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NCT ID: NCT00883116 Terminated - Endometrial Cancer Clinical Trials

A Study of Ixabepilone as Second-line Therapy for Locally Advanced, Recurrent, or Metastatic Endometrial Cancer

IXAMPLE2
Start date: August 2009
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to investigate whether administration of ixabepilone results in superior outcome as assessed by overall survival compared with that achieved with standard chemotherapy (paclitaxel or doxorubicin) in women with advanced endometrial cancer that has progressed following first-line chemotherapy.

NCT ID: NCT00882908 Completed - Hepatitis C Clinical Trials

A Study of TMC435 in Combination With Pegylated Interferon Alp\Fa-2a and Ribavirin in Patients Infected With Genotype 1 Hepatitis C Virus Who Never Received Treatment

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

The purpose of this study is to evaluate the efficacy of 4 different regimens of TMC435 in combination with peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV), defined as the proportion of patients with sustained virologic response at Week 72 (patients with undetectable plasma HCV RNA [less than 25 IU per mL undetectable] at the end of treatment and at Week 72), compared to the control group receiving PegIFN and RBV in combination with TMC435-matched placebo.

NCT ID: NCT00882453 Completed - Multiple Sclerosis Clinical Trials

Physical Activity and Fatigue in Early Multiple Sclerosis (MS)

BEGIN
Start date: August 2006
Phase: N/A
Study type: Observational

The purpose of this observational study is to obtain a survey on physical activity in patients who for the first time have experienced symptoms which indicate a high risk for developing multiple sclerosis (MS) and in patients with recently diagnosed MS, and to obtain information on factors potentially influencing the patients' level of activity.

NCT ID: NCT00882336 Completed - Obesity Clinical Trials

European Study of Cardiovascular Risk

EURIKA
Start date: May 2009
Phase: N/A
Study type: Observational

The main objective of this study is to describe the management of patients with cardiovascular risk factors in primary prevention among different European countries. The patient's participation consists of a single study visit during a routine visit of the patient to the clinic/office. Study variables will be measured: - By an interview between physician and patient during the visit and/or available medical records' information: social and demographic patient characteristics, relevant family medical history, current medication. - By questions asked to the physician: physician perception of patients' CV risk factor, guidelines adherence and cost-containment. - By measurement performed to the patient during the visit: weight, height, BMI, waist and hip circumference will be measured. - CV risk factors (blood parameters) will be measured by collecting available data documented within the last year in the medical records and by the collection and analyses of a blood sample during the visit.

NCT ID: NCT00881530 Completed - Clinical trials for Diabetes Mellitus, Type 2

Empagliflozin (BI 10773) in Type Two Diabetes (T2D) Patients, Open Label Extension

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

The objective of the current study is to investigate the safety and efficacy of BI 10773 in 2 different doses compared to Metformin or to Sitagliptin given for 78 weeks in different modalities of treatment in patients with type 2 diabetes mellitus.

NCT ID: NCT00879970 Terminated - Clinical trials for Diabetes Mellitus, Type 2

Thiazolidinedione Intervention With Vitamin D Evaluation

TIDE
Start date: May 2009
Phase: Phase 4
Study type: Interventional

This study will answer two separate questions. The first question is to test the cardiovascular effects of long-term treatment with rosiglitazone or pioglitazone when used as part of standard of care compared to similar standard of care without rosiglitazone or pioglitazone in patients with type 2 diabetes who have a history of or are at risk for cardiovascular disease. The second question will compare the effects of long-term supplementation of vitamin D on death and cancer

NCT ID: NCT00879658 Completed - Clinical trials for Relapsing-remitting Multiple Sclerosis

Safety, Tolerability, Efficacy and Optimal Dose Finding Study of BAF312 in Patients With Relapsing-remitting Multiple Sclerosis

Start date: March 30, 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study was to determine the dose-response curve for the MRI-based efficacy of BAF312 compared with placebo in patients with Relapsing-Remitting Multiple Sclerosis (RRMS), and to characterize its safety and tolerability for the selection of an optimal dose in a later phase III study. Study Design Rationale An adaptive design was chosen to characterize the dose response curve of BAF312. In a first period of study ("Period 1"), three doses of BAF312 and placebo were tested for MRI efficacy. Based on an interim analysis (IA) after 3 months of treatment, two additional active doses for period 2 wereselected , thus allowing to optimize the overall determination of the dose response curve with 5 data points of active treatment, and placebo. The doses were kept blinded. The use of Modeling and Simulation allowed to establish the full range and dynamics of the dose-response curve in silico, and hence the definition of the optimal dose for later phase III studies. The choice of placebo as treatment control was essential to obtain information on the specific compared to non-specific effects of active treatment and provides the best way of evaluating the efficacy and of assessing the true safety and tolerability profile of BAF312. Short-term placebo exposure (6 (Period 1) or 3 (Period 2) months, respectively) was unlikely to lead to longer term differences in outcomes [Polman, 2008]. The use of an adaptive design strategy contributed to a significant reduction of placebo exposure, both in terms of the number of patients and duration, as compared to conventional trial models. Patients having completed the study within the protocol might be eligible for the Extension Phase study where they receive long-term BAF312 treatment (a separate protocol).

NCT ID: NCT00876564 Completed - Trauma Clinical Trials

Rogaland Trauma System Study

RTSS
Start date: February 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to improve performance, Stavanger University Hospital (SUH) reorganized key system structures and introduced in 2009 mandatory documentation of field Revised Trauma Score on trauma patients, tiered trauma team activation and new guidelines for field triage. Through a before and after study, the investigators aim to measure how the quality improvement initiative will influence structure, process and outcomes variables.

NCT ID: NCT00875992 Completed - Tibial Fractures Clinical Trials

Trial to Evaluate the Effectiveness of Angular Stable Locking System (ASLS) in Patients With Distal Tibial Fractures

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

In many cases, the existing locking bolts and screws in intramedullary nails do not provide sufficient stability. The play between screw and nail can result in loss of reduction and the instability due to the interfragmentary movement can result in malunions or nonunions. Therefore, an Angular Stable Locking System for Intramedullary Nails (ASLS) was developed to enhance axial and angular fracture stability. ASLS provides angular-stable fixation between nails and screws with resorbable sleeves used as dowels in the nail locking holes. Preliminary results of a pre-study show a trend towards reduced time to pain-free full weight bearing in patients being treated with ASLS. This hypothesis will be tested in the present randomized controlled study.

NCT ID: NCT00875914 Completed - Clinical trials for Radiofrequency Ablation

Magnetically Navigated vs. Manually Guided Radiofrequency in Atrioventricular-node-reentry-tachycardia

MAGMA-AVNRT
Start date: April 2009
Phase: Phase 4
Study type: Interventional

The MAGMA-AVNRT study compares two different methods of handling the ablation catheters for av-node-reentry-tachycardia with regard to x-ray dose, safety and success: manually guided vs magnetically navigated RF-catheter.