Clinical Research Directory

M3-JIA: Making Mindfulness Matter for Children With JIA

The investigator will evaluate the efficacy of M3©, an intervention for patients with JIA and their caregivers. Children with Juvenile arthritis and their parents will attend an 8 week online program called Making Mindfulness Matter (M3). This is a facilitator-led program that integrates knowledge and skills related to mindfulness, social-emotional learning, neuroscience, and positive psychology to promote coping and resiliency for children and families in context of the challenges of pediatric chronic disease. The child program is designed for children 4-12 years of age, with each lesson including a variety of concrete ways to teach children skills based on their age/developmental level.

Cognitive Neuroscience of Autism Spectrum Disorders

Background: * Autism spectrum disorders (ASDs) are a group of developmental disorders that affect communication, social interaction, and behavior. Relatively little is known about the relationship between genetics and behavior among these individuals and their close relatives. Researchers are interested in using interviews and rating scales to better understand these issues, as well as collecting brain scan data and genetic samples for testing and comparison. * By comparing test results and genetic samples from healthy volunteers, people with ASD, and parents (or caregivers or legal guardians) of the first two groups, researchers hope to better understand the neuroscience of ASD. Objectives: * To learn more about the brain in healthy people and in people with autism spectrum disorders. * To study genes that might be involved in autism spectrum disorders by collecting DNA samples from participants. Eligibility: The following groups of participants will be eligible for the study: * Individuals between 5 and 89 years of age who have autism spectrum disorders. * Healthy volunteers between 5 and 89 years of age. * Cognitively impaired children between 5 and 17 years of age. * Parents/caregivers/legal guardians of individuals in the above three groups. Design: * Participants will visit the National Institutes of Health Clinical Center for research tests, which will be administered over multiple visits. Researchers will determine the specific tests to be administered based on the medical history of the study participant. * Researchers will study the brain through interviews, tests of thinking and memory (neuropsychological tests), brain imaging with magnetic resonance imaging (MRI), and magnetoencephalography (MEG). * The study will also collect blood or saliva to obtain a DNA sample.

Think-Find-Solve Activities for Insulin Self-Management in Type 1 Diabetes

Children with type 1 diabetes require lifelong insulin therapy. However, improper management of insulin therapy may lead to serious, potentially life-threatening complications. The aim of this study is to examine the effect of an activity book developed for insulin therapy on insulin self-management among children with type 1 diabetes and their parents. The study is designed as a cluster randomized controlled experimental trial at the center level, including pre-test, 1- month, and 3-month follow-up measurements. The study will be initiated after obtaining ethical approval and institutional permissions. The sample will consist of children aged 8-12 years with type 1 diabetes and their parents. The study will be conducted in two different hospitals in Istanbul; using cluster randomization, one hospital will be assigned to the intervention group and the other to the control group. Prior to the main study, a pilot study will be conducted with 15 participants in each group, and the sample size will be calculated using G\*Power based on the pilot data. Data will be collected using the "Descriptive Information Form for Children with Diabetes" and the "Insulin Treatment Self-Management Scale (ITSMS) - Child (8-18 years) and Parent Forms." The "Find-Solve-Learn Insulin Self-Management Activity Book" will be applied to the children in the intervention group. The children will be monitored to complete the activity book at least twice a month for three months, and feedback will be obtained from their families regarding the process. The data collection process will include pre-test, 1-month, and 3-month follow-up measurements. The obtained data will be analyzed using appropriate statistical methods.

Rural Autistic Individuals - Supporting Expression

This research study investigates how hand gestures can support language comprehension and communication skills of hearing speaking, non-speaking, and/or minimally verbal individuals with Autism Spectrum Disorders (ASD), who are especially disadvantaged by the lack of accessible services in their rural communities. Individuals with other cognitive profiles, including Developmental Language Disorder (DLD), ADHD, Dyslexia, and others are welcome too. The study uses methods of eye tracking and recording of brain activity to understand how hand gestures adapted from signs from American Sign Language, such as \[cry\], can promote successful understanding of words like "cry". The overarching goal is to help families effectively utilize gestures to support communication with their children.

