Clinical Trials Logo

Filter by:
NCT ID: NCT04544449 Active, not recruiting - Clinical trials for Multiple Sclerosis, Primary Progressive

A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Ocrelizumab in Adult Participants With Primary Progressive Multiple Sclerosis

FENtrepid
Start date: October 26, 2020
Phase: Phase 3
Study type: Interventional

A study to evaluate the efficacy and safety of fenebrutinib on disability progression in adult participants with Primary Progressive Multiple Sclerosis (PPMS). All eligible participants will be randomized 1:1 to either daily oral fenebrutinib (and placebo) or intravenous (IV) ocrelizumab (and placebo) in a blinded fashion through an interactive voice or web-based response system (IxRS). Approximately 946 participants will be enrolled and will be recruited globally. Participants who discontinue study medication early or discontinue from the study will not be replaced. The Open-Label Extension (OLE) phase is contingent on a positive benefit-risk result in the Primary Analysis of the study.

NCT ID: NCT04544436 Active, not recruiting - Multiple Sclerosis Clinical Trials

A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS)

Start date: November 26, 2020
Phase: Phase 3
Study type: Interventional

This is a randomized, double blind, controlled, parallel group, multicenter study to evaluate efficacy, safety and pharmacokinetics of a higher dose of ocrelizumab per intravenous (IV) infusion every 24 weeks in participants with RMS, in comparison to the approved 600 mg dose of ocrelizumab.

NCT ID: NCT04544293 Active, not recruiting - Clinical trials for Autoimmune Pulmonary Alveolar Proteinosis

Clinical Trial of Inhaled Molgramostim Nebulizer Solution in Autoimmune Pulmonary Alveolar Proteinosis (aPAP)

IMPALA-2
Start date: May 10, 2021
Phase: Phase 3
Study type: Interventional

160 subjects with autoimmune pulmonary alveolar proteinosis (aPAP) will be randomized to receive once daily treatment with inhaled molgramostim or placebo for 48 weeks. Subjects completing the 48 week placebo-controlled period will receive open-label treatment with once daily inhaled molgramostim for 96 weeks.

NCT ID: NCT04543760 Completed - Covid19 Clinical Trials

Effect of Prone Positioning Combined With High Flow Oxygen Therapy on Oxygenation During Acute Respiratory Failure Due to COVID-19

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

The main manifestation of COVID-19 is acute hypoxemic respiratory failure (AHRF). In patients with AHRF, the need for invasive mechanical ventilation is associated with high mortality. Prone positioning (PP) is a recommended strategy for patients with moderate to severe acute respiratory distress syndrome (ARDS) undergoing invasive mechanical ventilation. Early PP combined with High Flow Oxygen Therapy may benefit spontaneous breathing patients with AHRF due to COVID-19 as recently reported in Jiangsu. Our hypothesis is that early PP combined with High Flow Oxygen Therapy in patients with AHRF due to COVID-19 improves oxygenation.

NCT ID: NCT04543617 Active, not recruiting - Clinical trials for Esophageal Squamous Cell Carcinoma

A Study of Atezolizumab With or Without Tiragolumab in Participants With Unresectable Esophageal Squamous Cell Carcinoma Whose Cancers Have Not Progressed Following Definitive Concurrent Chemoradiotherapy

SKYSCRAPER-07
Start date: September 28, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo in participants with unresectable esophageal squamous cell carcinoma (or those who are unable or unwilling to undergo surgery) and whose cancers have not progressed following definitive concurrent chemoradiotherapy (dCRT). Participants will be randomized in a 1:1:1 ratio to receive either tiragolumab plus atezolizumab (Arm A), tiragolumab matching placebo plus atezolizumab (Arm B), or double placebo (Arm C).

NCT ID: NCT04543591 Recruiting - Clinical trials for Thrombotic Microangiopathy

Ravulizumab in Thrombotic Microangiopathy After Hematopoietic Stem Cell Transplant

Start date: December 10, 2020
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of ravulizumab in adult and adolescent participants with hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). In Stage 1, an open-label, single-arm period, the dosing regimen will be confirmed. In Stage 2, participants will be randomized to receive either blinded ravulizumab plus best supportive care or matching placebo plus best supportive care. The treatment period is 26 weeks (open-label for Stage 1, and randomized, double-blind, and placebo-controlled for Stage 2) followed by a 26-week follow-up period.

