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## Delta GREENS Food is Medicine Intervention - NCT ID: NCT06358859 - Study ID: STUDY00004203 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-04 - Lead Sponsor: Tufts University ### Study Description Though the Mississippi Delta has a rich agricultural history and some of the nation's most fertile soil, residents have experienced the legacy of slavery and economic exploitation through food insecurity and poverty for generations. This project focuses on Bolivar, Washington, and Sunflower, contiguous counties in the Delta that are designated as health disparity populations. Over 65% of the 100,000 residents are Black/African American and \~30% live at or below the poverty level. Obesity rates are high and the rate of diabetes is almost double the national average. Tufts University received a grant from the National Institute of Minority Health and Health Disparities to develop, test, and evaluate a Food is Medicine program in Mississippi. The Delta Growing a Resilient, Enriching, Equitable, Nourishing food System (GREENS) Food is Medicine (FIM) Project, is a collaborative project in Bolivar, Washington, and Sunflower counties in Mississippi. The intervention involves regularly distributed fruit and vegetable produce boxes as well as nutrition education materials to the intervention group. The control group will receive produce boxes later, after they complete study activities. The project's primary goal is to improve health outcomes by creating a FIM intervention. The Delta GREENS FIM Project aims to become a model for promoting nutrition security and management of chronic conditions in varied communities nationwide. ### Conditions - Cardiometabolic Risk Factors - Diabetes - High Blood Pressure - Obesity - Nutrition Security ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Food is Medicine ### Outcomes Primary Outcomes - Change in hemoglobin A1c (HbA1c) Secondary Outcomes - Change in cardiometabolic risk factor composite score - Change in BMI - Change in LDL cholesterol - Change in non-HDL cholesterol - Change in blood pressure - Change in nutrition security, assessed via a survey - Change in dietary intake of fruits and vegetables, assessed via a survey - Change in health care utilization, assessed via review of Electronic Health Records (EHR) - Change in food insecurity, assessed via a survey ### Location - Facility: Tufts University, Boston, Massachusetts, 02111, United States @@
## Effectiveness of Educational Intervention on Footcare Among Individuals Having Type 2 Diabetes at Slums of Karachi, Pakistan. - NCT ID: NCT06358846 - Study ID: 00004 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2024-07-31 - Lead Sponsor: SINA Health Education and Welfare Trust ### Study Description There are multiple studies conducted in Pakistan that supports the topic of foot care knowledge among individual with type 2 diabetes but all are descriptive cross-sectional studies and investigators cannot develop cause effect relationship out of it. Secondly, there is a lack of documented research on the foot care knowledge shown by people with T2D residing in the slums of Karachi. In order to assess the knowledge intervention among the individual having T2D through qualified diabetes educators and pictorial educational pamphlet along with the standard care of treatment. Consequently, it may aid in the development of effective methods aimed at mitigating foot-related complications among this specific population. Individuals diagnosed with diabetes are required to engage in proactive and structured self-care activities by providing the foot care knowledge in order to effectively manage their condition and mitigate the risk of potential complications. The incorporation of health-deviation knowledge and activities into routine is crucial. ### Conditions - Diabetic Foot - Educational Intervention - Foot Care - Foot Ulcer, Diabetic - Foot Cellulitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Self-care behavior to promote foot care through educational guidance among individual with diabetes ### Outcomes Primary Outcomes - Improved Foot Care Knowledge - Behavior Change Secondary Outcomes - Reduction in Foot Complications - Empowerment and Self-efficacy ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparison of Endodontic Postoperative Pain Using Different Irrigation Systems - NCT ID: NCT06358833 - Study ID: 24-82-03 - Status: RECRUITING - Start Date: 2024-04-15 - Completion Date: 2024-12-31 - Lead Sponsor: Qassim University ### Study Description Summary:After a root canal procedure, it is common to experience postoperative pain. Cleaning the root canal thoroughly is crucial for pain relief, but removing all debris with standard methods is difficult. Irrigation, using either traditional endodontic needles or newer methods like endodontic activation, helps clean the canal. This study aims to compare pain levels after using conventional needles versus an Endo1 Ultrasonic Endo Activate Device for irrigation. Patients will undergo standard root canal preparation and then be randomly assigned to one of two groups for final irrigation: the Endo1 device (EA) and the conventional endodontic needles (EN). The study will provide insights into which method is more effective in reducing postoperative pain. ### Conditions - Postoperative Pain - Irreversible Pulpitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - endodontic needle (EN) - Endodontic activation (EA) ### Outcomes Primary Outcomes - Postoperative pain - Postoperative pain - Postoperative pain - Postoperative pain Secondary Outcomes - Irrigation time ### Location - Facility: Muhammad Zubair Ahmad, Ar Rass, Qassim, 58883, Saudi Arabia @@
## Exploring the Effectiveness and Safety of Amino Acid Peritoneal Dialysis Solution - NCT ID: NCT06358820 - Study ID: PHGaozhou - Status: RECRUITING - Start Date: 2023-12-03 - Completion Date: 2025-07 - Lead Sponsor: The People's Hospital of Gaozhou ### Study Description This study adopts a multicenter, open, prospective, and self controlled study design, in which each participant serves as their own control before and after receiving amino acid peritoneal dialysis solution treatment to compare changes in their nutritional status. Each subject received treatment with 1 bag of amino acid peritoneal dialysis per day and 2-4 bags of glucose peritoneal dialysis solution per day for 6 months (the amount of glucose peritoneal dialysis solution used was determined based on the treatment plan selected by the patient during the screening period when they entered the study).Before treatment and during the 3rd and 6th months of treatment, subjects were evaluated for various efficacy and safety indicators, and any adverse or serious adverse events were recorded. ### Conditions - Exploring the Effectiveness and Safety of Amino Acid Peritoneal Dialysis Solution in Improving Nutritional Status of Maintenance Peritoneal Dialysis Patients ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Amino acid peritoneal dialysis solution ### Outcomes Primary Outcomes - blood albumin - prealbumin Secondary Outcomes ### Location - Facility: Gaozhou People's Hospital, Gaozhou, Guangdong, 525200, China @@
## Microfracture With Platelet Rich Plasma Gel Injection for Ostechondral Lesion of the Talus - NCT ID: NCT06358807 - Study ID: M2023438 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2026-12-31 - Lead Sponsor: Peking University Third Hospital ### Study Description The goal of this clinical trial is to learn if combined local injection of platelet rich plasma (PRP) gel adds clinical efficacy to isolated arthroscopic microfracture in treatment of osteochondral lesion of the talus (OLT). The interface integration of the injured area will also be assessed via radiographic follow-up. The main questions it aims to answer are:* Does arthroscopic microfracture combined with PRP gel injection improve ankle function of participants based on American Orthopedic Foot and Ankle Society (AOFAS) Score?* Does arthroscopic microfracture combined with PRP gel injection improve interface integration of the injured cartilage on magnetic resonance imaging (MRI)? Researchers will compare arthroscopic microfracture with concomitant local injection of PRP gel to isolated microfracture to see if intraoperative PRP gel injection adds clinical efficacy to isolated arthroscopic microfracture in treatment of OLT.Participants will:* Undergo either isolated arthroscopic microfracture or microfracture with intraoperative injection of PRP gel* Receive clinical follow-up 3, 6, 12, and 24 months after surgery and answer scales of ankle function assessment* Take MRI preoperatively and 6, 12 and 24 months after surgery ### Conditions - Osteochondral Lesion of Talus - Microfractures - Platelet Rich Plasma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Arthroscopic microfracture with intraoperative local PRP gel injection - Isolated microfracture ### Outcomes Primary Outcomes - American Orthopedic Foot and Ankle Society Score (AOFAS) Secondary Outcomes - Foot and Ankle Outcome Score (FAOS) - Ankle Activity Score (AAS) - Visual Analogue Scale (VAS) - Patient Satisfaction - Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) - Return-to-Sport Rate - Complications ### Location - Facility: Peking University Third Hospital, Beijing, N/A, N/A, China @@
## Machine Learning Based-Personalized Prediction of Sperm Retrieval Success Rate - NCT ID: NCT06358794 - Study ID: IRB00006761-M2022692 - Status: COMPLETED - Start Date: 2022-06-01 - Completion Date: 2023-05-31 - Lead Sponsor: Peking University Third Hospital ### Study Description Non-obstructive azoospermia (NOA) stands as the most severe form of male infertility. However, due to the diverse nature of testis focal spermatogenesis in NOA patients, accurately assessing the sperm retrieval rate (SRR) becomes challenging. The current study aims to develop and validate a noninvasive evaluation system based on machine learning, which can effectively estimate the SRR for NOA patients. In single-center investigation, NOA patients who underwent microdissection testicular sperm extraction (micro-TESE) were enrolled: (1) 2,438 patients from January 2016 to December 2022, and (2) 174 patients from January 2023 to May 2023 (as an additional validation cohort). The clinical features of participants were used to train, test and validate the machine learning models. Various evaluation metrics including area under the ROC (AUC), accuracy, etc. were used to evaluate the predictive performance of 8 machine learning models. ### Conditions - Infertility, Male - Azoospermia, Nonobstructive ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Machine learning-based predictive model ### Outcomes Primary Outcomes - SRR of micro-TESE Secondary Outcomes ### Location - Facility: Peking University Third Hospital, Beijing, Beijing, 100191, China @@
## A Dose-response Study to Validate the Biomarkers for Whole Grain Dietary Intake - NCT ID: NCT06358781 - Study ID: xuyajun197673-002 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-22 - Completion Date: 2024-06-30 - Lead Sponsor: Peking University ### Study Description Dose-response validation of whole grain dietary intake biomarkers remains limited, and it is debatable whether these markers could be utilized as classifiers for different levels of whole grain consumption. Because there are significant disparities in genetic background and dietary patterns between Chinese and Western cultures, it is unclear if whole grain dietary intake biomarkers can characterize whole grain consumption in Chinese populations. To address these issues, the current study was designed to evaluate the sensitivity and specificity of potential whole grain markers in a randomized controlled trial, as well as to validate the markers' dose-response relationship, so that they can be used in nutritional epidemiological studies and dietary intake assessments of whole grains. ### Conditions - Chronic Disease Prevention ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Whole grain wheat flour ### Outcomes Primary Outcomes - whole grain plasma and urine biomarkers discovery and identification Secondary Outcomes - Validate the performance of the potential WG biomarkers. ### Location - Facility: Department of Nutrition and Food Hygiene, School of Public Health, Peking University, Beijing, N/A, N/A, China @@
## Post-Partum Haemorrhage (PPH) Improvement of Skills With Actor Simulations - NCT ID: NCT06358768 - Study ID: ObGynEASC005 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-09-30 - Lead Sponsor: G. d'Annunzio University ### Study Description Pre test and post test questionnaire for evaluation of skills and teamwork capacities in PPH management ### Conditions - PPH - Postpartum Hemorrhage ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - teamwork job improvement overall - teamwork job improvement in actor scenario vs mannequin scenario ### Outcomes Primary Outcomes - teamwork - skills Secondary Outcomes - scenario quality ### Location - Facility: Claudio Celentano, Pescara, PE, 65100, Italy @@
## Combination Effect of Optical Defocus and Low Dose Atropine in Myopia Control - NCT ID: NCT06358755 - Study ID: 10211476 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-10-31 - Lead Sponsor: The Hong Kong Polytechnic University ### Study Description The purpose of the study is to investigate the combination effect of optical defocus and low dose atropine on myopia control in schoolchildren. ### Conditions - Myopia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Defocus Incorporated Multiple Segments lenses - single vision spectacle lenses - Low dose atropine ### Outcomes Primary Outcomes - Changes in cycloplegic refraction - Changes in axial length Secondary Outcomes ### Location - Facility: Centre for Myopia Research, The Hong Kong Polytechnic University and Department of Ophthalmology, The University of Hong Kong, Hong Kong, N/A, No postcode, Hong Kong @@
## Evaluation of the Effect of Zinc Citrate Trihydrate Toothpaste on the Oral Plaque Microbiome - NCT ID: NCT06358742 - Study ID: ORL-GUM-2787 - Status: COMPLETED - Start Date: 2017-01-10 - Completion Date: 2017-05-19 - Lead Sponsor: Unilever R&D ### Study Description This study is of a double-blind, randomised, parallel group study. Subjects will be enrolled onto the study according to the inclusion/exclusion criteria. After recruitment, subjects will be given a fluoride toothpaste without gum care agents to use for the 4-week run-in period prior to the commencement of the test phase of the study. Following the run-in period, baseline supragingival plaque samples will be collected 12 hours after last brushing, from the upper and lower jaws separately. Subjects will then then randomly allocated to one of two products (zinc citrate trihydrate \[ZCT\] toothpaste or control toothpaste) according to the randomization. Subjects will be instructed to use the toothpaste at home, brushing twice a day for 12-weeks. Supragingival plaque samples will be collected again from the upper and lower jaws after 2, 6 and 12 weeks. Plaque samples will then undergo metataxonomic and metatranscriptomic analyses. ### Conditions - Dental Plaque ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - ZCT toothpaste - Control toothpaste ### Outcomes Primary Outcomes - Plaque microbiome Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Pre-Pregnancy Weight Loss and Baby Behavior Study - NCT ID: NCT06358729 - Study ID: HUM00239775 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2027-04 - Lead Sponsor: University of Michigan ### Study Description This study will help researchers learn more about how babies respond to bottle nipples with larger or smaller holes. Researchers guess that infants of mothers with obesity who did not lose weight prior to pregnancy will have the greatest Suck Effect on the challenging compared with the typical nipple. ### Conditions - Obesity; Familial - Pregnancy Related - Infant Behavior ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Typical Nipple - Challenging Nipple ### Outcomes Primary Outcomes - Suck effect Secondary Outcomes - Sucking pressure - Sucking frequency - Milk/Formula intake - Milk/Formula consumption rate - Number of Feedings Over 24 Hours - Total Hours of Sleep per 24 Hours within 24 hours of intervention - Total Night Wake-ups within 24 hours of intervention ### Location - Facility: The University of Michigan, Ann Arbor, Michigan, 48109, United States @@
## Glycaemic Index Determination in Oral Nutrition Supplements - NCT ID: NCT06358716 - Study ID: CEIC-3037 - Status: RECRUITING - Start Date: 2024-04-15 - Completion Date: 2024-08-15 - Lead Sponsor: Universitat de Lleida ### Study Description The glycemic index is the ability of carbohydrates in foods to induce increases in blood glucose levels after consuming them. Based on the capacity for increasing blood glucose levels, foods can be classified as having a low, medium, or high glycemic index. This property is of interest in health and nutrition because it allows estimating the impact the food will have on postprandial glycemia, which may able better food selection in situations where adequate glycemic control is required, such as in individuals diagnosed with Diabetes Mellitus. The objective of this study is to determine the glycemic index of 9 formulations of complete oral nutrition supplements and classify them based on their glycemic response. ### Conditions - Glucose Metabolism Disorders ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Complete Oral Nutrition Supplement 1 - Complete Oral Nutrition Supplement 2 - Complete Oral Nutrition Supplement 3 - Complete Oral Nutrition Supplement 4 - Complete Oral Nutrition Supplement 5 - Complete Oral Nutrition Supplement 6 - Complete Oral Nutrition Supplement 7 - Complete Oral Nutrition Supplement 8 - Complete Oral Nutrition Supplement 9 - Glucose ### Outcomes Primary Outcomes - Glycemic Index Secondary Outcomes ### Location - Facility: University of Lleida, Lleida, N/A, 25198, Spain @@
## Impact of Acute iTTP Therapies on Long Term Neurologic and Cognitive Outcomes in iTTP Survivors - NCT ID: NCT06358703 - Study ID: P400 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2028-05 - Lead Sponsor: US Thrombotic Microangiopathy Alliance ### Study Description 1. We expect to find that the silent cerebral infarct (SCI) rate is two fold higher in patients treated without caplacizumab. We also expect to find that the rate of mild and major cognitive impairment in patients treated with caplacizumab within 3 days of starting plasma exchange will be lower than patients treated without caplacizumab.2. We expect that the differences in cognitive impairment in cases (caplacizumab) versus controls (no caplacizumab) will persist on serial evaluation 1 year later. We also expect that there will be differences in these groups even after adjusting for time since episode and severity of presentation.3. We expect to find that SCI and cognitive impairment is associated with worse scores on the health related quality of life instrument (SF-36)4. Based on studies in non-TTP populations, we expect to find that the rate of incident stroke over the period of follow up is at least 2 fold higher in patients that have SCI compared with patients who do not have SCI ### Conditions - Immune Thrombotic Thrombocytopenia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Caplacizumab ### Outcomes Primary Outcomes - Silent cerebral infarction - Cognitive impairment Secondary Outcomes - Depression scores on BDI-II - SF-36 scores for quality of life - Patient reported cognitive performance ### Location - Facility: USTMA, Groveport, Ohio, 43125, United States @@
## [Trial of device that is not approved or cleared by the U.S. FDA] - NCT ID: NCT06358690 - Study ID: HSC-MS-24-0050 - 