Benevento

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

Researchers are evaluating which rescue bowel preparation works best for adults who need a repeat colonoscopy after a previous bowel preparation did not clean the bowel well enough. The study aims to find out which preparation helps more participants achieve adequate bowel cleansing, which works better in different parts of the colon, and which is better tolerated by participants. This research includes adults aged 18 years or older who have had prior inadequate bowel preparation and require a repeat outpatient colonoscopy. Participants will be randomly assigned to one of three rescue bowel preparation regimens before their repeat colonoscopy. The regimens include 4 liters of polyethylene glycol (PEG) with 12 mg of bisacodyl, 1 liter of PEG plus ascorbic acid with 10 mg of bisacodyl, or 2 liters of PEG with additional PEG taken over the three days before the colonoscopy. These preparations are studied to compare their effectiveness and tolerability in cleansing the bowel. During the study, participants will undergo a repeat colonoscopy to assess bowel cleanliness. Researchers will measure bowel preparation adequacy on the day of the procedure and collect participants' satisfaction ratings with their assigned regimen. The study monitors preparation effectiveness and tolerability to determine which regimen best supports successful repeat colonoscopy after a prior cleansing failure.

Researchers are investigating the best treatment approach for patients with acute coronary syndrome (ACS) who have intermediate narrowing (40-70% diameter stenosis) in coronary arteries not responsible for the current heart event. The study compares strategies based on optical coherence tomography (OCT), a detailed imaging method identifying vulnerable plaques, against physiology-based methods like fractional flow reserve (FFR), instantaneous wave-free ratio (iFR), and resting full-cycle ratio (RFR) that measure blood flow to guide treatment. This trial involves about 1420 ACS patients from around 40 sites worldwide and aims to clarify which method better guides intervention in these intermediate lesions. Participants are randomly assigned to one of two groups: the OCT-guided group or the physiology-guided group. In the OCT group, lesions showing specific vulnerability signs on imaging, such as thin fibrous caps and macrophage clusters, or very small minimum lumen areas, will receive treatment using a drug-eluting stent (DES). In the physiology group, treatment with DES occurs if flow measurements (iFR, RFR, or FFR) indicate significant blockage. If these criteria are not met, intervention may be deferred. Both groups use advanced devices for imaging and flow measurement to guide decisions. During the study, participants will be closely monitored for cardiac events such as cardiac death or spontaneous heart attacks related to the treated vessel over a period of 2 years, with follow-up extending to 5 years. Researchers will assess these outcomes to determine the effectiveness of each strategy. The study includes detailed imaging, physiological assessments, and clinical evaluations to track patient progress and safety throughout the trial.

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 conducting an international, multicenter, prospective, non-interventional observational registry to study patients with X-Linked Hypophosphatemia (XLH). The goal is to gather data to better understand the treatment approaches, disease progression, and long-term outcomes for both adults and children with XLH. This registry also supports a Post-Authorisation Safety Study (PASS) requested by the European Medicines Agency to monitor safety concerns related to burosumab treatment. Patients of all ages and genders with XLH can join the registry, regardless of whether they are currently receiving treatment. The registry collects data through a web-based system, including baseline, retrospective, and ongoing information from regular visits. Physicians will update patient data approximately every 12 months or more frequently if part of standard care, without any additional interventions required beyond routine clinical practice. Participants or their legal representatives provide informed consent, with assent sought from children when appropriate. Data collection involves recording clinical, radiological, biochemical, and genetic information supporting the diagnosis. Safety monitoring includes tracking treatment-related adverse events over a 10-year period. The registry follows patients over time, capturing comprehensive information to improve understanding of XLH and its management.

Oligometastatic breast cancer occurs when breast cancer has spread to only a few other parts of the body. Patients with this limited spread may live longer than those with more widespread disease. Researchers are exploring whether adding local treatments like stereotactic body radiotherapy (SBRT), which delivers high doses of radiation in a few sessions without surgery, can improve disease control and survival compared to standard whole-body treatments such as chemotherapy or hormonal therapy. This study is a multicenter retrospective analysis aimed at better understanding the benefits of SBRT in this patient group. The study focuses on patients who have received SBRT to extracranial sites of oligometastatic breast cancer, with treatments delivering a minimum dose of 50 Gy EQD2 in up to 12 sessions. As a retrospective database study, it collects data from multiple institutions on patients treated with SBRT following the Oligocare definition. The study reviews treatment details and outcomes from patients aged 18 years and older with confirmed breast cancer and limited metastatic spread. Participants will have their medical records reviewed to assess progression-free survival, which is the primary outcome measure tracked from January 2010 to December 2023. Researchers will analyze disease control and survival outcomes following SBRT treatment. Since this is a retrospective study, there is no direct patient involvement, but the study relies on comprehensive data collection and evaluation from existing patient records across multiple centers.

