Imola

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.

Patients with Spinal Cord Injury (SCI) often experience impaired trunk and postural control, which significantly affects daily activities. This study focuses on improving trunk control, a primary goal in rehabilitation, by evaluating the use of an integrated approach combining standard rehabilitation with robotic-assisted therapy using the Hunova device. The trial aims to compare the effects of this combined treatment versus standard rehabilitation alone and to determine the optimal number of robotic sessions needed. Additionally, the study will assess the relationship between trunk control improvements measured by the Hunova device's data and a validated clinical scale. Participants will receive either standard rehabilitation, which includes physiotherapy, occupational therapy, and sports rehabilitation conducted 3 hours per day, 5 days a week, or an integrated treatment adding Hunova rehabilitation. The robotic therapy is performed in a dedicated gym for 1 hour per day, 5 days a week, supervised by a physiotherapist, with adjustments in the device's seat tilting based on individual progress. Randomization is stratified by SCI lesion completeness, with equal allocation to each group. Throughout the study, trunk control and equilibrium will be evaluated at baseline and two weeks after completing 10 sessions of Hunova rehabilitation. Assessments include objective measurements from the robotic device and clinical scales. Participants must have stable clinical conditions and be able to sit continuously for at least one hour. The study monitors functional outcomes to better understand trunk control improvements in SCI patients over this rehabilitation period.

Researchers are evaluating an internet-based lifestyle intervention delivered through a web app to improve Health Related Quality of Life in adults who have survived an out-of-hospital cardiac arrest and experience symptoms such as anxiety, depression, cognitive impairment, social functioning difficulties, or sexual dysfunction. The study tests whether this web-based program can support recovery and well-being in this group. The intervention is a multimodal, web-based lifestyle program that addresses anxiety, depression, and cognitive impairment through educational sessions and practical, game-like activities. These focus on improving cognitive skills, social relationships, emotional health, and physical activity and nutrition. Participants access this program online, enabling them to engage with the content remotely. Participants will be involved for a period of 12 months, during which the primary outcome measure is their Health Related Quality of Life. Researchers will monitor how the intervention affects participants' quality of life throughout this time. To participate, individuals need to have been discharged from hospital after an out-of-hospital cardiac arrest with good cerebral performance and be able to use the internet to access the program content.

Researchers are conducting an Italian multicenter, observational, prospective study to gather information on patients with bone metastases. The study aims to establish a National Bone Metastasis Database by collecting detailed data from all patients with bone metastases referred to participating centers. This effort helps track and understand the condition better over a long period. Patients with bone metastases from solid tumors will be registered in a specially designed online database created for this study. Each enrolled patient will be entered into this database and followed over time until death or until follow-up is stopped for any other reason. This approach allows researchers to monitor the disease progression and treatment outcomes using a centralized digital system. Participants will provide informed consent to be part of the study. Their medical data, including diagnosis information, will be collected and stored in the database. This process includes ongoing monitoring and follow-up assessments as available during the study, which may last up to 15 years. The main outcome is the creation and maintenance of the comprehensive National Bone Metastasis Database to support research and patient care.

This research focuses on patients with Severe Acquired Brain Injuries and aims to identify medium-term factors that can predict their rehabilitation outcomes. The study also seeks to develop a continuous system to assess the quality of care provided by rehabilitation units treating these patients. Identifying these prognostic factors helps understand which patients are likely to experience key rehabilitation milestones. Data will be collected from rehabilitation units and will include information about the units themselves and detailed patient data at admission and again four months after the acute brain injury event. The study will use statistical models to analyze the likelihood of achieving important rehabilitation goals such as removal of tracheostomy tubes, trunk control, and feeding entirely by mouth, all evaluated four months after the injury. Participants will be assessed at the start of rehabilitation and then re-evaluated four months later. The study measures include monitoring tracheostomy tube status, trunk control ability, and feeding methods. This allows researchers to track patient progress and evaluate care quality over time. The total participation duration includes the initial admission and follow-up assessments up to four months post-injury.

Infant weaning is the process where a baby's diet changes from only milk to including a variety of foods that provide all necessary nutrients for healthy development. Different weaning methods exist, influenced by culture, tradition, and scientific views. These include traditional weaning, baby-led weaning (BLW), and baby-led introduction to solids (BLISS), each with unique approaches to how and when foods are introduced. This research aims to understand how common each weaning method is and how parents and pediatricians perceive their benefits and risks, especially concerning feeding mistakes and choking hazards. The study involves surveying parents of children aged 4 to 18 months and Italian pediatricians to collect information on weaning practices through dedicated questionnaires. Traditional weaning uses specific infant foods given in set amounts and times, while BLW allows the infant to self-feed at their own pace during family meals. BLISS is a safer variation of BLW, starting at 6 months with advice to reduce choking risks. Pediatricians play an important role by advising on the best weaning methods and food preparation. Participants will be asked to complete surveys that explore the types of weaning used and any perceived advantages or problems. The study will monitor how weaning is implemented over about one year. Researchers are particularly interested in the safety of different weaning styles and how parents and pediatricians manage the transition to complementary feeding. This information may help improve guidance on feeding infants safely and effectively.