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 assess cross-reactivity and tolerability of ertapenem in patients with IgE-mediated allergy to at least one beta-lactam molecule.
In the setting of ST elevation myocardial infarction newer therapies has been recently studied and, following encouraging results, introduced into the clinical practice. Prasugrel showed to be a valid alternative to overcome limitation of clopidogrel therefore providing a better ischemic protection. On the other hand, bivalirudin is at least as beneficial as heparin/abciximab as anticoagulant agent but associated with fewer hemorrhagic events. The primary hypothesis of the study is that the combination of prasugrel plus bivalirudin can be associated with a better risk/benefit profile.
The aim of this study is to evaluate the effect and safety of Floseal in this preliminary prospective trial with patients undergoing acute laparoscopic cholecystectomy for acute cholecystitis
Nephrolithiasis is a disease that strikes roughly 10% of the Italian population and its incidence in industrialized countries is on the increase. The most common form of the disease (80%) is Idiopathic Calcium Nephrolithiasis (ICN) with calcium-oxalate (CaOx) and/or calcium-phosphate (CaP) stones. The etiopathogenesis involves both genetic and acquired factors, the interplay of which leads to urinary biochemical anomalies at the root of stone formation. The elements and urinary compounds involved are known as "urinary stone risk factors". The risk factors for CaOx stones consist of low urine volume, hypercalciuria, hyperoxaluria, hyperuricosuria, hypocitraturia and hypomagnesuria. In the case of CaP stones, the hyperphosphaturia and pH parameters are of particular importance; a pH>7 promotes the formation of stones prevalently composed of phosphates, while a pH of between 6 and 7, associated with a volume <1l/day, can raise CaP supersaturation to a dangerously high level and lead to the formation of mixed CaOx and CaP stones. For uric acid stones, the elements involved are hyperuricosuria and pH<5.5. In general, the most prevalent alteration in ICN is hypercalciuria (50%). Hypertension and obesity are also social diseases with important epidemiological similarities to nephrolithiasis. These affinities have led to the search for a common pathogenic moment. As far as hypertension is concerned, various studies have demonstrated high calciuria in hypertensives with a linear relationship between 24-h calciuria and arterial blood pressure. The incidence of stone disease is greater in hypertensives than in normotensives and, by the same token, the incidence of hypertension is greater in stone formers than in non stone formers, but it is not clear whether nephrolithiasis is a risk factor for hypertension or vice versa. Moreover, a linear relationship exists between calciuria and natriuria, where the calcium is the dependent variable, with a much steeper slope of the straight line in stone formers and hypertensives compared to controls. It has, in fact, been demonstrated that to reduce calcium, it is more efficacious to reduce sodium intake as opposed to calcium intake. Finally, BMI and body weight are independently associated with an increase in stone risk even though, due to a number of bias (limited weight categories, low number of obese persons in the study populations, no control group, no recording of food intake) the studies published failed to be conclusive. In the final analysis, stone disease, arterial hypertension and excess weight/obesity prove to be closely interconnected and it is possible to intervene with targeted diets aimed at reducing the risk of illness and death from these diseases. Among such dietary approaches, the reduction of sodium chloride in food, increased hydration and an increased intake of foods with an alkaline potential seem to play an important role. For many years now, the investigators research unit has been involved in projects, partially financed by the Italian Ministry of University and Research (MIUR), geared towards studying the effects induced by dietary changes in patients with calcium stone disease. The aim of the present project is to analyse in depth the relationship between stone disease, hypertension, body weight and water and salt intake both in the general population of the area of Parma (where historically and by gastronomic tradition, the usual diet tends to have a high salt content) and in a selected population of stone formers and hypertensives not under treatment. A representative sample of the population of the area of Parma will be studied, divided on the basis of weight category, in order to assess water and salt intake and relationships with the presence of hypertension, and a sample of normal and hypertensive stone formers randomized to receive for one year either water therapy+low salt diet or water therapy alone.
The present study is part of an international program and deals with the translation and validation program for the Italian version of the MDS-UPDRS. The program will be articulated in three steps: - Phase I: translation and back-translation of the MDS-UPDRS in Italian (completed) - Phase II: Cognitive testing. This step is aimed at a preliminary testing of a subset of potentially culturally sensitive items in a limited set of PD patients (approximately 10). Should this phase identify issues in the understanding and ease of use of some items a revised translation of some individual items might be envisaged. - Phase III: large validation testing: this phase will involve 350 PD patients from 12-14 Italian PD centres. The IRIS protocol deals with phase II and III of the program.
