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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: NCT02679378 Completed - Breast Cancer Clinical Trials

Exploratory Study Comparing ClearSight System 2D Map to Post Surgery Histopathological Analysis in Lumpectomy

Start date: October 2015
Phase:
Study type: Observational

Prospective, single-arm, multicenter, open label, non-randomized exploratory clinical study comparing ClearSight system to histopathological to determine negative-margins in breast conserving surgery.

NCT ID: NCT02679326 Completed - Plantar Fasciitis Clinical Trials

Plantar Fasciitis and Therapeutic Ultrasound

Start date: May 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether Therapeutic Ultrasound is effective in the treatment of Plantar fasciitis (PF).

NCT ID: NCT02678312 Completed - Clinical trials for Pediatric Heart Failure

Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LCZ696 Followed by a 52-week, Double-blind Study of LCZ696 Compared With Enalapril in Pediatric Patients With Heart Failure

Start date: November 3, 2016
Phase: Phase 2/Phase 3
Study type: Interventional

This study consists of two parts (Part 1 and Part 2). The purpose of Part 1 is to evaluate the way the body absorbs, distributes, metabolizes and removes the drug LCZ696. This will help determine the proper dose of LCZ696 for Part 2 of the study. The purpose for Part 2 is to compare the effectiveness and safety of LCZ696 with enalapril in a double-blind manner, in pediatric heart failure patients over 52 weeks of treatment.

NCT ID: NCT02678078 Recruiting - Cancer Clinical Trials

Characterization of Cancer Tissue Using 3D Biosynthetic Material

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

Characterization of Cancer Tissue Using 3D Biosynthetic Materials. Using liver biopsy from stage 4 cancer patients, the investigators will evaluate and characterize the metastatic cells.

NCT ID: NCT02677896 Active, not recruiting - Clinical trials for Metastatic Hormone Sensitive Prostate Cancer

A Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

ARCHES
Start date: March 9, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate the efficacy of enzalutamide plus androgen deprivation therapy (ADT) as measured by radiographic progression-free survival (rPFS) based on central review. The study also evaluated the safety of enzalutamide plus ADT in mHSPC.

NCT ID: NCT02676271 Completed - Clinical trials for Legg-Calvé-Perthes Disease

The Long Term Outcome of Varus Derotational Osteotomy for Legg-Calvé-Perthes' Disease

Start date: March 2015
Phase: N/A
Study type: Observational

Background: Varus derotation osteotomy (VDRO) is one of the most popular surgical treatments for Legg-Calvé-Perthes disease yet its long term results have not been assessed. Our purpose was to determine the long term clinical and radiographic outcomes of these patients. Methods: Forty patients (43 hips) who had undergone VDRO for LCPD who participated in a long term follow-up study a decade ago were approached for the present study. All patients were treated in our institution during 1959 to 1983 with proximal VDRO. The patients were invited to for a medical interview and a physical examination. They were also asked to fill out questionnaires and to provide or undergo a standing anteroposterior (AP) pelvic and a lateral hip radiographs during the visit. Patients were asked to self-grade their hip pain as none, mild, moderate or severe and to grade their back pain using the Visual Analogue Scale (VAS) between 0-10. Details regarding daily function, physical activity, work status and family history were obtained. All participants completed the Harris Hip Score (HHS) with a maximum score of 100 and the Short Form-36 which is composed of 8 sections and has a maximum score of 100. The physical examination included an assessment of the hip range of motion, leg length discrepancy and the presence of a Trendelenburg sign. Radiographic parameters evaluated were the Tonnis grade (with a score between 0-3), head size ratio, and the center-edge (CE) angle.

NCT ID: NCT02674308 Completed - Clinical trials for Ulcerative Colitis and Crohn's Disease

Entyvio (Vedolizumab) Long Term Safety Study

Entyvio PASS
Start date: March 24, 2015
Phase:
Study type: Observational

The purpose of this study is to assess the long-term safety of vedolizumab versus other biologic agents in participants with Ulcerative Colitis (UC) or Crohn's Disease (CD).

NCT ID: NCT02674269 Withdrawn - Overactive Bladder Clinical Trials

Safety and Efficacy Study of Intravesical Instillations of BotuGelTM, Slow Release RTGel Based Botox® Formulations, in Idiopathic OAB Patients With Urinary Incontinence ("INTIMO2")

INTIMO2
Start date: October 2016
Phase: Phase 1/Phase 2
Study type: Interventional

The study will investigate the safety and efficacy of UroGen's TC-3 Gel for sustained release of Botulinum Toxin A (BTX) in urinary bladder in patients with idiopathic overactive bladder.

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.