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## Evaluation of EEG Power Spectrum in Patients With Traumatic Coma - NCT ID: NCT06321146 - Study ID: LY2024-029-B - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-04-30 - Lead Sponsor: RenJi Hospital ### Study Description Development of objective, reliable, and convenient assessment methods of disorders of consciousness is crucial. We aim to conduct multicenter prospective observational study and non-invasively collect EEG from patients with traumatic coma to analyze the sequential characteristics of EEG power spectrum, and explore their prognostic value for consciousness recovery. ### Conditions - Coma - Brain Injuries, Traumatic ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - EEG power spectrum Secondary Outcomes - Coma Recovery Scale-Revised (CRS-R) ### Location - Facility: Anhui No.2 Provincial People's Hospital, Hefei, Anhui, N/A, China @@
## High Flow Nasal Cannula Weaning in Acute Bronchiolitis - NCT ID: NCT06321133 - Study ID: 5402589 - Status: RECRUITING - Start Date: 2024-02-13 - Completion Date: 2026-12-31 - Lead Sponsor: Kuopio University Hospital ### Study Description The goal of this clinical study is to compared two different strategies to end high flow nasal cannula treatment in acute bronchiolitis. This study compared the immediate ending of high flow treatment to weaning strategy, in which the flow rate is gradually decreased. The aim is to assess if the immediate ending shortens the hospitalization time and whether it is a safe strategy. ### Conditions - Acute Bronchiolitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - High flow nasal cannula immediate ending - High flow nasal cannula weaning ### Outcomes Primary Outcomes - Hospitalization time from randomization Secondary Outcomes - Treatment failures - Readmission rate - Overall hospitalization time ### Location - Facility: Siun Sote, Joensuu, N/A, N/A, Finland @@
## Using Chronobiology to Improve Lenvatinib Efficacy - NCT ID: NCT06321120 - Study ID: 0749-21-HMO-CTIL - Status: RECRUITING - Start Date: 2023-03-01 - Completion Date: 2024-06 - Lead Sponsor: Hadassah Medical Organization ### Study Description The goal of this proof-of-concept clinical trial is to assess the efficacy and safety of chronobiology implementation into lenvatinib treatment regimens of thyroid cancer patients, via a mobile application.Participants will use a mobile application to follow variability-based physician approved drug administration schedules. ### Conditions - Lenvatinib Treatment ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - variability-based lenvatinib regimen ### Outcomes Primary Outcomes - disease progression/ tumor response Secondary Outcomes - Adverse effects occurrence ### Location - Facility: Hadassah Medical Organization, Jerusalem, N/A, 91120, Israel @@
## Long-term Follow-up Safety of a Single Injection of GenSci094 for Ovarian Stimulation Using Daily Recombinant FSH as Reference - NCT ID: NCT06321107 - Study ID: GenSci094-304 - Status: RECRUITING - Start Date: 2024-02-29 - Completion Date: 2025-10-31 - Lead Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. ### Study Description The purpose of this study is to evaluate the safety of a single injection of GenSci094 during Controlled Ovarian Stimulation up to 1 year old of the infants from previous studies. ### Conditions - Infertility ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Summary of Pregnancy Outcome Secondary Outcomes - neonatal birth outcomes - Infant development ### Location - Facility: The Sixth Affiliated Hospital, Sun Yat-sen University Guangdong Gastrointestinal Hospital, Guangzhou, Guangdong, N/A, China @@
## Effect of Vericiguat on Endpoint Events in Acute Coronary Syndrome( ACS）Patients With Ejection Fraction <45% - NCT ID: NCT06321094 - Study ID: VERI-ACS - Status: RECRUITING - Start Date: 2023-10-01 - Completion Date: 2025-12-01 - Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University ### Study Description Investigators evaluate whether differences exsit in acute coronary syndrome（ACS） patients with ejection \<45% between participants who take vericiguat regularly and those who donot. ### Conditions - Acute Coronary Syndrome - Heart Failure With Reduced Ejection Fraction ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Vericiguat ### Outcomes Primary Outcomes - a composite of death from cardiovascular causes or first hospitalization for heart failure Secondary Outcomes - results of echocardiogram - the numerical value of NT-proBNP - level of procalcitonin - interleukin-6 level - life quality score ### Location - Facility: the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, N/A, China @@
## ICE Study: Combination of Irinotecan Plus Cetuximab and Envafolimab as a Rechallenge Regimen in mCRC - NCT ID: NCT06321081 - Study ID: 2023BJYYEC-428-02 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-08-14 - Lead Sponsor: Beijing Hospital ### Study Description This is a non-profit phase II, open, clinical study of the combination of irinotecan plus cetuximab and envafolimab as a rechallenge regimen, in pre-treated RAS/BRAF wild type metastatic colorectal cancer patients (according to liquid biopsy at baseline). Patients have been treated in front lines with irinotecan and cetuximab and had a clinical benefit (complete or partial response) from both of them, no matter whether they had treated by any PD-1 inhibitor before. ### Conditions - RAS Mutation - Metastatic Colorectal Cancer - MSS ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - irinotecan, cetuximab, envafolimab ### Outcomes Primary Outcomes - progression free survival Secondary Outcomes - Overal survival ### Location - Facility: Beijing Hospital, Beijing, Beijing, 100730, China @@
## BAT1308 in Combination With Platinum-containing Chemotherapy is Used for the First-line Treatment of Advanced or Recurrent dMMR Endometrial Cancer - NCT ID: NCT06321068 - Study ID: BAT-1308-003-CR - Status: RECRUITING - Start Date: 2024-04-09 - Completion Date: 2027-10 - Lead Sponsor: Bio-Thera Solutions ### Study Description Phase II study: Safety and preliminary efficacy of BAT1308 combined with platinum-containing chemotherapy;Phase III study: Confirmatory safety and efficacy study of BAT1308 combined with platinum-containing chemotherapy for first-line treatment of advanced or recurrent mismatch repair protein-deficient (dMMR) endometrial carcinoma ### Conditions - Endometrial Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - carboplatin - Paclitaxel - Recombinant humanized anti-PD-1 monoclonal antibody injection ### Outcomes Primary Outcomes - vital signs - Physical examination - Adverse events - Clinical laboratory tests - Clinical auxiliary tests - Dose-limiting toxicity (DLT) - Progression Free Survival Secondary Outcomes - Initial efficacy - Pharmacokinetic - Pharmacokinetic - Pharmacokinetic - Pharmacokinetic - Immunogenicity - Immunogenicity ### Location - Facility: Affiliated Cancer Hospital of Chongqing University, Chongqing, Chongqing, N/A, China @@
## An Observational Study to Learn More About Treatment With Regorafenib in People With Advanced Gastrointestinal Stromal Tumors in the United States - NCT ID: NCT06321055 - Study ID: 22533 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-20 - Completion Date: 2024-04-28 - Lead Sponsor: Bayer ### Study Description This is an observational study in which data already collected from people with advanced gastrointestinal stromal tumors are studied.In this observational study data are collected from participants who have private insurance or Medicare and who had started regorafenib treatment.Gastrointestinal stromal tumor (GIST) is a type of cancer that most commonly originates from the stomach or small intestine. Advanced means that the cancer has spread to other parts of the body.The study drug, regorafenib, is already approved for doctors to prescribe to people with GIST. Regorafenib works by blocking certain proteins that cause the growth of cancer cells. Regorafenib is recommended as the third choice of treatment for patients after imatinib and sunitinib have stopped working or have caused side effects that are too severe to continue the treatment. In addition, it is also the recommended first choice of treatment in people with GIST who had low levels of protein called succinate dehydrogenase (SDH) protein. This condition is called SDHdeficient GIST. However, doctors might sometimes give it in a different order. To better understand the treatment patterns with regorafenib for GIST, more knowledge is needed about its use in the real world.The participants in this study had started treatment with regorafenib as part of their regular care from their doctors.The main purpose of this study is to learn more about the use of regorafenib treatment among people with advanced GIST who have private insurance or Medicare in the United States. To do this, researchers will collect information on:Duration of treatment with regorafenib (also known as duration of therapy)The length of time it took for participants to switch to another GIST treatment after starting regorafenib (also known as time to next therapy)The data will come from the participants' information stored in a database, called Merative MarketScan for people in the United States. Data collected will be from April 2002 to September 2023.Researchers will track the data of people with GIST who started regorafenib and will follow them for at least 28 days.In this study, only available data are collected. No visits or tests are required as part of this study. ### Conditions - Advanced Gastrointestinal Stromal Tumor ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Regorafenib (Stivarga, BAY73-4506) ### Outcomes Primary Outcomes - Duration of Therapy (DOT) on regorafenib - Time to Next Therapy (TTNT) therapy after regorafenib Secondary Outcomes - Number of the guideline-listed medications other than regorafenib - Descriptive analysis of baseline demographic - Descriptive analysis of clinical characteristics - Number of patients with evidence of any metastasis on or after the index date during the follow-up period. - Number of patients with evidence of surgery on or after the index date during the follow-up period using Current Procedural Terminology (CPT) codes and International Classification of Disease 9/10 Procedure codes (ICD-PC). ### Location - Facility: Bayer, Whippany, New Jersey, 07981, United States @@
## Evaluation of the Clinical Outcomes of the Total Knee ps Prosthesis Implanted With the Use of Inertial Sensors - NCT ID: NCT06321042 - Study ID: SYMPHO-EM - Status: RECRUITING - Start Date: 2023-01-13 - Completion Date: 2027-03 - Lead Sponsor: Istituto Ortopedico Rizzoli ### Study Description evaluate the clinical outcome of the implantation of a specific primary TKA model implanted with the aid of inertial sensors for the execution of bone cuts through the administration of questionnaires for the calculation of clinical-functional scores; ### Conditions - Prosthesis Durability ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Knee arthroplasty ### Outcomes Primary Outcomes - Knee Society Score - Knee Society Score - Knee Society Score - Knee Society Score - Western Ontario and McMaster Universities Arthritis Index - Western Ontario and McMaster Universities Arthritis Index - Western Ontario and McMaster Universities Arthritis Index - Western Ontario and McMaster Universities Arthritis Index - Knee injury and Osteoarthritis Outcome Score - Knee injury and Osteoarthritis Outcome Score - Knee injury and Osteoarthritis Outcome Score - Knee injury and Osteoarthritis Outcome Score - 36-Item Short Form Health Survey - 36-Item Short Form Health Survey - 36-Item Short Form Health Survey - 36-Item Short Form Health Survey - Forgotten joint score - Forgotten joint score - Forgotten joint score - Forgotten joint score Secondary Outcomes - Radiographic evaluation of prosthetic femoral component positioning ### Location - Facility: Stefano Zaffagnini, Bologna, Italia, N/A, Italy @@
## Electronic Diabetes Tune-Up Group (eDTU) for African Americans - NCT ID: NCT06321029 - Study ID: 4-22-ICTSHD-44 - Status: RECRUITING - Start Date: 2023-10-19 - Completion Date: 2025-03-31 - Lead Sponsor: Indiana University ### Study Description The primary aims of this study are:1. To test the acceptability and feasibility of the electronic DTU intervention (eDTU) that has been adapted for cultural relevance and online delivery compared to waitlist control and the in-person DTU (iDTU). The hypothesis is that the adapted intervention will be culturally acceptable (by participant satisfaction scores) and well-subscribed (intervention attendance rates).2. To test differences in diabetes distress and A1c change scores between intervention (changes in T2 to T4) and waitlist control (change in T1 to T2) by intervention group (eDTU vs. waitlist control; iDTU vs. waitlist control). The hypothesis is that both the eDTU and iDTU groups will show significant improvements in diabetes distress and A1c compared to waitlist control. In order to conserve sample size and budget, participants in each intervention group will serve as their own waitlist control.Secondary Objective. The secondary aim of the study is to evaluate changes in depressive symptoms, diabetes self-efficacy, and general and diabetes-specific quality of life in intervention (T2-T3 \& T4) compared to waitlist control (T1-T2). An exploratory aim will be to compare changes in eDTU to the iDTU pre/post intervention (T2-T3 \& T4). The hypothesis is that both groups will show comparable improvements in diabetes distress and A1c. ### Conditions - Diabetes Mellitus, Type 2 - Diabetes Complications ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Diabetes Tune-Up Group ### Outcomes Primary Outcomes - Diabetes Distress Scale-17 (DDS-17) - HbA1c (A1c) - Acceptability of intervention (content and delivery modality) - Feasibility of intervention and delivery modality Secondary Outcomes - Patient Health Questionnaire-9 (PHQ-9) - Confidence in Diabetes Self-Care (CDSC) - Short Form-12 (SF-12) - Diabetes Therapy-Related Quality of Life Questionnaire ### Location - Facility: Indiana University School of Medicine, Indianapolis, Indiana, 46202, United States @@
## POZIKIDS: Exercise and Comprehensive Care to Improve the Quality of Life of Children and Adolescents With Cancer - NCT ID: NCT06321016 - Study ID: 2023111039 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2026-12-30 - Lead Sponsor: Nere Mendizabal ### Study Description Objective: To assess the feasibility of a supervised, controlled and personalised physical exercise programme and its potential efficacy in improving functional capacity and quality of life in children and adolescents with cancer.Design: Hybrid quasi-experimental pilot trial, clinical and phase I implementation.Methods: The learning collaborative approach based on the Institute for Healthcare Improvement Breakthrough Series Collaborative Model will be followed through quarterly Plan-Do-Study-Act (P-D-S-A) cycles. Participants: For feasibility, at least, 45 patients will be included in 3 successive PDSA cycles of at least 15 patients each, aged 4-18 years diagnosed with any type of cancer. Variables: clinical and socio-demographic, body composition, physical condition and mobility, quality of life, physical activity and implementation. Intervention: Everyone will receive a physical exercise intervention combining strength and aerobic capacity work. Initially it will be carried out in the hospital setting, and later in streaming supervised by a professional. The intervention will be modelled through a formative evaluation process with the collaboration of all the agents involved, experimenting in each cycle with an increasingly adapted version of the exercise programme.Statistical analysis: Recruitment rates will be calculated, characteristics associated with project participation and adherence to the exercise programme will be identified. Outcome variables will be compared before and after the intervention, identifying those with the greatest validity, reliability and sensitivity to change, which will then be used in phase II and III trials. ### Conditions - Exercise - Childhood Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Physical exercise program - Type of the physical exercise program ### Outcomes Primary Outcomes - Quarterly recruitment rates assessed by comparing those who participate with those who do not. - Adherence rates assessed by the proportion of sessions completed and adherence to the prescribed exercise protocol - Body composition assessed by the Body Mass Index - Muscle mass - Bone mineral density - Physical condition assessed by the 6 min walking test and manual grip test with a dynamometer - Muscular strength assessed by manual grip test with a dynamometer - General Quality of life assessed by the PedsQL 4.0 questionnaire - Specific Quality of life assessed by the PedsQL cancer questionnaire - Fatigue assessed by the PedsQL Multidimensional Fatigue Scale Acute Version (PedsQL-MFS) - Physical activity level assessed by accelerometers Secondary Outcomes - Security assessment - Costs associated estimation - Implementation barriers and facilitators ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## SYsteMatical Trained learnIng aLgorithms for Oral carcInogenesiS Interpretation by Optical Coherence Tomography - NCT ID: NCT06321003 - Study ID: OCT01 - Status: RECRUITING - Start Date: 2024-03-13 - Completion Date: 2027-04-01 - Lead Sponsor: University of Palermo ### Study Description This clinical trial aims to assess the efficacy of Optical Coherence Tomography (OCT) in the early diagnosis of oral cancer. It focuses on Oral Potentially Malignant Disorders (OPMDs) as precursors to Oral Squamous Cell Carcinoma (OSCC). Despite the availability of oral screening, diagnostic delays persist, underscoring the importance of exploring non-invasive methodologies. The OCT technology provides cross-sectional analysis of biological tissues, enabling a detailed evaluation of ultrastructural oral mucosal features.The trial aims to compare OCT preliminary evaluation with traditional histology, considered the gold standard in oral lesion diagnosing. It seeks to create a database of pathological OCT data, facilitating the non invasive identification of carcinogenic processes. The goal is to develop a diagnostic algorithm based on OCT, enhancing its ability to detect characteristic patterns such as the keratinized layer, squamous epithelium, basement membrane, and lamina propria in oral tissues affected by OPMDs and OSCC.Furthermore, the trial aims to implement Artificial Intelligence (AI) in OCT image analysis. The use of machine learning algorithms could contribute to a faster and more accurate assessment of images, aiding in early diagnosis. The trial aims to standardize the comparison between in vivo OCT images and histological analysis, adopting a site-specific approach in biopsies to improve correspondence between data collected by both methods.In summary, the trial not only evaluates OCT as a diagnostic tool but also aims to integrate AI to develop a standardized approach that enhances the accuracy of oral cancer diagnosis, providing a significant contribution to clinical practice. ### Conditions - Oral Squamous Cell Carcinoma - Oral Potentially Malignant Disorder - Oral Leukoplakia - Proliferative Verrucous Leukoplakia - Oral Lichen Planus - Oral Lichenoid Lesion - Graft-versus-host-disease - Oral Erythroplakia - Actinic Keratoses - Actinic Cheilitis - Oral Cancer - Oral Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - OCT (Optical Coherence Tomography) ### Outcomes Primary Outcomes - Phase I: Standardization of Biopsy and OCT Imaging Techniques - Phase II: Development of Standardized OCT Patterns, Creation of Comprehensive Image Repository, and Training Algorithms - Phase III: Development and Large-Scale Validation of Diagnostic OCT Software Secondary Outcomes ### Location - Facility: University of Palermo, Palermo, N/A, N/A, Italy @@
## Chemoprevention With Tamoxifen in Pre-Invasive Pancreas Mucinous Cystic Neoplasms Not Undergoing Immediate Resection - NCT ID: NCT06320990 - Study ID: 0074-24-CB - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2027-05 - Lead Sponsor: University of Nebraska ### Study Description This is an open-label pilot study of tamoxifen as chemoprevention in patients with pancreatic MCN who will not undergo immediate resection. Up to 15 subjects will be enrolled and take tamoxifen 20mg by mouth daily for up to 24 weeks. ### Conditions - Pancreatic Cyst - Pancreatic Mucinous Cystic Neoplasm ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Tamoxifen 20mg ### Outcomes Primary Outcomes - Feasibility, by adherence rate - Feasibility, by retention rate Secondary Outcomes - Objective response rate (ORR) of pancreatic MCN ### Location - Facility: University of Nebraska Medical Center, Omaha, Nebraska, 68198, United States @@
## The Influence of Acute Static Stretching on the Ankle Joint-position Sense of Soccer Players - NCT ID: NCT06320977 - Study ID: ESS/FSA-397/23-2 - Status: COMPLETED - Start Date: 2024-02-12 - Completion Date: 2024-03-29 - Lead Sponsor: University Fernando Pessoa ### Study Description The aim of this study isto investigate the influence of acute static stretching on the ankle joint position sense of soccer players. