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NCT ID: NCT04576988 Completed - Clinical trials for Pulmonary Arterial Hypertension

A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (MK-7962-003/A011-11)(STELLAR)

Start date: January 25, 2021
Phase: Phase 3
Study type: Interventional

The objectives of this study are to evaluate the efficacy and safety of sotatercept (MK-7962) treatment (plus background pulmonary arterial hypertension (PAH) therapy) versus placebo (plus background PAH therapy) at 24 weeks in adults with PAH. The primary hypothesis of the study is that the participants receiving sotatercept will have improved 6-minute walk distance (6MWD) at 24 weeks compared to participants receiving placebo.

NCT ID: NCT04575636 Completed - Clinical trials for Lymphedema of Upper Limb

MRL in the Upper Extremity

Start date: September 10, 2020
Phase: N/A
Study type: Interventional

Objective: The aim of this study is to examine the feasibility and applicability of the MRL protocol for the upper extremity in Maastricht University Medical Center, and to examine the differences of the lymphatic system between lymphedema patients and healthy volunteers. Study design: An explorative study of an MRL protocol for the upper extremity in Maastricht University Medical Center+. Study population: There are two study groups. The first group (n=10) consists of patients with secondary lymphedema in the upper extremity. The second group (n=10) consists of healthy volunteers. Intervention (if applicable): All participants will undergo an MRL examination with the same protocol, developed in a previous 'proof of principle' study, in the Maastricht University Medical Center+. After localizer scans, a T2-weighted sequence is used. Then a T1-weighted sequence will be made before the injection of contrast. After the injection of the contrast agent a T1-weighted sequences of the upper and lower arm are performed alternately. Main study parameters/endpoints: The primary outcome is to determine the feasibility and applicability of the MRL protocol by evaluating the images of the upper extremity in patients with secondary lymphedema and healthy subjects. The secondary outcome is to assess the value of MRL in staging lymphedema.

NCT ID: NCT04574427 Completed - Clinical trials for Head and Neck Cancer

INtra-operative Evaluation of a Novel FLUorescENt C-mEt Tracer in Penile and Tongue

INFLUENCE
Start date: November 13, 2019
Phase:
Study type: Observational

In this study we evaluate the feasibility of intraoperative visualization of penile and tongue tumours using the fluorescent tracer EMI-137.

NCT ID: NCT04568434 Completed - Clinical trials for Familial Chylomicronemia Syndrome

A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) Administered to Patients With Familial Chylomicronemia Syndrome (FCS)

BALANCE
Start date: November 16, 2020
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the efficacy of Olezarsen as compared to placebo on the percent change in fasting triglycerides (TG) from baseline.

NCT ID: NCT04567316 Completed - Healthy Clinical Trials

A Study in Healthy Men to Test How BI 1358894 is Taken up and Handled by the Body

Start date: October 19, 2020
Phase: Phase 1
Study type: Interventional

The main objective of this trial is to investigate the basic pharmacokinetics of BI 1358894 and its metabolites, total radioactivity, including mass balance, excretion pathways and metabolism following a single oral dose of [14C] BI 1358894 in Part 1 and to investigate the pharmacokinetics of BI 1358894 and its metabolite(s) following multiple-dose treatment over 21 days with non- radiolabelled compound of BI 1358894 in Part 2.

NCT ID: NCT04565418 Completed - Clinical trials for Diabetes Mellitus, Type 2

Exercise to Restore 24h Rhythms in Metabolism

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

This study will investigate the effect of exercise training on 24h rhythms in substrate metabolism in overweight subjects with impaired glucose tolerance. Subjects will perform exercise training for 12 weeks. Before and after the exercise period, they will be admitted to research facilities for 45 hours to assess 24h rhythms in substrate metabolism. In a single-arm longitudinal design, subjects will serve as their own control.

NCT ID: NCT04564066 Completed - Healthy Volunteers Clinical Trials

A Phase 1 Study to Compare the Safety and Effect of Efgartigimod as an Intravenous Infusion With the Effect of Efgartigimod as a Subcutaneous Injection in Healthy Volunteers

Start date: August 18, 2020
Phase: Phase 1
Study type: Interventional

This study will compare the pharmacodynamics, pharmacokinetics and safety of efgartigimod as an intravenous infusion with efgartigimod as a subcutaneous injection in healthy adults.

NCT ID: NCT04563169 Completed - Clinical trials for Obstructive Sleep Apnea

Video Consultation in CPAP for Patients With Obstructive Sleep Apnea

Start date: January 2, 2019
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate the effects of video consultation versus face-to-face consultation for patients with obstructive sleep apnea on patients' CPAP use (minutes/per night), self-efficacy, risk outcomes, outcome expectancies, experiences with technology and, patients' and nurses' satisfaction.

NCT ID: NCT04562155 Completed - Clinical trials for Refractory and/or Unexplained Chronic Cough

Clinical Study to Evaluate the Efficacy and Safety of Three Different Doses of BAY1817080 Compared to Placebo in Patients With Chronic Cough

PAGANINI
Start date: October 2, 2020
Phase: Phase 2
Study type: Interventional

Researchers in this study want to find the optimal therapeutic dose of drug BAY1817080 for patients with long-standing cough with or without clear causes (refractory and/or unexplained chronic cough, RUCC). Study drug BAY1817080 is a new drug under development for the treatment of long-standing cough. It blocks proteins that are expressed by the airway sensory nerves which are oversensitive in patients with long-standing cough. This prevents the urge to cough. Researchers also want to learn the safety of the study drug and how well it works in reducing the cough frequency, severity and urge-to-cough. Participants in this study will receive either the study drug or placebo (a placebo looks like the test drug but does not have any medicine in it) tablets twice daily for 12 weeks. Observation for each participant will last about 18 weeks in total. Participants will be asked to wear a digital device to record the cough and to complete questionnaires every day to document the symptoms. Blood samples will be collected from the participants to monitor the safety and measure the blood level of the study drug.

NCT ID: NCT04561284 Completed - Insulin Resistance Clinical Trials

Carbohydrate-induced Resilience of the Gut Microbiome After Antibiotics Use

CARMA
Start date: November 1, 2020
Phase: N/A
Study type: Interventional

The gut microbiome is a complex ecosystem with a wide range of functions, and it is thought that it can influence multiple processes in the human body. In turn, the composition and activity of the gut microbiome is affected by many factors as well. Antibiotics can be very effective in treating bacterial infections, but they are also associated with detrimental health effects. Previous studies have already shown that antibiotics disturb the human gut microbiome composition by destroying commensal bacteria. As it is well known that the microbiome influences host metabolism, perturbation of the healthy microbiome (dysbiosis) is thought to be disease causing. Prebiotics, on the other hand, are beneficial for the gut microbiome. These so-called indigestible fibers are naturally present in our foods, but cannot be metabolised by the human body. Many bacteria in the human gut are able to ferment these fibers and they subsequently produce beneficial products for the rest of the body. Besides this, fiber intake stimulates growth of commensal bacteria in the human gut. Although it has become increasingly clear that prebiotics have a beneficial effect on the gut microbiome and general health, it is still unclear to which extent the beneficial effects of prebiotics supplementation occur after the gut microbiome is disturbed by antibiotics. We hypothesize that prebiotic supplementation after antibiotics use will improve restoration of the gut microbiome to a healthy state compared to placebo.