A Study to Learn More About How Safe the Study Treatment Finerenone is in Long-term Use When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker Over 18 Months of Use in Children and Young Adults From 1 to 18 Years of Age With Chronic Kidney Disease and Proteinuria

Researchers are looking for a better way to treat children who have chronic kidney disease (CKD), which is long-term kidney disease, and proteinuria, a condition in which a person´s kidneys leak protein into the urine. The kidneys filter waste and fluid from the blood to form urine. In children with CKD, the kidney´s filters do not work as well as they should. This can lead to accumulation of waste and fluid in the body and proteinuria. CKD can lead to other medical problems, such as high blood pressure, also known as hypertension. Vice versa, hypertension and proteinuria can also contribute to worsening of CKD. Therefore, the treatment of CKD aims to control blood pressure and proteinuria. There are treatments available for doctors to prescribe to children with CKD and hypertension and/or proteinuria. These include "angiotensin-converting enzyme inhibitors" (ACEI) and "angiotensin receptor blockers" (ARB). Both ACEI and ARB can help improve kidney function by reducing the activity of the renin-angiotensin-aldosterone system (RAAS). The RAAS is a system that works with the kidneys to control blood pressure and the balance of fluid and electrolytes in the blood. In people with CKD, the RAAS is often too active, which can impair the ability of the kidneys to work properly and cause hypertension and proteinuria. However, ACEI or ARB treatment alone does not work for all patients with CKD as they only target the angiotensin part of the renin-angiotensin-aldosterone system. The study treatment, finerenone, is expected to help control RAAS overactivation together with an ACEI or ARB. So, the researchers in this study want to learn more about whether finerenone given in addition to either an ACEI or ARB can help their kidney function. The main purpose of this study is to learn how safe the treatment is when used of finerenone in addition to an ACEI or ARB in long-term. To see how safe the treatment is, the study team will collect information on medical problems which are also known as "treatment emergent adverse events" (TEAEs). And they will also collect levels of an electrolyte called potassium in the blood by taking blood samples, and measure blood pressure during the study. The secondary purpose of this study is to learn how well long-term use of finerenone can reduce the amount of protein in the participants' urine and benefit kidney function when taken with standard of care. To see how the treatment works, the study team will collect participants' urine samples to assess urinary albumin-to-creatinine ratio (UACR) and urinary protein-to-creatinine ratio (UPCR), which are important assessments for calculating the level of protein in the urine. Researchers will also collect blood samples to analyze serum creatinine and calculate estimated glomerular filtration rate (eGFR). A significant decline in eGFR indicates worsening kidney function. The study will include participants who had previously participated in FIONA study (NCT05196035). The participants will be aged from 1 year up to 18 years. The participants will be in the study for approximately 19 months. They will take study treatment for up to 18 months and will be follow up for 1 month. During this period, at least 12 visits are planned for patients who newly start finerenone, and at least 8 visits for patients who already received finerenone. In the visit, the study team will: * have their blood pressure, heart rate, temperature, height and weight measured * have blood and urine samples taken * have physical examinations * have their heart examined by an electrocardiogram and echocardiography (a sonogram of the heart) * answer questions about their medication and whether they have any adverse events, or have their parents or guardian's answer * answer questions about how they are feeling, or have their parents or guardian's answer * answer question about how they like the study medication, or have their parents or guardian's answer The doctors will keep track of any adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. The doctors will check the participants' health about 30 days after the participants take their last treatment.

Motor-Cognitive Training , Cognitive Performance and Balance

This RCT design investigates the effects of an 8-week motor-cognitive training program on cognitive performance and balance in preschool-aged children. Participants in the intervention group received structured motor-cognitive activities twice a week in addition to their regular physical education (PE) classes. The control group attended only standard PE classes and was restricted from participating in any other physical activity. Assessments included cognitive testing (Go/No-Go, Tower of Hanoi, and Corsi Block), anthropometric measurements, and static/proprioceptive balance testing. All measurements were conducted pre- and post-intervention.

Comparison of Induced Membrane Technique With Vascularized Fibula Flap for Pediatric Limb Reconstruction

This study has for goal to evaluate vascularised fibula flap and induced membrane for children's bone loss.

