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## DermAI to Evaluate Human Factor of Testing - NCT ID: NCT06387472 - Study ID: 23-007636 - Status: RECRUITING - Start Date: 2024-04-29 - Completion Date: 2024-12-31 - Lead Sponsor: Mayo Clinic ### Study Description The purpose of this research is to improve how well remote patch allergy testing works and make sure they are easy and practical for people to use from home. ### Conditions - Contact Dermatitis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - AI algorithm to evaluate photographs of skin test patch regions - Allergen Patch ### Outcomes Primary Outcomes - Classification of test site region reaction Secondary Outcomes - Classification of test site region using a 5-point scale - False Positive Rate - False Negative Rate - Early termination of testing - Participants that removed patches early - Adverse events related to allergen exposure ### Location - Facility: Mayo Clinic in Florida, Jacksonville, Florida, 32224, United States @@
## Feasibility of Fabric Orthosis for Knee Support in Elderly Gait Improvement - NCT ID: NCT06387459 - Study ID: 2022M3C1A3090827 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2026-05-14 - Lead Sponsor: Seoul National University Hospital ### Study Description This pilot clinical trial assesses the safety and feasibility of a novel fabric-type orthosis designed to mimic the knee extensor muscles and improve gait in elderly patients with mobility impairments due to conditions like sarcopenia, diabetes, or knee osteoarthritis. The study aims to test this orthosis in a real- world setting to see if it can enhance mobility and stability for elderly individuals, potentially reducing falls and improving quality of life. A total of 30 participants aged 65 and older will be recruited to use this orthosis across multiple sessions, where their gait will be analyzed under various conditions to measure the device's impact on walking speed, stability, and muscle activation. ### Conditions - Gait - Fall - Orthotic Devices ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Fabric-Type Knee Extensor Muscle-Mimicking Orthosis ### Outcomes Primary Outcomes - Completion Rate Secondary Outcomes - Dropout Rate - User Feedback - 6-Minute Walk Test - 10-Meter Walk Test - Surface Electromyography - Gait Analysis ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Allogeneic Valve Transplantation - NCT ID: NCT06387446 - Study ID: RB-P00044611 - Status: RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-06-01 - Lead Sponsor: Boston Children's Hospital ### Study Description Valves will be taken from hearts donated by organ donors, and implanted into patients who need a new heart valve. ### Conditions - Valve Heart Disease - Valve Disease, Heart - Valve Disease, Aortic ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Valve transplant ### Outcomes Primary Outcomes - Valve Regurgitation - Valve Annulus Growth - Leaflet Growth Secondary Outcomes - Ventricular Function - Survival ### Location - Facility: Boston Children's Hospital, Boston, Massachusetts, 02115, United States @@
## Effectiveness of an mHealth Mobile App - NCT ID: NCT06387433 - Study ID: mHealth - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-20 - Completion Date: 2025-08 - Lead Sponsor: Dow University of Health Sciences ### Study Description Type II diabetes is a serious challenge for Pakistan. Not using medications properly increases healthcare costs and diabetes-related deaths. A mobile app in local language can improve medication adherence and self-management among diabetics. Therefore, in this 18 months long study we will develop a diabetes-related mobile application in Urdu, and will conduct a trial to assess whether it improves medication compliance and self-management, and how much economical this app would be compared to the usual standard of care for type II diabetics in Pakistan. This trial will be conducted at the National Institute of Diabetes and Endocrinology Karachi. The study participants will be divided in two groups. Only one group will use this application. We will measure medication compliance and self-management through diabetes-specific blood test and self-reporting questionnaires between two groups. We will also determine how much economic costs would be saved by using this app to improve medication compliance ### Conditions - Type II Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - mobile app use ### Outcomes Primary Outcomes - adherence to medication - self-management among diabetics Secondary Outcomes - Intervention usability - economic effectiveness of the app ### Location - Facility: National Institute of Diabetes and Endocrinology, Karachi, Sindh, N/A, Pakistan @@
## A Study of AK117 in Combination With Azactidine Plus Venetoclax in Patients With Acute Myeloid Leukemia - NCT ID: NCT06387420 - Study ID: AK117-206 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-29 - Completion Date: 2027-04 - Lead Sponsor: Akeso ### Study Description This is a phase 1b/2 study. All patients are diagnosed with Acute Myeloid Leukemia (AML), Eastern Cooperative Oncology Group (ECOG) performance status 0-3. The purpose of this study is to evaluate the safety and efficacy of AK117 + azacitidine + venetoclax in subjects with AML. ### Conditions - ACUTE MYELOID LEUKEMIA; AML ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - AK117 - Azacitidine - Venetoclax - Placebo ### Outcomes Primary Outcomes - Phase 1b: Number of participants with dose limiting toxicity (DLT) - Phase 1b/2: Number of participants with adverse events (AEs) - Phase 1b/2: Composite complete remission rate (CCR) Secondary Outcomes - Overall response rate (ORR) - Time to response (TTR) - Time to CCR (TTCCR) - Duration of response (DoR) - Duration of CCR (DoCCR) - Rate of CCR Without Minimal Residual Disease (CCR MRD-) - Event-free survival (EFS) - Overall survival (OS) - Peak of Serum Concentration (Cmax) - Anti-drug antibody (ADA) - Receptor occupancy (RO) ### Location - Facility: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, N/A, N/A, China @@
## Population Pharmacokinetic Study of the Effect of Polymorphisms in the ABCB1 and CES1 Genes on the Pharmacokinetics of Dabigatran - NCT ID: NCT06387407 - Study ID: 2024037K - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-11-25 - Lead Sponsor: The Affiliated Hospital Of Guizhou Medical University ### Study Description According to published studies, the effects of genetic polymorphisms in the ABCB1 and CES1 genes on the blood concentration of dabigatran are controversial, and it is not clear whether dabigatran dosage and dosing intervals need to be adjusted according to genotype or other covariates in Chinese subjects. For these purposes, we will include patient demographics, genetic polymorphisms, and PK data based on a population pharmacokinetic study of dabigatran ester in healthy Chinese subjects to analyze the effect on dabigatran pharmacokinetics.The aim of this study was to develop a population pharmacokinetic model to understand the relationship between dabigatran-related genes and dabigatran plasma levels after a single oral dose in healthy Chinese subjects and patients, and to analyze the effects of genetic variation on the efficacy and safety of dabigatran etexilate. ### Conditions - Combined Analysis of Polymorphisms and Dabigatran Pharmacokinetic Parameters ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Dabigatran Etexilate 150mg ### Outcomes Primary Outcomes - Plasma drug concentration Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study to Assess BOTOX Injections in Adult Participants for the Change of Masseter Muscle Prominence - NCT ID: NCT06387394 - Study ID: M21-416 - Status: RECRUITING - Start Date: 2024-04-22 - Completion Date: 2026-01-26 - Lead Sponsor: AbbVie ### Study Description The masseter muscle is one of the muscles in the lower face used for chewing. The prominence of the masseter muscle can appear as a widened lower face which some individuals deem as aesthetically undesirable and can be treated by selectively weakening the masseter muscles with small quantities of botulinum toxin. The purpose of this study is to assess how safe and effective injection of onabotulinumtoxinA (BOTOX) is in adult participants with Masseter Muscle Prominence (MMP).BOTOX is being investigated for the treatment of Muscle Masseter Prominence. In Period 1, participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment, placebo or BOTOX. There is a 1 in 4 chance that participants will be assigned to placebo. In Period 2, eligible participants can receive an optional open-label retreatment of BOTOX. Approximately 200 adult participants with MMP will be enrolled in the study at approximately 20 sites in the United States.Participants will receive intramuscular injections across both the right and left masseter muscle of either BOTOX or placebo on Day 1. Participants who are eligible for re-treatment will be given BOTOX injections on either the Day 180, 210, 240, or 270 visit and will be followed up for up to 6 months.There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular monthly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects, and completing questionnaires. ### Conditions - Masseter Muscle Prominence ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - BOTOX - Placebo ### Outcomes Primary Outcomes - Composite Achievement of MMP Severity Improvement and at Least a 2-Grade Improvement from Baseline by Both Investigator-Rated MMPS and Participant-Rated MMPS-P - Number of Participants with Adverse Events (AEs) Secondary Outcomes - Percentage of Participants Achieving Investigator-Rated MMPS Improvement Over Time - Percentage of Participants Achieving Participant-Rated MMPS-P Improvement Over Time - Percentage of Participants who Responded as "Very satisfied" or "Satisfied" on the Lower Facial Shape Questionnaire - Treatment Satisfaction Assessment (LFSQ-TXSAT) - Percentage of Participants who Responded as "Much improved" or "Moderately improved" on the MMP Participant Self-Assessment of Change (MMP-PSAC) - Percentage of Participants who Responded as "Not at all bothered" or "A little bothered" on the Bother Impact Assessment for Masseter Muscle Prominence (BIA-MMP) - Change from Baseline in Lower Facial Shape Questionnaire-Impact Assessment (LFSQ-IA) Summary Score ### Location - Facility: Delricht Research /ID# 249825, New Orleans, Louisiana, 70115, United States @@
## 68Ga-PSFA PET Imaging in Patients With PSMA/FAP Positive Disease - NCT ID: NCT06387381 - Study ID: CYYY-KY-2024-048-01 - Status: RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-12-31 - Lead Sponsor: First Affiliated Hospital of Chongqing Medical University ### Study Description As a new dual receptor (PSMA and FAP) targeting PET radiotracer, 68Ga-PSFA is promising as an excellent imaging agent applicable to PSMA/FAP positive diseases. In this research, we investigate the safety, biodistribution and potential usefulness of 68Ga-PSFA positron emission tomography (PET) for the diagnosis of lesions in PSMA/FAP positive diseases. ### Conditions - PSMA - FAP - Positron-Emission Tomography ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - 68Ga-PSFA ### Outcomes Primary Outcomes - Diagnostic efficacy Secondary Outcomes ### Location - Facility: The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, 400016, China @@
## Clinical Study of Huaier Granule in the Treatment of Unresectable Pancreatic Cancer - NCT ID: NCT06387368 - Study ID: HE-202303 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2028-08 - Lead Sponsor: Health Science Center of Xi'an Jiaotong University ### Study Description This is a prospective, multicenter, randomized, open, parallel controlled clinical study to evaluate the efficacy and safety of Huaier Granules combined with capecitabine in the treatment of unresectable pancreatic cancer. ### Conditions - Pancreatic Cancer Non-resectable ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Huaier Granule - Capecitabine ### Outcomes Primary Outcomes - Overall survival Secondary Outcomes - Objective response rate - Progression free survival - Conversion surgery rate - The incidence and severity of adverse events (AE) and severe adverse events (SAE) - The incidence and severity of ADR, severe adverse reactions (SADR), suspicious and unexpected severe adverse reactions (SUSAR) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Diagnosis and Treatment of CAD in Severe PAD After Lower Extremity Revascularization - NCT ID: NCT06387355 - Study ID: SURG-006-23S - Status: NOT_YET_RECRUITING - Start Date: 2024-08-01 - Completion Date: 2029-08-01 - Lead Sponsor: VA Office of Research and Development ### Study Description Peripheral artery disease, lack or blood flow to the legs, has a high prevalence in the Veteran population. In patients with severe peripheral artery disease that requires an endovascular or surgical intervention for lower leg revascularization, the long-term mortality of approximately 50% is worse that most cancers. The goal of this study is to develop a management strategy to improve cardiovascular outcomes in this high-risk peripheral artery disease population after lower extremity revascularization. ### Conditions - Peripheral Artery Disease - Coronary Artery Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Coronary computed topography (CT) angiography with FFR-CT ### Outcomes Primary Outcomes - Major adverse cardiovascular events (MACE) Secondary Outcomes - Cardiovascular-related death - Myocardioal infarction - All-cause mortality - Amputation-free survival ### Location - Facility: Rocky Mountain Regional VA Medical Center, Aurora, CO, Aurora, Colorado, 80045, United States @@
## Namodenoson Treatment of Advanced Pancreatic Cancer - NCT ID: NCT06387342 - Study ID: CF102-222PC - Status: NOT_YET_RECRUITING - Start Date: 2024-07-15 - Completion Date: 2026-12-15 - Lead Sponsor: Can-Fite BioPharma ### Study Description This is an open-label trial in patients with advanced pancreatic cancer. The trial will evaluate the safety, clinical activity, and pharmacokinetics of the study drug, namodenoson, in this group of patients. ### Conditions - Pancreatic Adenocarcinoma - Pancreatic Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Namodenoson 25mg ### Outcomes Primary Outcomes - Adverse Events - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Change from baseline Secondary Outcomes - Objective response rate - Progression free survival - Disease control rate - Duration of response - Overall survival ### Location - Facility: Rabin Medical Center Institute of Oncology, Petach Tikva, N/A, 49100, Israel @@
## Bladder Botox UTI Antibiotic Prophylaxis - NCT ID: NCT06387329 - Study ID: WRNMMC-2023-0438 - Status: RECRUITING - Start Date: 2024-04-04 - Completion Date: 2025-06-30 - Lead Sponsor: Walter Reed National Military Medical Center ### Study Description Overactive bladder (OAB) is a common condition with a prevalence of 17% in the general population that significantly affects quality of life. Intradetrusor onabotulinumtoxinA injections are an advanced therapy for OAB as well as interstitial cystitis/bladder pain syndrome (IC/BPS). The most common adverse event following intradetrusor injection of onabotulinumtoxinA in urinary tract infection (UTI), which occurs in 8.6-48.1% of patients. To prevent UTIs, patients are given a course of antibiotics, however the ideal prophylactic regimen has not been determined for the timing, duration, and type of antibiotic. Four retrospective studies in the literature address this question with variable conclusions, and there are no prospective studies. Identifying the ideal regimen is important for preventing UTIs as well as minimizing antibiotic use to prevent adverse effects and development of antibiotic resistance.The population to be studied will be female patients 18 years and older who are patients of the urogynecology and urology clinics at Walter Reed National Military Medical Center with a diagnosis of OAB or IC/BPS and have chosen to be treated with intradetrusor onabotulinumtoxinA injections. It will be a non-blinded randomized controlled noninferiority trial in which the patients are randomly placed into 2 groups. The first group will receive a 3 day course of twice daily oral nitrofurantoin 100mg starting at the time of the procedure, and the second group will receive a single dose of 100mg oral nitrofurantoin at the time of the procedure.The patients will be screened at the clinic at the time that they schedule their intradetrusor onabotulinumtoxinA injection appointment or by phone 1-2 weeks prior to their procedure. If the patient agrees to participate in the study then they will be instructed to give a urine sample for urinalysis and culture 1 week prior to the procedure appointment to exclude existing UTI. If a UTI is diagnosed at this time they must complete treatment prior to the procedure or will need to reschedule their procedure. On the day of the procedure patients will receive the clinic standard 10ml of 2% viscous lidocaine through the urethra 10-20 minutes prior to the procedure, and may be offered 5-10mg oral diazepam at the discretion of the treating physician. All patients will be given 200mg of phenazopyridine and 100mg of nitrofurantoin prior to the initiation of the procedure. The procedure will take place as directed by the treating physician per standard operating procedure.A urinalysis and urine culture will be placed for all study participants at time of their procedure appointment in case they have symptoms of UTI, and they will be instructed to follow up with the research team by phone if they have concerns for a UTI. Patients will be contacted 30-45 days after the procedure by phone, email, or message through genesis and asked about any UTI symptoms, UTI diagnoses and secondary outcomes during the 30 days following the procedure. Data will be analyzed for the primary outcome of UTI rates in the 30 days following intradetrusor onabotulinumtoxinA injection. ### Conditions - Overactive Bladder - Bladder Pain Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Nitrofurantoin 100 MG ### Outcomes Primary Outcomes - Urinary tract infection Secondary Outcomes - Urinary tract infection symptoms - Urinary retention - Adverse effects ### Location - Facility: Walter Reed National Military Medical Center, Bethesda, Maryland, 20899, United States @@
## Cephalic Phase Responses to Nutritive and Non-Nutritive Sweeteners - NCT ID: NCT06387316 - Study ID: 2023-1526 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-26 - Completion Date: 2025-03-30 - Lead Sponsor: Purdue University ### Study Description This study will focus on changes in blood sugar in response to tasting different types of sweeteners using continuous glucose monitoring (CGM) technology. ### Conditions - Pre Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - No Oral Stimulation - Oral water stimulation - Oral Salt Stimulation - Oral Sucralose Stimulation - Oral Sucrose stimulation ### Outcomes Primary Outcomes - Blood glucose concentration Secondary Outcomes ### Location - Facility: Purdue University, West Lafayette, Indiana, 47907, United States @@
## Pain Control and Quality of Recovery After Intravenous Methadone Versus Intrathecal Morphine in Major Abdominal Surgery - NCT ID: NCT06387303 - Study ID: HSR230492 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-12 - Completion Date: 2026-05-11 - Lead Sponsor: University of Virginia ### Study Description Moderate to severe postoperative pain is relatively common after major abdominal surgery and is associated with less than optimal surgical experience, poor quality of recovery, and development of persistent postsurgical pain. Opioids remain a major component of postoperative pain management. Side effects of opioids used for treatment of postoperative pain include constipation, pruritus, nausea, and vomiting.1,2 Enhanced recovery after surgery (ERAS) protocols involve utilization of multimodal analgesia. Analgesic techniques used include epidural analgesia, nerve blocks, and Intrathecal (IT) administration of morphine. IT morphine reduces postoperative opioid requirement for 18-24 hours after major abdominal