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Static Stretching ### Outcomes Primary Outcomes - Absolute angular error - Relative angular error - Variable angular error Secondary Outcomes ### Location - Facility: Escola Superior de Saúde Fernando Pessoa, Porto, N/A, 4200-253, Portugal @@
## The TARANG Intervention - NCT ID: NCT06320964 - Study ID: R01HD108252_1 - Status: COMPLETED - Start Date: 2023-07-14 - Completion Date: 2024-01-21 - Lead Sponsor: University of California, San Francisco ### Study Description The mixed methods pilot study aims to evaluate the acceptability, feasibility, and implementation challenges of the TARANG intervention in villages in rural/tribal Rajasthan to inform the study design and operational details for a larger cluster-randomized controlled trial. ### Conditions - Feasibility - Acceptability - Family Planning - Unintended Pregnancy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - TARANG ### Outcomes Primary Outcomes - Feasibility of the intervention - Acceptability - Usefulness Secondary Outcomes ### Location - Facility: Vikalp Sansthan, Udaipur, Rajasthan, N/A, India @@
## VITAL-IMPACT: Improving Cardiometabolic Health in Black Individuals Through Therapeutic Augmentation of Cyclic Guanosine Mono-Phosphate Signaling Pathway - NCT ID: NCT06320951 - Study ID: 300012681 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2029-04-30 - Lead Sponsor: University of Alabama at Birmingham ### Study Description This study investigates the potential of vericiguat, a soluble guanylate cyclase stimulator, to improve cardiometabolic health in obese Black individuals with insulin resistance by directly enhancing cyclic guanosine monophosphate (cGMP) activity. Given that this population has been shown to have lower cGMP activity and the association of lower cGMP activity with increased cardiometabolic disease risk, the proposed study hypothesizes that augmenting cGMP activity in obese individuals will improve insulin sensitivity and energy expenditure. This study is a placebo-controlled randomized trial involving 200 Black obese participants with insulin resistance, assessing the effects of vericiguat on insulin sensitivity, resting, and exercise-induced energy expenditure over 12 weeks. Additionally, it will explore changes in brown adipose tissue and gene expression related to energy metabolism in white adipose tissue, aiming to provide insights into how increasing cGMP activity may improve cardiometabolic health in Black obese individuals. ### Conditions - Cardiovascular Diseases - Insulin Sensitivity/Resistance - Metabolic Disease - Metabolism - Energy Expenditure - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Vericiguat 10 MG - Placebo - Insulin Sensitivity Test - Resting Energy and Exercise Energy Expenditure Assessment - White Adipose Tissue Biopsy - MRI-PET Scan for Brown Adipose Tissue Volume Assessment ### Outcomes Primary Outcomes - Change in insulin sensitivity after vericiguat in Black obese individuals with insulin resistance. - Change in resting energy expenditure (REE) after vericiguat in Black obese individuals with insulin resistance. Secondary Outcomes - Change in BAT volume after vericiguat in Black obese individuals with insulin resistance. - Change in BAT activity after vericiguat in Black obese individuals with insulin resistance. - Change in UCP1 gene expression after vericiguat in Black obese individuals with insulin resistance. - Change in exercise energy expenditure (EEE) after vericiguat in Black obese individuals with insulin resistance. - Change in glycosylated hemoglobin (HbA1C) after vericiguat in Black obese individuals with insulin resistance. - Change in Body Mass Index (BMI) after vericiguat in Black obese individuals with insulin resistance. - Change in Total Cholesterol (TC) after vericiguat in Black obese individuals with insulin resistance. - Change in low-density lipoprotein-cholesterol (LDL-C) after vericiguat in Black obese individuals with insulin resistance. ### Location - Facility: University of Alabama at Birmingham, Birmingham, Alabama, 35294, United States @@
## Effectiveness of Neuroscience-based Pain Education in Patients With Chronic Neck Pain - NCT ID: NCT06320938 - Study ID: 2024/18 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-18 - Completion Date: 2025-03-15 - Lead Sponsor: Turkoglu Dr. Kemal Beyazit State Hospital ### Study Description The effectiveness of neuroscience-based pain education, myofascial induction technique, and home exercise programs will be compared in patients with chronic neck pain. ### Conditions - Cervical Spine Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Neuroscience-Based Pain Education Combined with Home Exercise Program - Myofascial Induction Techniques Combined with Home Exercise Program - Home Exercises Group ### Outcomes Primary Outcomes - Short Form McGill Pain Questionnaire - Algometric Digital Measurement - Central Sensitization Inventory - Head Posture Evaluation - Neck Disability Index - Pittsburgh Sleep Quality Index - 36-Item Short Form Health Survey Questionnaire - Pain Catastrophizing Scale Secondary Outcomes ### Location - Facility: Türkoğlu Dr. Kemal Beyazıt State Hospital, Kahramanmaraş, N/A, N/A, Turkey @@
## SportsPro: Post-Market Clinical Follow Up Study - NCT ID: NCT06320925 - Study ID: SYK-SM-2022-02 - Status: RECRUITING - Start Date: 2023-12-05 - Completion Date: 2024-12-01 - Lead Sponsor: Stryker Endoscopy ### Study Description Retrospective, multi-center, chart review (only to include data that is part of the surgeons' standard practice) ### Conditions - Shoulder Injuries - Knee Injuries - Hip Injuries ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Standard of Care Treatment ### Outcomes Primary Outcomes - ASES - iHOT-12 - mHHS Secondary Outcomes ### Location - Facility: Musculoskeletal-Orthopedic Research and Education Foundation, Phoenix, Arizona, 85023, United States @@
## Efficacy and Safety of Intraparenchymal Portal Vein Covered Stents in Treating Portal Hypertension and Its Complications - NCT ID: NCT06320912 - Study ID: TIPS01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-05 - Completion Date: 2026-11-01 - Lead Sponsor: Shanghai Shenqi Medical Technology Co., Ltd ### Study Description The objective of this study is to assess the non-inferiority of the intraparenchymal portal vein covered stent in terms of safety and efficacy for managing portal hypertension and its related complications, in comparison to the currently available TIPS Covered Stent System by GORE. ### Conditions - Portal Hypertension ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - The intraparenchymal portal vein covered stent - TIPS Covered Stent System GORE ### Outcomes Primary Outcomes - Postoperative Stent Patency Rate Secondary Outcomes - Immediate Postoperative Technical Success Rate - Incidence of Secondary Interventions at 1 Month, 6 Months, and 12 Months Postoperatively - Incidence of Stent Dysfunction at 1 Month, 6 Months, and 12 Months Postoperatively - Incidence of Major Adverse Events (MAE) at 1 Month, 6 Months, and 12 Months Postoperatively - All-Cause Mortality Rates at 1 Month, 6 Months, and 12 Months Postoperatively - Incidence of Grade II or Higher Hepatic Encephalopathy at 1 Month, 6 Months, and 12 Months Postoperatively - Incidence of Portal Hypertension Rebleeding Confirmed by Endoscopy or Clinical Investigator at 1 Month, 6 Months, and 12 Months Postoperatively (For Original Bleeding Subjects Only) - Incidence of Ultrasound-Confirmed Recurrence of Grade 2 or Higher Ascites due to Portal Hypertension at 1 Month, 6 Months, and 12 Months Postoperatively (For Subjects with Original Ascites Only) - Incidence of Adverse Events/Serious Adverse Events ### Location - Facility: Southern Medical University Nanfang Hospital, Guangzhou, Guangdong, N/A, China @@
## Mid- or High-flex Rods Versus Low-flex Rods of SpineShape System IV for Treatment of Degenerative Lumbar Spine Diseases - NCT ID: NCT06320899 - Study ID: SpineShape_CH_001 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-02 - Completion Date: 2031-08-31 - Lead Sponsor: SpineSave AG ### Study Description The purpose of this multi-center, randomized, clinical study is to show that the treatment of degenerative lumbar spine with high- or mid-flex rods is not inferior to the treatment with low-flex rods in terms of clinical and safety-related results.The primary aim is to compare the reduction in back pain after the treatment with high- or mid-flex rods with that after treatment with low-flex rods. Secondary, the functionality after treatment with high- or mid-flex rods will be compared to that after treatment with low-flex rods. ### Conditions - Degenerative Lumbar Spinal Stenosis - Facet Joint Arthrosis - Spondylarthritis - Discopathy - Degenerative Spondylolisthesis - Instability Lumbar Spine ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - SpineShape System IV straight rod elastic - SpineShape System IV straight rod medium - SpineShape System IV straight rod stiff ### Outcomes Primary Outcomes - VAS Score lower back pain Secondary Outcomes - VAS Score leg pain - walking duration - medication consumption - adverse events - segmental mobility index level - ability to work/ activity (for retirees) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Role of Ultrasonography in Acute Abdomen in Adults in Correlation to Computed Tomography Scan - NCT ID: NCT06320886 - Study ID: Soh-Med-24-02-05MS - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2024-10-31 - Lead Sponsor: Sohag University ### Study Description The study aims to evaluate the role of Ultrasonography in the diagnosis of the cause of acute abdominal pain in 50 adults presenting in the ER at Sohag University Hospital and compares it to the Computed Tomography scan results of the same patients to discover the superiority of both over the other in the diagnosis of different acute abdomen cases. ### Conditions - Acute Abdomen - In Adults ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Diagnostic Test ### Outcomes Primary Outcomes - Comparison between the role of Ultrasonography and Computed Tomography in Acute Abdomen diagnosis Secondary Outcomes ### Location - Facility: Sohag University Hospital, Sohag, N/A, N/A, Egypt @@
## The Effect of Respiratory on Sports Performance in Archers - NCT ID: NCT06320873 - Study ID: zselcuk1 - Status: COMPLETED - Start Date: 2021-07-26 - Completion Date: 2022-01-01 - Lead Sponsor: Halic University ### Study Description Purpose: The physical, physiological, and functional characteristics of archers affect target shooting performance. In our study, we aimed to examine the effect of pulmonary functions and respiratory muscle strength on sports performance in archers.Methods: Our study included 46 (27 female, 19 male) professional archers registered in archery sports clubs. Sociodemographic and physical characteristics were recorded. Pulmonary function test (PFT), respiratory muscle strength, shooting performance test, Moberg-pickup collection test, Nelson hand reaction test, and Fatigue Severity Scale (FSS) were applied to all participants. ### Conditions - Sports Physical Therapy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - archery respiratory parameters ### Outcomes Primary Outcomes - FEV1 (liter) - FEV1 (%-percentage) - FVC (liter) - FVC (%-percentage) - FEV1/FVC (percentage) - Inspiratory muscle test - Expiratory muscle test - Shooting performance - Nelson Hand Reaction Test - Moberg-pickup collection test - The Fatigue Severity Scale (FSS) Secondary Outcomes ### Location - Facility: Halic University, Istanbul, N/A, N/A, Turkey @@
## FlexStone Enabled Kidney Stone Retrieval - NCT ID: NCT06320860 - Study ID: IRB231189 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03-08 - Completion Date: 2024-09-08 - Lead Sponsor: EndoTheia ### Study Description This study investigates if additional basket control in helpful during retrieval of kidney stones especially those that are difficult to reach for standard baskets. ### Conditions - Kidney Calculi ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DEVICE_FEASIBILITY ### Interventions - Kidney Stone Retrieval ### Outcomes Primary Outcomes - Successful retrieval of kidney stones Secondary Outcomes ### Location - Facility: Vanderbilt University Medical Center, Nashville, Tennessee, 37203, United States @@
## Predictive Remote Photoplethysmography Algorithm for Blood Pressure Pressure Assessment and Monitoring - NCT ID: NCT06320847 - Study ID: Predictbloodpressure - Status: RECRUITING - Start Date: 2024-01-02 - Completion Date: 2024-12 - Lead Sponsor: Singapore General Hospital ### Study Description Significant advancements in the field of medical technologies have resulted in the rise of contact-free methods of haemodynamic monitoring. Remote photoplethysmography (rPPG) is a videobased, contactless form of monitoring that operates through a camera-enabled device. This innovation interprets minute variations in skin colour due to blood flow which, when analysed with complex signal processing algorithms, generates vital sign readings. Currently, Nervotec's rPPG technology allows for the collection of rPPG waveforms, which enables the measurement of heart rate, heart rate variability, respiration rate and blood oxygen saturation (SpO2) level through signal processing techniques. The plethysmography signals can be used to estimate blood pressure through the creation and training of a predictive model. By examining and extracting key features of a continuous PPG waveform by training an artificial neural network, correlations between these features and BP can be studied. ### Conditions - Remote Photoplethysmography , Blood Pressure ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - rPPG ### Outcomes Primary Outcomes - To determine the correlation between remote photoplethysmography (rPPG) and blood pressure variations. - To develop a predictive model in using rPPG for determination of blood pressure. - To validate this predictive model by comparing blood pressure readings obtained using rPPG with standard procedures such as contact sensors and automated oscillometry. Secondary Outcomes ### Location - Facility: Singapore General Hospital, Singapore, N/A, 169608, Singapore @@
## [Trial of device that is not approved or cleared by the U.S. FDA] - NCT ID: NCT06320834 - Study ID: PTL-1000294 - 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 @@
## RAKT OUTCOME ANALYSIS - NCT ID: NCT06320821 - Study ID: RAKT Version 1.0 - Status: ENROLLING_BY_INVITATION - Start Date: 2021-08-21 - Completion Date: 2024-08-30 - Lead Sponsor: Seoul National University Hospital ### Study Description The goal of this observational study is to compare outcomes of robot-assisted kidney transplantation and open kidney transplantation. The main questions are- comprehensively analyze our early experience of robot-assisted kidney transplant patients and compare the results with those of open kidney transplant patients ### Conditions - Kidney Transplantation - Robotic Surgery ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - learning curve Secondary Outcomes - renal function ### Location - Facility: Seoul National University Hospital, Seoul, N/A, 110-744, Korea, Republic of @@
## Evaluating FDA's Proposed Patient Medication Information Handout - NCT ID: NCT06320808 - Study ID: STUDY2023_00000449 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-03 - Completion Date: 2025-03-03 - Lead Sponsor: Carnegie Mellon University ### Study Description The goal of this study is to assess how useful the proposed one-page FDA-template PMI is to potential users.The main questions it aims to answer are:How does the proposed one-page FDA-template PMI compare with the current drug information insert in terms of usefulness and comprehension?andHow does the proposed one-page FDA-template PMI compare with a revision adding drug benefit information?Participants will randomized to review one of three patient medication information sheets and then asked questions related to usefulness and comprehension. ### Conditions - Knowledge - Attitude ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - FDA template PMI - Decision Critical PMI - Standard Information ### Outcomes Primary Outcomes - Perceived difficulty or ease in reading information - Perceived usefulness of the medication information guide in making a use decision - Perceived usefulness of the medication information guide in taking the medication properly - Comprehension Secondary Outcomes - Strength of Evidence ### Location - Facility: Carnegie Mellon University, Pittsburgh, Pennsylvania, 15213, United States @@
## Prospective Study for the Clinical Validation of the Soundi Wearable Medical Device - NCT ID: NCT06320795 - Study ID: IT-MF-000031905 - Status: RECRUITING - Start Date: 2023-11-22 - Completion Date: 2024-05-31 - Lead Sponsor: Biocubica srl ### Study Description This is a pre-marketing, single-centre, prospective clinical trial with the aim of comparison the effectiveness and safety of the SOUNDI medical device compared to polysomnography in detecting parameters for the diagnosis of obstructive sleep apnea (OSA) syndrome in subjects with suspected diagnosis of sleep disorders. ### Conditions - OSA ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - SOUNDI ### Outcomes Primary Outcomes - To evaluate the accuracy of the clinical diagnosis of OSA - To evaluate the agreement between the Apnea Hypopnea Index (AHI) from the home sleep study with SOUNDI and the home sleep study with polysomnography (PSG) Secondary Outcomes - Patient satisfaction ### Location - Facility: Ambulatorio del Sonno- Istituto Auxologico Italiano IRCCS - Ospedale San Luca, Milan, N/A, 20149, Italy @@
## Effects of Different Dietary Interventions on Abdominal Fat Components and Cardiometabolic Parameters. - NCT ID: NCT06320782 - Study ID: 4659262 - Status: ENROLLING_BY_INVITATION - Start Date: 2021-08-23 - Completion Date: 2024-08 - Lead Sponsor: University of Pernambuco ### Study Description The study aims to evaluate the impact of different dietary interventions on abdominal fat components and cardiometabolic parameters. This is a randomized clinical trial study conducted in overweight adults, selected by voluntary adherence, in an outpatient clinic of a cardiology hospital. The sample was calculated based on data from a study with the Brazilian population, with the sample size calculated as a function of a mean difference (d) in visceral adipose tissue (VAT) after the interventions, standard deviation (s) and a significance level of 5% (z). To correct eventual losses, the number was increased by 20%. Four dietary interventions will be applied in the 6-month period: group with calorie restriction and balanced distribution of macronutrients (group 1); group with calorie restriction and low-carbohydrate diet (group 2); group with calorie restriction and low-fat diet (group 3) and group with collective nutritional guidance (group 4). Patients will be followed up monthly to assess weight loss, analyze adherence to the diet therapy plan, reinforce