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 observe the evolution of the CRTD system with left quadripolar lead, in terms of electrical parameters in all pacing configurations and to evaluate the impact on the clinical outcome.
"CHildhood ASthma and Environment Research study - CHASER study" is an observational longitudinal study in outpatient clinic of Pediatric Allergology & Pulmonology (PAP) of Respiratory Disease Research Center (RDRC) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (RDRC-IBIM CNR), Italy. The first phase - transversal study will identify determinants of pediatric asthma control The second phase - longitudinal study, in patients with persistent asthma, will be focused on: - predictors for asthma exacerbations and loss of control - real life adherence to asthma therapy guidelines - phenotypic characterization through the collection of saliva samples - assessment of alterations and inflammatory changes in the nasal mucosa through nasal brushing - evaluation of the presence of 8-isoprostane, nicotine, cotinine and bisphenol-A through urine analysis. Chaser Project is expected to improve the knowledge of pediatric asthma in patients with different level of control, identifying predictors for asthma exacerbations and loss of control.
Recently a new clinical entity, gluten sensitivity (GS), a form of gluten intolerance in which neither allergic nor autoimmune mechanisms can be identified, has been added to the spectrum of gluten-related disorders. This condition is characterized by gastrointestinal and extra-intestinal symptoms including abdominal pain (68%); eczema or rash (40%); headache (35%); diarrhoea (33%) and fatigue (33%). The small intestine of GS patient is usually normal. The prevalence of GS is not yet established although it is estimated that up to 6% of the general population might be affected. GS has been described only in adults and no data are available for the paediatric population.The main problem with this new condition is that, at present, there are no specific biomarkers to confirm GS diagnosis. In the absence of a serological or histological marker, the diagnosis remains clinical. In order to avoid placebo effect of the dietary treatment, presently GS diagnosis needs to performed with double-blind randomized placebo-controlled challenge provided that both wheat allergy and CD have previously been excluded. The primary aim of the study is to evaluate the prevalence of GS in IBS paediatric patients. The secondary aims are: 1) to describe clinical, serologic, genetic and histological profile of GS patient and 2) to study the role of gluten or other possible wheat components in the onset of GS. Study design Randomized double blind placebo controlled cross over re-challenge trial. Patient consecutively diagnosed as having IBS (Rome III criteria) in whom the diagnosis of coeliac disease and wheat allergy has been excluded, will be considered eligible for the study. Diagnosis of coeliac disease and wheat allergy will be excluded by the negativity of TTG-IgA and/or EMA and of Skin Prick Test, RAST immuno-CAP and Atopy patch test respectively. Patients will entered a three-phase study with a running in phase (phase I: weeks 1-2), diagnostic elimination diet phase (phase II: week 3-4) and re-challenge phase (phase III: week 5-12)
Background. Anecdotal reports and uncontrolled studies have described an association between generic substitution of antiepileptic drugs (AEDs) and adverse events, including loss of seizure control. Although these results are likely to be influenced by methodological bias, they have led to a strong opposition, among physicians and patients, to the use of generic products in epilepsy. Objectives. The primary objective is to assess potential risks associated with substitution of the currently taken AED product with an equivalent product, using as endpoint changes in serum drug levels at steady-state after substitution compared with baseline. Secondary objectives will be the assessment of inter-subject variability in serum drug concentration on an unchanged treatment schedule, and evaluation of potential short-term changes in seizure control and adverse events rate. Methods. The study will use an experimental randomized open-label non-inferiority design. The population will consist of 200 adults stabilized on chronic treatment with carbamazepine, valproic acid, topiramate, oxcarbazepine, levetiracetam or lamotrigine and admitted to hospital for diagnostic evaluation or other indications, with no expected treatment changes during the subsequent 5 to 6 days. Patients will be randomized to two groups. One group will continue to receive the AED products used before enrollment (brand or generic), whereas the other group will be switched to an alternative equivalent product. Dosing schedules of the AEDs being tested as well as comedications will be unaltered throughout the 6- to 7day period of the study. Serum AED levels (mean of two values obtained at peak and trough, respectively in the evening and the next morning) will be measured on day 1 (baseline) and 5 days post-randomization (6 days for patients receiving AEDs with half-lives above 12 h). The primary outcome endpoint will be the proportion of patients who, post-randomization, show a greater than 25% change in serum drug concentration compared with baseline. Secondary endpoints will include comparison of distributions of rough serum concentration changes between groups, other pharmacokinetic parameters, time to first seizure, total number of seizures, and adverse events.
