Bagno A Ripoli

Researchers are evaluating the SensMode System, a set of wearable devices designed to analyze upper and lower limb movements. This study involves healthy adults, subjects with idiopathic hyposmia, patients with Parkinsons disease, and individuals with newly diagnosed drug-nafve extrapyramidal syndrome. The goal is to establish normal ranges for objective motor measurements and explore how this technology might aid in early diagnosis and management of Parkinsons disease. Participants will use the SensMode System, which includes SensHand and SensFoot devices. SensHand consists of sensorized rings and a wristband that measure movement and orientation of the hand and forearm, while SensFoot is a device placed over the shoe to assess lower limb motion. All subjects undergo motor analysis using these sensors at enrollment. During the study, researchers will monitor various motor outcome measures such as the number of repetitions of specific movements, time to stand up, gait time, rotation time, fundamental frequencies from accelerometer signals, and stride count at enrollment. This data will help characterize motor function and support further research into Parkinsons disease diagnosis and care. The study runs from May 2024 to January 2026 and includes adults aged 50 to 80 years.

Researchers are evaluating the effectiveness and safety of inavolisib combined with Phesgo compared to a placebo combined with Phesgo as maintenance treatment for participants with previously untreated HER2-positive advanced breast cancer that has a PIK3CA mutation. This Phase 3 study focuses on participants with locally advanced or metastatic breast cancer who have completed induction therapy. Participants first receive induction therapy with Phesgo plus taxane-based chemotherapy. Following this, they enter the maintenance phase where they are randomly assigned to receive either inavolisib tablets taken orally once daily for 21 days of each 21-day cycle along with Phesgo administered subcutaneously every 3 weeks, or a matching placebo tablet with Phesgo on the same schedule. Optional endocrine therapy may be given based on the investigators choice according to standard care. Throughout the study, participants undergo regular monitoring including tumor assessments, quality of life questionnaires, and safety evaluations lasting up to approximately 111 months. Key outcomes measured include progression-free survival assessed by investigators, overall survival, response rates, duration of response, and adverse event rates. Plasma concentrations of inavolisib are also measured at specific timepoints. Participants will be followed closely during and after treatment to assess these outcomes over an extended period.

This research aims to compare the effects of a new low glucose peritoneal dialysis solution called XyloCore against standard glucose-based solutions in patients with End-Stage Renal Disease ESRD who are undergoing Continuous Ambulatory Peritoneal Dialysis CAPD. The study is randomized, controlled, and open-label with blinded assessment of the main outcomes, conducted over a 6-month period. It includes patients already using common glucose peritoneal dialysis solutions and Extraneal for their long-dwell exchange. Participants will be randomly assigned to receive either the experimental XyloCore solution or continue with their current glucose peritoneal dialysis solutions. XyloCore is provided in low, medium, or high strengths matched to the glucose concentration of the patients prior prescription, while the control group maintains their usual glucose-based solutions. Both groups will continue using Extraneal for the nocturnal long-dwell exchange. Dialysis prescriptions may be adjusted by investigators to meet a target dialysis adequacy measure KtV > 1.7 per week. Throughout the study, participants will undergo regular assessments including measurement of dialysis adequacy total weekly KtVurea, blood tests such as HbA1c, cholesterol levels, hemoglobin, and insulin, as well as monitoring of kidney function, fluid removal, fatigue, and adverse events. The study includes follow-up visits for up to 6 months, with careful monitoring of safety and treatment effects. The trial is sponsored by Iperboreal Pharma Srl and uses centralized randomization with blinded evaluation of primary endpoints.

