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NCT ID: NCT00864331 Completed - Clinical trials for Non Small Cell Lung Cancer

Optimization of Treatment of Advanced Nonsmall Cell Lung Cancer Using Radiotherapy and Chemotherapy

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

Primary objectives of the study are: To assess the differences in survival of the two treatment options in both stage III (A and B) nonsmall cell lung cancer (NSCLC) (Study A) and Stage IIIB (wet) and stage IV NSCLC (Study B), respectively Secondary objectives are: To assess the differences in toxicity of two treatment options in both stage III (A and B) NSCLC (Study A) and Stage IIIB (wet) and stage IV NSCLC (Study B), and To assess the differences in Health Related Quality of Life (HRQoL) of two treatment options in both Study A and Study B

NCT ID: NCT00855530 Completed - Clinical trials for Major Depressive Disorders

Long Term Safety and Tolerability of SR58611 in Patients With Major Depressive Disorder

Start date: September 2005
Phase: Phase 3
Study type: Interventional

Primary objective: - To evaluate the long-term safety and tolerability of SR58611A (amibegron) patients with major depressive disorder (MDD). Secondary objective: - To determine plasma concentrations of SR58878 (the active metabolite of SR58611A), for pharmacokinetic population analyses, to evaluate the quality of life (QoL) in patients with MDD, and to evaluate the efficacy of amibegron in patients with MDD.

NCT ID: NCT00813709 Completed - Multiple Sclerosis Clinical Trials

Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX)

REFLEXION
Start date: December 2008
Phase: Phase 3
Study type: Interventional

REFLEXION is a double blind extension of the study 27025 (NCT00404352) (REFLEX). The purpose of the study is to obtain long-term follow-up data in subjects with clinically definite multiple sclerosis (MS) and subjects with a first demyelinating event at high risk of converting to MS, treated with fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of interferon [IFN]-beta-1a (RNF).

NCT ID: NCT00809965 Completed - Clinical trials for Myocardial Infarction

An Efficacy and Safety Study for Rivaroxaban in Patients With Acute Coronary Syndrome

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

The purpose of this study is to determine whether rivaroxaban in addition to standard care reduces the risk of the composite of cardiovascular death, myocardial infarction, or stroke in patients with a recent acute coronary syndrome compared with placebo.

NCT ID: NCT00793390 Completed - Diabetes Clinical Trials

Case-Control Study of Inflammatory Breast Cancer in North Africa

Start date: November 17, 2008
Phase:
Study type: Observational

Background: - Inflammatory breast cancer (IBC) is a rare, poorly understood and particularly aggressive form of breast cancer. - Three characteristics of IBC tumors their rapid progression, their extensive formation of new blood vessels, and the fact that these characteristics are present from the inception of the tumor make it an ideal model for studying factors associated with tumor aggressiveness. - This study is a collaboration among several institutions in the United States and North Africa that have extensive epidemiological experience and experience with IBC. Objectives: - To understand what causes certain types of breast conditions, including IBC. Eligibility: - Women 18 years of age and older with IBC and non-IBC and healthy women volunteers are eligible. Women who have had a previous diagnosis of any kind of breast cancer are excluded. Design: - Participants complete a questionnaire providing information about their background, including medical and reproductive history, family health history and lifestyle habits and undergo the following additional procedures: - Height, weight, hip and chest measurements. - Saliva sample collection to measure biological factors that may be related to breast conditions. - Breast examination and, if permission is given, photographs of affected breast. - Analysis of biopsied tissue for genetic and biochemical factors.

NCT ID: NCT00738153 Completed - Clinical trials for Diabetes Mellitus, Type 2

An Observational Study on Efficacy and Safety in Subjects Using Levemir® for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes

Start date: June 2008
Phase: N/A
Study type: Observational

This observational study is conducted in Africa. The aim of this observational study is to evaluate the efficacy and the incidence of serious adverse drug reactions while using insulin Levemir® under normal clinical practice conditions.

NCT ID: NCT00722137 Completed - Clinical trials for Mantle Cell Lymphoma

Study of the Combination of Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Mantle Cell Lymphoma

Start date: May 1, 2008
Phase: Phase 3
Study type: Interventional

This is a randomized, open-label, multicenter, prospective study to compare the efficacy and safety of the combination of VcR-CAP to that of R-CHOP in participants who have newly diagnosed mantle cell lymphoma grade II, III or IV and who are ineligible to undergo bone marrow transplantation.

NCT ID: NCT00712673 Completed - Clinical trials for Diabetes Mellitus, Type 2

GLP-1 Receptor Agonist Lixisenatide (Morning or Evening) in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Metformin

GETGOAL-M
Start date: June 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to metformin, over a period of 24 weeks of treatment, followed by an extension. The primary objective is to assess the effects of lixisenatide as an add-on treatment to metformin in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24. The secondary objectives are to assess the effect of lixisenatide, in comparison to placebo, when administered in the evening within 1 hour prior to the meal in terms of HbA1c reduction, percentage of patients reaching HbA1c less than (<) 7 percent (%), percentage of patients reaching HbA1c less than or equal to 6.5%, fasting plasma glucose (FPG), plasma glucose, plasma insulin, C-peptide, glucagon, and proinsulin during a 2-hour standardized meal test (only in morning injection arms), body weight, beta-cell function assessed by homeostasis model assessment (HOMA)-beta, fasting plasma insulin (FPI) and adiponectin; to evaluate safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development, beta-cell function 4 weeks after study drug discontinuation (only in patients from the morning injection arms in some selected centers).

NCT ID: NCT00708344 Completed - Hypertension Clinical Trials

ACTUAL: Efficacy and Safety of Irbesartan/Hydrochlorothiazide Combination

ACTUAL
Start date: June 2008
Phase: Phase 4
Study type: Interventional

To compare the antihypertensive efficacy of the combination irbesartan/hydrochlorothiazide (HCTZ) using either a usual or an active elective titration regimen. The main efficacy criteria will be the change in mean Systolic Blood Pressure (SBP), measured at doctor's office with an automatic device, after a 10-week treatment period in hypertensive patients insufficiently controlled by monotherapy.

NCT ID: NCT00641537 Completed - Clinical trials for Relapsing-Remitting Multiple Sclerosis

CLARITY Extension Study

Start date: February 29, 2008
Phase: Phase 3
Study type: Interventional

The purpose of this extension trial was to further evaluate the safety and tolerability of oral cladribine in subjects who have previously completed treatment within Trial 25643 (CLARITY). This trial also explored clinical benefit of prolonged 192-week versus 96-week treatment.