengbu, N/A, N/A, China @@
## Efficacy of Injectable Gentamicin in Hereditary Ichthyosis - NCT ID: NCT06362447 - Study ID: RC31/22/0320 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-23 - Completion Date: 2027-04-01 - Lead Sponsor: University Hospital, Toulouse ### Study Description 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. ### Conditions - Ichthyosis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Gentamicin Injectable Solution ### Outcomes Primary Outcomes - Gentamicin efficacity Secondary Outcomes - Gentamicin efficacity - Gentamicin efficacity on quality of life ### Location - Facility: Hôpital Saint-Louis APHP, Paris, N/A, 75010, France @@
## Visual Telerehabilitation in Children, Adolescents and Young Adults With Hemianopsia Consecutive to a Brain Tumour - NCT ID: NCT06362434 - Study ID: UHN-HHREHAB-24-xxxx - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2027-06-01 - Lead Sponsor: University Health Network, Toronto ### Study Description 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. ### Conditions - Hemianopsia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Audiovisual stimulation ### Outcomes Primary Outcomes - Binocular Visual Field Secondary Outcomes - Patient-related Outcome Measures - National Eye Institute - Visual Function Questionnaire - 25 - Patient-related Outcome Measures - World Health Organization - Quality of Life questionnaire - BREF - Reading Speed - Fixation Stability - Contrast Sensitivity ### Location - Facility: Alberta Children's Hospital, Calgary, Alberta, T3B 6A8, Canada @@
## Saliva Testing for High-Risk Human Papillomavirus Infection Oral Cavity and Pharynx Cancer - NCT ID: NCT06362421 - Study ID: ONC-HN-2402 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-07 - Lead Sponsor: Wake Forest University Health Sciences ### Study Description 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. ### Conditions - Oropharyngeal Squamous Cell Carcinoma - Human Papillomavirus Infection ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Pre-Radiation Dental Evaluation/Sample Collection - Pre-Study Visit - Oral Medicine Consultation Visit/Sample Collection ### Outcomes Primary Outcomes - Number of Participants with Sensitivity for Detection of HPV 16, 18 and gene ACTB - Number of Participants with Specificity Detection of HPV 16, 18 and gene ACTB - Overall Accuracy - All Participants Secondary Outcomes ### Location - Facility: Hayworth Cancer Center, High Point, North Carolina, 27262, United States @@
## Effect of Dexmedetomidine on Postoperative Mental Disorders and Long-term Survival in Elderly Patients - NCT ID: NCT06362408 - Study ID: PLAGH-DEX-PSM/IPTW-001 - Status: COMPLETED - Start Date: 2022-06-01 - Completion Date: 2023-06-01 - Lead Sponsor: Chinese PLA General Hospital ### Study Description 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. ### Conditions - Cohort Studies ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Dexmedetomidine ### Outcomes Primary Outcomes - Postoperative mortality rate Secondary Outcomes - The incidence of postoperative delirium - The incidence of postoperative anxiety - The incidence of postoperative depression - Postoperative sleep disorders - Surgical related complications - Postoperative quality of life evaluation ### Location - Facility: Chinese PLA General Hospital, Beijing, Beijing, N/A, China @@
## Ultra-high Dose Radiation for Liver Metastasis Using MR-guided TReatment With Stereotactic Ablative Single-fraction - NCT ID: NCT06362395 - Study ID: 24-5022 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2030-06 - Lead Sponsor: University Health Network, Toronto ### Study Description 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. ### Conditions - Liver Metastases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Magnetic resonance (MR)-guided stereotactic ablative single-fraction (SBRT) ### Outcomes Primary Outcomes - Local control (LC) of treated target lesion compared to high dose MR-guided stereotactic single-fraction radiation. Secondary Outcomes - Overall survival (OS) - Progression free survival (PFS) - Intra-hepatic progression - Widespread progression. - Physician-assessed toxicities: National Cancer Institute (NCI) Common Terminology Criteria of Adverse Events (CTCAE) V.5. - Patients-reported toxicity: Patient Reported Outcomes - Common Terminology Criteria of Adverse Events (PRO CTCAE) V.1. - 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) - Quality of life (QOL): European Organization for Research and Treatment of Cancer Quality of Life Questionnaires, liver metastases (EORTC QOQ-LM21). ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Mobile Internet-based Remote Home Rehabilitation Improves Prognostic Function and Life Quality in Pulmonary Hypertension - NCT ID: NCT06362382 - Study ID: 2024-zxm-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-22 - Completion Date: 2026-05-01 - Lead Sponsor: China-Japan Friendship Hospital ### Study Description 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. ### Conditions - Pulmonary Hypertension ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - tele-rehabilitation training - health propaganda and education ### Outcomes Primary Outcomes - changes in 6MWD after 3 months - changes in muscle mass after 3 months Secondary Outcomes - peak VO2 - VO2peak% - VE/VCO2 slope - PET CO2 - Changes in muscle mass evaluated by CT - Changes in grip strength - the time for 5 sit-to-stand test - Quality of life measured by SF-36 after 3 months - Quality of life measured by SF-36 after 6 months - Quality of life measured by emPHasis-10 after 3 months - Quality of life measured by emPHasis-10 after 6 months - Changes in WHO Cardiac Function Classification - Change in NT-proBNP - Change in TAPSE by cardiac doppler ultrasound - Changes in hemodynamic indice after 6 months - Changes in sleep quality score after 3 months - Changes in sleep quality score after 6 months - Changes in psychosocial score after 3 months - Changes in psychosocial score after 6 months - All-cause mortality in 3 months - All-cause mortality in 6 months - The occurrence rate of primary events in pulmonary hypertension in 3 months - The occurrence rate of primary events in pulmonary hypertension in 6 months ### Location - Facility: Fuwai Hospital, Beijing, Beijing, 100037, China @@
## A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy - NCT ID: NCT06362369 - Study ID: 7HP-111 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2028-12-31 - Lead Sponsor: 7 Hills Pharma, LLC ### Study Description 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 ### Conditions - Advanced Cancer - Advanced Solid Tumor - Melanoma - Metastasis - Pleural Mesothelioma - Renal Cell Carcinoma - MSI-High - Mismatch Repair Deficiency - Colorectal Cancer - Hepatocellular Carcinoma - Hepatocellular Cancer - Renal Cell Cancer - Kidney Cancer - Skin Cancer - Non Small Cell Lung Cancer - NSCLC - Anaplastic Lymphoma Kinase Genomic Tumor Aberrations - ALK Genomic Tumor Aberrations ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Alintegimod - Ipilimumab - Nivolumab ### Outcomes Primary Outcomes - Number of participants treated with Alintegimod monotherapy with treatment related adverse events as assessed by CTCAEv5.0 - Number of participants treated with Alintegimod in combination with treatment related adverse events as assessed by CTCAEv5.0 - Define RPTDs for Alintegimod Secondary Outcomes - Characterize Pharmacokinetics of Alintegimod monotherapy by measuring Maximum Plasma Concentration (Cmax) - Characterize Pharmacokinetics of Alintegimod monotherapy by measuring Area Under the Curve (AUC) - Characterize Pharmacokinetics of Alintegimod plus ipilimumab by measuring Maximum Plasma Concentration (Cmax) - Characterize Pharmacokinetics of Alintegimod plus ipilimumab by measuring Area Under the Curve (AUC) - Determine Progression Free Survival (PFS) response in patients treated with Alintegimod plus ipilimumab followed by nivolumab using RECIST v1.1 tumor assessment criteria. - Determine Overall Response Rate (ORR) in patients treated with Alintegimod plus ipilimumab followed by nivolumab using RECIST v1.1 response assessment criteria. ### Location - Facility: Florida Cancer Specialists, Lake Mary, Florida, 32746, United States @@
## Microbial Metabolites and Outcomes of Pregnancy Study - NCT ID: NCT06362356 - Study ID: 24-106 - Status: RECRUITING - Start Date: 2024-03-05 - Completion Date: 2026-12-31 - Lead Sponsor: The Cleveland Clinic ### Study Description 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. ### Conditions - Hypertensive Disorder of Pregnancy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - TMAO level - TMAO level - TMAO level Secondary Outcomes ### Location - Facility: Cleveland Clinic, Cleveland, Ohio, 44195, United