A Comprehensive Oral Health Intervention Program for Preschool and Primary School Children in Suzhou

This study aims to evaluate the effectiveness of a comprehensive oral health intervention program among preschool and primary school children in Suzhou, China. Preschools and primary schools in selected districts of Suzhou will be assigned to intervention or control groups. Children in the intervention group will receive a comprehensive oral health program involving oral health education, toothbrushing and rinsing instruction and practice, school- and family-based behavioral support, oral health promotion materials, and interactive educational activities. Children in the control group will receive basic oral health education and educational materials. Oral health examinations, anthropometric assessments, questionnaires, and other follow-up assessments will be conducted to evaluate changes in dental caries, oral hygiene, gingival health, oral health-related knowledge, and oral health behaviors. Participants will be followed for up to three years after the baseline assessment.

Effects of the Pediatric Intensive Care Unit Diary on Parents

Pediatric intensive care unit (PICU) admission is a highly stressful and potentially traumatic experience for parents, who may experience anxiety, uncertainty, helplessness, and post-traumatic stress symptoms that can persist after discharge. PICU diaries have emerged as a family-centered intervention to help parents understand and reconstruct the intensive care experience, reduce memory gaps, facilitate emotional expression, and strengthen communication with healthcare professionals. Previous studies suggest that PICU diaries are feasible, acceptable, and potentially effective in reducing psychological distress and improving family experiences. However, randomized controlled studies evaluating their effects on parental traumatic stress, anxiety, and satisfaction with care remain limited. Moreover, no experimental study evaluating a structured PICU diary intervention in Türkiye has been identified. Therefore, evaluating the effects of PICU diaries on parental psychological outcomes and satisfaction with care is warranted.

Video Games and Mask Painting on During Nebulizer Application in Children

The clinical features of respiratory system diseases seen in childhood are generally moderate and improve in a short time. Respiratory system diseases are divided into two as upper respiratory system diseases and lower respiratory system diseases. The respiratory tract, from the mouth and nose, which are the upper respiratory tract, to the glottis (nasal mucosa, nasopharynx, oropharynx, sinuses, middle ear tonsils and epiglottis) and the infections that occur in these sections are called upper respiratory tract infections (URTI). Lower respiratory system diseases are considered as tuberculosis, asthma, cystic fibrosis and bronchopulmonary dysplasia. The most common diseases in children are respiratory tract diseases. The diseases that are considered as priorities for each age group vary. According to the Turkish Thoracic Society, the incidence of lower respiratory tract infections (LRTI) between the ages of 0-5 is 29%. According to TUIK 2022 data, upper respiratory tract infections are the most common infectious diseases experienced by children between the ages of 0-6 with a rate of 31.3%, and lower respiratory tract infections are the third with a rate of 6.9%. In children between the ages of 7-14, upper respiratory tract infections are the most common with a rate of 27.1%, and lower respiratory tract infections are the third with a rate of 5.3%.

Improving School Climate and Children's Well-being Through the Life Skills "Feel Good" Intervention in French Schools: A Controlled Before-and-After Study

Life skills are major determinants of health that can be influenced through health promotion initiatives. Numerous educational interventions exist to foster the development of life skills. However, few interventions have been validated in France. The Feel Good program has been implemented for six years by CRIPS Île-de-France, particularly to address these public health challenges related to promoting children's health. Its goal is to improve life skills and the school climate among children in the 4th and 5th grades (CM1 and CM2). A playful, interactive, and recurring approach to developing PSS at school is expected to effectively promote a positive school climate and enhance children's well-being at school. The main objective of this study is to evaluate the effectiveness of a school-based life skills development program in improving school climate and children's well-being, through a before-after, here-elsewhere (control group) design. This action-research project adopts an interdisciplinary approach and will use mixed methods to evaluate the intervention. Three components are planned: 1) the study of implementation, 2) the effectiveness evaluation (main objective), and 3) the development of recommendations for the development and evaluation of such interventions. A theoretical model of change has been developed for the effectiveness study, aligned with process data. The project has received ethical and regulatory approvals (UPC and Inserm), and a pilot study has already been conducted. The expected outcomes include scientific knowledge on the validity of health promotion programs based on the development of life skills for children. The project also aims to develop research methodologies for evaluating health promotion interventions (evidence-based data) and to establish recommendations (replicability), as well as for other themes or populations (transferability).

