Pediatric

Researchers are studying changes in the shape of the palate in growing children with different vertical facial growth patterns who have a posterior cross-bite. The study focuses on patients with mixed dentition, skeletal Class I relationship, and who are in the prepubertal stage. The goal is to understand how rapid palatal expander treatment affects the palate morphology among hyperdivergent, hypodivergent, and normodivergent facial types. The treatment involves using a rapid palatal expander device for about 6 months. Patients will be grouped based on their facial divergence patterns. Digital dental casts will be recorded before and after the treatment using an intraoral scanner. Researchers will perform linear measurements and a comprehensive study of the palate shape using a set of 240 landmarks and semi-landmarks. Geometric Morphometric Analysis GMA will compare the palate shape changes among the different groups. Participants will undergo clinical evaluations and have pre-treatment and post-treatment digital records including oral scans and photographs. The primary outcome is to measure morphological changes of the palate after 6 months. Secondary outcomes include detailed shape analysis of the palatal vault among the different facial types. The study requires good quality records and informed consent from participants, with total participation lasting around 6 months.

Researchers are studying the brains 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 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 PETMR imaging for children suspected of malignant tumors. It focuses on making PETMR 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 PETMR 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 PETMR examination is feasible and effective for pediatric use. Participants will undergo PETMR imaging, and researchers will assess several outcomes over one year, including lesion detection rates, completion rates of PETMR 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.

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 cows 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 childs 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.

Many children with cancer experience emotional distress, fatigue, and difficulties in relationships. Their parents also face increased responsibilities and may feel more distressed and tired. While psychological interventions for these families have shown promise in improving social skills, coping, and well-being, further research is needed. Hypnosis is commonly used in pediatric oncology to reduce pain and distress during procedures and has also been effective in enhancing well-being in adults with cancer. This trial explores the feasibility and potential benefits of combining self-care and hypnosis in a group setting for children with cancer and their parents. The intervention involves six monthly group sessions, each lasting two hours, where participants learn self-hypnosis exercises and discuss self-care techniques like understanding personal needs, self-respect, assertiveness, and managing negative thoughts. Homework assignments are given to encourage positive changes. Two groups participate one including children with cancer and their siblings, and another for their parents. Data are collected before and after the intervention through questionnaires and interviews to assess its impact. Participants will complete assessments measuring changes in childrens quality of life, fatigue related to cancer, and parents perceptions of their childs quality of life and their own fatigue. Secondary outcomes include the impact of cancer on the family, parents emotional distress, and coping strategies. These are evaluated before the program starts and immediately after its conclusion at six months. The study aims to improve understanding of how this combined self-care and hypnosis intervention may enhance the well-being of children with cancer and their families.

Researchers are conducting a master protocol trial designed to efficiently study several different drugs for children and young adults with various types of cancer. This approach allows multiple clinical trials under one common research plan, with each trial focusing on specific cancers like desmoplastic small round cell tumor, synovial sarcoma, and Ewings sarcoma. New drug studies may be added over time as new treatments emerge. Participation depends on how long the treatment benefits last. The study evaluates combinations of drugs given in cycles, including intravenous and oral medicines such as ramucirumab, cyclophosphamide, vinorelbine, gemcitabine, docetaxel, abemaciclib, irinotecan, and temozolomide. Different treatment groups receive specific drug combinations tailored to the cancer type, with treatment cycles lasting 21 or 28 days depending on the regimen. Each group is randomized to receive either an experimental drug combination or an active comparator without any blinding. Participants will be involved from screening through treatment and monitored regularly. Researchers will assess how many participants are assigned to each specific intervention plan within the first four weeks and track treatment effects. Participants must have measurable or evaluable disease, adequate organ function, and meet performance status criteria. Female participants of childbearing potential undergo pregnancy testing and must use contraception during and after treatment. Safety, adherence, and side effects are carefully monitored throughout the study, which is expected to continue until 2027.

This research focuses on adults with obesity or overweight and aims to evaluate the safety and effectiveness of various investigational treatments for chronic weight management. It is a Phase 2 master protocol study that uses a framework to test multiple interventions, each detailed in separate appendices. The study establishes criteria for enrolling new participants and reports results when all intervention appendices have completed. Participants may receive different investigational drugs administered either by subcutaneous injection or orally, including LY3305677, LY3841136, tirzepatide, LY3549492, and others. Each intervention-specific appendix outlines the particular treatment details and analyses. Some participants receive placebos matching the administration method of the active treatments. Treatments and analyses are conducted in parallel groups, and interventions may start independently as they become available. Throughout the study, participants undergo screening to confirm eligibility and are randomly assigned to one of the intervention groups or placebo. Researchers monitor participant allocation up to week 6. The trial emphasizes double-blind procedures, and participant involvement includes receiving study treatments and attending scheduled visits. Safety and efficacy data are collected, and the study is planned to continue until early 2028, with primary outcome measures focusing on participant allocation to interventions.

Researchers are evaluating a 12-week home-based mobile health mHealth intervention called the Shining Star study, aimed at improving adherence to the 24-Hour Movement Guidelines among preschool-aged children 3-4 years old who currently meet zero or one of the guidelines for physical activity, screen time, and sleep. The trial seeks to determine if the intervention increases the number of children meeting all three guidelines and if the program is feasible for parents to implement. This randomized controlled trial compares an intervention group using the app to a waitlist control group. Participants in the intervention group will use the Shining Star mobile app, which delivers weekly lessons and behavior-related goals through concise messages, gamification features, behavior trackers, and a parent forum. The control group will receive no intervention during the initial 12 weeks but will complete the same assessments as the intervention group. After 12 weeks, control group participants will gain access to the app and resources. Physical activity and sleep will be tracked with accelerometers, and parents will complete questionnaires. Childrens physical activity, sedentary behavior, and sleep patterns will be assessed at baseline, 6 weeks, and 12 weeks using accelerometers. Parents will provide feedback on their childs movement behaviors, development, and app usability through questionnaires and weekly surveys. Additional measures include motor skills tests, cognition assessments, behavioral problems, executive function, and BMI. Data will be securely stored and analyzed to evaluate the interventions impact and app feasibility over the 12-week period.