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Researchers are evaluating the long-term safety and effects of nerandomilast in people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) who have previously completed treatment with nerandomilast in earlier studies. The study aims to understand how well participants tolerate nerandomilast over time, and whether it helps improve lung function, delays symptom worsening, reduces hospital visits, or impacts survival. This is a Phase 3 open-label extension trial. Participants take nerandomilast tablets daily for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study follows an open-label design where all participants receive nerandomilast. There are no placebo or comparator groups in this extension phase. Throughout the study, participants regularly visit their doctors for health assessments and lung function tests. Doctors monitor any health problems or side effects experienced during treatment. The main outcome measured is whether participants experience any adverse events up to the final follow-up visit, which occurs at week 99. This close monitoring helps evaluate the long-term safety and potential benefits of nerandomilast in this patient group.

This research focuses on men with prostate cancer who have previously participated in an enzalutamide clinical study sponsored by Astellas or Medivation. It aims to gather long-term safety information from participants who continue to benefit from enzalutamide treatment. This is a Phase 2 open-label extension study designed to monitor ongoing treatment effects after the initial study has completed its primary analysis or evaluation period. Participants will continue their previous treatment regimens, which may include enzalutamide taken orally once daily. Some may also receive abiraterone acetate with prednisone or leuprolide acetate depending on their prior study enrollment. Dose adjustments are allowed with medical monitor approval. The first visit of this study should occur within seven days of the last visit of the prior study unless treatment is temporarily paused. Participants are asked to return to their study site every 24 weeks for safety reviews, including adverse event monitoring and medication checks. At visits every 12 weeks, participants return unused study drugs and receive new supplies if needed. Safety data, including all adverse events and serious adverse events, are collected from consent until study completion, which may last up to 96 months. The study follows local standard care guidelines and includes a post-marketing phase in South Korea.

Researchers are conducting the AMIPE study to gather detailed information about patients who experience acute coronary syndrome or myocardial injury. This multicenter study includes patients admitted between January 1, 2016, and December 31, 2023. The goal is to improve understanding of these heart conditions by analyzing patient characteristics, treatment approaches, and long-term outcomes. The study involves creating a comprehensive database that collects clinical data, including patient presentation, treatment details, and flow indexes. All medical interventions follow established clinical guidelines and good practice standards. Statistical analyses will be used to examine outcomes, employing various tests to evaluate variables and identify significant factors. Participants provide written informed consent if enrolled prospectively. Researchers will review hospital medical records to collect information. They will monitor outcomes such as all-cause mortality and major adverse cardiac events at 1, 3, and 5 years. The study aims to support improved treatment strategies and patient care through thorough data analysis over several years.

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 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 the diagnostic criteria currently used to identify placenta accreta, a condition where the placenta abnormally attaches to the uterus, and they aim to understand maternal outcomes related to different management strategies. The study focuses on comparing conservative management, where the placenta is left in place during cesarean section, versus more radical management involving cesarean section followed by hysterectomy. This study is both retrospective and prospective, conducted across multiple centers nationally, and seeks to help standardize care for suspected placental accretism cases. Patients will receive treatment according to usual clinical practice without experimental interventions. Data collection includes main instrumental findings of suspected placenta accreta cases, and monitoring will cover pregnancy progression and postpartum periods using laboratory and instrumental tests. Clinical trends are tracked through vital signs, laboratory tests, ultrasound, and other examinations during pregnancy, immediately after surgery, and at follow-up outpatient visits. Prepartum visits generally occur twice weekly if no complications arise, while postpartum follow-up varies depending on the procedure used and any complications. Participants will be monitored for the accuracy of prenatal diagnosis compared to findings during surgery, focusing on outcomes up to one month after birth. There are no questionnaires or rating scales involved. The study tracks vital and laboratory parameters, imaging results, and clinical progression to assess the safety and effectiveness of management approaches. Monitoring continues through immediate postoperative periods and outpatient visits to gather comprehensive maternal and fetal outcome data.

This research focuses on invasive bacterial diseases caused by Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae, which lead to severe health problems and frequent serious complications. The study aims to understand the epidemiology of these infections, including the distribution of bacterial strains, to better plan prevention and treatment strategies. It highlights the importance of monitoring these infections to guide public health actions, detect vaccine failures, and assess the impact of vaccination programs. The study uses molecular diagnostic testing on blood samples to identify the pathogens, even when traditional culture methods fail due to prior antibiotic use or sample handling issues. Molecular diagnosis allows for more accurate detection of these bacteria regardless of their viability in samples. This testing is conducted on patients from hospitals within and outside the Tuscany region as part of ongoing surveillance. Participants include both pediatric and adult patients diagnosed with invasive bacterial diseases caused by these bacteria. Researchers will track the incidence rates of infections caused by each pathogen over about one year. The study involves collecting biological samples for molecular testing and monitoring the presence and types of bacteria. This will help improve understanding of infection trends and support the development of better prevention and treatment approaches.

Researchers are conducting a study to continuously evaluate the quality of healthcare provided in semi-intensive care units. The goal is to develop indicators that measure healthcare quality based on data collected from patients in these units and the structural characteristics of the hospitals. This evaluation aims to identify areas of care that need improvement for different types of patients. The study will collect and analyze data over a period of five years. Each year, a report will be produced to show the results and quality levels of care in each semi-intensive care unit. This ongoing monitoring will help assess the care provided and guide improvements. Participants in the study are patients hospitalized in semi-intensive care units. Data related to patient care and hospital structures will be gathered and used to create quality indicators. The outcomes measured include healthcare quality for various patient risk groups, with continuous evaluation from January 2021 through December 2025. Annual reports will track the progress and effectiveness of care in these units.

Researchers are evaluating the effects of maridebart cafraglutide, given alongside standard care, in reducing heart failure events such as hospitalizations, urgent visits, cardiovascular deaths, and improving symptoms in people with heart failure who have preserved or mildly reduced ejection fraction and are obese. This is a global phase 3, multicenter trial with a two-part design including a double-blind period followed by an open-label extension. The first part will end once around 850 key events have been recorded. Participants will receive either maridebart cafraglutide or a placebo, both administered by injection under the skin. The study includes an initial randomized, double-blind phase and a later open-label extension where all participants may receive the active treatment. The trial is designed to monitor participants over time to assess the safety and effects of the treatment compared to placebo. During the trial, participants will undergo assessments including monitoring for cardiovascular events, heart failure symptoms, and laboratory tests such as NT-proBNP levels. Researchers will track time until the first occurrence of cardiovascular death or heart failure events over approximately 35 months. Safety evaluations, adherence to treatment, and ongoing health status will be followed throughout the study period.