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NCT07635862
The goal of this study is to conduct a randomized, placebo-controlled trial (RCT) of ganaxolone, a neuroactive steroid (NAS), in autistic children and adolescents aged 5 to 17 years old. Ganaxolone is approved and effective for treating seizures in children as young as 2 years old who have CDKL5 deficiency disorder (CDD), a neurogenetic condition associated with developmental delays, seizure disorder, hypotonia, visual impairments, and autistic features. The primary outcome of interest for this trial is irritability on the Aberrant Behavior Checklist (ABC) because it is a common symptom of emotion dysregulation in ASD that impacts quality of life, including mental health, independence, educational opportunities, and integration into the community. The secondary domains of interest for this trial are restricted and repetitive behaviors (RRB), specifically insistence on sameness (IS), a subdomain of RRB characterized by inflexibility and a strong preference for predictable routines and familiar environments. Secondary outcome measures include the IS subscale from the Dimensional Assessment of Repetitive Behaviors (DARB) and subscales of the Clinical Global Impressions Scale for irritability (CGI-IR) and IS (CGI-IS). For participants living within 150 miles of Stanford University, we require participants to attend site visits and attempt EEG and MRI procedures before and after the trial, though we are recruiting nationally and the study can be completed without site vists.
NCT07593560
Scoliosis is a sideways curvature of the spine that often develops during childhood and adolescence. When detected early, scoliosis can be managed effectively with non-invasive approaches such as bracing and physiotherapy, while late detection frequently leads to surgical intervention. Current screening methods rely on physical examination and X-ray imaging, which exposes children to ionizing radiation and may miss early-stage cases. This observational study investigates whether millimeter-wave (mmWave) radar, combined with deep learning (a type of artificial intelligence), can detect early signs of scoliosis by analyzing how a child walks. The radar sensor records subtle movement patterns during walking without using cameras and without producing any identifiable images, fully preserving the participant's privacy. No ionizing radiation is involved. Pediatric participants attending the orthopedic clinic for routine scoliosis evaluation are invited to walk a short distance in front of a mmWave radar sensor. The collected gait recordings are then analyzed using deep learning models, and the results are compared with the participant's standard clinical scoliosis assessment performed by a pediatric orthopedic specialist. The diagnostic performance of the deep learning model is evaluated using sensitivity, specificity, and overall accuracy. If the approach proves accurate, it could offer a radiation-free, privacy-preserving, and low-cost alternative for early scoliosis screening in schools, primary healthcare centers, and pediatric orthopedic clinics, ultimately supporting earlier diagnosis and reducing the long-term clinical burden of untreated scoliosis.
NCT04717349
Background: Gynecologic conditions are those that are related to the reproductive system. They can be reproductive gland disorders or reproductive system tumors. They can also be inborn anomalies of the reproductive tract. Researchers want to gather data over time from a large group of young people with these conditions. Objective: To create a database about child and teenage gynecologic conditions. Eligibility: Participants of any age with known or suspected pediatric and adolescent gynecologic conditions, and their adult family members Design: Participants will be screened with a review of their medical records. Participants may have a medical history and physical exam. Participants will have blood drawn using a needle. The blood will be used for genetic tests. Participants will have saliva collected. They will spit into a small plastic container. Or their spit will be absorbed from their mouth using a small sponge. The saliva will be used for genetic tests. Participants may have samples collected from their vagina. A small cotton swab will be used to gather the samples. This procedure is optional. If participants have a surgery related to their condition, a small tissue sample will be taken. It will be stored for future research. Participants may complete optional surveys. These surveys ask about their physical and emotional health. They can choose not to answer any of the questions. Researchers will collect medical data from participants standard tests. Such tests may include blood and urine tests, X-rays, nuclear medicine scans, and other tests. Data will also be collected from standard treatments they may receive.
