Siracusa

Researchers are conducting a Phase III, international, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the safety and effectiveness of androgen deprivation therapy (ADT) with or without darolutamide in men with newly diagnosed metastatic prostate cancer who have vulnerable functional ability. These patients have not chosen treatment with docetaxel or other androgen receptor pathway inhibitors. The study plans to enroll 300 participants who meet specific frailty and disease criteria. Participants will be randomly assigned to one of two groups: the experimental group will receive ADT plus darolutamide 600 mg taken orally twice daily, and the control group will receive ADT plus a placebo taken orally twice daily. Treatment will continue until there is evidence of disease progression on radiographic scans or if the patient or investigator decides to stop treatment for reasons such as side effects or other health conditions. After stopping treatment, patients will enter a follow-up phase lasting up to 10 years to monitor survival, additional cancer treatments, and any ongoing or new side effects. During the study, patients will undergo assessments according to established prostate cancer clinical trial criteria to evaluate their response to treatment. Researchers will monitor the time until disease progression or death for up to 18 months as the main outcome. Safety and treatment effects will be tracked through scheduled visits, laboratory tests, and imaging. The long-term follow-up will help understand survival outcomes and the impact of subsequent treatments over many years.

Researchers are investigating the best treatment approach for patients with acute coronary syndrome (ACS) who have intermediate narrowing (40-70% diameter stenosis) in coronary arteries not responsible for the current heart event. The study compares strategies based on optical coherence tomography (OCT), a detailed imaging method identifying vulnerable plaques, against physiology-based methods like fractional flow reserve (FFR), instantaneous wave-free ratio (iFR), and resting full-cycle ratio (RFR) that measure blood flow to guide treatment. This trial involves about 1420 ACS patients from around 40 sites worldwide and aims to clarify which method better guides intervention in these intermediate lesions. Participants are randomly assigned to one of two groups: the OCT-guided group or the physiology-guided group. In the OCT group, lesions showing specific vulnerability signs on imaging, such as thin fibrous caps and macrophage clusters, or very small minimum lumen areas, will receive treatment using a drug-eluting stent (DES). In the physiology group, treatment with DES occurs if flow measurements (iFR, RFR, or FFR) indicate significant blockage. If these criteria are not met, intervention may be deferred. Both groups use advanced devices for imaging and flow measurement to guide decisions. During the study, participants will be closely monitored for cardiac events such as cardiac death or spontaneous heart attacks related to the treated vessel over a period of 2 years, with follow-up extending to 5 years. Researchers will assess these outcomes to determine the effectiveness of each strategy. The study includes detailed imaging, physiological assessments, and clinical evaluations to track patient progress and safety throughout the trial.

This research aims to evaluate the use of HIV pre-exposure prophylaxis (PrEP) in Italy by establishing a large prospective cohort of HIV-negative adults who are sexually active and eligible for PrEP. The study focuses on assessing PrEP's effectiveness, tolerability, adherence, and barriers to long-term use in a real-world setting. It also monitors the incidence of new HIV infections and other sexually transmitted infections (STIs), along with psychological, behavioral, and treatment factors related to PrEP use. Participants include about 5,000 adults aged 18 years or older who are either starting or already using PrEP according to national and international guidelines. The study is conducted across 49 university and hospital infectious disease clinics and 4 community-based checkpoints throughout Italy. Participants attend routine clinical visits every 3 to 5 months, where they undergo HIV and STI testing, safety laboratory tests, and complete electronic questionnaires through a dedicated mobile app. The study will continue for at least 10 years and is coordinated by the National Institute for Infectious Diseases "L. Spallanzani" IRCCS in Rome. During the study, researchers collect sociodemographic, clinical, laboratory, behavioral, and quality-of-life data in a secure electronic case report form managed by the ICONA Foundation. The main outcome measured is the incidence of HIV seroconversion from enrollment onward. Secondary outcomes include monitoring STIs, evaluating PrEP safety and tolerability, and analyzing adherence, persistence in care, and related behavioral factors. Ethics committees at all participating centers have approved the study, ensuring participant safety and confidentiality throughout the long-term follow-up.

Researchers are evaluating a new diagnostic and treatment approach for patients with myocardial bridge (MB), a condition where a coronary artery is compressed during heartbeats. The study aims to compare a full-physiology approach, which uses detailed invasive tests to uncover the causes of heart ischemia, with a standard angiographic evaluation. This randomized, open-label trial seeks to improve diagnosis and personalize treatment plans for MB patients. Patients diagnosed with MB during coronary angiography will be randomly assigned to one of two groups. The full-physiology approach group will undergo comprehensive functional tests including measurements of artery pressure and flow, responses to medications like adenosine and dobutamine, and a provocative acetylcholine test to detect artery spasms. The standard approach group will receive a typical angiographic evaluation of the affected artery segment. Both procedures involve coronary angiography through radial or femoral access. Participants will be monitored for outcomes including significant angina and major adverse cardiac events over a one-year period. The study includes detailed physiological assessments during the initial procedure, continuous symptom and ECG monitoring, and follow-up to evaluate the effectiveness of the diagnostic strategies. Safety and event rates will be analyzed with statistical methods, including an interim analysis after six months for half of the participants.