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NCT ID: NCT01150448 Completed - Schizophrenia Clinical Trials

A Safety and Pharmacokinetic Study of Paliperidone Palmitate in Patients With Schizophrenia

Start date: September 2007
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the long term safety of flexible doses (50 to 150 mg equivalent) of paliperidone palmitate in the treatment of patients with schizophrenia and to document the pharmacokinetics of paliperidone following fixed multiple intramuscular injections of paliperidone palmitate 150 mg eq.

NCT ID: NCT01150214 Completed - Atrial Fibrillation Clinical Trials

DECAAF: Delayed-Enhancement MRI (DE-MRI) Determinant of Successful Radiofrequency Catheter Ablation of Atrial Fibrillation

DECAAF
Start date: July 2010
Phase: N/A
Study type: Observational

This is a multi-center, observational, 1-year prospective cohort study (1 year follow-up, at 3, 6 and 12 month) with approximately 675 participants. We will conduct a thorough outcomes assessment utilizing data from Magnetic Resonance Imaging (MRI) scans, as well as pre-procedure and follow-up data. Scans will be blinded to location of participating site. MRI scans will be sequenced and analyzed as they arrive from the database. Imaging Protocol: All patients will undergo a Delayed-Enhancement MRI (DE-MRI) within 30 days prior to the atrial fibrillation (AF) ablation procedure. The purpose of the initial MRI is to quantify the degree of atrial structural remodeling or fibrosis pre-ablation. Following ablation, DE-MRI will be obtained at 3, 6, and 12 months follow-up to detect and quantify ablation-related scar formation. Clinical Follow-up: The institution where the ablation was performed will continue post-procedural care following standard of care procedures. Atrial arrhythmia recurrences will be catalogued up to one year post-ablation and predictors of recurrences of AF will be determined by statistical analysis. The specific mechanism and electrophysiological characteristics of atrial arrhythmia recurrence will also be analyzed. Our hypotheses are (1) DE-MRI will reproducibly stage the progression left atrium fibrosis in AF; (2) DE-MRI will reproducibly aid in quantifying and identifying the distribution of catheter ablation-related scarring in the left atrium; and (3) the stage of left atrium fibrosis pre-ablation and the amount and location of scarring will predict success of catheter ablation therapy for AF.

NCT ID: NCT01150097 Completed - Clinical trials for Liver Transplant Recipient

Extension Study to Evaluate the Long-term Efficacy and Safety of Everolimus in Liver Transplant Recipients

Start date: March 31, 2010
Phase: Phase 3
Study type: Interventional

The reason for this extension is to evaluate the long-term safety and efficacy of two concentration-controlled everolimus regimen in de novo liver transplant recipients. The most important long-term safety assessments include evaluation of renal function, progression of HCV related allograft fibrosis, and other treatment related effects at Month 36 post-transplantation compared to extension baseline (Months 24 post-transplantation).

NCT ID: NCT01149044 Completed - Clinical trials for Acute Coronary Syndrome

A Trial of Routine Aspiration Thrombectomy With Percutaneous Coronary Intervention (PCI) Versus PCI Alone in Patients With ST-Segment Elevation Myocardial Infarction (STEMI) Undergoing Primary PCI

TOTAL
Start date: August 2010
Phase: N/A
Study type: Interventional

This is an international, randomized, controlled, parallel group study in which patients with ST-Segment Elevation Myocardial Infarction (STEMI) will be allocated to one of the following: Manual aspiration thrombectomy with Percutaneous Coronary Intervention (PCI) or PCI alone.

NCT ID: NCT01148758 Completed - Clinical trials for Colorectal Cancer, Ovarian Cancer

A Dose-finding Study of RO5323441 in Patients With Metastatic Treatment-Refractory Colorectal or Ovarian Cancer

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

This exploratory, open label study will assess the the dose-effect relationship, efficacy and safety of RO5323441 in patients with metastatic treatment-refractory colorectal or ovarian cancer. Cohorts of patients will receive doses of intravenous RO5323441 in the range of 25mg to 3g every 1 or 2 weeks and will undergo serial dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) assessments. In the absence of disease progression and unacceptable toxicity, patients may continue to receive their maximum dose of RO5323441 for a core treatment phase of up to a total of 6 months. Treatment with RO5323441 can be extended at the investigator's discretion until disease progression or unacceptable toxicity occurs. Target sample size is <100.

NCT ID: NCT01148329 Completed - Clinical trials for Coronary Heart Disease

PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post-Approval Surveillance Study

PE-Prove
Start date: June 2010
Phase: N/A
Study type: Observational

The goal of the PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post- Approval Surveillance Study is to evaluate real world clinical outcomes data for the PROMUS™ Element™ Coronary Stent System in unselected patients in routine clinical practice.

NCT ID: NCT01147939 Completed - Clinical trials for Acute Myeloid Leukemia (AML)

Study of Elacytarabine Versus Investigator's Choice in Patients With Late Stage Acute Myeloid Leukaemia (AML)

CLAVELA
Start date: June 2010
Phase: Phase 3
Study type: Interventional

The purpose of the study is to assess the efficacy and safety of elacytarabine versus investigator's choice treatment in patients with relapsed or refractory acute myeloid leukemia (AML).

NCT ID: NCT01147250 Completed - Clinical trials for Acute Coronary Syndrome

Evaluation of Cardiovascular Outcomes in Patients With Type 2 Diabetes After Acute Coronary Syndrome During Treatment With AVE0010 (Lixisenatide)

ELIXA
Start date: June 2010
Phase: Phase 3
Study type: Interventional

Primary Objective: - To demonstrate that lixisenatide can reduce cardiovascular morbidity and mortality [composite endpoint of cardiovascular (CV) death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina] compared to placebo in type 2 diabetic patients who recently experienced an acute coronary syndrome (ACS) event. Secondary Objectives: To demonstrate that when compared to placebo, lixisenatide can reduce: - composite endpoint of cardiovascular death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, or hospitalization for heart failure - composite endpoint of cardiovascular death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, hospitalization for heart failure, or coronary revascularization procedure - urinary albumin excretion (based on the urinary albumin/creatinine ratio). To assess the safety and tolerability of lixisenatide.

NCT ID: NCT01147185 Completed - Clinical trials for Spinal Cord Injuries

Effectiveness of Automated Locomotor Training in Patients With Acute Incomplete Spinal Cord Injury: A Multicenter Trial

Start date: February 2010
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether longer locomotor training results in a mor favorable outcome in patients with incomplete spinal cord injury.

NCT ID: NCT01146990 Completed - Clinical trials for Children Whose Mothers Received 17P and Those Who Received Vehicle in the 17P Efficacy Trial

A Prospective, Noninterventional Follow-Up Study of Children Aged 23 to 25 Months, Born to Mothers Who Received Hydroxyprogesterone Caproate Injection, 250 mg/mL, or Vehicle for Prevention of Preterm Birth

Start date: November 9, 2010
Phase:
Study type: Observational

In the continuing efforts to understand the benefits and risks of in utero exposure to 17P this study is designed to evaluate differences in developmental outcomes of children, aged 23 to 25 months, born to mothers who participated in the 17P Efficacy Trial sponsored by Hologic (Protocol number 17P-ES-003).