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NCT ID: NCT00410306 Completed - Hypogonadism Clinical Trials

Use of Nebido® to Assess Tolerability and Treatment Outcomes in Daily Clinical Practice

IPASS Nebido
Start date: October 2006
Phase: N/A
Study type: Observational

This is an observational study with a drug called Nebido, a new testosterone replacement therapy, which is available for the treatment of male hypogonadism. The benefit and safety of Nebido have already been thoroughly evaluated through well controlled clinical trials. The main purpose of this observational study is to confirm the established safety profile of Nebido in daily clinical practice.

NCT ID: NCT00400478 Completed - Clinical trials for Diffuse Large B-Cell Lymphoma (DLBCL)

A Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation in Patients With Aggressive B-cell Lymphoma: NHL-13

Start date: January 2006
Phase: Phase 3
Study type: Interventional

This is a randomized, open label, phase III study to evaluate the ability of rituximab maintenance therapy to prolong event-free survival in aggressive NHL. Patients will be screened after successful standard induction therapy (CR or Cru following standard R-CHOP-like therapy with 8 infusions of rituximab plus CHOP-like chemotherapy (4-8 cycles). Patients will be followed until an event occurs as defined in the protocol. To evaluate the clinical efficacy of rituximab maintenance therapy as compared to observation in patients with aggressive B-cell Non-Hodgkins lymphoma or follicular lymphoma grade 3b who have achieved a complete remission after appropriate first-line therapy, measured by event-free survival (EFS), 440 patients with DLCBL or follicular NHL grade 3 (220 per arm) will be recruited.

NCT ID: NCT00395577 Completed - Clinical trials for Rheumatoid Arthritis

A Study in Rheumatoid Arthritis With an Investigational Oral p38 MAP Kinase Inhibitor VX-702

Start date: November 2006
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and effects of VX-702 in subjects with moderate to severe rheumatoid arthritis and who are taking the drug methotrexate.

NCT ID: NCT00378391 Completed - Clinical trials for Acute Coronary Syndrome

European Registry on STEMI Patients Transferred for PCI With Upstream Use of Abciximab - EuroTransfer Registry

Start date: November 2005
Phase: N/A
Study type: Observational

EUROTRANSFER Registry is a prospective, international, web-based European Registry on Patients with ST-Elevation MI Transferred for Mechanical Reperfusion (PCI) with a Special Focus on Upstream Use of Abciximab. This registry is designed to collect data on approximately 1800 patients during a 12 month enrollment period in up to 20 interventional cardiology centres with hospital transfer networks from all over Europe. Analysis of this registry should allow to monitor transfer timelines of patients arriving to the cath-lab from the regional hospital with or without upstream start of abciximab and scheduled for mechanical reperfusion (PCI) as well as to monitor regional differences across Europe in regard to the impact that time of various stages of the treatment chain may have on clinical outcomes.

NCT ID: NCT00361959 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

SERETIDE 50/500mcg Versus Tiotropium Bromide On Exacerbation Rates In Severe Chronic Obstructive Pulmonary Disease

Start date: June 2003
Phase: Phase 4
Study type: Interventional

This is a comparator study to assess the relative efficacy of the combination product fluticasone propionate/salmeterol 50/500 and tiotropium bromide on the rate of exacerbations of chronic obstructive pulmonary disease (COPD) over a two year study interval.

NCT ID: NCT00351468 Completed - Clinical trials for Purpura, Thrombocytopaenic, Idiopathic

EXTEND (Eltrombopag Extended Dosing Study)

EXTEND
Start date: June 2006
Phase: Phase 3
Study type: Interventional

An open-label, dose-adjustment, extension study to evaluate the safety and efficacy of eltrombopag for the treatment of subjects with idiopathic thrombocytopenic purpura (ITP) who have previously been enrolled in an eltrombopag trial. This study will allow adjustment of the eltrombopag dose to achieve an individualized dose and schedule for each subject. In addition, the ability to reduce the dose of concomitant ITP medications in the presence of eltrombopag, while maintaining platelet counts = 50,000/microL will be investigated.

