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 probability to achieve CR with R-chemotherapy in patients failing a rituximab containing first line regimen is quite low, in particular in cases with non GCB profile. The bioCORAL trial suggest that ABC subset have a dismal outcome whichever the induction treatment. Thus it can be argued the addition of new molecule to the RDHAP regimen could be of value. Bortezomib appears the best candidate in this setting as ABC subtypes constitutively express NFkb, which is the target of bortezomib itself. Data from the literature suggest an encouraging activity of R-chemo+ bortezomib in non GCB-derived DLBCL, although in small series. Thus, the addition of bortezomib is here justified by the need to circumvent constitutional resistance to chemotherapy. Published experience of the association between bortezomib and cytarabine are also encouraging with acceptable cumulative toxicity.
The primary purpose of this study is to assess the effects of the use of EVADO with respect to a conventional cardio-pulmonary bypass (CBP) system on surgical morbidity and mortality. As secondary aim this study wants to conduct appropriate laboratory investigations in order to detect the major biological mechanisms potentially responsible for the beneficial effects of the EVADO system on the coagulation cascade and inflammatory activation.
The study aims to validate the clinical efficacy of a telemedicine- and web-based system platform for Self-monitoring of blood glucose (SMBG) data transmission and analysis in terms of improved metabolic control, assessed by measuring changes in HbA1c, in insulin-treated diabetic patients. The system platform involves (i.) systematic (real-time and anywhere) transmission of SMBG data to a decision supported software (DSS)-assisted server, (ii.) web-based analysis of data, and (iii.) feedback on patients and medical staff to implement metabolic control. The expected outcome is that using this telemedicine-based system with transmission of SMBG data, web-based analysis of data and medical feedback to patients and medical team will improve glucose control in insulin-treated individuals with type 1 or type 2 diabetes mellitus.
Sepsis is widespread (1.8 million cases annually worldwide) and accounts for a very high mortality: 20-25% of all severe sepsis, 40-70% of all septic shock. The Surviving Sepsis Campaign (SSC) recommends a first 6 hours "resuscitative bundle" to improve patient's outcome. Despite this, the bundle is poorly performed, because of a superficial knowledge of the guidelines and several difficulties in their clinical implementation. In recognition of this, a "sepsis six" bundle is designed to facilitate early intervention with just three diagnostic and three therapeutic steps to be delivered by staff within 1 h. The aim of our study is to evaluate if an Educational and Organizational Intervention (EOI) could improve septic patient's outcome in no Critical Care Units. The second endpoint is to evaluate if the compliance to the "sepsis six" bundle could improve after this sort of intervention.
This is a trial for patients affected by metastatic or relapsed osteosarcoma which progressed after first or further line treatments. In this trial, all patients will be treated until progression or unacceptable toxicity with sorafenib and everolimus. The treatment with sorafenib and everolimus aimed to obtain a 50% rate of patients free from further progression of the disease after 6 months from study entry.
Epilepsy requires long-term drug treatment and is frequently associated with other clinical conditions. Combinations of antiepileptic drugs and other compounds are fairly common and increase with age. Adverse drug reactions and drug interactions are expected and may affect compliance, particularly in patients not receiving adequate information. Primary objective of the study is to verify if a comprehensive and standardized educational plan is followed by a significant reduction of the number of adult patients with epilepsy and comorbidity presenting clinically relevant adverse treatment effects. Secondary objectives include effects on number of adverse treatment events, health-related quality of life (HRQOL), direct medical costs, and patient's compliance. The study is a randomized, controlled, open-label, pragmatic trial. Included are consecutive adult outpatients with 1+ concurrent clinical conditions on chronic treatment and at least one clinically relevant treatment-related adverse event and/or clinically relevant drug interaction. Eligible patients will be randomized to receive a comprehensive and standardized educational plan (experimental arm) or to usual care, ie management of adverse event/drug interaction as done in clinical practice (control arm). The experimental plan consists in discussing with patient and caregiver the cause and nature of adverse event/drug interaction, the tolerability profile of each drug, the clinical manifestations associated with current drug interaction(s), contraindications of potentially interfering over-the-counter drugs, indications and benefits of suggested treatment changes, and withdrawal of potentially interfering, contraindicated or ineffective drugs. All patients will be seen at one, three and six months after admission. Expected results: The number of patients free from clinically relevant adverse treatment events and/or drug interactions in each treatment arm at end of study is expected to be higher in patients assigned to comprehensive and standardized educational plan compared to usual care (primary outcome). Patients on the experimental plan are also expected to be more commonly free from relevant adverse events and/or drug interactions at each intermediate visit, to present a lower number of adverse treatment events, to imply lower costs for medical contacts, hospital admissions, and drugs, to present better HRQOL scores, and to present less weekly treatment omissions.
