Bassano Del Grappa

Researchers are investigating the effectiveness, safety, and tolerability of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in people with chronic kidney disease (CKD) and high blood pressure. This Phase III, international, multicenter, double-blind, placebo-controlled study aims to see if this combination reduces risks such as significant kidney function decline, kidney failure, heart failure events, or cardiovascular death. The study includes a 4-week run-in period where participants not previously treated with SGLT2 inhibitors receive dapagliflozin alone. After this, participants are randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin in a double-blinded manner. Study visits occur frequently initially (at 2, 4, 8, 16, 34, and 52 weeks after randomization) and then approximately every 4 months. If participants stop the blinded treatment early, they continue dapagliflozin alone unless specific criteria require its discontinuation. Participants will undergo regular assessments including blood pressure monitoring and laboratory tests related to kidney function and cardiovascular health. The primary outcome measures the reduction in risk of major kidney and heart events over up to 37 months. Even if participants stop the study treatment, they will continue follow-up visits and data collection to ensure comprehensive safety and efficacy evaluation throughout the study duration.

Researchers are studying the real-world effectiveness of pegcetacoplan in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH). This long-term, multicenter observational study aims to fill knowledge gaps about how pegcetacoplan works in routine medical practice. It also seeks to provide important information on red blood cell transfusions and healthcare resource use before and after starting pegcetacoplan treatment. Patients who have started pegcetacoplan treatment within the last 12 months or are prescribed it at enrollment will be followed for approximately 36 months. The study will collect both retrospective data from up to 12 months before treatment start and prospective data during treatment, with a total data collection period of up to about 48 months. After stopping pegcetacoplan, patients will remain in the study for 8 weeks to monitor for any adverse events. Participants will attend their usual medical visits, and data from these visits will be collected, including effectiveness measures, safety reports, patient- and clinician-reported outcomes, and healthcare use. The primary outcome includes changes in hemoglobin levels over 6 months from the start of pegcetacoplan treatment. The study plans to enroll about 200 patients across multiple countries, and data collection includes both retrospective and prospective periods, capturing comprehensive information on pegcetacoplan use in real-world settings.

Researchers are evaluating the effectiveness and safety of efgartigimod given through intravenous infusion in adults with primary immune thrombocytopenia (ITP), a condition characterized by low platelet counts. This Phase 3 trial includes participants who have had ITP for over a year and have previously received treatments like corticosteroids or immunoglobulins but had insufficient responses. The study aims to measure disease control by tracking the number of weeks during which platelet counts remain at or above 50 x 10^9/L over a 24-week treatment period. After a screening period of up to 2 weeks, participants are randomly assigned in a 2:1 ratio to receive either efgartigimod IV or a placebo IV during a 24-week double-blinded treatment period. Following this, all participants enter a 52-week open-label treatment phase where everyone receives efgartigimod IV. Those who complete this phase may continue for an additional 52 weeks in a second open-label treatment period. After finishing these treatment phases, participants undergo an approximately 8-week follow-up period without the study drug. Throughout the study, participants will have their platelet counts regularly monitored to assess the extent of disease control. Researchers will also evaluate safety and monitor participants for any medical conditions that might affect the study results or their well-being. The total duration of participation can be up to 138 weeks, including screening, treatment, and follow-up periods.

Researchers are evaluating the effects of a dietary supplement made of diosmin, hesperidin, bromelain, and Ruscus aculeatus (Vesvein Gambe) on the quality of life in individuals showing early symptoms possibly related to Chronic Venous Disease (CVD) in one or both lower limbs. The study aims to measure changes in quality of life using the CIVIQ-20 questionnaire after 12 weeks of treatment compared to the baseline. This research focuses on people experiencing symptoms like heaviness, swelling, pain, cramps, itching, or restlessness in the lower limbs that may be prodromal to CVD. Participants will take the dietary supplement containing the combination of diosmin, hesperidin, bromelain, and Ruscus aculeatus. Although the individual components have known activities, this study assesses the combined effect on quality of life when taken as a single product. Treatment is given over a 12-week period, during which participants are monitored for any changes in symptoms and overall well-being. During the study, participants will undergo evaluations at the start and after 12 weeks to assess symptom changes and quality of life using the CIVIQ-20 questionnaire. Researchers will monitor for safety and adherence to the treatment throughout the study duration. The total participation time is 12 weeks, during which participants must comply with study procedures and attend scheduled visits for assessments.