NCT06797050
The aim of the present study is to improve cognitive processes that are frequently impaired in children characterised by neuromotor impairment, such as the skills of visual-perceptual analysis and selective attention, working memory, narrative organisation, logical-inferential reasoning and motor planning. For this purpose, a task of reordering figurative stories and action sequences, which include the aforementioned processes, will be used through an innovative Learning by Teaching training paradigm with a social robot. Furthermore, the study aims to verify the children's level of behavioural, cognitive and emotional engagement during the interaction with the social robot and to test the generalisation effects of the intervention on other processes, such as working memory, inhibition and planning.
NCT04036331
The purpose of this research is to determine the effectiveness of a coordinated program (Dyad Plus) that would help to facilitate self-monitoring, positive communication, joint problem solving, and social support to increase physical activity, healthy eating, and weight loss. Participants of the Brenner FIT (Families In Training) pediatric weight management program and their parent/guardian will co-enroll in weight loss programs. Parents/guardians will receive the components of By Design Essentials.
NCT06309121
This study investigates the effects of a postbiotic combination called ABB C3 on reducing body fat and improving metabolic health in children and teenagers. The study consists of a 3-month trial with half participants taking ABB C3 and the other half a placebo, monitoring body composition and blood markers. Afterward, participants can continue with ABB C3 for an additional 3 months. The goal is to determine if ABB C3 is a safe and effective way to help young people improve their health by reducing body fat.
NCT03369691
The study will examine the mechanisms linking race, stress and biobehavioral factors to energy balance and obesity in both natural and controlled environments in African-American and Caucasian adolescent females. A Hispanic/Latina cohort has recently been added with permission for the sponsor.
NCT07252687
Breast dysphoria in transmasculine or genderdiverse individuals is a distinct psychological burden associated with depression, anxiety and suicidality. The aim is to systematically investigate the effect of GAHT (gender-affirming hormone therapy) and mastectomy on this form of dysphoria. The primary objective of this study is to analyse and investigate the psychological and physical effects of breast development on trans men or genderdiverse individuals. A secondary objective is to determine the extent to which the stress affects the well-being of trans men depending on the coping strategies used (binding vs. taping).
NCT07285551
The aim of this study is to assess how physiotherapy based on the Rigo Concept, combined with WBV, affects sagittal spinal curvatures, the angle of trunk rotation (ATR), and trunk symmetry in girls with AIS. Participants undergo a 5-day individualized physiotherapy program. The exercises follow the four general principles of the Rigo Concept: three-dimensional postural correction, expansion technique, muscle activation, and integration. Therapy is delivered for 3 hours per day, with three 15-minute breaks. Additionally, participants in the Rigo Concept with WBV group perform exercises in a standing position using two poles while exposed to WBV on a Galileo Med 35 platform (Novotec Medical GmbH, Pforzheim, Germany) at a frequency of 25 Hz, with a peak-to-peak displacement of 2 mm. Each session includes three 3-minute bouts of vibration, with 3-minute rests between them. During WBV, participants perform exercises according to the principles of the Rigo Concept.
NCT07441213
Thoracic hyperkyphosis is a common spinal deformity that may alter the biomechanical and viscoelastic properties of trunk muscles. This comparative study aims to investigate differences in the mechanical properties of selected back and chest muscles between individuals with hyperkyphosis and healthy controls. A total of 88 participants will be categorized based on thoracic kyphosis angle (≥50° hyperkyphosis; \<50° control). The kyphosis angle will be measured using a flexible ruler method. Muscle tone, stiffness, elasticity, and relaxation properties of the trapezius, erector spinae, and pectoralis major muscles will be assessed using a handheld myotonometer. Spinal appearance perception will be evaluated using a kyphosis-specific questionnaire. The study is designed to examine whether differences exist in muscle mechanical properties and whether kyphosis severity is associated with asymmetry in viscoelastic muscle characteristics.
NCT07426588
The study was conducted to compare the effective of thoracic extension exercises and global postural corrective exercises on pain, range of motion and posture among hyperkyphotic individuals.
