Search Bar & Filters
Found 4 Actively Recruiting clinical trials
Actively Recruiting
Researchers are conducting an international multicenter prospective study focused on ulcerative colitis (UC). The goal is to develop a simple new endoscopic score that uses advanced imaging techniques to better distinguish between inactive and mild inflammation in UC. This study will compare the new scoring system's ability to define disease activity and remission against current endoscopic and tissue-based scores, while also predicting long-term clinical outcomes. Additionally, the study aims to adapt artificial intelligence (AI) algorithms to these imaging techniques to improve disease assessment and outcome prediction. The study involves several phases, starting with developing the score using 30 video recordings from UC patients with varying disease activity. Experts will review the images using white light endoscopy with high definition (WLE-HD), texture and color enhancement imaging (TXI), red dichromatic imaging (RDI), and narrow-band imaging (NBI). After reaching consensus on key features, a machine learning approach will help generate a reproducible and valid score. Next, the scoring system will be validated in a larger group of UC patients, focusing on those with inactive or mild disease, assessing diagnostic accuracy and ability to predict clinical outcomes. Further phases include testing score reproducibility among gastroenterologists and adapting AI algorithms to grade and standardize disease assessment. Participants will undergo colonoscopy with various imaging modes and have at least two biopsies taken from each colon segment. Blood and stool samples will be collected for standard tests, including faecal calprotectin to measure disease activity. Patients will be followed up at 6 and 12 months through clinic visits or phone calls to reassess disease status and clinical outcomes using the Partial Mayo Score. The main outcome measured is the diagnostic performance of the new scoring system at 6 months. This comprehensive approach will help evaluate and improve assessment and management of ulcerative colitis over time.
Actively Recruiting
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.
Actively Recruiting
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.
Actively Recruiting
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.