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 purpose of this study is to test the safety and tolerability of eltrombopag when used to increase and maintain platelet count. Platelet count to be maintained at a level sufficient to facilitate initiation of antiviral therapy, to minimize antiviral therapy dose reductions, and to avoid permanent discontinuation of antiviral therapy.
The present study was conducted as a prospective, randomized study to investigate the effects of vasopressin receptor agonists terlipressin and vasopressin on systemic hemodynamics and microcirculation in patients with catecholamine-dependent septic shock.
The purpose of this pivotal trial is to evaluate subcutaneous (SQ) AIN457 as an adjunctive therapy to reduce the rate of exacerbations of posterior uveitis or panuveitis secondary to Behçet's disease during the 24 weeks of study therapy as compared to standard of care alone.
Low cardiac output syndrome (LCOs) is a serious complication in critically ill patients or those undergoing major surgery, resulting in multiple organ damage with significant in-hospital and long-term morbidity and mortality, as well as prolonged hospital stay. In this setting the mortality rate is distressingly high despite improvements in intensive care treatment, but survivors have an acceptable quality of life.
Insulin secretion and insulin sensitivity are related with an inverse, hyperbolic function, the so called disposition index, that shows the critical importance of the ß-cell dysfunction for the development of T2DM. A consequence of the hyperbolic relationship is that increased insulin resistance is compensated by up-regulation of insulin secretion, as it happens in obesity. However, when a defective insulin secretion in relation to insulin sensitivity takes place (i.e. reduced disposition index) then impaired glucose tolerance or type 2 diabetes develop. The investigators have recently demonstrated that bilio-pancreatic diversion determines a prompt reversibility of T2DM by normalizing peripheral insulin sensitivity and enhancing ß-cell sensitivity to glucose; these changes occur within few days after surgery, largely before changes in body weight occur. This operation may affect the entero-insular axis function, by diverting nutrients away from the proximal gastro-intestinal tract and by delivering incompletely digested nutrients to the ileum, thus abnormally stimulating the secretion of intestinal incretins. It has been shown that male Wistar rats undergoing three different types of small intestinal surgery, namely ileal transposition (either 10 or 20 cm of lower ileum transposed to mid-duodenum) or 85% jejuno-ileal bypass, showed a sustained post-operative reduction in food intake and a significant change in body weight gain. All experimental groups had a large increase in basal and meal-stimulated enteroglucagon, while the area under the curve of plasma levels of gastrin, gastric inhibitory polypeptide (GIP), insulin and blood glucose were significantly reduced. GIP is produced mainly in the duodenum and jejunum as shown in dogs .The aim of the present study is to investigate the intestinal site of production of incretins in response to intraluminal nutrients stimulation in order to establish the relationship between insulin resistance, insulin hypersecretion and different small intestinal segments in insulin resistance conditions, such as obesity and T2DM. To this purpose a mixed test meal will be infused in the duodenum, proximal jejunum or ileum and glucose uptake and insulin secretion studied, in relation to glucagon and incretin response. Studies are carried out in 20 obese subjects of both sexes, 10 of whom with type 2 diabetes and 10 with normal glucose tolerance.
Phase IIIb study to evaluate the long-term efficacy of ferric carboxymaltose (FCM) (using targeted ferritin levels to determine dosing) or oral iron in non-dialysis-dependent chronic kidney disease (NDD-CKD) subjects with iron deficiency anaemia (IDA).
The main objective of this study is to demonstrate superiority in progression-free survival (PFS) when NGR-hTNF is added to standard chemotherapy regimen (cisplatin/gemcitabine or cisplatin/pemetrexed) in locally advanced (stage IIIb with supraclavicular lymph node metastases or malignant pleural or pericardial effusion), metastatic (stage IV) or recurrent non-small cell lung cancer (NSCLC).
This is a multi-centre, multinational, open-label, single-dose acute hemodynamic study followed by randomized, double-blind, parallel-group, placebo controlled study. Eligible subjects will undergo an open-label, single-dose acute hemodynamic study with ACT-293987(NS-304) and 21 weeks of double-blind treatment during which subjects will receive either ACT-293987 (NS-304) or placebo b.i.d. Subjects who have completed the double-blind study can enter the open extension study (separate protocol) and receive administration of ACT-293987 (NS-304) if the subject wishes and the Investigator considers it appropriate.
The Primary Objective was to assess the efficacy of celivarone for the prevention of Implantable Cardioverter Defibrillator (ICD) interventions or death. Secondary Objectives were: - To assess the tolerability and safety of the different dose regimens of celivarone in the selected population. - To document SSR149744 plasma levels during the study.
The results of antiviral therapy in patients with recurrent hepatitis C after liver transplantation are lower than standard. Ribavirin has immune-modulating effects and seems to be crucial to optimize viral treatment. The aim of this multicenter controlled study is to examine the effect of Ribavirin pre-treatment preceding the combination therapy with peginterferon plus ribavirin on the sustained virological response.