NCT05832957
Background: Attention deficit hyperactivity disorder (ADHD) is associated with a high risk for driving accidents. Adolescents with ADHD are 1.2 to 4 times more prone to be involved in car accidents. Driving accidents are the leading cause of death among adolescents. Objective: Examining a multidimensional applied intervention based on serious gaming principles to improve the driving capabilities and skills of adolescents with ADHD Methodology: The study will include 90 adolescents (aged 15-18 years old) with ADHD diagnosis who did not yet start driving lessons. Participants will undergo a stratified randomized clinical trial, single-blinded. The stratified randomization process will include gender, age, and medication status. There exist three different intervention modalities: (1) A personalized cognitive-functional intervention- 'Drive-Fun' (group1) (2) educational intervention (group2); and (3) no intervention (group3). Meetings will entail 11 once-a-week sessions. Participants will be evaluated before intervention (baseline), after the intervention, and at a 6-month follow-up. Evaluations will include simulated driving skills, meta-cognitive abilities, eye tracking, and brain activity (EEG) measures. The evaluation and the intervention will be conducted by two certified occupational therapists. Participants and the therapist performing the evaluations will be blinded to group type and intervention. The potential scientific contribution of the proposed research: Given the great risks of injury to adolescents with ADHD and other road users, it is important to identify dangerous driving behaviors as well as develop methods that can lead to better driving skills and a safer driving experience. It is anticipated that evidence will be presented by the evaluation battery that the personalized intervention program developed will significantly improve potential driving skills on the simulator and hopefully also actual driving.
NCT07365891
The goal of this study is to find out how well adolescents in Dutch-speaking secondary schools in Brussels can recognize emotional neglect, and how this relates to their intention to seek help. The main research questions are: 1. How well do adolescents recognize situations of emotional neglect, and do boys and girls differ in their recognition? 2. Does recognition of emotional neglect predict adolescents' intention to seek help? This study is conducted through an online survey. Participants will read one of four short written stories about an adolescent experiencing emotional neglect. The stories vary by gender (boy or girl) and by the clarity of the neglect (clear or ambiguous). After reading, participants answer questions about the story, including their thoughts and how they might respond in a similar situation. They also answer questions about their own experiences and attitudes toward help-seeking.
NCT07368166
Population-based and clinical studies indicate that a substantial proportion of children and adolescents are exposed to one or more potentially traumatic events (PTEs) Approximately 16 % of those affected by childhood trauma go on to develop post-traumatic stress disorder (PTSD), with an even higher proportion experiencing subclinical levels of post-traumatic stress symptoms (PTSS). In Switzerland, over half of adolescents report exposure to at least one PTE, with 4.2 % meeting diagnostic criteria for PTSD. PTSD frequently impacts young people's social and educational functioning, often impairing their ability to engage in everyday life activities that are important or meaningful to them. Although the psychological consequences of PTSD are well documented, there is limited empirical understanding of how PTSS specifically affects day-to-day functioning in young people. A key reason for this gap is the absence of a validated instrument specifically designed to assess PTSD-related functional impairment in children and adolescents. To address this need, the PTSD-iMPairment in Adolescent \& Children's Capacity for Thriving (PTSD-iMPACT) measure was developed. This tool aims to systematically assess the extent of PTSD-related functional impairment in children and adolescents across key life domains, such as family, friends, school, apprenticeship, hobbies or media use. The overall aim of this study is to evaluate the psychometric properties of the PTSD-iMPACT questionnaire in a clinical and in a non-clinical sample and to provide an internationally applicable standard instrument for the assessment of PTSD-related functional impairment in trauma-exposed children and adolescents. In the long term, the aim is to ensure that the care and support provided to children and adolescents who experience difficulties in their daily lives due to post-traumatic stress symptoms are sustainably monitored and improved.
