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NCT ID: NCT04849728 Recruiting - Clinical trials for NASH - Nonalcoholic Steatohepatitis

A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 )

NATiV3
Start date: August 19, 2021
Phase: Phase 3
Study type: Interventional

This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis histological stage F2 or F3

NCT ID: NCT04846543 Recruiting - Forearm Fracture Clinical Trials

Bioresorbable Intramedullary Nailing of Forearm Fractures

BRINFF
Start date: March 1, 2021
Phase: N/A
Study type: Interventional

The Activa IM-Nail™ is used in the fixation of forearm fractures with cast to achieve a level of reduction and stabilisation that is appropriate to the age of the child. The post-market clinical follow-up study will be performed to identify the residual risk related to re-fracture and to determine its impact to the risk/benefit ratio of Activa IM-Nail™.

NCT ID: NCT04845750 Recruiting - Clinical trials for Cardiovascular Diseases

The RODEO Micro Mapping Catheter in Cryoablation Procedures

RODEO-MaPS
Start date: April 14, 2021
Phase: N/A
Study type: Interventional

This clinical investigation evaluates the feasibility of the Rodeo Micro Mapping Catheter in combination with cryoablation ssystem (sclerotherapy of muscle tissue of the heart by freezing) in patients with atrial fibrillation (permanent atrial fibrillation excepted). Further aims of this study are the evaluation of safety of the device and average procedure and fluoroscopy times.

NCT ID: NCT04844931 Recruiting - Clinical trials for ST Elevation Myocardial Infarction

Remote Ischemic Conditioning With Local Ischemic Postconditioning in High-Risk ST-elevation Myocardial Infarction

RIP-HIGH
Start date: July 5, 2021
Phase: N/A
Study type: Interventional

The RIP-HIGH trial is a two-arm randomized controlled trial aiming to compare the impact of combined remote ischemic conditioning (RIP) and local ischemic postconditioning (PostC) vs. standard of care on clinical outcome in high-risk ST-elevation myocardial infarction patients undergoing primary percutaneous coronary intervention.

NCT ID: NCT04844866 Recruiting - Clinical trials for Diffuse Large B-cell Lymphoma

Efficacy and Safety of MB-CART2019.1 vs. SoC in Lymphoma Patients

DALY 2-EU
Start date: August 18, 2021
Phase: Phase 2
Study type: Interventional

This is a pivotal Phase II randomised, multi-centre, open-label study to evaluate the efficacy and safety of MB-CART2019.1 compared to standard of care therapy in participants with relapsed/refractory diffuse large B-cell lymphoma, who are not eligible for high-dose chemotherapy and autologous stem cell transplantation.

NCT ID: NCT04844606 Recruiting - Ulcerative Colitis Clinical Trials

A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)

SHINE-ON
Start date: May 26, 2021
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to evaluate the long-term efficacy of mirikizumab in pediatric participants with ulcerative colitis (UC) or Crohn's disease (CD). The study will last about 172 weeks and may include up to 44 visits.

NCT ID: NCT04843462 Recruiting - Clinical trials for Major Depressive Disorder

Add-on Therapy With Edupression.Com® on Therapy Resistant Depressive Patients Treated With Nasal Esketamine Spray

Esketamin+
Start date: April 29, 2021
Phase: N/A
Study type: Interventional

Pragmatic clinical trial of an add-on therapy regarding the use of edupression.com® - a licensed computer based self-help program - on patients with therapy-resistant depression receiving esketamine nasal spray

NCT ID: NCT04843436 Recruiting - Open Surgery Clinical Trials

PRIMO Post-Market Clinical Follow Up Study

PRIMO
Start date: April 13, 2021
Phase: N/A
Study type: Interventional

Post Market Clinical Follow up Study aimed to collect clinical data on safety and efficacy of Robotically Assisted System called Symani to perform microsurgery techniques such as anastomosis, suturing and ligation for open surgery procedures on small anatomical structures such as blood vessels, lymphatic ducts and nerves.

NCT ID: NCT04843072 Recruiting - Valve Heart Disease Clinical Trials

Balloon vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis

BASELINE
Start date: May 1, 2021
Phase: N/A
Study type: Interventional

Transcatheter aortic valve implantation (TAVI) serves a growing spectrum of patients with symptomatic severe aortic stenosis (AS). Approximately 80% of surgical aortic valve replacements is performed using a bioprosthesis1. Durability of surgical bioprostheses varies based on the patient's age at the moment of implantation, type and size etc2. TAVI has become the preferred treatment for degenerated aortic bioprostheses in elderly patients3. The median time since index surgical aortic valve replacement (SAVR) and for bioprosthetic valve degeneration is typically 8 - 10 years4-6. TAVI in this setting has proven to have equally favorable results as in native aortic valves7. Balloon expandable8 and self-expanding9 transcatheter heart valves (THV) can be used in a degenerated bioprosthesis and each have specific assets and limitations. TAVI in a failed bioprosthesis can cause coronary obstruction, THV migration, paravalvular leakage and prosthesis patient mismatch. The SAPIEN-3 / Ultra and EVOLUT R/Pro are the 2 most commonly used THV platforms in contemporary clinical practice including treatment of failing surgical aortic bioprostheses. Objective: To compare TAVI with EVOLUT R/Pro vs. SAPIEN-3 / Ultra in terms of device success. Study design: International multi-center randomized study with 1:1 randomization to TAVI with SAPIEN-3 / Ultra or Evolut R/Pro. Study population: 440 patients with a failing surgical aortic bioprosthesis (aortic stenosis with or without aortic regurgitation) and selected for transfemoral TAVI by heart-team consensus. Investigational intervention: Transfemoral TAVI with SAPIEN-3 / Ultra or Evolut R/PRO Main study parameters/endpoints: 1. Primary endpoint is device success at 30 days Defined by - Absence of procedural mortality AND - Correct positioning of a single prosthetic heart valve into the proper anatomical location AND - Intended performance of the prosthetic heart valve (no severe prosthesis- patient mismatch and mean aortic valve gradient < 20 mmHg or peak velocity < 3 m/s, AND no moderate or severe prosthetic valve regurgitation). Severe prosthesis patient mismatch is defined by effective orifice area (EOAi) ≤0.65 cm2/m2 2. Safety endpoint at 1 year defined by the composite of all-cause death, disabling stroke, rehospitalization for heart failure or valve related problems.

NCT ID: NCT04842591 Recruiting - Clinical trials for Pulmonary Hypertension

Characteristics of Pulmonary Vascular Changes in Patients With Kidney Transplantation

Start date: December 23, 2020
Phase:
Study type: Observational

The aim of the study is to investigate pulmonary hemodynamics at rest and during exercise in patients before and after kidney transplantation.