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NCT ID: NCT02329769 Terminated - Clinical trials for Duchenne Muscular Dystrophy

Open Label, Extension Study of PRO044 in Duchenne Muscular Dystrophy (DMD)

Start date: December 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to see whether PRO044 is safe and effective to use as medication for Duchenne Muscular Dystrophy (DMD) patients with a mutation around location 44 in the DNA for the dystrophin protein.

NCT ID: NCT02324556 Terminated - Colorectal Neoplasm Clinical Trials

A LAparoscopic and TransAnal Total Mesorectal Excision (TME) for Rectal Cancer Trial

LATA
Start date: January 2015
Phase:
Study type: Observational

All patients planned for an anterior resection due to rectal cancer with a total mesorectal excision are included. This is a feasibility study, thus no randomization will be performed. Primary endpoint is clinical and pathologic examination of the specimen. Secondary end-points include clinical variables such as conversion rate, re-admission and/or re-operation due to any complication and health economy analyses.

NCT ID: NCT02313909 Terminated - Stroke Clinical Trials

Rivaroxaban Versus Aspirin in Secondary Prevention of Stroke and Prevention of Systemic Embolism in Patients With Recent Embolic Stroke of Undetermined Source (ESUS)

NAVIGATE ESUS
Start date: December 23, 2014
Phase: Phase 3
Study type: Interventional

This is a study in patients who recently had a brain attack (stroke) and in whom no clear cause of the stroke could be identified. These strokes are likely due to a blood clot and therefore, can be called embolic stroke of undetermined source. The abbreviation is ESUS. The study will compare 2 blood thinners. Patients will be randomly assigned to either Rivaroxaban 15 mg or Aspirin 100 mg and the study is intended to show, if patients given rivaroxaban have fewer blood clots in the brain (stroke) or in other blood vessels.

NCT ID: NCT02311088 Terminated - Dyspnea Clinical Trials

Trial of Caffeine to Alleviate Dyspnea Related to Ticagrelor

TROCADERO
Start date: December 2014
Phase: Phase 2
Study type: Interventional

Ticagrelor treatment is associated with increased rates of dyspnea, where previous studies have implied a possible role of adenosine. The purpose of this study is to determine if the caffeine-antagonist is effective in reducing dyspnea related to ticagrelor.

NCT ID: NCT02308111 Terminated - Clinical trials for Liver Cirrhosis, Biliary

Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis

COBALT
Start date: December 26, 2014
Phase: Phase 4
Study type: Interventional

Primary Biliary Cholangitis (PBC) is a serious, life-threatening, bile acid related liver disease of unknown cause. Without treatment, it frequently progresses to liver fibrosis and eventual cirrhosis requiring liver transplantation or resulting in death. The investigational drug, Obeticholic Acid (OCA) is a modified bile acid and FXR agonist that is derived from the primary human bile acid chenodeoxycholic acid. The key mechanisms of action of OCA, including its choleretic, anti-inflammatory, and anti-fibrotic properties, underlie its hepatoprotective effects and result in attenuation of injury and improved liver function in a cholestatic liver disease such as PBC. The study will assess the effect of OCA compared to placebo, combined with stable standard care, on clinical outcomes in PBC participants.

NCT ID: NCT02301585 Terminated - Shock, Septic Clinical Trials

Optimization of Fluid Therapy in Sepsis by a Passive Leg Raising Test

OFTaPLR
Start date: February 2014
Phase: N/A
Study type: Interventional

A randomized controlled clinical trial to evaluate whether a passive leg raising test to guide fluid therapy of patients with septic shock can reduce fluid balance and weight gain. Patients will be treated according to an algorithm in which the indexed stroke volume (stroke volume related to body surface area) and mean arterial pressure will guide the timing and amount of fluid and the use of inotropic and vasoactive support. Patients will be randomized to either an intervention group in which a passive leg raising test will be made prior to any decision for fluid administration or to a control group where this test is not performed and fluid administration is carried out according to standard of care at the department. Hypothesis: A passive leg raising test, will reduce weight gain by day 3 by 30%.

NCT ID: NCT02292771 Terminated - Clinical trials for Obstetric Labour, Premature

A Randomized Study Comparing the Efficacy and Safety of Retosiban Versus Atosiban for Women in Spontaneous Preterm Labour

Start date: March 16, 2015
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to demonstrate the superiority of retosiban to prolong pregnancy in females with spontaneous preterm labor compared with atosiban. This objective is based on the hypothesis that prolonging the time to delivery in the absence of harm may benefit the newborn, particularly in women who experience spontaneous preterm labor at early gestational ages (GA). This study is designed to test this hypothesis through a direct comparison with atosiban, a mixed oxytocin vasopressin antagonist indicated for short-term use to delay imminent preterm birth in women between 24^0/7 and 33^6/7 weeks' gestation in preterm labor. This is a randomized, double-blind, double-dummy study, which consists of 6 phases: Screening, Inpatient Randomized Treatment, Post Infusion Assessment, Delivery, Maternal Post Delivery Assessment, and Neonatal Medical Review. Approximately 330 females will be randomly assigned to retosiban or atosiban treatment in a 1:1 ratio. The duration of any one subject's (maternal or neonatal) participation in the study will be variable and dependent on GA at study entry and the date of delivery.

NCT ID: NCT02281721 Terminated - Cerebral Aneurysm Clinical Trials

Surpass Flow Diverter for Intracranial Aneurysms: SURMOUNT Registry Data Collection

Start date: March 18, 2015
Phase:
Study type: Observational [Patient Registry]

The purpose of this observational post-marketing registry will be to collect and analyze safety, effectiveness, and quality of life outcomes, during and after treatment with the Surpass Flow Diverter. Health Economics assessments (cost data) will also be collected and analyzed.

NCT ID: NCT02247531 Terminated - Geographic Atrophy Clinical Trials

A Study Investigating the Safety and Efficacy of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration

SPECTRI
Start date: October 6, 2014
Phase: Phase 3
Study type: Interventional

This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled study evaluating the efficacy and safety of lampalizumab administered by intravitreal injections in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

NCT ID: NCT02240355 Terminated - Clinical trials for Muscular Atrophy, Spinal

A Study of RO6885247 in Adult and Pediatric Patients With Spinal Muscular Atrophy (MOONFISH)

Start date: November 2014
Phase: Phase 1
Study type: Interventional

This multicenter, randomized, double-blind, 12-week, placebo-controlled multiple dose study will investigate the safety and tolerability of RO6885247 in adult and pediatric patients with spinal muscular atrophy (SMA).