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 pathogenesis of cardiomyopathies is complex and a simple approach cannot describe the whole picture. Different etiologies are reported in pediatric age and heart failure onset can lead to poor prognosis in term of need of heart transplantation and ventricular assist device implantation. Based on hypothesis that heart failure development is related to heart inability to meet metabolic demands of the body, our study will focus to evaluate cardiac metabolism as one of the most critical factors and the accompanying changes of metabolic and echocardiographic profiles at different stages of heart failure. The heart is a unique organ working continuously as a pump supplying blood to the body. To meet this requirement, the myocardium utilizes fatty acids to generate 70-90% of the adenosine triphospate, with the rest being produced by oxidation of glucose, lactate, ketone bodies, aminoacids. Utilization of fatty acids is reduced in the failing heart and there is a metabolic shift to generation of adenosine triphospate from glucose. In patients with advanced cardiomyopathies, the heart is unable to utilize either metabolite and thus "runs out of fuel". It is reported that the adenosine triphospate level is approximately 30% lower in failing human hearts compared with non-failing hearts. In addition to this premise about the metabolic profile of the failing heart, recent advances in the field of metabolomics have indicated that several metabolites and/or metabolic pathways have a role in heart failure. Metabolism of lipids, glycolysis, fructolysis, aminoacids, and ketone oxidation have been found to be altered in non-ischemic cardiomyopathy in adult population. Also in adult heart failure patients some metabolic profiles resulted pronounced perturbated. Taking advantage of the high throughput, metabolomics is a platform for identifying metabolic signatures in children at each stages of heart failure (from pre clinical heart failure to end stage forms). We also will determine whether metabolomic analysis provides sensitive evaluation of heart failure in terms of remodelling at different stages and in disease regression after therapeutic interventions. Study desing is conceived in two parts. The first part is retrospective and we will analyze all echocardiograms in all children affected by cardiomyopathies. The second part is a cross sectional study in which will evaluate untargeted metabolomics in children at any stage of heart failure (A,B, C, D) and in control group. We will evaluate the clinical applicability and significance of plasma metabolomic analysis in the diagnosis and prognosis of heart failure in pediatric ages.
Robotic pancreatoduodenectomy is the most complex surgery for a general surgeon and consequently a pancreatic surgeon can aspire to. Due to the close proximity of the pancreas to the large vessels, great skill and experience in the field of pancreatic surgery, robotic surgery and also vascular surgery is essential. The ability to predict the depth of robotic pancreatoduodenectomy in each individual patient would be extremely important, for patient selection and for the implementation of the learning curve. This study aims to provide a difficulty score (DS) for robotic pancreatoduodenectomy to be used to select cases based on the experience and expertise of the surgeon.
The BORNTOGETTHERE consists of improving health programs for early detection and surveillance of Cerebral Palsy (CP) by implementing the first International Clinical Practice Guidelines (Novak et al, 2017) in multiple sites in Europe (Italy, Denmark, Netherlands), in low- and middle-income countries (Georgia, Sri Lanka) and hard to reach populations (Remote Queensland, QLD and Western Australia, WA). In addition, exploiting early detection of infants at very high risk of CP, the investigators will implement best-evidence knowledge on early intervention in CP, thereby improving the outcomes of the infants and of their caregivers.
This study will collect information on side effects and how well Esperoct® (turoctocog alfa pegol (N8-GP)) works during long-term treatment (prophylaxis) in males with haemophilia A. Participants in this study will get the same treatment as they would normally get, if they were not participating in the study. All visits at the clinic are done in the same way as participants are used to, when visiting their doctor. During visits at the clinic participants might be asked for some relevant tests if considered useful by the study doctor. During the visits the study doctor might ask if participants had any side effects since the last study visit. Participants will be asked to note down in their own diary the number of bleeds and how these were treated, as well as their regular prophylaxis. Participation in the study will last for about 5-7 years, depending on when participants join the study. Participants are free to leave the study at any time and for any reason. This will not affect their current and future medical care.
