Mantova

Researchers are studying the use of bempedoic acid combined with ezetimibe and either rosuvastatin or atorvastatin, known as triple therapy, in adults with primary hypercholesterolemia or mixed dyslipidemia. The study aims to evaluate the effectiveness and safety of this combination in real-world clinical practice, focusing on lowering LDL cholesterol LDL-C levels. This is an observational study, meaning no drugs are administered by the study team instead, existing treatments are monitored. Participants are adults who have started triple therapy within the past four weeks and are followed for up to one year. The study looks at LDL-C changes after 8 weeks and 1 year of treatment, adherence to the therapy, side effects, and cardiovascular events such as heart attacks and strokes. No new treatments are given instead, researchers collect information on the participants ongoing treatments involving bempedoic acid, ezetimibe, and either rosuvastatin or atorvastatin. During the study, participants LDL-C levels, laboratory values, and treatment adherence are regularly reviewed. Researchers will also record any adverse events and track major cardiovascular events over the year. The primary measurement is the change in LDL-C from before treatment to 8 weeks after starting triple therapy. Participants health is followed through routine clinical assessments, and the study lasts for up to one year after beginning triple therapy.

This research investigates patients who have experienced aneurysmal subarachnoid hemorrhage aSAH, a type of stroke caused by bleeding from a ruptured brain aneurysm. The study focuses on a complication called delayed ischemic neurological deficit DIND, which can lead to delayed cerebral ischemia and poor neurological outcomes despite early treatment. Researchers aim to understand how often DIND occurs, how it is diagnosed, and the treatments used across different centers, as well as the impact on patients recovery both short- and long-term. Participants include those diagnosed with aSAH, confirmed by imaging tests, who are admitted to intensive care. The study collects data on neurological symptoms and imaging to identify DIND and monitors instrumental methods like continuous EEG and ultrasound for diagnosis, especially in patients unable to be examined clinically. Researchers also observe various treatment approaches such as blood pressure management, local drug infusions, and mechanical interventions like angioplasty to compare their use and outcomes. During participation, patients undergo neurological examinations and imaging tests including CT and MRI to assess brain function and injury. Instrumental monitoring of intracranial pressure and cerebral blood flow is recorded to support diagnosis and management. The study follows patients for 12 months to measure the incidence of DIND and evaluate neurological and functional outcomes over time. Data on treatment intensity and monitoring usefulness are also collected to improve understanding of managing this condition.

Researchers are studying patients with early breast cancer, focusing on those with HER2-positive and Triple Negative tumors who have received neoadjuvant treatment in the past five years. The study aims to understand the percentage of such patients among all who underwent neoadjuvant treatment, along with analyzing treatment choices, tumor characteristics, responses to therapy, surgical procedures, and survival outcomes based on molecular subtypes and initial cancer staging. This observational study reviews clinical data collected from multiple oncology centers in Italy. It examines neoadjuvant treatments given before surgery, the radiological responses assessed by breast MRI, ultrasound, or mammography, and the surgical methods used on the breast and axilla. The study also looks at adjuvant therapies after surgery and tracks changes in eligibility criteria for neoadjuvant treatments over the last five years. Participants medical records will be evaluated to capture information on tumor pathology, treatment responses, and survival rates including disease-free and overall survival. The primary measurement is the percentage of HER2-positive and Triple Negative patients treated neoadjuvantly during the defined period. Secondary analyses include treatment patterns, pathological and radiological responses, surgical details, and correlations between complete pathological response and survival outcomes. The study spans five years of retrospective data and is led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.

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.

Researchers are conducting the PREgnancy and FERtility PREFER study to improve care and understanding of fertility preservation and pregnancy issues in young women with breast cancer. This comprehensive program includes two parts one focusing on fertility preservation choices and outcomes, and the other on managing breast cancer diagnosed during pregnancy and the health of children born after cancer treatment exposure. The study collects data over a long time to better understand these important topics. The PREFER study gathers information on fertility preservation strategies available in Italy, including patients preferences, the techniques used, and their success and safety. It also tracks breast cancer cases diagnosed during pregnancy or soon after, monitoring pregnancy management, child health after exposure to cancer treatments in the womb, and outcomes for survivors who become pregnant later. The program is carried out across multiple Italian centers under a research group. Participants provide data through medical records and follow-up over many years. Researchers measure how many patients choose fertility preservation, the types of treatments given during pregnancy, pregnancy complications, survival rates, ovarian function recovery, number of eggs preserved, and pregnancies achieved after treatment. They also evaluate hormone changes during chemotherapy and the health of children born to affected mothers. The study continues for up to 15 years to gather long-term safety and outcome information.

Spontaneous coronary artery dissection SCAD is a recognized cause of non-atherosclerotic acute coronary syndromes, mainly affecting young women without typical risk factors. Researchers are building the first pan-European SCAD registry to improve understanding of this conditions diagnosis and management, inform guidelines, educate clinicians, and promote research. This international, multicenter, observational study includes both retrospective and prospective patient data. The study collects data without any treatment interventions, enrolling at least 500 new patients and 500 historical cases from about 30 countries and 120 sites. Patient information is gathered from their first SCAD event, at enrollment, and then yearly for up to five years or until study completion. There are no study drugs or procedures involved as it is purely observational. Participants will provide data at multiple time points including baseline and yearly follow-ups for up to five years. Researchers will review patient status, vital signs, recurrent SCAD events, imaging results, medications, menstrual and obstetric history, and discharge details. Additional information on procedures, other coronary events, symptoms, pregnancy and hormonal therapy, exercise habits, mental health, and employment after SCAD will also be collected. This allows a comprehensive understanding of SCAD over time.