nutritional guidelines and monitor anthropometric measurements and abdominal adipose tissue. The evaluation of VAT and subcutaneous adipose tissue (SAT) by ultrasonography will be performed at baseline and after 6 months of intervention. The present study is expected to clarify the effects that different dietary interventions produce over 6 months on abdominal fat deposits and cardiometabolic parameters. ### Conditions - Abdominal Obesity - Cardiac Disease - Metabolic Disease - Cardiometabolic Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Calorie restriction and balanced distribution of macronutrients - Calorie restriction and low-carbohydrate diet - Calorie restriction and low-fat diet - Collective nutritional guidance ### Outcomes Primary Outcomes - Thickness, measured in centimeters, of visceral adipose tissue - Weight loss measured in kilograms Secondary Outcomes - Serum levels of fasting glucose - Serum levels of Insulin - Serum levels Triglycerides - Serum levels Lipid profile - Serum levels C-reactive protein (hs-CRP) ### Location - Facility: Isa Galvao Rodrigues, Recife, PE, 51021120, Brazil @@
## Role of Rotational Guided Growth in Management of Increased Femoral Anteversion - NCT ID: NCT06320769 - Study ID: 24101994 - Status: RECRUITING - Start Date: 2024-02-20 - Completion Date: 2026-03-01 - Lead Sponsor: Ain Shams University ### Study Description Efficacy of guided growth in coronal plane deformity correction and limb length discrepancy has been well-established. Recently, studies have explored the validity of guided growth in correction of rotational deformity through a modified method of application.This concept has been validated in animal studies, biomechanical studies and two limited human case series through different methods.This study evaluates the efficacy of rotational guided growth in management of increased femoral anteversion using three different constructs. ### Conditions - Increased Femoral Anteversion ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Plate Technique ### Outcomes Primary Outcomes - Gait Secondary Outcomes - Limb length discrepancy - Angular Deformities ### Location - Facility: Faculty of Medicine, Ainshams University, Cairo, El-Waily, N/A, Egypt @@
## Examining the Feasibility of Wysa in Hindi - NCT ID: NCT06320756 - Study ID: 24-WYSA-101 - Status: RECRUITING - Start Date: 2024-02-23 - Completion Date: 2024-05-31 - Lead Sponsor: Wysa ### Study Description The principal objective of this study is to investigate the feasibility of including a digital mental health intervention (Wysa in Hindi) within pre-existing usual care to support adolescents and young adults with Type 1 Diabetes (T1D) who have mild and above mental health distress (operationalized as Patient Health Questionnaire-9: 5-14 scores; or Diabetes Distress Scale-17: \>2.0 mean score) with their mental health distress. This will be conducted through an exploratory randomized control study comparing Wysa in Hindi plus usual care with a control arm that just has usual care. The study further explores the effectiveness of the digital mental health intervention using the Patient Health Questionnaire (PHQ-9) and Diabetes Distress Scale (DDS-17). ### Conditions - Mental Health Issue - Diabetes Distress ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Wysa in Hindi - Individual and group sessions on topics like motivation, coping, wellbeing ### Outcomes Primary Outcomes - Feasibility - Recruitment rate (Proportion of participants who completed consent procedures) - Feasibility - Retention rate (Proportion of participants who remained enrolled within the study for the entire study duration) - Feasibility - Wysa Engagement (Proportion of recruited participants who engaged in at least 1 interaction with the Wysa app) - Feasibility - App therapist engagement rate (Proportion of recruited participants who completed at least one therapist session within the Wysa app) - Satisfaction with the app which is collected through 3 quantitative questions and 1 free text qualitative question on the app - Therapist Satisfaction feedback collected through 3 quantitative questions and 1 free text qualitative question on the app Secondary Outcomes - Change in mental health distress as measured by the Patient Health Questionnaire (PHQ-9) - Change in mental health distress as measured by the Diabetes Distress Scale (DDS-17) ### Location - Facility: Udaan, Aurangabad, Maharashtra, 431003, India @@
## Cerebral and Peripheral Near Infrared Spectroscopy Monitoring in Low and High Flow Anaesthesia in Pediatric - NCT ID: NCT06320743 - Study ID: Low Flow Anaesthesia And NIRS - Status: RECRUITING - Start Date: 2024-03-20 - Completion Date: 2024-09-19 - Lead Sponsor: Ankara City Hospital Bilkent ### Study Description To investigate the effects of non-invasive cerebral and peripheral NIRS monitoring and low and high flow sevoflurane anaesthesia on cerebral and peripheral NIRS in paediatric patients. To determine the effects of two different flows on these monitoring techniques and thus to facilitate intraoperative patient monitoring and to predict complications (hypoxia) that may occur. ### Conditions - Child, Only - Inhalation; Vapor - Anesthesia - Cerebral Oxygenation - Cerebral Hypoxia - Peripheral Oxygenation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - NIRS ,Ventilation parameters - Oxygen concentration ### Outcomes Primary Outcomes - Near infrared spectroscopy (NIRS) Secondary Outcomes - Ventilation parameters - Ventilation parameters - Ventilation parameters - Ventilation parameters - Ventilation parameters - Ventilation parameters - Ventilation parameters - İntraoperative sevoflurane consumption ### Location - Facility: Ankara Bilkent City Hospital, Ankara, Çankaya, 06800, Turkey @@
## Impact of Glycemic Control After Reperfusion on Acute Kidney Injury in Living Donor Liver Transplantation - NCT ID: NCT06320730 - Study ID: 2020-0675 - Status: COMPLETED - Start Date: 2020-08-25 - Completion Date: 2021-03-01 - Lead Sponsor: Asan Medical Center ### Study Description This retrospective cohort study of patients classified by the blood glucose level after reperfusion in liver transplantation repicient. Our object is to investigate whether controlling BG levels within the optimal range during neohepatic phase is associated with a reduction of AKI incidence. Furthermore, severe AKI, chronic kidney disease (CKD), major adverse cardiac event (MACE) and mortality were also investigated. ### Conditions - Acute Kidney Injury - Hyperglycemia - Hypoglycemia - End Stage Liver Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Observational study, records of blood glucose level after reperfusion ### Outcomes Primary Outcomes - incidence of acute kidney injury Secondary Outcomes - incidence of severe AKI - incidence of chronic kidney disease (CKD) - incidence of Major adverse cardiac event (MACE) - overall mortality ### Location - Facility: Jun-Gol Song, Seoul, Song-pa Gu, 05500, Korea, Republic of @@
## AI Derived Biomarker to Select Neoadjuvant Treatment for Borderline Resectable Pancreatic Ductal Adenocarcinoma - NCT ID: NCT06320717 - Study ID: I-3574823 - Status: RECRUITING - Start Date: 2024-01-02 - Completion Date: 2026-07-02 - Lead Sponsor: Roswell Park Cancer Institute ### Study Description To collect samples and information from patients who will be undergoing standard of care neoadjuvant treatment with either FOLFIRINOX or Gemcitabine + Nab-paclitaxel.The information collected will be used to determine if there are any "biomarkers" in your blood or tumor tissue that, when compared to your response to the neoadjuvant treatment, could be used to choose the best treatment option for future patients with similar biomarkers. ### Conditions - Pancreatic Ductal Adenocarcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Blood sample ### Outcomes Primary Outcomes - Retrospective prediction of pCR in resectable patients - Retrospective prediction of pCR in borderline resectable patients Secondary Outcomes - Survival status - RECIST 1.1 response ### Location - Facility: Roswell Park Comprehensive Cancer Center, Buffalo, New York, 14263, United States @@
## Occlusal Balance Effect on Mandibular Bone Density by Using Fractal Analysis in Complete Denture Patients (Split-Mouth Study) - NCT ID: NCT06320704 - Study ID: 01067485392 - Status: RECRUITING - Start Date: 2024-03-21 - Completion Date: 2024-09-21 - Lead Sponsor: Badr University ### Study Description Although the number of individuals who are edentulous is declining, a sizable fraction still needs a complete denture for their oral rehabilitation.Tooth loss is an issue in public health that determines quality of life since it is linked to socioeconomic, physiological, and psychological aspects. In patients who are completely edentulous, dental implants have been viewed as a favorable choice for rehabilitation. ### Conditions - Bone Density ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Digital occlusal adjustment using Occulosense digital device ### Outcomes Primary Outcomes - Bone Density - Bone Density - Bone Density - Bone Density Secondary Outcomes ### Location - Facility: Badr University in Cairo, Cairo, القاهرة, N/A, Egypt @@
## General vs Spinal Anesthesia for Total Joint Arthroplasty-Anterior Approach: A Single-Institution Observational Study - NCT ID: NCT06320691 - Study ID: BezmialemVU 1 - Status: COMPLETED - Start Date: 2014-01-10 - Completion Date: 2017-05-25 - Lead Sponsor: Bezmialem Vakif University ### Study Description The study compares the effects of various anesthetic techniques on anterior approach total hip arthroplasty results retrospectively ### Conditions - Arthroplasty Complications - Anesthesia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Total Hip Arthroplasty - General Anesthesia - Spinal Anesthesia ### Outcomes Primary Outcomes - Mean intraoperative estimated blood loss - mean duration of surgery - length of hospital stay - stem subsidence - stem varus/valgus degrees - acetabular abduction Secondary Outcomes ### Location - Facility: Bezmialem Vakif University, Istanbul, N/A, 34140, Turkey @@
## Parenteral Drug Administration Training for Nursing Students - NCT ID: NCT06320678 - Study ID: Aysun Acun 5 - Status: RECRUITING - Start Date: 2024-02-29 - Completion Date: 2024-04 - Lead Sponsor: Bilecik Seyh Edebali Universitesi ### Study Description This study aims to evaluate the effect of blended self-directed learning with concept mapping on the level of knowledge regarding parenteral drug administration in nursing students. With out-of-class, online, interactive teaching methods, a memorable learning away from complex structure is aimed. ### Conditions - Nursing Education ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Nursing Students Education ### Outcomes Primary Outcomes - Students' knowledge level after blended learning method Secondary Outcomes ### Location - Facility: Bilecik Şeyh Edebali University, Bilecik, N/A, 11000, Turkey @@
## Assessment of Sagittal and Vertical Pattern in Correlation With Third Molar Inclusion : A 3D CBCT Analysis - NCT ID: NCT06320665 - Study ID: 2024PI003 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-09-30 - Lead Sponsor: Central Hospital, Nancy, France ### Study Description The objective is to compare the sagittal and vertical skeletal parameters of patients with an impacted third molar.Patients will be analyzed according to their skeletal characteristics: skeletal class (sagittal direction) and facial skeletal typology (vertical direction).The inclusion characteristics of third molars will also be analyzed, to see the links between typology and inclusion. The principal hypothesis is no significant difference in third molar inclusion patterns in relation to skeletal divergence. ### Conditions - Impacted Third Molar Tooth ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Radiographic measurement ### Outcomes Primary Outcomes - Distance between the occlusal plane and the second molar - Angle of the third molar Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Implementation and Evaluation of Telemedicine in Cardiac Rehabilitation - NCT ID: NCT06320652 - Study ID: CUHospital - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-08-31 - Lead Sponsor: Copenhagen University Hospital, Hvidovre ### Study Description The overall aim is to develop and test the effect of a tailored patient and family focused cardiac tele rehabilitation intervention on health literacy by comparing it to standard care. Furthermore, to evaluate health-related quality of life, family support, and how the patients experience the communication and relationship with outpatient clinic nurses. ### Conditions - Cardiac Rehabilitation ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Cardiac telerehabilitation (video consultation and home monitoring) ### Outcomes Primary Outcomes - Health Literacy Questonnaire Secondary Outcomes - The European Quality of life five dimensions questionnaire - The Iceland-Family Perceived Support Questionnaire - The eHealth Literacy Questionnaire ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## DRIVing Simulator and People With NeuroCognitive Disorders - NCT ID: NCT06320639 - Study ID: UGustaveEiffel - Status: RECRUITING - Start Date: 2023-10-03 - Completion Date: 2026-10-10 - Lead Sponsor: University Gustave Eiffel ### Study Description The ageing of the population is leading to an increasing number of older drivers on the roads. At the same time, the proportion of older people with pathological ageing and neurocognitive disorders (NCD) is increasing. In terms of road safety, this raises the question of whether these drivers should continue to drive or not. People with NCDs may not be aware of the presence, extent and progression of their cognitive impairment and the impact it can have on daily life, including driving.Despite their loss of autonomy and medical advice, 22% of people with major NCD continue to drive. In addition, the presence of minor NCD also puts people at a higher risk of road accidents.However, several studies demonstrated that an NCD does not lead to a systematic and immediate impairment of driving ability and abruptly stopping driving leads to health problems, such as the risk of depression and greatly reduces quality of life.It is therefore relevant to focus research on driving with people with NCD in order to have a reliable indicator of the person's abilities and the impact of their cognitive impairment on driving activity. The proposed study seeks to meet this need by studying the performance of people with NCD on a driving station (mini-simulator) while assessing their ability to evaluate their performance.To achieve this goal, people with NCDs will perform tasks on a driving simulator. In addition, after each task on the driving simulator, they will answer questions about how they evaluate their own driving. Two assessors will observe the participants' driving and will estimate their driving performance. By comparing the driver's self-assessment with the assessors' assessment, an "awareness score of driving ability" will be calculated to determine whether the driver correctly assessed his or her performance.Another project already underway aims to collect similar data from people without a diagnosis of NCDs (control group).The principal objective of the present study is to compare the driving performance in a simulator and the awareness of driving ability of people with NCDs with those of a control group. Secondary objectives are :1. to measure driving performance in a simulator and awareness of driving abilities (i.e. self-assessment skills) of people with NCDs.2. to analyse driving performance and awareness of driving abilities according to the diagnosis and severity of the disorder (i.e. minor or major neurocognitive disorders).3. to establish a methodology to identify a driver at risk of dangerous driving.It is mainly an exploratory study however some hypotheses can be made :* The driving performance and awareness of driving skills of people with NCDs are poorer compared to those of older, control individuals.* Individuals' driving performance and awareness of driving ability are lower in the presence of major NCDs compared to minor NCDs. ### Conditions - Neurocognitive Disorders ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Awareness score of driving ability - Driving performance variables measured by the driving simulator Secondary Outcomes ### Location - Facility: Hôpital des Charpennes, Villeurbanne, N/A, 69100, France @@
## Pharmacokinetic-guided Dosing of Emicizumab - NCT ID: NCT06320626 - Study ID: 22-571 - Status: RECRUITING - Start Date: 2022-09-08 - Completion Date: 2026-08 - Lead Sponsor: Kathelijn Fischer ### Study Description The goal of this multicentre, prospective, open-label, cross-over clinical study is to determine whether individualized PK-guided dosing of emicizumab is non-inferior to conventional dosing of emicizumab in the prevention of bleeding in congenital haemophilia A patients. ### Conditions - Hemophilia A With Inhibitor - Hemophilia A Without Inhibitor - Hemophilia A, Severe - Adolescent - Child - Adult ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Emicizumab - PK-guided dose reduction - Emicizumab - Dosis continuation group - Emicizumab - Dose adjustment group ### Outcomes Primary Outcomes - Proportion of patients without treated bleeds Secondary Outcomes - Proportion of patients without treated bleeds - Proportion of patients without spontaneous joint- or muscle bleeds - Annualized bleeding rate (ABR) of treated bleeds, including joint bleeds and sport-induced bleeds - To compare cost-effectiveness between conventional dosing and individualized PK-guided dosing of emicizumab - To assess the cumulative number of coagulation factor (sc. and/or iv.) of per year. - To assess the performance of the population PK model - To investigate whether direct joint health remains stable measured by physical examination when switching to lower-dosed emicizumab compared to conventional treatment - To investigate whether direct joint health remains stable measured by ultrasound when switching to lower-dosed emicizumab compared to conventional treatment - To investigate if indirect joint health, as measured by biomarkers, remains stable when switching to lower doses of emicizumab compared to conventional treatment. - To investigate if indirect joint health, as measured by biomarkers, remains stable when switching to lower doses of emicizumab compared to conventional treatment. - To investigate whether Health Related Quality of Life (HR-QoL) are similar in patients receiving conventional dosing compared with PK-guided dosing of emicizumab. - To investigate whether Health Related Quality of Life (HR-QoL) are similar in patients receiving conventional dosing compared with PK-guided dosing of emicizumab. - To investigate whether sports participation are similar in patients receiving conventional dosing compared with PK-guided dosing of emicizumab. - To investigate whether thrombin generation parameters can be used as a pharmacodynamic (PD) biomarker for emicizumab treatment efficacy. - To assess and monitor pain during emicizumab administration ### Location - Facility: Radboud University Medical Center, Nijmegen, Gelderland, 6525 GA, Netherlands @@
## Effect of Implementing Snap-needle Therapy Combined With Ginger Paste During Anesthesia Recovery on the Recovery of Gastrointestinal Function After Gynecologic Laparoscopy - NCT ID: NCT06320613 - Study ID: KYLL20240117-2 - Status: RECRUITING - Start Date: 2024-03-20 - Completion Date: 2024-09-20 - Lead Sponsor: Weifang Medical University ### Study Description The aim of this study was to investigate the effect of implementing snap-needle therapy combined with ginger paste during anesthesia recovery on the recovery of gastrointestinal function after gynecological laparoscopy. ### Conditions - Gastrointestinal Motility - Postoperative Nausea and Vomiting ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Acupuncture therapy - Ginger Acupuncture Point Patch ### Outcomes Primary Outcomes - Postoperative nausea and vomiting - Postoperative nausea and vomiting - Postoperative nausea and vomiting - Postoperative nausea and vomiting - Postoperative