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NCT ID: NCT00526136 Completed - Atrial Fibrillation Clinical Trials

Vernakalant (Oral) Prevention of Atrial Fibrillation Recurrence Post-Conversion Study

Start date: March 2007
Phase: Phase 2
Study type: Interventional

To evaluate the safety, tolerability and efficacy of 3 doses of vernakalant (oral) (150 mg, 300 mg and 500 mg b.i.d.) administered for up to 90 days in subjects with sustained symptomatic atrial fibrillation (AF duration > 72 hours and < 6 months).

NCT ID: NCT00526045 Completed - Breast Cancer Clinical Trials

Phase I-II Study to Determine the Maximum Tolerated Dose (MTD) of AUY922 in Advanced Solid Malignancies, and Efficacy in HER2+ or ER+ Locally Advanced or Metastatic Breast Cancer Patients

Start date: July 2007
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase I/II, open-label, multicenter study of AUY922 administered intravenously in patients with advanced solid malignancies to determine the maximum tolerated dose. Phase II expansion arms will investigate efficacy in patients with either HER2 positive or ER positive locally advanced or metastatic breast cancer. Additional patients with advanced solid malignancies will also be investigated in a separate expansion arm. Safety, pharmacokinetics and pharmacodynamics will be assessed.

NCT ID: NCT00525707 Completed - Acute Heart Failure Clinical Trials

Tezosentan in Acute Heart Failure

VERITAS 1
Start date: April 2003
Phase: Phase 3
Study type: Interventional

The randomized patients with acute heart failure will be stratified based on the presence or absence of a Swan-Ganz catheter and assigned to receive either tezosentan 5 mg/h for the first 30 minutes and 1 mg/h thereafter or matching placebo in a 1:1 manner. The duration of the treatment is 24 hours up to 72 hours. The duration of the follow-up period is 30 days after treatment initiation for death, re-hospitalizations and SAEs followed by a follow-up period of 5 months for vital status.

NCT ID: NCT00523562 Completed - Liver Diseases Clinical Trials

Effects of Macronutrients on Hepatic Lipids, Plasma Triglycerides, and Insulin Sensitivity

MACRONUTR
Start date: July 2006
Phase: N/A
Study type: Interventional

The purpose of this study is to assess how the macronutrient composition of the diet effects - lipid and glucose metabolism - intrahepatic lipids - insulin sensitivity in healthy lean subjects and in subjects with a high metabolic risk (ie overweight and offsprings of patients with type 2 diabetes mellitus).

NCT ID: NCT00523354 Completed - Esophagitis Clinical Trials

Off Label Use of Infliximab in Adult Patients With Severe Eosinophilic Esophagitis

IEE
Start date: August 2007
Phase: Phase 2
Study type: Interventional

Eosinophilic Esophagitis (EE) is a chronic inflammatory disorder of the esophagus with a constantly increasing prevalence. It has been demonstrated that the expression of the cytokine TNF-α is up regulated in EE and that this pro-inflammatory cytokine is highly expressed by the keratinocytes of the esophageal epithelium in patients with active EE. Furthermore, it has been shown that TNF-α is capable to induce eotaxin-3 production in keratinocytes. These results suggest that TNF-α plays a crucial role in the pathogenesis of EE. Based on these findings, the investigators plan a prospective T1 translational study with the purpose to evaluate the efficacy of an Infliximab monotherapy in adult patients with severe, corticosteroid-dependent EE.

NCT ID: NCT00523159 Completed - Clinical trials for Renal Cell Carcinoma

IMA901 in Advanced Renal Cell Carcinoma Patients With Measurable Disease

IMA901-202
Start date: May 2007
Phase: Phase 2
Study type: Interventional

This study was conducted in order to evaluate the efficacy and safety of the cancer vaccine IMA901 and GM-CSF as adjuvant in the treatment of advanced renal cell carcinoma. Patients received vaccination with GM-CSF followed by IMA901 during the study period of 9 months. Patients received pre-treatment with a single i.v. infusion of cyclophosphamide prior to the first vaccination.

NCT ID: NCT00522691 Withdrawn - Fecal Incontinence Clinical Trials

Efficacy of Sacral Nerve Stimulation Before Definitive Implantation

SNStest
Start date: September 2007
Phase: N/A
Study type: Interventional

Sacral nerve stimulation (SNS) is an emerging treatment for patients with severe fecal incontinence. The test stimulation is minimally invasive, associated to low morbidity and relatively cheap. On the contrary, implantation of the definite stimulator is related to higher morbidity and considerable costs. A careful patent selection for definite implantation is therefore crucial. However, indication for implantation is actually based only on the subjective criteria reported in the patients´ diary only. Patients and care providers are likely to overestimate the real effect of SNS leading to an unjustified overuse of this expensive device. It is therefore necessary to evaluate real efficacy of SNS during the testing phase in a unbiased setting in order to avoid unnecessary morbidity and costs.

NCT ID: NCT00521872 Completed - Surgery Clinical Trials

Stapled Trans Anal Rectal Resection (STARR) for Outlet Obstruction: Functional and Morphological Outcome

Start date: April 2004
Phase: Phase 4
Study type: Interventional

This study compares pre- and postoperative (at 6 month) quality of life and pathomorphology of the pelvis (by MRI defecation) after a STARR procedure for outlet obstruction. - Trial with surgical intervention

NCT ID: NCT00521625 Completed - Clinical trials for Acute Respiratory Distress Syndrome

Epidemiologic Multicenter Study on Mechanical Ventilation Management in Children With Acute Lung Injury

PALIVE1
Start date: June 2007
Phase: N/A
Study type: Observational

PALIVE 1 is an observational multicenter study on mechanical ventilation strategies used in children with an acute lung injury (ALI). The objective of the study is to describe mechanical ventilation strategies in children with an ALI. Our hypothesis is that daily clinical practice is heterogenous among pediatric intensivists as few pediatric data exists on optimal mechanical ventilation strategies in this group of patients. Furthermore, different strategies may affect patient outcome.

NCT ID: NCT00521482 Not yet recruiting - Glioblastoma Clinical Trials

Temozolomide vs. Temozolomide and Thalidomide Treatment in Recurrent Glioblastoma

Start date: September 2007
Phase: Phase 2
Study type: Interventional

The aim of this study is to evaluate the efficacy and safety of intensive dose temozolomide treatment alone in parallel to a combination with thalidomide in patients with recurrent glioblastoma after standard therapy. In the treatment arm A of the study it will be investigated whether or not continuous dosing of temozolomide may overcome alkylator resistance in patients with glioblastoma who progress on the 5/28 day dosing regimen. For treatment arm B it is postulated that the combination of thalidomide and temozolomide is effective with respect to time to progression and progression-free survival due to the fact that temozolomide and thalidomide have different mechanisms of action.