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NCT ID: NCT04131556 Terminated - Healthy Volunteers Clinical Trials

A Study Comparing the Pharmacokinetics and Palatability of Two Candidate Pediatric Powder-for-Oral-Suspension Formulations of Maribavir to the Current Maribavir Tablet Formulation Administered in Healthy Adult Participants

Start date: October 25, 2019
Phase: Phase 1
Study type: Interventional

The Purpose of this study is to assess the relative bioavailability, dose proportionality, the impact of food on the rate and extent of absorption, palatability of the selected pediatric formulation of maribavir and the safety and tolerability of two candidate pediatric formulations and the adult tablet formulation of maribavir in healthy participants.

NCT ID: NCT04130919 Terminated - Ulcerative Colitis Clinical Trials

Study to Evaluate the Efficacy and Safety of Tilpisertib in Adults With Moderately to Severely Active Ulcerative Colitis

Falcon
Start date: December 20, 2019
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to demonstrate the efficacy of tilpisertib (formerly GS-4875) compared with placebo control in achieving clinical remission per modified Mayo Clinic Score (MCS) in adults with moderately to severely active ulcerative colitis (UC).

NCT ID: NCT04128696 Terminated - Clinical trials for Neoplasms, Head and Neck

Study of GSK3359609 and Pembrolizumab in Programmed Death Receptor 1-ligand 1 (PD-L1) Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

INDUCE-3
Start date: November 21, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of study is to evaluate if the addition of GSK3359609 to pembrolizumab as first-line treatment improves the efficacy of pembrolizumab in participants with recurrent or metastatic (R/M) head and neck squamous cell carcinoma/cancer (HNSCC).This is a randomized, double-blind, adaptive Phase II/III study comparing a combination of GSK3359609 inducible T cell co-stimulatory receptor (ICOS) agonist and pembrolizumab to pembrolizumab plus placebo in participants with programmed death receptor 1-ligand 1 (PD-L1) combined positive score (CPS) >=1 R/M HNSCC.

NCT ID: NCT04128514 Terminated - Cataract Clinical Trials

Spectacle Independence and Overall Satisfaction With AcrySof® Panoptix® Toric Intraocular Lens

Start date: October 11, 2019
Phase:
Study type: Observational

The study was designed to assess the spectacle independence and satisfaction of patients receiving the AcrySof® Panoptix® Toric intraocular lens (IOL) after uneventful cataract surgery.

NCT ID: NCT04128475 Terminated - Clinical trials for Cardiovascular Diseases

Observational Study of Cardiovascular Disease.

FOURIER LEGACY
Start date: February 5, 2020
Phase:
Study type: Observational

This observational study will follow participants who completed follow-up in the FOURIER OUTCOMES trial to evaluate the long-term effects of evolocumab treatment. Long-term post-trial (legacy) beneficial effects have been reported with statins, niacin, hypoglycemic therapy and fibrates. Whether similar effects are seen after LDL cholesterol (LDL-c) lowering by PCSK9 inhibition is currently unknown. Evolocumab therapy causes a profound reduction in LDL cholesterol of approximately 60%. Statins have shown legacy effects over 5 years post-trial, including a 7% reduction in total mortality in meta-analysis and 12% reduction in coronary mortality. It would therefore be hypothesized that additional effects beyond the trial period would be conferred by previous evolocumab treatment. It is also important to assess the long-term safety of prior evolocumab treatment.

NCT ID: NCT04128371 Terminated - Angioedema Clinical Trials

Mepolizumab in Episodic Angioedema With Eosinophilia

Start date: January 14, 2021
Phase: Phase 2
Study type: Interventional

Background: Gleich syndrome is also called episodic angioedema with eosinophilia (EAE). People with EAE have episodes of swelling. They may also have itching, hives, fever, and weight gain. During episodes, the body has very high numbers of white blood cells, especially a kind called eosinophils. Researchers think a drug called mepolizumab could help. Objective: To see if mepolizumab causes EAE symptoms to be less severe and happen less often. Eligibility: People ages 18 or older with EAE. Design: Participants will be screened under NIH protocol 94-I-0079. Participants will have 8 visits over about 6 months. The timing of some visits will depend on each participant s EAE episodes. Visits will include: - Medical history - Physical exam - Blood and urine tests - Optional bone marrow collection at first or second visit. For this, a needle will be inserted through the participant s hip bone into the marrow. Participants will get mepolizumab 3 times over about 3 months. They will get their first dose when their eosinophils are at their lowest point. They will get the drug by IV. A needle will guide a thin plastic tube into an arm vein. The drug will be given through the tube over about 30 minutes. Participants will keep a daily online log for about 3 months. The log will track their weight, temperature, and EAE symptoms. During the whole study, they will complete 2 online questionnaires about their symptoms. They will fill out 1 daily and 1 monthly. Participants will have blood and urine tests 2-3 times a week. For these, they will go to their local doctor.

NCT ID: NCT04128319 Terminated - Clinical trials for Steroid-Refractory Acute Graft Versus Host Disease

T-Guard as Treatment for Steroid Refractory Acute GVHD (BMT CTN 1802)

1802
Start date: November 21, 2019
Phase: Phase 3
Study type: Interventional

The study is designed as an open-label, single arm Phase III, multicenter trial to evaluate the efficacy and safety of T-Guard treatment in patients with Steroid-Refractory acute Graft versus Host Disease (SR-aGVHD).

NCT ID: NCT04128293 Terminated - HIV Infections Clinical Trials

A Relative Bioavailability and Food-Effect Study of GSK3640254 Tablet and Capsule Formulations in Healthy Participants

Start date: October 8, 2019
Phase: Phase 1
Study type: Interventional

This is an open-label, single-dose, four-period, four sequential, and crossover study conducted to assess the relative bioavailability of GSK3640254 mesylate tablets and GSK3640254 mesylate capsules (in the presence of a moderate fat meal). This study will also evaluate the effect of food (fasted, moderate fat meal, and high fat meal) on the pharmacokinetics of GSK3640254 mesylate tablet formulation. Participants will be randomized to receive a single dose of GSK3640254 200 milligram (mg) capsules under moderate fat conditions and GSK3640254 200 mg tablets under moderate fat, fasted and high fat conditions in each treatment period. Approximately 16 participants will be enrolled and the duration of the study will be approximately 54 days.

NCT ID: NCT04128267 Terminated - Clinical trials for Head and Neck Cancer

Central Pain Syndrome in Survivors of Head and Neck Cancer

Start date: November 4, 2019
Phase: N/A
Study type: Interventional

This is a cross-sectional pilot study of head and neck cancer survivors who have completed multi-modal treatment to assess and characterize the presence of distinct pain syndromes.

NCT ID: NCT04126278 Terminated - Calcific Tendinitis Clinical Trials

Calcific Tendonitis Treatment: Barbotage vs. Barbotage With Cortisone Injection

Start date: December 1, 2020
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine the efficacy of barbotage therapy by comparing the clinical and sonographic changes in patients that solely receive barbotage to patients receiving the standard of care, barbotage with cortisone injection.