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NCT ID: NCT04898335 Recruiting - Clinical trials for Mitral Regurgitation

Tendyne European Experience Registry

TENDER
Start date: April 15, 2021
Phase:
Study type: Observational [Patient Registry]

TENDER is a multicenter, single-device, retrospective and prospective, observational study to assess safety and efficacy of the Tendyne Mitral Valve System in a real-world population.

NCT ID: NCT04894578 Recruiting - Osteoarthritis Clinical Trials

A Comparative Trial of a Minimal-invasive Technique Versus Open Arthrodesis in the Treatment of Midfoot Arthritis

Start date: May 14, 2021
Phase: N/A
Study type: Interventional

Group A: Patients suffering from midfoot arthritis after failed prior conservative therapy who undergo a reverse distal metatarsal minimal-invasive osteotomy Group B: Patients suffering from midfoot arthritis after failed prior conservative therapy who undergo a fusion of one or more midfoot (tarsometatarsal) joints

NCT ID: NCT04889872 Recruiting - Clinical trials for Aortic Valve Stenosis

PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR

PROGRESS
Start date: October 12, 2021
Phase: N/A
Study type: Interventional

This study objective is to establish the safety and effectiveness of the Edwards SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve systems in subjects with moderate, calcific aortic stenosis. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.

NCT ID: NCT04883905 Recruiting - Clinical trials for Acute Hepatic Porphyria

ELEVATE, a Registry of Patients With Acute Hepatic Porphyria (AHP)

ELEVATE
Start date: April 26, 2021
Phase:
Study type: Observational

This global patient registry is being conducted to characterize the natural history and real-world clinical management of patients with AHP, and to further characterize the real-world safety and effectiveness of givosiran and other approved AHP therapies.

NCT ID: NCT04881578 Recruiting - Atrial Fibrillation Clinical Trials

Atrial Fibrillation Before and After Patent Foramen Ovale Closure Study

ALFA ROMEO
Start date: March 31, 2021
Phase:
Study type: Observational

The aim of the ALFA ROMEO study is to better understand the association between cryptogenic stroke, PFO, PFO closure and AF.

NCT ID: NCT04877496 Recruiting - Immunosuppression Clinical Trials

Responses to COVID19 Vaccination in Patients With a Treatment History of Rituximab.

RituxiVac
Start date: April 26, 2021
Phase:
Study type: Observational [Patient Registry]

Patients with treatment history of rituximab since 01.01.2019 and immunocompetent volunteers will be contacted to give a blood sample after their COVID19 vaccination, and in a subset also before vaccination. Immune responses of antibodies and SARS-CoV2-specific T-cells to the vaccination will be quantified and the rituximab effect on COVID19 vaccine-induced immune responses is analyzed.

NCT ID: NCT04876742 Recruiting - ICU Delirium Clinical Trials

Wheat Beer for Prevention of Delirium in Intensive Care Patients

BABE-D
Start date: January 18, 2023
Phase: N/A
Study type: Interventional

The investigators hypothesise that the daily administration of 0.5L alcohol-containing wheat beer at 8 pm over a study period of 6 days in a row leads to a lower prevalence of delirium compared to water following the same administration scheme.

NCT ID: NCT04874428 Recruiting - Liver Cirrhosis Clinical Trials

Direct Oral Anticoagulants (Rivaroxaban and Apixaban) in Patients With Liver Cirrhosis

Start date: May 19, 2021
Phase: Phase 1
Study type: Interventional

The aim of this study is to investigate the pharmacokinetic and pharmacodynamic parameters of rivaroxaban and apixaban in patients with compensated liver cirrhosis (Child-Pugh class A and B). The enrolled participants receive a prophylactic single oral dose of either rivaroxaban (10 mg) or apixaban (2.5 mg) at around 8 a.m. on the day of the trial. Blood samples are taken 0.5 hours pre-dose and 1, 2, 3, 4, 6, 8, 12 hours post-dose. A follow-up telephone call is performed 5 days after the study intervention to collect safety data.

NCT ID: NCT04873583 Recruiting - Paediatric Stroke Clinical Trials

High Dose Steroids in Children With Stroke

PASTA
Start date: November 16, 2021
Phase: Phase 3
Study type: Interventional

This clinical trial deals with focal cerebral arteriopathy and childhood stroke, a rare but devastating condition. Focal cerebral arteriopathy (FCA) is an inflammatory vessel wall disease provoked by infection and there is increasing evidence that inflammatory processes play a crucial role in childhood stroke, influencing the outcome of the disease. Analysis of existing data suggests that outcomes are improved and that there is less stroke recurrence in children treated with steroids to reduce the acute inflammatory processes. This clinical trial will be conducted in over 20 hospitals in several countries in order to investigate this. Participants will be randomly separated into two groups. The first group will be treated with standard of care (including aspirin) combined with high dose steroids. The second group will be treated with standard of care (including aspirin) but without steroid treatment. The objective is to investigate if children treated with a combination of high dose steroid and aspirin will have a better and quicker recovery of FCA, better clinical functional outcome, and less recurrence compared to children treated with aspirin alone. This project has been identified by international pediatric stroke experts as the most important topic for a clinical trial in the field and is as well one of the most important research priorities identified by parents. The study results will also provide insight into the evolution of inflammatory vessel disease.

NCT ID: NCT04871217 Recruiting - Clinical trials for Coronary Artery Disease

68Ga-NODAGA-RGD PET in Patients With an Occluded Coronary Artery

RGDHeart
Start date: December 4, 2018
Phase: N/A
Study type: Interventional

Background: In patients with coronary artery disease, acute or chronic coronary artery occlusion is associated with various degrees of ischemic myocardial injury and left ventricle dysfunction. The integrin αVβ3 plays a role in angiogenesis, i.e. formation of new capillaries from pre-existing blood vessels that is increased during repair of ischemic myocardial injury. 68Ga-NODAGA-RGD is a radiopharmaceutical for positron emission tomography (PET) imaging of αVβ3 integrin expression. Aim: This study aims at evaluating the feasibility of imaging myocardial αVβ3 integrin expression using 68-Ga-NODAGA-RGD PET and whether 68Ga-NODAGA-RGD uptake is associated with myocardial contractile function in patients with an acute or chronic coronary artery occlusion. Study design: An academic, prospective, open-label study in 60 patients with an acute or chronic coronary occlusion. Study population: 30 patients with an ST-elevation acute myocardial infarction weeks and left ventricular ejection fraction <50%. 30 patients with planned percutaneous re-opening of a chronic coronary total occlusion and left ventricular ejection fraction <50%. Study procedures: Patients will undergo cardiac 68Ga-NODAGA-RGD PET within 3 to 14 days after an ST-elevation acute myocardial infarction or within 4 weeks before and 2 weeks after planned percutaneous re-opening of chronic coronary total occlusion. Myocardial perfusion reserve will be evaluated in patients with chronic total occlusion by PET. Echocardiography will be performed at the time of PET imaging and repeated 6 months later to evaluate global and regional left ventricle contractile function. Data on relevant cardiovascular clinical history and blood sample will be obtained at imaging visits. Cardiac events will be evaluated after two years. End-points: Primary: Myocardial uptake of 68-Ga-NODAGA-RGD after an acute myocardial infarction or before and after opening of chronic coronary occlusion. Secondary: Global and regional left ventricle systolic function. Blood biomarkers of myocardial injury and heart failure. Myocardial perfusion reserve. Adverse cardiac events including death, myocardial infarction, unstable angina pectoris, repeat revascularization and heart failure hospitalizations.