Pediatric

The aim of the present study is to assess the changes of palatal morphology among growing patients with different vertical facial growth patterns treated with rapid palatal expander. Thirty-six patients referred to "Policlinico Agostino Gemelli" university hospital will be selected. The eligible criteria are posterior cross-bite, mixed dentition, skeletal Class I relationship and prepubertal stage of cervical vertebral maturation. The patients will be split into three groups according to facial divergency (hyper-, hypo-, normodivergent subjects). For each subject, digital dental casts will be recorded before and after treatment using an intraoral scanner. To evaluate two-dimensional maxillary arch changes, linear measurements will be done. To study comprehensively the palatal shape, a set of 240 landmark and semi-landmarks will be digitized on the palatal vault. Then, Geometric Morphometric Analysis (GMA) will be performed to compare morphological variations of the palate among different vertical facial growth pattern groups.

In healthy humans, brain functional representation of actions, either executed or observed, relies on the human action observation network (AON). Several studies demonstrated that AON activation is crucial for action understanding and for subserving imitation by observation of new motor skills. The demonstration of the activation of this circuit in patients with motor disorders have opened the way to new rehabilitation protocols based on the observation of meaningful actions followed by their execution (Observation to Imitate), often referred as Action Observation Therapy (AOT). In the last decade, AOT was widely used in adult stroke patients as well as in children with cerebral palsy (CP). Overall, these studies demonstrate a significant motor improvement after therapy, that is maintained at follow-up. Functional Magnetic Resonance Imaging (fMRI) studies on the effects of AOT found a positive correlation between the functional improvements of manual abilities of these patients and the enlargement of movement-related brain regions, suggesting that AOT can promote the activation of mechanisms of brain plasticity and functional reorganization of the cortical areas responsible for movements. Recently, fMRI studies have demonstrated that also other brain regions, such as the cerebellum, the thalamus and the basal ganglia, belong to the AON. Despite numerous studies on AON, the fine-grained details of this complex network, especially at subcortical level, and the reciprocal interactions between different brain regions are largely unknown. Moreover, no studies are available at submillimeter level concerning the involvement of subcortical structures. Compared with lower magnetic field systems, Ultra-High Field Magnetic Resonance (UHF-MR) permits a remarkable gain in terms of signal to noise ratio (SNR). This significant increase in SNR produces a great improvement of all imaging parameters, and can be exploited increasing spatial and/or temporal resolution. Moreover, at 7T, we assist also to an empowered sensitivity of the signal to modifications of the composition of tissue that can be translated in new or improved contrasts, such as susceptibility-weighted imaging. fMRI technique is an advanced MR method that benefits from the use of UHF thanks to the positive combination of increased SNR and increased sensitivity to the effect generating the contrast (BOLD effect). It has been demonstrated that an increase in the spatial resolution of UHF fMRI allows to describe the functional architecture of the cerebral cortex at mesoscopic (sub-millimeter) scale, hence revealing cortical columns-laminar fMRI profiles, and to segment subcortical structures, to explore their functional selectivity to external stimuli and topographic organization, and to study the cortex. Moreover, the increase in the sensitivity of fMRI at 7T allows to obtain statistically significant functional maps of brain activation not only in groups of subjects but also in individual subjects and individual events, opening new perspectives in the use of fMRI for clinical purposes. The present study aims to use 7T fMRI to understand the mechanisms of the functional organization of the AON circuit, and in particular the relationship between the cerebral cortex and other structures such as the subcortical nuclei and the cerebellum, and to explore how this organization changes in the presence of lesions acquired at an early age, such as in patients with brain lesions that arose in the pre- or perinatal period, like Cerebral Palsy (CP). We intend to enroll 28 healthy human subjects and 12 adolescents or young adults with CP. All participants will perform a 7 Tesla MRI scan, with a functional and anatomical dedicated protocol and CP patients will have a comprehensive clinical assessment before the MRI exam. The MR protocol includes 3D MR sequences with very high spatial resolution. In particular, T1-weighted sequences with isotropic voxel size of 0.8mm is used in order to highlight and segment small substructures, but at the same time evaluating the compliance of subjects, especially of patients, in maintaining the position for long acquisition, without introducing motion artifacts. Analogously, 3D FLAIR sequences are acquired for a detailed study of lesions in CP patients. fMRI acquisitions in humans are carried out by using Gradient-Echo Echo-Planar Imaging (GRE-EPI) sequences with spatial resolutions depending on the target of each functional series and by using imaging acceleration techniques as SENSE and multi-band approaches. For the study of functional connectivity and the whole AON circuit, comprehensive of the cerebellum, we will privilege whole brain coverage and