La Spezia

This trial studies participants with previously untreated, unresectable, or metastatic colorectal cancer. It evaluates the safety and effectiveness of pumitamig combined with chemotherapy compared to bevacizumab combined with chemotherapy. The study includes participants who do not have specific genetic markers like dMMR, MSI-H, or BRAF V600E mutations, which may affect treatment response. Participants receive treatment with study drugs such as pumitamig, bevacizumab, and chemotherapy regimens including FOLFOX, FOLFIRI, and CAPOX. The treatments are given at specified doses on specific days. The study uses a randomized, double-blind design with multiple experimental and comparator arms to assess these combinations. Throughout the study, participants undergo regular assessments to measure tumor response and survival outcomes. Key evaluations include imaging tests using RECIST v1.1 criteria, monitored by both investigators and independent reviewers, over a period of up to 5 years. Researchers track objective response, progression-free survival, and overall survival to determine treatment outcomes and safety.

Researchers are evaluating ziltivekimab, a new medicine not yet approved anywhere, to see if it can help people who were hospitalized due to a heart attack. The study aims to find out if ziltivekimab can reduce the development of heart disease and prevent future heart attacks or strokes. This is a Phase 3 clinical trial comparing ziltivekimab to a placebo in patients with acute myocardial infarction. Participants will receive an initial loading dose of ziltivekimab or matching placebo by injection under the skin as soon as possible after an invasive heart procedure, within 36 hours for STEMI or 48 hours for NSTEMI patients. After the loading dose, they will get monthly injections of the same study medicine for up to two years, in addition to their standard care. During the study, participants will be monitored for major cardiovascular events such as heart attack, stroke, and cardiovascular death. Researchers will also track other heart-related outcomes and safety measures over a period of up to 25 months. The study involves regular visits for injections, assessments, and laboratory tests to evaluate the medicines effects and patient health throughout the trial.

Researchers are evaluating a surgical approach called Complete Mesocolic Excision with Central Vascular Ligation CMECVL compared to standard right hemicolectomy in patients with malignant tumors located in the right or proximal transverse colon. This Italian randomized controlled trial focuses on patients with stage II-IV colon cancer and aims to determine differences in disease-free survival as the primary outcome. The study also looks at safety, oncologic results, surgical quality, and quality of life as secondary outcomes. Participants will be randomly assigned to one of two groups one undergoing the conventional non-CME right hemicolectomy and the other receiving the CMECVL procedure. The CMECVL technique involves removing lymphovascular tissue at the origin of supplying vessels and preserving the mesocolon as an intact envelope. Various surgical approaches, including open, laparoscopic, or robotic surgery, are allowed. Surgeons decide the type of anastomosis and drain placement. The trial plans to enroll 416 patients over one and a half years, with five years of postoperative follow-up. During the study, patients will be monitored at 1, 4, 12, 24, 36, and 60 months after surgery. Researchers will collect demographic, baseline, perioperative, and postoperative data, evaluating outcomes such as disease-free survival at three years, safety measures including operative time and complications, overall survival, and quality of life. The total study duration is expected to be six and a half years, providing both short- and long-term information on these surgical methods.

Researchers are evaluating the use of a new device called the pressure microcatheter to measure the severity of coronary artery lesions in patients with stable coronary artery disease or stabilized non-ST elevation acute coronary syndrome ACS. This trial compares clinical outcomes of patients guided by the pressure microcatheter versus those guided by the conventional pressure wire during percutaneous coronary intervention PCI. The study aims to determine if the pressure microcatheter strategy is not worse than the pressure wire strategy for clinical decision making. Participants will be randomly assigned to receive PCI guided by either the pressure microcatheter or the pressure wire. After an angiographically successful PCI, patients will either undergo fractional flow reserve FFR-guided stent optimization using the assigned device or receive standard care treatment. The interventions are compared in four groups pressure microcatheter with optimization, pressure wire with optimization, pressure microcatheter with standard care, and pressure wire with standard care. Participants will be followed in hospital initially, then at 12 months, and yearly up to five years to monitor clinical outcomes. The study involves collecting data on major adverse cardiac events MACE, procedural times, resource use during hospitalization, post-PCI FFR measurements, and rates of symptoms and complications. This follow-up aims to assess safety, effectiveness, and long-term results of the two guidance strategies.

