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NCT ID: NCT01142102 Completed - Bladder Cancer Clinical Trials

Feasibility of Online Adaptive Radiotherapy for Muscle Invasive Bladder Cancer

BOLART
Start date: October 2010
Phase: N/A
Study type: Interventional

The principal objective of the trial is to test the hypothesis that Online Adaptive Radiotherapy for Muscle Invasive Bladder Cancer is feasible across multiple Radiation Oncology departments.

NCT ID: NCT01141855 Completed - Clinical trials for Tobacco Use Disorder

Smoking Termination Opportunity for inPatients

STOP
Start date: May 2008
Phase: Phase 2/Phase 3
Study type: Interventional

The Smoking Termination Opportunity for inPatients, (STOP) project is designed to capture the opportunity that is provided by admission for acute smoking related illness, to assist patients through withdrawal by use of a combination of: - the new medication Champix with - best practice counselling - initiated in an inpatient setting to achieve: - sustained smoking abstinence - reduced hospital bed and health service utilisation - reduced inpatient smoking and craving prior to discharge

NCT ID: NCT01141023 Completed - Parkinson Disease Clinical Trials

Study to Identify Clinical, Imaging and Biologic Markers of Parkinson Disease Progression

PPMI
Start date: June 2010
Phase: Phase 2
Study type: Interventional

This is a observational, multi-center study to assess progression of clinical features, imaging and biologic biomarkers in Parkinson disease (PD) patients compared to healthy controls (HC) and in PD patient subtypes. The primary objective of this study is to identify clinical, imaging and biologic markers of PD progression for use in clinical trials of disease-modifying therapies.

NCT ID: NCT01140581 Completed - Atrial Fibrillation Clinical Trials

Optimal Timing of Dronedarone Initiation After Conversion in Patients With Persistent Atrial Fibrillation

ARTEMIS Load
Start date: September 2010
Phase: Phase 4
Study type: Interventional

Primary Objective: - Evaluate the rate of Atrial Fibrillation (AF) recurrences one month after randomization according to different timings of initiation of dronedarone. Secondary Objective: - Evaluate the rate of AF recurrences two months after randomization. - Assess the safety of the change from amiodarone to dronedarone - Assess dronedarone safety - Explore dronedarone and its active metabolite plasma level (in a subset of countries) - Explore potential Pharmacokinetic (PK) interaction between dronedarone and amiodarone (in a subset of countries)

NCT ID: NCT01140347 Completed - Clinical trials for Hepatocellular Carcinoma

A Study of Ramucirumab (IMC-1121B) Drug Product (DP) and Best Supportive Care (BSC) Versus Placebo and BSC as 2nd-Line Treatment in Participants With Hepatocellular Carcinoma After 1st-Line Therapy With Sorafenib

REACH
Start date: October 2010
Phase: Phase 3
Study type: Interventional

This is a Phase 3 multicenter, randomized study evaluating the safety and efficacy of ramucirumab DP plus BSC as a double-blind, placebo-controlled (placebo plus BSC) comparison. Approximately 544 participants, at least 18 years of age, with Child-Pugh score < 7 and diagnosed with hepatocellular carcinoma will be randomized. Participants must have received sorafenib as first-line systemic treatment for hepatocellular carcinoma (HCC), and must have discontinued sorafenib prior to entering the study. Hypothesis: This sample size will allow differentiation of the expected increase in median overall survival (OS), from 8 months in the placebo arm to 10.67 months in the ramucirumab arm. Upon registration and completion of screening procedures, eligible participants with HCC who have disease progression during or following first-line therapy with sorafenib, or were intolerant to this agent, will be randomized to receive either ramucirumab DP or placebo. The treatment regimen will be continued until radiographic or symptomatic progression, the development of unacceptable toxicity, noncompliance or withdrawal of consent by the participant, or investigator decision.

NCT ID: NCT01139866 Completed - Pain Clinical Trials

An Extension Trial to Evaluate Long-term Safety of SABER™-Bupivacaine for Pain Following Shoulder Surgery

Start date: June 2010
Phase:
Study type: Observational

This is an extension to a previous research trial testing SABER™-Bupivacaine (an experimental pain-relieving medication). The purpose of this extension trial is to assess whether treatment with SABER™-Bupivacaine or SABER™-Placebo has had any effect on healing of the participant's shoulder, wound, or the skin near their scar. This trial will also assess safety (side effects).

NCT ID: NCT01139138 Completed - Colorectal Cancer Clinical Trials

Safety Study of the Combination of Panitumumab, Irinotecan and Everolimus in the Treatment of Advanced Colorectal Cancer

PIE
Start date: June 2010
Phase: Phase 1/Phase 2
Study type: Interventional

This study will assess the safety of panitumumab, irinotecan and everolimus when given in combination to treat advanced colorectal cancer

NCT ID: NCT01138111 Completed - Alzheimer Disease Clinical Trials

Florbetaben (BAY94-9172) PET (Positron Emission Tomography) Imaging in MCI (Mild Cognitive Impairment) Patients

Start date: June 2008
Phase: Phase 1
Study type: Interventional

The aim of the study is to investigate whether Florbetaben (BAY94-9172)positron emission tomography (PET) is able to distinguish between subjects with mild cognitive impairment (MCI) progressing to Alzheimer's disease (AD) from those with MCI not progressing to AD.

NCT ID: NCT01138033 Completed - Cancer Clinical Trials

Study of a Focal Adhesion Kinase Inhibitor in Subjects With Solid Tumors

Start date: July 27, 2010
Phase: Phase 1
Study type: Interventional

This study is a Phase I dose escalation study in subjects with solid tumors. Part 1 will identify the maximum tolerated dose (MTD) using a dose-escalation procedure. Following identification of the MTD, enrollment into Parts 2, 3, 4 and 5 may be concurrent. Part 2 will explore further the safety, PK, tolerability, and anti-tumor activity of GSK2256098 in subjects with tumors known to overexpress focal adhesion kinase (FAK). Part 3 will characterize the range of biologically effective doses by assessing pharmacodynamic (PD) markers in hair, skin and tumor tissue at doses that will not go lower than 80 mg or above the MTD dose levels tested during the Phase 1 dose escalation. Part 4 will explore further the safety, PK, tolerability and anti-tumor activity of GSK2256098 in subjects with relapsed glioblastoma multiforme (GBM). The primary objective of this study is to determine the safety, tolerability, and MTD of GSK2256098. Secondary objectives are to characterize the pharmacokinetics (PK) of GSK2256098; to identify a range of biologically active doses; to explore the anti-tumor activity of GSK2256098, and to explore relationships between GSK2256098 PK, PD and clinical endpoints. Part 5 will investigate the time course, the extent of an apparent change in the PK of GSK2256098 following repeated dosing, and screen for potential CYP3A induction as a possible mechanism of reduced systemic exposure of GSK2256098 at Day 15 and later time points. The primary objective of this study is to determine the safety, tolerability, and MTD of GSK2256098.

NCT ID: NCT01136967 Completed - Stage IV Melanoma Clinical Trials

An Open-Label, 2-Cohort, Multicenter, Study of Lenvatinib in Previously Treated Subjects With Unresectable Stage III or Stage IV Melanoma

Start date: August 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the objective response rate of lenvatinib in previously treated participants with American Joint Committee on Cancer (AJCC) unresectable Stage III or Stage IV melanoma and disease progression.