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.
This is a prospective, multicentre, randomized clinical trial comparing two different neo-adjuvant radiation-based strategies prior to intended surgery for locally advanced adenocarcinoma of the rectum. This trial may establish the investigational therapy to be superior to, or at least not inferior to conventional treatment.
The cohort of post-menopausal women represents a group of very-difficult-to-treat patients in whom a more powerful approach is required in order to improve the disappointing response rate. Thus the addition, in patients with previous failure to PEG/RBV treatment or in naïve patients, of a powerful drug like Boceprevir could greatly improve SVR rate as suggested by the results of SPRINT_2 trial in whom Boceprevir addition determined a 30% improvement in SVR rate in difficult gt 1 patients of African descent versus standard PEG IFN/Ribavirin therapy or by those of RESPOND-2 that showed the same percent improvement of RGT-retreatment with Boc/P/R of previous failure of standard therapy. Goal of the study is to verify whether the addition of a 24-week treatment with boceprevir to standard antiviral therapy with Peg IFN and ribavirin will increase the rate of SVR in patients difficult to treat, such as HCV-positive women in post-menopausal women with genotype 1, not only those who have never been treated, but also in those who have not responded to previous treatment with peginterferon and ribavirin (Riba).
Verify with a prospective randomised trial if intracorporeal mechanical anastomosis in laparoscopic right colectomy reduces post-operative bowel canalisation time and length of stay in comparison with extracorporeal mechanical anastomosis.
A carotid stenosis is treated with invasive procedures of revascularization when the lumen is reduced by more than 70% or when the lumen is reduced by more than 50% in patients who have had symptoms attributable to the affected carotid district in last the 6 months. Two options for the treatment of patients with carotid stenosis exist currently: the traditional surgical intervention of removal of the plaque by carotid endoarterectomy (CEA)and percutaneous transluminal carotid angioplasty with a balloon associated to the positioning of a stent through a catheter brought directly in the carotid artery (CAS). The main complication of both the procedures is early thrombosis, a phenomenon in which platelets play a central role. The importance of an effective inhibition of platelet activation in these patients has been widely demonstrated. Clinical studies in patients undergoing PTCA have demonstrated that the optimal treatment for the prevention of stent thrombosis is a dual antiplatelet regimen with aspirin plus clopidogrel, as compared with the single drugs. Given that no specific clinical trial has assessed the best antiplatelet therapeutic regimen in CAS with stenting, by extension from these findings in ischemic heart disease CAS patients are treated with aspirin plus clopidogrel. Several studies have demonstrated that an elevated residual platelet reactivity despite treatment with clopidogrel is associated to an increased risk of major adverse cardiovascular events (MACE) after stenting for coronary disease. No data are instead available on the possible predictive value of residual platelet reactivity for the incidence of ischemic cardiovascular events in patients with atherosclerotic carotid disease undergoing CAS with stenting. Aim of the study will be to assess the predictive value of residual platelet reactivity, as measured by different laboratory tests in patients undergoing CAS with stenting and treated with aspirin plus clopidogrel, for the incidence of cardiovascular complications (major adverse ischemic events).
The main objective of this post-market surveillance study is to compare the subject's weight loss and quality of life, and device safety performance of the abiliti System and the adjustable gastric banding therapies in obese to morbidly obese subjects.
The objective of this active surveillance study is to make available crucial data about epidemiology, serotype distribution, and longitudinal pattern of antibiotic susceptibility of nasopharyngeal strains of Streptococcus pneumoniae carried in the population of healthy children aged less than years and living in the area of Milan and surroundings, Lombardy, Italy. - To estimate the nasopharyngeal carriage rate and longitudinal pattern of Streptococcus pneumoniae in healthy children aged less than 5 years living in the area of Milan, Italy; - To describe the circulation of antimicrobial non-susceptible Streptococcus pneumoniae strains in healthy children aged less than 5 years Secondary objectives: - To describe the nasopharyngeal carriage distribution of Streptococcus pneumoniae strains in healthy subjects less than 5 years old; - To examine the role of risk factors in the Streptococcus pneumoniae carriage rate in healthy children; - • To evaluate the possible impact of vaccination policy in the referenced population.
Single-arm pilot clinical trial. Patients will be subjected to irreversible electroporation (IRE) as the sole treatment of nodules not considered treatable by resection or thermal ablation.
Although pulmonary hypertension (PH) is a quite frequent complication of advanced pulmonary diseases, and it is an independent prognostic factor, until now no evidence-based treatment approach exists for those patients. This study will address if the drug sildenafil can lower pulmonary vascular resistance in patients with significant pulmonary hypertension (high blood pressure in the lungs) associated to chronic obstructive pulmonary disease (COPD). It will see if this treatment can improve effort capacity, quality of life without causing a deterioration in pulmonary gas exchange (mainly arterial oxygenation). Patients 18 years of age and older with moderate COPD and pulmonary hypertension (mean pulmonary arterial pressure >30 mmHg) may be eligible for this study. Participants are randomly assigned to receive sildenafil or placebo (pill with no drug) for 16 weeks. Before starting treatment (baseline), and a the end of the study, the patients have a comprehensive assessment including: - a chest x-ray and CT scan (only at baseline); - pulmonary function tests to measure how much air the patient can breathe in and out, and the capacity of diffusion of gases; - arterial blood gases analysis (for safety reason this examination is performed at baseline, before the randomization after one hour from the administration of a tablet (20 mg) of sildenafil, and every month) - an echocardiogram (heart ultrasound) (only at baseline); - a 6-minute walk test to measure exercise capacity; - a quality-of-life assessment (SF-36 questionnaire) - a right heart catheterization to evaluate the severity of hypertension At the end of the 16-week period, patients may opt to continue to receive sildenafil and monitoring in an open-label phase of the study for up to 1 year.
A 1-year prospective, randomized, investigator-masked trial comparing the confocal and clinical effects of treatment with unpreserved prostaglandins (tafluprost) versus preserved prostaglandins (latanoprost) in newly-diagnosed glaucoma patients.
While the number of assisted reproduction cycles increases worldwide, the introduction of actual technological improvements in the ability to quickly and non-invasively identify the best embryos for transfer still represents a critical goal for reproductive medicine. Indeed, embryo assessment is currently performed through the analysis of morphology and cleavage rate. Recent studies have sought to identify a correlation between qualitative-quantitative profiles of small molecules of metabolic interest and the outcome of embryo transfer. Some of these molecules seem to be best suited for this purpose, including glucose, lactate, pyruvate or amino acid levels. Approaches relying on both optical and non-optical spectroscopy have been proposed to non-invasively monitor the embryo culture media. However, the non-invasive approach only offers an indirect strategy to monitor embryos and a turn-around solution to bypass the limits of detection of these analytical techniques. In this paper the investigators pave the way for direct assessment of embryos through the mass spectrometry-based analysis of blastocoele fluid, which is withdrawn from the blastocoele cavity prior to cryostorage of blastocysts. The investigators show how it is possible to detect most of the already documented metabolites of interest right at the very heart of the blastocyst, without disrupting the workflow of a classic laboratory pipeline.