During last 6 years approximately 10.000 ceramic balls and 5.000 ceramic liners have been implanted in the region Emilia-Romagna in Italy (4 million Every single year approximately 60.000 hip prostheses are implanted in Italy. Quality of life of patients after surgery is very good, as widely demonstrated in the literature. On the basis of data produced by the only complete hip register in Italy that is run in our Lab (RIPO, Register of Orthopedic Implants in the Regione Emilia-Romagna) survival rate of primary total hip prosthesis is 95.6% at 9 years. Reasons for revision are mainly aseptic loosening of one or both components (40% of the total) and dislocation (26%), being the latter much more frequent in the first two years. Less frequently revision is due to sepsis (7% of the total),bone fracture (11%), prosthesis fracture (3%) or pain (3%). Revision is relates, among the others, to prosthesis-related factors, such as fixation to bone and articular coupling. In our experience, during the last ten years 32% of implants had both articular component in ceramic , 34% had metal head and plastic liner, 24% ceramic head and plastic liner, 10% both components in metal. Each solution has strengths and weakness and they have been identified and clinically applied in order to overcome step by step limitations observed in the previous one. The most recent are the hard-on-hard bearings, that is ceramic on ceramic and metal on metal. These two solutions, beside very promising results on wear resistance, show some peculiar failures: respectively fracture of the ceramic component and hypersensitivity induced by metal ions. Aim of research proposal is to investigate two uncommon and less investigated early symptoms of failure: - 'noising hip' in ceramic on ceramic total hip arthroplasty - pain without radiographic signs of loosening in metal on metal total hip arthroplasty These two situations are extremely relevant, as they prelude to a failure of the prosthesis. If clearly identified they could represent a powerful tool in early diagnosis of pending failure To reach this goal our patients wearing hard-on-hard total hip arthroplasty, suffering for described symptoms will undergone a specific diagnostic procedure. The first group will be studied through CT scan of the patients to evaluate impingement or instability of the prosthesis, and a needle aspiration for synovial fluid. The fluid will be examined to identify ceramic wear debris, according to a method of separation and analysis in scanning electron microscopy that was set in our Lab. Sound will be recorded by means of a wearable sensor set capable of recording the articular noise produced during level walking. This instrumentation will be coupled to motion analysis technology. This would make possible a diagnostic approach able to correlate the involved factors to clinical occurrences, on the basis of the recorded frequencies. -Second group will be studied through the dosage of circulating ions, deriving from the articular surfaces and through the histological classification of vasculitis in periimplant tissues. There is increasing evidence, indeed that locale release of submicron particles worn out from articular surfaces can release metal ions (mainly Chromium and Cobalt) responsible for lymphocyte local infiltration. In particular CD20 positive B lymphocyte and CD3 positive T lymphocyte and sometimes CD68 positive plasma cells are present. The cells could justify the development of pseudotumors in metal-on metal hip prosthesis. Data collected from patients matched to in vitro results will allow us to to avoid or at least propose a more appropriate timing for revision surgery.
