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NCT ID: NCT01808287 Completed - Clinical trials for Aortic Valve Disease

Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve/ The SAPIEN 3 Study

SAPIEN3
Start date: January 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the safety and device success of the Edwards SAPIEN 3 Transcatheter Heart Valve (S3 THV) and the Edwards Commander and Certitude Delivery Systems in patients with symptomatic, severe aortic stenosis who are indicated for aortic valve replacement.

NCT ID: NCT01808092 Completed - Clinical trials for Ventilator-associated Pneumonia (VAP)

A Study Comparing Ceftazidime-Avibactam Versus Meropenem in Hospitalized Adults With Nosocomial Pneumonia

Start date: April 2013
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the effects of Ceftazidime-Avibactam compared to Meropenem for treating hospitalized adults with nosocomial pneumonia including ventilator-associated pneumonia

NCT ID: NCT01807923 Completed - Clinical trials for Cystic Fibrosis, Homozygous for the F508del CFTR Mutation

A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR Mutation

TRAFFIC
Start date: May 2013
Phase: Phase 3
Study type: Interventional

The primary objective of the study was to evaluate the efficacy of lumacaftor in combination with ivacaftor at Week 24 in participants aged 12 years and older with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene.

NCT ID: NCT01807780 Completed - Vaccination Failure Clinical Trials

Safety, Immunogenicity And Efficacy Of Vaccination In Military Personnel

Start date: September 2012
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine if multiple vaccination in military personnel may be correlated with the appearance of poorly defined diseases as symptomatic multisyndrome, autoimmune or lymphoproliferative disorders. At the same time, considering possible interference between different vaccines, proteins and polysaccharides, living and inactivated, the study aims to assess the immunogenicity and efficacy also in relation to the specific Human Leucocyte Antigens (HLA) genetic structure.

NCT ID: NCT01807416 Completed - Clinical trials for Jaw, Edentulous, Partially

Bone Dimensional Changes at Different Implant-to-abutment Connections: a 1-year Clinical and Radiological Study

Start date: March 2013
Phase: Phase 4
Study type: Interventional

Aim of the present study will be to evaluate if the platform switching and the flat abutment can modify the peri-implant marginal bone remodelling. A clinical assessment of the soft tissues will also be provided. 80 consecutively inserted dental implants will be included in this study. Maxillary and mandibular implants will be considered, both in frontal and posterior area. After 6 to 12 weeks, the definitive prosthetic abutment will be screwed and the temporary crown cemented. After 2 more months, the definitive porcelain crown will be delivered. The final outcomes will be collected after 1 year from implant insertion. Data will refer to the following timing: T0= implant installation T1= temporary crown cementation T2= definitive crown cementation T3= 1 year follow-up The 80 implants will be randomly divided into 4 groups of 20 implants each, with different implant/abutment design. Group 1: Tapered T3 Standard Collar implants + GingiHue abutments Group 2: Tapered T3 Standard Collar implants + Tissuemax IL abutments Group 3: Tapered T3 Prevail implants + GingiHue abutments Group 4: Tapered T3 Prevail implants + Tissuemax IL abutments On x-rays, the mesial and distal Marginal Bone Level will be measured and compared among and between the groups at the 4 different timing. Pocket Depth and Bleeding on probing (mesial, buccal, distal and lingual) will be measured at T0, T1, T2 and T3. Data will be statistically analyzed.

NCT ID: NCT01807221 Completed - Heart Failure Clinical Trials

Phase IIb Safety and Efficacy Study of Different Oral Doses of BAY94-8862 in Subjects With Worsening Chronic Heart Failure and Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Chronic Kidney Disease Alone

ARTS-HF
Start date: June 17, 2013
Phase: Phase 2
Study type: Interventional

To assess a new drug, BAY94-8862, given orally at different doses, to evaluate whether it was safe and can help the well-being of patients with worsening chronic heart failure and either type II diabetes with or without chronic kidney disease or kidney disease alone. These treatment doses were compared to eplerenone, another marketed drug approved to treat heart failure.

NCT ID: NCT01806493 Completed - Obesity Clinical Trials

Fat Mass Estimation in Overweight and Obesity

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

The prevalence of individuals who are classified as overweight or obese is increasing all over the world and it represents a primary health concern due to the relationship between obesity and a number of diseases, disabilities, comorbidities, and mortality. The definition of obesity should consider not only the increase of body weight but more precisely the increase in body fat mass. However, body composition evaluation is rarely performed in overweight and obese subjects and the diagnosis is almost always achieved just considering body mass index (BMI). In fact, whereas BMI can be considered an important tool in epidemiological surveys, different papers stated the limitations of the use of BMI in single individuals. Aim: to assess the determinants of body composition in a population of overweight and obese subjects and to propose a different model of estimation of fat mass (FM) in these subjects when more reliable equipments for the evaluation of body composition are not available. Methods: in 103 overweight or obese subjects ( 74 women, aged 41.5±10 years, and 29 men, aged 43.8±8 years); a multidimensional evaluation was performed including the assessment of body composition using Dual Energy X-Ray Absorptiometry (DXA), anthropometry, bioimpedance analysis (BIA) and biochemical parameters (total cholesterol, triacylglycerol, HDL- and LDL- cholesterol, free fatty acids and glycerol, glucose, insulin, C-reactive protein, plasma acylated and unacetylated ghrelin, adiponectin and leptin serum levels).

NCT ID: NCT01806467 Completed - Clinical trials for Hemodynamic Instability

Validation of a New Method to Measure Cardiac Output: Comparison With Thermodilution

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

Many mini-invasive devices to monitor cardiac output (CO) have been introduced and among them the Pressure Recording Analytical Method (PRAM). The aim of this study is to assess the agreement of PRAM with the intermittent transpulmonary thermodilution (ThD) and continuous pulmonary ThD in measuring CO in hemodynamically unstable patients.

NCT ID: NCT01806428 Completed - Septic Shock Clinical Trials

Activated Protein C and Microcirculation

Start date: July 2009
Phase: N/A
Study type: Observational

Objective: to test the hypothesis that recombinant activated protein C (aPC) therapy improves the microcirculation of severe septic patients. Design: Prospective, open study. Setting: University 12-beds intensive care unit. Patients: Septic patients with at least two sepsis-induced organ failures occurring within 48 hours of the onset of sepsis were included in a one year period. Interventions: Patients who had no contraindication to aPC administration received aPC at a dose of 24 mcg/kg/h for 96 hours. Patients with contraindications to aPC infusion were considered as controls.

NCT ID: NCT01805570 Completed - Clinical trials for Myocardial Infarction

Rapid Activity of Platelet Inhibitor Drugs Study 2

Start date: November 2012
Phase: Phase 4
Study type: Interventional

The aim of the RAPID study is to evaluate the superiority rapid onset of action of Ticagrelor 360 mg LD versus Prasugrel 60 mg LD, in 50 patients with STEMI (ST segment elevation myocardial infarction) undergoing PPCI with bivalirudin monotherapy. Secondary study aim is to found out clinical predictors of high residual platelet reactivity in the first hour after a novel oral antiplatelet agent LD.