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NCT ID: NCT02679404 Terminated - Aortic Stenosis Clinical Trials

Sorin Universal REgistry on Aortic Valve Replacement

SURE-AVR
Start date: May 2015
Phase:
Study type: Observational

Multi-center, International, Prospective, Non comparative, Non randomized, Open label. 5,000 patients to be enrolled approximately worldwide. The objective of this registry is to collect safety and clinical performance post market data related to the procedure and follow-up of the Sorin Group aortic valve devices in accordance with the Instructions for Use (IFU). This observational global registry is intended to collect data without requiring any deviation from the standard of care and IFU in each participating center. The participating centers shall include those patients that have provided their informed consent to participate in this registry in accordance with the local applicable regulations.

NCT ID: NCT02678715 Terminated - Clinical trials for Temporomandibular Joint Dysfunction Syndrome

Effectiveness of Three Oral Devices as Mouthguard in Electroconvulsive Therapy. Randomized Crossover Clinical Trial.

Start date: February 2016
Phase: N/A
Study type: Interventional

This observer-blind crossover intervention study aims to determine the most effective type of device as oral mouthguard in modified-Electroconvulsive Therapy (m-ECT) comparing three types of devices: standard, prefabricated and manufactured in the dental laboratory. Patients from the ECT Unit of Psychiatric Department of the University Hospital of Bellvitge will use the three devices at a random sequence during the twelve treatment sessions, so each device (A, B, C) will be used for two weeks, that is, for four consecutive sessions.

NCT ID: NCT02673697 Terminated - Aortic Stenosis Clinical Trials

Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement

PERSIST-AVR
Start date: March 22, 2016
Phase: N/A
Study type: Interventional

Prospective, randomized, stratified non blinded multi-center, international, post market trial assessed in a non-inferiority study. The trial has a flexible sample size that will be determined adaptively. The trial will enroll up to 1234 subjects, but accrual may stop earlier at approximately 900 or 1050 subjects These subjects will be enrolled at approximately 60 worldwide investigational sites where the device is commercially available The primary objective of this trial is to test the safety and efficacy of Perceval versus standard sutured stented bioprosthetic aortic valves among the intended trial population.

NCT ID: NCT02671344 Terminated - Clinical trials for Donor Site Complication

Determining the Genetic Profile in Semen Donors With Pregnancy, Donor Versus no Pregnancy Obtained in TRA

Start date: April 2015
Phase:
Study type: Observational

Microarray experiments to assess the expression of thousands of genes providing vast amount of information. Because the molecular requirements in the different processes related to playback,on the hypothesis that there may be more apt semen samples for technical or other assuming molecular differences in RNA content messengers or gene expression profile between the They getting semen samples in gestation versus those who do not. In an attempt to give a functional data obtained view, it is to find out how many of these genes in donors who have obtained gestation, they are differentially expressed in playback related processes against those donors who did not get pregnant.

NCT ID: NCT02670330 Terminated - Clinical trials for Epidermolysis Bullosa

Open Label Extension Study to Evaluate the Long-term Safety of Zorblisa (SD-101-6.0) in Patients With Epidermolysis Bullosa

Start date: June 9, 2015
Phase: Phase 3
Study type: Interventional

The study aimed to assess the long-term safety of topical use of Zorblisa (SD-101-6.0) in participants with Epidermolysis Bullosa (EB).

NCT ID: NCT02670083 Terminated - Alzheimer's Disease Clinical Trials

A Study Evaluating the Efficacy and Safety of Crenezumab Versus Placebo in Participants With Prodromal to Mild Alzheimer's Disease (AD).

CREAD
Start date: March 22, 2016
Phase: Phase 3
Study type: Interventional

This randomized, double-blind, placebo-controlled, parallel group study will evaluate the efficacy and safety of crenezumab versus placebo in participants with prodromal to mild AD. Participants will be randomized 1:1 to receive either intravenous (IV) infusion of crenezumab or placebo every 4 weeks (Q4W) for 100 weeks. The final efficacy and safety assessment will be performed 52 weeks after the last crenezumab dose. Participants will then have the option to enter the Open Label Extension (OLE) study if eligible. Participants who do not enter the OLE study will have additional follow-up visits at 16 and 52 weeks after the last dose, primarily for safety and also for limited efficacy assessments.

NCT ID: NCT02660359 Terminated - Clinical trials for Urinary Incontinence

Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 2

CONTENT2
Start date: July 8, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to provide confirmatory evidence of the safety and efficacy of two Dysport® doses (600 units [U] and 800 U), compared to placebo in reducing urinary incontinence (UI) in adult subjects treated for neurogenic detrusor overactivity (NDO) due to spinal cord injury (SCI) or multiple sclerosis (MS).

NCT ID: NCT02657356 Terminated - Clinical trials for Connective Tissue Disease-Associated Pulmonary Arterial Hypertension

Bardoxolone Methyl in Patients With Connective Tissue Disease-associated Pulmonary Arterial Hypertension - CATALYST

Start date: October 4, 2016
Phase: Phase 3
Study type: Interventional

This study assesses the safety and efficacy of bardoxolone methyl relative to placebo in patients with connective tissue disease-associated pulmonary arterial hypertension to determine the recommended dose range and evaluate the change from baseline in 6-minute walk distance (6MWD) following 24 weeks of study participation.

NCT ID: NCT02656329 Terminated - Heart Failure Clinical Trials

International Study to Determine if AdreView Heart Function Scan Can be Used to Identify Patients With Mild or Moderate Heart Failure (HF) That Benefit From Implanted Medical Device

ADMIRE-ICD
Start date: December 30, 2015
Phase: Phase 3
Study type: Interventional

This is an event-driven Phase IIIb, multicentre, randomised, clinical study to demonstrate the efficacy of AdreView™ imaging for appropriately guiding the decision of implantable cardioverter defibrillator (ICD) implantation, in New York Health Association (NYHA) class II and III heart failure participants with 25%<=left ventricular ejection fraction (LVEF)<=35%, and in particular, for identifying participants who are at low risk for sudden cardiac death and who would not benefit, or may suffer harm, from implantation of an ICD device.

NCT ID: NCT02655159 Terminated - Breast Neoplasms Clinical Trials

Study of Nab-paclitaxel (Abraxane®) Treatment in Patients With Metastatic Breast Cancer in Routine Clinical Practice

AMBER
Start date: January 2016
Phase: N/A
Study type: Observational

This is a national, multicenter, retrospective, observational post-authorization study (EPA-OD) study. The study will be conducted by reviewing the medical records of patients up to the start of the study. In each case, only data from before the start of the study will be obtained in order to ensure they are retrospective in nature, thus reflecting the regular use of nab-paclitaxel in clinical practice and avoiding interference with the physician's clinical practice. To ensure the observational nature of this study, these data will be collected whenever they are available in the patient's medical record, and so no diagnostic or therapeutic intervention outside regular clinical practice will be used.