States @@
## The Study of Monitoring and Dosing Guidance of Direct Oral Anticoagulants Based on Pharmacokinetics, Pharmacodynamics, and Pharmacogenomics - NCT ID: NCT06362343 - Study ID: PUMCH-Rivaroxaban-Monitoring - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2027-01-30 - Lead Sponsor: Peking Union Medical College Hospital ### Study Description 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. ### Conditions - Pulmonary Embolism ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Rivaroxaban ### Outcomes Primary Outcomes - Bleeding events - Recurrent thromboembolic events Secondary Outcomes ### Location - Facility: Peking Union Medical College Hospital, Beijing, Beijing, 100730, China @@
## Multi-parametric MRI in Patients of Bladder Cancer - NCT ID: NCT06362330 - Study ID: 2022-SR-471 - Status: RECRUITING - Start Date: 2021-07-01 - Completion Date: 2024-06-30 - Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University ### Study Description 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). ### Conditions - Muscle-invasive Bladder Cancer - Artificial Intelligence ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - magnetic resonance imaging ### Outcomes Primary Outcomes - Muscle-invasive bladder cancer - Non-muscle-invasive bladder cancer Secondary Outcomes ### Location - Facility: Yu-Dong Zhang, Nanjing, N/A, 210029, China @@
## Toripalimab With or Without Lenvatinib or Chemotherapy in First-Line Treatment of Advanced Biliary Tract Cancer - NCT ID: NCT06362317 - Study ID: K5247 - Status: RECRUITING - Start Date: 2024-03-06 - Completion Date: 2026-03-06 - Lead Sponsor: Peking Union Medical College Hospital ### Study Description 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 ### Conditions - Biliary Tract Neoplasms Immunotherapy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Toripalimab - Lenvatinib - Gemox Chemotherapy（Gemox or GC） ### Outcomes Primary Outcomes - Objective response rate (ORR) Secondary Outcomes - Disease control rate (DCR) - Progression-free survival (PFS) - Overall survival - Duration of response - Clinical benefit rate ### Location - Facility: Chinese Academy of Medical Sciences & Peking Union Medical College Hospital (CAMS&PUMCH), Beijing, Beijing, 100005, China @@
## 99mTc-CNDG SPECT/CT in Brain Tumors - NCT ID: NCT06362304 - Study ID: 2024-DG-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-04 - Lead Sponsor: Peking Union Medical College Hospital ### Study Description 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. ### Conditions - Intracranial Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - 99mTc-CNDG SPECT/CT ### Outcomes Primary Outcomes - SUVmax Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparison of MRI AI-cTB Versus Routine cTB in Prostate Cancer Diagnosis: a Prospective Randomized Controlled Trial - NCT ID: NCT06362291 - Study ID: 2023IR27 - Status: RECRUITING - Start Date: 2023-08-01 - Completion Date: 2025-04-30 - Lead Sponsor: Peking University First Hospital ### Study Description 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. ### Conditions - Prostate Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - MRI-AI guided cognitive prostate targeted biopsy - Routine cognitive prostate targeted biopsy ### Outcomes Primary Outcomes - The clinically significant prostate cancer (csPCa) detection rate for targeted biopsy (TB) and TB combined with systematic biopsy (SB) Secondary Outcomes - The PCa detection rate - The Gleason score (GS) of the biopsy sample - The GS of radical prostatectomy (RP) specimens ### Location - Facility: Peking University First Hospital, Beijing, Beijing, 100034, China @@
## A Multi-omics Study of "Healthy" Premature CAD Patients - NCT ID: NCT06362278 - Study ID: 026 - Status: RECRUITING - Start Date: 2024-03-20 - Completion Date: 2025-12 - Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University ### Study Description 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？ ### Conditions - Coronary Artery Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - multi-omics studies ### Outcomes Primary Outcomes - common & rare variants associated with "healthy" pre-mature CAD phenotype - Unique metabolomic fingerprints associated with "healthy" pre-mature CAD phenotype Secondary Outcomes ### Location - Facility: First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, 210000, China @@
## A Study to Evaluate Pharmacokinetics of LY3209590 in Pediatric Participants With Type 2 Diabetes Mellitus - NCT ID: NCT06362265 - Study ID: 18437 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-11 - Lead Sponsor: Eli Lilly and Company ### Study Description 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. ### Conditions - Type 2 Diabetes Mellitus ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - LY3209590 ### Outcomes Primary Outcomes - Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve (AUC) of LY3209590 - PK: Maximum Observed Plasma Concentration (Cmax) of LY3209590 Secondary Outcomes - Change from Baseline in Fasting Glucose ### Location - Facility: Honor Health Research Institute, Scottsdale, Arizona, 85258, United States @@
## 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) - NCT ID: NCT06362252 - Study ID: DS7300-189 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-17 - Completion Date: 2026-12-30 - Lead Sponsor: Daiichi Sankyo ### Study Description 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. ### Conditions - Extensive Stage-small Cell Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ifinatamab deruxtecan - Atezolizumab - Carboplatin - Etoposide ### Outcomes Primary Outcomes - Number of Participants Reporting Dose-limiting Toxicities Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A) - Overall Number of Participants With Treatment-emergent Adverse Events Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B) Secondary Outcomes - 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) - 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) - 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) - 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) - 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) - 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) - 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) - Overall Survival Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B) - Pharmacokinetic Parameter Maximum Serum Concentration of I-DXd - Pharmacokinetic Parameter Time to Maximum Serum Concentration of I-DXd - Pharmacokinetic Parameter Area Under the Concentration Curve of I-DXd - The Number of Participants Who Are Anti-Drug Antibody (ADA)-Positive At Any Time and Who Have A Treatment-emergent Anti-Drug Antibody ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Prospective Home-Based Palliative Care and Hospice Study - NCT ID: NCT06362239 - Study ID: STUDY00003853 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2027-10 - Lead Sponsor: Steven Smith ### Study Description 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. ### Conditions - Pediatric Palliative Care ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Study Surveys ### Outcomes Primary Outcomes - Hospital Utilization Differences Secondary Outcomes - Demographic Differences - Location of death differences ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## OPTIMIZING OCULAR OUTCOMES: A DUAL-ARMED STUDY FOR PERIORBITAL BURN MANAGEMENT - NCT ID: NCT06362226 - Study ID: HM20029491 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-10 - Lead Sponsor: Virginia Commonwealth University ### Study Description 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. ### Conditions - Periorbital Burns ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Steroid/Antibiotic - 5-FU/Kenalog ### Outcomes Primary Outcomes - Comparison of wound healing time - Comparison of infection rate - Comparison of complication rates Secondary Outcomes - Comparison of pain level - Comparison of quality of life - Comparison of cosmetic outcome through the Vancouver scar scale (VSS) - Comparison of cosmetic outcome through the Patient Observer Scar Assessment Scale (POSAS) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Gaining Insight Into Dual Sensory Loss - NCT ID: NCT06362213 - Study ID: NL76924.029.22 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-04 - Lead Sponsor: Amsterdam UMC, location VUmc ### Study Description 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. ### Conditions - Dual Sensory Impairment of Vision and Hearing ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - information access - mobility - communication - fatigue Secondary Outcomes ### Location - Facility: Amsterdam UMC, location VUmc, Amsterdam, Noord Holland, 1081 HV, Netherlands @@
## The Validation and Biological Index Studies on the