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 find out which way of giving high-dose radiation works best for treatment of cancer that has spread to bone, the spine, soft tissue, or lymph nodes. This study will look at the effects, good and/or bad, of giving 27 Gy in three fractions (3 days) or 24 Gy in one fraction (1 day) using image-guided intensity-modulated radiotherapy (IG-IMRT). IG-IMRT is radiation that is given directly to the cancer site and reduces the exposure to normal tissue. Currently there are no studies that compare the effects of giving radiation in either hypofractionated doses (higher total doses of radiation spread out over several treatment days) or a single-fraction dose (entire radiation dose given in one treatment session). The patient may be asked to participate in an additional part of this study where we will get a a (DW/DCE) MRI before treatment start and within one hour after radiation treatment. If the patient is asked to take part in this portion of the study, all they will need to do is get up to 3 MRIs with standard contrast injection. The purpose of this is to see if as a result of the treatment there are changes in the blood flow going to the cancer which could suggest that the treatment may be successful. In addition some patients can present new lesions and may be asked if they would like to have these new lesions treated on the protocol. If they are given this option, this will not extend their follow up period. The follow up of the new lesions will match with the prior follow up dates.
Cardiovascular diseases belong to the major causes of mortality in western populations, and atherosclerosis is the lesion responsible for clinical events, such as acute myocardial infarction and stroke. Atherosclerosis remains asymptomatic until a clinical event occurs, and in the pre-clinical stage it may be difficult to diagnose. As disease surrogate, a large number of risk factors for atherosclerosis are being recognized. Some of them are responsible for the epidemiologically very serious metabolic syndrome, which accounts for development of hyperlipidemia, obesity, diabetes or arterial hypertension. Health providers in continental diet-based countries suggest to embracing Mediterranean diet in order to contribute in reducing cardiovascular mortality. However, countries in the Mediterranean area are experiencing a shift in dietary habit towards continental diet with potential harmful change in mortality rates. Oxidative stress, including free radical-driven reactions and antioxidant status are considered important mediators to be considered in the diet-mediated effect on health. Important metabolic functions are also mediated by certain fatty acids. A comprehensive study of oxidative stress, including free radical-driven products and protective antioxidants, and fatty acids metabolism has never been reported in healthy subjects. In particular, high sensitive mass-spectrometry methods to study oxidative stress and fatty acids metabolism are rarely applied to epidemiological studies. The aim of the present grant project is therefore to assess in a large cross-sectional study the prevalence of oxidative stress markers, and fatty acids and to find any causal relation between these variables and metabolic syndrome. This population sample will be followed prospectively not only for time of the present grant project, but we would like to study metabolic variables with relation to the development of oxidative stress-mediated diseases, in particular those of cardiovascular system, on a longitudinal basis (prospective epidemiological study for at least 10 years). At same time we should be able to define the importance of individual markers of oxidative stress and fatty acids for early detection of these diseases.
Study phase: phase III Study objective: - Comparison of Bortezomib, Melphalan, Prednisone (VMP) with High Dose Melphalan followed autologous stem cell transplantation (ASCT) - Comparison of Bortezomib, Lenalidomide, Dexamethasone(VRD) as consolidation versus no consolidation - Comparison of single versus tandem high dose Melphalan with ASCT Patient population: Patients with symptomatic multiple myeloma,previously untreated, ISS stages 1-3, age 18-65 years inclusive Study design: Prospective, multicenter, intergroup, randomized Duration of treatment: Expected duration of induction, stem cell collection and intensification is 6 - 9 months. Consolidation with VRD will last 2 months Maintenance therapy with Lenalidomide will be given until relapse. All patients will be followed until 10 years after registration.