nausea and vomiting - Postoperative nausea and vomiting - Abdominal distention - Abdominal distention - Abdominal distention - Abdominal distention - Abdominal distention - Abdominal distention - Time to first flatus Secondary Outcomes - Postoperative pain response - Postoperative pain response - Postoperative pain response - Postoperative pain response - Postoperative pain response - Postoperative pain response - Consumption of postoperative analgesic - Consumption of postoperative rescue antiemetic - Time to first defecation ### Location - Facility: Lin Cheng, Weifang, Shandong, 261000, China @@
## Precision Medicine of Diabetes Program in China - NCT ID: NCT06320600 - Study ID: PDC - Status: RECRUITING - Start Date: 2023-07-01 - Completion Date: 2028-12 - Lead Sponsor: Second Xiangya Hospital of Central South University ### Study Description The prevalence of diabetes has been increasing year by year. According to the International Diabetes Federation (IDF) statistics in 2021, the global number of people with diabetes has reached 537 million. The patient population is large and heterogeneous, and precise diagnosis and treatment of diabetes patients have been a focus of attention. The objective of this study is to clarify the current status of precision classification and diagnosis of diabetes patients through retrospective and prospective cohort studies, and to establish a model for precision classification and diagnosis of diabetes, improving the accuracy of diabetes classification and diagnosis; based on big data of precision medicine for diabetes patients and follow-up cohorts, to establish precise diagnostic, therapeutic, and predictive methods for diabetes; and through multi-omics data analysis, to explore the potential pathogenesis of diabetes, explaining the heterogeneity of patients, and guiding individualized treatment for patients. ### Conditions - Diabetes ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - no intervention ### Outcomes Primary Outcomes - The currency analysis of diabetes classification Secondary Outcomes - To establish a model for predicting diabetic retinopathy - To establish a model for predicting diabetic kidney disease - To establish a model for predicting diabetic neuropathy ### Location - Facility: the Second Xiangya Hospital, Changsha, Hunan, 410010, China @@
## The Effect of Kangaroo Care on Parents' Perceived Parenting Self-Efficacy, Infant Attachment and Newborn Vital Signs - NCT ID: NCT06320587 - Study ID: AEŞH-EK1-2023-508 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2024-05-30 - Lead Sponsor: Saglik Bilimleri Universitesi ### Study Description This study was planned to determine the effect of kangaroo care applied by parents of premature newborns in the neonatal intensive care unit on the newborn's vital signs, perceived parenting self-efficacy level and attachment to the baby. ### Conditions - Kangaroo Care - Fathers - Mother-Infant Interaction - Premature Infant ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Kangaroo care practice by both mother and father - Kangaroo care practice only mother ### Outcomes Primary Outcomes - Mother-To-Infant Bonding Scale - Perceived Mother Parenting Self-Efficacy Scale - Postnatal Paternal-Infant Attachment Questionnaire - Perceived Father Parenting Self-Efficacy Form - Physiological parameters of the premature infant: peak heart rate (BPM) - Physiological parameters of the premature infant: oxygen saturation (%) - Physiological parameters of the premature infant: body temperature (°C) - Physiological parameters of the premature infant:Respiration rate (RPM) Secondary Outcomes ### Location - Facility: Ankara Etlik City Hospital, Ankara, N/A, 06170, Turkey @@
## Nurses' Competence in Gastric Ultrasound - NCT ID: NCT06320574 - Study ID: 2023-16880 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-14 - Completion Date: 2024-08-01 - Lead Sponsor: Radboud University Medical Center ### Study Description The goal of this observational cohort study is to investigate gastric ultrasound skills in surgical nurses. The main question it aims to answer is:• how much training is required for surgical nurses to obtain competency in performing gastric ultrasound.Participants will follow a training involving* theoretical background using e-learning, picture library and lecture* practical skill development in an interactive hands-on workshop on live models directed by expert gastric ultrasonographer* and formative assessments during training sessions scanning healthy volunteers by participants and examiners (expert gastric ultrasonographers). ### Conditions - Gastric Content - Healthy Volunteers ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Number of required training Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Muscular Changes in the First 12 Weeks After Stroke. - NCT ID: NCT06320561 - Study ID: 23485_StrIMuC12 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2027-05 - Lead Sponsor: Vrije Universiteit Brussel ### Study Description The investigators will use 3D freehand ultrasound to investigate changes in muscle morphology of the paretic m. rectus femoris and m. gastrocnemius medialis during the first 3 months after stroke. Additionally, 2D ultrasound and surface EMG will be synchronized to examine muscle activation and morphological changes resulting from this activation. Clinical tests will be conducted on the same test occasions to objectify lower limb impairment and gait recovery. As such, the investigators will explore the relationship between the muscle specific changes and functional recovery. ### Conditions - Stroke ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Longitudinal prospective cohort study ### Outcomes Primary Outcomes - Functional Ambulation Categories (FAC)-score - Muscle volume - Cross-sectional area (CSA) - Physiological cross-sectional area (pCSA) - Muscle tickness - Fascicle length - Muscle length - Tendon length - Pennation angle - Echo Intensity - Dynamic muscle morphology - Change in cross-sectional area - Change in fascicle length - Average root mean square (RMS) - Peak root mean square (RMS) - Muscle strength - Spasticity - Lower limb motor impairment - Spatiotemporal gait parameters - Gait quality Secondary Outcomes - TWIST-score - Knee extension strength - Balance ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Efficacy of Preoperative Low-residue Diet on Postoperative Ileus Following Cesarean Section - NCT ID: NCT06320548 - Study ID: 0724/2018 - Status: COMPLETED - Start Date: 2018-10-01 - Completion Date: 2020-12-02 - Lead Sponsor: University of Roma La Sapienza ### Study Description The aim of the present study was to evaluate the efficacy of preoperative low-residue diet on postoperative ileus in women undergoing elective cesarean section. It is a surgeon-blind, randomized controlled trial enrolling pregnant women at ≥39 weeks of gestation undergoing elective cesarean section. Patients were preoperatively randomized to receive either low-residue diet (arm A) or free diet (arm B) starting from three days before surgery. The primary outcome was the postoperative ileus at 24 hours after surgery. The secondary outcomes were the postoperative pain (assessed through VAS scale), the quality of the surgical field (scored using a 5-point scale, from poor to excellent), postoperative complications, and the length of hospital stay. Perioperative data were collected and compared between groups. ### Conditions - Cesarean Section Complications ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Low-residue diet - Free diet ### Outcomes Primary Outcomes - Number of participants who have passage of flatus within the first 24 hours after caesarean section. Secondary Outcomes - Postoperative pain - Postoperative complications - Quality of the surgical field ### Location - Facility: Sapienza University of Rome, Rome, N/A, N/A, Italy @@
## A Phase 1 Study to Assess an Escalating Dose, Multi-prime Vaccination Schedule of R21/Matrix-M™ - NCT ID: NCT06320535 - Study ID: VAC096 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2027-04 - Lead Sponsor: University of Oxford ### Study Description This is a phase I clinical study that aims to assess the safety and immunogenicity of a novel, escalating dose regimen of R21/Matrix-M™ in healthy, malaria-naïve adults. ### Conditions - Malaria,Falciparum ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - R21/Matrix M™ (Group 1) - R21/Matrix M™ (Group 2) - R21/Matrix M™ (Group 3) - Fine needle aspiration (FNA) ### Outcomes Primary Outcomes - To compare the safety of R21/Matrix-M™ administered in an escalating dose, multi prime vaccination schedule with a standard prime-boost regimen in healthy UK adults - To compare the safety of R21/Matrix-M™ administered in an escalating dose, multi prime vaccination schedule with a standard prime-boost regimen in healthy UK adults - To compare the humoral immunogenicity of R21/Matrix-M™ administered in an escalating dose, multi-prime vaccination schedule with a standard prime-boost regimen in healthy UK adults Secondary Outcomes ### Location - Facility: Centre for Clinical Vaccinology and Tropical Meducine, Churchill Hospital, University of Oxford, Oxford, Oxfordshire, OX3 7LE, United Kingdom @@
## Exogenous Ketosis in a Fed and a Fasted State - NCT ID: NCT06320522 - Study ID: R82053/RE002 - Status: RECRUITING - Start Date: 2023-02-15 - Completion Date: 2024-05 - Lead Sponsor: University of Oxford ### Study Description The kinetics of circulating βHB following ingestion of the ketone monoester are dependent on several variables that determine the balance between appearance into, and disappearance from, the bloodstream. These dynamics have been well characterised in fasted humans but in the real world the ketone monoester is likely to be ingested in a fed state, pertinently within athletic spheres consumption would proceed a substantial high-carbohydrate meal. Within this, it is unclear how metabolism under exogenous ketosis might be affected in a fed versus fasted state.This four-arm crossover study looks to characterise the relationship between feeding status, βHB pharmacokinetics, and resting metabolism.As exogenous ketosis is known to reduce circulating glucose levels, this study will also explored if hepatic metabolism - for example, de novo lipogenesis - might consequently be altered, with implications for metabolic disease states such as Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) and type II diabetes.Participants will be asked to consume either the ketone monoester drink or a placebo drink when fasted and when having previously consumed a meal. ### Conditions - Ketosis - Exogenous Ketosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Ketone Monoester - Placebo ### Outcomes Primary Outcomes - Plasma β-hydroxybutyrate (βHB) kinetics - Plasma glucose kinetics - Postprandial de novo lipogenesis (DNL) Secondary Outcomes - Plasma biochemistry - Very low-density lipoprotein-triglyceride (VLDL-TG) fatty acid composition - Breath acetone - Urine volume - Urine composition - Indirect calorimetry - Subjective measures of appetite - Subjective measures of gastrointestinal distress ### Location - Facility: Oxford Centre for Diabetes, Endocrinology, and Metabolism (OCDEM), Oxford, Oxfordshire, OX3 7LE, United Kingdom @@
## Interest of Urinary Oxygen Partial Pressure (PO2u) in Predicting the Onset or Recovery of Acute Renal Failure During Shock States - OXYpi Study - NCT ID: NCT06320509 - Study ID: 49RC23_0417 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-07 - Lead Sponsor: University Hospital, Angers ### Study Description Shock state is defined as an acute, life-threatening, circulatory failure with impaired tissue oxygenation (or tissue hypoxia). The cause of the shock state can be septic, anaphylactic, hypovolemic or cardiogenic. Its management is based on etiological treatment and replacement of organ failures. Acute kidney injury (AKI) may be lead by renal hypoxia. Acute kidney injury is frequent in patients admitted to intensive care unit (ICU) and associated with an increased mortality. Serum creatinine is the reference biological marker in the diagnosis of Acute kidney injury. However, its use is limited by a delayed increase in plasma creatinine level in relation to the causal renal agression, at a time when renal tissue damage may already be established. Thus, the identification of a biological marker making it possible to estimate renal hypoxia continuously during a shock could allow us to identify early a situation at risk of evolving into Acute kidney injury.The renal medulla is vulnerable to tissue hypoxia with a risk of acute tubular necrosis. As in situ measurement of mPO2 is not possible in current practice in humans, several studies have shown a positive correlation between variations in mPO2/uPO2 and occurence of Acute kidney injury. In humans, studies have shown a significant association between the reduction in uPO2 in cardiac surgeries and the occurrence of postoperative Acute kidney injury. The aim of the study is to describe the association between uPO2 values and the onset of Acute kidney injury and/or the ocurrence of early recovery of renal function after Acute kidney injury. Any patient in shock (group A) or without shock and requiring urinary catheterization as part of treatment (group B) admitted to the Medical-Intensive Care Unit of Angers University Hospital is eligible for inclusion. After inclusion, a continuous uPO2 measuring probe is introduced with the placement of the urinary probe. uPO2 is collected continuously for the first 5 days of admission or until discharge from intensive care or removal of the urinary catheter. uPO2 is also measured by a gasometry on a urine sample on a multi-daily basis. Serum creatinine is collected every 12 hours (twice a day) and diuresis every two hours for 5 days. ### Conditions - Shock Circulatory ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SCREENING ### Interventions - Continuous measurement of uPO2 (both groups) ### Outcomes Primary Outcomes - A - For patients without acute kidney injury at inclusion, the occurence of acute kidney injury and its severity according to the KDIGO criteria - B - For patients with acute kidney injury occurring during the first 3 days following inclusion, early recovery is defined by the return to pre-shock renal function 48 hours from the start of acute kidney injury Secondary Outcomes - In patients in group A, assess the association between uPO2 variation and acute kidney injury, defined by KDIGO criteria, in different subgroups (septic shock, sepsis without norepinephrine, non-septic shock). - In patients in group A with newly occured acute kidney injury, assess the association between uPO2 variation and recovery of acute kidney injury in different subgroups (septic shock, sepsis without norepinephrine, non-septic shock). - In patients in group A, assess the evolution of uPO2 during the first 5 days in patients with and without sepsis - Describe the variation of uPO2 according to evolution of Mean Arterial Pressure and cardiac output in the subgroup of patients who received fluid expansion - Describe the variation of uPO2 according to evolution of Mean Arterial Pressure and cardiac output in the subgroup of patients who received blood transfusion - In patients with need of increasing Mean Arterial Pressure by increase of norepinephrine doses, describe the evolution of uPO2 according to Mean Arterial Pressure evolution. - In patients with need of introduction or increase of dobutamine, describe the evolution of uPO2 according to cardiac output or Mean Arterial Pressure evolution. - Evaluation the correlation between uPO2 assessed by Oxylite Pro® device and urinary gasometry. - In patients without shock, describe the evolution of uPO2 during the first 5 days. ### Location - Facility: University Hospital of Angers, Angers, N/A, 49933, France @@
## Evaluation of the Effect of a Physical Activity Recovery Stay - NCT ID: NCT06320496 - Study ID: IRR-FLAVIGNY-2021-2 - Status: RECRUITING - Start Date: 2022-03-22 - Completion Date: 2025-03 - Lead Sponsor: Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est ### Study Description A WHO study in 2020 revealed that 81% of adolescents (aged 11-17) do not respect the recommendation of one hour of moderate physical activity per day. In the context of disability, many factors impose limits on physical activity. While the pathology itself induces limitations and restrictions (prolonged sitting time, assisted movement, etc.), organizational constraints also apply to both children and parents, who have to divide their time between work, school and therapeutic care, which is sometimes numerous and varied over the course of a single week. These limitations generate stress and fatigue, and prolonged sedentary periods lead children with chronic illnesses, rare diseases or disabilities into a process of physical deconditioning. The accumulation of sedentary time is detrimental to cardiovascular and metabolic health.To combat this deconditioning, the 2008 National Physical Activity and Sport Plan (PNAPS) sets out the main guidelines for treatment and implementation. The plan explains that "for patients with chronic illnesses, rare diseases or disabilities, the aim is to encourage care and guidance towards Adapted Physical Activity (APA). The attending physician will be able to identify local therapeutic education programs, rehabilitation services and "sport-santé" offers, to improve access for these patients to supervised local programs". In addition, the plan suggests "developing APA programs in healthcare establishments to enable people with chronic illnesses, rare diseases or disabilities to access health education incorporating practical sessions".In line with this plan, an exercise reconditioning program has been set up at our facility. This three-month stay includes children with a variety of pathologies, but with a common feature of physical deconditioning. ### Conditions - Children With Cerebral Palsy - Children With Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Diagnoform test score Secondary Outcomes - KidScreen52 quality-of-life scale score. - Impedance measurement - Exercise test on ergometer - Anamnesis - 6-minute walk test - Energy expenditure index - Gluteal bridge - Shirado test - Sorensen test - Timed Up and Down Stairs (TUDS) test - Floor survey test - Mini Bestest : Each of the 14 tests is graded from 0 to 2. "0" represents the lowest functional level and "2" the highest functional level. Maximal score : 28. - The Canadian Occupational Performance Measure - A motivational questionnaire ### Location - Facility: Institut Régional de Médecine Physique et de Réadaptation, Nancy, N/A, 54000, France @@
## Evaluation of the Effectiveness and Safety of Vibro-acoustic Pulmonary Therapy (VAPT) in Complex Therapy for Acute Respiratory Failure of Mixed Type I-II Stages in Comparison With Percussion Massage in Cardiac Surgical Patients in the Early Postoperative Period - NCT ID: NCT06320483 - Study ID: BT-01-23 - Status: RECRUITING - Start Date: 2023-09-20 - Completion Date: 2024-09 - Lead Sponsor: Bark Technology LLP ### Study Description The goal of this observational study is to evaluate the effectiveness and safety of vibro-acoustic pulmonary therapy (VAPT) in complex therapy for the acute respiratory failure of mixed type I-II stages in comparison with percussion massage in cardiac surgical patients in the early postoperative period. ### Conditions - Cardiac Surgical Patients (CABG,Mammary Coronary Bypass Surgery,Plastic and Replacement of Valves, Atrial Septal Defect,Ventricular Septal Defect) ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Vibroacoustic device BARK VibroLUNG ### Outcomes Primary Outcomes - Partial pressure of oxygen (PaO2) - Partial pressure of carbon dioxide (PaCO2) - Blood oxygen saturation level (SpO2) on pulse oximeter (peripheral capillary oxygenation) - Ratio of peripheral arterial oxygen saturation(SaO2) to the inspired fraction of oxygen FiO2 - Ratio of venous saturation (SvO2) to the inspired fraction of oxygen FiO2 - ROX Index - P/F index (ratio of arterial blood PO2 to oxygen fraction) Secondary Outcomes - pH of blood - BE (base excess) of blood - CBC indicators (hemoglobin) - CBC indicators (hematocrit) - CBC indicators (platelets) - Coagulogram indicators (prothrombin time) - Coagulogram indicators (prothrombin index) - Coagulogram indicators (international normalized ratio) - Coagulogram indicators (fibrinogen) - Coagulogram indicators (activated partial thromboplastin time) - Number of days spent in the high dependency unit (intensive care ward in the department) - Number of days in hospital - Number of days of O2 support - Proportion of patients with postoperative complications (pneumonia/atelectasis/pulmonary infiltration) ### Location - Facility: JSC "National Research Cardiac Surgery Center", Astana, N/A, N/A, Kazakhstan @@
## MIVetsCan: Can-Coach Trial (Phase 1) - NCT ID: NCT06320470 - Study ID: HUM00231159a - Status: COMPLETED - Start Date: 2023-08-07 - Completion Date: 2023-12-11 - Lead Sponsor: University of Michigan ### Study Description The goal of the MIVetsCan Can-Coach Trial is to pilot and modify a trial of four coaching sessions to help Veterans with chronic pain use their own cannabis products more effectively to manage pain and related symptoms. ### Conditions - Chronic Pain ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Educational Session ### Outcomes Primary Outcomes - Patient Global Impression of Change (PGIC) score Secondary Outcomes - Average satisfaction level of the cannabis coaching overall assessed from a single survey question on satisfaction. - Average helpfulness level of the cannabis coaching assessed from a single survey question on cannabis coaching. ### Location - Facility: The University of Michigan, Ann Arbor, Michigan, 48109, United States @@
## A Brief Case Management Intervention for People Involuntarily Admitted to a Psychiatric Hospital - NCT ID: NCT06320457 - Study ID: 2024-00095 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-21 - Completion Date: 2024-10-31 - Lead Sponsor: University of Lausanne Hospitals ### Study Description The goal of this clinical trial is to assess whether a brief case management intervention aimed at promoting personal recovery and reducing the negative effects of coercion among people involuntarily admitted to a psychiatric hospital would be well accepted by them, practically feasible and useful. The main questions it aims to answer are:* Is the case management intervention acceptable and feasible?