Children

Researchers are studying the brain's action observation network (AON), which is involved in understanding and imitating movements, especially focusing on subcortical areas and the cerebellum. The study aims to explore how this network functions in healthy individuals and in people with Cerebral Palsy (CP) who have early brain injuries. This research seeks to understand differences in brain activation patterns and their relation to clinical features in CP patients using advanced imaging techniques. Participants will undergo a 7 Tesla MRI scan using a high-resolution functional and anatomical protocol. The MRI will capture detailed images of brain structures including the cerebral cortex, subcortical nuclei, and cerebellum. Visual tasks involving observation of hand movements and tool use will be presented during the scan. CP patients will also receive a full clinical assessment before the MRI. The study includes both healthy volunteers and CP patients, with careful monitoring of participant compliance to avoid motion artifacts. During the study, researchers will evaluate brain activation and connectivity maps of the AON from the 7T MRI data. Participants' motor functions and clinical characteristics will be assessed for correlation with imaging results. The study involves observation during MRI scanning, clinical assessments, and monitoring of participants' responses to visual stimuli. This trial is expected to provide detailed insights into brain network organization and its changes in CP. The total participation includes MRI scanning and clinical evaluations around a single visit.

Researchers are evaluating the safety, tolerability, and how the body processes Semaglutide Nasal Spray compared to a placebo and a known injection in adults who are overweight or obese. This Phase I clinical trial aims to better understand the effects of the nasal spray formulation of Semaglutide in this population. The study is sponsored by Shanghai World Leader Pharmaceutical Co., Ltd. and focuses on adults aged 18 to 65 years with specific body mass index ranges. Participants will receive either the Semaglutide Nasal Spray, placebo, or a Semaglutide injection (Wegovy®) in different randomized groups. The study involves a single-dose administration and includes several cohorts receiving various combinations of the nasal spray and placebo or the injection. Treatments are given once, and the study monitors the participants for up to 36 days after administration to assess drug levels and effects. During the study, participants will undergo various evaluations including blood tests, vital signs monitoring, physical examinations, electrocardiograms (ECGs), and urine analyses from Day 1 to Day 36. Researchers will measure how much of the drug reaches the blood, how long it stays, and any side effects that occur. Antibody levels against the drug will also be checked up to Day 29. Participants will be closely monitored for any safety concerns throughout the study period.

Researchers are evaluating the effects of increasing soluble fiber intake on the gut microbiome in children aged 6 to 17 with asthma. This Phase II randomized controlled trial aims to understand how diet, specifically fiber intake, may influence asthma symptoms and related biological pathways. Participants will be assessed through dietary recalls and various biological samples to explore connections between diet and asthma control. Participants will be randomly assigned to receive either soluble fiber (Fruitafit Inulin) or a placebo (Maltodextrin). After initial assessments including dietary recall, nasal wash, blood samples, and an asthma control questionnaire, participants will receive counseling on how to include the study product in their diet. Over approximately 30 days, participants will collect and submit three stool samples for microbiome and metabolomic analysis, and repeat assessments at a second visit about 25 days later. Throughout the study, participants will complete questionnaires, provide biological samples including blood, nasal wash, and stool, and undergo dietary intake assessments. Researchers will monitor gut microbiome diversity, asthma control, nasal inflammation, and circulating short-chain fatty acids. The study includes safety monitoring for minimal risks such as discomfort from sample collection and blood draws. Participants receive compensation and partial dietary results, with total involvement lasting about one month.

This clinical trial studies the use of a linear cognitive aid app designed to help emergency medical service (EMS) teams respond to pediatric emergencies. Researchers want to see if this new tool is practical and well accepted by EMS teams in both urban and rural settings. The study compares current standard cognitive aids with the new linear cognitive aid during simulated critical resuscitation scenarios for children. Participants will be randomized into two groups: one using their current standard cognitive aids, and the other using the linear cognitive aid app. Each team will perform two high-fidelity, in situ simulations of critical pediatric resuscitation emergencies. The linear cognitive aid app offers minimal input, linear step-by-step guidance, tailored recommendations based on the patient’s age and scenario, and audio prompts timed to the resuscitation process. During the study, researchers will assess the time it takes teams to reach American Heart Association (AHA) technical milestones, teamwork quality, and participants' perceived cognitive load during each 10-minute simulation. The study aims to evaluate how well teams perform and how the different cognitive aids affect their experience. The trial is led by Beth Israel Deaconess Medical Center and includes adult EMS providers who speak English and are actively practicing.

Researchers are investigating the effects of the PAX Good Behavior Game (GBG) in Swedish primary schools to address growing concerns of mental health issues among children and stress-related symptoms in teachers. This cluster-randomized controlled trial involves 28 schools and about 84 teachers, aiming to improve student well-being and reduce teacher stress. The study compares PAX GBG to active control interventions that also provide teacher training but with different content. The trial includes extensive measurements over two years, including self-assessments, classroom observations, sound level monitoring, sick leave data, and qualitative interviews. Teachers randomized to the PAX GBG group receive a two-day training on ten specific tools designed to promote prosocial and focused behaviors in classrooms, including a team-based game rewarding good behavior. Control schools choose between two alternatives: 'Count On Me!', a math fluency application for pupils, or a Collegial Learning Community intervention focused on professional development for teachers. Both groups receive similar amounts of training and supervision, including multiple sessions during the school year. The interventions are integrated into regular classroom activities starting in grade 1 through grade 3. Participants include approximately 2200 pupils and their teachers, with data collected through various methods such as questionnaires, standardized tests, observer ratings, and registry data. Measurements occur at multiple time points over two years, focusing on pupil well-being, teacher stress, classroom behavior, noise levels, and implementation fidelity. The study also evaluates cost-effectiveness by comparing health outcomes and related expenses. Safety and adverse events are monitored through teacher reports and interviews, ensuring comprehensive assessment of the interventions' impact.

