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NCT ID: NCT00954967 Completed - Diabetes Mellitus Clinical Trials

Trial for Tobacco Cessation With Intensive Advice in Diabetic Patients: the ITADI Project

ITADI
Start date: September 2009
Phase: N/A
Study type: Interventional

This study addresses an important problem in public health, smoking in diabetics. The morbidity and mortality observed in diabetics is linked to macro and microvascular problems. The consumption of tobacco has a multiplying effect on these vascular problems in diabetics. This study aims to evaluate the effectiveness of an intensive intervention in tobacco addiction in diabetic patients in primary care.

NCT ID: NCT00954447 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of Linagliptin in Combination With Insulin in Patients With Type 2 Diabetes

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

The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to Placebo during long term treatment (52 weeks and longer) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control.

NCT ID: NCT00952757 Completed - Schizophrenia Clinical Trials

Changes in Hyperprolactinemia Secondary to Antipsychotics After Switching to Quetiapine

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

Hyperprolactinaemia is a common side effect of some antipsychotics (APS), including some atypicals. Clinical consequences of hyperprolactinaemia are broad including amenorrhea, galactorrhea, tender breasts, gynecomastia and sexual dysfunction. Less known but also present is the increased cardiovascular risk, specially in women, disorders of osteoporotic type and a potential increased risk of breast and prostate cancer. Despite this growing evidence, there are no consistent published data in order to adopt evidence-based decisions that may be beneficial for the patient. This naturalistic observational 6 months follow-up study on patients with APS-induced hyperprolactinemia aims to obtain more information about the switching approach in cases of hyperprolactinemia secondary to APS and to better establish the role of switching to quetiapine (APS not related with the increase prolactin levels) in this problem.

NCT ID: NCT00952588 Completed - Clinical trials for Acute Myeloid Leukemia

Study to Investigate the Efficacy, Safety and Tolerability of AZD1152 Alone and in Combination With Low Dose Cytosine Arabinoside (LDAC)in Acute Myeloid Leukaemia (AML) Patients

SPARK-AML1
Start date: July 2009
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy, safety and tolerability of AZD1152 alone and in combination with low dose cytosine arabinoside (LDAC) in comparison with LDAC alone in AML patients.

NCT ID: NCT00952497 Completed - Gastric Cancer Clinical Trials

A Study of Telatinib in Combination With Chemotherapy in Subjects With Advanced Gastric Cancer

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

The objectives of this study are to evaluate the anti-tumor activity, safety, and tolerability of telatinib when used in combination with chemotherapy (capecitabine and cisplatin) as first-line therapy in subjects with advanced gastric cancer. The primary objective is to assess progression free survival (PFS) in subjects receiving telatinib in combination with chemotherapy (capecitabine and cisplatin). The secondary objectives are to assess overall survival, overall response rate, safety and tolerability, pharmacokinetics and biomarkers.

NCT ID: NCT00952380 Completed - Clinical trials for Venous Thromboembolism

Fragmin for the Treatment of Acute VTE in Pediatric Cancer Patients

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

Three month treatment of acute VTE with Fragmin in pediatric cancer patients

NCT ID: NCT00951015 Completed - Clinical trials for Infection, Human Immunodeficiency Virus

A Dose Ranging Trial of GSK1349572 and 2 NRTI in HIV-1 Infected, Therapy Naive Subjects

ING112276
Start date: July 30, 2009
Phase: Phase 2
Study type: Interventional

This Phase IIb study in HIV-infected antiretroviral naive subjects will select an optimal once daily dose of GSK1349572 from a range of doses for future evaluation.

NCT ID: NCT00950859 Completed - Clinical trials for Infection, Human Immunodeficiency Virus

A Pilot Study Assessing the Integrase Inhibitor GSK1349572 in HIV-infected Persons With Virus Resistant to Raltegravir

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

Integrase is an enzyme produced by HIV so that the virus can multiply in the human body. GSK1349572 is a new drug in the integrase inhibitor class that prevents the enzyme from working properly and therefore prevents the virus from multiplying. GSK1349572 has shown to be effective against viruses in a short-term monotherapy study in adults with no previous exposure to integrase inhibitors. The purpose of this study is to determine whether GSK1349572 is effective in the treatment of HIV-infected patients who no longer respond to treatment with the approved integrase inhibitor raltegravir and carry viruses with resistance to this drug. The safety and efficacy of GSK1349572 50mg once daily in combination with the background HIV drugs previously administered (unless discontinuation of a particular drug is required) will be assessed over 10 days (functional monotherapy phase), followed by the evaluation of the safety and efficacy of GSK1349572 given with a new optimised background regimen from Day 11 through at least Week 24.

NCT ID: NCT00950300 Completed - Breast Cancer Clinical Trials

A Study to Compare Subcutaneous (SC) Versus Intravenous (IV) Administration of Herceptin (Trastuzumab) in Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer

Start date: October 16, 2009
Phase: Phase 3
Study type: Interventional

In this open-label multicenter trial, participants with operable or locally advanced breast cancer will be randomized to pre-operative treatment with 8 cycles of chemotherapy (4 cycles of docetaxel followed by 4 cycles of 5-fluorouracil, epirubicin, and cyclophosphamide) concurrent with either SC Herceptin or IV Herceptin. After surgery, participants will receive a further 10 cycles of SC or IV Herceptin as per randomization to complete 1 year of treatment. All cycles will be 21 days in length. After the end of study treatment, participants will be followed for safety and efficacy for up to 5 years or until disease recurrence, whichever is earlier.

NCT ID: NCT00950170 Completed - Hemophilia A Clinical Trials

Study of Safety And Efficacy Of ReFacto AF In Previously Untreated Hemophilia A Patients In The Usual Care Setting

Start date: February 10, 2010
Phase: Phase 4
Study type: Interventional

Study to evaluate the safety and effectiveness of ReFacto AF for the treatment of severe hemophilia A in patients who have not yet received treatment for their hemophilia. Study subjects will be males less than 6 years old who have not taken any clotting factor or other blood products before the study. The safety and effectiveness of ReFacto AF will be determined in this study by tests and procedures done at the doctor's office.