relatively short temporal resolution (1-1.5 seconds), with a spatial resolution of 1.5mm isotropic voxel. On the other hand, for small substructures and laminar column studies, we will optimize an fMRI acquisition with isotropic voxel size of 0.7-0.9mm. As functional task we use paradigms already described in previous studies and adapted for the 7T scanner. Visual stimuli are presented in binocular vision by means of Liquid Cristal Display (LCD) goggles (VisuaStim-SVGA-Resonance Technology, USA). Participants observe short video-clips (lasting 4 s each), showing unimanual or bimanual actions performed by an actor, from a subjective perspective. The observed actions consist in grasping and using different tools (e.g., hammering, using a screwdriver, opening a jar etc.) or, as control condition, observation of the static initial frame of each clip. The objects are of different colors in order to avoid visual adaptation. The visual characteristics of each video are balanced between the experimental conditions to control the effects of brightness, contrast, sharpness and amount of visual information. During the rest period, in the absence of experimental stimuli, the participant have to fixate a white cross on a black background. During the entire fMRI acquisition, subject's performance are visually checked by the experimenter and kinematic parameters are recorded by using MR-compatible cameras.

The specific aim of this study is to examine the Safety, Tolerability and Pharmacokinetic of Semaglutide Nasal Spray compared with placebo and positive control in Adult Overweight or Obese Participants.

The goal of this clinicial trial is to test the acceptability and feasibility of linear cognitive aid intervention to support EMS teams in responding to pediatric emergencies. We are testing the hypothesis that cognitive aids with linear logic will be feasible to use and acceptable to EMS teams in urban and rural areas. Researchers will compare technical performance, teamwork, and self-assessed cognitive load of participants to see the difference between performing resuscitations using their current standard with existing cognitive aids and using our linear cognitive aid. Participants' teams will: * perform in situ high-fidelity simulation of two critical children's resuscitation scenarios * be randomized to 1) perform both resuscitations with their current standard with existing cognitive aids or 2) perform both resuscitations using our linear cognitive aid.

Design A cluster-randomized controlled trial will be conducted randomizing approximately 28 schools (clusters) with a total of 84 teachers/classrooms into either receiving training and supervision in PAX GBG or receiving equally much training and supervision for implementing one of the control interventions. Teachers in both arms will be implementing and using the intervention they were randomized to during the first year and then start implementing also the other intervention, while continuing using the first. When the baseline measure occurs at the end of grade 2 and the initial intervention is implemented for pupils during grade 3, the pupils in these classes will only receive one intervention since they move up to middle school where none of the methods are used. The teacher will instead start over with new pupils in grade 1 and use both methods with them. The sub-group of pupils that receives only one intervention will thus preserve the randomized controlled design also for long-term follow-ups. Procedure Ideally, half of the classrooms will be enrolled to start the intervention/control intervention during the spring semester and half during the autumn semester. The purpose of this is to control for the occasional effect of the point in time during the school year, and calendar year, when the intervention is introduced. Credible control interventions requiring the same amount of training and supervision will be used, to control for unspecific effects of implementing a new method. It also makes it possible to promote the study to schools and teachers as a way to implement and compare several useful methods, although for different purposes, which helps to avoid too high expectation or placebo effects for PAX and to minimize possible disappointment and nocebo effects related to having to wait one year before starting with PAX. The school will have the possibility to choose one of the two control interventions - a math application, 'Count On Me!', or Collegial learning community. This serves two purposes; (1) the possibility to choose will further reduce the risk of nocebo or being dissatisfied if not randomized to PAX and (2) it will enable more schools to participate if one of the control interventions would be seen as impractical to implement. Since neither fo the control interventions are deemed to have the same specific effects as PAX, at least not to the same extent, they will both act as controls for unspecific effects. A total of seven measures will be administered in relation to pupils, teachers and the classroom during the two years, with the baseline (Measurement 0) at the end of the semester before the implementation starts (Semester 0) and the primary endpoint (Measurement 4) one year afterwards. To reduce the burden for teachers and pupils, the full range of outcome measures will be conducted only on two occasions (Measurement 0 and Measurement 4) and otherwise a reduced set of measures will be used for pupils and teachers (For measures on classroom level, the full set of measures will always be applied). The reduced set of self-rating measures for teachers will include work related stress (primary outcome), classroom management, general stress, sleep problems, work ability and observed negative/positive