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NCT ID: NCT06274489 Recruiting - Alport Syndrome Clinical Trials

A Study to Evaluate Setanaxib in Patients With Alport Syndrome

Start date: November 27, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of the study is to learn about the safety and tolerability of setanaxib in subjects with Alport syndrome, when added to their standard of care treatment. The study will assess how safe setanaxib is when compared to placebo. Study participants will be asked if they are experiencing any side effects at each study visit. In addition, tests in blood, urine and other examinations will be used to look at the safety of setanaxib. The study will also measure how well setanaxib works in comparison to a placebo, by measuring urine protein and certain markers in the blood and urine. The concentration of setanaxib in the blood will also be measured throughout the course of the study. Setanaxib is planned for use together with the current standard of care to hopefully provide additional therapeutic benefits by preserving kidney function. The study will be conducted at multiple research sites in the UK, Spain, and Czech Republic. Eligible participants will be randomly assigned to receive either setanaxib or placebo. Setanaxib dose level will depend on age and all participants will receive their standard of care in addition to setanaxib or placebo. The study consists of a Screening period of up to 4 weeks, a 24-week Treatment period and a 4- week Follow-up period.

NCT ID: NCT06272682 Recruiting - Clinical trials for Carpal Tunnel Syndrome

Corticosteroids in Carpal Tunnel Syndrome. Prospective Randomised Controlled Non-inferiority Study

Start date: July 17, 2023
Phase: N/A
Study type: Interventional

The goal of this prospective, randomised, controlled, non-inferiority analytical study is to compare the Boston score in patients treated with systemic (intramuscular) versus local infiltration corticosteroids in mild and moderate carpal tunnel syndrome in patients over 18 years of age with mild or moderate carpal tunnel syndrome. The main questions it aims to answer are: - What is the effectiveness of intramuscular injection of corticosteroids compared to local infiltration in the treatment of mild/moderate carpal tunnel syndrome? - What are the adverse effects and application site pain associated with each route of administration? Patients who meet the inclusion criteria will be asked to participate in the study and sign an informed consent form. The Redcap randomizer will be used to assign the patient to one of the branches. Researchers will compare - Branch A: patients treated with local corticosteroid infiltration in carpal tunnel under ultrasound - Branch B: patients treated with intramuscular corticosteroid injection. Researchers will: - Compare Boston Carpal Tunnel Questionnaire score at 1.5 months, 3 months, 6 months and 12 months post-procedure. - Describe adverse reactions associated with the route of administration. - Compare the pain at the site of application associated with the route of administration.

NCT ID: NCT06271200 Recruiting - Metabolic Syndrome Clinical Trials

Strategic Lifestyle Intervention for Metabolic Syndrome (SLIM-MET)

Start date: March 14, 2024
Phase: N/A
Study type: Interventional

This study is a randomized, parallel-group, observer-masked clinical trial. A total of 120 obese participants with MetS will be enrolled. Eligible subjects will be randomly assigned to the ILI group or ULI group with an allocation ratio of 2:1. The ILI group will be instructed to eat in 8 hours while fasting in 16 hours on daily basis over 24 weeks. Furthermore, enhanced daily physical activities with walking more than 10,000 steps will be implemented. The enrolled participants will be instructed to follow a diet with reduction of daily intake of 500 kcals per day. ILI group will be asked to use the Health2Sync mobile app to track self-measured outcomes and daily diet control. The investigators objectively measure step counts for participants of ILI group during 24-week intervention period using a wearable device (Fitbit Inspire 2). Participants are asked to attach the pedometer on their waist belt, except while bathing and sleeping. The ULI group will be instructed to follow habitual meal timing. In addition, all participants of both groups will receive the health education. Anthropometric, sociodemographic data, biochemical variables, and metabolic variables will be measured at baseline and during follow-up visit. DEXA and MRI of abdomen will be measured at baseline and during following up visits. The proposed trial is designed to provide 85% statistical power to detect a significant difference in changes in the metabolic syndrome severity score after reduction > 5% body weight over 24 weeks.

