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## Registry of Catheter Intervention in Pulmonary Embolism - NCT ID: NCT06348459 - Study ID: 18/010-E - Status: RECRUITING - Start Date: 2018-09-18 - Completion Date: 2030-12-31 - Lead Sponsor: Hospital San Carlos, Madrid ### Study Description Multicenter longitudinal observational ambispective (retrospective cases from 2014 and prospective from 2018 onwards) cohort study. The registry recruits a series of consecutive patients admitted for moderate-high risk or high-risk pulmonary embolism (according to 2019 European Society of Cardiology guidelines) treated invasively. This study aims to describe the acute management of the safety and effectiveness of different percutaneous interventions for acute pulmonary embolism. ### Conditions - Pulmonary Embolism - Pulmonary Embolism Acute Massive - Pulmonary Embolism Acute - Pulmonary Embolism and Thrombosis - Pulmonary Thromboembolisms ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - All cause-death Secondary Outcomes - all cause-death - all cause-death - all cause-death - procedural success - in-hospital complications ### Location - Facility: Hospital Clinico San Carlos, Madrid, N/A, 28040, Spain @@
## Tacrolimus Exposure in Kidney Transplantation - NCT ID: NCT06348446 - Study ID: FY20-2963 - Status: RECRUITING - Start Date: 2022-02-01 - Completion Date: 2024-08-30 - Lead Sponsor: Seoul National University Hospital ### Study Description Using CDW data from 5 tertiary hospitals in Korea, this study identify the optimal range of trough level that can prevent adverse outcome in the early periods after transplantation. ### Conditions - Kidney Transplant Rejection ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - relationship between time varying periodic mean of tacrolimus trough and a composite 1-year allograft outcomes Secondary Outcomes - relationship between time varying periodic mean of tacrolimus trough level during 12-72 mo. post-transplant and 6-year composite allograft outcome - relationship between post-transplant time varying periodic mean tacrolimus trough level and severe infection - relationship between post-transplant time varying periodic mean tacrolimus trough level and cardiovascular event - relationship between post-transplant time varying periodic mean tacrolimus trough level and patient mortality ### Location - Facility: Asan medical center, Seoul, Korea, Seoul, N/A, N/A, Korea, Republic of @@
## Efficacy Evaluation and Mechanism Study of Ketogenic Diet on Autism Spectrum Disorder in Children - NCT ID: NCT06348433 - Study ID: QL000003 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-02-01 - Completion Date: 2024-12-31 - Lead Sponsor: Qilu Hospital of Shandong University ### Study Description Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder, which is characterized by social interaction and communication defects, rigid repetitive behaviors, and often accompanied by speech development retardation. According to the report released by the Morbidity and Mortality Weekly Report (MMWR) of the Centers for Disease Control and Prevention (CDC), according to the statistical data analysis in 2020, one out of every 36 8-year-old children (2.76%) was confirmed to have autism spectrum disorder (ASD). This ratio is higher than that published in December 2021, when the prevalence rate of 8-year-old children was 1/44 (2.3%) according to the statistics in 2018. Although ASD has a high incidence, there is still a lack of effective treatment measures for autism at present. Drug treatment can only partially alleviate some related symptoms, such as irritability and aggressiveness. Other interventions mainly focus on behavioral and educational interventions, which have limited help to patients. The high cost also leads to a huge burden on families and health care systems. Therefore, finding targeted treatment measures and treatment mechanisms for ASD as soon as possible has become an urgent problem for us to solve.Faced with limited treatment options, as many as a third of parents try various dietary pattern interventions to help their autistic children. In recent years, ketogenic diet, as a diet mode with extremely low carbohydrate, high fat, proper amount of protein and other nutrients, has attracted wide attention. In this mode, increased lipolysis puts the body in a ketosis state, thus ensuring energy supply.Although ketogenic diet (KD) has been proved to be effective in reducing the core symptoms in autistic patients and mouse models, the specific mechanism of KD in autism spectrum disorder (ASD) is still not completely clear.This study aims to evaluate the efficacy of ketogenic diet in improving core symptoms, sleep disorders and gastrointestinal symptoms of ASD children, explore the changes of excitation/inhibition (dorsolateral prefrontal cortex) in prefrontal cortex of ASD children before and after ketogenic diet intervention, and try to reveal the mechanism of ketogenic diet in treating ASD. ### Conditions - Autism Spectrum Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Ketogenic diet ### Outcomes Primary Outcomes - Autism Behavior Checklist（ABC） - Childhood Autism Rating Scale(CARS) Secondary Outcomes - Gastrointestinal Symptom Scale（GSRS) - Children's Sleep Habits Questionnaire（CSHQ) ### Location - Facility: Yu Wang, Jinan, Shandong, 274400, China @@
## Anti-reflux Mucosal Valvuloplasty Versus PPIs for GERD Treatment - NCT ID: NCT06348420 - Study ID: 2023-QILU-LU 03 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-10 - Completion Date: 2027-08-13 - Lead Sponsor: Qilu Hospital of Shandong University ### Study Description The study objective is to evaluate the relative merits, safety and effectiveness of Anti-reflux mucosal valvuloplasty (ARMV) in GERD patients currently treated with daily Proton Pump Inhibitors (PPIs). ### Conditions - Gastroesophageal Reflux Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - anti-reflux mucosal valvuloplasty (ARMV) ### Outcomes Primary Outcomes - The total score of the GERD-HRQL questionnaire Secondary Outcomes - Number of Participants with PPI usage - Appearance of the mucosal flap - Presence of reflux esophagitis - Safety evaluation indicators - Total score of GERD GerdQ questionnaire - DeMeester score ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Clinical Study of Omalizumab in the Treatment of Allergic Asthma(ESSENCE) - NCT ID: NCT06348407 - Study ID: 2024-BA-001 - Status: RECRUITING - Start Date: 2023-12-01 - Completion Date: 2024-11-30 - Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University ### Study Description Allergic asthma being the most widespread and easily identifiable phenotype, accounting for 60-80% of cases.Previous studies have reported that nearly 90% of patients with severe asthma were cases of allergic asthma, in which Immunoglobulin E (IgE) plays a critical role.Omalizumab was approved as an anti-IgE humanized monoclonal antibody for the treatment of patients with poorly controlled moderate-to-severe asthma, and was the first targeted drug used in the field of asthma treatment.The drug was launched in mainland China in August 2017.whereas,the clinical application experience, effects, and relevant data in the domestic population still lacking.The aim of this study was to observe the efficacy and safety of omalizumab, and to investigate whether baseline clinical characteristics and biomarkers can predicted response and adherence to treatment. ### Conditions - Moderate to Severe Allergic Asthma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - IgE monoclonal antibody ### Outcomes Primary Outcomes - Change in Asthma Control Test (ACT) - Global Evaluation of Treatment Effectiveness (GETE) Secondary Outcomes - Forced Expiratory Volume in 1 second（FEV1) - FEV1/predicted%. - Forced Vital Capacity （FVC） - FEV1/FVC. - Number of Acute Exacerbations（AE） - Oral glucocorticoid dosage - Good adherence - Poor adherence - Adverse events ### Location - Facility: Linfu zhou, Nanjing, Jiangsu, 210000, China @@
## Intracardiac Versus Transesophageal Echocardiographic Guidance for Left Atrial Appendage Occlusion - NCT ID: NCT06348394 - Study ID: 023-318 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-12-14 - Completion Date: 2025-12-30 - Lead Sponsor: Baylor Research Institute ### Study Description This single-center, prospective, randomized study will evaluate the safety and feasibility of Intracardiac echocardiography (ICE)-guided Left atrial appendage closure (LAAC) when compared to the traditional Transesophageal echocardiography (TEE) approach. ### Conditions - Left Atrial Appendage Closure ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Intracardiac Echocardiography ### Outcomes Primary Outcomes - Procedural success following implantation of the left atrial appendage occlusion (LAAO) device. Secondary Outcomes - Periprocedural complications - Procedural characteristics - Patient satisfaction - Periprocedural complications - Periprocedural complications - Procedural characteristics - Procedural characteristics - Procedural characteristics ### Location - Facility: Baylor Scott and White Heart Hospital, Plano, Texas, 75093, United States @@
## Prediction of Anastomotic Complications and Recurrent Laryngeal Nerve Injury Based on Postoperative Early Endoscopic Evaluation - NCT ID: NCT06348381 - Study ID: IS24030 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-12-31 - Lead Sponsor: Shanghai Chest Hospital ### Study Description Analyze the correlation between the conformity of the anatomy (based on endoscopic examination) and postoperative anastomotic fistula and anastomotic stenosis; establish an anastomotic classification; and construct a predictive model combined with perioperative-related test indicators to provide more accurate risk assessment for clinical practice. Analyze the natural recovery process of postoperative recurrent laryngeal nerve injury in esophageal cancer by tracking vocal cord movement (based on endoscopic examination) and hoarseness symptoms; combined with perioperative related surgical and laboratory indicators, identify the relevant risk factors associated with delayed recovery of recurrent laryngeal nerve injury. ### Conditions - Esophageal Neoplasm - Anastomotic Leak - Recurrent Laryngeal Nerve Injuries - Anastomotic Stenosis - Endoscopic Evaluation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No intervention ### Outcomes Primary Outcomes - anastomotic leak - anastomotic stenosis - laryngeal nerve injury Secondary Outcomes ### Location - Facility: Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, N/A, SH 21, China @@
## Refractive and Corneal Topographic Characteristics in Upper Egypt Children With High Cylinder - NCT ID: NCT06348368 - Study ID: Soh-Med-23-01-29 - Status: COMPLETED - Start Date: 2023-01-01 - Completion Date: 2024-02-01 - Lead Sponsor: Sohag University ### Study Description Refractive and Corneal Topographic Characteristics in upper Egypt children with high cylinder: A cross sectional study ### Conditions - Corneal Ectasia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Pentacam and autorefractometry ### Outcomes Primary Outcomes - Values anterior and posterior corneal elevation values by pentacam. Secondary Outcomes ### Location - Facility: Elshimaa A.Mateen, Sohag, N/A, N/A, Egypt @@
## A Positron-emission Tomography Study to Determine Brain Exposure of [11C]Savolitinib in Healthy Volunteers - NCT ID: NCT06348355 - Study ID: D5084C00016 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-22 - Completion Date: 2024-06-28 - Lead Sponsor: AstraZeneca ### Study Description The purpose of this study is to measure brain exposure of \[11C\]savolitinib in healthy volunteers.This study will determine brain exposure of \[11C\]savolitinib in up to 8 healthy volunteers under physiological conditions, ie, when the BBB is intact. The study design allows up to 3 site visits. Two PET examinations will be performed for each healthy volunteer. The first PET examination will use IV administration of \[11C\]savolitinib. The second PET examination using \[11C\]savolitinib will occur after a single oral dose of 300 mg of savolitinib. PET image analysis will include kinetic compartment modelling using arterial input function, and will generate a set of brain exposure parameters (eg, maximum %ID, maximum \[11C\]savolitinib concentration in brain, partition coefficients between brain and plasma). ### Conditions - Healthy Volunteers ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - [11C]savolitinib - Savolitinib ### Outcomes Primary Outcomes - Percentage of injected radioactivity entering the brain (%ID) as %IDmax_brain Secondary Outcomes - The following endpoint: Cmax_brain SUV - The following endpoint: Tmax brain - The following endpoint: AUCbrain 0-90 - The following endpoint: AUCplasma 0-90 - The following endpoint: Kp - The following endpoint: Kp,uu - The following endpoint: VT - The following endpoint: Cmax_brain SUV - The following endpoint: Tmax brain - The following endpoints: AUCbrain 0-90 - The following endpoints: AUCplasma 0-90 - The following endpoints: Kp - The following endpoints: Kp,uu - The following endpoints: VT ### Location - Facility: Research Site, Solna, N/A, 171 64, Sweden @@
## Pelvic Floor Muscle Exercises and Core Exercises in Menopausal Women - NCT ID: NCT06348342 - Study ID: TÜTF-GOBAEK 2023/24 - Status: ENROLLING_BY_INVITATION - Start Date: 2023-10-15 - Completion Date: 2024-06-30 - Lead Sponsor: Trakya University ### Study Description The prospective and four-arm randomized controlled study was conducted on n = 136 (34 = control, 34 = kegel, 34 = core, 34 = kegel+ core group) menopausal women at Trakya University Health Research and Application Center Urology Polyclinic between Oct 2023 and June 2024. In the first interview, the researcher will apply an information form to all four groups, asking about personal information, habits, bladder irritants and fluid intake-related features, obstetric, gynecological and systemic disease-related features, and stress urinary incontinence-related features. This form will only be filled at the beginning. In addition, the \&#34;Pelvic Floor Distress Scale (PFDI)\&#34; and \&#34;Pelvic Floor Impact Questionnaire (PFIQ)\&#34; will be applied and will be repeated by the executive researcher at the 1st, 2nd and 3rd controls. It will be terminated at the 3rd follow-up. Descriptive statistics, Pearson, Spearman\&#39;s correlation, and regression analyzes will be used in the analysis of research data. ### Conditions - Menopause - Stress Urinary Incontinence - Kegel Exercises - Core Strength ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Pelvic Floor Muscle Exercise - Core Exercise ### Outcomes Primary Outcomes - Pelvic floor evaluated using the Pelvic Floor Distress Inventory (PFDI - Pelvic Floor Distress Inventionary) - Pelvic floor impact evaluated using the Pelvic Floor Impact Questionnaire (PFIQ Pelvic Floor Impact Questionnaire) Secondary Outcomes - Urinary incontinence evaluated using the Stress Test - Urinary incontinence evaluated using the Uroflowmetry - Urinary incontinence evaluated using the Pelvic Floor Muscle Strength Measurement - Urinary incontinence evaluated using the Digital Palpation ### Location - Facility: Bartın University, Bartin, N/A, 78100, Turkey @@
## Pregnant Women Participating in Birth Preparation Training With Their Spouses on the Parenting Role, Attitudes of Their Spouses Towards Participating in the Birth, and Birth Self-Efficacy - NCT ID: NCT06348329 - Study ID: TÜTF-GOBAEK 2023/41 - Status: RECRUITING - Start Date: 2023-06-29 - Completion Date: 2024-04-15 - Lead Sponsor: Trakya University ### Study Description In this prospective, randomized controlled study, it was aimed to examine the effect of pregnant women participating in birth preparation training together with their partners on the parenting role, spouses' attitudes towards participation in birth, and birth self-efficacy.The study was shared via the web on social media (Facebook, Instagram, Twitter, Telegram) forum pages between 25.09.2023-25.03.2025, and n=158 pregnant women who met the inclusion criteria and volunteered to participate in the study (79= education without spouse participation, 79= spouse Participatory education) will be conducted randomly in two groups: case and control.Before starting the research, two groups will be randomly formed among pregnant women. As a randomization method, pregnant women who meet the sampling inclusion criteria determined in the research will be identified and listed. Individuals to be taken into two groups will be determined by randomization method from the random numbers table. (http://www.stattrek.com/statistics/randomnumber-generator.aspx). ### Conditions - Birth Order - Parenting - Self Efficacy - Pregnancy Related ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Birth Preparation Training ### Outcomes Primary Outcomes - Parenting behavior evaluated using the Postpartum Parenting Behavior Scale - Parenting self-efficacy in labor evaluated using the Self-Efficacy in Labor Scale - Spouse support evaluated using the Spouse Support Scale - Father candidates towards participating in the birth evaluated using the Attitude Scale for Father Candidates Towards Participating in the Birth Secondary Outcomes ### Location - Facility: Trakya University, Edirne, N/A, 22030, Turkey @@
## Early Half Swaddling and Kangaroo Care Practices on Maternal Sleep Quality and Postpartum Depression in Term Babies - NCT ID: NCT06348316 - Study ID: TÜTF-GOBAEK 2023/45 - Status: RECRUITING - Start Date: 2023-09-30 - Completion Date: 2024-07-30 - Lead Sponsor: Trakya University ### Study Description Aim: In this prospective, randomized controlled study, it was aimed to examine the effects of early half-swaddle and kangaroo care practices in term babies on maternal sleep quality and postpartum depression.Design: The prospective, randomized controlled study ### Conditions - Mothers - Postpartum Depression ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Half swaddle - Kangaroo care ### Outcomes Primary Outcomes - Mother sleep quality evaluated using the Pittsburgh Sleep Quality Index (PSQI) - Postpartum depression evaluated using the Edinburgh Postnatal Depression Scale (EPDS) Secondary Outcomes ### Location - Facility: Trakya University, Edirne, N/A, 22030, Turkey @@
## Study to Assess Drowsiness, Cognition, Fall Risk After Metaxalone 640 mg and Metaxalone 800 mg - NCT ID: NCT06348303 - Study ID: PMMD-01 - Status: RECRUITING - Start Date: 2024-03-15 - Completion Date: 2025-03-15 - Lead Sponsor: Primus Pharmaceuticals ### Study Description Every participant will receive Metaxalone in two (2) stages, one week after the other. A single dose of each Metaxalone dose will be taken one (1) time after a high fat meal which must be eaten within 30 minutes. Every participant will be given written tests to measure drowsiness, reaction time and thinking process and will also be asked to take walking tests to assess fall risk. Participation in this study will last approximately 2-4 weeks. ### Conditions - Healthy Participants ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: PREVENTION ### Interventions - Metaxalone m640 mg oral tablet - Metaxalone 800 mg oral tablet ### Outcomes Primary Outcomes - Percentage of participants unable to maintain Tandem Stand Position for more than 10 seconds (position 3 of the 4-Stage Balance Test). - Change from baseline of gait during a stopwatch timed, stand, and walk activity from a seated position along a 30 foot path - Change from baseline of correct number of steps taken on a fixed 4 inch wide, 9 feet long path Secondary Outcomes - Change from baseline of participants' subjective report of drowsiness on a 10-point scale - Change from baseline of reaction to stimulus by computer generated visual prompts measured in milliseconds - Change from baseline of participants' reasoning ability to recognize differences in six (6) computer generated shapes for 30 minutes - The number of product related adverse events experienced by participants from Visit 2 through Visit 4 ### Location - Facility: ClinOhio Research Institute, Columbus, Ohio, 43213, United States @@
## Study to Evaluate the Drug-drug Interaction of JMKX001899 in Healthy Subjects - NCT ID: