Datasets:

hackint0sh
/

md_dataset

Dataset card Data Studio Files Files and versions Community

Split (1)

train · 10k rows

record stringlengths 560 23.9k
## Guided Bone Regeneration Using Fixed vs Non-Fixed Resorbable Collagen Membranes - NCT ID: NCT06334159 - Study ID: PER-ECL-2019-08 - Status: RECRUITING - Start Date: 2020-11-05 - Completion Date: 2027-07-20 - Lead Sponsor: Universitat Internacional de Catalunya ### Study Description The aim of this clinical trial is to compare the horizontal bone gain when grafting a bone substitute with non fixed resorbable collagen membranes (control group), versus fixed resorbable collagen membranes (test group) in resorbed ridges requiring Guided Bone Regeneration (GBR) to facilitate implant placement at 6 months. ### Conditions - Bone Resorption ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: TREATMENT ### Interventions - Horizontal GBR with the use of non-resorbable pins for the stabilization of the collagen membrane - Horizontal GBR without the use of non-resorbable pins for the stabilization of the collagen membrane ### Outcomes Primary Outcomes - Horizontal Bone Gain - Bone Width Gain Secondary Outcomes - Horizontal Dimensional Stability - Post-surgical complications - Patient's satisfaction - Histologic examination of the augmented bone at 6 months ### Location - Facility: Georgios Markantonatos, Barcelona, Sant Cugat Del Vallès, 08195, Spain @@
## Tap Dance for Adults With Lower Limb Amputation - NCT ID: NCT06334146 - Study ID: UNLV-2023-62 - Status: RECRUITING - Start Date: 2024-03-04 - Completion Date: 2025-05 - Lead Sponsor: University of Nevada, Las Vegas ### Study Description The goal of this study is to determine whether it is possible for people with lower limb amputation (LLA) to perform adapted tap dance, whether an adapted tap dance program would be enjoyable, and whether it may improve balance and balance confidence.There is a lack of research investigating therapeutic interventions for people with lower limb amputation (LLA). Tap dance encourages balance and novel movements of the limbs, while providing auditory feedback from the feet that provide information about the foot's contact with the ground, which may help prosthesis users gain a better ability to understand where their prosthetic foot is in space. As with most forms of dance, tap is usually taught and practiced in a group setting, which encourages community involvement. It has been shown to be safer than many forms of dance due to low impact forces. It also, as a genre, can incorporate canes, chairs and partner work, providing the ability to modify steps/moves when required so that they remain practical, achievable and safe for people with mobility limitations, while still enabling participation. It therefore may be an accessible dance medium to help improve balance, balance confidence, and build community for people with LLA.Participants will be asked to:* come to 1 hour dance classes, once per week, for 8 weeks.* do mobility tests before and after the program* complete questionnaires before, during and after the program. The total time for participation is approximately 8-10 weeks. ### Conditions - Amputation; Traumatic, Leg, Lower ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Tap dance program ### Outcomes Primary Outcomes - Session Adherence - Physical Activities Enjoyment Scale (PACES) Secondary Outcomes - Change in Timed Up-and-Go test score - Change in Four Square Step Test score - Change in Berg Balance Scale score - Change in Activities-Specific Balance Confidence Scale score - Physical Activities Enjoyment Scale (PACES) score - Mid program - Change in Trinity Amputation and Prosthesis Experience Scale (TAPES) functional activity restriction subscale score - Change in Trinity Amputation and Prosthesis Experience Scale (TAPES) social activity restriction subscale score - Change in Trinity Amputation and Prosthesis Experience Scale (TAPES) athletic activity restriction score - Use of assistive devices per session - Session completion per session ### Location - Facility: University of Nevada Las Vegas, Las Vegas, Nevada, 89154, United States @@
## Cadisegliatin as Adjunctive Therapy in Type 1 Diabetes - NCT ID: NCT06334133 - Study ID: TTP399-302 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-03 - Lead Sponsor: vTv Therapeutics ### Study Description This is a Phase 3 trial of cadisegliatin in participants with Type 1 Diabetes Mellitus. ### Conditions - Diabetes Mellitus, Type 1 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Cadisegliatin 800 mg QD - Cadisegliatin 800 mg BID - Placebo ### Outcomes Primary Outcomes - Change in incidence of Level 2 or Level 3 hypoglycemia Secondary Outcomes - To assess the change in HbA1c - To assess the effects of treatment on CGM-based metrics for glycemic control - To assess the effects of treatment on the incidence of diabetic ketoacidosis - To assess the effects of treatment on insulin dosing - To assess the effects of treatment on body weight - To assess the incidence of adverse events ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## An Observational Study to Learn More About the Safety of Darolutamide in Men With Prostate Cancer in Korea - NCT ID: NCT06334120 - Study ID: 20654 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-31 - Completion Date: 2026-03-31 - Lead Sponsor: Bayer ### Study Description This is an observational study in which participants receive a treatment which is already available for doctors to prescribe for non-metastatic castration-resistant prostate cancer (nmCRPC) or metastatic hormone-sensitive prostate cancer (mHSPC). nmCRPC is a prostate cancer that has not yet spread to other parts of the body and does not respond to lowering testosterone in the body. mHSPC is a prostate cancer that has spread to other parts of the body and can be treated by lowering testosterone levels.This study looks at the safety of the study drug, darolutamide, in Korean patients with nmCRPC or mHSPC. Darolutamide is currently available for doctors to prescribe to men with nmCRPC or mHSPC. It works by attaching to the special molecules called androgen receptors (AR) within prostate cells and blocks hormones called androgens from attaching to AR, which helps delay cancer growth.To learn more about the safety of Darolutamide, the researchers will study whether the participants have adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. The researchers will also learn more about how well darolutamide is working in these participants.During this study, the researchers will collect information from the medical records of patients who have been prescribed darolutamide by their doctors.Each participant will be in this study for 1 year. The whole study will last about 6 years. During this time, the participants will visit their doctor every 2 to 4 months as part of their usual care. At these visits, the doctors will do scans to check the patients' cancer and take blood samples. The patients will answer questions about any medications they are taking and whether they have any adverse events. ### Conditions - Non-metastatic Castration-resistant Prostate Cancer - Metastatic Hormone-sensitive Prostate Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Darolutamide (Nubeqa, BAY1841788) ### Outcomes Primary Outcomes - Number, severity of adverse events (including SAEs) - Number, severity of adverse drug reactions (including SADRs) - The outcome of (serious) adverse events - The outcome of (serious) adverse drug reactions Secondary Outcomes - Metastasis-free survival (MFS) - Time to symptomatic skeletal event (SSE) - Time to prostate-specific antigen (PSA) progression - Number of patients with metastasis of castration-resistant prostate cancer (mCRPC) - Overall survival - Duration of Darolutamide treatment - Reasons for ending Darolutamide - Dosage and dose modification of Darolutamide ### Location - Facility: Multiple locations, Multiple Locations, N/A, N/A, Korea, Republic of @@
## Mitochondrial DNA Signatures of Poor Aerobic Exercise Trainability in Young Adults Born Preterm - NCT ID: NCT06334107 - Study ID: 24AIREA1191995 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-12-31 - Lead Sponsor: Texas Tech University ### Study Description Young adults born very preterm (32 weeks gestation or earlier) do not respond well to aerobic exercise training, meeting the recommendations set by the Physical Activity Guidelines for Americans, where they do not increase their fitness level (or cardiorespiratory fitness). Thus, they do not receive the health benefits of exercise. Achieving physical fitness through aerobic exercise training is the most cost-effective method for preventing and treating many diseases. Young adults born very preterm also have a higher risk of these conditions. Thus, their inability to respond to increase their fitness is a major problem.One likely explanation for poor exercise trainability and increased heart disease risk in young adults born very preterm is the effect of the early birth on the major energy producers in all our cells: Mitochondria. During late-stage gestation, mitochondria change from relying on sugar as a major fuel source to fat. Unfortunately, individuals born very preterm miss this transition in fuel source reliance, which causes significant stress and damage to mitochondria. Mitochondria are critical for post-natal organ development; thus, it is thought that preterm birth-induced mitochondrial dysfunction is the underlying cause of poor trainability and high disease risk in young adults born very preterm. Indeed, mitochondrial dysfunction is evident in these individuals.To date, there is not a way to help young adults born preterm improve their fitness level. One likely target is in the mitochondria: it's DNA. Mitochondrial DNA helps determine how mitochondria function and can be damaged under stress. Our goal in this proposed work is to determine the role of mitochondrial DNA in mitochondrial dysfunction and its link to their poor trainability.Questions:1. Are there mitochondrial DNA markers linked to mitochondrial dysfunction and poor exercise trainability in young adults very born preterm?2. Do mitochondrial DNA in young adults born very preterm respond differently to aerobic exercise training than those born at term?The investigators expect this work will show mitochondrial DNA changes linked to mitochondrial dysfunction and poor trainability, which can be used for future targets to improve health. This work supports AHA mission by helping to identify a marker in individuals born very preterm linked to their higher heart disease risk and death early in life. ### Conditions - Preterm Birth ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Exercise ### Outcomes Primary Outcomes - Mitochondrial DNA heteroplasmy - Mitochondrial DNA sequence variants - Change in maximal aerobic capacity - Change in mitochondrial oxidative capacity in peripheral blood mononuclear cells Secondary Outcomes - Daily sleep habits ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Assessing the Cognitive Benefits of Ozanimod and Their Brain-Biomarkers in MS - NCT ID: NCT06334094 - Study ID: IRB-23-486 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2028-05-31 - Lead Sponsor: The University of Texas at Dallas ### Study Description The primary objective of this study is to investigate the cognitive benefits of ozanimod in individuals with Multiple Sclerosis (MS). The study aims to understand the neural basis of cognitive improvement in Relapsing-Remitting MS patients under ozanimod treatment using neuroimaging and behavioral techniques to characterize the brain and behavioral changes due to ozanimod treatment. ### Conditions - Multiple Sclerosis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Ozanimod ### Outcomes Primary Outcomes - Change in Processing Speed/Symbol-Digit Modality Test (SDMT) Performance Secondary Outcomes - Change in Volumetric Blood-Oxygen-Level-Dependent (BOLD) signal as Measured by Dual Echo Functional Magnetic Resonance Imaging (fMRI) - Change in Cerebral Blood Flow (CBF) as Measured by Dual Echo Functional Magnetic Resonance Imaging (fMRI) - Change in Cerebral Metabolic Rate of Oxygen (CMRO2) as Measured by Dual Echo Functional Magnetic Resonance Imaging (fMRI) - Change in Whole Brain Volume as Measured By Structural Magnetic Resonance Imaging - Differences in Diffusion parameters of ozanimod-responders to non-responders as Measured By a Diffusion Kurtosis Resonance Imaging (DKI) ### Location - Facility: Center for Brain Health, Dallas, Texas, 75228, United States @@
## Different Surgical Drilling Protocols in Posterior Maxilla - NCT ID: NCT06334081 - Study ID: A02040230S - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-06-29 - Completion Date: 2024-06-30 - Lead Sponsor: Mansoura University ### Study Description Sixteen dental implants inserted in sixteen patients who were selected from the outpatient clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University, for the rehabilitation of missed single maxillary posterior tooth by an immediately loaded dental implants ### Conditions - Missing Teeth ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - undersized drilling technique - single drilling technique ### Outcomes Primary Outcomes - bone density measurement - marginal bone loss Secondary Outcomes ### Location - Facility: Heba Elsheikh, Mansoura, N/A, N/A, Egypt @@
## SHOrt-term Glycemic Control for Reducing Post-SURGical Complications - NCT ID: NCT06334068 - Study ID: MS.24.03.2725 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-10 - Lead Sponsor: Mansoura University ### Study Description Perioperative dysglycemia-hyperglycemia, hypoglycemia, and glycemic variability-is associated with an increased risk for adverse outcomes. Several studies have reported the association between elevated preoperative HbA1c and postoperative complications.There are no studies that confirm that postponing elective surgery improves patient outcomes. Likewise, no prospective trials have studied whether short-term glycemic control reduces postoperative complications and unnecessary patient delays in elective surgeries.Consequently, we designed a randomized controlled trial to investigate the effects of short-term glycemic control before major abdominal surgery on postoperative morbidity and mortality. ### Conditions - Diabetes - Uncontrolled Diabtetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Short-term glycemic control group - Standard-of-care group ### Outcomes Primary Outcomes - Number of days at home after surgery (DAH-30). Secondary Outcomes - Loss of follow-up after surgery - Loss of follow up after the clinic preoperative assessment - 30-day mortality - Length of hospital stay - incidence of postoperative complications - Quality of Recovery15 (QoR-15) ### Location - Facility: Moataz Maher Emara, Mansoura, Aldakahlia, 35516, Egypt @@
## [Trial of device that is not approved or cleared by the U.S. FDA] - NCT ID: NCT06334055 - Study ID: CIP-1091 - 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 @@
## Examination of the Effects of Chromium Levels on Glucose Metabolism, Lipid Metabolism, Morbidity and Mortality Rates in Patients Followed in Intensive Care Unit - NCT ID: NCT06334042 - Study ID: GO 23/488 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2024-09-01 - Lead Sponsor: Oguzhan Kahveci ### Study Description The goal of this observational study is to learn about the effects of chromium serum levels on glucose metabolism, lipid metabolism, morbidity and mortality rates in critically ill intensive care patients. The investigators' goal is to provide a different perspective on solving the common problems of hyperglycemia and dyslipidemia encountered in intensive care patients, aiming to reduce morbidity and mortality rates.Participants will give a single blood sample (into trace element serum tube) on the day of admission to the intensive care unit, along with routine blood tests, and samples will be taken once a week during their stay in the intensive care unit. ### Conditions - Chromium Deficiency - Diabetes Mellitus - Hyperlipidemias - Hypercholesterolemia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Serum Chromium Level ### Outcomes Primary Outcomes - Serum Chromium Level Secondary Outcomes - HbA1c - Blood Glucose - Lipid Profile ### Location - Facility: Hacettepe University, Ankara, N/A, 06230, Turkey @@
## Observational Study of the Structural-functional Connectome in Patients With Epilepsy - NCT ID: NCT06334029 - Study ID: 12.2022 - Status: RECRUITING - Start Date: 2023-06-22 - Completion Date: 2026-12-31 - Lead Sponsor: IRCCS Eugenio Medea ### Study Description Over the past decade, the concept of the brain as a complex network has extremely influenced the way regarding how the latter is studied (Bartolomei et al., 2017). The structure of both structural and functional networks within the brain has been related to optimal brain functioning (Duma et al., 2022). This evolution of methods and approaches of investigation has directly impacted the study of epilepsy. An early conception of focal epilepsy was that it was related to the activity of the epileptogenic zone, which was identified as the generative element of seizures. However, what was previously considered focal was found to be network alterations at various levels, thus moving from the epileptogenic zone to the concept of the epileptogenic network. Alterations in both the structural and functional network, compared with a healthy control population, have been identified in various forms of epilepsy from focal to idiopathic generalized epilepsy (Lariviere et al., 2022, Zhang et al., 2009). Often the identification and removal of the epileptogenic network, turns out to be the elective therapy in drug-resistant focal epilepsies. The process of diagnosing and defining the epileptogenic network is still debated today. One of the most widely used methods is the implantation of intracranial electrodes for electroencephalographic recording of seizures (Bartolomei et al., 2017). This methodology carries with it several, albeit controlled, risks to the patient. New noninvasive approaches are being developed seeking to integrate information from structural neuroimaging and cortical electrical activity measured by high-density electroencephalography with external electrodes (Duma et al., 2021). These new approaches also include simulative approaches that exploit individualized information such as cortex geometry and patient-specific white matter connections (Courtiol et al. 2020). Thus, starting from a simple structural and diffusion MRI, which is done in routine clinical examinations, multiple localizing hypotheses of the epileptogenic network can be tested using simulative models and then compared with the real EEG signal as validation. Of great relevance is also to understand how the structural-functional connectome relates to cognitive function in patients with epilepsy, who have a high probability of presenting impaired functioning in one or more cognitive domains. ### Conditions - Epilepsy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Functional and structural Connectome ### Outcomes Primary Outcomes - Identification of regional alteration in the value of functional connectivity Secondary Outcomes - Measuring the spread of the epileptogenic network ### Location - Facility: IRCCS E.Medea, Conegliano, Treviso, 31015, Italy @@
## Evaluating the Delivery and Effects of THC Vaping Liquids in the Bloodstream - NCT ID: NCT06334016 - Study ID: I-3597023 - Status: NOT_YET_RECRUITING - Start Date: 2025-03-27 - Completion Date: 2028-03-01 - Lead Sponsor: Roswell Park Cancer Institute ### Study Description This clinical trial assesses differences in the delivery of THC to the bloodstream depending on whether nicotine vapes are used before or after THC. While there has been much recent publicity about vaping products and concern about their safety considering their increasing use for THC administration, the THC delivery profile associated with THC liquid vaping products in human subjects is currently unknown. Importantly, how the delivery to the