Improved Social Function of ASD by 40 Hz tACS - NCT ID: NCT06362200 - Study ID: LYG20230083 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2028-12-31 - Lead Sponsor: Central South University ### Study Description 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. ### Conditions - Autism Spectrum Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - 40 Hz tACS intervention ### Outcomes Primary Outcomes - Autism assessment assessment index Secondary Outcomes - EEG physiological detection index - Magnetic resonance detection index - Eye movement index - Emotion recognition index - Understanding of social interaction index - Understanding of thoughts and intentions index - Social Communication Changes index - Stereotyped behavior index - Sensory index - Abnormal behavior indicator - Sleep index ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## VR Pilot for Pancreatitis - NCT ID: NCT06362187 - Study ID: STUDY00003238 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-05 - Lead Sponsor: Cedars-Sinai Medical Center ### Study Description 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. ### Conditions - Chronic Pancreatitis - Recurrent Pancreatitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Gut Directed VR - Sham Control VR ### Outcomes Primary Outcomes - Feasibility of home-based VR Secondary Outcomes - Impact of home-based VR ### Location - Facility: Marissa Podell, Los Angeles, California, 90048, United States @@
## Capsule & Omics for pRedicting Exacerbation of Crohn's Disease - NCT ID: NCT06362174 - Study ID: SHEBA-22-9902-SBH-CTIL - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-02-07 - Completion Date: 2025-12-31 - Lead Sponsor: Sheba Medical Center ### Study Description 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. ### Conditions - Crohn's Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Crohn's Disease Activity Index score (CDAI) - Disease related complications - disease related hospitalization - Change of crohn's disease medications - opinion of the principle investigator (PI) or the treating physician Secondary Outcomes - The rate of clinical flare accompanied by objective signs of mucosal inflammation. - The rate of inflammatory worsening with/without accompanying clinical symptoms ### Location - Facility: Sheba Medical Center, Tel-Hashomer, N/A, N/A, Israel @@
## Establishment of an Interdisciplinary Functional Neurological Disorder (FND) Treatment Program and Development of a Clinical Care Pathway for FND - NCT ID: NCT06362161 - Study ID: IRB-300011066 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2028-12-31 - Lead Sponsor: University of Alabama at Birmingham ### Study Description 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. ### Conditions - Functional Neurological Disorder - Convulsion, Non-Epileptic - Functional Seizure ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Patient Demographic Information - Hospital Anxiety and Depression Scale (HADS) - ASM 121 functional assessment definitions - SF-36 (subjective health and wellbeing) - Work and Social Adjustment Scale (WSAS) - Patient Health Questionnaire 15 - Dizziness Handicap Inventory - Dizziness Symptom Profile - Adult Tic Questionnaire (ATQ) - Child Self-Report Tic Questionnaire - Parent Tic Questionnaire (PTQ) - Seizure Questionnaire - Level 2-Somatic Symptom report - Revised Children's Anxiety and Depression Scale (RCADS) - Functional Disability Inventory (FDI) - Impact on the Family Scale - Pediatric Quality of Life (Peds-QL) - Healthcare Utility Questionnaire - Assessment of control over symptoms Secondary Outcomes ### Location - Facility: University of Alabama at Birmingham, Birmingham, Alabama, 35294, United States @@
## Circulating Tumor DNA in Peripheral T-cell Lymphomas - NCT ID: NCT06362148 - Study ID: 1-10-72-134-23 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2030-12 - Lead Sponsor: University of Aarhus ### Study Description 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). ### Conditions - Peripheral T-cell Lymphoma - NK/T-Cell Lymphoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Tumor- and plasma-informed, next-generation sequencing (NGS)-based patient-specific droplet digital (dd)PCR assay - 18F-fludeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT) ### Outcomes Primary Outcomes - ctDNA occurrence - ctDNA quantification Secondary Outcomes - Progression free survival - Overall survival - Radiographic assessment by PET/CT - Comparison of molecular and radiographic response - Spatial and temporal mutational homo- or heterogeneity - Fragment pattern analysis ### Location - Facility: Department of Hematology, Aarhus University Hospital, Aarhus, Central Denmark Region, 8200, Denmark @@
## Virtual Home Visits for Stroke Patients and Their Caregivers - NCT ID: NCT06362135 - Study ID: 0733 - Status: RECRUITING - Start Date: 2023-08-01 - Completion Date: 2025-03-01 - Lead Sponsor: The Scientific and Technological Research Council of Turkey ### Study Description 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 ### Conditions - Stroke - Caregiver - Virtual - Home Visit ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Virtual Home Visit - Control Group ### Outcomes Primary Outcomes - Effect of Virtual and Face to face to home visit - Level of competence of stroke caregiver - Frequency of unplanned hospital readmission Secondary Outcomes - Effect of the virtual home visit ### Location - Facility: Yasemin Demi̇r Avci̇, Antalya, N/A, 07058, Turkey @@
## Anatomo-clinico-biological Profiles in Severe Nasal Polyps - NCT ID: NCT06362122 - Study ID: PREDICTO-POLYP - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-10-01 - Lead Sponsor: Poitiers University Hospital ### Study Description 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. ### Conditions - NASAL POLYPS ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - identification anatomo-clinico-biological profiles ### Outcomes Primary Outcomes - Identify anatomical profiles present in nasal sinus polyposis resistant to medical treatment. - Evaluation of symptoms related to nasal sinus polyposis by visual analogue scale - Evaluation to quality of life by Sino-Nasal Outcome Test - Identify biological profiles for patients with nasal sinus polyposis - Evaluation to cytokine concentration in serum for patients with nasal sinus polyposis Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Impact of Intermittent Nutritional Tube Supplementation in Elderly Patients With Dysphagia - NCT ID: NCT06362109 - Study ID: Once tubefeeding - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-12 - Lead Sponsor: Zhao Song Ling ### Study Description 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. ### Conditions - Dysphagia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Routine rehabilitation - Intermittent Oro-esophageal Tube Feeding ### Outcomes Primary Outcomes - Nutritional status-prealbumin Secondary Outcomes - Nutritional status-albumin - Nutritional status-hemoglobin ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## 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 - NCT ID: NCT06362096 - Study ID: pyrotinib diarrhra - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-05 - Lead Sponsor: Huihua Xiong ### Study Description To explore a reasonable and effective way to reduce the incidence of grade 3 or above diarrhea caused by pyrotinib ### Conditions - Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Trastuzumab+pyrotinib+taxene ### Outcomes Primary Outcomes - Incidence of ≥ grade 3 diarrhea Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Urethral Stricture Database - NCT ID: NCT06362083 - Study ID: 34-317 ex 21/22 - Status: RECRUITING - Start Date: 2024-01-15 - Completion Date: 2034-03-15 - Lead Sponsor: Medical University of Graz ### Study Description Establishment of a clinical urethral stricture database for a prospective longitudinal cohort study. ### Conditions - Urethral Stricture ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Questionnaires and data collection ### Outcomes Primary Outcomes - Success rate of urethral reconstructive surgeries Secondary Outcomes - Complications of urethral reconstructive surgeries - Sexual function after urethral reconstructive surgeries - Health status after urethral reconstructive surgeries ### Location - Facility: Röthl Martina Anna, Graz, Styria, 8036, Austria @@
## Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Gastrectomy - NCT ID: NCT06362070 - Study ID: COMPAR-G - Status: RECRUITING - Start Date: 2024-01-31 - Completion Date: 2025-07-31 - Lead Sponsor: Azienda Ospedaliera Universitaria Integrata Verona ### Study Description 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. ### Conditions - Gastric Cancer - Gastrointestinal Cancer - Neoplasms - Gastric Diffuse Adenocarcinoma - Gastric Neoplasm - Stomach Adenocarcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - DaVinci® Surgical System - Hugo™ RAS System - Versius® Robotic Surgery System ### Outcomes Primary Outcomes - Conversion rate to open or laparoscopic approach (Phase 1) - Number of participants with major intraoperative complications (Phase 1) - Evaluation of surgical times of the standardized procedures (Phase 2) - Analysis of video of surgical procedures (Phase 2) Secondary Outcomes - Estimated Blood Loss - Overall duration of the surgery - Anesthesia, Lymphadenectomy, Gastrectomy (10 different surgical steps) - Number of participants with major postoperative complications - Compliance rate to ERAS protocol - Postoperative hospitalization - Postoperative pain - Re-admission rate to hospitalization - Damage due to positioning - Positive Surgical Margin - Lymph nodes resection - Quality of Life Evaluation - Time taken for platform-related technical steps - Possible malfunction of the platform - Non-Technical Skills Assessment (NTS) demonstrated by members of the surgical team during the intraoperative phase. - Procedure-related costs ### Location - Facility: General and Upper GI Unit, Verona, N/A, 37126, Italy @@