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 @@
## Topical Tretinoin Prophylaxis for Anti-EGFR Induced Skin Toxicity in Metastatic Colorectal Cancer - NCT ID: NCT06358677 - Study ID: HCI171997 - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2029-07 - Lead Sponsor: University of Utah ### Study Description The goal of this clinical trial is to learn if using topical tretinoin will help patients with colorectal cancer who are experiencing an acneiform rash as a side effect of their treatment.Researchers will compare the use of tretinoin on one side of the face to the use of a placebo on the other side of the face to see if there is an impact. ### Conditions - Metastatic Colon Cancer - Metastatic Rectum Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Topical Tretinoin - Placebo ### Outcomes Primary Outcomes - The maximum difference in modified Investigators Global Assessment (IGA) score between the treated and untreated sides of the face at any assessment. Secondary Outcomes - Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NIH CTCAE version 5.0 and the modified IGA), seriousness, duration, and relationship to study treatment. ### Location - Facility: Huntsman Cancer Institute at University of Utah, Salt Lake City, Utah, 84112, United States @@
## Caffeine and Cataract After Pars Plana Vitrectomy - NCT ID: NCT06358664 - Study ID: Caffeine Vitrectomy - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-04-01 - Lead Sponsor: Vienna Institute for Research in Ocular Surgery ### Study Description Assessment of cataract development in patients with regular caffeine consumption and those without caffeine consumption after pars plana vitrectomy. ### Conditions - Cataract ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Pars plana vitrectomy ### Outcomes Primary Outcomes - Significant cataract formation at year 1 Secondary Outcomes - Significant cataract formation at month 6 - Distance corrected visual acuity (DCVA) ### Location - Facility: Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital, Vienna, Vienna, N/A, 1140, Austria @@
## Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-3) - NCT ID: NCT06358651 - Study ID: PH94B-CL042 - Status: RECRUITING - Start Date: 2024-03-28 - Completion Date: 2026-06 - Lead Sponsor: VistaGen Therapeutics, Inc. ### Study Description This U.S. Phase 3 clinical trial is designed to evaluate the efficacy, safety, and tolerability of the acute intranasal (i.n.) administration of Fasedienol Nasal Spray (fasedienol) (3.2 µg) to relieve symptoms of acute anxiety in adult subjects ages 18 through 65 with Social Anxiety Disorder induced by a public speaking challenge (PSC) in a clinical setting. In addition, safety and tolerability of i.n. administration of 3.2 µg of fasedienol, as-needed, up to 6 times per day for up to 12 months, will be assessed in those subjects who complete PALISADE-3 and choose to enter the distinct open-label extension phase of the study. ### Conditions - Social Anxiety Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Fasedienol Nasal Spray - Placebo Nasal Spray ### Outcomes Primary Outcomes - Subjective Units of Distress Scale (SUDS) Secondary Outcomes - Global Impression Scale of Improvement (CGI-I) - Patient Global Impression of Change (PGI-C) ### Location - Facility: Vistagen Clinical Site, Oceanside, California, 92056, United States @@
## Sickle Cell Disease Transplant Using a Nonmyeloablative Approach for Patients With Anti-donor Red Cell AntibodY - NCT ID: NCT06358638 - Study ID: STUDY00000859 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2054-09 - Lead Sponsor: Children's National Research Institute ### Study Description This multicenter prospective study seeks to determine if daratumumab given, prior to HLA-identical sibling donor transplantation using alemtuzumab, low dose total-body irradiation, and sirolimus, can prevent pure red blood cell aplasia with an acceptable safety profile in patients with anti-donor red blood cell antibodies, achieving an event-free survival similar to transplanted patients without such antibodies. ### Conditions - Sickle Cell Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Daratumumab - Alemtuzumab - Sirolimus - Total Body Irradiation ### Outcomes Primary Outcomes - To determine the event-free survival of children and adolescents with SCD undergoing nonmyeloablative HCT who received 4 doses of pre-HCT daratumumab for donor-directed red blood cell antibodies. Secondary Outcomes - To evaluate changes in antibodies to red blood cell antigens pre and post exposure to daratumumab and HCT. - To characterize the safety of adding pre-HCT daratumumab to the conditioning regimen, as defined by adverse events grade 3 or greater. ### Location - Facility: Children's National Hospital, Washington, District of Columbia, 20010, United States @@
## Identification of Risk Factors for Brain Recurrence in Patients With HER2-positive Localised Breast Cancer - NCT ID: NCT06358625 - Study ID: 2023-4-1-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2031-04-30 - Lead Sponsor: Center Eugene Marquis ### Study Description HER2 gene amplification, detected in 20% to 30% of breast cancers, was a poor prognostic factor before the advent of anti-HER2 therapies. In the early 2000s, trastuzumab revolutionised the management of patients with HER2-positive (HER2+) breast cancer in the metastatic and localised stages of the disease.At the time of diagnosis of metastatic disease, 7-11% of patients have brain metastases, with (70% of cases) or without symptoms (30% of cases). In the absence of brain metastases, 30% to 50% of patients will develop brain metastases within the first two years of treatment, depending on whether the disease is hormone receptor positive (HR+) or negative (HR-).The presence of brain metastases is the most important prognostic factor. The neurological symptoms caused by the presence of these lesions, but also by the local treatments offered, affect patients' quality of life, although improvements in surgical and radiotherapy techniques have significantly reduced the need for particularly toxic whole brain radiotherapy.International guidelines do not recommend systematic brain MRI in the absence of neurological symptoms, either in the adjuvant or metastatic stages of this disease. However, there may be a role for more systematic and earlier screening for cerebral recurrence, as single cerebral recurrences without extracranial involvement are common and the new anti-HER2 agents (i.e. tucatinib, an anti-HER2 tyrosine kinase inhibitor, and T-Dxd) have shown significant objective response rates in cerebral metastases.To date, no clinical or histological prognostic factor (proliferation index, HR expression, etc.) has been used to identify a population of patients at high risk of cerebral relapse, allowing monitoring and treatment to be personalised.New tools for these indications would significantly modify our clinical practice, allowing the identification of a subpopulation at high risk of cerebral recurrence, suitable for increased monitoring and therapeutic adjustment. ### Conditions - HER2-positive Breast Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Pre-treatment biopsy ### Outcomes Primary Outcomes - Transcriptomic profile change of HER2+ primary breast tumours before any treatment Secondary Outcomes - Transcriptomic profile change on circulating tumour DNA (ctDNA) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Evaluation of an Anxiety Reduction Tool During Thyroid and Prostate Biopsy Procedures - NCT ID: NCT06358612 - Study ID: DALNSHA2024ABR001 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-08-31 - Lead Sponsor: Nova Scotia Health Authority ### Study Description Patients undergoing either thyroid or prostate biopsy under local anesthetic will be asked to fill out a questionnaire that evaluates their anxiety level before and after a thyroid or prostate biopsy procedure that they undergo. Patients will be randomly assigned to either use an anxiety reducing tool (stress balls in each hand) to take their mind off the procedure or will not receive an anxiety reducing tool. ### Conditions - Anxiety State ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Stress Balls - No Stress Balls ### Outcomes Primary Outcomes - Change in anxiety level of greater than 20% based on Visual Analog Score (VAS) Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Impact of Neoadjuvant Chemotherapy on Survival Outcomes in Patients With Variant Histologies Bladder Cancer Who Underwent Radical Cystectomy - NCT ID: NCT06358599 - Study ID: TUO-UR-21-01 - Status: COMPLETED - Start Date: 2021-01-07 - Completion Date: 2024-01-15 - Lead Sponsor: Ankara Etlik City Hospital ### Study Description The World Health Organization 2016 bladder tumor classification reported that the diagnosis of variant histology has increased from 6% to 33% in the last 2 decades, and there is an increasing interest in investigating the effects on disease management, treatment options, and survival outcomes in bladder tumors with variant histology. In bladder tumors, variant histology is known to be more aggressive and has a worse prognosis than pure urothelial cancer, and most cases are muscle invasive at diagnosis. Neoadjuvant cisplatin-containing combination chemotherapy is known to improves overall survival in patients with urothelial cancers. However, it is unclear whether patients with non-pure urothelial cancer (variant) histology will also benefit from neoadjuvant chemotherapy. The investigators aimed to evaluate the role of Neoadjuvant cisplatin-containing combination chemotherapy in the final treatment plan and its impact on survival in patients with bladder cancer who were diagnosed with variant histology in the radical cystectomy specimen. ### Conditions - Bladder Cancer - Bladder Cancer Stage I - Bladder Cancer Stage II ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Cisplatin ### Outcomes Primary Outcomes - Change in survival outcomes at postoperative 2-year follow-up in patients with variant histology who received neoadjuvant chemotherapy before radical cystectomy. Secondary Outcomes - Factors associated with worse survival outcomes in cox-regression analysis at 2-year follow-up of all patients with variant histology who underwent radical cystectomy. ### Location - Facility: Ankara Etlik City Hospital, Ankara, N/A, 06170, Turkey @@
## New Paediatric Formulation of Tachipirina® - NCT ID: NCT06358586 - Study ID: 044(H)MD21176 - Status: COMPLETED - Start Date: 2022-04-09 - Completion Date: 2022-04-25 - Lead Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A ### Study Description This is a single centre, single dose, single-arm, open-label, palatability study.The aim of the present study is to investigate the palatability of the newly developed Tachipirina® 120 mg/5 mL oral suspension with strawberry flavour. The study will be conducted in paediatric volunteers that represent the target population for this product. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Tachipirina® 120 mg/5 mL oral suspension, new flavour ### Outcomes Primary Outcomes - Palatability of new flavour - Taste (1) - Palatability of new flavour - Taste (2) - Palatability of new flavour - Smell - Palatability of new flavour - Aftertaste (1) - Palatability of new flavour - Aftertaste (2) - Palatability of new flavour - Aftertaste (3) - Palatability of new flavour - Texture (mouthfeel) - Palatability of new flavour - Overall Secondary Outcomes - Treatment emergent adverse events (TEAEs) ### Location - Facility: CROSS Research S.A. - Phase I Unit,, Arzo, N/A, CH-6864, Switzerland @@
## Intratumoral INT230-6 Followed by Neoadjuvant Immuno-chemotherapy in Patients With Early TNBC. INVINCIBLE-4-SAKK - NCT ID: NCT06358573 - Study ID: SAKK 66/22 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-30 - Completion Date: 2029-12 - Lead Sponsor: Swiss Group for Clinical Cancer Research ### Study Description About 10-20% of all individuals with breast cancer have a so-called triple-negative tumor (TNBC). This type of breast cancer has a particularly unfavorable course and a higher mortality rate compared to other forms of breast cancer. Research studies show that it is important for individuals with TNBC to achieve a so-called pathologic complete response (pCR) to treatment. In the phase II study SAKK 66/22, it is being investigated whether the administration of the drug INT230-6 before surgery for breast cancer can increase the rate of pCR in the tumor and affected lymph nodes. The tolerability of INT230-6 as well as other factors such as response to treatment and the possibility of breast-conserving surgery are also being examined. ### Conditions - Triple-negative Breast Cancer - TNBC - Triple-Negative Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - INT230-6 - neoadjuvant immuno-chemotherapy ### Outcomes Primary Outcomes - Pathological complete response (pCR) in the primary tumor (ypT0/Tis) and affected lymph nodes (ypN0). Secondary Outcomes - pCR (invasive and in-situ, only invasive, respectively) in the breast - pCR in lymph nodes - Pattern of non pCR - Overall response according to RECIST v1.1 - Radiological tumor response using two perpendicular diameters - Event free survival (EFS) - Rate of breast conserving surgery (BCS) at the time of definitive surgery - Conversion of intention for mastectomy to BSC and axillary lymph node dissection (ALND) to sentinel lymph node dissection (SLND) or tailored axillary surgery (TAS) after treatment ### Location - Facility: Tumor Zentrum Aarau, Aarau, N/A, 5000, Switzerland @@
## Applied Clinical Neuroscience and Its Effect on Self-reported Stress and Other Physiological Markers - NCT ID: NCT06358560 - Study ID: BrainHealthClinics - Status: RECRUITING - Start Date: 2024-03-04 - Completion Date: 2024-12-15 - Lead Sponsor: Dylan Saulsbery ### Study Description The purpose of this study is to see if an applied clinical neuroscience (ACN) approach to the symptom of 'stress' has a measurable effect on an individual's self-reported stress level. Physiological markers will be measured and analyzed to potentially allow for greater insight and aid in setting up any future research on this topic. This is an independent research study. ### Conditions - Stress ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Therapeutic exercises ### Outcomes Primary Outcomes - NIH Toolbox® Item Bank v3.0 - Perceived Stress (Ages 18+) - Fixed Form Secondary Outcomes ### Location - Facility: The Brain Health Clinics, Nashville, Tennessee, 37217, United States @@
## Preimplantation Genetic Testing for Aneuploidy (PGT-A) in Women Aged 37-41 Years - NCT ID: NCT06358547 - Study ID: H-23072469 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2029-04-01 - Lead Sponsor: Rigshospitalet, Denmark ### Study Description A multinational multi-centre, randomized, controlled non-blinded trial with participation of three fertility clinics in Denmark and one in Spain to assess the efficacy and safety of preimplantation genetic testing for aneuploidy (PGT-A) in 37-41-year-old women. ### Conditions - Infertility ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - PGT-A ### Outcomes Primary Outcomes - Live birth rate per first embryo transfer - Cumulative live birth rate after one complete ART treatment Secondary Outcomes ### Location - Facility: Rigshospitalet, København Ø, N/A, 2100, Denmark @@
## The Effect of Acceptance and Commitment Therapy in Patients With Chronic Renal Failure - NCT ID: NCT06358534 - Study ID: RTEU-SBF-KB-01 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-06-01 - Completion Date: 2024-07-30 - Lead Sponsor: Recep Tayyip Erdogan University ### Study Description Psychological flexibility, life satisfaction and adaptation to the disease of individuals with chronic kidney disease were increased with psychoeducation based on acceptance and commitment therapy to be given to individuals with chronic kidney disease. ### Conditions - Kidney Failure, Chronic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - psychoeducation based on acceptance and commitment therapy ### Outcomes Primary Outcomes - Chronic Disease Adaptation Scale (CHAS): - Acceptance and Action Questionnaire-II Scale (AAQ-II) - Life Satisfaction Scale Secondary Outcomes ### Location - Facility: Recep Tayyip Erdoğan University Faculty of Health Sciences, Rize, Güneysu, 53100, Turkey @@
## Determining the Impact of a Physiotherapist-led Primary Care Model for Hip and Knee Pain - A Cluster Trial - NCT ID: NCT06358521 - Study ID: 6040471 - Status: RECRUITING - Start Date: 2023-10-02 - Completion Date: 2025-11-01 - Lead Sponsor: Queen's University ### Study Description This is a cluster randomized controlled trial to to evaluate the individual and health system impacts of implementing a new physiotherapist-led primary care model for hip and knee pain in Canada. ### Conditions - Hip Osteoarthritis - Knee Osteoarthritis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Physiotherapist-led primary care model for hip and knee pain - Usual physician-led primary care model for hip and knee pain ### Outcomes Primary Outcomes - Self-Reported Functioning Secondary Outcomes - Self-Reported Pain Intensity - Health-Related Quality of Life - Pain Self Efficacy - Catastrophic Thinking - Fear of Movement - Depression Subscale - Global Rating of Change - Satisfaction with Health Care - Adverse Events - Health-Care Utilization - Consultations in Electronic Medical Record (EMR) - Health-Care Utilization Survey - Visits to health professionals - Health-Care Utilization Survey - Medications - Health-Care Utilization Survey - Walk-In Clinic Visits - Health-Care Utilization Survey - Emergency Department Visits - Health-Care Utilization Survey - Inpatient Hospital Stays - Health-Care Utilization Survey - Surgeries, Procedures, Injections - Health-Care Utilization Survey - Specialist Visits - Health-Care Utilization Survey - Diagnostic Imaging - Process Outcome - Medications prescribed - Process Outcome - Diagnostic Imaging Ordered - Process Outcome - Exercises Prescribed - Process Outcome - Education Provided - Process Outcome - Referrals to other health care providers (HCPs) - Process Outcome - Primary Care Visits - Process Outcome - Notes to Employers or Insurers - Self-Report Time Lost - Assistance Needed - Extra Expenses - Cost outcomes - Health Care Accessibility ### Location - Facility: Queen's University, Kingston, Ontario, K7L3N6, Canada @@
## Sapphire 3 CTO Study - NCT ID: NCT06358508 - Study ID: VP-0786 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2025-07 - Lead Sponsor: OrbusNeich ### Study Description A prospective, open label, multi-center, single arm, observational study designed to evaluate the acute safety and device performance of the Sapphire 3 0.85, 1.0 and 1.25mm diameter coronary dilatation catheter in predilatation of Chronic Total Occlusion (CTO) lesions during percutaneous coronary intervention.One hundred seventy (170) subjects will be enrolled with a target of one hundred fifty-three (153) evaluable subjects by the angiographic core laboratory at up to 15 clinical sites with the Sapphire 3 0.85, 1.0 and 1.25mm diameter PTCA dilatation catheter to pre-dilate CTO lesions in coronary arteries during their index procedure. All subjects will be screened according to the protocol inclusion and exclusion criteria and will be followed through study completion, which is defined as 24-hours post-procedure or hospital discharge, whichever comes first. ### Conditions - Coronary Artery Disease - Coronary Disease - Myocardial Ischemia - Heart Diseases - Arteriosclerosis - Cardiovascular Diseases - Chronic Total Occlusion - Chronic Total Occlusion of Coronary Artery ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Sapphire 3 Coronary Dilatation Catheter ### Outcomes Primary Outcomes - Number of Participants With