Clinical Trials Logo

Filter by:
NCT ID: NCT04040049 Terminated - Fabry Disease Clinical Trials

A Fabry Disease Gene Therapy Study

MARVEL1
Start date: July 8, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This is a multinational, open-label study to assess the safety and efficacy of FLT190 in up to 15 adult male participants with classical Fabry disease.

NCT ID: NCT04039607 Active, not recruiting - Clinical trials for Hepatocellular Carcinoma

A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma

CheckMate 9DW
Start date: September 30, 2019
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to compare the overall survival (OS) of nivolumab plus ipilimumab versus standard of care (SOC) (sorafenib or lenvatinib) in all randomized participants with advanced hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

NCT ID: NCT04039568 Completed - Depression Clinical Trials

Meditation Versus Education for Improving Depression in Chronic Pain, a Randomized Controlled Trial

Start date: October 30, 2019
Phase: N/A
Study type: Interventional

In this study two possible treatment options available for depression and chronic pain will be explored. Both of these treatments will be offered through online group video calls, which could translate to cost-savings for the health care system. The two treatment options are: 1. The Health Enhancement Program (HEP). Designed to give participants information and guidance on how to lead a healthy lifestyle, which could be beneficial in treating depression. 2. Sahaj Samadhi Meditation (SSM). A unique and easy-to-learn meditation technique that reduces stress and provides deep relaxation which could be beneficial in treating depression. This study will use a hybrid type 1 evaluation design that primarily focuses on a single-site, single-blinded (investigator, and clinician), 12-week randomized controlled trial (RCT) comparing SSM (n=80) versus HEP (n=80) in 160 adults with depression and chronic pain. Participants will be blinded to the treatment hypothesis while investigators, raters and treating clinicians will be additionally blinded to the intervention. Evaluations of depression (PHQ-9), pain symptoms (BPI), quality of life (SF-36), and opioid use will be collected at baseline, intervention completion (12 week), and at 24 week follow-up. An implementation evaluation will draw from four key study populations: (1) the participants of the RCT; (2) the expert meditation instructors facilitating the intervention; (3) the site staff and investigators involved in supporting the logistics of the intervention arm of the RCT.

NCT ID: NCT04039464 Recruiting - Clinical trials for Pediatric Pulmonary Hypertension

Mono vs. Dual Therapy for Pediatric Pulmonary Arterial Hypertension

MoD
Start date: August 1, 2022
Phase: Phase 3
Study type: Interventional

The investigators' central hypothesis is that early combination therapy with two PAH-specific oral therapies that have been shown to be well tolerated in the pediatric population, sildenafil and bosentan, will result in better World Health Organization (WHO) functional class at 12 months after initiation of PAH treatment than therapy with sildenafil alone.

NCT ID: NCT04039113 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Tezepelumab COPD Exacerbation Study

COURSE
Start date: July 30, 2019
Phase: Phase 2
Study type: Interventional

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2a Study to Explore the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT04038983 Active, not recruiting - Old Age Clinical Trials

Risk for Short-term Adverse Events in Older Users in the Emergency Department

Start date: July 24, 2019
Phase:
Study type: Observational

The study evaluates the performance criteria of abnormal PRISMA-7 score, length of stay in Emergency department and in hospital, and hospital admission in older Emergency department users.

NCT ID: NCT04038294 Recruiting - Nutrition Poor Clinical Trials

PROTein to Enhance outComes of (Pre)Frail paTients Undergoing Cardiac Surgery

PROTECT-CS
Start date: February 12, 2020
Phase: N/A
Study type: Interventional

Heart disease in an aging population has resulted in heart surgery being offered to older and more frail patients. Frail patients which make up more than 50% of patients currently undergoing heart surgery are vulnerable to having long-recovery times after surgery, greater loss of independence (i.e. being admitted to a nursing home), experience more depression and anxiety, and have a worse quality of life. In fact, nearly 10% of frail, older adult patients die within 30 days after their heart surgery. The Investigators previous study found that weight-loss and poor muscle strength (i.e. weakness) of frail patients can lead to a worse recovery after heart surgery. Furthermore, inadequate nutrition (aka. malnutrition which is defined as an unintentional, nutritional intake imbalance (not necessarily a decreased intake) before an operation can lead to a vicious cycle of muscle loss causing more frailty, a desire to eat less leading to more muscle loss and increased frailty. At present there is no process to address this important issue in older adults undergoing heart surgery. The Investigators propose to study a practical, real-world, treatment plan that focuses on good nutrition to prevent muscle loss and reduced frailty in vulnerable heart surgery patients.

NCT ID: NCT04038008 Completed - Bioequivalence Clinical Trials

Single Dose Crossover Comparative Bioavailability Study of Two Formulations of Fluconazole 200 mg in Healthy Adult Subjects Under Fasting Conditions

Start date: July 26, 2019
Phase: Phase 1
Study type: Interventional

This single dose study is designed in accordance with EMA (the European Medicines Agency) regulatory guidelines, with the aim of characterizing the comparative bioavailability of fluconazole in the two formulations in healthy subjects. As this is a bioequivalence trial where each subject will receive each study treatment in a crossover fashion, a control group is not included. Within the clinical portion of the study each subject will receive a single oral dose of the test and the reference formulation in compliance with the generated randomization code. The primary study endpoints are the pharmacokinetic (PK) parameters Cmax and AUC0-t of fluconazole.

NCT ID: NCT04037969 Completed - Evaporative Dry Eye Clinical Trials

Comparison of Tear Evaporation Rate With DAILIES TOTAL1 and Biotrue ONEday

MALTESE
Start date: August 7, 2019
Phase: N/A
Study type: Interventional

The purpose of this pilot study is to compare the effect of DAILIES TOTAL1, a low water content silicone hydrogel lens, and Biotrue ONEday, a high water content hydrogel lens, on the rate of tear evaporation. The study will also serve to validate the novel, in-house developed evaporimeter.

NCT ID: NCT04037917 Terminated - Glaucoma Eye Clinical Trials

First-In-Man Study for an Ophthalmic Synthetic Tissue Substitute

Start date: December 11, 2020
Phase: N/A
Study type: Interventional

Study Name: The CorNeat EverPatch - a First-In-Man Clinical Study for demonstrating the Safety of a Synthetic Tissue Substitute for concealment of artificial implants and glaucoma tube shunts Objective: The objective of this clinical trial is to demonstrate the Safety of the Corneat Everpatch for concealment of artificial implants and glaucoma tube shunts The study will consist 10 subjects requiring concealment of a glaucoma shunt or other ophthalmic implant. Eligible subjects who signs an ICF will be enrolled to the study. Subjects will be implanted with the Corneart EverPatch as part of a glaucoma shunt surgery or during a corrective surgery to repair a breached conjunctiva over an implanted device. Subjects will be monitored for a period of 12 months post-op during which follow up visits will occur at 1 week, 1, 2, 3, 6, 9 & 12 months following surgery including clinical examination of the operated eye using slit-lamp biomicroscopy and imaging using OCT or UBM (will be performed only at the 6 & 12 months follow up visits).