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.
Primary Objective: To evaluate the efficacy of dupilumab, compared with placebo, for reducing the use of maintenance oral corticosteroids (OCS) in participants with severe steroid-dependent asthma. Secondary Objectives: - To evaluate the safety and tolerability of dupilumab. - To evaluate the effect of dupilumab in improving participants-reported outcomes. - To evaluate dupilumab systemic exposure and the incidence of treatment-emergent antidrug antibodies.
Evaluation of decellularized human heart valves for aortic heart valve replacement in comparison to current valve substitutes. Safety endpoints include cardiovascular adverse events, time to re-operation, re-intervention and explantation. Efficacy endpoints include freedom from valve dysfunction and hemodynamic performance.
This trial is conducted globally. The aim of this trial is to investigate the effect of liraglutide for weight management in paediatric subjects with Prader-Willi Syndrome.
One thousand, six hundred forty-eight IVF patients undergoing ET with fresh embryos, randomized to receive mTVET (n=828) or UGET (n=820). The transfer in uteri of 1-2 embryos on day 2-3 of culture was performed using a soft catheter either under trans-abdominal US guidance (UGET group) or after measurement of uterine cavity by transvaginal US and calculation of the discharge site (mTVET). Mai outcome measures was the clinical pregnancy rate (CPR), secondary outcomes were the implantation rate (IR), and the patient's discomfort during ET procedure.
The primary efficacy objective of this study is to establish the effect of burosumab treatment compared with placebo on increasing serum phosphorus levels in adults with XLH.
A placebo-controlled, randomized, double-blind, parallel group, phase III multicenter study in subjects recently hospitalized for ACS and with the appropriate genetic profile. Subjects will provide informed consent before any study-specific procedures are performed. Subject enrollment may begin in the hospital and will continue following release from the hospital. Screening procedures may be performed at the time of the index ACS event or anytime thereafter, with the condition that randomization must occur within the mandated window (4-12 weeks after the index event). Subjects will be assessed based on their medical history. Those who are likely to qualify will undergo Genotype Assay testing to evaluate genetic determination for the presence of AA genotype.
A Phase III, multi-centre, double-blind randomised controlled trial in subjects with chronic antibiotic refractory pouchitis. Subjects will undertake a <2 week screening period to provide baseline data and be assessed for eligibility. At the Baseline visit (Day 1) eligible subjects will be randomised on a 1:1 basis to either a) 240 mg alicaforsen enema or b) matching placebo. Study drug will be administered once nightly (on going to bed) up to and including week 6. Following the Day 1 Visit, subjects will return to the clinic for safety and efficacy assessments at Week 3, 6, 10, 18 and 26. Subjects may receive certain permitted medications as per Entry Criteria, which must remain at stable doses throughout the trial. Introduction of any new medication for pouchitis, or a dose change to an existing concomitant medication for pouchitis, other than those detailed in the protocol, will not be permitted. Clinical symptoms associated with pouchitis will be recorded daily by the patient in a diary card. Subjects will undergo endoscopic examination of their pouch (during Screening, and at Weeks 6 and 10). Where technically feasible, each endoscopy will provide at least one biopsy sample for histopathology. In addition to endoscopic, histopathologic and symptomatic assessments, Quality of Life will be assessed. Bloods for routine assessment, including haematology and biochemistry will be taken. Bloods and stool samples will be collected to evaluate relevant biomarkers.
Patients were randomized in 3 groups: two intervent groups and a control group. The first group received two weeks of daily session of repetitive Transcranial Magnetic Stimulation (rTMS, 10 sessions) and, at least 6 months after, two weeks of daily transcranial Direct Current Stimulation (tDCS, 10 sessions); the second group received 10 daily session of tDCS and, after at least 6 months, 10 sessions of rTMS; the control group received 10 daily session of sham tDCS. Physiatric evaluations (ARAT scale), neuropsychological assessment and ERP (P300) were performed before (1 week) and after (1 week) the end of each treatment. Furthermore, all patients underwent follow-up neuropsychological assessment 6 months after the end of each stimulation period and follow-up physiatric evaluation at 3 and 6 months after the end of each stimulation period.
The aim of this study is to assess: 1. Evaluation of the feasibility of laparoscopic nerve sparing radical hysterectomy type III/C1 as regard surgical technique, blood loss and operative time. 2. Evaluate patients' outcome as regard bladder function. in order to preserve the function of the bladder and the rectum, it is necessary to modify the traditional procedures, so as to identify the precise anatomical information directing the technique for optimal preservation of bladder function at the time of radical hysterectomy. The laparoscopic technique offers several well-known advantages. Under the magnified view of the laparoscope, the anatomy can be clearly visualized to allow for the meticulous and precise dissection of the para-cervical structures and areolar tissue, including the blood vessels and the nerves. Laparoscopic identification (neurolysis) of the inferior hypogastric nerve and inferior hypogastric plexus is a feasible procedure for trained laparoscopic surgeons who have a good knowledge not only of the retroperitoneal anatomy but also of the pelvic neuro-anatomy as this qualification could prohibit long-term bladder and voiding dysfunction during nerve-sparing radical hysterectomy
The purpose of this study is to test the hypothesis that the function and/or regulation of urinary aquaporin 2 in hypercholesterolemic humans is affected by standard statin therapy, as compared with diet alone