Device Procedural Success Secondary Outcomes - Number of Participants With In-hospital Major Adverse Cardiac Events (MACE) - Number of Deaths (Cardiac and Non-Cardiac) - Number of Participants With Myocardial Infarctions (MI) - Number of Participants With Target Lesion Revascularization (TLR) - Number of Participants With In-hospital stent thrombosis (ST) Within the Target Vessel - Number of Participants With Clinically Significant Arrhythmias (Requiring Intervention) - Number of Participants With Absence of Sapphire 3 Study Balloon Rupture - Number of Participants That Had Improvement in the Minimum Lumen Diameter (MLD) following use of Sapphire 3 catheter (independently measured by the Angiographic Core Lab using QCA) - Number of Participants With Technical Success ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Improving Sleep to Prevent Depression & Anxiety in Adolescents at High Risk - NCT ID: NCT06358495 - Study ID: REB24-0253 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-07-30 - Lead Sponsor: University of Calgary ### Study Description Emerging evidence has shown that sleep interventions such as Cognitive Behavioral Therapy for Insomnia (CBT-I) improve depressive and anxiety symptoms in adults, even when the intervention is brief, such as four to six sessions. The overarching aim of the proposed research is to conduct a pilot trial to evaluate whether a brief intervention for insomnia adapted for improves sleep and subthreshold depressive and anxiety symptoms in adolescents at risk (i.e., with a parental history of depressive or anxiety disorders). ### Conditions - Insomnia - Sleep Disturbance - Depressive Symptoms - Anxiety Symptoms ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Cognitive Behavioral Therapy for Insomnia - Active Control ### Outcomes Primary Outcomes - Insomnia Severity Index - Pittsburgh Sleep Quality Index - Internalizing Symptoms Subscale of the Youth Self-Report Secondary Outcomes - Sleep Logs - Total sleep time - Sleep Logs - Onset latency - Sleep Logs - Wake after sleep onset - Sleep Logs - Sleep efficiency ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Electric Toothbrush Efficacy in Preventing Dental Plaque Development - NCT ID: NCT06358482 - Study ID: ORAL1 - Status: RECRUITING - Start Date: 2023-01-30 - Completion Date: 2024-07-30 - Lead Sponsor: Riccardo Polosa ### Study Description The present study will be the first to compared dental plaque quantitation between an oscillating-rotating electric toothbrush and a manual toothbrush with a new QLF technology. ### Conditions - Dental Plaque - Calculus, Dental ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - oscillating toothbrush - standard manual toothbrush ### Outcomes Primary Outcomes - fluorescence intensity of at least 30% (ΔR30) - the fluorescence intensity of at least 120% (ΔR120) Secondary Outcomes - oral hygiene (SOH) scoring, The score can be from 0, 1, .. to 5. A SOH value of 0 indicates no plaque, and 5 is the maximum and stands for maximum plaque teeth coverage an is the worst state. ### Location - Facility: ADDENDO, Catania, N/A, 95100, Italy @@
## STRatIfication of Vulvar SCC by HPV and p53 Status to Guide Excision - NCT ID: NCT06358469 - Study ID: VU2 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-30 - Completion Date: 2031-11-30 - Lead Sponsor: Canadian Cancer Trials Group ### Study Description This study is being done to answer the following question: Are there types of early-stage vulvar cancer that require either less or more treatment than the usual approach? ### Conditions - Vulvar Squamous Cell Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Surgery - Active Surveillance ### Outcomes Primary Outcomes - Estimate the 3-year local recurrence rates in patients with HPV-Independent (HPV-I) and HPV-Associated (HPV-A) vulvar squamous cell carcinoma (VSCC) surgically managed based on dVIN/p53 status and tumour margin clearance Secondary Outcomes - HPV-I and HPV-A VSCC cohorts: Recurrence-free survival - HPV-I and HPV-A VSCC cohorts: Disease-specific survival - HPV-I and HPV-A VSCC cohorts: Overall-survival - HPV-I and HPV-A VSCC cohorts: Estimate health economic impact of surgical management based on molecular biomarker stratification and margin status assessment utilizing EQ-5D-5L - HPV-I and HPV-A VSCC cohorts: Describe patient-reported outcomes utilizing EORTC QLQ-C30 - HPV-I and HPV-A VSCC cohorts: Describe patient-reported outcomes utilizing EORTC QLQ-VU34 - HPV-I and HPV-A VSCC cohorts: Describe patient-reported outcomes utilizing Fear of Recurrence Scale - HPV-I cohort: Estimate recurrence rates of vulvar dVIN and/or p53abn ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Influence of Artificial Tears on Keratometry and Biometry Measurements With Different Devices - NCT ID: NCT06358456 - Study ID: 20-928 - Status: COMPLETED - Start Date: 2020-11-20 - Completion Date: 2022-04-22 - Lead Sponsor: University Clinic Frankfurt ### Study Description The goal of this clinical trial is to learn about the influence of artificial tears on measurements of healthy eyes with three different devices. The main questions it aims to answer are:* Do artificial tears alter the measurements of the corneal surface* Is there a difference between the devices used in this studyThis is relevant because high quality measurements improve the postoperative outcome after cataract surgery. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Artificial tear - No artificial tears ### Outcomes Primary Outcomes - Does the application of artificial tears (Artelac EDO) alter the measurement of the anterior surface of the cornea (K mean in Diopters) using devices that either use keratometry or Scheimpflug-technology (IOL Master 700, Pentacam AXL or Galilei G6) Secondary Outcomes - Is there any difference in anterior corneal refractive power measurements (K mean in Diopters) between the three different devices (IOL Master 700, Pentacam AXL, Galilei G6) after artificial tear (Artelac EDO) application? - Does the application of artificial tears (Artelac EDO) alter the anterior astigmatism measurements (in diopters) using devices that either use keratometry or Scheimpflug-technology (IOL Master 700, Pentacam AXL or Galilei G6) - If there is an influence of artificial tears (Artelac EDO) on the measurement of the anterior surface of the cornea (K mean in Diopters) using the devices (IOL Master 700, Pentacam AXL or Galilei G6), how long does it last (in minutes)? ### Location - Facility: Goethe University Hospital, Frankfurt, Hesse, 60590, Germany @@
## The Long-term Effect of Daily Jarlsberg Cheese Intake in Patient With Osteopenia - NCT ID: NCT06358443 - Study ID: PF-Jarlsberg/IIIB - Status: NOT_YET_RECRUITING - Start Date: 2024-04-02 - Completion Date: 2025-02-23 - Lead Sponsor: Meddoc ### Study Description Aim: To estimate the effect of daily optimal efficacy dose (OED) of Jarlsberg cheese in patients with Osteopeni (OP).Study population: Post-menopausal women and men above 55 years of age in risk of Osteoporosis Treatment: Daily OED Jarlsberg cheese + vitamin D and Calcium tablets. Design: An open and one-armed observational study. Main variables: Bone Mineral Density (BMD), Bone turnover markers (BTMs), Osteocalcin and K2 vitameres.Study Procedure: Prior to inclusion in this study, all the patients have undergone 32 days of daily OED intake of Jarlsberg cheese + vitamin D and caicium tablets. Thid is the baseline of this observational study. The duration of this study is 12 months with clinical examination and bloodsampling after 6 and 12 months.Sample size: At least 16 patients will be included ### Conditions - Osteoporosis - Osteopenia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Jarlsberg cheese ### Outcomes Primary Outcomes - Bone Mineral Density - Bone Turnover Markers - Osteocalcin Secondary Outcomes - Vitamin K2 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Phase 1 Dose Escalation and Expansion Study of TROP2 CAR Engineered IL-15- Transduced Cord Blood-derived NK Cells in Combination With Cetuximab in Patient With Colorectal Cancer (CRC) With Minimal Residual Disease (MRD) - NCT ID: NCT06358430 - Study ID: 2023-1017 - Status: NOT_YET_RECRUITING - Start Date: 2024-10-31 - Completion Date: 2029-01-18 - Lead Sponsor: M.D. Anderson Cancer Center ### Study Description To find the highest and/or recommended dose of TROP2-CAR-NK cells combined with cetuximab in participants with MRD CRC. ### Conditions - Colorectal Cancer - Minimal Residual Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Fludarabine Phosphate - Cyclophosphamide - Cetuximab - TROP2-CAR-NK Cells - Rimiducid (AP1903) - Lymphodepleting Chemotherapy ### Outcomes Primary Outcomes - Safety and adverse events (AEs) Secondary Outcomes ### Location - Facility: MD Anderson Cancer Center, Houston, Texas, 77030, United States @@
## CHW Intervention to Improve Nutrition Security of Patients With Hypertension - NCT ID: NCT06358417 - Study ID: 2024P000873 - Status: NOT_YET_RECRUITING - Start Date: 2024-08-01 - Completion Date: 2027-05-01 - Lead Sponsor: Massachusetts General Hospital ### Study Description The goal of this study is to implement and evaluate a randomized pilot study of a 4-month Nutrition-enhanced community health worker (CHW) intervention for primary care patients with nutrition insecurity and poorly controlled hypertension. The nutrition intervention will be added to the pre-existing Massachusetts General Hospital CHW hypertension (Basic CHW) program that provides hypertension education, coaching about adherence to medications and primary care visits, and home BP cuffs and promotion of BP self-monitoring over the course of approximately 4 months. ### Conditions - Hypertension - Nutrition, Healthy - Food Insecurity - Community Health Worker ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Nutrition-enhanced CHW - Basic CHW ### Outcomes Primary Outcomes - Feasiblity - Feasibility of CHW nutrition intervention (intervention arm only) - Acceptability (intervention arm only) Secondary Outcomes - Diet quality - Blood pressure ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Developing a Peer Support Intervention for Depression in SCD - NCT ID: NCT06358404 - Study ID: 2024P000615 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-04-30 - Lead Sponsor: Massachusetts General Hospital ### Study Description The purpose of this study is to assess the feasibility, acceptability, and fidelity of an 8-week intervention where peer coaches will deliver depression care to adults 60 years of age or older who have depression and subjective cognitive decline. ### Conditions - Subjective Cognitive Decline - Depression in Old Age ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - PeersCOG ### Outcomes Primary Outcomes - Feasibility of Intervention - Acceptability of Intervention - Fidelity of Intervention Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Puncture for Left Atrial Access. - NCT ID: NCT06358391 - Study ID: TS-RF system - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-03-31 - Lead Sponsor: Starmed ### Study Description The purpose of this study is to compare and assess efficacy and safety between the study device "TS-RF system consisting of a electrosurgical system, general-purpose (TS-RF Generator) and a electrosurgical system electrode, hand-controlled, general-purpose, single-use (TS-RF Needle)" and the control device "needle, puncture, single-use (BRK Transseptal needle)", both of which are used for the transseptal puncture performed to enable left atrial access for the treatment of symptomatic arrhythmia and mitral stenosis and then to demonstrate that the study device is non-inferior to the control device. ### Conditions - Arrhythmias, Cardiac - Atrial Fibrillation - Heart Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - TS-RF Transseptal Needle - BRK Transseptal Needle ### Outcomes Primary Outcomes - First-pass TSP Success Rate (percent) Secondary Outcomes - TSP Time (Second) - Fluoroscopy Time (Second) for TSP - Needle cross-over between the study and control groups - Intra-TSP procedural device-associated complications - Changes in patient's quality of life - Complications ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Accuracy of Cuffless Ambulatory Blood Pressure Monitors Compared to Cuff-based Monitors in an Ambulatory Elderly Population: A Pilot Study - NCT ID: NCT06358378 - Study ID: 995 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2024-09-30 - Lead Sponsor: Sligo General Hospital ### Study Description Hypertension is extremely common amongst the elderly, typically manifesting as a silent disease with potentially devastating consequences if left undetected and untreated. Such consequences include stroke, myocardial infarction, kidney and eye disease. Opportunistic screening for hypertension is therefore standard in clinical practice. Currently, the standard of care for screening in the western world is with 24-hour ambulatory cuff-based devices which are often intolerable, particularly for elderly patients.Several novel cuffless wearables have been developed to overcome the limitations of cuff-based monitors. These devices offer significant advantages over cuff-based devices, including improved patient tolerance and user acceptability. Numerous cuffless monitors are now commercially available. However, validation of such devices is challenging as there is no current universal standard for validating such devices.5 This is highlighted by the heterogenous and often inadequate study methods used to demonstrate accuracy of commercially available cuffless devices for blood pressure measurements. Indeed, the uncertainty about their merit is reflected in international guidelines. The 2023 European Society of Hypertension guidelines currently do not recommend routine use of such devices in clinical practice for evaluation of blood pressure.There are limited clinical trials comparing 24-hour cuff-based devices directly to cuffless devices, and even fewer specifically in an elderly population where they may be particularly advantageous due to design features that improve tolerability. This study thus aims to address this important gap in the literature to better understand if cuffless devices provide reliable blood pressure measurements in the elderly population by directly comparing these devices to the current standard of care in blood pressure evaluation. The Aktiia device will be used as a surrogate for cuffless wearables while a standard 24-hour ambulatory cuff-based device will represent cuff-based devices. The Aktiia device is a cuffless solution worn as a bracelet on the wrist. It contains optical sensors which collect photoplethysmography signals from arteries in the patient's wrist and uses these to estimate blood pressure. This device is commercially available and clinically validated for use in patients up to age 85. ### Conditions - Hypertension ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Aktiia SA Bracelet ### Outcomes Primary Outcomes - Mean paired difference between cuffless daytime blood pressure measurements (systolic and diastolic) and cuff-based measurements Secondary Outcomes - Mean paired difference between cuffless daytime blood pressure measurements (systolic and diastolic) and cuff-based measurements taken in a resting state - Mean difference between mean 24-hour cuffless daytime blood pressure measurements (systolic and diastolic) and cuff-based measurements on a per patient basis - Tolerability : Mean paired differences on Comfort Rating Scale (CRS) between devices - User Acceptability: Mean paired differences on System Usability Scale (SUS) between devices ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Enhancing Fluid Transfer Through the Skin, by Increased Sweat Rate, on Hemodialysis Patients - NCT ID: NCT06358365 - Study ID: AQP-DCL-026 - Status: COMPLETED - Start Date: 2023-03-29 - Completion Date: 2023-11-07 - Lead Sponsor: AquaPass Medical Ltd. ### Study Description To demonstrate safety and performance of AquaPass System for improving fluid balance in hemo-dialysis patients, by increasing fluid loss via the skin. ### Conditions - Acute Kidney Failure - Chronic Kidney Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - The AquaPass System ### Outcomes Primary Outcomes - Differences in weight gain over the long interdialytic period - Device related Adverse Events Secondary Outcomes - Changes in NT-proBNP - Changes in Blood Urea Nitrogen - Effect on Quality of Life - Affect on Ultrafiltration Rates after the long inter dialytic gap ### Location - Facility: Nazareth Hospital EMMS, Nazareth, Al Wadi Al Jawani 1611, 16100, Israel @@
## Clinical and Radiographic Assessment of PRF Versus Lutein Placement - NCT ID: NCT06358352 - Study ID: M18080921 - Status: COMPLETED - Start Date: 2021-10-01 - Completion Date: 2023-05-01 - Lead Sponsor: Mansoura University ### Study Description Thirty patients seeking for prosthetic replacement of non-restorable single rooted maxillary teeth by dental implant placement will be selected from the Out-Patient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University.Inclusion criteria: 1. Badly destructed maxillary single rooted teeth due to trauma or caries. 2. Age between 20 and 45 years. 3. Good oral hygiene. 4. Patients willing to complete the study follow up intervals. 5. Patients will be informed about the aim of the study and a written consent will be obtained. The patients have the right to withdraw from the study at any time.Exclusion criteria: 1. periapical infection in the teeth to be replaced. 2. Alcohol or drug abuse. 3. Patients with systemic diseases that absolutely contraindicate implant placement 4. Pregnancy. 5. Patients with parafunctional habits (bruxism and clenching) 6. Uncooperative patients 7. Heavy smokers.7Patients grouping: Patients will be randomly divided into three groups:Group A: Immediate implant placement with leaving the gap distance emptyGroup B: Immediate implant placement then placement of PRF around the implant in the gap distanceGroup C: Immediate implant placement then placement of lutein around the implant in the gap distanceClinical evaluation:Patients will be evaluated clinically for:1-Postoperative Pain: By using a 10-point Visual Analogue Scale (VAS) for assessment of pain by the patient on the 1st, 3rd, and 7th days after surgery.