Empoli

Researchers are evaluating the effectiveness and safety of Datopotamab Deruxtecan (Dato-DXd) with or without durvalumab compared to the investigator's choice chemotherapy combined with pembrolizumab in patients who have PD-L1 positive locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC). This Phase III, randomized, open-label, international study aims to see if adding durvalumab to Dato-DXd can help patients live longer without their cancer worsening or simply live longer compared to standard chemotherapy with pembrolizumab. The study also examines how the treatments and cancer impact patients' quality of life. Participants will be randomly assigned to one of three treatment groups: Dato-DXd plus durvalumab, Dato-DXd alone, or investigator's choice chemotherapy (paclitaxel, nab-paclitaxel, or gemcitabine plus carboplatin) combined with pembrolizumab. All treatments are given by intravenous infusion. The study design includes stratification based on geographic location, disease-free interval history, and prior PD-1/PD-L1 treatment for early-stage TNBC. During the study, participants will have regular assessments to monitor their disease status using RECIST 1.1 criteria and undergo imaging reviewed by blinded independent central review. Researchers will track progression-free survival, quality of life, safety, and other health measures over an anticipated period of up to 33 months. Participants must provide tumor samples for PD-L1 testing, and safety monitoring will continue throughout the study.

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 the clinical characteristics and procedural efficacy and safety of different permanent cardiac pacing implantation approaches in patients over 18 years old who need a pacemaker or intracardiac defibrillator. The study focuses on various pacing methods including right chamber endocardial pacing, epicardial pacing, cardiac resynchronization therapy (CRT), conduction system pacing (CSP), and leadless pacing. The study aims to understand how these methods affect patient survival and quality of life, as well as the potential benefits of non-fluoroscopic anatomical and electrophysiological systems during implantation. Participants will receive permanent cardiac pacing devices according to European Society of Cardiology guidelines. The pacing types studied include conventional right ventricular pacing, conduction system pacing (such as His bundle and left bundle branch area pacing), CRT involving biventricular or left ventricular pacing, epicardial pacing, and leadless pacing. The study will observe the safety and effectiveness of these modalities at 30 days, 6 months, and 12 months, considering factors like stable electrical parameters, absence of hospitalizations, and device-related complications. During the study, researchers will collect clinical and procedural data from patients who have undergone device implantation at participating centers over a 10-year period, with an equal follow-up duration. Assessments will include monitoring device function, hospitalizations for heart failure, all-cause mortality, heart failure occurrence, and arrhythmias. Safety evaluations will track procedural complications, infections, and need for re-intervention. This comprehensive data collection aims to improve understanding of pacing methods and their impact on patient outcomes.

Researchers are evaluating Trastuzumab deruxtecan (T-DXd) in adult patients with unresectable or metastatic HER2-low expressing breast cancer. This non-interventional study aims to assess the effectiveness of T-DXd, patients' demographic and clinical characteristics, treatment patterns, tolerability, management of adverse drug reactions, and patient experience. The study also collects data on conventional chemotherapy treatments in a disease registry to better understand treatment outcomes in this population. Participants will receive treatment with Trastuzumab deruxtecan or conventional chemotherapy drugs such as capecitabine, eribulin, gemcitabine, paclitaxel, or nab-paclitaxel according to the Summary of Product Characteristics and routine clinical practice. No study drug will be administered by the researchers, as treatments follow physicians' standard care decisions. This approach allows observation of real-world treatment use and outcomes. During the study, patients' treatment timelines and responses will be followed, focusing on the time to next treatment up to 31 months. Researchers will monitor tolerability, adverse drug reactions, and patient-reported experiences. Data collection includes clinical and demographic information, treatment patterns, and outcomes to provide a comprehensive understanding of T-DXd and conventional chemotherapy use in this patient group.

Researchers are evaluating a program called EuroHeart, developed by the European Society of Cardiology (ESC), which aims to improve care for patients with common heart conditions like Acute Coronary Syndrome (ACS), heart failure, and atrial fibrillation. This observational, prospective, multicenter initiative collects standardized patient data continuously in real-world clinical settings to support ongoing quality improvement. The focus is on how well healthcare providers follow ESC quality indicators proven to improve patient outcomes, addressing gaps between research and everyday practice. The study specifically looks at the Italian implementation of EuroHeart, monitoring adherence to ESC quality indicators in clinical care. It does not involve experimental treatments but collects detailed data on the management of patients hospitalized with ACS, heart failure, or atrial fibrillation. Participants' care is tracked throughout their hospital stay and beyond, with no additional interventions imposed by the study. Participants will be followed for 12 months after enrollment. During this period, researchers will collect data on clinical events, treatment adherence, and patient status to evaluate how well ESC quality indicators are met, such as timely reperfusion for STEMI patients and appropriate medication prescriptions at discharge. This long-term follow-up supports efforts to enhance care quality and patient outcomes in cardiovascular diseases.

