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NCT ID: NCT01773746 Terminated - Clinical trials for Extreme Prematurity - Less Than 28 Weeks

Study of Room Air Versus 60% Oxygen for Resuscitation of Premature Infants

PRESOX
Start date: August 2013
Phase: N/A
Study type: Interventional

The most appropriate initial oxygen concentration for the resuscitation of the extremely low birth weight infant has not been established using large well designed, randomized, blinded, prospective trials and the level of oxygen utilized by practitioners in this situation is highly variable. This proposed trial will use targeted oxygen saturation levels over the first 15 to 20 minutes of life to compare a low and a higher initial oxygen level for the resuscitation of such infants, and will be large enough to evaluate short term outcomes of survival without oxygen at 36 weeks and survival without retinopathy of prematurity, and the long term outcome of survival without significant neurodevelopmental impairment at 2 years of age. Such information is urgently required to provide an evidence basis for the initial oxygen concentration for resuscitation of these very preterm infants.

NCT ID: NCT01773460 Terminated - Clinical trials for Metastatic Breast Cancer

Everolimus Beyond Progress for Patients Who Had Progress Under Everolimus and Exemestane

Evelyn
Start date: July 2013
Phase: Phase 3
Study type: Interventional

Everolimus will be given to patients with metastatic breast cancer who already has a progress taking Everolimus but with a change in the endocrine treatment.

NCT ID: NCT01773187 Terminated - Clinical trials for Primary Myelofibrosis

Pacritinib Versus Best Available Therapy to Treat Myelofibrosis

Start date: January 2013
Phase: Phase 3
Study type: Interventional

Phase 3, randomized, controlled study to evaluate the safety and efficacy of oral pacritinib compared to Best Available Therapy (BAT) in patients with primary or secondary myelofibrosis.

NCT ID: NCT01772108 Terminated - Clinical trials for Cardiovascular Diseases

A Randomized Study of the MitraClip Device in Heart Failure Patients With Clinically Significant Functional Mitral Regurgitation

RESHAPE-HF
Start date: April 2013
Phase: N/A
Study type: Interventional

This trial is a randomized study of the MitraClip device in heart failure patients with clinically significant functional mitral regurgitation. A hierarchical composite of all-cause mortality and recurrent heart failure hospitalizations is hypothesized to occur at a lower rate with the use of the MitraClip device in addition to optimal standard medical therapy compared to optimal standard of care therapy alone.

NCT ID: NCT01770158 Terminated - Clinical trials for Acute Myeloid Leukemia

Maintenance Therapy With Histamine Dihydrochloride and Interleukin-2 in Adult Acute Myeloid Leukemia (AML) Patients With Measurable Minimal Residual Disease (MRD)- a Non-interventional Study (NIS)

Start date: October 2012
Phase:
Study type: Observational

This is a non-interventional multi-center study (NIS) in adult patients with AML in first complete remission with measurable minimal residual disease (MRD). Patients are eligible when gene status was already determined for previous induction and consolidation therapy of AML and showed carrier of NPM1, CBFβ-MYH11, or MLL-AF9 mutation. The study objective is to observe the impact of pre-emptive therapy with histamine dihydrochloride (HDC) and interleukin-2 (IL-2) with regard to assess leukemia-free survival/time to relapse and to monitor MRD level trend over time. HDC and IL-2 are approved drugs for AML patients in first complete remission. Therapy is administered for 10 treatment cycles as outlined in the Summary of Product Characteristics.

NCT ID: NCT01769196 Terminated - Clinical trials for Idiopathic Pulmonary Fibrosis

A Phase 2 Study to See if Simtuzumab (GS-6624) is Safe and Works in Idiopathic Pulmonary Fibrosis (IPF)

RAINIER
Start date: January 2013
Phase: Phase 2
Study type: Interventional

This study is to evaluate the efficacy and safety of simtuzumab (GS-6624) in adults with idiopathic pulmonary fibrosis.

NCT ID: NCT01769053 Terminated - Acute Lung Injury Clinical Trials

Variable Pressure Support Trial

ViPS
Start date: January 2013
Phase: N/A
Study type: Interventional

In 2008 a new ventilation strategy termed variable Pressure Support ventilation (PSV) was introduced, which is able to increase the variability of the respiratory pattern independent from the inspiratory effort. In experimental lung injury, variable PSV was found to improve gas exchange and decrease the inspiratory effort, while reducing alveolar edema and inflammatory infiltration compared to conventional(non-variable) PSV. Importantly, variable PSV reduced peak airway pressure and respiratory system elastance in a variability dependent manner.In addition, preliminary observations suggest that variable PSV can reduce the work of breathing and improve patient comfort, but it is not known whether this new ventilatory strategy is able to speed the weaning from mechanical ventilation. Since variable PSV can reduce the mean pressure support, it may lead to a faster reduction of pressure support and, therefore, a shorter weaning period than conventional PSV. The hypothesis of this study is that variable pressure support ventilation reduces the duration of mechanical ventilation to non-variable (conventional) pressure support ventilation.

NCT ID: NCT01764997 Terminated - Clinical trials for Rheumatoid Arthritis

An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate

RA-COMPARE
Start date: April 2013
Phase: Phase 3
Study type: Interventional

Primary Objective: To demonstrate the treatment effect of sarilumab and methotrexate (MTX) compared to etanercept and methotrexate (MTX) in patients with rheumatoid arthritis (RA) and an inadequate response to adalimumab and methotrexate by evaluation of the Disease Activity Score for 28 joints (DAS28). Secondary Objectives: To assess the signs and symptoms of rheumatoid arthritis (RA) in patients taking sarilumab in combination with methotrexate (MTX). To assess the quality of life of patients with rheumatoid arthritis (RA) taking sarilumab in combination with methotrexate (MTX). To assess the safety and tolerability of sarilumab in combination with methotrexate (MTX) in patients with rheumatoid arthritis (RA).

NCT ID: NCT01759238 Terminated - Colorectal Cancer Clinical Trials

Chemoradiotherapy for Patients With Oligometastatic Colorectal Cancer

OLGA
Start date: May 2013
Phase: Phase 2
Study type: Interventional

This study tries to evaluate the role of chemoradiation with capecitabine and bevacizumab in oligometastatic patients neither being progressive nor resectable after chemotherapy.

NCT ID: NCT01755871 Terminated - Clinical trials for Relapsing Remitting Multiple Sclerosis

Long-term Effect of Fingolimod on Circulating Immunocompetent Mononuclear Cells in Patients With Multiple Sclerosis

BiobankII
Start date: January 2013
Phase: Phase 4
Study type: Interventional

The purpose of this study is to explore immunomodulatory and immunosuppressive mechanisms of action of fingolimod in patients with Relapsing remitting multiple Sclerosis to collect data on biomarkers after initiation of fingolimod treatment.