effects of the method being implemented. For pupils, the reduced set will contain questions on well-being (primary measure). Teachers will also measure the well-being for each pupil at each measurement point. Following time frames will apply to the measurement points: Measurement 0 (M0) - semester before the first implementation semester, a 4-weeks administration window ending two weeks before the end of the semester. Measurement 1 (M1) - the first implementation semester, a 6-weeks administration window starting two weeks after the start of the semester (and preferably two weeks after the completion of the intervention training). Measurement 2 (M2) - the first implementation semester, a 4-weeks administration window ending two weeks before the end of the semester). Measurement 3 (M3) - the second implementation semester, a 4-weeks administration window starting two weeks after the start of the semester). Measurement 4 (M4) - primary endpoint, the second implementation semester, a 4-weeks administration window ending two weeks before the end of the semester. Measurement 5 (M5) - the third implementation semester, a 4-weeks administration window ending two weeks before the end of the semester. Measurement 6 (M6) - the fourth implementation semester, a 4-weeks administration window ending two weeks before the end of the semester. Participants and recruitment Schools, teachers, classrooms and other school staff The cluster-randomization will be performed on the school-level, and will in turn decide which teachers and pupils that are included. The schools will be recruited via an established network of PAX GBG trainers in Sweden and the research groups other connections with school-related networks and the recruitment will be country wide. The schools will be recruited from at least two different Regions and at least four different municipalities (kommuner) to increase the generalizability of the results. In total, around 28 schools will be included, depending on the number of classrooms participating from each school. A total of 84 classes, with an expected total of up to 100 teachers (as some classes have more than one teacher) will be included in the project. Other school staff is recruited only to participate in the qualitative evaluation of expectations and experiences of the interventions. The selection of these will be pragmatic and theoretically lead to reaching a saturation of qualitative data, with a maximum of four extra staff from each school. Pupils and their participation in interventions and data collection In total, 2200 pupils will be included, with approximately 26 pupils included from each classroom. All the pupils in a class related to the included teachers/classrooms will participate in the intervention since those are all implemented in the regular operation/teaching at the school and focused on the teachers' way of teaching and managing the class and the classroom and is not possible to exclude specific pupils from. Pupils can however be included in the data collection in three different ways: * Data from pupils to parents/custodians having signed the informed consent will have the data from their self-ratings, from the teachers ratings of them, and from registries connected to an ID-number, which in turn can be connected to their social security number (personnummer). * Data on pupils whose parents have not filled out the consent will still be collected, but without any ID-number or other identifier, which makes it impossible to connect it to the specific pupil and hence make the data anonymous. Only the interventions the pupil has been randomized to, and at which time-point the data was collected, is connected to this data. * Parents/custodians and the pupil himself/herself will be informed that the pupils do not need to fill out the self-ratings if they inform the teacher or researchers about their wish. Pupils will be informed of this before each self-rating. Randomization To ensure that the socioeconomic status (SES) of the schools do not differ too much, each school will be classified as being low, middle, or high SES and then, when there are enough schools in a cohort, randomized consecutively according to one of three corresponding block-randomized lists with block sizes varying randomly between 2, 4 and 6. The randomization will be handled by an independent third party, the Karolinska Trial Alliance, to ensure the researchers are not able to assess the lists or otherwise predict randomization results. Interventions The implementation procedure will be similar for each intervention, with smaller adjustments to fit specific needs of each method. Each starts with brief initial written information about the interventions, followed by one to two days of training/education for teachers. This is then followed by regular supervision face-to-face or via video/telephone depending on practical aspects and possible restrictions due to the Covid-19 pandemic. Supervision always includes some form of observation and monitoring of the use of the method by the supervisor, as a source to further inform the supervision. A total of six supervision sessions are planned: 4 sessions during the first implementation semester (held during the 1st to 4rth quarter of the semester respectively, starting with 2 individual sessions, followed by 1 group session and then by 1 individual session) and 2 sessions during the second implementation semester (held during the 1st and 2nd half of the semester respectively, 1 group session followed by 1 individual session). Teachers in all groups will also be able to receive briefer supervision on demand or additional supervision sessions initiated by the supervisor if deemed necessary. PAX Good Behavior Game