Researchers are investigating how emotional distress ED affects treatment outcomes in patients with metastatic breast cancer mBC who are receiving first-line therapies. This study focuses on the impact of baseline emotional distress on the effectiveness of various treatments according to breast cancer subtypes. Emotional distress is common among breast cancer patients and has been linked to poorer treatment adherence and quality of life, but its role in metastatic breast cancer treatment success is not well understood. Participants will be grouped based on their breast cancer subtype and receive standard first-line treatments accordingly triple-negative PD-L1 positive patients receive chemotherapy with immune checkpoint inhibitors, triple-negative PD-L1 negative patients receive chemotherapy alone, HR-positiveHER2-negative patients receive a CDK46 inhibitor plus endocrine therapy, and HER2-positive patients receive chemotherapy combined with trastuzumab and pertuzumab. Emotional distress and quality of life will be assessed through questionnaires at baseline and during treatment. During the study, patients will complete specific questionnaires to measure emotional distress, quality of life, and fear of cancer progression. Researchers will monitor progression-free survival and objective response rates over two years, comparing outcomes based on emotional distress levels at the start and early in treatment. Quality of life and psychological factors will also be evaluated over three months. All participants must provide informed consent and meet eligibility criteria before joining.

This research aims to evaluate the impact of Nirsevimab, a monoclonal antibody used to prevent respiratory syncytial virus RSV infection, in reducing hospitalizations related to RSV in infants under one year of age. Conducted at eight pediatric departments in Tuscany, Italy, the study includes a matched case-control portion investigating how well Nirsevimab prevents RSV-related lower respiratory tract infection hospitalizations during the 2024-2025 RSV epidemic season. Additionally, a descriptive study examines how the immunization campaign with Nirsevimab influences RSV patterns, including patient age, other health conditions, infection severity, and clinical results. Findings will help improve RSV prevention strategies and support public health decisions. The study involves evaluating drug exposure to Nirsevimab among two groups infants under 12 months hospitalized with confirmed bronchiolitis or pneumonia cases and infants under 12 months hospitalized for conditions other than respiratory infections controls. The evaluation period spans November 2024 to March 2025, focusing on the proportion of children immunized with Nirsevimab who are hospitalized for RSV-related lower respiratory tract infections compared to controls. This observational study collects data without administering treatments. Participants are infants younger than 12 months admitted to hospital with either RSV-related lower respiratory tract infections or other conditions. Researchers will review medical records and test results, including RSV PCR on nasopharyngeal swabs, to assess immunization status and clinical outcomes. The study monitors the real-world use and effectiveness of Nirsevimab during the RSV season while analyzing patterns of infection and severity. The total study period covers the RSV epidemic season from November 2024 through March 2025.

Researchers are studying acute intoxications in children to better understand how often these poisonings occur and what social and care factors contribute to them. This research focuses on children from 1 month to 16 years old who experience acute intoxication, aiming to improve future national diagnostic and treatment approaches. The study is a prospective, multicenter observational cohort conducted by AMIETOX at Poison Control Centres and paediatric emergency rooms. The study observes children who come to emergency rooms or contact Poison Control Centres due to acute intoxication, defined as exposure to harmful substances either by toxic nature or improper use. It does not involve specific treatments or interventions but records data over approximately one year to assess incidence and prevalence. This observational approach allows researchers to collect real-world information about poisoning cases in paediatric settings. Participants will be monitored through their visits or calls to study centers, with data collected on the nature and circumstances of the intoxications. Researchers will measure how often these poisonings occur and how widespread they are among children in the study. The study involves no active treatment or placebo, focusing instead on gathering information to inform better care strategies. Participation lasts about one year, during which safety and outcomes are tracked through standard care processes.

Nephrotic syndrome is a kidney disorder mainly affecting children, characterized by high protein levels in urine, low protein levels in blood, and swelling. Many children respond to steroid treatment, but some experience relapses, become dependent on therapy, or do not respond to standard treatments, potentially leading to chronic kidney disease. Research suggests that immune system factors, especially autoantibodies against nephrin, a key kidney protein, may influence disease activity and treatment response. This study investigates the presence of anti-nephrin autoantibodies and other autoantibodies targeting kidney filtration components in children and adults with nephrotic syndrome. Researchers will collect and analyze serum and kidney biopsy samples obtained during routine care using advanced laboratory techniques, including ELISA testing and high-resolution microscopy, to better understand these antibodies and their link to kidney structure and function. Participants will provide clinical data and biological samples collected as part of their usual care. The study will analyze anti-nephrin antibody levels from enrollment through five years of follow-up. Data from medical records and laboratory tests will be integrated to explore disease mechanisms and outcomes. This research aims to improve diagnosis and treatment personalization while reducing ineffective therapies.