Vercelli

Researchers are investigating autoinflammatory diseases AID, which involve recurring inflammatory episodes without infection, cancer, or adaptive immune system problems. This study focuses on both monogenic hereditary periodic syndromes and polygenic or multifactorial AID, including rare conditions like Behets disease, Still disease, Schnitzlers disease, PFAPA syndrome, chronic recurrent multifocal osteomyelitis, non-infectious uveitis and scleritis, among others. The goal is to gather detailed data to improve understanding and management of these rare diseases through an international collaboration. The study uses the AIDA registry, a secure online platform for collecting demographic, genetic, clinical, laboratory, radiologic, and therapeutic information. Data are gathered retrospectively and prospectively during routine clinical visits scheduled every 3-6 months. Eleven registries focus on different AID conditions, enabling comprehensive data collection to identify clinical patterns, treatment impacts, and long-term outcomes over a period of at least 10 years. Participants provide information during their usual care visits, allowing researchers to track changes in disease activity, organ involvement, inflammatory markers, visual function, pain levels, fatigue, fertility, and socioeconomic factors. The study monitors these outcomes over multiple timepoints up to 120 months. Data privacy is ensured by pseudonymizing patient information. This registry supports multiple clinical studies and aims to enhance knowledge, awareness, and future research on autoinflammatory diseases worldwide.

Emergency departments EDs provide the first clinical evaluation and treatment for patients with urgent health issues. However, these departments often face crowding due to a large number of patients, which can reduce care timeliness and increase patient risks. This research aims to develop a multipurpose dashboard to monitor ED situations, improve patient awareness, and help healthcare providers manage department workflow more effectively. The study is observational and supported by the Mario Negri Institute for Pharmacological Research. The study involves no intervention but focuses on observing adults who attend the emergency department during the year 2025. The dashboard will collect and display real-time data on patient flow, waiting times, and departmental bottlenecks to support decision-making by emergency physicians, nurses, and policymakers. The system is designed to empower patients by informing them about ED status and reduce visits for non-urgent conditions through increased awareness. Participants will be adults attending the emergency department between January 1 and December 31, 2025. Researchers will monitor and collect data continuously from September 2024 to September 2027 using the dashboard. The primary outcome is the development and use of these dashboards to provide timely information on ED situations. This long-term data collection will help evaluate the dashboards ability to improve emergency care management and public awareness.

Researchers are developing and validating a language model called eCREAMLM designed to interpret emergency department electronic health records EHRs from adult patients treated between 2021 and 2023. This observational, retrospective study aims to see if the language model can accurately extract relevant information from free-text medical notes for research and clinical analysis across six languages. The study involves multiple centers across several European countries and addresses challenges in emergency medicine research due to high patient volume and limited staff for data collection. The eCREAMLM model will be created by training and fine-tuning existing open-source language models on billions of medical texts and millions of free-text notes from hospital records. Expert physicians will annotate thousands of clinical notes to guide the fine-tuning process. Once developed, the models accuracy will be validated by comparing its data extraction against physician annotations in 1,000 clinical notes. Data will be anonymized and pooled by language to protect patient privacy. Participants contribute by having their anonymized emergency department medical notes included in the study database. The researchers will analyze how well the language model fills out a virtual case report form compared to experts, using statistical measures of agreement. This process requires no active participation from patients. The study is expected to run until September 2027, with outcomes measured at one month after validation starts.

