La Spezia

This research aims to evaluate the safety and effectiveness of pumitamig combined with chemotherapy compared to bevacizumab combined with chemotherapy in adults with previously untreated, unresectable, or metastatic colorectal cancer. The study is a blinded, randomized Phase 2/3 trial targeting participants with histologically confirmed recurrent or metastatic colorectal adenocarcinoma that cannot be cured with surgery. Participants must not have certain genetic markers such as mismatch repair deficiency, microsatellite instability-high status, or BRAF V600E mutation. Participants will receive either pumitamig or bevacizumab along with chemotherapy regimens including FOLFOX, FOLFIRI, or CAPOX at specified doses and schedules. The interventions involve administering these drugs on specified days, though exact dosing details are not provided. The study compares these two treatment combinations to assess their safety and efficacy in this patient population. Throughout the study, participants will be monitored for tumor response using RECIST v1.1 criteria, progression-free survival, and overall survival for up to five years. Researchers will evaluate confirmed complete or partial tumor responses, survival rates, and disease progression. The study includes regular assessments to track treatment effects and safety over a long-term follow-up period, ensuring comprehensive monitoring of participant outcomes.

Researchers are evaluating whether ziltivekimab can help people who were hospitalized due to a heart attack by potentially reducing the development of heart disease and preventing new heart attacks or strokes. This Phase 3 study compares ziltivekimab with a placebo, which is a dummy medicine that has no effect on the body. Both treatments are given by chance, with equal likelihood for participants to receive either ziltivekimab or placebo. Participants will inject the study medicine once a month under the skin in the stomach, thigh, or upper arm. Ziltivekimab is given as an initial loading dose followed by monthly maintenance doses. The placebo group receives a matching injection schedule. The study duration is about two years. During the study, researchers will monitor participants for the time until the first serious heart-related event, including cardiovascular death, non-fatal heart attack, or non-fatal stroke. Participants will be closely observed from the start of randomization up to 25 months. The study includes regular follow-ups to assess safety and effectiveness of the treatments throughout this period.

The trial investigates the outcomes of Complete Mesocolic Excision with Central Vascular Ligation (CME+CVL) compared to standard right hemicolectomy without CME in patients with stage II to IV right or proximal transverse colon cancer. The purpose is to evaluate disease-free survival as the primary outcome, along with safety, cancer-related results, surgical quality, and quality of life as secondary outcomes. This is a randomized controlled trial conducted in Italy involving adult patients with right colon cancer who require surgery. Patients will be randomly assigned in equal numbers to either the CME+CVL surgery group or the standard non-CME right colectomy group. The CME+CVL surgery involves precise removal of lymphovascular tissue and vessels at their origins while preserving intact mesocolon coverage. The standard surgery involves vessel transection near the superior mesenteric vessels without extensive clearing. Surgical approaches can be open, laparoscopic, or robotic, with choices about anastomosis and drain placement left to the surgeon. Participants will be followed for a total of five years after surgery, with evaluations at 1, 4, 12, 24, 36, and 60 months. Data collected will include demographic information, perioperative and postoperative characteristics, oncologic outcomes, safety measures, and quality of life assessments. The primary outcome measured is disease-free survival at three years. The study plans to recruit 416 patients over one and a half years and continue follow-up for five years, totaling about six and a half years of study duration.