* What are the preliminary effects of the case management intervention on patients' personal recovery and its sub-dimensions, as well as on their level of perceived coercion and their global satisfaction with hospital care?Participants will be asked to take part in:* the five sessions of the case management intervention;* two evaluation sessions (pre and post-intervention);* a final in-depth semi-structured interview (optional). ### Conditions - Psychiatric Disorder - Involuntary Psychiatric Hospitalization ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Brief case management intervention ### Outcomes Primary Outcomes - Eligibility rate - Participation rate - Drop-out rate - Intervention dosage - Missing data rates - Number of unexpected adverse events - Participants' acceptance and degree of satisfaction - Implementation barriers and facilitating factors Secondary Outcomes - Recovery Assessment Scale (RAS) - Empowerment Scale - Rosenberg Self-Esteem Scale (RSS) - The Paradox of Self-Stigma scale (PaSS-24) - Beck Hopelessness Scale (BHS) - WHOQOL-BREF - International Trauma Questionnaire (ITQ) - Coercion Ladder (CL) - Index of fairness and Index of effectiveness - Satisfaction with hospital care - Brief INSPIRE scale ### Location - Facility: Lausanne University Hospital, Lausanne, Canton Of Vaud, 1003, Switzerland @@
## Non-invasive Spinal, Cortical, and Sensorimotor Biomarkers in Motor Neurone Disease - NCT ID: NCT06320444 - Study ID: CRFSJ0297 - Status: RECRUITING - Start Date: 2023-06-15 - Completion Date: 2025-07-15 - Lead Sponsor: University of Dublin, Trinity College ### Study Description Substantial variability exists in the onset, and rate of degeneration across individuals with Motor Neurone Disease (MND) or Amyotrophic Lateral Sclerosis (ALS). This variability requires biomarkers that accurately classify and reliably track clinical subtypes as the disease progresses. Degeneration occurs in the brain and spinal cord, however, non-invasive diagnosis of spinal cord function remains highly challenging due to its unique alignment in spine. Disruption of complex spinal and cortical circuits that transmit and process neural signals for position sense and movement has not been adequately captured in the neurophysiological profiling of ALS patients. The overarching aim of this study is to reveal and quantify the extent of change in the sensorimotor integration and its potential contribution to network disruption in ALS. ### Conditions - Motor Neuron Disease, Amyotrophic Lateral Sclerosis - Motor Neuron Disease Progressive Spinal Muscle Atrophy - Primary Lateral Sclerosis - Multiple Sclerosis - Postpoliomyelitis Syndrome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - 232 Electrode Electrophysiology (EEG-ECG-EMG-EXG) ### Outcomes Primary Outcomes - Biomarker of sensorimotor integration - Determination of the feasibility of sensorimotor signatures as reliable biomarkers of ALS - Non-invasive recording of the SC functional neuro-electric activity Secondary Outcomes ### Location - Facility: Academic Unit of Neurology, Trinity College Dublin, The University of Dublin, Dublin, Leinster, Dublin 2, Ireland @@
## ACT-GLOBAL THROMBOLYSIS (ACT-WHEN-001) Domain Within the ACT-GLOBAL Adaptive Platform Trial-NCT06352632 - NCT ID: NCT06320431 - Study ID: ACT-WHEN-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2030-12-31 - Lead Sponsor: University of Calgary ### Study Description This domain has a prospective, randomized, controlled, open-label, parallel group with blinded endpoint assessment (PROBE) design. Up to 4,000 patients with presumed acute ischemic stroke (AIS) will be followed for 90 days (or until death, if prior to 90 days). The end of the trial is defined as the date that all participants have completed their Day 90 assessment.This domain aim is to efficiently, reliably, and simultaneously, determine the comparative effectiveness of intravenous thrombolysis (IVT) using standard-dose intravenous tenecteplase (0.25 mg/kg body weight), vs. low-dose intravenous tenecteplase (0.18 mg/kg body weight) in all patients who present to hospital with acute ischemic stroke and are considered for intravenous thrombolysis. In addition, this domain also seeks to study standard-dose intravenous tenecteplase (0.25 mg/kg body weight), vs. low-dose intravenous tenecteplase (0.18 mg/kg body weight) vs. no TNK upfront with rescue IA TNK if necessary (in those eligible for emergency EVT) and no TNK upfront in those who have taken DOACs during the preceding 24 hours. This domain therefore seeks to generate more robust randomized evidence to guide clinicians in their decisions over the balance of risks and treatment with intravenous thrombolysis with tenecteplase wherever such evidence is currently insufficient.This domain will currently evaluate four research questions in relation to the use of IVT with tenecteplase:1. In patients with recent (24 hours) intake of a standard-dose direct oral anticoagulant (DOAC), how should IVT be used? - Use standard-dose (0.25 mg/kg body weight) or low-dose tenecteplase (0.18 mg/kg) or not at all.2. In patients planned to be treated with endovascular thrombectomy, how should tenecteplase be used? -Treat with IV tenecteplase (standard- or low-dose) or not at all.3. In any patient receiving IVT, what is the optimal dose of tenecteplase? - use standard-dose (0.25 mg/kg body weight) or low-dose tenecteplase (0.18 mg/kg).4. To what extent is the treatment effect of standard- vs. low-dose tenecteplase modified by key patient characteristics, such as diabetes, prior antiplatelet therapy, renal failure, or frailty, old age or having a heavy burden of cerebral small vessel disease on brain imaging. ### Conditions - Acute Ischemic Stroke AIS - Stroke Acute - Stroke, Acute, Stroke Ischemic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Tenecteplase ### Outcomes Primary Outcomes - A reduction of functional dependence analyzed across the whole distribution of outcomes assessed on the modified Rankin Scale (mRS), Secondary Outcomes - 90-day mortality - Proportion of participants with a Modified Rankin Scale (mRS) of 0-1 at Day 90. - Proportion of participants with a Modified Rankin Scale (mRS) of 0-2 at Day 90. - Health-related quality of life, as measured by the EQ-5D-5L at Day 90. - The frequencies of Serious Adverse Events (SAEs) from enrollment up to Day 4 - Symptomatic intracranial hemorrhage - Large parenchymal hemorrhage (PH-2) - Ordinal shift of 7 levels of mRS at 90 days - Proportion of participants achieving first pass (eTICI 2c or higher) reperfusion (when treated with EVT). - Proportion of participants achieving successful recanalization (revised arterial occlusive lesion [rAOL] score of 2b-3) at first angiographic acquisition (when treated with EVT). - Ambulatory status at discharge - Place of residence at 90 days - Imaging assessment (e.g., infarct size and edema volume) - Summative total length of hospital stay in the first 90-days after stroke onset ### Location - Facility: The George Institute for Global Health, Sydney, Barangaroo, NSW 2000, Australia @@
## The Epigenetic Regulatory Role of P-element Induced Wimpy Testis (Piwi) Interacting RNA-823 (piR-823) in Ovarian Cancer Progression - NCT ID: NCT06320418 - Study ID: RHDIRB2020110301REC#196 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-06-15 - Completion Date: 2024-06 - Lead Sponsor: Ain Shams University ### Study Description Ovarian cancer (OC) has one of the highest mortality rates for female malignant tumors, attributed to advanced cancer stages upon diagnosis as well as a high recurrence rate. Piwi-interacting RNA-823 (piR-823) is a single-stranded non-protein coding RNA (ncRNA) star molecule in epigenetics research. Extensive cellular regulatory functions and aberrant expression of piR-823 have been implicated in carcinogenesis. Therefore, the findings of piwi-ncRNA dysregulated-expression in OC Egyptian female patients' cohort could be employed as a potential novel mechanism for OC precision, a step toward ncRNA-precision ### Conditions - Ovarian Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Association of piR-823 expression with ovarian cancer progression Secondary Outcomes ### Location - Facility: Faculty of Pharmacy, Ain Shams University, Advanced Biochemistry Research Lab, Cairo, N/A, 11566, Egypt @@
## Axatilimab in Combination With Retifanlimab and Paclitaxel for the Treatment of Patients With Advanced or Metastatic Solid Tumors - NCT ID: NCT06320405 - Study ID: STUDY00025940 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2029-04-01 - Lead Sponsor: OHSU Knight Cancer Institute ### Study Description This phase I/II trial tests the safety, side effects, and effectiveness of axatilimab in combination with retifanlimab and paclitaxel for the treatment of patients with a solid tumor that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Axatilimab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as retifanlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Giving axatilimab in combination with retifanlimab and paclitaxel may be safe, tolerable and/or effective in treating patients with advanced or metastatic solid tumors. ### Conditions - Advanced Malignant Solid Neoplasm - Metastatic Malignant Solid Neoplasm - Recurrent Malignant Solid Neoplasm - Refractory Malignant Solid Neoplasm ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Axatilimab - Biopsy - Biospecimen Collection - Computed Tomography - Magnetic Resonance Imaging - Paclitaxel - Positron Emission Tomography - Retifanlimab ### Outcomes Primary Outcomes - Incidence of dose limiting toxicities (phase Ib) - Recommended phase 2 dose of the study drug combination (phase Ib) - Clinical benefit rate (phase Ib/II) Secondary Outcomes - Incidence of ≥ grade 3 toxicities possibly or definitely related to study drugs - Changes in immune cell composition and functionality - Change in immune cell population ### Location - Facility: OHSU Knight Cancer Institute, Portland, Oregon, 97239, United States @@
## Implication of CCR4-NOT Complex Subunit 7 Expression in Natural Killer Cell Resistance in Metastatic Breast Cancer - NCT ID: NCT06320392 - Study ID: RHDIRB2020110301 REC#48 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2021-07-01 - Completion Date: 2024-06-01 - Lead Sponsor: Ain Shams University ### Study Description Being a mechanistic study, this work aims to figure out "the role of the cytoplasmic mRNA deadenylase CNOT7 expressed protein on NK cell resistance in metastatic BC". In other words, to explore, whether, "CNOT7 contributes to metastasis in Egyptian female metastatic BC patient's cohort, through NK cell resistance, or not." ### Conditions - Metastatic Breast Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Cytoplasmic mRNA deadenylase CNOT7 protein expression level in metastatic/advanced localized and non-metastatic BC sera using ELISA. - CNOT7 tissue expression level in BC tissue samples categorized as metastatic vs non-metastatic tumor alongside with adjacent non-tumor tissue margin using immunohistochemistry. - LAIR-1 protein expression level in BC patients peripheral blood samples using ELISA. Secondary Outcomes ### Location - Facility: Faculty of Pharmacy, Ain Shams University, Advanced Biochemistry Research Lab, Cairo, N/A, 11566, Egypt @@
## Zypan Functional Dyspepsia - NCT ID: NCT06320379 - Study ID: RB071522 - Status: RECRUITING - Start Date: 2023-03-15 - Completion Date: 2024-12-31 - Lead Sponsor: National University of Natural Medicine ### Study Description The purpose of this study is to determine the effects of a readily available dietary supplement on quality of life and digestion in adults with functional dyspepsia. ### Conditions - Dyspepsia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Zypan - Placebo Comparator ### Outcomes Primary Outcomes - Protein Assimilation - Protein Assimilation Secondary Outcomes - Mineral concentrations in blood - Mineral concentrations in blood - Fat-soluble vitamin concentration in blood - Fat-soluble vitamins - Leeds Dyspepsia Questionnaire - Leeds Dyspepsia Questionnaire - Patient Reported Outcomes Measurement Information System (PROMIS)-29 Physical Function Subscale - Patient Reported Outcomes Measurement Information System (PROMIS)-29 Physical Function Subscale ### Location - Facility: Helfgott Research Institute, Portland, Oregon, 97201, United States @@
## Testing an Accelerated TMS Protocol for Methamphetamine Use Disorder - NCT ID: NCT06320366 - Study ID: 23-1044 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2028-05-31 - Lead Sponsor: University of Colorado, Denver ### Study Description The investigators will evaluate the effects of an accelerated Transcranial Magnetic Stimulation (TMS) protocol of the left dorsolateral prefrontal cortex (DLPFC) for moderate to severe methamphetamine use disorder. This is a randomized parallel group design to assess feasibility and safety, evaluate efficacy (use, craving) and identify magnetic resonance imaging (resting state and cue craving) associated with group/outcomes. ### Conditions - Methamphetamine Use Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Sham TMS - Active TMS ### Outcomes Primary Outcomes - Tolerability - Study emergent adverse events Secondary Outcomes - Weeks of continuous abstinence - Days of methamphetamine use - Methamphetamine craving - Methamphetamine craving on visual analog scale - MRI cue craving - MRI resting state ### Location - Facility: University of Colorado Anschutz Medical Campus, Aurora, Colorado, 80045, United States @@
## Study сomparing the Efficacy and Safety of RPH-075 and Keytruda® in Patients With Unresectable or Metastatic Skin Melanoma - NCT ID: NCT06320353 - Study ID: CL01860211 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-09-27 - Completion Date: 2026-01 - Lead Sponsor: R-Pharm ### Study Description The goal of this double-blind, randomized study is to establish the equivalence of the efficacy, safety and immunogenicity of the drugs RPH-075 (international nonproprietary name (INN) is pembrolizumab) and Keytruda® (INN is pembrolizumab) when used in patients with unresectable or metastatic skin melanoma first or second line therapy in a monotherapy regimen.The main task is to evaluate and compare the effectiveness of RPH-075 and Keytruda® drugs when used in patients with unresectable or metastatic skin melanoma as a 1 or 2 line therapy in monotherapy regimen, according to the objective response rate (ORR) parameter for up to 24 weeks of therapy. ### Conditions - Skin Melanoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - RPH-075 - Keytruda® ### Outcomes Primary Outcomes - The objective response rate (ORR) Secondary Outcomes - The disease control rate (DCR) - The time to response (TTR) - The Duration of response (DOR) - The Progression-free survival (PFS) ### Location - Facility: Federal State Budgetary Institution "National Medical Research Center of Radiology" of the Ministry of Health of the Russian Federation, Obninsk, Kaluga Region, 249036, Russian Federation @@
## Effectiveness of NMES on Neck Pain - NCT ID: NCT06320340 - Study ID: 07032024 - Status: COMPLETED - Start Date: 2021-03-15 - Completion Date: 2021-09-15 - Lead Sponsor: Istanbul University - Cerrahpasa (IUC) ### Study Description The aim of this randomized-controlled study was to determine the effectiveness of neuromuscular electrical stimulation (NMES) applied simultaneously to exercise on pain, static endurance of cervical deep flexor muscles, fear of movement and disability in chronic neck pain. The participants were randomly assigned to one group which in only five clinical pilates exercises were performed (Group I) or the other group which NMES was applied on lower trapezius and serratus anterior muscles while the same exercises were performing (Group II). ### Conditions - Chronic Neck Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Exercise - Electrotherapy ### Outcomes Primary Outcomes - Neck disability - Neck disability Secondary Outcomes - Pain intensity - Pain intensity - Range of Motion - Range of Motion - Static endurance of cervical deep flexor muscles - Static endurance of cervical deep flexor muscles - Fear of the movement - Fear of the movement ### Location - Facility: İstanbul Aydın University, İstanbul, N/A, N/A, Turkey @@
## Topical CBD's Effects on Soreness and Performance - NCT ID: NCT06320327 - Study ID: 80177 - Status: COMPLETED - Start Date: 2022-08-23 - Completion Date: 2023-04-30 - Lead Sponsor: Joseph Pastina ### Study Description Exercise-induced muscle damage (EIMD) results from unaccustomed exercise and can lead to delayed onset muscle soreness (DOMS). Impairments associated with EIMD and DOMS can result in moderate-to-severe discomfort and hindered performance. Recently, a compound derived from the cannabis plant, cannabidiol (CBD), has been used as a recovery tool for EIMD and DOMS. Despite the rising popularity of CBD products, their effectiveness in mitigating EIMD and DOMS is unknown. Specifically, to the investigators' knowledge, no clinical trials have been completed to assess the effects of topical CBD cream application on soreness, recovery and performance.Therefore, the purpose of the present study was to investigate the effects of CBD cream on DOMS and performance after an intensive lower-body exercise protocol. Specifically, the study's aims were:Aim 1: To assess the effect of topical CBD cream administration on muscle soreness following fatiguing exercise.Hypothesis 1: CBD cream would decrease perceived muscle soreness when compared to a placebo or control (no cream) group.Aim 2: To assess the effect of topical CBD cream administration on muscular performance following fatiguing exercise.Hypothesis 2: Recovery of muscular power would be quicker when CBD cream is applied, compared to a placebo or control (no cream) group.Aim 3: To assess if topical CBD cream has a