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NCT ID: NCT02142283 Completed - Ischemic Stroke Clinical Trials

Clinical Mismatch in the Triage of Wake Up and Late Presenting Strokes Undergoing Neurointervention With Trevo

DAWN
Start date: July 2014
Phase: N/A
Study type: Interventional

The purpose of the study is to evaluate the hypothesis that Trevo thrombectomy plus medical management leads to superior clinical outcomes at 90 days as compared to medical management alone in appropriately selected subjects experiencing an acute ischemic stroke when treatment is initiated within 6-24 hours after last seen well.

NCT ID: NCT02141399 Completed - Clinical trials for Major Depressive Disorder

A Long-Term Safety Study of ALKS 5461

Start date: May 2014
Phase: Phase 3
Study type: Interventional

This is a 52-week open-label study to evaluate the safety and tolerability of ALKS 5461.

NCT ID: NCT02141074 Completed - Clinical trials for Congenital Bleeding Disorder

Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated Patients With Haemophilia B

paradigm™6
Start date: July 2, 2014
Phase: Phase 3
Study type: Interventional

This trial is conducted globally. The aim of the trial is to investigate the safety and efficacy of nonacog beta pegol (N9-GP) in previously untreated patients with Haemophilia B.

NCT ID: NCT02139800 Completed - Preterm Birth Clinical Trials

Sustained Aeration of Infant Lungs Trial

SAIL
Start date: August 27, 2014
Phase: N/A
Study type: Interventional

This study is a 2-arm randomized, controlled, multi-center clinical trial to determine which of two strategies at birth are best to optimally aerate the lung of preterm infants. Specifically we will determine in 600 infants of 23-26 weeks gestational age (GA) requiring respiratory support at birth which of two lung opening strategies - either a standard PEEP/CPAP of 5-7 cm H2O in the delivery room (DR), as compared to early lung recruitment using Sustained Inflation (SI) in the DR, will result in a lower rate of the combined endpoint of death or bronchopulmonary dysplasia (BPD) at 36 weeks gestational age. Hypotheses: 1. Early lung recruitment with SI superimposed upon standard PEEP/CPAP in the DR will reduce the need for mechanical ventilation in the first seven days of life, and reduce need for surfactant use; and 2. A policy of DR SI on standard PEEP/CPAP recruitment will confer better outcomes at 36 weeks post-menstrual age (PMA) than standard PEEP/CPAP

NCT ID: NCT02139306 Completed - Cystic Fibrosis Clinical Trials

Study of Ataluren in Nonsense Mutation Cystic Fibrosis (ACT CF)

Start date: August 2014
Phase: Phase 3
Study type: Interventional

This is a Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, efficacy and safety study of ataluren in patients with nonsense mutation cystic fibrosis (nmCF) not receiving chronic inhaled aminoglycosides.

NCT ID: NCT02137850 Completed - Clinical trials for Congenital Bleeding Disorder

Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Previously Untreated Patients With Haemophilia A

pathfinder™6
Start date: June 26, 2014
Phase: Phase 3
Study type: Interventional

This trial is conducted globally. The aim of the trial is to investigate the safety and efficacy of turoctocog alfa pegol (N8-GP) in previously untreated patients (PUPs) with haemophilia A.

NCT ID: NCT02136862 Completed - Clinical trials for Alport Syndrome Patients With eGFR Between 45-90 ml/Min/1.73 m2

ATHENA: Natural History of Disease Study in Alport Syndrome Patients

RG012-01
Start date: September 4, 2014
Phase:
Study type: Observational

There is limited published clinical data about the natural history of renal disease in Alport syndrome. The RG012-01 study will collect data to characterize the progression of renal dysfunction in Alport syndrome patients. Patients with a confirmed diagnosis of Alport syndrome who have qualifying GFR will be considered for enrollment. The sequential sampling of subjects' urine and/or blood will allow an assessment of the rate of change of established clinical endpoints, such as GFR and/or the rate of change of other renal biomarkers (proteinuria and β-2 microglobulin) in subjects whose renal function is steadily declining. The identification of surrogate markers that track the decline of renal function and could correlate with time to end-stage renal disease (ESRD) is a key goal of the natural history study.

NCT ID: NCT02136615 Completed - Clinical trials for Overweight and Obesity

Does Hyperbaric Oxygen Therapy Lead to a Sustained Increase in Insulin Sensitivity?

HOTAIR3
Start date: July 2014
Phase: N/A
Study type: Observational

In a recent series of studies performed by our group, we have shown that exposure to hyperbaric oxygen (HBOT) leads to an increase in insulin sensitivity in male subjects and that this improvement can be measured in all men, not just those with diabetes. The aim of this study is to investigate the time course of this effect and explore the mechanisms involved when exposure to HBOT induces an increase in peripheral insulin sensitivity. Aims: 1. To determine whether the insulin sensitising effect of HBOT is apparent 24-hours after an HBO session. 2. To examine mechanisms underpinning the increase in insulin sensitivity following HBOT.

NCT ID: NCT02136134 Completed - Multiple Myeloma Clinical Trials

Addition of Daratumumab to Combination of Bortezomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma

Start date: August 15, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the effects of administration of daratumumab when combined with VELCADE (bortezomib) and dexamethasone compared with bortezomib and dexamethasone alone, for participants with relapsed or refractory multiple myeloma.

NCT ID: NCT02135692 Completed - Asthma Clinical Trials

A Phase 3a, Repeat Dose, Open-label, Long-term Safety Study of Mepolizumab in Asthmatic Subjects

Start date: May 29, 2014
Phase: Phase 3
Study type: Interventional

This is a multi-center, open-label, long-term study of subcutaneously (SC) administered mepolizumab 100mg in addition to standard of care (SOC), in subjects with severe eosinophilic asthma. This study will enroll a subset of subjects from Study MEA115661 who have demonstrated clear benefit from therapy and who without continuation of mepolizumab therapy are individuals at greatest risk of serious deterioration of their health status. In order to target individuals at greatest risk for serious deterioration of their health status, only subjects from the MEA115661 study with a history of life-threatening or seriously debilitating asthma, will be allowed to participate. Subjects meeting all of the eligibility criteria for the study will be offered the opportunity to consent for this study of up to 128 weeks in length (including the Follow-Up Visit). This study will give opportunity to extend the collection of clinical data for long-term use and further assess the sustainability of efficacy in a population likely to experience significant loss of asthma control and the need for higher doses of systemic steroids if returned to SOC only.