Bassano Del Grappa

Researchers are evaluating the combination of baxdrostat and dapagliflozin in people with chronic kidney disease CKD and high blood pressure hypertension. This Phase III, double-blind, placebo-controlled study aims to assess whether this combination reduces the risk of serious kidney damage, heart failure events, or cardiovascular death compared to dapagliflozin alone. The study includes participants with CKD and hypertension who meet specific kidney function and blood pressure criteria. Participants who are not already taking SGLT2 inhibitors will first complete a 4-week dapagliflozin run-in period. Then, they will be randomly assigned to receive either baxdrostat plus dapagliflozin or a placebo plus dapagliflozin. Baxdrostat dosing may start low and be increased if needed. Study visits will occur at 2, 4, 8, 16, 34, and 52 weeks after randomization, and then approximately every four months until the study ends, which is based on the number of key kidney or heart-related events. Throughout the study, participants will have regular assessments including blood tests to monitor kidney function and potassium levels, blood pressure measurements, and evaluations of heart and kidney health. If participants stop the blinded study drug early, they will continue dapagliflozin if possible and remain in the study for ongoing visits and monitoring. The main outcome is whether the combination treatment reduces the risk of a 50% sustained decline in kidney function, kidney failure, heart failure events, or cardiovascular death over up to 37 months.

This research aims to observe the real-world use and effects of pegcetacoplan in adults diagnosed with Paroxysmal Nocturnal Hemoglobinuria PNH. As a new treatment with a unique mechanism of action, pegcetacoplans effectiveness and safety in routine medical practice are being studied to provide valuable information for patients, healthcare providers, and payers. The study will also gather data on blood transfusions and healthcare resource use before and after starting pegcetacoplan. Patients who have started pegcetacoplan treatment within the past 12 months or are prescribed the drug at enrollment will be included. Data collection includes retrospective information from up to 12 months before treatment start and prospective monitoring for approximately 36 months, with the total data period extending up to about 48 months. After stopping pegcetacoplan, patients remain in the study for 8 weeks to record any adverse events. Patients continue regular clinic visits, where data from each visit will be gathered. Participants will have data collected on various health measures such as hemoglobin levels, blood markers, transfusion needs, and patient and physician treatment satisfaction at regular intervals up to 36 months. Safety and adverse events will be monitored throughout. The main outcome measured is the change in hemoglobin level from treatment start to 6 months. This long-term observational study allows for comprehensive tracking of pegcetacoplans use and effects over time in usual care settings.

Researchers are evaluating the effects and safety of efgartigimod given intravenously in adults with primary immune thrombocytopenia ITP, a condition where the immune system attacks platelets. This phase 3 clinical trial aims to determine how well efgartigimod controls platelet counts compared to a placebo during a 24-week double-blinded treatment period. The study is sponsored by argenx and includes follow-up periods to monitor ongoing effects and safety. Participants will be randomly assigned in a 21 ratio to receive either efgartigimod IV or placebo IV during the double-blinded treatment period. After this, all participants will receive efgartigimod IV during a first 52-week open-label treatment phase, followed by an optional second 52-week open-label phase. After completing these treatment periods, participants will have an approximately 8-week follow-up while off the study drug, with total study participation lasting up to 138 weeks. During the study, participants will have regular blood tests to measure platelet counts and assess disease control. Researchers will track the number of weeks participants maintain platelet counts above specified levels and monitor any bleeding events or adverse effects. Safety is closely observed throughout the trial, including antibody responses to the drug. Participants will have scheduled visits and assessments throughout treatment and follow-up to gather comprehensive data on efgartigimods impact.

Researchers are tracking patients with Fabry disease through an ongoing international observational program called the Fabry Registry. This registry collects routine clinical outcomes for patients regardless of whether they are receiving treatment. The study aims to better understand the diseases variability, progression, and natural history, including in women who carry one copy of the gene, and to help improve patient care by developing monitoring recommendations and reporting outcomes. Additionally, the registry evaluates the long-term safety and effectiveness of Fabrazyme4, a treatment used in Fabry disease. The registry includes a special pregnancy sub-registry for women with Fabry disease who are pregnant or have been pregnant. This sub-registry observes pregnancy outcomes and infant growth up to 36 months after birth, collecting medical and obstetric history and treatment details. No experimental treatments are given participants continue to receive their usual care as determined by their physicians. Data from both registries support regulatory requirements and ongoing research. Participants undergo regular clinical assessments and receive standard care from their doctors throughout the study. The research team collects data on disease progression, treatment effectiveness, pregnancy outcomes, and infant development. The study is observational, meaning no study drugs or procedures are administered. The total participation can last up to 33 years, allowing for long-term monitoring of safety and outcomes related to Fabry disease and pregnancy.