localized (if any) or systemic effect on muscle soreness.Hypothesis 3: Improvements in muscle soreness would only be observed in localized muscles around where the CBD cream was applied. ### Conditions - Muscle Soreness ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Cannabidiol cream - Placebo cream ### Outcomes Primary Outcomes - Vertical Jump Test Secondary Outcomes - Peak Isokinetic Torque Test - Pressure-Pain Threshold Test ### Location - Facility: Seaton Center Building, Lexington, Kentucky, 40502, United States @@
## Efficacy and Tolerability of Tested Formula After 3 Months in Treatment of Facial Hyperpigmentation of 3 Origins - NCT ID: NCT06320314 - Study ID: LRP23021-E serum - Status: RECRUITING - Start Date: 2024-02-19 - Completion Date: 2024-05-22 - Lead Sponsor: Cosmetique Active International ### Study Description The objective of this study is to evaluate the efficacy, cosmetic acceptability and improvement of the stigmatization of the tested product (2039125 03) used bis in die (BID) for 3 months in adult patients suffering from mild to moderate melasma, or mild to moderate acne induced post-inflammatory hyperpigmentation, or solar lentigo. ### Conditions - Hyperpigmentation ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - tested product (2039125 03) ### Outcomes Primary Outcomes - IGA score for patients with melasma or acne induced post-inflammatory hyperpigmentation (PIHP) - modified Melasma Area and Severity Index (mMASI) for patients with melasma - Post-Acne Hyperpigmentation Index (PAHPI) Secondary Outcomes - colorimetry measurements ### Location - Facility: PhDTrials Center, Lisboa, N/A, N/A, Portugal @@
## Adebrelimab and a TKI in Combination With GEMOX in First-line Treatment of Advanced Biliary Tract Cancers (BTC) - NCT ID: NCT06320301 - Study ID: SYSKY-2024-027-01 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-06-01 - Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ### Study Description Patients with advanced biliary tract malignant tumors who had not received systematic treatment before and could not be cured were selected as the subjects of the study. The primary endpoint of the study was investigator-assessed 6-month progression-free survival (6-month PFS%) based on the RECIST v1.1 criteria, and 43 subjects were planned to be enrolled. Patients eligible for enrollment will receive Adebrelimab and a tyrosine kinase inhibitor (TKI) in combination with gemcitabine and oxaliplatin (GEMOX). ### Conditions - Biliary Tract Cancer - Gemox Chemotherapy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Adebrelimab + GEMOX + TKI ### Outcomes Primary Outcomes - the effectiveness of first-line treatment with Adebrelimab and a tyrosine kinase inhibitor (TKI) in combination with gemcitabine and oxaliplatin (GEMOX) in patients with advanced BTC Secondary Outcomes - To assess the progression-free survival (PFS) - To evaluate the time to progression (TTP) - To evaluate the disease control rate (DCR), - To evaluate the objective response rate (ORR) - To evaluate the duration of response (DoR) - To evaluate the overall survival (OS). ### Location - Facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guanzhou, Guangdong, 512000, China @@
## Analysis of Trunk and Center of Mass Control Development During Gait in Children With Cerebral Palsy (VERTEBRAL) - NCT ID: NCT06320288 - Study ID: IRR-FLAVIGNY-2023-1 - Status: RECRUITING - Start Date: 2023-09-20 - Completion Date: 2028-09 - Lead Sponsor: Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est ### Study Description During the acquisition of posturokinetic abilities such as walking, postural control of the trunk is of paramount importance. Indeed, its development is strongly linked to the overall motor function of children. In cerebral palsy (CP), a term that refers to a set of motor disorders following a perinatal lesion, deficits in axial control are present from early childhood. These deficits are strongly correlated with the functional deficits observed in this population. In particular, during walking, deviations of the trunk (amplitudes, accelerations) are observed in the three planes of space. While recent literature increasingly questions the impact of trunk control deficit on the walking of children with CP, elements are still missing for a holistic understanding of the interaction between locomotor and postural disorders in children with CP. In particular, no study has focused on the deviations of trunk control and the center of mass (which is a global indicator of balance strategies) during the development and maturation of walking in children with CP. Therefore, the primary objective of this cross-sectional observational study will be to characterize the development of trunk control and center of mass during walking in children with CP. ### Conditions - Children With Cerebral Palsy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Trunk and center-of-mass accelerations and acceleration variability Secondary Outcomes - Gait Variability Index - Trunk Control Measurement Scale score (TCMS) - Early Clinical Assessment of Balance score ### Location - Facility: Institut Régional de Médecine Physique et de Réadaptation, Nancy, N/A, 54000, France @@
## Fathers' Breastfeeding Self-efficiency - NCT ID: NCT06320275 - Study ID: self-efficiency - Status: COMPLETED - Start Date: 2023-02-01 - Completion Date: 2023-07-30 - Lead Sponsor: Cukurova University ### Study Description The purpose of this study was planned to examine the effect of the education given through digital storytelling method on fathers' breastfeeding self-efficacy perception. The research is in a quasi-experimental design with no pretest-posttest control group. ### Conditions - FATHER - BREASTFEEDING ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Storytelling Intervention ### Outcomes Primary Outcomes - Breastfeeding Self-Efficacy Scale for Fathers Short Form Secondary Outcomes ### Location - Facility: Cukurova University, Adana, Balcalı, 01 330, Turkey @@
## Evaluation of the Effect of Wet Cupping (Hijama) on Primary Fibromyalgia - NCT ID: NCT06320262 - Study ID: NRC/TDF/01/F - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-04 - Lead Sponsor: Rasmia Elgohary ### Study Description Fibromyalgia has become one of the most prevalent chronic pain conditions that impair quality of life. Wet cupping has gained increasing popularity in treating painful conditions.This study aims to investigate the effectiveness of wet cupping therapy combined with home-based exercise compared to home-based exercise alone in improving patients diagnosed with primary fibromyalgia syndrome. ### Conditions - Treatment ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Wet cupping therapy (WCT) ### Outcomes Primary Outcomes - Change from baseline brain MRS Secondary Outcomes - Change from baseline Visual Analog Scale (VAS) - Change from baseline in the individual components of the Fibromyalgia Impact Questionnaire Revised (FIQR) - Change from the baseline sleep disturbance using the Jenkins sleep score (JSS) - Change from baseline Fatigue- VAS. - Change from baseline of Hospital Anxiety and Depression Scale (HADS) - Change from baseline of the Montreal Cognitive Assessment (MoCA) - Change from baseline of the Widespread pain index (WPI) - Change from baseline hemoglobin - patient compliance on exercise as instructed ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Rotation-traction Manipulation of Different Treatment Frequency in Cervical Radiculopathy - NCT ID: NCT06320249 - Study ID: WJYY-XZKT-2023-05 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-06-30 - Lead Sponsor: Wangjing Hospital, China Academy of Chinese Medical Sciences ### Study Description The evidence for different frequencies of rotation-traction manipulation treatment in cervical radiculopathy is insufficient. This study determined whether 3 sessions per week of rotation-traction manipulation treatment are superior to 1 session per week for symptomatic outcomes in cervical radiculopathy based on a multicenter randomized controlled trial. ### Conditions - Cervical Radiculopathy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - High-frequency rotation-traction manipulation - Low-frequency rotation-traction manipulation - Cervical traction ### Outcomes Primary Outcomes - The Visual Analog Scale for Pain Secondary Outcomes - The Visual Analog Scale for Pain - The Visual Analog Scale for Pain - The Visual Analog Scale for Pain - The Visual Analog Scale for Pain - The Visual Analog Scale for Pain - The Visual Analog Scale for Numbness - The Visual Analog Scale for Numbness - The Visual Analog Scale for Numbness - The Visual Analog Scale for Numbness - The Visual Analog Scale for Numbness - The Visual Analog Scale for Numbness - The Neck Disability Index - The Neck Disability Index - The Neck Disability Index - The Neck Disability Index - The Neck Disability Index - The Neck Disability Index - The Short Form 12 - The Short Form 12 - The Short Form 12 - The Short Form 12 - The Short Form 12 - The Short Form 12 - The total cost - The recurrence rate - Expectation of Treatment and Credibility Scale - Expectation of Treatment and Credibility Scale - Adverse reactions ### Location - Facility: Wangjing Hospital, China Academy of Chinese Medical Sciences, Beijing, Beijing, 100102, China @@
## Emergency Medicine Pulmonary Embolism Testing Multicentre Study - NCT ID: NCT06320236 - Study ID: 4603 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2027-09-30 - Lead Sponsor: Dr. Kerstin de Wit ### Study Description It is important to diagnose pulmonary embolism in a timely manner to prevent death and long-term disability. More than half a million people (4-5% of emergency department patients) are tested for pulmonary embolism, although positive results are low. Imaging for PE testing exposes patients to radiation, is expensive, adds time to the emergency visit, and can lead to a false positive diagnoses. Existing protocols aimed at reducing unnecessary pulmonary embolism imaging are complex and seldom used by emergency physicians. Too many patients undergo unnecessary pulmonary embolism imaging.We have created a new tool (called Adjust-Unlikely) which could safely reduce pulmonary embolism imaging in Canada. Our research group composed of researchers, emergency physicians, and patients developed the Adjust-Unlikely clinical decision rule: a rule which has been customized for emergency physicians and emergency patients. Adjust-Unlikely is highly sensitive at the bedside, meaning there are very few false negative results.Our study aim is to prospectively validate Adjust-Unlikely pulmonary embolism testing in emergency patients with suspected pulmonary embolism. ### Conditions - Pulmonary Embolism - D-dimer - Diagnosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Adjust-Unlikely ### Outcomes Primary Outcomes - Venous thrombosis Secondary Outcomes - Venous thrombosis - Index presentation Adjust-Unlikely testing results ### Location - Facility: Kingston Health Sciences Centre, Kingston, Ontario, K7L 2V7, Canada @@
## PROMISE PET Registry on PSMA-PET and Outcome in Prostate Cancer - NCT ID: NCT06320223 - Study ID: PROMISE PET Registry - Status: RECRUITING - Start Date: 2024-03-05 - Completion Date: 2035-03-05 - Lead Sponsor: University Hospital, Essen ### Study Description Background:PROMISE criteria have been defined for standardized reporting of Prostate-Specific Membrane Antigen (PSMA) PET whole-body stage of prostate cancer. PSMA PET disease extent by PROMISE has been associated with oncologic outcome.Need:Improved prognostication across various stages of prostate cancer is needed for management guidance and study design.Aim:1. To assess the prognostic value of PSMA PET2. To compare the prognostic value of PSMA PET with clinical prognostic scores in patients with prostate cancer at various disease stagesInclusion:* Adult patients with* biopsy/histo proven prostate cancer who* underwent PSMA PET (any type)* for staging or re-staging at any stage and who* have at least 3-year overall survival follow-up data available will be included consecutively.Exclusion:* Patients with neuroendocrine prostate cancer* Patients with metastasized or disseminated malignancy other than prostate cancer ### Conditions - Prostate Cancer - PET/CT - Survivorship - PSMA ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Overall survival Secondary Outcomes - Metastasis-free survival ### Location - Facility: University Hospital Essen, Essen, N/A, 45147, Germany @@
## Chicago Asthma School-Directed Child-Centered Assessment and Dissemination of Evidence - NCT ID: NCT06320210 - Study ID: IRB19-1308 - Status: RECRUITING - Start Date: 2023-08-31 - Completion Date: 2025-12-30 - Lead Sponsor: University of Chicago ### Study Description Research has shown that adherence to evidence-based asthma guidelines leads to improved outcomes, yet critical gaps remain in the implementation of these guidelines, particularly among minority and low-income youth. Schools represent a crucial point of intervention, as demonstrated by school-based asthma programs that have addressed individual components of the guidelines with promising results. This project aims to develop, implement, and evaluate a pragmatic, multi-component asthma program that builds upon existing targeted interventions to fully implement the asthma guidelines and integrate them in school practices to foster sustainability. The investigator seeks to understand whether this type of program will improve asthma outcomes at the child and school level. ### Conditions - Asthma in Children ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Multicomponent program ### Outcomes Primary Outcomes - Asthma control Secondary Outcomes - Missed work days in parents - Asthma knowledge - parents - Asthma knowledge - child - Asthma quality of life - child - Caregiver quality of life - Asthma impact - parent - Missed school days - Healthcare utilization - Asthma impact - child ### Location - Facility: University of Chicago Charter Schools, Chicago, Illinois, 60640, United States @@
## In Situ Simulation Training in Lifeguard Organisations - NCT ID: NCT06320197 - Study ID: DROWN_INSITU - Status: RECRUITING - Start Date: 2018-01-01 - Completion Date: 2024-12-31 - Lead Sponsor: Prehospital Center, Region Zealand ### Study Description This retrospective study will analyse a dataset consisting of 919 in situ simulation assessments collected between 2018 and 2023 in a Danish nationwide surf lifeguard organisation. The primary objective is to estimate the pass/fail ratio of in situ simulation assessments. The secondary objective is to analyse risk factors associated with a failed assessment. These results may guide future efforts to improve the Danish surf lifeguard training program. ### Conditions - Drowning - Drowning, Near - Drowning and Nonfatal Submersion - Drowning/Submersion - Drowning and Submersion While in Natural Water ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - In situ simulation assessment ### Outcomes Primary Outcomes - Pass/fail ratio of in situ simulation assessments Secondary Outcomes - Risk factors associated with a failed assessment ### Location - Facility: Prehospital Center, Næstved, Region Zealand, 4700, Denmark @@
## AI for Lung Cancer Risk Definition in Computed Tomography Screening Programs - NCT ID: NCT06320184 - Study ID: INT 0083/23 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-04-30 - Completion Date: 2026-04-30 - Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano ### Study Description Low-dose computed tomography (LDCT) lung cancer (LC) screening can reduce mortality among heavy smokers, but there is a critical need to better identify people at higher risk and to reduce harms related to management of benign nodules. The most promising strategy is to combine novel tools to optimize clinical decisions and increase the benefit of screening.In this respect, the investigators already demonstrated that the combination of baseline LDCT features with a minimal invasive microRNA blood test was able to more precisely estimate the individual risk of developing LC. The investigators posit that additional immune-related and radiologic features can be integrated with the help of artificial intelligence (AI) to further implement LDCT screening strategies. The project will answer whether the combination of (bio)markers of different origin can predict LC development at baseline and over time, indicate which screen-detected lung nodules are likely to be malignant and ultimately reduce LC and all cause mortality. ### Conditions - Lung Cancer - Blood Biomarkers ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Artificial Intelligence risk model ### Outcomes Primary Outcomes - Aim 1 Secondary Outcomes - Aim 2 - Aim 3 ### Location - Facility: Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, N/A, 20133, Italy @@
## Efectivity of Non-invasive Neuromodulation in Parasympathic Nervous System and Vascular System - NCT ID: NCT06320171 - Study ID: 240118,2024-481 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-06 - Lead Sponsor: Universidad Europea de Madrid ### Study Description The study, conducted by the Universidad Europea de Madrid, examines the immediate effects of a single session using NESA microcurrents on various circulatory system variables in healthy subjects. It divides participants into three groups based on session duration (15, 30, 45 minutes), measuring pre and post-intervention changes. The focus is on autonomic nervous system responses, aiming to understand the minimum treatment characteristics needed for significant autonomic changes. Variables studied include systolic and diastolic blood pressure, heart rate, and several ultrasound measurements of the common carotid artery (CSA), including thickness and peak systolic flow velocity. ### Conditions - Hypertension ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Non-Invasive neuromodulation ### Outcomes Primary Outcomes - Systolic and diastolic Blood Pressure: - Heart rate Secondary Outcomes - Ultrasonographic variables: Cross-sectional area of the jugular vein - Ultrasonographic variables:Cross-sectional area of the common carotid - Ultrasonographic variables:Thickness of the common carotid - Ultrasonographic variables:Peak systolic velocity. - Cortisol measurement ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Dissecting the Molecular and Cellular Pathophysiology of Sarcopenic Obesity in the Elderly - NCT ID: NCT06320158 - Study ID: PNRR-MAD-2022-12376672 - Status: RECRUITING - Start Date: 2023-05-22 - Completion Date: 2024-12-31 - Lead Sponsor: IRCCS San Raffaele ### Study Description Ageing is characterised by a change in body composition with a parallel decrease in muscle mass and an increase and central redistribution of fat. When drastically exacerbated, these two processes culminate in a condition known as sarcopenic obesity (SO). SO is characterised by the coexistence of obesity and sarcopenia (i.e. reduced muscle mass and function) and is a growing public health problem in the elderly. The health risks of obesity and sarcopenia act synergistically, maximising the risk of disability of OS. The molecular mechanisms underlying OS are largely unknown. Increased fat mass induces chronic systemic inflammation and alters the profiles of adipokines and hormones, promoting the development of sarcopenia. On the other hand, the reduction in muscle tissue (SM) typical of sarcopenia is characterised by an alteration in the metabolic properties of skeletal muscle with an increase in insulin resistance and a reduction in energy expenditure that favours the accumulation and dysfunction of adipose tissue (AT). The cellular alterations that would seem to underlie OS are: altered autophagy, cellular senescence, epigenetic and mitochondrial alterations and maladaptive activation of intra- and intercellular inflammatory circuits (e.g. cytokines, extracellular vesicles, dysfunctional circulating leukocytes). However, the interconnections between these mechanisms are still unclear. The impact of OS can be dramatic on the health and quality of life of those affected. Therefore, the identification of early biomarkers that can recognise overweight and obese