Researchers are conducting an international, multicenter study called SE2030, building upon the SE2020 stress echocardiography (SE) study. This research aims to validate and expand the use of a comprehensive ABCDE protocol for functional heart testing across a wide range of cardiovascular diseases including coronary artery disease, heart failure, hypertrophic cardiomyopathy, congenital heart disease, valvular heart disease, and effects of chest radiotherapy or chemotherapy. The study plans to enroll at least 10,000 patients from over 20 quality-controlled laboratories in at least 10 countries, following them for 5 years to evaluate outcomes such as all-cause death, cardiac death, and cancer diagnosis. Participants will undergo stress echocardiography using the ABCDE protocol, which involves a series of steps assessing different aspects of heart function under stress, including myocardial ischemia, pulmonary congestion, preload reserve, coronary circulation, and autonomic balance. Various types of stress can be applied, such as physical exercise, pharmacologic agents like dobutamine or vasodilators, or pacing stress, depending on patient suitability and physician preference. Specific assessments include diastolic and right ventricular function evaluations, and a separate protocol is included for evaluating potential heart donors. Artificial intelligence software and ultrasound enhancing agents are provided to improve imaging quality and analysis. Throughout the study, participants will be evaluated using standardized procedures with data entered directly into a secure, centralized database with quality control. Researchers will collect information on heart function, wall motion, ventricular volumes, pressures, strain, and other parameters at rest, during intermediate, and peak stress. The study aims to produce evidence supporting the use of stress echocardiography as a versatile, radiation-free, and widely accessible imaging method, with long-term follow-up over 5 years to assess clinical outcomes and safety.

Researchers are conducting a multicenter observational study to collect and analyze data from cancer patients registered in the ROC platform in the Campania region. This study aims to create a combined retrospective and prospective registry to better understand cancer patient outcomes and healthcare processes in this region, which has worse oncological outcomes compared to other Italian regions. The study hopes to use this large, representative dataset to guide decision-making and improve cancer care. The study involves collecting patient data retrospectively from the start of the ROC platform in November 2018 up to the ethics committee approval date, and prospectively from the approval date onward. All ROC centers participate, and the data collection focuses on patients entering the ROC platform and following a GOM path. There is no experimental treatment; rather, the study monitors data and performance related to the ROC platform's use and cancer patient management. Participants will have their data analyzed regularly over several years, with outcomes measured including tumor incidence and prevalence, timing and frequency of medical activities, adherence to guidelines, clinical trial participation, and healthcare costs. Data will be reviewed every 2 to 6 months up to 5 years depending on the outcome. This long-term follow-up aims to assess the effectiveness of public oncology interventions and improve care coordination.

Researchers are investigating the relationship between vitamin D levels and head and neck cancer outcomes and treatment side effects. This observational study focuses on patients with histologically confirmed head and neck squamous cell carcinoma, particularly those with non-metastatic locally advanced stages who are receiving radical or adjuvant radiotherapy. The study aims to understand how vitamin D levels vary over time and how these levels relate to therapy toxicity and disease prognosis. The study will follow a multicenter cohort of patients prospectively, collecting vitamin D measurements at various time points. There are no investigational treatments or interventions being administered as part of the study; instead, participants will be observed during their standard clinical care, including bilateral neck irradiation when applicable. Researchers will analyze vitamin D level changes and assess their impact on radiotherapy side effects and disease outcomes. Participants will be monitored according to routine clinical practice, with vitamin D levels measured and recorded over a 7-week period as a primary outcome. The study will evaluate correlations between vitamin D variations, treatment toxicity, and disease progression. Overall, the participation involves regular clinical visits and laboratory tests as part of their standard care, with data collection focused on vitamin D status and patient health outcomes.