NCT06348290 - Study ID: JY-JM1899-105 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-09-15 - Lead Sponsor: Jemincare ### Study Description This is an open-label, non-randomized, clinical study to evaluate the drug interaction between itraconazole, rifampin or Cocktail and JMKX001899 in healthy subjects. A total of three cohorts of 72 healthy subjects were planned to be enrolled in each cohort. ### Conditions - Solid Tumor, Adult ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - JMKX001899 - Itraconazole - Midazolam - Rifampin - dextromethorphan - Rosuvastatin - digoxin ### Outcomes Primary Outcomes - maximum concentrations (Cmax ) for plasma - area under the curve from time 0 to infinity(AUC0-inf) for plasma - area under the curve from time 0 to the last time point (AUC0-t) for plasma Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Brief App-based Mood Monitoring and Mindfulness Intervention for First-year College Students - NCT ID: NCT06348277 - Study ID: 121119 - Status: COMPLETED - Start Date: 2018-01-02 - Completion Date: 2020-06-17 - Lead Sponsor: Lawrence University ### Study Description The investigators examined whether brief, app-based interventions were helpful in alleviating mental health symptoms during the transition to college. In particular, the investigators were interested in whether a brief mobile-app mindfulness intervention combined with mood monitoring was more effective in alleviating first-year students' psychological distress than mood monitoring alone. ### Conditions - Depression, Anxiety - Self-Injurious Behavior ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Mindfulness plus mood monitoring - Mood monitoring ### Outcomes Primary Outcomes - Depressive Symptoms - Anxiety Symptoms - Urges to Self-injure - Rumination - Worry Secondary Outcomes - Depressive Symptoms - Depressive Symptoms - Anxiety Symptoms - Anxiety Symptoms - Urges to self-injure - Urges to self-injure - Rumination - Rumination - Worry - Worry ### Location - Facility: Lawrence University, Appleton, Wisconsin, 54911, United States @@
## Adjuvant Rezvilutamide in Combination With Androgen Deprivation Therapy in Androgen Receptor-positive, High-risk Salivary Duct Carcinoma - NCT ID: NCT06348264 - Study ID: SDC-1 - Status: RECRUITING - Start Date: 2024-03-30 - Completion Date: 2031-03-30 - Lead Sponsor: Peking University First Hospital ### Study Description The purpose of the study is to evaluate the efficacy and safety of rezvilutamide in combination with androgen deprivation therapy (ADT) in participants with androgen receptor (AR) positive, high-risk salivary duct carcinoma (SDC).The procedures include screening, treatment and follow-up period. The treatment includes rezvilutamide plus Luteinizing Hormone Releasing Hormone agonist (LHRHa) for up to 2 years. ### Conditions - Salivary Gland Neoplasm Duct ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Rezvilutamide - Leuprolide Acetate ### Outcomes Primary Outcomes - 3-year disease-free survival (DFS) Secondary Outcomes - 3-year overall survival (OS) - 3-year disease-specific survival (DSS) - 3-year distant-metastatic free survival (DMFS) - Adverse events - 5-year disease-free survival (DFS) ### Location - Facility: Peking University First Hospital, Beijing, Beijing, 100034, China @@
## FoodSteps for Binge Eating & Food Insecurity - NCT ID: NCT06348251 - Study ID: STU00219612 - Status: RECRUITING - Start Date: 2024-03-26 - Completion Date: 2024-11-30 - Lead Sponsor: Northwestern University ### Study Description The purpose of this study is to conduct a pilot trial of a mobile intervention that targets binge eating and weight-related behaviors, to determine the feasibility, acceptability, and preliminary efficacy of the intervention among adults with recurrent binge eating, diabetes, and food insecurity. ### Conditions - Binge Eating - Type 2 Diabetes - Food Insecurity ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - FoodSteps ### Outcomes Primary Outcomes - Recruitment and retention rates Secondary Outcomes ### Location - Facility: Northwestern University Feinberg School of Medicine, Chicago, Illinois, 60611, United States @@
## Strategies to Improve Well-Being and Diabetes Management - NCT ID: NCT06348238 - Study ID: 2074997 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-02-28 - Lead Sponsor: Elizabeth Scharnetzki ### Study Description This project aims to implement an adapted self-affirmation intervention among a population of individuals with diabetes to reduce the negative psychosocial impacts of stigma. In a self-affirmation, participants are guiding through a writing exercise writing designed to reinforce sources of self-worth before they encounter or engage in stressful or stigmatizing events. Participants in this study will be asked to complete self-affirmation exercises before their 3-month wellness appointments with their endocrinologists over the course of a year. The main questions the investigators are asking are:* Will self-affirmation reduce feelings of stigmatization?* Will self-affirmation increase self-efficacy and motivation to engage in condition management behaviors.* Will self-affirmation improve blood glucose control. Participants will be randomly assigned to either the intervention condition or a waitlist control condition. Participants in the waitlist control condition will also complete writing exercises but they will be abbreviated (this in the psychological literature is referred to as a "low affirmation condition"). At the end of the study, waitlist control participants will have access to the full exercise should they like to receive it.After each appointment and self-affirmation, participants will complete surveys assessing feelings of stigma and motivation to engage in condition management. All participants will already be using continuous glucose monitors. The investigators will compare both survey responses and continuous glucose data between our conditions to assess the efficacy of the self-affirmation intervention. ### Conditions - Diabetes Mellitus, Type 2 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Self-Affirmation ### Outcomes Primary Outcomes - Social Identity Threat Concerns (SITC) Scale - Two-Factor Weight Bias Internalization Scale - Diabetes Stigma Assessment Scale - The Revised Diabetes Self-Management Questionnaire - Confidence in Diabetes Self-Care Scale - Blood glucose Secondary Outcomes - Hemoglobin A1C - Patient-reported age - Patient Gender - Patient Race - Patient ethnicity - Patient's highest level of education completed - Household income - Zip code - Years since diagnosis - Diabetes Management Plan - Physical activity - Continuous glucose monitor use - Height - Weight - History of weight-based victimization (moderator/covariate) - Problem Areas in Diabetes Questionnaire (moderator/covariate) - Generalized Anxiety Disorder 7-item (moderator/covariate) - Patient Health Questionnaire (PHQ-9) (moderator/covariate) - Stigma Consciousness Questionnaire (moderator/covariate) ### Location - Facility: MaineHealth Institute for Research, Center for Interdisciplinary and Population Health Research, Westbrook, Maine, 04092, United States @@
## Post-exercise Hot Water Immersion to Improve Overnight Blood Pressure - NCT ID: NCT06348225 - Study ID: FY24-10 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-12-31 - Lead Sponsor: Providence College ### Study Description The goal of this clinical trial is to test whether putting your legs in a hot bath after exercise improves blood pressure in people with higher blood pressure.. The main questions it aims to answer are:* Whether exercise alone, hot water leg bath alone, or both treatments together cause blood pressure to be lower during sleep.* If there are any changes in heart rhythm or blood vessel health after exercise, hot water leg bath, or the two treatments together that relate to changes in blood pressure.Participants will complete four different trials:* 30 minutes of walking with a 45-minute lukewarm leg bath after* 30 minutes of walking with a 45-minute hot leg bath after* 45 minutes of a hot leg bath with no exercise* A day with no exercise or leg bath Researchers will look at their heart rhythm, blood vessels, and blood pressure after each of these trials to see if there are differences, and if exercise and heat together can improve heart health more than exercise or heat alone. ### Conditions - Elevated Blood Pressure ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: PREVENTION ### Interventions - Exercise or heat treatment ### Outcomes Primary Outcomes - Ambulatory blood pressure - Heart Rate Variability - Flow-mediated dilation Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of Probiotic Strain Lactobacillus Paracasei PS23 on Brain Fog in People With Long COVID - NCT ID: NCT06348212 - Study ID: 2022-11-008C - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-12 - Lead Sponsor: Taipei Veterans General Hospital, Taiwan ### Study Description The goal of this clinical trial is to test whether the intervention of probiotics supplement can improve symptoms of long covid syndrome.Participants will be given probiotics or placebo capsules for two month. Symptom questionnaires, cognitive function, eeg and fecal sample are recorded/collected before and after the supplement.Researchers will compare the probiotic group and the placebo to see if probiotic supplement really make differences. ### Conditions - Long COVID - Brain Fog - Cognitive Change ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Lactobacillus paracasei PS23 - microcrystalline cellulose ### Outcomes Primary Outcomes - Long covid related symptoms - Hospital Anxiety and Depression Scale - The Pittsburgh sleep quality index - Fatigue Severity Scale - GI symptoms - Cognitive function-Digit symbol substitution test - Cognitive function-The Montreal Cognitive Assessment(MoCA) - Cognitive function-Color Trails making Test - Cognitive function-Cogstate Brief Battery (CBB) - EEG - Gut microbiota - Fecal metabolite Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer - NCT ID: NCT06348199 - Study ID: SB27-3004 - Status: RECRUITING - Start Date: 2024-03-12 - Completion Date: 2027-03 - Lead Sponsor: Samsung Bioepis Co., Ltd. ### Study Description The goal of this clinical trial is to confirm that SB27 works in the same way as Keytruda in metastatic non-squamous non-small cell lung cancer (NSCLC) patients. The main question it aims to answer is:• How effective the study drug is Participants will receive either investigational product (SB27 or Keytruda) and chemotherapy every 3 weeks.Researchers will compare SB27 and Keytruda to see if SB27 works in the same way as Keytruda. ### Conditions - Non-small Cell Lung Cancer Stage IV ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - SB27 - Keytruda ### Outcomes Primary Outcomes - Objective response rate (ORR) at Week 24 Secondary Outcomes ### Location - Facility: SB Investigative Site, Batumi, N/A, N/A, Georgia @@
## Fascial Tissue Response To Manual Therapy: Implications In Long Covid Rehabilitation - NCT ID: NCT06348186 - Study ID: Fascial Tissue Response - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2024-07-31 - Lead Sponsor: University of the State of Santa Catarina ### Study Description According to the World Health Organization (WHO), as of mid-September 2022, more than 21 million Brazilians have recovered from COVID-19. However, post-infection symptoms continue to appear months after the end of the acute infection, a syndrome called long COVID. Therefore, the aim of this study is to investigate the responses of fascia-focused manual therapy in participants with long COVID. ### Conditions - COVID-19 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Guidebook - Guidebook and Myofascial Reorganization® (RMF). ### Outcomes Primary Outcomes - Functioning and disability - Biomechanical and tissue viscoelastic properties Secondary Outcomes - Work capacity - Quality of life - Upper limb dysfunctions - Balance ### Location - Facility: Santa Catarina State University, Florianópolis, Santa Catarina, 88.035-001, Brazil @@
## Response and Remission to Treatment With Anti-IL5/IL5R Antagonists - NCT ID: NCT06348173 - Study ID: 2021-2190 - Status: COMPLETED - Start Date: 2023-06-01 - Completion Date: 2023-11-30 - Lead Sponsor: Université de Montréal ### Study Description The aim of this retrospective observational study is to compare the response and remission rate after treatment with IL5/IL5-R antagonists in asthmatics who would and would have not met the inclusion criteria of the original randomized clinical trials.This study will be performed using the charts of the patients. ### Conditions - Asthma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Mepolizumab ### Outcomes Primary Outcomes - Response to IL5/IL5R antagonists one year after cohort entry among subjects fulfilling and not fulfilling the original RCT inclusion criteria - Remission rate with IL5/IL5R antagonists one year after cohort entry in subjects fulfilling and not fulfilling the original RCT inclusion criteria Secondary Outcomes ### Location - Facility: Hôpital du Sacré-Coeur de Montréal, Montréal, Quebec, H4J 1C5, Canada @@
## iHERO Study: Insurance, Health and Economic Resources Online for Emerging Adults With Type 1 Diabetes - NCT ID: NCT06348160 - Study ID: STUDY20230187 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-03-31 - Lead Sponsor: Julia Blanchette ### Study Description This research study aims to test a financial and health insurance iHERO Toolkit for young adults with type1 diabetes. The iHERO Toolkit was developed over one year with the type 1 diabetes community, The Diabetes Link organization, and experts. Now, the investigators want to understand the impact of the iHERO Toolkit on diabetes self-management, financial stress, and health insurance literacy outcomes. The investigators are doing this study because it will help to better understand how to support health insurance and financial stress and improve self-management outcomes in young adults with type 1 diabetes. The investigators want to understand how the iHERO Toolkit helps all young adults with diabetes, but especially those on Medicaid and who are racially or ethnically diverse. The investigators will ask participants to participate at four-time points over one year. For the first time, participants will fill out online enrollment and demographic forms and 9 surveys. The 9 surveys have 8-40 short questions each, estimated to take about 45 minutes. Participants will also be asked to complete a home A1c collection with a University Hospitals team member on Zoom. ### Conditions - Type 1 Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - iHERO Toolkit Resource ### Outcomes Primary Outcomes - Change in financial stress as measured by the Personal Financial Well-Being Scale© (PFW) Scale (PFW) - Change in health insurance literacy as measured by The Health Insurance Literacy Measure (HILM) Measure (HILM) - Change in diabetes-specific quality of life as measured by The Type 1 Diabetes and Life Young Adult (T1DAL- Young Adult) for ages 18-25 or The Type 1 Diabetes and Life (T1DAL- Adult) for Ages 26-30. - Change in transition navigation readiness as measured by the The Readiness for Emerging Adults with Diabetes Diagnosed in Youth (READDY) Navigation Subscale - Change in HbA1c levels as measured by self-collect capillary HbA1c Secondary Outcomes ### Location - Facility: Children's Hospital Los Angeles, Los Angeles, California, 90027, United States @@
## Dara-RVd Induction for Newly Diagnosed Multiple Myeloma With Autologous Stem Cell Transplantation - NCT ID: NCT06348147 - Study ID: LCCC2323 - Status: NOT_YET_RECRUITING - Start Date: 2024-08 - Completion Date: 2028-08 - Lead Sponsor: UNC Lineberger Comprehensive Cancer Center ### Study Description This Phase II hybrid decentralized trial will examine the effect of daratumumab-based quadruplet induction therapy administered at an attenuated schedule in subjects with newly diagnosed multiple myeloma (NDMM) who are eligible for standard-of-care autologous stem cell transplantation (ASCT). Daratumumab, lenalidomide, bortezomib, and dexamethasone (Dara-RVd) have recently become a standard induction regimen for patients with NDMM who are eligible for ASCT in the United States. As implemented in clinical trials, Dara-RVd involves twice weekly bortezomib administration, which is inconvenient for patients and may result in increased rates of limiting toxicity, such as peripheral neuropathy. Adoption of alternate schedules involving once-weekly bortezomib is common in real-world practice, however a paucity of prospective data supporting this practice exists.This study examines the efficacy of an attenuated Dara-RVd schedule involving once-weekly bortezomib dosing. ### Conditions - Newly Diagnosed Multiple Myeloma - Multiple Myeloma - Autologous Stem Cell Transplantation ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Daratumumab - Lenalidomide - Bortezomib - Dexamethasone ### Outcomes Primary Outcomes - The rate of achievement of bone marrow minimal residual disease (MRD) negativity Secondary Outcomes - Progression Free Survival (PFS ) - Stringent complete response (sCR) - Overall Survival (OS) - Therapeutic discontinuation - Time to first response - Time to best response - Maximum depth of response (from PR to CR, including sCR) - Overall response rate (ORR) ### Location - Facility: UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, 27516, United States @@
## Assessing the Efficacy and Safety of Anti-HER2 Therapy in Nigerian Women With HER2+ Breast Cancer Before and After Surgery - NCT ID: NCT06348134 - Study ID: IRB23-0502 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2036-07-01 - Lead Sponsor: University of Chicago ### Study Description Doctors leading this study would like to learn about providing cancer treatment/therapies to Nigerian women with breast cancer based on their human epidermal growth factor receptor 2 (HER2) status. This study will focus on the efficacy and safety of anti-HER2 cancer treatment before and after surgery. ### Conditions - Human Epidermal Growth Factor 2 Negative Carcinoma of Breast - HER2-positive Breast Cancer - Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Trastuzumab emtansine - Pertuzumab Injection - Docetaxel - Tamoxifen - Letrozole - Goserelin ### Outcomes Primary Outcomes - Pathological Complete Response Secondary Outcomes - Reported Adverse Events and clinical/medical records of participants - Percentage of participants who are suitable for breast-conserving surgery - Event-free survival duration reported among participants - Quality of life reported among study participants - Genetic and epigenetic factors associated with breast cancer in Nigeria ### Location - Facility: University of Chicago, Chicago, Illinois, 60615, United States @@
## Impact of Probiotics on Children With ADHD - NCT ID: NCT06348121 - Study ID: WK2024003 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-07 - Completion Date: 2024-12-31 - Lead Sponsor: Wecare Probiotics Co., Ltd. ### Study Description To evaluate the efficacy and safety of probiotic product WecProB as food supplements for the treatment of clinical symptoms in children with ADHD, in comparison with placebo. ### Conditions - Attention Deficit Hyperactivity Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Probiotic ### Outcomes Primary Outcomes - Clinical symptoms of ADHD Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Talquetamab in Combination With Iberdomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma - NCT ID: NCT06348108 - Study ID: 232514 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2028-06-30 - Lead Sponsor: Thomas Martin, MD ### Study Description This phase I trial tests the safety, side effects, and best dose of talquetamab in combination with iberdomide and dexamethasone in treating patients with multiple myeloma that has come back after a period of improvement (relapsed) or has not responded to previous treatment (refractory). There is currently a significant unmet need for patients with relapsed or refractory multiple myeloma (RRMM) who are triple class refractory and have been exposed to B-cell maturation antibody (BCMA) targeted therapy. These patients currently have limited treatment