Acquaviva Delle Fonti

Researchers are monitoring the use of the Virtue4 Male Sling System in men with stress urinary incontinence following prostate surgery. This observational study aims to collect medical data on the devices effectiveness and safety over 12 and 36 months after implantation. The study is conducted in multiple centers across Europe and focuses on real-world use by experienced urologists. The Virtue4 Male Sling is an implantable device made of polypropylene mesh designed to support the urethra and help manage urinary incontinence caused by intrinsic sphincter deficiency. This study involves men who have already received the sling during routine clinical care. Follow-up includes visits at baseline before implantation, between 1 and 3 months post-operation, and at 12 months, with additional annual questionnaires sent out at 24 and 36 months. Participants will undergo routine clinical assessments, including questionnaires about their urinary symptoms and quality of life, pad weight testing, uroflowmetry, and measurement of urine remaining after voiding at several points during the study. Researchers will monitor patient-reported improvement and any adverse events at 12 months. The study extends to 36 months with ongoing questionnaires to track long-term outcomes and satisfaction. Participation involves regular clinical visits and mailed surveys over three years.

Researchers are studying the use of bempedoic acid combined with ezetimibe and either rosuvastatin or atorvastatin, known as triple therapy, in adults with primary hypercholesterolemia or mixed dyslipidemia. The study aims to evaluate the effectiveness and safety of this combination in real-world clinical practice, focusing on lowering LDL cholesterol LDL-C levels. This is an observational study, meaning no drugs are administered by the study team instead, existing treatments are monitored. Participants are adults who have started triple therapy within the past four weeks and are followed for up to one year. The study looks at LDL-C changes after 8 weeks and 1 year of treatment, adherence to the therapy, side effects, and cardiovascular events such as heart attacks and strokes. No new treatments are given instead, researchers collect information on the participants ongoing treatments involving bempedoic acid, ezetimibe, and either rosuvastatin or atorvastatin. During the study, participants LDL-C levels, laboratory values, and treatment adherence are regularly reviewed. Researchers will also record any adverse events and track major cardiovascular events over the year. The primary measurement is the change in LDL-C from before treatment to 8 weeks after starting triple therapy. Participants health is followed through routine clinical assessments, and the study lasts for up to one year after beginning triple therapy.

Researchers are evaluating IMVT-1402 in a global, randomized, double-blind, placebo-controlled Phase 2b study for adults with Graves disease GD who remain hyperthyroid despite antithyroid drug ATD treatment. The study aims to assess the efficacy, safety, and tolerability of IMVT-1402 in this population. Participants will receive one of two doses of IMVT-1402 or a placebo for 26 weeks. The study includes two experimental groups with different doses of IMVT-1402 and a placebo comparator group. Treatments are given over the same 26-week period to evaluate their effects. During the study, participants will be monitored to see if they become euthyroid and are able to stop ATD by Week 26. Researchers will measure thyroid hormone levels such as triiodothyronine T3 and free thyroxine FT4 at various time points, including Weeks 2, 4, and 26. Safety and tolerability will also be assessed throughout the trial, which is expected to complete in May 2027.

Researchers are studying adult patients with generalized myasthenia gravis gMG who are positive for acetylcholine receptor AChR antibodies. The study aims to gather real-world evidence from Italian clinical practice on how efgartigimod alfa affects clinical outcomes and patient-reported experiences in those treated for gMG. This observational study will follow patients over a total duration of up to 23 months. The study involves collecting primary data at a baseline visit and follow-up visits at 6 and 12 months after baseline. Researchers will also gather secondary data from medical charts covering the 12 months before baseline, including details on MG-related therapies, exacerbations, hospitalizations, and the patients medical history. The treatment with efgartigimod alfa is decided independently by the treating physician as part of routine care, not influenced by study participation. Participants will be monitored through clinical assessments and questionnaires measuring changes in MG-Activities of Daily Living MG-ADL scores and the percentage achieving minimal symptom expression MSE up to 12 months. Additional measures include quality of life, fatigue, anxiety and depression, sleep quality, and caregiver burden scores tracked over the same period. The study collects comprehensive data to understand disease experience and treatment impact, with safety and outcomes evaluated throughout the 23-month period.