surgery and reduces hospital length of stay (LOS) compared with epidural analgesia.3,4 Significant number of patients that receive IT morphine still experience moderate to severe postoperative pain.5 Additionally, many patients refuse the invasive procedure or cannot receive IT morphine due to procedure contraindications; thrombocytopenia and/or coagulopathy.6Intravenous (IV) methadone has a long analgesic half-life and has N-methyl-D-aspartate (NMDA) receptor antagonist and serotonin and norepinephrine reuptake inhibitor (SNRI) properties.7-9 It has previously been shown to reduce postoperative opioid requirements, postoperative nausea and vomiting (PONV), and postoperative pain scores in patients that underwent orthopedic, abdominal, complex spine, and cardiac surgery.10-13 Similar findings have been shown in obstetric patients that underwent caesarean delivery under general anesthesia as well as patients that underwent gynecologic surgery.14,15 IV methadone has, however, never been compared with IT morphine as a postoperative analgesic.Our hypothesis is that intravenous (IV) methadone is non-inferior to IT morphine in patients who undergo major abdominal surgery. It offers the advantage of being a noninvasive analgesic, modality that may contribute to decreasing opioid consumption during the first 72 hours postoperatively, controlling postoperative pain, and improving quality of recovery after surgery. ### Conditions - Pain, Postoperative ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Methadone - Morphine ### Outcomes Primary Outcomes - Quality of Recovery 15 score - Overall Benefits of Analgesic Score (OBAS) - morphine milligram equivalent - Verbal Rating Scale (VRS) pain scores Secondary Outcomes - McGill Pain questionnaire score - Verbal Rating Scale (VRS) pain scores ### Location - Facility: University of Virginia, Charlottesville, Virginia, 22908-0710, United States @@
## Optimizing Chronic Pain Care With Mindfulness and Chronic Pain Management Visits - NCT ID: NCT06387290 - Study ID: 00172836 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-06 - Completion Date: 2030-05-01 - Lead Sponsor: University of Utah ### Study Description The primary aim of this implementation-effectiveness trial is to examine the effectiveness of Mindfulness-Oriented Recovery Enhancement (MORE) and patient-centered chronic pain management visits in primary care as interventions to reduce chronic pain, improve quality of life, and reduce opioid-related harms among chronic pain patients on long-term opioid therapy. ### Conditions - Chronic Pain - Prescription Opioid Misuse - Substance-Related Disorders - Pain - Narcotic-Related Disorders - Chemically-Induced Disorders - Mental Disorders - Opioid-Related Disorders - Neurologic Manifestations ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Mindfulness Oriented Recovery Enhancement - Patient-Centered Chronic Pain Management Visits ### Outcomes Primary Outcomes - Opioid Misuse - Chronic Pain Secondary Outcomes - Change in Quality of Life - Opioid Dosing - Opioid Craving - PTSD Symptoms - Depression - Generalized Anxiety ### Location - Facility: Rutgers University Primary Care Clinics, New Brunswick, New Jersey, 08901, United States @@
## Re-epithelialization Efficacy Evaluation of Cosmetic Product RV1551P vs Non-treated Forearm of Healthy Adult Women - NCT ID: NCT06387277 - Study ID: RV1551P20220376 - Status: COMPLETED - Start Date: 2022-09-19 - Completion Date: 2022-12-12 - Lead Sponsor: Pierre Fabre Dermo Cosmetique ### Study Description The aim of this study was to evaluate the impact of the product RV1551P GB3224 on skin microbiota during wound healing process, based on swab samples collected from lesion areas using an epidermally ablated skin model of erbium YAG laser. ### Conditions - Healthy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - RV1551P GB3224 ### Outcomes Primary Outcomes - Time to re-epithelialization as assessed by in vivo examination by the investigator and standardized photographs taken with a C Cube Camera® Secondary Outcomes - Skin microbiota diversity from swab samples. - Skin microbiota composition from swab samples. - Metabolomic analysis from swab samples ### Location - Facility: Skin Research Centre, Toulouse, Haute-Garonne, 31300, France @@
## Compont - Varicose Veins of the Lower Extremities - NCT ID: NCT06387264 - Study ID: 2022PHC032 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-01-11 - Completion Date: 2024-12 - Lead Sponsor: Peking University People's Hospital ### Study Description The purpose of this clinical trial is to evaluate the effectiveness and safety of Medical Adhesive produced by Beijing Compont Medical Devices Co., Ltd. in the treatment of varicose veins in the lower extremities.The main questions it aims to answer is: What medical problems do participants have when using tissue glue? Researchers will compare Medical Adhesive to ClosureFast Endovenous Radiofrequency Ablation (RFA) Catheter (produced by Medtronic Inc. to see if Medical Adhesive works to treat varicose veins in the lower extremities.Participants will:Treated with closed varicose veins of the lower extremity by Medical Adhesive or ClosureFast.Return to the hospital at 1, 12, and 24 weeks postoperatively for Doppler ultrasound, and at 4, 12, 24 weeks postoperatively for venous scoring. ### Conditions - Varicose Veins of Lower Limb ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Medical Adhesive - ClosureFast Endovenous Radiofrequency Ablation(RFA) Catheter ### Outcomes Primary Outcomes - Clinical success rate Secondary Outcomes - Technical success rate - Target vascular closure rate at 12 weeks after operation. - Clinical signs - Venous Clinical Severity Score (VCSS) - Aberdeen Varicose Vein Questionnaire (AVVQ) - Operation duration - Evaluation of product performance ### Location - Facility: Peking University People's Hospital, Beijing, N/A, N/A, China @@
## Assess the Effects of a 30 Day-wellness Program on Digestive Health, Weight and Overall Well-being - NCT ID: NCT06387251 - Study ID: 2023-11-437-0003 - Status: COMPLETED - Start Date: 2024-01-29 - Completion Date: 2024-02-29 - Lead Sponsor: Peryam & Kroll Research Corporation ### Study Description The digestive system is a pivotal component of human health, playing a crucial role in the absorption of nutrients, elimination of waste, and even influencing mental well-being. Poor digestive health can significantly impact one's quality of life and overall well-being. Issues such as bloating, constipation, or imbalanced gut microbiome can affect one's overall well-being. Moreover, the gut-brain connection underscores how digestive health can affect mental well-being. The gut can contribute to serotonin and energy production thus influencing one's mood, energy levels and cognitive functions, affecting one's emotional stability. Additionally, inadequate nutrient absorption from an imbalanced digestive system may lead to suboptimal health, weakening the body and causing fatigue. Overall, maintaining good digestive health is crucial not only for physical comfort but also for normal metabolism, immune function, cognitive abilities, sleep and skin health, ultimately enhancing the overall quality of life. Products designed by the sponsor contains a blend of ingredients recognized for their potential benefits in promoting digestive health (including prebiotics, probiotics, postbiotics, plant-based extracts and plant-based protein). Furthermore, it is well established in the literature that diet, exercise, hydration and mindfulness all impact our gut health and overall well-being. Therefore, this scientific study seeks to validate the efficacy of the combination of products and life-style changes by assessing its impact on gut health and related health aspects like weight, metabolic health, fitness level, energy/fatigue levels, satiety/hunger, food cravings, cognitive abilities and overall well-being. ### Conditions - Digestive Health ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - 30 day wellness program ### Outcomes Primary Outcomes - Bristol Stool Scale - Digestive symptom frequency questionnaire Secondary Outcomes - Waist Circumference - Improvements in sleep - Improvements in stress - Fitness Level - Satiety Responsiveness and Hunger - Craving Intensity - Cognitive Abilities - Fatigue - Skin Appearance - General Health - Program Feedback ### Location - Facility: Wilkins Research, Chattanooga, Tennessee, 37421, United States @@
## Exploration of the Value of PSMA PET/CT in Dynamic Monitoring of the Efficacy of Novel Endocrine Therapy in Patients With Metastatic Hormone Sensitive Prostate Cancer - NCT ID: NCT06387238 - Study ID: PSMA-mHSPC - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-06-30 - Lead Sponsor: Peking University First Hospital ### Study Description 1. Based on the treatment response and prognosis of mHSPC patients with novel endocrine therapy, a PSMA PET whole-body tumor burden classification was constructed to guide treatment and evaluate prognosis.2. Based on the treatment response and prognosis of mHSPC patients with novel endocrine therapy, a multivariable model will be constructed using quantitative parameters of PSMA PET/CT imaging, pre-treatment gene status, PSA, GS/ISUP and other clinical pathological parameters to further achieve accurate patient classification, guide treatment, and evaluate prognosis. ### Conditions - Prostate Adenocarcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - PSMA PET/CT ### Outcomes Primary Outcomes - rPFS Secondary Outcomes - PSA-PFS - OS ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Early and Objective Assessment of Neurological Prognosis in Cardiac Arrest Patients - NCT ID: NCT06387225 - Study ID: RC23_0248 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-01 - Completion Date: 2026-12-01 - Lead Sponsor: Nantes University Hospital ### Study Description Cerebral lesions are responsible for two thirds of deaths in patients admitted to intensive care following cardiac arrest. Patients with neurological lesions should be the priority target for neuroprotective interventions, which are the cornerstone of post-cardiac arrest care (allowing a reduction in the burden of care for patients without this type of lesion). Furthermore, these interventions must be based on a precise assessment of the severity of these brain lesions: carrying out neuro-protective interventions in patients without brain lesions exposes these patients to unnecessary treatment potentially associated with adverse effects without any possible benefit. However, the early assessment of neurological prognosis, particularly on admission to intensive care, is an area where there is little research and where it is not possible to obtain a precise and reproducible assessment. Several tools can be used to assess this prognosis at an early stage: anamnesis and characteristics of the cardiac arrest and the patient's comorbidities, imaging, electrophysiology and biomarkers.To assess the predictive value of early biomarker testing in patients resuscitated after cardiac arrest, whatever the cause, the investigators plan to conduct a prospective observational multicentre trial.It is important to bear in mind that the aim of this study is not to assess the long-term prognosis of patients suffering cardiac arrest in order to take measures to limit or discontinue active therapies, but simply to provide a reliable tool, simple and quick to use, in order to be able to identify a sub-population of patients who should be the subject of preferential neuro-protection measures, and conversely to simplify management (moderate temperature control, early cessation of sedation, early extubation) for patients with no neurological lesions. ### Conditions - Cardiac Arrest - Neurologic Symptoms - Intensive Care Neurological Disorder ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Dosage of biomarker UCHL-1 (Ubiquitin carboxy-terminal hydrolase L1) at the time of admission to intensive care - Dosage of biomarker GFAP (Glial fibrillary acidic protein) at the time of admission to intensive care - Neurological outcome at D90 assessed by modified Rankin scale (mRS) Secondary Outcomes - Dosage of biomarkers UCHL-1 ((Ubiquitin carboxy-terminal hydrolase L1) and GFAP (Glial fibrillary acidic protein) at the time of admission to intensive care - Dosage of biomarkers UCHL-1 ((Ubiquitin carboxy-terminal hydrolase L1) and GFAP( Glial fibrillary acidic protein) at 4 hours for recovery of effective cardiac activity (RACS) - Neurological outcome at D90 assessed by modified Rankin scale (mRS) ranging from 0 to 6 ### Location - Facility: CHD Vendée, La Roche-sur-Yon, N/A, 85025, France @@
## Clinical Efficacy and Safety of 35 kDa Hyaluronan Fragment (HA35) Injection in the Treatment of Skin Problems. - NCT ID: NCT06387212 - Study ID: HUI0001 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-05 - Lead Sponsor: Nakhia Impex LLC ### Study Description To explore the clinical effect and safety of 35 kDa hyaluronic acid fragment ( HA35 ) combined with negative pressure microneedle technology in improving skin problems. ### Conditions - Skin Inflammation - Cosmetic Skin ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - 35 kDa hyaluronan fragment HA35 injection ### Outcomes Primary Outcomes - A skin dryness scale - A fair or smooth skin scale - A skin pore size scale - A inflammatory skin thick hardness scale - An erythema color and area scale Secondary Outcomes - Self-satisfaction evaluation ### Location - Facility: Nahia Impex LLC, Ulaanbaatar, N/A, N/A, Mongolia @@
## Alleviating Carbohydrate Counting for Patients With Type-1 Diabetes Using a Closed Loop System With Weekly Subcutaneous Semaglutide - NCT ID: NCT06387199 - Study ID: 2024-10227 - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2026-07 - Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre ### Study Description A closed-loop insulin system, often labelled the "artificial pancreas" (AP), consists of an insulin pump, a continuous glucose monitor, and an interface coordinating between them to regulate insulin dosage based on glucose levels. Primarily designed for managing type 1 diabetes, this system has demonstrated significant benefits in previous studies. Yet, despite these advantages, certain challenges persist.Semaglutide, utilized in treating type 2 diabetes and obesity, is a once-weekly injectable medication that elevates levels of a gastrointestinal hormone known as Glucagon-Like Peptide-1 (GLP-1). This hormone alters gastric emptying, inhibits glucagon release, and reduces appetite. While not officially sanctioned for type 1 diabetes treatment in North America, studies have explored its efficacy as an adjunctive therapy alongside insulin, yielding favorable outcomes in blood glucose regulation. Comparable drugs like liraglutide and exenatide have been employed in type 1 diabetes treatment as well, albeit with less pronounced glucose-regulating effects compared to semaglutide, even in type 2 diabetes.The goal of this 50-week randomized placebo-controlled crossover 2x4 factorial designed trial is to assess whether commercial automated insulin delivery (AID) systems using rapid-acting insulin with adjunct weekly injections of semaglutide (at the maximally tolerated dose) can replace carbohydrate counting with simple meal announcements (SMA) without degrading glucose control. ### Conditions - Type 1 Diabetes - Diabetes Mellitus ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Semaglutide with 4 meal strategies - Placebo with 4 meal strategies ### Outcomes Primary Outcomes - Percentage of daytime plasma glucose levels spent in target range (semaglutide vs. placebo) Secondary Outcomes - Percentage of time spent in the range of glucose levels between 3.9 and 7.8 mmol/L - Percentage of time spent in glucose levels below 3.9 and 3.0 mmol/L - Percentage of time spent in glucose levels above 7.8, 10 and 13.9 mmol/L - Mean glucose level - Standard deviation of glucose levels as a measure of glucose variability - Percentage coefficient of variation of glucose levels - Proportions of participants with time in range between 3.9 - 10.0 mmol/L≥ 70% - Glycated hemoglobin (HbA1c) - Area under the curve 0-2h post meal, 0-3h post peal - Average scores between interventions on the Type 1 Diabetes Distress Scale questionnaire - Average scores between interventions on the Diabetes Treatment Satisfaction questionnaire - Average scores between interventions based on the Hypoglycemic Fear Survey - II - Heart rate - Blood pressure - Measure of body weight - Measure of body mass index - Measure of waist circumference and hip circumference - Measure of waist-to-hip ratio - Lipid profile, specifically: LDL-cholesterol, HDL-cholesterol, triglycerides - Urine albumin-creatinine ratio ### Location - Facility: Research Institute of the McGill University Health Centre, Montreal, Quebec, H4A 3J1, Canada @@
## Leucine Enriched Essential Amino Acid Powder as an Add-on to a Classic Ketogenic Diet in Refractory Epilepsy - NCT ID: NCT06387186 - Study ID: 2023P003233 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-03-31 - Lead Sponsor: Elizabeth Anne Thiele ### Study Description The main purpose of this study is to evaluate the safety and tolerability of a Leucine-Enriched Essential Amino Acid (LEAA) Powder as an add-on to a classic ketogenic diet (KD) in pediatric and adult patients with refractory epilepsy. ### Conditions - Refractory Epilepsy - Drug Resistant Epilepsy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Leucine-Enriched Essential Amino Acid powder ### Outcomes Primary Outcomes - Number of participants with treatment-related adverse events Secondary Outcomes - Number of participants with improved nutritional status as assessed by weight. - Number of participants with improved nutritional status as assessed by body mass index (BMI). - Number of participants with improved nutritional status as assessed by serum ketone and glucose level. ### Location - Facility: Massachusetts General Hospital, Boston, Massachusetts, 02114, United States @@
## Registry of Patients Undergoing Cryoablation for Early Stage Breast Cancer - NCT ID: NCT06387173 - Study ID: 23-001743 - Status: RECRUITING - Start Date: 2024-01-04 - Completion Date: 2099-01-03 - Lead Sponsor: Jonsson Comprehensive Cancer Center ### Study Description This study evaluates the side effects and outcomes of patients who undergo cryoablation for early stage breast cancer. ### Conditions - Early Stage Breast Carcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Non-Interventional Study ### Outcomes Primary Outcomes - Prospectively track patients who undergo cryoablation for breast cancer and record post-treatment related events. Secondary Outcomes ### Location - Facility: UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, 90095, United States @@
## To Determine the Predictors of Reversibility for Acute-on-Chronic Liver Failure at 6-months. - NCT ID: NCT06387160 - Study ID: ILBS-ACLF-18 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-20 - Completion Date: 2026-02-27 - Lead Sponsor: Institute of Liver and Biliary Sciences, India ### Study Description ACLF is defined differently in APASL,EASL and AASLD.APASL talks of reversibility in ACLF as per its definition and constitution of Homogenous population with ACLF.The definition of ACLF as per APASL is an acute hepatic insult manifesting as jaundice (serum bilirubin ≥ 5 mg/dL (85 micromol/L) and coagulopathy (INR ≥ 1.5 or prothrombin activity \<40%) complicated within 4 weeks by clinical ascites and/or encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease/cirrhosis, and is associated with a high 28-day mortality .From the point of view of intensivists, events in form of organ dysfunction , failure or mortality would cumulatively effect the outcome.Reversibility of ACLF syndrome is a feature of the ACLF defined by the AARC criteria, as nearly all the patients included are after the index presentation.With mitigation of the acute insult and over time, the hepatic reserve improves ,fibrosis regresses and the portal pressure decreases. Further, unlike patients with decompensated cirrhosis and similar to patients with ALF, the