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NCT ID: NCT00409188 Completed - Clinical trials for Non-small Cell Lung Cancer

Cancer Vaccine Study for Unresectable Stage III Non-small Cell Lung Cancer (START)

START
Start date: January 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether the cancer vaccine tecemotide (L-BLP25) in addition to best supportive care is effective in prolonging the lives of subjects with unresectable stage III non-small cell lung cancer, compared to best supportive care alone. A local ancillary (sub) study in European centers will evaluate the immune response in peripheral blood after tecemotide (L-BLP25) or placebo vaccination.

NCT ID: NCT00408850 Recruiting - Metabolic Syndrome Clinical Trials

Effects of Pioglitazone Treatment on Sympathetic Nervous System Function in Metabolic Syndrome Obesity

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

An abdominal distribution of fat is associated with the greatest heart disease risk, because commonly, several risk factors of metabolic origin cluster in these individuals. When this occurs the condition is called the 'metabolic syndrome'. Increased activity of the sympathetic nervous system resulting in enhanced release of the stress hormone 'noradrenaline', may be one mechanism by which adverse cardiovascular and metabolic sequela of the metabolic syndrome might be mediated. Impaired insulin action may be one factor contributing to increased noradrenaline release. The aim of this Study is to determine whether treatment with a drug called pioglitazone which is known to improve insulin action, results in reduced sympathetic nervous system activity and stress hormone release when compared to treatment with a dummy drug (placebo).

NCT ID: NCT00408629 Completed - Ulcerative Colitis Clinical Trials

Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Active Ulcerative Colitis

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

This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of the human anti-tumor necrosis factor (TNF) monoclonal antibody adalimumab (ADA) in patients with moderately to severely active ulcerative colitis (UC).

NCT ID: NCT00408148 Terminated - Obesity Clinical Trials

High Density Lipoprotein Turnover

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

The objective of the study is to evaluate the effect of Rimonabant 20mg in comparison to placebo, on HDL and VLDL lipoprotein kinetics, over a 12 months period. Primary objectives: - To assess effect of Rimonabant on HDL ApoA-I fractional catabolic rate (FCR). Secondary objectives: - To assess effect of Rimonabant on HDL ApoA-I production rate (PR) and on other lipoprotein kinetics. - To assess effect of Rimonabant on lipids, glycemic and inflammatory parameters - To assess effect of Rimonabant on body composition - To assess safety of Rimonabant

NCT ID: NCT00408005 Active, not recruiting - Clinical trials for T Acute Lymphoblastic Leukemia

Combination Chemotherapy in Treating Young Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma

Start date: January 22, 2007
Phase: Phase 3
Study type: Interventional

This randomized phase III trial is studying different combination chemotherapy regimens and their side effects and comparing how well they work in treating young patients with newly diagnosed T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. After a common induction therapy, patients were risk assigned and eligible for one or both post-induction randomizations: Escalating dose Methotrexate versus High Dose Methotrexate in Interim Maintenance therapy, No Nelarabine versus Nelarabine in Consolidation therapy. T-ALL patients are risk assigned as Low Risk, Intermediate Risk or High Risk. Low Risk patients are not eligible for the Nelarabine randomization, Patients with CNS disease at diagnosis were assgined to receive High Dose Methotrexate, patients who failed induction therapy were assigned to receive Nelarabine and High Dose Methotrexate. T-LLy patients were all assigned to escalating dose Methotrexate and were risk assigned as Standard Risk, High Risk and induction failures. Standard risk patients did not receive nelarabine, High risk T-LLy patients were randomized to No Nelarabine versus Nelarabine, and Induction failures were assigned to receive Nelarabine.

NCT ID: NCT00406653 Terminated - Crohn's Disease Clinical Trials

A Study of Abatacept in Patients With Active Crohn's Disease

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

The purpose of this clinical research study is to learn if abatacept can improve signs and symptoms of active Crohn's Disease in patients who have not had an adequate response to other therapies. The safety of this treatment will also be studied.

NCT ID: NCT00405756 Active, not recruiting - Clinical trials for Newly Diagnosed Multiple Myeloma

A Study to Compare MPR With MP in Newly Diagnosed Multiple Myeloma Subjects 65 Years Old or Older.

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

The purpose of this study is to determine whether lenalidomide is safe and effective in the treatment of patients with newly diagnosed Multiple Myeloma who are 65 years of age or older.

NCT ID: NCT00405587 Completed - Malignant Melanoma Clinical Trials

Safety Study of PLX4032 in Patients With Solid Tumors

Start date: November 2006
Phase: Phase 1
Study type: Interventional

The primary objective of this FIH study is to assess the safety and pharmacokinetics of PLX4032 in patients with solid tumors. The secondary objective is to assess the pharmacodynamic activity in paired biopsy specimens obtained from patients with malignant melanoma who have the V600E BRAF oncogenic mutation.

NCT ID: NCT00405418 Completed - Clinical trials for Diabetes Mellitus, Type 2

Lantus Versus Levemir Treat-To-Target

L2T3
Start date: November 2006
Phase: Phase 4
Study type: Interventional

Primary objective: To demonstrate the non-inferiority of insulin glargine in comparison to insulin detemir in term of percentage of patients who reach the target of HbA1c < 7% at the end of the treatment period and do not experience symptomatic hypoglycemia, confirmed by plasma glucose (PG) ≤ 56 mg/dL (3.1 mmol/L) Secondary objectives: - To compare between the 2 treatment groups, the percentage of patients who reach the target of HbA1c < 7% and < 6.5% at the end of the treatment period - To compare the changes in HbA1c and fasting plasma glucose (FPG) - To compare the evolution of blood glucose profiles - To compare the day to day FPG variability, the insulin doses - To determine in each treatment group the biochemical and patient-related determinants of failure to reach HbA1c targets - To compare the overall incidence and rate of symptomatic hypoglycemia and nocturnal symptomatic hypoglycemia confirmed by PG ≤ 56 mg/dL (3.1 mmol/L) - To compare over the treatment period, the overall incidence and rate of symptomatic hypoglycemia and symptomatic nocturnal hypoglycemia (with PG ≤ 70 mg/dL [3.9 mmol/L]), of symptomatic day-time hypoglycemia (with PG ≤ 70 mg/dL and with PG ≤ 56 mg/dL), of severe hypoglycemia, of asymptomatic hypoglycemia with PG ≤ 56 mg/dL - To compare the overall safety: incidence of adverse events (including serious hypoglycemia and local tolerance at injection site), change in body weight, in waist circumference and in waist / hip ratio - To assess the quality of life and treatment satisfaction

NCT ID: NCT00405184 Completed - Clinical trials for Primary Immune Deficiency (PID)

Ig NextGen 10% in Patients With Primary Immune Deficiency (PID)

Start date: May 2007
Phase: Phase 3
Study type: Interventional

This study aims to assess the safety, tolerability and pharmacokinetics of Ig NextGen 10% in patients with primary immune deficiency currently being treated with Intragam P. Eligible patients will switch from 3 to 4 weekly intravenous Intragam P therapy to receive seven cycles of Ig NextGen 10% treatment administered intravenously at three- to four-weekly intervals. Patients will be monitored on the study for up to 36 weeks.