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NCT ID: NCT04233216 Completed - HIV-1 Infection Clinical Trials

Doravirine/Islatravir (DOR/ISL) in Heavily Treatment-Experienced (HTE) Participants for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-019)

Start date: March 18, 2020
Phase: Phase 3
Study type: Interventional

This is a 2-part, phase 3 clinical study evaluating the antiretroviral activity and safety/tolerability of islatravir (ISL), doravirine (DOR), and a fixed dose combination (FDC) of DOR/ISL (also known as MK-8591A) in heavily treatment-experienced (HTE) participants with human immunodeficiency virus type 1 (HIV-1) infection. It is hypothesized that the percentage of participants receiving DOR/ISL to achieve ≥0.5 log10 decrease in HIV-1 ribonucleic acid (RNA) from study baseline (Day 1) to Day 8 is superior to placebo, each given in combination with failing antiretroviral therapy (ART).

NCT ID: NCT04233060 Completed - Clinical trials for Advanced Solid Tumor

A Study of CS3005 in Advanced Solid Tumors

Start date: January 10, 2020
Phase: Phase 1
Study type: Interventional

A Phase I, Multi-center, Open-label, Dose Escalation Study of CS3005 in Subjects with Advanced Solid Tumors

NCT ID: NCT04223804 Completed - HIV Infection Clinical Trials

A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of ABBV-181 (Budigalimab) in Adult Participants With Human Immunodeficiency Virus (HIV)-1

Start date: January 30, 2020
Phase: Phase 1
Study type: Interventional

This study will be conducted in two stages and will test the safety/tolerability, pharmacokinetics (how the body handles study drug) and pharmacodynamics (effects on the immune system and the virus) of the study drug ABBV-181 in Human immunodeficiency virus (HIV)-1 infected participants undergoing Antiretroviral therapy (ART) interruption.

NCT ID: NCT04220866 Completed - Clinical trials for Head and Neck Squamous Cell Carcinoma (HNSCC)

Study of Intratumoral (IT) Ulevostinag (MK-1454) in Combination With Intravenous (IV) Pembrolizumab (MK-3475) Compared to IV Pembrolizumab Alone as the First Line Treatment of Metastatic or Unresectable, Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) (MK-1454-002)

Start date: March 4, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of intratumoral (IT) ulevostinag PLUS pembrolizumab (MK-3475) compared to pembrolizumab alone as a first line treatment of adults with metastatic or unresectable, recurrent head and neck squamous cell carcinoma (HNSCC). The primary study hypotheses are that IT ulevostinag in combination with pembrolizumab results in a superior Objective Response Rate (ORR), per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), compared to pembrolizumab alone: 1. In participants with a tumor that has a programmed cell death-ligand 1 (PD-L1) Combined Positive Scoring (CPS) ≥ 1, and 2. In participants with a tumor that has a PD-L1 CPS ≥ 20.

NCT ID: NCT04213300 Completed - Clinical trials for Type 1 Diabetes Mellitus

Low Carbohydrate Diet, Glycaemic Control and Quality of Life in Australian Adults With Type 1 Diabetes

Start date: January 15, 2021
Phase:
Study type: Observational

The aim of this study is to examine the association between a low carbohydrate diet, quality of life and glycaemic control in Australian adults with T1DM. The first phase of the study will develop and validate a diabetes specific quality of life questionnaire for adults with T1DM. The second phase will undertake a low carbohydrate diet intervention and examine its association with quality of life and glycaemic control, pre and post the dietary intervention. The novel outcomes will include a new validated Australian T1DM specific quality of life questionnaire and an investigation as to whether a low carbohydrate diet mediates the relationship between quality of life and glycaemic control in Australian adults with T1DM.

NCT ID: NCT04212169 Completed - Atopic Dermatitis Clinical Trials

Efficacy and Safety of MEDI3506 in Adult Subjects With Atopic Dermatitis

Start date: December 9, 2019
Phase: Phase 2
Study type: Interventional

This is a research study to determine the efficacy and safety of investigational drug MEDI3506 for the treatment of adult subjects with Atopic Dermatitis.

NCT ID: NCT04211857 Completed - Knee Reconstruction Clinical Trials

Retro-prospective Study of Safety & Performance of Round XTENDOBUTTON™ Fixation Device Post Knee Repair

XTENDOBUTTON
Start date: November 21, 2019
Phase:
Study type: Observational

The 12 month post-operative study is designed to provide safety and performance data on the Round XTENDOBUTTON™ fixation device after knee repair.

NCT ID: NCT04210752 Completed - Clinical trials for Prevention of Herpes Zoster (HZ)

Study to Assess the Safety, Tolerability and Explore the Immunogenicity of EG-HZ in Healthy Adult Volunteers

Start date: February 24, 2020
Phase: Phase 1
Study type: Interventional

This is a Phase 1, first in human (FIH), randomised, active-controlled, double-blind study designed to assess the safety and tolerability and explore preliminary efficacy of the EG-HZ vaccine. Oversight will be provided by a Safety Review Committee (SRC).

NCT ID: NCT04210245 Completed - Clinical trials for Nonalcoholic Steatohepatitis

Study of Aldafermin (NGM282) in Subjects With Compensated Cirrhosis (ALPINE 4)

Start date: March 23, 2020
Phase: Phase 2
Study type: Interventional

A multi-center evaluation of aldafermin in a randomized, double-blind, placebo-controlled study in subjects with compensated cirrhosis.

NCT ID: NCT04209114 Completed - Bladder Cancer Clinical Trials

A Study of Nivolumab Plus Bempegaldesleukin (Bempeg/NKTR-214) vs Nivolumab Alone vs Standard of Care in Participants With Bladder Cancer That May Have Invaded The Muscle Wall of the Bladder and Who Cannot Get Cisplatin, A Type of Medicine Given To Treat Bladder Cancer

Start date: February 5, 2020
Phase: Phase 3
Study type: Interventional

The purpose of the study is to see if treatment with nivolumab plus bempegaldesleukin or nivolumab alone, before and after surgery to remove the bladder, is more effective than surgery alone in participants with high-risk urothelial cancer, including muscle-invasive bladder cancer who are not able to receive cisplatin chemotherapy.