Acquaviva Delle Fonti

Researchers are monitoring the use of the Virtue4 Male Sling System in men with stress urinary incontinence following prostate surgery. This study aims to collect real-world medical data on the device's effectiveness and safety over a period of 12 and 36 months after implantation. The study is a multicenter, prospective, non-interventional follow-up involving urologists experienced with the device. The Virtue4 Male Sling is an implantable device made of polypropylene mesh designed to support the urethra and treat male stress urinary incontinence caused by intrinsic sphincter deficiency. Participants receive the device through surgical implantation, and their progress is tracked during routine clinical visits. Follow-up visits occur around baseline (preoperative and implantation), between 1 and 3 months post-operation, and at 12 months. Afterward, annual questionnaires are mailed for two more years to continue monitoring. Participants are involved in routine clinical care with additional questionnaires to assess their condition. Researchers evaluate patient-reported improvement and monitor any adverse events at 12 months. The total study duration includes follow-up up to three years post-implantation, allowing long-term observation of device performance and safety in a real-world setting.

Researchers are evaluating the effectiveness and safety of a combination treatment called triple therapy, which includes bempedoic acid, ezetimibe, and either atorvastatin or rosuvastatin. This study focuses on patients with primary hypercholesterolemia or mixed dyslipidemia who are at high or very high cardiovascular risk. The goal is to understand how well this combination lowers LDL cholesterol (LDL-C) in a real-world clinical setting. The study observes patients who have already started triple therapy within the last four weeks. No drugs are administered as part of this study; instead, it monitors the ongoing treatment with bempedoic acid combined with ezetimibe and either rosuvastatin or atorvastatin. The study measures LDL-C changes from baseline to eight weeks after starting triple therapy and continues follow-up for one year to assess lipid goal achievement, adherence to therapy, treatment changes, laboratory value shifts, and occurrence of cardiovascular events. Participants will have their LDL-C levels and other lab values assessed at baseline, eight weeks, and one year after starting triple therapy. Researchers will collect data on adverse events, adherence to treatment, and cardiovascular outcomes such as heart attack, stroke, death from cardiovascular causes, and coronary procedures during the follow-up year. The study also tracks treatment pathways and changes over this period to better understand real-world use and effectiveness of this triple therapy approach.

Researchers are collecting clinical data to evaluate the ongoing safety and performance of commercially approved Biosense Webster Inc. (BWI) medical devices used in standard cardiac arrhythmia mapping and ablation procedures. The study focuses on patients diagnosed with cardiac arrhythmias such as atrial fibrillation, supraventricular tachycardia, or ventricular tachycardia. The goal is to confirm safety and performance of these devices in real-world use and to expand the evidence on their application in treating arrhythmias. Participants will be treated with commercially approved BWI medical devices following routine clinical practice. Sub-studies include participants treated with the Varipulse Catheter and the Dual Energy THERMOCOOL SMARTTOUCH SF Catheter. No specific intervention or experimental procedure will be imposed for the study; the treatments follow standard care procedures. During the study, researchers will monitor safety by tracking adverse events related to the devices or procedures within seven days of treatment. They will also assess treatment effectiveness by evaluating specific outcomes such as isolation of pulmonary veins, non-inducibility of targeted tachycardias, and elimination of ventricular arrhythmias. Follow-up and compliance with standard hospital testing and care are expected as part of the participant involvement.

Researchers are evaluating whether ziltivekimab can help people who were hospitalized due to a heart attack by potentially reducing the development of heart disease and preventing new heart attacks or strokes. This Phase 3 study compares ziltivekimab with a placebo, which is a dummy medicine that has no effect on the body. Both treatments are given by chance, with equal likelihood for participants to receive either ziltivekimab or placebo. Participants will inject the study medicine once a month under the skin in the stomach, thigh, or upper arm. Ziltivekimab is given as an initial loading dose followed by monthly maintenance doses. The placebo group receives a matching injection schedule. The study duration is about two years. During the study, researchers will monitor participants for the time until the first serious heart-related event, including cardiovascular death, non-fatal heart attack, or non-fatal stroke. Participants will be closely observed from the start of randomization up to 25 months. The study includes regular follow-ups to assess safety and effectiveness of the treatments throughout this period.