options and poor survival. Talquetamab is approved for use by the Food and Drug Administration (FDA) to treat RRMM when given alone. Talquetamab can bring T-cells to the myeloma cell, resulting in myeloma cell death. Iberdomide is an investigational drug. Iberdomide works by targeting and destroying proteins that help myeloma cancer cells to survive. Dexamethasone is a corticosteroid, is similar to a natural hormone produced by the adrenal glands. It relieves inflammation (swelling, heat, redness, and pain) and is used to treat certain types of cancer including myeloma. Giving talquetamab in combination with iberdomide and dexamethasone may be safe, tolerable and effective in treating patients with RRMM ### Conditions - Multiple Myeloma - Refractory Multiple Myeloma - Relapsed Multiple Myeloma ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Talquetamab - Iberdomide - Dexamethasone - Bone Marrow Biopsy ### Outcomes Primary Outcomes - Proportion of participants reporting treatment-emergent adverse events (AEs) (Dose Escalation Cohorts) - Proportion of participants experiencing Dose-Limiting Toxicity (DLTs) (Dose Escalation Cohorts) - Recommended phase 2 dose (RP2D) (Dose Escalation Cohorts) - Proportion of participants experiencing Dose-Limiting Toxicity (DLTs) (Dose Expansion Cohort) - Objective response rate (ORR) (Dose Expansion Cohort) Secondary Outcomes - Objective response rate (ORR) (Dose Escalation Cohorts) - Number of participants achieving VGPR or CR and MRD (negative (-)) response - Proportion of participants with treatment-related adverse events - Changes in scores on the European Organization for Research and Treatment of Cancer - Quality of Life questionnaire (EORTC-QLQ-C30) over time - Changes in scores on the EORTC QLQ- Multiple Myeloma Questionnaire (EORTC-QLQ-M20) over time ### Location - Facility: University of Calfornia, San Francisco, San Francisco, California, 94143, United States @@
## Effect of Probiotics on Viral Pneumonia - NCT ID: NCT06348095 - Study ID: WK2024004 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-07 - Completion Date: 2024-12-31 - Lead Sponsor: Wecare Probiotics Co., Ltd. ### Study Description To evaluate the effectiveness and safety of compound probiotic in shortening the course of illness in children with viral pneumonia, in comparison with placebo. ### Conditions - Viral Pneumonia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Probiotic - Placebo ### Outcomes Primary Outcomes - Respiratory syncytial virus (RSV) viral load Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Project Women's Insomnia Sleep Health Equity Study (WISHES) - NCT ID: NCT06348082 - Study ID: 2000036068 - Status: NOT_YET_RECRUITING - Start Date: 2025-09 - Completion Date: 2028-07 - Lead Sponsor: Yale University ### Study Description The purpose of this study is to achieve health and healthcare equity by implementing an equity-focused, mindfulness-based sleep intervention to reduce stress and sleep deficiency-related cardiometabolic disease burden in Black women. ### Conditions - Insomnia - Sleep Health - Cardiometabolic Health ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Mindfulness-based therapy for insomnia (MBTI) ### Outcomes Primary Outcomes - Change in Insomnia Severity - Change in Perceived Stress - Acceptability of Intervention (AIM) - Feasibility of Intervention (FIM) - Treatment Fidelity Secondary Outcomes ### Location - Facility: Yale School of Nursing Biobehavioral Lab, West Haven, Connecticut, 06516, United States @@
## Pharmacy-based PrEP for Young Women Who Sell Sex in Zimbabwe - NCT ID: NCT06348069 - Study ID: 2022-11-15783 - Status: RECRUITING - Start Date: 2024-03-25 - Completion Date: 2025-12-31 - Lead Sponsor: University of California, Berkeley ### Study Description Pharmacy-based PrEP for Young Women who Sell Sex in Zimbabwe is a cluster-randomized control trial and pilot study co-led by Dr. Euphemia Sibanda, Reader (Associate Professor) of Global Health and Epidemiology at Liverpool School of Tropical Medicine, UK and Research Director at the Centre for Sexual Health and HIV Research (CeSHHAR Zimbabwe) and Dr. Sandra McCoy, Professor of Epidemiology and Biostatistics at the University of California, Berkeley. The goal of the proposed study is to optimize, refine and pilot a pharmacy-based PrEP intervention for female sex workers (FSW) in Zimbabwe. Despite efforts to reach the most impacted and vulnerable populations with PrEP, retention rates, particularly among FSW in Africa, are very low. Relatively high levels of uptake indicate that FSW are interested in PrEP and ready to initiate it, but in most cases fewer than 50% of those who initiate return for medication refills by month 4. Pharmacy-based PrEP has the potential to address known barriers to PrEP retention among FSW such as stigma and access, and coupled with a small escalating incentive in the form of a gift card incentive, could also boost motivation for effective use of PrEP. ### Conditions - Adherence, Medication - HIV Prevention ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Pharmacy-based PrEP refill and gift voucher - Control (Standard of care) ### Outcomes Primary Outcomes - PrEP retention at 6 months Secondary Outcomes ### Location - Facility: CESHHAR Zimbabwe, Harare, N/A, 0000, Zimbabwe @@
## A Comparison of the Metabolic Effects of Zinc-Amino Acid (ZnAA) Versus Zinc Gluconate - NCT ID: NCT06348056 - Study ID: 2022-07-15499 - Status: RECRUITING - Start Date: 2024-01-22 - Completion Date: 2024-12-31 - Lead Sponsor: University of California, Berkeley ### Study Description Food consumption affects zinc metabolism within the body. Lowe and colleagues demonstrated that zinc is directed out of plasma and into tissues, such as into the liver, postprandially . It is likely that zinc absorbed with a meal is directed to the liver via the portal circulation whereas that zinc taken in the fasted state is more readily directed to peripheral blood plasma. Zinc taken with food is more likely to be bound to components of the food matrix and, therefore, it is not absorbed as efficiently by Zip4 ionic zinc transporters in the upper gastrointestinal tract. Some of the zinc in the food matrix may, however, be co-absorbed with amino acids over the whole length of the small intestine . Co-absorption of zinc with amino acids may explain the greater effects of zinc taken with food on omega-6 fatty acid desaturation . The investigators propose that this effect may be maximized by providing supplemental zinc complexed with amino acids. Since the zinc amino acid complex likely mimics the absorption and retention of zinc bound to protein in food, the investigators further propose that zinc, bound to amino acids taken in the fasted state will be directed into the cellular compartments more efficiently than zinc associated with gluconate.The primary aim in this study is to determine whether providing a zinc amino acid complex has a greater effect on indices of essential fatty acid desaturation compared with zinc gluconate when the zinc complexes are taken in the fasting state.The investigators hypothesize that taking a zinc amino acid (Zn-AA) complex in a fasted state daily for two weeks has a greater effect on the Fatty Acid Desaturase 1 (FADS1) activity compared with zinc gluconate. Also, if the uptake of ionic zinc gluconate into cellular compartments is reduced in comparison to Zn-AA because the zinc gluconate is retained in the plasma, two weeks of a daily zinc gluconate will have a greater effect on fasting plasma zinc concentrations compared to a Zn- AA complex. ### Conditions - Response of Fatty Acid Desaturation to Zinc Intake ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - 30 mg Zn Amino Acid daily for 13 days - 30 mg Zn Gluconate daily for 13 days ### Outcomes Primary Outcomes - FADS1 activity index Secondary Outcomes - Fasted plasma zinc concentration ### Location - Facility: University of California, Berkeley, Berkeley, California, 94720, United States @@
## Pumps for Kids, Infants and Neonates (PumpKIN): The Jarvik 2015 Pivotal Trial - NCT ID: NCT06348043 - Study ID: SU_PumpKIN - Status: NOT_YET_RECRUITING - Start Date: 2024-08 - Completion Date: 2029-12 - Lead Sponsor: Stanford University ### Study Description This is a 22-subject prospective, multicenter, single-arm clinical trial to evaluate the safety and effectiveness of the Jarvik 2015 left ventricular assist device (LVAD) as a bridge to heart transplant in children weighing 8 to 30 kilograms. Data generated from the study will be used to support FDA review and potential approval of the device under the Humanitarian Device Exemption (HDE) regulation, the FDA approval pathway for devices intended to treat rare and orphan diseases. ### Conditions - Heart Failure With Reduced Ejection Fraction - Pediatric HD, Stage IV - LVAD ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Jarvik 2015 LVAD ### Outcomes Primary Outcomes - Survival to heart transplant, recovery or 180 days of support in the absence of severe stroke. - Freedom from symptomatic stroke Secondary Outcomes - Incidence rate of all protocol-defined SAE's through 180 days of support definitely or probably related to the device - Distribution of Pediatric Stroke Outcomes Measures - The KOSCHI score - Overall survival on Jarvik 2015 support to 180 days ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Totally Robotic Versus Surgeon-Assisted Robotic Lung Resection For Early-Stage NSCLC - NCT ID: NCT06348030 - Study ID: 17401 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-03 - Lead Sponsor: St. Joseph's Healthcare Hamilton ### Study Description Robotic-assisted thoracoscopic surgery (RTS) is safe and effective for patients with early-stage non-small cell lung cancer (NSCLC). During RTS, division, dissection, and sealing of lung tissue, bronchi, and blood vessels can be performed using handheld staplers with assistance from a bedside surgeon (Surgeon-Assisted), or totally robotically with robotic staplers and energy devices by the console surgeon (Totally Robotic). Totally Robotic lung resection enables the operating surgeon to perform the case independently, but its implication on costs and patient outcomes remains unknown. There also is, however, a lack of prospective research evaluating the costs of the two methods for dissection and vessel sealing in RTS. This RCT aims to evaluate the costs and perioperative patient outcomes of Totally Robotic lung resection using the Vessel Sealer Extend energy device (for vessels \<7mm) and the SureForm robotic stapler (Intervention) versus Surgeon-Assisted robotic lung resection using the Signia stapler (Control) during RTS for NSCLC using the da Vinci system. ### Conditions - Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Medtronic Signia Stapler - Vessel Sealer Extend Energy Device and SureForm Stapler ### Outcomes Primary Outcomes - Costs of Totally Robotic versus Surgeon-Assisted Robotic Lung Resection Secondary Outcomes - Operating Room Time - Length of Stay in Hospital - Duration of Chest Tube - Intraoperative Complications and Adverse events (AEs) ### Location - Facility: St. Joseph's Healthcare Hamilton, Hamilton, Ontario, L8N 4A6, Canada @@
## Frequency of Neuropathic Pain in Patients With Plantar Fasciitis - NCT ID: NCT06348017 - Study ID: Yozgat City Hospital - Status: COMPLETED - Start Date: 2023-10-19 - Completion Date: 2024-03-15 - Lead Sponsor: Yozgat City Hospital ### Study Description Study Design This prospective cross-sectional study was undertaken between November 2023 and March 2024. Written and verbal informed consent was obtained from all patients. The study protocol was approved by University Human Research Ethics Committee (AEŞH-EK 1-2023-612).Patients While 106 patients who applied to the City Hospital Physical Medicine and Rehabilitation outpatient clinic with heel pain that had been present for at least six months, received foot radiography and were diagnosed with PF were included in the study as a patient group; 100 patients who did not have foot pain and had musculoskeletal pain for at least 6 months were included in the study as a control group, between November 2023 and March 2024. All the participants were aged 18 to 65 years. Patients with a history of diabetes, hypothyroidism and CKD, a history of malignancy, with vasculitis, neurological diseases that may cause neuropathic pain, lumbar discopathy, those with a previous history of fracture or surgery in the heel area, received injections or ESWT treatment due to heel pain in the last 3 months, rheumatic diseases that may affect pain such as rheumatoid arthritis, ankylosing spondylitis, fibromyalgia, and severe circulatory disorders on the side with pain, were excluded from the study. The study was commenced after obtaining the approval of the local ethics committee and informed consent of the participants.All patients' personal information (age, gender, occupation, education information), general health information (smoking and alcohol use information, known chronic disease history, body mass index), severity of heel pain and when it started were recorded. While the Foot Function Index (FFI) scale, which evaluates the functionality of the foot, was applied to the patient group; the Visual Analog Scale (VAS), which evaluates pain intensity, the Pain-DETECT scale, which evaluates neuropathic pain, and the Central Sensitization Scale (CSI), which evaluates central sensitization, were applied to the patient and control groups. The details of the implementation of the instruments are as follows: ### Conditions - Chronic Plantar Fasciitis - Control Group ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Pain-DETECT - Foot Function Index - Central Sensitization Scale Secondary Outcomes ### Location - Facility: Yozgat City Hospital, Yozgat, N/A, 66100, Turkey @@
## The Association Between Albumin Administration and Short-term Rebleeding Risk in Cirrhosis Patients With Acute Variceal Hemorrhage and Stable Hemodynamics - NCT ID: NCT06348004 - Study ID: 2024IIT-0125 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-02-01 - Completion Date: 2024-04 - Lead Sponsor: Zhejiang University ### Study Description The impact of albumin administration in cirrhotics with acute variceal hemorrhage (AVH) is controversial. We aim to investigate the short-term rebleeding risk associated with albumin administration in a retrospective study of hospitalized cirrhotics with AVH with stable hemodynamics. This retrospective analysis includes clinical data of cirrhosis patients with acute variceal bleeding admitted to our hospital from January 2021 to October 2023. Propensity score matching will be performed to account for potential confounders associated with albumin use for outcome analysis. According to the outcome, patients will be divided into rebleeding group and non-rebleeding group. To investigate the impact of albumin infusion on the rebleeding risk in the propensity-matched cohort, patients will be divided into albumin user group and albumin non-user group. The primary outcome is the rebleeding risk within 30 days after discharge. ### Conditions - Cirrhosis - Acute Variceal Haemorrhage ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - The rebleeding risk within 30 days after discharge. Secondary Outcomes ### Location - Facility: The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310000, China @@
## Alberta Chiropractic SelfBack Study - NCT ID: NCT06347991 - Study ID: Pro00140155 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-12-31 - Lead Sponsor: University of Alberta ### Study Description Recurrent and persistent low back pain (LBP) is a massive problem in Canada that causes a substantial pain, disability, cost, and even premature death.The good news is that treatments for recurrent and persistent LBP are available. Many guidelines now recommend education and exercise as the best intervention for chronic LBP. Unfortunately, education and exercise programs are not publicly funded in Canada-only Canadians with extended health benefits can access these programs.As a result, the 50% of Canadians who do not have extended health benefits often seek care for LBP from their publicly funded physicians. Physicians, in turn, have little choice but to reach for what they have available, including opioids, x-rays and referrals to specialists. Not only are these interventions unhelpful for chronic LBP, they are often harmful, sometimes deadly, and disproportionately affect lower socio-economic status households.A possible solution to this problem exists in a validated app (SelfBack) that provides tailored self-management plans consisting of advice on physical activity, physical exercises, and educational content. Tailoring of treatment plans to individuals is achieved by using case-based reasoning (CBR) methodology which is a branch of artificial intelligence.This study will evaluate the feasibility of distributing the SelfBack app to persons experiencing LBP through their chiropractors.The results of this study will help us understand the barriers and facilitators of distributing and using the app through Alberta Chiropractors. This information will be used to apply for funding for a larger study to understand the effectiveness of the app as an intervention for persistent and recurrent LBP. ### Conditions - Chronic Low-back Pain ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - SelfBack ### Outcomes Primary Outcomes - The percentage of patients who utilize the SelfBack app Secondary Outcomes - The percentage of clinicians who utilize the SelfBack app ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Personalized DBS for OCD Guided by Stereoencephalography Mapping - NCT ID: NCT06347978 - Study ID: 24-41296 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2028-04 - Lead Sponsor: Andrew Moses Lee, MD, PhD ### Study Description This is a double-blinded, randomized, crossover study design for SEEG-guided 4-lead DBS for treatment-refractory OCD, followed by open label stimulation for an additional 6 months. The study will be conducted in 3 stages: Stage 1 will consist of SEEG brain mapping and optimization of stimulation parameters. Stage 2 will consist of 4-lead DBS surgery with bilateral IPGs and further optimization of stimulation parameters. Stage 3 will be randomized, crossover treatment, followed by open label treatment. ### Conditions - Obsessive-Compulsive Disorder - OCD ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Deep Brain Stimulation ### Outcomes Primary Outcomes - Primary Feasibility Endpoint #1 - Stimulation Target That Acutely Improves OCD Symptoms - Primary Feasibility Endpoint #2 - Identifying an electrophysiological biomarker of OCD - Primary Feasibility Endpoint #3 - Acute Symptomatic Improvement - Primary Feasibility Endpoint #4 - Completion of Stages 1 and 2 - Primary Safety Endpoint - Serious Adverse Events - Primary Efficacy Endpoint - Treatment Response Secondary Outcomes - Secondary Efficacy Endpoint #1 - Improvement in YBOCS scores from Baseline - Secondary Efficacy Endpoint #2 - Improvement in OCD Symptoms from Baseline - Secondary Efficacy Endpoint #3 - Improvement in Depression Symptoms from Baseline ### Location - Facility: University of California, San Francisco, San Francisco, California, 94143, United States @@
## Construction and Effect Evaluation of the Low Load Blood Flow Restriction Training Program for Lung Cancer Patients Complicated With Sarcopenia During Chemotherapy - NCT ID: NCT06347965 - Study ID: IIT20220541B-R1 - Status: COMPLETED - Start Date: 2023-02-01 - Completion Date: 2024-02-20 - Lead Sponsor: Xin Wang ### Study Description The goal of this clinical trial is to verify the effectiveness and safety of the low load blood flow restriction training program. The intervention effect, tolerance and compliance of low load blood flow restriction training and progressive resistance training on lung cancer patients complicated with sarcopenia during chemotherapy will be compared, in order to provide new ideas for improving or reversing sarcopenia.The main questions it aims to answer are:Can low load blood flow restriction training improve sarcopenia in chemotherapy induced lung cancer patients? Which training method is more effective and tolerable between low load blood flow restriction training