This research aims to develop a system for continuously evaluating healthcare quality in semi-intensive care units. By collecting patient data and hospital structure information, the study will identify indicators of unsuccessful care tailored to different patient types. These indicators will help assess the overall quality of care in each semi-intensive care unit over time. The study will last for five years, from 2021 to 2025, during which data from patients admitted to semi-intensive care units will be gathered. Annually, a detailed report will be produced to analyze and compare the results from each unit, helping to track improvements or identify areas needing attention. Participants include all patients hospitalized in participating semi-intensive care units, with an expected total of at least 39,000 patients over the study period. Researchers will monitor outcomes for various patient risk groups to assess healthcare quality. The study involves ongoing data collection and yearly evaluations to support continuous quality improvement in these care units.

Mild traumatic brain injury TBI is a common reason for visits to emergency departments EDs. Researchers are studying how brain computed tomography CT scans are used in Italian EDs to assess patients with mild TBI. The study aims to understand the variability in CT use, validate existing clinical decision tools, and develop a new model to predict medium-term outcomes for patients with mild head trauma. The study observes adult patients who come to the ED with mild head trauma, defined by a Glasgow Coma Scale score between 13 and 15. Patients with longer-lasting loss of consciousness or amnesia are excluded. Researchers will analyze when and how CT scans are used and compare this with guidelines such as the Canadian CT Head Rule and others. They will also validate current scoring systems and work on creating an improved decision-making tool to help doctors decide when CT scans are necessary. Participants will be monitored from September 2025 through August 2027. During this time, researchers will assess CT scan use, validate common scoring methods, and develop a new score. The study involves reviewing patient data and clinical outcomes to better understand the best practices in managing mild TBI in the ED. This research aims to improve patient care by reducing unnecessary CT scans while identifying those at risk of serious complications.

This research investigates patients with newly diagnosed oligometastatic prostate cancer OMPCa who meet the CHAARTED criteria for low metastatic volume disease. The study aims to collect data in a registry from major urological centers in the Triveneto region to evaluate how local treatments, such as surgery or radiotherapy of the primary tumor, combined with systemic hormonal therapies, affect cancer outcomes and quality of life. Patients with high volume metastatic disease, defined by specific bone and visceral metastases criteria, are excluded from this study. The study is observational and involves patients receiving local treatment for their primary prostate cancer along with systemic hormonal therapy, which may be androgen deprivation therapy ADT alone or combined with other agents like Docetaxel or androgen receptor signal inhibitors ARTA. Participants will be followed to observe outcomes without randomization or comparison groups since this is a single-arm study. Participants will be monitored for overall survival, cancer-specific survival, progression to castration-resistant prostate cancer, radiological progression, quality of life, as well as treatment complications for up to three years. Data collection includes clinical assessments and quality of life evaluations from the start of treatment through follow-up. The study helps track how these treatments impact patients over time in routine clinical practice.

This research aims to understand how quality of life changes during the treatment of low-grade non-Hodgkin lymphoma in elderly patients aged 70 years and older. It focuses on identifying key factors at diagnosis and during treatment that affect quality of life. The study is observational and involves multiple centers, enrolling 150 patients with confirmed indolent non-Hodgkin lymphoma. Patients may receive various treatments including immunotherapy, immunochemotherapy at full or reduced doses, andor radiotherapy as part of their usual care. Before starting any treatment, all participants undergo a Comprehensive Geriatric Assessment. Quality of life is measured at three key points before treatment begins, at the end of treatment which can last from 1 to 6 months, and one year after starting therapy. Participants will be followed through routine clinical care, including baseline, post-treatment, and follow-up assessments. Quality of life is evaluated using detailed questionnaires EORTC-QLQ-C30 and FACT-Lym-LymS that cover general and lymphoma-specific symptoms. Researchers will also monitor survival outcomes and treatment safety over up to 30 months. This study involves no experimental treatments and focuses on observing real-world patient experiences.

This observational study focuses on adult patients with Paroxysmal Nocturnal Hemoglobinuria PNH in Italy who are treated with iptacopan. The research aims to evaluate the long-term hematological response to iptacopan, including changes in hemoglobin levels and avoidance of red blood cell transfusions over 12 months. The study uses real-world clinical data to better understand treatment outcomes in routine practice. Participants include those new to iptacopan treatment as well as patients transitioning from a Managed Access Program. The study collects data retrospectively, prospectively, and retro-prospectively, following patients from the start of iptacopan treatment for up to 24 months or until treatment discontinuation or other endpoints occur. No additional visits or procedures beyond routine care are required, though questionnaires may be collected during scheduled clinical visits. During the study, researchers will monitor hemoglobin levels, transfusion needs, adverse events, and patient-reported outcomes using validated questionnaires. Data on hospitalizations, infections, vascular events, medication adherence, and quality of life will also be collected. This approach allows assessment of iptacopans effects and safety in a real-world setting without altering standard medical care.