reversal of coagulopathy preceded the reversal of jaundice,that is ,median time to reversal of syndrome, i.e jaundice and coagulopathy was 7 (4-30)days versus 19 (7-60)days for jaundice, respectively. The median time for reversal of syndrome, i.e, jaundice and coagulopathy ,was 30 days. Baseline albumin, AARC score and Transient elastography predicted long term reversibility .The disease severity assessment is needed for prognostication and to guide the therapy. Furthermore,the available prediction scores have been validated at baseline,but none has been evaluated in a dynamic manner for prognostication in ACLF patients.A DYNAMIC Model that could predict the reversibility in ACLF is urgently required. ### Conditions - Acute-On-Chronic Liver Failure ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - as per institutional protocol ### Outcomes Primary Outcomes - To determine predictors of Reversibility[ Serum Bilirubin < 5mg/dl and PTINR <1.5] at 6 months in Patients of Acute on chronic liver failure as defined by Asian pacific association of study of liver disease[APASL] Secondary Outcomes - Change in Asian Pacific Association of Research consortium [AARC] Score from baseline to 90 days and 6 month follow up - Change in liver stiffness measurement [LSM] by Velocity controlled transient elastography[VCTE] at Baseline and 28 Days with values at 90 Days and 6 months. - Change in Spleen stiffness measurement [SSM] by Velocity controlled transient elastography[VCTE] at Baseline and 28 Days with values at 90 Days and 6 months - Change in Grade of fibrosis at Baseline [Day 0 to 28 Day of presentation] measured by Magnetic resonance elastography with 90 Days and 6months values - Proportion of Acute on Chronic Liver failure patients achieving reversibility [Sr Bilirubin <5mg/dl and INR <1.5] as per Asian pacific association of study of liver disease[APASL] at 90 Days. - Proportion of Acute on Chronic Liver failure patients achieving reversibility [Sr Bilirubin <5mg/dl and INR <1.5] as per Asian pacific association of study of liver disease[APASL] at 6months. - Proportion of Acute on Chronic Liver failure patients maintaining reversibility [Sr Bilirubin <5mg/dl and INR <1.5] as per Asian pacific association of study of liver disease[APASL] at 1year. - Proportion of Cirrhotic patients of Acute on Chronic Liver failure patients achieving re compensation at 1year. - Proportion of Cirrhotic patients of Acute on Chronic Liver failure patients achieving survival at 1year. ### Location - Facility: Institute of liver and Biliary Sciences, New Delhi, Delhi, 110070, India @@
## ORal Antibiotics In Acute Mesenteric Ischemia - NCT ID: NCT06387147 - Study ID: APHP220818 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-01 - Completion Date: 2027-10-01 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description Acute mesenteric ischemia (AMI) is a life-threatening condition with an increasing incidence (7-13/100000 PY). The mortality of AMI is associated with the development and extent of transmural intestinal necrosis (IN), ranging from 25% without IN to 75% with IN. Given its potential reversibility, preventing the progression of AMI towards IN is now considered a primary therapeutic goal. Early management of AMI can thus avoid fatal outcomes and prevent lifelong complications such as short bowel syndrome. Following the results of a pilot study showing an improvement in survival and lower resection rates, our team created a first-of-its-kind intestinal stroke center (SURVI unit, Beaujon Hospital, Clichy, France) that provides 24/7 standardized multimodal and multidisciplinary care to AMI patients referred from all hospitals in the Paris region. As no randomized clinical trial has ever been conducted, the treatment offered by SURVI is based on pathophysiological knowledge and observational clinical data. AMI naturally progresses to sepsis, surgical complications, and multi-organ failure, direct consequences of IN. Features of sepsis are reported in up to 90% of AMI patients compared with 3-22% of patients with brain or myocardial ischemia, supporting a specific septic component in AMI. Experimental studies demonstrated reduced translocation and mortality in germ-free animals or after administration of oral antibiotics targeting Gram-negative and anaerobic early bacterial overgrowth and translocation. In a prospective observational study, the investigators recently suggested a protective effect of systematic oral antibiotics in terms of intestinal preservation, yielding a reduced occurrence of IN (HR: 0.16, 95% confidence interval 0.03-0.62). However, the systematic use of oral antibiotics in AMI remains controversial due to the individual and collective risk of increasing the carriage of multi-drug resistant bacterias. ### Conditions - Acute Mesenteric Ischemia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Gentamicin - Placebo - Metronidazole ### Outcomes Primary Outcomes - The primary objective is to assess the efficacy of oral antibiotics compared to placebo on reducing the rate of intestinal necrosis or death (composite primary outcome) in AMI patients within 30 days following the randomisation. Secondary Outcomes - the rate of intestinal necrosis in the 30 days following the randomisation - the rate of short bowel syndrome (<200cm of remnant small bowel) at day-30 following the randomisation - the length of intestinal resection at day-30 following the randomisation - the occurrence of organ failures within the 30 days following the randomisation - the length of ICU stay - the length of hospital stay - expected minor side effects during the 14 days of treatment - hypersensitivity reactions during the 14 days of treatment - unexpected or serious adverse event throughout the duration of the study - the occurrence of healthcare-associated infection - the gentamicin during the 14 days of treatment - the metronidazole during the 14 days of treatment ### Location - Facility: Gastroentérologie-Hépatologie Beaujon, Clichy, N/A, 92110, France @@
## Lifei Xiaoji Wan Treatment's of Early-stage NSCLC and Its Impact on the Tumor Microenvironment - NCT ID: NCT06387134 - Study ID: TCM for early-stage LUAD - Status: RECRUITING - Start Date: 2022-12-01 - Completion Date: 2025-05-31 - Lead Sponsor: Henan University of Traditional Chinese Medicine ### Study Description This study evaluated the relationship between the clinical efficacy, histopathological changes and tumor microenvironment of the pharmacopharmacologic Lifei Xiaoji Wan in the treatment of early stage lung adenocarcinoma, and improved high-level clinical evidence and action targets for the prevention and treatment of early stage lung cancer by traditional Chinese medicine ### Conditions - Early Stage Lung Adenocarcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Lifei Xiaoji Wan - Conventional treatment with Western medicine ### Outcomes Primary Outcomes - Lung Cancer Quality of Life Scale (FACT-L) - TCM symptoms and syndromes - Evaluation of tumor efficacy using RECIST criteria to measure changes in tumor body Secondary Outcomes - Tumor markers：CEA - Tumor markers：CA211 - Tumor markers：squamous cell carcinoma antigen - Complete blood count: white blood cells - Complete blood count: haemoglobin - Complete blood count: Platelet - Liver function tests: ALT - Liver function tests: AST - Renal function tests: BUN - Renal function tests: Cr ### Location - Facility: Mingli Zhao, Zhengzhou, N/A, N/A, China @@
## Efficacy and Safety of Low-dose Chemotherapy Plus Immuno-targeted Drugs in Newly Diagnosed Elderly/Unfit Ph- B-ALL - NCT ID: NCT06387121 - Study ID: IIT2023060-EC-1 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2028-12-31 - Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China ### Study Description In the treatment of Ph-negative (Ph-) B-cell acute lymphoblastic leukemia (B-ALL), despite the achievements of chemotherapy and immunotherapy, the therapeutic outcomes are unsatisfactory in elderly or unfit patients. In recent years, tumor immunotherapy has demonstrated a high safety and efficacy profile in refractory Ph- B-ALL patients. These findings suggest that the advancement of immunotherapy application may be an important approach to improve patient survival. In this study, we propose a treatment approach that combines immuno-targeted drugs with low-dose chemotherapy for newly diagnosed elderly or unfit patients with Ph- B-ALL, aiming to enhance the measurable residual disease (MRD)-negative complete remission (CR) rate measured through flow cytometry following induction therapy, reduce the risk of relapse, and ultimately improve patients' overall survival. ### Conditions - Precursor Cell Lymphoblastic Leukemia-Lymphoma ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Vincristine - Cyclophosphamide - Dexamethasone - Venetoclax - Inotuzumab ozogamicin - Blinatumomab - 6-mercaptopurine - Methotrexate - Cytarabine - Prednisone ### Outcomes Primary Outcomes - MRD-negative complete remission rate measured by flow cytometry. Secondary Outcomes - Complete remission (CR) rate - Overall survival (OS) - Relapse free survival (RFS) - Disease-free Survival (DFS) - Mortality ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Evaluation of a Training Course for Educational Professionals - NCT ID: NCT06387108 - Study ID: 24-0045 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2025-01 - Lead Sponsor: Ludwig-Maximilians - University of Munich ### Study Description The aim of this study is to evaluate the efficacy of a two-hour online training course on depression and mental health in childhood and adolescence in educational professionals to improve depression and mental health literacy. It will further be investigated whether the course leads to changes in attitudes towards the illness (reduction of stigma) and to an increased behavioural confidence and behavioral change in dealing with pupils with symptoms and illnesses. ### Conditions - Depression - Depression in Children - Depression in Adolescence ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - training course ### Outcomes Primary Outcomes - increase in Knowledge - decrease in depression stigma Secondary Outcomes - Change in helping behaviour towards pupil - Change in conficende in dealing with pupils with mental health issues ### Location - Facility: LMU University Hospital (recruitment is conducted online), Munich, N/A, N/A, Germany @@
## Efficacy of Parasternal Blocks in Cardiovascular Surgery Patients Undergoing Median Sternotomy - NCT ID: NCT06387095 - Study ID: 2024/01/756 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2025-08-01 - Lead Sponsor: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital ### Study Description Acute and chronic pain after cardiac surgery is a common problem that negatively affects quality of life. Postoperative pain after cardiac surgery is most intense in the first two days and decreases in the following period. However, postoperative pain with incomplete management in the acute period may become chronic. This may negatively affect the patient's quality of life. Although central blocks such as thoracic epidural and paravertebral blocks are considered the gold standard in analgesia control, the advantages of thoracic plan blocks, which are more superficial due to peroperative heparinisation; coagulation disorders; and procedural difficulties, are undeniable. Thoracic plane blocks, which can also be used in patients receiving anticoagulant and/or antiplatelet therapy, have recently been used for acute pain. The aim of this study was to evaluate the effect of thoracic plane blocks on extubation time, pain scores, intensive care unit (ICU) and hospital stays in patients undergoing median sternotomy. ### Conditions - Postoperative Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: SUPPORTIVE_CARE ### Interventions - 1. no block - 2. superficial parasternal block - 3. deep parasternal block ### Outcomes Primary Outcomes - postoperative chronic pain Secondary Outcomes - postoperative 24 hours acute pain - extubation time - icu time ### Location - Facility: Kosuyolu High Education and Training Hospital, Istanbul, Kartal, N/A, Turkey @@
## A Clinical Study of HMPL-506 in Patients With Hematological Malignancies - NCT ID: NCT06387082 - Study ID: 2023-506-00CH1 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-09 - Completion Date: 2027-12-08 - Lead Sponsor: Hutchmed ### Study Description This is a Phase 1, multicenter, open-label clinical study of HMPL-506 administered orally in the treatment of hematological malignancies. Only eligible patients who provide the signed informed consent form (ICF) can be enrolled in this study. The study consists of two phases, i.e., a dose escalation phase and a dose expansion phase. The study is expected to enroll approximately 60 to 98 patients, including approximately 30 to 38 patients in the dose escalation phase and approximately 30 to 60 patients in the dose expansion phase. ### Conditions - Hematological Malignancies ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - HMPL-506 ### Outcomes Primary Outcomes - Safety evaluation: Safety Incidence of Dose-limiting Toxicity (DLTs) - Safety evaluation: Incidence of serious adverse events (SAEs) and Relationship to Study Drug - Efficacy evaluation: Anti-tumor efficacy evaluation. Secondary Outcomes - Incidence of adverse events (AEs) and Relationship to Study Drug - Adverse Events Associated with Dose Modifications - Evaluate electrocardiogram (ECG) assessments. - Complete response rate (CR rate) - Complete response (CR)+ Complete response with partial recovery of hematology (CRh) rate - Composite complete response (CRc) rate - Objective response rate (ORR) - Time to Complete response (CR)+Complete response with partial recovery of hematology (CRh) - Time to Complete response (CR)+Complete response with partial recovery of hematology (CRh) +incomplete hematological recovery (CRi) - Time to disease response (TTR) - Duration of Complete response (CR)+Complete response with partial recovery of hematology (CRh) - Duration of response (DOR) - Event-free survival (EFS) - Relapse-free survival (RFS) - Overall survival (OS) - Pharmacokinetic analysis-Maximum concentration (Cmax) - Pharmacokinetic analysis: Peak time (Tmax) - Pharmacokinetic analysis: Clearance half-life (T1/2) - Pharmacokinetic analysis: area under the plasma concentration-time curve (AUC0-t) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study to Evaluate HMPL-306 in Patients With IDH1- and IDH2-mutated Acute Myeloid Leukemia - NCT ID: NCT06387069 - Study ID: 2023-306-00CH1 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2028-06-29 - Lead Sponsor: Hutchmed ### Study Description An open-label design is adopted in this study. All patients will first undergo pre-screening to determine the mutation status of IDH, and all patients will be assigned to the registry study of the corresponding cohorts of IDH1 and IDH2 based on the pre-screening results. Patients with both IDH1 and IDH2 mutations will be enrolled in the IDH2 cohort. This study is divided into two cohorts. Cohort 1 includes R/R AML patients with IDH1-R132 mutations; Cohort 2 includes R/R AML patients with IDH2-R140 and R172 mutations. The two cohorts are designed independently and will be analyzed separately for statistical hypothesis testing. Patients in both cohorts will be randomized in a 1:1 ratio according to the central Interactive Web Response System (IWRS) into the test or control group, patients in the test group will receive HMPL-306 monotherapy at a dose of 250 mg once daily (QD) (Cycle 1, C1) + 150 mg QD \[starting from Cycle 2 (C2)\]. Patients in the control group will receive salvage chemotherapy (one of four options) consisting of two intensive chemotherapy regimens (MEC regimen and FLAG ± Ida regimen) and two non-intensive chemotherapy regimens (azacitidine and LoDAC) ### Conditions - Acute Myeloid Leukemia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - HMPL-306 Regimen - Salvage Chemotherapy Regimen ### Outcomes Primary Outcomes - OS Secondary Outcomes - CR rate - CR + CRh rate - CR + CRi + CRh rate - Assessments for PK (pharmacokinetics) - Assessments for PK (pharmacokinetics) - Duration of response (DOR) - Transfusion-dependence conversion ratio - HSCT(hematopoietic stem cell transplantation) ratio - Safety - Quality of life (QoL) - Time to response (TTR) - EFS ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Genomic Biomarker-guided Neoadjuvant Therapy for Prostate Cancer (SEGNO) - NCT ID: NCT06387056 - Study ID: XMYY-2024KY040 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2029-04-01 - Lead Sponsor: The First Affiliated Hospital of Xiamen University ### Study Description To evaluated the safety and efficacy of genomic biomarker-guided neoadjuvant therapy for locally advanced and oligometastatic prostate cancer. ### Conditions - Locally Advanced Prostate Cancer - Oligometastatic Prostate Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Rezvilutamide - Goserelin Microspheres for Injection - Docetaxel - Pamiparib - Cisplatin - Tislelizumab ### Outcomes Primary Outcomes - Rate of clinical complete response (cCR) - Rate of pathological minimal residual disease (pMRD) - Rate of complete pathologic response (pCR) Secondary Outcomes - Progression-free survival - Overall survival ### Location - Facility: The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, 361000, China @@
## Effects of Balance Exercises Performed With Different Visual Stimuli - NCT ID: NCT06387043 - Study ID: MS and Balance - Status: NOT_YET_RECRUITING - Start Date: 2024-12-01 - Completion Date: 2026-12-01 - Lead Sponsor: Halic University ### Study Description The study aims to examine the effects of balance exercises applied with different visual stimuli on individuals with MS. ### Conditions - Multiple Sclerosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Balance exercises with Virtual Reality Glasses - Balance Exercises with Stroboscopic Glasses - Balance Exercises with Visual-Based Metaphor Training - Traditional Balance Exercises ### Outcomes Primary Outcomes - Functional Near Infrared Ray Spectroscopy (fNIRS) - Timed Up and Go Test - Functional Reach Test - Berg Balance Scale - Timed 25 Step Walking Test Secondary Outcomes - Lower Extremity Motor Coordination Test - Fatigue Severity Scale - Quality of Life in Multiple Sclerosis Patients ### Location - Facility: Haliç University, Istanbul, Eyüpsultan, N/A, Turkey @@
## EDN and Eosinophilic Esophagitis - NCT ID: NCT06387030 - Study ID: APHP231662 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-04 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description Eosinophilic esophagitis is a recent and emerging chronic disease, secondary to eosinophilic infiltration of the esophageal mucosa leading to esophageal dysfunction. The diagnosis of this pathology, and monitoring of the efficacy of therapies, relies on the assessment of eosinophilic density on esophageal biopsies: follow-up requires numerous digestive endoscopies under general anesthesia, at each therapeutic change, to assess remission. The search for non-invasive biomarkers of active eosinophilic esophagitis is therefore a subject of major interest.The first step is to study EDN (Eosinophil-Derived Neurotoxin), a protein secreted when eosinophils are activated. Several studies have investigated the association between serum EDN, EDN on esophageal brushing or esophageal biopsies with eosinophilic esophagitis activity, and the results look promising. Urinary EDN is associated with atopy but has not been studied in eosinophilic esophagitis. EDN is a biomarker of interest because it is stable over time and, above all, can be measured routinely, making it applicable to routine patient management and care. Our main objective is to evaluate the correlation of EDN in urine, blood and esophageal brushings with the eosinophilic infiltrate counted on esophageal biopsies in patients undergoing upper GI endoscopy at Trousseau Hospital for suspected eosinophilic esophagitis, or as part of the re-evaluation of known eosinophilic esophagitis under treatment.Finally, esophageal and salivary dysbiosis has been described in eosinophilic