and progressive resistance training?Participants will be randomly divided into 3 groups：1. Routine care group (Control group, CON): The researchers will provide participants with regular exercise and dietary guidance.2. Low load blood flow restriction group (LL-BFRT): The researchers will provide participants with a low load blood flow restriction training program constructed by our research group.3. Progressive resistance training group (PRE): The researchers will provide participants with progressive resistance training. ### Conditions - Sarcopenia - Lung Neoplasms ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Low load blood flow restriction training - Progressive resistance training group ### Outcomes Primary Outcomes - Grip strength - Appendicular Skeletal Muscle Index (ASMI) - Step speed Secondary Outcomes - Body mass index (BMI) - Quality of life for lung cancer patients - Exercise compliance - Exercise safety ### Location - Facility: The First Affiliated Hospital, Zhejiang University School of Medicine, HangZhou, Zhejiang, 310020, China @@
## Mapping Arterial Perforators Within the Breast During Mammoplasty - NCT ID: NCT06347952 - Study ID: SE1188 - Status: COMPLETED - Start Date: 2022-04-27 - Completion Date: 2024-01-29 - Lead Sponsor: Royal Marsden NHS Foundation Trust ### Study Description Breast cancer surgery can often be carried out as part of a breast reduction procedure known as 'therapeutic mammoplasty'. Where a woman has a breast with adequate volume, even larger cancers can be removed in an aesthetically acceptable way with re-shaping of the breast (often reduction and lift) incorporated into the cancer removal. An expectation and desire for most women is that the nipple and areola (known as the 'nipple-areolar complex' or NAC) is not only preserved, but re-positioned (usually lifted) to re-balance the overall aesthetic result.In moving the NAC, the surgeon must ensure an adequate blood supply is maintained to preserve nourishment of the NAC tissue otherwise it can die (necrose) resulting in its removal. The tissue carrying the blood supply is known as a 'pedicle' and is fashioned by the surgeon for each patient during surgery.We know as surgeons, that in most areas of anatomy of the human body there are variations in the pattern of blood vessels. The NAC blood supply is no exception. Yet for each individual patient, the only way to safely know these anatomical patterns is to map them before or during surgery.A surgical tool utilising an aspect of ultrasound (known as doppler) is often used to locate visually (or by hearing) blood flow from blood vessels in operations where such knowledge is critical to the success of the procedure (for example DIEP-based breast reconstruction or chest wall perforator flaps).We would like to evaluate the effectiveness of the routine use of doppler for NAC preservation during mammoplasty procedures to see if it gives the consultant surgeon and/or trainee a greater degree of confidence when shaping the NAC pedicle to preserve its blood supply.In addition, we evaluate the training potential of patients undergoing symmetrising breast reduction, whereby the tissue removed is first mapped using acoustic doppler as for the NAC above. ### Conditions - Breast Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Use of Acoustic and color imaging doppler during surgery for breast cancer ### Outcomes Primary Outcomes - Full-thickness (complete or partial) necrosis of nipple-areolar complex Secondary Outcomes ### Location - Facility: Royal Marsden - Surrey, Sutton, England, SM2 5PT, United Kingdom @@
## Mediastinal EBUS Cryobiopsy Study In Sweden - NCT ID: NCT06347939 - Study ID: 2023-06638-01 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2028-12-31 - Lead Sponsor: Region Skane ### Study Description This study is a prospective observational non-randomized clinical trial where all the participitants undergo the same procedure and every participitant's samples are compared to each other. The investigators conduct EBUS TBNA and EBUS TBMCB on all the study participants.The cryobiopsy samples are numbered to evaluate the number of biopsies needed to reach a definite diagnosis and to assess the added value of every sample taken from the same participitant. Every participitant's own samples are compared to each other and added value of EBUS TBMCB is defined as the difference in diagnostic yield between the EBUS TBNA alone and the combination of EBUS TBNA with EBUS TBMCB. Diagnostic yield is defined as the efficacy of the investigation module in reaching a definite diagnosis (percentage of cases with a definite diagnosis).Follow up four weeks after the procedure to assess the risk for postoperative complications. ### Conditions - Mediastinal Lymphadenopathy - Lung Cancer - Sarcoidosis - Lymphoma - Tuberculosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Mediastinal lymph nodes cryobiopsies ### Outcomes Primary Outcomes - Number of mediastinal cryobiopsies needed per patient to lead to a definite diagnosis. Secondary Outcomes - Adequacy of mediastinal cryobiopsies for PDL1 analysis in lung cancer. ### Location - Facility: Respiratory medicine and allergy department, Skåne University Hospital, Lund, N/A, N/A, Sweden @@
## Evaluation of the Effect of Photobiomodulation on Sexual Quality of Life in Women With Breast Cancer - NCT ID: NCT06347926 - Study ID: PROICM 2023-11 EVA - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2025-08 - Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle ### Study Description The treatment of breast cancer as well as the disease are responsible for genito-urinary symptoms that can persist over time and impair quality of life. Given the improved prognosis of breast cancer, more and more patients are confronted with specific post-cancer issues, and the care has become a major health challenge.Sexual health is a crucial component of well-being and overall quality of life. Vaginal dryness and dyspareunia are symptoms frequently found in patients treated for breast cancer, with chemotherapy and hormone therapy as risk factors. However, the treatment of sexual disorders remains underdeveloped in France.Vaginal dryness is part of a broader syndrome known as genitourinary syndrome of menopause (GSM), or vulvovaginal atrophy, which may combine vulvovaginal (dryness, irritation, burning), sexual (dyspareunia) and urinary (infections, pollakiuria, urgency) symptoms secondary to hypoestrogenemia, exacerbated by breast cancer treatments. Since hormonal treatments are contraindicated, the first-line treatment for GSM in patients treated for breast cancer is the application of non-hormonal trophic treatments (regular vaginal moisturizers, lubricants during intercourse). However, these treatments are often insufficient to provide effective relief. There is therefore growing interest in the development of second-line treatments for GSM : intra-vaginal hyaluronic acid injections, laser, photobiomodulation (PBM), etc. PBM using Light Emitting Diodes (LED) has been proposed as an alternative treatment for genitourinary syndrome of the menopause. The tissues are exposed to light sources in the visible spectrum, inducing non-thermal, non-cytotoxic biological effects that improve vaginal tissue trophicity. A study is planned to evaluate the use of photobiomodulation in 2nd-line treatment of GSM (after 1st-line treatment with vaginal moisturizers) and on the quality of sexual life of patients treated for breast cancer at any stage of treatment. ### Conditions - Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Photobiomodulation ### Outcomes Primary Outcomes - Sexual satisfaction score on one dimension of the SHQ-22 questionnaire Secondary Outcomes - Sexual quality of life scores obtained on all dimensions of the SHQ-22 questionnaire - Patient Global Impression of Improvement (PGI-I) score - Determination of the Vaginal Health Index clinical score - Determination of symptoms of vulvovaginal atrophy by a visual numerical scale - Determination of adverse events by using Common Terminology Criteria for Adverse Events (CTCAE) scale of the National Cancer Institute. - Number of patients taking other treatments for treating sexual troubles ### Location - Facility: Institute of Cancer in Montpellier, Montpellier, Hérault, 34298, France @@
## Umblical Artery Systolic \Diastolic Ratio and Amniotic Fluid Index in Prediction of Fetal Outcome in Term Pregnancy - NCT ID: NCT06347913 - Study ID: Soh-Med-24-03-09MS - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-03 - Lead Sponsor: Sohag University ### Study Description Antepartum fetal surveillance is the cornerstone of management in pregnancy. \[1\] It is done primarily to reduce the incidence of adverse fetal outcomes. It minimizes morbidity by optimizing the timing of delivery. Fetus at risk of chronic hypoxia is identified and unnecessary interventions are avoided. However, fetal surveillance acts as a diagnostic modality to detect the influence of maternal, placental, and fetal factors on the fetus. The timely detection of morbid changes in the fetal status followed by adequate interventions to avoid death or disability is one of the most important objectives of prenatal care. \[2\] Tests now commonly done for antepartum fetal surveillance are nonstress test (NST), amniotic fluid index (AFI), biophysical profile, Doppler study of umbilical artery (UA), and middle cerebral artery (MCA).\[3 6\] However, AFI and UA Doppler velocimetry both form an essential part of the antenatal surveillance in the assessment of fetal well being. UA Doppler is a powerful tool that allows the obstetrician to follow a sequence of fetal hemodynamic events that happen in response to placental insufficiency. \[7\] However, several studies have reported higher sensitivities and specificities for UA Doppler ratio for prediction of fetal prognosis. \[3 6\] Amniotic fluid is the product of complex and dynamic fetal and placental physiologic processes. Disruption of the fine balance may result in overproduction or underproduction of fluid. Liquor adequacy often reflects the fetal status. Oligohydramnios is associated with increased perinatal loss. Furthermore, other studies indicate that UA velocimetry is a predictor of adverse outcomes in pregnancies complicated by oligohydramnios. \[8,9\] Thus, arterial Doppler velocimetry measurement may be useful in predicting adverse pregnancy outcomes adjunct to other antenatal surveillance tests, especially the AFI. Therefore, the present study will be done to evaluate the comparative assessment of UA ratio and AFI in predicting adverse perinatal outcomes. ### Conditions - Umblical Artery Doppler in Term Pregnancy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - ultrasound ### Outcomes Primary Outcomes - Umbilical Artery Systolic/Diastolic Ratio Secondary Outcomes ### Location - Facility: Sohag university Hospital, Sohag, N/A, N/A, Egypt @@
## Corneal Topographic Changes in Different Grades of OSA - NCT ID: NCT06347900 - Study ID: Soh-Med-23-09-7PD - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2024-06-30 - Lead Sponsor: Sohag University ### Study Description Corneal topographic parameters in different degrees of obstructive sleep apnea ### Conditions - Corneal Ectasia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Pentacam (corneal topographic changes detection), Polysymnography ### Outcomes Primary Outcomes - Keratometric readings in diopters, corneal thickness in um, average progression index value, anterior and posterior corneal elevation values. Secondary Outcomes ### Location - Facility: Ophthalmology department, Sohag University, Sohag, N/A, 82511, Egypt @@
## Clinical Validation of ColonAiQ (a Blood-based Assay Targeting ctDNA Methylation) for Colorectal Cancer Detection - NCT ID: NCT06347887 - Study ID: SGI-PCR-01 - Status: COMPLETED - Start Date: 2021-05-31 - Completion Date: 2024-01-16 - Lead Sponsor: Singlera Genomics Inc. ### Study Description The DNA methylation targets in preoperative plasma samples of the subjects will be detected by the multi-gene methylation test (ColonAiQ), and the test accuracy will be evaluated by compared with the clinical diagnosis evidence. ### Conditions - Colorectal Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - ColonAiQ test and Colonoscopy ### Outcomes Primary Outcomes - Sensitivity for colorectal cancer with ColonAiQ test - Specificity for colorectal cancer with ColonAiQ test Secondary Outcomes - PPV for colorectal cancer with ColonAiQ test - NPV for colorectal cancer with ColonAiQ test ### Location - Facility: The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, 221000, China @@
## Cryo Rib Fracture Study - NCT ID: NCT06347874 - Study ID: ANES-2024-32820 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-11-30 - Lead Sponsor: University of Minnesota ### Study Description The purpose of this study is to determine if patients with rib fractures who undergo cryoablation of the intercostal nerves have improved pain control 7 days from procedure when compared to those who have a ESP catheter. ### Conditions - Rib Fractures ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Cryoablation - ESP Catheter ### Outcomes Primary Outcomes - Maximum pain score on POD (Post Operative Day) 7 - Opioid Use - Functional Pain Scores - Number of Patients using opioids at POD 30 - Length of hospital stay - Number of patients returned home by POD 30 - time to first ambulation - number of patients admitted to ICU - number of patients that required mechanical ventilation - Pulmonary Function Testing. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study to Learn How Various Tablets of the Study Medicine Vepdegestrant Are Taken up Into the Blood of Healthy Adults - NCT ID: NCT06347861 - Study ID: C4891003 - Status: RECRUITING - Start Date: 2024-04-02 - Completion Date: 2024-07-05 - Lead Sponsor: Pfizer ### Study Description The purpose of the study is to look at how various tablets of a study medicine called vepdegestrant are processed in the body. This will be studied in healthy adult participants after food.This study looks at how the medicine is changed and removed from the body after a participant takes it.This study is seeking for participant who:* are healthy males, and healthy females who do not have the possibility to have children.* are 18 years of age or older.* weigh more than 45 Kilograms (99 pounds).The study consists of 3 treatments. Each participant will be assigned by chance to receive the 3 treatments in a certain sequence. This will be done over 3 study periods. Each treatment consists of a single amount of vepdegestrant taken by mouth in each study period. There will be a washout period between each study periods. The washout period is the time allowed for the medicine to get washed out from the body. How the medicine was processed will be calculated following each dose in each period. The total study duration is about 13 weeks. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - single dose of vepdegestrant as tablet formulation (Treatment A) - single dose of vepdegestrant as tablet formulation (Treatment B) - single dose of vepdegestrant as tablet formulation (Treatment C) ### Outcomes Primary Outcomes - Maximum observed concentration (Cmax) for vepdegestrant - Area under the curve from time zero to extrapolated infinite time [AUC (0 - ∞)] for vepdegestrant Secondary Outcomes - Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) - Number of Participants With Clinical Laboratory Abnormalities - Number of Participants With Clinically Significant Change From Baseline in Vital Signs - Number of Participants With Electrocardiogram (ECG) Abnormalities ### Location - Facility: Prism Research LLC dba Nucleus Network, Saint Paul, Minnesota, 55114, United States @@
## The Effect of Psychoeducation Focused on Reducing Internalized Stigma - NCT ID: NCT06347848 - Study ID: IstanbulUCKA - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2024-09-01 - Lead Sponsor: Istanbul University - Cerrahpasa (IUC) ### Study Description In the fight against stigma, the focus should be on the education of individuals diagnosed with mental illness. Psychoeducation has an important place in the treatment and rehabilitation of mental health problems. Psychoeducation is necessary for early recognition of signs and symptoms of diseases, ensuring compliance with treatment, improving coping skills, as well as combating stigma, preventing internalized stigma, and counteracting social stigma. If individuals with mental disorders have adequate knowledge about the causes of stigma, they may be less prone to internalized stigma. ### Conditions - Schizophrenia - Treatment Adherence - Stigma, Social ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Psychoeducation Focused on Reducing Internalized Stigma ### Outcomes Primary Outcomes - Internalized Stigma of Mental Illness Scale - Medication Adherence Reporting Scale Secondary Outcomes ### Location - Facility: Istanbul University - Cerrahpasa (IUC), Istanbul, Şişli, N/A, Turkey @@
## Biomarker Identification and Nutritional Intervention of Primary Sarcopenia Based on Gut-muscle Axis - NCT ID: NCT06347835 - Study ID: Gut-Intervention-SAR-2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-01 - Lead Sponsor: Peking Union Medical College Hospital ### Study Description The loss of skeletal muscle mass and function usually occurs with aging, known as primary sarcopenia. Sarcopenia has a prevalence of 11.6% among the elderly population in China and is closely associated with increased risks of falls, disability, and mortality. Currently, there is a lack of definition criteria for sarcopenia based on biomarkers. The Gut-Muscle Axis hypothesis suggests a complex interplay between gut microbiota and skeletal muscle. Nutritional intervention targeting the gut microbiota potentially plays a significant role in muscle regeneration. Therefore, this study aims to explore the effects of symbiotic and whey protein on muscle, gut microbiota, and clinical outcomes among sarcopenia patients, to provide a reference for further diagnosis and treatment of sarcopenia. ### Conditions - Sarcopenia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - symbiotic - whey protein - symbiotic placebo - whey protein placebo ### Outcomes Primary Outcomes - Change from Baseline of Appendicular skeletal muscle mass index at 12 weeks - Change from Baseline of grip strength at 12 weeks Secondary Outcomes - Change from Baseline of Short Physical Performance Battery score at 12 weeks - Change from Baseline of gait speed at 12 weeks - Change from Baseline of gut microbiota composition at 12 weeks - Change from Baseline of inflammation status at 12 weeks - Change from Baseline of microbiota-derived metabolites at 12 weeks ### Location - Facility: Peking Union Medical College Hospital, Beijing, Beijing, 100730, China @@
## Increasing Access to Evidence-Based Care in Integrated Behavioral Health - NCT ID: NCT06347822 - Study ID: 23-011276 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2024-10 - Lead Sponsor: Mayo Clinic ### Study Description The purpose of this research is to explore whether a single-session therapy visit may be of interest to patients seeking mental health services in Mayo Clinic's Integrated Behavioral Health program and whether a single-session therapy visit may be helpful in improving mental health. Researchers hope to better understand whether single-session visits could be a helpful option to offer patients in the future. ### Conditions - Psychotherapy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Therapy Session ### Outcomes Primary Outcomes - Satisfaction with IBH therapy - Satisfaction with Action Plan - Change in readiness for change scores - Change in PHQ-9 scores - Change in GAD-7 scores Secondary Outcomes - Change in Valuing Questionnaire (Values Progress subscale) - Change in Valuing Questionnaire (Values Obstruction subscale) - Change in CompACT scores (Valued Action) - Change in CompACT scores (Openness to Experience) - Change in CompACT scores (Behavioral Awareness) ### Location - Facility: Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States @@
## DNA Methylation in Adenocarcinoma of the Prostate: Analysis of Validated Biomarkers in Urine - NCT ID: NCT06347809 - Study ID: 18-006343 - Status: ENROLLING_BY_INVITATION - Start Date: 2018-11-07 - Completion Date: 2029-02-01 - Lead Sponsor: Mayo Clinic ### Study Description This study explores the potential use of DNA markers in the detection of prostate cancer and patient perceptions of this screening approach and other current or future prostate cancer screening and diagnostic tests. ### Conditions - Prostate Adenocarcinoma - Prostate Carcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Non-Interventional Study ### Outcomes Primary Outcomes - Accuracy of methylated DNA markers (MDMs) for detection of cancer of the prostate (CAP) Secondary Outcomes - Accuracy of CAP detection - Comparison of sample volumes ### Location - Facility: Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States @@
## Chronic Subdural Hematoma Treatment With Embolization Versus Surgery Study - NCT ID: NCT06347796 - Study ID: 23-0160 - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2029-09 - Lead Sponsor: The University of Texas Medical Branch, Galveston ### Study Description The goal of this clinical trial is to test in moderately symptomatic chronic subdural hematoma (CSDH) patients if middle meningeal artery embolization (MMAE) can be used as an alternative to conventional open surgery. The main questions it aims to answer are:* Compared to open conventional surgery, does MMAE reduce the need for rescue surgery or deaths?