Researchers are evaluating the use of a new device called the pressure microcatheter compared to the traditional pressure wire in guiding treatment decisions and optimizing percutaneous coronary intervention (PCI) for patients with stable coronary artery disease or stabilized non-ST elevation acute coronary syndrome. This Phase 4, multicenter, randomized, open-label trial aims to see if clinical outcomes with the pressure microcatheter are not worse than those with the pressure wire. The pressure microcatheter is designed to provide similar physiological measurements while being easier to use during the procedure. Participants will be randomly assigned to one of four groups: pressure microcatheter guided strategy with incremental optimization (PIOS MC), pressure wire guided strategy with incremental optimization (PIOS PW), pressure microcatheter guided strategy with standard care, or pressure wire guided strategy with standard care. Each group will receive PCI guided by their assigned device, followed by either the incremental optimization strategy or standard care treatment as described. The study device is used during the PCI procedure to measure lesion severity and help guide treatment. During the study, patients will be monitored in the hospital and followed up at 12 months, then yearly for up to five years. Researchers will compare major adverse cardiac events (MACE) occurring within 12 months between the two device strategies. Assessments will include clinical evaluations and tracking of outcomes related to heart health and procedure success. This long-term follow-up will help determine the safety and effectiveness of using the pressure microcatheter compared to the pressure wire in guiding PCI.

Researchers are studying men with metastatic castration-resistant prostate cancer (mCRPC) who are treated with lutetium (177Lu) vipivotide tetraxetan. This study is a long-term, prospective, multicenter, observational research project designed to describe routine clinical use of this treatment in real-world settings. The focus is on understanding patient experiences and outcomes outside of clinical trials. The study observes patients receiving lutetium (177Lu) vipivotide tetraxetan as prescribed by their doctor, without any experimental interventions introduced by the study itself. The observation period starts from the beginning of treatment and continues for up to 18 months after treatment ends. No additional procedures or changes to treatment are made by the study team. Participants will be monitored through regular clinical assessments to track their progression-free survival, which measures how long patients remain free from disease worsening after treatment. The study collects primary data during this observation to provide insight into the real-world effectiveness and safety of lutetium (177Lu) vipivotide tetraxetan for men with mCRPC. Overall, involvement in this study lasts up to 18 months post-treatment.

This research focuses on rare cerebrovascular diseases (rCVDs) such as CADASIL, Fabry disease, COL4A1 syndrome, Sneddon syndrome, and Moyamoya arteriopathy. These rare conditions contribute to a portion of strokes that often remain undiagnosed due to challenges in recognition by clinicians. The study aims to better understand the clinical features and natural progression of these diseases and to improve diagnosis and care through a large Italian network, addressing the limited knowledge and geographical disparities in expertise across Italy. The study does not specify particular interventions but involves creating a clinical and research network to empower diagnostic pathways for rCVDs. This network will help gather detailed clinical and genetic data from patients diagnosed with these rare conditions, who have undergone at least one brain MRI study. The initiative seeks to enhance diagnostic accuracy, share knowledge, and support appropriate management including genetic counseling. Participants will be monitored for up to 12 months to describe their phenotypic characteristics and observe the natural history of their disease. Evaluations include clinical, genetic, and neuroradiological assessments based on existing diagnoses. The study supports improved patient management through better understanding of disease features and progression, aiming to fill gaps in diagnosis and care, especially for patients in Southern Italy.

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.

Upper limb disabilities are a common and serious problem following a cerebral stroke. Researchers are evaluating the effects of a wearable and non-invasive device called FitFES, which provides electrical stimulation controlled by the muscle activity of stroke patients. This device aims to restore muscle feedback to the nervous system during voluntary movements. The study compares the use of FitFES with traditional rehabilitation treatment in post-stroke patients. Participants will be randomly assigned to either an experimental group or a control group. Both groups will undergo 15 individual rehabilitation sessions lasting 60 minutes each, scheduled 3 to 5 times per week over 3 to 5 weeks. The experimental group will perform task-oriented exercises assisted by the FitFES device, while the control group will perform the same exercises without device support. Assessments will be done at baseline, after completing the 15 rehabilitation sessions, and at a 1-month follow-up. These evaluations include tests measuring arm function and quality of life, such as the Action Research Arm Test, Fugl-Meyer Upper Extremity scale, Box and Block test, and the EuroQol 5-Dimension 5-level questionnaire. Data collected will help compare the effects of the FitFES device and traditional rehabilitation over the study period.