Pozzuoli

Researchers are evaluating whether adding axitinib to nivolumab maintenance therapy after induction with nivolumab plus ipilimumab can improve treatment response in patients with metastatic renal cell carcinoma (mRCC). This phase II, open-label trial involves patients who completed induction therapy without achieving complete response or progressive disease. The goal is to increase the rate of partial responses from about 30% to 50%, based on results from previous trials. Participants are randomly assigned in a 1:1 ratio to receive either axitinib plus nivolumab or nivolumab alone. Axitinib is given at a standard dose of 5 mg twice daily, and nivolumab is administered intravenously at 480 mg every four weeks. Treatment continues until disease progression, unacceptable side effects, patient choice, or physician decision. The study plans to enroll 118 patients, with 59 in each treatment arm. During the trial, patients will undergo regular assessments including tumor measurements following RECIST criteria, laboratory tests, and evaluations of organ function and performance status. Researchers will monitor treatment efficacy by tracking the time until disease progression or death. Safety and tolerability will be closely observed, and patients must agree to contraception measures if applicable. The study aims to provide detailed information on the benefits and risks of adding axitinib to nivolumab maintenance therapy in mRCC.

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 collecting detailed information about patients with venous thromboembolism (VTE), which includes blood clots in veins such as deep-vein thrombosis and pulmonary embolism. The project aims to improve doctors' understanding of VTE, especially in patients often excluded from clinical trials, like pregnant women, elderly individuals, cancer patients, and those with other complex health issues. The goal is to reduce deaths, clot recurrence, bleeding problems, and artery-related events by sharing this knowledge widely. The study involves gathering extensive data on each patient's health status, treatments, and outcomes during the first three months of therapy. This registry is available online to help doctors quickly find information on patients with similar medical profiles and make informed decisions about managing high-risk individuals. There are no specific interventions being tested; instead, the focus is on collecting real-world patient data. Participants provide informed consent and are followed for at least three years to monitor for new clot events and complications. Researchers track recurrences of VTE, bleeding episodes, and deaths, aiming to create tools that predict which patients are most at risk for problems. This ongoing data collection supports improving care and guiding treatment decisions for diverse patient groups over time.

Researchers are developing and validating a natural language processing (NLP) tool called eCREAM_LM to interpret emergency department electronic medical records (EHRs) from adult patients. The goal is to extract important information from free-text notes to support clinical research and quality care assessments in emergency medicine across multiple languages. This retrospective cohort study collects data from 30 centers in various European countries, covering a three-year period from 2021 to 2023. The study involves training and fine-tuning the eCREAM_LM model using billions of medical texts and millions of free-text notes from participating hospitals. Physicians annotate thousands of clinical notes to create a virtual clinical report form (vCRF) for training. Validation is performed by comparing how well the model fills out the vCRF against expert physicians using a separate set of 1,000 clinical notes. Data are anonymized to protect patient privacy and combined into language-specific databases for analysis. Participants are adult patients who visited emergency departments during the specified period. Researchers evaluate the model's accuracy by measuring agreement between the model and clinicians in completing the vCRF within one month. The study uses Cohen's kappa statistic to assess concordance, aiming for a value over 0.75. There is no intervention or treatment given, as the study solely analyzes existing medical records to improve emergency care research tools.

Researchers are investigating the safety and effectiveness of TYRA-300 in adults with low-grade, intermediate-risk non-muscle invasive bladder cancer (NMIBC) that has specific FGFR3 gene changes. This Phase 2, open-label, multicenter study focuses on participants whose tumors have FGFR3 mutations or fusions and who have residual visible bladder tumors after prior surgery. It aims to assess how well TYRA-300 works in this group at 3 months after treatment begins. Participants will self-administer oral TYRA-300 tablets daily, with doses of 50mg or 60mg or a dose to be determined. The study does not include a placebo or other comparator groups. Treatment continues while participants are monitored for response and safety. The study includes careful eligibility screening to ensure participants meet specific tumor and health criteria, including no recent bladder cancer treatments or certain infections. During the study, participants will undergo regular evaluations including laboratory tests, imaging, and clinical assessments to monitor tumor response and safety. Researchers will track treatment effects and adverse events throughout the study. Participants must be able to swallow tablets and commit to contraception requirements if of childbearing potential. The total duration and follow-up details are based on treatment and safety monitoring schedules defined by the study protocol.

Researchers are conducting an Italian multicenter, observational, prospective study to gather information on patients with bone metastases. The study aims to establish a National Bone Metastasis Database by collecting detailed data from all patients with bone metastases referred to participating centers. This effort helps track and understand the condition better over a long period. Patients with bone metastases from solid tumors will be registered in a specially designed online database created for this study. Each enrolled patient will be entered into this database and followed over time until death or until follow-up is stopped for any other reason. This approach allows researchers to monitor the disease progression and treatment outcomes using a centralized digital system. Participants will provide informed consent to be part of the study. Their medical data, including diagnosis information, will be collected and stored in the database. This process includes ongoing monitoring and follow-up assessments as available during the study, which may last up to 15 years. The main outcome is the creation and maintenance of the comprehensive National Bone Metastasis Database to support research and patient care.

Researchers are evaluating whether the drug valproic acid (VPA) can enhance the effect of anti-EGFR treatments and prevent or reverse resistance to these therapies in patients with advanced or metastatic colorectal cancer that is RAS/BRAF wild-type. This phase 2, open-label, randomized study focuses on patients eligible for rechallenge therapy, meaning they have received at least two prior treatment lines and show specific genetic markers in their blood. The trial aims to understand tumor changes and identify biomarkers that predict treatment response through tissue and blood sample analysis. Participants will be randomly assigned to one of two treatment groups. One group receives standard treatment with irinotecan and panitumumab every two weeks, while the other group receives valproic acid daily along with the same irinotecan and panitumumab regimen. Valproic acid dosing starts with gradual escalation to reach a target blood level known from epilepsy treatment and preclinical studies. After initial safety checks in the valproic acid group, treatment continues until disease progression, unacceptable side effects, or other stopping reasons. Patients completing treatment enter a follow-up phase where their health is monitored until death. Throughout the study, patients undergo regular tumor assessments every 8 weeks using CT or MRI scans and blood tests for tumor markers. Side effects are tracked at every visit and for four weeks after treatment ends using standardized criteria. Patients also complete quality of life and symptom questionnaires at baseline and every 8 weeks. Blood and tissue samples collected at multiple times help researchers study treatment effects and toxicity. The main outcome measured is progression-free survival at 16 weeks, comparing the two treatment arms. Participants remain in the study until death, with data collected on subsequent treatments for comprehensive evaluation.