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NCT ID: NCT00391222 Completed - Bipolar Disorder Clinical Trials

A Study to Evaluate the Efficacy and Safety of Risperidone for the Prevention of Mood Episodes in the Treatment of Patients With Bipolar I Disorder

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

The purpose of this randomized, double blind, double dummy, multicenter study was to evaluate the efficacy of risperidone long-acting injectable (LAI) monotherapy in comparison with placebo in the prevention of a mood episode in treatment of patients with bipolar I disorder. Oral olanzapine was used to assess the validity of the study design. The primary objective of this study is to evaluate the efficacy of risperidone LAI versus placebo in the prevention of a mood episode (recurrence event) in patients with bipolar I disorder after a 12-week (3 month) stabilization period on risperidone LAI, as measured by the time to recurrence of any mood episode. Risperidone LAI has been approved by the FDA in the USA for the treatment of patients with schizophrenia and for the prevention of mood recurrences in bipolar I disorder, as monotherapy or add-on treatment. It is approved at EMEA and other European and non-European health authorities for the treatment of patients with schizophrenia, too.

NCT ID: NCT00389155 Completed - Bladder Cancer Clinical Trials

First-Line Treatment of Advanced Bladder Cancer Randomized vs. Gemcitabine ± Vinflunine in Patients Ineligible to Receive Cisplatin-Based Therapy

Start date: January 2007
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to test an investigational drug, vinflunine (BMS-710485), in combination with gemcitabine in patients with Transitional Cell Carcinoma who cannot be treated with cisplatin. This study will help to determine whether vinflunine in combination with gemcitabine will extend the time period until further growth of the tumor more than gemcitabine alone.

NCT ID: NCT00388856 Completed - Preeclampsia Clinical Trials

Antioxidant Supplementation in Pregnant Women With Low Antioxidant Status

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

The purpose of this study is to investigate antioxidants supplementation in pregnant women with low antioxidant status at 10-12 weeks gestation age in relation to adverse pregnancy outcome in randomized prospective study.

NCT ID: NCT00364351 Completed - Clinical trials for Non Small Cell Lung Cancer

Efficacy Trial Comparing ZD6474 With Erlotinib in NSCLC After Failure of at Least One Prior Chemotherapy

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

To determine if ZD6474 a new investigational drug, is effective in treating Non Small Lung Cancer and if so, how it compares with another type of anti cancer therapy chemotherapy, Erlotinib

NCT ID: NCT00358943 Recruiting - Gaucher Disease Clinical Trials

International Collaborative Gaucher Group (ICGG) Gaucher Disease Registry & Pregnancy Sub-registry

Start date: April 1, 1991
Phase:
Study type: Observational [Patient Registry]

The ICGG Gaucher Registry is an ongoing, international multi-center, strictly observational program that tracks the routine clinical outcomes for patients with Gaucher disease, irrespective of treatment status. No experimental intervention is involved; patients in the Registry undergo clinical assessments and receive care as determined by the patient's treating physician. The objectives of the Registry are: - To enhance understanding of the variability, progression, identification, and natural history of Gaucher disease, with the ultimate goal of better guiding and assessing therapeutic intervention. - To assist the Gaucher medical community with the development of recommendations for monitoring patients, and to provide reports on patient outcomes, to optimize patient care. - To characterize the Gaucher disease population. - To evaluate the long-term effectiveness of imiglucerase and of eliglustat. Gaucher Pregnancy Sub-registry: The primary objective of this Sub-registry is to track pregnancy outcomes, including complications and infant growth, in all women with Gaucher disease during pregnancy, regardless of whether they receive disease-specific therapy. No experimental intervention is given; thus a patient will undergo clinical assessments and receive standard of care treatment as determined by the patient's physician.If a patient consents to this Sub-registry, information about the patient's medical and obstetric history, pregnancy, and birth will be collected, and, if a patient consents to data collection for her infant, data on infant growth through month 36 postpartum will be collected.

NCT ID: NCT00338286 Completed - Breast Cancer Clinical Trials

A Study of Epoetin Alfa Plus Standard Supportive Care Versus Standard Supportive Care Only in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy

Start date: March 2, 2006
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the impact on tumor progression as evaluated by progression-free survival (PFS) of epoetin alfa plus standard supportive care as compared with standard supportive care alone (packed red blood cell (RBC) transfusions), for treating anemia according to label guidance in patients with metastatic breast cancer receiving standard chemotherapy.

NCT ID: NCT00338247 Approved for marketing - Neoplasms, Breast Clinical Trials

EAP (Expanded Access Protocol) Of Lapatinib Combined With Capecitabine In Metastatic Breast Cancer

Start date: July 2006
Phase: Phase 4
Study type: Expanded Access

This study will provide pre-approval drug access to lapatinib, in combination with capecitabine, to patients whose breast cancer had progressed on other therapies

NCT ID: NCT00332020 Completed - Clinical trials for Venous Thromboembolism

Regulation of Coagulation in Orthopedic Surgery to Prevent DVT and PE, a Controlled, Double-blind, Randomized Study of BAY 59-7939 in the Extended Prevention of VTE in Patients Undergoing Elective Total Hip Replacement

RECORD 2
Start date: February 2006
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess if 10 mg BAY 59-7939, taken once daily as a tablet, is safe and can help prevent blood clots forming after a hip replacement operation.

NCT ID: NCT00328068 Recruiting - Spondyloarthritis Clinical Trials

Assessment of SpondyloArthritis Society (ASAS) Classification and Diagnostic Criteria for Early Axial Spondyloarthritis (SpA)

Start date: July 2006
Phase: N/A
Study type: Observational

Background: Existing criteria for AS/SpA such as mod. New York, ESSG, or Amor criteria for classification and/or diagnosis of spondyloarthritis have limitations when applied to early disease. Moreover, MRI is not part of any of the established criteria and the precise role of MRI in early axial disease has not been fully defined yet. Even less is known about sacroiliac (SI) changes in SpA patients with peripheral symptoms. A pilot study using data from 'paper patients' led to new candidate criteria for early spondyloarthritis. Subsequently, the members of the ASAS International Working Group decided to conduct a prospective multi-centre study to evaluate (validate) the new candidate criteria, and to assess their performance as diagnostic criteria. Aims of the study: 1. To evaluate the new candidate criteria for axial SpA in a multi-centre setting. 2. To assess the potential role of the new candidate criteria to be used as diagnostic criteria. To accomplish this, inclusion of consecutive and undiagnosed patients is mandatory as are longer periods of follow-up . 3. To compare criteria encompassing the whole group of SpA such as ESSG and Amor criteria against criteria which are tailored to either predominant axial disease or predominant peripheral disease. To accomplish this, both patients with predominant axial disease (back pain) but also patient with predominant peripheral disease (arthritis/enthesitis) will be included.

NCT ID: NCT00322452 Completed - Clinical trials for Non-Small Cell Lung Cancer

First Line IRESSAâ„¢ Versus Carboplatin/Paclitaxel in Asia

IPASS
Start date: March 2006
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare gefitinib with carboplatin / paclitaxel doublet chemotherapy given as first line treatment in terms of progression free survival in selected NSCLC patients with the objective of demonstrating non-inferiority.