esophagitis without direct evidence of its influence on esophageal inflammation and disease. Our secondary objective is to study the esophageal, salivary and fecal microbiota in these same patients in order to describe the composition, alpha and beta-diversity of bacterial and mycological flora between patients and controls, as well as their association with pathology, and to propose possible alternative therapies aimed at modulating the esophageal and/or salivary microbiota in the management of eosinophilic esophagitis.This study will be carried out on a cohort of pediatric patients followed up in the pediatric nutrition and gastroenterology department of the Trousseau-APHP hospital and hospitalized for upper GI endoscopy, either as part of a suspected case of eosinophilic esophagitis, or during follow-up of a previously known case of eosinophilic esophagitis. Blood, urine, stool, saliva, 4 additional esophageal biopsies and esophageal brushings were collected on the day of the digestive endoscopy. Depending on the eosinophilic densitý on the biopsies, subjects will be classified into either the "patient with active eosinophilic esophagitis" group, the "patient with eosinophilic esophagitis in remission" group, or the "control without eosinophilic esophagitis" group. The investigator aim to include 60 patients undergoing upper GI endoscopy, at least half of whoḿ will have active or remitting eosinophilic esophagitis.Furthermore, the study of the immunological, allergological and metabolomic signature of this disease is essential to enable the identification of new biomarkers to guide the creation of models combining several biomarkers predictive of eosinophilic density on esophageal biopsies. In a second step, the concentration of a panel of cytokines in blood and esophageal biopsies, the allergic sensitization profile in blood and esophageal biopsies, and an untargeted description of esophageal metabolomics will be compared between groups. In terms of clinical prospects, the investigator plan to develop a patient follow-up strategy based on the biomarkers studied, which is better adapted to clinical practice, better tolerated by patients and less costly than repeated endoscopies with esophageal biopsies. ### Conditions - Eosinophilic Esophagitis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Blood sampling - Esophageal biopsies - Unstimulated saliva sampling - Urine sampling - Stool sampling ### Outcomes Primary Outcomes - Urinary EDN Secondary Outcomes - Serum EDN - Endoluminal EDN - Eosinophilic infiltrate of esophagus - Blood eosinophilia - Concentrations of a panel of serum cytokines - Concentrations of a panel of cytokines on esophageal biopsies - Esophagus metabolomic profile - Total IgE and tryptase - Food or respiratory allergens sensitivity - Serum specific-IgE - Specific-IgE on esophageal biopsies - Composition of esophageal, salivary and fecal microbiota - Quality of life scale - Symptom score ### Location - Facility: Nutrition et gastro-entérologie pédiatrique-Trousseau Hospital, Paris, N/A, 75012, France @@
## Prospective Multicenter Cohort Study to Validate Four Groups of Biomarkers for Assessing Lung Cancer Risk Among Patients With Atheromatous Cardiovascular Disease in a Screening Pathway - NCT ID: NCT06387017 - Study ID: RCAPHM22_0411 - Status: RECRUITING - Start Date: 2024-04-02 - Completion Date: 2029-07 - Lead Sponsor: Assistance Publique Hopitaux De Marseille ### Study Description Interventional study with minimal risks and constraints, with evaluation of the incidence of lung cancers by low-dose thoracic CT scan without injection of contrast medium, of the immunological, inflammatory and metabolic blood profile and of the microbiota; systematic proposal of smoking cessation for active smokers or assistance in maintaining cessation. ### Conditions - Smoking-related Pathology - Atheroma - Non-progressive Cancer > 5 Years - Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - blood sampling - stool collection - low dose CT scan ### Outcomes Primary Outcomes - biomarker group validation Secondary Outcomes - Describe changes in biomarkers over time - Describe and compare biomarkers according to clinical characteristics of participants - Describe changes in quality of life over time - Describe changes in smoking habits over time - Describe changes in anxiety over time - Describe and compare biomarkers according to medical characteristics of participants - Describe and compare biomarkers according to geographic characteristics of participants - Describe and compare biomarkers according to socioeconomic characteristics of participants ### Location - Facility: Assistance Publique Hopitaux de Marseille, Marseille, N/A, N/A, France @@
## Radiation-Related Dysphagia Development Prediction Using a Two-Step Ultrasonographic Model (R-2D-2) - NCT ID: NCT06387004 - Study ID: 2023-A01971-44 - Status: RECRUITING - Start Date: 2024-01-18 - Completion Date: 2026-02-18 - Lead Sponsor: Hopital Forcilles ### Study Description Radiotherapy for head and neck cancers (H\&NC) heightens the risk of swallowing disorders (SD), impacting nutrition, quality of life, and overall health, leading to increased hospitalization and mortality. Dietary plans hinge on patients' nutritional status, swallowing ability, and prognosis. Early interventions are crucial, emphasizing the need for precise assessments guiding prognosis, specifying structures for intervention, and facilitating targeted rehabilitation.Clinical examinations lack precision, while existing complementary methods like videofluoroscopy or Fiberoptic Endoscopic Evaluation of Swallowing are invasive, irradiating, resource-intensive, and challenging to access, with uncertain prognostic values.Ultrasound imaging emerges as a non-invasive alternative, offering morphological and dynamic evaluation of swallowing-related structures. It enables qualitative and quantitative analyses, improving precision in targeting structures for rehabilitation. Researchers propose an ultrasound predictive model to anticipate SD risk during H\&NC radiotherapy, assessing its reliability and accuracy.Over eighteen months, 124 outpatients beginning H\&NC radiotherapy at Forcilles's Hospital will undergo weekly clinical and water-swallow tests by a speech language therapist, with videofluoroscopy when SD is suspected. Ultrasound evaluations pre-treatment and at seven and fourteen days will be conducted by blinded ultrasonographers. Cox models will test ultrasound measurement thresholds for SD prediction, estimating sensitivity, specificity, and prediction values. A global ultrasound predictive model will be developed via logistic multivariable regression.The study aims to establish an association between ultrasound markers and SD, improving early detection for tailored management. This non-invasive alternative to videofluoroscopy offers potential for enhancing patient outcomes in H\&NC radiotherapy. ### Conditions - Swallowing Disorders ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - The primary endpoint is the predictive ability of morphology and/or movement of the tongue, hyoid bone and suprahyoid muscles measured by ultrasound on the occurrence of TDs during radiotherapy. Secondary Outcomes - Inter and intra-rater evaluation ### Location - Facility: Hôpital Forcilles, Férolles-Attilly, N/A, 77150, France @@
## Effect of Different Irrigation Solutions on Postoperative Pain and Lesion Healing - NCT ID: NCT06386991 - Study ID: 2024/206 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2026-01-01 - Lead Sponsor: TC Erciyes University ### Study Description In this study researchers plan to conduct, three different irrigation solutions that are responsible for the release of growth factors necessary for the success of regenerative endodontic treatments will be used. These solutions; Ethylene Diamine Tetra Acetic Acid (EDTA), Etidronic Acid and Citric Acid. The aim of this study is to evaluate the effect of different irrigation solutions used in regenerative endodontic treatment of necrotic open apex molar teeth on postoperative pain. Additionally, the healing of these teeth will be monitored for 1 year. ### Conditions - Endodontic Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Using ethylenediaminetetraacetic acid (EDTA), citric acid ((MONO/ANH) and etidronic acid (HEBP) to clean root canals during regenerative endodontic treatments ### Outcomes Primary Outcomes - Determining and recording pain levels on the pain scale between treatment sessions Secondary Outcomes - In the follow-up sessions after the treatment, the size of the lesion in the bone (mm2) is measured by radiography. ### Location - Facility: Erciyes Üniversitesi Diş Hekimliği Fakültesi, Kayseri, N/A, 38039, Turkey @@
## Analgesic Efficacy of Transvers Abdominis Plane Block and Transversalis Fascia Plane Block in Cesarean Section - NCT ID: NCT06386978 - Study ID: 2024/209 - Status: RECRUITING - Start Date: 2024-05-30 - Completion Date: 2026-05-30 - Lead Sponsor: TC Erciyes University ### Study Description This study was designed as a prospective, randomized observational clinical trial.A total of 90 adult women were included in the study performed elective cesarean section.After excluding patients, the care of 90 was included and 3 of these amounts were reserved.TAP Block Group (n=30,Group 1): Spinal Anesthesia + TAP block ; TFP Block group (n=30,Group 2): Spinal Anesthesia + TFP block ; Control group (n=30,Group 3); Spinal Anesthesia + No block; ### Conditions - Obstetric ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Transverse Facia Plane Block (TAP Block) - Transversalis Facia Plane Block (TFP Block) - Control ### Outcomes Primary Outcomes - VAS score evaluation Secondary Outcomes - time until the first analgesic request ### Location - Facility: Erciyes University, Kayseri, N/A, 38039, Turkey @@
## Sevoflurane Versus Propofol: Effect on Stress Response - NCT ID: NCT06386965 - Study ID: 010.99/15 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-05 - Completion Date: 2024-06-05 - Lead Sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital ### Study Description Stress is defined as hormonal and metabolic changes in the biological system that follow any injury. The stress response occurs as a general systemic response to injury and includes a wide range of endocrinological, immunological and hematological effects. The level of stress in the surgical process can affect not only the patients outcome but also the overall health system.The two main agents used in maintenance for general anesthesia are inhalation and intravenous anesthetics. Both inhalation anesthesia and TIVA (Total Intravenous Anesthesia) approaches provide general anesthesia suitable for surgical operations. However, the mechanisms of action of these two methods differ and are not fully understood.The aim of investigators' for this study was to investigate the effect of different anesthetic agents on stress inflammatory response in the preoperative, peroperative and postoperative periods. ### Conditions - Propofol - Sevoflurane - Inflammatory Response ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - taking blood sample ### Outcomes Primary Outcomes - compare inflammatory markers with sevolurane and propofol : glucose, WBC, procalcitonin, CRP, erytrocyte sedimentation rate, ferritin, pre albumin, albumin,tranferrin Secondary Outcomes ### Location - Facility: University of Health Science, Kartal Dr Lutfi Kırdar Training and Researh Hospital, İstanbul, N/A, N/A, Turkey @@
## To Compare People With T2DM Who Have Double Hump Versus Who do Not Have Double Hump - NCT ID: NCT06386952 - Study ID: 02/2024-2025 - Status: RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-06-30 - Lead Sponsor: Diabetes Foundation, India ### Study Description Hypothesis: Double Hump in people with T2D is associated with higher magnitude of complication than people with single hump or no humpObjectives: To correlate single and double hump with diabetes complication T2DM patient will be recruited from endocrine OPD1. Clinical History and Examination:1. General Physical Examination: Height, weight, waist circumference, hip circumference, BMI, Blood Pressure, Hand grip. Buffalo Hump.2. Complications Assessment: Patient will be analyzed for:Micro Vascular(a) Diabetic retinopathy (i) Mild NPDR (ii) Mod NPDR (iii) Macular Edema / CSME (b) Neuropathy (Mild/Mod/Severe) (c) Chronic Kidney Disease (i) Micro/Macro albumin urea (ii) Increased Creatinine (iii) Decreased eGFRMacro Vascular1. Low ABI/PAD2. CVD-MI/PTCA/CABG/Heart Failure3. CVS-Stroke/ TIA/Carotid Blockage \>50% ### Conditions - Type 2 Diabetes Mellitus With Complication ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Double Hump increases diabetes complications Secondary Outcomes ### Location - Facility: Anoop misra, New Delhi, Delhi, 110048, India @@
## Comparison of Micro- and Macrovascular Disease(s) in People With T2D, Who Have Moderate to Severe Acanthosis Nigricans vs. Those Who do Not Have Acanthosis Nigricans - NCT ID: NCT06386939 - Study ID: 01/2024-2025 - Status: RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-11-30 - Lead Sponsor: Diabetes Foundation, India ### Study Description Hypothesis: Moderate to severe acanthosis nigricans in people with T2D is associated with higher magnitude of complication than people who do not have acanthosis nigricans.Objectives: To correlate moderate to severe acanthosis nigricans with diabetes complicationMethodology:T2DM patient will be recruited from endocrine OPD1. Clinical History and Examination:1. General Physical Examination: Height, weight, waist circumference, hip circumference, BMI, Blood Pressure, Hand grip. Acanthosis Nigricans.2. Complications Assessment: Patient will be analysed for:Micro Vascular(a) Diabetic retinopathy (i) Mild NPDR (ii) Mod NPDR (iii) Macular Edema / CSME (b) Neuropathy (Mild/Mod/Severe) (c) Chronic Kidney Disease (i) Micro/Macro albumin urea (ii) Increased Creatinine (iii) Decreased eGFRMacro Vascular1. Low ABI/PAD2. CVD-MI/PTCA/CABG/Heart Failure3. CVS-Stroke/ TIA/Carotid Blockage \>50% ### Conditions - Type 2 Diabetes Mellitus With Complication ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Moderate to Severe Acanthosis Nigricans increases diabetes complications Secondary Outcomes ### Location - Facility: Anoop misra, New Delhi, Delhi, 110048, India @@
## Radial Shockwave Versus Ultrasound Phonophoresis - NCT ID: NCT06386926 - Study ID: P.T.REC/012/005075 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-09 - Lead Sponsor: Cairo University ### Study Description Comparative study to compare the effect of radial shockwave versus ultrasound phonophoresis in management of chronic supraspinatus tendinitis consists of 3 groups exp1(shockwave treatment + conventional physical therapy) , exp2( ultrasound phonophoresis+ conventional physical therapy) and control group ( conventional physical therapy) ### Conditions - Supraspinatus Tendinitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Electro Therapy ### Outcomes Primary Outcomes - change in the thickness of supraspinatus tendon - change in pain intesity - Change in shoulder range of motion Secondary Outcomes - Function of the Upper Limb - measure weight in kg and height in cm ### Location - Facility: Cairo university, Giza, N/A, N/A, Egypt @@
## Implementation and Evaluation of Measurement-Based Care (MBC) Training - NCT ID: NCT06386913 - Study ID: IRB-20-1065 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2021-02-09 - Completion Date: 2024-12-31 - Lead Sponsor: Carilion Clinic ### Study Description The purpose of this study is to get feedback on a new standardized Measurement-Based Care (MBC) provider training program. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Training ### Outcomes Primary Outcomes - Digital MBC training rate - Assessing feasibility of a novel digital MBC training in mental health providers (FIM) - Assessing acceptability of a novel digital MBC training program in mental health providers (AIM) - Assessing appropriateness of a novel digital MBC training program in mental health providers (IAM) Secondary Outcomes ### Location - Facility: Carilion Clinic, Roanoke, Virginia, 24014, United States @@
## The Impact of Grand Tour Cycling on Sleep and the Hematological and Metabolomic Profile in World-class Cyclists - NCT ID: NCT06386900 - Study ID: S67595 - Status: ENROLLING_BY_INVITATION - Start Date: 2023-07-01 - Completion Date: 2024-12-01 - Lead Sponsor: KU Leuven ### Study Description This project aims to identify the effect of a 3-week Grand Tour (e.g. Tour de France, Giro d'Italia, and Vuelta a España) on sleep, hematological parameters and the serum metabolome in world-class cyclists. ### Conditions - Overreaching ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Cyclist ### Outcomes Primary Outcomes - Serum metabolome abundance of cyclists participating in a Grand Tour - Sleep efficiency during the Grand Tour - Total sleep time during the Grand Tour - Blood haemoglobin concentration Secondary Outcomes - Wakefulness after sleep onset - Light sleep - Deep sleep - REM sleep - Red blood cell concentration - Subjective fatigue ### Location - Facility: KU Leuven, Leuven, Vlaams-Brabant, 3000, Belgium @@
## Fasting During Neoadjuvant Chemotherapy in Patient With Epithelial Ovarian Cancer - NCT ID: NCT06386887 - Study ID: CASE1824 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2026-01-01 - Lead Sponsor: Case Comprehensive Cancer Center ### Study Description The goal of this clinical trial is to see if timed fasting (periods of time that you don't eat) in participants who are receiving chemotherapy prior to surgery is achievable, safe and can improve quality of life, symptoms and outcomes (results) compared to participants who receive standard dietary recommendations in individuals being treated for epithelial ovarian cancer . The main questions it aims to answer are:* Is it feasible to use intermittent fasting during neoadjuvant chemotherapy?* Is it safe to use intermittent fasting during neoadjuvant chemotherapy?* Do participants find it acceptable to use intermittent fasting during neoadjuvant chemotherapy?Researchers will compare participants who receive standard dietary recommendations to see which method is more achievable, safe, and able to improve quality of life, symptoms and outcomes.Participants will:* Receive either the fasting intervention (schedule of times when you do not eat) or standard diet recommendations for 6-9 weeks prior to your surgery starting with the second cycle of chemotherapy.* All participants will be asked to complete chemotherapy and surgery, cancer imaging, baseline screening tests, nutritional assessments, food diaries, blood tests, and surveys about wellbeing.