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Researchers are studying people with idiopathic pulmonary fibrosis IPF or progressive pulmonary fibrosis PPF who have previously taken nerandomilast in another study. The aim is to assess how well patients tolerate long-term treatment with nerandomilast and to evaluate whether it improves lung function and delays worsening symptoms, hospital visits, or death. This open-label extension trial is sponsored by Boehringer Ingelheim and focuses on treatment over an extended period. Participants take nerandomilast tablets for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study involves a single treatment group receiving the drug, and no placebo or comparison groups. Regular visits with doctors help monitor health and collect data during this extended treatment phase. Throughout the study, participants undergo regular lung function tests and health assessments to track any adverse events and changes in lung capacity. The main outcome measured is the occurrence of any adverse events for up to about 99 weeks. Secondary outcomes include changes in forced vital capacity and time to worsening of disease symptoms or hospitalization. The study includes ongoing safety monitoring with a total participation time of up to nearly two years.

Researchers are evaluating AZD8965 in a Phase IIb trial to study its safety, tolerability, and effectiveness in treating Idiopathic Pulmonary Fibrosis IPF. The study compares three doses of AZD8965 to a placebo in participants with IPF, including those who are on stable doses of approved antifibrotic therapies such as nintedanib, pirfenidone, or nerandomilast, as well as those not taking antifibrotic treatment. The trial is randomized, placebo-controlled, double-blind, and parallel-group in design. Participants are assigned to one of four groups placebo, low dose AZD8965, medium dose AZD8965, or high dose AZD8965. The treatment lasts for 24 weeks, during which participants receive their assigned medication. The study includes approximately 360 participants across around 200 sites worldwide. Researchers aim to assess the clinical efficacy of AZD8965 by measuring changes in lung function and study the relationship between dose and outcomes. During the study, participants will undergo various assessments including lung function tests such as forced vital capacity FVC, monitoring for adverse events, and pharmacokinetic analyses of AZD8965. Safety and tolerability are monitored up to 25 weeks. Researchers will also track any serious adverse events and treatment discontinuations. The total participation time covers the 24-week treatment period with scheduled visits to assess the study outcomes and participant health.

Researchers are conducting an observational study called AMIPE to collect and analyze data on patients with acute coronary syndrome or myocardial injury. The study is both retrospective and prospective, enrolling patients admitted to participating hospitals from January 1, 2016, to December 31, 2023. The goal is to improve understanding and knowledge about these heart conditions by creating a detailed database of patient characteristics and outcomes. The study involves gathering information from patient medical records during hospitalization and requires written informed consent for prospective participants. No specific treatments are assigned as this is an observational study all diagnostic and therapeutic interventions follow established guidelines and good clinical practice. Researchers will document patient characteristics, long-term outcomes, and treatment regimens. Participants will be monitored for major outcomes such as all-cause mortality and major adverse cardiac events over 1, 3, and 5 years. Additional data on cardiovascular risk factors, clinical presentations, and complications will also be collected. Statistical analyses including univariate and multivariate methods will be used to evaluate these outcomes. The study is led by IRCCS Azienda Ospedaliero-Universitaria di Bologna and aims to provide new scientific evidence about these heart conditions.

Researchers are evaluating the clinical characteristics and procedural outcomes of patients receiving permanent cardiac pacing to treat various heart rhythm disorders. This observational study compares the effectiveness and safety of different device implantation methods used in routine clinical practice, including the contribution of advanced non-fluoroscopic anatomical and electrophysiological mapping systems. The study focuses on patients over 18 years old who require a pacemaker or intracardiac defibrillator implant following European Society of Cardiology guidelines. The study includes several types of cardiac pacing approaches conventional right ventricular pacing, conduction system pacing such as His bundle or left bundle branch area pacing, cardiac resynchronization therapy CRT with biventricular or left ventricular pacing, epicardial pacing often done during cardiac surgery, and leadless pacing via a percutaneous femoral vein approach. Each method involves implantation of a device connected to cardiac leads positioned in specific heart locations, with vascular access through veins like the cephalic, axillary, or subclavian. Electrical parameters such as pacing threshold and sensing are measured to ensure device stability before final placement. Participants will be followed for up to 120 months with clinical and procedural data collected, including assessments of device efficacy and safety at 30 days, 6 months, and 12 months. Outcome measures include stable electrical device performance, absence of cardiovascular hospitalizations or death, and monitoring for heart failure or arrhythmia events. The study also tracks procedural times, radiation exposure, and complications such as infections or lead dislocations. This long-term observation aims to understand the benefits and risks of various pacing strategies in real-world settings.

Researchers are evaluating the current main criteria used to diagnose placenta accreta and studying the maternal outcomes related to different management strategies for suspected placental accretism. The goal is to better understand the complications and improve standardization of care for affected pregnant women aged 18 to 44 years. This observational study is both retrospective and prospective and conducted across multiple centers nationally. Patients will receive treatment based on usual clinical practice. The study will collect and analyze key imaging and instrumental findings from cases of suspected accretism. It will compare outcomes between conservative management cesarean section with placenta left in place and more radical management cesarean section with concurrent hysterectomy. Monitoring includes vital signs, laboratory tests, ultrasound, and other examinations during pregnancy, immediate postpartum, and follow-up visits. Participants will have visits twice a week during pregnancy unless complications arise. Postpartum follow-up depends on the procedure performed and any complications. Researchers will assess the agreement between prenatal diagnosis and surgical findings, as well as maternal complications such as surgical site infection up to one month after delivery. No questionnaires or rating scales are used. The study runs until December 31, 2026.

