Datasets:

hackint0sh
/

md_dataset

Dataset card Viewer Files Files and versions Community

Split (1)

train · 10k rows

record stringlengths 560 23.9k
## ERP Plus Improv Group Therapy for OCD (IMPROVE Study) - NCT ID: NCT06265233 - Study ID: 69668 - Status: RECRUITING - Start Date: 2024-02-09 - Completion Date: 2025-01 - Lead Sponsor: Stanford University ### Study Description The goal of this study is to pilot test a novel group therapy intervention for adults with OCD. ### Conditions - Obsessive-Compulsive Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Group Improv sessions - Group Exposure and Response Prevention (ERP) Therapy ### Outcomes Primary Outcomes - Change in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS) Secondary Outcomes - Change in Intolerance of Uncertainty Score ### Location - Facility: 401 Quarry, Stanford, California, 94304, United States @@
## AB-101 in Combination With B-Cell Depleting mAb in Patients Who Failed Treatment for Class III or IV Lupus Nephritis - NCT ID: NCT06265220 - Study ID: AB-101-03 - Status: RECRUITING - Start Date: 2024-02-24 - Completion Date: 2026-10 - Lead Sponsor: Artiva Biotherapeutics, Inc. ### Study Description AB-101 (also known as AlloNK) is an off-the shelf, allogeneic cell product made of "natural killer" cells, also called NK cells. White blood cells are part of the immune system and NK cells are a type of white blood cell that is known to enhance the effect of monoclonal antibody therapies.This clinical trial will enroll adult patients with lupus nephritis Class III or IV either with or without the presence of Class V who relapsed or did not respond to previous standard of care treatment approaches.The primary objective is to assess the safety, tolerability and preliminary activity of AB-101 plus rituximab after cyclophosphamide and fludarabine in adult subjects with relapsed/refractory lupus nephritis Class III or IV, with or without the presence of Class V.Patients will be assigned to receive either AB-101 alone as monotherapy or in combination with rituximab. All patients will receive at least 1 treatment cycle of AB-101, followed by scheduled assessments of overall health and response status.Patients may receive up to 2 cycles of treatment spaced 24 weeks apart. ### Conditions - Lupus Nephritis - WHO Class III - Lupus Nephritis - WHO Class IV ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - AB-101 - Cyclophosphamide - Fludarabine - Rituximab ### Outcomes Primary Outcomes - Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events - AB-101 Clinical Activity Secondary Outcomes ### Location - Facility: University of California, San Diego, San Diego, California, 92121, United States @@
## The Effect of Virtual Reality on Pain, Anxiety and Satisfaction Level Before Mammography - NCT ID: NCT06265207 - Study ID: ArdahanU-Simsekli-DS-02 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-04-15 - Lead Sponsor: Ardahan University ### Study Description In this study, it is planned to determine the effect of virtual reality applied to women before mammography on pain, anxiety and satisfaction levels. For this purpose, individuals applying for breast cancer screening will first be randomly divided into experimental and control groups. Pain, anxiety and satisfaction level evaluation forms will be applied to the experimental group before the mammography procedure. A relaxing video will be watched with virtual reality glasses and the mammography will be performed. At the end of the mammography, the relevant forms will be applied to the individuals again. The control group will not be subjected to any additional application that will continue with the applied routine. ### Conditions - Mammography - Early Diagnosis of Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Virtual reality - routine maintenance ### Outcomes Primary Outcomes - Visual Comparison Scale - State Anxiety Inventory - Satisfaction Evaluation Scale Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of EMDR in the Treatment of Fibromyalgia - NCT ID: NCT06265194 - Study ID: ZAT2024 - Status: COMPLETED - Start Date: 2015-01-01 - Completion Date: 2018-03 - Lead Sponsor: Academy of Therapeutic Sciences, Turkey ### Study Description The goal of this randomized-controlled study is to investigate the impact of EMDR therapy on fibromyalgia symptoms, depression, sleep quality, and traumatic stress in fibromyalgia patients.The main questions it aims to answer are:* Does EMDR become useful in relieving pain and complaints in fibromyalgia patients?* Is specific EMDR Fibromyalgia Protocol effective of fibromyalgia patients?* Does EMDR therapy decrease depression, sleep quality and traumatic stress symptoms of individuals with fibromyalgia? ### Conditions - Fibromyalgia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - EMDR - TAU ### Outcomes Primary Outcomes - Fibromyalgia Impact Questionnaire (FIQ) - Pittsburgh Sleep Quality Index (PSQI) - Trauma Symptom Checklist-40 (TSC-40) Secondary Outcomes - Beck Depression Inventory (BDI) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Diabetes Coaching on Distress and Diabetes Self-Management - NCT ID: NCT06265181 - Study ID: AIBU-SBF-SK-04 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-27 - Completion Date: 2027-12-31 - Lead Sponsor: Abant Izzet Baysal University ### Study Description This research is a randomized controlled, experimental study planned to evaluate the effect of diabetes coaching on diabetes self-management, glycosylated hemoglobin and diabetes distress levels in individuals with type 2 diabetes.The research is planned to start on 01.01.2024. Participants will be divided into experimental and control groups using the block randomization method. Participants in the experimental group will first receive 8 sessions of diabetes coaching every 10 days after the chemistry interview. No intervention will be made to the control group. The preliminary implementation of the research will be carried out with 4 individuals with diabetes who voluntarily accept participation and meet the inclusion criteria. Data will be collected by face-to-face interview method. Data will be analyzed with IBM SPSS V23 program. ### Conditions - Diabetes Mellitus, Type 2 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Diabetes coaching ### Outcomes Primary Outcomes - Type 2 Diabetes Self-Management Scale Secondary Outcomes - Diabetes Distress Scale - HbA1c Monitoring Form - Introductory Features Form ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comprehensive Observations and Multidisciplinary Approaches in the Management of Unconscious Patients - NCT ID: NCT06265168 - Study ID: req-2023-01512; am23Sutter3 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-12-31 - Lead Sponsor: University Hospital, Basel, Switzerland ### Study Description This prospective observational high-fidelity simulation study aims to observe and better understand how physicians from different disciplines differentiate in the management of a comatose patient and how their diagnostic and treatment approaches adhere to current recommendations in a highly standardized simulated scenario. The results gained by this study will give more insight into the current quality of diagnostic procedures and treatment and help refine recommendations in this context. The investigators hypothesize that physicians do not strictly adhere (regarding diagnostic approach and treatment) to current guidelines/recommendations when confronted with a comatose patient. ### Conditions - Coma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Simulation ### Outcomes Primary Outcomes - To reveal diagnostic and treatment approaches of physicians from different disciplines when confronted with a comatose patient. Secondary Outcomes - Physicians' grade of adherence to current recommendations regarding diagnostic procedures and treatment of a comatose patient - Participants' self-evaluation of their performance in hindsight ### Location - Facility: University Hospital Basel, Basel, N/A, N/A, Switzerland @@
## Triggers of Acute Ischemic Stroke Due to Large Vessel Occlusion - NCT ID: NCT06265155 - Study ID: SuzhouMHAnhui - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2025-12-31 - Lead Sponsor: Anzhi Li ### Study Description Acute ischemic stroke has a high incidence, ischemic stroke caused by large vessel occlusion is serious and has a poor prognosis, and its triggers in the short term before onset are not clear. The aim of this study was to evaluate the short-term risk of acute ischemic stroke caused by multiple triggers. In this trial, through a case-crossover study design, patients were asked about the exposure to each trigger in the previous year and the exposure during the preictal risk period (the exposure observed during the risk period) for each potential trigger of acute ischemic stroke caused by large vessel occlusion. To evaluate the relative risk of ischemic stroke resulting from exposure to triggers, comparing exposure during the dangerous period with the usual frequency of exposure. Relative risks and corresponding 95% CIs were estimated for past-year exposure and past-year mean exposure (assessed as chronic risk factors) and time to last exposure (assessed as triggers). Scientifically evaluate exposure to a range of potential triggers, including infection, mood, smoking, alcohol consumption, diarrhea and vomiting, extreme temperature changes, and several factors that increase blood pressure and their risk of developing acute ischemic stroke. ### Conditions - Triggers of Acute Ischemic Stroke Due to Large Vessel Occlusion ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - RR values for exposure during the risk period versus exposure in the past year for each trigger Secondary Outcomes ### Location - Facility: Suzhou Hospital Anhui Medical University, Suzhou, Anhui, 234000, China @@
## Clean Catch Urine Feasibility and Contamination Rate Compared to Bladder Catheterization Urine in Pre-Continent Children - NCT ID: NCT06265142 - Study ID: MoH/CSR/23/26368 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-15 - Completion Date: 2024-12-01 - Lead Sponsor: Oman Medical Speciality Board ### Study Description Introduction: Urinary tract infections (UTIs) are a common source of infection in children, accounting for a significant proportion of visits every year. Diagnosing UTIs requires obtaining a urine specimen, which can be collected using four methods: invasive techniques, such as suprapubic aspiration and urethral bladder catheterization, and noninvasive techniques, such as sterile bag and clean catch. However, catheterization can be a painful and invasive procedure, particularly in young infants who are less cooperative, and sometimes tends to be rejected by parents.Given the availability of alternative methods with comparable contamination rates, we aim to investigate the feasibility and contamination rate of clean catch urine compared to bladder catheterization, as well as secondary outcomes such as pain scores, parental satisfaction, and time required to collect urine for each technique.Methods: To achieve this, we will conduct a randomized control trial in precontinent pediatric patients. A pilot study with 40 samples in each arm will be conducted since there is no prior information about contamination rates in our setting. A well-designed and labeled data collection sheets will be used for data collection, and the data will be entered using EPI-data software. Statistical analysis will be performed using IBM SPSS statistics.Aim: The main aim of this study is to introduce clean catch urine (bladder massage technique) to our setting, and to compare its feasibility with the bladder catheterization which is the standard practice.Patient Population: young infants from 0 to 6 months of ageIntervention: There will be two groups:1. Group A (Experimental group):Urine samples will be collected using the clean catch urine method (bladder massage technique).2. Group B (Control group): Urine samples will be collected using the standard bladder catheterization method.Clinical Measurement: All collected urine samples will be labeled and sent to the laboratory. All results will be retrieved from the medical records. Direct measurement will be for the duration of the procedures in both experiment and control group (stopwatch will be used). Pain score (Neonatal Infant Pain Scale) and parental satisfaction survey will be filled at the time of the procedure.Outcome: Contamination rate and feasibility of both urine sampling techniques ### Conditions - Urinary Tract Infections ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Bladder catheterization - clean catch urine via bladder massage technique ### Outcomes Primary Outcomes - Urine culture contamination rate - Parental satisfaction questionnaire Secondary Outcomes - duration of the procedure - Pain score ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Association Between Obstructive Sleep Apnea Severity and Red Blood Cells Indices - NCT ID: NCT06265129 - Study ID: R.23.12.2429 - Status: COMPLETED - Start Date: 2023-03-20 - Completion Date: 2023-12-20 - Lead Sponsor: Mansoura University ### Study Description Obstructive sleep apnea syndrome (OSAS) is characterized by recurrent episodes of obstructive events (apnea and hypopnea) and intermittent hypoxia, which in turn contributes to the systemic inflammation that underlies this disease and its consequences (Ryan et al 2009, Gileles-Hillel et al 2014). This systemic inflammation leads to endothelial dysfunction, which contributes to the pathogenesis of cardiovascular complications in OSAS, in addition to the exposure to risk factors, such as male gender, older age, obesity, and lack of exercise (Lorenzi Filho et al 2010). Some red blood cells (RBC) and platelets indices have emerged as inflammatory biomarkers in various diseases (Tertemiz et al 2016) The severity of OSA is significantly associated with increase hematocrit, even after controlling for possible confounding variables. However, nocturnal hypoxemia in OSA does not usually lead to clinical polycythemia (Choi et al 2006). In patients referred with a clinical diagnosis of OSAS, RDW may be a marker for the severity of the condition. As RDW is usually included in a complete blood count, it could provide an inexpensive tool for triaging OSAS patients for polysomnography evaluation (Sökücü et al 2012). The hematological indices white blood cell count (WBC), neutrophil count, lymphocyte count, mean platelet volume (MPV), platelet distribution width (PDW), and red blood cell distribution width (RDW) have been proposed as alternative markers to those normally used clinically, e.g., interleukin-6 (IL6) and C-reactive protein, to evaluate the burden of inflammation in OSAS (Wu et al 2018) ### Conditions - Obstructive Sleep Apnea ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Complete blood picture (done in the morning after the night of monitored sleep by PSG. With stress on red blood cell indices (RBC count, MCV, MCH, RDW) ### Outcomes Primary Outcomes - Red Blood Cells Indices Secondary Outcomes ### Location - Facility: Tamer Awad Elsayed, Mansoura, Dakhlia, 050, Egypt @@
## One-Step Universal Adhesives: A 3-year Clinical Trial in Class II Composite Restorations - NCT ID: NCT06265116 - Study ID: A0801024 CD - Status: RECRUITING - Start Date: 2024-01-23 - Completion Date: 2027-01-30 - Lead Sponsor: Mansoura University ### Study Description to evaluate and compare the clinical performance and periodontal responses of four commercially available one-step universal adhesives with different formulations in Class II composite restorations over a three-year period. ### Conditions - Dental Caries Class II - Marginal Integrity of Composite Restorations With Universal Adhesives ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - One-step universal adhesive ### Outcomes Primary Outcomes - Percentage of functional and biological properties for each group Secondary Outcomes ### Location - Facility: Omar Abd El-Fattah Abd El-Maksoud, Mansoura, Dakahlia, 35516, Egypt @@
## Epilepsy Learning Healthcare System (ELHS) - NCT ID: NCT06265103 - Study ID: 20190407 - Status: RECRUITING - Start Date: 2019-03-20 - Completion Date: 2099-02-14 - Lead Sponsor: Epilepsy Foundation of America ### Study Description The Epilepsy Learning Health System (ELHS) is a quality improvement and research network to improve outcomes for people with epilepsy. The ELHS is designed as a model of value-based chronic care for epilepsy as envisioned by the National Academies of Medicine Committee in their landmark reports "The Learning Health System" and "Epilepsy Across the Spectrum: Promoting Health and Understanding".The ELHS network is a collaboration among clinicians, patients and researchers that promotes the use of data for multiple purposes including one-on-one clinical care, population management, quality improvement and research. The ELHS Registry includes data on children and adults with epilepsy collected during the process of standard epilepsy care. These data are used to create population health reports and to track changes in outcomes over time. ELHS teams use quality improvement methods, such as Plan-Do-Study-Act (PDSA) cycles, to continuously learn how to improve care. ### Conditions - Epilepsy - Seizure Disorder - Neurologic Disorder - Rare Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Clinical care and quality improvement ### Outcomes Primary Outcomes - Seizure Frequency - Seizure Freedom - Quality of Life documentation Secondary Outcomes ### Location - Facility: Barrow Neurological Institute Comprehensive Epilepsy Center, Phoenix, Arizona, 85013, United States @@
## Effect of Lumbar Stabilization Exercises Combined With Ball and Balloon Exercise in Treatment of Chronic Non-specific Low Back Pain - NCT ID: NCT06265090 - Study ID: F.P.T 2307017 - Status: COMPLETED - Start Date: 2022-01-10 - Completion Date: 2023-01-10 - Lead Sponsor: Delta University for Science and Technology ### Study Description \[Background\] Low back pain occurs when a poor lifestyle weakens the muscular strength of the waist and excessive loads on and tensions of the muscles create pain. Mediating muscle weakening to stabilize the trunk is an important aspect in the recovery of body function in patients with LBP \[Purpose\], this study was conducted to investigate the effect of core stability exercises combined with ball and balloon exercises on chronic non-specific low back pain. \[Subjects and Methods\] a sixty patient of chronic non-specific low back pain were randomly assigned into two groups, group (A) received core stability exercises combined with ball and balloon exercises and group (B) received core stability exercises, these exercises were performed for three times a week for four weeks. Pain was assessed by visual analogue scale (VAS). Spinal function was measured by Arabic Oswestery Disability Index (AODI) and pulmonary function was assessed by pulmonary function test including forced expiratory volume in the first second (FEV1), forced vital capacity (FVC), FEV1/FVC, maximum voluntary ventilation (MVV) and peak expiratory flow (PEF) before and after the study.Keywords: core stability exercises, ball and balloon exercises, chronic non-specific low back pain ### Conditions - Chronic Mechanical Low Back Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - therapeutic exercises - exercises ### Outcomes Primary Outcomes - visual analogue score Secondary Outcomes - forced expiratory volume in the first second (FEV1) in liters - forced vital capacity (FVC) in liters - FVC/FEV1 ratio - maximum voluntary ventilation (MVV) - peak expiratory flow (PEF) in liter/min ### Location - Facility: Delta University For Science and Technology, Al Manşūrah, Gamasah, 11152, Egypt @@
## Novel Preventive Approach Against Filgrastim-Induced Bone Pain in Cancer Patients - NCT ID: NCT06265077 - Study ID: 2023-199 - Status: NOT_YET_RECRUITING - Start Date: 2024-02 - Completion Date: 2024-08 - Lead Sponsor: Noha Mansour ### Study Description No randomized controlled trial evaluated the safety and efficacy of double blockade on G-CSF induced bone pain. Therefore, this study aims to evaluate the efficacy and safety of double blockade on the incidence and severity of G-CSF induced bone pain. ### Conditions - Breast Cancer - Filgrastim Adverse Reaction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Placebo - famotidine and loratadine ### Outcomes Primary Outcomes - The incidence of grade 2 or 3 bone pain in cycle 1 according to Common Terminology Criteria for Adverse Events Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## STOP-Bang Score and Factors Predicting Difficult Intubation for Prediction of Difficult Mask Ventilation in Obese Patients - NCT ID: NCT06265064 - Study ID: KhonKaenUniversity - Status: COMPLETED - Start Date: 2022-07-11 - Completion Date: 2023-10-31 - Lead Sponsor: Khon Kaen University ### Study Description The goal of this prospective observational study is to test combination of STOP-Bang score and factors predicting difficult intubation can improve accuracy of prediction difficult mask ventilation in obese patients that undergoing to elective surgery under general anesthesia.The main question\[s\] it aims to answer are:* Can combination of STOP-Bang score and factors predicting difficult intubation improve accuracy of prediction difficult mask ventilation in obese patients?