## Biomechanical Effects of Digitally Constructed Subperiosteal Implants - NCT ID: NCT06362057 - Study ID: ADMNF-0020324 - Status: RECRUITING - Start Date: 2024-04-04 - Completion Date: 2024-07-27 - Lead Sponsor: Menoufia University ### Study Description Subperiosteal implants were first introduced in 1940 and then used worldwide for the treatment of edentulous maxilla or mandible with advanced bone atrophy. ### Conditions - Bone Loss ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Subperiosteal implant framework ### Outcomes Primary Outcomes - bone loss under the implants Secondary Outcomes ### Location - Facility: Mohammed A. El-Sawy, Mansoura, N/A, 12345, Egypt @@
## 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 - NCT ID: NCT06362044 - Study ID: P24-120 - Status: RECRUITING - Start Date: 2023-06-07 - Completion Date: 2024-12-31 - Lead Sponsor: AbbVie ### Study Description 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. ### Conditions - Chronic Lymphocytic Leukemia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Percentage of Participants with Undetectable Minimal Residual Disease (uMRD) Secondary Outcomes ### Location - Facility: National Cancer Center Hospital East /ID# 265970, Kashiwa, Chiba, 277-8577, Japan @@
## A Study to Explore Treatment Patterns, Treatment Outcomes, Healthcare Resource Utilization in Adult Participants With Acute Myeloid Leukemia (AML) Receiving Venetoclax Through Chart Review - NCT ID: NCT06362031 - Study ID: H18.Oncology.12-SR1812 - Status: WITHDRAWN - Start Date: 2023-06-01 - Completion Date: 2024-04-30 - Lead Sponsor: AbbVie ### Study Description 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. ### Conditions - Acute Myeloid Leukemia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Overall Survival (OS) - Event-free survival (EFS) - Percentage of Participants Achieving Best Overall Response - Duration of Response (DoR) - Percentage of Participants with Transfusion Independence (TI) Secondary Outcomes - Number of Participants with Healthcare Resource Utilization (HRU) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Bioavailability of Three Mitopure Formulations - NCT ID: NCT06362018 - Study ID: MHC/CT/23-24/055 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-09 - Completion Date: 2024-06-30 - Lead Sponsor: Amazentis SA ### Study Description 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. ### Conditions - Healthy Adults ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Mitopure (Urolithin A) ### Outcomes Primary Outcomes - Plasma concentrations of Urolithin A over time and maximal plasma concentration (Cmax) - Exposure to Urolithin A over time measured as area under the curve (AUC) Secondary Outcomes - Number of adverse events and serious adverse events throughout the study. ### Location - Facility: Lokmanya Medical Research Centre and Hospital, Pune, N/A, 411033, India @@
## The Efficacy of Selenium as an Alternative or Complementary Topical Treatment of Oral Lichen Planus - NCT ID: NCT06362005 - Study ID: AUAREC2023011-1 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2025-03-01 - Lead Sponsor: Al-Azhar University ### Study Description 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. ### Conditions - Lichen Planus, Oral ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Triamcinolone Acetonide 0.1% Oint - Tacrollimus Topical - Selenium - Selenium & Triamcinolone Acetonide 0.1% Oint - Selenium& Tacrollimus topical ### Outcomes Primary Outcomes - to assess a visual analog scale (VAS)of the oral lichen planus lesion Secondary Outcomes - to assess The associated Oral Disease Severity Score 3- Glutathione biomarker level as an antioxidant enzyme in saliva by ELISA analysis - Biochemical evaluation of salivary Glutathione level using (ELISA) ### Location - Facility: Alazhar university ,faculty of Dental Medicine, Assiut, N/A, 0000, Egypt @@
## Efficacy and Safety of Blue Cap for the Treatment of Atopic Dermatitis in Children - NCT ID: NCT06361992 - Study ID: BC_SERBIA_2022 - Status: COMPLETED - Start Date: 2022-03-15 - Completion Date: 2024-02-13 - Lead Sponsor: Catalysis SL ### Study Description 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. ### Conditions - Atopic Dermatitis - Atopic Dermatitis and Related Conditions - Atopic Dermatitis Eczema - Atopic Dermatitis \(AD\) ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Blue Cap Foam ### Outcomes Primary Outcomes - Grade of Patient Tolerability to the investigation product - Clinical Improvement of Patients with Dermatitis - Clinical assessment of symptoms and sings associated with Dermatitis Secondary Outcomes - Evaluation of the therapeutic effect of Blue Cap in paediatric patients with dermatitis. - Evaluation of the therapeutic effect of Blue Cap on healing of the skin at the patients ### Location - Facility: University of Niš Faculty of Medicine, Department of Dermatology and Venereology, University Clinical Center of Niš, Niš, Nišava, 18108, Serbia @@
## SHR-A1811 Combined With Bevacizumab in HER2-positive Breast Cancer With Brain Metastases - NCT ID: NCT06361979 - Study ID: A1811 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-05 - Lead Sponsor: Huihua Xiong ### Study Description This study aimed to evaluate the use of SHR-A1811 and bevacizumab in HER2-positive Breast Cancer with brain metastases ### Conditions - Breasr Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - SHR-A1811 - Bevacizumab ### Outcomes Primary Outcomes - CNS-ORR Secondary Outcomes - PFS - ORR - AE ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Evaluating User Satisfaction and Feasibility of a Remote Model for 3d Scanned and Printed Transtibial Prosthetic Sockets - NCT ID: NCT06361966 - Study ID: 2021/00638 - Status: COMPLETED - Start Date: 2022-01-11 - Completion Date: 2023-01-09 - Lead Sponsor: Tan Tock Seng Hospital ### Study Description 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. ### Conditions - Amputation - Prosthesis User ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - 3d printed prosthetic socket ### Outcomes Primary Outcomes - Prosthesis Evaluation Questionnaire - Socket Comfort Score Secondary Outcomes ### Location - Facility: Tan Tock Seng Hospital, Singapore, N/A, 308433, Singapore @@
## Comparing the Efficacy of Two Neurofeedback Protocols for Generalized Anxiety Disorder - NCT ID: NCT06361953 - Study ID: IR.SBMU.MSP.REC. 1401. 