bloodstream of THC vaping liquids compare to delivery from smoked cannabis, which is the most used method of cannabis delivery, will serve as an important benchmark for evaluating the delivery and effects of THC vaping products, and their relative safety. ### Conditions - Cannabis Dependence ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Biospecimen Collection - Cannabis sativa Extract - Nicotine - Placebo Administration - Questionnaire Administration ### Outcomes Primary Outcomes - Maximum concentration of THC in plasma (Cmax) - Area under the plasma concentration-time curve from 0-360 minutes (AUC0-360) - Time to maximum concentration of THC in plasma (Tmax) Secondary Outcomes - Incidence of adverse events (AEs) - Puffing behaviors - Puffing behaviors - Short-term drug effects - Marijuana Withdrawal Checklist [MWC) - Digit Symbol Substitution Task (DSST) - Paced Auditory Serial Addition Task (PASET) - Tobacco Craving Questionnaire (Short Form) ### Location - Facility: Roswell Park Cancer Institute, Buffalo, New York, 14263, United States @@
## Cardiometabolic Function in Offspring, Mother and Placenta After Assisted Reproductive Technology - NCT ID: NCT06334003 - Study ID: H-23071266 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-12-01 - Lead Sponsor: Rigshospitalet, Denmark ### Study Description The overall objective is to establish the first-of-its-kind longitudinal cohort of pregnant women, biological fathers/partners and offspring from pregnancies achieved by frozen embryo transfer (FET), fresh-embryo transfer (fresh ET) and naturally conceived (NC) to investigate maternal cardiometabolic profiles, fetal growth patterns and placental function during pregnancy as well as metabolic and endocrine health in the offspring. Additionally, the aim is to explore genetic and epigenetic patterns in placenta, fetus and parents. As secondary objectives, the investigator group will examine telomere length and minipuberty hormones in children born after FET, fresh-ET and NC. ### Conditions - ART - IVF - Children, Only - Cardiovascular Disease Other ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Offspring body composition - Maternal cardiometabolic profile Secondary Outcomes - Epigenetic in placenta and cord blood - Early markers of reproductive function in FET, fresh-ET and NC children: LH, FSH, SHBG, AMH, androgens, estrogens (SDS) - Telomere length in children born after FET, fresh-ET and NC children ### Location - Facility: Fertility Clinic, Rigshospitalet, Copenhagen University Hospital, Copenhagen, N/A, 2100, Denmark @@
## Quetiapine to Reduce Post Concussive Syndrome After Mild Traumatic Brain Injury (mTBI) - NCT ID: NCT06333990 - Study ID: 20220796HU - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2028-03 - Lead Sponsor: Foundation for Advancing Veterans' Health Research ### Study Description A two site, 2-arm, Phase III randomized pragmatic clinical trial evaluating the effectiveness of quetiapine monotherapy in comparison to Treatment As Usual (TAU) medication management for symptoms experienced by veterans receiving rehabilitation therapy for mild traumatic brain injury (mTBI) and comorbid symptoms of posttraumatic stress disorder (PTSD). ### Conditions - Mild Traumatic Brain Injury ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Quetiapine Fumarate - TAU ### Outcomes Primary Outcomes - Neurobehavioral Symptom Inventory - World Health Organization Disability Assessment Scale - World Health Organization Quality of Life BREF Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study of LC542019 in Healthy Subjects and Subjects With T2DM - NCT ID: NCT06333977 - Study ID: LG-GQCL001 - Status: COMPLETED - Start Date: 2022-03-25 - Completion Date: 2023-12-14 - Lead Sponsor: LG Chem ### Study Description to assess the safety, tolerability, Pharmacokinetics and Pharmacodynamics in healthy subjects and subjects with type 2 diabetes (T2DM). ### Conditions - Healthy - Diabetes Mellitus, Type 2 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - LC542019 - Placebo ### Outcomes Primary Outcomes - Incidence, severity of adverse events Secondary Outcomes - Maximum Concentration (Cmax) in Plasma - Renal Clearance (CLR) in urine ### Location - Facility: PPD Development, LP (PPD Clinical Research Unit, Las Vegas), Las Vegas, Nevada, 89113, United States @@
## Phase III Clinical Trial to Evaluate the Efficacy and Safey of AST-001 in ASD Children - NCT ID: NCT06333964 - Study ID: AST-001P_P301_ASD - Status: RECRUITING - Start Date: 2023-08-29 - Completion Date: 2024-12-31 - Lead Sponsor: Astrogen, Inc. ### Study Description 1. Study purpose: To demonstrate the superiority of AST-001 compared to placebo in improving core symptoms of autism spectrum disorder (ASD) in children with ASD.2. Background: ASD is a neurodevelopmental disorder characterized by deficits in social communication and social interaction as well as restricted, repetitive patterns of behavior, interests, or activities. There are no approved medicines to treat the core symptom of ASD. Although these drugs and other psychotropic medications are associated with side effects, the use of psychotropic drugs to treat associated psychiatric comorbidities is common. AST-001 is developed to treat the core symptom of ASD.3. Design: Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 clinical trial followed by an Open-Label Extension Treatment Period ### Conditions - Autism Spectrum Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - AST-001 - Placebo of AST-001 ### Outcomes Primary Outcomes - K-VABS-II (Korean-Vineland Adaptive Behavior Scale-II) Secondary Outcomes - CGI (Clinical Global Impression) - SRS-2 (Social Responsiveness Scale-2) - K-PSI-4-SF (Korean-Parenting Stress Index-4th Edition Short Form) ### Location - Facility: Soon Chun Hyang University Hospital Cheonan, Cheonan, Chungcheongnam-do, N/A, Korea, Republic of @@
## AMG 193 Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol) - NCT ID: NCT06333951 - Study ID: 20230167 - Status: RECRUITING - Start Date: 2024-06-03 - Completion Date: 2029-10-07 - Lead Sponsor: Amgen ### Study Description The study aims to determine maximum tolerated dose (MTD) or recommended combination dose of the MTA-cooperative PRMT5 inhibitor AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-deleted thoracic tumors. The study also aims to determine the safety profile of AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced MTAP-deleted thoracic tumors. ### Conditions - Thoracic Tumors - Non-small Cell Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - AMG 193 - Carboplatin - Paclitaxel - Pembrolizumab - Pemetrexed - Sotorasib ### Outcomes Primary Outcomes - Number of Participants Experiencing Dose Limiting Toxicities (DLT) - Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE) - Number of Participants Experiencing Serious Adverse Events (SAE) Secondary Outcomes - Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) - Disease Control (DC) per RECIST v1.1 - Duration of Response (DOR) per RECIST v1.1 - Time to Response (TTR) per RECIST v1.1 - Overall Survival (OS) per RECIST v1.1 - Progression-free Survival (PFS) per RECIST v1.1 - Maximum Plasma Concentration (Cmax) of AMG 193 - Time to Maximum Plasma Concentration (tmax) of AMG 193 - Area Under the Plasma Concentration-time Curve (AUC) of AMG 193 - Intracranial objective response (IOR) per Response Assessment in Neuro Oncology Brain Metastases (RANO-BM ) - Intracranial Disease Control (IDC) per RANO-BM - Intracranial Duration of Response (IDOR) per RANO-BM - Time to Intracranial Radiation Therapy per RANO-BM ### Location - Facility: City of Hope (COH), Duarte, California, 91010, United States @@
## Veterans Enhanced Recovery Using Integrative Treatments Around Surgery - NCT ID: NCT06333938 - Study ID: 01968 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2025-06 - Lead Sponsor: Durham VA Medical Center ### Study Description The study aims to assess the effectiveness of NSS2-Bridge in postoperative pain management in comparison to Battlefield Acupuncture (BFA). ### Conditions - Anesthesia - Surgery - Knee Arthropathy ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Bridge - BFA ### Outcomes Primary Outcomes - Pain and Pain Interference assessed among patients using the Defense veterans pain rating scale 2.0 - Heart Rate Variability among Patients as assessed using time and frequency domain analysis of the heart rate. - Implementation of Treatment among Patients as assessed by the Acceptability of Intervention, Appropriateness of Intervention, and Feasibility of Intervention Measures. - Fidelity of Treatment among Patients as assessed by a Fidelity Checklist - Implementation of Treatment among Providers as assessed by the Acceptability of Intervention, Appropriateness of Intervention, and Feasibility of Intervention Measures. - Fidelity of Treatment among Providers as assessed by a Fidelity Checklist Secondary Outcomes - Amount of Opioid medication received by patients assessed in average daily oral morphine equivalents. - Quality of Recovery among patients as measured using the Quality-of-Recovery 40 tool. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Using Neurostimulation to Accelerate Change in Misophonia: a Pilot Study - NCT ID: NCT06333925 - Study ID: Pro00114183 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-10-31 - Lead Sponsor: Duke University ### Study Description Misophonia, the inability to tolerate certain repetitive distressing sounds that are common, is gaining, recognition as an impairing condition. It is not a well-understood condition and there are no known treatments. The purpose of this study is to test a new misophonia intervention that uses emotion regulation strategies and different types of brain stimulation on misophonic distress. This study will examine changes in brain activity during presentation and regulation of misophonic versus distressing sounds. The study team plans to alter activity in a key area of the brain responsible for emotion regulation circuitry over 4 sessions with the goal to test if this intervention helps misophonic distress.Sixty adult participants with moderate to severe misophonia will be recruited and taught an emotion regulation skill and randomly assigned to receive one of two types of repetitive transcranial magnetic stimulation (rTMS). The study includes 9-10 visits: the remote screening visit(s), the initial MRI, the four neurostimulation sessions, the follow-up MRI, and two additional remote 1- and 3-month follow-up visits. ### Conditions - Misophonia - Emotion Dysregulation - Sensory Processing Disorder - Auditory Over Responsivity - Anxiety Disorder - Sound Sensitivity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - High Frequency Repetitive Transcranial Magnetic Stimulation (HF rTMS) - Sham Repetitive Transcranial Magnetic Stimulation (sham- rTMS) - Cognitive Restructuring ### Outcomes Primary Outcomes - Number of clusters across the whole brain with significant BOLD changes between conditions contrasting follow up with intake, and exposure to misophonic versus aversive sounds - Number of clusters across the whole brain with significant BOLD changes between conditions contrasting follow up with intake, and downregulation of versus exposure to misophonic sounds - Differential change in BOLD signal within the Anterior Insular Cortex (AIC) activation when being presented with misophonic versus non-misophonic but aversive sounds - Differential change in BOLD signal connectivity between the left Anterior Insular Cortex (AIC) and the right dorsolateral prefrontal cortex (dlPFC) when downregulating versus experiencing distress related to misophonic trigger sounds - Change in misophonia impairment and severity using a composite - Skin conductance level (scl) - Change in Subjective Unites of Distress (SUDS) Secondary Outcomes - Changes in self-reported psychopathology - Changes in clinician-assessed psychopathology - Emotional dysregulation as measured by the Difficulties in Emotion Regulation Scale (DERS) ### Location - Facility: Duke University Medical Center, Durham, North Carolina, 27710, United States @@
## Accuracy of Guided Ridge Splitting With Simultaneous Implant Placement - NCT ID: NCT06333912 - Study ID: ridgesplittingguided - Status: COMPLETED - Start Date: 2023-08-02 - Completion Date: 2024-02-27 - Lead Sponsor: Alexandria University ### Study Description Assessing whether is there a difference between computer-guided ridge splitting and conventional technique with simultaneous implant placement in patients with maxillary width deficiency. ### Conditions - Dental Implant ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - dental implant placement with ridge splitting. ### Outcomes Primary Outcomes - Assessing the accuracy of guided surgery Secondary Outcomes - the bone-width increase between control and study group. ### Location - Facility: Alexandria University, Faculty of dentistry, Alexandria, N/A, 21619, Egypt @@
## Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion - NCT ID: NCT06333899 - Study ID: CONNECT2111 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-01 - Completion Date: 2034-09-01 - Lead Sponsor: Nationwide Children's Hospital ### Study Description The goal of this study is to determine the response of the study drug loratinib in treating children who are newly diagnosed high-grade glioma with a fusion in ALK or ROS1. It will also evaluate the safety of lorlatinib when given with chemotherapy or after radiation therapy. ### Conditions - High Grade Glioma - Diffuse Intrinsic Pontine Glioma - Anaplastic Astrocytoma - Infant Type Hemispheric Glioma - Glioblastoma - Glioblastoma Multiforme - WHO Grade III Glioma - WHO Grade IV Glioma - Diffuse Midline Glioma, H3K27-altered ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Lorlatinib - Lorlatinib with chemotherapy1 - Lorlatinib with chemotherapy 2 - Lorlatinib post Radiation ### Outcomes Primary Outcomes - Disease Control Rate - Number of participants with lorlatinib-related adverse events as assessed by CTCAE v5.0 Secondary Outcomes - Objective Response Rate (ORR) in HGG - Overall Survival (OS) in HGG - Progression-Free Survival in HGG ### Location - Facility: Children's Hospital Colorado, Aurora, Colorado, 80045, United States @@
## Use of Point-of-care Neuro-sacral Electrophysiology Following Spinal Cord Injury - NCT ID: NCT06333886 - Study ID: ciusss-nordmtl_ESG - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-18 - Completion Date: 2028-12-31 - Lead Sponsor: Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal ### Study Description Assessing the sacral nerves is an integral aspect of the evaluation after a spinal cord injury. Being located at the lower end of the spinal cord, the sacral nerves reflect how signals travel through the injured spinal cord. Sacral assessment is therefore essential to determine the level and severity of the spinal cord injury, which helps selecting the proper treatment and predicting recovery (worse when abnormal sacral function. The current assessment relies solely on a manual evaluation, which depends heavily on the physician's experience and does not provide any quantitative value of the dysfunction. The lack of a quantitative method adapted to the clinical setting is a major barrier limiting our knowledge on the impact of sacral function on recovery. We have recently developed an electrophysiological method providing quantitative sacral assessment at bedside after spinal cord injuries. Using this method, we will quantify sacral function in 250 patients with acute spinal cord injuries, and determine its association with recovery 6 months post-injury. We hypothesize that sacral function assessed early within the first 6 weeks after the injury with our method is associated with a better 6-month recovery of motor, sensory, bowel and bladder function. Our objectives are to assess the changes is sacral function during the first 6 months after the injury, and the relationship between early sacral function and 6-month recovery. Sacral function and recovery will be assessed up to 6 months post-injury by the attending physician, in order to measure the electromyographic magnitude of voluntary anal contraction, electromyographic magnitude of anal contraction elicited through sacral reflex testing, and minimal electrical stimulation for which anal sensation is present. The analysis will determine if and how sacral function evolves in time, and if there are specific quantitative criteria of sacral function that physicians can use to determine if patient will have a favorable recovery. ### Conditions - Spinal Cord Injuries - Neurogenic Bowel - Neurogenic Bladder Dysfunction ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Sacral electromyography ### Outcomes Primary Outcomes - Precise assessment and evaluation of neuro-sacral dysfunction Secondary Outcomes - Assessment of clinical phenotypes - Clinical prognosis assessment ### Location - Facility: Hôpital du Sacré-Coeur de Montréal, Montréal, Quebec, H4J 1C5, Canada @@
## Impact of Age-related Macular Degeneration on Daily Living Activitie - NCT ID: NCT06333873 - Study ID: P22-09 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2029-06 - Lead Sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts ### Study Description The complex and variable course of age-related diseases makes it all the more necessary to carry out personalised, reasoning-based examinations to improve the personalised assessment and management of AMD. However, functional assessment of AMD is most often based solely on visual acuity, and classifications of AMD are based solely on structural markers. There is therefore a need to improve the detection and functional assessment of this vision-threatening eye disease, by complementing and extending the standard assessments of clinical outcomes (COA) ### Conditions - Age-Related Macular Degeneration ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - patient-reported outcome ### Outcomes Primary Outcomes - Validity of criteria - Validity of content - Reproducibility of results Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study to Learn How Safe and Effective Risankizumab is When Compared to Deucravacitinib to Treat Participants With Moderate Plaque Psoriasis and Who Need to Try Systemic Treatment (Works Throughout the Whole Body) - NCT ID: NCT06333860 - Study ID: M24-541 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-07 - Completion Date: 2026-03-31 - Lead Sponsor: AbbVie ### Study Description Psoriasis is a long-term skin disease which causes red, itchy, scaly patches most commonly on the knees, elbows, scalp, and torso (chest, back, and abdomen). In participants with psoriasis, certain skin cells multiply much faster and the skin can develop rough patches that may be red or white with scales. There are many types of psoriasis, but plaque psoriasis is the most common. The exact cause of psoriasis is unknown, but researchers think it may be caused by the body's immune system not working properly.This study is designed to enroll 336 participants 18 years of age and older with have been diagnosed with moderate chronic plaque psoriasis for at least 6 months prior to Baseline (Day 1) and who have not previously been treated with a biologic treatment (natural substance that is made by using living cells in a laboratory). This is a Phase 4, randomized, open-label, assessor blinded, active comparator study with 2 Parts. Phase 4 studies test treatments that have already been approved to treat patients with a condition or disease. This study is open-label, which means that both participants and study doctors know which study treatment is given to participantsParticipants will be administered subcutaneous (SC) treatment of risankizumab every 12 weeks for up to 44 weeks or provided deucravacitinib oral tablets to be taken once daily.There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular (weekly, monthly) visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. ### Conditions - Moderate Plaque Psoriasis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Risankizumab - Deucravacitinib ### Outcomes Primary Outcomes - Period A: Percentage of Participants Achieving 90% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 90) - Period A: Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of 0 (Clear) or 1 (Almost Clear) with at least 2-grade improvement from Baseline - Period B: Percentage of Participants Achieving 90% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 90) in the Intent to Treat Population for non-responders in Period B (ITT_B_NR). Secondary Outcomes - Period A: Percentage of Participants Achieving 100% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 100) - Period A: Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of 0 with at least 2-grade improvement from Baseline - Period B: Percentage of Participants Achieving 100% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 100) among participants in the ITT_B_NR Population - Period B: Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of 0 with at least 2-grade improvement from Baselineamong participants in the ITT_B_NR Population. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Is Multimorbidity a Source of Non-response Bias in Patients With Spinal Pain? - A Pilot Study - NCT ID: NCT06333847 - Study ID: K2023-059 - Status: ENROLLING_BY_INVITATION - Start Date: 2023-06-01 - Completion Date: 2024-04-20 - Lead Sponsor: Jacob Christiansen Gandløse ### Study Description The purpose of this study is to investigate whether the number of chronic diseases, the treatment burden resulting from multimorbidity, and health-related quality of life contribute to non-response bias in individuals with chronic back pain. Data is collected from patients at Aalborg University Hospital's Rheumatology Department through electronic means and medical records. The statistical analyses consist of two wave analyses, where we examine differences between patients who respond to invitations to participate in the study based on their response patterns; whether they respond after the first, second, or third invitation. Based on baseline data, a one-way ANOVA is conducted to identify any between-group differences in the aforementioned factors, followed by a repeated measures ANOVA to assess if there are differences between the groups over time. Finally, statistical tests are also performed to examine differences in age and gender distribution between those who complete the questionnaires at baseline compared to those who do not respond to the invitation to participate. ### Conditions - Back Pain - Low Back Pain - Neck Pain - Comorbidities and Coexisting Conditions ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Multimorbidity Treatment Burden Questionnaire (MTBQ). Secondary Outcomes - Health-related quality of life (EQ-5D-5L) ### Location - Facility: Aalborg University Hospital, Aalborg, N/A, 9000, Denmark @@
## Assessment of the Efficacy of Scorpion Antivenom Therapy in a Dose-response Manner, in Patients With Scorpionism - NCT ID: NCT06333834 - Study ID: Dosis Seriada de Alacramyn - Status: NOT_YET_RECRUITING - Start Date: 2024-03-30 - Completion Date: 2024-08-30 - Lead Sponsor: Selene Guadalupe Huerta Olvera ### Study Description The clinical study aims to compare the effectiveness of applying two different regimens of scorpion antivenom therapy. In the first regimen (control), the medication is administered to all patients, and depending on the severity of the condition, the dosage varies. In the experimental regimen, an identical dose of scorpion antivenom is administered to patients exhibiting signs and symptoms of scorpion sting intoxication, in addition to pain and other symptoms at the sting site. The primary response variable is the time taken for signs and symptoms to resolve, but differences in complications, adverse effects, venom and antivenom concentration in the blood, and the need for other therapeutic measures are also evaluated. ### Conditions - Centruroides Envenomation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Traditional scorpion antivenom regimen - Serial dose of scorpion antivenom regimen ### Outcomes Primary Outcomes - Time to resolution of signs and symptoms - Serum venom concentration Secondary Outcomes - Mortality - Length of intrahospital stay - Serum antivenom concentration ### Location - Facility: Servicios Médicos Municipales de San Pedro Tlaquepaque., Tlaquepaque, Jalisco, 45560, Mexico @@
## A Study of Nimotuzumab Plus Concurrent Chemoradiotherapy Sequential Maintenance Treatment for Cervical Carcinoma - NCT ID: NCT06333821 - Study ID: BPL-Nim-CC-3003 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2030-04-01 - Lead Sponsor: Biotech Pharmaceutical Co., Ltd. ### Study Description The purpose of this study is to evaluate the efficacy and safety of nimotuzumab plus concurrent chemoradiotherapy sequential maintenance therapy versus placebo combined with concurrent chemoradiotherapy in patients with locally advanced cervical squamous cell carcinoma.The primary hypotheses are that nimotuzumab plus concurrent chemoradiotherapy sequential maintenance therapy is superior to placebo plus concurrent chemoradiotherapy with respect to progression-free survival. ### Conditions - Cervical Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Nimotuzumab - Cisplatin - External Beam Radiotherapy (EBRT) - Brachytherapy - placebo for Nimotuzumab ### Outcomes Primary Outcomes - Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed Blinded Independent Central Review (BICR) Secondary Outcomes - Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by by the Investigator - 3-,5-Year Overall Survival (OS) - 3-,5-Year Disease Free Survival(DFS) - 3-,5-Year Locoregional Recurrence-Free Survival(LRRFS) - 3-,5-Year Distant Metastasis-free Survival (DMFS) - Tumor Regression Rate(TRR) - Complete Response Rate - Complete Response Rate - Objective Response Rate - Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status Score - Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Symptom Specific Scale for Cervical Cancer (EORTC QLQ-CX24) Score - Incidence of Treatment-Emergent Adverse Events ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy - NCT ID: NCT06333808 - Study ID: GS-US-621-6290 - Status: RECRUITING - Start Date: 2024-03-25 - Completion Date: 2029-12 - Lead Sponsor: Gilead Sciences ### Study Description The goal of this clinical study is to learn more about the effects of switching to the study drugs, bictegravir (BIC)/lenacapavir (LEN), fixed-dose combination (FDC) versus current therapy bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) FDC in people living with HIV-1 (PWH).The primary objective of this study is to learn how effective it is to switch to BIC/LEN FDC tablets versus continuing on B/F/TAF FDC tablets in virologically suppressed PWH. ### Conditions - HIV-1-infection ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Bictegravir - Lenacapavir - B/F/TAF - Placebo to match B/F/TAF - Placebo to match BIC/LEN ### Outcomes Primary Outcomes - Proportion of Participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm Secondary Outcomes - Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm - Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 48 - Treatment Group 1: Proportion of Participants with HIV-1 RNA ≥ 50 copies/mL at Week 96 as Determined by the US FDA-defined Snapshot Algorithm - Treatment Group 1: Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 96 as Determined by US FDA-defined Snapshot Algorithm - Treatment Group 1: Change from Baseline in CD4 Cell Count at Week 96 - Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) through Week 48 - Treatment Group 1: Percentage of Participants Experiencing Treatment-Emergent AEs through Week 96 ### Location - Facility: Ruane Medical and Clinical Research Institute, Los Angeles, California, 90036, United States @@
## Faecal Microbiota Transplantation Against Chronic Diarrhea in Patients With Systemic Sclerosis - NCT ID: NCT06333795 - Study ID: 1-10-72-131-23 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-12-31 - Lead Sponsor: University of Aarhus ### Study Description This clinical trial aims to assess the safety and effectiveness of faecal Microbiota Transplantation (FMT) in improving chronic diarrhea symptoms among patients with systemic sclerosis. ### Conditions - Diarrhea - Systemic Sclerosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Faecal Microbiota Transplantation (FMT) - Placebo ### Outcomes Primary Outcomes - Number of adverse events (AE) severity grade 2 or more assessed by CTCAE v5.0. during the first week after intervention (FMT or placebo). Secondary Outcomes - Patient-reported treatment outcome on symptoms - Patient-reported measures from the schedule of side effects and telephone call 1 week after each intervention. - Patient-reported outcomes from questionnaires. - Patient-reported outcomes from questionnaires. - Patient-reported outcomes from questionnaires. - Patient-reported overall symptom burden - Objective measures from the wireless motility capsule. - Objective measures from the wireless motility capsule. - Objective measures from the wireless motility capsule. - Objective measures from the wireless motility capsule. - Objective measures from the low-dose CT scan. - Breath Test - Faecal microbiota composition - Faecal-calprotectin - Blood plasma proteomics - Blood plasma Fibrosis markers - Blood parameters - Health-related Quality of life - Patient perception of FMT treatment satisfaction ### Location - Facility: Aarhus University Hospital, Aarhus, N/A, N/A, Denmark @@
## Evaluation of the Safety and Efficacy of Hyaluronic Acid Injection in Labia Majora Augmentation - NCT ID: NCT06333782 - Study ID: 2023-EU-GEN-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-31 - Completion Date: 2025-07-01 - Lead Sponsor: Bioscience Cosmetics SL ### Study Description The goal of this interventional clinical investigation using Genefill Contour® CE marked device outside of its indication is to compare with other hyaluronic acid device already marketed for labia majora augmentation in women with labia majora hypotrophy/atrophy.The primary objective is the evaluation of the safety of Genefill Contour®. The secondary objectives is effectivenes of the investigational device (improvement of patient´s symptoms, patient´s satisfaction, sexual function \& pain during injection).Participants will come to a total of 8 visits (including 2 phone calls) over a period of 12 months. Participants would be enrolled in Genefill Contour® or comparator group.An ancillary study would be conducted in a cohort of participants evaluating the increase in volume and distance between labia after HA injection ### Conditions - Vulvar Atrophy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Experimental- Genefill Contour® - Marketed comparator - Desirial®Plus ### Outcomes Primary Outcomes - Mean of number of occurred ADEs (Adverse device effects) Secondary Outcomes - Global Aesthetic Improvement Scale (GAIS) assessment by investigator - Global Aesthetic Improvement Scale (GAIS) assessment by participant - Patient (Atrophy/Hypotrophy) symptoms - Sexual function Assessment, The Female Sexual Function Index (FSFI) - Patient´s satisfaction - Pain during injection-Visual Analogical Scale (VAS) - Adverse Events collection (Global safety during the study period) ### Location - Facility: Cabinet renaissance, Levallois-Perret, Paris, 92300, France @@
## A Phase II Multicenter Clinical Study of Improved Short-course Radiotherapy Combined With CAPOX and PD-1 Monoclonal Antibody for Locally Advanced Mid-low Rectal Cancer - NCT ID: NCT06333769 - Study ID: CATIMOR - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2026-12-01 - Lead Sponsor: Fujian Cancer Hospital ### Study Description To explore the complete response (CR) rate of improved short-course radiotherapy combined with CAPOX and tislelizumab for locally Advanced Mid-low Rectal Cancer ### Conditions - Mid-low Rectal Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Short-course Radiotherapy - Tislelizumab - capecitabine - Oxaliplatin ### Outcomes Primary Outcomes - complete response (CR) rate Secondary Outcomes - 3y-DFS ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effects of Muscle Strengthening and Fatigue on Activities in Cortex and Muscle - NCT ID: NCT06333756 - Study ID: YM110099E - Status: COMPLETED - Start Date: 2021-05-01 - Completion Date: 2022-08-01 - Lead Sponsor: National Yang Ming University ### Study Description We will explored the effect of cross education training on different cortex functional connectivity, cortex and muscle functional connectivity, and maximal voluntary contraction.Healthy participants receive cross education training of the elbow flexor (12 rep./set, 3sets, 60%MVC, 180°/s, eccentric).Maximal voluntary contraction, electroencephalogram and electromyogram will record during cross education tasks to determine the effects of cross education training on cortical network and muscle functional connectivity ### Conditions - Healthy Adults ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Cross education ### Outcomes Primary Outcomes - Corticocortical coherence - Corticomuscular coherence - Maximal voluntary contraction Secondary Outcomes ### Location - Facility: National Yang-Ming University, Taipei, N/A, 112, Taiwan @@
## Laser Ablation in the Treatment of High-grade Cervical Lesions - NCT ID: NCT06333743 - Study ID: ZhuLan - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-05 - Lead Sponsor: Peking Union Medical College Hospital ### Study Description Cervical laser ablation is an effective, minimally invasive treatment with a low incidence of perinatal complications and minimal impact on fertility. Research has confirmed that laser ablation treatment of cervical HSIL (including CIN2 and CIN3) is effective and feasible and is useful for young CIN3 patients who wish to get pregnant in the future. There have been no randomized clinical trials of laser ablation therapy for cervical HSIL in Chinese women. This study focuses on the application of laser ablation in the treatment of cervical HSIL, explores the efficacy, feasibility, and safety of laser ablation in the treatment of cervical HSIL, and strives to promote the reasonable application of laser ablation in the treatment of cervical HSIL. ### Conditions - High-Grade Squamous Intraepithelial Lesions ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - laser ablation - LEEP or Conization ### Outcomes Primary Outcomes - the rate of HSIL recurrence Secondary Outcomes - the satisfaction with the treatment - the length of the cervix - Psychological state change related to the treatment ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparison of Anesthetic Efficacy of Mental Nerve Block Versus Inferior Alveolar Nerve Block in Mandibular Anterior Teeth and Premolars in Symptomatic Irreversible Pulpitis - NCT ID: NCT06333730 - Study ID: PMC - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-06-20 - Lead Sponsor: Prime Foundation ### Study Description Symptomatic irreversible pulpitis is a painful condition that requires anesthesia to perform effective dental procedures. The mental nerve block and inferior alveolar nerve block are two commonly used techniques for achieving anesthesia in the mandibular teeth.Study design: This randomized clinical trial study Number of participants: 96 participants which will be randomly divided into two groups: MINB and IANB.Inclusion criteria: Participants with mandibular premolars or lower anterior experiencing sharp and persistent pain in response to thermal stimuli and an electric pulp tester, as well as bleeding during access opening, will be included.Exclusion criteria: Participants with a medical history, allergies or contraindications to the local anesthetic, pregnant or breastfeeding women, those taking pain-affecting medication, or those experiencing pain in more than one tooth will be excluded.Both techniques will use 2% lidocaine and adrenaline 1:80,000. Age, gender, and the efficacy of anesthesia will be recorded in both groups. The chi-square test will be used for comparison. ### Conditions - Symptomatic Irreversible Pulpitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - inferior alveolar nerve block - mental nerve block ### Outcomes Primary Outcomes - COMPARISON OF ANESTHETIC EFFICACY OF MENTAL NERVE BLOCK VERSUS INFERIOR ALVEOLAR NERVE BLOCK IN MANDIBULAR ANTERIORS TEETH AND PREMOLARS IN SYMPTOMATIC IRREVERSIBLE PULPITIS Secondary Outcomes ### Location - Facility: Peshawar Dental College, Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan @@
## Impact of Whole Grain Rye Bread on Health - NCT ID: NCT06333717 - Study ID: Dnr 2020-03709 - Status: COMPLETED - Start Date: 2021-03-03 - Completion Date: 2021-11-05 - Lead Sponsor: Örebro University, Sweden ### Study Description This randomized controlled trial aims to study how a high intake of a fibre-rich bread affects the composition and functioning of the gut microbiota in healthy subjects, and how this, in turn, impacts on the release of gut peptides, intestinal permeability, stress and cognitive performance. ### Conditions - Healthy Diet ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Whole grain bread - Control bread ### Outcomes Primary Outcomes - Microbiota composition baseline vs after intervention using 16S RNA gene sequencing Secondary Outcomes - Microbiota composition whole grain rye bread vs control bread using 16S RNA gene sequencing - Concentrations of circulatory short-chain fatty acids SCFA - Concentrations of faecal SCFA - Concentrations of blood glucagon like peptide-1 (GLP-1) - Concentrations of blood glucagon like peptide-2 (GLP-2) - Concentrations of blood peptide YY (PYY) - Concentrations of blood gastric inhibitory polypeptide (GIP) - Concentrations of blood neuroactive peptide Y (NPY) - Concentrations of blood brain-derived neurotrophic factor (BDNF) - Concentrations of blood cytokines - Concentrations of blood alkylresorcinols - Concentrations of blood lipopolysaccharide-binding protein (LBP) - Concentrations of blood soluble CD-14 (sCD-14) - Concentrations of sugars in urine - Concentrations of saliva cortisol during stress test - Concentrations of saliva alpha-amylase during stress test ### Location - Facility: Örebro University, Örebro, N/A, N/A, Sweden @@
## Post-marketing Surveillance (PMS) Use-Result Surveillance With SPIKEVAX BIVALENT and SPIKEVAX X Injection. - NCT ID: NCT06333704 - Study ID: mRNA-1273-P924 - Status: RECRUITING - Start Date: 2023-03-10 - Completion Date: 2026-12-07 - Lead Sponsor: ModernaTX, Inc. ### Study Description The main objective of the surveillance is to evaluate the incidence of the adverse events (AEs), and other safety related information in South-Korean population. ### Conditions - SARS-CoV-2 ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - SPIKEVAX Bivalent - SPIKEVAX X ### Outcomes Primary Outcomes - Number of Participants With AEs Secondary Outcomes ### Location - Facility: Yonseimin Clinic, Wonju, Gangwon-do, 26428, Korea, Republic of @@
## Comparative Study Between Calcium Gluconate With Diosmin, Cabergoline and Cabergoline With Diosmin - NCT ID: NCT06333691 - Study ID: Aya Mohammed - Status: COMPLETED - Start Date: 2022-10-01 - Completion Date: 2024-02-15 - Lead Sponsor: Minia University ### Study Description Ovarian hyperstimulation syndrome is a potentially fatal iatrogenic condition. This syndrome is characterized by a sudden increase of the vascular permeability which results in the development of a massive extravascular exudate in the peritoneal cavity, pleural, pericardium causing ascites, pleural and pericardial effusion.Severe forms are also accompanied by electrolyte disturbances and cardiopulmonary, hepatic, renal, and hemoconcentration associated with increased thromboembolic risk.This syndrome is avoidable by the judicious use of gonadotropins and careful monitoring of stimulation regimens. ### Conditions - Ovarian Hyperstimulation Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Calcium Gluconate ### Outcomes Primary Outcomes - the incidence rate of moderate to severe OHSS. Secondary Outcomes ### Location - Facility: Minia University, Faculty of Pharmacy, Minya, N/A, N/A, Egypt @@
## A Study Comparing Sotorasib