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 aim of the study is to evaluate whether tamoxifen at a low dose of 5mg/d reduces in the long term the incidence of invasive breast cancer and ductal carcinoma in situ, DCIS (DIN 1c, 2, 3) of the breast, in woman operated for lobular intraepithelial neoplasia (LIN1, 2 and 3) or ER-positive ductal intraepithelial neoplasia (DIN 1b, DIN2, DIN3, 1a excluded) of the breast. To improve the risk-benefit ratio, the use of lower doses of the drug has been proposed. Biomarker trials revealed that 5 mg/d was noninferior to 20 mg/d in inhibiting proliferation of breast cancer and normal endometrial tissue. By contrast, the risk of endometrial cancer si dose-dependent, and the dose reduction can lead a substantial decrease. Morover a dose of 5 mg/day is associated with an overall decrease of the estrogenic activity of tamoxifen on insulin like growth factor (IGF-I), sex hormone-binding globulin (SHBG) and antithrombin-III, with a decrease of venous thromboembolic events. Moreover, tamoxifen exhibits a high tissue distribution, so that a dose of 5 mg/day attains at the breast tissue level a concentration 10 times higher than that needed to inhibit cell growth in vitro. A prospective cohort study also showed that 10 mg on alternate days halves recurrence of DCIS in postmenopausal women. It has been shown that the treatment of dysplasia or pre-cancer drives the reduction of the invasive neoplasms onset. This is a chemoprevention trial designed to validatate the low-dose Tamoxifen in women with diseases at high evolutionary risk. The demonstration of efficacy and safety of such a treatment for the prevention of the invasive breast cancer would lead improvements in term of survival and quality of life for the patients at increased risk.
The primary purpose of this study is to find the recommended dose of LGK974 as a single agent and in combination with PDR001 that can be safely given to adult patients with selected solid malignancies that have progressed despite standard therapy or for which no effective standard therapy exists
The PROMUS Element™ clinical trial (PLATINUM-PLUS) consists of a randomized controlled trial (RCT) in the European Union (EU) which will enroll approximately 2980 subjects (2:1 randomization PROMUS Element™: Xience™ Prime) in a Population of consecutive, all comers in the reimbursed indications per-country All subjects will be screened per the protocol required inclusion/exclusion criteria.
Primary and secondary prevention trials with statins, as well as with antiplatelet, clearly demonstrated that these drugs are able to reduce cardiovascular events. Even if the principal mechanism of action of statins is to lower cholesterol, other effects, the so-called pleiotropic effects, have been considered as adjunctive properties potentially accounting for the anti-atherosclerotic effect of statins. Inhibition of oxidative stress may be considered an intriguing pleiotropic effect in view of the fact that oxidative stress is thought to be a key event in the initiation and progression of atherosclerotic disease. Reduction of several markers of oxidative stress including isoprostanes, 8-hydroxydeoxyguanosine (8-OHdG), and nitrotyrosine have been observed after statin treatment. NADPH oxidase is among the most important sources of reactive oxygen species involved in atherosclerotic disease. The investigators developed an ELISA to evaluate serum levels of soluble-gp91phox, the catalytic core of phagocyte NADPH oxidase. Recently the investigators showed that statins (30 days treatment) exert an antioxidant effect via inhibition of soluble gp91phox expression. The exact mechanism by which atorvastatin reduces NADPH oxidase, however, is unclear. Recent study showed that statin treatment inhibits leukocyte ROCK activity, a protein kinase implicated in the activation of NADPH oxidase, with a mechanism that seems to be independent from lowering cholesterol. To further study the mechanism(s) implicate in gp91phox downregulation by statin the investigators planned the present study in patients with high risk of vascular events such as hypercholesterolemic and Type 2 Diabetes mellitus patients. In addition the investigators want to evaluate the synergistic role of atorvastatin with aspirin treatment.
Cisplatin and pemetrexed combination or carboplatin, paclitaxel and bevacizumab are now considered as standard treatment in non-squamous cell lung carcinoma (NSCLC). Both main registrative trials are considered positive because they reached their objectives, but within them, the Quality of Life (QoL) of patients was not detailed neither has represented as primary objective of the studies. It is considered that, together with enhancements that are added to the knowledge of the biology of NSCLC, QoL may influence the therapeutic choice if one of the associations show to be better tolerated by the patient and favours an amelioration of his QoL.
Gait rehabilitation with treadmill has been reported to be useful in patients with Parkinson's disease. In the last years, interest in robotic devices for gait training has grew up for patients with different neurological disorders, since they minimize demands on physical therapists and may provide a more reliable and constant treatment. The aim of this study is to evaluate if robotic gait training with Lokomat® can improve walking more than conventional gait training with treadmill in patients affected by Parkinson's disease.
The purpose of this study is to evaluate the effect of patient outreach program on the proportion of time patients with MTC experience moderate or severe AEs during first 12 months of treatment with vandetanib
Parts A & B: Conversion of stable pediatric allograft recipients from Prograf® immunosuppression to Advagraf® immunosuppression to compare exposure and one year follow-up for safety and efficacy. Part C: Continuation of long-term follow-up and provision of ongoing study medication to subjects to whom Advagraf® is currently not available.
Compare completeness and modality of revascularization, operative and postoperative results and 1 year clinical outcomes in unselected high risk patients referred for primary coronary artery bypass surgery. Patients will be randomized to undergo off-pump coronary artery bypass graft (OPCAB) or coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB).
This open-label, multi-center study will evaluate the safety and efficacy of RO5 185426 in patients with metastatic or unresectable papillary thyroid cancer posi tive for the BRAF V600 mutation and resistant to radioactive iodine therapy. Pat ients will receive RO5185426 960 mg orally twice daily until progressive disease or unacceptable toxicity occurs.