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NCT ID: NCT01471782 Completed - Clinical trials for Acute Lymphoblastic Leukemia

Clinical Study With Blinatumomab in Pediatric and Adolescent Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia

Start date: January 2012
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine the dose of the bispecific T cell engager blinatumomab (MT103) in pediatric and adolescent patients with relapsed/refractory Acute Lymphoblastic Leukemia (ALL) and to assess whether this dose of blinatumomab is effective.

NCT ID: NCT01471522 Completed - Clinical trials for Coronary Artery Disease

International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA)

ISCHEMIA
Start date: July 2012
Phase: N/A
Study type: Interventional

The purpose of the ISCHEMIA trial is to determine the best management strategy for higher-risk patients with stable ischemic heart disease (SIHD). This is a multicenter randomized controlled trial with 5179 randomized participants with moderate or severe ischemia on stress testing. A blinded coronary computed tomography angiogram (CCTA) was performed in most participants with eGFR ≥60 mL/min/1.73m2 to identify and exclude participants with either significant unprotected left main disease (≥50% stenosis) or those without obstructive CAD (<50% stenosis in all major coronary arteries). Of 8518 participants enrolled, those that had insufficient ischemia, ineligible anatomy demonstrated on CCTA or another exclusion criterion, did not go on to randomization. Eligible participants were then assigned at random to a routine invasive strategy (INV) with cardiac catheterization followed by revascularization, if feasible, plus optimal medical therapy (OMT) or to a conservative strategy (CON) of OMT, with cardiac catheterization and revascularization reserved for those who fail OMT. SPECIFIC AIMS A. Primary Aim The primary aim of the ISCHEMIA trial is to determine whether an initial invasive strategy of cardiac catheterization followed by optimal revascularization, if feasible, in addition to OMT, will reduce the primary composite endpoint of cardiovascular death, nonfatal myocardial infarction, resuscitated cardiac arrest, or hospitalization for unstable angina or heart failure in participants with SIHD and moderate or severe ischemia over an average follow-up of approximately 3.5 years compared with an initial conservative strategy of OMT alone with catheterization reserved for failure of OMT. B. Secondary Aims Secondary aims are to determine whether an initial invasive strategy compared to a conservative strategy will improve: 1) the composite of CV death or MI; 2) angina symptoms and quality of life, as assessed by the Seattle Angina Questionnaire; 3) all-cause mortality; 4) net clinical benefit assessed by including stroke in the primary and secondary composite endpoints; and 5) individual components of the composite endpoints. Condition: Coronary Disease Procedure: Coronary CT Angiogram Procedure: Cardiac catheterization Phase: Phase III per NIH Condition: Cardiovascular Diseases Procedure: Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions Phase: Phase III per NIH Condition: Heart Diseases Procedure: Coronary Artery Bypass Surgery Phase: Phase III per NIH

NCT ID: NCT01471145 Completed - Clinical trials for Opioid-Related Disorders

Depot Naltrexone Mechanism of Action in Heroin Dependent Patients Using fMRI and SPECT

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

The aim of this project is to study brain functions of 20 heroin addicts (compared to brain functions of 20 healthy controls) just before and during a three month extended release naltrexone treatment using functional MRI and dopamine transporter SPECT. The following hypotheses are tested: - XRNT modulates the fMRI response to drug cues in predetermined brain regions. - The expression of striatal transporters (assessed with SPECT) will decrease after a three-month course of extended release naltrexone

NCT ID: NCT01470690 Completed - HCV Infections Clinical Trials

Pharmacokinetic Study of the HCV Protease Inhibitor Bo-cePRevir and the Proton Pump Inhibitor OMeprazOle (PROMO)

PROMO
Start date: October 2011
Phase: Phase 1
Study type: Interventional

The objective of this study is to determine the effect of multiple dose omeprazole on the pharmacokinetics of boceprevir and vice versa. Furthermore, the safety of steady state boceprevir combined with multiple dose omeprazole will be evaluated.

NCT ID: NCT01470612 Completed - Ulcerative Colitis Clinical Trials

Long-Term Study Of CP-690,550 In Subjects With Ulcerative Colitis

OCTAVE
Start date: October 1, 2012
Phase: Phase 3
Study type: Interventional

This study is an open label, long-term extension study for subjects with moderate to severe ulcerative colitis designed to evaluate long term therapy of CP-690,550.

NCT ID: NCT01470599 Completed - Crohn's Disease Clinical Trials

A Open-Label Study Of CP-690,550 As Long-Term Therapy (48 Weeks) In Subjects With Crohn's Disease

Start date: April 2012
Phase: Phase 2
Study type: Interventional

The study hypothesis is to establish the safety and tolerability of long-term open-label (OL) CP-690,550 therapy in subjects with Crohn's disease.

NCT ID: NCT01469793 Completed - Ovarian Cancer Clinical Trials

A Study of DMOT4039A in Participants With Unresectable Pancreatic or Platinum-Resistant Ovarian Cancer

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

This multicenter, open-label, dose-escalating study will assess the safety, tolerability, and pharmacokinetics of DMOT4039A in participants with unresectable pancreatic or platinum-resistant ovarian cancer. Cohorts of participants will receive multiple ascending intravenous doses of DMOT4039A.

NCT ID: NCT01468987 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Study in Participants With Type 2 Diabetes Mellitus

IMAGINE 4
Start date: December 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is: - To compare blood glucose (blood sugar) control on LY2605541 with insulin glargine after 26 weeks of treatment. - To compare the rate of night time hypoglycemia (low blood glucose) on LY2605541 with insulin glargine during 26 weeks of treatment. - To compare the number of participants on LY2605541 reaching blood glucose targets without hypoglycemia episodes at night to those taking insulin glargine after 26 weeks of treatment. - To compare the rate of hypoglycemia over a 24-hour period on LY2605541 with insulin glargine during 26 weeks of treatment.

NCT ID: NCT01468688 Completed - 3rd Line GIST Clinical Trials

A Dose-finding Study of a Combination of Imatinib and BKM120 in the Treatment of 3rd Line GIST Patients

Start date: April 20, 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine a maximum tolerated dose and/or recommended phase 2 dose of a combination of imatinib and BKM120 in the treatment of 3rd line GIST patients.

NCT ID: NCT01467167 Completed - Anesthesia,General Clinical Trials

Utility of the Smart Pilot View in Clinical Practice: A Two Center Prospective Observational Study

Start date: October 2011
Phase:
Study type: Observational

Recently, a new software program for anesthesia has been developed, called Smart Pilot View. This program monitors the patient, the anesthetic drugs given, and the calculated depth of the anesthesia. The purpose of this study is to determine whether the use of this program improves the quality of anesthesia.