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NCT ID: NCT04315948 Completed - Clinical trials for Corona Virus Infection

Trial of Treatments for COVID-19 in Hospitalized Adults

DisCoVeRy
Start date: March 22, 2020
Phase: Phase 3
Study type: Interventional

DisCoVeRy is a randomized controlled trial among adults (≥18-year-old) hospitalized for COVID-19. This study is an adaptive, randomized, open or blinded, depending on the drug to be evaluated, clinical trial to evaluate the safety and efficacy of possible therapeutic agents in hospitalized adult patients diagnosed with COVID-19. The study is a multi-centre/country trial that will be conducted in various sites in Europe with Inserm as sponsor. The study will compare different investigational therapeutic agents to a control group managed with the SoC including corticosteroids and anticoagulants. There will be interim monitoring to allow early stopping for safety and to introduce new therapies as they become available. If one therapy proves to be superior to others in the trial, this treatment may become part of the SoC for comparison(s) with new experimental treatment(s). In previous versions of the DisCoVeRy protocol, remdesivir, lopinavir/ritonavir with or without interferon ß-1a and hydroxychloroquine were evaluated as potential treatments for COVID-19. These treatments have been discontinued based on analyses review by both DSMC/DSMB, the Solidarity Executive Group and the DisCoVeRy steering committee. This version of the protocol, therefore, describes a randomized blinded placebo-controlled trial among adults (≥18-year-old) hospitalized for COVID-19 that randomly allocates them (1:1 ratio) between 2 arms: SoC + placebo versus SoC + AZD7442. Randomization will be stratified by region (according to the administrative definition in each country), antigenic status (positive or negative) obtained from the result of a rapid antigen test on nasopharyngeal swab performed at enrolment and vaccination initiation (yes or no). The primary analyses will be conducted on patients with antigen-positive results. A positive antigenic test is evidence of high viral shedding consistent with a recently started or uncontrolled infection. Overall, the number of antigen-negative patients will be at most 30% of all included subjects. The number of patients with vaccination (partly or fully) will be limited to 20% of all participants, split evenly between antigen positive and antigen negative patients (i.e. vaccinated patients can make up at most 20% of antigene positive patients and 20% of antigene negative patients). Sensitivity analyses will be performed in all patients, stratified by antigenic status and vaccination initiation. A global independent data and safety monitoring board (DSMB) monitors interim data to make recommendations about early study closure or changes to conduct, including adding or removing treatment arms. However, the current version of the protocol does not allow for efficacy or futility analysis, and the ability to add trial arms will be limited by the study being blinded and placebo-controlled during the investigation of AZD7442.

NCT ID: NCT04311931 Completed - Clinical trials for Community-dwelling Older Adults

Creative Dance Effects on Community-dwelling Older Adults

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

The aim of present study is to analyze the effect of a Creative Dance program on well-being, physical function, body awareness, and rhythm perception and reproduction of community-dwelling older adults. This quasi-experimental study is a controlled trial. Participants will be allocated to two groups: experimental group (who attend the Creative Dance program) and control group (who maintain usual activity). The Creative Dance program will run for 12 weeks (3 sessions/week of 60 minutes). Participants will be assessed 1) at baseline and at 2) at 12 weeks.

NCT ID: NCT04304508 Completed - Clinical trials for Acute Non-cardioembolic Ischemic Stroke

Study to Gather Information About Proper Dosing and Safety of the Oral FXIa Inhibitor BAY 2433334 in Patients Following a Recent Non Cardioembolic Ischemic Stroke Which Occurs When a Blood Clot Has Formed Somewhere in the Human Body (But Not in the Heart) Travelled to the Brain.

PACIFIC-STROKE
Start date: June 15, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to try to find the best dose of the new drug BAY 2433334 to give to participants and to look at how well BAY 2433334 works on top of antiplatelet therapy in patients following a recent non cardioembolic ischemic stroke which occurs when a blood clot that has not formed in the heart travelled to the brain. BAY 2433334, works by blocking a step of the blood clotting process in our body and thins the blood and is a so called oral FXIa inhibitor.

