San Benedetto Del Tronto

Researchers are studying ischemic stroke cases in patients who are taking oral anticoagulants for atrial fibrillation or other heart rhythm problems that can cause clots. This study, called ASPERA, aims to understand the characteristics of these stroke cases and to evaluate short- and long-term outcomes related to different secondary prevention strategies to prevent stroke recurrence. The study includes two parts: a retrospective phase (ASPERA-R) and a prospective phase (ASPERA-P), involving multiple centers worldwide. The University of L'Aquila coordinates data collection, analysis, and management. The retrospective part (ASPERA-R) will collect data for 5 years from the study start, with centers having 6 months to enter existing patient data. The prospective part (ASPERA-P) will enroll patients for 2 years after study approval, followed by 5 years of follow-up. Participants must have had an acute ischemic stroke while on oral anticoagulants, with confirmed imaging showing stroke lesions. The study will observe different secondary prevention treatments, including continuing the same anticoagulant or switching therapies, to compare outcomes. Participants undergo baseline assessments of demographics, clinical status, and brain imaging at the time of their stroke. Researchers will track new strokes or transient ischemic attacks at 90 days, 1 year, and 5 years after the initial stroke. They will also monitor safety events like bleeding complications and other major ischemic events such as heart attacks. Data collection includes ongoing clinical evaluations and imaging studies to identify factors linked with stroke recurrence and treatment safety.

Researchers are evaluating patients who have experienced athero-thrombotic events such as coronary artery disease, cerebrovascular disease, or peripheral artery disease. The study aims to assess how well patients follow guideline recommendations, particularly focusing on improving cholesterol levels and other modifiable risk factors to reduce the chance of cardiovascular event recurrence. This observational and prospective study takes place across multiple cardiology centers in Italy to represent a broad patient population. The study includes several phases starting with an educational intervention to discuss guideline recommendations for secondary prevention. Following this, data is collected for three months or until 30 patients with documented cardiovascular conditions are enrolled, using a web-based case record form that identifies when guidelines are not followed and records reasons for non-adherence. After six months, primary and secondary outcomes are evaluated. A second educational intervention then shares findings from the first phase to highlight gaps in clinical practice, followed by another three-month data collection period and a further six-month outcome assessment. Finally, all patients are followed for 12 months to monitor longer-term results. Participants provide informed consent and are monitored through data collection forms that track adherence to guidelines and clinical outcomes. The main outcome measured is adherence to cholesterol management guidelines over six months. Additional assessments include adherence to recommendations for other cardiovascular risk factors. Throughout the study, researchers gather data to understand how guideline adherence affects patient health and to identify barriers to following best practices, with continuous follow-up over a year to evaluate sustained effects.

Researchers are evaluating the impact of a mobile health (m-health) solution on improving the self-management skills of adults with Type 2 Diabetes Mellitus (T2DM) living in the Marche region of Italy. This randomized clinical trial compares the personalized m-health solution, integrated with patients' Electronic Patient Records (EPR), to usual care. The main goal is to assess changes in glycated haemoglobin (HbA1c) levels from the start of the intervention through 18 months, along with other health-related factors like medication adherence, lifestyle habits, self-efficacy, and quality of life. Participants in the treated group will receive training and personalized setup of the m-health solution, which includes mobile applications for tracking health data, receiving alerts and motivational messages, communicating with healthcare professionals, and accessing educational materials. Healthcare providers at Diabetes Centres (CADs) will monitor patient data via a dedicated EPR interface and maintain communication as needed. The intervention begins at the CADs and continues at participants' homes, with follow-up evaluations at 6, 12, and 18 months. Throughout the study, participants will complete self-administered questionnaires and clinical assessments during routine physician visits. Data will be collected from the m-health solution, clinical evaluations, and focus groups to evaluate usability, patient experience, and cost-effectiveness. Importantly, no extra visits or laboratory tests beyond usual care are required. The total observation period spans 18 months from baseline to final follow-up.

Researchers are comparing the effects of a new low glucose peritoneal dialysis solution called XyloCore to traditional glucose-based solutions in patients with End-Stage Renal Disease (ESRD) who are undergoing Continuous Ambulatory Peritoneal Dialysis (CAPD). This Phase 3, randomized, controlled, open-label, multicenter study aims to assess the efficacy and safety of XyloCore over a 6-month period while maintaining blinded evaluation of key outcomes. Participants will be randomly assigned to receive either the investigational XyloCore solution—available in Low, Medium, or High Strength formulations based on glucose concentration—or to continue their standard glucose-based peritoneal dialysis treatments such as Physioneal, Fixioneal, Dianeal, Balance, Bicavera, Bicanova, or Equibalance. All patients will continue using Extraneal (7.5% Icodextrin) for their long-dwell nocturnal exchange. The number and osmotic strength of daily short dwell exchanges can be adjusted by investigators as needed, with the goal of achieving a weekly total Kt/V urea clearance above 1.7. During the study, participants will be monitored for dialysis effectiveness, mainly by measuring total weekly Kt/V urea at 24 weeks. Clinical status will be regularly assessed, including evaluation of safety and tolerability. Randomization is stratified to balance patients with diabetes and those treated with only one daily exchange. The study's open-label design includes blinded assessment of primary endpoints to reduce bias, and treatment adjustments will be tailored to each patient's clinical situation throughout the trial.

Researchers are evaluating whether the drug zilebesiran can reduce the risk of major cardiovascular events such as cardiovascular death, nonfatal heart attacks, strokes, or heart failure in adults who have hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This Phase 3 global study is designed to continue until enough cardiovascular events have occurred to assess the treatment's effect. Participants will be randomly assigned to receive either zilebesiran or a placebo, both given as injections under the skin (subcutaneous administration). All participants will continue with their standard care, which includes treatment with at least two antihypertensive medications, one of which must be a diuretic such as a thiazide or loop diuretic. The study is double-blind, so neither participants nor researchers know who is receiving the active drug or placebo. During the study, participants will be closely monitored for cardiovascular events including heart attacks, strokes, heart failure hospitalizations, and cardiovascular deaths over approximately five years. Researchers will collect data on these events to determine the time until the first occurrence of any of these outcomes. Safety assessments and standard clinical evaluations will also be performed throughout the study period to ensure participant well-being.