* Participants in the intervention group will be asked to follow a fasting schedule that consists of not eating for 16 hours a day followed by normal eating for the remaining 8 hours of the day for 5 days in a row followed by 2 days of regular eating each week. ### Conditions - Epithelial Ovarian Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Intermittent Fasting - Neoadjuvant chemotherapy ### Outcomes Primary Outcomes - Intermittent fasting compliance as measured by serum glucose laboratory testing - Intermittent fasting compliance as measured by ketone laboratory testing - Intermittent fasting compliance as measured by IGF-1 laboratory testing - Intermittent fasting compliance as measured by insulin laboratory testing - Intermittent fasting compliance as measured by serum glucose laboratory testing - Intermittent fasting compliance as measured by ketone laboratory testing - Intermittent fasting compliance as measured by IGF-1 laboratory testing - Intermittent fasting compliance as measured by insulin laboratory testing - Intermittent fasting compliance as measured by serum glucose laboratory testing - Intermittent fasting compliance as measured by ketone laboratory testing - Intermittent fasting compliance as measured by IGF-1 laboratory testing - Intermittent fasting compliance as measured by insulin laboratory testing - Intermittent fasting compliance as measured by self-reported assessment - Intermittent fasting compliance as measured by self-reported assessment - Intermittent fasting compliance as measured by food diary - Intermittent fasting compliance as measured by food diary - Intermittent fasting compliance as measured by food diary - Pre body composition - Post body composition Secondary Outcomes - Chemotherapy related toxicity at Cycle 2 - Chemotherapy related toxicity at Cycle 3 - Chemotherapy related toxicity at Cycle 4 - Chemotherapy related toxicity at post treatment - ESAS Score at Enrollment - ESAS Score at Cycle 2 - ESAS Score at Cycle 3 - ESAS Score at Post Treatment - SF-125 Score at Baseline - SF-125 Score at Cycle 2 - SF-125 Score at Cycle 3 - SF-125 Score at Post Treatment - Pre Quality of Life (QLQ-C30) Score at Baseline - Post Quality of Life (QLQ-C30) Score Post Treatment - Pre Functional Assessment (FACT-O) Score at Baseline - Post Functional Assessment (FACT-O) Score Post Treatment - AIM Survey Score at Cycle 2 - AIM Survey Score at Cycle 3 - AIM Survey Score at Post Treatment ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## [Trial of device that is not approved or cleared by the U.S. FDA] - NCT ID: NCT06386874 - Study ID: BQ7 - 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 @@
## Validating the Spanish "Attitudes Toward Genomics and Precision Medicine" (AGPM). - NCT ID: NCT06386861 - Study ID: 24.210.01e - Status: RECRUITING - Start Date: 2024-04-14 - Completion Date: 2024-12-31 - Lead Sponsor: Boston College ### Study Description the investigators aim to evaluate English and Spanish versions of the "Attitudes toward genomics and precision medicine" instrument (AGPM). This study will help validating a Spanish version of the AGPM among people identifying as Hispanic, Latino/a, or Latinx. Having a valid instrument is important for developing tailored interventions to decrease disparities in genomic healthcare for this population. ### Conditions - Adult ALL ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Attitudes Toward Genomics and Precision Medicine (English) - Attitudes Toward Genomics and Precision Medicine (Spanish) ### Outcomes Primary Outcomes - Psychometric properties Secondary Outcomes - Health literacy/numeracy ### Location - Facility: Boston College, Chestnut Hill, Massachusetts, 02467, United States @@
## Strategy to Adapt Botulinum Toxin Doses in Dystonia - NCT ID: NCT06386848 - Study ID: 2023PI187 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-06-01 - Lead Sponsor: Central Hospital, Nancy, France ### Study Description The study is designed to observ and collect the doses of botulinum toxin injected in dystonia in different centres to compare the initial dose and the dose recommended.We we ll study the increase of the dose injected over the time, the side effects...The hypothesis is that we inject smaller doses than we could regarding the recommandations ### Conditions - Dystonia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Botulinum toxin ### Outcomes Primary Outcomes - First dose of botulinum toxin injected, U Secondary Outcomes - Effective dose of botulinum toxin - Side effects ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Collagen Paste vs Mucosal Advancement Flap for FIA - NCT ID: NCT06386835 - Study ID: CREC2021.724-T - Status: RECRUITING - Start Date: 2024-01-26 - Completion Date: 2027-03-31 - Lead Sponsor: Chinese University of Hong Kong ### Study Description The treatment for fistula-in-ano (FIA) remains a challenge to General and Colorectal Surgeons Worldwide. A variety of surgical treatments have been described for high anal fistulas, but none offers the panacea of fistula eradication with guaranteed preservation of continence. This study compares Collagen paste injection to mucosal advancement flap for the treatment of fistula-in-ano. ### Conditions - Fistula-in-ano ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Collagen Paste - Mucosal advancement ### Outcomes Primary Outcomes - Clinical healing of Fistula-in-ano Secondary Outcomes - 30-day morbidity - Quality of life score - Postoperative pain score - Faecal incontinence rate - Hospital readmission rate ### Location - Facility: Department of Surgery, Chinese University of Hong Kong, Shatin, New Territories, N/A, Hong Kong @@
## The Development of a System for the Measurement of Tremor - NCT ID: NCT06386822 - Study ID: 23-1562H - Status: RECRUITING - Start Date: 2023-08-01 - Completion Date: 2024-12 - Lead Sponsor: The Bionics Institute of Australia ### Study Description The goal of this clinical trial is to develop a system which can be used to measure movements in people with Essential Tremor (with or without dystonia). The main questions it aims to answer are:* Can individuals with Essential Tremor be distingushed from individuals without tremor using Virtual Reality (VR)* Can the current Essential Tremor Assessment Scale (the TETRAS) be reproduced in VR* Can Essential Tremor be quantified using a measurement system* Can Dystonia be quantified using a measurement system.Participants will don the equipment used to measure their tremor and replicate a series of standardised movements to measure their tremor, in and out of the VR platform. The assessment will take no longer than an hour. ### Conditions - Tremor ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - HTC Vive Pro Eye - HTC Vive Tracker - Valve Index Controllers - Biokin ### Outcomes Primary Outcomes - To quantify Essential Tremor and dystonia using a measurement system Secondary Outcomes ### Location - Facility: The Royal Victorian Eye and Ear Hospital, East Melbourne, Victoria, 3002, Australia @@
## Effectiveness of Transcutaneous Auricular Vagus Nerve Stimulation in Bruxism - NCT ID: NCT06386809 - Study ID: 2024 -25 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-11-01 - Lead Sponsor: Bandırma Onyedi Eylül University ### Study Description Our study aimed to investigate the effects of transcutaneous auricular vagus nerve stimulation (TAVNS) application on treatment efficacy in bruxism in terms of masseter muscle activity, pain, stress level, sleep and life quality, and autonomic functions. ### Conditions - Bruxism ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - TAVNS - Exercise program ### Outcomes Primary Outcomes - Pain Severity - Oral Health Quality of Life - Stress Level - Sleep Quality - Pressure Pain Threshold - Muscle Activation Measurement - Measurement of heart rate variability/ Autonomic nervous system evaluation Secondary Outcomes ### Location - Facility: Bandırma Onyedi Eylül University, Balıkesir, N/A, N/A, Turkey @@
## Renal Resistive Index as a Predictor of Acute Renal Impairment in High-risk Patients - NCT ID: NCT06386796 - Study ID: Asw.U./867/11/23 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-04-01 - Lead Sponsor: Aswan University ### Study Description To study the ability of RRI, measured by bedside Doppler ultrasound, in detecting acute kidney injury in high-risk patients admitted to surgical intensive care unit, Aswan university hospital, compared with renal biomarkers and conventional assessment using urine output and serum creatinine levels. ### Conditions - Acute Kidney Injury - Critical Illness ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Early detection of acute kidney injury. - Diagnosis of acute kidney injury. Secondary Outcomes - To grade the severity of AKI. - To predict clinical outcome (clinical improvement) - To predict clinical outcome (necessity for renal replacement therapy) - To predict clinical outcome (death) ### Location - Facility: Aswan University, Aswan, N/A, 81528, Egypt @@
## Fentanyl Versus Dexmedetomidine as an Adjuvant to Bupivacaine in Spinal Anesthesia ; Peritoneal Symptomatic Effects - NCT ID: NCT06386783 - Study ID: Asw.U./823 /7/23 - Status: RECRUITING - Start Date: 2023-07-01 - Completion Date: 2025-07-01 - Lead Sponsor: Aswan University ### Study Description To compare whether 5 μg dexmedetomidine with 25 μg fentanyl added to 0.5% hyperbaric bupivacaine as adjuvants in spinal anaesthesia in patients undergoing appendectomy could reduce intraoperative peritoneal related symptoms. ### Conditions - Dexmedetomidine - Fentanyl ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Dexmedetomidine Injection [Precedex] - Fentanyl HCl ### Outcomes Primary Outcomes - intraoperative peritoneal symptoms during appendectomy. Secondary Outcomes - Assessment of motor block with Modified Bromage scale - Degree of post-operative analgesia - Assessment of sensory block by using pin prick method ### Location - Facility: Aswan University, Aswan, N/A, 81528, Egypt @@
## Systemic Versus Local Dexmedetomidine as An Adjuvant to Bupivacaine in Ultrasound Guided Erector Spinae Block - NCT ID: NCT06386770 - Study ID: Asw.U./742 /2/23 - Status: RECRUITING - Start Date: 2023-02-01 - Completion Date: 2025-12-31 - Lead Sponsor: Aswan University ### Study Description The aim of this study is to investigate the analgesic effect of local versus systemic dexamedetomedine as adjuvant to bupivacaine in erector spinae block in kidney exploration surgeries. ### Conditions - Erector Spinae Block - Dexmedetomidine ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Dexmedetomidine Injection [Precedex] - Bupivacaine Hydrochloride - Dexmedetomidine in 0.9 % NaCl 200 Mcg/50 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML) ### Outcomes Primary Outcomes - The duration of analgesia, this was defined as the time in minutes to the first request for postoperative analgesics. Secondary Outcomes - 2. Total postoperative opioid consumption (Nalbuphine consumption (mg) within the 48-hour period . - Ramsay Sedation Scale (RSS) (1: anxious; 2: cooperative and tranquil; 3: responding to command; 4: brisk response to stimuli; 5: sluggish response to stimuli; and 6: no response to stimuli) will be all assessed - Intraoperative hemodynamic parameters blood pressure - Minimum alveolar concentration (MAC) requirements ### Location - Facility: Aswan University, Aswan, N/A, 81511, Egypt @@
## Incidence Of Nasal and Oropharyngeal Bleeding: Video Laryngoscopy Versus Direct Laryngoscopy - NCT ID: NCT06386757 - Study ID: Asw.U. 911/3/24 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-12-31 - Lead Sponsor: Aswan University ### Study Description The objective of this study is to compare the effectiveness and safety of video laryngoscopy versus direct laryngoscopy for nasal intubation in patients with maxillofacial fractures regarding less bleeding to oral and nasal structures, quicker intubation times, increased success rates for first intubation attempts, fewer uses of the Magill forceps and the less need for cervical spine extension ### Conditions - Maxillofacial Injuries - Nasal Bleeding - Intubation Complication ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Combined Video Laryngoscopy (VL) and Bougie - Combined Direct Laryngoscopy (DL) and Bougie ### Outcomes Primary Outcomes - Incidence of nasal and oropharyngeal bleeding Secondary Outcomes - Time of successful intubation, defined as the time from removal of mask ventilation and beginning of bougie insertion until inflation of tube cuff - Overall rate of first trial success. - The use of magill forceps ### Location - Facility: Aswan University, Aswan, N/A, 81528, Egypt @@
## Dusquetide for the Treatment of Behcet's Disease - NCT ID: NCT06386744 - Study ID: DUS-AUBD-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2025-03 - Lead Sponsor: Soligenix ### Study Description This is a clinical study to see if dusquetide can treat flares of oral and genital ulcers caused by Behcet's Disease. Study participants will receive an infusion of dusquetide twice a week for 4 weeks (8 treatments total), with weekly follow-up visits for an additional 4 weeks. ### Conditions - Behçet Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Dusquetide ### Outcomes Primary Outcomes - Number of Oral Ulcers - Number of Genital Ulcers Secondary Outcomes - Pain of Oral Ulcers - Pain of Genital Ulcers ### Location - Facility: Istanbul University - Cerrahpasa, Cerrahpasa School of Medicine, Istanbul, N/A, N/A, Turkey @@
## Continuous Versus Intermittent Phototherapy in Treatment of Neonatal Jaundice - NCT ID: NCT06386731 - Study ID: SYNEO-01 - Status: COMPLETED - Start Date: 2022-07-05 - Completion Date: 2023-04-28 - Lead Sponsor: Goztepe Prof Dr Suleyman Yalcın City Hospital ### Study Description One of the most common diseases in the neonatal period is indirect hyperbilirubinemia (IHB). After phototherapy was discovered accidentally in 1958, it has been used as the most effective treatment method for IHD for more than 60 years. Sources that provide phototherapy are developing rapidly technologically. However, there is no clearly defined usage table in the literature for applying phototherapy with faster effects and fewer side effects. In recent years, the use of intermittent phototherapy has been recommended with similar effectiveness. Phototherapy has significant side effects such as dehydration, diarrhea, chromosome breaks, retinal damage, skin rashes, hypocalcemia, thrombocytopenia. As phototherapy exposure decreases, its side effects decrease.In our study; We plan to find the most ideal method in the treatment of IHB by comparing intermittent PT with continuous phototherapy in terms of effectiveness. We aim to achieve the best bilirubin reduction and minimal side effects with less exposure to phototherapy. ### Conditions - Neonatal Jaundice - Phototherapy Complication ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Intermittent Phototherapy ### Outcomes Primary Outcomes - Comparison of the effectiveness of CPT and IPT Secondary Outcomes - Comparison of side effect frequency of CPT and IPT ### Location - Facility: Göztepe Prof. Dr. Suleyman Yalcin City Hopital, Kadıköy, İstanbul, 34730, Turkey @@
## Ultrasonographic Evaluation of Arteries of the Hand in Pediatric Patients - NCT ID: NCT06386718 - Study ID: USG for ped art can - Status: RECRUITING - Start Date: 2023-05-15 - Completion Date: 2025-05-01 - Lead Sponsor: Ankara University ### Study Description Ultrasound measurements of the ulnar artery and radial artery at different angles are obtained and compared to determine the optimal diameters for possible arterial cannulation in pediatric patients. ### Conditions - Ulnar and Radial Artery ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Determining the Diameter and Depth at different angles - Comparing Ulnar and Radial Artery Diameters Across Age Groups Secondary Outcomes ### Location - Facility: Ankara University School Of Medicine, Ankara, N/A, 06100, Turkey @@
## A Study of TSN084 in Patients With Advanced Malignant Tumors - NCT ID: NCT06386705 - Study ID: TSN084-101CH - Status: RECRUITING - Start Date: 2022-07-20 - Completion Date: 2026-03-30 - Lead Sponsor: Tyligand Bioscience (Shanghai) Limited ### Study Description TSN084 is a novel type II kinase inhibitor with demonstrated anti-tumor effects in vitro and in vivo and targets multiple tyrosine kinases, such as c-MET, FLT3, TRK and serine/threonine kinase CDK8/19. This phase 1a/1b study is conducted to assess the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of TSN084 in advanced or metastatic malignancies in China. ### Conditions - Malignant Neoplasm ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - TSN084 ### Outcomes Primary Outcomes - Dose limiting toxicity (DLT) - Incidence of Treatment-Emergent Adverse Events (TEAE) Secondary Outcomes - Maximum plasma concentration (Cmax) - Time to Cmax (Tmax) - Area under the concentration versus time curve from time 0 to the last measurable concentration (AUC 0-t) - Objective response rate (ORR) - Duration of response (DoR) - Disease control rate (DCR) - Time to response (TTR) - Progression free survival (PFS) - Overall survival (OS) ### Location - Facility: Cancer Hospital Chinese Academy of Medical Sciences, Beijing, Beijing, 100021, China @@
## Community Based Promotion of Physical Activity in Nepal (COBIN-PA) - NCT ID: NCT06386692 - Study ID: Aarhus111 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-12-30 - Lead Sponsor: University of Aarhus ### Study Description Globally, one in four adults does not meet the WHO-recommended level of physical activity. Insufficient physical activity is the fourth leading risk factor, contributing to 9% of global premature mortality. PA is effective in weight management, cardiorespiratory fitness, and increasing quality of life. However, there is lack of evidence on effectiveness on promoting physical activity in community level. The aim of the study is to test the effectiveness of Female Community Health Volunteers (FCHVs)-led community-based educational program on physical activity promotion in community level. This is an open label cluster-randomized controlled trial with 1:1 allocation where FCHVs will deliver a family-based education for the promotion of physical activity at community level in Nepal. The intervention package will be guided by Theory of planned behavior and will contain home-based interactive health education sessions focused on increasing PA in a household setting. FCHVs will use resource materials for health education. The mixed-effect linear regression model will determine the adjusted interaction between time and intervention. The results of this study will show the changes in the mean moderate to vigorous physical activity minutes per day due to time intervention interaction. The evidence generated from this study will help to provide new knowledge on the community-based promotion of Physical Activity and its effectiveness for policymakers and researchers. It will hopefully support the attainment of the national and global target of reducing insufficient physical activity. ### Conditions - Exercise ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - FCHVs-led community based educational physical activity intervention ### Outcomes Primary Outcomes - Mean moderate to vigorous physical activity Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Amniotic Fluid Mesenchymal Stem Cells Developed for Chondrogenic Treatment (AFCC) Injection in Elderly Knee Osteoarthritis Patients - NCT ID: NCT06386679 - Study ID: R016634005 - Status: ENROLLING_BY_INVITATION - Start Date: 2023-08-17 - Completion Date: 2025-03 - Lead Sponsor: Siriraj Hospital ### Study Description Amniotic fluid mesenchymal stem cells developed for chondrogenic treatment (AFCC) are used to treat elderly patients suffering from knee osteoarthritis (OA). The injection reduces inflammation and promotes the recovery of knee function, leading to an improved quality of life. ### Conditions - Knee Osteoarthritis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - allogenic amniotic fluid mesenchymal stem cell ### Outcomes Primary Outcomes - Incidence of abnormal physical examination - Incidence of abnormal vital sign - Incidence of abnormal laboratory test results - Incidence of abnormal ECG parameters - The type of Adverse event (AE), numbers of AE and proportion of patients with AE. Secondary Outcomes - Pain score - Knee Injury and Osteoarthritis Outcome Score (KOOS) - Degree of cartilage change ### Location - Facility: Siriraj Hospital, Bangkok Noi, Bangkok, 10700, Thailand @@
## A Clinical Trial to Evaluate the Safety and Efficacy of Single-use Fibrous Ring Sutures for the Suture of Fibrous Ring Incision After Nucleus Pulposus Removal - NCT ID: NCT06386666 - Study ID: RLRL-CTP - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-07-15 - Lead Sponsor: Suzhou Kerui Medical Technology Co., Ltd ### Study Description The objective of this clinical trial was to evaluate the safety and effectiveness of single-use annular sutures for the closure of annular incisions after nucleus pulposus removal. Participants used single-use annular sutures to close the annular fibers. The success rate of suture, reduction value of annulus, proportion of annulus reduction, intraoperative blood loss, suture time, VAS pain score (low back, bilateral lower extremities), Oswestry index (ODI index), and Short were evaluated The effectiveness evaluation results of Form-12 health survey (SF-12 score), treatment success rate, device defects, product operation satisfaction, and safety evaluation results of recurrence rate, adverse