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.
Osteopathic manipulative treatment (OMT) has been used to treat term and preterm newborns. Recent studies demonstrated the effectiveness of OMT in reducing length of stay and costs (Cerritelli, 2013) as well as the likelihood of gastrointestinal episodes (Pizzolorusso 2011). Moreover it was reported the absence of adverse events and side effects considering the approach safe (Cerritelli 2013, 2014). OMT was extensively used to treat, prevent and manage pain symptoms. Numerous research was published addressing acute and chronic pain in different medical conditions. However, no trials were carried out on pain in newborns. The aim of the present clinical trial is to explore the effectiveness of OMT in reducing pain in a sample of preterm infants.
The management of children with confirmed cow's milk allergy is based on complete avoidance of cow's milk proteins and leaves the physician with several dietary options, none of which, given the prevalence, spectrum and potential seriousness of the condition, can be recommended to all patients. In the absence of an alternative to cow's milk, the management of cow's milk allergy is based on the use of safe, affordable and nutritionally adequate formulas. Extensively hydrolyzed cow's milk protein formulas, which are considered as safe for most children with cow's milk allergy, are still liable to contain residual peptides, and hypersensitivity reactions may occur in infants allergic to cow's milk protein. Thus, specific product allergenicity must be addressed on an individual basis before recommending a formula as a substitute for cow's milk. Soy-based formula can also concomitant sensitize cow's milk allergy children to soy. Amino acid-based formulas have been studied from safety and nutritional efficacy perspectives. These formulas have been proposed for subjects highly sensitive to cow's milk protein and that cannot be managed using extensively hydolyzed formula and for children with multiple food allergies. In these conditions aminoacid based formulas are able to effectively cure allergic symptoms and to improve body growth.
Type 2 diabetes is epidemic and its treatment has become more and more difficult. Consensus algorithms have been developed to help clinicians to select among the numerous medications and their combinations for achieving and maintaining a target glycated hemoglobin A1c (HbA1c) of <7%. AMAZING, a pragmatic clinical trial, aims to compare commonly used oral diabetes medications, when combined with metformin, on glycemia-lowering effectiveness.
The Continuous Subcutaneous Insulin Infusion (CSII) might have an impact on psychological distress and some psychological factors might be predictors of metabolic control; however, very few studies conducted so far were specifically focused on the psychological aspects of CSII therapy in adults affected by T1DM.
There is evidence of superiority of AV junction ablation strategy over pharmacological therapy only for symptoms of atrial fibrillation, but not for heart failure, hospitalization, morbidity and mortality. Hypothesis of trial is that AV junction ablation is superior to pharmacological therapy as regard hospitalization and mortality
This global product exposure registry is a multicentre, long-term, prospective, observational cohort study (exposure registry), designed to evaluate the long term safety and effectiveness of lomitapide.
The aim of the present study is to determine whether there is a relationship between osteopathic treatment and the change of physiological axes of the lumbar spine, through the use of Dynamic Magnetic Resonance Imaging.
During orthotopic liver transplantation (OLT), respiratory system function may be severely impaired for several reasons including anaesthesia effects, hyperdynamic volume state with fluid overload and ischemia reperfusion injury. In particular, reperfusion syndrome is characterised by the release of several inflammatory mediators such as cytokines and oxygen free radicals which may contribute to alveolar endothelial barrier dysfunction. The object of this study is to investigate the respiratory system mechanics impairment in its partitioning between lung and chest wall. We hypothesize that impairment of respiratory system mechanics (of both lung and chest wall) occurs after reperfusion phase of liver. This impairment is associated with the systemic inflammatory response following liver reperfusion.
The human body houses a huge microbial ecosystem, including the intestinal and oral microbiota. Both these ecosystems, and, in particular, the intestinal one, are responsible for maintaining human health. The response of the organism to the diet and the relative alteration of the susceptibility to disease are worth of investigation to comprehend the role of the microbiota to maintain the state of well being in humans. This concept, which is the overall scientific basis of the entire project, perfectly fits with the declared scopes of Horizon 2020. Understanding the impact of omnivore, vegetarian and vegan diets on human intestinal microbiota is aligned to the Grand Societal Challenge of the Horizon 2020 scheme, which is addressing the human nutritional needs and the impact of food on human physiological functions. In particular, studying the link between dietary habits and the intestinal microbiota activity will be pivotal to improve the food-based promotion of health and well being. The project aims at studying how the omnivore, vegetarian and vegan diets may affect the oral intake of microorganims, and the composition of the oral and fecal microbiota. With the aim to build up a permanent European platform for such type of studies, ten Research Units (RUs) are involved in the proposal, with the partnership of 16 National and, especially, foreign Institutions, covering 12 different countries. About 50 omnivore, vegetarian and vegan volunteers, for a total of 150 subjects will be recruited. Volunteers will be asked to fill in diaries, describing their dietary habits, and to collect biological samples (saliva, feces and urine), once a week for three weeks. For obvious ethical constraints, biopsies will be not available in this study. RUs will share their tasks, mainly depending on the nature of the samples to be studied, namely foods and biological samples. Based on the different dietary habits, the presumptive intake of microorganims will be estimated using literature data and, especially, culture-dependent methods. Typing and antibiotic resistance of some food related microbial communities or foods will be also investigated. The microbial diversity of foods, whose microbiota has never been studied in depth, will be characterized by PCR-DGGE and deep sequencing. The metabolome characterization will complete the overview on foods. After collecting and preparing biological samples from the three diet groups, the oral and fecal microbiota will be studied. The viable cell number of several microbial groups will be estimated in fecal samples, before freezing. Preliminarily, the microbial diversity of saliva and fecal ecosystems will be analyzed through PCR-DGGE. PCR assessment of genetic basis of antibiotic resistance will be also carried out. Selected numbers of biological samples will be further subjected to next generation sequencing, aiming at determining representative individuals/samples of the three types of diet. Only for feces, representative samples (e.g., 4/5 for each diet) will be subjected to meta-omics analyses based on meta-genomic, meta-transcriptomic and meta-proteomic approaches. An integrated and iterative workflow will be also developed, by assembling an in house synthetic meta-genome. The functionality of fecal samples and/or of isolates from feces will be characterized based on fecal genotoxic and anti-genotoxic activities, and modulation of the immune response. In agreement with an holistic approach, the metabolome analysis of saliva, feces and urine will complete the characterization of biological samples. All data available from the different RUs will merge into a common database, whose structure will be developed during the project. Based on the literature data (ISI Web of Knowledge), this is the first study that aims at correlating the effect of the main dietary habits on the oral and fecal microbiota through integrated meta-omics analyses.
This program initially aims to recruit 1300 breast cancer patients from a large number of hospitals across Europe. Eligible patients are those who are 18 or older, either female or male, and who have not received more than 1 type of treatment from the time metastases were discovered, metastasi(e)s has just been diagnosed or their disease has come back (disease relapse). Biopsy samples from both the primary and metastatic (or relapsed) tumor will be collected for central analyses, together with blood, serum and plasma samples. Any samples not analyzed immediately will be stored in an independent bio-repository to enable future (not yet defined) research aimed at better understanding metastatic breast cancer. In summary, the main objectives of AURORA are to better understand the genetic aberrations in metastatic breast cancer and to discover the mechanisms of response or resistance to therapy, in order to ultimately identify the "right therapy for each individual patient". At the same time, patients with genetic aberrations that are being targeted by new drugs in development will be offered the possibility to participate in clinical trials, when approved and available in their countries. Ultimately, the aim of AURORA is to improve the outcomes of all patients diagnosed with metastatic breast cancer.