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NCT ID: NCT00873041 Completed - Clinical trials for Non-transfusion Dependent Thalassemia

Efficacy and Safety of Deferasirox in Non-transfusion Dependent Thalassemia Patients With Iron Overload and a One Year Open-label Extension Study

THALASSA
Start date: November 2008
Phase: Phase 2
Study type: Interventional

CICL670A2209: This study will evaluate the safety and efficacy of deferasirox in non-transfusion dependent thalassemia patients with iron overload. Patients will be treated either with active treatment (deferasirox) or placebo for 12 months (core study phase). Patients who complete the core study phase will be offered to continue their study with the active treatment (deferasirox) in a 12 months extension phase. During the core and extension, the effects of treatment on iron overload in the liver will be evaluated using magnetic resonance imaging (MRI) assessments. CICL670A2209E1: A one-year open-label extension to a randomized, double-blind, placebo-controlled, phase II study to evaluate efficacy and safety of deferasirox in non-transfusion dependent thalassemia patients with iron overload (Thalassa).

NCT ID: NCT00857051 Completed - Stress Clinical Trials

Postpartum Support: Can we Facilitate the Transition to Motherhood?

Start date: March 2009
Phase: N/A
Study type: Interventional

We are conducting a study to look interventions that may reduce stress in the postpartum period for first- time mothers. One of these interventions is an educational film that describes the common stressors that first-time parents go through in the early postpartum period. The other is a hotline service that women can call at anytime during the first 3 months postpartum to ask about problems she or the baby may be experiencing.

NCT ID: NCT00851903 Completed - Clinical trials for Diabetes Mellitus, Type 2

Evaluation of Insulin Glargine in Combination With Sitagliptin in Type 2 Diabetes Patients: EASIE Extension Trial

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

This study was the extension of the LANTU_C_02761 study named EASIE and identified as NCT00751114 (core study comparing insulin glargine versus sitagliptin in insulin-naïve patients treated with metformin and not adequately controlled). All patients with Glycosylated Hemoglobin A1c (HbA1c) ≥ 7% at the end of the core study had the possibility to enter this extension study if they met the other inclusion criteria and did not present with any exclusion criteria. The visit 14 of the core study (week 24) was the visit 1 (baseline, week 0) of the extension study which consisted of a 12-week treatment period. The objectives of this extension study were: - To assess the glycemic control (HbA1c <7%) of a 3-month combination therapy with metformin, insulin glargine and sitagliptin in patients not adequately controlled by a previous treatment with metformin plus either insulin glargine or sitagliptin. - To assess the effect of insulin glargine in combination with sitagliptin on HbA1c level, fasting plasma glucose, 7-point glucose profile, hypoglycemia occurrence, body weight and overall safety.

NCT ID: NCT00842192 Completed - Clinical trials for Diabetes Mellitus, Type 2

An Observational Study in Type 2 Diabetic Patients on Oral Antidiabetic Drugs and Basal Insulin in Near East Countries

BO2NE
Start date: April 2009
Phase: N/A
Study type: Observational

This study is conducted in Asia. The aim of this observational study is to investigate the safety and efficacy of insulin detemir as add-on therapy in type 2 diabetic patients who are using oral antidiabetic drugs.

NCT ID: NCT00831714 Completed - Clinical trials for Venous Thromboembolism

Xarelto for VTE Prophylaxis After Hip or Knee Arthroplasty

XAMOS
Start date: February 2009
Phase: N/A
Study type: Observational

The main goal is to provide additional information to the risk-benefit assessment of the drug.

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: NCT00803101 Completed - Clinical trials for Reversal of Coagulopathy

An Open-label, Randomized, Multicenter Phase IIIb Study to Assess the Efficacy, Safety and Tolerance of BERIPLEX® P/N (Kcentra) Compared With Plasma for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Subjects Requiring an Urgent Surgical Procedure

BE1116_3003
Start date: February 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate efficacy, safety and tolerance of Beriplex® P/N (Kcentra) compared with plasma in regard to rapid reversal of coagulopathy induced by vitamin K antagonists in subjects who require immediate correction of international normalized ratio (INR) because of emergency surgery.

NCT ID: NCT00790127 Completed - Beta Thalassemia Clinical Trials

Phase 1/2 Study of HQK-1001 in Patients With Beta Thalassemia

Start date: March 2009
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of HQK-1001 administered daily for 8 weeks in subjects with beta thalassemia intermedia

NCT ID: NCT00790036 Completed - Clinical trials for Diffuse Large B-cell Lymphoma

Phase III Study of RAD001 Adjuvant Therapy in Poor Risk Patients With Diffuse Large B-Cell Lymphoma (DLBCL) of RAD001 Versus Matching Placebo After Patients Have Achieved Complete Response With First-line Rituximab-chemotherapy

PILLAR2
Start date: July 2009
Phase: Phase 3
Study type: Interventional

Phase III study of RAD001 adjuvant therapy in poor risk patients with Diffuse Large B-Cell Lymphoma (DLBCL) of RAD001 versus matching placebo after patients have achieved complete response with first-line rituximab-chemotherapy

NCT ID: NCT00789633 Completed - Pancreatic Cancer Clinical Trials

Masitinib in Combination With Gemcitabine for Treatment of Patients With Advanced/Metastatic Pancreatic Cancer

Start date: November 25, 2008
Phase: Phase 3
Study type: Interventional

The objective of this study is to compare the efficacy and safety of masitinib in combination with gemcitabine to placebo in combination with gemcitabine in patients with advanced/metastatic pancreatic cancer.