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NCT ID: NCT00877760 Completed - Chronic Hepatitis B Clinical Trials

Augmenting Response to Entecavir With Peginterferon a-2a for the Treatment of HBeAg-positive Chronic Hepatitis B

ARES
Start date: August 2009
Phase: Phase 4
Study type: Interventional

The purpose of this study is to investigate whether it is possible to augment the response of patients with HBeAg-positive chronic hepatitis B to entecavir by using a temporary peginterferon alpha-2a add-on strategy

NCT ID: NCT00877643 Completed - Atrial Fibrillation Clinical Trials

Routine Versus Aggressive Upstream Rhythm Control for Prevention of Early Atrial Fibrillation in Heart Failure

RACE 3
Start date: May 4, 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate whether in patients with early persistent atrial fibrillation and mild to moderate early heart failure an aggressive upstream rhythm control approach, including aldosterone receptor antagonists and statins, dietary restrictions, counseling and cardiac rehabilitation programs, increases persistence of sinus rhythm compared with conventional rhythm control after one year of follow-up. A randomized long term extension of the RACE 3 will be performed with a total follow-up of 5 years to investigate the long term effects on persistence of sinus rhythm and cardiovascular morbidity and mortality of the two treatment strategies.

NCT ID: NCT00877383 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease

INTRUST2
Start date: April 2009
Phase: Phase 3
Study type: Interventional

This study assessed the efficacy and safety of indacaterol (150 µg once daily [od]) when combined with tiotropium (18 µg od) versus tiotropium (18 µg od) treatment alone in patients with chronic obstructive pulmonary disease (COPD).

NCT ID: NCT00877227 Completed - Clinical trials for Mild Hyperhomocysteinemia

Does B Vitamin Supplementation Decrease Homocysteine Concentrations in Newborns

Start date: January 2003
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine whether supplementation with folinic acid, a B vitamin, lowers the concentrations of total homocysteine in newborns. Increased homocysteine concentrations are associated with an increased risk of cerebrovascular accidents in adult, children and newborns. These increased concentrations can easily and safely be lowered by folic acid in adults.

NCT ID: NCT00876525 Completed - Clinical trials for Heart Valve Diseases

Clinical Investigation of the Freedom SOLO Stentless Heart Valve

Start date: March 2009
Phase: N/A
Study type: Interventional

This is a trial to demonstrate the safety and effectiveness of the Freedom SOLO heart valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.

NCT ID: NCT00876447 Completed - Overactive Bladder Clinical Trials

A Long-term Follow-up Study of Botulinum Toxin Type A in Patients With Overactive Bladder as a Result of Spinal Injury or Multiple Sclerosis

Start date: January 1, 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the long-term safety and effectiveness of botulinum toxin type A on patients with overactive bladder as a result of spinal cord injury or multiple sclerosis. This is a follow-up study to two Allergan sponsored studies (NCT00311376 and NCT00461292).

NCT ID: NCT00876421 Completed - Overactive Bladder Clinical Trials

Study of ONO-8539 in Patients With Overactive Bladder

Start date: April 2009
Phase: Phase 2
Study type: Interventional

The objective of this study is to investigate efficacy, safety and tolerability of ONO-8539 in patients with overactive bladder.

NCT ID: NCT00875667 Completed - Clinical trials for Mantle Cell Lymphoma

A Study to Determine the Efficacy of Lenalidomide Versus Investigator's Choice in Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL)

Sprint
Start date: April 30, 2009
Phase: Phase 2
Study type: Interventional

To evaluate the safety and efficacy of lenalidomide versus investigator choice in patients with relapsed or refractory mantle cell lymphoma.

NCT ID: NCT00875368 Completed - HIV Infections Clinical Trials

Maraviroc Immune Recovery Study

MIRS
Start date: February 2009
Phase: Phase 4
Study type: Interventional

Rationale: Improving cellular immunity by means of increasing CD4 cells is one of the goals of antiretroviral therapy in HIV, which is achieved by means of virological suppression. A certain group of patients, the so called "immunologic non responders", fail to reach an acceptable CD4 cell increase despite an adequate virologic response on antiretroviral treatment. Recently a new antiretroviral agent, maraviroc (Celsentry®), is registered for the treatment of patients infected with CCR5 tropic HIV-1 virus. However, data is available suggesting that treatment with maraviroc leads to immune recovery (increase in CD4 cells) in patients who are infected with dual/mixed tropic HIV-1 virus, in the absence of a virologic response. This suggests an alternative mechanism for immune recovery, which could be especially beneficial for this group of patients. Hypothesis: Maraviroc, by a yet unknown mechanism, stimulates immune recovery by increasing CD4+ cell count. Objective: The primary objective is to confirm the hypothesis that maraviroc stimulates immune recovery; the secondary objective is to explore, by virologic and immunologic investigations, the underlying mechanisms of this hypothesis. Study design: multicentre, randomized, placebo-controlled, double blind, exploratory mechanistic study. Study population: HIV-1 infected patients 18 years or older, who meet the inclusion criteria. Intervention: One group receives maraviroc (dose dependent on co-medication), the other group placebo. Main study parameters/endpoints: A 30% increase in CD4 cell rise in the treatment group (compared with placebo). Nature and extent of the burden and risks associated with participation, benefit and group relatedness: 1. In the treatment group subjects will start with a registered antiretroviral agent (maraviroc). 2. During the treatment year patients will perform several study visits, probably three more compared with regular visits on the outpatient clinic. 3. Each visit, blood will be drawn by venepuncture for immunologic and virologic investigations (see flow chart).

NCT ID: NCT00874224 Completed - Colorectal Cancer Clinical Trials

Surgical Recovery After Left Lateral Hepatic Sectionectomy: Laparoscopic Versus Open Surgery.

ORANGE II
Start date: January 2010
Phase: N/A
Study type: Interventional

The ORANGE II trial is a double blinded randomised controlled trial that will provide evidence on the merits of laparoscopic surgery in patients undergoing a left lateral hepatic sectionectomy in terms of time to functional recovery, hospital length of stay, quality of life, readmission percentage, morbidity and mortality, hospital costs, body image and cosmesis, and long term incidence of incisional hernias.