PAX Good Behavior Game (GBG) is based on its precursor programme Good Behavior Game (GBG) that trains teachers to use principles of social learning in order to maximize the childrens' task-oriented and prosocial behaviors and minimize the occurrence of disruptive and off-task behaviors. PAX GBG is packaged into ten specific tools that the teachers are trained to introduce in their classroom management practice. The program introduces verbal and visual cues that facilitate prosocial and attentive behaviors One of the core elements of the program is the PAX-game, meaning that the children - while focusing on ordinary school tasks like math - get to play a game in teams where each team tries to make as few classroom rules infractions as possible during a certain period of time. The teams that succeed in achieving predetermined goals get a reward (often a fun and desirable activity) that serves as a reinforcer of prosocial and task-oriented behaviors. Supervision is performed individually with each teacher (4 sessions) and in group (2 sessions) and includes that the PAX-trainer observes a lecture given by the teacher before each supervision session. Count On Me! (Control condition) Count On Me! is an adaptive application teaching fluency in addition and subtraction facts (i.e., math facts), equality, compose and decompose numbers and a few more basic mathematical skills taught in the first grades of schooling. Count on me! is set in adventure game where the child has an avatar that travels thru different worlds/platforms by using their mathematical skills. The child starts of in the home of the avatar, in a house like environment, where the child discovers a magical map that brings the child into a different world called Numberia. During the adventures in Numberia the child learns that it has certain skills, called the mathemagical powers, that will be used to liberate Numberia from the evil Prince Claw that has captured all the beautiful things (e.g., the birds that used to sing in the forest). Count on me! was developed within a behavior analytic framework using a nonlinear programming process originally developed by Tiemann and Markle and later slightly revised by other researchers while creating Headsprout Early Reading and Headsprout Reading Comprehension. Instructional design elements from Tiemann and Markle, explicit instruction and the Morningside model of generative instruction were used to build the exercises. The math exercises contain at least one of three recurrent phases used in all training: the modeling, guide, and fluency phase. Modeling of new skills involves animations and hand-drawn examples along with audial instructions and requires frequent untimed student responding. Guided practice of newly modeled skills helps students achieve high levels of accuracy without timing. Finally, fluency building is aimed at developing proficiency with the skill at hand using timing. The guide and fluency phases comprise gamified elements. The application has been scientifically evaluated among Swedish low-performing elementary school pupils having shown significant improvements in math skills among the children having used the application with the largest improvement among the children with lower cognitive skills. Prior to the implementation start, the teachers' session focus on the functionality and content of the application and the way it corresponds to the math study plan for the class they're teaching. The training session will include the methods to introduce the application in the classroom, move forward and overcome common challenges. The teachers will be encouraged to start using the application in the classroom directly after the training session. The teachers will be recommended to use the application at least 4 times each week, approximately 15 minutes each time. Supervision will be held individually and in groups and will partly be based on the supervisors monitoring reports on how much and how the application is used. Collegial learning community (Control condition) Muijs and colleagues has defined five cyclical steps for professional learning for teachers. The first step is to assess the skill or knowledge gaps for students, using various data sources (for example testing, grades, surveys, student interviews). The second step is to reflect upon what skills the teacher needs to acquire in order to help the students to meet the goals. The third step is to deepen the professional knowledge and skills. The fourth step is engaging the students in the new practice, and in the fifth step to evaluate the impact the new practice has had on student outcomes. According to Timperley and other researchers, a feasible format for this kind of learning is a Collegial learning community, where teachers take help from their peers in each of these steps in a structured way. For example, way of deepening tacit or procedural knowledge (in step two) is to visit a colleague during class and make observations on their classroom practice. Timperley points out the importance of having a professional supervisor for maintaining the structure of the learning process. One common pitfall that the supervisor helps the teacher avoid is shifting focus from professional learning and instead ending up in entrenching current teacher practices, instead of learning new skills. Collegial learning communities can focus on practically any kind of teacher skills. The current intervention provide material to focus on any of the following: 1) formative assessment, 2) how to formulate and follow up on homework in order to engage students 3) How to teach fact knowledge in order to facilitate higher reasoning with students. These themes are chosen to mimimize the overlap with the content