individuals at risk of developing SO is of paramount importance. This would shed light on the heterogeneity of an otherwise homogeneous clinical condition, opening new horizons towards the conscious design of more personalised therapeutic strategies, allowing a more rational use of the limited resources available for the growing elderly population.The study design designed to achieve this aim is a cross-sectional observational study with an additional multicentre procedure lasting two years. ### Conditions - Sarcopenic Obesity ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - clinical evaluation of sarcopenic obesity ### Outcomes Primary Outcomes - Identifying new molecular markers in elderly patients with sarcopenic obesity Secondary Outcomes - Assessing the ability of new markers (identified in the pre-clinical phase of this project) to predict individual disease trajectories ### Location - Facility: Ospedale San Raffaele, Milan, N/A, 20132, Italy @@
## Effect of Cryotherapy on Primary Dysmenorrhoea - NCT ID: NCT06320145 - Study ID: P.T.REC/012/004045 - Status: COMPLETED - Start Date: 2023-03-13 - Completion Date: 2023-10-01 - Lead Sponsor: Cairo University ### Study Description Dysmenorrhea is a menstrual disorder defined by the presence of painful cramps of uterine origin that occur during menstruation. It is one of the most common causes of pelvic pain and short-term absenteeism from school or work, among young and adult women.Cryotherapy, therapeutic cooling, is one of the modalities widely used in sports medicine for a variety of treatment purposes. Physiological and neurological responses of musculoskeletal tissues to cooling have been extensively examined in the literature. ### Conditions - Dysmenorrhea Primary ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Cryotherapy - core stability exercises ### Outcomes Primary Outcomes - Pain assessed by VAS Secondary Outcomes ### Location - Facility: Faculty of Physical Therapy,Cairo University, Cairo, N/A, N/A, Egypt @@
## BLANDISH (Brain, Loss of Function, Aneurism, Disease, Injury, Stroke, Hemorrhage) - NCT ID: NCT06320132 - Study ID: BLANDISH - Status: RECRUITING - Start Date: 2024-03-13 - Completion Date: 2029-01-31 - Lead Sponsor: IRCCS Ospedale San Raffaele ### Study Description The goal of this observational study is to train a machine learning system based on data from patients affected by spontaneous Intracranial Hemorrage. The main question it aims to answer is whether there is a correlation between actual clinical pratice, reached outcomes and favorable or unfavorable predictive factors, and anamnesis.Participants will be treated as per standard clinical practice. ### Conditions - Intracranial Hemorrhages ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Treatment of spontaneous intracranial hemorrhage ### Outcomes Primary Outcomes - Mortality Secondary Outcomes ### Location - Facility: IRCCS Ospedale San Raffaele, Milano, MI, N/A, Italy @@
## Setting a PERSONalized Outcome in ASthma: the PERSONAS Study. A Patient Driven Outcome (PDO) Study - NCT ID: NCT06320119 - Study ID: 2943 - Status: RECRUITING - Start Date: 2023-01-01 - Completion Date: 2025-09-30 - Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico ### Study Description To optimize the effectiveness of asthma therapy there is a need to identify and address individual patient goals. Considering the self-management discussion as central for the achievement of health outcomes, Healthcare Providers may help patients make specific actions to obtain their desired goals.The current evidence suggest that Healthcare Professionals need to develop a more patient-centered and partnership-based approach based on the development and review of action plans, including the experiential asthma knowledge of patients and caregivers. From a practical perspective, the specialist (i.e. pulmunologists, allergologists, etc) has clear therapeutic targets to be reached in asthmatic patients: for example, improving the disease control, the spirometric values and asthma control test (ACT) score vs. pre-treatment evaluations represent the standard outcomes to reach (GINA 2019). However, as previously described, patients are more likely to achieve an improved clinical outcome when the treatment is driven by a personalized goal. This builds on the same principle as shared decision making between the physician and patient, recognizing both the personal motivation and the accountability on behalf of the patient (Hoskins et al. 2016).This study aims to evaluate if the identification of a personalized outcome allows patients to achieve a better control of asthma in terms of asthma control test (ACT) and asthma quality of life questionnaire (AQLQ). In addition, a set of clinical outcomes (i.e. forced expiratory volume in one second - FEV1, use of rescue therapy, night awakeness) will also be assessed. ### Conditions - Bronchial Asthma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - PDO Group ### Outcomes Primary Outcomes - Primary Outcome. The primary outcome of the study is to evaluate the impact of the personalized approach on asthma control (PDO group) versus a non-personalized approach (UC group). Secondary Outcomes - Secondary Outcome. To evaluate the impact of the personalized approach on asthma control (PDO group) versus a non-personalized approach (UC group) assessed by the change of ACT from month 3 to month 6. - Secondary outcome. To evaluate the impact of the personalized approach on asthma control (PDO group) versus a non-personalized approach (UC group) assessed by the change of AQLQ from baseline to month 3. - Secondary outcome. To evaluate the impact of the personalized approach on asthma control (PDO group) versus a non-personalized approach (UC group) assessed by the change of AQLQ from month 3 to month 6. - Secondary outcome. To evaluate the impact of the personalized approach on asthma control assessed by the change of lung function (pulmonary functions tests: FEV1, FVC, FEV1/FVC) from baseline to month 3. - Secondary outcome. To evaluate the impact of the personalized approach on asthma control assessed by the change of lung function (pulmonary functions tests: FEV1, FVC, FEV1/FVC) from baseline from month 3 to month 6. - Secondary outcome. To measure the proportion of patients in the PDO group who achieve their own personal outcome at month 3, assessed by VAS (1-10) to V1. - Secondary outcome. To measure the proportion of patients in the PDO group who achieve their own personal outcome at month 6, assessed by a VAS (1-10) as minimal clinically important difference (MCID) of 1.5 points to V1. - Secondary outcome. To measure the proportion of patients in the PDO group who maintain/improve their own personal outcome at month 6, assessed by a VAS (1-10) to V2. ### Location - Facility: ASST Papa Giovanni XXIII, Bergamo, N/A, 24127, Italy @@
## Assessment of Navigation Abilities in Children With Cerebral Palsy and Their Peers - NCT ID: NCT06320106 - Study ID: GIP 1021 - Status: RECRUITING - Start Date: 2023-02-07 - Completion Date: 2025-01-31 - Lead Sponsor: IRCCS Eugenio Medea ### Study Description Spatial navigation skills are very important in everyday activities and quality of life but spatial navigation abilities are not part of the standard process of assessment and rehabilitation of patients. Furthermore, it is known that children with cerebral palsy have impaired visuo-spatial competences. The main objective of this study is to evaluate and compare the spatial navigation abilities of typically developing children and of children with cerebral palsy using the "StarMaze" application delivered by means of a Head Mounted Display (HMD). The second aim is to investigate the user experience during the session. A similar application was already developed and tested in a virtual reality large scale platform whose size and cost limit the accessibility. Therefore, the assessment (and future training) of navigation abilities with affordable and easy-to-use technology such as HMD open new perspectives. ### Conditions - Cerebral Palsy - Healthy Volunteers ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Virtual Reality baseline assessment ### Outcomes Primary Outcomes - Navigation strategy Secondary Outcomes - Learning rate - Simulator Sickness Questionnaire - System Usability Scale - Independent Television Commission-Sense of Presence Inventory - Suitability Evaluation Questionnaire - simplified version - Short-form of PANAS-Positive Affect and Negative Affect Scales ### Location - Facility: Scientific Institute, IRCCS E. Medea, Bosisio Parini, Lecco, 23842, Italy @@
## Training Social and Health Care prOfessionals in mUsic-based Therapeutic iNterventions to Support Older People With Dementia - NCT ID: NCT06320093 - Study ID: INRCA_002_2024 - Status: COMPLETED - Start Date: 2023-10-03 - Completion Date: 2024-02-20 - Lead Sponsor: Istituto Nazionale di Ricovero e Cura per Anziani ### Study Description The study will investigate the effects of an inovative intervention based on the use of music on 45 professionals in the field of dementia, 45 elderly people with dementia. ### Conditions - Dementia - Older People ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - SOUND Intervention ### Outcomes Primary Outcomes - Change in mental wellbeing of patients with dementia - Change in cognitive status of patients with dementia - Change in stress of health care providers Secondary Outcomes ### Location - Facility: INRCA Hospital, Ancona, N/A, 60127, Italy @@
## Clinical Study of TQB2223 Injection Combined With AK105 Injection in the Treatment of Advanced Hepatocellular Carcinoma. - NCT ID: NCT06320080 - Study ID: TQB2223-AK105-Ib-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-10 - Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. ### Study Description TQB2223 is a recombinant, fully human antibody that binds to lymphocyte activation gene-3 (LAG-3) and blocks the LAG-3/ major histocompatibility complex class II (MHC-II) interaction, thus allowing for increased T-cell proliferation and cytokine production. This is a phase Ib study aimed at evaluating the safety, tolerability, and immunogenicity characteristics of TQB2223 injection combined with AK105 injection in the treatment of advanced hepatocellular carcinoma. ### Conditions - Advanced Hepatocellular Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - TQB2223 injection - Penpulimab Injection ### Outcomes Primary Outcomes - Objective Response Rate (ORR) - Progression-free survival (PFS) Secondary Outcomes - Overall survival (OS) - Disease control rate (DCR) - Duration of Response (DOR) - Number of patients with adverse events (AEs) and/or serious adverse events (SAEs) - Immunogenicity ### Location - Facility: Affiliated Cancer Hospital of Harbin Medical University, Harbin, Heilongjiang, 150000, China @@
## A Randomised Controlled Platform Trial Testing Treatments in Metastatic Hormone Sensitive Prostate Cancer - NCT ID: NCT06320067 - Study ID: PR12 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2034-03 - Lead Sponsor: University College, London ### Study Description STAMPEDE2 is a clinical trial comparing three new treatments with standard of care in people with prostate cancer that has spread to other parts of the body and is responsive to hormone therapy. People from all backgrounds and ethnicities are encouraged to take part and multiple hospitals across the UK are involved. University College London is running the trial.Each comparison within the trial has its own control arm where people get the best standard of care (Arm A) versus a research arm where a new treatment is added to standard of care.Participants are allocated to an arm by a computerised system with a 50% chance of getting the research treatment.Comparison S: Arm A versus Arm S (Stereotactic Ablative Body Radiotherapy (SABR)) - Tests whether giving targeted doses of radiotherapy (SABR) to parts of the body where the cancer has spread slows the spread of the cancer and improves survival. 2476 people will be in this comparison.Comparison P: Arm A versus Arm P (PSMA-Lutetium (177Lu-PSMA-617)) - Tests whether giving a radioactive material (177Lu-PSMA-617) that targets prostate cancer cells slows the spread of the cancer and improves survival. 1756 people will be in this comparison.Comparison N: Arm A(N) versus Arm N (Niraparib-Abiraterone Acetate+Prednisolone (Nira-AA+P)) - Tests whether giving a new drug (Nira-AA+P) slows the spread of the cancer and improves survival. Only people with certain genetic changes in their tumour sample can take part in Comparison N. 682 people will be in this comparison.Participants may be able to take part in more than one comparison.All participants will be followed up with scans and tests to monitor their cancer. Doctors will check for any side effects from the treatments. Treatments will be stopped if side effects are serious, or people no longer wish to take the treatments. ### Conditions - Prostate Cancer Metastatic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Stereotactic Ablative Body Radiotherapy (SABR) - 177Lu-PSMA-617 - Niraparib and Abiraterone Acetate Dual Action Tablet DAT - Abiraterone Acetate - Apalutamide - Androgen Deprivation Therapy (ADT) - Androgen Receptor Signalling Inhibitor (ARSI) - Local Radiotherapy - Prednisolone - Docetaxel ### Outcomes Primary Outcomes - Radiographic Progression-Free-Survival (rPFS) - Overall Survival (OS) Secondary Outcomes - Failure-Free Survival (FFS) - Prostate cancer specific survival (PCSS) - Safety through reporting of SAEs - Toxicity using CTCAE classification and reporting of all Adverse Events that are ≥ grade 3 or grade 1 and 2 leading to a change in trial treatment - Compliance with randomised allocation. Formal definitions for compliance with treatment will be pre-specified in the statistical analysis plan. This is still in development. - EQ-5D-5L questionnaire for QoL and cost effectiveness assessment ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Preventing Obstetric Complications With Dietary Intervention - NCT ID: NCT06320054 - Study ID: PRO00049771 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-08-31 - Lead Sponsor: Medical College of Wisconsin ### Study Description The goal of this study is to learn whether access to healthy and fresh food, health coaching, and nutrition support intervention can reduce adverse birth outcomes in pregnant women. The main questions it aims to answer are:* Does access to healthy and fresh food, health coaching and nutrition support reduce the risk of gestational diabetes or preeclampsia and ultimately improve health outcomes for mothers and their newborns?* Are participants able to successfully utilize the health program? Are participants satisfied and self-equipped to apply the teachings of the program within their lives following their participation in the study? Participants will be randomly assigned to one of two groups.Participants in the standard of care will be asked to:* Complete surveys* Biometric screeningsParticipants in the intervention group will be asked to:* Complete surveys* Biometric screenings* Participate in weekly personal health coaching* Receive and consume provided weekly meals.Researchers will compare the standard of care to those who receive the intervention to see the impact of the intervention on clinical outcomes including: gestational weight gain, blood pressure, diagnosis of gestational diabetes, diagnosis of gestational hypertension or preeclampsia, and gestational age at birth. ### Conditions - Gestational Diabetes - Gestational Hypertension - High Risk Pregnancy - Preeclampsia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Maternal Health Management Program ### Outcomes Primary Outcomes - Clinical Outcomes - Clinical Outcomes - Clinical Outcomes - Clinical Outcomes - Clinical Outcomes Secondary Outcomes - Patient Reported Outcomes - Patient Reported Outcomes - Patient Reported Outcomes - Patient Reported Outcomes - Patient Reported Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Efficacy and Safety of Oliceridine for Moderate to Severe Acute Pain After Orthopedic Surgery - NCT ID: NCT06320041 - Study ID: KY-2024-028 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-12-31 - Lead Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine ### Study Description The goal of this clinical trial\] is to further explore the effectiveness and safety of oxelidine in the treatment of moderate to severe acute pain after orthopedic surgery. The main question it aims to answer is: Pain management after orthopaedic surgery provides more effective and safe drug options, provides new options for clinical treatment, and provides a scientific basis for clinical practice.Participants will be asked to pain score in the different time, treatments they'll be given and use optimal drug. Researchers will compare analgesic effect of oxelidine of different dose. ### Conditions - Postoperative Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Low dose oxelidine group - High dose oxelidine group - Hydromorphone group ### Outcomes Primary Outcomes - Pain score at rest 0-72 hours after surgery Secondary Outcomes - The total amount of opioid after operation. - PCIA as a remedial analgesic press time ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Altering Default Mode Network Activity With Transcranial Focused Ultrasound to Reduce Depressive Symptoms - NCT ID: NCT06320028 - Study ID: 019782-00001 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-04-27 - Completion Date: 2024-06-03 - Lead Sponsor: University of Arizona ### Study Description Depression is a leading cause of disability worldwide, affecting roughly 21 million adults. Repetitive Negative Thought (RNT) has been identified as a potential maintaining factor in depression, such that those who exhibit higher degrees of RNT endorse greater symptoms. Research also suggests that the Default Mode Network (DMN), responsible for self-referential processing, plays an important role in depression wherein it has been linked to RNT. In depressed individuals, this network appears to be hyper-connected, or "too connected", within itself which, in turn, is thought to promote RNT.Half of depressed individuals are treatment-resistant, creating a critical need to identify more effective interventions derived from a better mechanistic understanding of the development and maintenance of depression. Non-invasive Transcranial-Focused Ultrasound Stimulation (tFUS) is promising for the treatment of depression. tFUS directs a low-intensity (nonthermal) focused ultrasound beam that passes safely through the skull. Compared to other noninvasive neuromodulation approaches, tFUS can target deeper brain regions with high spatial precision.The present study is an exploratory non-blinded single treatment study to investigate whether tFUS targeting a major hub of the DMN, the anterior-medial prefrontal cortex, can improve depression symptoms and reduce RNT. Twenty depressed individuals with high RNT (75th percentile) will complete up to eleven ultrasound sessions targeting the anterior medial prefrontal cortex, a hub of the brain's default mode network that has been found to be hyper-connected in depression. MRI scans will be obtained before the first and after the last ultrasound sessions. Based on previous literature, it is predicted that depression interview ratings and self-report symptoms will decrease after the intervention, and also that DMN connectivity will decrease following intervention. ### Conditions - Depressive Disorder, Major - Depression ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Non-Invasive Transcranial Focused Ultrasound ### Outcomes Primary Outcomes - Beck Depression Inventory - II (BDI-II) - Perseverative Thinking Questionnaire (PTQ) - Hamilton Depression Rating Scale (HDRS) - Default Mode Network (DMN) Connectivity Secondary Outcomes - The Montgomery-Åsberg Depression Rating Scale (MADRS) ### Location - Facility: University of Arizona, Tucson, Arizona, 85721, United States @@
## Emergency Medicine Peer Outreach Worker Engagement for Recovery - NCT ID: NCT06320015 - Study ID: R01CE003632-01-00 - Status: NOT_YET_RECRUITING - Start Date: 2024-08-01 - Completion Date: 2025-09 - Lead Sponsor: University