NCT ID: NCT04543409 Terminated - Clinical trials for Eosinophilic Esophagitis

A Study of Benralizumab in Patients With Eosinophilic Esophagitis

MESSINA
Start date: September 22, 2020
Phase: Phase 3
Study type: Interventional

The aim of this Phase 3 study is to investigate the use of benralizumab as a treatment for patients with EoE. The effect of doses of benralizumab on EoE histologic signs and symptoms will be assessed over a 52-week treatment period (including a 24-week double-blind placebo-controlled treatment period and a 28-week open-label treatment period). It is proposed that benralizumab will deplete eosinophils from GI tissue(s), improve the symptoms of dysphagia, and improve endoscopy scores as well as other markers of disease activity. Upon completion of the initial 52-week treatment period, patients will be offered an additional Open Label Extension period of at least 1 year, with benralizumab treatment and ongoing study assessments.

NCT ID: NCT04543162 Recruiting - Clinical trials for Traumatic Brain Injury

Usefulness of Biomarkers in the Management of Mild Traumatic Brain Injury in Adults (Biotraumap)

Biotraumap
Start date: October 2, 2019
Phase:
Study type: Observational

The indication of cranial computed tomography (CCT) is difficult to define for patients with mild traumatic brain injury (mTBI). For mTBI patients with a medium risk of intracranial complications, CCT scans are indicated although 90% of them are normal. The interest of the S100B protein has been widely demonstrated in the management of mTBI in adults. Its serum concentration (for blood sampling drawn less than 3 hours after trauma) can accurately predict a normal CCT scan for mTBI patients with a medium risk of intracranial complications. That's why, serum assay of the S100B protein is routinely used in the Emergency Department of Clermont-Ferrand University Hospital for the treatment of patients with mTBI. The objective of the study is to optimize the management strategy for mTBI patients by blood testing of new brain biomarkers. These biomarkers are synthesized by brain cells and are released into the blood in case of intracranial lesions.

NCT ID: NCT04543058 Recruiting - Parkinson Disease Clinical Trials

BeatPark: Self-rehabilitation in Walking With Parkinson's Disease

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

Physical activity has beneficial effects on the quality of walking for persons with Parkinson's disease (PD). However, regular physical activity is still limited in most patients' daily lives. The rhythm of music makes you want to move whether you are sick or not. In addition, it has been found that in people with PD, it can also improve walking by helping the participant to regain the regularity of alternating steps and a better walking dynamic (i.e. better position, better arm swinging, etc.). Studies have shown that music allows persons with PD to walk faster, with bigger steps. However, if the tempo of the music does not correspond to the participant's walking pace, instead of helping him, it can disturb him. So it seems necessary for music to help people with PD to walk better if the tempo of the music is set to match their steps. BeatPark is a smartphone application which makes it possible to synchronize the tempo of the music with the participant's walking rhythm detected thanks to feet insoles. Once synchronized to the participant's walking pace, BeatPark imperceptibly accelerates the tempo of the music to help the participant's acceleration. This clinical trial proposes to study the effects of walking rehabilitation depending on the use of music synchronized to the participant's step with BeatPark, music with random tempo or without music.

NCT ID: NCT04542889 Terminated - Clinical trials for STEMI - ST Elevation Myocardial Infarction

Coronary Microcirculation Assessment After Primary Angioplasty in Myocardial Infarction

NATHANAEL
Start date: September 7, 2020
Phase: N/A
Study type: Interventional

In the management of acute myocardial infarction treated with primary angioplasty, despite effective epicardial clearance obtained in 95% of cases, microvascular obstruction (MVO) in the damaged territory concerns 50% of patients. The Index of Microvascular Resistance (IMR) allows early assessment of the microcirculatory state during the angioplasty procedure. A value of IMR>40 indicates MVO and is correlated with morbi-mortality. A new method for immediate evaluation of MVO using thermodilution with a new Rayflow® microcatheter has been described: it no longer allows the estimation but the measurements of absolute coronary resistance and coronary flow. We hypothesize that these measurements allows a better evaluation of the microcirculatory state after primary angioplasty, comparing to IMR. The main objective is to study the diagnostic performance of Rayflow® to predict MVO - no reflow (NR) - in ST-Elevation Myocardial Infarction (STEMI) patients in order to determine an absolute coronary resistance threshold by thermodilution for early diagnosis of MVO. The main secondary objectives will be to compare the different microcirculatory assessment parameters with each other, not indexed and indexed to the myocardial mass at risk (coronary resistance, IMR, CFR, Resistance Reserve Ratio) and to establish a link between high resistance or IMR and the occurrence of rhythm disorders at D1, D2 and D3.