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NCT ID: NCT04776252 Active, not recruiting - HIV-1 Infection Clinical Trials

Open-label, Follow-up of Doravirine/Islatravir (DOR/ISL 100 mg/0.75mg) for Participants With Human Immunodeficiency Virus-1 (HIV-1) Infection (MK-8591A-033)

Start date: September 15, 2021
Phase: Phase 3
Study type: Interventional

The safety and tolerability of MK-8591A, a 2-drug fixed dose combination (FDC) of doravirine (DOR 100mg) and islatravir (ISL 0.75mg) will be evaluated in participants with Human Immunodeficiency Virus -1 (HIV-1) who were treated with DOR and ISL in earlier clinical studies.

NCT ID: NCT04776148 Active, not recruiting - Clinical trials for Colorectal Neoplasms

Study of Lenvatinib (MK-7902/E7080) in Combination With Pembrolizumab (MK-3475) Versus Standard of Care in Participants With Metastatic Colorectal Cancer (MK-7902-017/E7080-G000-325/LEAP-017)

Start date: March 29, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of lenvatinib (MK-7902/E7080) in combination with pembrolizumab (MK-3475) in participants with metastatic colorectal cancer. The study will also compare lenvatinib plus pembrolizumab with the standard of care treatment of regorafenib and TAS-102 (trifluridine and tipiracil hydrochloride). The primary study hypothesis is that lenvatinib plus pembrolizumab is superior to standard of care with respect to overall survival.

NCT ID: NCT04776122 Completed - Breathing, Mouth Clinical Trials

Usability of a Breathing-CBT Platform (CBT = Cognitive Behavioural Therapy)

Start date: June 1, 2018
Phase: N/A
Study type: Interventional

The study will examine the usability of a breathing platform in the home environment. It will be a randomized, open-label crossover study of 10 participants who will complete the CBT and breathing components in their home, prior to sleeping. Usability will be measured by scores assigned by participants. Qualitative feedback and compliance information will also be collected.

NCT ID: NCT04776031 Completed - Clinical trials for Early Age Related Macular Degeneration (Disorder)

Evaluation of R:GEN as Intervention in Subjects With Early Stages of AMD for Safety and Exploratory Efficacy Outcomes

Start date: February 15, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of the R:GEN Laser System in subjects with the early stages of age-related macular degeneration.

NCT ID: NCT04775797 Terminated - Chronic Hepatitis Clinical Trials

Safety, Tolerability, and Pharmacokinetics of AB-836 in Healthy Subjects and Subjects With Chronic HBV Infection

Start date: June 25, 2021
Phase: Phase 1
Study type: Interventional

This three-part, Phase 1 protocol will be the first clinical study of AB-836. Parts 1 and 2a/b will be a Phase 1a SAD/MAD of AB-836 in healthy adult subjects. Part 3 will be a Phase 1b dose-ranging assessment of AB-836 in non-cirrhotic Chronic Hepatitis B (CHB) subjects.

NCT ID: NCT04775485 Recruiting - Clinical trials for Advanced Solid Tumor

A Study to Evaluate DAY101 in Pediatric and Young Adult Patients With Relapsed or Progressive Low-Grade Glioma and Advance Solid Tumors

FIREFLY-1
Start date: April 22, 2021
Phase: Phase 2
Study type: Interventional

FIREFLY-1 is an ongoing, Phase 2, multi center, open-label study to evaluate the safety and efficacy of oral pan-RAF inhibitor DAY101 in pediatric, adolescent, and young adult patients with recurrent or progressive low-grade glioma or an advanced solid tumor harboring a known RAF alteration.

NCT ID: NCT04774718 Recruiting - Clinical trials for ALK Fusion-positive Solid or CNS Tumors

A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors

Start date: September 14, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This study will evaluate the safety, pharmacokinetics, and efficacy of alectinib in children and adolescents with ALK fusion-positive solid or CNS tumors for whom prior treatment has proven to be ineffective or for whom there is no satisfactory standard treatment available.

NCT ID: NCT04774224 Active, not recruiting - Type 1 Diabetes Clinical Trials

Baricitinib in New-onset Type 1 Diabetes

BANDIT
Start date: October 30, 2020
Phase: Phase 2
Study type: Interventional

Type 1 diabetes (T1D) results from the killing of insulin-producing pancreatic beta cells by cells of the immune system. The study aims to slow the progressive, immune-mediated loss of insulin-producing beta cells that occurs after clinical presentation. The investigators have identified a pathway that is important for immune cells to kill beta cells, and a drug that will block this pathway and prevent beta cell death. This drug, baricitinib, is already in clinical use for rheumatoid arthritis, and is currently in clinical trials for other diseases, including childhood autoimmune diseases. It is hypothesized that baricitinib treatment for 48 weeks will preserve beta cell function in children and young adults with recently-diagnosed T1D. The trial aims to recruit 83 participants aged 10-30 years who have been recently diagnosed with T1D. Two thirds of the participants will be randomly assigned to receive baricitinib, one third will receive placebo. The trial will test if baricitinib can slow the progressive loss of insulin-producing beta cells in these patients. The primary objective is to determine if baricitinib can reduce the loss of meal-stimulated plasma C-peptide, a measure of beta-cell function. Maintaining endogenous insulin in recent-onset T1D improves glucose control and may lead to long-term improvements in glucose and lower rates of serious diabetes complications and death.

NCT ID: NCT04774185 Completed - Hearing Loss Clinical Trials

Hearing Aid Transmitter Performance Study - SRF-366

Start date: April 26, 2021
Phase: N/A
Study type: Interventional

Sonova Hearing Systems pass through different development and study stages. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. Afterwards, and prior to product launch, the Sonova Hearing Systems undergo a final quality control in terms of clinical trials. This is a confirmatory study, investigating benefits of a modified hearing aid loudspeaker. This will be a clinical investigation which will be conducted mono centric at National Acoustic Laboratories a well known institution with exceptional experience (Australia).

NCT ID: NCT04773782 Recruiting - CNS Tumor Clinical Trials

A Study of Avapritinib in Pediatric Patients With Solid Tumors Dependent on KIT or PDGFRA Signaling

Start date: February 24, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1/2, multicenter, open-label trial of avapritinib in participants 2 to < 18 years of age with advanced relapsed/refractory (R/R) solid tumors, including central nervous system (CNS) tumors, that harbor a PDGFRA and/or KIT mutation (including non-synonymous point mutations, insertions, and deletions) or amplification, or DMG-H3K27a who have no available curative treatment options. This is a single-arm trial in which all participants will receive avapritinib. The study consists of 2 parts: dose confirmation, safety, and PK (Part 1) and initial efficacy, safety, and PK at the Part 2 recommended dose (Part 2).