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NCT ID: NCT04443426 Active, not recruiting - Heart Failure Clinical Trials

Modulation of Circulating Levels of the Ketone Body 3-hydroxybutyrate in Patients With Chronic Heart Failure: Cardiovascular Effects

KETO-KINETICS1
Start date: April 25, 2019
Phase: Phase 2
Study type: Interventional

The ketone body 3-hydroxybutyrate (3-OHB) is a naturally occurring energy substrate, and is associated with increased life span and improved health. We have previously shown that intravenous 3-OHB treatment increases myocardial blood flow > 70% in healthy humans and data from our group show that 3-OHB increases cardiac output by 40 % in patients with heart failure. In this study the investigators aim to investigate: 1. If this effect is reproducible with a commercially available oral ketone supplements 2. The safety of commercially available ketone supplements in heart failure patients

NCT ID: NCT04443023 Active, not recruiting - Clinical trials for Transcatheter Aortic Valve Implantation

Comparison of Eligible TAVI-valves - Cohort B

Compare-TAVI
Start date: June 15, 2020
Phase: N/A
Study type: Interventional

The study performs head-to-head comparison of two TAVI-valves: Sapien and Myval.

NCT ID: NCT04435626 Active, not recruiting - Heart Failure Clinical Trials

Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenone on Morbidity (Events Indicating Disease Worsening) & Mortality (Death Rate) in Participants With Heart Failure and Left Ventricular Ejection Fraction (Proportion of Blood Expelled Per Heart Stroke) Greater or Equal to 40%

FINEARTS-HF
Start date: September 14, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect of finerenone compared to placebo (a tablet without active substance) in the reduction of cardiovascular death (generally meaning death due to disease of the heart or blood vessels) and total Heart Failure (HF) events, including HF hospitalization and urgent visits for HF(generally meaning a hospital stay or urgent presentation to a healthcare unit due to worsening symptoms of heart failure) in patients suffering from HF with an ejection fraction greater than or equal to 40%. Researchers will also collect information on how much the heart disease has impact on patient's lives, change of kidney function, and how well finerenone treatment is tolerated. The study plans to enroll 6000 male and female patients of the age of 40 years and above suffering from heart failure with ejection fraction greater than or equal to 40%. Participants will take the study product as oral tablet with a dose between 0 (Placebo) 40 mg once daily. Study duration will be up to 43 months.

NCT ID: NCT04428749 Active, not recruiting - Critical Illness Clinical Trials

Swallowing Difficulties in ICU Patients [Synkebesvær Hos Intensivpatienter]

ICU-Swallow
Start date: April 1, 2020
Phase:
Study type: Observational

Swallow disorders or dysphagia related to mechanical ventilation affects between 1,300 and 2,000 patients in Danish intensive care units every year and increases aspiration, pneumonia and risk of dying. In intensive care units, dysphagia may vary around the clock as fatigue and fluctuating alertness play an important role for the patients' ability to swallow effectively without aspiration to the airway. For this reason, ICU nurses must be able to assess dysphagia in the ICU patient day and night, but guidelines are lacking. One of the simplest and most sensitive methods is the Yale Swallow Protocol, however, this protocol requires translation and validation before it can be implemented in Danish intensive care units. This project aims to translate and validate the Yale Swallow Protocol for use in Danish intensive care units. Furthermore, this project will explore nurses' perceptions and management of dysphagia in the intensive care unit as well as feasibility and acceptability of the Yale Swallow Protocol.

NCT ID: NCT04425031 Active, not recruiting - Clinical trials for Hypoxemic Respiratory Failure

Handling Oxygenation Targets in COVID-19

HOT-COVID
Start date: August 25, 2020
Phase: Phase 4
Study type: Interventional

Patients with COVID-19 and hypoxaemic respiratory failure and admitted to the intensive care unit (ICU) are treated with supplementary oxygen as a standard. However, quality of quantity evidence regarding this practise is low. The aim of the HOT-COVID trial is to evaluate the benefits and harms of two targets of partial pressure of oxygen in arterial blood (PaO2) in guiding the oxygen therapy in acutely ill adult COVID-19 patients with hypoxaemic respiratory failure at ICU admission.