(10) (0-1=None, 2-4=Mild, 5-7=Moderate, 8-10=Severe) 2. Implant stability Will be assessed at the time of implant insertion and at a period of 3, 6 and 12 months intervals. Resonance frequency analysis (RFA) values expressed as implant stability quotient (ISQ) will be recorded by a transducer attached to the implant by a screw and a frequency response analyzer (Osstell Mentor Device) with the average of 2 measurements performed with the probe in 2 perpendicular directions.3. Sulcus Bleeding Index (SBI) An early sign of gingivitis is bleeding on probing and, in 1971, Muhlemann and Son described the Sulcus Bleeding Index (SBI). It will be assessed at 3, 6 and 12 months intervals.4. Peri-implant probing depth: Depth of the peri-implant sulcus will be made at 3, 6 and 12 months intervals with light force to avoid undue tissue damage and over-extension into the healthy tissue.Radiographic evaluation:conebeam CT will be done to evaluate the vertical and horizontal changes to the alveolar bone following immediate implant placement. It will be done immediately after implant placement , after 3 months and after 12 months ### Conditions - Osteogenesis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Lutein / Zeaxanthin - Platelet rich fibrin ### Outcomes Primary Outcomes - bone formation Secondary Outcomes ### Location - Facility: faculty of dentistry,Mansoura university, Mansoura, N/A, N/A, Egypt @@
## TEEM-GIFTS: A Gamified mHealth to Reduce Post-Discharge Suicide Risk - NCT ID: NCT06358339 - Study ID: 72374095 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-01 - Completion Date: 2027-12-31 - Lead Sponsor: Shenzhen Kangning Hospital ### Study Description Patients with mental disorders are at significantly higher risk of suicide after discharge compared to the general population and patients with other diseases. Currently, there is a lack of post-discharge community suicide risk management services in China. The research team's preliminary research suggests that mHealth interventions are well-accepted and feasible for reducing the suicide risk in patients with mental disorders. Furthermore, the inclusion of gamification elements can enhance treatment adherence and user engagement. However, determining the appropriate combination of gamification elements and evaluating the implementation effectiveness of gamified mHealth interventions for suicide risk are challenges in transforming these into regular community mental health services. This study will leverage gamification theory and community-based participatory research to design a gamified mHealth intervention model aimed at reducing suicide risk among discharged patients with mental disorders, and to develop a corresponding management strategy. Using the multi-phase optimization strategy (MOST), the study will identify the optimal combination of gamification elements to reduce suicide risk and increase the outpatient follow-up rate. Through an implementation science framework, the investigators will evaluate the process, outcomes, feasibility, and sustainability of this management strategy with the goal of reducing suicide risk among these patients. The findings from this study will provide a scientific basis for innovative suicide risk management models for discharged patients with mental disorders in China, thereby paving the way for the application of implementation science in mental health. ### Conditions - Suicide ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - TEEM ### Outcomes Primary Outcomes - Suicide ideation at three months after discharge - The rate of re-visits to outpatient clinic at three months after discharge Secondary Outcomes - Self-determination at at three months after discharge - Social connectedness at three month after discharge - Social support at three months after discharge ### Location - Facility: Shenzhen Kangning Hospital, Shenzhen, Guangdong, 518020, China @@
## Dry Needling and Rehabilitatin Carpal Tunnel Syndrome - NCT ID: NCT06358326 - Study ID: Karabuk-1 - Status: RECRUITING - Start Date: 2024-04-05 - Completion Date: 2024-09-30 - Lead Sponsor: Karabuk University ### Study Description Dry needling is used for myofascial release. However, its effectiveness in carpal tunnel syndrome (CTS) is not well known. It is thought that dry needling may also be an effective treatment for CTS by providing relaxation in the fascial tissue. Therefore, this study will examine the effects of dry needling treatment on pain, function, range of motion, proprioception and disability in patients with CTS. ### Conditions - Dry Needling - Carpal Tunnel Syndrome - Myofacial Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Dry needling - Control group ### Outcomes Primary Outcomes - Pain severity - Wrist range of motion - Position sense - Severity of symptoms - Functional status - Hands activity level - neuropathic pain severity - Nerve cross-sectional area Secondary Outcomes ### Location - Facility: Pursaklar State Hospital, Ankara, N/A, N/A, Turkey @@
## Concomitant Use of Clopidogrel With Atorvastatin or Rosuvastatin in Patients With Minor Stroke or TIA - NCT ID: NCT06358313 - Study ID: 0023098816 - Status: RECRUITING - Start Date: 2024-04-10 - Completion Date: 2025-05-10 - Lead Sponsor: Kafrelsheikh University ### Study Description Along with the current clinical trial, the impact of adding atorvastatin or rosuvastatin in the first 24 hours on the clinical outcomes of first-ever minor stroke or TIA patients treated with clopidogrel and aspirin assessed through NIHSS, mRS, and possible adverse effects. ### Conditions - Ischemic Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Atorvastatin 40mg - Rosuvastatin 20mg ### Outcomes Primary Outcomes - the rate of new stroke at 90 days Secondary Outcomes - Value of National Institute of Health Stroke Scale (NIHSS) after one week - value of Modified Rankin Scale (mRS) at one week - value of Modified Rankin Scale(mRS) at three months - rate of composite recurrent stroke, myocardial infarction, and death due to vascular events - rate of drug adverse effects - Drug adverse effects: all side effects related to the drugs of our study will be reported ### Location - Facility: Kafr Elsheikh University Hospital, Kafr Ash Shaykh, N/A, 33511, Egypt @@
## Visceral Adiposity Index Differences Between Subtypes of Polycystic Ovary Syndrome - NCT ID: NCT06358300 - Study ID: Usakpcos2 - Status: COMPLETED - Start Date: 2022-01-01 - Completion Date: 2023-07-20 - Lead Sponsor: Uşak University ### Study Description We aimed to investigate visceral adiposity index (VAI) in patients with different phenotype of policystic ovary syndrome (PCOS) and to compare healthy controls. ### Conditions - Visceral Adiposity Index - Polycystic Ovary Syndrome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Visceral Adiposity Index Differences Between Subtypes of Polycystic Ovary Syndrome Secondary Outcomes ### Location - Facility: Usak Training and Research Hospital, Usak, N/A, 64100, Turkey @@
## Neural Correlates of Auriculotherapy - NCT ID: NCT06358287 - Study ID: STUDY19030375 - Status: COMPLETED - Start Date: 2021-07-15 - Completion Date: 2022-11-07 - Lead Sponsor: Keith M. Vogt, MD, PhD ### Study Description Chronic pain continues to be a major health issue, creating a significant societal burden, as it is an independent risk factor for opioid use disorder (OUD) and deaths. Acute pain episodes can often engender OUD due to lack of effective strategies to treat pain and prevent the transition to chronic pain. One potential non-opioid method for pain relief is auriculotherapy (AT), where acupuncture-like treatment is administered to the ear. The objective of this pilot study is to illustrate that AT-related brain effects can be found using functional connectivity MRI (fcMRI) in patients with low back pain. ### Conditions - Chronic Pain ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - cryogenic auriculotherapy ### Outcomes Primary Outcomes - Default Mode Network (DMN)-to-Anterior Cingulate Cortex (ACC) connectivity Secondary Outcomes - Brief Pain Inventory (BPI) Severity Scores MRI #1 - BPI Pain Severity Scores MRI #2 - General Anxiety Disorder-7 (GAD-7) Scoring ### Location - Facility: UPMC Montefiore, Pittsburgh, Pennsylvania, 15213, United States @@
## Nutritional and Metabolic Dynamics of Thru-Hiking: A Longitudinal Study on the Colorado Trail - NCT ID: NCT06358274 - Study ID: MED-2024-32848 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-07-01 - Lead Sponsor: University of Minnesota ### Study Description Thru-hiking the Colorado Trail presents distinct challenges owing to its diverse landscapes and high altitudes. The study aims to delve into the physiological and nutritional facets of extended wilderness trekking among thru-hikers. Activities encompass participant recruitment from the Colorado Trail Foundation community, baseline and post-trail assessments including blood lipid panel analysis and anthropometric measurements, data collection during the trail period involving recording daily mileage, exertion levels, and dietary intake, rigorous statistical analysis to explore correlations among various parameters, and adherence to ethical considerations including obtaining formal approval and ensuring informed consent procedures are followed to safeguard participants' rights and privacy. Through this endeavor, the study seeks to offer insights into the metabolic responses and cardiovascular implications associated with thru-hiking, shedding light on the interplay between diet, lifestyle factors, and metabolic health in challenging environments.The specific aims include examining the metabolic responses and cardiovascular implications associated with thru-hiking, exploring correlations between dietary intake and blood lipid profiles, and elucidating the interplay between lifestyle factors and metabolic health in demanding environments. This study is not limited to program evaluation, quality assurance, or improvement activities within a specific department or setting but rather seeks to contribute to scientific knowledge and inform evidence-based recommendations for individuals engaging in thru-hiking or similar high-intensity activities. ### Conditions - Thru-hiking ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Thru-hiking ### Outcomes Primary Outcomes - blood lipid panel: total cholesterol - blood lipid panel: high-density lipoprotein (HDL) - blood lipid panel: low-density lipoprotein (LDL) - blood lipid panel: triglycerides Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Study of a Diabetes Prevention Patient Activation Clinical Decision Support Tool - NCT ID: NCT06358261 - Study ID: IRB00433279 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2025-09 - Lead Sponsor: Johns Hopkins University ### Study Description The investigators overarching goal is to increase the percentage of patients engaging in diabetes prevention activities to reduce the incidence of diabetes. The investigators objective is to design and pilot test a prediabetes clinical decision support (CDS) tool in the electronic health record (EHR) that will assess the patient's activation level based on responses to a questionnaire. Based on the patient's assessed level of activation, the tool will generate several communication recommendations to guide clinicians in conversations related to prediabetes/lifestyle change and tailor recommendations about available resources (e.g., care manager, health coach, DPP) to support patient activation. ### Conditions - PreDiabetes - Lifestyle, Healthy - Activation, Patient ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Diabetes Prevention Patient Activation Clinical Decision Support Tool ### Outcomes Primary Outcomes - patient activation as assessed by the Patient Activation Measure Survey (PAM) Secondary Outcomes - number of participants referred to Diabetes Prevention Program - number of participants prescribed metformin - percent of participants who make diet changes - change in amount and frequency of physical activity ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Standardized Physician-modified Fenestrated Endograft Registry - NCT ID: NCT06358248 - Study ID: SPHERE - Status: RECRUITING - Start Date: 2023-10-01 - Completion Date: 2033-10-01 - Lead Sponsor: University Hospital Padova ### Study Description Multicenter retrospective study including all consecutive patients treated by PMEG using a standard modification technique of Valiant Captivia (Medtronic, Minneapolis, MN-USA). ### Conditions - Aortic Aneurysm, Thoracoabdominal - Aortic Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Physician-modification of Valiant Captivia Endograft (Medtronic, Minneapolis, MN-USA). ### Outcomes Primary Outcomes - Technical success - Freedom from target vessel instability - Freedom from endograft instability Secondary Outcomes - Early (30-days) Major Adverse Event (MAE) - Aneurysm sac dynamics ### Location - Facility: Vascular and Endovascular Clinic - Padova University, Padova, N/A, 35020, Italy @@
## The Effect of Music Therapy on Dyspnea Severity and Vital Signs - NCT ID: NCT06358235 - Study ID: SDU-IH-HA-01 - Status: RECRUITING - Start Date: 2024-01-07 - Completion Date: 2024-06-30 - Lead Sponsor: Suleyman Demirel University ### Study Description This study aims to investigate the effect of music therapy on dyspnea severity and quality of life indicators in patients with Chronic Obstructive Pulmonary Disease (COPD) admitted to the intensive care unit. The study will be conducted at Isparta City Hospital and Kumluca State Hospital in Antalya, Turkey, using an experimental design. Patients will be divided into experimental and control groups, selected using randomization.Patients in the experimental group will receive music therapy in the Hüseyni maqam, while those in the control group will not receive any music therapy. Life indicators and Modified Borg Scale (MBS) values of patients in the experimental group will be recorded before, immediately after, and 30 minutes post-application. Music therapy will be administered to patients for only one day, once in the morning. Data for patients in the control group will be collected at the same time intervals. The results of this study aim to contribute to the literature on the impact of music therapy on dyspnea severity and quality of life indicators in COPD patients. ### Conditions - Dyspnea - Chronic Obstructive Pulmonary Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Music Therapy - No Music therapy ### Outcomes Primary Outcomes - Patient Identification Form - Modified Borg Scale - Vital Signs Record Chart - Blood Test Results Record Chart Secondary Outcomes ### Location - Facility: Suleyman Demırel University, Isparta, N/A, 32200, Turkey @@
## Predicting Non-small Cell Lung Cancer (NSCLC) Lymph Node Metastasis: Integrating Circulating Tumor DNA (ctDNA) Mutation/ Methylation Profiling With Positron Emission Tomography-computed Tomography (PET-CT) Scan - NCT ID: NCT06358222 - Study ID: LUNon-invasive - Status: RECRUITING - Start Date: 2023-12-15 - Completion Date: 2027-12-31 - Lead Sponsor: Shanghai Chest Hospital ### Study Description This is a single center, prospective and observational study conducted in three stages to predict the NSCLC lymph node metastasis based on ctDNA/specific methylation molecular features combined with PET-CT imaging features and intervention study. ### Conditions - Carcinoma - Non-small Cell Lung Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Blood ctDNA + methylation + PET-CT and Postoperative pathology - MRD+ methylation (or combined with PET-CT) and Invasive mediastinoscopy /EBUS-TBNA - Intraoperative lymph node dissection ### Outcomes Primary Outcomes - Negative prediction value (NPV) of lymph node metastasis rates - Disease-free survival (DFS) - ctDNA-free interval (CFI) Secondary Outcomes - Overall Survival (OS) ### Location - Facility: Shanghai Chest Hospital, ShangHai, N/A, N/A, China @@
## Safety and Efficacy of Ventricular Irrigation for Ventriculitis - NCT ID: NCT06358209 - Study ID: LY2024-045-B - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2026-05-30 - Lead Sponsor: RenJi Hospital ### Study Description Ventriculitis is a severe infectious disease of the central nervous system with diverse etiologies. Currently, the treatment for ventriculitis is challenging, with poor prognosis. The mortality rate of ventriculitis is generally reported to be higher than 30%, with the highest reaching over 75%. Even among survivors, over 60% suffer from a variety of neurological sequelae, including cognitive impairment, gait disturbances, paralysis, behavioral disorders, and epilepsy.Currently, treatments for ventriculitis recommended by guidelines primarily focus on the selection and administration of antibiotics, while the effects of surgical interventions have not been fully elucidated. In recent years, several studies have explored the use of ventricular irrigation in ventriculitis, indicating that ventricular irrigation techniques may accelerate the control of ventricular infection, mitigate damage to the central nervous system caused by infections, improve the prognosis of ventriculitis, and reduce complications such as hydrocephalus. However, current studies are still relatively scarce, and mostly case reports and retrospective studies. High-quality evidence is still lacking for the application of ventricular irrigation in ventriculitis.This multicenter randomized controlled trial aims to explore the safety and effectiveness of ventricular irrigation compared to conventional treatment for severe ventriculitis, analyze the effectiveness of ventricular irrigation across different pathogen subgroups, and investigate independent risk factors for different prognostic states in patients with severe ventriculitis. ### Conditions - Central Nervous System Infections ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ventricular irrigation ### Outcomes Primary Outcomes - Mortality rate Secondary Outcomes - GOSE - CRS-R - DRS - mRS - Microbial culture - CSF glucose - CSF protein - CSF WBC count - Length of stay ### Location - Facility: First Affiliated Hospital of Wannan Medical College, Wuhu, Anhui, N/A, China @@
## Complex Exploratory Study of Alcohol-Associated Hepatitis - NCT ID: NCT06358196 - Study ID: CESAH - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-04-30 - Lead Sponsor: Pavol Jozef Safarik University ### Study Description Alcohol-associated hepatitis is a clinical syndrome distinct from steatohepatitis or liver cirrhosis. It is associated with high mortality and characterized by an absence of effective treatment, while corticosteroids, which are currently used as the first-line treatment are effective only in a subpopulation of patients and only on 28-days survival - their effect on survival does not last beyond this interval. The proposed study is a complex exploratory study of alcohol-associated hepatitis with several epidemiology- and prognosis-related aims. ### Conditions - Alcoholic Hepatitis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Standardized annual incidence of (severe) alcoholic hepatitis in the Kosice Urban Area Secondary Outcomes - Threshold of alcohol consumption associated with (an increased risk of) developing AH - Diagnostic accuracy of NIAAA and NIAAAm-CRP - Prognostic performance of Maddrey, MELD, MELD-Na, MELD 3.0, GAHS, ABIC, Lille score - Prognostic performance of SOFA and CLIF-C - An update of Maddrey, MELD, MELD-Na, MELD 3.0, GAHS, ABIC, Lille score - Alternative to Lille model - Prognostic model for 90 day survival - Uper limit of MELD or Maddrey scores beyond which patients no longer derive any therapeutic benefit from corticosteroid treatment - Natural course of nonsevere alcoholic hepatitis - Natural course of severe alcoholic hepatitis - Risk score for bacterial infection before corticosteroid treatment in patients with alcoholic hepatitis - Distinguishing sterile Inflammation from infection in alcoholic hepatitis - GUT microbiome and treatment response in alcoholic hepatitis - Hypothalamus-pituitary-adrenal axis and treatment response in alcoholic hepatitis - Adherence to outpatient psychiatric management - Nutritional status and treatment response in alcoholic hepatitis ### Location - Facility: Pavol Jozef Safarik University, Kosice, N/A, 04012, Slovakia @@
## Surgical Capacity in Zimbabwean Public Hospitals - NCT ID: NCT06358183 - Study ID: ESC001 - Status: COMPLETED - Start Date: 2019-04-24 - Completion Date: 2024-03-15 - Lead Sponsor: Parirenyatwa Hospital ### Study Description This study aimed to understand how ready Zimbabwe's public hospitals are to perform essential surgeries, which are critical for treating a wide range of health issues from emergencies like car accidents to planned procedures such as childbirth by caesarean section. The researchers looked at hospitals across Zimbabwe to see what kind of surgery facilities, equipment, and specialists were available. ### Conditions - Surgery - Anesthesia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No intervention ### Outcomes Primary Outcomes - Bellwether procedures - Procedures - SAO density - Infrastructure Secondary Outcomes ### Location - Facility: Parirenyatwa Hospital, Harare, N/A, N/A, Zimbabwe @@
## Effects of Circuit Training Combine With Square-Stepping Exercise, Strength Training and Balance Training on Senior