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 objective of this randomized, blinded, multicenter, controlled study is to compare the performance of the IBV Valve System (treatment group) to a control group receiving a sham bronchoscopy procedure without valve placement.
This study will evaluate the efficacy and safety of single agent oral panobinostat in patients who have refractory de novo or refractory secondary AML.
The object of this research study is to examine these associations in children as very little is known about psoriasis and cardiovascular risk factors in the pediatric population.
There are few longitudinal studies in the Caucasian population and even less in the Italian population in subjects with impaired glucose regulation to allow: 1. An estimate of the rate of conversion to type 2 diabetes; 2. To identify subjects at risk; and 3. To assess the physiopathologic mechanisms responsible for the conversion. In order to set up a longitudinal study capable of defining the above parameters it is mandatory that the physiological, biochemical, and, genetic markers specific for IGR are identified. The goals of the present research proposal are: 1. To clarify the physiological mechanisms responsible for IGR; 2. To identify the biochemical and beta-cell auto-immune parameters present in IGR; 3. Identify genetic markers. The subjects who will be identified will add up to other 900 individuals who will be recruited as part of a follow-up program sponsored by the Italian Society of Diabetes, specifically designed to assess conversion rate to diabetes.
The purpose of this study was to determine the dose-response curve for the MRI-based efficacy of BAF312 compared with placebo in patients with Relapsing-Remitting Multiple Sclerosis (RRMS), and to characterize its safety and tolerability for the selection of an optimal dose in a later phase III study. Study Design Rationale An adaptive design was chosen to characterize the dose response curve of BAF312. In a first period of study ("Period 1"), three doses of BAF312 and placebo were tested for MRI efficacy. Based on an interim analysis (IA) after 3 months of treatment, two additional active doses for period 2 wereselected , thus allowing to optimize the overall determination of the dose response curve with 5 data points of active treatment, and placebo. The doses were kept blinded. The use of Modeling and Simulation allowed to establish the full range and dynamics of the dose-response curve in silico, and hence the definition of the optimal dose for later phase III studies. The choice of placebo as treatment control was essential to obtain information on the specific compared to non-specific effects of active treatment and provides the best way of evaluating the efficacy and of assessing the true safety and tolerability profile of BAF312. Short-term placebo exposure (6 (Period 1) or 3 (Period 2) months, respectively) was unlikely to lead to longer term differences in outcomes [Polman, 2008]. The use of an adaptive design strategy contributed to a significant reduction of placebo exposure, both in terms of the number of patients and duration, as compared to conventional trial models. Patients having completed the study within the protocol might be eligible for the Extension Phase study where they receive long-term BAF312 treatment (a separate protocol).
This study is designed to assess the safety and efficacy of RAD001 monotherapy in patients with advanced gastric cancer which has progressed after one or two lines of prior chemotherapy.
This study will assess the safety and efficacy of deferasirox in patients with cardiac MRI T2* < 20 msec.
The purpose of this study is to investigate whether neratinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab.
The purpose of the study is to demonstrate the safety and functionality of the CircuLite Synergy Pocket Circulatory Assist Device.
This is a phase 1, dose escalating study to determine the safety of PF-03084014 in patients with advanced cancer and leukemia