Como

Researchers are evaluating the effectiveness and safety of bowel cleansing using 100 g Mannitol compared to the standard Plenvu same-day dosing regimen for people undergoing elective colonoscopy. This Phase III international study aims to determine if Mannitol is not worse than Plenvu in preparing the bowel for colonoscopy. The study is randomized, parallel-group, and endoscopist-blinded to ensure unbiased results. Participants are randomly assigned to one of two groups. One group will self-administer a single dose of 100 g Mannitol dissolved in 1 liter of water within 45 minutes on the day of colonoscopy. The other group will follow a split-dose regimen of Plenvu the same day, involving dissolving doses in water and drinking specified amounts over a period with a waiting time between doses. Both groups consume a total of 2 liters of preparation liquid. During the study, participants will undergo colonoscopy within 28 days of signing consent, where bowel cleansing quality will be assessed using the Boston Bowel Preparation Scale. Researchers will also measure adenoma detection rate, cecal intubation rate, repeat colonoscopy rates, and presence of colonic bubbles. Participants must complete the entire study and follow instructions. Safety and patient acceptance will also be monitored throughout the trial period.

Researchers are investigating the detection rates of clinically significant serrated lesions CSSL in people undergoing colonoscopy using water exchange WE combined with artificial intelligence AI-based computer-aided detection CADe. The study compares two methods one using CADe alone and another adding linked-color imaging LCI to CADe during WE colonoscopy. The goal is to determine if LCI improves the detection of CSSL during screening, surveillance, diagnostic colonoscopy, or after positive stool test results. This trial involves two groups one uses standard high-definition colonoscopy with CADe assistance during the withdrawal phase, and the other adds LCI imaging to enhance lesion visualization. Both groups use water instead of air to insert the colonoscope, with water infusion and suction to expand the colon and clean the view. The study is randomized and unblinded, with procedures performed by experienced endoscopists using the ELUXEO 7000 system. The trial is planned to run for two years across multiple international centers. Participants aged 40 to 80 at average risk for colorectal cancer will undergo colonoscopy and have CSSL detection rates recorded using pathology reports released about one week after the procedure. The study also measures detection rates of other lesion types and adenomas. Sedation options vary, and procedures follow consistent techniques. Safety and effectiveness of lesion detection are monitored closely during the study period ending in July 2027.

This research aims to investigate the effectiveness of play-based rehabilitation as usual care for children with cerebral palsy, a condition that affects movement and posture development and often involves other challenges like epilepsy and cognitive impairments. The study will also compare two rehabilitation formats intensive care provided in hospital inpatient units and extensive care delivered in community rehabilitation centers, to see if the timing of treatment affects outcomes. Children will receive either an extensive rehabilitation program consisting of 3-hour weekly sessions for 15 weeks in outpatient settings or an intensive program with 3-hour daily sessions, 5 days a week for 3 weeks in hospital care units. Both treatments include the same total dose of therapy and focus on goals involving gross motor skills, manipulative abilities, visual, and visual-cognitive functions. Participants will be assessed at the start, immediately after treatment, and at an 8-month follow-up using measures such as the Functional Independence Measure for children WeeFIM, the Gross Motor Function Measure 88 GMFM-88, and the Behavior Rating Inventory of Executive Function for preschool children. The study involves regular monitoring to evaluate the rehabilitation impact over time and to adjust care plans as needed, with total participation lasting through the follow-up period.

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.

Researchers are investigating chemotherapy-induced peripheral neurotoxicity CIPN in patients receiving neurotoxic chemotherapy drugs in an international, multi-center observational study. The study aims to evaluate how well different assessment methods measure changes in CIPN from before treatment to after treatment, helping define the best tools to assess this condition. It also seeks to understand how mid-treatment assessments can predict outcomes and how patients recover over time, considering different chemotherapy drugs. Participants will undergo a core set of assessments at baseline and end of treatment, including standard oncology evaluations and patient-reported outcome measures like pain scales and neuropathy questionnaires. An extended study phase includes additional tests such as nerve conduction studies, quantitative sensory testing, biomarker analysis, and other specialized questionnaires conducted at multiple time points, including follow-ups up to 24 months after treatment. All participants receive standard chemotherapy the study does not influence treatment or provide medications. During the study, trained investigators will supervise assessments and collect data through questionnaires and clinical scales. The study measures changes in neuropathy symptoms and quality of life using various tools over five to seven years. Data collection includes patient self-reports, clinical evaluations, and biological samples. Follow-up visits help track neurological status and recovery. Participants are expected to complete study-related activities and follow-up visits according to their treatment plan, with data securely uploaded by participating centers.