* What is the safety of MMAE and conventional open surgery in these patients?Participants will be asked to:* Share their medical history and undergo physical examinations* Have blood drawn* Have CT scans of the head* Answer questionnaires* Undergo MMAE or conventional open surgery* Provide information about possible adverse events Researchers will compare participants in the MMAE group with those in the conventional open surgery group to see if there is a reduced need for rescue surgery or deaths and evaluate safety. ### Conditions - Chronic Subdural Hematoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Conventional Surgery - Middle Meningeal Artery Embolization (MMAE) ### Outcomes Primary Outcomes - Need for Rescue Surgery or Death Secondary Outcomes - Safety of MMAE and Conventional Open Surgery ### Location - Facility: University of Texas Medical Branch, Galveston, Texas, 77555, United States @@
## Automated Insulin Delivery vs. Injections: Sleep Impact in Pediatric Type 1 Diabetes - NCT ID: NCT06347783 - Study ID: STUDY00026893 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2024-12-15 - Lead Sponsor: Oregon Health and Science University ### Study Description The purpose of the study is to learn about the effect of insulin pumps on sleep in pediatric patients with type 1 diabetes and their caregivers. We are hoping to find out if insulin pumps improve sleep, worsen sleep, or have no effect at all. We are hoping to also explore the relationship between insulin pumps, sleep, and overnight blood sugar control. Your information will not be stored and used for future research.The goal of this observational study is learn about the effect of insulin pumps on sleep in pediatric patients with type 1 diabetes and their caregivers. The main questions it aims to answer are:Do insulin pumps improve sleep, worsen sleep or have no effect at all? What is the relationship between insulin pumps, sleep, and overnight blood sugar control?Participants will be asked to:* Complete questionnaires regarding demographic data and diabetes history.* Complete surveys regarding sleep quality before and after starting an insulin pump.* Wear a FitBit during sleep for 2 weeks and fill out daily sleep diaries over a 2 week period prior to starting an insulin pump.After 1-2 months after initiation of an insulin pump, participants will be asked again to:* Complete surveys regarding sleep quality* Wear a FitBit during sleep for 2 weeks* Fill out daily sleep diaries over the same 2 week period. ### Conditions - Type1diabetes ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Insulin pump ### Outcomes Primary Outcomes - Sleep duration - Sleep efficiency Secondary Outcomes - Sleep Disturbance Scale for Children - Promis Short Form 8a ### Location - Facility: Oregon Health and Science University, Portland, Oregon, 97239, United States @@
## Effect of Probiotics Before Cesarean Section on Postoperative Recovery in Pregnant Women - NCT ID: NCT06347770 - Study ID: ThirdSunYat-senECII202329903 - Status: RECRUITING - Start Date: 2023-11-01 - Completion Date: 2025-10 - Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University ### Study Description This study aims to evaluate the effect of probiotics 7 days before cesarean section (CS) on postoperative recovery and the change of gut microbiota in pregnant women. Samples were obtained from a total of 80 pregnant individuals, divided into control group and probiotics group. Anal exhaust time and first defecating time were set as the primary outcome of recovery of CS. 16S rRNA amplicon sequencing of the V4 region was analyzed to evaluate the composition of them. ### Conditions - Microbiota - Postoperative Recovery ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Probiotic Blend Oral Tablet ### Outcomes Primary Outcomes - analysis of postoperative recovery - 16S rRNA amplicon sequencing of the V4 region Secondary Outcomes ### Location - Facility: Zhe Li, Guangzhou, Guangdong, 510000, China @@
## A 3-Arm Study Comparing the Efficacy of Anti-Reflux Reconstruction Protocols After Laparoscopic Proximal Gastrectomy - NCT ID: NCT06347757 - Study ID: NorthernJiangsuhospital1 - Status: COMPLETED - Start Date: 2020-01-01 - Completion Date: 2024-03-15 - Lead Sponsor: Northern Jiangsu People's Hospital ### Study Description The efficacy of three different alimentary reconstruction methods after proximal gastrectomy will be investigated in this study in a prospective, multicenter, randomized controlled trial. ### Conditions - Anti-Reflux Alimentary Reconstruction - Laparoscopic Proximal Gastrectomy - Siewert Type II/III Adenocarcinoma of the Esophagogastric Junction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Anti-Reflux Alimentary Reconstruction After Laparoscopic Proximal Gastrectomy ### Outcomes Primary Outcomes - Incidence of reflux esophagitis Secondary Outcomes - Incidence of anastomotic leakage - Incidence of anastomotic stenosis - Operative time - Intra-operative blood loss - Overall survival, and disease-free survival ### Location - Facility: Jiajie Zhou, Yangzhou, N/A, N/A, China @@
## Radicle Rest 24: A Study of Health and Wellness Products on Sleep and Related Health Outcomes - NCT ID: NCT06347744 - Study ID: RADX-P-2401 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2024-12 - Lead Sponsor: Radicle Science ### Study Description A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on sleep and related health outcomes. ### Conditions - Sleep - Sleep Disturbance - Sleep Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Radicle Rest Placebo Control Form 1 - Radicle Rest Active Study Product 1.1 Usage - Radicle Rest Placebo Control Form 2 - Radicle Rest Active Study Product 2.1 Usage ### Outcomes Primary Outcomes - Change in sleep Secondary Outcomes - Change in feelings of anxiety - Change in fatigue - Change in mood (emotional distress-depression) - Minimal clinically important difference (MCID) in sleep - Minimal clinically important difference (MCID) in feelings of anxiety - Minimal clinically important difference (MCID) in fatigue - Minimal clinically important difference (MCID) in mood (emotional distress-depression) ### Location - Facility: Radicle Science, Inc, Del Mar, California, 92014, United States @@
## Varian ProBeam360° Proton Therapy System China Clinical Trial (Wuhan) - NCT ID: NCT06347731 - Study ID: VAR-2024-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2025-03 - Lead Sponsor: Varian, a Siemens Healthineers Company ### Study Description This study is a clinical trial of prospective, single-center, single-arm objective performance criteria. This trial will be conducted with a total of 47 participants enrolled. All participants will be treated with radiation therapy using the medical device of Varian ProBeam360° Proton Therapy System (ProBeam360°), aim to compare the data with objective performance criteria (OPC) to evaluate the effectiveness and safety of ProBeam radiotherapy system for oncology patients, providing a clinical basis for the medical device registration. ### Conditions - Tumor, Solid ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Proton Radiation Therapy ### Outcomes Primary Outcomes - Effectiveness measure: tumor disease control rate reaches the objective performance criteria (80%) - Safety measure: Incidence of CTCAE grade 3 toxic reaction is acceptable (lower than 5%) - Safety measure: Incidence of CTCAE grade 4 and 5 toxic reaction is acceptable (0%) Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## CAR-T Cells in Systemic B Cell Mediated Autoimmune Disease - NCT ID: NCT06347718 - Study ID: CASTLE - Status: RECRUITING - Start Date: 2023-07-17 - Completion Date: 2026-05-31 - Lead Sponsor: University of Erlangen-Nürnberg Medical School ### Study Description The investigational product is designed to effectively combat B cells in patients with autoimmune diseases. Autologous T cells enriched with CD4/CD8 are genetically engineered using a lentiviral vector to express chimeric antigen receptors (CARs) that target the CD19 antigen on the cell surface of B cells and their precursors. During treatment, patients undergo leukapheresis, lymophodepleting chemotherapy and administration of the expanded CD19-CAR-transduced T cells. ### Conditions - Systemic Lupus Erythematosus - Systemic Sclerosis - Dermatomyositis - Polymyositis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - anti-CD19 CAR T cell therapy ### Outcomes Primary Outcomes - To assess the safety of anti-CD19 CAR T cell therapy in subjects with active B-driven autoimmune disease (SLE, SSc and DM/PM). Secondary Outcomes - Clinical efficacy SSc - Clinical efficacy SLE - Clinical efficacy DM - Cellular response - Serological response - Success of IMP process - Physicians Global Assessment to measure quality of life - Patient's Global Assessment to measure quality of life - Health Assessment Questionnaire - Functional Assessment of Chronic Illness Therapy - SLE-specific disease activity over time per subject - SSc-specific disease activity over time per subject - DM/PM-specific disease activity over time per subject - SLE-specific disease activity over time per subject - DM/PM-specific disease activity over time per subject ### Location - Facility: Universitätsklinikum Erlangen, Erlangen, Bavaria, 91054, Germany @@
## A Study of 2141-V11 in Combination With Standard Treatments in People With Prostate Cancer - NCT ID: NCT06347705 - Study ID: 23-252 - Status: RECRUITING - Start Date: 2024-03-28 - Completion Date: 2029-03-28 - Lead Sponsor: Memorial Sloan Kettering Cancer Center ### Study Description The purpose of this study is to see whether combining 2141-V11 with various standard treatments is an effective treatment approach for prostate cancer. 2141-V11 works by activating the immune system to find and kill cancer cells. Researchers will look at whether this treatment approach is able to completely get rid of cancer in participants, and they will check for the presence of minimal residual disease (MRD) in participants. MRD is a small number of cancer cells that can be detected in the body after treatment. ### Conditions - Prostate Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - 2141-V11 Antibody ### Outcomes Primary Outcomes - Number of participants with a complete response or minimal residual disease. Secondary Outcomes ### Location - Facility: Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, 07920, United States @@
## Effect of Antigravity Treadmill in Knee Osteoarthritis (AGTreadmill) - NCT ID: NCT06347692 - Study ID: SCBR-240/2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-07 - Completion Date: 2025-04-20 - Lead Sponsor: Prince Sattam Bin Abdulaziz University ### Study Description To date, the anti-gravity treadmill, as a representative method of lower body positive pressure treadmills, has been rarely reported for knee osteoarthritis rehabilitation.Purpose: This study aims to evaluate the effect of antigravity treadmill training on pain, gait characteristics, and function in patients with knee osteoarthritis. ### Conditions - Knee Osteoarthritis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - antigravity treadmill - physical therapy exercise program ### Outcomes Primary Outcomes - Assessment of patient pain - Evaluation of gait parameters (step length) - Evaluation of gait parameters (step time) - Evaluation of gait parameters (velocity) - Evaluation of patient function Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effects of Aromatherapy on Anxiety and Pain During Dental Treatments in Adults: a Randomized Controlled Clinical Trial - NCT ID: NCT06347679 - Study ID: WCHSIRB-CT-2024-160 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-04-01 - Lead Sponsor: Sichuan University ### Study Description Dental anxiety is a common problem in dental care. The aim of this protocol is to evaluate the effect of orange and tea essential oil for the control of anxiety and pain in adults during dental treatments. ### Conditions - Dental Anxiety ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Aroma diffuser with single-note sweet orange essential oil - Aroma diffuser with single-note tea tree essential oil - Aroma diffuser with water ### Outcomes Primary Outcomes - Anxiety scale 1 - Modified Dental Anxiety Scale (MDAS) - Pain scale - Visual Analog Scale (VAS) Secondary Outcomes - Anxiety scale 2 - State-Trait Anxiety Inventory for State Anxiety (STAI-S) - Vital sign 1 - systolic blood pressure (SBP) - Vital sign 2 - diastolic blood pressure (DBP) - Vital sign 3 - heart rate (HR） - Vital sign 4 - oxygen saturation (SpO2） ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Coaching in Early Development Project - NCT ID: NCT06347666 - Study ID: 23082905 - Status: RECRUITING - Start Date: 2024-01-12 - Completion Date: 2025-07 - Lead Sponsor: Rush University Medical Center ### Study Description Among young children, homelessness is an independent predictor of child developmental delay and disability, and children experiencing homelessness (CEH) are 2-4x more likely to demonstrate developmental delays compared to housed children. The purpose of this project is to evaluate an evidence-based model of caregiver coaching for CEH that screen positive for developmental delay. We will also evaluate the societal costs of the program, its preliminary efficacy, and the acceptability among caregivers and shelter staff. ### Conditions - Developmental Delay ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Caregiver coaching ### Outcomes Primary Outcomes - Parenting Sense of Competence Scale - Parenting Stress Scale Secondary Outcomes - Mullen Scales of Early Learning - Maternal Behavior Responsivity Scale ### Location - Facility: Rush University Medical Center, Chicago, Illinois, 60612, United States @@
## Linperlisib-based Treatment Regimen in Newly Diagnosed Nodal T-follicular Helper Cell Lymphoma (nTFHL) - NCT ID: NCT06347653 - Study ID: 2023KT127 - Status: RECRUITING - Start Date: 2023-11-28 - Completion Date: 2030-01-31 - Lead Sponsor: Peking University ### Study Description This study is conducted to evaluate the efficacy and safety of linperlisib combined with CHOP regimen followed by autologous hematopoietic stem cell transplantation and linperlisib monotherapy maintenance for newly diagnosed nTFHL patients. ### Conditions - Nodal T-follicular Helper Cell Lymphoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - linperlisib combined with CHOP regimen ### Outcomes Primary Outcomes - progression-free survival Secondary Outcomes - ORR - CR rate - Success rate of stem cell collection - overall survival (OS) - time to next anti-lymphoma treatment - adverse events ### Location - Facility: Bejing Cancer Hospital, Beijing, Beijing, N/A, China @@
## Outcome of Pulp Revascularization of Necrotic Mature Permanent Teeth Using Platelet-rich Fibrin - NCT ID: NCT06347640 - Study ID: KingAbdullahUH2 - Status: RECRUITING - Start Date: 2023-04-01 - Completion Date: 2027-12-01 - Lead Sponsor: King Abdullah University Hospital ### Study Description Regenerative endodontic procedures are intended to replace damaged tooth structures, including dentine and root structures, in addition to cells of the pulp-dentine complex. This treatment modality have been tested on immature necrotic teeth because they are anticipated to have a greater chance of pulp tissue regeneration.However, it has been recently suggested for treating fully formed mature necrotic permanent teeth with closed apices since the conventional root canal treatment yielded many drawbacks.A number of studies have evaluated the regeneration outcomes of using blood clot as a scaffold. However, there are limited studies in the literature on using other scaffolds such as platelet-rich fibrin (PRF).This clinical study will evaluate clinically and radiographically the effectiveness of PRF versus induced bleeding in treating mature necrotic teeth. Fifty patients with necrotic mature teeth with periapical lesions will be invited to participate in this study. Teeth will be treated using calcium hydroxide as intracanal medicament then using PRF (n=25) and blood clot (n=25) as scaffold. All teeth will be sealed coronally using NeoMTA Plus™. Treated teeth will be assessed clinically and radiographically using 2D periapical radiographs. The reported clinical and radiographic outcomes will be compared using SPSS. ### Conditions - Pulp Revascularization ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - induced bleeding - plasma rich fibrin ### Outcomes Primary Outcomes - Complete healing Secondary Outcomes - regain the pulp sensibility ### Location - Facility: Jordan University of Science and Technology, Irbid, N/A, POBOX 3030, Jordan @@
## Communicating Human Papillomavirus Vaccine With Japanese Parents and Caregivers With Daughters Aged 12-18 - NCT ID: NCT06347627 - Study ID: UW23139 - Status: ENROLLING_BY_INVITATION - Start Date: 2023-12-22 - Completion Date: 2024-12 - Lead Sponsor: The University of Hong Kong ### Study Description This study aims to comprehensively assess confidence in and acceptance of human papillomavirus (HPV) vaccines among Japanese parents and caregivers with daughters aged 12-18 and their decision-making process. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Group 1 (I x S x S x F) - Group 2 (O x S x S x F) - Group 3 (I x E x S x F) - Group 4 (O x E x S x F) - Group 5 (I x S x S x M) - Group 6 (O x S x S x M) - Group 7 (I x E x S x M) - Group 8 (O x E x S x M) - Group 9 (I x S x D x F) - Group 10 (O x S x D x F) - Group 11 (I x E x D x F) - Group 12 (O x E x D x F) - Group 13 (I x S x D x M) - Group 14 (O x S x D x M) - Group 15 (I x E x D x M) - Group 16 (O x E x D x M) ### Outcomes Primary Outcomes - Willingness to receive HPV vaccines for daughters Secondary Outcomes - Confidence in HPV vaccine safety ### Location - Facility: London School of Hygiene and Tropical Medicine, London, N/A, N/A, United Kingdom @@
## Modified Radical Prostatectomy for Prostate Cancer Patients With Enlarged Prostate and Severe Lower Urinary Tract Symptoms: a Single-center, Retrospective Study - NCT ID: NCT06347614 - Study ID: 2021-FXY-042 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2021-09-01 - Completion Date: 2024-12-31 - Lead Sponsor: Sun Yat-sen University ### Study Description The goal of this retrospective, observational study is to preliminarily learn about the safety and efficacy of two-step radical prostatectomy in the treatment of low- to intermediate-risk prostate cancer patients with enlarged prostate and severe benign prostatic hyperplasia. The main questions it aims to answer are: 1. Whether two-step prostatectomy is safe enough to decrease the surgical difficulty of these patients? 