* Study about complication after endotracheal tube insertion in obese patients that undergoing to elective surgery under general anesthesia.Participants who undergoing to elective surgery under general anesthesia will* Routine preoperative evaluation and ask about STOP bang questions, evaluate neck circumference, Mallampati grade,Thyromental distance (That routine physical examination for anesthetic care pre-operation)* In operation room, patients will be inducted anesthesia by anesthesiologist (step routine for general anesthesia),observe difficult mask ventilation grading before intubate endotracheal tube and complication after endotracheal tube insertion.If there is a comparison group:Researchers will compare obese patients with/without high STOP bang score \>=3 point plus factor predicting difficult intubation (Mallampati grade 3-4, Neck circumference \> 42 cm, Thyromental distance \< 6 cm)to prediction difficult mask ventilation ### Conditions - Obesity - OSA ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - STOP-Bang score >= 3 with factors predicting difficult intubation ### Outcomes Primary Outcomes - Difficult mask ventilation Secondary Outcomes - Resipiratory complication ### Location - Facility: KhonKaen University, Nai Muang, Khonkaen, +66, Thailand @@
## Tirofiban After Successful MT Recanalization in AIS - NCT ID: NCT06265051 - Study ID: 100939 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2027-09-01 - Lead Sponsor: Xiang Luo ### Study Description Acute ischemic stroke with large vessel occlusion is a frequently occurring life-threatening condition. Although endovascular treatment can effectively open occluded vessels, the successful reperfusion rate exceeds 80%, but the rate of good prognosis is less than 50%. The current clinical focus is on how to improve futile recanalization. Tirofiban is widely used in the treatment of stroke, as it can effectively prevent vascular reocclusion and improve microcirculation perfusion. It has the potential to improve futile recanalization, but there is a lack of high-level evidence-based medical support. This multicenter, prospective, double-blind, randomized controlled trial was conducted to assess the effectiveness and safety of sequential tirofiban therapy following successful mechanical thrombectomy within 24 hours of onset. ### Conditions - Acute Ischemic Stroke - Vessel Occlusion ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Tirofiban - Saline placebo ### Outcomes Primary Outcomes - Proportion of patients functionally independent (mRS score 0 to 2) at 90 days - Number of participants with symptomatic intracranial hemorrhage Secondary Outcomes - Modified ranking scale (mRS) - Proportion of patients non-disabled (mRS score 0 to 1) or return to pre-morbid mRS score at 90 days (for patients with mRS > 1) - Proportion of patients ambulatory or bodily needs-capable or better (mRS score 0 to 3) - Number of participants with improvement of neurological function - Health-related quality of life, assessed with the European Quality Five Dimensions Five Level scale (EQ-5D-5L) - All-cause mortality - Proportion of intracranial hemorrhage of any type ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Confirmatory Investigation to Evaluate the Performance and Safety of ReSpace TiCell Cage Implants in TLIF - NCT ID: NCT06265038 - Study ID: SANAT-CAGE-2022 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2026-10-01 - Lead Sponsor: Sanatmetal Orthopaedic and Traumatologic Equipment Manufacturer Ltd. ### Study Description The primary objective of this study is to confirm superiority for the efficacy of the ReSpace Ticell Cage implants in Transforaminal Lumbar Interbody Fusion compared to state-of-the-art.The secondary objective of the study is to evaluate further efficacy and safety of the ReSpace Ticell Cage implants in Transforaminal Lumbar Interbody Fusion with the following secondary efficacy and safety objectives:* To evaluate if implantation causes significant reduction in patient's back, hip/buttock, and leg pain.* To evaluate if implantation causes significant increase quality of life of the patients.* To evaluate if using the device can be considered as safe overall. ### Conditions - Degenerative Instability - Spondylolisthesis - Post-discectomy Syndrome - Post-traumatic Instability ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - ReSpace TiCell Cage ### Outcomes Primary Outcomes - CT imaging_1 - cumulative fusion rate - CT imaging_2 - fusion status Secondary Outcomes - Visual Analog Scale - Oswestry Disability Index (ODI) ### Location - Facility: National Center for Spinal Disorders, Budapest, Pest, 1126, Hungary @@
## GM103 Intratumoral Injection in Patients With Locally Advanced, Unresectable, Refractory and/or Metastatic Solid Tumors - NCT ID: NCT06265025 - Study ID: GM103-CT-101 - Status: RECRUITING - Start Date: 2024-02-20 - Completion Date: 2028-10-30 - Lead Sponsor: GeneMedicine Co., Ltd. ### Study Description The purpose of this study is to measure safety, tolerability, and preliminary antitumor efficacy of GM103 administered alone and in combination with pembrolizumab in patients with locally advanced, unresectable, refractory and/or metastatic solid tumors (including but not limited to head and neck cancer, malignant melanoma, CRC, renal cell carcinoma, cervical cancer, and breast cancer). Study details include: ### Conditions - Head and Neck Cancer - Malignant Melanoma - Colorectal Cancer - Renal Cell Carcinoma - Cervical Cancer - Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - GM103 (Part A) - GM103 (Part B) - GM103 and Pembrolizumab (Part C) ### Outcomes Primary Outcomes - Percentage of patients with DLTs by cohorts - Percentage of patients with DLTs - Incidence of AEs, AESIs, SAEs, AEs leading to discontinuation, and AEs resulting in death Secondary Outcomes - ORR - DCR defined as the proportion of patients whose BOR was CR, PR and SD - Median PFS defined as the time from the date of the first administration of study drug to the date of disease progression or death - Incidence of GM103 detection - Changes in the level of anti-adenovirus antibodies(ADA) in blood compared to baseline (ADA in genome copies/mL using qPCR) ### Location - Facility: National Cancer Center, Goyang-si, Gyeonggi-do, 10408, Korea, Republic of @@
## Study to Evaluate the Recombinant Vesicular Stomatitis Virus (rVSV)-Marburg Virus Vaccine Candidate (PHV01) in Healthy Adult Subjects - NCT ID: NCT06265012 - Study ID: PHV01-C-101 - Status: RECRUITING - Start Date: 2024-02-05 - Completion Date: 2024-09-16 - Lead Sponsor: Public Health Vaccines LLC ### Study Description This is a Phase 1 randomized, single-blind, placebo-controlled, ascending dose study to evaluate the safety and immunogenicity of rVSV∆G-MARV-GP \[Angola\] (PHV01, Marburg Virus glycoprotein \[MARV GP\] Vaccine) in healthy adults. PHV01 is a live, attenuated rVSV vaccine expressing the MARV GP. The main questions it aims to answer are:* Which dose of PHV01 is safe to administer to, and well-tolerated by healthy adult subjects?* What is the immunologic response (Marburg-specific Immunoglobulin G (IgG) ELISA antibody and neutralizing antibodies) to each dose level?Participants will receive 1 intramuscular injection of PHV01 or placebo on Day 1 and will be followed for 181 days. ### Conditions - Marburg Virus Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: PREVENTION ### Interventions - PHV01 - Placebo ### Outcomes Primary Outcomes - Solicited Adverse Events (AEs) - Unsolicited AEs - Other AEs - Immunogenicity, Antibodies (Ab) - Immunogenicity, Neutralizing antibodies (NEUT) Secondary Outcomes ### Location - Facility: CenExel RCA, Hollywood, Florida, 33024, United States @@
## Robotic Assisted Knee Arthroplasty - Retain the Anterior Cruciate Ligament or Not - NCT ID: NCT06264999 - Study ID: 427976 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-04 - Lead Sponsor: St. Olavs Hospital ### Study Description The goal of this clinical trial is to compare the function of the knee after retaining or sacrificing the anterior cruciate ligament in robotic assisted knee arthroplasty.The main questions it aims to answer are:Does retaining the anterior cruciate ligament improve postoperative gait? Participants will perform* Gait analysis* Stair performance test* CT based Micromotion analysis of the implant micromovement ### Conditions - Arthritis Knee - Arthroplasty - Gait Analysis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Journey II CR - Journey II XR ### Outcomes Primary Outcomes - Preferred walking speed (meter/minute) after surgery - CT-RSA measured maximum total point of motion(MTPM) Secondary Outcomes - evaluation of max walking speed(m/minute) - stride length(cm) - step length in mid stance phase (cm) - single leg support time(s) - double-leg support time(s) - stair performance(s) - Rating pain using NRS (Numeric Rating Scale). - KOOS-PS (Knee Injury and Osteoarthritis Outcome score) - Clinical evaluation of range of motion . - Rating outcome using EQ-5D-5L(European quality of life index version 5D-5L), - IKSS (International Knee Society System knee and function score) - FJS-12 (Forgotten Joint score) - Clinical evaluation of Anteroposterior stability. - Clinical evaluation of Mediolateral stability. ### Location - Facility: St.Olavs Hospital, Trondheim, Trøndelag, 7006, Norway @@
## The Effects of Ashwagandha (Withania Somnifera) Supplementation on Exercise Performance in Female Footballers - NCT ID: NCT06264986 - Study ID: 2023-09-02 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-01-13 - Completion Date: 2024-02-21 - Lead Sponsor: Blanca Roman-Viñas, MD ### Study Description The goal of this clinical trial is to evaluate the effects of short-term root extract ashwagandha supplementation on exercise performance in female footballers. The main question it aims to answer are:Will short-term supplementation of root extract ashwagandha improve muscle strength markers in female footballers? Will short-term supplementation of root extract ashwagandha improve perception of recovery following high-intensity exercise in female footballers?Participants will either supplement 600mg (5% withanolides) root extract ashwagandha or placebo once a day for 28 days. There will be three data points: baseline, 14 days and 28 days. Researchers will compare values of intervention against placebo to see if there is an effect on muscle strength or perception of recovery. ### Conditions - Muscle Strength ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Ashwagandha - Placebo ### Outcomes Primary Outcomes - Increased lower body muscle strength - Increased maximum voluntary muscle strength - Increased upper body muscle strength and explosiveness - Improved overall muscle strength Secondary Outcomes - Improved perception of wellbeing - Improved perception of recovery ### Location - Facility: Club Esportiu Seagull, Badalona, Barcelona, 08917, Spain @@
## Maternal and Fetal/Neonatal Pharmacokinetics and - Dynamics of Corticosteroids During Pregnancy - NCT ID: NCT06264973 - Study ID: NL9318 - Status: RECRUITING - Start Date: 2021-01-01 - Completion Date: 2025-12-01 - Lead Sponsor: Erasmus Medical Center ### Study Description Improving pregnancy outcome is essential in improving health of both parents and their offspring during the life course. Preterm birth (PTB) occurs in 10-15% of all pregnancies, is the leading cause of perinatal mortality and morbidity {Goldenberg, 2008}, has long-term adverse consequences for postnatal health {Huddy, 2001} and is a burden for health care expenditure. In order to improve neonatal outcome, antenatal corticosteroids (ACS) are routinely administered to women at risk for preterm delivery before 34 weeks of pregnancy. {Jobe, 2018;Roberts, 2017;Travers, 2018} However, the current, worldwide standard of care, for the use of ACS is still based on animal experiments performed in the 1970's. {Liggins, 1969} Although ACS treatment to improve neonatal outcome was clinically introduced in the 70's, still only two dosing regimens are used, neither of which have been investigated, re-evaluated or refined to determine the optimal doses or treatment interval. With the current health care approach of personalized medicine in mind, the same universal approach for everybody, independent of gestational age, number of fetus, maternal weight or comorbidity one dose does not fit all since it often has not the desired effect. Due to the lack of optimization of the above mentioned synthetic corticosteroid drug regimens {Kemp, 2019}, significant gaps in knowledge exist. An important aspect to set up, investigate and understand dosing and also dosing interval experiments, is knowledge of the maternal individual pharmacokinetics and pharmacogenetics of the drug of interest during pregnancy. ### Conditions - Preterm Birth ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Pharmacokinetics of antenatal corticosteroids by investigation of betamethasone concentrations in serum Secondary Outcomes - Maternal age - Fetal sex - Maternal weight/BMI - Number of fetus - Parity: the number of times a woman has given birth to a live neonate (any gestation) or at 24 weeks or more - PE by urine measurement of protein-creatinine ratio - Oestradiol concentration in serum - Cord blood and neonatal blood ### Location - Facility: Erasmus Medical Center, Rotterdam, Zuid Holland, 3015GD, Netherlands @@
## The Effect of Music Therapy and Breathing Exercise on Anxiety and Pain in Patients Undergoing Coronary Angiography - NCT ID: NCT06264960 - Study ID: E10208771 - Status: COMPLETED - Start Date: 2022-09-15 - Completion Date: 2023-10-02 - Lead Sponsor: Ulku Gunes ### Study Description Coronary angiography serves as the primary diagnostic technique for cardiovascular disease. However, this invasive procedure commonly triggers pain, anxiety, and fear in patients. The objective of this randomized controlled trial was to examine the impact of music and breathing exercises on anxiety and pain levels in individuals undergoing coronary angiography. The study, conducted as a single-blind, randomized controlled trial, involved a sample of 165 patients, with 55 in each group: the control group, the breathing exercise group, and the music therapy group. Patients in the music group listened to music during angiography, those in the breathing exercise group practiced exercises 30 minutes before the procedure, while the control group received standard treatment. Anxiety levels were assessed both before and after the procedure, and pain levels were measured post-procedure. The study strictly adhered to the CONSORT statement guidelines. ### Conditions - Procedural Pain - Procedural Anxiety ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Music therapy - Breathing exercise ### Outcomes Primary Outcomes - State-Trait Anxiety Inventory - Visual Analog Scale Secondary Outcomes ### Location - Facility: Ege University, Bornova, İzmir, 35100, Turkey @@
## Efficacy of Laser Acupuncture on Zanzhu (BL02) for Dry Age-related Macular Degeneration - NCT ID: NCT06264947 - Study ID: CMUH112-REC2-141 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-01-26 - Completion Date: 2024-11-01 - Lead Sponsor: China Medical University Hospital ### Study Description This study is to see if laser acupuncture is a better way to treat dry-AMD (Age-related Macular Degeneration) compared to sham laser acupuncture, in the aspect of visual acuity. Investigators planed to recruit participants who are diagnosed with dry-AMD, and not younger than 20 years old. Before the study, investigators will measure the participants' BCVA (Best Corrected Visual Acuity), and then practice laser acupuncture and sham-laser acupuncture on experiment group and control group respectively. After the 4-week study, investigators will measure the participants' BCVA again. ### Conditions - Age-related Macular Degeneration ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - laser acupuncture - sham laser acupuncture ### Outcomes Primary Outcomes - BCVA (Best Corrected Visual Acuity) Secondary Outcomes ### Location - Facility: China Medical University Hospital, Taichung, N/A, 404, Taiwan @@
## An Investigation Into Dielectric Assessment of Permittivity and Cancer in Human Using a Novel Electrical Capacitance Tomography Scanner - NCT ID: NCT06264934 - Study ID: DiCECT - Status: RECRUITING - Start Date: 2024-01-25 - Completion Date: 2024-12 - Lead Sponsor: Zedsen Limited ### Study Description The goal of this observational study is to investigate the ability of a the Z-scanner to identify and differentiate cancer and benign lesions from healthy breast tissue based