Como

Researchers are evaluating the effectiveness and safety of a bowel cleansing agent called Mannitol compared to a standard preparation named Plenvu® in adults undergoing elective colonoscopy. The study is designed as a Phase III, international, multicenter, randomized, parallel-group trial with endoscopist blinding. It aims to determine if 100 g Mannitol is not inferior to Plenvu® when both are taken on the same day before the procedure. Participants are divided into two groups: half will receive 100 g of Mannitol dissolved in 1 liter of water, which they should drink within 45 minutes. The other half will use Plenvu®, which involves two doses taken the same day; the first dose is dissolved in 500 ml of water plus an additional 500 ml, taken within an hour, followed by a one-hour wait, then a second dose dissolved in 500 ml of water plus another 500 ml, also taken within an hour. Both preparations are self-administered according to these schedules. During the study, researchers will assess bowel cleanliness using the Boston Bowel Preparation Scale during colonoscopy up to 28 days after consent. Participants will be monitored for the preparation's effectiveness, safety, and acceptance. The study includes regular follow-up visits and adherence to instructions to ensure reliable results and participant safety throughout the trial period.

Researchers are evaluating whether adding linked-color imaging (LCI) to water exchange (WE) colonoscopy with artificial intelligence (AI)-assisted computer-aided detection (CADe) improves the detection of clinically significant serrated lesions (CSSL) in adults aged 40 to 80. This multicenter, randomized controlled trial compares two methods for colonoscopy screening, surveillance, and diagnosis, including patients referred due to positive fecal tests. The study aims to determine if LCI combined with CADe during WE colonoscopy increases CSSL detection rates compared to CADe alone. Participants are assigned to one of two groups: water exchange colonoscopy with AI-assisted detection (CADe) alone or water exchange colonoscopy with AI-assisted detection plus linked-color imaging (LCI). The colonoscope is inserted using warm water infusion instead of air to expand the colon, with suction of unclean water during insertion. During withdrawal, CADe provides real-time alerts of suspected polyps, and in the second group, LCI is additionally activated to enhance lesion visualization. The study uses high-definition colonoscopy video processors and is conducted at four hospitals across Canada, Taiwan, Thailand, and Italy over two years from August 2025 to July 2027. Participants will undergo colonoscopy with either method, with sedation options ranging from none to full sedation. The same experienced endoscopist performs the procedure from insertion to withdrawal. Researchers will collect data on the detection rate of clinically significant serrated lesions one week after colonoscopy, when pathology reports are available. The study includes informed consent, stratified randomization, and safety monitoring. Total participation involves the colonoscopy procedure and follow-up for pathology results to assess the primary outcome.

Researchers are evaluating the effectiveness of play-based rehabilitation as usual care for children with cerebral palsy, a common childhood disability affecting movement and posture. The study aims to compare two rehabilitation methods: intensive care provided in hospital inpatient units and extensive care offered in community rehabilitation centers. Both methods deliver the same total treatment dose but differ in session frequency and duration to determine if treatment timing affects outcomes. The intensive rehabilitation consists of 3-hour daily sessions, 5 days a week for 5 weeks, totaling 45 hours, while the extensive rehabilitation involves 3-hour weekly sessions over 15 weeks, also totaling 45 hours. Both approaches focus on improving gross motor skills, manipulative abilities, visual, and visual-cognitive functions. Treatments are delivered according to usual care practices in either hospital or outpatient settings. Participants will be assessed using the Functional Independence Measure for children (WeeFIM) and the Gross Motor Function Measure 88 (GMFM-88) at the start, immediately after treatment, and at an 8-month follow-up. Researchers will monitor motor function, independence, and treatment effects over time. The study includes children aged between 6 months and 5 years diagnosed with cerebral palsy and involves long-term follow-up to evaluate sustained outcomes.

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 investigating chemotherapy-induced peripheral neurotoxicity (CIPN) in patients undergoing neurotoxic chemotherapy for various cancers. The aim is to assess and validate a range of outcome measures in an international, multi-center setting to establish a gold standard for evaluating CIPN. This observational study will examine how well different assessment tools capture changes in nerve damage and symptoms over time. Participants will be assessed at baseline and at the end of their chemotherapy treatment through a core set of evaluations including sensory and motor grading scales, patient-reported outcomes, pain intensity ratings, and neurotoxicity questionnaires. An extended study allows additional assessments such as nerve conduction studies, sensory testing, biomarker analysis, and further questionnaires at various time points including mid-treatment and follow-up visits. There are no study-prescribed treatments; patients will receive their usual chemotherapy care. During the study, trained investigators will collect clinical and patient-reported data at multiple time points including baseline, end of treatment, and up to 5 years follow-up. Assessments include physical exams, questionnaires, nerve tests, and blood samples to monitor nerve damage and symptoms. The study measures changes in neurotoxicity using various validated scales and questionnaires, with the goal of evaluating responsiveness and recovery patterns related to chemotherapy exposure.

