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 MultiSENSE study is to collect chronic information from multiple sensors in an implanted device for evaluation in heart failure patients.
The aim of this study is to demonstrate the efficacy of fibrin sealant (Tissucol-Baxter) in preventing pocket haematoma and subsequent complications in patients undergoing pacemaker or ICD implantation/replacement which cannot discontinue dual antiplatelet therapy (i.e. ASA and clopidogrel, ASA and prasugrel) or anticoagulant therapy (i.e. warfarin, heparin, low molecular weight heparin). Fibrin-based sealant is available for local haemostasis. A recent study (Milic DJ et al, 2005 Europace, 7: 374-379) has shown the efficacy of the fibrin sealant in prevention of pacemaker pocket haematoma in 40 patients undergoing pacemaker implantation who are receiving anticoagulant treatment. Patients with dual antiplatelet therapy (DAT) are prone to a high risk of bleeding during surgical procedures. Thus, the routine use is the discontinuation of DAT al least 4-7 days before the intervention. This practice may result in a high risk of thrombotic events in patients with coronary stenting. Recently, in our Center we started the use of a fibrin sealant for local haemostasis (Tissucol Baxter), and the investigators observed a reduction in the incidence of pocket haematoma complication, the need of vacuum drainage system, and the reduction of hospital stay.
This study will assess tolerability and safety and health outcomes in relapsing MS patients taking FTY720.
The overall objective is to collect and assess data on the treatment, safety, and treatment outcomes of subjects prescribed, receiving and participating in the Ceprotin treatment registry.
Respiratory allergy due to Alternaria is a relevant clinical problem, and specific immunotherapy may represent a viable treatment option. Sublingual immunotherapy (SLIT) is safe and effective, but data for Alternaria are lacking. The study is aimed at assessing the efficacy of a standardized SLIT in patients sensitised to Alternaria, in a randomized, double blind, placebo controlled fashion. Patients with rhinitis with/without intermittent asthma, and ascertained allergy to Alternaria are enrolled. After a baseline season, SLIT or matched placebo are given for 10 months. Symptoms and rescue medication intake are recorded on diary cards from June to October. Skin prick test, specific IgE and IgG4 and precipitins are measured at baseline and at the end of the study. Alternaria spore count is also performed. Primary outcome is the change in symptom score in the active vs placebo group. Secondary outcomes: changes in rescue medication intake, alternaria specific IgE and IgG4, skin prick test reactivity.
The purpose of this study is to determine whether Eribulin Mesylate Administered in Combination with Pemetrexed is safe and tolerable and to gain a preliminary indication of clinical benefit when administered to Patients with Stage IIIB or IV Nonsquamous Non Small Cell Lung Cancer.
Direct comparison studies of the tiotropium HandiHaler® 18 µg and Respimat® 5 µg formulations have been limited to 4-week crossover studies. Therefore, prospective data from a trial of adequate size and duration is required to establish that compared to tiotropium HandiHaler®, tiotropium Respimat® will have (a) similar effects on safety and (b) similar or superior effects on exacerbations.
Phase I dose-escalation study to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of LDE225 given orally on a daily dosing schedule in children with recurrent or refractory medulloblastoma, or other tumors potentially dependent on Hedgehog signaling pathway. Phase II study is to assess preliminary efficacy in both adult and pediatric patients with recurrent or refractory MB.
The aim of the proposed research is to compare two commonly used pediatric strength testing measures: handheld myometry (HHM) and CINRG Quantitative Measurement System (CQMS), with the goal of identifying a sensitive and valid tool for measuring muscle strength in children with DMD. The data obtained from this study will be used to make recommendations for strength measurement endpoints in prospective muscular dystrophy trials and provide more reliable and accurate recommendations in the clinic for strength assessment. This study will be performed at six participating sites in the Cooperative International Neuromuscular Research Group (CINRG).
To investigate the efficacy and safety of BIBW 2992 in combination with vinorelbine i.v. chemotherapy as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed one prior trastuzumab (Herceptin®) treatment