Researchers are evaluating the use of intracoronary optical coherence tomography OCT guidance compared to angiography-only guidance during percutaneous coronary intervention PCI to treat coronary in-stent restenosis ISR. ISR remains a challenge despite advances in drug-eluting stents, and this trial aims to understand whether OCT can improve acute PCI outcomes by providing more detailed imaging guidance. The study is a randomized, multicenter, non-blinded trial including patients with acute coronary syndrome or stable ischemic heart disease who have ISR requiring PCI. Participants will be randomly assigned to one of two groups PCI guided by OCT plus angiography or PCI guided by angiography alone. In the OCT group, operators perform at least one OCT imaging run before and after PCI and may perform additional OCT runs during the procedure. In the angiography-only group, operators perform PCI guided by angiography, but OCT imaging is also done before and after PCI without the operator seeing the results to allow outcome comparison. Operators use standard PCI tools and techniques at their discretion in both groups. During the study, participants undergo diagnostic angiography followed by PCI with assigned imaging guidance. Researchers will assess the cross-sectional area of the treated coronary segment before and after PCI using imaging techniques. Additional data collected include the number of PCI maneuvers, intracoronary devices used, and quantitative flow ratio values. Participants will be followed for one year to monitor major adverse cardiovascular events. The total participation period includes the PCI procedure and follow-up evaluations up to one year post-procedure.

Researchers are evaluating how different emergency departments EDs in Europe decide to hospitalize patients by comparing hospitalization rates across centers. The study aims to develop a predictive model that estimates each patients likelihood of hospitalization based on clinical conditions and other factors. This model will establish an average hospitalization benchmark, helping to fairly compare each EDs performance considering patient characteristics and operational conditions. This observational retrospective study involves collecting data from adult patients who attended EDs between January 2021 and December 2023. There is no intervention or treatment given in this study. The main goal is to create two separate databases and develop multivariable models between September 2024 and September 2026, which will be used for adjusted comparisons of hospitalization rates among the centers. Participants will be adults who visited the ED during the specified period. Researchers will use the collected data to build and validate the predictive model that estimates hospitalization probability. The studys primary outcomes include database creation, model development, and adjusted comparison of hospitalization rates. The study is sponsored by the Mario Negri Institute for Pharmacological Research and is expected to continue until February 2027.

Researchers are comparing two types of drug-coated balloons, Selution sirolimus coated balloon and SeQuent Please Neo paclitaxel coated balloon, for treating new coronary artery lesions in medium-small vessels sized between greater than 2.00 mm and 3.00 mm. The study aims to evaluate differences in artery diameter improvement Net Gain and blood flow measurement Fractional Flow Reserve at 12 months after treatment. This multicenter, randomized study focuses on patients with small vessel coronary artery disease and stable or stabilized heart conditions. Participants will receive angioplasty using one of the two drug-coated balloons after successful lesion preparation. Patients are randomized 11 to either the sirolimus or paclitaxel balloon groups, stratified by balloon length less than 30 mm or 30 mm and longer. Other non-study lesions may be treated with standard devices if needed. Follow-ups include phone calls at 1 and 6 months, with an angiographic and blood flow assessment at 12 months at the original treatment center. During the study, participants will undergo imaging assessments before and after the procedure and at one year to measure artery narrowing and blood flow. Measurements include quantitative coronary angiography and fractional flow reserve. Dual antiplatelet therapy is required for at least one month post-procedure, followed by aspirin alone indefinitely. Researchers will monitor device and procedure success, heart-related events, and vessel health throughout the 12-month period.

Researchers are creating a large registry of patients with ATTR amyloidosis to better understand the diseases natural history in a real-world setting. This study aims to collect data from diagnosis and during follow-up to develop and validate models that predict outcomes and response criteria at any stage of the disease. The registry also promotes data sharing and collaboration among amyloidosis experts and physicians nationwide, improving diagnosis and management of systemic amyloidosis. The study involves an online registry tool accessible to healthcare providers, facilitating data entry and sharing. This network allows physicians to request diagnostic support from the Amyloidosis Research and Treatment Center ARTC, enhancing patient care through expert collaboration. The registry collects ongoing data during patient follow-up at participating centers. Participants contribute by allowing their clinical data to be included in the registry, either prospectively or retrospectively if they have given informed consent. Researchers will monitor the establishment and use of the online data-sharing tool over five years. The study does not involve experimental treatments but focuses on observation and data collection to improve understanding and management of ATTR amyloidosis.