of California, Los Angeles ### Study Description This is an observational, prospective case-control study evaluating the effects of an emergency department community health worker-peer recovery specialist program (PCHW), the Substance Misuse Assistance Response Team (SMART). Aims of this study are to 1) understand participant experiences working with a SMART PCHW and identify possible mechanisms for successful recovery linkage; 2) Evaluate SMART effectiveness on patient-centered outcomes, building recovery capital, and recovery linkage; 3) Evaluate SMART implementation and effectiveness on patient outcomes over time.Using a combination of surveys and data linkages to state administrative databases, study investigators will prospectively compare changes in addiction treatment engagement, recovery capital, health related social needs, acute care utilization, and death between people receiving a ED PCHW and those who do not. After consenting to study participation, participants will complete surveys at time of study enrollment and 3 and 6 months after their initial ED visit. Primary outcomes include engagement in addiction treatment, social services engagement, acute care utilization, and mortality will be assessed through linkages to state administrative databases. ### Conditions - Substance Use Disorders - Overdose - Opioid Use Disorder - Alcohol Use Disorder ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Substance Misuse Assistance Response Team (SMART) ### Outcomes Primary Outcomes - Treatment engagement - Recovery Capital Secondary Outcomes - Emergency Department Utilization - Repeat Hospitalization - Repeat Overdose - Mortality - Social Services Engagement - Housing Services Engagement - Employment - Incarceration ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Communication Intervention for Fecal Ostomy Surgery - NCT ID: NCT06320002 - Study ID: 2023P003564 - Status: RECRUITING - Start Date: 2024-03-18 - Completion Date: 2024-08-30 - Lead Sponsor: Massachusetts General Hospital ### Study Description In this study the investigators will evaluate the acceptability of a communication intervention for fecal ostomy surgery (CI-oSurg) to address the needs of adults who are undergoing fecal ostomy surgery. The investigators will recruit 24 patients and 4 clinicians (surgical nurses, wound ostomy nurses). At least half of patients are 65 years or older to understand the unique needs of older adults recovering from fecal ostomy surgery that might impact intervention acceptability. Questionnaires will be administered at two time-points for patient participants: upon study start and 4 weeks after exposure to the intervention. ### Conditions - Surgery - Colostomy Stoma - Ileostomy - Stoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Communication Intervention for fecal ostomy surgery ### Outcomes Primary Outcomes - Intervention Acceptability Secondary Outcomes - Intervention Usability ### Location - Facility: Massachusetts General Hospital, Boston, Massachusetts, 02114, United States @@
## The Efficacy of Biplane Versus Single Plane Ultrasound in Facilitating Caudal Epidural Anesthesia in Pediatric Patients. - NCT ID: NCT06319989 - Study ID: IRB202301905 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-25 - Completion Date: 2026-09-30 - Lead Sponsor: University of Florida ### Study Description Ultrasound guidance plays a pivotal role in caudal epidural block in pediatric patients. In comparison to conventional single-plane ultrasound, biplane ultrasound offers the advantage of providing simultaneous transverse and longitudinal imaging. Better visualization under biplane ultrasound is postulated to enhance the efficacy of caudal epidural blocks. This improvement is expected to manifest through higher first puncture success rate, shorter procedure time, and longer time to first postoperative analgesics use. ### Conditions - Educational Problems ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Biplane Ultrasound - Single plane ultrasound ### Outcomes Primary Outcomes - First puncture success Secondary Outcomes - Number of Needle redirections - Duration of epidural - Postoperative analgesic use ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of Rotator Cuff Training on Hand Grip in Adults - NCT ID: NCT06319976 - Study ID: P.T.REC/012/004883 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2024-12-30 - Lead Sponsor: Cairo University ### Study Description Purpose of the study:* To investigate the effect of rotator cuff training on hand grip strength in adults with different body mass index.* To investigate the effect of rotator cuff training on hand grip static endurance in adults with different body mass index.* To investigate the effect of rotator cuff training on hand grip dynamic endurance in adults with different body mass index.* To investigate the effect of rotator cuff training on upper limb function in adults with different body mass index. ### Conditions - Hand Grasp ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - open chain exercises for rotator cuff muscles - Advices for postural correction ### Outcomes Primary Outcomes - Hand grip strength Secondary Outcomes - Hand grip static endurance - Hand grip dynamic endurance - Upper limb function ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study to Evaluate Lenti-HPV-07 Immunotherapy Against HPV+ Cervical or Oropharyngeal Cancer - NCT ID: NCT06319963 - Study ID: Lenti-HPV-07-CT01 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-12 - Lead Sponsor: Theravectys S.A. ### Study Description The goal of this clinical trial is to learn about the safety and efficacy of a potential new treatment called Lenti-HPV-07 in patients with a cancer induced by Human Papilloma Virus (HPV).The main questions aim to answer are:* Is Lenti-HPV-07 safe?* Does Lenti-HPV-07 induce an immune response?Participants will be assigned to a group based on their cancer type* either study drug group A: recurrent and/or metastatic cancer* or study drug group B: newly diagnosed with locally advanced cancerAfter they finish the study treatment, they will be followed for up to 1 year. Follow-up visits will occur via clinic visits or phone calls 4 weeks after the last study treatment and then quarterly for up to 1 year. ### Conditions - HPV-Related Cervical Carcinoma - HPV Positive Oropharyngeal Squamous Cell Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Two IM injections Lenti-HPV-07 - One IM injection Lenti-HPV-07 ### Outcomes Primary Outcomes - Safety and Tolerability - OBD Secondary Outcomes - Immunogenicity - PD-L1 expression ### Location - Facility: Florida Cancer Specialists (from Sarah Canon research Institute), Orlando, Florida, 32827, United States @@
## High-dose Furmonertinib Versus Osimertinib in Advanced EGFRm NSCLC Patients With Brain Metastases - NCT ID: NCT06319950 - Study ID: 20240229 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-12-30 - Lead Sponsor: Taizhou Hospital ### Study Description The investigators were to explore whether high-dose Furmonertinib, compared with osimertinib, could achieve longer survival in patients with EGFR-mutated NSCLC with CNS metastasis. ### Conditions - Lung Cancer, Nonsmall Cell ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Furmonertinib - Osimertinib ### Outcomes Primary Outcomes - progression free survival(PFS) Secondary Outcomes - objective response rate(ORR) - Intracranial objective Response Rate(iORR) - Intracranial progression free survival(iPFS) - overal survival time(OS) - Disease control rate(DCR) - Intracranial disease control rate(iDCR) - Depth of response (DepOR) - Depth of intracranial response(iDepOR) - Time to intracranial remission(iTTR) - Duration of response(DoR) - Duration of intracranial response(iDoR) - Rate of improvement in neural function - Health-related quality of life - Adverse events ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Muscle Architecture in Knee Osteoarthritis - NCT ID: NCT06319937 - Study ID: OA2023 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-09-01 - Lead Sponsor: Hacettepe University ### Study Description Background: The aim of this study was to compare the knee and ankle muscle architecture and plantar pressure distribution differences in knee osteoarthritis (OA) women with healthy women.Methods: Fifty women with knee OA (Mean age=52.11±4.96 years, mean BMI=30.94±4.23 kg/m2) and fifty healthy women (Mean age= 50.93±3.78 years, mean BMI=29.06±4.82 kg/m2) were included in the study. Ultrasonography was used to evaluate Rectus Femoris (RF), Vastus Medialis (VM), Vastus Lateralis (VL), Peroneus Longus (PL), Tibialis Anterior (TA), and Medial Gastrocnemius (MG) muscle thickness, pennation angle, fascicle length, and fat thickness. The plantar pressure distribution was evaluated using the Digital Biometry Scanning System and software (DIASU, Italy). ### Conditions - Knee Osteoarthritis - Foot Deformities - Muscle Weakness - Kinesiophobia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Ultrasound ### Outcomes Primary Outcomes - Muscle thickness - Pennation angle - Fat thickness Secondary Outcomes - Stair climbing test - Sit-stand test ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Fixed Low-dose Simethicone Combined With Macrogol 4000 (PEG) Reduces Colon Bubble Formation in Colonoscopy - NCT ID: NCT06319924 - Study ID: XIMEPEG-RL - Status: COMPLETED - Start Date: 2020-02-01 - Completion Date: 2022-09-15 - Lead Sponsor: Hospital St. Joseph, Marseille, France ### Study Description Several randomised studies have shown that the addition of low-dose Simethicone to the bowel preparation was sufficient to reduce the presence of bubbles during colonoscopy. The aim of this study was to evaluate the efficacy and safety of a bowel preparation containing low-dose Simethicone on bubble formation.Patients and Methods This prospective, real-life, phase 4 study was conducted from February 2020 to May 2021, in five private endoscopy centres, among adult patients undergoing a colonoscopy. Clinical, endoscopic and histological parameters were collected on e-CRF. The primary endpoint was the measurement of bubble formation in the various colon segments. ### Conditions - Colorectal Cancer - Colonoscopy - Bowel Preparation Solution ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Simethicone combined with Macrogol 4000 (PEG) ### Outcomes Primary Outcomes - Assess the quality of the bowel preparation assessed by Bubble scale - Assess the quality of the bowel preparation assessed by Boston Bowel Preparation Scale (BBPS) Secondary Outcomes - Colonoscope removal time - The frequency of adverse events (AEs) - volume of bowel preparation ingested - Caecal intubation rate ### Location - Facility: Clinique des Cèdres, Ramsay Santé,, Cornebarrieu, N/A, 31700, France @@
## AETOS Shoulder System - NCT ID: NCT06319911 - Study ID: AETOS 2022.04 - Status: RECRUITING - Start Date: 2024-03-31 - Completion Date: 2030-08-30 - Lead Sponsor: Smith & Nephew, Inc. ### Study Description The goal of this study is to confirm the safety and performance of the AETOS Shoulder System for USA adoption. This is a prospective, open, adaptive, non-comparative, multi-centre investigation enrolling a maximum of 220 subjects in 2 cohorts (anatomic and reverse) at up to 15 sites. No intra-study comparator group will be included, and there will be no randomization ### Conditions - Shoulder Osteoarthritis - Shoulder Arthritis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - AETOS ### Outcomes Primary Outcomes - Implant Survivorship Secondary Outcomes - Implant Survivorship at 6 months, 1 year, 3.5 years and 5 years - Radiographic Assessment - Glenoid Migration/Subsidence - Radiographic Assessment - Glenoid Radiolucency - Radiographic Assessment - Humeral Radiolucency - Radiographic Assessment - Humeral Migration/Subsidence - Radiographic Assessment - Humeral Head Centeredness - Radiographic Assessment - Bone Remodeling - Radiographic Assessment - Glenohumeral Subluxation - Radiographic Assessment - Device Condition: Anatomic - Radiographic Assessment - Device Condition: Reverse - American Shoulder and Elbow Score (ASES) - Constant Murley Score - Simple Shoulder Test (SST) - Single Assessment Numeric Evaluation (SANE) ### Location - Facility: California Pacific Orthopedics, San Francisco, California, 94118, United States @@
## Relaxing Environment to Lower Anxiety During Onabotulinum Toxin Chemodenervation of the Bladder - NCT ID: NCT06319898 - Study ID: IRB00110787 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-02 - Lead Sponsor: Wake Forest University Health Sciences ### Study Description Chemodenervation of the bladder with onabotulinum toxin A is an effective treatment option for patients with refractory urgency urinary incontinence (UUI). It is often performed as an office-based procedure under local anesthesia. Alternatively, it can be performed in the operating room under general anesthesia. The ability to receive intra-detrusor chemodenervation in the office allows patients to avoid the risks associated with general anesthesia and is significantly more cost effective. The procedure, however, is painful and can be anxiety provoking for patients; especially given that patients typically return every six to nine months for repeat injections. Relaxation and distraction techniques are one way to ease patients' anxiety before an office-based procedure. While we do not know exactly how anxiety provoking office bladder chemodenervation is for patients, we do know that anxiety disorders are highly prevalent in women with overactive bladder as a population.The purpose of this study is to investigate whether women with Urge urinary incontinence (UUI) who receive office intra-detrusor chemodenervation injections performed in a relaxing environment of lavender aromatherapy, calming music, dim lighting, and modest positioning (Relaxing Environment Package) will have decreased anxiety and pain as well as increased post-procedure satisfaction compared to patients who receive chemodenervation in a typical office environment. Also investigate whether exposure to the relaxing environment impacts the well-being of staff involved in these procedures. This study design is a randomized control trial. Women scheduled for office intra-detrusor chemodenervation at Atrium Health women's Care Urogynecology \& Pelvic Surgery - Mercy clinic will be invited to participate. Participants will be randomized to the relaxing environment package or the placebo group after informed consent is obtained and immediately before undergoing intra-detrusor chemodenervation. The participants will complete the pre-procedure visual analog scale (VAS) for anxiety and a VAS for pain at baseline. ### Conditions - Anxiety - Pain - Burnout, Professional ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Lavender aromatherapy sticker ### Outcomes Primary Outcomes - Mean change in Visual Analog Scale (VAS) Anxiety Scores Secondary Outcomes - Visual Analog Scale (VAS) Pain during the chemodenervation procedure - Procedure Staff Burnout Scores - Burnout Battery visual analog scale for healthcare worker burnout - Patient satisfaction with their procedure experience Scores ### Location - Facility: Wake Forest University Health Sciences, Winston-Salem, North Carolina, 27157, United States @@
## Text Messaging to Reduce High-risk Alcohol Use Among Older Adults - NCT ID: NCT06319885 - Study ID: SDU project nr. 3110386 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-04 - Lead Sponsor: University of Southern Denmark ### Study Description High-risk drinking is very prevalent among Danes aged 55+. It poses a serious risk to health and independent living, burdening health care systems and family members. Measures to reduce high-risk alcohol use in this growing group at need are urgently needed. A recent small study from the US shows that text messaging reduces high-risk alcohol intake in older adults. The investigators will conduct a pilot study with the same intervention in Denmark, with adaptations to language and culture. The pilot study will investigate among Danish older adults whether text messaging is well-accepted by participants and feasible in terms of reducing 1) high-risk drinking and 2) commonly accompanying problems with daily functioning, social relationships, and mental and physical health. The pilot-trial will include n=60 adults aged 55-80 years who will receive alcohol-related text messages (within a secure app for data protection purposes) over 12 weeks. Assessments will include a baseline assessment and a post-assessment. ### Conditions - Hazardous Alcohol Use ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Text messaging ### Outcomes Primary Outcomes - High-risk alcohol use (yes/no) Secondary Outcomes - WHOQOL-Bref (The World Health Organization Quality of Life Brief Version ) - OBSESSIVE-COMPULSIVE DRINKING SCALE (OCDS) - Drinker Inventory of Consequences (DrInC-2R) - Frequency of alcohol use - Amount of alcohol use - Heavy drinking days - User evaluation (tailor-made) - PHQ-9 (Patient Health Questionnaire-9 ) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effects of Disulfiram (Antabuse®) on Visual Acuity in Patients With Retinal Degeneration - NCT ID: NCT06319872 - Study ID: STUDY00009118 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-04-15 - Lead Sponsor: University of Rochester ### Study Description Oral disulfiram (Antabuse®) has been shown to improve image-forming vision in animal models with retinal degeneration due to its ability to decrease Retinoic Acid synthesis and consequently reduce hyperactivity in the inner retina. The investigator will aim to evaluate the impact of oral disulfiram on the vision of patients with retinal degeneration who are being treated with the drug in the management of their concurrent alcohol use disorder. ### Conditions - Alcohol Use Disorder - Retinal Dystrophies - Age-Related Macular Degeneration - Retinitis Pigmentosa - Stargardt Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Oral disulfiram ### Outcomes Primary Outcomes - mean change in Best Corrected Visual Acuity (BCVA) score assessed by ETDRS Secondary Outcomes - mean change in total contrast sensitivity score using Pelli-Robson charts - mean change in light-adapted microperimetry sensitivity assessed using standard MAIA microperimetry equipment - mean change in outer retinal thickness assessed using Spectral Domain Optical Coherence Tomography (SD-OCT) - mean change in fundus autofluorescence (FAF) - number of participants with retinal anatomy changes assessed using fundus photos - mean change in visual field perimetry using full-field stimulus test - mean change in isopter constriction using Goldmann visual field - mean change in size of scotomas using Goldmann visual field - mean change in cone and rod latency assessed using Full field electroretinogram (ffERG) - mean change in cone and rod amplitude assessed using Full field electroretinogram (ffERG) - mean change in cone and rod latency assessed using multifocal electroretinogram (mfERG) - mean change in cone and rod amplitude assessed using multifocal electroretinogram (mfERG) - mean change in National Eye Institute-Visual Functioning Questionnaire 25 composite score. ### Location - Facility: Flaum Eye Institute, University of Rochester Medical Center, Rochester, New York, 14642, United States @@
## Intrathecal Non-preservative-free Morphine With Bupivacaine Versus Intrathecal Bupivacaine Alone for Analgesia in Unilateral Inguinal Hernia Repair Surgeries - NCT ID: NCT06319859 - Study ID: N-72-2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-10 - Lead Sponsor: Cairo University ### Study Description This study will evaluate the efficacy and safety of intrathecal non-preservative-free morphine and its effect on pain in patients undergoing unilateral inguinal hernia surgeries. ### Conditions - Pain, Postoperative ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Morphine - Placebo ### Outcomes Primary Outcomes - Time to first analgesic requirement Secondary Outcomes - Nalbuphine consumption - Postoperative pain - The incidence of other adverse effects ### Location - Facility: Kasr Alaini hospital, Cairo, N/A, N/A, Egypt @@

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