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NCT ID: NCT01290211 Completed - Healthy Clinical Trials

Pharmacokinetic Interaction Between Maraviroc And Fosamprenavir/Ritonavir In Healthy Subjects

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

This is will be an open-label, fixed-sequence, multiple dose crossover study in 2 cohorts of 14 healthy male and/or female subjects, to estimate the effect of maraviroc on the pharmacokinetics of amprenavir and ritonavir and fosamprenavir/ritonavir on the pharmacokinetics of maraviroc.

NCT ID: NCT01290172 Completed - Clinical trials for Liver Transplant With Clinically Significant Portal Hypertension

Evaluation of Efficacy and Safety of Somatostatin Used as Inflow Modulator in Liver Transplantation.

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

This study is a 5 day, single-center, randomized, double blind, placebo-controlled study to evaluate the efficacy and safety of Somatostatin used as inflow modulator in liver transplantation. Patient systemic and hepatic dynamics will be collected and recorded at predefined time-points. To evaluate the ischemia-reperfusion injury, it is planned to perform liver biopsies at two different time-points to compare the liver structure and proteomic variations.

NCT ID: NCT01289990 Completed - Clinical trials for Diabetes Mellitus, Type 2

Safety and Efficacy of Empagliflozin (BI 10773) and Sitagliptin Versus Placebo Over 76 Weeks in Patients With Type 2 Diabetes

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

This study will investigate the efficacy and long term safety and tolerability of BI 10773 in type 2 diabetic patients.

NCT ID: NCT01289821 Completed - Clinical trials for Colorectal Neoplasms

First Line Treatment of Metastatic Colorectal Cancer With mFOLFOX6 in Combination With Regorafenib

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

This is a study to evaluate the efficacy (effectiveness) and the safety of regorafenib when given in combination with chemotherapy mFOLFOX6 as first line therapy in patients with metastatic colorectal cancer (CRC). mFOLFOX6 is an approved chemotherapy. Regorafenib is an oral (i.e. taken by mouth) multi-targeted kinase inhibitor. A kinase inhibitor targets certain key proteins that are essential for the survival of the cancer cell. By specifically targeting these proteins, regorafenib may stop cancer growth. The growth of the tumor may be decreased by preventing these specific proteins from functioning. The primary endpoint (the most meaningful result to be tracked) of this study is based on the rate of response, i.e. the disease getting smaller. The aim is to show that the therapy of colorectal cancer with mFOLFOX6 in combination with regorafenib improves the response rate observed for the standard therapy only.

NCT ID: NCT01289041 Completed - Clinical trials for Advanced Endometrial Cancer

BKM120 as Second-line Therapy for Advanced Endometrial Cancer

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

This is a prospective multi-center, open-label, single arm, Phase II study to investigate the safety and efficacy of BKM120 in patients with advanced endometrial carcinoma whose disease progressed on or after a first-line antineoplastic treatment. Patients will receive BKM120 orally at a dose of 100 mg/day. Availability of tumor specimen (either archival tissue or a fixed fresh biopsy) is mandatory for assessment of the PI3K (Phosphatidylinositol 3 Kinase (PI3K) pathway activation status.

NCT ID: NCT01288911 Completed - Prostatic Neoplasms Clinical Trials

A Study of Enzalutamide Versus Bicalutamide in Castrate Men With Metastatic Prostate Cancer

Start date: March 22, 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study was to determine the efficacy and safety of oral enzalutamide compared to bicalutamide in castrate men with metastatic prostate cancer who have progressed while on Luteinizing Hormone Receptor Hormone (LHRH) agonist/antagonist or after receiving a bilateral orchiectomy.

NCT ID: NCT01288573 Completed - Neuroblastoma Clinical Trials

A Combined Study in Pediatric Cancer Patients for Dose Ranging and Efficacy/Safety of Plerixafor Plus Standard Regimens for Mobilization Versus Standard Regimens Alone

Start date: March 3, 2014
Phase: Phase 1/Phase 2
Study type: Interventional

This is a multi-site study with plerixafor in pediatric cancer patients. The study will be conducted in 2 stages: - Stage 1 is a dose-escalation study. - Stage 2 is an open-label, randomized, comparative study using the appropriate dosing regimen identified in the Stage 1 dose-escalation study. All participating patients will receive a standard mobilization regimen as per study site practice guidelines (either chemotherapy plus once daily granulocyte-colony stimulating factor (G-CSF) or once daily G-CSF alone). The only change to the standard mobilization regimen is the addition of plerixafor treatment prior to apheresis for all patients in Stage 1 (dose escalation), and for those patients randomized to the plerixafor plus standard mobilization treatment arm in Stage 2 (randomized, comparative). Stage 1 will enroll at least 27 patients. Stage 2 will enroll at least 40 patients.

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: NCT01288326 Completed - Clinical trials for Diabetes Mellitus, Type 2

Observational Study on Effectiveness and Safety of Liraglutide in Subjects With Type 2 Diabetes

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

The study is conducted in Europe. The aim of this observational study is to assess glycaemic control while using liraglutide under normal clinical practice conditions in Belgium.