on permittivity. The main questions it aims to answer are:1. Determine the permittivity values of the Z-scanner associated with healthy, benign, and malignant tissue in human breasts.2. Determine the repeatability, reproducibility, inter-and intra-operator variability of the Z-scanner. ### Conditions - Breast Cancer - Benign Breast Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Breast scan using the Z-scanner - Breast scan using the Z-scanner ### Outcomes Primary Outcomes - Measurement of complex permittivity of breast tissue components Secondary Outcomes - Permittivity target-to-background contrast ratios for targets of interest (e.g. malignant lesion, benign lesion) ### Location - Facility: Imperial College Healthcare NHS Trust, London, N/A, N/A, United Kingdom @@
## A Study With NKT3447 for Adults With Advanced/Metastatic Solid Tumors - NCT ID: NCT06264921 - Study ID: NKT3447-101 - Status: RECRUITING - Start Date: 2024-02-23 - Completion Date: 2025-05 - Lead Sponsor: NiKang Therapeutics, Inc. ### Study Description The goal of the Dose Escalation phase of the study is to evaluate the safety, tolerability, and pharmacokinetics (PK) to determine the maximum tolerated dose (MTD) and/or preliminary recommended dose for expansion (RDE) of NKT3447 in adults with advanced or metastatic solid tumors. The goal of the Expansion phase of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), and the preliminary antitumor activity of NKT3447 in adult subjects with cyclin E1 (CCNE1) amplified ovarian cancer at the RDEs selected in Dose Escalation and to determine the preliminary recommended phase 2 dose (RP2D). ### Conditions - Solid Tumor - Solid Tumor, Adult - Advanced Solid Tumor - Metastatic Tumor - Ovarian Cancer - Ovarian Neoplasms - Ovarian Carcinoma - Metastatic Ovarian Carcinoma - Endometrial Cancer - Endometrial Neoplasms - Endometrial Diseases - Metastatic Endometrial Cancer - Metastatic Endometrial Carcinoma - Advanced Endometrial Carcinoma - Advanced Ovarian Carcinoma - Gastric Cancer - Advanced Gastric Carcinoma - Metastatic Gastric Cancer - Metastatic Gastric Carcinoma - Small-cell Lung Cancer - Small Cell Lung Carcinoma - Triple Negative Breast Cancer - Triple Negative Breast Neoplasms - Platinum-resistant Ovarian Cancer - Platinum-refractory Ovarian Carcinoma - CCNE1 Amplification - Hormone Receptor Negative Breast Carcinoma - Human Epidermal Growth Factor 2 Negative Carcinoma of Breast - Progesterone-receptor-positive Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - NKT3447 ### Outcomes Primary Outcomes - Number of Participants with Dose Limiting Toxicity (DLT) events - Objective Response Rate (ORR) Secondary Outcomes - Progression-free survival (PFS) - Duration of Response (DOR) - Disease control rate - Overall Survival (OS) - Time to Response (TTR) - Number of Participants with Adverse Events - Maximum observed plasma concentration (Cmax) of NKT3447 - Time to maximum observed plasma concentration of NKT3447 (Tmax) - Observed trough concentration of NKT3447 (Ctrough) - Area under the plasma concentration-time curve (AUC0-t) of NKT3447 - Apparent clearance (CL/F) - Apparent volume of distribution (V/F) - Half-life (t1/2) - Accumulation ratio (AR) ### Location - Facility: Sarah Cannon Research Institute at HealthONE, Denver, Colorado, 80218, United States @@
## An Integrated Self Management Programme to Improve Outcomes in Patients With Hand Osteoarthritis - NCT ID: NCT06264908 - Study ID: 20240125-010-000 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2028-04 - Lead Sponsor: Dr Iris Tang Yan Ki ### Study Description The goal of this trial is to evaluate the efficacy of an integrated self-management programme in improving clinical outcomes in patients with hand osteoarthritis (OA).This is an open-labelled, randomized controlled trial with an objective to determine the efficacy of an integrated self-management programme versus routine clinical care for participants with symptomatic hand OA.Participants will be randomized into early intervention group and routine clinical care groups in a 1:1 ratio. Patients who randomized into early intervention group will receive 8 week integrated self-management programme delivered by occupational therapists and rheumatology nurse on hand OA management. Patients who randomized into routine clinical care group will receive usual clinical care for OA for 26 weeks and then receive an identical 8 weeks integrated self-management programme. The primary outcome is the improvement in pain at 26 weeks between the two groups. ### Conditions - Hand Osteoarthritis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Integrated self-management programme ### Outcomes Primary Outcomes - Change in Pain visual analogue scale (VAS) Secondary Outcomes - Change in pain Visual Analogue Scale (VAS) - Change in Functional index hand osteoarthritis (FIHOA) - Change in Quick Disabilities of the Arm, Shoulder, and Hand (DASH) score - Change in Australian/Canadian Hand Osteoarthritis Index (AUSCAN) 3.1 - Change in Short-form 36 items health survey - Change in hand grip strength - Change in hand dexterity measurement - Radiographic changes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Protocol for a Low Threshold Exercise Intervention for Women Experiencing Homelessness and Addiction. - NCT ID: NCT06264895 - Study ID: Trinity College Dublin 211202 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-26 - Completion Date: 2024-07-31 - Lead Sponsor: University of Dublin, Trinity College ### Study Description Background: Frailty is a complex multi-dimensional state of increased vulnerability to adverse health outcomes and is usually associated with older age but there is growing evidence of accelerated ageing and frailty in non-geriatric populations, including those experiencing socio-economic deprivation and extreme social exclusion, such as people experiencing homelessness. Addiction, as a coping mechanism for prior trauma, is common among people who are homeless and can have a gendered dimension. Women experiencing homelessness and addiction have unique needs which require a gendered approach. The aim of this study is to explore the effectiveness of an exercise intervention to target the known physical functioning deficits and frailty which this population experiences.Methods: This mixed-methods study will explore physical functioning deficits and frailty in women experiencing homelessness and addiction, using a bespoke test battery and an exercise intervention. Physical function (10m Walk Test, 2 Minute Walk Test, Single Leg Stance Test, Chair Stand Test, hand grip dynamometry), frailty (Clinical Frailty Scale and the SHARE-FI) and nutritional status (Mini-Nutritional Status), pain (Numerical Pain Rating Scale) and quality of life (SF 12-V2) will be evaluated. The intervention will involve a 3-times weekly exercise programme with protein supplementation for 10 weeks. Following this, qualitative interviews, which will be thematically analysed using Braun \& Clarke methodology, will be conducted. This study will be conducted in Dublin from February to July 2024.Discussion: Little is kn own about frailty-focussed interventions in women experiencing homelessness and addiction. This proposed study will help to increase the knowledge base regarding the physical health burden and frailty experienced by this extremely vulnerable population and will deliver a targeted intervention with a gendered dimension to mitigate its affects. The findings of this research will help narrow this research gap and will guide clinicians and policy makers to implement unique gender-based treatment strategies for this population. ### Conditions - Social Exclusion - Chronic Disease - Physical Disability - Addiction ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Exercise ### Outcomes Primary Outcomes - Recruitment - Retention - Adverse events Secondary Outcomes - Hand grip dynamometry - Limb circumference - 10 Metre Walk Test - 2 Minute Walk Test - The Chair Stand Test - Single Leg Stance Test - Numerical Rating Scale (NRS) - Clinical Frailty Scale (CFS) - SHARE-Frailty Instrument (FI) - Mini Nutritional Assessment (MNA) - Short Form-12 V2 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Cardiometabolic Consequences of the Loss of Ovarian Function - NCT ID: NCT06264882 - Study ID: 23-1518 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2028-08-31 - Lead Sponsor: University of Colorado, Denver ### Study Description The menopause transition is associated with a decrease in artery health and an increased risk for weight gain in storing fat in the stomach area which may increase the risk for heart disease. The purpose of this research is to study how the decrease in estrogen at menopause changes artery health and fat gain, and risk of disease in women as they age. The first aim in this study will determine whether short term and long term low estrogen levels in premenopausal women decreases artery function and whether this is related to an increase in fat in the stomach area. The second aim will determine whether the changes in artery health and body fat are related to changes in a pathway that breaks down an important amino acid called tryptophan. This pathway is thought to play a role in regulating the aging process. Therefore, the investigators will determine whether the decrease in artery health and the increase in body fat in the stomach region with low estrogen is related to changes in this pathway in the blood, in vascular cells and fat tissue. Because estrogen levels fluctuate in premenopausal women, the investigators will use an approach (intervention) that controls estrogen levels to address these aims. The investigators will use a medication that is typically used to treat endometriosis or uterine fibroids to lower estrogen levels and an estrogen patch to increase estrogen in some women. Some women will receive a patch that has no estrogen (called a placebo patch). The intervention period will be 20 weeks. The study will provide us with new knowledge on how low estrogen with menopause affects artery health and fat gain estrogen. ### Conditions - Menopause - Estrogen Deficiency - Aging - Adiposity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Degarelix - Transdermal Estradiol Patch - Transdermal Placebo Patch ### Outcomes Primary Outcomes - Brachial artery flow mediated dilation (FMD) Secondary Outcomes - Visceral fat area (VFA) ### Location - Facility: University of Colorado Anschutz Medical Campus, Aurora, Colorado, 80045, United States @@
## Interdental Guided Creeping Technique - NCT ID: NCT06264869 - Study ID: 141123 - Status: NOT_YET_RECRUITING - Start Date: 2024-02 - Completion Date: 2024-11 - Lead Sponsor: October 6 University ### Study Description The aim of this randomized clinical trial is to treat interdental papillary deficiency with minimally invasive interdental guided creeping technique (IGCT) comparing collagen membrane versus connective tissue graft. ### Conditions - Interdental Papilla Recession ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Interdental guided creeping technique (IGCT) and connective tissue graft (CTG) - Interdental guided creeping technique (IGCT) and collagen membrane (CM) ### Outcomes Primary Outcomes - Black triangle height Secondary Outcomes - Percentage of interdental papillary fill - Papillary gain, black triangle reduction - Papillary height, attached gingiva width - Pocket depth, clinical attachment level, keratinized tissue thickness - Plaque index - Gingival index - Duration of surgery - Patient Reported Outcome - Patient Reported Outcome ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Bronchoscopy for Thoracic Trauma Patients - NCT ID: NCT06264856 - Study ID: 202210096RIND - Status: SUSPENDED - Start Date: 2024-12-01 - Completion Date: 2025-12-31 - Lead Sponsor: National Taiwan University Hospital ### Study Description The study aims to evaluate the effectiveness of bronchoscopic sputum suction in patients with severe thoracic illness-induced respiratory failure. The study will compare the outcomes of patients who receive bronchoscopic sputum suction versus blind negative pressure aspiration for sputum removal. The study will measure baseline data, postoperative blood gas conditions, and clinical parameters, such as time of invasive ventilation, total time of ventilation, hospital stay, weaning success rate, reintubation rate, ventilator-associated pneumonia incidence, and fatality rate. The study aims to determine whether bronchoscopy-assisted sputum removal is superior to blind negative pressure aspiration in improving patient outcomes. ### Conditions - Chest Trauma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - bronchoscopic sputum suction - negative pressure aspiration suction ### Outcomes Primary Outcomes - Rate of pneumonia Secondary Outcomes - Intensive Care Unit admission interval - admission interval - tracheostomy rate - intubation rate ### Location - Facility: Department of Traumatology, National Taiwain University Hospital, Taipei, N/A, 10002, Taiwan @@
## Peripheral Bypass Trial for Completion Control - NCT ID: NCT06264843 - Study ID: 724 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2027-12 - Lead Sponsor: Medistim ASA ### Study Description The goal of the study is to identify and validate flow measurement and ultrasound images in patients undergoing vein bypass surgery below-knee and above ankle ### Conditions - Chronic Limb-Threatening Ischemia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Medistim MiraQ system with TTFM and L15 HFUS probes ### Outcomes Primary Outcomes - Primary graft patency rate Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## 3D Visualization System in Highly Myopic Cataract Operation - NCT ID: NCT06264830 - Study ID: 202307103DIPC - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2024-12 - Lead Sponsor: National Taiwan University Hospital ### Study Description This study aims to investigate the impact of depth of field differences between the use of the 3D imaging system (NGENUITY® 3D Visualization System, Alcon, TX, USA) and conventional optical microscope in cataract surgery for highly myopic patients on intraoperative parameters and outcomes. ### Conditions - Cataract - High Myopia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Alcon-NGENUITY®(NG)-system - Standard cataract operation ### Outcomes Primary Outcomes - Number of times of Microscopic focus adjustment, measured by counting from the video recordings - Total moving distance in millimeter of microscope-lens-system relative to suspension arm, measured by ruler set on microscope - Distance of subjective focus change in millimeter between corneal surface and surface of posterior capsule, measured by ruler set on microscope Secondary Outcomes - Total operation time - Cumulative dissipated energy (CDE) of phacoemulsification, that is automatically measured and demonstrated on the screen of phacoemulsification machine (Centurion) - Number of Participants with intraoperative complication - Best-corrected visual acuity of the operated eye of Participants at each postoperative follow-up within 3 month, measured with Snellen chart under standard condition (6 meters in distance and standard illumination of environment) - Number of Participants with post-operative complication - Intraocular pressure of the operated eye of participants at each postoperative follow-up within 3 month, measured with pneumatic tonometer ### Location - Facility: Department of Ophthalmology, National Taiwan University Hospital, Taipei, N/A, 100, Taiwan @@
## Auto-Adjustable MOBIDERm Autofit Armsleeve in the Management of Upper Limb Lymphedema. - NCT ID: NCT06264817 - Study ID: EC 48 LyberT - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2025-04-15 - Lead Sponsor: Thuasne ### Study Description This study aims to assess Auto-Adjustable MOBIDERM® Autofit Armsleeve effect on upper limb volume excess compared to the compression bandages to manage the volume of upper limb lymphedema in patients with breast cancer related lymphedema ### Conditions - Lymphedema of Upper Limb ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - MOBIDERM Autofit Armsleeve - Compressive bandaging ### Outcomes Primary Outcomes - Volume excess variation Secondary Outcomes - Resource consumption - Resource consumption - Resource consumption - Lymphedema related Quality of life (QoL) - Doctors' opinion on improving the patient's health condition - Patient's opinion on Global Impression of Change - Satisfaction about the device - The safety - Compliance to treatment - General quality of life (QoL) - Skin elasticity - Ttissue induration ### Location - Facility: Pinar BORMAN, Ankara, N/A, N/A, Turkey @@
## Risk Factors for Progressive Suction Loss in Corneal Refractive Surgery - NCT ID: NCT06264804 - Study ID: [2023] No. 86 - Status: RECRUITING - Start Date: 2024-02-16 - Completion Date: 2024-12-01 - Lead Sponsor: Yifeng Yu ### Study Description The goal of this Prospective observational studiesis to Characteristics of progressive suction loss. ### Conditions - Refractive Surgery ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Identify risk factors for progressive suction loss Secondary Outcomes ### Location - Facility: Yuyifeng, Nanchang, Jiangxi, 330008, China @@
## Stress-motivated Alcohol Use as a Value-based Decision-making Process - NCT ID: NCT06264791 - Study ID: STUDY00018516 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2024-10-01 - Lead Sponsor: University of Washington ### Study Description The goal of this experimental study is to improve our understanding of the effects of stress on the decision to consume (more) alcohol in regular drinkers. The main question\[s\] it aims to answer are:* Does psychological stress affect the decision to consume (more) alcohol?