With Durvalumab in People With Non-Small Cell Lung Cancer (NSCLC) - NCT ID: NCT06333678 - Study ID: 22-321 - Status: RECRUITING - Start Date: 2024-03-20 - Completion Date: 2027-03 - Lead Sponsor: Memorial Sloan Kettering Cancer Center ### Study Description In this study, the researchers will look at whether having participants switch from durvalumab to sotorasib when they have detectable minimal residual disease (MRD) is an effective treatment approach for locally advanced non-small cell lung cancer (LA-NSCLC). The researchers will see whether this switch to sotorasib can control LANSCLC longer compared to the treatment approach of staying on durvalumab (and not switching to sotorasib). ### Conditions - Non-Small Cell Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Durvalumab - Sotorasib ### Outcomes Primary Outcomes - Progression-free survival (PFS) Secondary Outcomes - Incidence of dose-limiting toxicity (DLT) ### Location - Facility: Memorial Sloan Kettering Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, 07920, United States @@
## PPIO-007 Correlation Analysis of Type II Diabetes Mellitus on Short-term and Long-term Outcomes of Patients With Esophageal Squamous Cell Cancer Undergoing Minimally Invasive Esophagectomy - NCT ID: NCT06333665 - Study ID: Wei G - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-02-20 - Completion Date: 2024-05-20 - Lead Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University ### Study Description To date, there is controversy as to whether type II diabetes mellitus is associated with adverse short- and long-term outcomes in patients with esophageal squamous cell carcinoma undergoing minimally invasive esophagectomy. At the same time, to the best of our knowledge, the impact of metformin use and glycemic control on short- and long-term outcomes in this patient population is also controversial. Therefore, this study aims to test the hypothesis that diabetes mellitus is associated with reduced survival in patients with esophageal squamous cell carcinoma undergoing minimally invasive esophagectomy and that treatment with metformin and/or good glycemic control (HbA1c\<7.0%) is associated with improved survival. ### Conditions - Esophageal Squamous Cell Carcinoma - Surgery ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Whether there is type 2 diabetes mellitus before surgery ### Outcomes Primary Outcomes - Overall survival - Disease-free survival Secondary Outcomes - postoperative adverse events - perioperative 90-day mortality ### Location - Facility: Army Medical Center of the People's Liberation Army, Chongqing, Chongqing, 400042, China @@
## Ravulizumab in Pregnancies Complicated by Severe Hypertensive Disorders - NCT ID: NCT06333652 - Study ID: 22-009239 - Status: RECRUITING - Start Date: 2024-06-01 - Completion Date: 2028-12-31 - Lead Sponsor: Mayo Clinic ### Study Description The researchers are testing a medication named ravulizumab for the treatment of severe preeclampsia and Hemolysis, Elevated Liver enzymes, Low Platelets (HELLP) syndrome. ### Conditions - Preeclampsia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Ravulizumab ### Outcomes Primary Outcomes - Alternative Complement Pathway Biomarkers at time of delivery Secondary Outcomes - Pregnancy duration - Clinical biomarkers of severe features of preeclampsia and HELLP syndrome - Hospitalization length in the postpartum period - Meningococcal infection after use of ravulizumab ### Location - Facility: Mayo Clinic Minnesota, Rochester, Minnesota, 55905, United States @@
## Implementing Virtual Reality in the Operating Room - NCT ID: NCT06333639 - Study ID: 24Chirortho01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-10-15 - Lead Sponsor: Centre Hospitalier Universitaire de Nice ### Study Description "Recently, virtual reality has become more accessible thanks to the use of smaller, more comfortable and easier-to-use devices. Its use in operating theatres is growing.However, despite the clinical effectiveness of virtual reality in reducing pain and anxiety, there are very few feedback studies from patients on their experience of surgery and their satisfaction, especially in orthopaedics.The aim of this study is to demonstrate the superiority, during long awake orthopaedic surgery, of equipping the patient with a virtual reality headset, on patient satisfaction, compared with the same surgery without a headset.The visual support offered will be appropriate to the duration of the surgery, i.e. more than 1 hour." ### Conditions - General Surgery - Orthopedic Procedures ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - orthopaedic surgery - orthopaedic surgery and fitted with a virtual reality headset ### Outcomes Primary Outcomes - To demonstrate the superiority, during long awake orthopaedic surgery, of equipping the patient with a virtual reality headset, on patient satisfaction, compared with the same surgery without a headset. Secondary Outcomes - 1. To demonstrate the superiority, during long awake orthopaedic surgery, of equipping the patient with a virtual reality headset, on the doses of premedication, compared with the same surgeries without headset. - Evaluate the Virtual Reality device in terms of comfort when wearing the headset, visual comfort and image and scenario quality, and auditory quality ### Location - Facility: CHU NiICE, Nice, Alpes Maritimes, 0600, France @@
## Effects of an Oral Multi-vitamin Carbohydrate Beverage on Intraoperative Nausea and Vomiting - NCT ID: NCT06333626 - Study ID: 2020281 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-03-31 - Lead Sponsor: The First Affiliated Hospital of Soochow University ### Study Description Nausea and vomiting are common and unpleasant symptoms for pregnant women during cesarean section, which can lead to aspiration, a serious complication that can cause pneumonia. Our study aimed to evaluate the effects of oral multi-vitamin carbohydrate beverage on maternal intraoperative nausea and vomiting by gastric ultrasound. ### Conditions - Nausea and Vomiting, Aspiration, Intraoperative ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - multi-vitamin carbohydrate ### Outcomes Primary Outcomes - Gastric antrum area Secondary Outcomes - vomiting - The pH of vomiting fluid ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Evaluation of Acuvue Oasys 1-Day Contact Lenses in New Wearers - NCT ID: NCT06333613 - Study ID: CR-6565 - Status: RECRUITING - Start Date: 2024-03-26 - Completion Date: 2024-05-20 - Lead Sponsor: Johnson & Johnson Vision Care, Inc. ### Study Description This is a multi-site, bilateral, dispensing, non-randomized, uncontrolled, unmasked, single arm study to evaluate visual acuity in neophytes. ### Conditions - Visual Acuity ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - ACUVUE OASYS® 1-DAY with HydraLuxe™ TECHNOLOGY (AO1D) ### Outcomes Primary Outcomes - Percentage of eyes with slit-lamp findings (Grade 3 or 4) related to study lens wear Secondary Outcomes ### Location - Facility: Scripps Poway Eyecare & Optometry, San Diego, California, 92131, United States @@
## Efficacy and Safety of Topical Vitamin D Analogue in Treatment of Female Pattern Hair Loss - NCT ID: NCT06333600 - Study ID: Soh-Med-23-07-05 - Status: RECRUITING - Start Date: 2023-05-20 - Completion Date: 2024-05-01 - Lead Sponsor: Sohag University ### Study Description The trial aims to study efficay of topical vitamin D analogue in treatment of female pattern hair loss cases ### Conditions - Dermatology - Female Pattern Baldness ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Topical minoxidil - Topical Vitamin D - Saline spray ### Outcomes Primary Outcomes - Change of Sinclaire grading of Female pattern hair loss - Change of Trichoscopic parameters (Hair dermoscopy) Secondary Outcomes ### Location - Facility: Facult of Medicine, Sohag Uniiversity, Sohag, N/A, 82515, Egypt @@
## Minimally Invasive Treatments of the Thyroid - NCT ID: NCT06333587 - Study ID: IEO 1810 - Status: RECRUITING - Start Date: 2022-10-10 - Completion Date: 2035-12-31 - Lead Sponsor: European Institute of Oncology ### Study Description This is a prospective cohort study to test Minimally Invasive Treatments of the Thyroid (MITT) as potential alternative to surgery in patients with Papillary Thyroid MicroCarcinoma (PTMC) ### Conditions - Papillary Thyroid Microcarcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - image-guided thermal ablation ### Outcomes Primary Outcomes - The proportion of patients with major complications occurring within one month after the date of intervention Secondary Outcomes - Percentage of patients with local recurrence at 10 years - Percentage of patients with distant metastasis at 10 years - Percentage of patients died at 10 years ### Location - Facility: European Institute of Oncology, Milan, N/A, N/A, Italy @@
## Weight Management of Dialysis Patients - NCT ID: NCT06333574 - Study ID: CDUTCM20240313 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-12-31 - Lead Sponsor: qinxiu zhang ### Study Description The goal of this clinical trial is to Improve the quality of life in Hemodialysis patient. The main questions it aims to answer are:* \[Improve the self-compliance of dialysis patients with weight management\]* \[alleviate the volume load of dialysis patients and reduce cardiovascular complications\] Participants will be divided into two groups based on a weight management regimen： Control group: received routine outpatient management. Specific methods: The dialysis doctor registered the information of the patient\'s weight and blood pressure at the end of dialysis, and informed the patient of the purpose, role and importance of weight management.Intervention group: On the basis of routine outpatient management, patients or their family members were subjected to remote follow-up management based on wechat, and the follow-up time was 6 months. Specific methods: Same as the control group, the information of weight and blood pressure of the patients was registered at the end of dialysis, and the purpose, role and importance of weight management were informed to the patients. On this basis, a special wechat signal is set up to add patients or patients\' family members as wechat friends and establish a wechat interaction platform with patients. In the interdialysis period, remind patients to weigh themselves through wechat (the time of each weighing is fixed, preferably consistent with the time of weighing in the hemodialysis center), control the weight gain during the interdialysis period not to exceed 4.5% of dry weight, and inform patients again about the purpose, role and importance of weight management. ### Conditions - Hemodialysis - Life Quality - Interdialytic Weight Gain - Cardiovascular Events - Hypertension - Dry Weight ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Family weight self-measurement and remote follow-up management based on wechat. - Routine care ### Outcomes Primary Outcomes - Adverse event rate - Rate of completion Secondary Outcomes - dialysis related symptoms - Laboratory index - level of Ga - level of P - level of PTH - level of K - level of Na - level of Cl - concentration of albumin and prealbumin - Laboratory index of total protein - Dialysis efficiency \ dialysis adequacy (KTV) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## HAIC Combined With Lenvatinib and PD-1 Inhibitor in Infiltrative Hepatocellular Carcinoma - NCT ID: NCT06333561 - Study ID: Liver Project 7 - Status: RECRUITING - Start Date: 2021-01-01 - Completion Date: 2024-12-30 - Lead Sponsor: Sun Yat-sen University ### Study Description Hepatic arterial infusion chemotherapy (HAIC) plus lenvatinib and programmed cell death protein-1 (PD-1) inhibitor have shown promising results for advanced hepatocellular carcinoma (HCC). However, the evidence for infiltrative is limited. In this study, we aimed to describe the efficacy and safety of lenvatinib and PD-1 inhibitor with HAIC plus lenvatinib for infiltrative HCC. ### Conditions - Hepatocellular Carcinoma - Lenvatinib - PD-1 Inhibitor - Hepatic Arterial Infusion Chemotherapy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Hepatic arterial infusion chemotherapy - Lenvatinib - Tislelizumab - Toripalimab - Sintilimab - Camrelizumab ### Outcomes Primary Outcomes - Overall survival Secondary Outcomes - Progression-Free-Survival ### Location - Facility: Chinese PLA General hospital, Beijing, Beijing, 100853, China @@
## Cord Blood Alarin Levels in Term Babies - NCT ID: NCT06333548 - Study ID: KSH_MB_2024_1 - Status: COMPLETED - Start Date: 2023-09-18 - Completion Date: 2024-01-15 - Lead Sponsor: Konya City Hospital ### Study Description In this study, alarin levels in the cord blood of babies with large birth weights will be compared with babies of normal weight. Thus, the investigators aimed to find out whether there is a relationship between babies' birth weights and alarin. ### Conditions - Birth Weight ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Appropriate for gestational age , small for gestational age, large for gestational age, Baby of mother diagnosed with GDM ### Outcomes Primary Outcomes - Comparison of cord blood alarin levels of babies in different groups according to birth weight (low-appropriate-large) and babies of mothers diagnosed with gestational diabetes regardless of birth weight. Secondary Outcomes ### Location - Facility: MELEK, Konya, Sıhhiye, 06100, Turkey @@
## Foot and Abdominal Massage Applied to After Colonoscopy - NCT ID: NCT06333535 - Study ID: 2022/568 - Status: COMPLETED - Start Date: 2023-06-01 - Completion Date: 2024-02-25 - Lead Sponsor: TC Erciyes University ### Study Description The aim of this study was to determine the effect of foot and abdominal massage applied to after colonoscopy on abdominal distention, pain and patient satisfaction.This was a randomized controlled experimental study conducted at the Colonoscopy unit in Medica Faculty Hospital . Participants assigned to the intervention group-1 received foot massages after colonoscopy, participants assigned to the intervention group-2 received abdominal massages after colonoscopy and participants assigned to the intervention group-3 received foot and abdominal massages after colonoscopy. Participants assigned to the control group received only "routine care" after colonoscopy. The abdominal pain, distension and satisfaction levels of the patients evaluated using the Numerical Rating Scale ### Conditions - Abdominal Pain - Distention - Satisfaction, Patient ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - foot massage - abdominal massage - foot and abdominal massage ### Outcomes Primary Outcomes - abdominal pain - Abdominal distension - Patient Satisfaction Secondary Outcomes ### Location - Facility: Erciyes University, Kayseri, N/A, 38000, Turkey @@
## Losartan Use to Mitigate Arthrofibrosis Following Total Joint Arthroplasty - NCT ID: NCT06333522 - Study ID: 23-00979 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2026-01-01 - Lead Sponsor: NYU Langone Health ### Study Description The purpose of this study is to determine the effect of Losartan, an Angiotensin II Receptor Blocker (ARB), on the formation development of arthrofibrosis in patients who have had a primary total knee arthroplasty. This study aims to assess the post-operative range of motion and the incidence of MUA within three months following the index arthroplasty in the treatment arm (losartan) and the control arm. ### Conditions - Arthrofibrosis of Knee ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Losartan ### Outcomes Primary Outcomes - Change in range of motion - Rate of manipulation under anesthesia (MUA) after elective total knee arthroplasty Secondary Outcomes ### Location - Facility: NYU Langone Health, New York, New York, 10016, United States @@
## Anti-GPRC5D CAR-T Cells (CT071) in Participants With RRMM or RRpPCL - NCT ID: NCT06333509 - Study ID: CT071-HM-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2027-12-31 - Lead Sponsor: CARsgen Therapeutics Co., Ltd. ### Study Description A Phase 1/2 Open label, multicenter, clinical trial of autologous CAR T-cell therapy targeting GPRC5D, in participants with relapsed/refractory multiple myeloma or relapsed/refractory primary plasma cell leukemia. ### Conditions - Multiple Myeloma - Primary Plasma Cell Leukemia ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - CT071 ### Outcomes Primary Outcomes - Phase 1: Evaluation of the Safety of CT071 and determination of Maximum Tolerated Dose (MTD). - Phase 2: Objective response rate Secondary Outcomes - Phase 1 and 2: Evaluate additional clinical efficacy outcomes - Phase 1 and 2: Evaluate additional clinical efficacy outcomes - Phase 1 and 2: Evaluate additional clinical efficacy outcomes - Phase 1 and 2: Evaluate additional clinical efficacy outcomes - Phase 2: Evaluate additional Safety of CT071. - Phase 1 and 2: Assess immunogenicity of CT071 - Phase 1 and 2: Evaluate PK profile of CT071 - Phase 1 and 2: Evaluate PK profile of CT071 - Phase 1 and 2: Evaluate PK profile of CT071 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of a Glucagon Like Peptide 1 (GLP1) Booster in Healthy Humans - NCT ID: NCT06333496 - Study ID: AB20240102H - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-01-02 - Completion Date: 2024-04-08 - Lead Sponsor: Alpine Biotech LLC ### Study Description BACKGROUND GLP1 booster (GB) was designed to stimulate the endogenous production of GLP1, which in turn releases insulin, controls blood glucose level, suppresses appetite and thus helps people lose weight.PURPOSE The purpose of this study is to assess several clinical endpoints and questionnaires in healthy volunteers taking the new GB formula.SCOPE The scope of this protocol covers the non-clinical portion as well as the assessment of several clinical endpoints and questionnaires. In brief, the non-clinical design will be an open-label study involving volunteers taking GB everyday for 12 weeks. Data analysis will involve measuring the clinical endpoints across the group at different timepoints. ### Conditions - Blood Sugar; High - Overweight and Obesity - Fat Burn - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - GLP1 Booster (GB) ### Outcomes Primary Outcomes - blood glucose level - blood HbA1c level - blood insulin level - blood GLP1 level - blood cholesterol level - body weight - body fat mass - body lean mass - body mass index - body fat index - waist hip ratio Secondary Outcomes - Satiety score - Resting metabolic rate - Blood pressure - Heart rate ### Location - Facility: Alpine Bio, Salt Lake City, Utah, 84109, United States @@
## A Study of CD19 Targeted CAR T Cell Therapy in Patients With Severe, Refractory Systemic Lupus Erythematosus (SLE) - NCT ID: NCT06333483 - Study ID: AUTO1-SL1 - Status: RECRUITING - Start Date: 2024-02-02 - Completion Date: 2025-10 - Lead Sponsor: Autolus Limited ### Study Description This is a Phase I study of obecabtagene autoleucel (obe-cel), autologous T cells engineered with a chimeric antigen receptor (CAR) targeting CD19, to establish the tolerability, safety, preliminary efficacy, and pharmacokinetics of obe-cel in patients with severe, refractory SLE. ### Conditions - Systemic Lupus Erythematosus ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Obecabtagene autoleucel (obe-cel) ### Outcomes Primary Outcomes - Dose limiting toxicities - Adverse events Secondary Outcomes - Remission rate according to Definition of Remission in SLE (DORIS) - Response over time according to Definition of Remission in SLE (DORIS) - Time to response according to Definition of Remission in SLE (DORIS) - Change over time in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) - Change over time in Physician's global assessment (PGA) - Pharmacokinetics (maximum serum concentration [Cmax]): Detection of CAR-T cells by polymerase chain reaction (PCR) in peripheral blood - Pharmacokinetics (time to reaching maximum serum concentration [Tmax]): Detection of CAR-T cells by polymerase chain reaction (PCR) in peripheral blood - Pharmacokinetics (area under the curve [AUC]): Detection of CAR-T cells by polymerase chain reaction (PCR) in