The Effect of Quilling Exercise Applied Before Cardiac Catheterization and Angiography

The heart is one of the most important organs of the body. Any defect in the heart or blood vessels can cause serious problems and include a number of health problems that reduce the quality of life. Despite recently developing technologies, heart diseases are one of the important causes of morbidity and mortality in children. He contributed to the determination of the treatment plan in more than 84% of the cases in cardiac catheterization and angiography, which are widely used in the diagnosis and treatment of congenital heart diseases. Since the cardiac catheterization and angiography procedure consists of a process, the nurse plays an important role in shortening the treatment time, increasing the comfort level, and reducing anxiety and fear as a result of the correct interventions that follow the patient before, during and after the procedure. For this reason, the nurse must be equipped and have sufficient knowledge in the field in the nursing care and interventions applied to patients for whom angiography is planned. Since cardiac catheterization and angiography is an invasive procedure and requires surgical intervention, it can cause negative situations such as fear, pain and anxiety in children. Since it is thought that it can be effective in reducing fear and anxiety in children through the Quilling Set activity planned to be implemented in the study in order to reduce the negative situations caused by the procedure, it is thought that the study will make a positive contribution to children and parents in physical and psychological terms.

New Generation Rehabilitation Approach in Children With Dysfunctional Voiding

The investigators hypothesize that Dynamic Neuromuscular Stabilization training, a next-generation exercise approach, and transabdominal ultrasound-guided pelvic floor muscle training (PFMT) will be more effective than PFMT guided solely by transabdominal ultrasound in reducing post-void residual volume, improving voiding disorder symptoms, and enhancing pelvic floor muscle relaxation in children with dysfunctional voiding.

Maternal Voice Versus White Noise in Pediatric Surgery

This randomized controlled study will evaluate the effects of maternal voice and white noise on postoperative pain, comfort, and physiological parameters in children aged 1 month to 3 years during the early postoperative period. The study will also compare the effectiveness of maternal voice and white noise in improving these outcomes.

Influence of Body Position on the Defecation Model During Anorectal Manometry.

Anorectal 3D manometry (3D HRAM) is the most advanced version of manometric equipment that measures pressures along the anal canal in a very detailed manner. It provides complete data about pressure profile of anorectum and may indicate impaired defecation dynamics. Resent studies suggest that the position in which 3D HRAM is performed should be changed. So far, no scientific research has been performed in children that directly compares both positions. The reference values of registered pressures during 3D HRAM in people without complaints were not specified, which would allow for a more precise diagnosis of patients with an incorrect defecation model and precise selection of patients who could benefit from biofeedback therapy.

Cerebral Palsy and the Study of Brain Activity During Motor Tasks

Background: \- Two ways to study the brain while people are moving are near-infrared spectroscopy (NIRS) and electroencephalography (EEG). NIRS uses light to look at blood flow in the brain when it is active. EEG records electrical activity in the brain. Both have been used safely for many years, even in very young children. NIRS or EEG can be used while a person is moving to show which parts of the brain are the most active. Researchers want to use NIRS and EEG to study brain activity during movement in people with cerebral palsy and healthy volunteers. Learning more about how people with and without cerebral palsy use their brain to control their muscles may lead to new ways of training people with cerebral palsy to move better. Objectives: \- To study how the brain controls body movement in people with and without cerebral palsy. Eligibility: * Individuals at least 5 years of age who have cerebral palsy. * Healthy volunteers at least 5 years of age. Design: * This study has three parts. People with cerebral palsy will be selected for all three. Healthy volunteers will be asked to do only two of them. Everyone who participates will have NIRS and/or EEG exams during movement. People with cerebral palsy may also have biofeedback sessions to train coordination of movement and brain activity. * Participants will be screened with a physical exam and medical history. Urine samples may be collected. * All participants will have at least one session of NIRS and/or EEG imaging studies. Sessions may also include the following tests: * Magnetic resonance imaging to look at the brain * Electromyography to measure electrical activity of the muscles * Motion analysis of specific body parts * Ultrasound to measure activity of the muscles * Motorized, robotic, and electrical stimulation of the muscles * Other clinical tests of muscle movement as needed. * Participants with cerebral palsy will have biofeedback sessions. These sessions will help them learn to coordinate muscle movement and brain activity.