- cooperation of an International team with many years of experience in surgical management of lymphedema - description of an effective surgical strategy to treat cancer-related lymphedema, a high incidence pathology - the combination of LVA and liposuction guarantees long lasting results
Undernutrition is a common problem in patients with cystic fibrosis (CF) despite international consensus that the patients shall be given 120-200% of energy recommendations. Studies imply that one problem might be that the patients are not compensated for the essential fatty acid deficiency (linoleic acid, LA), which is well known in these patients. This deficiency is shown not to be due to fat malabsorption, but related to an increased turnover of arachidonic acid, a transformation product of LA. This abnormality is related to mutations associated with a more severe clinical phenotype. The most common and typical symptom of LA deficiency is poor growth. Studies in animals have further indicated that many of the symptoms in CF are related to the deficiency. A series of recent prospective studies from Wisconsin corroborate the importance of LA for growth. In Sweden LA has been supplemented to most patients since the late 70´, and the condition of patients have been among the leading in the world regarding growth, pulmonary function and survival. Short-term studies have shown better effect of LA supplementation compared to similar supply of energy without including extra LA. There are few long-term studies, performed before the gene was identified, giving very heterogeneous patient groups in regard to genotype, but with some positive results on growth and physiology. It´s of interest that modern personalized extremely expensive therapy with correctors and potentiators for Cystic Fibrosis Transmembrane Conductance Regulator may influence lipid metabolism. LA might thus tentatively be a cheap adjuvant to this modern therapy, but this has to be specially studied. The aim of the study is to find if there are differences in clinical and metabolic outcome between two groups, blindly given similar amount of extra calories, in one group consisting of linoleic acid.The benefit for the patients would be great if the expected positive effect can be proved in the planned study. The treatment will be cheap and without adverse effects. From socioeconomic point of view is would be a great advantage.
This is a prospective multi-center international registry. The objective of this registry is to collect prospective data on patients undergoing catheter ablation for Ventricular Tachycardia (VT) and Premature Ventricular Contractions (PVC). The registry will be used for clinical monitoring, research, and quality improvement purposes.
The proposed clinical trial will employ the NEUROExos Elbow Module (NEEM), an active robotic exoskeleton, for the passive mobilization and active training of elbow flexion and extension in 60 sub-acute and chronic stroke patients with motor impairments (hemiparesis and/or spasticity) of the right arm. The study protocol is a randomized controlled trial consisting of a 4-week functional rehabilitation program, with both clinical and robotically instrumented assessments to be conducted at baseline and post-treatment.
During the current pandemic, in Italy the majority of asymptomatic or pauci-symptomatic COVID-19 cases were not identified nor diagnosed and this fact caused a decrease in the effectiveness of the various containment measures implemented. Therefore, in a future scenario where a new viral swarm is expected, the early identification of all infected cases becomes essential to plan and activate a containment strategy for the spread of the virus, given the current absence of vaccines. The typical radiological finding of COVID-19 is an interstitial pneumonia, which can be responsible, in a significant portion of patients, of an acute respiratory distress syndrome (ARDS). Low-dose chest CT and simple blood tests could identify sub-solid pulmonary nodules (SSNs) indicative of COVID-19 infection in asymptomatic subjects. Objectives of this observational study are the early detection of COVID-19 markers indicative of prior exposure or persisting viral infection in asymptomatic subjects and the assessment of the frequency and outcome of COVID-19-related SSNs in asymptomatic subjects by time, domicile, and other individual risk factors. SMILE lung CT screening program cohort has been considered, based on 960 subjects at high lung cancer risk for tobacco smoking (≥20 pack/year) and age (50-75 years), together with inflammatory and respiratory profile. SMILE utilizes a top technology dual-source CT scanner (Somatom Force) with the lowest radiation dose ever applied to lung screening. All chest CT images from screening subjects will be re-evaluated by two additional CAD programs, specifically designed for the analysis of SSNs and quantification of the total volume of lung parenchyma showing an increased density. This re-evaluation will improve the sensitivity and specificity of radiomic assessment. This study cohort, enriched by the already established longitudinal biobank of frozen plasma samples, represent an ideal opportunity to assess the frequency of SSNs in asymptomatic subjects, due to the effect of COVID-19, particularly among subjects living in areas at high risk of viral exposure. It will also be possible to evaluate if COVID-19-related SSNs are associated with chronic co-morbidity, other individual risk factors, inflammatory (CRP) / immunomodulatory (25(OH)D) blood profile, and/or can be traced by immune markers such as IgM/IgG and other cytokines. Clinical data will be integrated with an analysis of the IgG-IgM profile specific for covid-19, on the plasma samples taken at the time of the CT scan, or subsequently, in collaboration with University of Milan, Luigi Devoto Work Clinic. The lasting collaboration with the Radiological Science Department of the University of Parma in lung screening also offers the opportunity to validate the results obtained in this cohort on chest CT performed at the University Parma Hospital during the last two months in symptomatic subjects for suspected covid-19 pneumonia. In collaboration with University of Milano Bicocca, Machine Learning (ML) tools will be applied to predict the clinical relevance, severity and ultimate outcome of SSNs, based on radiomic CT features, epidemiologic risk, co-morbidity and inflammatory/immune blood biomarkers. ML analysis will generate a predictive algorithm for clinical outcome of SSNs, and specifically the risk of COV-I9 infection and unfavorable disease prognosis.
The rationale of the ROSY-O study is to continue to provide study treatment for patients who have participated in a parent study with olaparib and who are continuing to derive clinical benefit from treatment at the end of such studies, as judged by the Investigator.