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NCT ID: NCT06270511 Recruiting - Healthy Volunteers Clinical Trials

A Study to Investigate Different Formulations of S-337395 in Healthy Adult Participants

Start date: March 13, 2024
Phase: Phase 1
Study type: Interventional

The aim of this study is to investigate different formulations of S-337395.

NCT ID: NCT06270316 Recruiting - Fabry Disease Clinical Trials

Safety, PK/PD, and Exploratory Efficacy Study of AMT-191 in Classic Fabry Disease

Start date: May 31, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open-label multi-center study to evaluate safety and biomarkers of efficacy of a single dose of intravenously-administered AMT-191. The study will also include exploratory functional efficacy assessments. The plan is to investigate 2 sequential dose cohorts in 3-6 Participants per cohort. Participants will be monitored for 24 hours following AMT-191 administration then follow-up study visits will continue for 24 months, during which safety, pharmacokinetics/pharmacodynamics, biomarkers, and efficacy assessments will be performed. Participants will continue receiving their regularly scheduled enzyme replacement therapy (ERT) until they meet the criteria for withdrawal.

NCT ID: NCT06270251 Recruiting - Clinical trials for Chronic Tic Disorder

Modeling Tic Change During Behavior Therapy for Tics

Start date: March 1, 2024
Phase: N/A
Study type: Interventional

Chronic tics are a disabling neuropsychiatric symptom associated with multiple child-onset mental disorders. Chronic tics affect 1-3% of youth and can be associated with impaired functioning, emotional and behavioral problems, physical pain, diminished quality of life, and peer victimization. Chronic tics are the primary symptom of Tourette Syndrome (TS) and Persistent Motor/Vocal Tic Disorders. CBIT is a manualized treatment focused on increasing tic controllability. Its core procedure is competing response training (CRT), in which patients learn to inhibit tics by learning and applying a competing motor action to one tic at a time. CBIT is recommended as a first-line treatment relative to medications and other therapies. However, only 52% of children and 38% of adults show clinically meaningful tic improvement. Large randomized trials have demonstrated the superiority of CBIT over supportive therapy in child and adult patients, and meta-analysis shows comparable effect sizes for CBIT and medication. Although increasing tic controllability is the primary goal of CBIT, tic controllability nor its correlates have been examined longitudinally during the intervention. The overall objective of this study is to use fine-grained data collection strategies to identify patterns in tic controllability and other relevant related variables that are associated with treatment response to CBIT. Participants with chronic tics will complete a manualized course of 8-session CBIT. Behavioral, psychosocial, and global functioning will be assessed longitudinally to examine predictors and correlates of response. CBIT sessions will be video recorded.

NCT ID: NCT06270082 Recruiting - Colorectal Cancer Clinical Trials

Study of IK-595 in RAS- or RAF-altered Advanced Tumors

Start date: December 18, 2023
Phase: Phase 1
Study type: Interventional

This is a Phase 1, FIH, Dose Escalation and Dose Expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) effects, and preliminary antitumor activity of IK-595, a MEK/RAF molecular glue, administered orally as monotherapy in patients with advanced solid tumors with gene alterations in the RAS- MAPK pathway for whom there are no further treatment options known to confer clinical benefit.

NCT ID: NCT06270043 Recruiting - Prostate Cancer Clinical Trials

Focal Therapy for Localized Prostate Cancer

Start date: February 1, 2024
Phase:
Study type: Observational [Patient Registry]

This prospective registry and longitudinal study that is designed to carefully measure details of prostate cancer patients' outcomes with focal therapy. The goal of which is to improve patient care.

NCT ID: NCT06269978 Recruiting - Clinical trials for Stage IV Colorectal Cancer AJCC v8

Intraperitoneal Oxaliplatin and Fluorouracil for the Treatment of Patients With Peritoneal Metastases From Colorectal Cancer

Start date: June 30, 2024
Phase: Phase 1
Study type: Interventional

This phase I trial tests the safety, side effects, and best dose of intraperitoneal oxaliplatin and fluorouracil in treating patients with colorectal cancer that has spread to the peritoneal cavity (peritoneal metastasis). Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's DNA and may kill cancer cells. Fluorouracil stops cells from making DNA and it may kill cancer cells. Both oxaliplatin and fluorouracil are approved by the Food and Drug Administration to treat patients with colorectal cancer, however administration of these drugs directly into the area between the muscles and organs in the abdomen (intraperitoneal) for the treatment of peritoneal metastases is experimental. Giving oxaliplatin and fluorouracil directly into the peritoneal space may be a safe and effective way of treating patients with peritoneal metastases from colorectal cancer.

NCT ID: NCT06269783 Recruiting - Urolithiasis Clinical Trials

Dual-process Mechanisms of Action for sipIT Intervention Effects in Patients With Urolithiasis

Start date: January 10, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to clarify the fundamental processes underlying behavior change, maintenance, and adherence during and after a 3-month fluid intake intervention period.

NCT ID: NCT06269705 Recruiting - Clinical trials for Glenohumeral Osteoarthritis

ZILRETTA in Subjects With Glenohumeral Osteoarthritis

Start date: February 5, 2024
Phase: Phase 3
Study type: Interventional

Primary Objective: To assess the efficacy of ZILRETTA on pain following an intra-articular (IA) injection in subjects with glenohumeral osteoarthritis (OA) relative to normal saline placebo Secondary Objective: - To assess the efficacy of ZILRETTA on pain following an IA injection in subjects with glenohumeral OA relative to triamcinolone acetonide injectable suspension, immediate release (TCA-IR) and normal saline placebo - To assess the safety of ZILRETTA in subjects with glenohumeral OA relative to normal saline placebo and TCA-IR

NCT ID: NCT06269666 Recruiting - Retinal Disease Clinical Trials

P200TxE Diseased Eye Image Collection

Start date: January 31, 2024
Phase: N/A
Study type: Interventional

The primary objective is to collect images on the P200TxE device in diseased eyes.

NCT ID: NCT06269653 Recruiting - Healthy Volunteers Clinical Trials

Measuring Protein Turnover in Humans Across the Lifespan by Metabolic Labeling With Deuterium Oxide

Start date: June 26, 2024
Phase:
Study type: Observational

Background: Proteins are essential to the health and structure of the cells that make up body tissues. Most proteins become damaged over time and are replaced with new ones. This process is called "protein turnover." Stress, disease, and aging can affect this process. Researchers want to better understand how aging affects protein turnover. Objective: To measure rates of protein turnover in healthy adults. Eligibility: Healthy people aged 20 years and older with a body mass index between 20 and 30. Design: Participants will have 6 study visits over 4 to 6 weeks. They will fast 12 hours before each visit. Participants will be screened. They will have a physical exam, with blood and urine tests and tests of their heart function. They will lie down while blood pressure cuffs are used on their arms and legs. Participants will be given bottles of heavy water to drink at home on a schedule for 21 days. Each bottle holds about 3.5 tablespoons. Heavy water is odorless, colorless, and tasteless, like normal drinking water. It is safe to drink and has been used in research for many years. Participants will have tests during study visits, including: Imaging scans of a leg. Exercise on a treadmill. Biopsies of muscle, skin, and fat: Small samples of tissue will be cut from the calf and abdomen. Resting metabolic rate: Participants will lie still and breathe into a mask for 20 minutes. Knee/grip strength: Participants will do strength tests with their legs. They will squeeze a device with their hands. D3-Creatine: Participants will take 1 pill of D3-Creatine, which occurs naturally in muscle.