Subclinical Myocardial Dysfunction in Children With Wilson's Disease

Wilson's disease (WD) is one of the most common metabolic liver diseases in older children. The most frequent clinical presentation is liver disease. However, Wilson's disease (WD) is a multisystem disorder. It is concluded that four modes of cardiac manifestations in Wilson's disease (WD) include arrhythmias, cardiomyopathy, cardiac death, and autonomic dysfunction. Such possible cardiac involvement should be added to the clinical picture of Wilson's disease (WD) involving the hepatic and central nervous system(CNS). The data on cardiac manifestations in children is very limited and only few adult studies are available. In this study, the investigators aim to unveil subclinical cardiac dysfunction in children with Wilson's disease with apparently normal cardiac functions by conventional assessment.

Testing and Evaluation of the Returning to the Land Intervention to Address and Prevent Substance Misuse

This study aims to test the Returning to the Land intervention in partnership with a tribal community. The program is designed to address caregiver substance use and child emotional and behavioral development.

Evaluation of a Multicomponent Early Intervention for Childhood Obesity Prevention in Vulnerable Families

Childhood obesity is a public health concern. Evidence-based, multicomponent, parenting interventions targeting early childhood and adapted to families' socioeconomic context are needed to prevent childhood obesity. This study aims to evaluate the effectiveness of an early intervention in primary care for the prevention of childhood obesity, targeting vulnerable families where the mother and/or the father has overweight or obesity. More specifically, the primary aim of this study is to evaluate the effectiveness the intervention to maintain a healthy weight in children aged 6 months to 3 years, measured by the BMI-for-age z-score at baseline, 6, 12, and 18 months, compared to usual care. The study also aims to evaluate the effectiveness of the intervention, compared to usual care, for: promoting responsive feeding, improving dietary intake, improving parents' and children's physical activity levels, improving parents' eating styles, and improving children's sleep. Finally, the study aims to determine the feasibility of implementing the intervention, and to identify factors influencing change and contextual factors in the implementation process. A pragmatic cluster randomized controlled trial will be conducted. Approximately 526 families (parent-child family dyads) will be recruited, belonging to approximately 76 primary care centers. Primary care centers will be randomly assigned to either an intervention or control group. The intervention has been previously co-designed with families and healthcare professionals, and consists of five weekly sessions and four monthly sessions, lasting two hours each. It will be delivered by previously trained healthcare professionals or by members of the research team, depending on the preferences and availability of the primary care center professionals. Approximately 38 intervention face-to-face groups will be conducted, one in each primary care center allocated to the intervention group. The study will be conducted in Catalonia, Andalusia, the Balearic Islands and Castile and León (Spain). Effectiveness outcomes include child body mass index (BMI) z-score, parent feeding practices (measured with the Feeding Practices and Structure Questionnaire), child dietary intake (measured with the multiple-pass 24-hour recall), parents' eating behaviours (measured with the Dutch Eating Behavior Questionnaire), child movement (measured with the Movement Behavior Questionnaire), parents' movement behaviours (measured with the Brief Physical Activity Assessment Tool), and child sleep (measured with selected items from the Brief Infant Sleep Questionnaire). Implementation and feasibility outcomes will be assessed through interviews during and at the end of the intervention, and through attendance sheets and a final satisfaction questionnaire. This study will provide pioneering insights into the implementation and effectiveness of this intervention within the public healthcare system in Spain. This will allow the potential implementation in the future at a larger scale.

Standard Urotherapy for Dysfunctional Voiding in Children

This study aims to assess the efficiency of the standard urotherapy for the management of dysfunctional voiding in children.

