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NCT ID: NCT06278857 Not yet recruiting - Clinical trials for Immune-related Adverse Event

SATELLITE Study (feaSibility sAfeTy Efficacy dostarLimab earLy-stage defIcient endomeTrial cancEr)

SATELLITE
Start date: June 1, 2024
Phase: Phase 2
Study type: Interventional

The main goal of this clinical trial is to evaluate dostarlimab, an immunotherapy drug, as a potential alternative to surgery for early-stage endometrial cancer with Mismatch Repair deficiency, a genetic cause for 20-30% of cases. The study aims to establish dostarlimab's efficacy and safety in early-stage endometrial cancer, exploring its potential as a non surgical option for those unsuitable or unwilling to undergo major surgery, allowing for fertility preservation or addressing specific health conditions. Participants will have seven dostarlimab sessions over 12 months. The treatment plan involves four cycles every three weeks, followed by a three-week break, and then three cycles every six weeks. This research is a promising step toward a new, less invasive treatment choice for patients with specific genetic traits. It expands the range of care options for endometrial cancer.

NCT ID: NCT06277037 Not yet recruiting - Long Term Follow-up Clinical Trials

Long-Term Follow-up Study for Subjects With CHB Previously Treated With Imdusiran (AB729)

Start date: July 15, 2024
Phase:
Study type: Observational

This is a long term follow-up study for chronic hepatitis B (CHB) subjects who have received imdusiran treatment in a prior clinical trial, stopped NA therapy during that trial, and remain off therapy. Subjects may enroll after completing the end of study visit (baseline visit within 12 weeks ± 1 week from the end of study [EOS] visit) from their imdusiran clinical trial (the "parent study"). No interventions will be performed in this study other than blood sample collections, review of current medications, and reporting of any adverse events related to study procedures or NA therapy if restarted. Study participation will be for approximately 2 years (to complete a total of at least 3 years of follow-up while off NA therapy, inclusive of parent study participation).

NCT ID: NCT06273813 Not yet recruiting - Acute Pain Clinical Trials

Treatment of Topical Ketorolac Gel in Acute Gouty Flare

Start date: February 2024
Phase: Phase 1
Study type: Interventional

This study will be a phase 1, open-label, bioavailability, safety and PK study of topically applied transcutaneous ketorolac tromethamine gel 12.5% (/w) (NOV-1776) versus intravenous administration of approved ketorolac tromethamine injection, USP (15mg/mL) comparator in healthy volunteers, including an evaluation of safety, tolerability, and efficacy in gout participants with flare-up.

NCT ID: NCT06264167 Not yet recruiting - Clinical trials for Ultrasound Therapy; Complications

NODE (groiN ultrasOunD cancEr)

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

This study is an open label, prospective, experimental, randomised clinical trial. The primary aim of this study is to determine whether it is feasible to randomise vulvar cancer patients into one of two treatment arms:1) surgical groin node dissection (as delivered though either a sentinel node biopsy or inguinofemoral lymph node dissection (IFL), or 2) serial high-resolution bilateral groin ultrasound surveillance and clinical examination every 2 months.

NCT ID: NCT06263270 Not yet recruiting - Osteoarthritis Clinical Trials

Evaluation of CYT-108, a Recombinant Protease Inhibitor, for Treatment of Mild to Moderate Primary Osteoarthritis of the Knee

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

The goal of this Phase 1 study is to investigate the safety of CYT-108, our experimental recombinant protease inhibitor drug candidate for osteoarthritis, in a population of patients suffering from osteoarthritis of the knee. The main questions this study aims to answer are: 1. are two doses of CYT-108, delivered 12 weeks apart, safe when injected directly into the joint? 2. does administration of CYT-108 result in a reduction in pain, stiffness, and improvement in daily physical function? Participants will either receive a placebo (Phosphate Buffer Saline, PBS) or CYT-108, and will be asked to report their pain/stiffness at weeks 1, 4, 8, 12, 16, and 26 (in a physician's office) after the initial injection, using a questionnaire to be provided by the physician. In addition to reporting the magnitude of pain, participants will also be asked about the onset of pain reduction. Researchers will compare the pain/stiffness scores between the CYT-108-treated to placebo-treated groups along the 26 week duration of the study. Participants will also receive blood draws along the course of the study, and researchers will analyze this blood for the presence of cartilage degradation product in attempt to identify "disease modification" (i.e., a reduction in cartilage degradation) in response to CYT-108 treatment.

NCT ID: NCT06259006 Not yet recruiting - Rheumatic Fever Clinical Trials

TREAT-SC: Early, Short Course Oral Dexamethasone for the Treatment of Sydenham Chorea in Children

TREAT-SC
Start date: May 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to find out whether an early three-day course of an oral steroid medication (dexamethasone) can improve the physical and mental recovery and wellbeing for children with Sydenham's chorea. Sydenham's chorea is a condition that impacts approximately 12% of children with acute rheumatic fever. It is caused by inflammation in the brain following an abnormal immune response to Group A streptococcus bacterial infection. Sydenham's chorea is a movement disorder that causes children's faces, hands, and feet to move quickly and uncontrollably, and can also affect mood and concentration. The physical recovery from Sydenham's chorea can take two to six months but the mental recovery (e.g. mood and concentration) can take longer to resolve. Sydenham's chorea remains endemic in Māori, Pacific Islander, Aboriginal and Torres Strait Islander children in New Zealand and Australia. There is limited evidence to direct treatment of Sydenham's chorea, and clinical practice differs widely around the world. Dexamethasone is an oral steroid which targets the abnormal immune response and successfully treats other immune-mediated brain disorders, with good tolerability. TREAT-SC is a randomized, double-blinded, placebo-controlled trial which will investigate whether a three day course of oral dexamethasone safely and effectively treats the movement disorder and psychiatric symptoms of Sydenham's chorea. The trial will recruit 80 participants from study sites in Australia and New Zealand.

NCT ID: NCT06215261 Not yet recruiting - Clinical trials for Post Traumatic Stress Disorder

An Evaluation of the Safety and Efficacy of Methylone for the Treatment of PTSD

IMPACT-2
Start date: March 2024
Phase: Phase 2
Study type: Interventional

This study is evaluating the safety and efficacy of methylone in adults with PTSD. The study is conducted in two parts. - Part A is open-label and will enroll up to 15 participants with PTSD - Part B is randomized (1:1), double-blind, placebo-controlled and will enroll up to 64 participants with PTSD Eligible participants will enter a 3-week Treatment Period where they will receive methylone (or placebo in Part B) once weekly for 3 weeks (3 treatment sessions). Following the Treatment Period, participants will enter a 6-week Follow-up Period.

NCT ID: NCT06208657 Not yet recruiting - Childhood Cancer Clinical Trials

Optimal Precision TherapIes to CustoMISE Care in Childhood and Adolescent Cancer

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

A companion platform trial to test novel targeted agents based on the patient's tumor profile.

NCT ID: NCT06203210 Not yet recruiting - Clinical trials for Small Cell Lung Cancer

A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer

IDeate-Lung02
Start date: June 10, 2024
Phase: Phase 3
Study type: Interventional

This study was designed to compare the efficacy and safety of I-DXd with treatment of physician's choice in participants with relapsed small cell lung cancer (SCLC).

NCT ID: NCT06199908 Not yet recruiting - Clinical trials for Advanced Solid Tumors

AMT-562 in Patients With Selected Advanced Solid Tumors

Start date: March 31, 2024
Phase: Phase 1
Study type: Interventional

This is a first-in-human, non-randomized, open-label, multicenter Phase 1 study of AMT-562 in patients with advanced solid tumors.