* How does psychological stress affect the decision to consume (more) alcohol? Participants will be randomly assigned to one of four conditions (stress alcohol, stress no alcohol, no stress alcohol, no stress no alcohol) and complete a value-based decision-making task twice (once before and once after the manipulations). ### Conditions - Psychological Stress - Alcohol Intoxication ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: BASIC_SCIENCE ### Interventions - Stress - Alcohol ### Outcomes Primary Outcomes - Proportion of choices for alcoholic over non-alcoholic drinks. Secondary Outcomes ### Location - Facility: University of Washington, Seattle, Washington, 98105, United States @@
## Exploration of Fenestration Decompression Combined With Dalafenib in the Treatment of BRAF Mutant Ameloblastoma - NCT ID: NCT06264778 - Study ID: 2023013 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-12-31 - Lead Sponsor: Shandong University ### Study Description This pilot clinical trial plans to carry out dabrafenib adjuvant therapy combined with lesion curettage after fenestrated decompressive surgery for BRAF mutation-positive multicystic ameloblastoma to explore the effectiveness of this therapy in preventing tumor recurrence, reducing or even avoiding postoperative deformity and dysfunction. effect. Based on this, we plan to launch a prospective clinical study of dabrafenib in the treatment of BRAF V600E ameloblastoma, verify the feasibility of drug treatment or drug-assisted treatment of ameloblastoma, and provide patients with a safer Effective new treatment options will benefit more patients. ### Conditions - Ameloblastoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Dabrafenib ### Outcomes Primary Outcomes - objective response rate Secondary Outcomes - Relapse-free survival ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Scalp Block -Craniotomi - NCT ID: NCT06264765 - Study ID: 22-12-23 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2026-01-01 - Lead Sponsor: Aydin Adnan Menderes University ### Study Description Postoperative pain after craniotomy is an important clinical problem as it can lead to hypertension and increased intracranial pressure. Multimodal analgesia methods are performed by anesthesiologists in different ways depending on the anesthetist's preference.In addition, both techniques have been shown in studies to provide intraoperative hemodynamic stabilization in addition to their effects on postoperative pain. Although there are many studies on both techniques, the number of studies comparing scalp block with infiltration technique is very limited. Therefore, postoperative use of scalp block and incisional infiltration for postoperative pain after craniotomy is recommended. ### Conditions - Hemodynamic Instability ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - scalp block - Incisional infiltration ### Outcomes Primary Outcomes - opioid consumption Secondary Outcomes - The Numeric Rating Scale (NRS) ### Location - Facility: Ferdi Gülaştı, Aydın, N/A, 09020, Turkey @@
## Multi-hospital Electronic Decision Support for Drug-associated Acute Kidney Injury - NCT ID: NCT06264752 - Study ID: STUDY20120008 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-02-15 - Completion Date: 2026-04 - Lead Sponsor: University of Pittsburgh ### Study Description This study is a randomized controlled trial at eight hospitals within the University of Pittsburgh Medical Center-UPMC system. The project will assess the efficacy of a clinical surveillance system augmented with real-time predictive analytics to support a pharmacist-led intervention delivered to attending physicians (primary service) to reduce the progression and complications of drug-associated acute kidney injury (D-AKI) in hospitalized (non-ICU) adults. ### Conditions - Acute Kidney Injury ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Level A - Level B - Passive Alert ### Outcomes Primary Outcomes - Major Adverse Kidney Events within 30 days of randomization (MAKE30) Secondary Outcomes - Progression of AKI from time of Level B intervention (first alert generated) to hospital discharge - AKI Intensity: Duration of AKI for all stages; Duration of AKI Stage 2; Duration of AKI stage 3 - Nephrotoxic burden ### Location - Facility: UPMC Altoona, Altoona, Pennsylvania, 16601, United States @@
## Erector Spinae Block -Dexmedetomidine - NCT ID: NCT06264739 - Study ID: 22-12-23/2 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2026-01-01 - Lead Sponsor: Aydin Adnan Menderes University ### Study Description Postoperative pain is common after spinal surgeries, including lumbar disc surgery. Surgical anesthesia and perioperative analgesic regimen are aimed at complete intraoperative amnesia, deep analgesia, effective control of autonomic responses and rapid discharge from the hospital.Although there are many studies on the use of these techniques for postoperative analgesia, the number of data comparing these techniques that can be used in meta-analyses is low. In our study, investigators aimed to compare the effects of remifentanil and dexmedetomidine accompanied by ESP block, which are different multimodal analgesia methods, on pain. ### Conditions - Postoperative Acute Pain - Opioid Consumption ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - esp Dexmedetomidine (dekstomid) - esp remifentanyl (ultiva) ### Outcomes Primary Outcomes - opioid consumption Secondary Outcomes - The Numeric Rating Scale (NRS) ### Location - Facility: Ferdi Gülaştı, Aydın, N/A, 09020, Turkey @@
## CommunityRx-Cardiovascular Disease - NCT ID: NCT06264726 - Study ID: 23-0254 - Status: RECRUITING - Start Date: 2024-03-12 - Completion Date: 2025-03-12 - Lead Sponsor: University of North Carolina, Chapel Hill ### Study Description The goal of this single arm pre-test post-test design study is to test the impact of providing patients with information about community-based resources to address health-related social needs and cardiometabolic health in rural African American patients. The main question it aims to answer is:• What is the effectiveness of community resource information on patient self-efficacy to use community resources?Participants will be given:* A personalized "HealtheRx" resource with information about community resources related to food, housing, utility support, transportation, and crisis support. The HealtheRx is personalized for patients based on their age and zip code.* Access to a community resource navigator for support with using the HealtheRx upon request* 2 text messages with reminders about the HealtheRx and access to the community resource navigator ### Conditions - Cardiovascular Diseases - Self Efficacy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - HealtheRx ### Outcomes Primary Outcomes - Change in participant self-efficacy for finding community resources Secondary Outcomes - Change in participant knowledge of community resources - Change in participant utilization of community resources ### Location - Facility: OIC Family Medical Center - Fairview, Rocky Mount, North Carolina, 27801, United States @@
## Immersive Virtual REality for Treatment of Unilateral Spatial NEglect Via Eye-tracking Biofeedback - NCT ID: NCT06264713 - Study ID: CE/2023_041 - Status: RECRUITING - Start Date: 2023-11-01 - Completion Date: 2025-12-01 - Lead Sponsor: I.R.C.C.S. Fondazione Santa Lucia ### Study Description The purpose of this study is to evaluate the effects of a treatment using virtual reality on the recovery of unilateral spatial neglect. The investigators hypothesize that the experimental group underwent to a protocol of active exercises within the virtual environment will show an improvement in the exploratory functions of the left hemispace, investigated with specific scales and clinical tests. ### Conditions - Neglect, Hemispatial - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Immersive Virtual Reality - Sham Immersive Virtual Reality ### Outcomes Primary Outcomes - Changes in the Behavioural Inattention Test Secondary Outcomes - Changes in the Copying drawings with or without programming elements - Changes in the Barrage Test - Changes in the Wundt Justrow area illusion test - Changes in the Kessler Foundation Neglect Assessment Process - Changes in the Stroke Specific Quality of Life Scale - Changes in the Fugl-Meyer Assessment scale - Changes in reaction time e time of fixation ### Location - Facility: IRCCS Santa Lucia Foundation, Rome, Lazio, 00142, Italy @@
## Applying Directly Observed Therapy to Hydroxyurea to Realize Effectiveness - NCT ID: NCT06264700 - Study ID: STUDY00003303 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-12 - Lead Sponsor: Nationwide Children's Hospital ### Study Description This study is for caregivers of young children with sickle cell disease and adolescents with sickle cell disease who are currently prescribed hydroxyurea and are receiving care at one of the study sites. The study will assess retention and engagement during a pilot randomized control trial comparing video directly observed therapy (VDOT) to attention control. We also hope to understand more about patient and family preferences longer-term adherence monitoring and intervention.Participants will use an electronic adherence monitor (provided by the study team) to measure how often they are taking their hydroxyurea. Participants will also be asked to complete questionnaires throughout the study period to provide information about their expectations for, experience with, and satisfaction with the study materials. ### Conditions - Sickle Cell Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Video Directly Observed Therapy (VDOT) - Health Reminder Tip Alerts ### Outcomes Primary Outcomes - Retention Rate - Sustained Engagement - Electronic Adherence Secondary Outcomes - Pediatric SCD Medication Self-Management Questionnaire - Frequency of acute care visits (ACS and VOC), ICU admissions, and LOS for hospitalizations - Laboratory Studies (i.e. MCV, HbF) - Treatment Satisfaction - Participant Satisfaction ### Location - Facility: Lurie Children's Hospital, Chicago, Illinois, 60611, United States @@
## Hepcidin After Intravenous Iron Treatment - NCT ID: NCT06264687 - Study ID: HepcidinIVIron - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-05-31 - Lead Sponsor: Pierre-Alexandre Krayenbühl ### Study Description The aim of this study is to investigate the hepcidin hormone response after intravenous iron administration. ### Conditions - Iron Deficiency (Without Anemia) ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Serum Hepcidin Change Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparison Between CHF5993 pMDI 200/6/12,5mg HFA-152a VS CHF5993 pMDI 200/6/12,5mg HFA-134a in Subjects With Asthma (Trecos) - NCT ID: NCT06264674 - Study ID: CLI-05993AB6-03 - Status: RECRUITING - Start Date: 2023-11-27 - Completion Date: 2025-09-18 - Lead Sponsor: Chiesi Farmaceutici S.p.A. ### Study Description The CLI-05993AB6-03 Study is an interventional study designed to compare potential for bronchoconstriction, safety and tolerability profile using of HFA 152a propellant versus using to HFA 134a. ### Conditions - Asthma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - CHF5993 200/6/12.5 μg pMDI HFA-152a - Inhaler CHF5993 200/6/12.5 μg pMDI HFA-134a ### Outcomes Primary Outcomes - Relative change from pre-dose Forced Expiratory Volume in one second with (FEV1) (Safety Assessment to evaluate of the potential bronchoconstriction of the study treatment) Secondary Outcomes - To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (relative change from pre-dose FEV1) - To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (absolute change from pre-dose FEV1) - To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (number and percentage of subjects with a relative decrease from pre-dose in FEV1) - To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (Absolute and relative changes from baseline in pre-dose FEV1) - To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (Change from pre-dose in FEV1) - Peak expiratory flow (PEF) change from baseline at each inter-visit period over the entire treatment period - Percentage of days without intake of rescue medication. - Change in the average daily use of rescue medication. - Change on the average daily asthma symptoms. - Change from baseline in Asthma Control Questionnaire 7 (ACQ 7) score. ### Location - Facility: Medicines Evaluation Unit, Langley Building, Wythenshawe Hospital, Manchester, N/A, M23 9QZ, United Kingdom @@
## Effect of Cognitive Behavioral Therapy and Phototherapy on Glycosylated Hemoglobin, CLOCK Genes and Quality of Life in Patients With Type 2 Diabetes Mellitus and Insomnia - NCT ID: NCT06264661 - Study ID: HJM 006/22-R - Status: COMPLETED - Start Date: 2022-08-08 - Completion Date: 2022-11-30 - Lead Sponsor: Centro Interdisciplinario de Ciencias de la Salud Unidad Santo Tomás ### Study Description Purpose: To analyze the efficiency of Cognitive Behavioral Intervention in combination with phototherapy to reduce insomnia and improve glycemic control, quality of life, and CLOCK genes expression in patients with type 2 diabetes mellitus. Methods: Clinical, quasi-experimental, pre-post, explanatory, non-probability sampling. Subjects were invited to participate in Hospital Juárez de México. They received eight sessions of Cognitive Behavioral Therapy in combination with phototherapy. The assessment was carried out with validated instruments for Mexican population and gene expression was evaluated by real-time PCR. ### Conditions - Type 2 Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Effect of Cognitive Behavioral Therapy with Phototherapy in glycated hemoglobin, CLOCK genes and quality of life in patients with type 2 diabetes mellitus and insomnia ### Outcomes Primary Outcomes - Sleep quality - Glycosylated hemoglobin - Quality of life - Insomnia Secondary Outcomes - Gene expression analysis of CLOCK - Gene expression analysis of BMAL1 - Gene expression analysis of PER1 - Gene expression analysis of PER2 ### Location - Facility: Centro Interdisciplinario de Ciencias de la Salud Unidad Santo Tomás, Cdmx, México, 11360, Mexico @@
## Investigation of Palpation Pressure Sensitivity - NCT ID: NCT06264648 - Study ID: AIBU-FTR-OOP-04 - Status: COMPLETED - Start Date: 2023-05-03 - Completion Date: 2023-10-20 - Lead Sponsor: Abant Izzet Baysal University ### Study Description The study is planned for searching physiotherapists palpation abilities. There were 2 groups of physiotherapists. They were asked for to push target pressures. After making some exercise, the assesment was done again. ### Conditions - Sensitivity Training Groups ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Pressure sensitivity education ### Outcomes Primary Outcomes - Measurement Palpation Pressure with Digital Scale - Measurement Palpation Pressure with Digital Scale Secondary Outcomes ### Location - Facility: Faculty of Health Sciences Bolu Abant İzzet Baysal University, Bolu, N/A, 14300, Turkey @@
## Evaluating the Efficacy of Platelet-Rich-Plasma (PRP) for Erectile Dysfunction - NCT ID: NCT06264635 - Study ID: HS26227 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-03 - Lead Sponsor: University of Manitoba ### Study Description There is great interest in restorative therapies (platelet-rich plasma (PRP) injections, shockwave therapy and stem cell therapy) for ED given their non-invasive nature. However, data is still limited and requires further research prior to widespread adoption. Unfortunately, therapies such as PRP injections are being widely used without clinical evidence demonstrating its safety or effectiveness for the treatment of erectile dysfunction. 2-7 To date, there are no treatments that address the underlying cause of endothelial dysfunction, although low-intensity shockwave therapy for ED has shown promising results. Platelet-derived therapies targeting inflammation and promoting tissue/nerve regeneration and may represent a potential treatment option towards this direction. The investigators propose to perform Canada's first pilot RCT to evaluate and safety and efficacy of PRP for the treatment of ED. ### Conditions - Erectile Dysfunction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Platelet-Rich-Plasma - Saline ### Outcomes Primary Outcomes - International Index of Erectile Function (IIEF) Secondary Outcomes - Adverse Events ### Location - Facility: Men's Health Clinic, Winnipeg, Manitoba, R3K 1M3, Canada @@
## ABG+/GarlACE Effects on Cardiovascular Risk Factors in Subjects With Grade I Hypertension - NCT ID: NCT06264622 - Study ID: CEIC-2996 - Status: RECRUITING - Start Date: 2024-02-26 - Completion Date: 2024-12-31 - Lead Sponsor: Universitat de Lleida ### Study Description The goal of this clinical trial is to evaluate the dose response effect on cardiovascular disease risk factors of a Black Garlic Extract in subjects with Grade I Hypertension. The main questions it aims to answer are:* If the reduction in blood pressure (systolic and diastolic) is in a dose-response manner* If the changes in lipid profile are in a dose-response mannerParticipants will be randomly assign to a low dose (250 mg/day), high dose (600 mg/day) or placebo of a standardized Garlic Extract (ABG+/GarlACE) during 12 weeks ### Conditions - Hypertension ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Low dose - High dose - Placebo ### Outcomes Primary Outcomes - Blood Pressure Secondary Outcomes - Blood Lipid Profile ### Location - Facility: University of Lleida, Lleida, N/A, 25198, Spain @@
## Precision Medicine Approach for Osteoporosis - Follow Up Study - NCT ID: NCT06264609 - Study ID: 91026 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-02-01 - Completion Date: 2029-12-31 - Lead Sponsor: Hartmut Malluche, MD ### Study Description Osteoporosis is a health problem of major proportions. It affects more than 40 million Americans and results in more than 2 million fractures annually among Medicare patients alone. Hospital admissions for osteoporotic fractures exceed those of heart attacks, strokes and breast cancer combined. Osteoporosis is commonly considered a disease associated with menopause. This estrogen deficiency related bone loss is characterized by high bone turnover with increased resorption without commensurate changes in bone formation. It is in contrast to age-related bone loss, which starts as early as in the fourth decade of life and continues with increasing age. Age-related bone loss is usually associated with lower bone turnover and decreased bone formation is the main abnormality.Current therapies do not address age-related bone loss and the special needs of the age-related osteoporosis population is currently ignored. This is to a great degree due to difficulties associated with the bone biopsy necessary for unequivocal determination of bone turnover status. Thus, the current standard of care relies on starting with an antiresorber, which is of limited effectiveness in age-related osteoporosis, and in fact impedes the effectiveness of the appropriate anabolic medication. In a current ongoing study - Novel precision medicine approach to treatment of osteoporosis based on bone turnover. EIRB#70781; efforts are focused on addressing this particular problem.Our follow-up study seeks to achieve one specific aim: to compare effectiveness of Alendronate vs Teriparatide after participants have been switched at the end of treatment at year one, to the other drug at year two for the same duration of treatment. ### Conditions - Osteoporosis ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Alendronate - Teriparatide - Alendronate ### Outcomes Primary Outcomes - Percent change in bone loss Secondary Outcomes - Percent change in Bone Mass Density at the hip ### Location - Facility: University of Kentucky, Lexington, Kentucky, 40536, United States @@
## Epinephrine in Irrigation Fluid for Visualization During Ankle Surgery - NCT ID: NCT06264596 - Study ID: 2310-72 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-04 - Lead Sponsor: The Guthrie Clinic ### Study Description The purpose of this study is to evaluate the effect of epinephrine in irrigation fluid for visual clarity in ankle arthroscopic surgery. ### Conditions - Intraoperative Bleeding ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Epinephrine - Normal Saline irrigation fluid ### Outcomes Primary Outcomes - visual clarity during ankle arthroscopic surgery, which will be evaluated by visual analog scale - surgeon's discomfort related to bleeding, measured by visual numeric rating scale Secondary Outcomes ### Location - Facility: Robert Packer Hospital, Sayre, Pennsylvania, 18840, United States @@
## HDV-Europe: Prevalence and Outcome of HDV in HIV/HBV Coinfection - NCT ID: NCT06264583 - Study ID: IN-DE-980-6998 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-12-31 - Lead Sponsor: University Hospital, Bonn ### Study Description The aim of this project is to set up a cross-sectional cohort study (France, Germany, The Netherlands, Poland, Spain, Switzerland, Italy, United Kingdom and Portugal) to assess the implementation of EACS guidelines for HDV-testing among PLWH with positive HbsAg and thereby evaluate the prevalence of HDV infection among HIV/HBV-coinfected in 2023, as well as corresponding risk factors. In addition to the testing itself, this study will also set up a cohort and databasee for future HDV studies among PLWH, including clinical, virological und laboratory parameters.1. Analyze the rate of HDV-testing and evaluate the prevalence of HDV-infection by testing. 