events, and serious adverse events were used to verify the safety and effectiveness of disposable fibrillar suture for annular incision suture after nucleus pulposus removal. ### Conditions - Intervertebral Disc Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Disposable fibrous ring sutures ### Outcomes Primary Outcomes - Success rate of suture Secondary Outcomes - Annulus fibril cleft decreased in value - Reduced proportion of annular fibril cleft - Intraoperative blood loss - Suture time - Treatment success rate - VAS pain score (lower back, bilateral lower limbs) - SF-12 rating - ODI index ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Molecular Imaging of EpCAM Receptors Using [123I]I-DARPIN-Ec1 - NCT ID: NCT06386653 - Study ID: [123I]I-DARPIN-Ec1 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-05-14 - Completion Date: 2024-12-31 - Lead Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences ### Study Description The study should evaluate the biological distribution of \[123I\]I-DARPIN-Ec1 in patients with lung and ovarian cancerThe primary objective are:1. To assess the distribution of \[123I\]I-DARPIN-Ec1 in normal tissues and tumors at different time intervals.2. To evaluate dosimetry of \[123I\]I-DARPIN-Ec1 .3. To study the safety and tolerability of the drug \[123I\]I-DARPIN-Ec1 after a single injection in a diagnostic dosage.The secondary objective are:1. To compare the obtained \[123I\]I-DARPIN-Ec1 SPECT imaging results with the data of CT and/or MRI and/or ultrasound examination and immunohistochemical (IHC) studies in lung and ovarian cancer patients. ### Conditions - Lung Cancer - Ovarian Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Diagnostic Test: whole body study and SPECT with [123I]I-DARPIN-Ec1 ### Outcomes Primary Outcomes - Gamma camera-based whole-body [123I]I-DARPIN-Ec1 uptake value (%) - SPECT-based [123I]I-DARPIN-Ec1 value in tumor lesions (counts) - SPECT-based [123I]I-DARPIN-Ec1 uptake value (counts) - Tumor-to-background ratio (SPECT) Secondary Outcomes - Percent of cases with abnormal findings in physical examination, vital signs and ECG associated with [123I]I-DARPIN-Ec1 injections. - Percent of cases with abnormal laboratory test results associated with [123I]I-DARPIN-Ec1 injections associated with [123I]I-DARPIN-Ec1 injections. - Incidence and severity of adverse events associated with [123I]I-DARPIN-Ec1 injections - Percent of cases requiring administration of concomitant medication due to [123I]I-DARPIN-Ec1 injections ### Location - Facility: TomskNRMC, Tomsk, N/A, N/A, Russian Federation @@
## A Holistic Patient-centred Intervention to Improve Outcomes of Older People Living With Frailty and Chronic Heart Failure - NCT ID: NCT06386640 - Study ID: 0784 - Status: RECRUITING - Start Date: 2023-01-27 - Completion Date: 2025-04-30 - Lead Sponsor: University of Leicester ### Study Description Two-centre complex intervention development and feasibility trial using mixed qualitative and quantitative approach ### Conditions - Chronic Heart Failure - Frailty ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Intervention Development ### Outcomes Primary Outcomes - Phase I: Qualitative evaluation with stakeholders to identify gaps in current HF care pathway leading to unmet healthcare needs in older people living with frailty and CHF - Phase II: Co-design and production of a holistic, patient-centered intervention addressing various healthcare needs of older people living with frailty and CHF - Phase IIa: Time spent in sedentary, light, moderate and vigorous activity over monitoring duration - Phase III: Change in physical function as assessed by the SPPB upon completion of 12-week intervention and at 6 month follow up (this may alter depending on findings from Phase II) Secondary Outcomes ### Location - Facility: Glenfield Hospital, Leicester, N/A, N/A, United Kingdom @@
## Study of Neurophysiological Markers of Motor Recovery in Post-stroke Patients. - NCT ID: NCT06386627 - Study ID: Skoltech-CNBR3 - Status: COMPLETED - Start Date: 2023-07-01 - Completion Date: 2024-03-15 - Lead Sponsor: Skolkovo Institute of Science and Technology ### Study Description The aim of the study was to explore potential pathways for recovery and adaptation of neural pathways after stroke by examining electrical activity of the brain cortex and cortico-spinal excitability using transcranial magnetic stimulation in people with motor impairment after stroke. Participants in the study performed a simple stimulus-response task with a healthy and a paralysed limb several times at different stages of basic rehabilitation. To compare the data, a group of healthy volunteers took part in a similar experiment. We recorded cortical activity using electroencephalography and muscle activity using electromyography. After the stimulus-response task, we also carried out a study using transcranial magnetic stimulation to assess the integrity of corticospinal connections. ### Conditions - Stroke ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Stimulus response task - Transcranial magnetic stimulation ### Outcomes Primary Outcomes - Atypical shape of lateralized readiness potential Secondary Outcomes - Absent of ipsilateral muscles contraction in response to primary motor cortex stimulation in both hemispheres ### Location - Facility: Skolkovo Institute of Science and Technology (Skoltech), Moscow, N/A, N/A, Russian Federation @@
## Effects of TDCS of the Frontal Lobe on Cognitive Function and BDNF in PSCI - NCT ID: NCT06386614 - Study ID: BDNF - Status: RECRUITING - Start Date: 2023-01-01 - Completion Date: 2024-06-01 - Lead Sponsor: The Second Affiliated Hospital of Dalian Medical University ### Study Description The purpose of the clinical trial is to find a treatment for stroke patients with cognitive impairment, and the main questions it aims to answer are:* \[Search for effective treatments of cognitive impairment after stroke\]* \[explore the relationship between BDNF level and cognitive function\] Participants will receive conventional treatment, tDCS treatment, .And then compare cognitive function and BDNF level ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Routine treatment - Transcranial Direct Current Stimulation ### Outcomes Primary Outcomes - BDNF Secondary Outcomes - Cognitive function level - Executive function level - Memory function level ### Location - Facility: Department of Rehabilitation Medicine, the Second Hospital of Dalian Medical University, DaLian, Liaoning, 116021, China @@
## Surgical Ergonomics Education During Minimally Invasive Gynecologic Skills Training - NCT ID: NCT06386601 - Study ID: 2024-15804 - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2024-10 - Lead Sponsor: Montefiore Medical Center ### Study Description The goal of this pilot study is to learn if a class and hands-on-practice of ergonomic body positions - or specific ways to move the body while working to prevent injury - is valuable to training obstetrics and gynecology doctors. The main questions the study team aims to answer are:* Will these lessons successfully teach the participants how to move bodies at work in a way that will prevent injury?* Will the participants feel that learning and practicing such lessons helps to avoid injury while at work?Researchers will compare training obstetrics and gynecology doctors that attend a class on ergonomics and have guided hands-on-practice of ergonomic body positions with training obstetrics and gynecology doctors that attend the class only to see if the first group learns and remembers how to move their bodies safely while working. All participants will attend a class that teaches basic ergonomic lessons before they are divided into two groups. Group 1 will practice common surgery skills on a model while being videotaped by an artificial intelligence application. The application will make a report on unsafe positions a participant does while practicing surgical skills. The Group 1 participant will then go over the report with one of the study supervisors to talk about ways that the participant can move safely while practicing the skills. The participant will then practice the skills one more time while being videotaped. The study supervisors will then compare the two reports to see if the participant improved.Group 2 will also practice common surgery skills on a model while being videotaped. Group 2 participants will not get to see the report that the application generates or speak with the study supervisors about ways to move safely while practicing the skills.There will be a follow up after two months to see if participants remembered what was learned during the class and during the hands-on practice lesson. All participants will again be videotaped. The study supervisors will compare the videos and reports from the last class to the most recent ones to see if the participants learned and remember how to move safely while working.Participants in both groups will take a quiz about the lessons learned in the class before and after the class to determine what had been learned from the lesson. A survey about how useful and helpful the class was and hands-on practice sessions were will also be completed. ### Conditions - Work-related Injury - Work Related Upper Limb Disorder - Surgery - Educational Problems ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Ergonomics Knowledge - Ergonomics Feedback/Guided Practice ### Outcomes Primary Outcomes - Number of participants that would recommend incorporating surgical ergonomics lecture/module as a permanent part of the didactic curriculum. - Number of participants that would recommend incorporating surgical ergonomics hands-on skills session with feedback and guided practice on surgical ergonomics as a permanent part of the didactic curriculum. - Change from baseline in surgical ergonomic knowledge score over two sessions - Change from baseline in surgical ergonomic practice based on rapid upper limb assessment (RULA) score over two sessions - Change from baseline in surgical ergonomic practice based on rapid entire body assessment (REBA) score over two sessions - Change from baseline in surgical ergonomic practice based on revised hand strain index (RHSI) score over two sessions Secondary Outcomes - Number of participants that reported an increase in knowledge following surgical ergonomics lecture/module and/or skills practice. - Number of participants that reported an increase in practice following surgical ergonomics lecture/module and/or skills practice. - Number of participants that reported that surgical ergonomics education is valuable following surgical ergonomics lecture/module and/or skills practice - Number of participants with a change in pain scores following surgical ergonomics lecture/module and skills practice ### Location - Facility: Montefiore Medical Center, Bronx, New York, 10467, United States @@
## The Effects of Auditory Stimulation During Sleep on Brain Networks in Schizophrenia - NCT ID: NCT06386588 - Study ID: 2024P000610 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-12-31 - Lead Sponsor: Massachusetts General Hospital ### Study Description In this research study the investigators will use sleep headbands to measure brain rhythms and to improve their coordination across brain regions. The headbands will be worn at home for multiple nights. On some nights the headbands will play soft sounds at specific times during sleep. The investigators are interested in learning whether this timed auditory stimulation may be a strategy to improve the coordination of sleep rhythms across brain regions, improve network communication, and as a result, improve memory. The investigators will study 30 adults aged 18-45 with schizophrenia and 30 demographically matched healthy controls. Participants will first have a daytime MRI scan, during which they will complete a finger tapping motor sequence task (MST), followed by a week of sleep at home with a sleep headband. They will also do the MST at home on two of the nights. On the final day of the study, participants will return for a second MRI scan. ### Conditions - Schizophrenia ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Closed loop auditory stimulation during sleep ### Outcomes Primary Outcomes - Changes in sleep physiology - Changes in functional connectivity of the hippocampus and thalamus - Changes in hippocampal activation during motor sequence task (MST) - Changes in hippocampal microstructural integrity Secondary Outcomes - Greater gains in typing speed over rest breaks during MST training (micro-offline gains) - Sleep dependent memory consolidation (SDMC) ### Location - Facility: Massachusetts General Hospital, Charlestown, Massachusetts, 02129, United States @@
## Suprainguinal Fascia Iliaca Block in Knee Arthroplasty - NCT ID: NCT06386575 - Study ID: suprainguinal - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-09-01 - Lead Sponsor: Konya City Hospital ### Study Description Total knee arthroplasty is the most commonly performed orthopedic surgery, especially in patients with advanced gonarthrosis and limited joint movement. After total knee arthroplasty, patients experience unbearably severe pain. Pain that is not adequately treated in the postoperative period increases the stress response in patients, increases the risk of embolism, causes bleeding in the surgical area, and causes undesirable conditions such as agitation and delirium in patients. This postoperative pain is successfully treated with various variants of multimodal analgesia. ### Conditions - Analgesia - Anesthesia, Local ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - control group; Patients who received physiological saline - suprainguinal fascia block; Patients receiving local anesthetic ### Outcomes Primary Outcomes - quality of recovery-15T Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Pilot Study of an Internet-based Parenting Program for Child Disruptive Behavior - NCT ID: NCT06386562 - Study ID: 2023-07489-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-24 - Completion Date: 2024-06-30 - Lead Sponsor: Karolinska Institutet ### Study Description The goal of this pilot randomized controlled trial is to learn about effects and experiences of an internet-based parenting program for parents of children and adolescents with behavioral problems (e.g., aggressive or defiant behavior).The main questions the study aims to answer are:* What are the preliminary effects of the internet-based parenting program?* What is the level of parents' engagement in the parenting program?* How do parents perceive the program?Families will be randomized to a version of an internet-based parenting program with support provided from family guides (psychologists) through chat messages in the program, or to the same internet-based parenting program with additional phone/digital support-meetings. Parents will answer quantitative measurements questions before, during, and after treatment. Parents will also be asked to participate in a qualitative interview after the program. Both within and between group comparisons will be conducted to see if there are trends within each arm and differences between the two types of support. ### Conditions - Child Behavior Problem - Disruptive Behavior - Oppositional Defiant Disorder - Conduct Problems - Parent-Child Relations ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Family Check-up and Cognitive behavior therapy online: a Swedish internet-based parenting program - Family Check-up and Cognitive behavior therapy online: a Swedish internet-based parenting program with additional parental support ### Outcomes Primary Outcomes - Mean change from baseline in behavior problems on the Disruptive Behavior Disorder scale (oppositional defiant disorder subscale). - Mean change from baseline in parenting on the Parenting Children and Adolescents Scale - Mean change from baseline in parenting on the Parenting Children and Adolescents Scale: Impact scale Secondary Outcomes - Mean change from baseline in child wellbeing on the KIDSCREEN-10 - Mean change from baseline in child wellbeing on the Strengths and Difficulties Questionnaire - Mean change from baseline in emotion regulation on the Difficulties in Emotion Regulation Scale - Mean change from baseline in parental emotion regulation on the Parent Emotion Regulation Scale - Mean change in family warmth - Mean change in family conflicts - Mean change in parental satisfaction with the week - Parental experiences of the internet-based parenting program explored through qualitative interviews - Parental experiences of each module in the internet-based parenting program - Parental experiences of the whole internet-based parenting program - Parental use of the internet-based parenting program: homework tasks, exercises - Parental use of the internet-based parenting program: time spent working with the program - Parental use of the internet-based parenting program: drop out rate ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of a Tele-rehabilitation Programme in Children With Burns: a Randomized Controlled Trial - NCT ID: NCT06386549 - Study ID: HSEARS20220424001 - Status: RECRUITING - Start Date: 2022-11-14 - Completion Date: 2024-12-31 - Lead Sponsor: LIAO Peng ### Study Description The goal of this clinical trial is to compare tele-rehabilitation and routine post-discharge rehabilitation in children with burn injuries. The main questions it aims to answer are:* Is tele-rehabilitation better for improving the quality and outcomes of care for burn children?* Is tele-rehabilitation more effective in improving scar management in children with burns injuries?* Is tele-rehabilitation more effective in improving perceived stress in parents of children with burns injuries? ### Conditions - Burns - Tele-rehabilitation - Scar - Children ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - tele-rehabilitation ### Outcomes Primary Outcomes - The scars of children with burns - The quality and outcomes of care for burn children Secondary Outcomes - psychological stress of caregvers ### Location - Facility: Hongkong Poly Uiniversity, Hong Kong, N/A, N/A, China @@
## Development and Evaluation of TRIVEL Smart Bike Training Prescription Programs. - NCT ID: NCT06386536 - Study ID: 2023-1796 - Status: RECRUITING - Start Date: 2024-01-15 - Completion Date: 2024-05 - Lead Sponsor: Sylvie Nadeau ### Study Description This pilot A-B study aims to develop and validate personalized training programs for older adults with decreased mobility on a Semi-Reclining Intelligent Stationary Bike prototype.The study also aims to assess the feasibility and acceptability of the training programs and to document their preliminary effects on physical health, perceived well-being, and quality of life. Ten participants will take part in five personalized training sessions with the intelligent bike and five standard training sessions with a traditional stationary bike. ### Conditions - Aging - Mobility Limitation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Intelligent stationary bike - Conventional stationary bilke ### Outcomes Primary Outcomes - Walking ability and functional capacity - Leg strength and endurance Secondary Outcomes - Well-being - Quality of life ### Location - Facility: L'Institut de réadaptation Gingras-Lindsay-de-Montréal, Montréal, Quebec, H3S 2J4, Canada @@
## Standardization of a New Psychophysical Olfactory Test, TODA2 - NCT ID: NCT06386523 - Study ID: 23-AOI-03 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2025-11-15 - Lead Sponsor: Centre Hospitalier Universitaire de Nice ### Study Description Recruitment of patients consulting the IUFC for another pathology unrelated to an olfactory disorder:Interview and clinical examination and Passing the 2 olfactory tests for 30 voluntary's patients, a second consultation of 15 minutes including the time of the test within 7 days after the 1st ### Conditions - Patients Without an Olfactory Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Passage of olfactory tests ### Outcomes Primary Outcomes - Passage of olfactory tests: - Passage of olfactory tests: - Passage of olfactory tests: Secondary Outcomes - Identify confounding factors, i.e. factors that can influence the results of the olfactory test - Identify confounding factors, i.e. factors that can influence the results of the olfactory test ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Cranial Nerve Neuromodulation to Improve Arm Function and Brain Plasticity in Stroke - NCT ID: NCT06386510 - Study ID: 2025-5517 - Status: NOT_YET_RECRUITING - Start Date: 2024-11-01 - Completion Date: 2027-07-01 - Lead Sponsor: Université de Sherbrooke ### Study Description Following a stroke, persistent residual muscle weakness in the upper limb (UL) drastically impacts the individuals' quality of life and level of independence. Training interventions are recommended to promote UL motor recovery, and recent studies have shown that training must be tailored to each individual's recovery potential to maximise training gains. Complementary to training interventions, non-invasive brain stimulation devices (NIBS) can help support the provision of post-stroke care by modulating brain excitability and enhancing recovery. Among NIBS, cranial nerve non-invasive neuromodulation (CN-NINM) is gaining increasing attention in rehabilitation since it can directly and non-invasively stimulate the tongue's cranial nerves. The impulses generated can then reach the motor cortex, induce neuroplastic changes and support recovery. Promising results in various neurological populations have been observed, but in stroke, the efficacy of CN-NINM at improving arm motor recovery and brain plasticity is yet to be determined. This is what the present project intends to address, using a stratified randomized controlled trial, where participants in the chronic phase of a stroke will take part in a 4-week individualized training program of their affected UL in combination with real or sham CN-NINM. Before and after the intervention, participants will undergo clinical and neurophysiological evaluations to thoroughly evaluate CN-NINM-induced changes in UL motor function and associated neuroplastic changes. The proposed study will allow an in-depth evaluation of the effects of CN-NINM for an eventual implementation in clinics and at home to support optimal post-stroke recovery. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Strength training - Cranial nerve non-invasive neuromodulation ### Outcomes Primary Outcomes - Change in UL motor function on the Fugl-Meyer Stroke Assessment Scale - Change in UL functional performance on the Wolf Motor Function Test - Change in motor cortex excitability by means of resting MEP amplitudes elicited by TMS over both hemispheres. Secondary Outcomes - Change in participants' subjective real life functional UL performance on the Motor Activity Log - Change in active and passive range of motion at both UL in shoulder flexion, elbow flexion and wrist extension - Change in resting motor threshold of the affected and unaffected FDI ### Location - Facility: CRIR/Feil/Oberfeld Research Center; Centre intégré de santé et de services sociaux de Laval; Jewish Rehabilitation Hospital, Laval, Quebec, H7V 1R2, Canada @@
## Acceptability of the Somnomat Casa for the Treatment of Parkinson's Disease - NCT ID: NCT06386497 - Study ID: 2023-D0100 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-12-31 - Lead Sponsor: Insel Gruppe AG, University Hospital Bern ### Study Description This pilot study aims to evaluate the feasibility and acceptability of nocturnal translational vestibular stimulations (VS) applied by a rocking bed (Somnomat Casa) for two months in patients with Parkinson's Disease. ### Conditions - Parkinson Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Nocturnal translational vestibular stimulation ### Outcomes Primary Outcomes - Evaluation of acceptability and feasibility - Evaluation of acceptability and feasibility Secondary Outcomes - Pittsburgh Sleep Quality Index (PSQI) - Pittsburgh Sleep Quality Index (PSQI) - Pittsburgh Sleep Quality Index (PSQI) - Pittsburgh Sleep Quality Index (PSQI) - Epworth Sleepiness Scale (ESS) - Epworth Sleepiness Scale (ESS) - Epworth Sleepiness Scale (ESS) - Epworth Sleepiness Scale (ESS) - Parkinson's Disease Sleep Scale version 2 (PDSS-2) - Parkinson's Disease Sleep Scale version 2 (PDSS-2) - Parkinson's Disease Sleep Scale version 2 (PDSS-2) - Parkinson's Disease Sleep Scale version 2 (PDSS-2) - Restless Legs Syndrome Rating Scale (IRLS) - Restless Legs Syndrome Rating Scale (IRLS) - Restless Legs Syndrome Rating Scale (IRLS) - Restless Legs Syndrome Rating Scale (IRLS) - Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) - Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) - Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) - Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) - Parkinson's disease quality of life questionnaire (PDQ-39) - Parkinson's disease quality of life questionnaire (PDQ-39) - Parkinson's disease quality of life questionnaire (PDQ-39) - Parkinson's disease quality of life questionnaire (PDQ-39) - Patients' Global Impression of Severity Scale (PGIS) - Patients' Global Impression of Change Scale (PGICS) - Patients' Global Impression of Change Scale (PGICS) - Patients' Global Impression of Change Scale (PGICS) ### Location - Facility: Insel Gruppe AG, University Hospital Bern, Bern, N/A, 3010, Switzerland @@
## Selective Head-and-neck Cooling on Biomarker Levels and Symptom Rating Following a Boxing Bout - NCT ID: NCT06386484 - Study ID: 2019-05463 - Status: RECRUITING - Start Date: 2021-11-02 - Completion Date: 2025-01-30 - Lead Sponsor: Region Skane ### Study Description Young, healthy elite boxers ≥ 18 years old are recruited. Prior to, and immediately after a competitive boxing bout over 3x2 or 3x3 minutes, blood samples are drawn. Boxers are randomized to intervention or control management by 1:1 allocation prior to baseline testing. After the initial post-fight blood sample is drawn and symptom rating using the sports concussion assessment tool-5 (SCAT-5) has been collected, the boxers receive either acute selective head-and-neck cooling for 45 min, or routine post-fight management. The number of head impacts are counted in all boxers on match video recordings. In both groups, blood samples are drawn 45 minutes after the initial post-bout blood sample, as well as 3 and 6 days post-fight. ### Conditions - Repetitive Head Impact - Selective Head and Neck Cooling ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - PolarCap System ### Outcomes Primary Outcomes - Selective head-and-neck cooling in boxing attenuates the release of brain injury biomarkers such as NFL and GFAP post fight. Secondary Outcomes - Selective head-and-neck cooling improves symptom rating post fight in boxing, using the Sports Concussion Assessment tool- 5 (SCAT-5). ### Location - Facility: Department of Clinical Sciences Lund, Department of Neurosurgery, Sweden, Lund, Skane, 22100, Sweden @@
## Personalized GI Motility Responses to Diet - NCT ID: NCT06386471 - Study ID: 24093 - Status: RECRUITING - Start Date: 2024-03-07 - Completion Date: 2025-06-02 - Lead Sponsor: University of Illinois at Urbana-Champaign ### Study Description The goal of this randomized, crossover, clinical trial is to link: 1) gastrointestinal motility patterns induced by acute consumption of whole and refined grains, 2) enteric microbial production of bioactive metabolites, and 3) circulating postprandial appearance of metabolites important to cardiometabolic health including glucose, triglycerides, and cholesterol.Participants will be asked to consume a Smartpill monitoring device that records metrics of gastrointestinal motility in response to whole or refined grains, monitor cardiometabolic metabolties over an 8 hour postprandial window, and provide a fecal sample for microbiome-related analyses. ### Conditions - Nutritional and Metabolic Diseases - Gastrointestinal Dysfunction - Cardiovascular Diseases - Dysbiosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Whole grain rye bread - Refined grain rye bread ### Outcomes Primary Outcomes - Gastrointestinal Pressure (mmHg) - Luminal pH (pH units) - Temperature (degrees celcius) - Gastrointestinal Transit Time (hours:minutes) - Blood Glucose - Triglycerides - Total Cholesterol - HDL cholesterol - LDL cholesterol - Lipopolysaccharide Binding Protein Secondary Outcomes - Microbiome - Metabolomics ### Location - Facility: University of Illinois at Urbana-Champaign, Urbana, Illinois, 61801, United States @@
## Assessing AThrough Radiofrequency Transseptal Puncture System for Left Atrial Access - NCT ID: NCT06386458 - Study ID: AT-01 - Status: COMPLETED - Start Date: 2022-07-08 - Completion Date: 2023-05-11 - Lead Sponsor: Hangzhou NOYA MedTech Co. Ltm. ### Study Description This study is a prospective, multicenter, randomized controlled trial with a non-inferiority design. Participants are patients scheduled for atrial septal puncture. After signing informed consent, subjects will be randomly assigned to either the radiofrequency transseptal puncture system group (referred to as the trial group) or the traditional mechanical transseptal puncture system group (referred to as the control group). All participants will undergo immediate postoperative and discharge clinical follow-ups. ### Conditions - Heart Diseases - Atrial Fibrillation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - AThrough radiofrequency transseptal puncture system - Traditional mechanical transseptal puncture needle ### Outcomes Primary Outcomes - Transseptal puncture success rate. Secondary Outcomes - Initial transseptal puncture success rate. - Time required to successfully complete the transseptal puncture. - Number of attempts needed to successfully complete the transseptal puncture. - Ratio of atrial septal puncture failures that cross over to the opposite group. ### Location - Facility: The 7th People's Hospital of Zhengzhou, Zhengzhou, Henan, 450000, China @@
## Study on the Serum Metabolic Markers and Early Complications After Allo-HSCT： Cohort Study - NCT ID: NCT06386445 - Study ID: XJTU1AF-CRF-2023-XK013 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-12-31 - Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University ### Study Description This study aims to establish a cohort of 500 patients with hematological disease who undergoing allogeneic hematopoietic stem cell transplantation in the northwest region. All patients will be followed up at the outpatient clinic once a week after transplantation until 100 days after transplantation to observe the presence of acute graft versus host disease, acute kidney damage, and major cardiovascular adverse events. Serum samples from the day before pre-treatment, day after pre-treatment, 2 weeks，4 weeks，8 weeks and 12 weeks after transplantation will be detected by metabolomics sequencing.The primary objective is to explore the serum metabolic markers of acute graft versus host disease，acute kidney injury, and major adverse cardiac events within 100 days after transplantation，the secondary objective is to observe the high-risk factors for early complications. ### Conditions - Stem Cell Transplant Complications - Acute Graft Versus Host Disease - Acute Kidney Injury - Major Adverse Cardiac Events ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Serum metabolomics sequencing ### Outcomes Primary Outcomes - acute graft versus host disease Secondary Outcomes - acute kidney injury - major adverse cardiac events ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## EQQUAL-NM for the Promotion of Smoking Cessation in Sexual and Gender Minority Young Adults in New Mexico - NCT ID: NCT06386432 - Study ID: RG1124189 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-01 - Completion Date: 2025-12-01 - Lead Sponsor: Fred Hutchinson Cancer Center ### Study Description This clinical trial assesses the acceptability and efficacy of Empowered, Queer, Quitting, and Living--New Mexico (EQQUAL-NM), a smoking cessation intervention for sexual and gender minority young adults in New Mexico. Smoking prevalence among sexual and gender minority (SGM) adults in New Mexico is more than twice as high as non-SGM adults. Helping young adult tobacco users to quit is critical, yet there have been few efforts to develop tailored treatments specifically for this population. EQQUAL-NM is a digital smoking cessation intervention designed specifically for SGM young adult smokers in New Mexico and may help them quit smoking. ### Conditions - Cigarette Smoking-Related Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Smartphone App-delivered Smoking Cessation Intervention - Smartphone App-delivered Smoking Cessation Intervention - Health Promotion and Education - Health Promotion and Education - Biospecimen Collection - Questionnaire Administration ### Outcomes Primary Outcomes - Participant satisfaction - Number of logins to the assigned application Secondary Outcomes - Self-reported 7-day point prevalence abstinence (PPA) from all nicotine and tobacco products - Biochemically confirmed 7-day point prevalence abstinence (PPA) from all nicotine/tobacco products - Self-reported 30-day PPA from all nicotine/tobacco products - Biochemically confirmed 30-day PPA from all nicotine/tobacco products - Self-reported 7-day PPA from cigarette smoking - Self-reported 30-day PPA from cigarette smoking - Change in Contemplation Ladder scores - Change in acceptance of tobacco-use triggers - Change in values-guided action ### Location - Facility: Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, 98109, United States @@
## A Clinical Study to Evaluate the Safety and Effectiveness of Inclisiran Sodium in Indian Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia - NCT ID: NCT06386419 - Study ID: CKJX839A1IN03 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2025-08-30 - Lead Sponsor: Novartis Pharmaceuticals ### Study Description This study is to generate post-marketing safety and effectiveness data of inclisiran sodium in Indian patients as per approved indication i.e., primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia that more closely resembles the real-world population intended to be treated with inclisiran sodium. ### Conditions - Primary Hypercholesterolemia - Mixed Dyslipidemia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - inclisiran ### Outcomes Primary Outcomes - Incidence and type of treatment-emergent adverse events (TEAEs) Secondary Outcomes - Mean change in LDL-C from baseline to Day 300. - Proportion of the participants with ≥50% LDL-C reduction on Day 300 - Proportion of the participants who attain global lipid targets for their level of atherosclerotic cardiovascular disorders (ASCVD) risk - Percentage change in TC, HDL-C, non-HDL-C, VLDL-C and TG ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## This is a Study to Evaluate a Pre-confectioned Plantar Insole for the Treatment of Plantar Heel Pain - NCT ID: NCT06386406 - Study ID: ORL-ORT-040 - Status: RECRUITING - Start Date: 2024-04-23 - Completion Date: 2026-03-31 - Lead Sponsor: Ente Ospedaliero Cantonale, Bellinzona ### Study Description Patients affected by plantar heel pain will be asked to use a pre-confectioned plantar insole for one year.The aim of the study is to assess if the insole under study allows the patient to reach a better mobility and a faster return to the normal everyday life. ### Conditions - Plantar Fascitis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - TAP insole ### Outcomes Primary Outcomes - Change in pain severity according to visual analog scale Secondary Outcomes - Change in pain severity according to visual analog scale - Subjective functional recovery based on the Foot Function Index (FFI) score [ - Quality of life and foot general health through the assessment of the Foot Health Status Questionnaire (FHSQ) - Patient satisfaction on a 0-10 numeric rating scale (NRS) ### Location - Facility: EOC, Lugano, N/A, 6900, Switzerland @@
## Survey on Where Parents Look for and Find Information and How They Use Information When Selecting Child Care - NCT ID: NCT06386393 - Study ID: HHSP233201500048I-75P00120F370 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03-28 - Completion Date: 2024-06-30 - Lead Sponsor: National Opinion Research Center ### Study Description The Administration for Children and Families (ACF) within the U.S. Department of Health and Human Services (HHS) is contracting with NORC at the University of Chicago to collect nationally representative survey data to learn more about where parents look for and find information about Child Care and Early Education (CCEE); how parents assess the people, places, or things that may offer CCEE information; what types of CCEE information parents look for; and how parents use information to make CCEE selections. The study aims to gather information that may be used by Child Care Lead Agencies to inform their consumer education efforts. This study is part of the Consumer Education and Parental Choice in Early Care and Education (CEPC) project.The study will select a nationally representative sample from NORC's probability-based AmeriSpeak panel. The AmeriSpeak panel provides sample coverage of approximately 97 percent of the U.S. population. It currently contains 48,900 panel members age 13 and over residing in over 40,000 households. U.S. households are randomly selected with a known, non-zero probability from the NORC National Frame, and then recruited by mail, telephone, and by field interviewers face-to-face. NORC's in-person recruitment enhances representativeness for young adults, lower socio-economic households, non-internet households, and other households that are typically hard to reach for statistical surveys of the population.The survey respondents are AmeriSpeak panelists of at least 18 years of age who have indicated that they have a young child in the household (under the age of 6 years, but not in kindergarten). If a household has two or more panel members who reside in a household with a young child, one will be selected at random to complete the survey, with preference given to parents/legal guardians. Selected panelists will be asked questions to confirm eligibility for the survey, including that the household has at least one child under the age of 6 but not in kindergarten. The study is designed to include parents and legal guardians across race/ethnicity, education level, and gender from the full spectrum of geographic locations. To include families who may not have English as a preferred language, a Spanish version of the survey will be provided. The survey will include parents and legal guardians using many kinds of CCEE and those who use parental care only to see if there are differences in how information is used depending on care type. In addition, the study will include understudied subgroups, such as parents who speak a language other than English, to help inform consumer education efforts. The survey is intended to produce findings that are generalizable to the larger population of parents with children under the age of 6, but not in kindergarten. ### Conditions - Searching for and Selecting Child Care in the US ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Primary sources of information about child care - How parents assess the people, places, or things that may offer CCEE information - What types of CCEE related information parents look for - Information about the last time parents made a decision about CCEE and what information they tried to learn about at that time Secondary Outcomes - Characteristics and experiences of the household and types of CCEE being used ### Location - Facility: NORC at the University of Chicago, Chicago, Illinois, 60603, United States @@
## Adversity and Its Association With the Development and Expression of Rheumatic Diseases - NCT ID: NCT06386380 - Study ID: IRE-4906 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2026-02-01 - Lead Sponsor: National Institute of Medical Sciences and Nutrition, Salvador Zubiran ### Study Description Epidemiological evidence shows that adverse experiences, particularly, but not exclusively in childhood, are predictors of poor long-term health outcomes and certain social domains. In the field of rheumatic diseases, traumatic