Fitness and Fall Risk in Elderly in the Community - NCT ID: NCT06358170 - Study ID: NYCU112169AF - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-07-01 - Lead Sponsor: Hsin-ching, Tsai ### Study Description According to the cause of death statistics compiled by the Ministry of Health and Welfare in 2022, among the causes of death among the elderly, falls ranked second among the causes of death from accidental injuries over the age of 65. Exercise has been proven to prevent falls in many studies, especially Square-Stepping Exercise can not only train strength and balance, but also improve cognitive function and reduce the fear of falling in the elderly. Therefore, this study will use Square-Stepping Exercise as the core and circuit training as the structure to design a set of exercise training that combines muscle strength and balance and is easy to implement in the community. The purpose of the study is to determine whether exercise training that combines circuit training with block stepping, muscle strength, and balance exercises can reduce the risk of falls among elderly people in the community (primary results: muscle strength, flexibility, cardiorespiratory endurance, balance; secondary results: cognitive function, Fear of falling, fall rate). This study will collect participant in the community, and subjects will be randomly assigned to the experimental group and the control group on a community basis. The experimental group will receive 12 weeks of exercise training, while the control group will follow their usual lifestyle, with 48 people in each group. The experimental design is exercise intervention for 12 weeks, twice a week, 90 minutes each time (30 minutes of main exercise). The exercise is designed into two stages according to the difficulty of Square-Stepping Exercise. The training of muscle strength and dynamic/static balance will also gradually increase in difficulty over the weeks. The research look forward to seeing the effects of multi-component exercise on physical fitness, cognitive function, fear of falling and fall rate. ### Conditions - Circuit-Based Exercise - Exercise Test - Community Health Nursing - Aged - Physical Fitness ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Circuit Training Combine with Square-Stepping Exercise ### Outcomes Primary Outcomes - Senior Fitness - upper body muscle strength (Arm Curl Test) - Senior Fitness - lower body muscle strength (Chair Stand Test ) - Senior Fitness - upper body flexibility (Back Scratch Test) - Senior Fitness - lower body flexibility (Chair Sit and Reach Test) - Senior Fitness - cardio respiratory endurance ( 2 Minute Step in Place Test) - Senior Fitness - dynamic balance (8-Foot Up and Go Test) - Senior Fitness - static balance (Single-Leg Balance with Eyes Open) Secondary Outcomes - cognitive function - Fear of falling - fall rate ### Location - Facility: National Yang Ming Chiao Tung University, Taipei, N/A, 112, Taiwan @@
## The Ladera Large Bore Closure Feasibility Study - NCT ID: NCT06358157 - Study ID: CLN02001 - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2025-02 - Lead Sponsor: Ladera Medical ### Study Description This study evaluates the safety and performance of the Ladera Medical suture-mediated large bore closure (LBC) system in gaining post procedure hemostasis in subjects undergoing interventional catheterization procedures using a large-bore procedure sheath. ### Conditions - Vascular Closure - Femoral Arteriotomy Closure ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Ladera LBC System ### Outcomes Primary Outcomes - Primary Safety Endpoint: Major Arterial Access Site Closure-related Complications - Primary Performance Endpoint: Time to Hemostasis Secondary Outcomes - Secondary Safety Endpoint: Minor Arterial Access Site Closure-related Complications - Secondary Performance Endpoint: Time-to-Ambulation - Secondary Performance Endpoint: Time-to-Discharge Eligibility - Secondary Performance Endpoint: Incidence of Procedural Success - Secondary Performance Endpoint: Incidence of Device Technical Success ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Cannabis Edibles Packaging Imagery Experiment - NCT ID: NCT06358144 - Study ID: IRB00111438 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2024-07 - Lead Sponsor: Wake Forest University Health Sciences ### Study Description The purpose of this study is to assess differences in perceptions of product appeal, harm, and subsequent willingness to try cannabis edibles products with/without packaging imagery. ### Conditions - Cannabis Use ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Packaging imagery - No Imagery (Control) ### Outcomes Primary Outcomes - Product Appeal Scoring - Harm Perceptions (Absolute) Scoring - Willingness to Try Product Scoring Secondary Outcomes - Appeal to Children Scoring - Harm Perceptions (Relative) Scoring - Perception of Quality Scoring ### Location - Facility: Wake Forest University Health Sciences, Winston-Salem, North Carolina, 27157, United States @@
## Propofol Versus Midazolam in Sedation for Upper and Lower Gastrointestinal Endoscopy. - NCT ID: NCT06358131 - Study ID: R.21.10.1493 - Status: RECRUITING - Start Date: 2022-01-01 - Completion Date: 2024-08-01 - Lead Sponsor: Mansoura University ### Study Description There has been rapid growth in the number and complexity of gastrointestinal (GI) endoscopic procedures performed during the last decade. To ensure safe and effective upper GI endoscopy, the choice of an appropriate sedative agent is crucial. Sedation usually categorized into four stages: minimal, moderate, deep and general anesthesia. The upper gastrointestinal \[GI\] endoscopy usually performed under moderate sedation Sedation usually categorized into four stages: minimal, moderate, deep and general anesthesia. The upper gastrointestinal \[GI\] endoscopy usually performed under moderate sedation. Benzodiazepines still the most common sedative agents used for conscious sedation, either solely or in combination with opioids for upper GI endoscopy. Propofol is a hypnotic drug used for induction of anesthesia with short half-life that permits rapid patient recovery and discharge. Thus, its use is for upper GI endoscopy was adopted in many endoscopy centers. So we are going to Evaluate all adverse events related to anesthesia; in patients recruited for upper and lower endoscopy and compare between propofol and midazolam based anesthesia associated adverse events.Also we are going to Evaluate patient and endoscopist satisfaction as regarding propofol and midazolam anesthesia. ### Conditions - Gastrointestinal Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SCREENING ### Interventions - Endoscopy ### Outcomes Primary Outcomes - Evaluate all adverse events related to anesthesia; in patients recruited for upper and lower endoscopy and compare between propofol and midazolam based anesthesia associated adverse events. Secondary Outcomes - Evaluate patient and endoscopist satisfaction as regarding propofol and midazolam anesthesia. ### Location - Facility: Mansoura University, Mansoura, Dakhlia, 35516, Egypt @@
## Buyuan-zhixiao Formula in the Treatment of Elderly Patients With Diabetes and Multiple Metabolic Disorders - NCT ID: NCT06358118 - Study ID: 2024-003-KY - Status: NOT_YET_RECRUITING - Start Date: 2024-05-06 - Completion Date: 2025-07-01 - Lead Sponsor: Qing Ni ### Study Description The primary objective of this clinical trial is to assess the clinical efficacy and safety of the Buyuan Zhixiao Formula in treating elderly patients with diabetes and multiple metabolic disorders exhibiting symptoms of renal deficiency and blood stasis. Furthermore, this study aims to intervene in high-risk factors to prevent arteriosclerosis and to investigate the clinical efficacy of the Buyuan Zhixiao Formula in the prevention and treatment of cognitive impairments.The main questions it aims to answer are:1. What are the clinical effects of Buyuan Zhixiao Formula, including lowering blood sugar, lowering blood pressure, lowering lipids, and treating obesity?2. Can Buyuan Zhixiao Formula improve cognitive impairment in diabetes? Researchers compared Buyuan Zhixiao Formula with a placebo (a drug that looks similar but contains only 10% of the active ingredients) to see if the drug Buyuan Zhixiao Formula can treat elderly people with diabetes and multiple metabolic disorders.Participants will:1. Take the drug Bu Yuan Zhi XiaoFormula or placebo every day for 6 months；Follow-up for 6 months；2. Check fasting blood sugar and 2-hour postprandial blood sugar every month; check HbA1c, blood lipids, vascular function, and cognitive impairment serum markers every 3 months;3. Conduct scores on TCM symptoms, cognitive ability, nutritional status and other scales and adverse events;4. Urine and serum samples were collected before and after treatment; ### Conditions - Diabete Mellitus - Aging - Metabolic Disorders - Traditional Chinese Medicine - Randomized Controlled Trial ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Buyuan Zhixiao Formula - Placebo ### Outcomes Primary Outcomes - HbA1c Secondary Outcomes - Fasting blood glucose - 2-hour postprandial blood glucose - blood pressure - weight - waist circumference - BMI - Total Cholesterol - Triglycerides - High density lipoprotein cholesterol - Low density lipoprotein cholesterol - Ankle-Brachial Index（ABI） - Fasting insulin - C-peptide - insulin resistance index - islet β-cell function index - lipid Lipid accumulation product - visceral adiposity index - Measurement Results of Tumor Necrosis Factor-alpha Levels at Different Time Points - Concentration Variation of Interleukin-10 - Change in Homocysteine Levels - Average Concentration of Interleukin-6 - Change in Endothelin-1 Levels - Average Concentration of Nitric Oxide - Concentration Variation of Von Willebrand Factor - Measurement Results of Vascular Endothelial Growth Factor Levels at Different Time Points - Change in Matrix Metalloproteinase-9 Levels" or "Participants' Matrix Metalloproteinase-9 Concentration - Average Concentration of Soluble Intercellular Adhesion Molecule-1 - Change in Serum Tau Protein Levels - Average Concentration of Aβ40 - Average Concentration of Aβ42 - Change in Neurofilament Light Chain Protein Levels - Carotid Ultrasound; Carotid Intima-Media Thickness. - Activities of Daily Living Scale score; Fried Frailty Phenotype Scale; Mini Nutritional Rating Scale; MoCA scale score; Traditional Chinese Medicine Kidney Deficiency and Blood Stasis Syndrome Scale score. - Montreal Cognitive Assessment Score - Fried Frailty Phenotype Scale - Activities of Daily Living Scale score - Mini Nutritional Rating Scale - Serum and urine metabolomics ### Location - Facility: China Academy of Chinese Medical Sciences Guang'anmen Hospital, Beijin, Beijing, 100053, China @@
## Simulator Training to Improve Interventional Cardiologist Skills (STARTERS) Trial - NCT ID: NCT06358105 - Study ID: id. 6457 - Status: NOT_YET_RECRUITING - Start Date: 2024-11-15 - Completion Date: 2025-11-15 - Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Study Description The goal of this clinical trial is to learn if simulator-based training will improve interventional cardiology fellows' skills and will improve patient outcomes.The main questions it aims to answer are:* Does this training improve specific operative parameters recorded during initial coronary interventions performed as first operators under senior supervision?* Will major and minor procedural complications be reduced after simulator-based training?Interventional cardiology fellows in their first year of training will be randomized between standard master-apprentice training or simulator-based training before starting their cath lab period.They will be supervised during their cath lab period as first operators by senior interventional cardiologists.During their first 50 procedures performed as supervised first operator, specific procedural data will be collected. ### Conditions - Coronary Artery Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Simulator-based training - Standard training ### Outcomes Primary Outcomes - Mean total fluoroscopy radiation time (expressed in seconds) Secondary Outcomes - Mean arterial cannulation time (expressed in seconds) - Total radiation dose (expressed in cGycm2) - Total contrast dose (expressed in ml) - Failure to achieve arterial cannulation (e.g.: rate of failure for each partecipant) - Failure to achieve right coronary cannulation (e.g.: rate of failure for each partecipant) - Failure to achieve left coronary cannulation (e.g.: rate of failure for each partecipant) - Number of catheters used - Any major or minor procedural and clinical complication ### Location - Facility*: Fondazione Policlinico Univrsitario Agostino Gemelli IRCCS, Rome, N/A, 00168, Italy @@
## Two-dimensional Shear Wave Elastography for Assessment of Cirrhosis and Portal Hypertension - NCT ID: NCT06358092 - Study ID: ZSSYXHNK2401 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-01-01 - Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University ### Study Description Exploring and establishing new non-invasive risk stratification techniques for portal hypertension based on E imaging technology for measuring liver and spleen stiffness is an urgent need in this field of research. ### Conditions - Cirrhosis, Liver - Portal Hypertension ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Hepatic venous pressure gradient - Two-Dimensional Shear Wave Elastography ### Outcomes Primary Outcomes - the diagnostic performance of liver and spleen stiffness by E imaging technology for clinically significant portal hypertension Secondary Outcomes - the diagnostic performance of microvessel imaging of hepatic microcirculation by E imaging technology for clinically significant portal hypertension - the difference among left, middle and right hepatic venous pressure gradient ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Re-infusion of Unwashed Shed Blood During Off-pump Surgery - NCT ID: NCT06358079 - Study ID: 258 - Status: RECRUITING - Start Date: 2024-03-27 - Completion Date: 2026-03-30 - Lead Sponsor: Damascus University ### Study Description To assess the efficacy and side-effects of re-infusion of unwashed shed blood during off-pump coronary artery surgery using a novel cardiotomy circuit. ### Conditions - Coronary Artery Disease - Blood Transfusion Complication - Cardiovascular Complication ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Re-infusion of unwashed shed blood ### Outcomes Primary Outcomes - blood transfusion requirements - inflammatory response - alveolar/arterial oxygen pressure gradients - cost-benefit - Neuro-markers - myocardial marker CK-MB - myocardial marker troponin-I - blood loss - complement response Secondary Outcomes ### Location - Facility: Damascus University Cardiac Surgery Hospital, Damascus, N/A, N/A, Syrian Arab Republic @@
## The Remineralization of Early Enamel Caries in Permanent Teeth - NCT ID: NCT06358066 - Study ID: self assembling peptides - Status: NOT_YET_RECRUITING - Start Date: 2024-04-06 - Completion Date: 2024-12-06 - Lead Sponsor: Tanta University ### Study Description Evaluate clinically the remineralizing potential of self-assembling peptide ( P11-4) fluoride plus in early enamel carious lesions of permanent anterior teeth. ### Conditions - White Spot Lesion ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - diagnodent - ICDAS 2 ### Outcomes Primary Outcomes - measurement of mineral contents of teeth with early carious lesions among 2 arms. quantitatively using the laser fluorescence DIAGNOdent and qualitatively using ICDAS II scoring system Secondary Outcomes - measurement of mineral contents of teeth with early carious lesions among 2 arms. quantitatively using the laser fluorescence DIAGNOdent and qualitatively using ICDAS II scoring system ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## CRTE7A2-01 TCR-T Cells for HPV-16 Positive Advanced Cancers - NCT ID: NCT06358053 - Study ID: CRTE7A2-2302C - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2028-04-30 - Lead Sponsor: Corregene Biotechnology Co., Ltd ### Study Description A single center, open, single arm dose escalation and dose expansion phase I study to evaluate the safety, tolerability, and efficacy of CRTE7A2-01 TCR-T cells in HLA-A\02:01+ Subjects HPV16 positive advanced cervical, anal, or head and neck cancers. The study will determine RP2D of CRTE7A2-01 TCR-T cell injection. ### Conditions - Cervical Cancer - Anal Cancer - Head and Neck Cancers - Other Solid Tumors ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - CRTE7A2-01 TCR-T cell therapy ### Outcomes Primary Outcomes* - DLT - RP2D - cevents (SAEs). Secondary Outcomes - Objective Response Rate (ORR) - Disease Control Rate (DCR) - Duration of Response (DOR) - Progression-Free Survival (PFS) - Overall Survival(OS) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Opioid Dispenser for Microdiscectomy/Laminectomy - NCT ID: NCT06358040 - Study ID: 2023-0328 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-07 - Lead Sponsor: Hospital for Special Surgery, New York ### Study Description The opioid crisis continues to plague the United States. While great strides have been made nationwide to decrease overprescribing, improvements are still needed to appropriately educate patients on the safe and responsible use, storage and disposal of opioids. Pain after surgery is often treated with opioid medications. Opioid medications can have side effects. Some side effects are relatively minor (constipation, nausea, vomiting), while others are more severe (sedation, abnormal breathing, etc.) and can lead to serious illness or death. Opioid pain medications when used the wrong way may also be addictive. Due to theses side effects, sometimes patients feel uncomfortable about taking these medications, and doctors prescribe them very cautiously. However, when used properly and safely, opioid pain medications are excellent pain relievers.Addinex, a technology company, has developed a device to help patients take opioids more safely. In this study the investigators aim to enroll a total of 30 patients who undergo spine surgery. Half will be randomly assigned to receive a standard pill bottle with opioids at discharge and will download a mobile app so that they can record their daily pain scores and the number of opioids they take for two weeks after surgery. The other half will receive the new opioid dispenser filled with opioids and a mobile app that generates a passcode that opens that device only at designated times. For this group of patients, every time the patient wants to take an opioid, they need to go to the app, enter their pain score before the app generates a passcode. The investigators will be tracking all study patients' opioid use and pain scores for the two weeks after surgery, will count how many pills they have left over 14 days after their surgery during a live telehealth session, and ask patients how they liked using the device. Results from this study will help understand if the Addinex device could potentially be useful to patients in the future after surgeries as opposed to typical pill bottles. ### Conditions - Opioid Use - Pain, Postoperative - Medical Device - Laminectomy - Diskectomy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Opioid-Dispensing Device - App - Standard Opioid Pill Bottle ### Outcomes Primary Outcomes - Cumulative Opioid Consumption at Postoperative Day 14 (POD14) Secondary Outcomes - NRS pain intensity ratings - Patient satisfaction with the app and with the dispensing device - Frequency of reported difficulties using the device - Frequency of reported difficulties using the app - Opioid prescription refill rates - Concordance of app data and medication left in the device or pill bottle (medication reconciliation) ### Location - Facility: Hospital for Special Surgery, New York, New York, 10021, United States @@
## Evaluation of the Effects of Different Ventilation Modes Used During Anesthesia Awakening on the Frequency of Postoperative Atelectasis - NCT ID: NCT06358027 - Study ID: DokuzEU-ACC-BOtlu-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-05 - Completion Date: 2024-04-30 - Lead Sponsor: Dokuz Eylul University ### Study Description In our study, we aimed to detect atelectasis developing in patients undergoing surgery under general anesthesia using transthoracic lung ultrasonography and to investigate the effect of ventilation methods used during recovery from anesthesia on the formation of postoperative atelectasis. ### Conditions - Atelectasis, Postoperative Pulmonary ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - lung ultrasound ### Outcomes Primary Outcomes - Modified Transthoracic Ultrasound Score Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Assessment of the Improvement in Cognitive Levels of Postmenopausal Depression Patients by Estrogen - NCT ID: NCT06358014 - Study ID: YX2021-02 - Status: RECRUITING - Start Date: 2023-05-12 - Completion Date: 2024-12-30 - Lead Sponsor: Xiao Wang ### Study Description After menopause, there is a certain tendency towards depression, with the risk of developing depression being about 3 to 4 times higher than before menopause. Additionally, postmenopausal women experience varying degrees of cognitive decline, which are closely associated with hormonal changes. Therefore, we should pay more attention to the cognitive levels of postmenopausal depression patients. Increasing evidence suggests that changes in cognitive function during menopause may be related to the effects of estrogen on cognitive function, and estrogen therapy can effectively improve cognitive decline. Estrogen is not only associated with cognitive symptoms after menopause, but estrogen intervention is also an adjunctive treatment for postmenopausal depression symptoms. There is a close relationship between cognitive levels and depression, as depression itself is accompanied by cognitive decline, and early cognitive decline can also manifest depressive symptoms. Therefore, the cognitive levels of postmenopausal depression patients are also worthy of further attention.This study is an 8-week randomized controlled trial. The subjects are patients with postmenopausal depression accompanied by cognitive decline, all of whom have undergone natural menopause for at least one year; with HAMD-17 scores ≥17 points; and MOCA scores ≤26 points. This study aims to recruit patients with postmenopausal depression accompanied by cognitive decline from the outpatient or inpatient departments of Beijing Anding Hospital, Capital Medical University. Patients who meet the inclusion criteria will be randomly assigned to the combination group and the control group using a random number method. The combination group will receive estrogen combined with SSRIs, while the control group will only receive Selective serotonin reuptake inhibitors (SSRIs) intervention. Patients' cognitive function and depressive symptoms will be assessed using scales at baseline, 2 weeks, 4 weeks, and the end of 8 weeks of treatment, and safety evaluations will be conducted. The primary efficacy endpoint is the change in MoCA scores from baseline to the end of the study. Secondary efficacy endpoints include changes in HAMD-17, modified Kupperman Scale, ADL Scale, and hormone levels from baseline to the end of the study. The safety of the study drug will be evaluated through adverse event reporting, clinical laboratory tests, and physical examinations. ### Conditions - Postmenopausal Depression - Estrogen ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Fematon (estradiol/estradiol-norethindrone acetate combination tablet package)+SSRIs - SSRIs ### Outcomes Primary Outcomes - The average change value of MOCA total scores from baseline to 8 weeks of treatment, as assessed by raters, is the primary efficacy endpoint(0-8week). Secondary Outcomes - The average change value of HAMD-17 total scores from baseline to 8 weeks of treatment, as assessed by raters, is secondary Outcome Measures - The average change value of HAMA total scores from baseline to 8 weeks of treatment, as assessed by raters, is secondary Outcome Measures - The average change value of Kupperman total scores from baseline to 8 weeks of treatment, as assessed by raters, is secondary Outcome Measures - The average change value of PSQI total scores from baseline to 8 weeks of treatment, as assessed by raters, is secondary Outcome Measures - The average change value of ADL total scores from baseline to 8 weeks of treatment, as assessed by raters, is secondary Outcome Measures ### Location - Facility: Beijing Anding Hospital Affiliated to Capital Medical University, Beijing, N/A, N/A, China @@
## EchoTip AcuCore Post-Market Clinical Study - NCT ID: NCT06358001 - Study ID: 21-07 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-06-01 - Lead Sponsor: Cook Research Incorporated ### Study Description The purpose of collecting this data is to continue to learn more about the EchoTip AcuCore and the device's ability to produce the desired favorable effect and if there are any undesired outcomes that may be related to the EchoTip AcuCore. ### Conditions - Adenocarcinoma - Neuroendocrine Tumors - Hepatocellular Carcinoma - Cholangiocarcinoma - Malignant Lymphoma - Metastasis - Chronic Pancreatitis - Autoimmune Pancreatitis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - EchoTip AcuCore ### Outcomes Primary Outcomes - Technical Success Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Testing GDC-0449 (Vismodegib) as Potentially Targeted Treatment in Cancers With Smoothened or Patched 1 Mutant Tumors (MATCH - Subprotocol T) - NCT ID: NCT06357988 - Study ID: NCI-2024-01149 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2016-02-24 - Completion Date: 2024-11-04 - Lead Sponsor: National Cancer Institute (NCI) ### Study Description This phase II MATCH treatment trial tests how well GDC-0449 (vismodegib) works for treating patients with solid tumors, lymphoma, or multiple myeloma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that does not respond to treatment (refractory) and who have a smoothened or patched 1 genetic mutation. Vismodegib is a type of medication called a hedgehog signaling pathway antagonist and works by blocks a type of protein involved in tissue growth and repair and may block the growth of cancer cells. ### Conditions - Advanced Lymphoma - Advanced Malignant Solid Neoplasm - Hematopoietic and Lymphatic System Neoplasm - Refractory Lymphoma - Refractory Malignant Solid Neoplasm - Refractory Multiple Myeloma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Biopsy - Biospecimen Collection - Echocardiography - Radionuclide Imaging - Vismodegib ### Outcomes Primary Outcomes - Objective response rate (ORR) Secondary Outcomes - Overall survival (OS) - 6-month progression-free survival (PFS) rate - Progression free survival ### Location - Facility: ECOG-ACRIN Cancer Research Group, Philadelphia, Pennsylvania, 19103, United States @@
## Testing Crizotinib as Potentially Targeted Treatment in Cancers With MET Genetic Changes (MATCH - Subprotocol C1) - NCT ID: NCT06357975 - Study ID: NCI-2024-01126 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2016-05-30 - Completion Date: 2024-11-15 - Lead Sponsor: National Cancer Institute (NCI) ### Study Description This phase II MATCH treatment trial tests how well crizotinib works in treating patients with solid tumors, lymphoma, or multiple myeloma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that does not respond to treatment (refractory) and who have MET gene amplification. Crizotinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of enzymes that cancer cells need to grow and spread. It may also prevent the growth of new blood vessels that tumors need to grow. ### Conditions - Advanced Lymphoma - Advanced Malignant Solid Neoplasm - Refractory Lymphoma - Refractory Malignant Solid Neoplasm - Refractory Multiple Myeloma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Biopsy - Biospecimen Collection - Crizotinib - Radiologic Examination ### Outcomes Primary Outcomes - Objective response rate (ORR) Secondary Outcomes - Overall survival (OS) - 6-month progression-free survival (PFS) rate - Progression free survival ### Location - Facility: ECOG-ACRIN Cancer Research Group, Philadelphia, Pennsylvania, 19103, United States @@
## Semi-permanent Acupuncture Effect on Cervical Ripening - NCT ID: NCT06357962 - Study ID: CSAPG-40 - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2025-10 - Lead Sponsor: Consorci Sanitari de l'Alt Penedès i Garraf ### Study Description Cervical ripening is a medical treatment that can cause physical or emotional discomfort in pregnant women and is not without risks. This is a pilot study to assess feasibility and calculate the number of participants necessary for a complete clinical trial. The aim is to evaluate whether acupuncture can reduce the need for treatment (cervical ripening) in pregnant women at low or intermediate risk. Participants will be divided into two groups: one group will receive acupuncture, and the other will receive a simulated treatment of acupuncture. ### Conditions - Pregnancy Complications ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Semi-permanent acupuncture - Sham of semi-permanent acupuncture ### Outcomes Primary Outcomes - Pharmacological induction Secondary Outcomes - Change on score of Bishop scale - Onset of spontaneous labor - Duration of induction period Duration of the induction period Duration of the induction period Duration of the induction period - Duration of labor period - Satisfaction of pregnants ### Location - Facility: Consorci Sanitari Alt Penedes i Garraf, Vilafranca Del Penedès, Barcelona, 08720, Spain @@
## The Effectiveness of High-intensity Laser Therapy on Plantar Flexor Muscle Spasticity in Stroke Patients - NCT ID: NCT06357949 - Study ID: E2-23-3615 - Status: RECRUITING - Start Date: 2024-04-05 - Completion Date: 2024-09 - Lead Sponsor: Hitit University ### Study Description The aim of this study is to investigate the effectiveness of high-intensity laser therapy for treating plantar flexor muscle spasticity in subacute and chronic stroke patients, focusing on its impact on spasticity, joint range of motion, pain, muscle thickness, functional ambulation, and quality of life. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - High-intensity laser - Sham laser ### Outcomes Primary Outcomes - 10-Meter Walk Test Secondary Outcomes - Visual analogue scale for pain (VAS- pain) - Modified Ashworth Scale - Joint Range of Motion (ROM) Measurement - Ultrasonography - Timed Up and Go test - Stroke Specific Quality of Life Scale ### Location - Facility: Ankara Gaziler Physical Therapy and Rehabilitation Training and Research Hospital, Ankara, N/A, N/A, Turkey @@
## Nanofat Grafting as a Method of Treating Critical Limb Ischemia - NCT ID: NCT06357936 - Study ID: CNMT002 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-20 - Completion Date: 2025-02-20 - Lead Sponsor: Center of New Medical Technologies ### Study Description This clinical trial will investigate nano fat grafting as a method for treating critical limb ischemia. The method involves the collection of adipose tissue under tumescent anesthesia through a separate incision in the anterior abdominal wall, followed by preparation and injection of nano fat into the tissues of the foot and leg without additional drug therapy. The novelty of this method lies in the use of autologous stem cells and growth factors, differing from current treatments like neovasculgen, which is a plasmid DNA-based treatment. The trial aims to assess the safety and effectiveness of nano fat grafting, including pain relief, the frequency of intraoperative complications, increased distance of pain-free walking, limb preservation, and mortality rates.The trial will involve patients with diagnosed occlusive lesions of the femoral-popliteal-tibial segment and chronic ischemia of III-IV degree according to Fontaine and 5-6 categories according to Rutherford, excluding those with contraindications for surgical intervention on the femoral-popliteal-tibial segment, chronic heart failure of III-IV NYHA class, severe liver or kidney failure, among others.The study design includes preoperative examinations, hospital phase activities including the surgery and post-operative assessments, and follow-up visits at 6 and 12 months post-operation to evaluate the method's safety, complications, and effectiveness based on various parameters like pain, trophic disturbances, and limb ischemia severity.Statistical methods will involve quantitative data presented as mean ± standard deviation, with qualitative traits compared using the Chi-square test or Fisher's exact test. The planned patient number is 40, aiming to demonstrate the effectiveness and safety of nano fat grafting for critical limb ischemia treatment compared to current treatments. ### Conditions - Limb Ischemia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - nano-fat grafting in chronic limb ischaemia - sham comparator ### Outcomes Primary Outcomes - Percent of pain absence in experimental group Secondary Outcomes - Number of any intraoperative complications - Number of any inhospital complications - Number of saved limbs - Percent change in visual analog pain score (VAS) change ### Location - Facility: Center of New Medical Technologies, Novosibirsk, Novosibirsk Region, 630090, Russian Federation @@
## Study of the Evolution of the Expression of the LAMP-2 Protein During the Advance in Age - NCT ID: NCT06357923 - Study ID: 23-PP-13 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-05-01 - Lead Sponsor: Centre Hospitalier Universitaire de Nice ### Study Description Recruitment on the RAV pole in consultation or day hospital. Competitive recruitment of subjects \> 60 years of age respecting a male/female ratio = 1. ### Conditions - Aging ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - dosage ### Outcomes Primary Outcomes - Expression level of LAMP2 (protein and isoform A and B mRNA) Secondary Outcomes - Presence of mutation in the "Oncomin Myeloid Reasearch Assay" gene panel targeting approximately 40 Different genes ### Location - Facility: Chu de Nice, Nice, N/A, 06003, France @@
## A Study to Evaluate the Pharmacokinetics and Safety Between HCP2303 and Co-administration of Each Component in Healthy Volunteers Under Fed Conditions - NCT ID: NCT06357910 - Study ID: HM-EMMA-102 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-17 - Completion Date: 2024-06-29 - Lead Sponsor: Hanmi Pharmaceutical Company Limited ### Study Description The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP2303 and co-administration of each component in fed condition in healthy volunteers. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - HCP2303 - RLD2302 - RLD2102 ### Outcomes Primary Outcomes - AUCt - Cmax Secondary Outcomes - AUCinf - Tmax - t1/2 - CL/F - Vd/F ### Location - Facility: Jeonbuk University Hospital, Jeonju, Jeollabuk-do, N/A, Korea, Republic of @@
## The Efficacy and Palatability of Developed Polyethylene Glycol-based Formula for Children With Functional Constipation - NCT ID: NCT06357897 - Study ID: 0093/67 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-06 - Lead Sponsor: Chulalongkorn University ### Study Description This study aims to evaluate the efficacy and palatability of a developed polyethylene glycol-based formula compared with the standard polyethylene glycol (PEG) in the treatment of children with functional constipation for 8 weeks. Besides, we also aim to assess the side effects of a developed PEG-based formula as well as evaluate the change of rectal diameter from baseline at each visit between 2 groups. ### Conditions - Functional Constipation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Local PEG4000 - Commercial PEG4000 ### Outcomes Primary Outcomes - The frequency of stool - Stool consistency assessed by Bristol stool chart Secondary Outcomes - Fecal incontinence - Rectal diameter - Adverse events - Palatability of medication assessed by facial Hedonic scale ### Location - Facility: Faculty of Medicine, Chulalongkorn University, Bangkok, N/A, 10330, Thailand @@
## Short-term Effect of Podiatric Callus Debridement on Plantar Pressure in Diabetic Neuropathic Patients - NCT ID: NCT06357884 - Study ID: CREC2023.572 - Status: RECRUITING - Start Date: 2024-02-23 - Completion Date: 2024-04-30 - Lead Sponsor: Chinese University of Hong Kong ### Study Description Diabetes peripheral neuropathy (DPN) affects up to 50% of the diabetes population. In the diabetic neuropathic foot, it commonly manifests as loss of protective sensation, foot deformity and skin dryness. Alongside with day-to-day weightbearing activities, this can lead to formation of callus over plantar pressure points. Studies have proven that callus formation leads to high plantar pressure and increased risk of diabetic foot ulcers. For podiatrists, diabetic foot screening and treatment is our daily practice. Plantar callus are commonly treated by sharp debridement to relief pressure from the hard skin build up and thus reducing the risk of ulceration. However, the effectiveness of callus sharp debridement is not commonly studied in researches. Only a few studies in the past evaluated the effectiveness of callus treatment by different outcome measurements. Among those studies only 2 were specifically done in diabetic patients, in which one reported results of diabetic neuropathic patients. All the available studies used peak plantar pressure only as their pedobarographic outcome measure. In this study, the treatment effect of podiatric sharp debridement of callus in diabetic neuropathic patients will be evaluated using a range of pedobarographic parameters and Foot and Ankle Outcome Score (FAOS) questionnaire. The immediate and short-term (3-4 weeks) effect of sharp debridement in DPN patients with callus could be quantified. Change in loading pattern could also be analysed based on different areas of the foot. ### Conditions - Diabetic Neuropathies - Plantar Callus ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Callus debridement ### Outcomes Primary Outcomes - Peak plantar pressure (PPP) (unit: kPa) Secondary Outcomes - Pressure time integral (PTI) (unit: kPasec) - Peak pressure gradient (PPG) (unit: kPa/cm) - Forefoot to rearfoot peak pressure ratio (F/R ratio) - Foot and Ankle Outcome Score (FAOS) ### Location - Facility*: Podiatry Department, Princess Margaret Hospital, Hong Kong, N/A, N/A, Hong Kong @@
## Role of Renal Biopsy in the Suspicion of Nephrotoxicity of Immunotherapy (Checkpoint Inhibitors) in Solid Cancer - NCT ID: NCT06357871 - Study ID: 2023PI178 - Status: RECRUITING - Start Date: 2023-11-28 - Completion Date: 2025-12-31 - Lead Sponsor: Central Hospital, Nancy, France ### Study Description Checkpoint inhibitors represent a new class of widely used immunotherapy, however with immune-mediated adverse effects, with renal damage estimated at 1.4% and 4.9% depending on the series.Acute tubulointerstitial nephritis (ATNI) represents the most common type of damage, although there are other types of damage, associated or not with NTIA.We aim to establish a probability score for the presence of histological NTIA lesions in a patient treated with CPI who presents with acute renal failure in order to guide the nephrologist and oncologist in their management in the event of AKI at the CPI, and determine the usefulness of a PBR to guide the suspension/resumption of immunotherapy +/- associated corticosteroid therapy; avoiding a PBR exposing to a high iatrogenic risk and sometimes impossible. ### Conditions - Chemotherapeutic Toxicity ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No intervention ### Outcomes Primary Outcomes - Estimation using a multivariate model of the factors associated with the histological presence of NTIA vs NTA lesions in a patient treated with CPI Secondary Outcomes ### Location - Facility: CHRU de Nancy, Vandoeuvre les nancy, N/A, 54500, France @@
## ASTX727 and Nivolumab in Squamous Cell Carcinoma of the Head and Neck - NCT ID: NCT06357858 - Study ID: CASE6323 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2026-02-28 - Lead Sponsor: Case Comprehensive Cancer Center ### Study Description The goal of this clinical trial is to see if the combination of experimental drug ASTX727 and Nivolumab enhances the antitumor immune response in participants will recurrent or metastatic squamous cell carcinoma of the head and neck.Participants will take a pill called ASTX727 for 4 or 5 days every month followed by an injection of Nivolumab one week after the first dose of study medication. ### Conditions - Recurrent Squamous Cell Carcinoma of the Head and Neck - Metastatic Squamous Cell Carcinoma - Head and Neck Squamous Cell Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - INQOVI (decitabine and cedazuridine) - Nivolumab ### Outcomes Primary Outcomes - Pharmacodynamics Effect of ASTX727 on global DNA methylation status - Immunogenicity of ASTX27 in combination with Nivolumab - Maximum Tolerated Dose - Safety of ASTX Secondary Outcomes - Objective Response Rate (ORR) - Overall Survival (OS) ### Location - Facility: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center, Cleveland, Ohio, 44106, United States @@
## Linking Somatic Mutation Rate With Baseline Exposure in East Palestine - NCT ID: NCT06357845 - Study ID: CASE5Z24 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-01-31 - Lead Sponsor: Case Comprehensive Cancer Center ### Study Description The goal of this study is to This research team is conducting this study to develop methods to measure the biological impact of exposure to the chemicals released following the February 3, 2023 train derailment on residents of East Palestine, Ohio, and surrounding communities. The main question it aims to answer is:* What biological impact will be measured based on DNA damage?