1. Evaluation of former screening of HDV by assessing existing data at study sites. 2. Determination of the HDV prevalence in European PLWH and HBV coinfection.2. Setting up a database of all PLWH with HBV/HDV coinfection 1. Analysis of transmission risk factors for HDV coinfection 2. Asses the rate of HDV positive patients with ongoing HDV replication. 3. Define the liver disease state by APRI score, fibroscan, ultrasound and routine laboratory test results. ### Conditions - Hepatitis D ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - HDV screening ### Outcomes Primary Outcomes - HDV prevalence in HIV/HBV coinfection Secondary Outcomes - Degree of liver disease in pateints with HIV/HBV/HDV triple infection ### Location - Facility: University Hospital Bonn, Bonn, NRW, 53127, Germany @@
## Evaluation of a Genetically Determined Personalized Approach in Prescribing Biologically Active Substances in Patients With Elevated Blood Homocysteine Levels. - NCT ID: NCT06264570 - Study ID: SW007 - Status: RECRUITING - Start Date: 2023-10-23 - Completion Date: 2024-11-30 - Lead Sponsor: S.LAB (SOLOWAYS) ### Study Description The clinical trial assesses the effectiveness and safety of a genetically-determined personalized approach to prescribing bioactive substances in patients with elevated blood homocysteine levels. Hyperhomocysteinemia (HHcy) is a risk factor for cardiovascular diseases (CVD), potentially exacerbating the effects of arterial hypertension and high cholesterol levels, increasing the risks of heart disease, stroke, and venous thrombosis. The trial aims to reduce plasma homocysteine levels to normal values (\<15 µmol/L) through a pilot, single-center, prospective, double-blind, placebo-controlled study. The study will involve a 6-month observation period with visits at 1, 3, and 6 months, assessing the efficacy of two composite bioactive substances not considered medicinal drugs. The primary endpoint is the reduction of homocysteine levels in patients with elevated levels, while secondary endpoints include lowering very low-density lipoprotein levels, absence of anxiety and depression (using the Spielberg Anxiety Scale), and the occurrence of major cardiovascular events. The sample size is planned for 111 patients across three groups, with a 1:1:2 distribution, considering a 40% reduction in homocysteine levels in the treated group and 5% in the control group, aiming for an 80% power and a 0.05 alpha. Inclusion criteria include adults aged 18-80 with elevated homocysteine (\>15 µmol/L) and LDL cholesterol levels (≥1.4 mmol/L), without taking any substances that could influence homocysteine levels for at least one month prior. The trial will also conduct an interim analysis after enrolling 55 patients, using statistical analysis to evaluate the results. ### Conditions - Hyperhomocysteinemia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - B-TMG supplementation - B-SAM supplementation - B-TMG placebo - B-SAM placebo ### Outcomes Primary Outcomes - Change in homocysteine levels in patients with elevated homocysteine levels in the blood evaluated by 15 µmol/l. Secondary Outcomes - change in the level of very low density lipoproteins - change of anxiety when using dietary supplements accessed by the Spielberg scale - change of depression when using dietary supplements by the Becks scale - occurrence of major cardiovascular events during follow-up ### Location - Facility: Center of New Medical Technologies, Novosibirsk, Novosibisk Region, 630090, Russian Federation @@
## Cognitive Therapy Software for Improving Cognitive Function for Patients With Mild Cognitive Impairment - NCT ID: NCT06264557 - Study ID: RW-MCI-01 - Status: RECRUITING - Start Date: 2024-01-17 - Completion Date: 2025-05-01 - Lead Sponsor: Rowan ### Study Description Cognitive therapy software for improving cognitive function for patients with mild cognitive impairment ### Conditions - Mild Cognitive Impairment - MCI ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - SB-100 - Educational book ### Outcomes Primary Outcomes - K-RBANS Secondary Outcomes - K-RBANS - K-MMSE-2 - CDR-SB - K-IADL - PRMQ - GDS-15 - QOL-AD - ADAS-Cog14 ### Location - Facility: Hanyang University Guri Hospital, Guri-si, Gyeonggi-do, 11923, Korea, Republic of @@
## Trial to Evaluate the Efficacy of a Zinc, Selenium, and L-Tyrosine Supplement in the Prevention of Thyrotoxicosis in Subjects With r25191G/A SEPP1 Polymorphism - NCT ID: NCT06264544 - Study ID: SW006 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-30 - Completion Date: 2024-12-30 - Lead Sponsor: S.LAB (SOLOWAYS) ### Study Description This randomized, double-blind, placebo-controlled trial evaluates the efficacy of a zinc, selenium, and L-tyrosine supplement in preventing thyrotoxicosis among adults aged 18-85 with elevated TPOAb levels and the r25191G/A SEPP1 polymorphism. The study excludes those with thyroid disease, pregnant/breastfeeding women, and individuals allergic to the supplement. Key endpoints include changes in thyroid antibodies and hormones over a 6-month period. With an estimated sample size of 150 participants per group, accounting for a 20% dropout rate, the trial seeks to demonstrate the supplement's potential in reducing thyrotoxicosis risk through a genetically-informed approach. ### Conditions - Thyrotoxicosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - zinc, selenium, and L-tyrosine in SEPP1 - Placebo ### Outcomes Primary Outcomes - Percent change of Thyroid Peroxidase Antibodies (TPOAb) in subjects with r25191 SEPP1 polymorphism Secondary Outcomes - Percent change in Thyroglobulin Antibodies (TgAb) in subjects with r25191 SEPP1 polymorphism - Free Thyroxine (Free T4) change in subjects with r25191 SEPP1 polymorphism - Free Triiodothyronine (Free T3) change in subjects with r25191 SEPP1 polymorphism - Thyroid Receptor Antibodies (TRAb) change in subjects with r25191 SEPP1 polymorphism - TSH Receptor Antibodies (TSHR-Ab) change in subjects with r25191 SEPP1 polymorphism ### Location - Facility: Center of New Medical Technologies, Novosibirsk, Novosibisk Region, 630090, Russian Federation @@
## Efficacy and Safety of Anti-angiogenic Therapy With IV Bevacizumab in Patients With Symptomatic Cerebral Arteriovenous Malformations - NCT ID: NCT06264531 - Study ID: JDS_2023_12 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2027-06 - Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild ### Study Description Brain arteriovenous malformations (AVMs) are responsible for hemorrhagic strokes, particularly in children and young adults. They can also be responsible for chronic neurological disorders: motor or sensory deficits, disturbances of higher functions, epilepsy or disabling headaches. The management of brain AVMs is complex and requires a multidisciplinary approach in an expert center. Available therapies include endovascular embolization, neurosurgical resection and/or radiosurgery. These procedures carry a risk of neurological complications, and are reserved for small AVMs located at a distance from highly functional cerebral structures. To date, no drug therapy is recommended if interventional treatment is not possible.Several studies on resected brain AVM tissue have demonstrated that these malformations are the site of significant evolutionary inflammatory and neo-angiogenesis processes. Other studies have specifically shown that VEGF (vascular endothelial growth factor) levels are increased in AVMs. More recently, a pre-clinical study showed that anti-angiogenic treatment with Bevacizumab reduced vascular proliferation within AVMs in mice. Finally, a Phase II clinical trial in patients with Rendu-Osler disease (a genetic vascular disorder characterized by recurrent epistaxis, cutaneous telangiectasia and the presence of visceral AVMs) showed a clinical benefit of IV Bevacizumab on the symptomatology of these vascular malformations, with a reduction in the risk of hemorrhage and the extent of hepatic arteriovenous shunts. A randomized Phase III trial is currently underway (NCT03227263) to assess the efficacy of IV Bevacizumab in Rendu-Osler disease.The aim of our study is to assess the efficacy of IV Bevacizumab on the disabling symptoms associated with symptomatic brain AVMs. ### Conditions - Cerebral AV Malformation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Bevacizumab - Placebo ### Outcomes Primary Outcomes - Proportion of patients showing at least one of the following improvements : cognition, neurological symptoms, epilepsy symptoms, headaches. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## An Observational Exploration of Clinical Trials Targeting Traumatic Brain Injury - NCT ID: NCT06264518 - Study ID: 56168915 - Status: NOT_YET_RECRUITING - Start Date: 2025-03 - Completion Date: 2027-03 - Lead Sponsor: Power Life Sciences Inc. ### Study Description Clinical study participation has historically been heavily biased toward specific demographics.Several people will be invited to enroll in this study so that it may collect a variety of data about traumatic brain injury clinical trial experiences and identify barriers to participation as well as the causes of participants' failure or withdrawal.People with traumatic brain injury who are invited to take part in medical research will benefit from the analysis of the data. ### Conditions - Traumatic Brain Injury ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Number of patients who decide to enroll in a traumatic brain injury clinical trial - Rate of patients who remain in traumatic brain injury clinical trial to trial completion Secondary Outcomes ### Location - Facility: Power Life Sciences, San Francisco, California, 94107, United States @@
## Investigative Analysis of Soft Tissue Sarcoma Clinical Trials: An Observational Study - NCT ID: NCT06264505 - Study ID: 55955210 - Status: NOT_YET_RECRUITING - Start Date: 2025-03 - Completion Date: 2027-03 - Lead Sponsor: Power Life Sciences Inc. ### Study Description Generally, specific demographic cohorts exhibit higher participation rates in medical research, yet there exists a scarcity of research elucidating the trial attributes impacting the engagement of these particular demographics.The primary objective of this study is to gather extensive data on the clinical trial experiences of individuals diagnosed with soft tissue sarcoma, with the aim of identifying factors hindering patient enrollment or trial completion. ### Conditions - Soft Tissue Sarcoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Rate of patients in soft tissue sarcoma clinical research - Number of soft tissue sarcoma study participants who maintain involvement until study finish Secondary Outcomes ### Location - Facility: Power Life Sciences, San Francisco, California, 94107, United States @@
## Delving Into Participation Trends of Scleroderma Clinical Trials - NCT ID: NCT06264492 - Study ID: 55777205 - Status: NOT_YET_RECRUITING - Start Date: 2025-03 - Completion Date: 2027-03 - Lead Sponsor: Power Life Sciences Inc. ### Study Description Typically, specific demographic subsets tend to exhibit greater engagement in medical research. Nonetheless, there is insufficient research elucidating the trial characteristics influencing the participation of these particular demographics.The study will analyze data from diverse demographic viewpoints to uncover recurring trends that could provide valuable insights for future patients with scleroderma. ### Conditions - Scleroderma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Rate of patients in clinical research for scleroderma - Number of scleroderma study participants who stay committed until clinical study wraps up Secondary Outcomes ### Location - Facility: Power Life Sciences, San Francisco, California, 94107, United States @@
## Prospective Evaluation of AI R&D Tool for Patient Stratification: a Trial for Renal Immuno-oncology Model Experimental Evaluation 2 - NCT ID: NCT06264479 - Study ID: PEAR-TREE2 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2029-03-31 - Lead Sponsor: Ourotech, Inc. ### Study Description Pear Bio has developed a predictive biomarker technology that combines 3D cell culture, microscopy and computer vision to measure the response of an individual patient's tumor sample to different systemic therapy regimens that are tested simultaneously ex vivo.This study will recruit patients with advanced or metastatic kidney cancer who are due to start a clinically-indicated new line of therapy.The oncologist will be blinded to the response on the Pear Bio test (the test will be run in parallel with the patient's treatment). The primary objective of this study is to establish the sensitivity and specificity of Pear Bio's test results against patient outcomes (objective response, progression-free survival, depth and duration of response, overall survival). ### Conditions - Kidney Cancer - Renal Cell Cancer Metastatic ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Biopsy ### Outcomes Primary Outcomes - Objective Response Rate correlation accuracy (sensitivity & specificity) Secondary Outcomes - Complete Response rate correlation accuracy (sensitivity & specificity) - Deep Response rate correlation accuracy (sensitivity & specificity) - Durable Response rate correlation accuracy (sensitivity & specificity) - PFS prediction accuracy ### Location - Facility: Addenbrooke's Hospital, Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom @@
## Safety and Efficacy of a Novel Flexible Bipolar in POEM - NCT ID: NCT06264466 - Study ID: IECED-010112023 - Status: RECRUITING - Start Date: 2023-12-01 - Completion Date: 2025-01-15 - Lead Sponsor: Instituto Ecuatoriano de Enfermedades Digestivas ### Study Description Per-oral endoscopic myotomy (POEM) is a minimally invasive therapy for achalasia. The procedure has demonstrated high technical and clinical success with lower adverse events. Different types of knives have been used for cutting and coagulation during the procedure; however, exchanging accessories is sometimes needed to perform all the stages of POEM.To overcome this disadvantage, the investigators aim to evaluate a single device that integrates in its tip bipolar radiofrequency and microwave, the Speedboat Ultraslim (Creo Medical, UK) for cutting and coagulation during POEM procedure. Some of the promise's advantages derived from its use are: (1) less inflammation, (2) clear differentiation between layers, (3) the use of a single device for the procedure.This single-center, prospective, interventional study will include patients with achalasia submitted to POEM procedure, with or without fundoplication (POEM-F). All stages (mucosal incision, submucosal tunneling, myotomy) of POEM will be performed using the Speedboat ultraslim flexible catheter. Technical and clinical success, along with safety will be the primary endpoints; while, post-procedure reflux symptoms and quality of life will be assessed as secondary outcomes with reflux severity index (RSI) and the Northwestern Esophageal Quality of Life (NEQOL), respectively. ### Conditions - Esophageal Achalasia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - POEM with Speedboat Ultraslim ### Outcomes Primary Outcomes - Technical success of procedure - Clinical success of procedure - Frequency of adverse events attributable to the procedure Secondary Outcomes - Rate of Gastroesophageal reflux disease - Assessment of Gastroesophageal reflux disease severity - Change in health-related quality of life after POEM ### Location - Facility: Instituto Ecuatoriano de Enfermedades Digestivas (IECED), Guayaquil, Guayas, 090505, Ecuador @@
## A Study to Evaluate the Efficacy and Safety of KH001 in Patients With Dentin Hypersensitivity - NCT ID: NCT06264453 - Study ID: KH-001-D201 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-11 - Completion Date: 2024-08-30 - Lead Sponsor: HysensBio Co., Ltd ### Study Description The purpose of this study is to evaluate the efficacy and safety of KH001 in patients with dentin hypersensitivity. ### Conditions - Dentin Hypersensitivity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - KH001 - Placebo ### Outcomes Primary Outcomes - Change from baseline in Schiff sensitivity score Secondary Outcomes - Change from baseline in a Schiff sensitivity score - Change from baseline in a Tactile threshold - Change from baseline in Visual Analogue Scale ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study to Assess the Potential for Gastric-pH Dependent Drug-Drug Interactions of BIIB122 With a Proton Pump Inhibitor in Healthy Participants - NCT ID: NCT06264440 - Study ID: 283HV104 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-02-12 - Completion Date: 2024-05-07 - Lead Sponsor: Biogen ### Study Description The primary objective of the study is to evaluate the effects of a proton pump inhibitor (PPI) \[rabeprazole\] on BIIB122 pharmacokinetics (PK) after a single dose in healthy participants. The secondary objective of the study is to evaluate the safety and tolerability of BIIB122, with and without a PPI (rabeprazole), after a single dose in healthy participants. ### Conditions - Healthy Volunteer ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - BIIB122 - Rabeprazole ### Outcomes Primary Outcomes - Maximum Observed Concentration (Cmax) of BIIB122 - Area Under the Concentration-Time Curve From Time Zero to Time of the Last Measurable Concentration (AUClast) of BIIB122 - Area Under the Concentration-Time Curve From Time Zero to Infinity (AUCinf) of BIIB122 Secondary Outcomes - Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) ### Location - Facility: PPD Development, LP, Austin, Texas, 78744, United States @@
## Phenotypic and Genotypic Characterization of Patients With Dysmetabolism in Greenland - NCT ID: NCT06264427 - Study ID: KVUG - 2022 - 10 - Status: RECRUITING - Start Date: 2022-07-15 - Completion Date: 2026-12-31 - Lead Sponsor: Steno Diabetes Center Greenland ### Study Description The goal of this clinical trial is to perform a detailed description of the feno- and genotype of people living with type 2 diabetes and severe obesity who are linked to care at Steno Diabetes Center Greenland.The main questions it aims to answer are:* Are monogenetic diabetes variants associated with the same risk of developing late diabetic complications as other types of diabetes?