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NCT ID: NCT01131676 Completed - Clinical trials for Diabetes Mellitus, Type 2

BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME).

Start date: July 2010
Phase: Phase 3
Study type: Interventional

The aim of the present study is to investigate the safety of BI 10773 treatment in patients with Type 2 Diabetes Mellitus and high cardiovascular risk.

NCT ID: NCT01130428 Completed - Osteoporosis Clinical Trials

Mechanical Bone Stimulation and Adenosine 5'-Triphosphate (ATP) Release in Humans

Start date: October 2010
Phase: Phase 1/Phase 2
Study type: Interventional

Rationale: Mechanical loading is well-known to have a strong anabolic effect on bone. It has therefore been proposed that a mechanical intervention could be an effective non-pharmacological approach to treat bone loss associated with conditions such as osteopenia and osteoporosis. Data from in vitro experiments indicate that the purine nucleotide adenosine 5'-triphosphate (ATP) is released by bone cells and mediates cellular crosstalk via P2 purinergic receptors in response to mechanical stimulation. ATP release by bone cells may thus be part of a general mechanism by which mechanical loading ultimately results in increased bone formation, but this remains to be investigated in humans in vivo. The investigators hypothesize that a mechanical intervention in humans leads to a rise in systemic ATP concentrations due to ATP release from bone. Objective: To investigate in vivo whether a measurable increase in systemic ATP levels occurs in response to mechanical stimulation of bone in humans. Study design: Intervention study with a non-randomized, non-blinded design. All subjects will participate in a single experiment, lasting approximately 3 hours, during which the subjects will receive a mechanical intervention at a fixed dose. Study population: Maximally 10 healthy human volunteers (18-35 y). Intervention: Subjects will receive a gentle and safe mechanical intervention, which will be administered by means of a Juvent 1000 Vibration Platform delivering low-magnitude mechanical stimuli (i.e. vibrations) to the forearm. The mechanical stimulation will be administered at a frequency of 90 Hz and amplitude of 10 µm in an intermittent fashion, i.e. three 10-minute periods of stimulation with 10-minute rest periods in between. Main outcome parameters: As the primary outcome parameter, a change in extracellular ATP concentrations as a result of the mechanical intervention will be assessed systemically.

NCT ID: NCT01130415 Completed - Overactive Bladder Clinical Trials

Screening Method in Sacral Neuromodulation

Start date: May 2002
Phase: N/A
Study type: Observational

The purpose of this study was to evaluate whether there is a difference in long-term outcome between patients screened with the percutaneous nerve evaluation (PNE) and first stage tined lead procedure (TLP).

NCT ID: NCT01128166 Completed - Heart Failure Clinical Trials

Evaluation of Multisensor Data in Heart Failure Patients With Implanted Devices

MultiSENSE
Start date: June 2010
Phase: N/A
Study type: Observational

The goal of the MultiSENSE study is to collect chronic information from multiple sensors in an implanted device for evaluation in heart failure patients.

NCT ID: NCT01127750 Completed - Clinical trials for Relapsing Multiple Sclerosis

Tolerability and Safety and Health Outcomes in Relapsing Multiple Sclerosis (MS) Patients

Start date: May 2010
Phase: Phase 3
Study type: Interventional

This study will assess tolerability and safety and health outcomes in relapsing MS patients taking FTY720.

NCT ID: NCT01127529 Completed - Clinical trials for Protein C Deficiency

Ceprotin Treatment Registry

Start date: June 23, 2010
Phase:
Study type: Observational

The overall objective is to collect and assess data on the treatment, safety, and treatment outcomes of subjects prescribed, receiving and participating in the Ceprotin treatment registry.

NCT ID: NCT01126437 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Comparison of Tiotropium in the HandiHaler Versus the Respimat in Chronic Obstructive Pulmonary Disease

Start date: May 2010
Phase: Phase 3
Study type: Interventional

Direct comparison studies of the tiotropium HandiHaler® 18 µg and Respimat® 5 µg formulations have been limited to 4-week crossover studies. Therefore, prospective data from a trial of adequate size and duration is required to establish that compared to tiotropium HandiHaler®, tiotropium Respimat® will have (a) similar effects on safety and (b) similar or superior effects on exacerbations.

NCT ID: NCT01126242 Completed - Clinical trials for Grade II and III Acute Lateral Ankle Ligament Injuries

Tape Versus Semirigid Versus Lace-up Ankle Support in the Treatment of Acute Lateral Ankle Ligament Injury.

Start date: May 2010
Phase: Phase 4
Study type: Interventional

The objective of this study is to compare tape versus semi rigid support versus lace up brace treatment for acute lateral ankle ligament injuries with regard to clinical outcome and cost effectiveness. There is a difference of 10 in functional outcome (Karlsson Score) between non-elastic adhesive taping and semi-rigid and lace-up ankle support, in favour of the last, for the treatment of acute lateral ankle ligament injury at 6 months follow-up.

NCT ID: NCT01125943 Completed - Hypertension Clinical Trials

Bevacizumab and Endothelium Dependent Vasodilation

Start date: June 2010
Phase: N/A
Study type: Interventional

The introduction of angiogenesis inhibitors has remarkably improved treatment of patients with several types of cancer. One of the most reported side effects of angiogenesis inhibitors is hypertension. In patients treated with bevacizumab, a monoclonal antibody against vascular endothelial growth factor, hypertension had an overall incidence up to 32%. The increase in blood pressure occurs early in treatment. The etiology of hypertension caused by treatment with angiogenesis inhibitors is unclear. Understanding the pathogenesis of this side effect is essential for optimal treatment with this class of drugs. The primary objective is to explore the effect of bevacizumab infusion on endothelium-dependent vasodilation of forearm resistance arteries.

NCT ID: NCT01125566 Completed - Breast Neoplasms Clinical Trials

LUX-Breast 1: BIBW 2992 (Afatinib) in HER2-positive Metastatic Breast Cancer Patients After One Prior Herceptin Treatment

Start date: June 22, 2010
Phase: Phase 3
Study type: Interventional

To investigate the efficacy and safety of BIBW 2992 in combination with vinorelbine i.v. chemotherapy as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed one prior trastuzumab (Herceptin®) treatment