Title of the study Aprepitant for prevention of acute and delayed nausea and vomiting: a phase III, double-blind, randomized, placebo-controlled trial in patients receiving a high-emetogenic dose of cyclophosphamide for peripheral blood stem cells harvesting Objective(s) Primary objective: to confirm and extend the investigators preliminary data on the efficacy and safety of combined aprepitant, palonosetron and dexamethasone in preventing CINV after high emetic therapy with cyclophosphamide 3 g/m2 compared with the palonosetron and dexamethasone regimen. Secondary objective: to monitor peripheral blood stem cell harvest. Methodology Single centre, randomized, double-blind, placebo-controlled phase III trial Endpoints Primary endpoint: the complete response (CR) rate defined as the number of patients with no emetic episodes and no rescue medication in the first 120 hours post-chemotherapy. Secondary endpoints: - CR rates for acute (0-24 h) and delayed (24-120 h) phases; - complete control rate (CC) defined as no emetic episode, no rescue medication use and no more than mild nausea; - number of emetic episodes; - severity of nausea; - impact of CINV on daily life as measured by the Functional Living Index-Emesis (FLIE) (total score > 108 = no impact); - peripheral blood stem cell harvest; - tolerability (adverse events, drug-related adverse events, serious adverse events; discontinuation of treatment due to an adverse event). Adverse events will be classified using NCI Common Toxicity Criteria. Number of patients A total of 120 patients will be enrolled Inclusion criteria - Male or female patients ≥ 18 years of age - Patient is able to understand study procedure and agrees to participate in the study by giving written informed consent. - Patient is scheduled to receive a highly emetogenic cyclophosphamide IV chemotherapy (3 g/m2) for autologous PBSC harvesting - Karnofsky score ≥60 - Normal laboratory values - Normal ECG - HBV-, HCV- and HIV- negative - Negative urine pregnancy test for women of childbearing age Treatment Eligible patients will be randomized to receive oral doses of Aprepitant (125 mg day 1, 80 mg days 2 and 3), dexamethasone (8 mg/day for 3 days) and a single intravenous dose of palonosetron (0.25 mg on day 1) versus placebo plus dexamethasone (8 mg/day for 3 days) and a single intravenous dose of palonosetron (0.25 mg on day 1) Duration of study 3 years Criteria for evaluation Efficacy and safety data will be obtained using the patient's daily diary (days 1 through 5) reporting the number of episodes of retching and vomiting, severity of nausea (using a categorical scale of none, mild, moderate or severe), and overall quality of life. The FLIE 8 questionnaire will be completed on days 1 (before starting chemotherapy) and 6 (after chemotherapy). All side effects attributed to this combination therapy will be recorded daily. Safety parameters: medical history, clinical examination and weight, vital signs, laboratory tests (hematology, chemistry, urine analysis and urine pregnancy test for women of childbearing age). Statistical aspects Sample size was defined assuming the cumulative incidence rate of the primary endpoint to be 68% in the treatment group and 41% in the control group. With balanced allocation in the two groups, considering a two sided test with α=0.05 and ß=0.20 a total of 110 patients is needed. As few withdrawals and drop-outs are expected a total of 120 patients will be enrolled. Intention to treat approach will be used for all efficacy analysis. The primary endpoint will be analysed by binomial logistic models. The dependent variable will be vomiting yes/no during the first 120 hours after chemotherapy. Anti-emetic treatment, gender and age will enter as explicative variables. Dichotomous secondary endpoints will also be analysed by binomial logistic models. Multinomial logistic models will analyze the severity of nausea, stratified in 4 classes. Generalized Linear Models will investigate quantitative variables such as number of retching or vomiting episodes and peripheral blood stem cell harvest. In all tests, p value <0.05 will be considered statistically significant. No interim analyses are planned.
The investigators hypothesize that chronic heart failure is associated with a general stem cell dysfunction, which translates into reduced paracrine function of adult stem cells from patients with chronic heart failure as compared to patients with preserved systolic function.
DOLCE Study: Day-care versus Overnight-stay Laparoscopic Cholecystectomy randomized, controlled trial. The aim of this study was to evaluate the feasibility, safety and patient acceptance of outpatient LC in Italy. In particular this randomized clinical trial will use the SF-36 as powerful instrument to compare quality of life and global health status after LC performed as a day-care procedure or with an overnight stay. Particular attention is taken to answer to the following methodological issues: - concealed randomization, - ITT analysis, - number of eligible, excluded and refusing patients clearly stated.
Normally breathing is controlled by a reflex that responds to the levels of carbon dioxide (CO2) in the blood. In heart failure, where the heart muscle is damaged and therefore does not pump as well, this reflex is exaggerated. The result is a vicious circle: blood CO2 levels fluctuate wildly and as a result breathing also fluctuates with patients hyperventilating at times and briefly stopping breathing at others. During sleep this is called central sleep apnoea (CSA). Patients with CSA wake up throughout the night and whilst some patients are oblivious to this, others are consciously breathless and many patients are tired during the day and feel unable to perform their daily activities. As part of the body's stress response to the erratic pattern of breathing, both blood pressure and heart rate may rise to a level that is harmful in a failing heart, exacerbating the underlying heart failure. Indeed patients who demonstrate this CSA die sooner than those who have heart failure and stable breathing. There are no proven specific therapies for CSA that stabilise breathing, improve sleep quality, and prolong life. We have designed a system which delivers very small doses of CO2, when the blood level of CO2 is predicted to be low. During short daytime recordings, using this system, we have demonstrated that it is possible to stabilise the body's CO2 levels. We aim to test what happens when CO2 is given overnight whilst the patient is sleeping to see whether we can stabilise their breathing over longer durations and whether sleep quality could be improved so that patients are less tired during the day. In addition, we would like to measure whether the stress response is lessened if the breathing is successfully stabilised.
This is a multicenter, open-label, single arm phase II non-randomized study of dasatinib in which subjects with systemic mastocytosis (SM) will be treated with a continuous regimen of dasatinib. Upon completion of a treatment induction period, subjects will be treated with dasatinib at a dose of 100 mg per os (OS) once daily (QD).