* In participants who provide a biospecimen, how are biomarker changes related to proximity to the derailment and variations in residents' health histories and behaviors?Participants will:* Complete a brief survey asking about experiences related to the February 3, 2023 train derailment, health experiences, and concerns following the derailment, and background information regarding health history.* Possibly contribute biospecimens such as blood, spit, hair, and/or toenail clippings.* Receive communication about study updates and future research opportunities.* A total of 40 study participants will be recruited to participate in a 90-minute interview. The interviews will be video and audio recorded. ### Conditions - Somatic Mutation ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - Survey - Biological specimen collection - Communications about study updates and future research opportunities - Qualitative interview ### Outcomes Primary Outcomes - Geographic Association of Somatic Mutation Rates Secondary Outcomes - Self-reported Symptomology Association of Somatic Mutation Rates ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## New Investigational Stimulation Protocol for Treatment of Major Depression Disorder (MDD) - NCT ID: NCT06357832 - Study ID: CTP-ACCiTBS-00 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2024-12-15 - Lead Sponsor: Brainsway ### Study Description The BrainsWay Deep Transcranial Magnetic Stimulation (Depp TMS) device is intended for the treatment of depressive episodes in patients suffering from Major Depressive Disorder (MDD). The device technology is based on the application of deep brain TMS by means of repetitive pulse trains at a determined frequency. The purpose of the current study is to evaluate the safety and effectiveness of a new investigational stimulation protocol delivered with the BrainsWay Deep TMS device, for the treatment of MDD, demonstrating that it is non-inferior to the current standard-of-care stimulation protocol, in a randomized, controlled study. ### Conditions - Major Depressive Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Brainsway Deep TMS System ### Outcomes Primary Outcomes - Change in Hamilton Depression Rating Scale (HDRS)-21 score in the investigational group Secondary Outcomes - Response rate in the investigational group - Remission rate in the investigational group - Change in Clinical Global Impression-Severity (CGI-S) scores in the investigational group - Change in Clinical Global Impression Improvement (CGI-I) scores in the investigational group ### Location - Facility: Novus Neurology, Tuscaloosa, Alabama, 35401, United States @@
## INSTI® HCV (Hepatitis C Virus) Antibody Self-Test Contrived Result Interpretation - NCT ID: NCT06357819 - Study ID: CLS-017A - Status: COMPLETED - Start Date: 2023-10-12 - Completion Date: 2023-12-17 - Lead Sponsor: bioLytical Laboratories ### Study Description The purpose of this Interpretation Assessment was to document if "lay" people, non-professional and inexperienced in self-testing, were able to successfully perform the steps to use a Hepatitis C Virus (HCV) Self-Test (HCVST) device, without product familiarization \[demonstration\]. ### Conditions - Hepatitis C ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - INSTI HCV Self Test ### Outcomes Primary Outcomes - Successful Interpretation of contrived devices Secondary Outcomes ### Location - Facility: bioLytical Laboratories Inc., Richmond, British Columbia, V6V 2A2, Canada @@
## The Treatment of PD-1 Antibody Combined With Peg-IFNα in NAs-suppressed CHB Patients - NCT ID: NCT06357806 - Study ID: PIN-CHB-1 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-09-30 - Lead Sponsor: Beijing 302 Hospital ### Study Description This is a prospective, open-labled, randomized controlled study to assess efficacy and safety of treatment with Sintilimab (PDL-1 antibody) combined Peg-IFNα-2b in CHB patients on stable NAs treatment. ### Conditions - Chronic Hepatitis B ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Sintilimab - Peg-IFNα-2b - NAs ### Outcomes Primary Outcomes - The rate of HBsAg loss at 24 weeks and 48 weeks. - Incidence of treatment-emergent adverse events/serious adverse events Secondary Outcomes - The rate of HBsAg decline > 1log(IU/ml) at 24 weeks and 48 weeks - The rate of HBsAb positive at 24 weeks and 48 weeks. - The concentration of HBcrAg at baseline, 12 weeks, 24 weeks and 48 weeks. - The concentration of pgRNA at baseline, 12 weeks, 24 weeks and 48 weeks. - The concentration of anti-HBc at baseline, 12 weeks, 24 weeks and 48 weeks. - Immune response of T cell, B cell, NK cell at baseline, 12 weeks, 24 weeks and 48 weeks. ### Location - Facility: the Fifth Medical Center, Chinese PLA General Hospital, Beijing, Beijing, 100039, China @@
## Evaluation of Work Productivity and Activities of the Fibromyalgia Patients' Relatives - NCT ID: NCT06357793 - Study ID: camsakuraftr - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2024-12-15 - Lead Sponsor: Başakşehir Çam & Sakura City Hospital ### Study Description Patients suffering from fibromyalgia (FM) are challenged by symptoms such as chronic pain, fatigue, sleep disturbance and emotional distress. Patients diagnosed with fibromyalgia can also negatively affect the relatives they live with due to their existing complaints. It is possible that their relatives accompanying them may lose their workforce due to untreated pain complaints and frequent hospital admissions. The main purpose of our study is to examine whether there is any impact on the working life of the people they live with and whether there is a decrease in their work productivity. ### Conditions - Fibromyalgia - Work Productivity - Quality of Life - Pain, Chronic ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Work Productivity and Activity of Fibromyalgia Patients' Relatives Secondary Outcomes - Quality of life Fibromyalgia Patients' Relatives ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Closed-loop syncHronization vErsuS convenTional Synchronization in sPontaneously Breathing Adult Nonivasive ventilationPatients - NCT ID: NCT06357780 - Study ID: 240396837 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-08 - Completion Date: 2024-12-31 - Lead Sponsor: Başakşehir Çam & Sakura City Hospital ### Study Description The study is a multicentric prospective randomised cross-over study. It evaluates the compatibility of patients with the device without altering the routine treatment applied. During this evaluation, either the clinician-adjusted values on the device or the standard pre-set values are used to obtain hourly and 30-minute PVA (Patient Ventilator Asynchrony) recordings. These recordings will be analysed offline to identify the settings used and to compare the hourly and 30-minute PVA (Patient Ventilator Asynchrony) values when synchronisation is automatically set. The relationships and differences between these values will be analysed. For this purpose, the IntelliSync+ option, already available on the device, will be used. This software continuously analyses waveform signals at least a hundred times per second. This allows for the immediate detection of patient efforts and the initiation of inspiration and expiration in real time, thereby replacing traditional trigger settings for inspiration and expiration. If the patient is already synchronised with this option, it will then be possible to switch to traditional synchronisation settings for comparison. Statistical analyses will be conducted using SPSS 24.0, JASP (Just Another Statistical Programme), Jamovi ( fork of JASP), or R software. Initially, all numerical and categorical data will be evaluated using descriptive statistical methods. The distributions of numerical variables will be examined using visual (histograms and probability plots) and analytical methods (Kolmogorov-Smirnov/Shapiro-Wilk tests). Mean/SD (standard deviation) or median/interquartile range (IQR) will be used as measures of distribution. For comparing numerical data that follows a normal distribution, the Student-t test will be used, and for non-normally distributed data, the Mann-Whitney U or Wilcoxon signed-rank tests will be employed. PVA (Patient Ventilator Asynchrony) values will be statistically compared. For the analysis of categorical data, the Chi-Square test will be applied. Bayesian analysis may also be used as necessary during the writing of the study. The results obtained will be interpreted and reported by the researchers. Results with a "p" value below 0.05 will be considered statistically significant. ### Conditions - Acute Respiratory Failure - Acute Respiratory Distress Syndrome - Chronic Respiratory Failure ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - close-loop synchronization controller with spontaneous mode - Conventional ### Outcomes Primary Outcomes - Asynchrony Index Secondary Outcomes - Major Asynchrony index - Minor Asynchrony index - Dyspnea Scale ### Location - Facility: Dr.Suat Seren Chest Diseasees Hospital, Izmir, N/A, 35230, Turkey @@
## Smoking Cessation Intervention for American Indian Women Experiencing Intimate Partner Violence - NCT ID: NCT06357767 - Study ID: S06GM146079 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-01-31 - Lead Sponsor: Black Hills Center for American Indian Health ### Study Description The goal of this project is to refine and test a culturally-tailored smoking cessation intervention for American Indian women who have experienced intimate partner violence (IPV). The primary aims of this study are to: (a) use a community-based participatory approach to refine intervention materials and finalize pilot intervention methodology for a culturally tailored, trauma-informed smoking cessation intervention for AI women who have experienced IPV; (b) examine feasibility, acceptability, satisfaction, and preliminary efficacy of the intervention; and (c) explore changes in alcohol and drug use over the course of the intervention.Participants will be asked to participate in the 8-week Healing Within: Smoking Cessation Intervention for American Indian Women Experiencing Intimate Partner Violence, and complete interviews at baseline, end-of-treatment, and three months from the end of treatment. ### Conditions - Smoking Cessation - Cigarette Smoking ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Healing Within: Smoking Cessation Intervention for American Indian Women Experiencing Intimate Partner Violence ### Outcomes Primary Outcomes - Trauma-Informed Practice Scales (TIPS) - Session Rating Scale (SRS) - Group Attitude Scale (GAS) Secondary Outcomes - Biochemical verification of smoking status - Biochemical verification of smoking status - Biochemical verification of smoking status - Quit Attempts - Quit Attempts - Quit Attempts ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Transgene Assay Testing Service of Tumor Samples From Patients Who Received a Bristol-Myers Squibb Manufactured Gene Modified Cell Therapy and Have a Qualifying Secondary Malignancy - NCT ID: NCT06357754 - Study ID: CA082-085 - Status: RECRUITING - Start Date: 2023-10-06 - Completion Date: 2038-10-06 - Lead Sponsor: Bristol-Myers Squibb ### Study Description The purpose of this transgene assay testing service is to evaluate the tumor samples for transgene levels in patients who received a Bristol-Myers Squibb manufactured gene modified cellular therapy and have reported a qualifying secondary malignancy. ### Conditions - Non-Hodgkin Lymphoma - Chronic Lymphocytic Leukaemia - Multiple Myeloma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Idecabtagene vicleucel - Lisocabtagene maraleucel ### Outcomes Primary Outcomes - Participant in situ hybridization (ISH) transgene testing results - Participant insertion site (ISA) analysis testing results Secondary Outcomes ### Location - Facility: CellCarta, Antwerp, N/A, N/A, Belgium @@
## Clinical Study of Desuzumab in the Treatment of Knee Osteoarthritis - NCT ID: NCT06357741 - Study ID: 202286 - Status: COMPLETED - Start Date: 2023-03-02 - Completion Date: 2024-03-10 - Lead Sponsor: Wuhan Union Hospital, China ### Study Description As an activator of inhibiting nuclear factor kB receptor, denosumab affects osteoclast differentiation and development by inhibiting OPG/RANKL-RANK bone regulatory axis pathway. Therefore, denosumab is widely used in the treatment of bone diseases such as osteoporosis. Osteoporosis is closely related to knee osteoarthritis. RANKL-RANK pathway also plays a key role in the pathogenesis of knee osteoarthritis. Therefore, the investigators propose the hypothesis that denosumab can effectively treat knee osteoarthritis. ### Conditions - Knee Osteoarthritis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Denosumab ### Outcomes Primary Outcomes - Knee pain relief Secondary Outcomes ### Location - Facility: Wuhan Union Hospital, Wuhan, Hubei, 430000, China @@
## Continuous Glucose Monitoring Glycemic cHAracterization During Pregnancy - NCT ID: NCT06357728 - Study ID: 2024/2035 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-12-01 - Lead Sponsor: KK Women's and Children's Hospital ### Study Description Our study named Integrated Continuous glucose monitoring glycemic cHAracterization during Pregnancy in comparison with oral glucose tolerance test (I-CHAP) aims to establish much needed preliminary evidence in our Asian population to show the capabilities of CGM use and its wealth of data for GDM diagnosis. This study aims to test the following aims and hypotheses in a single-armed intervention pilot trial study of pregnant women undergoing the oral glucose tolerance test:Aim 1. To characterize CGM glucose values with the 3-point blood glucose measured during the OGTT procedure.The investigators hypothesize that the CGM glucose values at single time points while fasted, and after the 75-g glucose load will be positively correlated with 3-timepoint blood glucose values captured during the OGTT.Aim 2. To correlate the CGM glucose excursions and CGM-derived metrics (glycaemic variability and glycaemic control) with maternal-fetal outcomes and treatment outcomes.The investigators hypothesize that higher AUC, glycemic variability and poorer glycaemic control will better distinguish maternal-fetal outcomes and treatment outcomes, compared to the OGTT.Aim 3. To describe the acceptability of using the Dexcom G6 CGM as a diagnostic tool instead of the OGTT. The investigators hypothesize that a higher proportion of participants will report CGM to be more acceptable than the OGTT for GDM diagnosis. ### Conditions - Gestational Diabetes - Glucose Metabolism Disorders - Metabolic Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Continuous glucose monitoring ### Outcomes Primary Outcomes - Maternal plasma glucose values measured by oral glucose tolerance test (OGTT) at 0-hour (mmol/L) - Maternal plasma glucose values measured by oral glucose tolerance test (OGTT) at 1-hour (mmol/L) - Maternal plasma glucose values measured by oral glucose tolerance test (OGTT) at 2-hour (mmol/L) Secondary Outcomes - Maternal obstetric outcomes - Pre-eclampsia - Maternal obstetric outcomes- Pregnancy-induced hypertension - Maternal obstetric outcomes - C-section - Neonatal outcomes- Large-for-gestational-age - Neonatal outcomes-Birth weigh - Neonatal outcomes- Small-for-gestational-age - Neonatal outcomes-Pre-term birth - Neonatal outcomes-Neonatal hypoglycaemia ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effectiveness of Neurodynamic Sliding Mobilisation in the "Slump" Position in Relation to the Perceptible Pain Threshold in Asymptomatic People - NCT ID: NCT06357715 - Study ID: 2021/373/HP - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-05-09 - Lead Sponsor: University Hospital, Rouen ### Study Description According to the French National Health Agency, the use of manual therapy techniques is "possible" \[grade B\] as part of a multimodal combination of treatments for low back pain. These include so-called "neurodynamic" neural mobilisations, which aim in particular to desensitise the pain system and activate descending inhibitory pathways, with effects on pain and function in patients with nerve-related low back pain. Most of the available evidence does not explain the mechanisms involved in neural mobilisation in the slump position. Pain reduction is observed in more areas of the body with sliding techniques than with traction techniques.In this cross-over, randomised controlled trial, we therefore hypothesise that the neurodynamic sliding technique in the slump position acts on mechanisms linked to central pain modulation processes ### Conditions - Voluntary ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - "slump"position - no" slump" position ### Outcomes Primary Outcomes - Difference in pressure at the moment when the volunteer indicates that the sensation of pressure becomes pain Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## K23- Physical Self Regulation vs Placebo - NCT ID: NCT06357702 - Study ID: 81313 - Status: RECRUITING - Start Date: 2024-04-04 - Completion Date: 2028-08-31 - Lead Sponsor: Ian Boggero, PhD ### Study Description This study will use a between-person design. Participants will be treatment-seeking patients with chronic masticatory muscle pain. Participants who are eligible for the study and consent to participate will be randomly assigned to receive a brief behavioral intervention for chronic orofacial pain called Physical Self-Regulation or a control intervention. Interventions