2. Whether the oncologic control is promising? ### Conditions - Prostate Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Two-step Radical Prostatectomy ### Outcomes Primary Outcomes - Biochemical Recurrence-free Survival Secondary Outcomes - Surgical time - Estimated blood loss - Hospital stay - Continence ContinenceContinence Continence Continence Continence Continence Continence Continence Continence - Lower urinary tract symptoms - Erectile function - Positive surgical margin rate - Complication ### Location - Facility: Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, China @@
## Survey on Sexual and Gender in the Healthcare in Taiwan - NCT ID: NCT06347601 - Study ID: 2024-03-011AC - Status: RECRUITING - Start Date: 2024-03-13 - Completion Date: 2025-02-20 - Lead Sponsor: Taipei Veterans General Hospital, Taiwan ### Study Description This study addresses the pervasive issue of sexual harassment within Taiwanese society, particularly within the medical field, where comprehensive research is lacking. The research objective is to explore patterns of sexual harassment and gender discrimination experiences among physicians and medical students in Taiwan, while also investigating potential associations with professional burnout and mental health. Employing a convergent mixed-methods design, the study combines quantitative surveys and qualitative in-depth interviews. While lacking a control group and utilizing non-blinding methods without random assignment, the study aims to recruit 1000 participants aged 18 or older, considering both valid responses and potential dropouts. Additionally, interviews will be conducted with 30 individuals who have experienced sexual harassment or are interested in gender issues. The research methods will assess sexual harassment experiences, professional burnout, and depressive symptoms as primary outcomes or indicators. ### Conditions - Sexual Harassment ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Without Intervention ### Outcomes Primary Outcomes - Center for Epidemiologic Studies Depression Scale Secondary Outcomes ### Location - Facility: Taipei Veterans General Hospital, Taipei, N/A, 100, Taiwan @@
## Risk of Reactivation of Occult Hepatitis B in Cancer Patients During Immunotherapy. - NCT ID: NCT06347588 - Study ID: OBI&ICI - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-12 - Lead Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia ### Study Description The goal of this observational study is to evalue the cumulative proportion of patients with OBI who do not develop HBsAg seroreversion and/or an increase of serum HBV DNA by at least 1 log above the lower limit of detection of the assay in a patient who had previously undetectable HBsAg and HBV DNA in serum during the study. ### Conditions - Occult Hepatitis B Infection in Cancer Patients ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Observational: Blood sample of HVB-specific Elispot assay, HBSAg, HBV-DNA ### Outcomes Primary Outcomes - To evaluate the cumulative proportion of patients with OBI who do not develop one seroreversion of HBsAg and/or an increase in serum HBV DNA of at least 1 log above the lower limit of detection of the test in a patient who had previously HBsAg and HBV Secondary Outcomes - Evaluation of the incidence of reactivation in patients during immunotherapy - Evaluation of the association between HBV-specific T-cell response and HBV reactivation - Analysis of the incidence of reactivation of HBV in patients with p-OBI according to tumor characteristics (histology and stage) and type and line of treatment (immunotherapy, combined treatment with chemotherapy + immunotherapy). ### Location - Facility: Irccs San Matteo Pavia, Pavia, PV, 27100, Italy @@
## Safety and Tolerability of a Novel Implantable Neurostimulator for Ameliorate Erectile Function on Spinal Cord Injured Patients - NCT ID: NCT06347575 - Study ID: APHP230522 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-11 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description The main objective of the study is to assess the safety and tolerability of cavernous nerve electrical stimulation in patients with spinal cord injured (SCI) by assessing and measuring complications.As the secondary objectives, despite the limited cohort size, this long-term study aims to obtain preliminary data on efficacy of cavernous nerve stimulation to improve erectile function for sexual intercourse, as well as to assess patient's satisfaction using:* Objective assessment of the erectile response upon CaverSTIM activation with the RigiScan device.* Subjective assessment of the erectile function with validated questionnaires: 1. A 6-item self-report instrument assessing male erectile function (Erectile Function domain of the International Index of Erectile Function, IIEF-EF); 2. A log-diary five item questionnaire completed after each sexual attempt (Sexual Encounter Profile, SEP); 3. A self-reporting measure that scores erection hardness on a 4-point scale (Erection Hardness Score, EHS); 4. The Global Assessment Question (GAQ).In addition, the study aims to refine the method of implantation (step-by-step delineation of all technical approaches for device implantation, including duration of surgical procedure, blood loss, methods to access the periprostatic region, tissue dissection, device placement and fixation) prior to planning for larger scale clinical investigation. ### Conditions - Spinal Cord Injuries - Erectile Dysfunction ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Implantation of the caverStim device ### Outcomes Primary Outcomes - Safety evaluation - Pain assessement - Complications related to implantation surgery Secondary Outcomes - Evaluation of IIEF-EF - Evaluation of EHS - Evaluation of SEP - Evaluation of GAQ ### Location - Facility: Department of neurology-urology-andrology, Raymond Poincaré hospital - APHP, Garches, N/A, 92380, France @@
## Optical Genome Mapping for the Diagnosis of Neurodevelopmental Disorders - NCT ID: NCT06347562 - Study ID: 934 - Status: RECRUITING - Start Date: 2022-06-15 - Completion Date: 2025-06-14 - Lead Sponsor: IRCCS Eugenio Medea ### Study Description to evaluate the ability of the Optical genome Mapping (OGM) approach to detect simple and complex constitutional chromosomal aberrations of clinical relevance, which had previously been identified with standard diagnostic approaches (karyotyping, FISH, CNV-microarray) in the context of neurodevelopmental disorders (NDDs) with/wo congenital anomalies (CA) ### Conditions - Neurodevelopmental Disorder (Diagnosis) ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Optical Genome Mapping ### Outcomes Primary Outcomes - Diagnostic concordance rate Secondary Outcomes ### Location - Facility: Scientific Institute E. Medea, Bosisio Parini, Lecco, 23842, Italy @@
## The Impact of Diaphragmatic Breathing Instructions and Inspiratory Pressures on Diaphragm Contraction in Healthy Adults - NCT ID: NCT06347549 - Study ID: HE-SF2024/09 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2026-04-15 - Lead Sponsor: Hong Kong Metropolitan University ### Study Description This is a cross-sectional obsessional study.This study aims (1) to investigate the relationship between sternocleidomastoid muscle recruitment and diaphragm thickness fraction during increasing inspiratory resistance in healthy adults; (2) to compare diaphragmatic and sternocleidomastoid muscle recruitment patterns with and without a standard diaphragmatic breathing instruction with increasing inspiratory resistance in healthy adults.Participants will be asked to breathe through a pressure threshold inspiratory loading device under different inspiratory resistances with and without a standard diaphragmatic breathing instruction. sternocleidomastoid muscle activity will be measured with surface electromyography, and diaphragm thickness will be assessed with ultrasonography. ### Conditions - Diaphragm ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Various intensities of inspiratory muscle training ### Outcomes Primary Outcomes - Diaphragmatic thickening fraction Secondary Outcomes - Muscle activation of the sternocleidomastoid muscle - Perceived Exertion Borg scale ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Supported Rescue Packs Post-discharge in Chronic Obstructive Pulmonary Disease - NCT ID: NCT06347536 - Study ID: IRAS331831 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2027-12-31 - Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust ### Study Description Chronic obstructive pulmonary disease (COPD) is a chronic lung disease affecting approximately 10% of the adult population globally. COPD is recognised to be an important area of focus, as part of one of the healthcare challenges defined by the Office of Life Sciences. Patients with COPD often experience exacerbations which are triggered episodes leading to disease worsening. Exacerbations are associated with increased morbidity and a risk of mortality.Severe exacerbations, where patients are hospitalised, are of particular concern to patients, carers and healthcare givers. The National Institute for Health and Care Excellence (NICE) recommends that hospital clinicians looking after patients with COPD should provide rescue packs (a course of prednisolone and antibiotics) and a basic management plan to patients on discharge. It is recognised that there is a high-risk 90-day period to patients with COPD following discharge from hospital, where there is a 43% risk of readmission and a 12% risk of mortality; however repeated national audit data has shown that, despite NICE recommendations this high risk of readmission and mortality has not changed.A multicentre randomised clinical trial of 1400 patients will be conducted in 30 acute NHS trusts. This will test the hypothesis that a self-supported rescue pack management plan consisting of rescue packs + written self-management plan + twice weekly telephone/text symptom alert assessments in the high-risk 90-day period is better than standard care in reducing 90-day readmission by 20%. If successful, this intervention would be rapidly implementable, improve patient clinical outcomes and have a cost saving of approximately £350 million per annum. ### Conditions - COPD - COPD Exacerbation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Supported rescue pack ### Outcomes Primary Outcomes - Time to first all-cause readmission within 90 days of discharge Secondary Outcomes - Time to and frequency of COPD-related readmissions at 30 and 90 days - Days alive and out of hospital at day 90 - Time to and frequency of all COPD exacerbations at days 30 and 90 - Cumulative systemic oral corticosteroids use over 90 days - Cumulative systemic antibiotic use over 90 days - Health care contacts at baseline, days 90 and 180, and 1 year - All cause readmission at 30 days - All cause-, cardiovascular- and COPD- related mortality at day 90 and over 12 months - EQ-5D-5L Health questionnaire (quality of life) at days 90 and 180, and 1 year - Incremental cost-effectiveness ratio (ICER, a ratio of the additional cost divided by the additional effectiveness of SRP compared to UC) at days 90 and 180 and 1 year - Qualitative interviews to examine and describe usual care - Qualitative interview examination of fidelity to and adaptation of the plan in the intervention arm - Serious adverse events - Antimicrobial resistance - Quality of life COPD assessment Test (CAT) score at days 90, 180 and 1 year ### Location - Facility: University Hospitals Birminham NHS Foundation Trust, Birmingham, N/A, N/A, United Kingdom @@
## VR-Based Preoperative Rehabilitation Program for Patients Undergoing Anterior Cruciate Ligament (ACL) Reconstruction - NCT ID: NCT06347523 - Study ID: FirstShantou - Status: RECRUITING - Start Date: 2024-04-02 - Completion Date: 2024-12-31 - Lead Sponsor: First Affiliated Hospital of Shantou University Medical College ### Study Description Between April 2, 2024, and October 1, 2024, a study will be conducted at the Department of Orthopedics in the First Affiliated Hospital of Shantou University Medical College involving 120 patients who will undergo anterior cruciate ligament reconstruction surgery. They will be randomly divided into two groups: an experimental group and a control group. ### Conditions - Anterior Cruciate Ligament (ACL) Reconstruction - Preoperative Rehabilitation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - The VR-based preoperative rehabilitation program; - standard nursing care, ### Outcomes Primary Outcomes - knee joint range of motion - Lysholm knee function score Secondary Outcomes - SAS self-rating anxiety scale scale - SDS self-rating depression scale scale - Visual Analog Scale pain score - Barthel Index for basic activities of daily living - time to first ambulation post-surgery ### Location - Facility: "The First Affiliated Hospital of Shantou University Medical College, Shantou, Guangdong, 515000, China @@
## The Level of sST2 in Pediatric Heart Failure - NCT ID: NCT06347510 - Study ID: E-25403353-050.99-174660 - Status: COMPLETED - Start Date: 2021-08-16 - Completion Date: 2024-02-16 - Lead Sponsor: Eskisehir Osmangazi University ### Study Description Introduction: Suppression of tumorigenicity 2 (ST2) is a receptor member belongs to the Interleukin-1 (IL-1) family. The ligand and soluble versions are its two isoforms. The interleukin-33-ST2 ligand complexs development provides protection against heart fibrosis and hypertrophy. Investigations on heart failure in adults has demonstrated that it does not change by age, body mass index (BMI), creatinine, hemoglobin, and albumin levels, in contrast to NT pro brain natriuretric peptit. In adult heart failure patients, it has been demonstrated to be an independent predictor of mortality and cardiovascular events. The most recent guideline recommends using it as class 2b in the diagnosis of adult heart failure. Studies on ST2 in children are rare. The purpose of this study is to assess the prognostic value of ST2 for cardiovascular events in young individuals suffering from heart failure.Method: The study included pediatric patients (0-18 years old) with congenital heart disease or cardiomyopathy who needed medical care as well as surgical or interventional treatment. Height, weight, gender, saturation, heart failure classification (Ross or New York heart Assosiation), medications taken, the electrocardiogram, echocardiography, Pro BNP, and sST2 values of the patients, as well as any hospitalization, lower respiratory tract infection, organ dysfunction, or need for angiography or surgery during follow-up Data on arrhythmia and death were gathered during a 1-year follow-up. The SPSS software application was used to carry out the statistical analysis. ### Conditions - Congenital Heart Disease - Congestive Heart Failure ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Suppression of tumorigenicity 2 (ST2) ### Outcomes Primary Outcomes - Soluble suppression of tumorigenicity levels with or without major cardiovascular event - Pro BNP levels - Major cardiovascular event ( such as hospitalization, lower respiratory tract infection, organ dysfunction, or need for angiography or surgery) Secondary Outcomes ### Location - Facility: Eskisehir Osmangazi University, Eskisehir, Odunpazarı, 26040, Turkey @@
## Zonisamide Versus Topiramate in Migraine - NCT ID: NCT06347497 - Study ID: 000001230988 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-05-01 - Lead Sponsor: Kafrelsheikh University ### Study Description Investigators aim to compare the effect of zonisamide versus topiramate in migraine by assessing the absolute reduction in MMD in each group, the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency ### Conditions - Migraine ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Zonisamide 50 MG - Topiramate 50 MG ### Outcomes Primary Outcomes - The change in migraine days per 28 days Secondary Outcomes - The total number of migraine days after three months of treatment - The percentage of patients who achieved ≥ 50% reduction in the monthly migraine days frequency compared to the baseline frequency. - HIT-6 score absolute reduction in each group after three months of treatment - The safety of lacosamide was evaluated by monitoring treatment-emergent adverse events (TEAE) for three months. ### Location - Facility: Kafr Elsheikh University Hospital, Kafr Ash Shaykh, N/A, 33511, Egypt @@
## Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT) - NCT ID: NCT06347484 - Study ID: IRB00411716 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-10 - Lead Sponsor: Johns Hopkins University ### Study Description The CONNECT: "Developing a learning COmmunity to increase eNgagemeNt and Enrollment in cardiovascular Clinical Trials" is comprehensive, participant-centered learning community that provides tailored education on cardiovascular (CV) health and research participation; connects community members to CV-related research; and disseminates CV-related study findings. The overreaching goal of CONNECT is to improve participation of underrepresented communities in CV research, including as women, Black adults, and Latino adults, through increasing participants' clinical trial awareness, trust in biomedical research, and willingness to participate in clinical trials. CONNECT will use digital and community-engaged approaches to identify and recruit 1000 adults with cardiovascular disease or a cardiovascular disease risk factor to join CONNECT. Participants who join CONNECT will receive tailored educational information on CV health and research participation via text message. Participants will also have the opportunity to be matched to ongoing CV research studies based on basic demographic information and areas of interest. The educational information will be sent to participants for 12 months. The investigators hypothesize that CONNECT will increase participants' clinical trial awareness, trust, and willingness to participate in clinical trials and that the proportion of Black and Latin adults and women enrolled in trials that partner with CONNECT will be higher following the use of CONNECT for recruitment. ### Conditions - Cardiovascular Diseases - Hypertension - Diabetes Type 2 - Stroke - Recruitment - Overweight and Obesity - Hyperlipidemias ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Formal Toned Educational Messages - Understanding Toned Educational Messages - Casual Toned Educational Messages ### Outcomes Primary Outcomes - Participant accrual Secondary Outcomes - Participant accrual in partnering cardiovascular research studies - Trust in Biomedical Research using the Perceptions of Research Trustworthiness Scale (PoRT) - Clinical trials awareness and knowledge will be assessed using items adapted from the Health Information National Trends Survey (HINTS) - Willingness to participate in research will be measured by asking participants one related question ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Transmission of Artemisinin Resistant Parasites Before and After Conventional Artemisinin-combination Therapy - NCT ID: NCT06347471 - Study ID: SBS-2023-477 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-04 - Lead Sponsor: Infectious Diseases Research Collaboration, Uganda ### Study Description A prospective study will be carried out in an area where parasites with reduced sensitivity to malaria drugs (artemisinins) have recently emerged. The study will recruit participants from patients who attend the clinic with uncomplicated malaria and are treated with conventional artemisinin-combination therapies (ACT) as part of standard clinical care. From this population, we will select P. falciparum gametocyte carriers.Before, during and after ACT treatment, the transmission potential of artemisinin resistant and wild type infections will be assessed by microscopy, molecular methods, parasite culture and mosquito feeding assays. Parasite clearance will be determined in the first days (d0-3) after treatment.The study population will consist of passively recruited patients with uncomplicated P. falciparum malaria who are microscopy positive for gametocytes. Participants will be treated with conventional therapies for uncomplicated malaria without randomization: artemether-lumefantrine (AL) or dihydroartemisinin-piperaquine (DHA-PPQ). All doses are supervised. Parasite clearance is assessed ex vivo by ring-stage survival assays and by daily slides during the first days of treatment.Gametocyte carriage and gametocyte commitment/production will be determined for resistant and wild type infections before, during and after treatment. In addition, venous blood will be collected at three timepoints to assess transmission to mosquitoes before (d0), during (d2) and after treatment (d7). The total duration of participation will be 7 days, the primary endpoint will be the reduction in mosquito infection rates at d2 (artemether-lumefantrine) or d7 (dihydroartemisinin-piperaquine) compared to pre-treatment. ### Conditions - Falciparum; Malaria ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Artemether-lumefantrine - Dihydroartemisinin-Piperaquine ### Outcomes Primary Outcomes - Mean within person percent change (presented as percent reduction) in mosquito infection rate in infectious individuals from baseline. Secondary Outcomes - Mean within person percent change (presented as percent reduction) in mosquito infection rate from baseline - Mean oocyst intensity (in all/all infected mosquitoes) - Male and female gametocyte sex ratio (proportion male) - Gametocyte circulation time - Gametocyte area under the curve - Asexual parasite prevalence - Asexual parasite density - Total parasite prevalence - Total parasite density - The density of ΔPfK13 vs wild type genotypes - The density of ΔPfK13 vs wild type genotypes in oocysts and sporozoites in mosquitoes that become infected before and after initiation of treatment ### Location - Facility: Dr. Ambrosoli Memorial Hospital, Kalongo, Agago District, N/A, Uganda @@