161 - Status: COMPLETED - Start Date: 2022-06-01 - Completion Date: 2023-07-01 - Lead Sponsor: Shahid Beheshti University of Medical Sciences ### Study Description 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. ### Conditions - Generalized Anxiety Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - EEG Neurofeedback ### Outcomes Primary Outcomes - The Beck Anxiety Inventory - The Perceived Stress Questionnaire - Spielberger's state-trait anxiety test Secondary Outcomes ### Location - Facility: Shahid Beheshti University of Medical Science, Tehran, N/A, 4739-19395, Iran, Islamic Republic of @@
## Molecular Analyses to Identify Pathways of Endocrine Resistance Following Short Term Neoadjuvant Endocrine Treatment in Patients With Hormone Receptor-Positive HER2-negative Breast Cancer - NCT ID: NCT06361940 - Study ID: IIT-CHAUDHARY-ENDOCRINE2-OPP - Status: NOT_YET_RECRUITING - Start Date: 2024-08 - Completion Date: 2029-12 - Lead Sponsor: Medical College of Wisconsin ### Study Description This is an exploratory phase II interventional study that initiates standard-of-care anti-estrogen treatment preoperatively for 4-12 weeks (+/- 2 weeks). ### Conditions - Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Aromatase inhibitors or tamoxifen ### Outcomes Primary Outcomes - Change from baseline in the number of subjects with increased HER-1 receptor tyrosine kinases protein expression in tumors. - Change from baseline in the number of subjects with increased HER-2 receptor tyrosine kinases protein expression in tumors. - Change from baseline in the number of subjects with increased HER-3 receptor tyrosine kinases protein expression in tumors. - Change from baseline in the number of subjects with increased HER-4 receptor tyrosine kinases protein expression in tumors. Secondary Outcomes ### Location - Facility: Froedtert Hospital and the Medical College of Wisconsin, Milwaukee, Wisconsin, 53226, United States @@
## A Phase II Study of SSGJ-707 Monotherapy in First-line PD-L1 Positive Advanced NSCLC Patients - NCT ID: NCT06361927 - Study ID: SSGJ-707-NSCLC-II-01 - Status: RECRUITING - Start Date: 2024-05 - Completion Date: 2025-07 - Lead Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. ### Study Description This study includes two cohorts, cohort A is for non-squamous NSCLC and cohort B is for squamous NSCLC. ### Conditions - NSCLC ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - SSGJ-707 ### Outcomes Primary Outcomes - ORR Secondary Outcomes - Safety and tolerability ### Location - Facility: The Hunan Cancer Hospital, Changsha, Hunan, N/A, China @@
## Digital CBT-I for Patients With Chronic Pain and Insomnia - NCT ID: NCT06361914 - Study ID: 2314393 - Status: RECRUITING - Start Date: 2024-04-12 - Completion Date: 2026-09-01 - Lead Sponsor: Odense University Hospital ### Study Description 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. ### Conditions - Chronic Pain - Insomnia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Digital CBT-I - Digital Sleep hygiene education ### Outcomes Primary Outcomes - Insomnia severity - Average pain intensity during the last 7 days Secondary Outcomes - The trajectory of ISI severity scores - 30% ISI responders - 50% ISI responders - Weekly pain intensity score trajectory - 30% pain intensity responders - 50% pain intensity responders - Global Perceived Effect (GPE) for sleep - Global Perceived Effect (GPE) for pain - Sleep Quality - Physical and Mental Health - Sleep diary - Thoughts about sleep and pain - Thoughts about sleep - Treatment compliance - Health-related quality of life - mobility - Health-related quality of life - self care - Health-related quality of life - usual activities - Health-related quality of life - pain/discomfort - Health-related quality of life - anxiety/depression - Health-related quality of life - global ### Location - Facility: Pain Center, Department of Anesthesiology and Intensive Care Medicine, University Hospital Odense, Odense, N/A, 5000, Denmark @@
## Comparison of Therapeutic Effect Between Speech Rehabilitation Program and Speech Therapy in Stroke Patients With Aphasia - NCT ID: NCT06361901 - Study ID: 2023GR0452 - Status: RECRUITING - Start Date: 2023-11-17 - Completion Date: 2024-12 - Lead Sponsor: Korea University Guro Hospital ### Study Description 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 ### Conditions - Stroke - Aphasia - Speech Therapy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Zenicog;language rehabilitation program - Conventional language rehabilitation ### Outcomes Primary Outcomes - Aphasic quatient Secondary Outcomes - Change of cerebral blood flow ### Location - Facility: Department of Rehabilitation Medicine, Korea University Guro Hospital, Seoul, N/A, 08308, Korea, Republic of @@
## A Phase II/III Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine in Metastatic Pancreatic Cancer - NCT ID: NCT06361888 - Study ID: 2023-012-00CH1 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-31 - Completion Date: 2027-08-31 - Lead Sponsor: Hutchmed ### Study Description 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 ### Conditions - Metastatic Pancreatic Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine - Nab-paclitaxel Plus Gemcitabine - Surufatinib with Nab-paclitaxel, and Gemcitabine ### Outcomes Primary Outcomes - Overall Survival (OS) Secondary Outcomes - Progression-free Survival (PFS) (RECIST1.1) - Objective response rate (ORR)(RECIST1.1) - Duration of response (DoR)(RECIST1.1) - Disease control rate (DCR)(RECIST1.1) - Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) - Cancer Quality of Life Questionnaire - PAN26(EORTC QLQ-PAN26) ### Location - Facility: Nanjing Tianyinshan Hospital, Nanjing, Jiang Su, 210000, China @@
## A Study to Investigate the Safety and Immunogenicity of the Quadrivalent Influenza mRNA Vaccines in Adults Aged 18 Years and Above - NCT ID: NCT06361875 - Study ID: VAV00045 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-05-22 - Lead Sponsor: Sanofi Pasteur, a Sanofi Company ### Study Description 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. ### Conditions - Influenza Immunization ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Quadrivalent Influenza mRNA Vaccine MRT5421 - Quadrivalent Influenza mRNA Vaccine MRT5424 - Quadrivalent Influenza mRNA Vaccine MRT5429 - Quadrivalent Influenza Standard Dose Vaccine - Quadrivalent Influenza High-Dose Vaccine - Quadrivalent Recombinant Influenza Vaccine ### Outcomes Primary Outcomes - Number of participants with immediate unsolicited systemic adverse events (AEs) - Number of participants with solicited injection site reactions - Number of participants with solicited systemic reactions - Number of participants with unsolicited AEs - Number of participants with medically attended adverse events (MAAEs) - Number of participants with serious adverse events (SAEs) - AESIs reported throughout the study - Number of participants with adverse events of special interests (AESIs) - Number of participants with out-of-range biological test results - Geometric Mean Titer (GMT) - Geometric Mean of individual Titer Ratio (GMTR) - Seroconversion - HAI Ab titer ≥ 40 (1/dil) Secondary Outcomes - Neutralizing Ab titers at D01 and D29 - Individual neutralizing antibodies titer ratio - 2-fold and 4-fold increase in neutralizing titers ### Location - Facility: Velocity Clinical Research Site Number : 8400048, La Mesa, California, 91942, United States @@
## Does Continuous Vital Sign Monitoring Increase Investigations and Interventions in Complication-free Patients? - NCT ID: NCT06361862 - Study ID: WARD - Overtreatment - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2025-04-01 - Lead Sponsor: Rigshospitalet, Denmark ### Study Description 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. ### Conditions - Cancer - Chronic Obstructive Pulmonary Disease - Surgery-Complications ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Active alarms from WARD software ### Outcomes Primary Outcomes - Frequency of patients having at least one of the following tests/treatments: Secondary Outcomes - The frequency of individual treatments and diagnostics: ### Location - Facility: Eske Kvanner Aasvang, Copenhagen, N/A, 2100, Denmark @@
## TauTona Pneumoperitoneum Assist Device (TPAD) - NCT ID: NCT06361849 - Study ID: 55013 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-01-01 - Completion Date: 2025-06-01 - Lead Sponsor: Stanford University ### Study Description 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. ### Conditions - Laparoscopic Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: DEVICE_FEASIBILITY ### Interventions - Trocar Placement Assist Device (TPAD) ### Outcomes Primary Outcomes - Surgeon satisfaction survey Secondary Outcomes - Time required to obtain peritoneal access and place primary trocar during laparoscopic surgery - Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0 ### Location - Facility: Stanford Hospital & Clinics, Palo Alto, California, 94305, United States @@
## Study of Single Doses of SBT777101 in Subjects With Hidradenitis Suppurativa - NCT ID: NCT06361836 - Study ID: SBT777101-02 - Status: RECRUITING - Start Date: 2024-05 - Completion Date: 2026-06 - Lead Sponsor: Sonoma Biotherapeutics, Inc. ### Study Description 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. ### Conditions - Hidradenitis Suppurativa ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - SBT777101 ### Outcomes Primary Outcomes - Incidence, nature, and severity of adverse events [Safety and Tolerability] - Incidence and nature of Dose Limiting Toxicities [DLTs] Secondary Outcomes ### Location - Facility: Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States @@
## Exploratory Study on the Efficacy and Safety of Semaglutide for Idiopathic Intracranial Hypertension Treatment - NCT ID: NCT06361823 - Study ID: IIH-Semaglutide - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-01-01 - Lead Sponsor: Capital