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NCT ID: NCT04232553 Recruiting - Crohn's Disease Clinical Trials

A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease

VIVID-2
Start date: June 22, 2020
Phase: Phase 3
Study type: Interventional

The reason for this study is to determine the long-term efficacy and safety of the study drug mirikizumab in participants with Crohn's disease.

NCT ID: NCT04232449 Recruiting - Clinical trials for Post-infectious Cough

Oral Corticosteroids for Post-infectious Cough in Adults

OSPIC
Start date: November 6, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess whether a 5-day treatment with orally administered prednisone provides patient-relevant benefits by improving the cough-related QoL of patients with post-infectious cough triggered by an Upper Respiratory Tract Infection (URTI) and seeking care in adult primary care practices. The study aims to describe an efficacy and safety profile for a 5-day prednisone treatment compared to a 5-day course of placebo.

NCT ID: NCT04231500 Recruiting - Clinical trials for Graft Versus Host Disease

The Skin Microbiome in Graft Versus Host Disease

Start date: March 1, 2023
Phase:
Study type: Observational

Based on the evidence on the impact of the intestinal microbiome on the Graft Versus Host Disease (GVHD) after allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT), it is hypothesized that the skin-microbiome may play a role in cutaneous GVHD as well. Therefore, this study aims at investigating the skin-microbiota of patients with GVHD after allo-HSCT and of patients without GVHD after allo-HSCT.

NCT ID: NCT04227769 Recruiting - Inflammation Clinical Trials

IL-1-receptor Antagonist During Cephalic Phase of Insulin Secretion in Health and Type 2 Diabetes

Cephalira
Start date: January 13, 2020
Phase: Phase 2
Study type: Interventional

A prospective, randomized, mixed double- and single-blinded, placebo-controlled, cross-over clinical trial to test whether acute treatment with an IL-1 receptor antagonist impacts insulin secretion over time during the cephalic phase, defined as the first 10 minutes after the first sensorial contact to food, in healthy individuals in healthy humans (Group 1) and in obese patients with type 2 diabetes (Group 2).

NCT ID: NCT04227301 Recruiting - Hyponatremia Clinical Trials

Influence of Serum Sodium Levels on Bone Metabolism and Turnover in Hospitalized Patients

BONA
Start date: November 14, 2019
Phase:
Study type: Observational

In this study, the possible role of serum sodium concentration and its changes on bone markers in hospitalized, hyponatremic patients is determined. Therefore, it is investigated whether in hospitalized, hyponatremic patients the level of carboxy-terminal collagen crosslinks (CTX) is modified by changes in plasma sodium concentration, independently from the aetiology of hyponatremia.

NCT ID: NCT04226547 Recruiting - Stroke Clinical Trials

Amplatzer Amulet LAAO vs. NOAC

CATALYST
Start date: July 7, 2020
Phase: N/A
Study type: Interventional

The objective of this trial is to evaluate the safety and effectiveness of the Amulet LAA occluder compared to NOAC therapy in patients with non-valvular AF at increased risk for ischemic stroke and who are recommended for long-term NOAC therapy. The clinical investigation is a prospective, randomized, multicenter active control worldwide trial. Subjects will be randomized in a 1:1 ratio between the Amulet LAA occlusion device ("Device Group") and a commercially available NOAC medication ("Control Group"). The choice of NOAC in the Control Group will be left to study physician discretion.

NCT ID: NCT04225520 Recruiting - Heart Failure Clinical Trials

AMEND-CRT: Mechanical Dyssynchrony as Selection Criterion for CRT

AMEND-CRT
Start date: December 10, 2020
Phase: N/A
Study type: Interventional

Previous experience with cardiac resynchronization therapy (CRT) candidates suggests that selection of these patients can be improved. Current clinical guideline approaches are mainly too unspecific and lead to a high non-responder rate of 30-40%, which causes a burden on health care systems and puts patients at risk of an unnecessary treatment who might benefit more from a conservative approach. Previous work indicated that using the assessment of mechanical dyssynchrony on echocardiography can lower the non-responder rate at least by 50% without compromising sensitivity for detecting amendable patients. The current prospective, randomized, multi-center trial was therefore designed to prove that the characterization of the mechanical properties of the left ventricle can improve patient selection for CRT. Patients will be randomized into one of two study arms: a control study arm with treatment recommendation based on clinical guidelines criteria, or an experimental study arm with treatment recommendation based on the presence of mechanical dyssynchrony. All patients will receive a CRT implantation. In the control study arm, bi-ventricular pacing will be turned on. In the experimental study arm, bi-ventricular pacing will be turned on or off, depending on the presence or absence of mechanical dyssynchrony, respectively. The primary endpoint will be non-inferiority in outcome of a treatment recommendation based on mechanical dyssynchrony, achieved with a lower number of CRT devices implanted, effectively leading to a lower number needed to treat. Outcome measures are the average relative change in continuously measured LVESV per arm and the percentage 'worsened' according to the Packer Clinical Composite Score per arm after 1 year follow-up.

NCT ID: NCT04223856 Recruiting - Urothelial Cancer Clinical Trials

Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer

EV-302
Start date: March 30, 2020
Phase: Phase 3
Study type: Interventional

This study is being done to see how well two drugs (enfortumab vedotin and pembrolizumab) work together to treat patients with urothelial cancer. The study will compare these drugs to other drugs that are usually used to treat this cancer (standard of care). The patients in this study will have cancer that has spread from their urinary system to other parts of their body.

NCT ID: NCT04221542 Recruiting - Prostate Cancer Clinical Trials

Study of AMG 509 in Participants With Metastatic Castration-Resistant Prostate Cancer

Start date: March 4, 2020
Phase: Phase 1
Study type: Interventional

Evaluate the safety and tolerability of AMG 509 in adult participants and determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D).

NCT ID: NCT04221035 Recruiting - Clinical trials for High-Risk Neuroblastoma

High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN)

HR-NBL2
Start date: November 5, 2019
Phase: Phase 3
Study type: Interventional

This is an international multicenter, open-label, randomized phase III trial including three sequential randomizations to assess efficacy of induction and consolidation chemotherapies and radiotherapy for patients with high-risk neuroblastoma.