Researchers are observing adult male patients with metastatic castration resistant prostate cancer mCRPC who are treated with lutetium 177Lu vipivotide tetraxetan. This non-interventional, prospective, multicenter study aims to describe routine clinical practice and gather real-world data on this treatment. The study will follow patients for a maximum of 18 months after their treatment ends. The study includes patients who have been prescribed lutetium 177Lu vipivotide tetraxetan by their treating physician team. There are no additional experimental treatments or interventions, as this is an observational study. The observation period covers from the start of treatment up to 18 months post-treatment, including monitoring during the treatment duration. Participants will be monitored through regular clinical assessments and data collection on outcomes such as progression-free survival, overall survival, prostate-specific antigen response, pain medication use, and quality of life measures. Researchers will also track hospitalizations related to the treatment, dosimetry, number of visits, and workdays lost. The total involvement for each participant can last up to 18 months after treatment completion.

Cerebrovascular diseases CVDs are a major cause of illness and death worldwide, with over 30% of strokes having unknown causes. Rare cerebrovascular diseases rCVDs, including inherited conditions like CADASIL, COL4A1 syndrome, and Fabry disease, as well as acquired ones like Sneddon syndrome and Moyamoya arteriopathy, contribute to some of these strokes. These rare diseases are often misdiagnosed due to difficulty in recognition, yet identifying them is crucial for proper management, genetic counseling, and potential therapy. Currently, diagnosis and care are limited to a few specialized centers, mainly in northern Italy, causing patients to travel long distances for care. This observational study aims to create a clinical and research network across Italy to improve diagnosis and understanding of rCVDs, especially in southern regions. The study will describe the clinical features and natural course of these diseases during the first 12 months. Later, between 12 and 30 months, it will explore molecular mechanisms, identify biomarkers, and work towards better clinical and therapeutic management. Participants diagnosed with rCVDs such as CADASIL, Fabry disease, COL4A1, Sneddon syndrome, or Moyamoya arteriopathy who have had at least one brain MRI will be included. Researchers will collect clinical, genetic, and neuroradiological data to characterize these patients and monitor their disease progression. The study does not involve treatments but focuses on gathering information to improve diagnosis and care. Participation may last up to 30 months with ongoing assessments and data analysis.

Reference intervals are important tools used to interpret laboratory test results. This research aims to evaluate indirect methods for determining these reference intervals using routine clinical laboratory data instead of relying on samples from actively recruited healthy individuals. The study focuses on improving accuracy and efficiency in defining reference intervals, particularly for complete blood count CBC parameters, and highlights the need for age-specific reference intervals due to variations in hemoglobin levels among the elderly. The study is observational and analyzes large-scale retrospective data collected from routine clinical laboratory tests across multiple Italian regions. It evaluates the RefineR statistical method, an open-source tool designed to distinguish normal from pathological data efficiently. The study will assess regional differences, establish age- and sex-specific reference intervals, and evaluate variations caused by different laboratory instruments over a period of up to three years. Participants are not actively recruited since the study uses existing laboratory data. Researchers will analyze these data to define reference intervals and compare results across regions, age groups, and testing platforms. The primary outcome is the definition of indirect reference intervals for CBC parameters. Secondary outcomes include assessments of regional and instrument variations. The study will run from October 2025 to June 2028, with no direct participant involvement beyond data analysis.

Researchers are evaluating a wearable device called FitFES designed to support upper limb motor rehabilitation in adults who have had a stroke. Upper limb disabilities are common and challenging after stroke, and this study aims to compare the effects of using FitFES with traditional rehabilitation therapy. The device works by stimulating muscles based on the patients residual muscle activity to help improve coordination and strength during voluntary movements. Participants will be randomly assigned to one of two groups an experimental group using the FitFES device during task-oriented exercises, or a control group performing the same exercises without the device. Both groups will complete 15 individual rehabilitation sessions, each lasting 60 minutes, conducted three to five times per week over three to five weeks depending on session frequency. Before and after the rehabilitation program, and again one month later, participants will be assessed using various tests including the Action Research Arm Test, Fugl-Meyer Upper Extremity scale, Box and Block test, and quality of life questionnaires. Additional measures like muscle activity and body movement will be recorded to evaluate changes. Safety and cost-effectiveness of the treatment will also be monitored throughout the study.