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NCT ID: NCT00514345 Recruiting - Sarcoma Clinical Trials

CYP3A5 Gene as a Risk Factor for Kidney Damage in Young Patients With Cancer Treated With Ifosfamide

Start date: July 2007
Phase: N/A
Study type: Observational

RATIONALE: Studying the genes expressed in samples of blood from young patients with cancer treated with ifosfamide may help doctors identify risk factors for kidney damage. PURPOSE: This clinical trial is looking at the CYP3A5 gene to see if having the gene may be a risk factor for kidney damage in young patients with cancer treated with ifosfamide.

NCT ID: NCT00513981 Completed - Sarcoma Clinical Trials

High-Dose Methotrexate in Treating Young Patients With Solid Tumors

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

RATIONALE: Drugs used in chemotherapy, such as high-dose methotrexate work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs, such as leucovorin calcium, may protect normal cells from the side effects of chemotherapy. PURPOSE: This phase I trial is studying the side effects, best way to give, and best dose of high-dose methotrexate in treating patients with solid tumors.

NCT ID: NCT00513877 Completed - Clinical trials for Malignant Mesothelioma

Bortezomib in Treating Patients With Malignant Pleural Mesothelioma

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

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying the side effects of bortezomib and how well it works in treating patients with malignant pleural mesothelioma.

NCT ID: NCT00510978 Active, not recruiting - Ulcerative Colitis Clinical Trials

Probiotics in GastroIntestinal Disorders

PROGID
Start date: January 2002
Phase: Phase 2/Phase 3
Study type: Interventional

All of us have millions of bacteria living in our gut. These bacteria are very important to our health providing us with protection against infections of the gut, allowing us to gain extra nutritional value from food we eat and helping our immune system. Changes in the balance of these many bacteria can make us vulnerable to infections both from within and from outside the gut. Certain bacteria may also be directly associated with some diseases of the gut. Research by doctors and scientists into relationships between the bacteria normally found in our gut and certain diseases of the gut is helping to develop food supplements and other therapies to treat these diseases. This study involves research into the usefulness and safety of two probiotic products in maintaining remission in Crohn's disease and ulcerative colitis. Approximately 360 patients with Crohn's disease and ulcerative colitis from Ireland, Finland and Spain will be involved in the study. The yoghurts used in this study contain either Lactobacillus salivarius subsp. salivarius or Bifidobacterium infantis.

NCT ID: NCT00505336 Completed - Clinical trials for Diastolic Heart Failure

The Effect of Eplerenone and Atorvastatin on Markers of Collagen Turnover in Diastolic Heart Failure

Start date: April 2006
Phase: N/A
Study type: Interventional

To investigate whether the medicines eplerenone or atorvastatin have a favourable effect on diastolic heart failure. Eplerenone is a drug that has been shown to be beneficial in Chronic Heart Failure due to pump failure. It can increase life expectancy and improve symptoms in these patients. It is not known whether or not eplerenone might be beneficial in heart failure with normal pump function (diastolic heart failure). Atorvastatin is one of a group of cholesterol lowering medicines called statins, which have been shown to reduce cardiovascular disease in patients irrespective of whether cholesterol levels are high or normal. It is not known whether atorvastatin also reduces fibrosis of the heart which is one of the causes of diastolic heart failure. Study hypothesis 1. To investigate the impact of aldosterone antagonism or statin therapy on markers of collagen turnover in patients with diastolic heart failure. 2. To assess the impact of aldosterone antagonism or statin therapy on markers of diastolic dysfunction and indices of clinical well being in patients with diastolic heart failure.

NCT ID: NCT00501059 Completed - Clinical trials for Moderate Risk of CVD

A Study to Assess the Efficacy and Safety of Enteric-Coated Acetylsalicylic Acid in Patients at Moderate Risk of Cardiovascular Disease

ARRIVE
Start date: July 5, 2007
Phase: Phase 3
Study type: Interventional

The use of acetylsalicylic acid in the primary prevention of cardiovascular events has been extensively studied but to a lesser extent in patients with moderate levels of cardiovascular risk. The current study is designed to prove the efficacy and tolerability of 100 mg enteric-coated Aspirin versus placebo in the prevention of cardiovascular disease (CVD) events, which include fatal and nonfatal myocardial infarction, fatal and nonfatal stroke and CV death, in a population with no history of known CVD who are at moderate risk of major CHD events (approximately 10-20% 10 year CHD risk). This corresponds to a patient population mean 10-year CVD risk of approximately 30%. Subjects are treated in a standard care setting and may receive treatment for the underlying risk factors as defined by the treating physician. Outcome events will be adjudicated by an Endpoint Adjudication Committee and the study will be monitored by an independent Data Safety Monitoring Board.

