Sesto San Giovanni

Researchers are conducting an observational, prospective, multicenter study in Italian cardiology centers to evaluate how well patients with Heart Failure with Reduced Ejection Fraction (HFrEF) follow guideline-recommended treatments. The study also aims to assess the safety of these treatments, monitor treatment patterns in patients with acute heart failure, and observe treatment approaches in all chronic heart failure patients regardless of their ejection fraction levels. The study involves two phases of educational interventions and data collection. Initially, healthcare providers will receive education on guideline recommendations and treatment patterns, followed by 3 months of patient data collection or up to 30 consecutive patients with chronic or acute heart failure. After 6 months, treatment modifications and outcomes will be evaluated. Then, a second educational session will highlight gaps between guidelines and practice, followed by another 3 months of data collection. Patients will be followed for 12 months total, with ongoing monitoring of treatment changes and outcomes. Participants will be assessed at enrollment and during the follow-up periods through clinical evaluations and data collection on treatment adherence and safety. The main outcome measured is adherence to guideline-directed medical therapies over 6 months. The study includes evaluations at 6 and 12 months after enrollment, with close monitoring of treatment patterns and patient health status throughout the study duration.

Researchers are evaluating patients who have experienced athero-thrombotic events such as coronary artery disease, cerebrovascular disease, or peripheral artery disease. The study aims to assess how well patients follow guideline recommendations, particularly focusing on improving cholesterol levels and other modifiable risk factors to reduce the chance of cardiovascular event recurrence. This observational and prospective study takes place across multiple cardiology centers in Italy to represent a broad patient population. The study includes several phases starting with an educational intervention to discuss guideline recommendations for secondary prevention. Following this, data is collected for three months or until 30 patients with documented cardiovascular conditions are enrolled, using a web-based case record form that identifies when guidelines are not followed and records reasons for non-adherence. After six months, primary and secondary outcomes are evaluated. A second educational intervention then shares findings from the first phase to highlight gaps in clinical practice, followed by another three-month data collection period and a further six-month outcome assessment. Finally, all patients are followed for 12 months to monitor longer-term results. Participants provide informed consent and are monitored through data collection forms that track adherence to guidelines and clinical outcomes. The main outcome measured is adherence to cholesterol management guidelines over six months. Additional assessments include adherence to recommendations for other cardiovascular risk factors. Throughout the study, researchers gather data to understand how guideline adherence affects patient health and to identify barriers to following best practices, with continuous follow-up over a year to evaluate sustained effects.

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 effectiveness of play-based rehabilitation as usual care for children with cerebral palsy, a common childhood disability affecting movement and posture. The study aims to compare two rehabilitation methods: intensive care provided in hospital inpatient units and extensive care offered in community rehabilitation centers. Both methods deliver the same total treatment dose but differ in session frequency and duration to determine if treatment timing affects outcomes. The intensive rehabilitation consists of 3-hour daily sessions, 5 days a week for 5 weeks, totaling 45 hours, while the extensive rehabilitation involves 3-hour weekly sessions over 15 weeks, also totaling 45 hours. Both approaches focus on improving gross motor skills, manipulative abilities, visual, and visual-cognitive functions. Treatments are delivered according to usual care practices in either hospital or outpatient settings. Participants will be assessed using the Functional Independence Measure for children (WeeFIM) and the Gross Motor Function Measure 88 (GMFM-88) at the start, immediately after treatment, and at an 8-month follow-up. Researchers will monitor motor function, independence, and treatment effects over time. The study includes children aged between 6 months and 5 years diagnosed with cerebral palsy and involves long-term follow-up to evaluate sustained outcomes.

Researchers are investigating the effects of a medicine called BI 690517 in combination with empagliflozin for adults with chronic kidney disease who are at risk of their condition worsening. This study includes people both with and without type 2 diabetes and those already taking certain kidney-related medicines like ACE inhibitors or angiotensin receptor blockers. The goal is to understand if adding BI 690517 helps protect kidney function and reduces risks related to kidney failure and heart problems. This is a Phase 3 clinical trial conducted over about 3 to 4 years. The study has two parts. First, participants receive either empagliflozin or a placebo similar to BI 690517 for at least six weeks, while continuing other indicated treatments like ACE inhibitors or ARBs. In the second part, participants are randomly assigned to take either BI 690517 tablets or placebo tablets once daily alongside empagliflozin for the rest of the study. The placebo tablets look like BI 690517 but contain no active medicine. Participants have regular visits to the study site, about four times in the first six months, then every six months afterward. During these visits, doctors monitor kidney function, heart health, blood pressure, weight, and any side effects. Blood and urine samples are taken to track health changes. The main outcomes measured are the time until worsening kidney disease, hospitalization for heart failure, or cardiovascular death. The study ends when a certain number of these events have occurred.