NCT07047794
In the sagittal plane, the average kyphosis angle between the superior endplate of the T1 vertebra and the inferior endplate of the T12 vertebra is approximately 40 degrees. A thoracic spine angle greater than 45 degrees is defined as hyperkyphosis. The most common types of hyperkyphosis observed in juveniles and adolescents are Scheuermann's kyphosis, postural hyperkyphosis, and congenital hyperkyphosis. Postural hyperkyphosis is the most prevalent form among these types. It results from the weakness of the muscles responsible for maintaining an upright posture and occurs due to external forces acting on the spine. The curvature of the spine in this condition is not rigid and can generally be corrected when the individual is asked to stand upright. Postural hyperkyphosis is typically seen during adolescence. An increased thoracic kyphosis angle in postural hyperkyphosis can affect scapular kinematics, potentially leading to shoulder pathologies later in life, such as impingement syndrome, rotator cuff tendinopathy, rotator cuff tears, glenohumeral instability, and adhesive capsulitis. Additionally, hyperkyphosis can negatively affect body image and overall quality of life. If it begins in childhood and remains untreated, hyperkyphosis may persist into adulthood and contribute to increased healthcare expenditures. Given the growing prevalence of technology dependence and its association with rising hyperkyphosis incidence, early management of this deformity during juvenile and adolescent periods is essential in terms of both health and economic outcomes. In managing postural hyperkyphosis, it is important to address not only the angular correction of the deformity but also to consider the entire spine within the kinetic chain model. The kinetic chain model is a biomechanical concept that defines the body as a system of interconnected segments. Any dysfunction within one segment of the kinetic chain can affect the quality of movement in both the upper and lower segments. The scapula serves as a foundation within this model, acting as a force transmitter that converts potential energy generated by muscles into kinetic energy in the upper extremity. Hyperkyphosis can lead to scapular protraction and downward rotation, disrupting the normal positioning of the scapula. As a result, joint range of motion, strength, and performance in the upper extremity may be negatively affected. Studies in the literature have shown that scapular positioning and movements play a critical role in upper extremity function. However, no study has been found that specifically investigates the impact of altered scapular position on upper extremity performance in children with thoracic hyperkyphosis. Considering the increasing prevalence of thoracic hyperkyphosis in children due to rising technology addiction, and the potential for this deformity to contribute to upper extremity pathologies in adulthood, identifying its effects is crucial for improving children's physical performance and reducing future healthcare costs.
NCT06318325
assessment of the musculoskeletal system will be performed twice a year, for three years of young gymnasts.
NCT07367919
The purpose of this study is to examine the effects of a digital literacy program on problematic internet use, emotion regulation, and loneliness among adolescents. The study aims to answer the following key questions: * Does a digital literacy program for adolescents affect problematic internet use, emotion regulation skills, and loneliness? * What is the effect of a digital literacy program for adolescents on the level of problematic internet use? * What is the effect of a digital literacy program for adolescents on emotion regulation skills? * What is the effect of a digital literacy program for adolescents on loneliness? Researchers will conduct pretest and posttest evaluations in the experimental and control groups to determine the effects of the digital literacy program on problematic internet use, emotion regulation, and loneliness in adolescents. Participants in the experimental group who meet the inclusion criteria will receive 8 weeks of positive youth development-based digital literacy training, 40 minutes per week. After the posttest measurements are completed, the intervention group will receive 2 weeks of digital literacy training.