Researchers are collecting clinical data to evaluate the ongoing safety and performance of commercial Biosense Webster Inc. BWI medical devices used during routine cardiac arrhythmia mapping and ablation procedures. This observational study aims to confirm the safety and effectiveness of these devices after they have been approved for market use, expanding knowledge on their role in treating cardiac arrhythmias such as atrial fibrillation, supraventricular tachycardia, and ventricular tachycardia. Participants diagnosed with cardiac arrhythmias and scheduled for an ablation procedure using BWI therapeutic catheters, including Varipulse and Dual Energy THERMOCOOL SMARTTOUCH SF catheters, will be observed during their routine clinical treatment. The study does not introduce additional interventions but monitors standard procedures using these commercial devices. Sub-studies involve participants treated specifically with the Varipulse or Dual Energy catheters. During the study, participants will be monitored for adverse events related to the devices and procedures within 7 days post-procedure and up to one year for serious or non-serious adverse events. Effectiveness measures include arrhythmia isolation or elimination and freedom from arrhythmia episodes over time. Data collection aligns with routine care standards, including follow-up visits up to 365 days to assess outcomes such as arrhythmia recurrence, repeated ablations, hospitalizations, and mortality. The study duration extends through December 2037.

Researchers are evaluating ziltivekimab, a new medicine not yet approved anywhere, to see if it can help people who were hospitalized due to a heart attack. The study aims to find out if ziltivekimab can reduce the development of heart disease and prevent future heart attacks or strokes. This is a Phase 3 clinical trial comparing ziltivekimab to a placebo in patients with acute myocardial infarction. Participants will receive an initial loading dose of ziltivekimab or matching placebo by injection under the skin as soon as possible after an invasive heart procedure, within 36 hours for STEMI or 48 hours for NSTEMI patients. After the loading dose, they will get monthly injections of the same study medicine for up to two years, in addition to their standard care. During the study, participants will be monitored for major cardiovascular events such as heart attack, stroke, and cardiovascular death. Researchers will also track other heart-related outcomes and safety measures over a period of up to 25 months. The study involves regular visits for injections, assessments, and laboratory tests to evaluate the medicines effects and patient health throughout the trial.

Researchers are studying the relationship between lung ultrasound LUS patterns and chest computed tomography CT findings in patients with panlobular or paraseptal emphysema. The study aims to better understand the acoustic signals from ultrasound evaluations and how they relate to lung tissue changes seen on CT scans. It involves COPD patients, individuals in lung cancer screening programs, and patients with suspected or known lung cancer, all showing emphysema on CT. Participants will undergo LUS evaluations using both clinical and research ultrasound scanners while lying on their backs with arms raised above their heads, the same position used during chest CT scans. The study compares ultrasound images with CT results using automated image analysis. In addition, COPD patients and those in lung cancer screening with emphysema will have respiratory oscillometry testing to assess lung function during normal breathing. During the study, participants will have lung ultrasounds, chest CT scans, and oscillometry tests if applicable. Researchers will evaluate the number of participants showing emphysema patterns on ultrasound over about two years. The study does not change any medical treatments and only observes patients at the time of enrollment. The involvement includes imaging assessments and lung function measurements to better understand emphysema detection methods.

Researchers are evaluating the effectiveness and safety of colchicine and non-enteric coated aspirin, used alone or together, to improve heart-related outcomes in high-risk adults aged 55 to 80 with type 2 diabetes. This study focuses on preventing major cardiovascular events such as heart attacks, strokes, and urgent hospitalizations in patients who have no prior history of coronary artery disease but possess other risk factors. Participants will be randomly assigned to one of four groups receiving either colchicine, aspirin, both drugs, or placebos. Aspirin is given as a 40 mg non-enteric-coated tablet twice daily, while colchicine is taken as a 0.5 mg tablet once daily. Those who cannot take aspirin will only be assigned to colchicine or its placebo groups. The study lasts up to 60 months, during which cardiovascular events and cognitive function using MoCA scores will be monitored. During the study, participants will undergo regular assessments to track cardiovascular events including heart attacks, stroke, cardiac arrest, atrial fibrillation, heart failure hospitalizations, and coronary procedures. Researchers will also evaluate cognitive function yearly. Safety checks and follow-up visits occur throughout the 5-year period to monitor the participants health and treatment adherence. The primary outcome is the time to the first major cardiovascular event after starting the study medications.

Researchers are collecting real-world data from cancer patients who receive radiotherapy to better understand the role of radiation oncology within a multidisciplinary treatment approach. This open-ended, prospective, non-interventional study aims to support radiotherapy research by observing patients over time without providing therapeutic interventions. The study includes patients with various cancer types who are planned to receive radiotherapy. Participants include patients treated with radical radiotherapy for oligometastatic disease as well as those receiving high-dose re-irradiation. The study is organized into multiple cohorts, such as OligoCare and ReCare, based on the type of radiotherapy treatment. Since it is an observational study, no experimental treatments or placebos are given. During the study, researchers will collect data on patient outcomes including disease-free survival, loco-regional control, distant metastasis-free survival, overall survival, and any adverse events related to radiotherapy over a period of five years. The main measure is the number of patients treated with radiotherapy enrolled in the program. Participants will have their health and treatment effects monitored regularly throughout this timeframe to provide valuable information about radiotherapy outcomes in real-world clinical settings.

Researchers are evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.