Belluno

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 evaluating whether letrozole, a hormonal therapy, is more effective than standard chemotherapy in treating women with hormone receptor positive low-grade serous epithelial ovarian carcinoma. This phase III, randomized, open-label trial conducted in Italy aims to see if letrozole can extend the time patients live without their cancer worsening compared to the usual chemotherapy treatment of carboplatin and paclitaxel. The study also investigates effects on tumor response, quality of life, pain, safety, and overall survival, along with genetic profiling and disease monitoring through blood tests. Participants will receive either letrozole tablets or the standard chemotherapy regimen of carboplatin AUC 5 and paclitaxel 175 mg/m2. Treatments are given as first-line therapy after surgery. The study includes detailed assessments of estrogen and progesterone receptor status and requires patients to have had surgery with residual disease status assessed. The trial also includes translational research components analyzing gene mutations and circulating tumor DNA to understand treatment response. During the study, women will be monitored for progression-free survival over a period of 54 to 84 months. Researchers will evaluate tumor response, health-related quality of life using specific questionnaires, pain levels, and safety according to established criteria. Imaging scans, blood tests, and physical exams will be regularly conducted to track disease status. Participants must provide informed consent and will be followed closely to assess long-term outcomes and side effects throughout the trial period.

Researchers are evaluating the impact of a healthy lifestyle-based Survivorship Care Plan (LS-SCP) on the quality of life in long-term lymphoma survivors who have been in remission for at least 3 years and up to 10 years. This prospective, randomized, open-label, multicenter study includes adults aged 18 to 50 who were treated for classical Hodgkin lymphoma (cHL), Diffuse Large B-cell lymphoma (DLBCL), or Primary mediastinal large B-cell lymphoma (PMBCL). The study aims to assess how lifestyle changes influence the quality of life in these survivors. Participants are divided into two groups: the experimental group receives the LS-SCP intervention, which includes a Survivorship Care Plan, nutritional guidance, and physical activity, all followed for 6 months. Compliance in this group is monitored through bi-monthly automatic calls. The control group receives usual follow-up care without any specific lifestyle intervention. Both groups complete validated questionnaires and clinical assessments at the start, and then at 6 and 12 months after randomization. During the study, participants complete several quality of life and health-related questionnaires and undergo clinical evaluations at baseline, 6 months, and 12 months. The study measures global quality of life over a period of up to 30 months. Researchers track adherence to the intervention through regular calls in the experimental group and monitor all participants for safety and health outcomes through follow-up visits and questionnaires.

Tuberculosis (TB) is increasingly affecting children, not just the elderly, with factors like immigration from high TB areas and immunodeficiency influencing its rise. According to the 2021 WHO report, about 10 million new TB cases were reported in 2020, including 1 million in children. However, TB in children is often underreported and underestimated due to difficulties in diagnosis and limited inclusion in national surveillance systems. This study is an observational cohort assessing TB in children aged 0 to 18 years in Italy. It focuses on both active and latent TB cases, as well as children exposed to TB but uninfected after the window period. The study aims to gather epidemiological data to better understand TB's impact on the pediatric population and its transmission within the community. Participants will be monitored from before treatment through an average treatment period of 6 months, with outcomes evaluated at 24 months. Researchers will collect clinical and diagnostic information to identify TB infection status and progression. The study emphasizes the importance of tracking latent TB in children, who are at higher risk of developing active disease and contributing to future TB spread.

Researchers are evaluating the early safety and effectiveness of a procedure called percutaneous deep foot venous arterialization for patients with "no-option" chronic limb-threatening ischemia (CLTI). CLTI is the most severe form of lower limb arterial disease, associated with high risks of death and major amputation. This condition affects about 5-10% of patients with peripheral arterial disease, and some patients cannot benefit from standard revascularization methods due to the severity of their disease. The study is a multicenter, prospective, single-arm observational trial where eligible patients undergo the PiPER procedure according to current clinical practice. This procedure involves using veins as a healthy conduit to restore arterial blood flow to the foot when arteries are too damaged. No additional tests or procedures beyond routine care are performed during the study. Participants will have their demographics, medical history, treatment details, and outcomes recorded for up to 24 months after the procedure. Follow-up visits will occur at 30 days, 6 months, 12 months, and 24 months after treatment to monitor safety and effectiveness, focusing on a safety composite outcome within 30 days and 6 months.

Reference intervals are important for interpreting laboratory test results. Traditionally, these intervals are based on samples from healthy individuals, which requires recruiting volunteers and is costly and time-consuming. Advances in electronic health records and laboratory test data have made it possible to define these intervals indirectly, using routine clinical laboratory data instead of actively recruiting healthy subjects. Indirect methods analyze routine data to determine reference intervals more quickly and cheaply while avoiding the selection bias of very healthy populations. One advanced technique called RefineR offers accurate, robust, and efficient statistical modeling to separate normal from abnormal data. This method is available as an open-source tool and has been promoted by the International Federation of Clinical Chemistry and Laboratory Medicine for its benefits. The study aims to define indirect reference intervals for complete blood count parameters by analyzing large-scale retrospective laboratory data collected over up to 3 years. The research also considers age-related changes in hemoglobin levels, especially in older adults, to provide age-specific reference intervals that are currently lacking in many laboratory reports. This can improve diagnostic accuracy for patients of various ages.