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NCT ID: NCT01294527 Completed - Heart Failure Clinical Trials

Wireless Stimulation Endocardially for Cardiac Resynchronization Therapy

WiSE-CRT
Start date: February 2011
Phase: N/A
Study type: Interventional

The WiCS-LV system is an alternative means to providing left ventricular stimulation for Cardiac Resynchronization Therapy (CRT). The purpose of this study is to evaluate the safety and performance of the WiCS-LV System in patients with indications for CRT.

NCT ID: NCT01294410 Completed - Colitis, Ulcerative Clinical Trials

Induction and Maintenance Study of BMS-936557 Patients With Moderate to Severe Ulcerative Colitis

Start date: March 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether BMS-936557 is effective in the treatment of moderate to severely active ulcerative colitis in patients who have had insufficient response and/or intolerance to other medical therapy for ulcerative colitis

NCT ID: NCT01294163 Completed - Clinical trials for Coronary Artery Disease

Xenon Compared to Sevoflurane and Total Intravenous Anaesthesia for Coronary Artery Bypass Graft Surgery

Start date: April 2011
Phase: Phase 3
Study type: Interventional

Xenon is a gaseous anaesthetic agent registered in several European countries. It has been administered safely during cardiac surgery in pilot studies. In animal studies, xenon decreases the size of experimental myocardial infarction. This 3-arm study will compare xenon, sevoflurane and a propofol-based total intravenous anaesthesia for maintenance of anaesthesia during coronary artery bypass graft surgery conducted with extra-corporeal circulation. Xenon and sevoflurane will be administered before and after extracorporeal circulation. Propofol will be administered during extracorporeal circulation in the three groups of patients. The study will compare the postoperative myocardial damage observed 24 hours after surgery from blood levels of troponin I, a largely accepted biomarker of myocardial necrosis. The main hypothesis is that the myocardial damage observed after xenon administration will not be superior to the damage observed after sevoflurane administration (non-inferiority). The second hypothesis is that the myocardial damage observed after xenon administration will be inferior to the damage observed after total intravenous anaesthesia.

NCT ID: NCT01293448 Completed - Esophageal Cancer Clinical Trials

Evaluation of Balloon-based Cryoablation of Human Esophageal Epithelium

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

The purpose of this study is to evaluate a cryoablation technique used to ablate human esophageal mucosa.

NCT ID: NCT01293435 Completed - Clinical trials for Community Acquired Pneumonia (CAP)

Study Evaluating Management of Patients With Community-Acquired Pneumonia (CAP) or Complicated Skin Infections

REACH
Start date: March 2011
Phase: N/A
Study type: Observational

This study will collect real-life data from patients with community acquired pneumonia (CAP) OR complicated skin and skin structure infections (cSSSI) to assess the burden of the disease, review the treatment pathways, evaluate how health resources are used and identify any areas of unmet medical needs. The aim of the study is to compare how patients who are admitted to hospital with CAP or cSSSI are managed across Europe. This will be done by collecting data to understand the patient and disease characteristics, current practice of treatment, and outcomes for the patient. Overall 4000 patients will be recruited from 10 European countries.

NCT ID: NCT01293071 Completed - Infections Clinical Trials

Effect of Antibiotic Rotation in the ICU on the Prevalence of Antibiotic Resistant Gram-negative Colonisation

SATURN
Start date: January 2011
Phase: Phase 4
Study type: Interventional

The SATURN ICU-trial studies the effect of antibiotic rotation on the prevalence of antibiotic resistant Gram-negative colonisation.

NCT ID: NCT01291836 Completed - Acute Kidney Injury Clinical Trials

Acute Kidney Injury Neutrophil Gelatinase-Associated Lipocalin Evaluation of Symptomatic Heart Failure Study

AKINESIS
Start date: December 2010
Phase:
Study type: Observational

AKINESIS is a clinical study to assess the utility of blood and urine NGAL tests in predicting worsening kidney function in patients who present with acute heart failure (AHF) and who are treated with diuretics. It is believed that rising NGAL levels in the blood and/or urine can predict acute kidney injury. It is also believed that patients who are admitted to the hospital with high NGAL levels in the blood/urine will have poorer outcomes.

NCT ID: NCT01291810 Completed - Crohn's Disease Clinical Trials

Clinical Efficacy of TNFa Kinoid in Crohn's Disease Patients

Start date: February 2011
Phase: Phase 2
Study type: Interventional

The safety and immunogenicity of the TNFα-Kinoid (TNF-K) have been evaluated in a phase I-II clinical study conducted in subjects with Crohn's Disease (CD). Preliminary results of clinical efficacy are promising. The principal aim of the present study is to confirm the clinical efficacy of the TNF-K in subjects with moderate to severe CD. Subjects with secondary resistance or intolerance to anti-TNFα monoclonal antibodies will be enrolled in this trial. In addition, the immune responses and the safety elicited by TNF-K will also be evaluated.

NCT ID: NCT01290939 Completed - Clinical trials for Glioblastoma Multiforme

Bevacizumab and Lomustine for Recurrent GBM

Start date: October 2011
Phase: Phase 3
Study type: Interventional

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as lomustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known which regimen of bevacizumab given together with lomustine is most effective in treating patients with glioblastoma multiforme in first recurrence. PURPOSE: The primary objective of this study is to investigate whether the addition of bevacizumab to lomustine improves overall survival (OS) in patients with recurrent glioblastoma compared to treatment with lomustine alone.

NCT ID: NCT01290809 Completed - NSCLC Clinical Trials

Prophylactic Cranial Irradiation (PCI) Cognitive Tests in Non-small Cell Lung Cancer (NSCLC) Patients

Start date: January 2011
Phase: N/A
Study type: Observational

Stage III non-small cell lung cancer (NSCLC) patients constitute a significant proportion of the lung cancer population. The prognosis of these patients has improved over the years due the introduction of combined modality treatment, including high-dose chemo-radiotherapy. The brain, however, remains one of the major sites of failure. Patients with brain metastasis suffer from a variety of neurological, cognitive and emotional difficulties that are known to adversely affect the health-related quality of life. Prophylactic Cranial Irradiation (PCI) can prevent or delay the development of brain metastasis, and as such can improve neurological disease-free survival and consequently health-related quality of life. But survival is short, and toxicities are real, as PCI in itself can also induce adverse effects. The cognitive adverse effects of PCI are not sufficiently illuminated and documented, due to the lack of formal and systematic evaluation in patient populations expected to have short survival. Also, recent attempts to reduce cognitive side effects of PCI by the application of hippocampal-avoidance PCI in order to prevent memory deficits have not been fully evaluated yet. Before PCI can be offered routinely to stage III NSCLC patients in daily practice, the costs and benefits of this therapy should be investigated properly, to allow for well-informed treatment choices.