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NCT ID: NCT04978506 Recruiting - Healthy Clinical Trials

A Study in Healthy Men to Test How Well Different Doses of BI 1569912 Are Tolerated

Start date: August 11, 2021
Phase: Phase 1
Study type: Interventional

The main objectives of this trial are to investigate (1) safety, tolerability, pharmacokinetics and pharmacodynamics following multiple rising doses of BI 1569912; (2) tolerability of BI 1569912 in an up-titrating dosing scheme.

NCT ID: NCT04976153 Recruiting - Fecal Incontinence Clinical Trials

Skeletal Muscle-derived Cell Implantation for Treatment of Fecal Incontinence

Fidelia
Start date: May 11, 2022
Phase: Phase 3
Study type: Interventional

The objective of this study is the final assessment of clinical safety and efficacy of autologous autologous skeletal muscle derived cells for patients with urge fecal incontinence due to external anal sphincter dysfunction caused by its disruption and/or weakness.

NCT ID: NCT04976062 Recruiting - Clinical trials for Coronary Artery Disease

NIRS-IVUS to Improve Assessment of Coronary Artery Disease Severity in Patients Referred for Transcatheter Aortic Valve Implantation

IMPACTavi
Start date: November 10, 2020
Phase:
Study type: Observational [Patient Registry]

The aim of the IMPACTavi prospective cohort study is to test feasibility and safety of clinically indicated intravascular coronary imaging with NIRS-IVUS in addition to routine coronary angiography in patients scheduled for TAVI, to improve assessment of CAD severity in this challenging group of patients.

NCT ID: NCT04975997 Recruiting - Multiple Myeloma Clinical Trials

Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

EXCALIBER-RRMM
Start date: June 23, 2022
Phase: Phase 3
Study type: Interventional

This is a multicenter, two-stage, randomized, controlled, open-label, Phase 3 study comparing the efficacy and safety of iberdomide in combination with dexamethasone and daratumumab (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM).

NCT ID: NCT04975490 Recruiting - Liver Cirrhosis Clinical Trials

Characterization and Pathogenesis of ACLF

ACLF-I
Start date: December 1, 2020
Phase:
Study type: Observational

This single-center prospective observational study aims at characterization of pathogenesis of ACLF. There will be three different cohorts investigated with the main endpoint mortality in these groups. 1. SAPIENT = Sepsis ACLF patients, to investigate the differences between ACLF and sepsis in cirrhosis 2. PROACT = Portal mediators as ACLF Targets, to assess portal venous biomarkers in patients receiving TIPS leading to ACLF and identify potential treatment targets 3. ELITE = prEdictors of beneficial LIver Tx in ACFL patiEnts, to assess in ACLF-patients receiving liver transplantation predictors of survival, which may improve selection of ACLF-patients for liver transplantation Secondary endpoints will be different in the three different cohorts and biological material will be collected for separate ancillary studies.

NCT ID: NCT04975308 Recruiting - Breast Neoplasms Clinical Trials

A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer

EMBER-3
Start date: October 4, 2021
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy, and how well imlunestrant with abemaciclib work compared to imlunestrant in participants with breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have breast cancer that is advanced or has spread to another part of the body. Study participation could last up to 5 years.

NCT ID: NCT04973839 Recruiting - Clinical trials for Healthy Participants

Optimizing the Efficacy of Progressive Muscle Relaxation Using Placebo Mechanisms in an Guided and Unguided Online-intervention

Start date: July 7, 2021
Phase: N/A
Study type: Interventional

This study aims to determine whether a brief video aiming to optimize expectations regarding the effectiveness of progressive muscle relaxation (PMR) can enhance the efficacy of a PMR compared to a neutral video control group in an online intervention. Another aim is to assess whether this effect will be moderated by the degree of human support (guided or unguided intervention).

NCT ID: NCT04973657 Recruiting - Clinical trials for Adrenomyeloneuropathy Form (AMN) of X-linked Adrenoleukodystrophy (X-ALD)

A Study to Assess the Pharmacodynamics of VK0214 in Male Subjects With AMN

Start date: June 22, 2021
Phase: Phase 1
Study type: Interventional

Subjects will be administered multiple doses of VK0214 in a cohort dose escalation process. A total of up to 36 subjects will be enrolled in the study, into one of three dose cohorts. For each cohort, up to 12 subjects will be randomized to receive VK0214 or placebo in a 3:1 ratio so that there will be a total of up to 9 subjects for each of the active doses and up to 3 subjects dosed with placebo in each cohort.

NCT ID: NCT04973137 Recruiting - Clinical trials for Light Chain (AL) Amyloidosis

A Study to Evaluate the Efficacy and Safety of Birtamimab in Mayo Stage IV Patients With AL Amyloidosis

AFFIRM-AL
Start date: August 30, 2021
Phase: Phase 3
Study type: Interventional

A Phase 3 study to evaluate the efficacy and safety of birtamimab plus standard of care compared to placebo plus standard of care in Mayo Stage IV patients with AL amyloidosis.

NCT ID: NCT04972721 Recruiting - Obesity Clinical Trials

SELECT-LIFE: A Research Study Looking at Long-term Effects of Semaglutide in People Who Took Part in the SELECT Cardiovascular Outcomes Trial

SELECT-LIFE
Start date: September 1, 2023
Phase:
Study type: Observational

Participants are being asked to participate in SELECT-LIFE study because participants take part in the SELECT trial. SELECT-LIFE study is a survey-based study that will start when the SELECT trial ends. SELECT-LIFE looks at the long-term effects of participants taking part in the SELECT trial including the trial medicine participants have been taking. When the SELECT trial ends, participants will no longer get the medicine participants got in the study, even if participants decide to take part in the SELECT-LIFE study. Participants will not get any specific treatment or medicine as part of the SELECT-LIFE study, and participants will be treated as participants normally would by their own doctor. The SELECT-LIFE study will last for up to 10 years after SELECT trial ends, and participants will be asked to fill in a questionnaire about their health every 6 months.