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NCT ID: NCT01288560 Completed - Clinical trials for Coronary Artery Disease

IMAGE-HF Project I-A: Cardiac Imaging in Ischemic Heart Failure (AIMI-HF)

AIMI-HF
Start date: January 2011
Phase: N/A
Study type: Interventional

Medical imaging is one of the fastest growing sectors in health care and increases in utilization underscore the need to ensure imaging technology is developed and used effectively. Evaluation of the clinical and economic impact of such imaging lags behind the technology development. Heart failure (HF) represents the final common pathway for most forms of heart disease and morbidity and mortality remain high. There is a need to identify imaging approaches that have a positive impact on therapy decisions, patient outcomes and costs. As well as standard methods to evaluate new and emerging techniques to better test their potential in a clinical management setting. PRIMARY OBJECTIVES: to compare the effect of HF imaging strategies on the composite clinical endpoint of cardiac death, MI, resuscitated cardiac arrest and cardiac re-hospitalization (WHF, ACS, arrhythmia). Patients with an ischemic heart disease (IHD) etiology will follow HF imaging strategy algorithms according to the question(s) asked by the physicians (is there ischemia and/or viability), in agreement with their local practices for standard and alternative imaging. SECONDARY OBJECTIVES: 1. To evaluate the effect of imaging modalities within and between the imaging subgroups (advanced (CMR and PET), PET, MRI and standard (SPECT)) on the primary and secondary outcomes in patients being evaluated either for viability and/or ischemia. 2. To evaluate the impact of adherence to recommendations between modalities on outcomes in patients being evaluated for either viability or ischemia. 3. To compare the effect of HF imaging strategies on: 1. The incidence of revascularization procedures (PCI, CABG, none) and the interaction of the imaging strategy and types of revascularization on outcomes 2. LV remodeling: LV volumes, LVEF, 3. HF symptoms, NYHA class 4. QOL (MLHFQ, the EQ5D) 5. The evolution of serum prognostic markers in HF (e.g. BNP, RDW, hs-cTnT, hs-CRP, ST2) 6. Health economics: Costs estimated through regression analysis and cost effectiveness assessed through decision modeling. 7. The safety of imaging tests measured by cumulative radiation, adverse reactions to imaging contrast agents and stress testing agents will also be determined. 8. The evolution of renal function (eGFR) and LV remodeling-associated biomarkers (e.g. PIIINP, OPN). 9. Event rates of each component of the composite endpoint as well as the combined endpoint of CV death and HF hospitalization 10. All-cause mortality

NCT ID: NCT01287741 Terminated - Clinical trials for Diffuse Large B-Cell Lymphoma

A Study of Obinutuzumab in Combination With CHOP Chemotherapy Versus Rituximab With CHOP in Participants With CD20-Positive Diffuse Large B-Cell Lymphoma (GOYA)

Start date: July 26, 2011
Phase: Phase 3
Study type: Interventional

This open-label, randomized, parallel group study will evaluate the efficacy and safety of obinutuzumab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisolone or prednisone (CHOP) chemotherapy versus rituximab (MabThera/Rituxan) with CHOP in previously untreated participants with cluster of differentiation 20 (CD20)-positive diffuse large B-cell lymphoma (DLBCL). Participants will be randomized to receive either obinutuzumab 1000 milligrams (mg) intravenously (IV) every 21 days or rituximab 375 milligrams per square meter (mg/m^2) IV every 21 days for 8 cycles, in addition to 6-8 cycles of CHOP chemotherapy IV every 21 days. Participants randomized to the obinutuzumab arm will receive an additional two doses on Days 8 and 15 of Cycle 1. Anticipated time on study treatment is 24 weeks.

NCT ID: NCT01286779 Completed - Hemophilia B Clinical Trials

BAX 326 (rFIX) Continuation Study

Start date: April 12, 2011
Phase: Phase 3
Study type: Interventional

The purpose of this BAX 326 Continuation Study is to further investigate incremental recovery over time, the hemostatic efficacy, the safety, immunogenicity, and health-related quality of life (HR QoL) of BAX 326 in previously treated patients (PTPs) with severe and moderately severe hemophilia B who participated in BAX 326 pivotal study 250901 or BAX 326 pediatric study 251101.

NCT ID: NCT01285609 Completed - Clinical trials for Lung Cancer - Non Small Cell Squamous

Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Versus Placebo in Addition to Paclitaxel and Carboplatin

Start date: January 16, 2011
Phase: Phase 3
Study type: Interventional

The purpose of the study is to determine whether Ipilimumab plus Paclitaxel and Carboplatin will extend the lives of patients with squamous only non small cell lung cancer more than placebo plus Paclitaxel and Carboplatin.

NCT ID: NCT01285557 Terminated - Clinical trials for Metastatic Diffuse Gastric Cancer Including Carcinoma of the Gastro-esophageal Junction

Diffuse Gastric and Esophagogastric Junction Cancer S-1 Trial

DIGEST
Start date: April 14, 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of S-1 and Cisplatin compared to 5-FU and Cisplatin in treatment of patients with metastatic diffuse gastric and gastro-esophageal junction cancer previously untreated with chemotherapy.

NCT ID: NCT01285479 Recruiting - Multiple Sclerosis Clinical Trials

The Gilenya Pregnancy Registry

Start date: October 15, 2011
Phase:
Study type: Observational [Patient Registry]

The purpose of the Multi-National Gilenya Pregnancy Exposure Registry in Multiple Sclerosis (MS) is to continuously monitor, evaluate, and assess for major and minor teratogenic effects in the offspring of women exposed to fingolimod before (up to 8 weeks before last menstrual period (LMP)) and during pregnancy in routine clinical practice. The overall aim is to collect and evaluate data on maternal, fetal, and infant outcomes and compare it with reference populations.

NCT ID: NCT01285323 Completed - Eosinophilic Asthma Clinical Trials

A Study to Evaluate the Efficacy and Safety of Reslizumab in Patients With Eosinophilic Asthma

Start date: March 2011
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to determine whether reslizumab is more effective than placebo in reducing the number of clinical asthma exacerbations (CAEs) in patients with eosinophilic asthma.

NCT ID: NCT01283594 Completed - Parkinson's Disease Clinical Trials

Safety and Efficacy Study of SYN115 in Parkinson's Patients Using Levodopa to Treat End of Dose Wearing Off

Start date: March 2011
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this research study is to test the effect of SYN115 compared to placebo (a "sugar pill" that looks like SYN115 but does not include active drug) on movement during the "on" and "off" states as well as other symptoms that some patients with Parkinson's disease experience. This study will also look at whether or not patients with Parkinson's disease experience "side-effects" with SYN115.

NCT ID: NCT01283139 Completed - Clinical trials for Systemic Lupus Erythematosus

A Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus

Start date: March 31, 2011
Phase: Phase 2
Study type: Interventional

To evaluate the efficacy and safety of sifalimumab compared to placebo in subjects with moderately to severely active Systemic Lupus Erythematosus (SLE).

NCT ID: NCT01281306 Completed - Clinical trials for Systolic Hypertension

An 8-week Study to Evaluate the Dose Response of AHU377 in Combination With Valsartan 320 mg in Patients With Mild-to-moderate Systolic Hypertension

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

The purpose of the study is to evaluate dose response of blood pressure lowering for 4 doses of AHU377, given once daily (50 mg, 100 mg, 200 mg and 400 mg) in combination with a fixed dose of valsartan (320 mg).