NCT06242821
The Problem: Adolescent Idiopathic Scoliosis (AIS), the pre-eminent spinal pathology affecting over 5% of children and adolescents, presents a pronounced spinal curvature exceeding 10 degrees, with prevalence amongst female adolescents at a ratio of 3:1 compared to males. A significant portion of these patients are not immediate candidates for surgical intervention. The acute shortage of viable non-operative management strategies, which is becoming increasingly imperative given the current barriers to physical therapy access and the growing opioid crisis. The investigator's research intends to explore the addition of a structured yoga protocol to standard of care. This research will thus explore the potential for improved relief and quality-of-life improvements for AIS patients not ready for surgery. Significance: AIS is a pervasive condition which correlates with chronic and episodic lower back pain, diminished sleep quality, and depressive symptoms. This extensive comorbid association coupled with the financial pressure to patients and the healthcare system cannot be understated. Needs Statement: There is a lack of sufficient non-operative management options for AIS. Many patients face limited access and require supplementary management strategies to address the patient's conditions effectively, creating a significant unmet need for non-pharmacological pain management interventions. This need is further highlighted in the context of the escalating opioid crisis, a leading cause of death among adolescents and young adults. Hypothesis: The introduction of a structured yoga protocol can serve as a non-inferior or even superior alternative to traditional standard of care i management of AIS, addressing both the physical and psychosocial aspects intertwined with the condition. IMPACT: Change in Problem Significance: This research trial aims to enhance current standard of care for patients grappling with AIS. If the trial demonstrates superiority of yoga, it will delineate a paradigm shift in the current care standards for AIS patients, fostering a move towards a more cost-effective and holistic approach. Yoga could help alleviate the burdens on the healthcare system by reducing costs and enhancing accessibility for patients. Improvement in Pediatric Orthopedics Practice: By paving the way for non-pharmacological interventions, the trial aspires to mitigate the reliance on opioids for pain management in the pediatric demographic, therefore promoting overall well-being. This project not only seeks to develop alternative pain management strategies amidst a growing opioid epidemic but also champions the cause of improving the quality of life for the pediatric population battling chronic conditions like AIS. It echoes the urgent call to innovate and expand upon the current strategies in place, steering the medical community towards a future where integrative approaches are not the exception but the norm. Ultimately, this research aspires to guide the trajectory of pediatric orthopedics towards a healthcare system that is more inclusive, accessible, and holistically oriented, thereby enhancing the quality of life for pediatric patients grappling with conditions like AIS. 2\. Objectives (include all primary and secondary objectives) Goals/Objectives: To create a randomized clinical trial aimed to evaluate the efficacy of yoga in conjunction with standard of care treatments for AIS patients. SPECIFIC AIMS Aim 1: Evaluate the feasibility and challenges of implementing a yoga protocol for AIS patients. Methodology: Online class attendance, survey completions, and follow-up appointments. Anticipated Results: Adequate participant adherence and data reliability. Aim 2: Compare clinical outcomes between patients who receive traditional care modalities versus those who added yoga to treatment plan. Methodology: Utilize validated tools such as the SRS-22 questionnaire and monitor outcomes including depression scale, sleep quality, analgesic usage, activity levels, and Cobb angle. Anticipated Results: Significant physical and psychological improvements in the yoga group.
NCT07331051
Soccer players' agility can be affected by many factors, including nutrition and body composition. The primary objective of our study is to reveal the relationship between nutritional attitudes and anthropometric measurements and agility in elite adolescent soccer players. Our secondary objective is to determine the effect of daily fluid intake and daily sleep duration on anthropometric measurements, nutrition attitude scores, and agility in soccer players. Study was conducted on 51 male soccer players aged 14-18. Information on the soccer players' sociodemographic characteristics and lifestyles was obtained via a questionnaire. Body composition analysis was measured using a Bioelectrical Impedance Analysis (BIA) device, and hand grip strength was measured using a hand grip dynamometer. Height, waist circumference, and hip circumference were measured. Soccer players' attitudes toward nutrition were assessed using the Nutrition Attitude Scale (NAS), and their agility was assessed using the Agility T-Test.
NCT07314801
The FINCARE-Young study aims to investigate the extent and development of financial toxicity in adolescents and young adults with cancer. The primary purpose of this study is to assess the level of financial burden experienced during the acute phase of cancer treatment and after completion of therapy, and to analyze changes over time. In addition, the study seeks to identify sociodemographic, clinical, and socioeconomic factors associated with financial toxicity, as well as its impact on employment and social reintegration. By focusing on young adult cancer survivors, this study addresses an underexplored population and seeks to generate evidence to improve supportive care strategies and reduce long-term financial consequences of cancer.