Researchers are studying familial dyslipidaemias, which are genetic disorders affecting blood lipid levels, including common conditions like familial hypercholesterolaemia and rarer ones such as familial chylomicronidaemic syndrome. The study involves Italian physicians and aims to improve diagnosis and treatment by collecting detailed clinical and genetic information about patients with these conditions. It also seeks to understand the genetic mutations responsible and evaluate long-term treatment effects and patient adherence. Participants continue their usual clinical care without additional procedures, although some may undergo further evaluations like ultrasounds to better assess their condition. The study collects data on family history, clinical findings, and genetics from patients of all ages across more than 50 centers in Italy. Participants may be using lipid-lowering treatments as part of their routine care. Throughout the study, researchers monitor lipid and genetic profiles at baseline and track outcomes including cardiovascular events. The study helps improve understanding and personalized treatment of these genetic lipid disorders while ensuring participants follow their normal clinical routines. There are no extra interventions beyond regular care, and the study is open to patients from childhood through adulthood.

Researchers are evaluating how well the DRIP score calculation and its related care strategies are followed in patients who have an ileostomy after elective colorectal surgery. This study focuses on preventing dehydration and hospital readmissions, which are common complications due to fluid loss through the ileostomy. The DRIP scoring system classifies patients into risk categories to help guide care and reduce these risks. The study is prospective and observational, involving multiple Italian colorectal surgical centers. The study observes patients from the time of ileostomy creation through a 6-month follow-up period. Care strategies include pre-discharge ostomy education, intravenous fluids at home, antidiarrheal medications, daily nursing and phone follow-ups, and outpatient visits with lab tests. Patients at medium to very high risk based on DRIP score may receive additional interventions such as home nursing and specific diets. Data on various clinical and surgical parameters, stoma care, and follow-up measures are collected. Participants will have their DRIP scores calculated and monitored throughout the study. Researchers will track adherence to the DRIP protocol items and measure readmission rates at 30, 90, and 180 days, including readmissions due to dehydration. Data collection occurs over one year, with a 6-month follow-up. The study uses a secure database to record pseudonymized patient data and aims to identify factors that predict readmission and dehydration risk to improve patient care.

Millions of children worldwide are diagnosed each year with neurodevelopmental disabilities (NDD), a broad group of conditions including genetic syndromes and brain injuries like cerebral palsy. These children often face challenges not only with language but also with social and communicative skills essential for early development. The parent-child relationship plays a key role in supporting these skills, so this research evaluates whether an intervention focused on early social and communication skills involving parents can help children with NDD aged 6 months to 5 years. The study compares two groups: one receiving an intervention called SPEAK that actively involves parents in supporting the child's social and communicative behaviors during activities such as play and snack time, and the other receiving standard speech therapy focused on traditional speech goals without active parental involvement. Both groups attend eight weekly sessions lasting 45 minutes each over two months. The SPEAK intervention covers topics like early interaction, gestures, attention, and verbal comprehension with flexible session content tailored by therapists. Participants undergo assessments before and after the interventions, including evaluations of language, social, and communication development and a 10-minute video recording of parent-child play to analyze parenting behavior. Researchers will measure changes in early socio-communicative skills, communication and language development, and parenting interactions at the start and two months after beginning treatment. Adherence will be tracked, and no risks beyond standard clinical practice are expected for participants.

Researchers are evaluating the effect of abelacimab compared to a placebo in patients with atrial fibrillation (AF) who are considered unsuitable for oral anticoagulation therapy. This study focuses on people at high risk for ischemic stroke or systemic embolism and aims to assess the safety and effectiveness of abelacimab in preventing these events. The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial involving patients with AF who have specific risk factors and treatment challenges. Participants will receive either abelacimab, provided as a liquid in vials at 150 mg/mL, or a matching placebo liquid. The study design includes parallel groups with blinded treatment assignment. The trial does not describe additional treatment phases or extensions but focuses on the comparison of abelacimab and placebo over the study duration. During the study, participants will be monitored for up to 30 months to measure the time until the first occurrence of ischemic stroke or systemic embolism, as well as the time until the first occurrence of serious bleeding as defined by the Bleeding Academic Research Consortium (BARC) type 3c/5 bleeding. Safety and efficacy will be closely evaluated, with ongoing assessments to track these outcomes throughout the follow-up period.

Researchers are evaluating the effectiveness and safety of the investigational drug omecamtiv mecarbil in patients with symptomatic heart failure and severely reduced ejection fraction. This study aims to see if the drug can lower the risk of serious heart-related events, such as cardiovascular death, heart failure events, need for heart device implantation, heart transplantation, or stroke. The study is a Phase 3, multi-center, double-blind, randomized, placebo-controlled trial involving adults aged 18 to 85 years. Participants will be randomly assigned to receive either omecamtiv mecarbil or a placebo, both given as oral tablets. The study is event-driven and will continue until at least 850 participants have experienced either a heart failure event or cardiovascular death. An interim analysis will be done after about 570 such events have occurred. The estimated participation period for each patient is up to 3 years. During the study, participants will be monitored for the time until the first occurrence of cardiovascular death or heart failure event. Researchers will collect various health data and monitor safety throughout the study. The study includes regular assessments to track heart function and adverse events, with follow-up until the study concludes when the required number of events is reached.