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NCT ID: NCT03403205 Terminated - Wilson Disease Clinical Trials

Efficacy and Safety of ALXN1840 Administered for 48 Weeks Versus Standard of Care in Participants With Wilson Disease

Start date: February 22, 2018
Phase: Phase 3
Study type: Interventional

The study will evaluate the efficacy and safety of ALXN1840 (formerly called WTX101) administered for 48 weeks compared to standard of care (SoC) in Wilson Disease (WD) participants aged 12 and older in the Primary Evaluation Period. In addition, efficacy and safety will be evaluated during an optional 60-month Extension Period.

NCT ID: NCT03383146 Terminated - Diabetes Mellitus Clinical Trials

A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 04

Start date: February 1, 2018
Phase: Phase 3
Study type: Interventional

A 52-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG) with respect to the core signs and symptoms of diabetic gastroparesis.

NCT ID: NCT03381196 Terminated - Influenza A Clinical Trials

A Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Non-Hospitalized Participants With Influenza A Infection Who Are at Risk of Developing Complications

Start date: January 21, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the clinical and virologic benefit of pimodivir in combination with Standard-of-Care (SOC) treatment compared to placebo in combination with SOC treatment.

NCT ID: NCT03376321 Terminated - Influenza A Clinical Trials

A Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Hospitalized Participants With Influenza A Infection

Start date: January 3, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the clinical and virologic benefit of pimodivir in combination with Standard-of-Care (SOC) treatment compared to placebo in combination with SOC treatment.

NCT ID: NCT03373422 Terminated - Endometriosis Clinical Trials

A Study to Test Whether Study Drug BAY1128688 Brings Pain Relief to Women With Endometriosis and if so to Get a First Idea Which Dose(s) Work Best

AKRENDO1
Start date: November 30, 2017
Phase: Phase 2
Study type: Interventional

Purpose of the study is to test whether study drug BAY1128688 brings relief for pain to women with endometriosis and if so to get a first impression which dose(s) work best.

NCT ID: NCT03339973 Terminated - Clinical trials for Peripheral Arterial Occlusive Disease

Allogeneic ABCB5-positive Stem Cells for Treatment of PAOD

Start date: March 5, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of this clinical trial is to investigate the efficacy (by monitoring the wound size reduction of Peripheral Arterial Occlusive Disease-related clinically relevant ulcers) and safety (by monitoring adverse events) of one dose of allo-APZ2-PAOD administered intramuscularly into an affected lower leg of patients with Peripheral Arterial Occlusive Disease.

NCT ID: NCT03334812 Terminated - Clinical trials for Knee Cartilage Lesion

Study on Safety, Tolerability and Prelimenary Efficacy of LNA043 in Patients Undergoing Autologous Chondrocyte Implantation

ACI
Start date: October 18, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study was to assess safety, tolerability, pharmacokinetics and preliminary efficacy of a single intra-articular (i.a.) administration of LNA043 in regenerating the articular cartilage of the knee, in a standardized clinical scenario of acute cartilage defect. The study aimed at characterizing the mechanism of action of LNA043

NCT ID: NCT03326674 Terminated - Breast Cancer Clinical Trials

Tesetaxel Plus Reduced Dose of Capecitabine vs. Capecitabine in HER2 Negative, HR Positive, LA/MBC

CONTESSA
Start date: December 21, 2017
Phase: Phase 3
Study type: Interventional

CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel in patients with HER2 negative, HR positive LA/MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. The primary objective of the study is to compare the efficacy of tesetaxel plus a reduced dose of capecitabine versus the approved dose of capecitabine alone based on progression-free survival (PFS) as assessed by the Independent Radiologic Review Committee (IRC). 685 patients were enrolled.

NCT ID: NCT03318523 Terminated - Parkinson's Disease Clinical Trials

Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants With Parkinson's Disease

SPARK
Start date: January 10, 2018
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to evaluate the clinical efficacy of BIIB054 via dose response using the change from baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score. The secondary objectives of the study are to evaluate the dose-related safety of BIIB054, to evaluate the clinical efficacy of BIIB054 via MDS-UPDRS total score, to assess the pharmacokinetic (PK) profile of BIIB054, to evaluate the clinical efficacy of BIIB054 based on MDS-UPDRS subparts, to evaluate the pharmacodynamic effects of BIIB054 on the integrity of nigrostriatal dopaminergic nerve terminals and to evaluate the immunogenicity of BIIB054.

NCT ID: NCT03308435 Terminated - Depression Clinical Trials

Effect of TF-TAVR on Emotional Status, Quality of Life, Frailty and Inflammation

Start date: November 6, 2017
Phase:
Study type: Observational

Aortic valve stenosis (AS) shows high and increasing prevalence in Western civilizations and leads to high morbidity and mortality. 15 years ago Alain Cribier performed the first catheter-based transfemoral aortic valve replacement at the University of Rouon. This historical step initiated a dramatic shift in the treatment of AS with more than 50% of patients being treated interventionally instead of the surgical approach, today. Comorbidities are major determinants of cardiovascular events and clinical outcome in aortic valve stenosis but little is known about psychiatric comorbidities or frailty in these patients. Data from our group suggest an inflammatory trigger for depression and potentially other psychiatric diseases and aortic valve stenosis as well as aortic valve replacement are associated with considerable changes in the inflammatory state of the patients. However, no study has prospectively examined the interaction of these inflammatory markers and mood disorders, yet. In addition, frailty is a key aspect of many of TAVR patients clinically, however, scientifically there is only emerging data with half of all PubMed-indexed publications being less than 18 months old and clinical use of various scores still under discussion. The " Effect of interventional aortic valve replacement on emotional status, quality of life, frailty and inflammation"-study is designed to fill these gaps in evidence. It will be a prospective epidemiological cohort study to recruit 102 patients with symptomatic severe aortic valve stenosis within 18 months. All of these patients will undergo standardized cardiologic, psychiatric and frailty assessment as well as a sophisticated laboratory analysis focussing on the inflammatory state. The study aims to integrate these interdisciplinary findings to optimize patient treatment.