of PAX GBG but still be highly relevant for teachers. The intervention will be based on a web resource, and 6 supervision sessions with assignments in between. Supervision and observation will be combined in that the supervisor initially observes when the teachers perform a group supervision with their colleagues, and then gives immediate feedback to the whole group. This is followed by a further discussion of the method and brief, 10 to 15 minutes long individual sessions with each teacher. Measures Background data and the effectiveness and implementation outcomes of the intervention will be assessed with a range of different measures described below. The timing of the measures is described in table 1 above, and in some cases commented more on below. Extra background measures at baseline (M0) for schools, classrooms and teachers The measures described here are not the only one used as background data, but those specifically measured only at baseline. The SES for each school district measured in average income for parents and average level of education for parents (based on the data from Statistics Sweden) Number of pupils, teachers and extra resource persons in each class The pupil's need for additional help and extra resources, as well as presence of a neurodevelopmental diagnosis. Extra COPSOQ-III questionnaire subscales Quantitative Demands, Work Pace, Influence at Work, Predictability, Social Support from Supervisor, Social Support from Colleagues, Sense of Community at Work. Extra items from TALIS, the questions about employment and about other teachers at school. Effectiveness measures The effects of implementing PAX will be assessed on school level, teacher level, classroom level and student level. Classroom-focused measures Classroom-observations by a trained observer will be conducted during two or three lessons during the same or conceding days, for a minimum time of 20 minutes for each class. To increase standardization of the measure, only lessons where the focus is on theoretical subjects will be included. The observations will be based on an observational schedule that has already been tested in the PAX pilot trial and will be slightly adapted in a separate project prior to being implemented in the current trial. The schedule will focus on direct observation of the following aspects: 1) pupils being on-task/off-task (primary outcome), 2) number of pupils disruptive behaviors, 3) time for transition between different tasks and 4) number of positive/negative teacher-pupil interactions. The observations will be conducted by trained observers and will never identify single pupils, and hence produce anonymous data. However, the gender of the pupil will be recorded for assessment (1) - (4) to provide opportunity to conduct gender analyses. After each observed lesson, both observers and teachers will rate the observed lecture using a questionnaire that is being developed together with the observational schedule focusing on overall ratings of aspects like severity of disruptive behaviors in the classroom, level of noise in the classroom, how focused the class was during the lecture etc. Again, this data will be rated at classroom-level, with no possibility to identify individual students. During one week connected to the fixed measurement occasions, data on noise levels will be collected in each classroom. The noise levels will be assessed by a measuring device that will be placed in the classroom without disturbing classroom environment. The device will measure and store very short snippets of sound with random intervals of on average three seconds, making it impossible to identify source and content of the sound activity (e. g. hear a conversation) but being enough to calculate the decibel level at different ranges of frequency. Thus, this data is also anonymous. School attendance and the need of additional personnel in the class will be measured at the class level. The topic of the intervention's effect on the classroom, both positive and negative, will be covered by the qualitative interviews with the teachers and other school staff (described in the section for Implementation measures). Also, four free-text questions to the teacher at M3, M4 and M6 will cover this, prompting them to describe positive and negative effects of the intervention in relation to (a) themselves and (b) to the pupils, since the last measurement point. The pupils will also be asked about their attitude to PAX/control intervention. Measures of teachers' health and work A number of self-rated measures will be collected from teachers using a secure platform used for conducting online psychological treatments and requiring two-step authentication. The measures will include self-rated health-related measures, self-rated work-related data and registry-based data on health-care and prescription drugs consumption. Pupil-focused measures Self-rated questionnaires be answered by the pupils, with the aid of trained research assistants who will make sure that the students have understood the questions and the response alternatives and minimize the risk of them disturbing or influencing each other. Different ways of administering the questionnaire battery are available (administration via paper-and-pen or tablet in the whole class, in smaller groups, or individually, with the administrator giving instructions, sometimes also using a pre-recorded instruction) to be able to adapt to what would be most feasible for a specific classroom. The pupils will rate their health and wellbeing. The teachers will fill out the dysregulations scale (5 items) of the Strengths and Difficulties Questionnaire. Registry-based data will be used to analyse the pupils' health-care and prescription drugs