Bagno A Ripoli

This research aims to use the SensMode System, which includes wearable devices for analyzing upper and lower limb movements, to study healthy adults, individuals with idiopathic hyposmia, patients with Parkinson's disease, and subjects with new untreated extrapyramidal syndrome. The goal is to establish normal motor measurement data and explore how this technology can aid in early diagnosis and management of Parkinson's disease. The SensMode System consists of two main devices: SensHand for upper limb motion analysis and SensFoot for lower limb monitoring. SensHand includes sensorized rings for the thumb and forefinger and a wristband that measure acceleration, angular velocity, and magnetic fields related to arm and hand biomechanics. SensFoot is worn over the shoe and contains similar sensors to capture lower limb movement data. Participants will be evaluated using various motor tests at enrollment, including measuring repetitions, time to stand up, gait time, rotation time, accelerometer signal frequencies, and stride count. The study involves collecting objective motor data to better understand movement patterns. Healthy subjects and Parkinson's patients aged 50 to 80 years will provide informed consent and undergo assessments to monitor motor function and neurological status throughout participation.

Researchers are evaluating the efficacy and safety of inavolisib combined with Phesgo compared to placebo with Phesgo as maintenance therapy in participants who have previously untreated HER2-positive advanced breast cancer with PIK3CA mutations. This Phase III, multicenter, randomized, double-blind, placebo-controlled study focuses on participants with locally advanced or metastatic breast cancer, aiming to understand the treatment impact after initial induction therapy. Participants will receive inavolisib orally once daily on Days 1 to 21 of each 21-day cycle, starting on Day 1 of Cycle 1 during maintenance treatment. Phesgo will be administered subcutaneously every three weeks on Day 1 of each cycle. The study includes an induction therapy phase where taxane-based chemotherapy is given after Phesgo. Optional endocrine therapy such as tamoxifen, aromatase inhibitors, or fulvestrant may be used based on the investigator's choice, with luteinizing hormone-releasing hormone agonists administered according to local guidelines. During the study, participants will be monitored for progression-free survival for up to approximately 40 months. Assessments include evaluation of heart function, organ function, and overall health status. Researchers will track the safety and effectiveness of the treatment combination through regular clinical evaluations and laboratory tests. The total duration includes maintenance treatment cycles and follow-up to measure outcomes and monitor safety.

Researchers are comparing the effects of a new low glucose peritoneal dialysis solution called XyloCore to traditional glucose-based solutions in patients with End-Stage Renal Disease (ESRD) who are undergoing Continuous Ambulatory Peritoneal Dialysis (CAPD). This Phase 3, randomized, controlled, open-label, multicenter study aims to assess the efficacy and safety of XyloCore over a 6-month period while maintaining blinded evaluation of key outcomes. Participants will be randomly assigned to receive either the investigational XyloCore solution—available in Low, Medium, or High Strength formulations based on glucose concentration—or to continue their standard glucose-based peritoneal dialysis treatments such as Physioneal, Fixioneal, Dianeal, Balance, Bicavera, Bicanova, or Equibalance. All patients will continue using Extraneal (7.5% Icodextrin) for their long-dwell nocturnal exchange. The number and osmotic strength of daily short dwell exchanges can be adjusted by investigators as needed, with the goal of achieving a weekly total Kt/V urea clearance above 1.7. During the study, participants will be monitored for dialysis effectiveness, mainly by measuring total weekly Kt/V urea at 24 weeks. Clinical status will be regularly assessed, including evaluation of safety and tolerability. Randomization is stratified to balance patients with diabetes and those treated with only one daily exchange. The study's open-label design includes blinded assessment of primary endpoints to reduce bias, and treatment adjustments will be tailored to each patient's clinical situation throughout the trial.