Medical University ### Study Description This study aims to investigate the safety and efficacy of semaglutide in patients with Idiopathic intracranial hypertension. ### Conditions - Idiopathic Intracranial Hypertension ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Semaglutide - Low calorie diet ### Outcomes Primary Outcomes - Intracranial pressure - Adverse reactions Secondary Outcomes - Headache severity - Degree of papilledema - Perimetric mean deviation - Optic nerve sheath diameter - Body mass index ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## PSMA Therapy and Immunotherapy in Kidney Cancer - NCT ID: NCT06361810 - Study ID: IRB00430008 - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2031-07 - Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ### Study Description 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. ### Conditions - Metastatic Renal Cell Carcinoma - Metastatic Clear Cell Renal Cell Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Pembrolizumab - 177Lu-PNT2002 - (F-18)-DCFPyL ### Outcomes Primary Outcomes - Safety assessed by the incidence of dose limiting toxicities. - Objective response rate by RECIST 1.1 criteria Secondary Outcomes - Progression free survival - Safety as assessed by number of participants experiencing adverse events - Disease control rates - Duration of response to study therapy - Overall survival rate ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Varying Bone Marrow-Derived Mesenchymal Stem Cells Concentrations' Impact on Rotator Cuff Repair Outcomes - NCT ID: NCT06361797 - Study ID: IRB00415412 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2027-10 - Lead Sponsor: Johns Hopkins University ### Study Description Randomized controlled trial comparing benefits of varying amounts of proximal humerus-derived bone marrow aspirate and bone marrow concentrate in rotator cuff repair. ### Conditions - Rotator Cuff Tears ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Rotator cuff repair augmented with whole bone marrow - Rotator cuff repair augmented with concentrated bone marrow ### Outcomes Primary Outcomes - Number of Rotator cuff re-tears as assessed by magnetic resonance imaging Secondary Outcomes - American Shoulder and Elbow Surgeons Score - Visual Analogue Pain Score - Subjective Shoulder Value score - Comprehensive Shoulder Assessment - Revision surgery rate - Rate of oral and/or intra-articular corticosteroid required ### Location - Facility: Johns Hopkins Howard County General Hospital, Columbia, Maryland, 21230, United States @@
## Improving the Success Rate for Thoracic Radiotherapy Through Specific Cardiac Substructure Dosimetry: Location Matters. (LOCATION MATTERS) - NCT ID: NCT06361784 - Study ID: INT216-23 - Status: RECRUITING - Start Date: 2024-03-29 - Completion Date: 2029-03-29 - Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano ### Study Description 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. ### Conditions - Locally Advanced Lung Non-Small Cell Carcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Variation in eco-cardio and eco-vascular parameters after thoracic radiotherapy Secondary Outcomes - Major adverse cardiac events post-RT - Increase in cardiac calcification after RT ### Location - Facility: Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, N/A, 20133, Italy @@
## Evaluation of Invisible Preparation Behaviors of Middle and High School Students in Sports Facilities (PRICELESS) - NCT ID: NCT06361771 - Study ID: 29BRC24.0079 - PRICELESS - Status: RECRUITING - Start Date: 2024-01-08 - Completion Date: 2024-12-20 - Lead Sponsor: University Hospital, Brest ### Study Description 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. ### Conditions - Sports Injury - Prevention - Training - Hydration - Nutrition - Sleep - Mental Health - Physical Well-Being ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - The proportion of teenagers who declare adopting the health behaviors recommended in the four areas of the Invisible Preparation. Secondary Outcomes - The proportion of girls who declare adopting these behaviors, compared to the proportion in boys. - The proportion of Middle School students who declare adopting these behaviors, compared to the proportion in High School students. - 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). - The proportion of young athletes with disabilities who declare adopting these behaviors, compared to the proportion in young athletes without disabilities. ### Location - Facility: Chu Brest, Brest, N/A, 29609, France @@
## Second-line Treatment With CAdonilimab and LEnvatinib for Unresectable HCC - NCT ID: NCT06361758 - Study ID: B2023-326(2) - Status: NOT_YET_RECRUITING - Start Date: 2024-05-31 - Completion Date: 2027-05-31 - Lead Sponsor: Shanghai Zhongshan Hospital ### Study Description 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. ### Conditions - Hepatocellular Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Cadonilimab+Lenvatinib ### Outcomes Primary Outcomes - Objective Response Rate (ORR) per RECIST v1.1 Secondary Outcomes - Objective Response Rate (ORR) per mRECIST - Disease control Rate (DCR) - Duration of response (DoR) - Progression-Free-Survival (PFS) - Overall survival Overall survival (OS) - Incidence of Adverse Events ### Location - Facility: Zhongshan Hospital, Fudan University, Shanghai, Shanghai, 200032, China @@
## Early Clinical Study of UTAA09 Injection in the Treatment of Relapsed/Refractory Autoimmune Diseases - NCT ID: NCT06361745 - Study ID: PG-005-6 - Status: RECRUITING - Start Date: 2024-04-02 - Completion Date: 2025-03-01 - Lead Sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd. ### Study Description 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. ### Conditions - Systemic Lupus Erythematosus - Idiopathic Inflammatory Myopathies - Systemic Sclerosis - IgG4 Related Disease - Primary Sjögren Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - T cell injection targeting CD19 chimeric antigen receptor ### Outcomes Primary Outcomes - AE Secondary Outcomes - Cmax - CD19-positive cells - Disease remission/response/improvement rates - anti-CAR antibody ### Location - Facility: PersonGen.Anke Cellular Therapeutice Co., Ltd, Hefei, N/A, N/A, China @@
## 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. - NCT ID: NCT06361732 - Study ID: ILBS-liver Transplant-03 - Status: RECRUITING - Start Date: 2022-12-17 - Completion Date: 2024-10-30 - Lead Sponsor: Institute of Liver and Biliary Sciences, India ### Study Description 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. ### Conditions - Pediatric Liver Transplant ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No intervention ### Outcomes Primary Outcomes* - 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 (CYP3A53/3 allele) versus fast metabolizer (CYP3A51/3 and 1/1 alleles) donors. Secondary Outcomes - Prevalence of CYP3A5 alleles in the donors of pediatric liver transplant recipients. - 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. - Prevalence of ABCB1 3435 C/T alleles in the recipients of pediatric liver transplant. - 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. - Comparison of the Number of Rejection episodes 1 year from LT. - Comparison of proportion of patients who were withdrawn from Mycophenolate or required addition of Mycophenolate 1 year from LT. - Comparison of proportion of patients with renal toxicity 1 year from LT. - Comparison of proportion of patients with Neurological toxicity 1 year from LT. - Comparison of e-GFRand cystatin-C levels in the two cohorts of pediatric liver transplant recipients with grafts from slow metabolizer (CYP3A53/3 allele) versus fast metabolizer (CYP3A51/3 and 1/1 alleles) donors. ### Location - Facility: Institute of Liver and Biliary Sciences, New Delhi, N/A, 110070, India @@
## Efficacy of Two HMOs in Chinese Infants - NCT ID: NCT06361719 - Study ID: 2312INF - Status: NOT_YET_RECRUITING - Start Date: 2024-05-31 - Completion Date: 2027-06 - Lead Sponsor: Société des Produits Nestlé (SPN) ### Study Description 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. ### Conditions - Healthy Infants ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Experimental Group (EG) - Control Group (CG) ### Outcomes Primary Outcomes - Bifidobacteria abundance in fecal samples Secondary Outcomes - Gut microbiota composition - Fecal metabolism - Fecal metabolism - Fecal markers of intestinal immune health - Fecal markers of gut barrier function - Fecal markers of gut barrier function - Fecal markers of gut barrier function - Fecal markers of inflammation - Fecal markers of inflammation - Fecal markers of inflammation - Stool patterns - Stool patterns - GI symptoms and behaviors - Immune competence - Infant sleep duration and night-time