consumption as well as the parents' need to take stay home from work to take care of a sick child. The children's academic attainment in mathematics and the Swedish language will be measured using standardized tests. Implementation measures The pre-conditions for the implementation process will be assessed using both quantitative and qualitative data collection. Semi-structured qualitative interviews will be conducted with randomly selected 25-50% of all the participating teachers. The goal of the interviews is to shed light on aspects that will not be captured by the standardized instruments, both in terms of the intervention's effectiveness and quality of implementation. The interview guide is being created as a part of a smaller pilot project. The interviews will be conducted by phone or video and will take approximately 20 minutes on average. The interviews will be conducted three times with each selected teacher: immediately after the PAX-training, at M2 and M4 (see the specification of the measurement points above). The interviews will be recorded, transcribed and analyzed using qualitative content analysis. Expectations and experience of the implemented intervention In order to study expectations, experiences and outcomes of the implemented intervention, the teachers and other school staff on several occasions will fill out the Normalisation Measure Development Questionnaire (NoMAD). The same dimensions will also be studied by by conducting interviews and collecting objective data, such as those on long-term use of the intervention according to the classroom observations, the proportion of the eligible teachers using the intervention in each school etc. Intervention Fidelity The teachers' fidelity to the method will be measured by direct observation conducted by the supervisor and by using a self-rated fidelity instrument for teachers to fill out. Adverse events Information on adverse events will be collected starting at M3 and onwards as open-ended questions that the teachers fill out in the platform. Questions on negative effects will also be included in the qualitative interviews. Statistical Analyses Statistical power of 80% for the pupils' psychological symptoms (the between-group effect size estimated from the pilot study equalling d=0.6) can be reached with a cluster-randomized design including 28 schools, 3 classes per school and 25 pupils in each class (a total of 2100 pupils), the expected data loss of 20% and the clustering effects known from similar studier in school environments of rho2=.1 (school level) and rho3=.25 (teacher level). Since the number of pupils can exceed 25, we expect the total number of included pupils to be 2200. Primary endpoint for outcomes will be at the one-year follow up (M4), before the teachers starts to use also the method they were not randomised to initially. The measures focusing on the teachers' and students' health, well-being and work/study environment, as well as classroom-based measures that are collected repeatedly will be analyzed with a hierarchal general linear model with a maximum of three nested levels (school, classroom/teacher, and pupil). The difference in the slopes of change over time between the PAX group and the control interventions will be tested for each outcome variable. A set of mixed effect models will be performed to detect factors (background factors and implementation-related factors) that influence the outcomes of the implementation (fidelity, acceptability, appropriateness etc.). Mixed effect models will also be used to detect whether implementation-related variables (e g readiness for change, fidelity, acceptability etc) affect the main outcomes of the trial (e g teachers' and students' health, well-being and work/study environment). The anonymous data from pupils will be used in two ways: (1) for missing data analyses by comparing the levels and changes in the anonymous data to the identifiable data and (2) to perform sensitivity analyses where all data are analysed on time and intervention group level only, i.e. ignoring information on school, classroom and pupil, even when those exists. The statistical methods will thus have less power, but on the other hand data from more pupils can be utilized and since the amount of missing data will be lower than in the main analyses, the risk for biases due to non-random attrition will be lower. For the anonymous data, if data from fewer than 10 pupils at one time-point and intervention are collected, the data will be discarded and deleted completely, in order to keep a safe margin from the possibility of in some way indirectly connect the data to a pupil. Cost effectiveness The teachers' mental health measured with GHQ-12 will be recalculated to quality adjusted life-years (QALY:s). The students health-related quality of life, measured with CHU9D, will be used to calculate QALY:s. The costs for the implementation (e g time for training and supervision), will be calculated together with the possible savings related to reduced sick leave absence for the teachers, as well as the need for additional personnel in the schools and reduced need of student health resources. The total QALY:s during the follow-up period will be studied using area under the curve method. The difference health outcome between the intervention group and the control condition will be analyzed using regression models. The costs and savings will be compared to the gains expressed in QALY:s, both for the teachers and the students. The results will be presented as a cost-effectiveness quota and illustrated as a cost-effectiveness plan, that will show the uncertainty in the results when it comes to the costs and health-effects for the intervention and the control group.