Acute intoxications are a significant public health concern, especially in children who are more vulnerable and at higher risk for unintentional and preventable poisonings. This research aims to study the patterns and social and care-related factors of acute intoxications in children to improve diagnosis and treatment approaches nationally. The study is a prospective, non-profit, multicenter observational cohort focusing on acute intoxications in pediatric patients, conducted by AMIETOX at Poison Control Centres and pediatric emergency rooms. The study observes children aged from 1 month up to 16 years who have experienced acute intoxication, defined as exposure to toxic substances or harmful amounts of substances via unintended routes. There are no specific treatments or interventions administered as it is an observational study. Participants are identified through visits or telephone contacts to participating centers. The study spans an average duration of one year to gather incidence and prevalence data. Participants will be monitored throughout the study to collect data on the occurrence and characteristics of acute intoxications. Researchers will assess the incidence and prevalence of intoxication in pediatric patients during the study period. Data collection includes social and care factors related to each case. The study ensures informed consent is acquired before including any child. Safety and follow-up are integral to the observational process to understand and eventually improve management of acute intoxications in children.

Researchers are evaluating the effects of Strategic Psychotherapy, a brief, goal-focused psychological treatment designed collaboratively with patients, on adults seeking help for clinically diagnosed mental disorders. This observational study takes place in private practice settings and includes adult patients aged 18 and older who independently seek treatment from two certified strategic therapists between January 2021 and December 2025. The goal is to understand whether this therapy improves psychological well-being, reduces symptoms, and enhances daily functioning. Participants will receive Strategic Psychotherapy as it is normally practiced, without any experimental manipulation of session number or therapy content. The therapy focuses on setting specific goals and using targeted interventions to help patients make changes. Data collection includes recording the number of therapy sessions, medication usage, initial diagnosis, family involvement, types of prescriptions, and patients' own evaluations of their treatment. Participants complete two psychological questionnaires, the Symptom Checklist-90 Revised (SCL-90R) and the Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM), before starting therapy and again after treatment ends, typically within 12 to 16 weeks depending on session attendance. Researchers will analyze these outcomes along with clinical and process information to assess the real-world impact of Strategic Psychotherapy. All personal data will be kept confidential and used solely for research purposes.

Researchers are evaluating the safety and effectiveness of a reduced dose of thrombolytic therapy combined with low-molecular-weight heparin in patients who have intermediate-high-risk acute pulmonary embolism. This Phase 3, randomized, placebo-controlled, double-blind, multinational trial aims to determine whether the lower dose of thrombolytic treatment can reduce risks while minimizing serious bleeding events compared to standard care. The study focuses on patients diagnosed within 24 hours who have a higher risk of death or hemodynamic collapse. Participants will be randomly assigned to receive either alteplase or a placebo. The treatment involves a single intravenous infusion given over 15 minutes at a dose of 0.6 mg per kilogram of body weight, not exceeding 50 mg. All patients will also receive parenteral anticoagulation with low molecular weight heparin, unfractionated heparin, or fondaparinux. The infusion is administered within 30 minutes of randomization, which occurs within 6 hours after confirming diagnosis and risk criteria. During the study, participants will be monitored for 30 days to assess outcomes including death, hemodynamic decompensation, and recurrent pulmonary embolism. Additional evaluations will include safety, clinical benefits, mortality rates at 30 days, and longer-term effects on functional impairment, heart function, and chronic pulmonary hypertension at 6 months and 2 years. The study will also track healthcare resource use over 30 and 180 days. Safety assessments, informed consent, and regular follow-up are part of the participant involvement throughout the study period.

Researchers are studying extracorporeal blood purification therapies (EBPT) used in critically ill patients, especially those with acute kidney injury, sepsis, or systemic inflammatory response syndrome. The study aims to identify specific groups of patients who benefit most from different EBPT membranes, as previous trials have shown mixed results on long-term outcomes like mortality. Personalized approaches to EBPT, called precision medicine, are being explored to improve patient care and outcomes. Participants will receive EBPT using commercial membranes prescribed by their healthcare centers according to local practices and expertise. This observational study does not change treatment plans but records detailed treatment settings in a web-based registry. This platform, accessible also by smartphone or tablet, helps clinicians manage patients and provides real-time feedback, including clinical scoring and antibiotic adjustments. During the study, researchers will collect and analyze clinical and biochemical data entered into the registry by multiple centers. They will track patient characteristics, treatment details, and outcomes to find patterns indicating which patients respond best to EBPT. The main outcome measured is identifying the subgroup of critically ill patients who most benefit from EBPT within 10 days of starting treatment. This large database approach supports personalized treatment strategies and ongoing clinical monitoring.