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.
Paediatric Type 1 Diabetes (T1D) patients are at greater risk for developing severe hypo and hyperglycaemic events due to poor glycaemic control and incorrect Insulin administration. To reduce the risk of adverse events, patients need to achieve the best possible glycaemic control through frequent blood glucose monitoring with finger prick or Continuous Glucose Monitoring (CGM) systems. However, several non-invasive techniques have been proposed aiming at exploiting changes in physiological parameters based on glucose levels. The overall objective of this study is to validate a deep learning algorithm to detect glycaemic events using electrocardiogram (ECG) signals collected through non-invasive device. This observational single-arm study will enrol participants with T1D aged less than 18 years old who already use CGM device. Participants will wear an additional non-invasive wearable device, for recording physiological data (e.g. ECG, breathing waveform, 3-axis acceleration) for three days. ECG variables (e.g. heart rate variability features), respiratory rate, physical activity, posture and glycaemic measurements driven through ECG variables and other physiological signals (e.g. the frequency of hypo or hyperglycaemic events, the time spent in hypo- or hyperglycaemia and the time in range) are the main outcomes. A quality-of-life questionnaire will be administered to collect secondary outcomes. Data collected will be used to design, develop and validate the personalised and generalized classifiers based on a deep-learning artificial intelligence (AI) algorithm developed during the pilot study, able to automatically detect hypoglycaemic events by using few ECG heartbeats recorded with wearable devices. This study is a validation study that will carry out additional tests on a larger diabetes sample population, to validate the previous promising pilot results that were based on four healthy adult subjects. Therefore, this study will provide evidence on the reliability of the deep-learning artificial intelligence algorithms investigators developed, in detecting glycaemic events in paediatric diabetic patients in free-living conditions. Additionally, this study aims to develop the generalized AI model for the automated glycaemic events detection on real-time ECG.
Establishment of a biological bank of subjects vaccinated against SARS-Cov-2 infection (COVID-BioVac)
This study will assess the safety, efficacy and immune response following the sequential treatment of GlaxoSmithKline's (GSK) ASO compound (GSK3228836) and CHB-TI (GSK3528869A) in participants 18 to 65 years stable on NA treatment for CHB. The aim is to quantify the efficacy of sequential therapy as well as to determine an added value of sequential therapy over GSK3228836 therapy in CHB patients treated with NAs. In addition, the study will assess the effect of different treatment durations of GSK3228836 (12 or 24 weeks) prior to initiating GSK3528869A treatment.
The overall objective is to study the safety, pharmacokinetics and efficacy of linsitinib (a small molecule IGF-1R inhibitor) administered orally twice daily (BID) vs. placebo, at 24 weeks in the treatment of subjects with active, moderate to severe thyroid eye disease (TED).
In pediatric patients Peripherally Inserted Central Catheters (PICC) insertion requires pharmacological sedation provided by an anesthesiologist, which poses a certain degree of risks. In enrolled subjects, PICC insertion is tried without drug sedation, using an immersive virtual reality experience as a distraction technique. If the subjects is not able to keep still or if pain levels are too high, the virtual reality attempt is stopped and standard drug sedation is provided by a pediatric anesthesiologist. Aim of study is to evaluate the feasibility of the PICC insertion procedure using the virtual reality distraction technique. The investigators hypothesize that this could avoid the need for drug sedation, reducing sedation-related risks and costs and reduce anxiety and pain related to the procedure.
VLCKD has showed to be an impactful diet on several metabolism aspects and has proven to be useful for preventing and treating diabetes mellitus type 2, overweight, chronic inflammation and fatty liver. For this reason, the aim of this pilot study is to examinate the potential effect of a VLCKD on a group of patients that contemporarily have DM2, obesity and Non alcholic fatty liver disease (NAFLD), comparing the results with an ipocaloric diet based on Mediterranean Principles and Italian LARN (SINU 2014). This study will consider several interrelated outcomes such as anthropometric data, hematochemical and hormonal parameters, questionnaires, stool microbiota and omics, blood microvescicles, urine tests, instrumental tests (DXA, BIVA, ecographies), biopses and functional tests. 40 subjects will be evaluated and divided in two groups of 20 (VLCKD) and 20 (MedDiet).
To assess the impact of Fill Mouth Scaling and Root planing or Quadrant Scaling and Root planing gingival crevicular fluid (GCF) levels of miRNA 7a-5p, miRNA 21-3p, miRNA 21-5p, miRNA 100-5p, miRNA 125-5p, miRNA 200b-3p and miRNA 200b-5p and their correlation with periodontitis extent.
The purpose of this study is to evaluate efficacy of the study intervention, based on hepatitis B surface antigen (HBsAg) levels at follow-up (FU) Week 24.
This study will collect clinical response data on participants who were already treated with eculizumab for at least 26 weeks and who started ravulizumab treatment as a specific therapeutic strategy as per ordinary clinical practice.
This is a prospective, observational evaluation study to assess the stability of the analytes tacrolimus, cyclosporine A, everolimus and sirolimus measured with Cascadion™ SM Immunosuppressants Panel. Study is pre-market evaluation for the regions where Cascadion™ SM Immunosuppressants Panel is not on the market yet and post-market evaluation where it is. To assess the stability of tacrolimus, cyclosporine A, everolimus and sirolimus in patient whole blood samples after they are collected, processed and subjected to various storage conditions or freeze-thaw cycles that represent common sample handling conditions in the commercial clinical laboratory setting. Study subjects will undergo one venous sample collection where 30 mL of blood is drawn.