peripheral blood - Pharmacokinetics (last observed quantifiable concentration [Clast]): Detection of CAR-T cells by polymerase chain reaction (PCR) in peripheral blood - Pharmacokinetics (time to reach last observed quantifiable concentration [Tlast]): Detection of CAR-T cells by polymerase chain reaction (PCR) in peripheral blood - Pharmacodynamics: B cell aplasia ### Location - Facility: University College London Hospitals NHS Foundation Trust, London, N/A, N/A, United Kingdom @@
## Liwan Eye Study: the Fourth Follow-up - NCT ID: NCT06333470 - Study ID: 2024KYPJ025 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-30 - Completion Date: 2024-09-30 - Lead Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University ### Study Description Primary angle-closure glaucoma (PACG) is one of the major causes of blindness affecting more than 20 million patients worldwide. The goals of this observational cohort study are to investigate the 20-year incidence of PACG in Chinese population aged 50 years and to develop prediction models for the long-term risk of progression from primary angle-closure suspect (PACS) to PACG. ### Conditions - Primary Angle-Closure Glaucoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Primary angle closure diseases ### Outcomes Primary Outcomes - The 20-year incidence of primary angle-closure glaucoma (PACG) in Chinese population aged over 50 years Secondary Outcomes - The development of prediction models for the long-term risk of progression from primary angle-closure suspect (PACS) to primary angle-closure glaucoma (PACG) - The 20-year incidence of visual impairment in Chinese population aged over 50 years ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Presence and Relapse Rates in Patients With Alcohol Use Disorder Using Virtual Reality - NCT ID: NCT06333457 - Study ID: EA4/024/24 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-02-01 - Lead Sponsor: Charite University, Berlin, Germany ### Study Description Investigation of the influence of the sense of presence during a Virtual Reality Cue-Exposure Therapy (VR-CET) with alcohol-associated cues on craving and relapse rates.Study group: abstinent patients (at least 18 years old) with a diagnosed alcohol dependence after completed inpatient withdrawal treatment in the the last 3 months.Primary hypothesis: the experience of presence during a virtual presentation of alcohol in alcohol-dependent patients is associated with levels of craving for alcohol during VR-CET. ### Conditions - Alcohol Dependence ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - VR Cue-Exposure Therapy ### Outcomes Primary Outcomes - Craving - Craving - Craving Secondary Outcomes - Relapse rates - Quality of Life - Motion Sickness - Presence in VR ### Location - Facility: Psychiatric University Hospital Charité at St. Hedwig Hospital, Berlin, N/A, 10115, Germany @@
## Counselling Intervention for College Students Experienced Psychological Distress - NCT ID: NCT06333444 - Study ID: n. 08, 09/03/2021 - Status: RECRUITING - Start Date: 2022-01-01 - Completion Date: 2025-12-31 - Lead Sponsor: University of Campania "Luigi Vanvitelli" ### Study Description The goal of this clinical trial is to evaluate mental health and academic motivation in university students asking help to university counselling service (UCS) in Southern Italy before anf after four weekly psychological sessions.The main question it aims to answer are:* is the psychological counselling intervention useful in improving psychological distress and academic motivation* which psychological variables predict the intervention outcome ### Conditions - University Students - Psychological Intervention - Psychological Distress ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - four weekly psychological counselling intervention ### Outcomes Primary Outcomes - psychological distress - Academic motivation Secondary Outcomes - Emotion regulation ability - perceived loneliness - drop-out intention ### Location - Facility: University of Campania, Caserta, N/A, 81100, Italy @@
## Effects of WN and WF During Gastroscopy - NCT ID: NCT06333431 - Study ID: WN/WF - Status: NOT_YET_RECRUITING - Start Date: 2024-04-03 - Completion Date: 2024-06-08 - Lead Sponsor: Suleyman Demirel University ### Study Description Background: Gastroscopy is an endoscopic procedure that allows examination of the upper gastrointestinal system, including the esophagus, stomach and duodenum. The procedure is a difficult and stressful diagnosis and treatment method for the patient. Problems such as stress, fear and pain experienced during endoscopy cause anxiety.Purpose: To examine effects of glass waterfall and white noise on pain, anxiety and physiological parameters during gastroscopy Method: The population of the study consists of all patients who applied to Mardin Education and Research Hospital, Department of General Surgery, Endoscopy Unit and were scheduled for gastroscopy. The sample will be represented by 156 patients whose gastroscopy procedure is planned between the specified dates and who meet the criteria for inclusion in the sample. In calculating the sample of the study, power analysis was performed and it was found the effect size of 1.16, 95% power and 0.05% margin of error for this study, that a total of 156 individuals for the three groups and at 52 individuals for each group. Before gastroscopy procedure, the patients included in the study will be randomly divided into three groups: 52 glass waterfall group, 52 white noise group and 52 control group. ### Conditions - Misadventure During Endoscopic Examination ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Glass Waterfall group - white noise group ### Outcomes Primary Outcomes - Patient Information Form - Visual Analogue Scale (VAS) - State and Trait Anxiety Scale (STAI) - The Patient Observation Form - Pulse rate before and after gatroscopy procedure - Respiratory rate before and after gatroscopy procedure - Systolic and diastolic blood pressure before and after gatroscopy procedure - Oxygen saturation values before and after gatroscopy procedure Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effects of VR and Glass WF Colonoscopy - NCT ID: NCT06333418 - Study ID: VR/WF - Status: NOT_YET_RECRUITING - Start Date: 2024-04-03 - Completion Date: 2024-06-08 - Lead Sponsor: Suleyman Demirel University ### Study Description Background: Today, colonoscopy is widely used in many diseases, especially in the screening and diagnosis of colorectal cancers. Colonoscopy is considered a procedure that disturbs the patient's comfort because it is a very invasive and painful procedure. Along with physical discomfort during the procedure, it triggers emotional disturbances such as fear, and anxiety in the patient.Purpose: To examine the effect of virtual rain forest and glass waterfall on satisfaction, comfort, anxiety, and vital signs before colonoscopy Method: The population of the study consists of all patients who applied to Mardin Education and Research Hospital, Department of General Surgery, Endoscopy Unit and were scheduled for colonoscopy. The sample will be represented by 135 patients whose colonoscopy procedure is planned between the specified dates and who meet the criteria for inclusion in the sample. In calculating the sample of the study, power analysis was performed and it was found the effect size of 0.40, 95% power and 0.01% margin of error for this study, that a total of 135 individuals for the three groups and at 60 individuals for each group. G\Power, version 3.0.10 was used for statistical power analysis. The study group of 93 people to participate in the study will be divided into three equal groups in accordance with the random numbers table obtained the computer- based Research Randomizer program. Before the arthroscopy procedure, the patients included in the study will be randomly divided into three groups: 45 rain forest video VR group, 45 glass waterfall group and 45 control group. All participants in the study will first fill out a patient identification form containing patient demographic information. ### Conditions - Misadventure During Endoscopic Examination ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Virtual Reality Glasses Group - Glass waterfall ### Outcomes Primary Outcomes* - Patient Information Form - Visual Analogue Scale (VAS) - State and Trait Anxiety Scale (STAI) - The Patient Observation Form - Pulse rate before colonoscopy procedure - Respiratory rate before colonoscopy procedure - Systolic and diastolic blood pressure before colonoscopy procedure - Oxygen saturation values before colonoscopy procedure Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Fecal Microbiota Transplantation (FMT) as a Prophylaxis of Necrotizing Enterocolitis (NEC) - Clinical Study - NCT ID: NCT06333405 - Study ID: FMTNEC/01/2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-01-31 - Lead Sponsor: Medical University of Warsaw ### Study Description The aim of the study is to assess the safety of fecal microbiota transplantation (FMT) as a preventive method for the development of Necrotizing enterocolitis (NEC) in a group of premature infants.This is the first stage of a clinical trial testing the effectiveness of FMT in NEC, the aim of which is to examine the safety profile and analyze all side effects. ### Conditions - Necrotizing Enterocolitis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Fecal Microbiota Transplantation ### Outcomes Primary Outcomes - Adverse reactions monitoring Secondary Outcomes ### Location - Facility: Medical University of Warsaw, Pediatric Surgery Clinic, Warsaw, Mazovian Voivodeship, 02-097, Poland @@
## Total Underwater Colonoscopy (TUC) for Improved Colorectal Cancer Screening: A Randomized Controlled Trial - NCT ID: NCT06333392 - Study ID: TotalUnderwater_REK577567 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-12 - Lead Sponsor: Vestre Viken Hospital Trust ### Study Description Colorectal cancer (CRC), the third most diagnosed cancer and second most common cause of cancer death. CRCs develop from precursors like adenomas (about 70% of CRCs) or serrated lesions (SSLs) (about 25-30% of CRCs). Colonoscopy is the cornerstone in CRC screening, in screening programmes often as a work-up examination after a positive primary screening test such as faecal immunochemical test (FIT). Norway and Sweden have recently launched a nationwide faecal haemoglobin CRC screening programmes. Recently, both a Dutch and an Austrian study showed that SSL detection rate (SSLDR) is inversely correlated to CRC at follow-up. Consequently, improved SSLDR can reduce the risk of post-colonoscopy CRC. SSLs are typically located in the right colon. They are flat, with indistinctive boarders, and consequently easily missed or incompletely resected. A Norwegian study showed incomplete resection of 40% of proximal SSLs. The prevalence of SSLs is higher in women than in men, with women being on a threefold risk of developing CRC from SSLs. It seems like post-colonoscopy CRC more often is caused by SSLs than by adenomas. Total underwater colonoscopy (TUC) is a technique replacing conventional CO2 insufflation by water infusion to distend the lumen and visualise the mucosa during withdrawal of the colonoscope and simultaneously removal of water. There are several reasons to advocate TUC:1. SSLs will be more visible as they "float" on the submucosa and contract into the lumen, while full distension by gas stretches the mucosa, making detection of flat lesions more difficult.2. Water works like a magnifying lens, making detection and detailed characterisation of lesions easier.3. uEMR is eased.4. Improved bowel cleansingThe goal of this clinical trial is to compare colonoscopy outcomes for standard gas (CO2) insufflation and TUC during withdrawal in patients participating in colonoscopy in the Norwegian and Swedish colorectal cancer screening programme after a positive fecal immunochemical test.The overarching research questions of the present trial is whether colonoscopy outcomes are improved when CO2 insufflation is replaced by TUC during withdrawal and whether the new technique reduces the ecological footprint of the colonoscopy examination.The project has five main hypotheses:1. TUC is superior to the standard approach (CO2 withdrawal) regarding detection of proximal SSLs.2. TUC increases the rate of complete resection of lesions \>= 10mm.3. TUC reduces the rate of painful colonoscopies and vasovagal reactions.4. TUC reduces the health care costs by reduced use of single use accessories and reduced number of redundant colonoscopies to obtain polypfree colon.5. TUC reduces the carbon footprint by reduced use of single use accessories.If TUC is superior to gas insufflation, the technique may be implemented rapidly since the technique is easy to learn. This study will increase endoscopy competence at participating centres. The centres are involved in national colonoscopy training programs, so the technique will quickly be passed on to other hospitals and screening centres.The trial can be linked to three of the Global Goals:* Good health and well-being: The increased detection and improved complete removal of sessile serrated lesions can subsequently decrease the risk of CRC and CRC mortality during follow-up. TUC will probably reduce the rate of painful procedures and vasovagal reactions and thus increase the acceptance of a screening programme. Consequently, the project can contribute significantly to improve screening effectiveness in Norway and Sweden, particularly in women (women have a higher risk for SSLs and a higher risk of colorectal cancer developing from this type of precursor).* Gender equality: Women have a similar lifetime risk for CRC as men but less benefit of screening regardless of whether they are screened by sigmoidoscopy, FIT or colonoscopy. The reason is probably missed sessile serrated lesions in the proximal colon. If TUC improves SSLDR and complete lesion resection, this may lead to an equal benefit from CRC screening for women and men. Women have also a higher risk of discomfort and pain during colonoscopy than men. It has been shown that women prefer non-invasive screening modalities, potentially to avoid pain during colonoscopy, even if colonoscopy may be the most beneficial screening method for women. If TUC reduces the rate of painful colonoscopies, it can reduce women's barriers to attend screening.* Responsible consumption and production: The TUC technique will also reduce the ecological footprint of colonoscopy activity due to reduced consumption of single use accessories and reduced number of colonoscopies to achieve polyp free colon. Furthermore, the cost for the health care system will be substantially reduced. ### Conditions - Colorectal Neoplasia - Screening Colonoscopy - Colorectal Cancer - Colorectal Cancer Screening - Vasovagal Reaction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Total underwater colonoscopy - Conventional colonoscopy ### Outcomes Primary Outcomes - Proximal sessile serrated lesion detection rate Secondary Outcomes - Complete resection rate for lesions > 10mm - Rate of painful procedures and vasovagal reactions - Leakage after colonoscopy - Detection rate for other neoplasia than SSL - Withdrawal time - Total procedure time - Bowel cleansing quality - Complications - Number of colonoscopies to achieve polyp free colon - Single use accessories for the procedure ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Aspergillosis Detection Via EBC-GM in Ventilated Patients - NCT ID: NCT06333379 - Study ID: SichuanPPHLC04 - Status: COMPLETED - Start Date: 2023-01-02 - Completion Date: 2024-01-10 - Lead Sponsor: Lin Chen ### Study Description Brief Research Proposal: Non-Invasive Detection of Invasive Pulmonary Aspergillosis in ICU Patients Background: Invasive Pulmonary Aspergillosis (IPA) is a critical threat to patients in ICUs, especially those undergoing mechanical ventilation. Traditional diagnostic methods are invasive and carry risks. This study proposes a non-invasive, innovative approach utilizing galactomannan (GM) analysis in Exhaled Breath Condensate (EBC) for early IPA detection.Objective: To evaluate the diagnostic accuracy of measuring GM levels in EBC for detecting IPA in mechanically ventilated patients, comparing it against the conventional Bronchoalveolar Lavage Fluid (BALF)-GM measurements.Methods: A clinical trial will be conducted with 75 mechanically ventilated patients suspected of having IPA. The study will compare the effectiveness of EBC-GM levels against BALF-GM levels in diagnosing IPA, focusing on sensitivity, specificity, and diagnostic accuracy. The novel, self-designed EBC collection device will facilitate the safe and efficient collection of EBC from patients.Expected Outcomes:Validation of EBC-GM Diagnostic Accuracy: Anticipate demonstrating that EBC-GM levels provide a comparable diagnostic accuracy to BALF-GM, establishing a non-invasive, safer alternative for IPA detection.Implementation of a Non-Invasive Diagnostic Tool: The study aims to introduce a non-invasive diagnostic approach that can potentially replace more risky, invasive methods, improving patient care in ICUs.Contribution to Clinical Practice: By providing a new method for early and safer detection of IPA, the study is expected to influence clinical guidelines and practices in the management of critically ill, ventilated patients.Significance: This research has the potential to revolutionize the diagnosis of fungal infections in critically ill patients by offering a non-invasive, accurate, and safer diagnostic tool, thereby improving patient outcomes and reducing the risks associated with invasive diagnostic procedures. ### Conditions - Bronchoalveolar Lavage Fluid - Sensitivity and Specificity - Critical Illness - Respiration Failure - Respiratory Fungal Infection - Exhaled Breath Condensate - Aspergillosis, Invasive Pulmonary ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Compare the levels of Galactomannan (GM) levels in exhaled breath condensate (EBC) and BALF ### Outcomes Primary Outcomes - Diagnostic accuracy of EBC-GM vs. BALF-GM - EBC-GM levels: Secondary Outcomes - Correlation between EBC-GM and BALF-GM levels ### Location - Facility: Sichuan Provincial People's Hospital, Chengdu, Sichuan, 86610072, China @@
## First-In-Human Study of PDT to Detect IAH - NCT ID: NCT06333366 - Study ID: 202301590A0C501 - Status: RECRUITING - Start Date: 2024-02-18 - Completion Date: 2025-09-20 - Lead Sponsor: Chang Gung Memorial Hospital ### Study Description PDT is a continuous pressure monitoring for Intra-Abdominal hypertension (IAH) designed to be less invasive than pan-endoscopic evaluation, more tolerable than abdominal tapping, and more effective than intravesical pressure measurement for IAH. The PDT device consists of a piezoelectric sensor module with a low power Bluetooth wireless transmitter encased in biocompatible capsule. The device will be swallowed after activation. Following PDT insertion, the patient is fitted with a custom, removable external waist accessory containing a receiver, which is worn during monitoring and provide PDT location by signal analysis with sufficient information to provide IAH trends. ### Conditions - Intra-Abdominal Hypertension ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Intra-gastrointestinal monitoring device (PDT) ### Outcomes Primary Outcomes - Incidence of device-related or sensor insertion/removal procedure-related adverse events - Rate of foreign body reaction due intra-gastrointestinal insertion - Rate of GI symptoms, i.e. inflammation, infection, diarrhea, bowel obstruction, and ileus - Incidence of sensor failure Secondary Outcomes - Percentage of users feedback in the form of clinical questionnaire to assess the 'easiness' of insertion procedure with questionnaire - Duration of PDT insertion and explantation procedure - Incidence of side effects in Post explantation follow-up - Rate of GI dysfunction after 10 days post explantation of the PDT sensor. Follow-up via phone call after 30 days ### Location - Facility: Dong-Ru Ho, Chiayi City, N/A, 60061, Taiwan @@
## Is Repetitive