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NCT ID: NCT04535609 Completed - Clinical trials for Primary Mitochondrial Myopathy

An Efficacy and Safety Study of 24 Week Treatment With Mavodelpar (REN001) in Primary Mitochondrial Myopathy Patients

STRIDE
Start date: May 21, 2021
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, parallel group, multi-centre, study designed to investigate the efficacy and safety of REN001 administered once daily over a 24-week period to patients with PMM.

NCT ID: NCT04535453 Completed - Healthy Clinical Trials

A Study to Evaluate a Range of Dose Levels and Vaccination Intervals of Ad26.COV2.S in Healthy Adults and Adolescents

Start date: August 28, 2020
Phase: Phase 2
Study type: Interventional

The primary purpose of this study is to assess humoral immune responses of 3 dose levels of Ad26.COV2.S administered intramuscularly (IM) as a 2-dose schedule (56 days apart); Ad26.COV2.S administered IM as a single vaccination; safety and reactogenicity of Ad26.COV2.S administered IM as a 2-dose or a single-dose schedule in adults (18-65 years or older) and to assess the safety and reactogenicity of Ad26.COV2.S, administered IM as single dose in adolescents (12-17 years) and to test both compressed and expanded 2-dose schedules of Ad26.COV2.S (28 and 84 days apart) in adults (18-55 years and 65 years or older).

NCT ID: NCT04535076 Completed - Clinical trials for Postoperative Delirium

Cognitive Outcome After Surgical and Transcatheter Aortic Valve Replacement

COSTA
Start date: February 28, 2019
Phase: N/A
Study type: Interventional

Aortic valve stenosis is one of the most common types of heart disease in the aging Western population. While surgical cardiac valve replacement (SAVR) is a standard therapy for patients with aortic stenosis, catheter-assisted aortic valve implantation (TAVI) has developed as an alternative to open-heart surgery, especially for high-risk patients. Recently, increased surgeon experience and improved transcatheter valve systems have led to a global trend to use TAVI in patients with low or intermediate risk. Although cognitive impairment after cardiac surgery is well known, the effect of TAVI on cognitive function has not yet been adequately investigated. The aim of this study is to compare the occurrence and progression of delirium, postoperative cognitive decline (POCD), cerebral infarction, and health-related quality of life (QOL) in patients with intermediate risk for catheter-assisted (TAVI) and surgical (SAVR) aortic valve replacement.

NCT ID: NCT04535037 Completed - Diphtheria Clinical Trials

A Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK)'s Infanrix Hexa Vaccine (DTPa-HBV-IPV/Hib) Versus MCM Vaccine BV's Vaxelis Vaccine (DTaP5-HBV-IPV-Hib) in Healthy Infants and Toddlers

Start date: February 17, 2021
Phase: Phase 4
Study type: Interventional

The purpose of this study was to assess the safety and immunogenicity of GSK's combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type b conjugate vaccine (DTPa-HBV-IPV/Hib) versus MCM Vaccine BV's DTaP5-HBV-IPV-Hib vaccine administered to healthy infants and toddlers, between 6 and 12 weeks of age at the time of first vaccination, based on a 2-, 4-, and 12-months of age vaccination schedule.

NCT ID: NCT04534348 Completed - Clinical trials for CLABSI - Central Line Associated Bloodstream Infection

Study on the Reduction of Catheter-related Infections by Use of Self-disinfecting Venous and Arterial Access Caps

STERILE
Start date: November 1, 2017
Phase:
Study type: Observational

Observational study on the reduction of catheter-related Infections by use of self-disinfecting venous and arterial access caps (Curos caps ;3M, Saint Paul, MN, USA)

NCT ID: NCT04534114 Completed - Clinical trials for End Stage Renal Disease Requiring Hemodialysis

Factor XI LICA to Reduce Events Such as Heart Attack and Stroke in Patients Whose Kidneys Are no Longer Able to Work as They Should and Require Treatment to Filter Wastes From the Blood: Focus is on the Safety of BAY2976217 and the Way the Body Absorbs, Distributes and Removes the Study Drug

RE-THINc ESRD
Start date: September 4, 2020
Phase: Phase 2
Study type: Interventional

Patients whose kidneys are no longer able to work as they should and require treatment to filter wastes from the blood (hemodialysis) are at high risk for blood clots that form in blood vessels (thrombosis) blocking blood flow that causes heart attacks, strokes, and other life-threatening conditions. BAY2976217 is under clinical development for prevention of thrombosis. The goal of the study is to learn more about the safety of BAY2976217, how it is tolerated and the way the body absorbs, distributes and gets rid of the study dug given as multiple doses in participants with renal impairment who require hemodialysis.

NCT ID: NCT04533087 Completed - Clinical trials for Invasive Fungal Infections

ImPACt on Invasive Fungal Infections by Immune Checkpoint Inhibition

PACIFIC
Start date: January 1, 2017
Phase:
Study type: Observational

This observational study aims to compare immune checkpoint expression in blood samples from patients with invasive fungal infections (IFI) against healthy controls.

NCT ID: NCT04532918 Completed - Clinical trials for Chronic Kidney Disease

Pharmacokinetics of Verinurad and Allopurinol in Combination With Cyclosporine and Rifampicin in Healthy Volunteers

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

This Phase 1 study aims to quantify the effects of cyclosporine, a broad transporter inhibitor, and rifampicin, an OATP1B1/3 inhibitor, on verinurad pharmacokinetics (PK). The study is conducted in accordance with Food and Drug Administration guidance on Clinical Drug Interaction Studies, 2020. Verinurad will be developed as a fixed combination since it will always be administered together with allopurinol.

NCT ID: NCT04532073 Completed - Elderly Patients Clinical Trials

Sub-study of the Essen Study Centre for the ENTAiER Trial

Start date: July 27, 2021
Phase: N/A
Study type: Interventional

The present study is a sub-study of the ENTAiER study. The ENTAiER study is a multicenter, randomized, controlled study to evaluate the efficacy and safety of eurythmy therapy and Tai Chi in comparison to standard care in chronically ill older patients with an increased risk of falling. In addition to the main questions of the ENTAiER study, three additional questions are being investigated at the Hospital Essen-Steele: Proteome and telomere analyses as well as qualitative parameters are recorded and examined. The aim is to compare the changes in proteomes, telomeres and qualitative factors under eurythmy therapy, Tai Chi and standard care in chronically ill older patients with an increased risk of falling.

NCT ID: NCT04531904 Completed - Clinical trials for Acute Ischemic Stroke

Prospective Evaluation to Characterize the Real-World Performance of the EMBOVAC Aspiration Catheter

PERFECT
Start date: October 15, 2020
Phase:
Study type: Observational [Patient Registry]

A post-market study evaluating the EMBOVAC Aspiration Catheter in acute ischemic stroke patients with confirmed intracranial large vessel occlusion.