Several randomized trials suggested a cardioprotective beneficial effect (eg reduction in cardiac troponin release) of remote ischemic preconditioning in cardiac surgery. Remote ischemic preconditioning by brief episodes of ischemia and reperfusion in a remote organ or vascular territory provides protection from injury by myocardial ischemia and reperfusion. In the translation of remote ischemic preconditioning from bench to bedside, the first proof of principle and small randomized controlled trials have shown a decreased release of myocardial biomarkers after aortic, congenital cardiac, adult valve and coronary artery by-pass graft surgery. This reduction in cardiac biomarkers release translated into better survival in a recent randomized trial performed in cardiac surgery. No clinical trial on remote ischemic preconditioning in non-cardiac surgery setting has been performed so far. The investigators study wants to test, for the first time, the hypothesis that remote ischaemic preconditioning is effective in reducing cardiac damage in high risk patients undergoing non-cardiac surgery. Remote ischaemic preconditioning will be achieved by inflation of a blood-pressure cuff to 200 mm Hg to the upper arm for 5 minutes, followed by 5 minutes reperfusion while the cuff will be deflated. General anesthesia will be induced and maintained without using propofol in both groups. Cardiac troponin will be used as marker of cardiac damage. If the results of a reduction in postoperative cardiac troponin release and perioperative cardiac ischaemic events will be confirmed in a non-cardiac surgery setting, the investigators could improve a strategy to prevent perioperative cardiac complication easy to apply, safe and low cost.
Background. Smoking is considered a global public health problem. For this reason, the smoking dependence was called by experts as a global epidemic. Over the past three years, this electronic devices (Tobacco Free Cigarettes, or TFC) has been an important expansion in many countries. Nevertheless, there is poor evidence that TFC are beneficial for smoking cessation. In particular, even though it has been proved that the nicotine replacement devices helps many individuals to give up smoking and to tolerate the withdrawal symptoms, it is still unclear their long-term effect. Hence, it must be tested its contribution in tobacco reduction. This protocol in particularly innovative, since it aims to test the efficacy of electronic devices in a screening program (the lung cancer prevention program COSMOS II at the IEO), where tobacco reduction is strictly needed in order to lower individual's risk. Methods and Design. This experimental protocol has been designed with the main aim to investigate the role of Tobacco Free Cigarettes (TFC), also called e-cigarettes, in helping smokers to improve their lung health and to quit or reduce tobacco consuming. In particular, the investigators aim at investigating clinical (physical symptoms, with particular focus on breathing quality and difficulties), the behavioral (number of tobacco cigarettes smoked), and psychological (wellbeing, mood and quality of life) effects of shifting to TFC. The investigators will also analyze, as a secondary aim, the psychological and lifestyle component of smokers involved in order to fine correlation data that might be used to compute a predictor index able to suggest the probability of success, with respect to the reduction of tobacco consuming, of the use of a TFC and to maintain the abstinence. The study will be organized as a nested randomized controlled study with two arms: one experimental group and one control group. The study will be nested in the screening program for lung cancer, where subjects will be recruited. All subjects will be entered in a psycho-cognitive low-intensity counseling program (6 months), but in the experimental group a TFC (with or without nicotine) will be used as replacement device for three months, while in the control group only low-intensity counseling will be provided. Furthermore, a low-cost non-invasive electronic device (the FitBit activity tracker) will be used in order to monitor behavioral (lifestyle), sleep quality and physical activities.
Pre-operative weight loss can reduce the risk intra- and post-operative complications but no optimal pre-operative weight loss strategy has been investigated. Very-low-calorie diets (VLCDs) were proven to results in higher metabolic improvements in the short-term than balanced, hypocaloric diets. Therefore, the aim of the study is to investigate whether a VLCD results in lower intra-and post-operative complications compared to a hypocaloric diet. However, to achieve a optimal compliance in patients having experienced multiple dietary intervention failures, administration of the intervention will be performed by the enteral route using a naso-gastric feeding tube.
Continuation of the CARRA Registry as described in the protocol will support data collection on patients with pediatric-onset rheumatic diseases. The CARRA Registry will form the basis for future CARRA studies. In particular, this observational registry will be used to answer pressing questions about therapeutics used to treat pediatric rheumatic diseases, including safety questions.
Aim of this study is to evaluate if low-dose radiotherapy (LDR) can intensify local effect of a chemotherapy regimen with Gem-based doublets administered sequentially with stereotactic body radiotherapy (SBRT) and to assess the safety and efficacy of this combined treatment on patients affected by locally advanced pancreatic adenocarcinoma (LAPC).