Researchers are evaluating whether letrozole is more effective than standard chemotherapy for treating patients with hormone receptor positive low-grade serous epithelial ovarian carcinoma LGSCO. This phase III, open-label, randomized trial aims to see if letrozole can extend progression-free survival compared to carboplatin and paclitaxel chemotherapy. The study also explores tumor response, quality of life, pain, overall survival, safety, and genetic markers related to the disease. Participants will be randomly assigned to one of two groups one group takes letrozole tablets daily by mouth for up to 60 months or until disease progression, while the other group receives carboplatin and paclitaxel intravenously on day 1 every 21 days for 6 to 8 cycles. The treatments are compared directly to assess their effects on cancer control and patient well-being. During the study, participants will have regular assessments including tumor response evaluations, quality of life questionnaires, pain inventory, and safety monitoring according to standard criteria. Genetic profiling and circulating tumor DNA will be analyzed to understand disease characteristics. Progression-free survival will be tracked for up to 84 months, with ongoing monitoring of overall survival and adverse events. Participants will be followed closely to observe treatment effects and side effects throughout the trial period.

Researchers are evaluating how a healthy lifestyle implemented through a Survivorship Care Plan LS-SCP may affect the quality of life for long-term lymphoma survivors who have been in remission for at least three years and up to ten years. The study focuses on patients with classical Hodgkin lymphoma, Diffuse Large B-cell lymphoma DLBCL, or Primary mediastinal large B-cell lymphoma PMBCL who have completed first-line therapy and are aged between 18 and 50 years. This randomized, open-label, multicenter trial aims to understand the impact of lifestyle changes on survivors well-being over time. Participants are randomly assigned to one of two groups the experimental arm receives a Survivorship Care Plan including a nutritional plan and physical activity guidance for six months, with bi-monthly automated calls to support adherence. The control arm receives no specific intervention and follows standard clinical care with self-administered questionnaires at 6 and 12 months. Both groups complete assessments using validated questionnaires at baseline, 6 months, and 12 months to evaluate various health and quality of life measures. During the study, participants undergo clinical assessments and complete questionnaires such as the EORTC QLQ-C30, SF12, MEDI-LITE, Chronic Fatigue Syndrome Self-assessment, Fatigue Assessment Scale, and Hospital Anxiety and Depression Scale. Researchers will monitor outcomes including global quality of life, psychosocial well-being, fatigue frequency, cognitive function, metabolic health, cardiovascular events, adherence to healthy behaviors, and overall survival for up to 30 months from study start. The study includes safety follow-up and compliance tracking to understand how lifestyle interventions might support long-term health in lymphoma survivors.

Researchers are conducting an observational, prospective cohort study to collect data from patients diagnosed with relapsed or refractory acute myeloid leukemia RR AML. This hard-to-treat condition has a poor survival rate despite advances in intensive treatments. The study aims to gather real-world data on outcomes and the effectiveness of new therapies, including in diverse populations such as children, elderly, and those with rare mutations across Europe. Participants will be registered into the STREAM platform where baseline and follow-up data will be recorded according to their normal clinical care. Patients will be followed for up to 4 years, with no experimental treatments assigned by the study. The study facilitates data collection across multiple sites using a GDPR-compliant system to allow cross-country participation and to support future international trials. Participants will provide informed consent and their clinical information, diagnosis methods, treatment options, and outcomes will be monitored. Researchers will measure overall survival, remission rates, event-free survival, relapse-free survival, transplant rates, and associations between clinical and biological factors over 8 years. This study supports understanding RR AML in routine practice and helps identify populations for future research.

Autism spectrum disorder ASD is a neurodevelopmental disorder affecting millions worldwide, with early symptoms often appearing in the first 6 to 12 months of life. This study focuses on infants at higher risk for ASD and other neurodevelopmental disorders NDDs, including siblings of children with ASD, preterm infants, and those small for gestational age SGA. It aims to improve early detection through a national surveillance network using both clinical and experimental protocols. The study involves monitoring infants from birth to 36 months using a combination of clinical assessments and advanced experimental methods. This includes tracking developmental milestones in motor skills, vocalizations, social behaviors, EEG activity, and collecting biological samples for genetic, epigenetic, metabolomic, and inflammatory markers. Data are collected at multiple time points and supported by telehealth services to assist health professionals in monitoring and scoring assessments. Participants will undergo structured interviews, physical measurements, developmental evaluations, and biological sample collections at scheduled visits between birth and 36 months. Researchers will analyze these data to identify early risk markers and build predictive models for ASDNDD diagnoses. The study also includes support for healthcare providers through an online platform and telehealth team, aiming to enhance early diagnostic and intervention processes for at-risk infants.

Primary biliary cholangitis PBC is a rare autoimmune liver disease that causes chronic inflammation of the bile ducts, leading to serious liver damage if untreated. This research aims to create a national database of PBC patients in Italy linked to biological sample storage to improve understanding of the disease, especially in patients who do not respond well to current treatment. The study involves about 60 centers across Italy and focuses on the biology of PBC and disease progression. Participants will have their clinical and laboratory data collected at the start and then annually through electronic case report forms. Biological samples will also be gathered to study patients genes and immune system differences among various PBC subtypes. This observational study collects data from adult PBC patients diagnosed based on established clinical, antibody, or histological criteria. Throughout the 10-year study, researchers will analyze patient phenotypes, responses to ursodeoxycholic acid therapy, factors affecting disease progression, and the safety and effectiveness of new treatments. Participants will be monitored regularly, with their clinical profiles and biological data helping to support future research, clinical care, and drug development efforts for PBC.