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NCT ID: NCT02108353 Completed - Clinical trials for Sleep Disorders, Circadian Rhythm

Circadian Phase Adjustment and Improvement of Metabolic Control in Night Shift Workers

Start date: January 2015
Phase: Phase 3
Study type: Interventional

EuRhythDia II is a multicenter, randomized, double-blind controlled study. The rationale of EuRhythdia is to explore the effects of 12 weeks of timed melatonin treatment on circadian rhythm, metabolic control and cardiovascular function in night shift workers. The 12 weeks of intervention will be followed by 12 weeks of washing out.

NCT ID: NCT02108262 Completed - Clinical trials for Acute Myocardial Infarction

A Phase 2b Study of CSL112 in Subjects With Acute Myocardial Infarction.

Start date: August 2014
Phase: Phase 2
Study type: Interventional

This is a multicenter randomized, double-blind, placebo-controlled, parallel-group, dose-ranging phase 2b study to investigate the hepatic and renal safety and tolerability of multiple dose administration of two dose levels of CSL112 compared with placebo in subjects with acute myocardial infarction (AMI).

NCT ID: NCT02107807 Completed - Influenza Clinical Trials

Safety and Immunogenicity of Two Doses of aH5N1 Vaccine in Adult and Elderly Subjects With and Without Immunosuppressive Conditions *aH5N1:Monovalent H5N1 Influenza Vaccine

Start date: April 2014
Phase: Phase 3
Study type: Interventional

Evaluate the safety, immune response and reactogenicity of aH5N1 vaccination in adult (18 through 60 years of age) and elderly (≥61 years of age) subjects with and without immunosuppressive conditions.

NCT ID: NCT02107196 Completed - Clinical trials for Irritable Bowel Syndrome With Diarrhea

12-Week Efficacy and Safety Study of Ibodutant in Women With Irritable Bowel Syndrome With Diarrhea (IBS-D)

IRIS-3
Start date: March 2014
Phase: Phase 3
Study type: Interventional

Irritable Bowel Syndrome with diarrhoea (IBS-D) is a functional gastrointestinal disorder characterised by chronic or recurrent abdominal pain or discomfort and diarrhoea. This trial aims at the evaluation of the efficacy and safety of oral ibodutant 10 mg once daily as compared to placebo in women with IBS-D over a 12-week treatment period.

NCT ID: NCT02107183 Completed - Clinical trials for Acute Respiratory Failure

Impact of Nasal High-flow vs Venturi Mask Oxygen Therapy on Weaning Outcome: a Multicenter, Randomized, Controlled Trial

RINO
Start date: June 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether, as compared with the Venturi mask, a nasal, high-flow oxygenation device (Optiflow) may reduce the extubation failure rate in patients needing oxygen therapy after extubation.

NCT ID: NCT02107001 Completed - Lung Cancer Clinical Trials

Lung Ultrasound in Pleuritic Chest Pain

UPP
Start date: March 2014
Phase: N/A
Study type: Observational

Chest pain is an alarming symptom and one of the most frequent causes of access to the Emergency Departement. Although chest X-ray remains an essential step in the diagnostic process, several studies showed numerous limitations of radiography which frequently is inconclusive. Ultrasonography is a non-radiating imaging technique. Albeit a wide use of ultrasound, the utilization of ultrasound in the study of the lung has only recently been introduced in the clinical practice. Several studies proved that lung ultrasound is useful in the diagnosis of lung consolidation in community acquired pneumonia. Nowadays, ultrasound is not routinely used in the presence of chest pain. Our hypothesis based on clinical experience is that, in patients with pleuritic chest pain, lung ultrasound is very sensitive in detecting pneumonia and other lung diseases (such as pneumothorax) thus performing better than radiography. The primary aim of this study is to verify, in patients affected by pleuritic chest pain, the accuracy of lung ultrasound compared to chest-X-ray. The secondary aim is to evaluate the accuracy of lung ultrasound consolidations in distinguishing lung consolidation in pneumonia, atelectasis, pulmonary infarction, or tumors.