Researchers are evaluating whether letrozole, a hormonal therapy, is more effective than standard chemotherapy in treating women with hormone receptor positive low-grade serous epithelial ovarian carcinoma. This phase III, randomized, open-label trial conducted in Italy aims to see if letrozole can extend the time patients live without their cancer worsening compared to the usual chemotherapy treatment of carboplatin and paclitaxel. The study also investigates effects on tumor response, quality of life, pain, safety, and overall survival, along with genetic profiling and disease monitoring through blood tests. Participants will receive either letrozole tablets or the standard chemotherapy regimen of carboplatin AUC 5 and paclitaxel 175 mg/m2. Treatments are given as first-line therapy after surgery. The study includes detailed assessments of estrogen and progesterone receptor status and requires patients to have had surgery with residual disease status assessed. The trial also includes translational research components analyzing gene mutations and circulating tumor DNA to understand treatment response. During the study, women will be monitored for progression-free survival over a period of 54 to 84 months. Researchers will evaluate tumor response, health-related quality of life using specific questionnaires, pain levels, and safety according to established criteria. Imaging scans, blood tests, and physical exams will be regularly conducted to track disease status. Participants must provide informed consent and will be followed closely to assess long-term outcomes and side effects throughout the trial period.

Researchers are evaluating the impact of a healthy lifestyle-based Survivorship Care Plan (LS-SCP) on the quality of life in long-term lymphoma survivors who have been in remission for at least 3 years and up to 10 years. This prospective, randomized, open-label, multicenter study includes adults aged 18 to 50 who were treated for classical Hodgkin lymphoma (cHL), Diffuse Large B-cell lymphoma (DLBCL), or Primary mediastinal large B-cell lymphoma (PMBCL). The study aims to assess how lifestyle changes influence the quality of life in these survivors. Participants are divided into two groups: the experimental group receives the LS-SCP intervention, which includes a Survivorship Care Plan, nutritional guidance, and physical activity, all followed for 6 months. Compliance in this group is monitored through bi-monthly automatic calls. The control group receives usual follow-up care without any specific lifestyle intervention. Both groups complete validated questionnaires and clinical assessments at the start, and then at 6 and 12 months after randomization. During the study, participants complete several quality of life and health-related questionnaires and undergo clinical evaluations at baseline, 6 months, and 12 months. The study measures global quality of life over a period of up to 30 months. Researchers track adherence to the intervention through regular calls in the experimental group and monitor all participants for safety and health outcomes through follow-up visits and questionnaires.

Researchers are studying patients diagnosed with relapsed or refractory acute myeloid leukemia (AML), a challenging form of AML where the disease returns or does not respond to treatment. Despite improvements in treatment, many patients still face poor survival rates, and no standard care exists for these difficult cases. This study aims to collect detailed real-world data from patients of all ages and AML subtypes across Europe to better understand treatment outcomes and support future clinical trials. Participants who meet eligibility requirements will be registered in the STREAM platform, where their baseline health information and ongoing treatment details will be recorded. Patients will be followed according to standard medical care practices for up to four years, with no specific treatment interventions mandated by the study itself. This observational approach allows for broad participation, including patients with rare mutations, post-transplant relapse, and those from diverse geographic and clinical backgrounds. During the study, researchers will gather and monitor data related to patient outcomes, including overall survival over an eight-year period. Information will be collected through existing clinical practices and registries, ensuring patient privacy with specialized data protection tools. The study's findings aim to improve knowledge about rare patient groups and contribute to the development of new treatment strategies worldwide.

Researchers are investigating early identification methods for Autism Spectrum Disorder (ASD) and other Neurodevelopmental Disorders (NDDs) in infants at higher risk, such as siblings of children with ASD, preterm infants, and those small for gestational age. These disorders affect millions worldwide and early detection and intervention can improve quality of life. The study aims to expand an existing national surveillance network in Italy, integrating behavioral, neurophysiological, and biological data collected during the first year of life. This will help clarify early signs and risk markers of ASD/NDDs. The study will monitor infants from birth to 36 months using a multi-observational protocol. Clinical assessments and experimental tasks will track motor, vocal, social, and sensory development at multiple time points (birth, 3, 6, 12, 18, 24, and 36 months). Biological samples will be collected from a subsample to explore genetic, epigenetic, and metabolic markers. A telehealth platform will support healthcare professionals by enabling audio and video data sharing, automated test scoring, and expert analysis to assist in monitoring and early diagnosis. Participants and their families will be involved in structured interviews and repeated assessments, including developmental measurements and standardized diagnostic tests. Data collected will feed into a digital platform where machine learning models will be developed to predict ASD/NDD risk. The study will evaluate the accuracy of these predictive models over time, aiming to provide timely individualized interventions. The overall participation period spans up to 36 months with continuous clinical and experimental monitoring and telehealth support.

Primary biliary cholangitis (PBC) is a rare autoimmune liver disease that causes chronic inflammation of the bile ducts inside the liver, leading to progressive damage and possible liver failure if untreated. Most patients with PBC in Italy are diagnosed early and treated with ursodeoxycholic acid (UDCA), the only approved medication, but a significant number, especially younger patients, do not respond well to this treatment. This study aims to create a national database of PBC patients in Italy linked to biological sample storage to better understand the disease's biology, subtypes, and progression. Researchers will collect detailed clinical information and laboratory investigations from PBC patients across about 60 participating centers in Italy. Data will be recorded using electronic forms at the start and annually thereafter. Biological samples will also be collected to study patients' genetics, immune system, and molecular differences among clinical profiles. This infrastructure will support translational research and improve knowledge about why some patients do not benefit from UDCA and may need liver transplantation. Participants will provide clinical and laboratory data and biological samples over time. The study will measure patient phenotypes and sub-phenotypes linked to disease progression over a total duration of 10 years. This resource will aid researchers, clinicians, epidemiologists, and industry by offering valuable data for clinical trials, patient care, and new treatment development. The study also supports European initiatives on rare diseases by building a comprehensive Italian PBC patient database.