NCT ID: NCT06271083 Recruiting - Tourette Syndrome Clinical Trials

Internet-based Behavior Therapy for Adults With Tourette Syndrome

TICNET
Start date: February 2, 2024
Phase: N/A
Study type: Interventional

This study protocol outlines a parallel-group, randomized controlled trial (RCT) designed to evaluate the effectiveness of Internet-delivered behavior therapy (BT) based on exposure with response prevention (ERP) for adults with Tourette syndrome (TS) or chronic tic disorder (CTD). The primary aim is to evaluate the effects of Internet-delivered ERP-based BT on tic severity compared to a control condition offering general psychological support at week 11 counting from the treatment start. The primary outcome measure is the Yale Global Tic Severity Scale - Total Tic Severity subscale (YGTSS-TTS). Secondary outcomes include measures of tics-related impairment, work and social adjustment, rates of responders, self-rated tic severity, symptoms of depression, and quality of life. Long-term maintenance of results will be assessed at week 23 and 14 months after the treatment start. Participants will be recruited nationwide. The intervention group will receive 10 weeks of ERP-based therapy delivered through an online platform, with therapist support. The control group will receive psychoeducational content and general psychological support. Adherence to treatment, adverse events, and patient safety will be closely monitored throughout the trial. The study population will be intent-to-treat and the between-group differences at the primary endpoint will be assessed using an analysis of covariance (ANCOVA) with pre-score of the measure as covariate. A health-economic evaluation will assess the cost-effectiveness of the intervention.

NCT ID: NCT06268964 Recruiting - Clinical trials for Functional Gastrointestinal Disorders

Exploring Treatments for Children's Abdominal Pain: Comparing Trimebutine and Probiotics

FAPD_RCT
Start date: March 1, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this clinical trial is to test the effectiveness of trimebutine and probiotics in treating Functional Abdominal Pain Disorders (FAPD) in a pediatric population. The main questions it aims to answer are: Is trimebutine effective in reducing the symptoms of FAPD in children? Are probiotics effective in reducing the symptoms of FAPD in children? Participants will be randomly assigned to one of three treatment groups (trimebutine/probiotics, probiotics/placebo, or trimebutine/placebo). Undergo measurements for pain and other relevant metrics at the start of the study, after 4 weeks, and after 8 weeks. Researchers will compare the trimebutine/probiotics group to the probiotics/placebo and the trimebutine/placebo groups to see if there are significant differences in the efficacy of these treatments in reducing symptoms of FAPD in children.

NCT ID: NCT06268717 Recruiting - Clinical trials for Irritable Bowel Syndrome

GI Alpha-Gal Study

Start date: October 17, 2023
Phase: N/A
Study type: Interventional

This is a double-blind, crossover food challenge study using pork with and without α-gal in patients with a clinical diagnosis of gastrointestinal (GI)- α-gal allergy, and to investigate the pathophysiology underlying their symptoms.

NCT ID: NCT06268288 Recruiting - Clinical trials for Autonomic Dysfunction

Non-invasive Vagal Neurostimulation (nVNS) in Adolescents With Postural Orthostatic Tachycardia Syndrome (POTS)

Start date: February 14, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if nVNS will decrease autonomic symptom intensity (COMPASS-31 and Child Functional Disability Inventory) in adolescent patients with postural orthostatic tachycardia syndrome (POTS) in comparison to standard recovery STEPS management.

NCT ID: NCT06267950 Recruiting - Clinical trials for Pierre Robin Syndrome

Effect of Oral Feeding in Infants With Pierre Robin Syndrome

Start date: February 29, 2024
Phase: N/A
Study type: Interventional

This was a randomized controlled study. The infants enrolled were randomly divided into the IOE group (with Intermittent Oro-Esophageal Tube Feeding) and the PNG group (with Nasogastric Tube Feeding), all receiving systemic therapy. Before and after 4-week treatment, pulmonary infection, swallowing function, nutritional status and body weight between the two group were compared.

NCT ID: NCT06267807 Recruiting - Lymphatic Diseases Clinical Trials

Lymphatic Phenotype in Noonan Syndrome Spectrum Disorders

LENS
Start date: March 27, 2024
Phase: N/A
Study type: Interventional

To get a better insight into the central conducting lymphatic system in adult volunteers with Noonan Syndrome (NS) without clinical symptoms or signs of lymphatic disease compared to NS and CardioFacioCutaan syndrome patients with severe lymphatic disease

NCT ID: NCT06261918 Recruiting - Breast Cancer Clinical Trials

Transcriptional and Epimetabolic Profile of Breast Carcinoma With Luminal or HER2+ or Locally Advanced Triple-negative Histotype in Patients With/Without Previous Clinical History of Metabolic Syndrome

PROMETA
Start date: February 1, 2024
Phase:
Study type: Observational

This prospective pilot study of biological specimens aims to identify new prognostic and predictive biomarkers of response to standard therapy for local advanced BC, as well as to identify new targets for the development of immuno- therapeutic protocols. First aim is therefore to expand our knowledge to increase the response to preoperative treatment, intensify treatment patterns, and select patients based on clinical parameters. In this regard, it appears imperative to investigate yet under-investigated factors that might impair the response to standard therapy for local advanced BC including association to metabolic syndrome and analysis of tumoral and stromal features supporting a tumor microenvironment impenetrable to both drugs and immune system cells.