There are about 20955 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 purpose of the study is to evaluate the reliability of spasticity measurement with Lokomat
The ARCHYTAS Registry is a long-term, global, multicenter, non-randomized, prospective, registry designed to collect "on-label" data in real world clinical settings on patients undergoing endovascular repair with the latest generation Aorfix™ AAA Flexible Stent Graft System. Registry data will augment existing data from ongoing and prospective Aorfix™ clinical trials for the purposes of publication, general product development and quality measures.
BACKGROUND: Post-operative cognitive dysfunction (POCD) is a potentially irreversible loss of brain functions observed in elderly patients after surgical operations under general anaesthesia. POCD at 3 post-operative months is observed in up to 15% of patients aged 70 years and more, and the only recognized risk factor for this condition is increasing age. Importantly, the incidence of POCD at 3 months has been associated to an increased disability and mortality. OBJECTIVES: The present study will evaluate in patients aged 75 years and older undergoing general anaesthesia for non-cardiac surgery, whether an hemodynamic strategy, aiming at maintaining intra-operative arterial blood pressure close to patient's preoperative blood pressure, i.e., to avoid hypotensive episodes, reduces the incidence of POCD at three months. METHODS: Around 1800 consecutive patients scheduled to undergo general anaesthesia for elective non-cardiac surgery will be enrolled. Each patient's cognitive function will be evaluated preoperatively and at 3 months and 1 year postoperatively, together with the occurrence of hearing loss and vestibular function impairment. Furthermore, the incidence of postoperative delirium and cardiovascular, respiratory and infectious complications will be evaluated. EXPECTED RESULTS: The primary outcome is a 25% relative reduction in the incidence of POCD at 3 postoperative months. Secondary outcomes are the reduction of POCD incidence at 1 postoperative year, a reduction in postoperative hearing loss and vestibular impairment at 3 months, a reduction in the incidence of delirium. Hospital length of stay and 90 day mortality will also be assessed. This present study could have a high socio-economic impact, reduce healthcare costs and patient morbidity and mortality with a simple not expensive intraoperative intervention.
The aim of this study is to compare the cannulation time during primary wire guided ERCP (Endoscopic Retrograde Cholangio-Pancreatography) according to two different length of guide wire: long wire or short wire rapid exchange, artery by a prospective randomized trial.
Randomized, multicenter trial to evaluate the cost-effectiveness of 2 different follows up programs in head and neck cancer survivors. Patients in complete remission at month 6 (+/- 1 month) after curative treatment will be randomized in two arms according to 2 different follow up approaches: Non Intensive Follow up approach (Arm A) with no radiologic evaltuations scheduled, but required only at the occurence of any signs or symptoms and Intensive Follow up approach (Arm B) with scheduled radiologic evaluations.
Current pharmacological options to treat an hemodynamically significant PDA (HsPDA) in preterm infants are limited to non-selective cyclo-oxygenase (COX) inhibitors, indomethacin or ibuprofen. Recently paracetamol exposure has been reported to successful closure of PDA. Aim of this randomized double-blind controlled study is to compare the efficacy and the safety of standard PDA treatment ibuprofen versus paracetamol-experimental treatment . We hypothesize that paracetamol is more effective than ibuprofen in closing PDA, perhaps ameliorating the safety profile of the pharmacological treatment.
Increasing evidence suggests that psychological disorders play an important role in the development and worsening of type 2 diabetes (T2D). Among the spectrum of psychological disorders, there is a wide literature about the association between depression and T2D and current data show an approximately two-fold prevalence of depression in adults affected by diabetes compared to un-affected subjects. Moreover, depression in diabetic patients is associated with higher blood glucose levels, poorer adherence to therapeutic regimens (whether pharmacological or therapeutic lifestyle changes), more medical complications, and higher hospitalization rates. Nevertheless, at the best of our knowledge, the mechanism underlying the association between depression and adverse diabetes-related outcomes is currently unresolved. Aim of this project is to assess the efficacy of a psychological treatment for diabetic patients with suboptimal level of Hemoglobin A1c. This project is a RCT that seeks to address the question if type 2 diabetic patients with suboptimal glycaemic control would benefit from a specific psychological intervention, as specified below. A total of 80 diabetic patients will be recruited and randomly assigned to two treatment arms: 1. Standard diabetes care 2. 24 individual sessions of psychological intervention The expected main outcome is the improvement of glycaemic control under psychological intervention in 38 weeks of follow up. Secondary outcomes: reduction of depression and anxiety, improvement in self-efficacy, perceived interference caused by diabetes, family support and eating problems.
The aim of the study is to verify if the periodic flush with normal saline 0.9% NaCl causes a longer or equal duration of patency of peripheral venous catheters, compared with heparin solution 50 U / ml flush, in children from 2 years to 14 years. Only 22 and 24 gauge catheters Will be included in the study.The study will assess in particular: - the difference of permanence in situ of the device - the difference in incidence of complications (in detail: obstruction, phlebitis, thrombocytopenia, systemic anticoagulation) - the difference in costs between use of saline normal saline 0.9% NaCl solution and heparinized 50 U / ml.
The purpose of this study is to evaluate the efficacy of drug-eluting balloon angioplasty followed versus conventional balloon angioplasty in superficial femoral artery and popliteal artery re-stenosis.
The aim of this study is to determine if local application of heat increases the probability of insertion of peripheral venous catheter at the first attempt, reduces the time needed to obtain cannulation and maintains the analgesic effect of Emla in children undergoing peripheral venous cannulation and previously treated with local analgesia with Emla.