* Can genotyping and thereby personalized medicine be implemented in Greenland, and can personalized medicine lead to improved treatment?* What is the prevalence of sleep apnea among high-risk individuals in Greenland?* Is it possible to develop and implement a simple algorithm for the identification of sleep apnea in Greenland that can ensure treatment of severe sleep apnea?Participants will:* Answer WHO-5 and FOSQ-10 questionnaires regarding quality of life and functional outcomes of sleepiness* Perform VAGUS examinations for Cardiovasculare Autonomic Neuropathy* Clinical examination of height, weight, circumference of hip, waist and neck, Friedman tonsil and tongue score, nasal air flow, nasal septal deviation* Blood samples for full genome sequencing ### Conditions - Diabetes Mellitus, Type 2 - Obesity, Morbid - Obstructive Sleep Apnea - MODY - Diabetic Retinopathy - Diabetic Neuropathies ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Whole genome sequencing - VAGUS - NightOwl - CPAP ### Outcomes Primary Outcomes - Number of participants with MODY diabetes and their complication status - Number of participants with diabetic complication - Number of participants with obstructive sleep apnea Secondary Outcomes - CPAP compliance in Greenlandic patients - CPAP treatment effect on quality of life measured with the World Health Organization Well-being Index (WHO-5). - CPAP treatment effect on daytime sleepiness measured with the functional outcome of sleep questionnaire (FOSQ-10). ### Location - Facility: Steno Diabetes Center Greenland, Queen Ingrids Hospital, Nuuk, Sermersooq, 3900, Greenland @@
## Efficacy and Safety of the DTT106 in the Treatment of Erectile Dysfunction Associated With Benign Prostatic Hyperplasia - NCT ID: NCT06264414 - Study ID: DTT106-III-0123 - Status: NOT_YET_RECRUITING - Start Date: 2025-02 - Completion Date: 2027-07 - Lead Sponsor: EMS ### Study Description The purpose of this study is to assess the safety and efficacy of the DTT106 in the treatment of erectile dysfunction associated with benign prostatic hyperplasia ### Conditions - Prostatic Hyperplasia, Benign - Erectile Dysfunction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - DTT106 - Dutasteride-Tamsulosin ### Outcomes Primary Outcomes - Change in the Erectile Function domain score of the International Index of Erectile Function (IIEF-EF) at the end of treatment, from baseline. Secondary Outcomes - Change in maximum urinary flow rate (Qmax) - Decrease in post-void residual volume (PVR) - Improvement in urinary symptoms. - Improvement in urinary emptying symptoms - Improvement in urinary storage symptoms. - Improvement in the participant's quality of life in relation to their urinary condition - Improvement in the participant's sexual function - Improvement in the participant's orgasmic function. - Effectiveness of the treatment in improving the participant's sexual desire - Effectiveness in improving the participant's satisfaction with sexual relations - Overall satisfaction of the participant regarding their sex life. ### Location - Facility: EMS, Hortolândia, São Paulo, N/A, Brazil @@
## Treatment Exercises With Core Stability and Dynamic Resistance Exercise for Postmenopausal Women With Osteoporosis - NCT ID: NCT06264401 - Study ID: menopausal with osteoporsis - Status: NOT_YET_RECRUITING - Start Date: 2024-02-22 - Completion Date: 2024-12-31 - Lead Sponsor: Cairo University ### Study Description osteoporosis is a common disease that affect most of postmenopausal women. various treatment procedures are used to avoid future complain among postmenopausal population. ### Conditions - Postmenopausal Osteoporosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Alendronate - treatment exercises ### Outcomes Primary Outcomes - Dual-energy x-ray absorptiometry - Oswestry Disability Index Secondary Outcomes ### Location - Facility: faculty of physical therapy, Cairo university, Giza, N/A, 12662, Egypt @@
## DB107-Retroviral Replicating Vector (RRV) Combined With DB107-Flucytosine (FC) in Patients With Recurrent Glioblastoma or Anaplastic Astrocytoma - NCT ID: NCT06264388 - Study ID: 20231234 - Status: RECRUITING - Start Date: 2024-05-01 - Completion Date: 2034-05-01 - Lead Sponsor: Ashish Shah ### Study Description The purpose of this study is to determine if the investigational products, DB107-RRV and DB107-FC, as a combination treatment will shrink high-grade glioma (HGG) in patients with recurrent/progressive, resectable or unresectable disease and increase the time that disease is controlled. ### Conditions - High Grade Glioma - Anaplastic Astrocytoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - DB107-RRV - DB107-FC ### Outcomes Primary Outcomes - Progression Free Survival - Overall Survival Secondary Outcomes - Assessment of Tumor Status Measured by Response Assessment in Neuro-oncology (RANO) Criteria - Number of Treatment Related Toxicities - Durable Response Rate (DRR) - Durable Clinical Benefit Rate (DCBR) - Duration of Durable Response Rate ### Location - Facility: University of Miami Hospital, Miami, Florida, 33136, United States @@
## Effect of a Specific and General Physical Exercise Intervention on Gaming and E-Sport Performance - NCT ID: NCT06264375 - Study ID: E-SPORT - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-01-19 - Completion Date: 2024-09-30 - Lead Sponsor: Universitaet Innsbruck ### Study Description The goal of this randomized control intervention study is to test the effect of i) a specific physical training for e-sport and ii) a general physical training on e-sport performance, compared to iii) not training physically at all.Participants are gamers and e-athletes who play at least \>2hours peer week. The main questions it aims to answer are:* Does physical training have an effect on e-sport related abilities (hand grip strength, reaction, anticipation)* Does the training of specific elements, which aim at these abilities "out-game", transfer on the actual skills needed using a keyboard and mouseParticipants will be randomly - but mediated by hours of playing per week - distributed in 1 of 3 groups.* Group 1 will 3 times per week for 30 minutes perform a specific physical training with focus on abilities needed in e-sport (grip strength, reaction, anticipation) over a timespan of 8 weeks.* Group 2 will perform a similar physical training (load, intensity) to Group 1, but without specific elements.* Group 3 will serve as control group without any training.Researchers will compare Group 1, Group 2 and Groups 3 to see if the different trainings (Group 1 and Group 2) have different effect on e-sport performance and if no training (Group 3) differs in e-sport performance development. ### Conditions - Physical Activity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Physical exercise ### Outcomes Primary Outcomes - Grip Strength (Out-Game) - Reaction Time (Out-Game) - Anticipation (Out-Game) - Whole Body Fitness - Gaming Performance - Accuracy/Speed and Anticipation Secondary Outcomes - Well-being after training ### Location - Facility: Department of Sport Science, Innsbruck, Tyrol, 6020, Austria @@
## Developing a Nonpharmacological Pain Intervention for Community-dwelling Older Adults With Dementia - NCT ID: NCT06264362 - Study ID: K23AG081547 - Status: RECRUITING - Start Date: 2023-10-09 - Completion Date: 2027-05-01 - Lead Sponsor: Drexel University ### Study Description The purpose of this study is to develop an exercise treatment program for knee osteoarthritis that works well for people with memory problems. This study will include two parts. Participants can choose to participate in either or both parts.In Part 1 - The investigators are inviting the following people to participate in an interview:1. Individuals aged 60 years or older who do not live in a nursing home and have both memory issues and knee pain.2. Care partners of people with knee pain and memory issues. A care partner can be a family member or friend who helps regularly.3. Clinicians (exercise physiologists or rehabilitation therapists like physical and occupational therapists) who have worked with older adults with memory issues and knee pain.The goal of these interviews is to learn from the experiences of people with memory issues and knee pain and those who care for them. From these interviews, the investigators hope to design a non-drug, tailored physical activity program that will be interesting and helpful in managing knee pain for older adults with memory problems.For people with memory problems and knee pain and their care partners: The investigators will ask some questions to determine eligibility to participate in the study.Those who qualify for the study will be invited to participate in an interview that could be completed online or in person (Philadelphia, PA). The interview could last up to 90 minutes (1 and a half hours) and can be completed as one or multiple sessions.For clinicians: Participants will engage in a 90-minute focus group with other clinicians where lunch will be served if in person. Those participating in an online focus group will receive a gift card equal to the value of lunch.In Part 2 - The program developed in Part 1 will be tested. The program will be physical activity-based. Specific program details for part 2 will be provided as they emerge. Participants can choose to sign up for either or both parts. Signing up for Part 1 does not mean participants have to sign up for Part 2.Please contact us for any questions. ### Conditions - Pain, Chronic - Dementia, Mild - Mobility Limitation - Physical Disability - Osteo Arthritis Knee - Mild Cognitive Impairment ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Tailored Physical Activity Program ### Outcomes Primary Outcomes - Program parameters - Program parameters - Feasibility of Intervention Measure - Perception of program Secondary Outcomes - Numeric Pain Score - Zarit Burden Interview-Short Form ### Location - Facility: Drexel University, Philadelphia, Pennsylvania, 19104, United States @@
## Women and Maternity: Development of a Nutritional Education Project - NCT ID: NCT06264349 - Study ID: 05102023 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2025-11-30 - Lead Sponsor: University of Pavia ### Study Description The "first 1000 days of life", from conception to 2 years of life, are crucial for promoting the health of both mother and baby. During this period, a woman's diet and lifestyle play a significant role in determining the future health of the child. The perinatal period is an ideal time for regular contact with healthcare providers who can institute an intervention to encourage pregnant women to make nutritional changes to improve their health and that of their babies.Therefore, an educational program on an appropriate lifestyle during the "first 1000 days" can represent a crucial primary prevention strategy in reducing the risk of developing obesity and non-communicable diseases (NCDs) during childhood and later adulthood. ### Conditions - Pregnancy - Lactation ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Lifestyle Educational Intervention ### Outcomes Primary Outcomes - Gestational weight gain management Secondary Outcomes - Nutritional aspects evaluation during pregnancy and lactation - Physical activity evaluation during pregnancy and lactation - Smoking habits during pregnancy and lactation - Maternal attitude towards infant feeding. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effects of High-intensity Gait Training on Fatigue, Gait, and Neuroplasticity in People With Multiple Sclerosis - NCT ID: NCT06264336 - Study ID: UIC AHS Pilot 2024 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-12-31 - Lead Sponsor: University of Illinois at Chicago ### Study Description Nearly 1 million individuals in the United States have multiple sclerosis, which causes fatigue and problems with walking. Fatigue and walking problems are poorly treated, but exercise training, particularly high-intensity walking exercise, may help. This provide insight into whether high-intensity walking exercise can improve fatigue and walking problems in people with multiple sclerosis, which could improve quality of life and reduce economic burden. ### Conditions - Multiple Sclerosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - treadmill training ### Outcomes Primary Outcomes - Symptomatic fatigue - Walking speed - Corticomotor excitability Secondary Outcomes - Fatigue impact - Walking endurance - Aerobic capacity - Visual processing speed - Verbal learning and memory ### Location - Facility: University of Illinois Chicago, Chicago, Illinois, 60612, United States @@
## Incidence of Acute Injuries in Boxing - NCT ID: NCT06264323 - Study ID: UI-5487 - Status: COMPLETED - Start Date: 2017-09-01 - Completion Date: 2018-11-30 - Lead Sponsor: University of Iceland ### Study Description A prospective cohort study with 9 months follow up was carried out in 2017-2018. Boxers of both sexes 18 years and older from all 7 boxing clubs in Iceland were invited to participate in the study. Participants filled out a questionnaire on previous injuries during boxing training and competition and were evaluated on the Sport Concussion Assessment Tool 3rd edition (SCAT3). Exposure at training and competition was measured and any injuries sustained during the study period were recorded via text messages and phone calls every 2 weeks. ### Conditions - Injuries ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Questionnaire - Sport Concussion Assessment Tool 3rd Edition (SCAT3) Secondary Outcomes ### Location - Facility: University of Iceland, Reykjavík, N/A, 102, Iceland @@
## To Evaluate the Safety, Tolerability and Efficacy of R2R01 Combined With SOC as Compared to SOC Alone in Outpatients With Worsening Heart Failure (WHF) - NCT ID: NCT06264310 - Study ID: R2R01-WHF-201 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-03 - Lead Sponsor: River 2 Renal Corp. ### Study Description This Study Aims to Evaluate the Safety, Tolerability and Efficacy of R2R01 Combined With SOC as Compared to SOC Alone in Outpatients With Worsening Heart Failure (WHF) ### Conditions - Heart Failure - Worsening Heart Failure (WHF) ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Placebo - R2R01 ### Outcomes Primary Outcomes - Number and rate of patients with one or more TEAEs (treatment emergent AE's) and/or serious TEAEs as assessed by CTCAE v5.0. - Number and rate of patients with one or more TEAEs (treatment emergent AE's) and/or serious TEAEs as assessed by CTCAE v5.0. Secondary Outcomes - Change from Baseline on NT-pro-BNP using descriptive and summary statistics by dose level at Day 7 and Day 30. - Change from baseline on Cystatin C and creatinine clearance using descriptive and summary statistics by dose level at Day 7 and Day 30. - Number of patients requiring dose adjustment of oral diuretics during the 30-day follow-up. - Number of patients with an event of: WHF-induced SDAC or other outpatient clinic visits requiring additional intensification of the therapy/IV loop diuretics using descriptive and summary statistics for change from baseline by dose level at Day 30. - Number of cardiovascular hospitalizations among patients using descriptive and summary statistics for change from baseline by dose level at Day 30. - Number of all-cause hospitalizations among patients using descriptive and summary statistics for change from baseline by dose level at Day 30. - Number of patients with CV mortality using descriptive and summary statistics for change from baseline by dose level at Day 30. - Number of patients with all-cause mortality using descriptive and summary statistics for change from baseline by dose level at Day 30. ### Location - Facility: Eastern Shore Research Institute, Fairhope, Alabama, 36532, United States @@
## High-Voltage Pulsed Radiofrequency of the Lumbar Dorsal Root Ganglion for the Treatment of Chronic Lumbar Radicular and Neuropathic Pain; A Prospective, Doble-blinded and Randomized Controlled Trial - NCT ID: NCT06264297 - Study ID: 01-22-270-111 - Status: RECRUITING - Start Date: 2023-02-20 - Completion Date: 2027-12 - Lead Sponsor: Consorci Sanitari de Terrassa ### Study Description The management of chronic lumbar radicular and neuropathic pain is complex and the treatment success rates are low. Pulsed radiofrequency (PRF) has been described in these cases. In order to determine whether high-voltage PRF show better results than PRF a prospective, doble-blinded and randomized study is conducted in patients with chronic lumbar radicular and neuropathic pain. ### Conditions - Pulsed Radiofrequency - Lumbar Radiculopathy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Radiofrequency ### Outcomes Primary Outcomes - OSWESTRY LOW BACK DISABILITY QUESTIONNAIRE Secondary Outcomes - DN4 - QUESTIONNAIRE - Visual Numeric Scale - Categorical scale - patient global impression of improvement (pgi-i) score ### Location - Facility: Consorci Sanitari de Terrassa, Terrassa, Barcelona, 08227, Spain @@
## Emergency (Red Code) Cesarean Section : Maternal and Fetal Prognosis Depending on Anesthetic Modalities in a Level 3 Maternity Ward - NCT ID: NCT06264284 - Study ID: 2023PI163 - Status: COMPLETED - Start Date: 2018-07-19 - Completion Date: 2023-07-19 - Lead Sponsor: Central Hospital, Nancy, France ### Study Description We try to evaluate whether the type of anesthesia used influences the occurrence of perioperative maternal complications as well as neonatal outcome on emergency (Red Code) Cesarean Section.This study occurred in a Level 3 Maternity Ward. ### Conditions - Anesthesia Complication ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - epidural anesthesia - general anesthesia ### Outcomes Primary Outcomes - To evaluate whether the type of anesthesia used influences the occurrence of perioperative maternal complications as well as neonatal outcome Secondary Outcomes ### Location - Facility: Stanowski, Nancy, N/A, 54000, France @@
## The Effect of Nutrition Education on Glycemic Control in Patients With Type 1 Diabetes - NCT ID: NCT06264271 - Study ID: GIP-22-NL-06-203 - Status: COMPLETED - Start Date: 2022-02-01 - Completion Date: 2024-02-01 - Lead Sponsor: Charles University, Czech Republic ### Study Description The study aims to elucidate whether patients with T1D initiating sensor monitoring experience greater improvement