NCT ID: NCT04417959 Active, not recruiting - Clinical trials for Fuchs' Endothelial Dystrophy

A Comparison of Visual Functions and Side-effects After DSAEK or DMEK for Fuchs' Endothelial Dystrophy

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

Descemet's stripping automated endothelial keratoplasty (DSAEK) and Descemet's membrane endothelial keratoplasty (DMEK) are becoming increasingly popular as treatments for Fuchs' endothelial dystrophy. However, despite several years of use the incidence of cystoid macular edema and damage related to increased intraocular pressure (IOP), and the forward scattering of light through the eye following DSAEK or DMEK have to our knowledge not been prospectively described. Therefore, this project will be a randomized controlled trial investigating these matters.

NCT ID: NCT04411641 Active, not recruiting - Clinical trials for Secondary Progressive Multiple Sclerosis

Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168)

HERCULES
Start date: September 24, 2020
Phase: Phase 3
Study type: Interventional

Primary Objective: To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in NRSPMS Secondary Objective: To evaluate efficacy of SAR442168 compared to placebo on clinical endpoints, magnetic resonance imaging (MRI) lesions, cognitive performance, physical function, and quality of life To evaluate safety and tolerability of SAR442168 To evaluate population pharmacokinetics (PK) of SAR442168 and relevant metabolites in NRSPMS and its relationship to efficacy and safety To evaluate pharmacodynamics (PD) of SAR442168

NCT ID: NCT04410978 Active, not recruiting - Clinical trials for Relapsing Multiple Sclerosis

Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 1)

GEMINI 1
Start date: June 30, 2020
Phase: Phase 3
Study type: Interventional

Primary Objective: To assess efficacy of daily SAR442168 compared to a daily dose of 14 mg teriflunomide (Aubagio) measured by annualized adjudicated relapse rate (ARR) in participants with relapsing forms of MS Secondary Objective: To assess efficacy of SAR442168 compared to teriflunomide (Aubagio) on disability progression, MRI lesions, cognitive performance and quality of life To evaluate the safety and tolerability of daily SAR442168 To evaluate population pharmacokinetics (PK) of SAR442168 and relevant metabolites and its relationship to efficacy and safety To evaluate pharmacodynamics (PD) of SAR442168

NCT ID: NCT04407897 Active, not recruiting - Solid Tumor Clinical Trials

SOFT- Stereotactic Ablative Radiotherapy of Infra-diaphragmatic Soft Tissue Metastases

SOFT
Start date: October 7, 2019
Phase: N/A
Study type: Interventional

The SOFT study will evaluate the feasibility and safety of MR-guided stereotactic ablative radiotherapy (SABR) for infra-diaphragmatic soft tissue metastases.

NCT ID: NCT04404283 Active, not recruiting - Clinical trials for Diffuse Large B-cell Lymphoma

Brentuximab Vedotin Plus Lenalidomide and Rituximab for the Treatment of Relapsed/Refractory DLBCL

ECHELON-3
Start date: August 20, 2020
Phase: Phase 3
Study type: Interventional

Participants in this study will have diffuse large B-cell lymphoma (DLBCL) that has come back or not gotten better with treatment. The trial will study whether brentuximab vedotin plus two drugs works better to treat this type of cancer than the two drugs alone. Participants will be randomly assigned to get either brentuximab vedotin or placebo. The placebo will look like brentuximab vedotin, but has no medicine in it. Since the study is "blinded," participants and their doctors will not know whether a participant gets brentuximab vedotin or placebo. All participants in the study will get rituximab and lenalidomide. These are drugs that can be used to treat DLBCL.