There are about 21062 clinical studies being (or have been) conducted in Italy. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The goal of the TAXUS™ Element™ Paclitaxel-Eluting Coronary Stent System European Post-Approval Surveillance Study is to evaluate real world clinical outcomes data for the TAXUS™ Element™ Coronary Stent System in unselected patients in routine clinical practice.
This is a prospective, randomised study to compare the endothelial dysfunction of BMS vs SES, both implanted in the same patient with multiple de novo coronary artery lesions undergoing elective PCI. The primary end point will be the evaluation of endothelial dysfunction at 6 months follow-up by measuring the change in vessel diameter in 5 points of the stent and peri-stent site after infusion of acetylcholine.
In critically ill pediatric patients with Acute Respiratory Failure (ARF), Noninvasive Continuous Positive Airway Pressure (NCPAP) is applied to avoid intubation and all related complications such as tracheal injury and predisposition to nosocomial pulmonary infections. The choice of the interface is one of the crucial issues affecting treatment outcome in pediatric age and in particular in preschool children in whom intolerance frequently compromise noninvasive respiratory treatment. NCPAP is applied either through nasal or facial tight fitting masks and the most important principle in guiding the selection of an interface is that it should fit comfortably. However, while nasal mask can leak gas when the infant opens his/her mouth, facial mask can cause significant gastric distension and vomiting, with risk of aspirating gastric contents. Moreover, complications such as air leaks, skin irritation on the bridge of the nose, and discomfort reported with nasal or facial masks in children frequently lead to interruption of the respiratory treatment. Thus, improving the interface between the patient and the ventilator would be expected to facilitate longer and more effective application of NCPAP. A new small helmet specifically designed for young infants has been recently introduced to administer NCPAP. In a recent short term crossover physiological randomized controlled trial, the investigators found that NCPAP by helmet was associated with enhanced feasibility, less need of sedation and prolonged application time (see references below). The purpose of this prospective randomized multicenter study is to compare the efficacy and feasibility of NCPAP delivered either by helmet or by facial mask to treat acute respiratory failure in infants admitted to Pediatric Intensive Care Unit (PICU).
AASD is a new dialysis technique based on the use of a mathematical model of intradialytic solutes and fluid kinetic, for the automatic elaboration of dialysate sodium and ultrafiltration rate profile. The aim of dialysate sodium and ultrafiltration rate profile is to obtain the higher stabilization of intradialytic extra cellular compartment, in consideration of end session targets: body weight and final patient's natremia. In this multicenter prospective controlled randomized trial the primary end-point is the clinical efficiency validation of AASD on intradialytic hypotension but also on thirst, cramps, headache, nausea, vomiting, hypotensive events observed in basal treatment (HD or HDF).
The goal of the study is to evaluate a Home-Based Disease Management program specifically developed for patients with Gold III/IV COPD. By improving disease knowledge, awareness of significant clinical deterioration and self-management skills for patients, this Home-Based COPD Management Program is expected to reduce the severity of exacerbations, the need for emergency hospitalisations, thus demonstrating the efficacy and the cost effectiveness of this intervention.
The primary objective of this study is to compare overall survival (OS) in patients receiving ON 01910.Na + best supportive care (BSC) to OS of patients receiving BSC in a population of patients with myelodysplastic syndrome (MDS) with excess blasts (5% to 30% bone marrow blasts) who have failed azacitidine or decitabine treatment. This patient population has no available therapy and a short life expectancy (approximately 4 months). The high level of bone marrow activity of ON 01910.Na documented in Phase 1 and 2 studies has the potential to delay substantially the transition of MDS to Acute Myeloid Leukemia(AML), a very significant and severe complication, which shortens survival of these MDS patients.
LY2409021 is being evaluated for possible treatment in type 2 diabetes. This study is designed to compare LY2409021 given alone or given in combination with metformin against placebo the change in hemoglobin A1c after a 24-week treatment period.
Objective The aim of the trial is to evaluate the beneficial effects of the oral administration of the probiotic L. Reuteri (Reuterin®) on the airways allergic inflammation in children with mild to moderate persistent asthma. Study design This is a randomized, double-blind, placebo controller trial. 50 children will be enrolled (age range 6-14 years), affected by mild to moderate persistent asthma based on the GINA Guidelines and allergic to acarus (Dermatophagoides farinae and D. pteronyssinus ++/+++). At the enrollment period all children have to show asthmatic symptoms and to be under antileukotrienes treatment (Montelukast 5mg/die) based on the GINA Guidelines. Any inhaling corticosteroids therapies have to be stopped 8 weeks before the trial beginning. Patients will be randomly divided into 2 treatment groups: Group A: 25 patients will take antileukotrienes + L. reuteri drops (108 CFU = 5 drops daily). Group B: 25 patients will take antileukotrienes + placebo. At the enrollment period (T0), after the 1st and the 2nd month of supplementation (T1 and T2), and also 1 month after the supplementation end (T3), all patients will be clinically evaluated through spirometry, FeNO determination and exhale condensate analysis. During the entire trial period the number of asthmatic exacerbations and the use of beta-2 antagonists will be monitored by a diary properly examined at T1, T2 and T3. All children will be enrolled at the Asthma and Infant Respiratory Physiopathology unit "Michele Miraglia del Giudice" of the "F. Fede" Pediatric Department. The analysis of the inflammatory markers on the exhaled condensate will be performer at T1, T2 and T3 in the Pharmacology unit of the Experimental Medicine Department. During the trial it will be possible to administer only salbutamole MDI if it needed. If patients will be administered with any systemic corticosteroids they will exit from the trial. At the enrolment period all patients will receive the completed information on the trial and the informed consent will be properly signed.
The purpose of this study is to determine whether the administration of topiramate to newborns with hypoxic-ischemic encephalopathy potentiates the neuroprotective effect of treatment with hypothermia.
MultiStem(r) is a new biological product, manufactured from human stem cells obtained from adult bone marrow or other nonembryonic tissue sources. Factors expressed by MultiStem cells are believed to reduce inflammation and regulate immune system function, protect damaged or injured cells and tissue, promote formation of new blood vessels, and augment tissue repair and healing. MultiStem cell treatment resulted in significant efficacy in a mouse model of Graft versus Host Disease with almost complete reversal of gastrointestinal pathology (similar to pathology that would be expected in Ulcerative Colitis). These data, together with safety data generated in 2 other clinical trials, suggest that MultiStem has the potential to be a new treatment option for patients with ulcerative colitis. This is the first study of MultiStem in this patient population and will cautiously explore the safety/toleration and potential benefit of this new treatment in patients with moderate to severe disease.