Clinical Trials Logo

Filter by:
NCT ID: NCT00796653 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Safety and Efficacy of BI 1744 CL in Patients With Chronic Obstructive Pulmonary Disease II

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

The primary objective of this study is to assess the long-term efficacy and safety of once daily treatment of BI 1744 CL inhalation solution (5 and 10 mcg) delivered via the Respimat® inhaler, in patients with COPD.

NCT ID: NCT00796614 Completed - Bladder, Neurogenic Clinical Trials

Study to Evaluate the Efficacy and Safety of Tamsulosin in Children With Neurogenic Bladder

Start date: January 2008
Phase: Phase 2/Phase 3
Study type: Interventional

Aim of this study is to evaluate the efficacy and safety of a range of doses of tamsulosin hydrochloride as treatment in children with an elevated detrusor leak point pressure associated with a known neurological deficit

NCT ID: NCT00796120 Completed - Sarcoma Clinical Trials

An Efficacy and Safety Study of Trabectedin Versus Doxorubicin-Based Chemotherapy in Participants With Translocation-Related Sarcomas (TRS)

Start date: November 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of trabectedin compared to standard doxorubicin in participants with advanced translocation-related sarcomas (cancer of connective tissue cells) (TRS).

NCT ID: NCT00795795 Completed - Clinical trials for Chromosomal Abnormalities

Preimplantation Genetic Screening in Women of Advanced Maternal Age

Start date: December 2008
Phase: N/A
Study type: Interventional

An increased incidence of aneuploid pregnancies has been reported in women of advanced maternal age, with higher miscarriage rates. Cytogenetic studies in preimplantation embryos have shown elevated aneuploidy rate, particularly in women over 38 years. For these reasons, PGS has been applied to these patients to improve ongoing implantation rates, and most importantly, to decrease the risk of further miscarriages and affected offspring. In the past two years, several RCT have raised the question whether PGS is benefitial or not in AMA patients. In our experience, PGS outcome in these patients offers higher ongoing implantation rates than the previously published in RCT studies, where no benefits for PGS were found. In these papers, poor technical skills, as well as unclear patients selection could explain the reported lack of PGS benefits. Therefore, the objective of the present RCT is to analyze the outcome of IVF cycles with and without PGS in two age groups: - Patients 38-39 years of age: 200 cyles per arm reaching embryo transfer should be performed - Patients 40-44 years of age: 120 cycles per arm reaching embryo transfer Sample size has been calculated according to our retrospective experience with higher differences in ongoing implantation rates between cycles with and without PGS in patients of 40-44 years of age. In all patients embryo transfer will be performed on day 5. In the PGS group one cell will be biopsy in embryos with ≥5 cells on day-3 and chromosomes 13, 15, 17, 18, 21, 22, X and Y will be analyzed in two rounds. In the third round, nuclei with undoubtful or non-conclusive results will be analyzed using subtelomeric probes.

NCT ID: NCT00795600 Completed - Clinical trials for Diabetes Mellitus, Type 2

Comparison of the Change in Fat Distribution in Overweight and Obese Subjects With Type 2 Diabetes After Insulin Treatment

Start date: April 2009
Phase: Phase 4
Study type: Interventional

This trial is conducted in Europe. The aim of this clinical trial is to compare the change in trunk fat mass, assessed by Double Energy X-ray Absorptiometry (DEXA) after 26 weeks of treatment with insulin detemir or insulin NPH (Neutral Protamine Hagedorn) (both combined with insulin aspart at the main meals) in overweight and obese subjects with type 2 diabetes.

NCT ID: NCT00795483 Completed - HIV Infections Clinical Trials

Efficacy And Security Of Annual And Biennial Zoledronic Acid For Osteoporosis Treatment In An HIV-Infected Patients' Cohort

Start date: November 2009
Phase: Phase 4
Study type: Interventional

The purpose of this project is to determine the incidence of osteoporosis in the investigators' population of HIV-infected patients and to assess the efficacy and security of zoledronic acid, whose efficacy in post-menopausal women with high fracture risk treatment and in Paget's disease treatment has already been demonstrated.

NCT ID: NCT00795444 Completed - HIV-1 Clinical Trials

Effect Of A CCR5 Coreceptor Antagonist On The Latency And Reservoir Of HIV-1

Start date: March 2008
Phase: Phase 2
Study type: Interventional

The presence of a pool of cells latently infected by HIV-1 in patients taking HAART and with a viral load below 50 copies/mL is the main limitation to eradication of the virus from the body. This viral reservoir prevents antiretroviral therapy from being interrupted; therefore, patients are obliged to continue with treatment for a period calculated to be greater than 60 years. Despite the important advances in knowledge of the biology of this reservoir, we still have no real knowledge about its dynamics. The opportunity to carry out a clinical trial for the first time with CCR5 coreceptor antagonists is exceptional, since the results could provide important information on the nature of this reservoir. If maintenance of the reservoir is a dynamic process, inclusion of CCR5 inhibitors is expected to lead to a reduction in the size of this reservoir. This effect could be critical when including IAT (viral reactivation), since, in theory, it would be necessary to act on a smaller reservoir. Current consensus is that it would be necessary to act on almost 100% of the viral reservoir (approximately 1,000,000 cells). The study has also been designed to enable us to understand the biochemical and molecular mechanisms by which certain drugs can induce viral reactivation in vitro as a previous step to a clinical trial aimed at reactivating viral latency and eradicating HIV-1 from the body.

NCT ID: NCT00793793 Completed - Clinical trials for Hepatitis C, Chronic

Safety, Antiviral Activity and PK of MRD of BI 201335 in Chronic Hepatitis C Patients Both Treatment Naive and -Experienced

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

This study will investigate safety, antiviral activity, and pharmacokinetics of BI 201335 NA in HCV genotype 1 infected patients treated for 14 days monotherapy followed by BI 201335 NA combination therapy with PegIFN/RBV for an additional 14 days for treatment-naïve patients; or for 28 days as BI 201335 NA combination therapy with PegIFN/RBV for treatment-experienced patients. A secondary objective is to investigate antiviral activity, potential drug-drug interactions and safety of combination therapy of BI 201335 NA and PegIFN/RBV up to 28 days for treatment-naïve patients.

NCT ID: NCT00793728 Completed - Morbid Obesity Clinical Trials

Prospective Randomized Trial Comparing Two Techniques of Sleeve Gastrectomy

Start date: October 2008
Phase: N/A
Study type: Interventional

This study compares if there is any difference doing antrectomy while performing a sleeve gastrectomy for treating morbid obesity. The investigators compare the differences between leaving or not leaving the antrum in terms of food tolerance, weight lost and quality of life.

NCT ID: NCT00793624 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Safety and Efficacy of BI 1744 CL in Patients With Chronic Obstructive Pulmonary Disease I

Start date: February 2009
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to assess the long-term efficacy and safety of once daily treatment of BI 1744 CL inhalation solution (5 and 10 mcg) delivered via the Respimat® inhaler, in patients with COPD.