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.
Objectives and Specific Aims Time efficiency of robot assisted radical cystectomy (RARC) with totally intracorporeal stapled orthotopic neobladder remains a main drawback of this procedure. According to a recent consensus panel, the benchmark for intracorporeal orthotopic neobladder should be 5 hours in high volume centers . This prospective single-stage phase 2 trial is designed to assess the time efficiency of using robotic stapler versus the conventional motorized staplers (Linear stapler articulated Endo GIA™, Covidien) in achieving the target outcome (total operative time <5 hr). Perioperative complications (intraoperative and 30-d postoperative complications according to the Clavien classification system), 30-d/90-d/ 180-d complication and readmission rates, early functional outcomes (time to recovery of urinary continence), 180-d and 360-d neobladder stone formation rates will be analyzed to assess the safety and the cost effectiveness of the procedure.
Phase III, medical, multicentric, controlled, open label, two-parallel groups, randomized, clinical trial. The aim of this study is to evaluate the efficacy of home enteral nutrition on the nutritional status, the quality of life and tolerance to chemotherapy, in malnourished patients who undergo major gastrointestinal surgery for malignancy (oesophagus, stomach, pancreas, biliary tract). Patients were randomized to receive either home enteral nutrition (HEN, treatment group) or nutritional counselling (control group).
ATLANTIS is a multicenter, phase IIIb, prospective, open-label, randomized trial. The objective of this study is to demonstrate superiority of a strategy of anticoagulation with apixaban (Anti-Xa Group) as compared to the current standard of care in patients who have undergone a successful TAVI procedure. The randomization is stratified according to the presence or not of a mandatory indication for anticoagulation for a reason other than the TAVI procedure (e.g. atrial fibrillation or DVT/PE).
Study hypothesis: Diet integrated with food prepared with olive, buckwheat, peas and chestnut flour as in PreBIOil product combination can modify the gut microbiota and the cholesterol metabolism. Primary objectives of the study are to assess whether the test product to be able to change: 1. fecal microbiota profile; 2. Plasma cholesterol LDL, total, total LDL and HDL ratio; 3. plasma triglycerides; 4. Apolipoprotein ApoA-I, ApoB, and Lp. Secondary objectives of the study are: 1. anthropometric indices; 2. secondary metabolites of polyphenols in human biofluids; 3. mass spectrometry plasma and urine metabolite profile; 4. blood glucose and fasting insulin levels; 5,6) C-reactive protein (PRC or hsPRC); 7) urinary isoprostane F2; 8) oxidized LDL in plasma. Study Design: placebo-controlled, randomized, double-blind parallel trial. Inclusion criteria: Aged 30-65 years; BMI 20-29,9 kg/m^2. Total Cholesterol 180-240 mg/dl Exclusion criteria: Fasting blood glucose >150 mg/dl; triglycerides >500 mg/dl; uncontrolled hypertension (blood pressure [BP] >160/100 mm Hg under antihypertensive therapy); any long term medical therapy; food intolerances; alcohol intake >5 drinks per day or use of narcotic substances; use of dietary supplements, pro or pre- biotics; special diet; pregnancy, tobacco smoking. Methodology: Determination of eligibility: for each volunteer aged between 30 and 65 years, will undergo to clinical and biochemistry evaluation. Clinical visit, clinical tests, and blood drawing will be performed after an overnight fasting at visit T-1 at the Casa di Cura Eremo di Arco (TN). In this T-1 visit the eligibility will be established and the participants will be randomized to receive supplementation with either PreBIOil biscuit (90g/day) or Control for 8 weeks in a double-blind manner. Clinical tests, blood drawing, and stool and urine collection will be performed during visits at the beginning and end of each treatment period (T0 and T1). A 4 day-food diary record will be collected before visits T0, at the beginning of T0 and before T1. Efficacy Assessments Arterial BP; BMI; ratio of waist to hip circumference; food questionnaires; blood sample analysis (total cholesterol, triglycerides, HDL and LDL cholesterol, oxidized LDL, serum glucose and insulin, C-RP, Apolipoproteins, Isoprostane; urinary and plasma metabolite profiling; fecal microbiota analysis. Safety assessments. Adverse events registration. Statistical analyses. The differences between the two group will be evaluated with univariate and multivariate statistical methods. The medium before and after the intervention will be compared with the General Linear Model (ANOVA) for repeated measures or for paired data. Simple and multiple linear regressions will be performed to determine the relationships between independent variables; also we will run the t-test to evaluate differences in compliance detected in the types of supplementation. The results are expressed as mean +/- SEM and the differences will be considered significant when P <0.05. Duration: Subjects will make three visits (visit T-1, beginning visit T0, and end of treatment period visit T1, week 8 from T0). The treatment duration is 8 weeks; a daily portion of about 90 g of biscuit is introduced.
Clinical hypotheses: The increasing number of people aging with HIV is a matter of fact. Differences in prevalence of comorbidities between the general population and HIV-positive patients are mainly driven by duration of HIV infection rather than chronological age of HIV+ patients. People aging with HIV display heterogeneous health conditions. Host factors and duration of HIV infection are associated with increased risk of MM, independently from chronological age and these factors are responsible of the prevalence difference of comorbidities and MM in comparison to the general population. Objectives: The study objective is to assess the prevalence of, and risk factors for, individual co-morbidities and multi morbidity (MM) between HIV-positive patients with similar duration of HIV infection, but 30 years difference. We compared estimates across both groups to a matched community-based cohort sampled from the general population.
Post-market registry on ACURATE TA™ Transapical Aortic Bioprosthesis and ACURATE TA™ Delivery System implantation in patients presenting severe symptomatic aortic stenosis to collect continued surveillance data pertaining to safety and performance of the device.
This study was designed to leverage the sensitivity of ultrasonography available in clinical practice setting to better describe the time course of response to secukinumab (150 mg and 300 mg) on joint synovitis and enthesitis in PsA patients with an inadequate response to non-biologic DMARDs. PDUS changes in joint synovitis will be assessed using the global Outcome Measures in Rheumatology (OMERACT)-European League against Rheumatism (EULAR) synovitis score (GLOESS) and changes in joint enthesitis were assessed using the OMERACT enthesitis score.
A randomized controlled multicenter trial on the usefulness of intraoperative angiography with indocyanine green to assess anastomosis perfusion in patients who undergo laparoscopic rectal resection or left colectomy.
This trial is conducted in Europe. The aim of this trial is to investigate the effectiveness of Tresiba® (insulin degludec) after switching basal insulin in a population with type 1 or type 2 diabetes mellitus. EU-TREAT (EUropean TREsiba AudiT)
The purpose of this study is to collect a multi-institutional database including all relevant data regarding the surgical and clinical features of patients underwent to laparoscopic lavage for complicated colic diverticulitis. The main objectives are: - To determine the surgical and clinical outcomes, in the short and long term. - To compare results according to the different type of techniques, device used and manner of execution of the different surgical steps. - To relate results of different surgeries with baseline characteristics of patients and stage of disease.