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NCT ID: NCT04458051 Recruiting - Clinical trials for Primary Progressive Multiple Sclerosis

Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (PERSEUS)

PERSEUS
Start date: August 13, 2020
Phase: Phase 3
Study type: Interventional

Primary Objective: To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in primary progressive multiple sclerosis (PPMS) Secondary Objectives: 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 in PPMS and its relationship to efficacy and safety To evaluate pharmacodynamics of SAR442168

NCT ID: NCT04441957 Recruiting - Surgery Clinical Trials

MechanO-Chemical Ablation Versus CompreSSion

MOCASS
Start date: January 1, 2018
Phase:
Study type: Observational

This study will be looking at the effect of Endovenous Mechano-Chemical Ablation (MOCA) in addition to multilayer elastic compression bandaging vs multilayer elastic compression bandaging only in patients with incompetent great saphenous vein (GSV) and venous ulcers (VU's).

NCT ID: NCT04434274 Recruiting - Surgery Clinical Trials

MIcronized Flavonoid Fraction After MechanO-Chemical Ablation

MIFFMOCA
Start date: January 1, 2019
Phase:
Study type: Observational

This study will be evaluate the clinical efficacy of micronized purified flavonoid fraction (MPFF) phlebotropic therapy for postoperative pain, venospecific symptoms, and quality of life in patients with incompetent great or small saphenous veins (GSV/SSV) following an endovenous mechanochemical ablation procedure (MOCA).

NCT ID: NCT04331769 Recruiting - Clinical trials for Dilated Cardiomyopathy

Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients Who Present With Symptomatic Heart Failure With Reduced Ejection Fraction (HFrEF): The CORCINCH-HF Study

Start date: December 21, 2020
Phase: N/A
Study type: Interventional

Prospective, randomized, open-label, international, multi-center clinical study to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with heart failure and reduced ejection fraction (HFrEF).

NCT ID: NCT04275726 Recruiting - Clinical trials for Aortic Valve Stenosis

LANDMARK Trial: a Randomised Controlled Trial of Myval THV

LANDMARK
Start date: November 4, 2020
Phase: N/A
Study type: Interventional

The primary objective of this study (LANDMARK) is to compare the safety and effectiveness of the Myval THV Series with Contemporary Valves (Sapien THV Series and Evolut THV Series) in patients with severe symptomatic native aortic valve stenosis. This study will be done in total 768 subjects (384:384, Myval THV Series vs. Contemporary Valves) The randomisation will be carried out with an allocation ratio of 1:1 between Myval THV Series vs. Contemporary Valves (Sapien THV Series and Evolut THV Series)

NCT ID: NCT04273945 Recruiting - Clinical trials for Pulmonary Arterial Hypertension

Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial Hypertension

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

The purpose of this study is to demonstrate superiority of macitentan 75 milligrams (mg) in prolonging the time to the first clinical events committee (CEC)-adjudicated morbidity or mortality (M/M) event in participants with symptomatic pulmonary arterial hypertension (PAH) compared to macitentan 10 mg.

NCT ID: NCT04259138 Recruiting - Colitis, Ulcerative Clinical Trials

Determination of the Optimal Treatment Target in Ulcerative Colitis

VERDICT
Start date: February 18, 2020
Phase: Phase 4
Study type: Interventional

Disease activity and response to therapy in ulcerative colitis (UC) can be assessed by a range of endpoints including symptoms, endoscopic mucosal activity, histological disease activity, and biomarkers. This study aims to determine the optimal treatment target, which is a research priority for the management of UC both to inform clinical practice and to help inform regulatory endpoints and targets for drug development. Participants with active UC will be randomized in a 5:4:1 (initially 2:3:5) ratio to 1 of 3 groups, each with a different treatment target. Treatment targets will be defined as: - Group 1: corticosteroid-free symptomatic remission - Group 2: corticosteroid-free endoscopic + symptomatic remission - Group 3: corticosteroid-free histological + endoscopic + symptomatic remission An interim analysis was performed to assess the proportion of subjects that reached their assigned treatment target after 50 subjects in each group had reached the first 32-week assessment. The interim analysis and projections made based on target achievement rates for all subjects included in the interim analysis resulted in a recommendation to adjust the randomization ratio from 2:3:5 to 5:4:1 for Groups 1, 2 and 3 respectively as of May 5th, 2023. This change was necessary in order to complete the study with approximately 100 subjects achieving treatment target within each group.

NCT ID: NCT04173273 Recruiting - Crohn's Disease Clinical Trials

A Study Evaluating the Efficacy and Safety of Oral Etrasimod in the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease

CULTIVATE
Start date: January 6, 2020
Phase: Phase 3
Study type: Interventional

This is a Phase 2/3 study that comprises 5 substudies designed to evaluate the efficacy, safety, and tolerability of oral etrasimod as therapy in adult participants with moderately to severely active Crohn's disease (CD) who are refractory or intolerant to at least 1 of the current therapies for CD (ie, corticosteroids, immunosuppressants, or biologics). The overall duration of this study is up to 282 weeks, inclusive of the Screening Period, Treatment Period of up to 274 weeks (Induction, Extension or Maintenance, and Long-term Extension Periods), and the 4-Week Follow-Up Period for safety assessment.

NCT ID: NCT04146519 Recruiting - Clinical trials for Transplantation:Mesenchymal Stem Cell Transplantation

Parkinson's Disease Therapy Using Cell Technology

Start date: July 1, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

Treatment of patients with Parkinson's disease using mesenchymal stem cells is a perspective method to influence on the pathogenesis of the disease. At the same time, this is a complex and still insufficiently explored process. Autologous mesenchymal stem cells will be transplanted to 30 patients with Parkinson's disease. The results of the effectiveness of the combined and intravenous routes of mesenchymal stem cells administration on the motor and non-motor symptoms in these patients will be evaluated and compared with the results of control group that received placebo therapy

NCT ID: NCT04049864 Recruiting - Clinical trials for Relapsed Neuroblastoma

DNA Vaccination Against Neuroblastoma

Start date: January 9, 2019
Phase: Early Phase 1
Study type: Interventional

This is pilot open-label study to evaluate the safety and immunogenicity of a DNA vaccine strategy in relapsed neuroblastoma patients following chemotherapy and HSC transplantation. The combined form of the vaccine includes an intramuscular injection of the DNA-polyethylenimine conjugate and oral administration using the attenuated Salmonella enterica as DNA vaccine carriers. Objectives of the study: 1. To assess safety and document local and systemic toxicity to combined DNA vaccine 2. To determine immunogenicity of the vaccine 3. To evaluate clinical response to vaccination. Control of minimal residual disease in bone marrow and duration of remission.