The study is the WP4 of the EU-funded (7th FW) project SATURN (Impact of Specific Antibiotic Therapies on the prevalence of hUman host ResistaNt bacteria). A total of 6 surgical and 6 medical wards will participate in the study. Sites of the study are located in 3 countries (Italy, Serbia, Romania). This WP will compare nosocomial acquisition rates of methicillin-resistant Staphylococcus aureus (MRSA) and extended-spectrum beta-lactamase (ESBL)-producing gram-negative bacteria (E.coli, Klebsiella spp. and Proteus spp.) among different treatment groups and define the temporal relationship between the start of antibiotic therapy, the acquisition of new colonisation in patients previously not colonised, and the development of a bacterial infection caused by the same strain isolated in a screening sample. This goal will be achieved by completing the following primary objectives: - To determine the rate of acquisition of target antibiotic-resistant bacteria by 1,000 antibiotic-days according to different classes of antibiotics, duration of therapy and antibiotic combination (monotherapy versus combination therapy); - To determine genotypic relation between colonising and infecting strain in the same patient and patients' and hospital staff colonising strains (to be performed in collaboration with WP1 of the SATURN project); - To study the virulence and fitness of the isolates (i.e. new colonising strains) causing subsequent nosocomial infections (to be performed in collaboration with WP1 of SATURN project); - To predict the risk for nosocomial infections due to target bacteria after a single treatment therapy adjusted by length of hospitalisation and ward colonisation pressure.
This study is carried out to see how Caucasian patients with lung cancer which has EGFR mutation will respond to gefitinib (IRESSA™) as a first line treatment. Safety data will also be collected and analysed to confirm that treatment with gefitinib is safe and well tolerated.
Aim of the present retrospective study is to evaluate molecular factors of primary resistance to tyrosine kinase inhibitors in metastatic non small cell lung cancer (NSCLC) patients. The investigators assess first, the incidence of epidermal growth factor receptor (EGFR) and Kirsten ras sarcoma viral oncogene homolog (KRAS) mutations, SOS and hepatocyte growth factor (HGF) expression, anaplastic lymphoma kinase (ALK) translocation and expression and, secondly, the investigators correlate molecular markers with clinical features and outcome in terms of response rate, progression free survival and overall survival.
Few reports described outcomes of complete compared with infarct related artery (IRA) only revascularization in patients with ST elevation myocardial infarction (STEMI) and multivessel coronary disease (CAD). The purpose of this study is to determine outcome (death, myocardial infarction, target vessel failure) of 180 consecutive patients with STEMI and multivessel CAD undergoing primary angioplasty. Before the first angioplasty patients are randomized to 2 different strategies: 1) culprit vessel angioplasty only, 2) staged revascularization.
This is a dose finding, open-label, uncontrolled, dose-escalation trial to determine the maximum Tolerated Dose (MTD) of the combination of CC-5013 (Lenalidomide)and paclitaxel in patients with advanced solid tumors. Other purposes of the study are: 1. Define the safety profile of the CC-5013 and paclitaxel given in combination 2. Define the pharmacokinetics of CC-5013 and paclitaxel given in combination 3. Define the pharmacodynamic effects of the combination by monitoring potential biomarkers of the different biological activities of each component of the regimen 4. Define the optimal biological dose (OBD) and the dose recommended (RD) for phase II studies in selected tumor types (breast, ovary, prostate, NSCLC) 5. Collect evidence of antitumor activity in selected tumor types
This is a dose finding, open-label, uncontrolled, dose-escalation trial to determine the Maximum Tolerated Dose (MTD) and the Recommended Dose (RD) of the combination RAD001 (escalating daily dose) and CaelyxTM (fixed dose) to patients with advanced solid tumors. Other purposes of the study are: 1. define the safety profile of the combination after repeated administrations 2. define hints of antitumor activity, to be confirmed in subsequent disease-oriented expansion phases at the RD. 3. define the pharmacokinetic profile of the combination
Thalidomide-Dexamethasone (TD) is a standard induction therapy for Multiple Myeloma (MM). The present study is designed to compare TD with VELCADE-Thalidomide-Dexamethasone (VTD) as induction therapy in preparation for, and as consolidation after, melphalan-based double autologous stem cell transplantation for previously untreated patients aged ≤65 years with symptomatic MM. Primary study endpoint is the rate of complete response (CR) plus near-complete response (nCR) to induction treatment. Secondary endpoints include the rate of CR plus nCR to double transplantation and subsequent consolidation therapy, time to progression (TTP), progression-free survival (PFS),overall survival (OS) and toxicity profile of both VTD and TD.