wakings per 24 hours - Infant Health Related Quality of Life - Growth - Growth - Growth - Growth - Growth - Physical Examination - Infant Illness - Infant illness, infections and medication usage - Medication use (type and duration) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## VR-Enhanced Psychoeducation for Chronic Pain: A Primary Care Pilot Study - NCT ID: NCT06361706 - Study ID: 24/047-P - Status: RECRUITING - Start Date: 2023-12-04 - Completion Date: 2025-12 - Lead Sponsor: Badalona Serveis Assistencials ### Study Description 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. ### Conditions - Chronic Pain - Central Sensitization ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - VR-Enhanced Psychoeducational Program for Chronic Pain ### Outcomes Primary Outcomes - Participant Satisfaction with the VR-enhanced Psychoeducational Program as measured by the Participants Satisfaction Questionnaire - Participants´ System Usability and VR Headset Comfort as assessed by the SUS for participants - Professionals System Usability as measured by the SUS for Professionals Secondary Outcomes - Mental Well-being as assessed by the WEMWBS-7 - Anxiety and Depression Severity as measured by the HADS - Central Sensitization as measured by the CSI - Changes in Functionality and Mobility as assessed by the EuroQol-5D-5L Scale - Adherence to the VR-enhanced Psychoeducational Program as indicated by session attendance and program completion rates ### Location - Facility: Primary Care Progrès-Raval, Badalona, Barcelona, 08912, Spain @@
## Descriptive Observational Study of Patient-performed Pre-oxygenation - NCT ID: NCT06361693 - Study ID: APHP240147 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2024-12 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description 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". ### Conditions - Anesthesia - Anxiety - ASA Physical Status I - ASA Physical Status II ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Auto-preoxygenation - APAIS scale - Visual analog anxiety scale (VAS-A) - Visual analog comfort scale (VAS-C) ### Outcomes Primary Outcomes - FeO2>90% Secondary Outcomes - APAIS anxiety score - Visual analog anxiety scale (VAS-A) score - Visual analog anxiety scale (VAS-A) score - Visual analog comfort scale (VAS-C) score ### Location - Facility: Anesthesia-intensive care department - Cochin - Port-Royal hospital - APHP, Paris, Ile De France, 75014, France @@
## Effect of Coenzyme Q10 on Diabetic Children - NCT ID: NCT06361680 - Study ID: Coenzyme Q10 on diabetic child - Status: NOT_YET_RECRUITING - Start Date: 2024-10-30 - Completion Date: 2025-11-30 - Lead Sponsor: Assiut University ### Study Description Determine the effect of Coenzyme Q10 on random blood sugar and glycosylated haemoglobin ### Conditions - Type 1 Diabetes Mellitus ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SCREENING ### Interventions - Coenzyme Q10 Cap/Tab as natural factors capsules or kirkman tablets ### Outcomes Primary Outcomes - Assess the effect of Coenzyme Q10 on glycated haemoglobin in type 1 diabetes mellitus Secondary Outcomes - Control of random blood sugar and glycated haemoglobin in children with type 1 diabetes mellitus . ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Culture and Well-being: Art as Prescription Therapy ("Art on Prescription") - NCT ID: NCT06361667 - Study ID: 1/02.02.2024 - Status: RECRUITING - Start Date: 2024-03-20 - Completion Date: 2025-01-15 - Lead Sponsor: KAVADIA ELENI ### Study Description 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). ### Conditions - Mental Health Issue - Anxiety Disorders - Depressive Disorder - Emotional Disorder - Schizophrenia - Autism ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Arts ### Outcomes Primary Outcomes - The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) Secondary Outcomes - Generalised Anxiety Disorder Assessment (GAD-7) - The Patient Health Questionnaire-9 (PHQ-9) - UCLA 3-item Loneliness Scale - The Strengths and Difficulties Questionnaire (SDQ) ### Location - Facility: Eleni Kavadia, Athens, N/A, N/A, Greece @@
## Effect of Muscular Imbalance Between Flexors and Extensors of the Fingers and Wrist on Upper Limb Injuries in Climbers - NCT ID: NCT06361654 - Study ID: 2023/0135/OB - Status: RECRUITING - Start Date: 2024-03-25 - Completion Date: 2025-09-01 - Lead Sponsor: University Hospital, Rouen ### Study Description 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. ### Conditions - Climber ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - The strength values of the flexors and extensors of the fingers and wrist will be measured using a dynamometer ### Outcomes Primary Outcomes - Athlete exposure Secondary Outcomes ### Location - Facility: Rouen, University Hospital, Rouen, Normandie, 76031, France @@
## Functional and Phenotypic Characterization of Monocytes in Myeloproliferative Syndromes - NCT ID: NCT06361641 - Study ID: 49RC23_0259 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-20 - Completion Date: 2027-10-19 - Lead Sponsor: University Hospital, Angers ### Study Description Prospective study for functional and phenotypic characterization of monocytes in philadelphia-negative myeloproliferative neoplasms ### Conditions - Myeloproliferative Neoplasm - Polycythemia Vera - Essential Thrombocythemia - Primary Myelofibrosis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Monocytes signatures in myeloproliferative neoplasms at diagnosis ### Outcomes Primary Outcomes - WHO 2016 criteria for polycythemia vera, prefibrotic myelofibrosis, essential thrombocytosis and overt myelofibrosis diagnosis Secondary Outcomes - Identify correlation between the monocytic signature and driver mutations (mutation in JAK2, CALR or MPL gene). - Identify correlation between the monocytic signature and the grade of fibrosis - 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 - Prognostic value of the monocyte signature for disease worsening according to Sureau et al., Blood Cancer Journal, vol. 12,4, 56. 8 Apr. 2022 - leukemia-free survival - myelofibrosis-free survival - Monocytes parameters for hematological progression ### Location - Facility: GOUBAND Agathe, Angers, Maine Et Loire, 49933, France @@
## Implementation and Evaluation of Tailored Interventions to Increase MMR and/or HPV Vaccine - NCT ID: NCT06361628 - Study ID: RIVER-EU WP4 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-06-01 - Lead Sponsor: University Medical Center Groningen ### Study Description 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? ### Conditions - Vaccination - Health Systems - Knowledge, Attitudes, Practice ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - multicomponent intervention on vaccination awareness ### Outcomes Primary Outcomes - Intention to vaccinate MMR and/or HPV by questionnaire Secondary Outcomes - Uptake of MMR and/or HPV vaccinations by questionnaire - Knowledge concerning MMR and/or HPV vaccinations in the target group using a questionnaire - Communication skills of health care professionals using a questionnaire - Satisfaction of the stakeholders as measured by a questionnaire ### Location - Facility: Prolepsis, Athens, Athene, 151 25, Greece @@
## Effect of a Dual-task Intervention Program on Physical and Cognitive Function - NCT ID: NCT06361615 - Study ID: CEC_FP_2023042 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-11-08 - Completion Date: 2024-04-05 - Lead Sponsor: University of Americas ### Study Description 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. ### Conditions - Functional Movement Disorder - Fragility ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Single-Task - Dual-Task ### Outcomes Primary Outcomes - Short Physical Performance Battery (SPPB) Secondary Outcomes - Montreal Cognitive Assessment (MoCA) - Barthel Index - Isometric Handgrip Strength (IHS) - Immobility Syndrome Scale ### Location - Facility: Universidad de las Americas, Santiago de Chile, Santiago, 7750495, Chile @@
## Exploring the Effectiveness and Factors Affecting the Collection of Single Nucleated Cells From Different Volunteers - NCT ID: NCT06361602 - Study ID: SYSKY-2023-1015-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-05-01 - Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ### Study Description 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. ### Conditions - Observational Study ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - inapplicable ### Outcomes Primary Outcomes - Exploring the effectiveness and factors affecting the collection of single nucleated cells from different volunteers Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Real World Study of Lolatinib for Advanced ALK+ NSCLC Patients - NCT ID: NCT06361589 - Study ID: EK2023003-1 - Status: RECRUITING - Start