## BG1805 Injection in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia in Children - NCT ID: NCT06347458 - Study ID: BG-CA-23-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2027-08 - Lead Sponsor: Guangzhou Bio-gene Technology Co., Ltd ### Study Description This is a single-arm, single-dose dose-escalation and dose-expansion study. ### Conditions - Leukemia - Acute Myeloid Leukemia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - BG1805 ### Outcomes Primary Outcomes - 1.Dose Limited Toxicity Rate - 2.Incidence of Treatment-Emergent Adverse Events Secondary Outcomes - 3.Concentration of CAR-T cells after Infusion (PK) - 4.overall response rate, ORR - 5.Concentration of Cytokine after Infusion (PD) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Turkish Nationwide SurvEy of Glycemic and Other Metabolic Parameters of Patients With Diabetes Mellitus-2 (TEMD-2 Study) - NCT ID: NCT06347445 - Study ID: GSM012024 - Status: COMPLETED - Start Date: 2022-10-01 - Completion Date: 2023-01-30 - Lead Sponsor: Gulhane School of Medicine ### Study Description This study evaluates the metabolic control status, cardiovascular risk and frequency of comorbidities in diabetic patients followed in tertiary treatment centers in Turkey. ### Conditions - Diabetes Mellitus ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - There is no intervention. ### Outcomes Primary Outcomes - Glycemia control status of Turkish adult patients with diabetes mellitus - Blood pressure control status of Turkish adult patients with diabetes mellitus - Lipid control status of Turkish adult patients with diabetes mellitus. - Weight control status of Turkish adult patients with diabetes mellitus. Secondary Outcomes ### Location - Facility: Gulhane School of Medicine Department of Endocrinology and Metabolism, Ankara, N/A, 06010, Turkey @@
## Em-power: Maximizing Functional Independence for Children With Severe Cerebral Palsy - NCT ID: NCT06347432 - Study ID: 24-119-H - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2027-03 - Lead Sponsor: Grand Valley State University ### Study Description For children with severe cerebral palsy, a powered wheelchair (PWC) may provide their only option for functional mobility and independence. PWC use is often restricted to a small percentage of children who can quickly demonstrate proficient PWC skills within a single 30-minute PWC trial. This 2-arm, parallel group, single blinded, pre-test-post-test randomized controlled trial will test our hypothesis that an 8-week PWC skills training intervention will produce greater improvements in children's PWC skills capacity immediately after the intervention and at an 8-week follow-up assessment. ### Conditions - Cerebral Palsy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Power wheelchair skills training using the IndieTrainer system ### Outcomes Primary Outcomes - Change in understanding how to use a power wheelchair - Change in power wheelchair skill performance Secondary Outcomes - Change in parental/caregiver perceptions of changes in their children's performance of power wheelchair skill performance - Change in children's perceptions of changes in their performance of power wheelchair skill performance ### Location - Facility: Grand Valley State University, Grand Rapids, Michigan, 49503, United States @@
## Body Awareness and Spinal Stability in Scoliosis - NCT ID: NCT06347419 - Study ID: Iayas8 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2024-07-30 - Lead Sponsor: Gazi University ### Study Description Thirty volunteer patients diagnosed with scoliosis by a specialist physician at Gazi University Hospital Orthopedics and Traumatology Department and subsequently referred to Gazi University Physiotherapy and Rehabilitation Department for exercise training will be included in the study. The lumbar Pressure Measurement Test with Stabilizer and Rotation Stability Tests will be utilized to evaluate the spinal stability of the patients. Body awareness will be assessed using the Body Awareness Survey, comprising 18 questions. All assessments will be conducted at the Orthopedic Rehabilitation Clinic within the relevant department.The results obtained from this study will elucidate the relationship between body awareness and spinal stability in individuals with scoliosis. ### Conditions - Scoliosis Idiopathic ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Physiotherapy evaluation ### Outcomes Primary Outcomes - Spinal stability - Rotary Stability - Body Awareness Secondary Outcomes ### Location - Facility: Gazi University Hospital, Ankara, N/A, 06500, Turkey @@
## Effects of Combined Physiotherapy Management and Education - NCT ID: NCT06347406 - Study ID: FSKesihatan - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-04-01 - Lead Sponsor: Fakulti Sains Kesihatan ### Study Description This observational study aims to determine the effects of combined physiotherapy programs and education in patellofemoral pain syndrome. The main questions it aims to answer are:* Are there any effects of combined physiotherapy program among individuals with PFPS on: i) Pain ii) Muscle functions (strength, muscle bulk, flexibility) iii) Knee muscle functional performance (anteromedial lunge, step-down, bilateral squat, and balance and reach) iv) Kinesiophobia v) Quality of life Participants will be* Measure for the anthropometrics data including body weight, height, and BMI.* Answer the Numerical Pain Rating scale* Abswe Malay version of KOOS-PF and TAMPA scale.* Once they finished with the questionnaire, the participants will be stationed into station 1 (HDD), station 2 (Realtime Ultrasound) and station 3 (Dartfish Motion Analysis) Treatment they will receive* Blood flow restrictions cuff with physiotherapy exercises* Patient education Researcher will compare Blood flow exercises combined with physiotherapy exercises and education (Group A) with Physiotherapy exercises (Group B) to see if there is an effect on i) Pain ii) Muscle Functions (strength, muscle bulk, flexibility iii) Functional performance (anteromedial lunge, step-down, bilateral squat, balance, and reach) iv) Kinesiophobia v) Quality of life ### Conditions - Patellofemoral Pain Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Blood flow restriction combined with physiotherapy and education ### Outcomes Primary Outcomes - Numerical Pain Rating - The Knee injury and Osteoarthritis Outcome Score for patellofemoral pain and osteoarthritis (KOOS-PF) - Tampa Scale - Hand held dynamometer (HDD) - Knee Muscle performance Test with Dartfish software - Real time ultrasounds Secondary Outcomes ### Location - Facility: Fakulti Sains Kesihatan, Shah Alam, Selangor Darul Ehsan, 42300, Malaysia @@
## Transgender and Gender Diverse Individuals Screening for Breast Cancer - NCT ID: NCT06347393 - Study ID: 6425 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-03-31 - Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Study Description The goal of this multicentric prospective study is to evaluate the incidence of Breast Cancer in transgender and gender-diverse population. ### Conditions - Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - Mammography and Breast Ultrasound ### Outcomes Primary Outcomes - Incidence of Breast Cancer Secondary Outcomes - The adherence rate to the screening ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Usability Study of the FemPulse System - NCT ID: NCT06347380 - Study ID: CIP011 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-08-30 - Lead Sponsor: FemPulse Corporation ### Study Description The objective of the study is to demonstrate that the FemPulse System can be used as indicated in the Instructions for Use (IFU), as applicable. ### Conditions - Overactive Bladder ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - FemPulse System ### Outcomes Primary Outcomes - Patient Satisfaction Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Short-term Effect of Exercise and Self-manual Approaches to Bloating - Distention - NCT ID: NCT06347367 - Study ID: EU-FTR-GK-01 - Status: RECRUITING - Start Date: 2023-01-01 - Completion Date: 2024-04-19 - Lead Sponsor: Ege University ### Study Description Abdominal bloating and distension (ABD) are the most commonly gastrointestinal symptoms reported by patients with various functional gut disorders such as functional dyspepsia, irritable bowel syndrome and it is frequently associated with constipation. The pathophysiology of ABD is complex, often multifactorial and poorly understood. The reseach was hypothesised that short-term self-manual approaches and exercise for core muscles would have a positive effect on the symptoms of ABD. ### Conditions - Gastrointestinal System Disease - Functional Bloating - Distension; Bowel - Gastrointestinal Motility Disorder - Pelvic Floor Dyssynergia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Group 1 (exercise and self-manual approaches targeting only the diaphragm muscles) - Group 2 (exercise and self-manual approaches targeting both diaphragm and core muscles) ### Outcomes Primary Outcomes - Abdominal bloating and distention (ABD) Perception of sensations Secondary Outcomes - Superficial Electromyography (EMG) ### Location - Facility: Ege University Faculty of Medicine, Department of Gastroenterology, İzmir, Bornova, 35100, Turkey @@
## Permanence of Indocyanine Green in Axillary Lymph Nodes 3 Weeks After Subdermal Injection in Patients With Breast Cancer and Metastatic Lymph Nodes - NCT ID: NCT06347354 - Study ID: CRO-2024-15 - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2025-08 - Lead Sponsor: Centro di Riferimento Oncologico - Aviano ### Study Description In the case of a pre-operative diagnosis of ductal carcinoma in situ (DCIS), sentinel lymph node biopsy is generally not indicated whereas it is considered standard clinical practice for patients with clinical stage I-II infiltrating breast cancer who have clinically negative axillary lymph nodes or clinically suspicious lymph nodes with negative needle aspiration findings. It is not uncommon that, in patients with ductal carcinoma in situ at preoperative diagnosis, there may be an upgrade on definitive histological examination due to the identification of foci of infiltration (about one-fifth of cases), requiring axillary lymph node biopsy in a second surgery. Prospective studies have shown that the sentinel lymph node identification rate after recent breast-conserving surgery is suboptimal. With regard to the false negative rate (FNR), several studies demonstrated that it could be associated with different techniques used for lymph node identification. Lymph node biopsy by Indocyanine green (ICG) is capable of identifying the sentinel lymph node, however, there are no data in literature on the permanence of ICG in the lymph node system. The knowledge of this data would allow the application of this method, already considered safe for the identification of the sentinel lymph node at the time of breast surgery, also in those situations in which the sentinel lymph node biopsy is postponed due to the upgrade of definitive histological diagnosis from carcinoma in situ to infiltrating/micro-infiltrating carcinoma.The main objective of this trial is to evaluate the permanence of fluorescence at the level of axillary lymph nodes 3 weeks after subcutaneous injection in patients who are candidates to radical axillary surgery. Marking the sentinel lymph node before breast surgery in cases of DCIS with risk factors could reduce the false negative rate, allowing to increase the accuracy of the procedure in identifying the lymph node potentially involved by metastatic infiltration. In addition, the identification of the sentinel lymph node in patients who are candidates to radical axillary surgery, could increase the sensitivity of the surgery in staging axillary disease and could make the lymph node exeresis more targeted, reducing the morbidity of the surgery resulting in a better outcome for the patient. ### Conditions - Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Indocyanine green ### Outcomes Primary Outcomes - Permanence of fluorescence at the level of axillary lymph nodes at 2-3 weeks after subcutaneous injection of Indocyanine Green (2.5 mg), in patients who will undergo radical axillary surgery Secondary Outcomes - Identification of the total number of fluorescent lymph nodes - Differences in the qualitative assessment (intensity) of fluorescence between the removed lymph nodes: lymph nodes will be divided into group A "intense fluorescence" and group B "mild fluorescence" - Association between histological positivity for metastases in sentinel and non-sentinel lymph nodes - Association between the patient's demographic/clinical variables and the presence or absence of fluorescent lymph nodes ### Location - Facility: Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS, Aviano, Pordenone, 33081, Italy @@
## GlutN : Randomized, Double-blind, Crossover Clinical Trial to Confirm the Role of Gluten in Non-celiac Gluten Sensitivity - NCT ID: NCT06347341 - Study ID: 2019-A02014-53 - Status: TERMINATED - Start Date: 2021-10-27 - Completion Date: 2023-03-24 - Lead Sponsor: University Hospital, Clermont-Ferrand ### Study Description For 25 years, non-celiac gluten sensitivity (NCGS) has been the subject of very prolific and confusing scientific literature. This clinical entity is defined by the appearance of digestive and extradigestive symptoms in the hours/days following the consumption of foods containing gluten, in the absence of celiac disease (CD) and wheat allergy (WA). The physiopathological mechanisms, neither allergic or autoimmune, remain poorly defined and no The main objective of the study was to demonstrate the role of gluten in triggering digestive symptoms and extradigestive products from the NCGS. The secondary objectives were to identify the pathophysiological mechanisms and diagnostic marker(s).usable diagnostic marker in the clinic has not yet been identified. ### Conditions - The Objective is to Confirm the Role of Gluten in Triggering the Digestive and Extradigestive Symptoms of NCGS ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: DIAGNOSTIC ### Interventions - Clinical study comparing a gluten-containing diet to a gluten-free diet ### Outcomes Primary Outcomes - The main objective of the study is to confirm the role of gluten in triggering the digestive and extradigestive symptoms of NCGS. Secondary Outcomes ### Location - Facility: Chu Estaing, Clermont-Ferrand, N/A, 63100, France @@
## The Benefits of Posterior Joint Infiltration in Chronic Low Back Pain - NCT ID: NCT06347328 - Study ID: 23-AOI-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2027-03 - Lead Sponsor: Centre Hospitalier Universitaire de Nice ### Study Description Lumbar facet joints have been implicated in chronic low back pain in over 45% of patients with isolated chronic common low back pain.Low back pain is the most common form of spinal pain, more chronic and severe than cancer pain. The annual prevalence of chronic low back pain ranges from 15% to 45% (one-off prevalence, 30%; lifetime prevalence, 54-80%). Because of this extremely high incidence, doctors from a wide range of specialities perform interventional techniques in a variety of settings.Facet joints have long been recognised as a source of back pain. In 1911, Goldthwait first recognised their role as a potential source of back pain. In 1933, Ghormley introduced the term "facet syndrome", defining lumbosacral pain with or without radicular pain. Badgley later suggested that facet joints could be a primary source of pain independently of spinal nerve compression. They demonstrated the role of posterior facet joints (PFJs) in a large number of patients with low back pain whose symptoms were not caused by a herniated disc. The underlying physiological concept of the PJF was introduced by Hirsch et al in 1963. They demonstrated that injecting a hypertonic saline solution into the region of the facet joints caused pain.The management of chronic low back pain due to zygapophyseal involvement (lumbar facet joints) consists primarily of conservative treatment. This is based on analgesics, anti-inflammatory drugs, physiotherapy and weight loss, where appropriate. Other non-surgical options may be proposed, including glucocorticoid injections into the facet joints. Glucocorticoid injections, which act by reducing inflammation, are commonly used in routine care to treat spinal pain. This pain may be due to a variety of pathologies, including discogenic or facet-related, or mixed, ligamentous or muscular, linked to a regional or global disorder of spinal statics. They are commonly used as a standard treatment for chronic spinal pain.Traditionally, in routine clinical practice, if there is significant paravertebral contracture and the clinical signs point to posterior joint involvement, a glucocorticoid injection is given in the doctor's surgery at the time of consultation, using anatomical landmarks to guide needle placement. However, few studies have demonstrated the efficacy of anatomical marking for infiltration of posterior joints, notably Cohen et al. Sui's systematic review of the use of this technique.With the advent of new imaging modalities such as ultrasound, more and more practitioners are turning to image-guided injections. To date, only the fluoroscopy-guided technique is considered reliable for facet joint infiltration.In order to improve the clinical efficacy of the various interventional therapeutic solutions, some authors have supported the use of ultrasound guidance. Several studies have been published comparing ultrasound-guided infiltration and infiltration using anatomical location in the shoulder region, the iliopsoas and in epicondilitis. While ultrasound guidance in areas such as the iliopsoas or the shoulder seems useful, it has not yet been proven that guidance is advantageous in spinal areas, such as the facet joints.To our knowledge, no randomised, methodologically sound study has yet been carried out to compare the benefit of ultrasound-guided infiltration versus infiltration with anatomical location.The aim of our study is to show that ultrasound-guided zygoapophyseal infiltration is superior to anatomically-guided infiltration in terms of pain assessment. ### Conditions - Chronic Low-back Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - echo-guided infiltration - non-echo-guided infiltration ### Outcomes Primary Outcomes - Change of pain progression Secondary Outcomes - measure function state by EIFEL questionnaire - measure function state by ODI questionnaire - pain evaluation by VAS scale ### Location - Facility: CHU de NICE, Nice, CHU De Nice, 06000, France @@
## Evaluation of the Effects of a Nutritional