Transcranial Magnetic Stimulation Effective in Reducing Endometriosis-associated Pain - NCT ID: NCT06333353 - Study ID: H-06-23-9278 - Status: RECRUITING - Start Date: 2024-04-12 - Completion Date: 2027-06-20 - Lead Sponsor: University of Ottawa ### Study Description The goal of this research is to improve pain outcomes for the over 500K Canadian women, girls and gender-diverse individuals who are newly diagnosed with endometriosis each year. Chronic pain that persists after interventions for endometriosis is a huge problem. There is some evidence that endometriosis-associated pain (EAP) is, at least to some extent, associated with changes in pain physiology, particularly central sensitization of pain. There is currently no effective evidence-informed intervention that addresses EAP. Yet a recent feasibility trial on a repetitive transcranial magnetic stimulation (rTMS) intervention demonstrated promising results compared to a sham intervention for reducing pain in a sample with EAP.The objectives of this trial are:1. to evaluate the effectiveness of an rTMS intervention for pain reduction among those with recalcitrant post-operative EAP,2. to inform on the utility of a long (10 session) vs short (5 session) protocol for pain reduction among those with recalcitrant post-operative EAP3. to determine if any improvements in pain observed 30 days after an rTMS intervention are retained 6 months later4. to identify physical and psychosocial mediators that impact the successful reduction of pain among patients with EAP treated using rTMS.5. to describe patients' perceptions of and satisfaction with rTMS as an intervention for EAP. ### Conditions - Endometriosis - Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Real RepetitiveTranscranial Magnetic Stimulation 5 sessions - Sham RepetitiveTranscranial Magnetic Stimulation 5 sessions - Real RepetitiveTranscranial Magnetic Stimulation 10 sessions - Sham RepetitiveTranscranial Magnetic Stimulation 10 sessions ### Outcomes Primary Outcomes - Numeric rating scale (NRS) used to record daily pain over 30 days - Numeric rating scale(NRS) used to record daily pain over 30 days - Patient Global Impression of Change (PGIC) in pain - Patient Global Impression of Change (PGIC) in pain - Patient Global Impression of Change (PGIC) in pain Secondary Outcomes - The Beck Depression Inventory (BDI-II) - The Beck Depression Inventory (BDI-II) - The Beck Depression Inventory (BDI-II) - The State-Trait Anxiety Inventory (STAI) - The Pain Catastrophizing Scale - The Central sensitization index - Female Sexual Distress Scale (FSDS) - Adherence to the intervention protocol - Pressure pain threshold (PPThresh) - Pressure pain threshold (PPThresh) - Pressure Pain Tolerance (PPTol) - Pressure Pain Tolerance (PPTol) - Perceived pain intensity (PPI) - Perceived pain intensity (PPI) - Temporal summation (TS) of pain - Temporal summation (TS) of pain - Pain rating during the tampon test - Pain rating during the tampon test - Conditioned pain modulation (CPM) - Conditioned pain modulation (CPM) - The Brief Pain Inventory - The Brief Pain Inventory - The Brief Pain Inventory - The Endometriosis Health Profile Questionnaire (EPH-30) - The Endometriosis Health Profile Questionnaire (EPH-30) - The Endometriosis Health Profile Questionnaire (EPH-30) - Patient satisfaction with treatment (PST) - Patient satisfaction with treatment (PST) - Patient satisfaction with treatment (PST) ### Location - Facility: McLean Function Measurement Lab, Ottawa, Ontario, K1S1S2, Canada @@
## Comparative Efficacy of Carbetocin and Oxytocin in Parturients at Risk of Atonic Postpartum Hemorrhage Undergoing Elective Cesarean Delivery - NCT ID: NCT06333340 - Study ID: 24-03 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-03 - Lead Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital ### Study Description The goal of this study is to compare 2 medications that are commonly used to prevent excess uterine bleeding (postpartum hemorrhage, or PPH) following cesarean delivery (CD), oxytocin and carbetocin. Most of the trials evaluating the preventative role of oxytocin and carbetocin after CD have focused on patient with low-risk of PPH.This trial will focus on patients that are at increased risk of PPH, with risk factors such as: multiple gestation (twins, or more multiples), large baby, polyhydramnios (excess amniotic fluid), history of PPH, body mass index greater than 40, diabetes mellitus, hypertension, and placenta previa.The investigators hypothesize that carbetocin would be more effective than an oxytocin regimen in reducing the risk of PPH in patients undergoing CD with any of the biological high-risk factors. ### Conditions - Post Partum Hemorrhage ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Oxytocin - Carbetocin ### Outcomes Primary Outcomes - Proportion of parturients requiring additional uterotonic agents intraoperatively Secondary Outcomes - Uterine Tone 3 minutes - Uterine Tone 5 minutes - Uterine Tone 10 minutes - Calculated blood loss (CBL) - Semi-quantitative blood loss (SQBL) - Presence of blood transfusion - Number of patients with ICU admission - Number of patients with conservative surgical methods to manage post partum hemorrhage - Number of patients with radiological methods used to manage post partum hemorrhage - Number of patients with surgical post partum hemorrhage management measures - Number of patients with hypotension defined as systolic blood pressure less than 80% of baseline - Number of patients with hypertension defined as systolic blood pressure greater than 120% of baseline - Number of patients with tachycardia defined as heart rate greater than 130% of baseline - Number of patients with bradycardia defined as heart rate less than 70% of baseline - Presence of ventricular tachycardia: ECG - Presence of atrial fibrillation: ECG - Presence of atrial flutter: ECG - Presence of nausea: questionnaire - Presence of vomiting: questionnaire - Number of patients with chest pain: questionnaire - Number of patients with shortness of breath: questionnaire - Number of patients with headache: questionnaire - Number of patients with flushing: questionnaire ### Location - Facility: Mount Sinai Hospital, Toronto, Ontario, M5G1X5, Canada @@
## Multicenter Registry of Atrial Fibrillation Ablation With Radiofrequency Balloon Catheter - NCT ID: NCT06333327 - Study ID: 1432022000278 - Status: RECRUITING - Start Date: 2021-01-01 - Completion Date: 2030-12-01 - Lead Sponsor: Universitair Ziekenhuis Brussel ### Study Description All consecutive patients with paroxysmal or persistent atrial fibrillation undergoing pulmonary vein isolation with the radiofrequency balloon catheter (RFB) "Heliostar" (Biosense Webster) will be included in a multicenter observational registry. The aim of the study is to assess the safety and arrhythmic outcome of atrial fibrillation ablation with the RFB in a real-world setting. ### Conditions - Atrial Fibrillation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Pulmonary vein isolation with the multielectrode radiofrequency balloon catheter ### Outcomes Primary Outcomes - Atrial arrhythmia recurrence after ablation - Procedural safety Secondary Outcomes ### Location - Facility: UZ Brussel Heart Rhythm Management Center, Brussels, N/A, 1090, Belgium @@
## Dostarlimab for Locally Advanced or Metastatic Cancer (Non-colorectal/Non-endometrial) With Tumor dMMR/MSI - NCT ID: NCT06333314 - Study ID: UC-IMM-2302 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2030-09 - Lead Sponsor: UNICANCER ### Study Description The goal of this open-label randomized, multicenter, comparative phase II trial is to evaluate the efficacy of the immunotherapy, dostarlimab, as first-line treatment for deficient mismatch repair (dMMR)/microsatellite instability (MSI) non-resectable metastatic or locally advanced non-colorectal and non-endometrial cancers compared to the standard of care chemotherapy.Adult patients (aged ≥18 years) with histologically confirmed dMMR/MSI duodenum and small bowel adenocarcinoma, gastric and oeso-gastric junction (OGJ) adenocarcinoma with combined positive score (CPS)\<5, pancreatic adenocarcinoma, ampulla of vater adenocarcinoma, adrenocortical carcinoma, carcinoma of unknown primary site, neuroendocrine carcinoma (Grade3) all primary, and soft tissue sarcoma (except Gastro-Intestinal Stromal Tumor) will be included in this study. They will be randomized and treated with either dostarlimab (experimental arm A), or chemotherapy (control arm B).Patients with documented disease progression following the first line chemotherapy (Arm B) may be eligible for crossover to be treated with dostarlimab, with the same schedule as arm A. ### Conditions - Pancreatic Adenocarcinoma - Ampulla of Vater Carcinoma - Adrenocortical Carcinoma - Neuroendocrine Carcinoma - Soft Tissue Sarcoma - Small Bowel Adenocarcinoma - Duodenum Adenocarcinoma - Gastric Adenocarcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Dostarlimab - Chemotherapy ### Outcomes Primary Outcomes - Progression-free survival Secondary Outcomes - Objective Response Rate - Duration of response - Overall Survival - Progression-Free Survival 2 - Objective response rate 2 - Progression-Free Survival -crossover - Circulating tumor DNA level - Incidence of treatment-emergent adverse events - Quality of life questionnaire - Core 30 (QLQ-C30) ### Location - Facility: Institut de Cancérologie de l'Ouest, Angers, N/A, N/A, France @@
## Translational Initiative to Map Epigenetics in Sleep - NCT ID: NCT06333301 - Study ID: TIME-ZZZ - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2034-04 - Lead Sponsor: Elysium Health ### Study Description The primary aim of TIME-ZZZ is to explore the relationship between chronotype, incidence of depression and biological age, and whether individuals working "out-of-phase" with their chronotype are more likely to exhibit signs of depression and accelerated biological aging. ### Conditions - Biological Aging ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Surveys ### Outcomes Primary Outcomes - Effect of being "out of phase" with chronotype on biological age Secondary Outcomes - Effect of Chronotype Alignment and Depression Risk in Relation to Rate of Aging - Identification of DNA methylation markers associated with chronotype - Identification of DNA methylation markers associated with depression ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Pilot Trial to Evaluate PROblem Solving Therapy and APPLE Watch for College Students - NCT ID: NCT06333288 - Study ID: 2024-0268 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-03-30 - Lead Sponsor: University of Illinois at Chicago ### Study Description The goals of this Pilot Trial are to test the preliminary efficacy of Problom-Solving Therapy (PST)-APPLE Watch in a 2-arm pilot Randomized Control Trial (RCT), vs education only-control to reduce alcohol use disorder symptoms and improve alcohol abstinence. ### Conditions - Alcohol Use Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - PST-APPLE Watch group - Education-only control group ### Outcomes Primary Outcomes - Alcohol abstinence Secondary Outcomes - Change in AUD severity at 3 months. - Change in AUD frequency status. - Change in Alcohol-related negative consequences at 3 months. - Change in Alcohol use at 3 months. - Change in Reasons for drinking at 3 months. - Change in negative affect at 3 months. - Change in positive affect at 3 months. - Change in Cognitive performance (executive cognitive ability and attention and working memory) at 3 months. - Change in the quality of life at 3 months. - Percent heavy drinking days at 3 months. - Percent binge drinking days at 3 months. - Percent days abstinence at 3 months. ### Location - Facility: University of Illinois at Chicago, Chicago, Illinois, 60608, United States @@
## Restoration of Immunity to Vaccine Preventable Diseases After CART-T Cell Therapy - NCT ID: NCT06333275 - Study ID: DLF-Nr: 5564 - Status: RECRUITING - Start Date: 2023-11-14 - Completion Date: 2026-12 - Lead Sponsor: Insel Gruppe AG, University Hospital Bern ### Study Description The goal of this observational study is to learn about vaccine immunity in patients with B-cell malignancies treated by chimeric antigen receptor T-cell therapies (CAR-T). The main questions it aims to answer are:* Do CAR-T cell therapy recipients lose vaccine protection against common vaccine-preventable pathogens* Are current re-vaccination recommendations sufficient in restoring vaccine-protection* Is this restored vaccine-protection after CAR-T cell therapy lost faster than usual* Do clinical or immunological factors predict vaccine response after CAR-T cell therapy ### Conditions - Vaccine Immunity in CAR-T Cell Therapy Recipients ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Vaccines against: Diphtheria, tetanus, pertussis, polio, haemophilus influenza type b, varicella and measles ### Outcomes Primary Outcomes - CAR-T cell therapy associated change in antibody levels against 5 vaccine preventable pathogens Secondary Outcomes - Rate of seroprotection against tetanus 6 months after CAR-T cell therapy - Rate of seroprotection against haemophilus influenza type B 6 months after CAR-T cell therapy - Rate of seroprotection against hepatitis B virus 6 months after CAR-T cell therapy - Rate of seroprotection against poliovirus 6 months after CAR-T cell therapy - Rate of seroprotection against measles virus 12 months after CAR-T cell therapy - Rate of seroprotection against tetanus after re-vaccination following CAR-T cell therapy - Rate of seroprotection against haemophilus influenza type B after re-vaccination following CAR-T cell therapy - Rate of seroprotection against hepatitis B virus after re-vaccination following CAR-T cell therapy - Rate of seroprotection against poliovirus after re-vaccination following CAR-T cell therapy - Rate of seroprotection against measles after re-vaccination following CAR-T cell therapy - Clinical predictors of vaccine elicited immune response - Immunological predictors of vaccine elicited immune response - Persistence of vaccine elicited seroprotection ### Location - Facility: University Hospital Bern, Bern, N/A, 3010, Switzerland @@
## Fixed Duration Pirtobrutinib and Obinutuzumab in Chronic Lymphocytic Leukemia - NCT ID: NCT06333262 - Study ID: 24-017 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2029-02-01 - Lead Sponsor: Inhye Ahn ### Study Description This study will evaluate fixed-duration therapy with pirtobrutinib and obinutuzumab given over 12 cycles (approximately 1 year) as first-line treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL or SLL). ### Conditions - Chronic Lymphocytic Leukemia - Small Lymphocytic Lymphoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Pirtobrutinib - Obinutuzumab ### Outcomes Primary Outcomes - Rate of complete response after initial therapy Secondary Outcomes - Overall response rate - Rate of partial response - Time to next line of therapy - Event-free survival - Progression-free survival - Overall survival - Rate of re-treatment with pirtobrutinib ### Location - Facility: Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States @@
## A Study Comparing Two Doses of AGTC-501 in Male Subjects With X-linked Retinitis Pigmentosa Caused by RPGR Mutations (SKYLINE) - NCT ID: NCT06333249 - Study ID: AGTC-RPGR-001 SKYLINE - Status: ACTIVE_NOT_RECRUITING - Start Date: 2021-04-13 - Completion Date: 2027-02 - Lead Sponsor: Beacon Therapeutics ### Study Description This study will evaluate the safety and efficacy of a recombinant adeno-associated virus vector (rAAV2tYF-GRK1-RPGR) in patients with X-linked retinitis pigmentosa caused by RPGR mutations. ### Conditions - X-Linked Retinitis Pigmentosa ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - rAAV2tYF-GRK1-RPGR ### Outcomes Primary Outcomes - The difference in the proportion of responding eyes between treated and control eyes in the low dose group and high dose group at 12 months, as measured by MAIA microperimetry, where response is defined as a 7dB or more improvement in at least 5 loci. Secondary Outcomes - Proportion of responding eyes in treated eyes versus control eyes in the low dose group and the high dose group at Month 12 where responder is defined as an ORA-VNC mobility test score improvement of 2 or more luminance levels. - Proportion of responding eyes in treated versus control eyes in the low dose group and the high dose group at Month 12, as measured by MAIA microperimetry, where responder is defined as a 7 dB or more improvement in at least 5 loci within bleb. - Proportion of responding eyes in treated vs control eyes in the low dose group and the high dose group at Month 12, measured by MAIA microperimetry where responder is defined as 7 dB or more improvement in at least 5 loci within the central 16 loci - Difference in mean change from baseline in the central 36 loci (C36) mean sensitivity, as measured by MAIA microperimetry, in treated eyes versus control eyes in the low dose group and high dose group at Month 12. - Difference in mean change from baseline in "within bleb" mean sensitivity, as measured by MAIA microperimetry, in treated eyes versus control eyes in the low dose group and high dose group at Month 12. - Difference in mean change from baseline in central 10 degrees of vision on light adapted static perimetry, as measured by Octopus 900, in treated eyes versus control eyes in the low dose group and high dose group at Month 12. - Difference in mean change from baseline in BCVA, as measured by ETDRS or tumbling "E" chart, in treated eyes versus control eyes in the low dose group and high dose group at Month 12. - Proportion of responding eyes in treated versus control eyes in the low dose group and high dose group at Month 12 where responder is defined as a 10-letter vision gain as measured by ETDRS or tumbling "E" chart. - Difference in mean change from baseline in the EZ area, as measured by SD-OCT, in treated eyes versus control eyes in the low dose group and high dose group at Month 12 Visit. - Mean change from baseline in Impact of Vision Impairment (IVI) (Weih et al, 2002; Lamoureaux et al, 2007) or Impact of Vision Impairment for Children (IVI-C) (Cochrane et al, 2008) in the low dose group and high dose group at Month 12 Visit - Mean change from baseline in Patient Global Impressions of Change (PGI-C) and Patient Global Impressions of Severity (PGIS) in the low dose group and high dose group at Month 12 Visit. ### Location - Facility: University of Florida, Jacksonville, Florida, 32209, United States @@
## Effect of Kron (Citicoline and Nicotinamide Oral Solution) on Patients With Open-angle Glaucoma - NCT ID: NCT06333236 - Study ID: OCU_KRON - Status: NOT_YET_RECRUITING - Start Date: 2024-03-25 - Completion Date: 2024-11-30 - Lead Sponsor: ASST Santi Paolo e Carlo ### Study Description Aim of this study is to investigate the administration effects of the combination of citicoline 40mg/ml and nicotinamide 15mg/ml oral solution (Kron®) on short term improvement in inner retinal function, bioelectrical activity of the visual cortex and visual function. ### Conditions - Glaucoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Food for Special Medical Purposes: Kron® ### Outcomes Primary Outcomes - Electrofunctional evaluation Secondary Outcomes - VF and SD-OCT ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Polyphenols and Probiotics to Improve Menopausal Symptoms Via the Gut-Brain Axis - NCT ID: NCT06333223 - Study ID: LSC 23/ 396 - Status: RECRUITING - Start Date: 2024-03-18 - Completion Date: 2025-03-30 - Lead Sponsor: University of Roehampton ### Study Description Menopause is one of the most significant lifecourse challenges for women. The decline in female sex hormones, in particular estrogen, during menopause leads to an increased risk in cardiometabolic diseases, and a decrease in quality of life due to symptoms such as low mood, anxiety, hot flushes and difficulty sleeping. As life expectancy continues to increase, on average, women will spend one third of their life in the postmenopausal period. Increasing evidence suggests that the gut