NCT ID: NCT04291586 Completed - Psychiatric Disease Clinical Trials

Comparing the Impact of Virtual Reality and Paper and Pencil on Psychosocial Rehabilitation

Start date: June 3, 2019
Phase: N/A
Study type: Interventional

Virtual Reality allows the integration of cognitive rehabilitation in a more ecologically valid context. The purpose of this study is to determine whether this methodology has more impact on psychosocial rehabilitation than a paper and pencil personalized program.

NCT ID: NCT04286750 Completed - Healthy Clinical Trials

Study in Healthy Subjects to Examine the Safety and Tolerability of ACT-1004-1239 Given as Multiple, Gradually Increasing Doses and to Examine the Effects of ACT-1004-1239 on the Body and the Way the Body Takes up, Distributes, and Gets Rid of ACT-1004-1239

Start date: July 11, 2020
Phase: Phase 1
Study type: Interventional

Study in healthy subjects to examine the safety and tolerability of ACT-1004-1239 given as multiple, gradually increasing doses and to examine the effects of ACT-1004-1239 on the body and the way the body takes up, distributes, and gets rid of ACT-1004-1239

NCT ID: NCT04284072 Completed - Epilepsy Clinical Trials

Clinical Scenarios for Long-term Monitoring of Epileptic Seizures With a Wearable Biopotential Technology

SeizeIT2
Start date: June 22, 2020
Phase: N/A
Study type: Interventional

Clinically validate a biopotential and motion recording wearable device (Byteflies Sensor Dot) for detection of epileptic seizures in the epilepsy monitoring unit (EMU) and at home.

NCT ID: NCT04282057 Completed - Clinical trials for Cardiovascular Risk Factor

Effects of Shockwave Therapy Versus Radiofrequency

Start date: February 22, 2020
Phase: N/A
Study type: Interventional

The main objective of this study is to compare the effect of 6 sessions of shock wave therapy versus radiofrequency followed by a protocol of moderate aerobic exercise, in the reduction of adiposity and abdominal flaccidity, in females between 18 and 60 years old. As a secondary objective, it is intended to understand the mechanism of fat mobilization by these two therapies.

NCT ID: NCT04275037 Completed - Hypertension Clinical Trials

The Hypotensive Effects of Home-Based Isometric Handgrip Training in Older Adults With Pre-Hypertension and Hypertension - The HoldAge Trial

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

New data suggests that isometric handgrip training (IHT) might become a novel tool in the treatment of hypertension. The main purpose of this research project is to evaluate the effects of home-based IHT on ambulatory blood pressure in older adults with pre-hypertension and hypertension. Eighty-four older adults with pre-hypertension and hypertension will be randomly distributed to one of three groups: home-based IHT, home-based aerobic exercise training (AET), or attention-control group (CON). Each intervention will have a total duration of 8 weeks. At baseline and after completing the intervention, patients will undergo the following evaluations: 24-hour ambulatory blood pressure, cardiorespiratory fitness, endothelial function, damage and repair, arterial stiffness, inflammatory biomarkers, autonomic function, physical activity levels, dietary intake and quality of life. A qualitative analysis will also be applied to enhance the understanding of the efficacy of this intervention from the patient's perspective.

NCT ID: NCT04271761 Completed - Hearing Impairment Clinical Trials

Evaluation of Carina Microphone Sensitivity and Maximum Stable Gain in Adult Recipients

CAMSEN
Start date: February 11, 2020
Phase:
Study type: Observational

This investigation is a single-centre, prospective, single-arm, post-market, non-interventional, pilot clinical investigation designed to characterize microphone sensitivity and maximum stable gain of the Cochlear Carina System.

NCT ID: NCT04271722 Completed - Clinical trials for Labor Onset and Length Abnormalities

Clinical Evaluation of Cervical Ripening in the Outpatient Setting

Start date: January 15, 2020
Phase: N/A
Study type: Interventional

A randomized controlled trial of mifepristone 200mg vs balloon catheter for cervical ripening.