This study was designed and developed in the Emilia Romania research and innovation program (PRI ER). The study does not have commercial sponsors and comes under the independent studies provided for by Ministerial Decree 17.12.2005. The PRI ER program will guarantee a contribution to the study for the first three years of recruitment through the regional Innovation Fund, to cover the costs of coordination and data management sustained by the Coordinating Center. Primary Objectives The study proposes to evaluate whether partial hypofractionated and accelerated irradiation of the sole surgical cavity, in patients suffering from breast cancer with low risk of local recurrence and who undergo conservative surgery, is not inferior to postoperative irradiation with conventional fractionation of the entire breast as regards local control (incidence of ipsilateral recurrences as prime event). Secondary Objectives Comparison of the global survivals, freedom from locoregional recurrences (with exception for contralateral tumors and second tumors), distant relapse-free (except for local or regional relapses or in the contralateral breast) in patients treated with conventional radiotherapy and accelerated partial radiation. To evaluate whether accelerated partial irradiation offers cosmetic results, acute toxicity comparable with conventional irradiation. Possible connection with other national and international studies Similar studies which nonetheless evaluate different methods of partial irradiation are currently underway. Study Design Multicenter phase III controlled randomized, unblinded study of non-inferiority. Number of cases Recruitment of 3302 patients is planned. Target Population of the Study Women aged = > 49, ECOG 0-2, undergoing conservative breast surgery for invasive breast cancer, pT 1-2 (< 3 cm in diameter) pN0-N1 M0, unifocal, resection margins histologically negative (³ 2 mm) at first intervention or after subsequent widening. Duration of the recruitment and of the subsequent follow-up A recruitment of 8 years is planned and a follow-up period of 5 years for an overall duration of the study of 13 years. Treatment The patients will be randomized to receive one of the following treatments: Trial arm 38.5 Gy total in 10 fractions (3.85 Gy per fraction), twice a day with an interval of at least 6 hours between the two fractions, for five consecutive working days. Control arm 50.0 Gy in 25 fractions (2 Gy per fraction), once a day for 5 days in the week. Endpoints Primary: survival free of local ipsilateral recurrence as prime event Secondary: global survival, locoregional recurrence-free, distant recurrence-free, acute and late toxicity (RTOG) and cosmetic result. Evaluation and Follow-Up Program Controls are planned during the radiotherapy, at the end of treatment, at 6 weeks, 3-6-12 months from the end of the radiotherapy and then once a year until the end of 5 years. Data Analysis Partial irradiation will be considered not inferior to the standard irradiation if the top extreme of the HR confidence interval at 95% (to endpoint) does not exceed the established value of 1.5 The study was sized in relation to the rate of local ipsilateral breast recurrences as prime event at 5 years and assuming that this rate in the standard treatment group is 4%, accepting as maximum Hazard Ratio inferior to 1.5 and error a and b equal respectively to 0.05 and 0.10 and test at an endpoint. The survivals will be calculated using the Kaplan-Meier method. The hazard ratio (HR) will be calculated using the Cox model and its confidence interval at 95% will be reported. Ethical Aspects and Informed Consent For participation in the study an informed consent is planned appropriately drawn up and submitted to the approval of the Ethics Committees. The clinical study will be carried out according to the ethical principles of the Helsinki Declaration, the GCP guidelines, the Italian laws and regulatory activities for carrying out clinical studies. Before formal commencement of the study its approval/sole opinion by the reference Ethics Committee of the proposing group is stipulated. The individual investigators of the different participating institutions are directly responsible for the submission for approval of the protocol by their Ethics Committees.
Pathophysiology of diabetic cardiomyopathy (DCM) is yet unclear and gender differences at baseline and a specific treatment have not been indicated. The investigators already demonstrated the positive impact of phosphodiesterase type 5A (PDE5A) inhibition in men. The investigators' study aims to characterize DCM, measuring molecular and neuroendocrine assessment to relate to intramyocardial metabolism and cardiac kinetic. The investigators will perform a randomized, placebo-controlled, double-blind study enrolling 164 diabetic patients (females and males) with DCM, to evaluate gender responses to 6 months of PDE5A inhibitors (PDE5Ai). The investigators' study will describe gender differences in DCM features. The proposed research will test whether PDE5Ai could become a new target for antiremodeling drugs and to discover a molecular pathways affected by this class of drugs and a network of circulating markers for the early diagnosis, monitoring and prediction of response to treatment of DCM.
The primary objective of the study is to establish whether budesonide/formoterol fumarate dihydrate (BF) Spiromax 160/4.5 micrograms (mcg) is as effective as Symbicort Turbohaler 200/6 mcg administered twice daily in participants with persistent asthma.
The purpose of this study is to evaluate the effectiveness of Pulmonary Vein Isolation (PVI) performed with the Arctic Front™ Advance Cardiac CryoAblation Catheter System as first-line therapy in comparison with antiarrhythmic drugs (AAD) in patients with paroxysmal atrial fibrillation (AF).