The trial investigates a new approach to PET/MR imaging for children suspected of malignant tumors. It focuses on making PET/MR scans faster, quieter, and more comfortable while using half the usual dose of radioactive tracer. The study explores the use of advanced technologies like flexible coils, silent scanning sequences, and deep learning-based image reconstruction to improve imaging for pediatric patients. Pediatric patients who show clinical symptoms and require 18F-FDG PET/MR scans to clarify their condition are included. The study tests this novel imaging solution in children aged 0 to 18 years. The goal is to demonstrate that this rapid, silent, and lower-dose PET/MR examination is feasible and effective for pediatric use. Participants will undergo PET/MR imaging, and researchers will assess several outcomes over one year, including lesion detection rates, completion rates of PET/MR exams, sedation requirements during scans, and the quality of the images obtained. The study involves cooperation throughout the entire research process to ensure reliable results and aims to improve the scanning experience and diagnostic accuracy in children.

Adults with cerebral palsy (CP) often face difficulties in accessing exercise programs tailored to their needs due to limited mobility, lack of suitable options, and restricted physiotherapy access. Regular exercise is important for improving physical health, mental well-being, and overall quality of life, but many adults with CP do not have structured opportunities for physical activity. This research aims to evaluate the feasibility of delivering an accessible online exercise program designed specifically for adults with CP, focusing on demand, practicality, acceptability, and potential benefits to physical, mental, and social health. The study will recruit 60 adults with CP who will be randomly assigned to one of two groups. One group will participate in an 8-week online exercise and education program that includes weekly online exercise classes targeting strength, balance, and range of movement, along with educational materials covering topics like exercise, nutrition, fatigue, bone health, pain management, mental health, and sleep. The other group will receive the same educational materials over 8 weeks without the exercise classes and will be informed about the home exercise program after the intervention period. Participants will be monitored throughout the study with data collected on attendance, completion rates, engagement with exercises, and any adverse events. Health-related surveys will be completed before and after the program to assess changes in physical function, mobility, pain, fatigue, sleep, self-efficacy, depression, and participation. Selected participants will also provide feedback through interviews. The study duration includes rolling recruitment over 1.2 years and outcome measurements over 2 years, aiming to support the development of effective online exercise programs for adults with CP.

Researchers are studying the development of neural flexibility, measured by MRI, as an indicator of cognitive flexibility in Chinese toddlers aged 32 to 42 months. The study also evaluates executive functions such as inhibition, shifting attention, emotional control, working memory, and planning using the Global Executive Composite score from a standardized rating scale. This research aims to better understand brain development and cognitive abilities during early childhood. Participants are divided into two groups based on their daily milk consumption: one group receives S-26 GOLD or ULTIMA GUM formula, while the other consumes cow's milk. Parents continue feeding their children these milk products throughout the study, and information about milk consumption is collected starting up to two months before and during the study period. The brain is examined using MRI, a safe and non-invasive imaging technology. During the study, toddlers undergo MRI scans and assessments of brain structure and function at the start and again at 42 months of age. Researchers also evaluate cognitive flexibility, behavior, curiosity, sleep quality, home environment, feeding practices, and fecal microbiota composition over time. Parents provide information through interviews, and the child's development and school readiness are monitored. The study runs from baseline through 42 months of age, with additional home environment data collected at 8 months after baseline.

Researchers are evaluating a new tablet game-based tool designed to assess neurodevelopment in young children aged 3 to 8 years. This study aims to determine if the game can accurately distinguish between typically developing children and those with neurodevelopmental disorders such as ADHD, Autism Spectrum Disorder, Specific Learning Disorder, or Communication Disorder. It also seeks to assess how valid and reliable the game-based assessment is for evaluating a child's neuropsychological functions. Participants will complete the tablet game-based assessment, which evaluates attention, memory, language, motor skills, executive functions, and social-emotional abilities. Parents or caregivers will fill out a demographic questionnaire and the Adaptive Behavior Assessment System, Third Edition (ABAS-3), to provide additional developmental information. Some children may be asked to repeat the game assessment about two weeks later to check the consistency and validity of the tool. Children's involvement includes playing the game-based assessment and having their caregivers complete questionnaires about their development and background. The study will measure diagnostic accuracy, validity, internal consistency, predictive validity, and safety of the assessment over a period of 16 months. Researchers will also collect preliminary normative data, evaluate the acceptability of the tool, and assess test-retest reliability to ensure the assessment's usefulness and safety throughout the study.

This research aims to monitor participants who previously received TSC-100 or TSC-101 T-cell receptor engineered T-cell (TCR-T) therapies in the TSCAN-001 study. The goal is to assess the long-term safety and efficacy of these investigational treatments over a 15-year period following their administration, focusing on people treated for conditions such as AML, ALL, and MDS. Participants will not receive any new study drug during this long-term follow-up study. Instead, they will be observed after completing the initial TSCAN-001 trial, while continuing any other cancer treatments as necessary. Monitoring will include a period lasting 15 years from the date of their original TCR-T cell therapy. During the study, participants will be evaluated for treatment-emergent adverse events to assess safety and tolerability. Researchers will also monitor overall survival, relapse-free survival, and progression-free survival over the 15 years. This observational study involves regular assessments to track long-term outcomes without administering additional investigational treatments.