in glycemic control (HbA1c) when provided with structured nutrition education compared to those initiating sensor monitoring without such education. ### Conditions - Diabetes Mellitus, Type 1 ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - structured nutrition intervention ### Outcomes Primary Outcomes - difference in HbA1c Secondary Outcomes - differences in time in range - differences in time below range - differences in time above range - differences in coefficient of variation ### Location - Facility: Charles University, Prague, N/A, 12808, Czechia @@
## Game-based Pediatric Diabetes Education - NCT ID: NCT06264258 - Study ID: STUDY2023_00000285 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-06-30 - Lead Sponsor: Carnegie Mellon University ### Study Description The goal of this study is to evaluate the impact of a mobile app video game called Digital Vaccine for Type 1 Diabetes (DVx-T1D)™, proposed as a low-risk, non-invasive, digital therapeutic candidate for behavior change in children 6 to 12 years of age with Type 1 Diabetes (T1D).The investigators hypothesize that adoption of DVx-T1D™ by T1D patients will positively influence healthy dietary and physical activity behaviors by providing nutrition and lifestyle education through a playful, Artificial Intelligence (AI)-based, cartoon-style medium of mobile gaming, and result in improvements in their T1D control. The investigators propose to conduct a longitudinal randomized controlled trial (RCT) over a 3-month period with a study population of 80 T1D participants (40 each in two arms of the trial) of 6-12 years old. The investigators will quantify the impact of the mobile game app plus standard care vs. standard care (with no exposure to the app) on T1D control (assessed by glycosylated hemoglobin or HbA1c measured during clinic visits and continuous glucose monitoring (CGM) parameters measured at home), physical activity levels and food choices of children (measured using food logs and surveys). Game telemetry, food logs, clinical, anthropometric, demographic, and survey data will be collected to obtain adequately powered, theory-driven evidence of the value of game-based approaches delivered via mobile apps. ### Conditions - Diabetes Mellitus, Type 1 - Behavior, Health ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - DVx-T1D™ app ### Outcomes Primary Outcomes - Change in HbA1c values and and insulin dose adjusted HbA1c before and after the intervention - Change in glucose average and variability Secondary Outcomes - Changes in the quality of food consumption - Change in game play patterns over time ### Location - Facility: UPMC Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, 15224, United States @@
## Users of Remote Conferencing and Compression of Sound Dynamics : Auditory Effects - NCT ID: NCT06264245 - Study ID: 2022-126 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-01-15 - Lead Sponsor: Institut Pasteur ### Study Description The COMPRESSED project is a descriptive, bi-centric and non-invasive study carried out by the CERIAH - IDA - Institut Pasteur and the Haute École Léonard de Vinci in Brussels on volunteer participants identified in two groups :* be subject to high exposure to compressed sound, as defined by professional participation in events on broadcast platforms using sound signal processing systems, over the last 3 years,* be subject to moderate or limited exposure to compressed and manipulated sound, equivalent to that of a student following certain distance learning courses. on a videoconferencing platform, alternating with other face-to-face courses, with the ability to listen during breaks, which have been taught for a maximum of 2 years.The main objective of the COMPRESSED study is to evaluate the auditory effects of exposure to manipulated sounds (compression, filtering, equalisation, accentuation, etc.) from sound distribution platforms on the auditory system of participants who are regularly exposed to these sounds as a result of their professional activity. ### Conditions - Auditory Perception ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Audiological profile - Hearing self-assessments - Objective and subjective audiological tests - Self-assessment of exposure sound quality ### Outcomes Primary Outcomes - Hearing assessments of participants exposed to manipulated sounds after and before exposure Secondary Outcomes - Audiometric thresholds in pure tone from 125 to 8000 Hz in the subject's exposed ear before and approximately one hour after exposure, - Difference between the threshold of the protective reflex of the auditory pathways (middle ear muscles) measured by impedancemetry in the exposed ear when a contralateral noise is presented for a few seconds. - Levels of otoemissions in acoustic distortion products in the exposed ear in response to pure tone sound stimuli - Tinnitus or auditory distortion (hyperacusis) reported by participants before and after exposure. - Effectiveness of the protective auditory reflexes (or acoustic reflexes), obtained by impedancemetry and derived from the reading of the otoemissions for each participant. ### Location - Facility: Haute Ecole Léonard De Vinci, Bruxelles, N/A, N/A, Belgium @@
## [Trial of device that is not approved or cleared by the U.S. FDA] - NCT ID: NCT06264232 - Study ID: AT ELANA 841P-BER-302-19 - 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 @@
## Restoration of the Gut Microbiome After Cesarean Section - NCT ID: NCT06264219 - Study ID: H-24002284 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-11-30 - Lead Sponsor: Professor Klaus Bønnelykke ### Study Description This study aims to develop a therapy for restoring the gut microbiome in infants born via CS. We will conduct a randomized, placebo-controlled feasibility trial to assess the ability of microbiome restoration by FMT and FVT in infants born by cesarean section. ### Conditions - Microbial Colonization ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Microbiome restoration - FMT - Microbiome restoration - FVT - Placebo - Vaginal birth, untreated control ### Outcomes Primary Outcomes - Microbial development trajectory Secondary Outcomes - Microbial development trajectory ### Location - Facility: Copsac, DBAC, Gentofte, Copenhagen, 2820, Denmark @@
## Effect of Immunomodulatory Treatment on IVF (in Vitro Fertilization) Outcomes in Patients With KIR AA Genotype - NCT ID: NCT06264206 - Study ID: CALLA_IVF_KIR - Status: COMPLETED - Start Date: 2022-01-01 - Completion Date: 2023-12-31 - Lead Sponsor: Calla IVF Center ### Study Description The aim of the study is to investigate the immune cause of recurrent implantation failure (RIF) and the role of immunomodulatory treatment in IVF (in vitro fertilization) patients that have a KIR AA genotype. We compared pregnancy rates in Group KIR AA without immunomodulatory treatment, and pregnancy rates in Group KIR AA with immunomodulatory treatment. ### Conditions - Immunomodulatory Drugs - Killer-cell Immunoglobulin-like Receptors (KIRs) - KIR Alleles (KIR AA) ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Killer-cell immunoglobulin-like receptors (KIRs) testing ### Outcomes Primary Outcomes - the incidence of immune cause of recurrent implantation failure - the efficiency of immnomodulatory treatment on pregnancy rate in patients with KIR AA Secondary Outcomes - comparation between the pregnancy rates in KIR AA group and KIR Bx group ### Location - Facility: Calla Ivf Center, Oradea, Bihior, 410103, Romania @@
## The Impact of Hypoxia on the Biochemical and Morphological Parameters of Blood in Rowers. - NCT ID: NCT06264193 - Study ID: Rowers - Status: COMPLETED - Start Date: 2014-11-30 - Completion Date: 2014-12-21 - Lead Sponsor: Poznan University of Physical Education ### Study Description The response to hypoxia is very individual and epending on many aspects, such as the type of training, duration, intensity, or hypoxic stimulus, hypoxia affects the athlete in various ways. The results of this study have shown that 18 days of the LH-TL method does not significantly increase the level of EPO and VEGF in rowers. However, reticulocytes, immature red blood cells, have shown significant differences after 18-d LH-TL between groups. Further research should be carried out to investigate an optimal hypoxic dose and time, which will raise EPO, VEGF, and morphology variables. ### Conditions - Hypoxia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - hypoxia ### Outcomes Primary Outcomes - Erythropoietin (EPO) mlU/ml - vascular endothelial growth factor (VEGF) mlU/ml Secondary Outcomes - creatine kinase (CK) ng/ml - Hs C-Reactive Protein (hsCRP) mg/L - hemoglobin (Hb)g/dL - hematocrit (Htc)% - red blood cells (RBC)mln/mm3 - white blood cells (WBC)10 3/µL - reticulocytes (Ret)‰ - SpO2 - oxygen saturation (%) - bpm - beats per minute(%) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs (IGNYTE-3) - NCT ID: NCT06264180 - Study ID: RP1-104 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2034-08-31 - Lead Sponsor: Replimune Inc. ### Study Description This is a randomized, controlled, multicenter, open-label Phase 3 clinical study comparing VO in combination with nivolumab versus Physician's Choice treatment for patients with unresectable Stage IIIb-IV cutaneous melanoma whose disease progressed on an anti PD-1 and an anti-CTLA-4 containing regimen (administered either as a combination regimen or in sequence) or who are not candidates for treatment with an anti-CTLA-4 therapy. ### Conditions - Advanced Melanoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Vusolimogene Oderparepvec - Nivolumab - Nivolumab + Relatlimab - Pembrolizumab - Single-agent chemotherapy ### Outcomes Primary Outcomes - Overall Survival (OS) Secondary Outcomes - Progression Free Survival (PFS) - Objective Response Rate (ORR) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## NODE (groiN ultrasOunD cancEr) - NCT ID: NCT06264167 - Study ID: NODE - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2028-03-31 - Lead Sponsor: Queensland Centre for Gynaecological Cancer ### Study Description This study is an open label, prospective, experimental, randomised clinical trial. The primary aim of this study is to determine whether it is feasible to randomise vulvar cancer patients into one of two treatment arms:1) surgical groin node dissection (as delivered though either a sentinel node biopsy or inguinofemoral lymph node dissection (IFL), or 2) serial high-resolution bilateral groin ultrasound surveillance and clinical examination every 2 months. ### Conditions - Vulvar Cancer Stage Ib - Vulvar Cancer Stage II - Lymph Node Metastasis - Groin Node - Ultrasound Therapy; Complications ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - High-resolution bilateral groin ultrasound surveillance ### Outcomes Primary Outcomes - Feasibility of randomisation: The percentage of patients willing to be randomised to either surgical groin node dissection or serial high-resolution bilateral groin ultrasound surveillance in conjunction with clinical examination every 2 months. Secondary Outcomes - Utility of tumour mutations to determine positive lymph node metastasis. - Utility of circulating tumour DNA to determine positive lymph node metastasis. - Utility of plasma to determine positive lymph node metastasis. - Utility of serum to determine positive lymph node metastasis. ### Location - Facility: St Andrew's War Memorial Hospital, Brisbane, Queensland, 4000, Australia @@
## The Role of Flavor in the Substitutability of E-cigarettes for Combustible Cigarettes Among Persistent Smokers - NCT ID: NCT06264154 - Study ID: 854051 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2027-12 - Lead Sponsor: University of Pennsylvania ### Study Description This between-subjects study aims to evaluate the effect of flavor on initial and sustained switching from combustible cigarettes to e-cigarettes among 210 cigarette smokers. After measuring baseline cigarette smoking rate, participants will be randomized to a six-week regimen of fruit-flavored, tobacco-flavored, or menthol-flavored e-cigarettes and be instructed to switch (versus smoking cigarettes) over a 6-week period. Flavor-associated subjective reward and the reinforcing value of flavored e-cigarettes relative to combustible cigarettes will be assessed as mechanisms. ### Conditions - Smoking - Tobacco Use - Cigarette Smoking - E-Cig Use ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - E-cigarettes ### Outcomes Primary Outcomes - Cigarette Consumption - Cigarette Smoking Behavior Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Evaluation of Nitric Oxide Nasal Spray (NONS) for Treatment of Recurrent Acute Rhinosinusitis - NCT ID: NCT06264141 - Study ID: NONS-RARS-01 - Status: RECRUITING - Start Date: 2024-01-16 - Completion Date: 2024-09 - Lead Sponsor: Sanotize Research and Development corp. ### Study Description A two-week therapy of nitric oxide nasal spray (NONS) vs Placebo (saline nasal spray) initiated immediately after the onset of a new Recurrent Acute Rhinosinusitis (RARS) episode to assess the acceleration to clinical success (cured/much improved symptoms), lack of use of intranasal corticosteroids (INCS) (Day 5, or thereafter) and rescue oral antibiotics (ATBs) (Day 8, or thereafter) after initiation of nitric oxide releasing solution (NORS) platform therapy. ### Conditions - Recurrent Acute Rhinosinusitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Nitric Oxide Releasing Solution - Nasal spray with isotonic saline ### Outcomes Primary Outcomes - Primary endpoint is the time to sinus symptoms resolution Secondary Outcomes - Time (days) to full recovery from sinusitis (participant reported) - Time (days) to sinus symptoms resolution, i.e., being cured or much improved (participant reported clinical success) - Time (days) to the initiation of rescue oral ATB(s), i.e., treatment failure i.e., treatment failure - Time (days) to initiation of INCS - Proportion of participants requiring INCS - Proportion of participants requiring rescue oral ATBs - Proportion of participants recovered from sinusitis - Proportion of participants with rapidly worsening symptoms requiring the use of INCS and oral ATBs - Proportion of participants achieving at least a 9-point improvement change from baseline in Sinonasal Outcome Test (SNOT)-22 - Tolerability and safety of NONS - Proportion of participants with clinically significant changes from baseline in vital signs - Proportion of participants with clinically significant changes from baseline in laboratory parameters - Number of participants with clinically significant changes from Baseline in physical examinations ### Location - Facility: Okanegan Clinical Trials, Kelowna, British Columbia, V1Y 1Z9, Canada @@
## TPAP for Comfort in OSA - NCT ID: NCT06264128 - Study ID: TheraPAP Comfort - Status: RECRUITING - Start Date: 2024-03-08 - Completion Date: 2024-06-30 - Lead Sponsor: SleepRes Inc. ### Study Description TheraPAP is a prototype device (with full documented electrical and isolation safety) being developed by SleepRes for the treatment of obstructive sleep apnea (OSA) that can deliver either standard CPAP at a set pressure or what is called TPAP . TPAP is a pressure control algorithm that lowers the pressure from the set pressure at the beginning of inspiration and does not return the pressure to the full set level until about halfway through expiration. The present study, TheraPAP Comfort, aims at assessing whether TPAP improves patient comfort vs. CPAP during supine wakefulness. ### Conditions - Obstructive Sleep Apnea ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - TPAP - CPAP ### Outcomes Primary Outcomes - CPAP v TPAP Patient Preference via Visual Analog Scale Secondary Outcomes - TPAP 1 v TPAP 2 Patient Preference via Visual Analog Scale ### Location - Facility: SleepCenters of Middle Tennessee, Murfreesboro, Tennessee, 37129, United States @@
## Outcomes of Three Ports Versus Four Ports Laparoscopic Cholecystectomy, Sohag General Surgery Department Experience - NCT ID: NCT06264115 - Study ID: Soh-Med-24-01-05MS - Status: ENROLLING_BY_INVITATION - Start Date: 2024-01-01 - Completion Date: 2024-12-31 - Lead Sponsor: Sohag University ### Study Description To compare the outcomes of three ports and four ports Laparoscopic Cholecystectomy ### Conditions - Cholecystitis, Chronic ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Laparoscopic Cholecystectomy ### Outcomes Primary Outcomes - Postoperative pain score Secondary Outcomes - Operative time - length of hospital stay ### Location - Facility: Sohag university, Sohag, N/A, N/A, Egypt @@
## Influence of Dalcroze Eurhythmics on Pains in Older Women - NCT ID: NCT06264102 - Study ID: 2024/1/1 - Status: COMPLETED - Start Date: 2019-01-11 - Completion Date: 2019-07-15 - Lead Sponsor: Poznan University of Physical Education ### Study Description In this study, we attempted to answer the question of whether participation in a 12-week rhythmic exercise program using the Dalcroze method affects the level of intensity of pain experienced by women over the age of 65. The level of pain was determined on a numerical scale from 1 to 10 and involved headaches, back pain and leg pain. ### Conditions - Back Pain - Headache - Leg Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Physical exercise program ### Outcomes Primary Outcomes - Pain levels before exercise program Secondary Outcomes - Results of pain levels after exercise program ### Location - Facility: Poznan University of Physical Education, Poznań, Wielkopolska, 61-871, Poland @@
## Effects of Preservation Rhinoplasty Nasal Valve Angle and Area - NCT ID: NCT06264089 - Study ID: 202015 - Status: COMPLETED - Start Date: 2020-08-06 - Completion Date: 2023-08-30 - Lead Sponsor: Yuzuncu Yıl University ### Study Description The study planned to compare the internal nasal valve angle measurements of patients who underwent preservation rhinoplasty before and after surgery. ### Conditions - Nasal Obstruction, Bilateral ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Preservation Rhinoplasty Nasal Valve Angle and Area ### Outcomes Primary Outcomes - Nasal Obstruction Symptom Evaluation Scale (NOSE) Secondary Outcomes - Reformatted coronal Computed tomography ### Location - Facility: Yaser Said Cetin, Van, N/A, 65080, Turkey @@
## Ligament Balancing in Total Knee Arthroplasty - NCT ID: NCT06264076 - Study ID: 686340 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-12-31 - Lead Sponsor: Oslo University Hospital ### Study Description The goal of this interventional pilot study is to evaluate if performing ligament balancing on the medial collateral ligament (MCL) in a more systematical manner with a novel instrument can produce more objective and repeatable ligament lengthening in Total Knee Arthroplasty. The main questions it aim to answer are:1. Is it feasible to perform systematic ligament balancing on the MCL using a novel instrument?2. Can a novel instrument for ligament balancing acquire