NCT ID: NCT02106546 Completed - Clinical trials for Squamous Non-Small Cell Lung Cancer

Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer

Start date: April 10, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of the addition of veliparib plus carboplatin and paclitaxel versus the addition of placebo plus carboplatin and paclitaxel in adults with advanced or metastatic squamous non-small cell lung cancer (NSCLC).

NCT ID: NCT02105948 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Study to Evaluate Efficacy and Safety of Mepolizumab for Frequently Exacerbating Chronic Obstructive Pulmonary Disease (COPD) Patients

Start date: April 15, 2014
Phase: Phase 3
Study type: Interventional

This is a multi-center, randomized, placebo-controlled, double-blind, parallel group trial evaluating mepolizumab 100 mg against placebo given every 4 weeks through subcutaneous (SC) injection. In severe COPD patients, sputum eosinophils levels are elevated similar as those seen in severe asthmatics. It is hypothesized that the reduction of eosinophils with mepolizumab in COPD patients would translate into a reduction of COPD exacerbations. The study will determine the reduction in exacerbations in subjects who are above and below the baseline blood eosinophil count of at least 150 cells/microlitres. The study will evaluate the efficacy and safety of mepolizumab on the frequency of moderate and severe exacerbations in COPD subjects at high risk of exacerbations, despite the use of optimized standard of care background therapy. Overall in this study, a total of 800 subjects will be randomised in 1:1 ratio to receive placebo or mepolizumab (100 milligram (mg)) administered SC. The total duration of this study will be approximately 62 weeks, consisting of a 1 to 2 week screening period, 52-week treatment period and 8-week follow-up period.

NCT ID: NCT02105636 Completed - Clinical trials for Squamous Cell Carcinoma of the Head and Neck

Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Head and Neck Carcinoma (CheckMate 141)

Start date: May 29, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to find out whether Nivolumab will significantly improve overall survival as compared to therapy of investigator's choice in patients with recurrent or metastatic head and neck carcinoma.

NCT ID: NCT02105610 Completed - Cardiac Surgery Clinical Trials

Volatile Anesthetics to Reduce Mortality in Cardiac Surgery

MYRIAD
Start date: April 14, 2014
Phase: Phase 4
Study type: Interventional

There is initial evidence that the choice of anesthesia can influence survival in the specific setting of coronary artery bypass grafting surgery (CABG). A recent international consensus conference included volatile agents among the few drugs/techniques/strategies that might reduce perioperative mortality in cardiac surgery and that should be further studied. Volatile anesthetics (desflurane, isoflurane and sevoflurane) have non-anesthetic pharmacological characteristics that confer cardiac protection when compared to Total IntraVenous Anesthesia (TIVA). Several randomized controlled studies were summarized in a meta-analysis that documented a reduction in perioperative cardiac troponin release and mortality in patients receiving volatile anesthetics when compared to patients receiving a TIVA. There are four published studies (Bignami et al. 2009) (De Hert et al. 2009) (Jackobsen et al. 2007) (Landoni et al. 2007) suggesting that these benefits can translate into a reduced mortality rate in patients receiving volatile agents. The level of evidence for these four studies is not high (one meta-regression, one underpowered randomized controlled study, one retrospective study and one meta-analysis of small randomized studies) and there is need for a large multicentre randomized controlled study to confirm these findings, as suggested by the international consensus conference on this topic published in 2011 (Landoni et al 2011). The purpose is to provide a large multicentre controlled randomized trial to demonstrate that volatile anesthetics can reduce 1 year mortality from 3% to 2% in patients undergoing CABG (either with or without cardiopulmonary bypass). The results of this study can support the use of volatile agents in all CABG procedures worldwide (more than 500.000 per year) with 2.500 lives saved per year (in the hypothesis that nowadays half the procedures are performed with a TIVA and that 1 year mortality can be reduced from 3% to 2% using volatile agents).