Sesto San Giovanni

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.

This research aims to investigate the effectiveness of play-based rehabilitation as usual care for children with cerebral palsy, a condition that affects movement and posture development and often involves other challenges like epilepsy and cognitive impairments. The study will also compare two rehabilitation formats intensive care provided in hospital inpatient units and extensive care delivered in community rehabilitation centers, to see if the timing of treatment affects outcomes. Children will receive either an extensive rehabilitation program consisting of 3-hour weekly sessions for 15 weeks in outpatient settings or an intensive program with 3-hour daily sessions, 5 days a week for 3 weeks in hospital care units. Both treatments include the same total dose of therapy and focus on goals involving gross motor skills, manipulative abilities, visual, and visual-cognitive functions. Participants will be assessed at the start, immediately after treatment, and at an 8-month follow-up using measures such as the Functional Independence Measure for children WeeFIM, the Gross Motor Function Measure 88 GMFM-88, and the Behavior Rating Inventory of Executive Function for preschool children. The study involves regular monitoring to evaluate the rehabilitation impact over time and to adjust care plans as needed, with total participation lasting through the follow-up period.

Researchers are evaluating the effects of a medicine called BI 690517 combined with empagliflozin in adults with chronic kidney disease CKD who are at risk of their kidney condition getting worse. The study includes people with or without type 2 diabetes and those who may already be taking medicines like angiotensin converting enzyme inhibitors ACEi, angiotensin receptor blockers ARB, or sodium-glucose cotransporter-2 inhibitors SGLT2i. The goal is to understand if adding BI 690517 can help delay worsening kidney function, hospitalizations due to heart failure, or cardiovascular death. After a run-in period where all participants take empagliflozin and other standard medications, participants are randomly assigned to receive either BI 690517 tablets or placebo tablets once daily alongside empagliflozin. The run-in period confirms that participants are stabilized on empagliflozin before randomization. The treatment phase continues for about three to four years until enough kidney or heart-related events have occurred to compare outcomes between the two groups. During the study, participants visit the study site about five times in the first six months and then every six months thereafter. At these visits, health is regularly checked through blood and urine tests, blood pressure and weight measurements, kidney function monitoring, and collection of any side effect information. The main outcome measured is the time until the first occurrence of kidney disease progression, hospitalization for heart failure, or cardiovascular death.

Researchers are conducting the LIPIGEN observational study to better understand diseases related to blood lipid levels, such as familial hypercholesterolaemia FH and other genetic dyslipidaemias. The study involves Italian physicians and researchers who aim to improve diagnosis and treatment by collecting detailed patient information and analyzing genetic causes. This research may help identify the most effective treatments and monitor long-term health outcomes. Participants continue their usual clinical care while the study collects data from their medical records, family history, and genetic testing without adding extra procedures. In some cases, additional evaluations like ultrasounds may be performed to better assess the condition. The study involves more than 50 centers across Italy, making it accessible to many individuals with these conditions. Throughout the study, researchers will evaluate patients lipid and genetic profiles at baseline and observe treatment adherence, cardiovascular events, and other important health outcomes over time. Participants involvement includes regular clinical visits and data collection as part of standard care. The study began in 2015 and will continue through 2026, aiming to enhance personalized diagnosis and treatment strategies for genetic lipid disorders.

This research aims to assess how well the Dehydration Readmission After Ileostomy Prediction DRIP score is used and how often its recommended care steps are applied to prevent dehydration and hospital readmissions in patients who have an ileostomy after elective colorectal surgery. The study focuses on patients at risk of dehydration, a common complication after ileostomy due to fluid loss through the stoma, which can lead to serious health issues and readmission. The study is prospective and observational, involving multiple Italian colorectal surgical centers. Patients undergoing ileostomy creation after elective colorectal resection will be observed for adherence to the DRIP scoring system and its preventive care protocol. The DRIP score categorizes patients into five risk levels from very low to very high, guiding different interventions such as pre-discharge education, intravenous fluids at home, antidiarrheal medications, nursing follow-up, phone check-ins, and outpatient visits with blood tests. Data collection will occur from May 2025 to April 2026, with a six-month follow-up period. Participants will have their clinical data recorded, including stoma care details, hydration status, creatinine levels, and post-discharge care measures. Researchers will track the application of DRIP scores, adherence to care strategies, and readmission rates at 30, 90, and 180 days. Data will be entered securely and analyzed to identify factors influencing readmission and dehydration. The study aims to improve patient outcomes by optimizing dehydration prevention and reducing hospital readmissions after ileostomy surgery.

