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NCT ID: NCT01288378 Completed - Leukemia Clinical Trials

Empirical Versus Preemptive Antifungal Therapy

Start date: March 2012
Phase: Phase 3
Study type: Interventional

RATIONALE: Caspofungin acetate may be effective in treating fungal infections in patients with acute myeloid leukemia or myelodysplastic syndrome who are receiving treatment for their cancer. It is not yet known whether caspofungin acetate is more effective when treatment starts after development of a fever or after the infection is shown in laboratory test, chest x-ray, or CT scan. PURPOSE: This randomized phase III trial is studying the best time to start caspofungin acetate therapy in treating patients with acute myeloid leukemia or myelodysplastic syndrome that is newly diagnosed or in first relapse.

NCT ID: NCT01288352 Completed - Stroke Clinical Trials

Early Treatment of Atrial Fibrillation for Stroke Prevention Trial

EAST
Start date: July 1, 2011
Phase: Phase 4
Study type: Interventional

EAST prospectively tests the hypothesis that an early, structured rhythm control therapy based on antiarrhythmic drugs and catheter ablation can prevent atrial fibrillation (AF) related complications in patients with AF when compared to usual care. Patients will be randomized to early therapy or usual care. In the early therapy group, patients will receive either catheter ablation (usually by pulmonary vein isolation), or adequate antiarrhythmic drug therapy at an early time point. The initial therapy will be selected by the local investigator. Upon AF recurrence, both modalities will be combined. Usual care will be conducted following the 2010European Society of Cardiology ( ESC )guidelines for AF treatment. Early rhythm control therapy will be guided by Electrocardiogram (ECG) monitoring.

NCT ID: NCT01288027 Completed - Clinical trials for Pompe Disease (Late-Onset)

Exploratory Muscle Biopsy Assessment Study in Patients With Late-Onset Pompe Disease Treated With Alglucosidase Alfa

Start date: June 2011
Phase: Phase 4
Study type: Interventional

This is an open-label, multicenter study of participants with late-onset Pompe disease naive to treatment with enzyme replacement therapy (ERT). The primary objective of this study is to evaluate glycogen clearance in muscle tissue samples collected pre and post alglucosidase alfa treatment in participants with Late-Onset Pompe disease. The secondary objectives are to characterize the disease burden in participants with late-onset Pompe disease and explore imaging, histologic, and functional assessments in these participants and to explore potential plasma or urine biomarkers relative to late-onset Pompe disease and participant's response to treatment with alglucosidase alfa (Myozyme®/Lumizyme®/GZ419829).

NCT ID: NCT01287715 Recruiting - Clinical trials for Juvenile Idiopathic Arthritis

Withdrawal of Etanercept After Successful Treatment of Juvenile Idiopathic Arthritis

ABC-STOP
Start date: January 2011
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether etanercept can be withdrawn successfully (i.e. no occurrence of flares) in juvenile idiopathic arthritis (JIA) patients in whom disease remission is reached. Goals: 1. to investigate in a randomized controlled trial: - which proportion of JIA patients in remission can successfully discontinue etanercept compared to JIA patients in remission who continue etanercept; - if time in remission on etanercept is an important factor in retaining remission after discontinuation of etanercept. 2. to investigate in alle JIA patients who discontinue etanercept (including the control group): - predicting factors (patient or disease characteristics, including time in remission, and MRP8/MRP14) for successfully discontinuation of etanercept; - the disease course after discontinuation of etanercept (time to flare) and the effect of restarting etanercept after flaring.

NCT ID: NCT01287325 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Efficacy of DNK333 in Patients With COPD and Cough

Start date: September 2003
Phase: Phase 1/Phase 2
Study type: Interventional

This study evaluates the efficacy and safety of two weeks treatment of DNK333 in patients with COPD and cough.

NCT ID: NCT01286896 Recruiting - Clinical trials for Malignant Solid Tumour

Use of Individual Pharmacokinetically (PK)-Guided Sunitinib Dosing: A Feasibility Study in Patients With Advanced Solid Tumors

Start date: March 2011
Phase: Phase 1
Study type: Interventional

The purpose of this prospective study is to determine the safety and feasibility of pharmacokinetically (PK) guided dosing of sunitinib in 30 patients. At day 15 ± 1day, day 29 ± 1day and after 8 weeks ± 1day of sunitinib treatment sunitinib and SU12662 trough levels will be measured. Depending on the sunitinib and SU12662 trough levels (and toxicity) dose adjustments will be made.

NCT ID: NCT01286831 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

A Single Dose Study to Determine the Excretion, Balance and Metabolic Disposition of Radiolabelled GW642444.

Start date: May 18, 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to characterise the metabolic disposition of radiolabelled GW642444 when administered orally.

NCT ID: NCT01286753 Active, not recruiting - Neoplasms Clinical Trials

A Study of RO5185426 (Vemurafenib) in Patients With Metastatic or Unresectable Papillary Thyroid Cancer Positive for the BRAF V600 Mutation

Start date: June 2011
Phase: Phase 2
Study type: Interventional

This open-label, multi-center study will evaluate the safety and efficacy of RO5 185426 in patients with metastatic or unresectable papillary thyroid cancer posi tive for the BRAF V600 mutation and resistant to radioactive iodine therapy. Pat ients will receive RO5185426 960 mg orally twice daily until progressive disease or unacceptable toxicity occurs.

NCT ID: NCT01286545 Not yet recruiting - Clinical trials for Ankylosing Spondylitis

European Ankylosing Spondylitis Infliximab Cohort (EASIC) Follow up Registration Study

EASIC registry
Start date: February 2011
Phase: N/A
Study type: Observational

Long term data on efficacy and safety of anti-TNF treatment with infliximab in patients with ankylosing spondylitis (AS) beyond 5 years is lacking. These data are important because patients with AS usually are younger and withdrawal of anti-TNF therapy in these patients almost always leads to a disease relapse. Furthermore it is still unclear whether long term anti-TNF treatment in AS patients can inhibit radiographic progression. Patients who participated in the EASIC and the DIKAS trial respectively who were treated with infliximab within these studies for 7 and 10 years respectively are followed up by using clinical outcome parameters every 6 months assessing efficacy and safety of long term treatment. Furthermore radiographs of the spine, if done for clinical indication, are analyzed. It is hypothesized that anti-TNF treatment with infliximab is effective and safe over a time period of 9 and 12 years respectively and that long term anti-TNF therapy may inhibit radiographic progression of the spine.

NCT ID: NCT01286116 Terminated - Heart Failure Clinical Trials

A Multinational Trial To Evaluate The Parachute Implant System

PARACHUTE
Start date: May 2011
Phase: Phase 3
Study type: Interventional

The primary objective is to assess the safety of the CardioKinetix Parachute Implant and Delivery System in the partitioning of the left ventricle in patients with heart failure due to ischemic heart disease.