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.
Target Population: female patients with HER2-negative, ER and/or PgR positive breast cancer in progression after first-line hormonal therapy. The study rationale is based on the potentiality of reversing endocrine-resistance by Lapatinib - Activity on compensatory-adaptive mechanisms of hyperactivity of signals generated by HER2 family - Modulation of energy balance and signals associated to survival through AMPK activation (via Calmodulin) Metformin - Indirect mechanism, through reduced insulin receptors and IGFR stimulation, with reduces proliferative effects downstream - Direct mechanism, through AMPK activation (via LKB1), with reduced protein synthesis (mTOR inhibition) and increased availability of intracellular energy Lapatinib and Metformin - AMPK "Double"activation, through different potentially additional mechanisms. - Inhibition of proliferative mechanisms for interference on various intracellular target - IR (A e/o B); IGFR - EGFR; HER2 Primary objectives : 1. To assess the rate of patients free from disease progression at 3 months from randomization Secondary objectives : 1. To assess the overall response rate 2. To assess the duration of response 3. To assess 3-years overall survival rate 4. To assess tolerability of each proposed treatment Female patients with HER2-negative, ER and/or PgR positive breast cancer in progression after first-line hormonal therapy will randomized to receive: hormonal therapy + lapatinib or hormonal therapy + metformin or hormonal therapy + metformin + lapatinib with a ratio 1:1:1. For each arm of the study the following sample size is required: - First step: 23 patients, for a total of 69 patients in all 3 arms - Second step: further 33 patients, for a total of 168 patients in all 3 arms.
This study will examine specific biomarkers in primary invasive breast cancer and explore their correlation with patient outcome following standard neoadjuvant treatment.
This study will evaluate the efficacy and safety of Azimilide on the incidence of cardiovascular hospitalizations, cardiovascular emergency department visits or cardiovascular death in patients with Implantable Cardioverter Defibrillators (ICDs)
This was a long-term, open-label study of migalastat (123 milligrams [mg] of migalastat [equivalent to 150 mg of migalastat hydrochloride]) (migalastat) in participants with Fabry disease who completed treatment in a previous monotherapy trial with migalastat.
Multicentric randomized Italian clinical trial, open label, not for profit. To evaluate the efficacy of 25-OH-D vitamin in terms of myocardial infarction, stroke, sudden death, death for other causes in chronic haemodialysis patients. Two arms of treatment: 25-OH-D vitamin per os versus no treatment.
Nosocomial spontaneous bacterial peritonitis (SBP) is frequently caused by multi drug resistant bacteria. Standard treatment of SBP could be ineffective. The aim of the study is to compare daptomycin + meropenem vs ceftazidime in the treatment of nosocomial SBP.
Patients with stable coronary artery disease, undergoing PCI by means of implantation of >33 mm of DES, will be randomized single-blinded to eptifibatide plus unfractioned heparin according to the ESPRIT protocol vs placebo plus unfractioned heparin.
The purpose of this study is to demonstrate the safety and efficacy of AeriSeal System treatment plus optimal medical therapy compared in patients with advanced upper lobe predominant (ULP) heterogeneous emphysema.
The objective of this study is to confirm the efficacy of the association of R-2cda in patients affected by Chronic Lymphocytic Leukaemia and Small Lymphocytic Lymphoma and of evaluating the efficacy of prolongation of therapy with additional infusions of Rituximab alone in increasing and prolonging the duration of the response.
This is a clinical study to investigate how well Biostate works in treatment of male patients below the age of 12 years who have a clotting factor deficiency that is aggravated by the development of antibodies. The antibodies are directed against the clotting factor that is given for replacement therapy and usually make therapy unsuccessful. The treatment used in this study is called immune tolerance therapy.