Researchers are conducting an observational, prospective, multicenter study in Italian cardiology centers to evaluate how well patients with Heart Failure with Reduced Ejection Fraction (HFrEF) follow guideline-recommended treatments. The study also aims to assess the safety of these treatments, monitor treatment patterns in patients with acute heart failure, and observe treatment approaches in all chronic heart failure patients regardless of their ejection fraction levels. The study involves two phases of educational interventions and data collection. Initially, healthcare providers will receive education on guideline recommendations and treatment patterns, followed by 3 months of patient data collection or up to 30 consecutive patients with chronic or acute heart failure. After 6 months, treatment modifications and outcomes will be evaluated. Then, a second educational session will highlight gaps between guidelines and practice, followed by another 3 months of data collection. Patients will be followed for 12 months total, with ongoing monitoring of treatment changes and outcomes. Participants will be assessed at enrollment and during the follow-up periods through clinical evaluations and data collection on treatment adherence and safety. The main outcome measured is adherence to guideline-directed medical therapies over 6 months. The study includes evaluations at 6 and 12 months after enrollment, with close monitoring of treatment patterns and patient health status throughout the study duration.

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 investigating the relationships between lung ultrasound (LUS) patterns and changes seen in high resolution computed tomography (HRCT) scans of patients with panlobular or paraseptal emphysema. This study aims to better understand the acoustic information from ultrasound in these lung conditions. It involves patients with chronic obstructive pulmonary disease (COPD), people participating in lung cancer screening, and patients with suspected or known lung cancer, all showing CT evidence of emphysema. Participants will undergo LUS evaluations using both clinical and research ultrasound machines while lying on their backs with arms raised, matching the position used for chest CT scans. Ultrasound videos will be recorded and analyzed alongside CT images to detect and quantify emphysema and air trapping. Additionally, COPD patients and lung cancer screening subjects with emphysema will be assessed with impulse oscillometry (IOS), a breathing test helpful in detecting and monitoring lung diseases. During the study, researchers will collect lung ultrasound images, chest CT scans, and respiratory oscillometry data. They will analyze these to find correlations between ultrasound patterns and lung tissue changes seen on CT. The main outcome measured is the number of participants showing specific ultrasound patterns of emphysema over about two years. The study will not alter patients' usual care and focuses on collecting diagnostic and research data to improve understanding of emphysema.

Researchers are evaluating the effectiveness and safety of colchicine and non-enteric coated aspirin, alone or combined, to improve heart-related outcomes in high-risk patients with type 2 diabetes. This Phase 3 trial focuses on adults aged 55 to 80 years who have type 2 diabetes and no prior coronary artery disease events but have additional risk factors like long diabetes duration, high blood sugar levels, smoking, or other markers of cardiovascular risk. The study aims to reduce serious cardiovascular events such as heart attacks, strokes, or urgent hospitalizations. Participants are randomly assigned to receive either colchicine 0.5 mg once daily, aspirin 40 mg twice daily, both medications together, or matching placebos. The aspirin is given as a non-enteric-coated tablet twice daily. Those who cannot take aspirin or have certain conditions may still receive colchicine or its placebo. The treatment and follow-up period lasts up to 60 months, during which the occurrence of serious cardiovascular events is closely monitored. During the study, participants will undergo regular assessments including monitoring for cardiovascular events like heart attacks and strokes. Safety labs and clinical evaluations will be conducted to track any side effects or adverse events. The main outcome measured is the time until the first major cardiovascular event occurs. Researchers will also ensure participants adhere to the medication schedule and will follow all patients for up to five years to evaluate long-term safety and effectiveness.

Researchers are collecting real-world data from cancer patients who are treated with radiotherapy. This study aims to support radiotherapy research and provide evidence on how radiation oncology fits into a multidisciplinary cancer treatment approach. It is a prospective, open-ended, non-interventional, and non-therapeutic multi-cohort study. Participants included in this study are those planned to receive radiotherapy as part of their cancer treatment. The study involves observing and collecting data without introducing any new treatments or interventions. It includes patients aged 12 years and older with pathologically confirmed cancer who have consented to participate. During the study, researchers will monitor and record the number of patients treated with radiotherapy over a five-year period. There are no additional interventions or treatments given; the focus is on gathering information to better understand radiotherapy's role in cancer care. Participation duration varies as the study is open-ended and ongoing.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.