Imola

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 studying trunk control improvement in patients with Spinal Cord Injury SCI, where balance and posture are impaired, affecting daily activities. This research evaluates the effects of adding robotic rehabilitation using the Hunovaae device to standard rehabilitation. The goal is to find the better rehab plan in terms of the number of Hunovaae sessions and to compare objective device data with clinical scales for trunk control. Participants receive either standard rehabilitation alone or combined with Hunovaae training. Standard rehab includes physiotherapy, occupational therapy, and sports rehabilitation for 3 hours per day, 5 days a week. The Hunovaae rehab is done in a dedicated gym for 1 hour daily, 5 days a week, with 10 or 20 sessions over 4 weeks. The Hunovaae seat tilting is adjusted based on patient progress. During the study, trunk control and equilibrium are assessed at baseline, 2 weeks, and 4 weeks using the Hunovaae output data and clinical scales. Muscle activity and patient satisfaction are also measured. The study tracks correlations between trunk control and functional abilities, quality of life, and treatment tolerability. Participation lasts approximately 4 weeks with regular evaluations to monitor progress and safety.

Researchers are evaluating an internet-based lifestyle intervention delivered through a web app to improve health-related quality of life in patients who survived an out-of-hospital cardiac arrest and experience symptoms such as cognitive impairment, depression, anxiety, social functioning difficulties, and sexual dysfunction. The trial is randomized and aims to assess how this approach may support survivors in managing these challenges. The intervention group receives a multimodal web-based program focusing on anxiety, depression, and cognitive impairment. This includes knowledge development sessions and practical or gaming activities targeting cognitive skills, social relationships, emotional health, physical activity, and nutrition. The study also includes a control group receiving no intervention. Participants are followed and assessed over 12 months. During the study, participants complete various assessments including the Hospital Anxiety and Depression Scale, Telephone Interview for Cognitive Status, Short Form Health Survey 36, Neurobehavioural Rating Scale, Patient Competency Rating Scale, Pittsburgh Sleep Quality Index, Sexual Interest and Satisfaction Scale, and Zarit Burden Inventory. Caregiver assessments are also included. Researchers monitor these outcomes to evaluate changes in quality of life and mental and cognitive health throughout the 12-month period.

Researchers are conducting a multicenter, observational study in Italy to collect detailed information on patients with bone metastases. The study aims to establish a national database to better understand clinical and biological factors related to primary tumors and their bone metastases. This research will also evaluate the impact of treatments and care pathways on skeletal events over a period of up to 15 years. Patients with bone metastases from solid tumors will be enrolled in this study and registered in a specialized online database. Each participant will be followed from enrollment until death or until they stop follow-up for other reasons. The study does not involve any experimental treatments but collects comprehensive data on patients conditions and care. Participants will provide informed consent and their medical data will be regularly recorded and analyzed. The study monitors clinical outcomes, skeletal-related events, and the efficiency of treatment pathways. Data collection will continue for up to 15 years, providing long-term insights into bone metastases and patient management.

This research aims to identify medium-term factors that influence recovery for patients with Severe Acquired Brain Injuries. It also seeks to develop a continuous system to assess the quality of care provided by rehabilitation units treating these patients. The study focuses on understanding key outcomes important to rehabilitation success. Data will be collected from each participating rehabilitation unit, including information about their structure and organization. Detailed patient data will be gathered upon admission to these units and then re-evaluated four months after their acute brain injury event. Statistical models will be used to predict the likelihood of achieving three key rehabilitation goals removal of tracheostomy tubes, trunk control, and full feeding by mouth. Participants will be adults admitted to these specialized rehabilitation units between July 2021 and December 2023. Patients admitted more than 14 weeks after their acute injury will not be included. Researchers will monitor patients for up to four months post-injury to evaluate the main outcomes. The study will help understand patient progress and care quality in these rehabilitation settings.

This research focuses on infant weaning, the process of transitioning from exclusive milk feeding to a varied diet that supports healthy development. It explores different weaning methods, including traditional spoon-fed foods and baby-led approaches, and aims to understand how parents and pediatricians perceive the advantages and disadvantages of these methods. The study also investigates potential risks, such as feeding errors or choking hazards, during this dietary transition. Participants include two groups parents of children aged 4 to 18 months and free choice pediatricians PLSs in Italy. Parents will complete a questionnaire about their weaning practices, while pediatricians will answer a separate survey regarding their advice on weaning modes and food choices. The study collects data over about one year to assess the prevalence and perspectives on weaning methods. Throughout the study, parents and pediatricians will provide information via questionnaires accessed electronically. Researchers will evaluate how weaning is implemented and the suggestions pediatricians offer concerning weaning. The study aims to gather insights on weaning practices and safety, including potential risks like choking, by analyzing the questionnaires completed within the study period.