San Benedetto Del Tronto

Researchers are investigating ischemic stroke cases in patients who are on oral anticoagulants due to atrial fibrillation or other cardioembolic arrhythmias. This observational study, called ASPERA, aims to understand the characteristics of these stroke cases and to evaluate the short- and long-term outcomes of different strategies used to prevent recurrent strokes. The study includes both retrospective and prospective data collection from multiple centers worldwide, coordinated by the University of LAquila. The study has two parts ASPERA-R and ASPERA-P. ASPERA-R collects retrospective data over five years, focusing on baseline demographic, clinical, and neuroimaging features of ischemic strokes in patients on oral anticoagulants. ASPERA-P enrolls patients prospectively for two years with follow-up for five years to assess risks of stroke recurrence and safety events under different secondary prevention approaches, such as continuing or changing oral anticoagulation. Participants will have their data collected at several time points, including hospital admission, discharge, and follow-ups at 90 days, 1 year, and 5 years after stroke. Assessments include clinical evaluations, neuroimaging exams, and monitoring for stroke recurrence, bleeding events, heart attacks, and mortality. The study tracks outcomes to better understand risks and to identify features linked to stroke recurrence and safety events, with total participation lasting up to seven years for prospective patients.

Researchers are evaluating a mobile health m-health solution designed to support self-management skills in adults with Type 2 Diabetes Mellitus T2DM living in the Marche region of Italy. This randomized clinical trial compares the use of the personalized m-health tool integrated with the Electronic Patient Record EPR against usual diabetes care, focusing on changes in glycated hemoglobin HbA1c levels over an 18-month period. The study aims to enhance patients abilities to manage their condition through technology combined with healthcare collaboration. Participants are randomly assigned to one of two groups the treated group receives regular care plus access to the m-health solution, while the control group continues with standard care alone. The m-health solution includes mobile apps for tracking health data such as blood sugar, lifestyle habits, and diet, receiving alerts and motivational messages, communicating with healthcare professionals, and accessing educational materials. Healthcare providers will monitor patient data through an integrated platform and communicate as needed. The intervention begins at diabetic centers and continues at participants homes. Participants will undergo evaluations at the start and at 6, 12, and 18 months, including clinical assessments, questionnaires, and data collected from the m-health solution. Researchers will assess changes in diabetes severity, medication adherence, lifestyle habits, self-efficacy, quality of life, and the usability and satisfaction with the m-health tool. There are no additional visits or lab tests beyond usual care. The study includes cost-effectiveness analysis and gathers participant feedback to understand their experience with the intervention.

This research aims to compare the effects of a new low glucose peritoneal dialysis solution called XyloCore against standard glucose-based solutions in patients with End-Stage Renal Disease ESRD who are undergoing Continuous Ambulatory Peritoneal Dialysis CAPD. The study is randomized, controlled, and open-label with blinded assessment of the main outcomes, conducted over a 6-month period. It includes patients already using common glucose peritoneal dialysis solutions and Extraneal for their long-dwell exchange. Participants will be randomly assigned to receive either the experimental XyloCore solution or continue with their current glucose peritoneal dialysis solutions. XyloCore is provided in low, medium, or high strengths matched to the glucose concentration of the patients prior prescription, while the control group maintains their usual glucose-based solutions. Both groups will continue using Extraneal for the nocturnal long-dwell exchange. Dialysis prescriptions may be adjusted by investigators to meet a target dialysis adequacy measure KtV > 1.7 per week. Throughout the study, participants will undergo regular assessments including measurement of dialysis adequacy total weekly KtVurea, blood tests such as HbA1c, cholesterol levels, hemoglobin, and insulin, as well as monitoring of kidney function, fluid removal, fatigue, and adverse events. The study includes follow-up visits for up to 6 months, with careful monitoring of safety and treatment effects. The trial is sponsored by Iperboreal Pharma Srl and uses centralized randomization with blinded evaluation of primary endpoints.

Mild traumatic brain injury TBI is a common reason for visits to emergency departments EDs. Researchers are studying how brain computed tomography CT scans are used in Italian EDs to assess patients with mild TBI. The study aims to understand the variability in CT use, validate existing clinical decision tools, and develop a new model to predict medium-term outcomes for patients with mild head trauma. The study observes adult patients who come to the ED with mild head trauma, defined by a Glasgow Coma Scale score between 13 and 15. Patients with longer-lasting loss of consciousness or amnesia are excluded. Researchers will analyze when and how CT scans are used and compare this with guidelines such as the Canadian CT Head Rule and others. They will also validate current scoring systems and work on creating an improved decision-making tool to help doctors decide when CT scans are necessary. Participants will be monitored from September 2025 through August 2027. During this time, researchers will assess CT scan use, validate common scoring methods, and develop a new score. The study involves reviewing patient data and clinical outcomes to better understand the best practices in managing mild TBI in the ED. This research aims to improve patient care by reducing unnecessary CT scans while identifying those at risk of serious complications.

Researchers are evaluating whether adding zilebesiran to standard antihypertensive treatment can reduce major cardiovascular events in adults with hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This phase 3, randomized, double-blind study aims to determine if zilebesiran lowers the risk of cardiovascular death, heart attacks, strokes, or heart failure events compared to placebo. The study will continue until a targeted number of these events have occurred, which may take up to about 5 years. Participants will be randomly assigned to receive either 300 mg of zilebesiran or a placebo, both given as subcutaneous injections every 6 months, alongside their usual blood pressure medications. The study uses a parallel design and includes careful monitoring of blood pressure and cardiovascular events over time. Both groups will continue their standard antihypertensive therapies, including at least two medications where one must be a diuretic. During the study, participants will be regularly assessed for cardiovascular events such as heart attacks, strokes, heart failure hospitalizations, and cardiovascular death. Blood pressure measurements will be taken at baseline and at 6 months, among other times. The primary outcome is the time until the first occurrence of a major cardiovascular event, with secondary outcomes including changes in blood pressure and other cardiovascular events. Participants will be followed for up to approximately 5 years to monitor these outcomes and overall survival.