Intervention of Ketogenic Medium-chain Triglycerides and B-vitamins on Cognitive Functioning in Older Adults With Mild Cognitive Impairment (COGNIKET-MCI) - NCT ID: NCT06347315 - Study ID: 2302.CLI - Status: NOT_YET_RECRUITING - Start Date: 2024-05-10 - Completion Date: 2027-12-15 - Lead Sponsor: Société des Produits Nestlé (SPN) ### Study Description Evaluation of the Effects of a Nutritional Intervention of Ketogenic Medium-chain Triglycerides and B-vitamins on Cognitive Functioning in Older Adults With Mild Cognitive Impairment (COGNIKET-MCI) ### Conditions - Mild Cognitive Impairment ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - BrainXpert - Placebo ### Outcomes Primary Outcomes - Preclinical Alzheimer's Cognitive Composite (PACC) score Secondary Outcomes - Preclinical Alzheimer's Cognitive Composite (PACC) (components effects) - Montreal Cognitive Assessment (MoCA) score - Preclinical Alzheimer's Cognitive Composite (PACC) accelerated decline - Wechsler Memory Scale - Fourth Edition (WMS-IV) Logical Memory IIb Delayed Recall Score accelerated decline - Mini-Mental State Examination (MMSE) score accelerated decline - Emergent Adverse Events (Safety and tolerability) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Study of Vitreoretinal Molecular Changes During Rhegmatogenous Retinal Detachment - NCT ID: NCT06347302 - Study ID: EID 2023 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-10 - Lead Sponsor: Centre Hospitalier Universitaire Dijon ### Study Description Retinal detachment is a condition with an estimated incidence of between 9.5 and 18.2 cases per 100,000 individuals.It is an ophthalmological emergency that threatens visual acuity and requires surgery. However, despite satisfactory post-operative anatomical results, vitreoretinal proliferation and photoreceptor death can still have a negative impact on visual prognosis. These complications are still not fully understood.A previous study carried out by the Eye, Nutrition and Cell Signalling team at the CSGA, comparing mouse models of retinal detachment with healthy control retinas, revealed an increase in pro-inflammatory cytokines and a change in retinal lipid abundance in detached retinas.However, these results have yet to be confirmed in humans. Our main hypothesis is that the vitreous content of omega-3 PUFAs and proteins is altered during the onset of retinal detachment, since it reflects both intraocular inflammation and photoreceptor apoptosis.We therefore wish to demonstrate that the protein and PUFA contents of the vitreous humour are different between eyes with retinal detachment and eyes not affected by retinal detachment after macular surgery (epiretinal membrane or macular hole). We would like to show that the vitreous PUFA content is lower in the macular surgery group due to the absence of photoreceptor apoptosis and the absence of dehiscence causing communication between the subretinal space (photoreceptors whose membranes are very rich in PUFAs) and the vitreous space. We also hope to identify changes in the protein composition of vitreous fluid in patients with retinal detachment, with overexpression of proteins involved in inflammation pathways.In addition, we hypothesise that retinal omega-3 PUFA content is a factor influencing retino-vitreal proliferation and functional and anatomical recovery from retinal detachment. To this end, we will study the correlation between retinal PUFA-3 content and the clinical presentation and postoperative course of retinal detachment.Finally, with the aim of identifying a serum marker for the prognostic evaluation of retinal detachment, we will use as a candidate a biomarker of retinal omega-3 PUFA content that we have developed in an Age-Related Macular Degeneration (AMD) model. We will analyse the correlation between this biomarker and levels of omega-3 PUFAs measured directly in the retina.To do this, we will analyse intraoperative samples of vitreous humour, sub-retinal fluid and retinal fluid from patients undergoing vitrectomy for retinal detachment in the Ophthalmology Department of the Dijon University Hospital. A group of control patients will consist of patients operated on by vitrectomy for macular surgery (epiretinal membrane or macular hole) for whom a vitreous humour sample will also be taken.Clinical information on the characteristics of the retinal detachment will be collected. During the consultation, the patient will be questioned about any history of dyslipidaemia and any current treatment, including the use of lipid-enriched food supplements. Post-operative follow-up with prospective collection of clinical and paraclinical data on anatomical and functional evolution will be carried out up to 6 months after the occurrence of retinal detachment.A blood sample will be taken to establish a lipid profile in all patients. We will thus gain a better understanding of the changes in lipid and protein content in the vitreous humour, sub-retinal fluid and retina, and the demonstration of a link between the initial presentation and the postoperative anatomical and functional evolution of retinal detachment. This will provide a better understanding of the lipid-dependent mechanisms linked to inflammation and photoreceptor degeneration during retinal detachment, and will ultimately make it possible to develop new therapeutic strategies to improve visual prognosis. ### Conditions - Rhegmatogenous Retinal Detachments ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Blood sampling - vitreous sampling - Sub-retinal fluid sampling - Retinal tissue sampling ### Outcomes Primary Outcomes - Molecular content of fatty acids and proteins in the vitreous humour of eyes operated on for retinal detachment and eyes operated on for macular surgery Secondary Outcomes ### Location - Facility: Chu Dijon Bourgogne, Dijon, N/A, 21000, France @@
## Refusal of Organ Donation: a Study of Psychological, Anthropological and Cultural Factors - NCT ID: NCT06347289 - Study ID: CHSD_0024_REA - Status: COMPLETED - Start Date: 2022-01-01 - Completion Date: 2024-03-29 - Lead Sponsor: Centre Hospitalier de Saint-Denis ### Study Description The Hospital of Saint Denis (HSD) has been involved for several years in the dynamics of organ donation. In spite of the evolution of the practices of coordination of the collection of samples, the rate of refusal of organ donation is increasing in our hospital, contrary to the rest of France.Based on hypotheses derived from psychological and anthropological perspectives, this survey will provide first-hand information on the personal, family and cultural issues related to organ donation. It will be a question of identifying and locating individual and collective representations concerning death, its definition, and the associated symbols and rites. Based on the collection of these representations, we will be able to propose hypotheses of a psychological, social and anthropological nature on resistance to organ donation. ### Conditions - Psychology - Anthropology - Refusal, Organ Donation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Demographic information - Demographic information - Demographic information - Demographic information Secondary Outcomes ### Location - Facility: Centre Hopitalier de Saint-Denis, Saint-Denis, Seine Saint Denis, 93200, France @@
## Cerebral Microembolization Associated With PFO Closure - NCT ID: NCT06347276 - Study ID: 2023-RW320-08 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2024-12-31 - Lead Sponsor: China National Center for Cardiovascular Diseases ### Study Description This study aims to investigate (1) the de novo cerebral microembolization in patients who undergo transcatheter closure of PFO or ASD, and (2) evaluate the relationship between de novo cerebral microembolization and in situ thrombus within PFO. ### Conditions - Thrombosis Cardiac ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - PFO occluder; ASD occluder ### Outcomes Primary Outcomes - De novo cerebral microembolization Secondary Outcomes ### Location - Facility: Chaowu Yan, Beijing, Beijing, 100037, China @@
## Clinical and Radiographic Evaluation of Using the Entire Papilla Preservation Technique With and Without Autogenous Bone Graft and Injectable Platelet Rich Fibrin in Treatment of Periodontal Intraosseous Defects - NCT ID: NCT06347263 - Study ID: PER 332 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2025-04-30 - Lead Sponsor: Cairo University ### Study Description The goal of this Clinical trial is to evaluate the clinical and radiographic outcomes of using entire papilla preservation technique with and without autogenous bone and injectable platelet rich fibrin in treatment of isolated Intrabony defects in patients with stage III periodontitis. ### Conditions - Isolated Intrabony Periodontal Defects in Patients With Periodontitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Entire papilla preservation technique ### Outcomes Primary Outcomes - Clinical attachment level (CAL) gain change from baseline to 12 months Secondary Outcomes - Linear bone fill change from baseline to 12 months ### Location - Facility: Faculty of dentistry, Cairo University, Cairo, N/A, 3753450, Egypt @@
## A Nerve Block Therapy for Bulbar Palsy Pharyngeal Dysphagia - NCT ID: NCT06347250 - Study ID: SGB-Bulbar Palsy - Status: COMPLETED - Start Date: 2022-01-01 - Completion Date: 2023-05-31 - Lead Sponsor: Babujinaya Cela ### Study Description This was a multicenter randomized controlled study. 66 post-stroke patients with pharyngeal dysphagia were randomly allocated to the observation group or the control group. Both groups were provided with comprehensive rehabilitation including routine rehabilitation and swallowing function training. Besides, the observation group additionally underwent the stellate ganglion block (SGB). At admission and after 20-day treatment,Yale Pharyngeal Residue Severity Rating Scale, video fluoroscopic swallowing study (VFSS), Functional Oral Intake Scale, and Rosenbek penetration-aspiration scale (PAS) were used to assess swallowing function. ### Conditions - Bulbar Palsy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Nerve Block - Lidocaine Hydrochloride - routine therapy - placebo block ### Outcomes Primary Outcomes - The Functional Oral Intake Scale Secondary Outcomes - Yale Pharyngeal Residue Severity Rating Scale - penetration-aspiration scale - Video fluoroscopic swallowing study - The Swallowing Quality of Life Questionnaire ### Location - Facility: ZhenD No.1 Hos., Zhenzhou, N/A, N/A, China @@
## PsA Digital Phenotyping and Inflammation Drivers Study - NCT ID: NCT06347237 - Study ID: NL84429.078.23 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-12 - Lead Sponsor: Jolanda Luime ### Study Description The goal of this observational study is to develop and internally validate a machine learning model for detecting flare using a digital biomarker and a machine learning model for predicting flare, in patients with psoriatic arthritis. The main questions it aims to answer are:* In patients with psoriatic arthritis, is a digital biomarker capable of detecting a flare as compared to clinical defined flare by the rheumatologist?* In patients with psoriatic arthritis, what factors trigger a psoriatic arthritis flare ?Participants will be requested to:* Install app on their phone* Use a smartwatch* Complete questionnaires* Collect biological material ### Conditions - Psoriatic Arthritis - Flare Up, Symptom - Psoriatic Arthritis Aggravated ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Absence of flare in patients Secondary Outcomes - Minimal disease Activity (MDA) - Psoriatic Arthritis Disease Activity Score (PASDAS) - Disease Activity Psoriatic Arthritis (DAPSA) - Psoriatic Arthritis Impact of Disease (PsAID) - Morning stiffness ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Both Column Fixation Corridor in Pelvic Surgery - NCT ID: NCT06347224 - Study ID: BCFC-BCS-VIRTUAL2024 - Status: COMPLETED - Start Date: 2023-10-01 - Completion Date: 2024-03-01 - Lead Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital ### Study Description The concepts of the Both Column Fixation Corridor (BCFC) and Both Column Screws (BCS) have emerged as innovative approaches in orthopedic surgery yet have not been extensively explored in the literature. This study aims to evaluate the feasibility and potential advantages of this novel screw fixation technique, thereby filling the existing gap in knowledge and establishing standards for its application. ### Conditions - Acetabular Fractures ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: SCREENING ### Interventions - Virtual placement of lag screws in both columns of the acetabulum on 3D pelvic CT models. ### Outcomes Primary Outcomes - Successful Visualization of Both Column Fixation Corridor (BCFC) and Placement of Both Column Screws (BCS) Secondary Outcomes ### Location - Facility: Bakırköy Dr. Sadi Konuk Education and Research Hospital, Department of Orthopedics and Traumatology, Istanbul, N/A, N/A, Turkey @@
## "Hypotension Probability Indicator" in TAVI/MitraClip for Hypotension Management - NCT ID: NCT06347211 - Study ID: Attikon Hospital - Status: RECRUITING - Start Date: 2024-01-10 - Completion Date: 2026-01-10 - Lead Sponsor: Attikon Hospital ### Study Description The study will investigate whether the use of Goal Directed Hemodynamic Therapy implemented with the HPI algorithm using a treatment algorithm will reduce the incidence of hypotension and improve treatment of hypotension. ### Conditions - Hypotension During Surgery - Prevention of Hypotension ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Acumen IQ sensor with Hemosphere monitor incorporating the HPI algorithm ### Outcomes Primary Outcomes - TWA hypotension (measured with Acumen IQ sensor) Secondary Outcomes - Incidence of hypotension - Time spent in hypotension - Treatment choice (drugs/fluids) - Diagnostic guidance protocol deviations ### Location - Facility: Attikon Hospital, Athens, N/A, 12462, Greece @@
## Oral Inulin in Combination With Fruquintinib Plus Sintilimab as Third- or Further-line Treatment in Metastatic Colorectal Cancer - NCT ID: NCT06347198 - Study ID: 20230807-02 - Status: RECRUITING - Start Date: 2024-04-10 - Completion Date: 2025-05-01 - Lead Sponsor: Wuhan Union Hospital, China ### Study Description This is a single-center exploratory clinical study to explore the efficacy and safety of Oral Inulin in Combination With Fruquintinib Plus Sintilimab as Third- or Further-line Treatment in Metastatic Colorectal Cancer. ### Conditions - Metastatic Colorectal Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Fruquintinib - Sintilimab - Inulin ### Outcomes Primary Outcomes - Intestinal microbiota diversity, abundance and taxonomic information - adverse events Secondary Outcomes - Objective remission rate (ORR) - Overall survival (OS) - Progression-free survival (PFS) - Disease control rate (DCR) - Duration of remission (DOR) - Concentration of various serum metabolites - Concentration of various plasma Cytokine Changes - Frequency of peripheral blood lymphocyte ### Location - Facility: Min Jin, Wuhan, Hubei, 430030, China @@
## Simultaneous Care in Recurrent and/or Metastatic Head and Neck Cancer: the SupCare Study - NCT ID: NCT06347185 - Study ID: EORTC-2236-HNCG-QLG - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2028-12 - Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC ### Study Description This is a late phase II, prospective, multicenter randomized study, to assess the value of early palliative care integrated with the standard oncologic care in patients with Recurrent Metastatic (RM) Head and Neck Cancer (HNC) proposed to first line palliative systemic treatment.The study randomizes patients in a 1:1 fashion to standard oncologic care, in which the palliative care is requested as needed (reactive approach) or to early palliative care integrated with the standard oncologic care (proactive approach).Standard of Care: the oncologist will be the main referral of the patient, deciding the therapeutic approach, the assessments requested, in terms of type of exams and timing and the need of possible further support from other expertise. The oncologist will base the choices also upon the results of the Liverpool Head and Neck Patient Concern Inventory (PCI-H\&N) and the patient's preferences. At the end of the first oncological visit, the physician will be asked to predict the survival of the patient.Integrated approach: Besides the Oncology visit, patient will have the palliative care expert visit and follow up. The oncologist will define the therapeutic approach and the assessments requested, in terms of type of exams and timing. The palliative care clinician and the oncologist will judge the burden of symptoms and together they will propose the suggested interventions to relief the symptoms, with a particular attention to a validated instrument (the PCI-H\&N) and patient priority questionnaire's results.Stratification Factors* Institution* Performance Status (PS) (0 vs 1-2)* Presence of any caregiver at home* Type of treatment (Immunotherapy alone vs any other combination)Study duration: the total study duration is estimated at 36 months, with a total accrual time estimated to be 24 months from first patient in (FPI) and with an additional follow-up period of 12 months.End of study occurs when all patients have completed their end of study visit and the study is mature for all analyses defined in the protocol and the database has been cleaned and frozen for these analyses. ### Conditions - Head and Neck Neoplasms ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Early palliative care, integrated with the standard oncologic care (proactive approach) - Palliative care requested as needed, integrated with the standard oncologic care (reactive approach) ### Outcomes Primary Outcomes - Change from baseline in emotional functioning and pain scores according to Item List (IL) 250 questionnaire at 15 weeks. Secondary Outcomes - Change from baseline in emotional functioning and pain scores according to Item List 250 (IL250) questionnaire at 6 weeks, 24 weeks and 52 weeks. - Change from baseline in the selected Health Related Quality of Life (HRQoL) scales from the Item List 250 (IL250) questionnaire at 6 weeks, 15 weeks, 24 weeks and 52 weeks - Number of unplanned visits to emergency room or specialist visits - Hospitalization due to treatment toxicities or tumour signs/symptoms, as evaluated by number of admissions and duration - Identification of the rate of patients starting a new systemic treatment in the last three months of life - Rate of patients receiving systemic treatment in the last month of life - Rate of patients with a tracheostomy performed in the last 3 months of life - Rate of patients with gastrostomy performed in the last 3 months of life - Caregiver/family members' satisfaction (FAMcare questionnaire) at 15 weeks - Overall Survival (OS) - Prediction error of survival (defined as the difference between actual survival (AS) of patients and clinician prediction of survival (CPS)) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Deprescribing in Patients Living With Dementia With Caregiver and Provider Nudges - NCT ID: NCT06347172 - Study ID: 2024p000278 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2025-01-15 - Lead Sponsor: Brigham and Women's Hospital ### Study Description The objectives of this study are to demonstrate the feasibility of implementing a deprescribing nudge intervention using pragmatic methods, confirm that outcomes can be feasibly measured and evaluated at scale in a subsequent embedded pragmatic clinical trial (ePCT), and explore representativeness of persons living with dementia and care partners identified. ### Conditions - Alzheimer Disease - Mild Cognitive Impairment - Dementia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Nudge Intervention ### Outcomes Primary Outcomes - Composite of the percentage of eligible PCPs or their PLWD/care partners who view or click on information Secondary Outcomes - Number of nudges that fire as intended: Fidelity - Discontinuation or prescribed reduction in medication ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@

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