Date: 2024-05-01 - Completion Date: 2028-11-01 - Lead Sponsor: Sichuan Cancer Hospital and Research Institute ### Study Description 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. ### Conditions - ALK-positive Non-small Cell Lung Cancer - Real World Study ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Lorlatinib ### Outcomes Primary Outcomes - PFS Secondary Outcomes - OS - ORR - AE - PRO1 - PRO2 - PRO3 ### Location - Facility: Sichuan cancer hospital, Chengdu, Sichuan, 610000, China @@
## Real-World Use of Nivolumab for the Treatment of Patients With Metastatic Upper Gastrointestinal Cancer in Canada - NCT ID: NCT06361576 - Study ID: CA209-1443 - Status: COMPLETED - Start Date: 2023-09-05 - Completion Date: 2024-01-25 - Lead Sponsor: Bristol-Myers Squibb ### Study Description 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. ### Conditions - Upper Gastrointestinal Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Nivolumab ### Outcomes Primary Outcomes - Particpant sociodemographics - Participant Eastern Cooperative Oncology Group (ECOG) score - Participant HER2 status - Participant comorbidities - Participant tumour location - Participant treatment history Secondary Outcomes - Initial nivolumab dosage prescribed to participants - Number of nivolumab treatments received by participants - Planned combination chemotherapy treatment - Nivolumab treatment initiation date - Nivolumab dosage modification - Participant treatment duration - Reason for participant discharge - Participant adverse events (AEs) - Management of participant adverse events (AEs) ### Location - Facility: Bayshore Specialty Rx Ltd., Mississauga, Ontario, L5K 2L3, Canada @@
## Real-World Use of Adjuvant Nivolumab in Patients With Upper Gastrointestinal Cancer in Canada - NCT ID: NCT06361563 - Study ID: CA209-1442 - Status: COMPLETED - Start Date: 2023-09-05 - Completion Date: 2024-01-25 - Lead Sponsor: Bristol-Myers Squibb ### Study Description 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. ### Conditions - Upper Gastrointestinal Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Nivolumab ### Outcomes Primary Outcomes - Participant sociodemographics - Participant Eastern Cooperative Oncology Group (ECOG) score - Participant histology results - Participant comorbidities - Participant tumour location - Date of tumour resection - Participant primary upper gastrointestinal cancer diagnosis Secondary Outcomes - Initial nivolumab dosage prescribed to participants - Number of nivolumab treatments received - Nivolumab dosage modification - Nivolumab treatment duration - Reason for participant discharge - Participant adverse events (AEs) - Management of participant adverse events (AEs) ### Location - Facility: Bayshore Specialty Rx Ltd., Mississauga, Ontario, L5K 2L3, Canada @@
## Nutritional Status Assessment and Dietary Recommendations Program (VENREDI) - NCT ID: NCT06361550 - Study ID: AYTO_SALAMANCA_001 - Status: RECRUITING - Start Date: 2023-11-02 - Completion Date: 2025-12-30 - Lead Sponsor: University of Salamanca ### Study Description 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). ### Conditions - Adherence to the Mediterranean Diet ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - VENREDI group - Health education ### Outcomes Primary Outcomes - Adherence to the Mediterranean Diet Secondary Outcomes - Physical activity - Sleep Quality - Cognitive function ### Location - Facility: Rosario Alonso Domínguez, Salamanca, N/A, 37007, Spain @@
## 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 - NCT ID: NCT06361537 - Study ID: CONE-02 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-12 - Lead Sponsor: Octapharma ### Study Description 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 ### Conditions - Acute Hereditary Angio Edema ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - OCTA-C1-INH - Placebo ### Outcomes Primary Outcomes - Time (h) to beginning of unequivocal symptom relief at the defining site in blinded participants. Secondary Outcomes - Percentage of participants responding to treatment - Time to beginning of unequivocal symptom relief at all sites involved - Changes in symptom severity at the defining site by VAS severity rating ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Gut Microbiome Profiling in Patients With Chronic Heart Failure - NCT ID: NCT06361524 - Study ID: 44967 - Status: ENROLLING_BY_INVITATION - Start Date: 2018-08-01 - Completion Date: 2028-12 - Lead Sponsor: Stanford University ### Study Description 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? ### Conditions - Heart Failure With Reduced Ejection Fraction - Nonischemic Cardiomyopathy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Advanced heart failure-associated microbiome signatures - Temporal changes in the gut microbiome community composition in chronic heart failure Secondary Outcomes - Comprehensive longitudinal metabolome profile in chronic heart failure - Comprehensive longitudinal cytokine profile in chronic heart failure - Longitudinal change in New York Heart Association (NYHA) functional class - Longitudinal change in the self-reported functional status ### Location - Facility: Stanford University, Stanford, California, 94305-5210, United States @@
## The Foods & Oil to Repair, Correct and Enhance Strength (FORCES) Study - NCT ID: NCT06361511 - Study ID: 2023H0284 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2030-05-01 - Lead Sponsor: Ohio State University ### Study Description 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. ### Conditions - Sarcopenia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - High Linoleic Acid Foods - High Oleic Acid Foods ### Outcomes Primary Outcomes - Changes is leg extensor muscle strength Secondary Outcomes - Changes in quadriceps muscle volume - Change in maximum leg press strength - Change in leg fatiguability - Change in muscle mitochondria function - Changes in cardiolipin species - Changes in grip strength - Changes in gait speed - Changes in chair rise time - Changes in stair climb power - Change in short physical performance battery score - change in blood fatty acids ### Location - Facility: The Ohio State University, Columbus, Ohio, 43210, United States @@
## Ultrasound for Evaluation of Percutaneous G-tube Position - NCT ID: NCT06361498 - Study ID: 23-3115 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-03 - Lead Sponsor: University of North Carolina, Chapel Hill ### Study Description 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. ### Conditions - Gastrostomy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Ultrasound Imaging ### Outcomes Primary Outcomes - Proportion of Ultrasound that Agree with Fluoroscopy with Respect to Identifying the GT Location Secondary Outcomes - Sensitivity of ultrasound (US) to determine the visualization of GT leakage - Specificity of ultrasound (US) to determine the visualization of GT leakage - Duration of ultrasound (US) to complete evaluation of GT position ### Location - Facility: University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 27599, United States @@
## Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Lumbar Pain - NCT ID: NCT06361485 - Study ID: 011624 - Status: RECRUITING - Start Date: 2024-03-25 - Completion Date: 2028-04-01 - Lead Sponsor: R3 Stem Cell ### Study Description 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. ### Conditions - Low Back Pain ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Lumbar Injections with 10cc's of Wharton's Jelly Allograft ### Outcomes Primary Outcomes - C-reactive protein - Erythrocyte sedimentation rate - Alanine transaminase (ALT) - Aspartate transaminase (AST) - Alkaline phosphatase (ALP) - Albumin - Creatinine - Blood Urea Nitrogen (BUN) Secondary Outcomes - 36-Item Short Form Survey (SF-36) - Numerical Pain Rating Scale (NPRS) - Oswestry disability index (ODI) - Roland Morris disability questionnaire (RMQ) - The Patient-specific functional scale (PSFS) ### Location - Facility: R3 Anti Aging Scottsdale, Scottsdale, Arizona, 85262, United States @@
## Contextual Factors-Enriched Standard Care on Mechanical Neck Pain - NCT ID: NCT06361472 - Study ID: 11695 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-11-30 - Lead Sponsor: Universidad Nacional de la Matanza ### Study Description 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. ### Conditions - Neck Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Standard Care - Contextual Factors ### Outcomes Primary Outcomes - Neck Pain Intensity - Neck Disability Secondary Outcomes - Active Range of Movement - Global Rating of Change - Satisfaction with treatment - Expectations - Credibility ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@

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