Metastatic breast cancer (mBC) is a common and serious condition affecting many patients worldwide. Emotional distress (ED) is reported by about half of breast cancer patients and can negatively influence treatment adherence, symptom management, and quality of life. This research investigates how baseline emotional distress impacts the outcomes of patients with mBC receiving their first line of treatment, aiming to better understand its effect on therapy effectiveness. Participants will receive first-line treatments based on their breast cancer subtype, including endocrine therapy, chemotherapy, immunotherapy, and targeted therapy. They will be grouped into cohorts depending on their disease characteristics and treatment plans, such as immunotherapy combined with chemotherapy or targeted therapies like CDK4/6 inhibitors and trastuzumab. During the study, patients will complete questionnaires to assess emotional distress and quality of life. Throughout the study, researchers will monitor participants' progression-free survival over two years, focusing on differences related to emotional distress at baseline. Patients will undergo evaluations through specific questionnaires about their emotional and quality of life status. The study includes careful observation of treatment outcomes and safety, providing valuable information on how emotional health relates to treatment effectiveness in metastatic breast cancer.

Researchers are evaluating the effect of Nirsevimab, a monoclonal antibody for RSV prevention, on reducing hospitalizations due to Respiratory Syncytial Virus (RSV) infections in infants under one year old. The study is conducted across eight pediatric departments in Tuscany, Italy, during the RSV epidemic season of 2024-2025. It includes a matched case-control study to assess the real-world effectiveness of Nirsevimab in preventing RSV-related lower respiratory tract infection (LRTI) hospitalizations, alongside a descriptive study examining how the immunization campaign impacts RSV epidemiology, including patient age, existing health conditions, infection severity, and clinical outcomes. The intervention involves evaluating exposure to Nirsevimab among infants hospitalized for RSV-related LRTI compared to control patients hospitalized for other reasons. The study monitors patients during the RSV epidemic season from November 2024 to March 2025, focusing on the proportion of children immunized with Nirsevimab in both groups. This approach helps understand how the immunization affects hospitalization rates and RSV disease patterns. Participants will be infants younger than 12 months admitted to hospital either for RSV-related LRTI or for other conditions. Researchers will gather clinical data, including RSV testing through PCR on nasopharyngeal swabs, and monitor immunization status. The main measure is the rate of Nirsevimab immunization in hospitalized children with RSV-related LRTI compared to controls. The study aims to inform and optimize RSV prevention strategies and public health policies based on these findings.

Acute intoxications are a significant public health concern, especially in children who are more vulnerable and at higher risk for unintentional and preventable poisonings. This research aims to study the patterns and social and care-related factors of acute intoxications in children to improve diagnosis and treatment approaches nationally. The study is a prospective, non-profit, multicenter observational cohort focusing on acute intoxications in pediatric patients, conducted by AMIETOX at Poison Control Centres and pediatric emergency rooms. The study observes children aged from 1 month up to 16 years who have experienced acute intoxication, defined as exposure to toxic substances or harmful amounts of substances via unintended routes. There are no specific treatments or interventions administered as it is an observational study. Participants are identified through visits or telephone contacts to participating centers. The study spans an average duration of one year to gather incidence and prevalence data. Participants will be monitored throughout the study to collect data on the occurrence and characteristics of acute intoxications. Researchers will assess the incidence and prevalence of intoxication in pediatric patients during the study period. Data collection includes social and care factors related to each case. The study ensures informed consent is acquired before including any child. Safety and follow-up are integral to the observational process to understand and eventually improve management of acute intoxications in children.

Nephrotic syndrome is a kidney condition mainly affecting children, marked by high protein in urine, low protein in blood, and swelling. Many children respond well to steroids, but some experience relapses, dependency, or resistance to treatment, potentially leading to chronic kidney disease. Recent research suggests immune system factors, including autoantibodies against nephrin, a key kidney protein, may influence disease activity and treatment response. This study aims to investigate these autoantibodies in children with nephrotic syndrome to better understand disease mechanisms and outcomes. It also explores other autoantibodies targeting the kidney filtration barrier using advanced laboratory methods. The study involves analyzing serum and kidney tissue samples collected during routine care. Laboratory procedures include ELISA tests to detect anti-nephrin and other anti-slit antibodies, along with advanced imaging techniques like high-resolution confocal microscopy and STED microscopy for research purposes. These analyses help identify antibody presence and their relationship with kidney structure and function. Participants provide clinical data from medical records and biological samples if available. Researchers will monitor anti-nephrin antibody levels from enrollment through up to five years of follow-up. This approach integrates lab findings with clinical information to enhance understanding of nephrotic syndrome and support development of personalized diagnostics and treatments, aiming to improve patient outcomes and reduce ineffective therapies.