Vitamin D2 vs Vitamin D2 Plus Calcitriol in Cholestatic Children With Vitamin D Deficiency

The goal of this clinical trial is to learn whether adding calcitriol to vitamin D2 can improve vitamin D deficiency in children with cholestasis and chronic liver disease. Cholestasis is a condition in which bile flow is reduced, which can make it difficult for the body to absorb and process vitamin D. The study will also learn about the safety of using vitamin D2 together with calcitriol. The main questions it aims to answer are: * Does vitamin D2 plus calcitriol increase blood 25-hydroxyvitamin D (25-OHD) levels more than vitamin D2 alone after 3 months of treatment? * Does vitamin D2 plus calcitriol help more children reach an adequate vitamin D level by 3 and 6 months? * What medical problems, especially high calcium or high phosphorus levels, occur during treatment? Researchers will compare children who receive vitamin D2 alone with children who receive vitamin D2 plus calcitriol to see which treatment improves vitamin D levels more effectively and safely. Participants will: * Take vitamin D2 alone or vitamin D2 plus calcitriol as assigned by randomization * Visit the clinic for study assessments at the start of the study, at 3 months, and at 6 months * Have blood tests to measure vitamin D levels, calcium, phosphorus, parathyroid hormone, liver function, and other safety markers * Have their treatment reviewed at 3 months; participants whose vitamin D level remains low may have their treatment adjusted according to the study plan * Bring back medication packages so researchers can check how regularly the study medicines were taken

Effective Implementation Control Trial

This study will evaluate the effectiveness and implementation of a theory-driven, WhatsApp-based family engagement intervention designed to improve oral health among primary school children. Parents or primary caregivers will be randomly assigned (individually or by school, depending on the study design) to either receive the digital intervention or usual care. The intervention will deliver structured oral health education, behaviour-change messages, reminder prompts, short videos, interactive quizzes, and parent-child brushing activities through WhatsApp over a predefined intervention period (e.g., 6-12 months). The primary effectiveness outcomes will include improvements in children's oral hygiene status (e.g., OHI-S, Plaque Index, Gingival Index, and dental caries where appropriate) and oral health behaviours such as twice-daily toothbrushing and reduced sugary snack consumption. Secondary outcomes may include parental oral health literacy, self-efficacy, and supervised brushing practices. Alongside effectiveness, the study will assess implementation outcomes-including acceptability, feasibility, adoption, fidelity, reach, and sustainability-to determine whether the intervention can be successfully integrated into routine school and community oral health programmes. Findings will provide evidence on both whether the intervention works and how it can be implemented and scaled in low- and middle-income countries.

Effects of Topical Anesthetics on Pain and Anxiety in Children

Dental anxiety and pain associated with local anesthetic injections are among the most common barriers to successful dental treatment in children. Topical anesthetic agents are widely used to reduce discomfort during needle insertion; however, evidence regarding the comparative effectiveness of different formulations remains limited. This prospective observational study aims to evaluate the effects of four routinely used topical anesthetic applications (benzocaine spray, benzocaine gel, lidocaine spray, and lidocaine gel) on pain and anxiety during local infiltration anesthesia in pediatric dental patients. The study will include 160 healthy children aged 6-8 years who require maxillary infiltration anesthesia for routine dental treatment. The choice of topical anesthetic will be determined by the treating clinician as part of routine clinical practice, and no additional intervention or treatment modification will be performed for research purposes. Dental anxiety will be assessed using the Modified Child Dental Anxiety Scale-faces version (MCDASf), behavioral responses during local anesthetic administration will be evaluated using the Sound, Eye, and Motor (SEM) scale, and self-reported pain will be measured using the Wong-Baker FACES Pain Rating Scale. Physiological parameters, including heart rate, blood pressure, peripheral oxygen saturation (SpO₂), and body temperature, will be recorded before, during, and after local anesthetic administration. The findings are expected to provide evidence regarding the effectiveness of commonly used topical anesthetic formulations in reducing pain and anxiety during pediatric dental treatment and may contribute to optimizing behavior management strategies in clinical practice.

A Multifaceted Intervention to Reduce Obesity Among Preschool Children: Study Protocol for a Randomized Controlled Trial in Suzhou City

This study aimed to develop a comprehensive, multi-faceted intervention program for weight control and systematically evaluated its effectiveness on indicators of adiposity.