Millions of children worldwide are diagnosed each year with neurodevelopmental disabilities, which include a variety of conditions such as genetic syndromes and brain injuries like cerebral palsy. These children often face challenges in communication, especially in social and interactive skills necessary for language development. This trial aims to assess whether an intervention involving parents and focusing on early social and communication skills can improve outcomes better than standard speech therapy in children aged 6 months to 5 years with neurodevelopmental disabilities. The study compares two groups one receives a parent-involved intervention called SPEAK, focusing on early socio-communicative and intersubjective skills, while the other undergoes standard speech therapy. Both interventions consist of eight weekly sessions lasting 45 minutes each over two months. The SPEAK intervention includes guided parent participation during activities like playtime and snack time, helping parents observe and support their childs social communication. Standard speech therapy targets vocalization, language understanding, and speech production without active parent involvement. Participants and their parents will undergo assessments before and after the interventions to evaluate the childs language, social, and communication development, as well as parenting behaviors through video-recorded parent-child interactions. Additional evaluations will measure early cognitive and emotional development. The study monitors session attendance and withdrawal reasons to track adherence. The goal is to understand how these interventions impact childrens development and parent-child interactions over the two-month treatment period.

Researchers are examining the effect of abelacimab compared to a placebo in patients with atrial fibrillation AF who are considered unsuitable for oral anticoagulation therapy. This Phase 3 study focuses on high-risk patients with AF to evaluate whether abelacimab can reduce the occurrence of ischemic stroke or systemic embolism. The study is led by Anthos Therapeutics, Inc. and aims to address treatment options in patients where traditional anticoagulation is deemed inappropriate. Participants are randomly assigned in equal numbers to receive either abelacimab 150 mg or a matching placebo by subcutaneous injection once a month. The study consists of three periods a screening period lasting up to 60 days, a double-blind treatment period that continues until at least 111 patients experience a primary endpoint event, and an end-of-treatment visit. Following this, participants may enter a 30-day follow-up or an optional open-label extension to receive abelacimab, depending on eligibility and regulatory approval. During the study, participants undergo assessments to monitor stroke, systemic embolism, and bleeding events, with the primary outcomes measured up to 30 months. Safety is tracked by recording bleeding events classified by the Bleeding Academic Research Consortium. Secondary outcomes include cardiovascular and all-cause mortality and other thrombotic events. The study also involves regular monitoring and follow-up visits to assess efficacy and safety throughout the treatment and observation periods.

Researchers are evaluating the investigational drug omecamtiv mecarbil to see if it can lower the risk of serious effects related to heart failure, such as hospitalization, heart transplantation, or death, in patients with symptomatic heart failure and severely reduced ejection fraction. This phase 3 trial aims to assess both the effectiveness and safety of the drug compared to placebo in reducing cardiovascular events including death, heart failure events, left ventricular assist device implantation, cardiac transplantation, and stroke. Participants will be randomly assigned to receive either omecamtiv mecarbil or a placebo. Those in the omecamtiv mecarbil group will take an oral tablet twice daily at a dose based on their blood drug levels 25, 37.5, or 50 mg. The placebo group will receive matching tablets twice daily. The study will continue until at least 850 participants experience a heart failure event or cardiovascular death. An interim analysis will be performed when about 67% of these events have occurred. The total estimated participation duration is up to 3 years. During the trial, participants will be regularly monitored for cardiovascular events, hospitalizations, and other health outcomes. Researchers will measure the time to first cardiovascular death or heart failure event among other secondary outcomes such as stroke and overall survival. Safety will be carefully tracked throughout the study. Participants adherence to the study medication and health status will be assessed at scheduled visits over the course of the study.