Researchers are tracking patients with Fabry disease through an ongoing international, multi-center observational program called the Fabry Registry. This program collects routine clinical data from patients regardless of their treatment status to better understand the disease's variability, progression, and natural history. It also focuses on enhancing patient care by supporting the development of monitoring recommendations and evaluating the long-term safety and effectiveness of Fabrazyme, a treatment for Fabry disease. The study includes a Fabry Pregnancy Sub-registry, which is a voluntary, international, longitudinal observation program that monitors pregnancy outcomes for women enrolled in the Fabry Registry who are pregnant or have been pregnant. This sub-registry collects medical and obstetric history, pregnancy, and birth data, along with infant growth information up to 36 months postpartum, regardless of the specific treatment received. No experimental treatments are administered in either registry; patients continue receiving routine care as determined by their physicians. Participants contribute data through clinical assessments and standard care evaluations performed by their doctors. The study measures long-term outcomes including safety and effectiveness of Fabrazyme over up to 33 years, as well as pregnancy outcomes and infant growth data. The program helps fulfill regulatory requirements and supports research while tracking patient health over extended periods without altering their usual care.

Researchers are conducting a study to continuously evaluate the quality of healthcare provided in semi-intensive care units. The goal is to develop indicators that measure healthcare quality based on data collected from patients in these units and the structural characteristics of the hospitals. This evaluation aims to identify areas of care that need improvement for different types of patients. The study will collect and analyze data over a period of five years. Each year, a report will be produced to show the results and quality levels of care in each semi-intensive care unit. This ongoing monitoring will help assess the care provided and guide improvements. Participants in the study are patients hospitalized in semi-intensive care units. Data related to patient care and hospital structures will be gathered and used to create quality indicators. The outcomes measured include healthcare quality for various patient risk groups, with continuous evaluation from January 2021 through December 2025. Annual reports will track the progress and effectiveness of care in these units.

Researchers are conducting a multicenter prospective observational study focused on patients with newly diagnosed oligometastatic prostate cancer, defined by specific criteria that exclude high metastatic volume disease. The study aims to create a registry of patients from major urological centers in the Triveneto region to assess the cancer outcomes and quality of life impacts of local treatments on the primary tumor alongside systemic hormonal therapies. Participants receive local treatment for the primary prostate tumor, which may include surgery or radiotherapy, combined with systemic hormone therapy. The systemic treatment options include androgen deprivation therapy alone or combined with Docetaxel or androgen receptor signaling inhibitors. Patients must have low-volume metastatic disease according to CHAARTED criteria, without prior local treatment of the primary tumor, and may have been on systemic therapy for less than six months before enrollment. During the study, researchers will monitor overall survival from the start of the chosen treatment up to three years. Participants will be evaluated for cancer progression, quality of life, and treatment effects while receiving local and systemic therapies. The study involves informed consent, regular follow-ups, and assessment of performance status to ensure safety and effectiveness of the combined treatment approach over time.

Researchers are studying how quality of life changes during treatment for elderly patients with low-grade non-Hodgkin lymphoma. The study aims to identify key factors at diagnosis and during therapy that affect quality of life. This observational, prospective research involves patients aged 70 and older who have an indolent B cell lymphoma and are receiving treatment such as immunotherapy, immunochemotherapy, or radiotherapy. Participants will undergo a Comprehensive Geriatric Assessment before starting any protocol treatment. Quality of life will be measured using the EORTC-QLQ-C30 questionnaire and the FACT-Lym-LymS lymphoma-specific symptom questionnaire. These assessments will be done at baseline before treatment, at the end of treatment (which may last from 1 to 6 months), and again one year after treatment begins. During the study, patients will receive routine clinical evaluations including scans and response assessments as part of their standard lymphoma care. Researchers will track changes in quality of life scores from baseline through treatment and follow-up for up to 30 months. The study plans to enroll 150 patients and will monitor health-related quality of life and treatment effects over time.

Researchers are evaluating the real-world effectiveness and safety of iptacopan in adult patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) in Italy. The study aims to assess long-term blood-related responses, particularly changes in hemoglobin levels and the ability to avoid red blood cell transfusions up to 12 months after starting iptacopan treatment. This observational study includes adult patients either new to iptacopan or transitioning from a Managed Access Program starting January 2023. Data will be collected retrospectively, prospectively, or both depending on the patient cohort. Patients will be followed for up to 24 months or until they stop iptacopan due to side effects, lack of effectiveness, or other reasons. No additional visits or procedures beyond routine care are required, although questionnaires may be collected when possible. Participants will have their hemoglobin levels monitored and transfusion status tracked for 12 months post-treatment initiation. Researchers will gather data from medical records and routine clinical visits without changing usual care. The study will also observe patient-reported outcomes and monitor safety throughout the follow-up period, which may last up to 24 months or until treatment discontinuation or other censoring events occur.