more objective and repeatable results, without risk of injury?Participants must consent prior to the surgery, but inclusion is only done once ligament balancing is indicated during surgery. Patients will be follow-up as standard protocol for Total Knee Arthroplasty patients at the hospital. ### Conditions - Ligament; Laxity, Knee - Knee Osteoarthritis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - A novel instrument for ligament balancing in total knee arthroplasty ### Outcomes Primary Outcomes - Is it feasible to perform systematic ligament balancing on the MCL using a novel instrument? Secondary Outcomes - MCL-lengthening in millimeters after ligament balancing using the novel instrument - Demographic information - height (cm) - and how this parameters affects ligament balancing. - Demographic information - weight (kg) - and how this parameters affects ligament balancing. - Demographic information - age (years) - and how this parameters affects ligament balancing. - Demographic information - sex (biologic, male/ female) - and how this parameters affects ligament balancing. - Demographic information - co-morbidities (disease state) - and how this parameters affect ligament balancing. - Patient reported outcome measures (PROM) using EQ-5D-5L - Patient reported outcome measures (PROM) using FJS-12 - Patient reported outcome measures (PROM) using KOOS-12 ### Location - Facility: Baerum Hospital, Vestre Viken Hospital Trust, Bærums Verk, Viken, 1346, Norway @@
## Study of Behavioral Dysfunctions and Related Neuronal Correlates in Patients With Dystonia - NCT ID: NCT06264063 - Study ID: D-DIST - Status: RECRUITING - Start Date: 2024-01-10 - Completion Date: 2025-10-10 - Lead Sponsor: IRCCS Centro Neurolesi "Bonino-Pulejo" ### Study Description Dystonias represent hyperkinetic movement disorders characterized by protracted muscle contractions, such as to cause torsional movements and anomalous postures in different parts of the body. Although they occur more often in a focal form (blepharospasm, oromandibular dystonia, cervical dystonia, laryngeal dystonia, attitudinal cramps of the limbs) than segmental (involvement of several contiguous muscle groups, e.g. facial muscles and neck muscles), they are nevertheless capable of significantly influencing the quality of life, with consequent social and health costs. Although described as a predominantly motor disorder, the presence of non-motor symptoms in dystonias associated with alteration of the fronto-striatal circuits is increasingly recognized. Neuroimaging studies have highlighted that the striatum and, more specifically, striatal dopamine, is involved in high cognitive processes such as attention, reward-based learning and decision making. Clinical conditions associated with cortico-striatal circuit dysfunction and abnormal meso-striatal or meso-cortical dopamine transmission also appear to influence temporal estimation, delay discounting, showing an impulsive preference for immediate rewards over delayed gratification.Based on these premises, the present project aims to evaluate the cognitive and affective aspects of dystonias, in line with neuroimaging research documenting structural and functional dysfunctions in the respective brain regions. ### Conditions - Dystonia - Neurologic Disorder - NEUROSCIENCE ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SCREENING ### Interventions - control group - experimental group - EEG power in alpha band ### Outcomes Primary Outcomes - montreal cognitive assessment - Beck depression inventory Secondary Outcomes - EEG power in alpha band ### Location - Facility: IRCCS Centro Neurolesi Bonino Pulejo, Messina, N/A, 98124, Italy @@
## Psychological Support Group and Its Effects on Mood, Anxiety and Coping - NCT ID: NCT06264050 - Study ID: 2023.04 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2004-01-08 - Completion Date: 2025-03-15 - Lead Sponsor: IRCCS San Camillo, Venezia, Italy ### Study Description The aim of this study is to verify the influence that participation in a Psychological Support Group has on anxiety, depression and coping skills in patients admitted to the IRCCS San Camillo Hospital.It is therefore an observational study with a pre-post design on a cohort of patients hospitalized at San Camillo IRCCS who attend the Psychological Support Group.The study consists of verifying whether the therapeutic activity of the Psychological Support Group (GSP) has an influence on the levels of anxiety, mood and coping skills in the patients who attend it. These purposes will be pursued through the administration to each patient at the beginning (pre) and at the end (post) of the period of attendance at the GSP, of validated scales: Stay Y2 (anxiety), BDI II(depressive symptoms), COPE NVD 25 (coping strategies) and the CORE-OM (outcomes of psychological activity). ### Conditions - Coping Strategies - Anxiety - Nurse-Patient Relations - Psychological - Mood Depressed - Rehabilitation - Neurologic Manifestations ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - evalutaion scales ### Outcomes Primary Outcomes - The State-Trait Anxiety Inventory (STAI) Y2 - The Beck Depression Inventory II (BDI-II) - The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) - The Coping Orientations to Problem Experienced NVI - 25 Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Experience in Neurorehabilitation Setting: a Qualitative Study - NCT ID: NCT06264037 - Study ID: 2023.03 - Status: RECRUITING - Start Date: 2023-03-15 - Completion Date: 2025-03-15 - Lead Sponsor: IRCCS San Camillo, Venezia, Italy ### Study Description In this exploratory qualitative study with a hermeneutic phenomenological approach, we will describe and understand the experience of treatment and hospitalization in hospitalized people suffering from stroke, multiple sclerosis, Parkinson\'s disease and patients post-neurosurgery for oncological causes. Patients will be interviewed in a semi-structured manner and sampling will take place for each of the pathology groups according to the saturation method. ### Conditions - Rehabilitation - Neurologic Disorder - Stroke - Parkinson Disease - Multiple Sclerosis - Neurosurgery ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - semi structured interview ### Outcomes Primary Outcomes - narrative contents Secondary Outcomes ### Location - Facility: Alberto Camuccio, Venezia, N/A, 30126, Italy @@
## Simultaneous pHototherapeutic Keratectomy and corneAl Collagen cRosslinking in Eyes With Keratoconus: a Randomized Trial (SHARK) - NCT ID: NCT06264024 - Study ID: 519516 - Status: RECRUITING - Start Date: 2024-02-12 - Completion Date: 2034-02-01 - Lead Sponsor: Oslo University Hospital ### Study Description The goal of this clinical trial is to compare CXL with combined treatment with CXL and t-PTK.The main questions it aims to answer are whether combined treatment can give better visual acuity and if the treatments are equally safe. ### Conditions - Keratoconus ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Corneal collagen cross linking (CXL) - Transepithelial phototherapeutic keratectomy (t-PTK) ### Outcomes Primary Outcomes - Visual acuity - Risk of progression Secondary Outcomes - Visual acuity - Visual acuity - Visual acuity - Visual acuity - Visual acuity - Risk of progression - Risk of progression - Risk of progression - Risk of progression - Risk of progression - Depth of demarcation line (OCT) - Depth of demarcation line (confocal microscopy) - Patient reported outcome measure (PROMs) - Patient reported outcome measure (PROMs) - Patient reported outcome measure (PROMs) - Patient reported pain after surgery ### Location - Facility: Department of Ophhtalmology, University of Oslo, Oslo, N/A, N/A, Norway @@
## Discrimination and Religious Experiences of Adult Muslimahs in Salaat - NCT ID: NCT06264011 - Study ID: 2023B0044 - Status: RECRUITING - Start Date: 2023-07-13 - Completion Date: 2024-06 - Lead Sponsor: Ohio State University ### Study Description This goal of this clinical trial is to examine the effects of the Muslim prayer (salaat) on physiological arousal among Muslim women. This study aims to measure EEG and HRV during the salaat performance among Muslim women. Using EEG as a measure of physiological relaxation, HRV will be utilized as a measure of stress experienced by Muslim women whose prayer have been understudied in research on the salaat. Thus, the main questions it aims to answer are 1) whether salaat performed by Muslim women influences physiological relaxation similar to what is seen by men, and 2) Evaluate health-related correlates of perceived discrimination among Muslim women.Participants will complete 15 questionnaires. Participants will be connected to a Heart Rate Variability (HRV) monitor as well as a 32-electrode EEG cap. After the baseline data are obtained, all participants will complete both conditions (salaat and counting) but the order of participation in conditions will be randomly assigned. The resting period will again occur between conditions and at the end of the second condition.All participants will pray the Duha prayer, an optional superogatory prayer that typically occurs in the early morning, to control for differences in timing and duration of prayer. The Duha is completed between the dawn and noon prayers and consists of four cycles of prayer as well as Qur'an recitation and supplication throughout the four positions. The salaat condition includes four cycles with four different positions during each cycle (standing with bowing at a 90-degree angle with both hands covering the knees, standing again briefly with arms at the sides, prostrating with forehead, hands, knees, and feet touching the ground, followed by sitting with knees bent under the torso, prostrating, and sitting again). The counting condition will include the same physical component as the salaat condition. This will include 4 cycles of movement through the four different positions (i.e., standing, bowing at a 90-degree angle with both hands covering the knees, standing again briefly with arms at the sides, prostrating with forehead, hands, knees, and feet touching the ground, followed by sitting with knees bent under the torso, prostrating, and a final sitting position in cycles two and four (see Figure 2)). Apart from not including the final sitting position, cycles one and three are identical to cycles two and four (see Figure 2). The counting condition will include replacing Qur'anic recitation and subsequent supplications throughout the prayer by counting "one one-thousand, two one-thousand, three one-thousand, etc." throughout the duration of time typically required to perform the full salaat. During the standing position, counting can last for approximately 30-60 seconds in line with the previous study by Doufesh and colleagues (2012). Thus, the first three cycles of prayer will require approximately 77 seconds each while the final cycle will require around 97 seconds based on the estimates by Doufesh and colleagues (2012), for a total of approximately five and a half minutes. To ensure that participant duration during the counting condition is, on average, equivalent to the salaat condition, an audio recording will be provided with counting aloud during each position. The duration of the counting in the audio recording will be an average of the duration of each position as found in Doufesh and colleagues (2012). A bell sound will be used to indicate when participants should change to the next position. After performance of each condition, participants will return to a comfortable seated position. Participants will complete a questionnaire to rate their mental focus in the condition. Blood pressure will be measured at the end of each condition. While at rest, assessment of blood pressure, HRV, and EEG will be obtained from participants for 5 minutes between each condition and at the end of the study. ### Conditions - Stress, Psychological - Control ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Salaat - Sham comparator ### Outcomes Primary Outcomes - Relative power alpha - High frequency heart rate variability (HF-HRV) - The Body Perception Questionnaire Body Awareness Very Short Form (BPQ-VSF) Secondary Outcomes - The SF 36-Item Health Survey (SF-36) - Modified International Physical Activity Questionnaire - Short Form (IPAQ-SF) - Health Care Discrimination Scale (HCDS; Martin, 2015) - Perceived Religious Discrimination Scale (PRDS; Rippy & Newman, 2008) - The Internalized Islamophobia Scale - Muslim Identification Scale (MIS; Verkuyten, 2007) - Brief Religious COPE - Salaat Frequency Scale - The Salaat Index - Hijab Frequency Scale ### Location - Facility: The Ohio State University, Columbus, Ohio, 43016, United States @@
## Clinical Study for the Evaluation of Safety and Tolerability of NCP112 Eye Drops - NCT ID: NCT06263998 - Study ID: HUC1-394 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-03 - Completion Date: 2026-01-30 - Lead Sponsor: Huons Co., Ltd. ### Study Description The objective is to evaluate the safety, local tolerability, and pharmacokinetics of NCP112 eye drops through single and multiple dose-escalation ocular administrations in healthy adults. ### Conditions - Xerophthalmia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - NCP112 - NCP112 Placebo ### Outcomes Primary Outcomes - Treatment-Emergent Adverse Events Secondary Outcomes - Evaluation of pharmacokinetic profile - Evaluation of pharmacokinetic profile ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Axis(TM) Solvent-dehydrate Dermal Allograft in the Treatment of Pelvic Organ Prolapse. - NCT ID: NCT06263985 - Study ID: 20214133 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2021-11-02 - Completion Date: 2025-05-30 - Lead Sponsor: Michigan Institution of Women's Health PC ### Study Description The goal of this study is to assess improvement in subjects who have undergone Axis Dermis, biologic mesh for pelvic organ prolapse repair. \[describe participant population/health conditions\]. The main question\[s\] it aims to answer are:* Is the leading edge of the prolapse above the hymen* Does subject notice a bulge Participants will undergo Axis Dermis pelvic organ prolapse repair procedure. ### Conditions - Pelvic Organ Prolapse ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Axis Dermis biologic mesh repair for pelvic organ prolapse ### Outcomes Primary Outcomes - Improvement in function - Improvement in Anatomy Secondary Outcomes - Assess complications or untoward side effects. ### Location - Facility: Advanced Urogynecology of Michigan, Dearborn, Michigan, 48124, United States @@
## Comparison of the Efficacy of Transcranial Direct Current Stimulation (tDCS) of the Primary Motor Cortex (M1) or the Prefrontal Cortex Combined With Aerobic Activity for Alleviation of Fibromyalgia Symptoms. - NCT ID: NCT06263972 - Study ID: 0168-21EMC - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-07 - Lead Sponsor: HaEmek Medical Center, Israel ### Study Description The goal of this study is to demonstrate the effectiveness of treating fibromyalgia using combination of electrical stimulation with aerobic activity.Participants will be randomly assigned to stimulation in a ratio of 1:1:1. 120 participants (40 in each group). The therapeutic course will include moderate aerobic physical activity (at 60% of the target heart rate adjusted for age) 3 times a week for 4 weeks (a week of adjustment, and 3 weeks of treatment), along with low current electrical stimulation for 3 weeks. ### Conditions - Fibromyalgia - Electric Shock ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Direct Stimulation Prefrontal Cortex - Shame cortex stimulation - Direct Stimulation to Motor Cortex - erobic physical activity ### Outcomes Primary Outcomes - Study objectives: • Comparing the effectiveness of direct electric current stimulation between the two stimulus areas Numeric pain rating scale. - Study objectives: • Comparing the effectiveness of direct electric current stimulation (tDCS) between the two stimulus areas and in relation Adult sensory profile test Raw score. - Study objectives: • Comparing the effectiveness of direct electric current stimulation between the two stimulus areas and in relation to The Montreal Cognitive Assessment (MoCA) score. - Study objectives: • Comparing the effectiveness of direct electric current stimulation between the two stimulus areas and in relation to Generalized Anxiety Disorder 7-Item Scale Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Randomized, Double-blind, Placebo-controlled Phase IIa Clinical Study to Evaluate the Safety and Efficacy of GST-HG131 Tablets in Patients With Chronic Hepatitis B - NCT ID: NCT06263959 - Study ID: GST-HG131-II-01 - Status: RECRUITING - Start Date: 2023-12-29 - Completion Date: 2024-11-01 - Lead Sponsor: Fujian Akeylink Biotechnology Co., Ltd. ### Study Description A randomized, double-blind, placebo-controlled Phase IIa clinical study to evaluate the safety and efficacy of GST-HG131 tablets in patients with chronic hepatitis B ### Conditions - Chronic Hepatitis B ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - GST-HG131 - Placebo to match GST-HG131 ### Outcomes Primary Outcomes - Change from Baseline in HBsAg levels Secondary Outcomes - Number of participants with adverse events (AEs), serious adverse events (SAEs), and withdrawals due to AEs ### Location - Facility: The Fifth Medical Center of Chinese PLA General Hospital, Beijing, N/A, N/A, China @@
## Essilor® Stellest® Lenses Multicentre European Study (SLOMES) - NCT ID: NCT06263946 - Study ID: WS10337 - Status: RECRUITING - Start Date: 2024-03-22 - Completion Date: 2026-12-30 - Lead Sponsor: Essilor International ### Study Description The goal of this post-market clinical follow up Study is to demonstrate the efficacy, safety, acceptability, and quality of life implications of Essilor® Stellest® spectacle lenses in slowing myopia progression in European children and adolescents. Participants will receive Essilor® Stellest® at inclusion visit and will be asked for a full time wear (\>12 hours daily) for 24 months. The primary endpoints are the change in axial length and cycloplegic autorefraction from baseline to 24 months compared to expected change based on axial length and refraction centile positions at baseline. ### Conditions - Myopia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Essilor® Stellest® spectacle lenses ### Outcomes Primary Outcomes - Change in cycloplegic axial length - Change in cycloplegic autorefraction Secondary Outcomes - Change in refraction progression centile - Change in cycloplegic axial length - Change in cycloplegic autorefraction - Change in refraction - Change in axial length - Change in choroidal thickness - Change in refraction - Change in axial length vs atropine - Change in choroidal thickness - Change in Paediatric Refractive Error Profile (PREP-2) score ### Location - Facility: Hôpital Fondation Adolphe de Rothschild - Ophthalmology Department, Paris, N/A, 75019, France @@