NCT ID: NCT00499070 Completed - Clinical trials for Myelodysplastic Syndromes

Assessing Immune Function in Young Patients With Cytopenia That Did Not Respond to Treatment

Start date: January 2007
Phase: N/A
Study type: Observational

RATIONALE: Studying biopsy, bone marrow, and blood samples from patients with cytopenia that did not respond to treatment may help doctors learn more about the disease and plan the best treatment. PURPOSE: This laboratory study is assessing immune function in young patients with cytopenia that did not respond to treatment.

NCT ID: NCT00490139 Completed - Neoplasms, Breast Clinical Trials

ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D

ALTTO
Start date: May 16, 2007
Phase: Phase 3
Study type: Interventional

This is a randomised, open label multi-centre phase III study comparing the activity of lapatinib alone versus trastuzumab alone versus trastuzumab followed by lapatinib versus lapatinib concomitantly with trastuzumab in the adjuvant treatment of patients with ErbB2 overexpressing and/or amplified breast cancer. Patients will be enrolled according to one of two design schemas, with Design 2 having two chemotherapy options (Design 2 and 2B), and will be randomised to one of four treatment regimens within each design schema. The primary objective of this study is to compare disease-free survival (DFS) in patients with HER2 overexpressing and/or amplified breast cancer randomised to trastuzumab for one year versus lapatinib for one year versus trastuzumab (12 or 18 weeks, according to assigned design) followed by a six-week treatment-free interval followed by lapatinib (28 or 34 weeks, according to assigned design) versus trastuzumab in combination with lapatinib for one year (52 weeks). Secondary objectives include treatment comparisons with respect to overall survival, time to recurrence, time to distant recurrence, safety and tolerability, incidence of brain metastasis, and analyses conducted separately for cohorts of patients defined by presence or absence of cMyc oncogene amplification, expression level of PTEN and presence or absence of the p95HER2 receptor. On August 18, 2011, the ALTTO Independent Data Monitoring Committee (IDMC) met to review the first planned interim analysis. The IDMC reported that the comparison of lapatinib alone versus trastuzumab alone crossed the futility boundary, indicating that the lapatinib alone arm was unlikely to meet the pre-specified criteria to demonstrate non-inferiority to trastuzumab alone with respect to disease-free survival (DFS). The IDMC also stated that the other three arms (trastuzumab alone, sequential trastuzumab/lapatinib arm and the combination arm) should continue as planned with no changes.

NCT ID: NCT00481390 Completed - HIV Infection Clinical Trials

Prospective Epidemiological Study Of The Prevalence Of HLA-B*5701 In HIV-1 Infected Patients

Start date: June 2007
Phase: N/A
Study type: Observational

This study is a cross-sectional observational study to evaluate the prevalence of HLA-B*5701 in the European area and in major European ethnotypes. Any HIV-1 infected patient will be eligible for this study including treatment naïve and experienced patients, as well as patients previously tested for HLA-B*5701. Patients will be approached during a standard clinic visit, and will be consented prior to any study specific procedure. They will be asked to provide a tissue sample (cheek cells and blood sample) which will be used to assess HLA-B*5701 status by local and central laboratories. In selected sites patients may be asked to provide an additional blood sample. This sample will be used to develop and validate different methodologies for assessing HLA-B*5701 status.

NCT ID: NCT00480025 Terminated - Clinical trials for Lung Cancer, Non-Small Cell

GSK1572932A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Non-Small Cell Lung Cancer

Start date: October 4, 2007
Phase: Phase 3
Study type: Interventional

The purpose of this clinical trial is to demonstrate the benefit of the immunotherapeutic product GSK1572932A when given to patients with Non-Small Cell Lung Cancer, after removal of their tumor. A course of 13 injections will be administered over 27 months. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.