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NCT ID: NCT02279862 Completed - Prostate Cancer Clinical Trials

Safety and Efficacy Study of Ipilimumab 3 mg/kg Versus Ipilimumab 10 mg/kg in Subjects With Metastatic Castration Resistant Prostate Cancer Who Are Chemotherapy Naive

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

The purpose of this study is to examine the safety and effectiveness (how well the drug works) of two different doses (3 mg/kg and 10 mg/kg) of Ipilimumab (Yervoy™) in patients with metastatic castration resistant prostate cancer.

NCT ID: NCT02279654 Completed - Clinical trials for Myelodysplastic Syndrome

Non-interventional Study of Lenalidomide in the Clinical Routine Treatment of TD Patients With IPSS Low or Int-1 MDS and Isolated Del(5q)

PASS MDS del5q
Start date: December 17, 2014
Phase:
Study type: Observational [Patient Registry]

This registry is a prospective, non-interventional, post authorisation safety study for patients diagnosed with Transfusion Dependent, IPSS low or intermediate-1-Risk Myelodysplastic Syndrome (MDS), associated to a single abnormality of the chromosome 5 [del(5q)]. The purpose of this study is to collect additional data about the safety of an oral drug (lenalidomide, Revlimid®) that may have been prescribed to relieve anemia and decrease the need of blood transfusions. However, also patients affected by the MDS del(5q) who receive other treatments different from lenalidomide can be included in this study, if they agree.

NCT ID: NCT02279173 Completed - Clinical trials for Immune Thrombocytopenia

Long-term Study of Romiplostim in Thrombocytopenic Pediatric Patients With Immune Thrombocytopenia (ITP)

Start date: December 10, 2014
Phase: Phase 3
Study type: Interventional

This is a phase 3b single arm, open label, multicenter study describing the percentage of time pediatric participants with ITP have a platelet response while receiving romiplostim, defined as a platelet count ≥ 50 x 10^9/L in the absence of ITP rescue medications for the past 4 weeks.

NCT ID: NCT02279095 Completed - Clinical trials for Fibrodysplasia Ossificans Progressiva

An Open-Label Extension Study of Palovarotene Treatment in Fibrodysplasia Ossificans Progressiva (FOP)

Start date: October 9, 2014
Phase: Phase 2
Study type: Interventional

Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by heterotopic ossification (HO), i.e., abnormal bone formation, often associated with painful, recurrent episodes of soft tissue swelling (flare-ups). Lesions begin in early childhood and lead to progressive ankyloses of major joints with resultant loss of movement. In this study, the ability of different palovarotene dosing regimens to prevent the formation of new HO will be evaluated in adult and pediatric participants with FOP.

NCT ID: NCT02278640 Completed - Clinical trials for Benign Disease Where Total Hysterectomy is Indicated

Harmonic ACE®+7 Shears in Laparoscopic Hysterectomy

Start date: October 2014
Phase: Phase 4
Study type: Interventional

This is a prospective, non-randomized, single arm, multicenter, study to assess the initial clinical experience with the Harmonic ACE®+7 Shears by evaluating vessel sealing during total laparoscopic hysterectomy. The study will not modify or influence current surgeon technique. Investigators will perform each procedure using the device in compliance with their standard surgical approach and product labeling. The Harmonic ACE®+7 Shears is cleared for commercial distribution and will be used in accordance with approved product labeling. The Harmonic ACE®+7 Shears will be assembled, calibrated, and/or used in accordance with manufacturer design specifications, product instructions and guidelines

NCT ID: NCT02278341 Completed - Anemia Clinical Trials

Roxadustat in the Treatment of Anemia in End Stage Renal Disease (ESRD) Patients on Stable Dialysis

Pyrenees
Start date: November 21, 2014
Phase: Phase 3
Study type: Interventional

This study was conducted to explore a new therapy for anemia in participants with end stage renal disease (ESRD) on dialysis. Anemia is a reduced number of red blood cells or hemoglobin. Hemoglobin (which contains iron) is important for the transport of oxygen in your blood. The purpose of this study was to evaluate if roxadustat is effective and safe in the maintenance treatment of anemia in ESRD participants on stable dialysis. Roxadustat was compared to epoetin alfa and darbepoetin alfa, commercially available medicines for treatment of anemia.

NCT ID: NCT02278250 Completed - Solid Tumor Clinical Trials

First in Human Study of M4344 in Participants With Advanced Solid Tumors

Start date: January 26, 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study was to evaluate the safety and tolerability of multiple ascending doses of single-agent M4344 administered twice-weekly (BIW), twice daily (BID) or once daily dose schedule in participants with advanced solid tumors. This investigation is a three part study examining M4344 alone and in combination with carboplatin to determine the safety and maximum tolerated dose.

NCT ID: NCT02278211 Completed - Clinical trials for Coronary Artery Disease

Prediction of Recurrent Events With 18F-Fluoride

PREFFIR
Start date: October 2015
Phase:
Study type: Observational

This is a multi-centre observational study. It will make use of the positron emission tomography (PET) tracer 18F-sodium fluoride (18F-NaF) as a marker of coronary plaque vulnerability to detect culprit and non-culprit unstable coronary plaques in patients with recent myocardial infarctions. The investigators will then perform long-term follow-up of these patients to determine the prognostic significance of coronary 18F-NaF uptake

NCT ID: NCT02278172 Completed - Clinical trials for Aerobic Fitness (VO2max)

The Effects of Vitamin D Supplementation on Aerobic Fitness in Athletes

VDAF
Start date: October 2014
Phase: Phase 4
Study type: Interventional

The primary aim of the study is to identify if vitamin D3 supplementation influences VO2max in athletes. Secondary aims are to determine if vitamin D3 supplementation impacts on measures of muscle function, lung function, body composition, immune function and the self-reported incidence of upper respiratory tract infection. This double-blind, randomised, placebo-controlled trial is of parallel design and will aim to recruit a total of 50 athletes randomised into either a placebo or treatment group for a 12-week intervention.

NCT ID: NCT02277990 Completed - Clinical trials for CIED Related Infection

World-wide Randomized Antibiotic Envelope Infection Prevention Trial

WRAP-IT
Start date: January 2015
Phase: Phase 4
Study type: Interventional

Medtronic , Inc. is sponsoring the World-wide Randomized Antibiotic Envelope Infection Prevention Trial (WRAP-IT), a randomized, prospective, multi-center, single blinded, post-market, interventional clinical study. This study will evaluate the ability of the TYRX™ envelope to reduce major Cardiac Implantable Electronic Device (CIED) infections through 12-months post-procedure following CIED generator replacement, upgrade, revision, or de novo cardiac resynchronization therapy defibrillator (CRT-D) implant. Additionally, this large device study provides the unique opportunity to prospectively characterize the performance of Medtronic's lead monitoring features in subjects whose CIED system includes a transvenous right ventricular (RV) defibrillation lead. Finally, the WRAP-IT study will serve as a post-approval study for those geographies requiring a post-approval study of the TYRX™ envelope.