events, not only in childhood, have been associated with hospitalization, chronic pain, inflammation, worse outcomes, severity of the disease, and mortality. Some mechanisms proposed to explain the association between the experience of adversity and the development of chronic diseases include an impact on the physiology of immune system cells, gene expression due to DNA modification, and cellular senescence.With this background, we wonder if, for patients with rheumatoid arthritis, the presence of adversity understood as a history of violence in childhood and abuse due to suffering from rheumatoid arthritis is associated with markers of cellular senescence and with the severity of illness. ### Conditions - RhA - Rheumatoid Arthritis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Rheumatic diseases Mistreatment Scale (RDMS) - Routine assessment of patient index data 3 (RAPID-3) - Health Assessment Questionnaire (HAQ) - WHOQOL-BREF - Depression, Anxiety and Stress Scale (DASS-21) - Brief Resilient Coping Scale - Expression of CDKN2A /p16INK4a - Immunophenotype of leukocyte subpopulations - Telomere length - Cellular senescence ### Outcomes Primary Outcomes - Adversity and senescence in patients with rheumatoid arthritis Secondary Outcomes - Eexpression of the p16INK4a gene in CD3+ - Telomere length ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Health Education by Buddhist Monks to Promote Malaria Knowledge and Preventive Practices in Rural Myanmar - NCT ID: NCT06386367 - Study ID: MHNO-001 - Status: COMPLETED - Start Date: 2022-07-01 - Completion Date: 2024-03-30 - Lead Sponsor: Myanmar Health Network Organization ### Study Description Malaria is still a leading public health concern in Myanmar. However, people living in rural areas usually showed poor prevention practice despite residing in malaria hotspots. The majority in Myanmar are Buddhists who frequently visit the monastery and receive the speech delivered by the monks. In a malaria high burden township of the Sagaing Region from northern Myanmar, current study will first explore the difference in malaria preventive practices among people residing in different malaria-endemic villages through a mixed-methods approach. Next, this research will address the knowledge gaps by a monastery-based health education delivered by trained Buddhist monks using standardized health messages instruction for six consecutive months between August 2022 to January 2023. To test whether the intervention could balance those gaps among different groups, quantitative data of baseline, 3-month, and 6-month will be compared using descriptive statistics, chi-square test, T-test or repeated ANOVA, and the Difference-In-Differences (DID) analysis, as applicable. ### Conditions - Buddhist Monks - Health Education - Malaria - Monastery-based - Myanmar - Preventive Practice ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Monastery-based health education by Buddhist monks ### Outcomes Primary Outcomes - Malaria knowledge and preventive practices Secondary Outcomes ### Location - Facility: Myanmar Health Network Organization, Yangon, N/A, 11091, Myanmar @@
## Residual Neuromuscular Block in the Post-Anesthetic Unit and Postoperative Complications - NCT ID: NCT06386354 - Study ID: 2023-464-1 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-06-30 - Lead Sponsor: Dr. Negrin University Hospital ### Study Description The use of neuromuscular blockers (NMB) is essential to optimize surgical conditions, ensure patient immobility during the intervention and prevent complications derived from involuntary movements. Intraoperative monitoring of neuromuscular relaxation allows the depth of neuromuscular blockade to be accurately evaluated, guaranteeing ideal conditions for the surgical team. Residual neuromuscular blockade (RNMB) is the persistence of muscle paralysis after the administration of NMB during a surgical intervention. The appearance of RNMB poses substantial challenges in the postoperative period, as it has negative repercussions for the safety and well-being of the patient. ### Conditions - Postoperative Neuromuscular Block - Postoperative Complications ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Train-of-four ### Outcomes Primary Outcomes - Residual Neuromuscular Block - Residual Neuromuscular Block Secondary Outcomes - Postoperative complications ### Location - Facility: Ángel Becerra, Las Palmas De Gran Canaria, Las Palmas, 35019, Spain @@
## QoL in OSA patiënts Treated With MMA Surgery. - NCT ID: NCT06386341 - Study ID: W23.154 - Status: RECRUITING - Start Date: 2023-08-02 - Completion Date: 2026-08-02 - Lead Sponsor: Diakonessenhuis, Utrecht ### Study Description The aim of this observational study is to evaluate the impact of maxillomandibular advancement surgery on the quality of life in patients treated with obstructive sleep apnea.The main question it aims to answer is:Does MMA surgery in OSA patiënts improve their quality of life?Patients will answer online surverys about their QoL and there will be data collected like length, weight and blood pressure. ### Conditions - Sleep Apnea, Obstructive - Quality of Life ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Maxillomandibular Advancement Surgery ### Outcomes Primary Outcomes - SF-36 Secondary Outcomes - OHIP-14 - ESS - FOSQ - EQ-5D-3L - OQLQ ### Location - Facility: Diakonessenhuis, Utrecht, N/A, 3582KE, Netherlands @@
## A Clinical Trial to Evaluate the Food Effect of CKD-378 - NCT ID: NCT06386328 - Study ID: A129_03FDI2317 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-03 - Completion Date: 2024-06-11 - Lead Sponsor: Chong Kun Dang Pharmaceutical ### Study Description A clinical trial to evaluate the food effect of CKD-378 ### Conditions - Type II Diabetes Mellitus ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - CKD-378, QD, PO ### Outcomes Primary Outcomes - AUCt of CKD-378 - Cmax of CKD-378 Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Reduced Dose Radiotherapy for the Treatment of Indolent Non-Hodgkin Lymphoma - NCT ID: NCT06386315 - Study ID: MC230808 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-05-30 - Lead Sponsor: Mayo Clinic ### Study Description This phase II trial compares the safety, side effects and effectiveness of reduced dose radiation therapy to standard of care dose radiation in treating patients with indolent non-Hodgkin lymphoma. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Standard of care radiation treatment for indolent non-Hodgkin lymphoma is usually delivered in 12 treatments. Studies have shown indolent lymphoma to be sensitive to radiation treatment, however, larger doses have higher rates of toxicities. A reduced radiation dose may be safe, tolerable and/or effective compared to standard of care radiation dose in treating patients with indolent non-Hodgkin lymphoma. ### Conditions - Indolent B-Cell Non-Hodgkin Lymphoma - Recurrent Indolent B-Cell Non-Hodgkin Lymphoma - Refractory Indolent B-Cell Non-Hodgkin Lymphoma - Recurrent Indolent Non-Hodgkin Lymphoma - Refractory Indolent Non-Hodgkin Lymphoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Computed Tomography - Endoscopic Procedure - Involved-site Radiation Therapy (3 Fractions) - Involved-site Radiation Therapy (12 Fractions) - Positron Emission Tomography - Questionnaire Administration ### Outcomes Primary Outcomes - Incidence of grade 2 or higher acute adverse events (AEs) Secondary Outcomes - Response rate - Time to progression rate - Patient reported quality of life ### Location - Facility: Mayo Clinic in Arizona, Scottsdale, Arizona, 85259, United States @@
## Chidamide, Venetoclax, and Azacitidine for Newly Diagnosed Acute Myeloid Leukemia - NCT ID: NCT06386302 - Study ID: CSIIT-A36 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-30 - Completion Date: 2027-12-30 - Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China ### Study Description To evaluate the feasibility, effectiveness and safety of chidamide combined with venetoclax and azacitidine in the treatment of newly diagnosed acute myeloid leukemia (AML) who are not suitable for intensive chemotherapy. ### Conditions - AML - Acute Myeloid Leukemia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Chidamide - Venetoclax - azacitidine ### Outcomes Primary Outcomes - Composite complete remission rate Secondary Outcomes - Overall response rate (ORR) - Overall survival (OS) - MRD response rate ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Safety, Performance of CEREGLIDE 92 Intermediate Catheter in Treatment of Acute Ischemic Stroke - NCT ID: NCT06386289 - Study ID: CNV202202 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-01 - Completion Date: 2026-06-30 - Lead Sponsor: Cerenovus, Part of DePuy Synthes Products, Inc. ### Study Description The device is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease ### Conditions - Acute Ischemic Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Cereglide 92 ### Outcomes Primary Outcomes - First pass reperfusion Secondary Outcomes ### Location - Facility: University of Iowa Hospital & Clinics, Iowa City, Iowa, 52242, United States @@
## Surgical TReatment of Women With Deep ENDometriosis - NCT ID: NCT06386276 - Study ID: 00025986 - Status: RECRUITING - Start Date: 2023-10-11 - Completion Date: 2029-06-30 - Lead Sponsor: Casa di Cura Privata 'Malzoni - Villa dei Platani' S.P.A. ### Study Description TrEnd trial is aimed to collect data from consecutive patients undergoing segmental sigmoid colon/rectal resection for deep endometriosis. The main purpose of this project is to gather a large series of cases treated using standardized surgical procedures, allowing a precise evaluation of complications and long-term outcomes. ### Conditions - Deep Endometriosis - Surgery ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Colorectal bowel resection ### Outcomes Primary Outcomes - To document the surgical strategies adopted for treating patients with deep endometriosis undergoing to sigmoid colon/rectal resection - To assess the rate of complications - To assess the rate of conversion to open surgery - To assess the rate of endometriosis-free bowel resection margins - To assess the rate of recurrence Secondary Outcomes - To assess the intraoperative blood loss - To assess the operating time - To assess the gastrointestinal function recovery - To assess the duration of hospital stay - To assess the reproductive outcomes ### Location - Facility: Casa Di Cura Malzoni Villa Platani Spa, Avellino, Campania, 83100, Italy @@
## HER-TEMPO - Real World Treatment-related Outcomes on T-DXd in Canada - NCT ID: NCT06386263 - Study ID: D9673R00032 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-26 - Completion Date: 2025-04-04 - Lead Sponsor: AstraZeneca ### Study Description Trastuzumab deruxtecan (T-DXd) has been studied in multiple global prospective DESTINY-Breast trials and has a marketing authorization from Health Canada for patients with HER2-positive metastatic breast cancer (mBC) and HER2-low mBC, respectively.Multiple stakeholders, including clinicians, patients, regulators, and healthcare decision makers, are interested in real-world treatment-related outcomes in order to better represent the effectiveness of therapies in routine care settings. ### Conditions - Unresectable Breast Cancer - Metastatic Breast Cancer - HER2-low Expressing Breast Cancer - HER2-positive Breast Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Trastuzumab deruxtecan ### Outcomes Primary Outcomes - Early treatment discontinuation rates - Dose modifications Secondary Outcomes - Real world time to treatment discontinuation (rwTTD) - Reasons for treatment discontinuations - Median treatment duration and dose intensity ### Location - Facility: NavieGo Patient ProgramsLtd & Affiliate, Oakville, Ontario, L6H 1A7, Canada @@
## Comparison of Regional Block, Caudal Block and Wound Infiltration in Inguinal Hernitomy - NCT ID: NCT06386250 - Study ID: 0005 - Status: COMPLETED - Start Date: 2019-01-05 - Completion Date: 2020-01-06 - Lead Sponsor: King Edward Medical University ### Study Description Background: Although Inguinal herniotomy in children is taken as a day care procedure, post-operative pain management still remain controversial in these cases and superiority of wound infiltration, caudal block or regional block over each isn't known.Objective: The objective of the study was compare regional block, caudal block and wound infiltration for post-operative pain management in children undergoing inguinal herniotomy ### Conditions - Postoperative Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - regional block - Caudal block - Epidural ### Outcomes Primary Outcomes - Postoperative pain intensity Secondary Outcomes ### Location - Facility: Muhammad Sharif, Lahore, Punjab, 53711, Pakistan @@
## Nutritional Modulation of Cognition and Brain Activity - NCT ID: NCT06386237 - Study ID: UVienna_NDNL_1 - Status: RECRUITING - Start Date: 2024-04-08 - Completion Date: 2025-02-28 - Lead Sponsor: University of Vienna ### Study Description The aim of the present study is to investigate the effects of different meal interventions on cognition (i.e., learning and decision making) and brain activity in healthy participants. ### Conditions - Nutrition, Healthy - Cognitive Change - Brain Activity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Dietary intervention: Standardized breakfast with varying amounts of macronutrients (in particular carbohydrate/protein ratios) ### Outcomes Primary Outcomes - Changes in cognition/behavior I - Changes in cognition/behavior II - Changes in brain activity Secondary Outcomes - Changes in metabolic parameters I - Changes in metabolic parameters II - Changes in metabolic parameters III - Changes in metabolic parameters IV - Changes in subjective affective state - Changes in experienced hunger ### Location - Facility: University of Vienna, Vienna, N/A, 1090, Austria @@
## Internet-Delivered Pain Self-Management for Persons With Acute Recurrent and Chronic Pancreatitis Pain - NCT ID: NCT06386224 - Study ID: 1R01DK137520-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-09-30 - Lead Sponsor: Seattle Children's Hospital ### Study Description Severe and disabling abdominal pain is common in individuals with chronic pancreatitis. Although pain is associated with reduced quality of life and high economic and societal costs, there are limited effective options for pain management in this population. This study proposes an evidence-based psychological intervention approach using an internet-delivered pain self-management program to minimize the impact of pain and improve quality of life. The ultimate goal is to maximize the public health impact of the intervention with successful implementation and dissemination to pancreas clinics and to the community. ### Conditions - Pancreatitis - Chronic Pancreatitis - Acute Recurrent Pancreatitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Internet-delivered pain self-management (CBT Condition) - Education Program ### Outcomes Primary Outcomes - Change in pain severity and pain interference Secondary Outcomes - Change in disease-specific pain - Change in physical functioning - Change in psychological functioning - Change in pain catastrophizing - Change in sleep disturbance - Change in disease specific health-related quality of life - Change in patient global impression of change - Change in opioid use - Treatment acceptability - Change in substance use ### Location - Facility: Seattle Children's Hospital, Seattle, Washington, 98105, United States @@
## Bioavailability Study of Magne-B6 New Formulation - NCT ID: NCT06386211 - Study ID: BDR17228 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-06 - Completion Date: 2024-06-15 - Lead Sponsor: Opella Healthcare Group SAS, a Sanofi Company ### Study Description The purpose of the study is to assess the relative bioavailability of two Magne-B6 preparations, in fasting conditions. ### Conditions - Healthy Volunteers ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - MAGNE-B6 Oral Solution - MAGNE-B6 New Formulation Tablet ### Outcomes Primary Outcomes - Maximal Observed Concentration (Cmax) of Magnesium in Plasma - Area Under the Concentration-time Curve from Time Zero Until time 12 hour (h) (AUC0-12) of Magnesium in Plasma - Area Under the Concentration-time Curve from Time Zero Until time 24 h (AUC0-24) of Magnesium in Plasma - Maximal Observed Concentration (Cmax) of Pyridoxine in Plasma - Area Under the Concentration-time Curve from Time Zero Until the Last Observed Concentration (AUClast) of Pyridoxine in Plasma - Area Under the Concentration-time Curve from Time Zero to Infinity (extrapolated) (AUC0-infinity) of Pyridoxine in Plasma - Time When the Maximal Concentration is Observed (Tmax) of Magnesium in Plasma - Time When the Maximal Concentration is Observed (Tmax) of Pyridoxine in Plasma - Cumulative Amount of Unchanged Drug Excreted into the Urine From Time Zero to the Time Point 24 hours (Ae0-24) of Magnesium in Urine Secondary Outcomes - Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## HEalth Advocate for Liver Transplantation: Improving Transition of Care for Adolescent Liver Transplant Recipients - NCT ID: NCT06386198 - Study ID: 23-40699 - Status: RECRUITING - Start Date: 2024-03-03 - Completion Date: 2026-06-30 - Lead Sponsor: University of California, San Francisco ### Study Description The Health Advocate for Liver Transplant (HEAL-Tx) Transition of Care Pilot is a nonrandomized, open-label intervention pilot of a health advocate intervention aimed to assess feasibility and acceptability of integrating a Health Advocate onto the transplant team to help adolescents transition their care to adult transplant teams. Across studies, health advocate roles vary, and can include coordinating medical care treatment, facilitating financial assistance (e.g., taxi vouchers), and connecting patients to community resources, which can improve self-management, mitigate social risks, and lead to better communication between the healthcare system and the family. In this pilot, the investigators will adapt this intervention for adolescent/young adult liver transplant patients and measure acceptability and feasibility according to RE-AIM. ### Conditions - Liver Transplant; Complications - Pediatric ALL ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Health Advocate ### Outcomes Primary Outcomes - Changes in patient experience Secondary Outcomes - Change in medication adherence using MLVI - The quality of health advocate interactions with the participants, healthcare team, and community-based resources. - A qualitative assessment of patient and healthcare provider satisfaction with the Health Advocate intervention. ### Location - Facility: University of California San Francisco, San Francisco, California, 94158, United States @@
## Developing the Probability Algorithm for Pulmonary Hypertension Echocardiography - NCT ID: NCT06386185 - Study ID: DRAPE - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2026-11-01 - Lead Sponsor: Royal United Hospitals Bath NHS Foundation Trust ### Study Description The goal of this observational study is to assess the efficacy that the addition of novel markers cardiac function, particularly of right ventricular (RV) function in echocardiography, and ECG have in detecting pulmonary hypertension.The main questions it aims to answer are:Can novel markers in ECG and echocardiography suggest the presence of PH? Can existing screening guidelines be improved with the addition of these markers? ### Conditions - Pulmonary Hypertension ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Electrocardiogram - Transthoracic echocardiogram - Right heart catheter ### Outcomes Primary Outcomes - Distinguish between patients with and without pulmonary hypertension - Distinguish between patients with pre-capillary hypertension and post-capillary hypertension Secondary Outcomes - Assess the impact of the severity of pulmonary hypertension - Assess the impact of additional ECG markers on existing PH probability stratification ### Location - Facility: Royal United Hospital NHS Foundation Trust, Bath, Banes, BA1 3NG, United Kingdom @@