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NCT ID: NCT02790138 Completed - Pouchitis Clinical Trials

A Study to Evaluate the Efficacy and Safety of Vedolizumab in the Treatment of Chronic Pouchitis

EARNEST
Start date: October 12, 2016
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare the efficacy of vedolizumab intravenous (IV) and placebo in terms of the percentage of participants with chronic or recurrent pouchitis achieving clinically relevant remission.

NCT ID: NCT02788747 Completed - Heart Failure Clinical Trials

Effect of Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Reduced Ejection Fraction

Start date: June 2016
Phase: Phase 2
Study type: Interventional

This was a randomized, double-blinded, placebo-controlled, multiple-dose study in subjects with stable heart failure (HF) with reduced ejection fraction (HFrEF).

NCT ID: NCT02787785 Completed - Diabetes Mellitus Clinical Trials

Multicenter Automatic Defibrillator Implantation Trial With Subcutaneous Implantable Cardioverter Defibrillator

MADIT S-ICD
Start date: April 17, 2017
Phase: N/A
Study type: Interventional

The MADIT S-ICD trial was designed to evaluate if subjects with a prior myocardial infarction, diabetes mellitus and a relatively preserved ejection fraction of 36-50% will have a survival benefit from receiving a subcutaneous implantable cardioverter defibrillator (S-ICD) when compared to those receiving conventional medical therapy. The trial enrollment was stopped in 2018 due to lower than expected enrollment, all subjects enrolled at that time were followed for approximately 5 years.

NCT ID: NCT02787733 Completed - Clinical trials for Exercise Recovery and Endurance

The Effect of an Orange Peel Extract on Exercise Performance

Start date: July 2014
Phase: N/A
Study type: Interventional

Rationale: Numerous studies have shown the positive effect of a healthy diet and regular moderate exercise. Although, exercise has also been correlated with an increase in reactive oxygen species (ROS) production and a higher incidence of injury. ROS production seems to induce muscle damage, which reduces muscle performance and induces fatigue. Increasing muscle recovery could be an effective way to increase exercise performance. Several food ingredients have been of growing interest due to their specific functioning on the human body. Citrus flavonoids are abundantly available in citrus fruits. Prior studies show a positive effect of citrus flavonoids on endothelial function, by promoting vasodilation. In addition it has a positive effect on the nitric oxide (NO) synthesis, a known compound in regulating endothelial response. This capacity of citrus flavonoids could be useful in stimulating performance and recovery after exercise. Additionally, the ability of scavenging ROS could reduce muscle damage caused by exercise induced oxidative damage. Objective: Determine the 4-week effect of daily citrus flavonoid supplementation on exercise recovery and performance. Study design: Randomized, double-blind, placebo-controlled study with parallel design, in which 40 subjects engage in three exercise sessions. The sessions will be subdivided into a pre-test and test 1 and 2. Between test 1 and 2, participants receive daily for 4 weeks citrus flavonoid supplement or a placebo. Each day, subjects should consume 2 capsules each morning, containing in total 500 mg of citrus flavonoids or 500 mg placebo. Study population: The subjects will be healthy normal weight trained males, with an age of 18 - 25. Additionally, subjects are non-smokers and free of a medication. Intervention: Participants will be randomly placed in either the citrus flavonoid or placebo group. Participants will be instructed to ingest 2 capsules each morning for 4 consecutive weeks. Each capsule equals to 250 mg of citrus flavonoids or cellulose in case of the placebo treatment. Main study parameters/endpoints: The main study parameter is the average amount of work load produced during the 10-minute time trail test. In addition, oxygen per minute will be determined as well as the heart rate. Finally, for each test, the subjective rating of perceived exertion (RPE) will be determined during the pre-test and test 1 and 2 by using a Borg scale.

NCT ID: NCT02784392 Completed - Clinical trials for Enteral Feeding Intolerance (EFI)

Efficacy, Safety, and Pharmacokinetics (PK) Study of Ulimorelin in Patients With Enteral Feeding Intolerance (EFI): The PROMOTE Trial

PROMOTE
Start date: October 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effect Ulimorelin in patients with enteral feeding intolerance.

NCT ID: NCT02783313 Completed - Thrombocytopenia Clinical Trials

Pathogen Reduction Evaluation & Predictive Analytical Rating Score

PREPAReS
Start date: November 17, 2010
Phase: N/A
Study type: Interventional

The objective of this study is to determine if pooled buffy coat-derived pathogen reduced plasma-stored platelet concentrates are non-inferior compared to plasma-stored platelet concentrates in terms of WHO bleeding complications in hemato-oncological patients with thrombocytopenia.

NCT ID: NCT02783300 Completed - Neoplasms Clinical Trials

An Open-label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK3326595 in Participants With Solid Tumors and Non-Hodgkin's Lymphoma

Meteor 1
Start date: August 30, 2016
Phase: Phase 1
Study type: Interventional

This first time in human (FTIH) open-label, dose escalation study will assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of GSK3326595 in participants with advanced or recurrent solid tumors, as well as clinical activity in participants with a subset of solid tumors and non-Hodgkin's lymphoma (NHL).

NCT ID: NCT02783053 Completed - Obesity Clinical Trials

Metformin and Core Temperature in Obese and Lean Males

McTOM
Start date: October 2015
Phase: N/A
Study type: Interventional

Metformin is known to increase 18F-FDG uptake in subjects using metformin in retrospective trials. In this study the researchers aim to investigate the influence of metformin (500 mg 1/day) on temperature in the colon, glucose uptake in the colon and energy expenditure in healthy lean (BMI < 24kg/m2) or obese subjects (BMI>28kg/m2). The investigators will measure 18F-FDG uptake in the colon, temperature in the colon, insulin sensitivity and energy expenditure before after using metformin.

NCT ID: NCT02782741 Completed - Clinical trials for Glycogen Storage Disease Type II;Pompe's Disease

Study to Compare the Efficacy and Safety of Enzyme Replacement Therapies Avalglucosidase Alfa and Alglucosidase Alfa Administered Every Other Week in Patients With Late-onset Pompe Disease Who Have Not Been Previously Treated for Pompe Disease

COMET
Start date: November 2, 2016
Phase: Phase 3
Study type: Interventional

Primary Objective: To determine the effect of avalglucosidase alfa treatment on respiratory muscle strength measured by percent (%) predicted forced vital capacity (FVC) in the upright position, as compared to alglucosidase alfa. Secondary Objective: To determine the safety and effect of avalglucosidase alfa treatment on functional endurance (6-minute walk test, inspiratory muscle strength (maximum inspiratory pressure), expiratory muscle strength (maximum expiratory pressure), lower extremity muscle strength (hand-held dynamometry), motor function (Quick Motor Function Test), and health-related quality of life (Short Form-12).

NCT ID: NCT02780492 Completed - Clinical trials for Duchenne Muscular Dystrophy

Outcome Measures in Duchenne Muscular Dystrophy: A Natural History Study

Start date: April 11, 2012
Phase:
Study type: Observational

Novel emerging therapies for Duchenne Muscular Dystrophy (DMD) require a deeper understanding of DMD natural history. This study aim to assess the natural history of DMD through a composite assessment tool capable of capturing disease progression linking ambulant and non-ambulant phases of the disease.