will be administered via telehealth in both arms. Both interventions will consist of 2 50-minute sessions scheduled approximately two weeks apart. Participants will be contacted two weeks and three months after completing the interventions to provide additional follow-up data. Investigators hypothesize that both PSR-TH and the control intervention will demonstrate strong feasibility (i.e., recruitment of at least 1 participant per week, \>75% retention, \>95% interventionist fidelity, and adequate acceptability, credibility, and burden). Investigators also hypothesize that specific biopsychosocial variables will moderate PSR-TH-related changes in outcomes, and that PSR-TH-related changes in perceived control over pain, self-efficacy, coping, parafunctional habits, and relaxation will mediate treatment effects. ### Conditions - Temporomandibular Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Physical Self Regulation Telehealth - Psycho-education Telehealth ### Outcomes Primary Outcomes - Change in pain intensity - Change in pain interference - Change in quality of life - Recruitment rate - Retention rate - Interventionist Fidelity Session 1 - Interventionist Fidelity Session 2 - Treatment Acceptability - Treatment Credibility - Research Burden Secondary Outcomes - Treatment Satisfaction ### Location - Facility: University of Kentucky, Lexington, Kentucky, 40506, United States @@
## Association of SNPs in Long Intergenic Noncoding RNA 00511 (LINC00511) With Breast Cancer Among the Egyptian Population - NCT ID: NCT06357689 - Study ID: REC ID 6 - Status: COMPLETED - Start Date: 2021-10-24 - Completion Date: 2023-04-29 - Lead Sponsor: Ain Shams University ### Study Description Long non-coding RNAs (lncRNAs) play an important role in different types of cancer, including breast cancer, through regulation of gene expression and epigenetic signatures. Genetic variations such as single nucleotide polymorphisms (SNPs) in lncRNAs have been found to be associated with cancer. Our aim was to provide information about the role of LINC00511 SNPs (rs11657109 or rs17780195 or rs9906859, rs4432291 and rs1558535) in breast cancer susceptibility in the Egyptian population. ### Conditions - Breast Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Investigating the relationship of the genotypes of each SNP of the LINC00511 SNPs (rs11657109 or rs17780195 or rs9906859 or rs4432291 and rs1558535) with either increased or decreased risk of breast cancer or no effect in the Egyptian population Secondary Outcomes - Finding out the association between LINC00511 SNPs (rs11657109 or rs17780195 or rs9906859 or rs4432291 and rs1558535) and Estrogen receptor - Finding out the association between LINC00511 SNPs (rs11657109 or rs17780195 or rs9906859 or rs4432291 and rs1558535) and Progesterone receptor - Finding out the association between LINC00511 SNPs (rs11657109 or rs17780195 or rs9906859 or rs4432291 and rs1558535) and HER2 status - Finding out the association between LINC00511 SNPs (rs11657109 or rs17780195 or rs9906859 or rs4432291 and rs1558535) and tumor stage - Finding out the association between LINC00511 SNPs (rs11657109 or rs17780195 or rs9906859 or rs4432291 and rs1558535) and tumor grade - Finding out the association between LINC00511 SNPs (rs11657109 or rs17780195 or rs9906859 or rs4432291 and rs1558535) and lymph node metastasis ### Location - Facility: Faculty of pharmacy, Ain Shams University, Advanced Biochemisrty Research Lab, Cairo, N/A, N/A, Egypt @@
## Glofitamab Plus Ibrutinib With Obinutuzumab for the Treatment of Patients With Mantle Cell Lymphoma - NCT ID: NCT06357676 - Study ID: STUDY00025355 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2029-05-01 - Lead Sponsor: OHSU Knight Cancer Institute ### Study Description This phase IB/II trial tests the safety, side effects and effectiveness of glofitamab plus ibrutinib with obinutuzumab for the treatment of patients with mantle cell lymphoma (MCL). Glofitamab is in a class of medications called bispecific monoclonal antibodies. It works by killing cancer cells. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). In the body, glofitamab binds to a receptor called CD3 on T-cells (a type of immune cells) and a receptor called CD20 on B-cells, a receptor that is often over-expressed on the surface of cancerous B-cells. When glofitamab binds to CD3 and CD20 receptors, it causes an immune response against the CD20-expressing cancerous B-cells. Ibrutinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells. Obinutuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Glofitamab plus ibrutinib with obinutuzumab may be safe tolerable and/or effective in treating patients with MCL. ### Conditions - Mantle Cell Lymphoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Biospecimen Collection - Bone Marrow Biopsy - Computed Tomography - Echocardiography - FDG-Positron Emission Tomography - Glofitamab - Ibrutinib - Magnetic Resonance Imaging - Obinutuzumab ### Outcomes Primary Outcomes - Incidence of dose-limiting toxicities (DLT) - Proportion of participants who achieve a complete response (CR) Secondary Outcomes - Incidence of grade 3 or above adverse events (AEs) - Proportion of patients treated with tocilizumab (TCZ) - Number of doses of TCZ per participant - Objective response rate (ORR) - Progression-free survival (PFS) - Duration of response (DOR) - Duration of complete response (DOCR) ### Location - Facility: OHSU Knight Cancer Institute, Portland, Oregon, 97239, United States @@
## Subtle Energy Transmission and Tao Calligraphy Mindfulness in Telomere Length in Peripheral Blood Leukocytes - NCT ID: NCT06357663 - Study ID: Pro00071128 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-06-15 - Completion Date: 2025-12-31 - Lead Sponsor: Sha Research Foundation ### Study Description Effect of Subtle Energy Transmission and Tao Calligraphy Mindfulness Practice on Telomere Length in Peripheral Blood Leukocytes A Follow-up Pilot StudyThe goal of this Pilot clinical trial is to learn if a Subtle Energy Transmission and Tao Calligraphy Mindfulness Practice works to increase Telomere Length in Peripheral Blood Leukocytes in adults. The main questions it aims to answer are:* Does A Subtle energy transmission and Tao Calligraphy Mindfulness increase Telomere Length in Peripheral Blood Leukocytes in adults?* Will this increase of Telomere Length in Peripheral Blood Leukocytes in adults be statistically significant? Researchers will compare the length of Telomere in peripheral blood Leukocytes at beginning of the mindfulness practices to the length of Telomere in peripheral blood Leukocytes at 3 months and at 9 months of regular daily practices.Participants will:* Receive a transmission of Subtle energy at beginning of practices* Visit the Laboratory for a blood sample taken at beginning, at 3 months and at 9 months of practices.* Fill the Study Questionnaires at beginning, at 3 months and at 9 months of practices.* Practice the Mindfulness with Tao Calligraphy daily 1 hour in the morning and 1 hour in the evening. ### Conditions - Telomere Length - Quality of Life ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Mindfulness practice with Calligraphy ### Outcomes Primary Outcomes - Telomere Length in Peripheral blood leukocytes Secondary Outcomes - Quality of Life by John Ware's SF-36 Quality of Life questionnaire (that produces eight scores with 0-to-100 scale, 100 being the best possible outcome). ### Location - Facility: Sha Research Foundation (Branch), North Vancouver, British Columbia, V7R 1P5, Canada @@
## Collaborative Open Research Initiative Study (CORIS-1) - NCT ID: NCT06357650 - Study ID: CSQ-2024-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-06-30 - Lead Sponsor: Chisquares Incorporated ### Study Description The Collaborative Open Research Initiative Study (CORIS) is a groundbreaking international research endeavor aimed at exploring vital topics within the field of health professions education. At its core, CORIS embodies the spirit of inclusivity by opening its doors to contributors from all corners of the globe, putting the power of research into the hands of the global community and fostering an environment of open collaboration and meaningful contribution. We invite anyone and everyone to join as collaborators and suggest questions for inclusion in the survey, ensuring that the research process is enriched by diverse perspectives. As a collaborator, you will not only have the opportunity to actively engage in survey design, question formulation, and the entire research process from start to finish, but also gain the prospect of achieving valuable publications, which may boost your professional career. ### Conditions - Patient Engagement - COVID-19 - Preventable Disease, Vaccine - Burnout, Professional - Emerging Infectious Disease - Artificial Intelligence - Climate Change - Online Education - Mental Health Issue - Substance Use Disorders ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No intervention. This is an observational study ### Outcomes Primary Outcomes - Percentage of health professions schools implementing changes in patient care strategies before versus after the COVID-19 pandemic. - Percentage of personnel in health professions education with adequate epidemic preparedness and readiness. - Percentage of faculty and staff in health professions schools experiencing burnout. - Percentage of healthcare professionals who report the integration and utilization of artificial intelligence (AI) in their education and practice. - Percentage of participants expressing positive attitudes and perceptions towards climate change and the role of individuals and society in mitigating it. - Percentage of participants reporting effectiveness and challenges of remote learning and online education in health professions schools. - Percentage of personnel within health professions education reporting substance use behaviors and their implications. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Abdominal Circumference Measure in Caesarian Section - NCT ID: NCT06357637 - Study ID: 59/2023 - Status: RECRUITING - Start Date: 2023-12-01 - Completion Date: 2024-05-31 - Lead Sponsor: CHU Mohammed VI Marrakech ### Study Description The goal of this observational study is to evaluate preoperative measures of abdominal circumference in patients admitted for a cesarean section. The main questions it aims to answer are:* Can preoperative abdominal circumference predict patients with difficult spinal anesthesia* Can preoperative abdominal circumference predict the occurrence of maternal hypotension during cesarean section Participants will be examined preoperatively in terms of visibility and palpation of spinous processes, abdominal circumference will be measured in the supine and sitting positions with other clinical parameters. Spinal anesthesia will be performed by the same experienced anesthesiologist with a standardized procedure. The number of skin punctures, needle reorientations, traumatic Cerebrospinal fluid, need for a paramedian approach or failure will be recorded. Maternal blood pressure and vasopressor requirements will also be monitored. ### Conditions - Anesthesia, Spinal - Cesarean Section ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Measure of abdominal circumference ### Outcomes Primary Outcomes - Number of patients with difficult spinal anesthesia Secondary Outcomes - Rate of Maternal hypotension ### Location - Facility: CHU Mohammed VI, Marrakech, N/A, 40000, Morocco @@
## Effectiveness of Mulligan Mobilization Technique - NCT ID: NCT06357624 - Study ID: Physiotherapy - Status: COMPLETED - Start Date: 2023-01-01 - Completion Date: 2023-05-30 - Lead Sponsor: Karabuk University ### Study Description The aim of this study was to investigate the effects of the Mulligan mobilization technique (MMT) on pain intensity, joint position sense (JPS), kinesiophobia, and disability level in individuals with nonspecific neck pain. A total of 34 female individuals with nonspecific neck pain were included in the study. Pain intensity, JPS, kinesiophobia, and disability levels of all participants were evaluated before and after the 3-week intervention. Participants were randomly divided into two groups. In the first group, the participants received MMT by the physiotherapist twice a week for 3 weeks, and self-mobilization techniques as a home exercise program. The second group was trained only self-mobilization techniques. ### Conditions - Neck Pain - Disability Physical - Kinesiophobia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Mulligan mobilization - Self-Mobilization ### Outcomes Primary Outcomes - Disability - Neck Pain Severity - Joint Position Sense Secondary Outcomes ### Location - Facility: Tarik Ozmen, Karabük, N/A, N/A, Turkey @@
## Combination of Two Osteopathic Techniques for the Hamstring's Stretching Capacity in Basketball Female Players - NCT ID: NCT06357611 - Study ID: OST1_015 - Status: RECRUITING - Start Date: 2024-09-16 - Completion Date: 2024-12-17 - Lead Sponsor: Natália Maria Oliveira Campelo ### Study Description It is known that there are studies that prove the effectiveness of muscle energy techniques and the fourth ventricle technique separately, however, information is scarce regarding the combination of the two and their effectiveness in the population. The aim of this randomized controlled study is to compare the immediate effects of the techniques compared to the muscle energy technique alone in female basketball players. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Simulated technique - Muscle energy technique - 4th ventricle technique and muscular energy technique ### Outcomes Primary Outcomes - Altered range of motion of the hamstring muscles. Secondary Outcomes ### Location - Facility: Escola Superior de Saúde do Porto, Porto, N/A, 4200-072, Portugal @@
## Preoperative Neoadjuvant Immunotherapy Combined With Chemotherapy for Stage Ⅲ Unresectable Non-small Cell Lung Cancer - NCT ID: NCT06357598 - Study ID: QYFYEC2023-95 - Status: RECRUITING - Start Date: 2024-01-18 - Completion Date: 2025-12-31 - Lead Sponsor: The Affiliated Hospital of Qingdao University ### Study Description Explorative study, which evaluates the effect of Tislelizumab combined with chemotherapy in neoadjuvant treatment of stage Ⅲ unresectable non-small-cell lung carcinoma. ### Conditions - Non-small-cell Lung Cancer (NSCLC) ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Tislelizumab - Pemetrexed (Non-squamous NSCLC) or Nab-paclitaxel(Squamous NSCLC) - Carboplatin or Cisplatin - Surgery ### Outcomes Primary Outcomes - R0 Resection Rate Secondary Outcomes - Objective Response Rate (ORR) - Resectability Rate - Major Pathological Response (MPR) Rate - Rate of grade 3 and higher grade treatment-related adverse events - Progression-Free Survival (PFS) ### Location - Facility: the Affiliated Hospital of Qingdao University, Qingdao, Shandong, 266000, China @@
## Providing Web-based Training to Parents Of Children With Leukemia - NCT ID: NCT06357585 - Study ID: SBUBURCUCALİK - Status: RECRUITING - Start Date: 2021-09-24 - Completion Date: 2024-04 - Lead Sponsor: Saglik Bilimleri Universitesi ### Study Description Following and implementing innovations and current developments in care practices for children diagnosed with leukemia and their parents will allow the quality of care to increase. The purpose of this research is to evaluate the effect of web-based education given to parents of children diagnosed with leukemia on their knowledge level, satisfaction and self-efficacy.The research is a single-blind randomized controlled experimental research type. The research will be conducted in a single center, Ankara Bilkent City Hospital MH4 Children's Hospital Hematology-Oncology Clinics and Leukemia Polyclinic. The population of the research consists of parents of children diagnosed with leukemia between the ages of 2-18 who are followed and treated in the specified places. The sample of the research consists of 72 participants, 36 in the experimental group (the group that received web-supported training) and 36 in the control group (the group that continued routine treatment).The consent of the parents who meet the research criteria and voluntarily agree to participate in the study will be obtained with the "Informed Voluntary Consent Form" and the parents in both the experimental group and the control group will be given the "Child and Parent Introductory Information Form", "Child with Leukemia Parent Information Level Pre-Test Evaluation Form". ", "Generalized Perceived Self-Efficacy Scale" will be applied. Once the sufficient number is reached, web-based training will be provided to the parents in the experimental group. "Parents of Children with Leukemia Knowledge Level Post-Test Evaluation Form", "Generalized Perceived Self-Efficacy Scale" and "Web-Based Parents of Children with Leukemia Training Satisfaction Evaluation Form" will be applied to the parents who complete the training. No intervention will be made to the parents in the control group, and the children will continue their routine care and treatment process. The "Child with Leukemia Parent Knowledge Level Posttest Evaluation Form" and the "Generalized Perceived Self-Efficacy Scale" will also be applied to the parents in the control group. ### Conditions - Leukemia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Web based education - inactive group ### Outcomes Primary Outcomes - Child with Leukemia Parent Knowledge Level Pre-Test Evaluation Form - Child with Leukemia Parent Knowledge Level Post-Test Evaluation Form - Web-Based Child with Leukemia Parent Education Satisfaction Evaluation Form - Generalized Perceived Self-Efficacy Scale - Generalized Perceived Self-Efficacy Scale Secondary Outcomes ### Location - Facility: University of Health Sciences, Ankara, Keçiören, 06018, Turkey @@
## Real-life Clinical FEIBA Samples Measured Using the Version A of the HemA EnzySystem - NCT ID: NCT06357572 - Study ID: ENZ13-2024 - Status: COMPLETED - Start Date: 2024-03-26 - Completion Date: 2024-03-27 - Lead Sponsor: Enzyre B.V. ### Study Description The goal of this observational study is to assess if the version A of the HemA EnzySystem, a novel portable coagulation testing platform, can be used in patients with hemophilia A treated with Factor VIII Bypassing Agent (FEIBA). The main question\[s\] it aims to answer are:* Can the version A of the HemA EnzySystem can record thrombin generation within a time frame of 60 min in fresh whole blood samples of patients with hemophilia A treated with FEIBA?* Are the TGA results of the version A of the HemA EnzySystem in agreement with the TGA results obtained with conventional methods in fresh non frozen plasma?Participants are asked to fill in a questionnaire regarding their general health and hemophilia treatment. Subsequently, blood will be drawn from the patients before, and at 30, 120, and 240 minutes after FEIBA administration. Whole blood is immediately tested using the Version A HemA EnzySystem, and plasma is generated for testing with the Ceveron s100 (Technoclone). Leftover samples are frozen for later additional coagulation testing. ### Conditions - Hemophilia A With Inhibitor - Hemophilia A ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Thrombin generation assay (EnzySystem HemA version A - whole blood) - Thrombin generation assay (Ceveron s100 (Technoclone) - fresh plasma) - Additional coagulation tests ### Outcomes Primary Outcomes - Time between venipuncture and TGA result Secondary Outcomes - Agreement between TGA obtained with the EnzySystem HemA version A and conventional TGA results ### Location - Facility: Institute of Hematology and Blood Transfusion, Warsaw, Mazowieckie Województwo, N/A, Poland @@

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