NCT ID: NCT00348140 Completed - Alzheimer's Disease Clinical Trials

Rosiglitazone (Extended Release Tablets) As Adjunctive Therapy In Subjects With Mild To Moderate Alzheimer's Disease

REFLECT-3
Start date: July 2006
Phase: Phase 3
Study type: Interventional

Rosiglitazone (RSG) has been tested in clinical studies and is approved by the FDA as a treatment for type II diabetes mellitus, a disease that occurs when the body is unable to effectively use glucose. RSG XR, the investigational drug used in this study, is an extended-release form of RSG. This study tests whether RSG XR safely provides clinical benefit to people with mild to moderate Alzheimer's disease (AD) when combined with one of the currently approved AD medications, Aricept®, Razadyne® or Exelon®. RSG XR is a new approach to AD therapy and this study tests a new way to treat AD by testing whether one's genetic makeup affects the response to the study drug. Clinical data suggesting that RSG may benefit AD patients was first seen in a small study performed at the University of Washington and then from a larger GSK study conducted in Europe and New Zealand. In the first study, subjects receiving RSG once daily for 6 months scored significantly better on 3 tests of memory and thought than those who did not receive RSG. In the GSK study, those that appeared to benefit most from treatment with RSG XR had a specific genetic pattern. They did not have the gene that caused them to produce the protein apolipoprotein E e4 (APOE e4). Subjects who have the APOE e4 gene may have two copies, one from each parent, or they may have only one APOE e4 gene meaning that they inherited either the APOE e2 or APOE e3 version of the gene, instead of APOE e4, from one of their parents. Subjects with one copy of the APOE e4 gene remained at their same level of thinking ability while those with two copies of the APOE e4 gene, continued to worsen during the 6-month treatment. The current study will more directly test the effectiveness or RSG XR on people who either have or lack the APOE e4 gene.

NCT ID: NCT00343486 Completed - Overactive Bladder Clinical Trials

Dose Ranging Study Of Solabegron Versus Placebo In Female Patients With Overactive Bladder Symptoms

Start date: May 2006
Phase: Phase 2
Study type: Interventional

This study will test the effectiveness and safety of two doses of solabegron against placebo in reducing the symptoms of overactive bladder.

NCT ID: NCT00340080 Completed - HIV Infection Clinical Trials

Clinical Utility Of Genetic Screening For HLA-B*5701, On Susceptibility To Abacavir Hypersensitivity

Start date: April 2006
Phase: Phase 4
Study type: Interventional

Study to evaluate the utility of prospective HLA-B*5701 screening on the incidence of abacavir hypersensitivity (ABC HSR) in 1800 previously ABC-naive adults with HIV-1 from Europe, Australia and other countries as applicable. The study has two (co-primary) objectives: i) to determine if screening for HLA-B*5701 prior to ABC-containing HAART results in a lower incidence of clinically-suspected HSR versus current standard of care (no genetic screening) and ii) to determine if screening for HLA-B*5701 prior to ABC-containing HAART, results in a significantly lower incidence of immunologically-confirmed HSR versus current standard of care (no genetic screening or patch testing). The study consists of up to a 28-day screening period, a randomised observation period (Day 1 through Week 6) and, for subjects experiencing a suspected ABC HSR and a subset of ABC-tolerant subjects, an epicutaneous patch test (EPT) assessment period. Eligible subjects will be randomised to one of two study arms: a Current Standard of Care Arm (no prospective genetic screening: Control) and a Genetic Screening Arm (prospective genetic screening). Subjects identified as HLA-B*5701 positive in the prospective Genetic Screening Arm will not receive ABC and will be excluded from further study. Subjects who experience suspected ABC HSR during the 6-week observation will be withdrawn from ABC-containing product and undergo EPT patch testing 6 weeks later.

NCT ID: NCT00312208 Completed - Breast Cancer Clinical Trials

Docetaxel in Breast Cancer

Start date: November 2001
Phase: Phase 3
Study type: Interventional

Primary objective : - To compare disease-free survival after treatment with docetaxel in combination with doxorubicin and cyclophosphamide to doxorubicin and cyclophosphamide followed by docetaxel in operable adjuvant breast cancer HER2neu negative patients with positive axillary lymph nodes. Secondary objectives : - To compare toxicity and quality of life between the 2 above-mentioned arms. - To evaluate pathologic and molecular markers for predicting efficacy.