microbiota plays a key role in menopause-related symptoms and conditions, being one of the main regulators of circulating sex hormones. Menopause has been linked to gut dysbiosis and lower gut microbial diversity, therefore nutritional strategies targeting the gut microbiome may be an effective approach to improve women's health during menopause. Both (poly)phenols and probiotics are promising candidates for the prevention and treatment of menopausal symptoms via different mechanisms, including the modulation of the gut-brain axis, while emerging evidence indicates that using both together may be a better approach than traditional carbohydrate-based synbiotics.To our knowledge, the efficacy of a (poly)phenol based synbiotic targeting the gut microbiome for improvement of menopausal symptoms has not been investigated so far. ### Conditions - Menopause ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - Mixture of (Poly)phenols and a probiotic supplement - Placebo comparator ### Outcomes Primary Outcomes - Change in blood chemistry levels Secondary Outcomes - Change in BMI (body mass index) Scores - Change in the gut microbiota diversity - Change in dietary habits - Change in Quality IPAQ - Change in inflammatory biomarkes ### Location - Facility: Health Sciences Research Centre, Life Sciences Department, University of Roehampton, London, UK, SW15 4JD, United Kingdom @@
## Study of the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of BCD-180 in Patients With Axial Spondyloarthritis (LEVENTA) - NCT ID: NCT06333210 - Study ID: BCD-180-3 - Status: RECRUITING - Start Date: 2023-12-25 - Completion Date: 2028-02 - Lead Sponsor: Biocad ### Study Description The aim of the study is to evaluate the efficacy, safety, immunogenicity, pharmacokinetics and pharmacodynamics of a fixed dose of study drug (BCD-180) in comparison with placebo in patients with active axial spondyloarthritis (axSpA). The study will include HLA-B27+ patients with radiographic (r-axSpA) and non-radiographic (nr-axSpA) who had no response to prior therapy with non-steroidal anti-rheumatic drugs (NSAIDs), have not received biologic disease-modifying anti-rheumatic drugs (bDMARDs) or targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs), and subjects with insufficient efficacy and/or loss of efficacy on bDMARDs and/or tsDMARDs. ### Conditions - Axial Spondyloarthritis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - anti-TRBV9 monoclonal antibody infusions - Placebo infusions - Adalimumab subcutaneous injection - Placebo subcutaneous injection ### Outcomes Primary Outcomes - Proportion of subjects who achieved ASAS40 among bDMARDs and tsDMARD-naive subjects - Proportion of subjects who achieved ASAS40 among bDMARDs and/or tsDMARD-experienced subjects Secondary Outcomes - Proportion of subjects who achieved ASAS40 among subjects with r-axSpA - Proportion of subjects who achieved ASAS40 among subjects with nr-axSpA - Proportion of subjects with the ASDAS-CRP <1.3 - Proportion of subjects with the ASDAS-CRP ≥1.3 - <2.1 - Proportion of subjects with the ASDAS-CRP ≥2.1 - ≤3.5 - Proportion of subjects with the ASDAS-CRP >3.5 - Proportion of subjects who achieved ASDAS-CII (clinically important improvement) - Proportion of subjects who achieved ASDAS-MI (Major improvement) - ASDAS-CRP change from baseline - Proportion of patients who achieved clinical response defined as an improvement of BASDAI by at least 50% compared to baseline - Change from baseline in BASDAI - Proportion of subjects who achieved ASAS40 - Proportion of subjects who achieved ASAS20 - Proportion of subjects who achieved ASAS5/6 - Proportion of subjects who achieved ASAS partial remission - Change from baseline in BASMI - Change from baseline in BASFI - Change from baseline in the swollen joint count (44 joints) - Change from baseline in MASES - Change from baseline in overall back pain severity (BASDAI No. 2) - Change from baseline in nocturnal back pain severity - Change in the patient global assessment of disease activity from baseline - Change in the quality of life score assessed with EQ-5D-3L questionnaire from baseline - Change from baseline in SF-36 Physical Functioning compared to baseline - Change from baseline in SF-36 Mental Health compared to baseline - Change in the WPAI score from baseline - Change in the ASAS HI score from baseline - Change in the concentration of hsCRP from baseline - Change in ESR from baseline - Changes in the SPARCC score (spine, SIJ) from baseline - Changes in mSASSS scores from baseline - Proportion of subjects with adverse events - Proportion of subjects with serious adverse events - Proportion of subjects with grade 3 or higher adverse events according to CTCAE 5.0 - Proportion of subjects prematurely withdrawn from the study due to adverse events ### Location - Facility: Chelyabinsk Regional Clinical hospital, Chelyabinsk, N/A, N/A, Russian Federation @@
## Approaches for Open Reduction and Internal Fixation of Mandibular Condylar Fracture - NCT ID: NCT06333197 - Study ID: Mandibular condylar fracture - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-07-01 - Lead Sponsor: Assiut University ### Study Description The condylar region is the most frequent anatomical site for mandibular fractures .Condylar fractures constitute 25.5% to 35.5% of all mandibular fractures. The mandibular condyle fracture is a type of fracture that affects the condyle, which is the knuckle-like projection of the mandible (lower jaw) that articulates with the temporal bone to form the temporomandibular joint (TMJ). ### Conditions - Mandibular Fractures ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - ORIF through transparotid approach - ORIF through retroparotid approach ### Outcomes Primary Outcomes - Facial nerve injury - Operative time Secondary Outcomes - Fracture stability - Mouth opening - Other Complication related to the Approach ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Smoothies and Blood Sugars - NCT ID: NCT06333184 - Study ID: 3085-4215 - Status: RECRUITING - Start Date: 2024-03-20 - Completion Date: 2024-12-31 - Lead Sponsor: University of Bath ### Study Description Glycaemic responses to fruit smoothies may depend on the food matrix (e.g., degree of processing and physical structure), ingestion rate, dose ingested and fibre content. Furthermore, the method of sampling could alter inferences. The aim of this project is to characterise how these factors affect the glycaemic response to a commercially available fruit smoothie. Participants will ingest 7 different test drinks in a randomised, crossover design with fingerstick capillary blood sampling alongside continuous glucose monitors. Test drinks will include a glucose reference (CONTROL), the commercial product matched for carbohydrate to CONTROL (PRODUCT), equivalent carbohydrate ingested as whole fruits (WHOLE), equivalent carbohydrate ingested as blended fruits (WHOLE), equivalent carbohydrate as the commercial product ingested slowly (SLOW), equivalent carbohydrate as the commercial product ingested with additional fibre (FIBRE), and the commercial product ingested in a dose typically bought (DOSE). These data will provide insight into how the food matrix and different patterns of ingestion can alter the glycaemic response to a fruit smoothie, and how the measurement method may alter interpretations. ### Conditions - Metabolic Disturbance ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Food ### Outcomes Primary Outcomes - Glycaemic index of product with capillary vs CGM Secondary Outcomes - Glycaemic index of all conditions with capillary vs CGM ### Location - Facility: Department for Health, University of Bath, Bath, N/A, BA2 7AY, United Kingdom @@
## 4-aminopyridine for Skin Wound Healing - NCT ID: NCT06333171 - Study ID: 00003872 - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2028-03 - Lead Sponsor: John Elfar ### Study Description Many patients suffer from chronic non-healing wounds as well as acute wounds. There is a need to develop treatments to accelerate and improve healing of chronic and acute wounds. More research is needed to evaluate the role of 4-aminopyridine (4-AP), a promising new agent with an excellent safety profile, on wound healing. The investigational treatment will be used to evaluate the role of (4-AP) on the treatment of wounds to accelerate wound healing in healthy adults.The purpose of this study is to evaluate the role of 4-AP on the treatment of wounds to accelerate healing.The investigational treatment will be used to test the hypothesis that 4-AP can speed wound healing. ### Conditions - Wounds - Wound of Skin - Wound Heal - Wounds and Injuries ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - 4-Aminopyridine - Placebo ### Outcomes Primary Outcomes - Return of skin integrity and wound closure after skin punch biopsy Secondary Outcomes - The effect of 4-AP on the hair number and growth at the skin punch biopsy site. ### Location - Facility: University of Arizona, Tucson, Arizona, 85724, United States @@
## Extracts of Amla, Walnut Leaf, Red Yeast Rice and Olive in Cardiovascular Prevention - NCT ID: NCT06333158 - Study ID: AmWaRO Study - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-12 - Lead Sponsor: Nina Hermans ### Study Description The aim of this study is to evaluate whether the use of a commercially available standardized combination preparation (Cholesfytol NG®), containing extracts of amla, walnut leaf, red yeast rice and olive, in individuals with hypercholesterolemia1. Leads to a clinically relevant reduction of cholesterol levels, especially LDL,2. Leads to a clinically relevant reduction of blood pressure on the short term,3. Leads to a change in oxidative stress biomarkers.Participants will be stratified by sex before randomization to one of the two treatments for 8 weeks:* Cholesfytol NG: 500 mg Amla dry extract, 50 mg Walnut leaf dry extract, 33.6 mg Red yeast rice powder (equivalent to 1.45 mg monacolins), 25 mg Olive dry extract (equivalent to 5 mg of hydroxytyrosol) per day* Placebo All treatments have an identical shape and color and should be used in the same way (oral intake; 3 capsules/day during dinner). No dietary instructions are given and participants are asked not to change their dietary habits, not to start other therapies (medication, supplements, slimming diets, extra physical activity, etc.) during their study period. Standardized questionnaires are used to obtain information on demographics, dietary habits and side effects. At baseline and after 8 weeks, 27 ml blood is drawn for various biological analyses, and blood pressure, BMI and waist circumference are measured. ### Conditions - Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Cholesfytol NG - Placebo ### Outcomes Primary Outcomes - Change from baseline LDL cholesterol at 8 weeks Secondary Outcomes - Frequency of side effects (+ their burden) as reported in the final questionnaire - Change from baseline Blood Pressure, Systolic at 8 weeks - Change from baseline Blood Pressure, diastolic at 8 weeks - Change from baseline total cholesterol level at 8 weeks - Change from baseline HDL cholesterol level at 8 weeks - Change from baseline non-HDL cholesterol level at 8 weeks - Change from baseline Remnant Cholesterol at 8 weeks - Change from baseline triglycerides level at 8 weeks - Change from baseline Apo A1 level at 8 weeks - Change from baseline Apo B level at 8 weeks - Change from baseline lipoprotein A (LP(a)) level at 8 weeks - Change from baseline OxLDL level at 8 weeks - Change from baseline malondialdehyde (MDA) level at 8 weeks - Change from baseline glutathion (GSH) level at 8 weeks ### Location - Facility: UAntwerp, NatuRAPT, Wilrijk, Antwerp, 2610, Belgium @@
## ED90 of Remimazolam Anesthesia Induction in Drug-induced Sleep Endoscopy in Adults - NCT ID: NCT06333145 - Study ID: EDRA - Status: RECRUITING - Start Date: 2024-02-04 - Completion Date: 2024-12-31 - Lead Sponsor: Tongji Hospital ### Study Description Exploring the ED90 of remimazolam in Drug-induced Sleep Endoscopy in adults at different BMI groups. ### Conditions - Effect of Drug ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Remimazolam ### Outcomes Primary Outcomes - Ramsey Sedation Scale Secondary Outcomes - Time records - Use of drugs - Respiratory suppression incidence - Incidence of Treatment-Emergent Adverse Events - Incidence of PACU Adverse Reactions ### Location - Facility: Tongji Hospital, Wuhan, Hubei, 430000, China @@
## Deciphering the Role of Incretin Hormones in Weight Loss-induced Remission of Type 2 Diabetes (DIABeat) - NCT ID: NCT06333132 - Study ID: DiabEAT.it - Status: NOT_YET_RECRUITING - Start Date: 2024-09-01 - Completion Date: 2026-02-01 - Lead Sponsor: Azienda Ospedaliero, Universitaria Pisana ### Study Description The goal of this mechanistic study is to investigate the role of incretin hormones on weight loss-induced type 2 diabetes remission. ### Conditions - Obesity - Diabetes Mellitus Type 2 in Obese ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Weight loss-induced Diabetes Remission ### Outcomes Primary Outcomes - Number of participants with incretin effect's restoration after achieving weightloss-induced diabetes remission Secondary Outcomes - Rate of sustained weightloss-induced diabetes remission assessed by 2 consecutive HbA1c <48mmol/mol within 6 months ### Location - Facility: Azienda Ospedaliero-Universitaria Pisana, Pisa, PI, 56127, Italy @@
## The Relationship Between Urinary Incontinence and Motor Symptoms - NCT ID: NCT06333119 - Study ID: 72867572-050.01.04-320 - Status: COMPLETED - Start Date: 2023-09-01 - Completion Date: 2024-02-15 - Lead Sponsor: Pinar Yasar ### Study Description There is no study in the literature examining the relationship between urinary incontinence and motor symptoms in individuals with stroke. The aim of this study is to determine the relationship between urinary incontinence and spasticity, balance and walking, which negatively affect quality of life and functional performance after stroke. ### Conditions - Stroke - Urinary Incontinence - Motor Skills Disorders ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - modified rankin scale ### Outcomes Primary Outcomes - relationship with between urinary incontinence and motor symptoms Secondary Outcomes ### Location - Facility: Suleyman Demirel University, Isparta, N/A, N/A, Turkey @@
## PoCUS Diagnostic Accuracy for Fecal Impaction in the Emergency Department: A Prospective Study - NCT ID: NCT06333106 - Study ID: FICUS - 2024/16FEV/077 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2024-12-31 - Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain ### Study Description Many medical and paramedical specialties regularly use point-of-care ultrasound (PoCUS) in clinical practice. The diagnosis of fecal impaction is quite common in the elderly living in nursing homes with a prevalence of 47.3%. Fecal impaction remains a major source of morbidity, while its etiology is often multifactorial and its diagnosis challenging. Current recommendations for the diagnosis of fecal impaction support the use of plain abdominal x-rays. PoCUS is a non-irradiating procedure and a clinical diagnostic tool that can be used in a variety of ways during abdominal examinations. Most scientific societies encourage the use of PoCUS to respond to a specific clinical question rather than to provide a diagnosis, which is usually confirmed by conventional ultrasound. However, the combination of physical examination and PoCUS may improve the diagnostic approach. This multicentric prospective study protocol aims to evaluate the diagnostic accuracy of PoCUS in patients aged 75 years or older with suspected fecal impaction in the emergency department compared with plain abdominal x-ray (or abdominal CT scan if required as part of the emergency department investigations). ### Conditions - Fecal Impaction of Colon ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - POCUS diagnostic value ### Outcomes Primary Outcomes - Evaluation of the diagnostic value of clinical ultrasound in the diagnosis of fecal impaction in the emergency room Secondary Outcomes - Influence of BMI on the diagnosis of fecal impaction at PoCUS - Influence of bladder repletion on the diagnosis of fecal impaction using PoCUS - Influence of patient echogenicity on the diagnosis of fecal impaction using PoCUS ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Duodenal tIssue ResEction aCquisiTion (DIRECT) Study - NCT ID: NCT06333093 - Study ID: NL82178.018.22 - Status: RECRUITING - Start Date: 2023-01-10 - Completion Date: 2024-06-01 - Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) ### Study Description To evaluate the quality of cold snare resection specimens of duodenal mucosa tissue in patients undergoing an upper gastrointestinal interventional endoscopy in order to improve the processing of histological samples and its assessment in general and for future duodenal ablation studies. ### Conditions - Duodenum Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Cold snare ### Outcomes Primary Outcomes - Acquiring larger pieces of tissue from the duodenum - Histopatholocial assessment of larger pieces of tissue from the duodenum - Checking if the tissue is of good quality enough for single cell RNA sequencing Secondary Outcomes ### Location - Facility: Amsterdam UMC, Amsterdam, North-Holland, 1105 AZ, Netherlands @@
## The Effect of Adherence to Oral Semaglutide on Glycaemic Control in People With Type 2 Diabetes Treated With Metformin - NCT ID: NCT06333080 - Study ID: N-20220017 - Status: RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-03 - Lead Sponsor: Aalborg University Hospital ### Study Description The objective of the trial is to investigate the effect of adherence to oral semaglutide dosing instructions on glycaemic control in people with type 2 diabetes, which are dysregulated on metformin and naïve to second line antidiabetic treatment. ### Conditions - Diabetes Mellitus, Type 2 ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Time-in-Range (TIR) Secondary Outcomes - Pre-dose Fasting - Post-dose Fasting - Occurrence of nausea or vomiting - Water Intake at Dosing Time - Treatment-Related Impact Measure for Diabetes (TRIM-D) ### Location - Facility: Steno Diabetes Center North Denmark, Aalborg, N/A, 9000, Denmark @@
## Treatment to Lift Facial Lax Skin and Improve Facial Wrinkles Using Precise and Lift Applicators - NCT ID: NCT06333067 - Study ID: Sofwave21 - Status: RECRUITING - Start Date: 2023-10-11 - Completion Date: 2024-11-01 - Lead Sponsor: Sofwave Medical LTD ### Study Description Open-label, non-randomized single-arm prospective, multi-center, self-controlled clinical study with masked evaluation. ### Conditions - Lax Skin ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Sofwave ### Outcomes Primary Outcomes - Primary Outcome Measure Secondary Outcomes ### Location - Facility: Costal Skin & Eye Institute, La Mesa, California, 91942, United States @@
## Safety and Efficacy of a Head Lice Shampoo - NCT ID: NCT06333054 - Study ID: NCLIN0091/ 14ct/mp37li - Status: COMPLETED - Start Date: 2014-10-13 - Completion Date: 2015-06-08 - Lead Sponsor: Oystershell NV ### Study Description This study is designed to compare the effectiveness and safety of test head lice shampoo (Test product) versus Goldgeist® Forte (reference product) following two applications. ### Conditions - Head Lice ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Pyrethrum Extract - Silcap Shampoo ### Outcomes Primary Outcomes - Cure Rate superior to 70% for the test product Secondary Outcomes - Cure Rate superior to 70% for the reference product - Superior cure rate to the reference - Non-inferiority rate to the reference - Local tolerability - Global tolerability - Skin irritation assessment - Eye irritation assessment - Esthetical effect of the anti-lice products - Adverse Events (AEs) ### Location - Facility: CardioSec Clinical Research GmbH, Erfurt, N/A, 99084, Germany @@
## Study of Cannabidiol in Sanfilippo Syndrome - NCT ID: NCT06333041 - Study ID: 32977-01-00 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2027-05 - Lead Sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center ### Study Description The goal of this clinical trial is to test cannabidiol in Sanfilippo syndrome. The main questions it aims to answer are: 1) determine the safety of cannabidiol in Sanfilippo syndrome, and 2) explore the efficacy of cannabidiol in treating the neurobehavioral symptoms and functional outcomes of Sanfilippo syndrome.Each participant's caregiver will be asked to complete surveys related to the participant's behavior, mood, sleep, stooling, pain, and caregiver stress intermittently throughout the study. All participants will be enrolled into one of two cohorts based on enrollment order:1. Sentinel Safety Cohort (first 5 participants) - all participants treated with Epidiolex (cannabidiol)2. Controlled Cohort (next 30 participants) - participants randomized 1:1 (equal chance) to start treatment with Epidiolex (cannabidiol) or placebo for 16 weeks, followed by an 8-week washout period (no treatment). Participants then switch to the opposite treatment group for 16 weeks followed by all participants treated for 52 weeks with Epidiolex (cannabidiol). ### Conditions - Sanfilippo Syndrome - Mucopolysaccharidosis III ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Epidiolex - Placebo ### Outcomes Primary Outcomes - Sanfilippo Behavior Rating Scale (SBRS)- mood/anger/aggression score Secondary Outcomes ### Location - Facility: The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, California, 90502, United States @@
## A Study to Evaluate the enVista® Aspire (EA) Intraocular Lens in Subjects Undergoing Cataract Extraction - NCT ID: NCT06333028 - Study ID: 938 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-09 - Lead Sponsor: Bausch & Lomb Incorporated ### Study Description A Study to Evaluate the enVista® Aspire (EA) intraocular lens in Subjects Undergoing Cataract Extraction ### Conditions - Cataract ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - enVista Aspire EA IOLs ### Outcomes Primary Outcomes - Mean binocular BCDVA (logMAR) at Visit 1 Secondary Outcomes ### Location - Facility: SITE 104, Dover, New Jersey, 07801, United States @@
## Study to Evaluate the Safety and Effectiveness of the enVista® Beyond (EY) EDF Intraocular Lens in Subjects Undergoing Cataract Extraction - NCT ID: NCT06333015 - Study ID: 924 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-10 - Lead Sponsor: Bausch & Lomb Incorporated ### Study Description This research study is evaluating the safety and efficacy (performance) of the Bausch + Lomb enVista Beyond Hydrophobic Acrylic Extended Depth of Focus Intraocular Lens (IOL) in subjects who receive this IOL in both eyes. ### Conditions - Cataract ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - enVista EY Beyond IOL - TECNIS 1-Piece monofocal IOL ### Outcomes Primary Outcomes - Mean Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) of first implanted eyes at Post-Operative Visit 4. - Median Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) of first implanted eyes at Post-Operative Visit 4. - Negative lens induced distance-corrected Depth of focus (D) at 0.20 logMAR of first implanted eyes at Post-Operative Visit 4. - Mean monocular best-corrected distance visual acuity (BCDVA) (logMAR) of first implanted eyes at Post-Operative Visit 4. - Rates with postoperative monocular BCDVA of 20/40 (0.30 logMAR) or better of first implanted eyes at Post-Operative Visit 4. Secondary Outcomes - Mean monocular photopic distance-corrected near visual acuity (DCNVA) of first implanted eyes at Post-Operative Visit 4. ### Location - Facility: Site 108, Northridge, California, 91325, United States @@
## Machine Learning Model to Predict Outcome and Duration of Mechanical Ventilation in Acute Hypoxemic Respiratory Failure - NCT ID: NCT06333002 - Study ID: PI24/00325 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-19 - Completion Date: 2026-05-30 - Lead Sponsor: Dr. Negrin University Hospital ### Study Description Acute hypoxemic respiratory failure (AHRF) is the most common cause of admission in the intensive care units (UCIs) worldwide. We will assess the value of machine learning (ML) techniques for early prediction of ICU death and prolonged duration (\>7 days) of mechanical ventilation (MV) in 1,241 patients enrolled in the PANDORA (Prevalence AND Outcome of acute Respiratory fAilure) Study in Spain. The study was registered with ClinicalTrials.gov (NCT03145974). Our aim is to evaluate the minimum number of variables models using logistic regression and four supervised ML algorithms: Random Forest, Extreme Gradient Boosting, Support Vector Machine and Multilayer Perceptron. ### Conditions - Acute Hypoxemic Respiratory Failure ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - machine learning analysis ### Outcomes Primary Outcomes - ICU mortality Secondary Outcomes - MV duration ### Location - Facility: Hospital General Universitario de Ciudad Real, Ciudad Real, N/A, 13005, Spain @@
## Stroke Triage Optimization by Ambulance Paramedics in the Pre-hospital Setting - NCT ID: NCT06332989 - Study ID: N22.129 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2027-02-01 - Lead Sponsor: Leiden University Medical Center ### Study Description There are everal scales designed to help ambulance paramedics to identify a patient with a stroke and activate a stroke code. These scales were never tested in the field in a large unselected patient sample. We aim to perform an in-the field head tot head comparison of all published stroke scales designed to be used by ambulance paramedics ### Conditions - Stroke, Acute - Pre-hospital Triage - Stroke Treatment - Stroke Code ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - stroke-APP ### Outcomes Primary Outcomes - final diagnosis - treated with reperfusion therapy - additional investigations Secondary Outcomes ### Location - Facility: Leiden University medical center, Leiden, N/A, N/A, Netherlands @@
## PrefeRences And ChemoTherapy In Breast Cancer patiEnts - NCT ID: NCT06332976 - Study ID: IEO 1521 - Status: RECRUITING - Start Date: 2021-06-04 - Completion Date: 2024-12-31 - Lead Sponsor: European Institute of Oncology ### Study Description The aim of the present study is to ask women treated with adjuvant or neoadjuvant chemotherapy for breast cancer what survival benefit would justify the treatment.The benefit should be evaluated in terms of Survival rate trade off and Survival time trade off value. The analyses will be conducted into three different groups of patients to value the survival benefit expected:1. before to start the chemotherapy2. during chemotherapy3. after the end of chemotherapy ### Conditions - Female Breast Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Completion of questionnaires ### Outcomes Primary Outcomes - Percentage of risk reduction needed to consider adjuvant or neoadjuvant chemotherapy worthwhile - Prolonged survival time gain needed to consider CT worthwhile Secondary Outcomes - Behavior assessment - Reaction to uncertain situations assessment - Regret and disappointment assessment ### Location - Facility: European Institute of Oncology, Milan, N/A, 20141, Italy @@
## Interoceptive Mechanisms of Body Image Disturbance in Anorexia Nervosa - NCT ID: NCT06332963 - Study ID: 2023-007 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2028-12 - Lead Sponsor: Laureate Institute for Brain Research, Inc. ### Study Description The proposed study utilizes a randomized experimental therapeutics design to test a mechanistic framework linking interoceptive processing and disturbed body image, with the purpose of informing the development of future therapies for body image dissatisfaction in anorexia nervosa (AN). A sample of 102 participants will be recruited from the Laureate Eating Disorder Program (LEDP). After being randomized, participants will all receive a one-hour session of acceptance- and mindfulness-based training with a therapist (the introduction session). They will then receive either the interoceptively focused treatment (IFT) or exteroceptively focused treatment (EFT) condition based on randomization. In the IFT condition participants will engage in floatation-REST (Reduced Environmental Stimulation Therapy) while practicing acceptance and mindfulness-based principles. The EFT condition is an exteroceptive intervention in which participants will be asked to view pre-recorded videos of acceptance and mindfulness-based skills to aid in the practice of these skills. Each condition will consist of one introduction session and three experimental sessions. All participants will then return for follow-up measures. Assessed outcomes will include acute changes in body image disturbance (BID) and interoception. Further, longitudinal intervention effects on self-reported eating disorder symptoms, body image dissatisfaction, and interoception; behavioral measures of interoception and body image dissatisfaction; and resting state and interoceptive functioning during functional magnetic resonance imaging (fMRI) will be explored. ### Conditions - Anorexia Nervosa - Body Image Disturbance - Interoception ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Floatation-REST - IFT - EFT ### Outcomes Primary Outcomes - Perceptual body image dissatisfaction on the Photographic Figure Rating Scale (PFRS) - Perceptual body image dissatisfaction on the Photographic Figure Rating Scale (PFRS) Secondary Outcomes - Cognitive/affective body image on the Body Image State Scale (BISS) - Body image dissatisfaction on the Somatomap3D - Appearance evaluation on the Multidimensional Body-Self Relations Questionnaire- Appearance Scales (MBSRQ-AS) Appearance Evaluation Subscale (range 7 to 35, higher scores indicate more satisfaction with appearance) - Appearance orientation on the Multidimensional Body-Self Relations Questionnaire- Appearance Scales (MBSRQ-AS) Appearance Orientation Subscale (range 7 to 35, higher scores indicate more satisfaction with appearance) - Body image satisfaction on the Multidimensional Body-Self Relations Questionnaire- Appearance Scales (MBSRQ-AS) Body Areas Satisfaction - Overweight preoccupation on the Multidimensional Body-Self Relations Questionnaire- Appearance Scales (MBSRQ-AS) Overweight preoccupation scale - Noticing on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2) - Not distracting on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2) - Not worrying on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2) - Attention regulation on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2) - Emotional awareness on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2) - Self-regulation on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2) - Trust on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2) - Interoceptive attention on the Interoceptive Attention Scale (IATS) - Cardiac interoceptive accuracy on the Heartbeat Tapping Task - Cardiac interoceptive intensity on the Heartbeat Tapping Task - Interoceptive intensity during experimental conditions - Perceived respiratory interoceptive intensity on the Breath Hold Task - Body image distortion on the Aperture Task - Body image distortion on the String task ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Safety and Efficacy of Adebrelimab Plus Irinotecan Liposome (II) With or Without Famitinib in ES-SCLC Pre-treated With Immunotherapy - NCT ID: NCT06332950 - Study ID: MA-SCLC-II-015 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-04-01 - Lead Sponsor: Baohui Han ### Study Description This is an open-label, randomized, multi-cohort, multi-center, phase Ib/II study to evaluate the safety and efficacy of Adebrelimab plus Irinotecan Liposome (II) with or without Famitinib in patients with extensive-stage small cell lung cancer (ES-SCLC) pre-treated with immune checkpoint inhibitor(s). ### Conditions - Extensive-stage Small-cell Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Adebrelimab, Irinotecan Liposome (II) - Adebrelimab, Irinotecan Liposome (II), Famitinib ### Outcomes Primary Outcomes - 6-month progression-free survival Secondary Outcomes - Safety - Objective response rate - Progression-free survival - Overall survival - Disease control rate - Duration of response ### Location - Facility: Shanghai Chest Hospital, Shanghai, N/A, N/A, China @@
## Breast Reconstruction - NCT ID: NCT06332937 - Study ID: H-2102-079-1197 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2021-02-22 - Completion Date: 2024-12-31 - Lead Sponsor: Seoul National University Hospital ### Study Description Complications following postmastectomy breast reconstruction can compromise surgical outcomes and lead to significant morbidity. The aim of this study was to determine factors associated with complication following two-stage implant-based reconstruction ### Conditions - Breast Implant; Complications ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - postmastectomy breast reconstruction ### Outcomes Primary Outcomes - Infection Secondary Outcomes ### Location - Facility: Seoul National University Hospital, Seoul, N/A, 03080, Korea, Republic of @@
## Primipara Pregnant Women and Motivational Interview - NCT ID: NCT06332924 - Study ID: 2023/19 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-08-01 - Lead Sponsor: Saglik Bilimleri Universitesi ### Study Description The first birth is the most important moment a woman experiences in her life as she embarks on her motherhood journey. Waiting for the birth of a new life can be very exciting for mothers. Positive birth is an approach that asks the woman to approach her birth story from a positive perspective and to have a stronger, more impressive and positive birth experience. Primipara pregnant women especially benefit from and need this positive birth approach. Motivational interviews are interviews conducted to support positive births and to help women develop a positive attitude towards their birth experiences.This planned study was planned as a randomized controlled trial with pre-test and post-test measurements, with the aim of determining the level of traumatic birth perception in primipara women who were given or not given training and examining the effects of positive birth motivational education by taking into account the need for education with numerical data. ### Conditions - Pregnancy Related ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - motivational discussion group ### Outcomes Primary Outcomes - Primipara Pregnant Women and Traumatic Birth Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair - NCT ID: NCT06332911 - Study ID: RO-231129 - Status: NOT_YET_RECRUITING - Start Date: 2024-08-01 - Completion Date: 2026-08-30 - Lead Sponsor: Rede Optimus Hospitalar SA ### Study Description Shockwave TEVAR is a nonrandomized, prospective, international, multi-center, PMCF, obervational study.The aim of this study is to evaluate the outcomes of the Shockwave™ Peripheral Intravascular Lithotripsy Balloon (Shockwave Medical Inc.) in the routine treatment of hostile iliac accesses during TEVAR and F/BEVAR. ### Conditions - Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture - Abdominal Aortic Aneurysm Without Rupture - Thoracic Aortic Aneurysm Without Rupture ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Shockwave™ Peripheral Intravascular Lithotripsy Balloon M5+ ### Outcomes Primary Outcomes - Efficacy: Technical success - defined as intention-to-treat basis Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effects of a Nutritional Supplement on Nutrient Status and Quality of Life - NCT ID: NCT06332898 - Study ID: AG-01-0324 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-31 - Completion Date: 2025-02-04 - Lead Sponsor: Athletic Greens International ### Study Description This study is a randomized, double-blind, placebo-controlled study of N=120 apparently healthy men and women. The purpose of this study is to assess the effect of a novel dietary supplement on blood markers of nutrient status, gut microbiome, and overall quality of life. ### Conditions - Nutrition, Healthy - Gastrointestinal Microbiome - Healthy Aging ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - AG1 - Nutritional Supplement - Placebo ### Outcomes Primary Outcomes - Homocysteine - Vitamin B12 - Folate - Red Blood Cell Folate - Zinc - Vitamin C - Gut Microbiome Secondary Outcomes - Dietary habits - Gastrointestinal Health - Fatigue & energy - Well-being - Complete Metabolic Blood Panel - Complete Blood Count ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Zephyr Valve Japan Post-Marketing Surveillance - NCT ID: NCT06332885 - Study ID: 630-2001-01 - Status: RECRUITING - Start Date: 2024-03-12 - Completion Date: 2028-03-31 - Lead Sponsor: Pulmonx Corporation ### Study Description This is a multicenter, prospective, observational surveillance enrolling 140 consecutive patients with severe emphysema who are candidates for bronchoscopic lung volume reduction using Zephyr Endobronchial Valve at up to 20 centers across Japan and followed for 12 months. ### Conditions - Emphysema - COPD - Severe Emphysema ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Zephyr Endobronchial Valve ### Outcomes Primary Outcomes - Incidence rate of pneumothorax at 45-days post-Zephyr Valve index procedure. Secondary Outcomes ### Location - Facility: Gifu Prefectural Medical Center, Gifu, N/A, N/A, Japan @@
## Comparison Effectiveness of Oral Ivermectin , 1% Permethrin Shampoo and 4% Dimeticone Liquid Gel in the Treatment of Pediculosis Capitis Among School Children in Chachoengsao Province, Thailand - NCT ID: NCT06332872 - Study ID: M046q/66 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-12-15 - Completion Date: 2024-05 - Lead Sponsor: Phramongkutklao College of Medicine and Hospital ### Study Description The goal of this clinical trial is to Comparison effectiveness of Oral ivermectin , 1% Permethrin shampoo and 4% Dimeticone liquid gel in the treatment of Pediculosis capitis, to assess the prevalence of lice and associated risk factors between severity groups by using questionnaire-based surveys and diagnostic tests among school children in Baan Nayao, Chachoengsao Province, Thailand.The main questions it aims to answer are* What is more effective between Oral ivermectin , 1% Permethrin shampoo and 4%Dimeticone liquid gel in the treatment of Pediculosis capitis in school children in Baan Nayao, Chachoengsao Province, Thailand?* What is Prevalence and risk factors of being infected with in head lice in school and community?* What is Side effects of Oral ivermectin , 1% Permethrin shampoo and 4%Dimeticone liquid gel?Participants will receive three different drugs are* oral ivermectin* 4% Dimeticone liquid gel* 1% Permethrin shampooParticipants voluntarily received oral ivermectin as per medical prescription, with treatment outcomes, side effects, and satisfaction levels monitored following two treatment cycles. Those exhibiting persistent lice infestations were subsequently treated with 1% permethrin shampoo, the standard treatment, while alternatives were provided for individuals allergic to permethrin. These findings will contribute to formulating tailored, effective, and safe treatment regimens for future patients. ### Conditions - Pediculus Capitis Infestation - Permethrin Adverse Reaction - Dimethicone Adverse Reaction - Permethrin Allergy - Dimethicone Allergy - Ivermectin - School-age Children ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Oral Ivermectin - 4% dimenticone liquid gel ### Outcomes Primary Outcomes - Comparison effectiveness of Oral ivermectin , 1% Permethrin shampoo and 4% Dimeticone liquid gel in the treatment of Pediculosis capitis Secondary Outcomes - Prevalence of head louse infestation among school children in Chachoengsao Province, Thailand - Side effects of Oral ivermectin , 1% Permethrin shampoo and 4%Dimeticone liquid gel - The association factor of head lice infestation among school children in Chachoengsao Province, Thailand ### Location - Facility: Phramongkutklao college of medicine, Bangkok, N/A, N/A, Thailand @@

Subsets and Splits

No community queries yet

The top public SQL queries from the community will appear here once available.