This study aims to address the challenges faced by PET/MR in pediatric applications by leveraging new technologies such as flexible coils, silent sequences, and deep learning-based image reconstruction. The objective is to provide a rapid, silent, comfortable, and half-dose PET/MR imaging solution for pediatric patients, and to demonstrate its feasibility in this patient population.

Adults with cerebral palsy (CP) often face challenges in accessing exercise programmes that are appropriate for their needs. Barriers such as limited mobility, a lack of tailored options, and restricted access to physiotherapy services can make participation difficult. Exercise is important for improving physical health, mental well-being, and overall quality of life. However, many adults with CP do not have regular opportunities to take part in structured physical activity. This study aims to investigate whether an online exercise programme can serve as an effective and accessible alternative. The main aim of the study is to assess the feasibility of delivering an online exercise programme for adults with CP. Key areas of focus will include demand, implementation, practicality, adaptability, acceptability, and potential benefits to physical, mental, and social well-being. A total of 60 adults with CP will be recruited and randomly assigned to one of two groups (30 participants per group). One group will complete an 8-week online exercise and education programme. The second group will receive the same educational materials during the study and will be provided with information about the home exercise programme after the 8-week intervention period. Data will be collected on attendance, completion rates, engagement with exercises, and any reported adverse events. Health-related surveys will be completed before and after the programme to assess any changes. In addition, a selected group of participants from the intervention group will take part in interviews to provide feedback on their experiences. Findings from this study may support the development of accessible, effective, and person-centred online exercise programmes for adults with CP. Results may help improve future programme design and contribute to better care and support for adults with CP in Ireland.

The primary objective of this clinical study is to characterize in Chinese toddlers ages 32 - 42 months old the developmental characteristics of MRI measured neural flexibility, as an index of cognitive flexibility, and to assess a range of executive functions (inhibit, shift, emotional control, working memory, plan/organize) using the Global Executive Composite summary score obtained from the BRIEF-P standardized rating scale.

The aim of this study is to evaluate a novel tablet game-based neurodevelopmental assessment tool for young children aged 3 to 8 years old. The study's main aims are: (1) to determine whether the novel tablet-game based assessment tool can accurately differentiate children's neurodevelopmental status based on their performance on the game and (2) assess the validity of the game-based neurodevelopment assessment tool. The study aims to recruit 590 children who are 'typically' developing and/or have a diagnosed neurodevelopmental disorder including Attention Deficit Hyperactivity Disorder (ADHD), Autism Spectrum Disorder (ASD), Specific Learning Disorder, or a Communication Disorder. All participants will complete the tablet game-based assessment which aims to assess a range of neuropsychological functions including attention, memory, language, motor, executive functions and social-emotional skills. Parents/carers of participants will also complete a demographic questionnaire and the Adaptive Behaviour System - Third Edition (ABAS-3), which is a questionnaire that assesses a child's development. Some participants will be re-tested on the tablet game-based assessment approximately 2 weeks after the first tablet game-based assessment to ensure the game's validity.

Background: A lot of children with cancer suffer from emotional distress, fatigue and relational difficulties. Their parents are also impacted by the disease: their responsibilities increase and they can feel more distressed and tired. Different psychological interventions designed for ill children and their parents seem to be efficient to improve their social functioning, coping strategies and well-being. However, more research is needed in this field. Hypnosis is often used in paediatric oncology, mostly to decrease procedure-related pain and distress. It has been used efficiently to improve the well-being of adults with cancer. This paper describes a pilot study designed to assess the feasibility and interest of a group intervention combining self-care and hypnosis for children with cancer and their parents, and a quasi-experimental protocol aimed at assessing the efficacy of this group intervention to improve the quality of life of children and their parents. Methods: Our pilot study showed that our intervention was feasible and positive for the participants. To test the efficacy of the intervention, two groups will be set up: one with children with cancer and their interested siblings, and one with their parents. Data will be collected for each group before and after the intervention by questionnaires and a semi-structured interview. Discussion: There is a growing interest in hypnosis in oncology settings. The results of this study should improve knowledge about the efficacy of a group intervention combining self-care and hypnosis to improve quality of life of children with cancer and their family.