This research aims to study the epidemiology of invasive bacterial diseases caused by Streptococcus pneumoniae pneumococcus, Neisseria meningitidis meningococcus, and Haemophilus influenzae hemophilus. These infections can cause severe illness and serious complications. The study focuses on monitoring these infections to guide public health efforts, evaluate vaccine impacts, and plan prevention and treatment strategies by identifying circulating strains and assessing vaccine failures. The study uses molecular diagnostic testing to identify these bacteria from blood samples, even when traditional culture methods may fail due to prior antibiotic use or sample handling issues. Pediatric and adult patients diagnosed with invasive bacterial diseases caused by these pathogens are included. This approach enables more accurate detection and characterization of the bacteria. Participants diagnosed with these invasive bacterial infections will have their samples analyzed using molecular methods. Researchers will monitor the incidence rates of these infections in children, the distribution of bacterial types, and the proportion of cases preventable by vaccination. The study will also assess vaccine failure rates. The average study duration for outcome measurement is about one year, supporting improved surveillance and public health interventions.

Researchers are evaluating maridebart cafraglutide as an additional treatment to standard care for adults with heart failure who have preserved or mildly reduced ejection fraction, and who are also obese. This phase 3, global, multicenter trial aims to see if this drug can reduce heart failure events like hospitalizations and urgent visits, lower cardiovascular deaths, and improve heart failure symptoms. The study has a double-blind phase and an open-label extension, and it will continue until about 850 primary endpoint events occur. Participants will be randomly assigned to receive either maridebart cafraglutide or a placebo, both given by subcutaneous injection. The trial lasts up to approximately 35 months and includes assessments at various time points to measure heart failure events, cardiovascular deaths, kidney function, blood pressure, weight, blood sugar, cholesterol, and quality of life using questionnaires. The study also tracks serious adverse events and drug concentrations. During the trial, participants will have regular visits for monitoring, including questionnaires, laboratory tests, and physical assessments. Researchers will evaluate the time to first cardiovascular events and heart failure hospitalizations as the main outcome. Secondary measures include changes in symptoms, kidney health, blood pressure, and metabolic factors. Safety will be monitored throughout, with follow-up continuing up to about 35 months from the start of treatment.

Researchers are studying the presence of micro- and nanoplastics MNPs in patients who have had a specific type of heart attack called ST segment elevation acute myocardial infarction STEMI. The study aims to understand how MNPs found in coronary blood clots relate to heart damage, plaque vulnerability, microvascular obstruction, and future heart-related events. This observational study will use imaging techniques like optical coherence tomography and cardiac magnetic resonance to explore these connections. The study involves patients undergoing urgent coronary angiography and thromboaspiration to remove blood clots. Researchers will compare those with MNPs in their clots to those without. Various assessments include measuring MNP levels in different vessels and biological samples, evaluating heart muscle damage, and analyzing plaque composition. The study will follow participants for up to one year to monitor heart events and recovery. Participants will undergo evaluations from enrollment through hospital discharge, including blood tests for inflammation and heart damage, imaging assessments, and monitoring of heart function and complications. Follow-up visits will occur up to one year after enrollment to assess cardiovascular events and heart function recovery. The primary outcomes focus on the burden of MNPs in coronary thrombi and their association with biomarkers and cardiac damage during the hospital stay, with extended observation for longer-term heart health outcomes.

Researchers are investigating the presence and impact of microplastics and nanoplastics MNPs in adults with chronic coronary syndromes CCS undergoing coronary CT angiography CCTA and invasive coronary angiography. This observational study aims to analyze these particles in coronary blood and explore their relationship with coronary artery disease features, including plaque characteristics and vessel ischemia. Patients are followed up clinically at 1 and 3 years according to standard care. Participants undergo routine coronary CT angiography to assess suspected or known CCS and then invasive coronary angiography when clinically indicated. During invasive procedures, coronary blood samples are collected for central laboratory analysis of MNPs using specialized techniques such as pyrolysis-gas chromatography-mass spectrometry and laser direct infrared spectroscopy. The CCTA images are centrally evaluated to quantify and characterize coronary plaques. Patients are grouped based on the presence or absence of MNPs in coronary blood. Throughout the study, patients receive standard clinical management without changes to their care. Data collected include coronary blood MNP burden, plaque features from CCTA, and clinical outcomes such as major adverse cardiovascular events and mortality over 1- and 3-year follow-ups. The study monitors correlations between MNP levels and various imaging and clinical parameters to better understand their role in CCS progression and outcomes.

Researchers are studying acute intoxications in children to better understand how often these poisonings occur and what social and care factors contribute to them. This research focuses on children from 1 month to 16 years old who experience acute intoxication, aiming to improve future national diagnostic and treatment approaches. The study is a prospective, multicenter observational cohort conducted by AMIETOX at Poison Control Centres and paediatric emergency rooms. The study observes children who come to emergency rooms or contact Poison Control Centres due to acute intoxication, defined as exposure to harmful substances either by toxic nature or improper use. It does not involve specific treatments or interventions but records data over approximately one year to assess incidence and prevalence. This observational approach allows researchers to collect real-world information about poisoning cases in paediatric settings. Participants will be monitored through their visits or calls to study centers, with data collected on the nature and circumstances of the intoxications. Researchers will measure how often these poisonings occur and how widespread they are among children in the study. The study involves no active treatment or placebo, focusing instead on gathering information to inform better care strategies. Participation lasts about one year, during which safety and outcomes are tracked through standard care processes.