Attention-Deficit/Hyperactivity Disorder (ADHD) is a neurodevelopmental condition affecting attention, impulsivity, and activity levels. Clinical trials explore various treatment approaches, including behavioral interventions and medication strategie...
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Researchers are investigating the use of 3D resin printed models in anatomy education, focusing on how fractured bone models affect students' decision-making and quiz results. This study aims to evaluate the practicality of these high-quality, detailed resin models compared to standard anatomical models, enhancing hands-on training for wrist fracture rehabilitation. The research is sponsored by Abant Izzet Baysal University and targets educational problems related to anatomical pathological conditions. Participants will receive a 60-minute theoretical lesson on wrist anatomy and fracture pathophysiology. Then, they are randomly assigned to one of two groups: one practices with 3D resin printed fractured wrist models, while the other uses standard anatomical wrist models. Both groups have 2-hour practical sessions scheduled during morning hours to reduce fatigue. The study compares the effectiveness of learning with these two types of models. During the study, participants undergo various assessments including a one-hour clinical test as the primary outcome. Secondary measures include academic motivation, test anxiety, and ease of use questionnaires, each taking about one hour. The study involves training sessions, practical handling of models, and evaluations to understand educational impact. The total study duration and follow-up details are as scheduled by the research team, concluding by October 30, 2025.
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Researchers are conducting the GENESIS clinical study to map the HLA genomic region in the Greek population and explore its possible links with various underlying diseases. This non-interventional, multicenter study aims to provide a pilot map of genetic variation in HLA that may be useful in medical research and clinical applications related to selected diseases. The study plans to include 12,000 participants over a total duration of 36 months. Each participant will attend one visit at a participating site during which they will provide demographic data, lifestyle information such as smoking and alcohol use, blood pressure measurements, details on diagnosed diseases and treatments, and recent laboratory test results if available. Buccal swab samples will be collected from each participant to extract DNA for HLA genotyping analysis. Selected samples will undergo further whole genome sequencing to investigate associations with autoimmune diseases. Participants will receive a personalized ancestry report after analysis completion. During the study visit, data collection includes demographic and health information, as well as laboratory and clinical test results from the past year. The genetic material from buccal swabs will be stored and processed for genetic analysis. Researchers will measure allele frequency of HLA alleles in the Greek population and assess the prevalence and risk associations of selected HLA-related diseases. The study's total duration is 36 months with results available at the end of this period.
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Researchers are evaluating the effects of a cognitive nutritional supplement on attention and focus in adults aged 25 to 65 years. This 12-week, double-blind, randomized study compares the supplement to a placebo in a general population of men and women in the United States, aiming to assess changes in cognitive functions related to attention and focus. Participants will take either pills of the cognitive nutritional supplement or matching placebo pills daily for 12 weeks. The study is conducted in a parallel design with two groups, where neither participants nor researchers know which treatment is given. Key assessments occur at the start, midpoint (week 6), and end (week 12) of the study. During the study, participants will use a study-provided iPad to complete various cognitive tests measuring attention and focus, including the Feature Match test and other related assessments at weeks 0, 6, and 12. Dietary intake and nutrient consumption are also monitored through food frequency questionnaires. Safety and adherence are tracked throughout the study period, with participants following specific guidelines on diet, physical activity, and substance use to ensure consistent testing conditions.
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Researchers are investigating the effects of the PAX Good Behavior Game (GBG) in Swedish primary schools to address growing concerns of mental health issues among children and stress-related symptoms in teachers. This cluster-randomized controlled trial involves 28 schools and about 84 teachers, aiming to improve student well-being and reduce teacher stress. The study compares PAX GBG to active control interventions that also provide teacher training but with different content. The trial includes extensive measurements over two years, including self-assessments, classroom observations, sound level monitoring, sick leave data, and qualitative interviews. Teachers randomized to the PAX GBG group receive a two-day training on ten specific tools designed to promote prosocial and focused behaviors in classrooms, including a team-based game rewarding good behavior. Control schools choose between two alternatives: 'Count On Me!', a math fluency application for pupils, or a Collegial Learning Community intervention focused on professional development for teachers. Both groups receive similar amounts of training and supervision, including multiple sessions during the school year. The interventions are integrated into regular classroom activities starting in grade 1 through grade 3. Participants include approximately 2200 pupils and their teachers, with data collected through various methods such as questionnaires, standardized tests, observer ratings, and registry data. Measurements occur at multiple time points over two years, focusing on pupil well-being, teacher stress, classroom behavior, noise levels, and implementation fidelity. The study also evaluates cost-effectiveness by comparing health outcomes and related expenses. Safety and adverse events are monitored through teacher reports and interviews, ensuring comprehensive assessment of the interventions' impact.
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Researchers are evaluating the accuracy of the MT1 algorithm using the MindTension biometric sensor device as a tool to help healthcare providers diagnose ADHD in youth aged 6 to 17 years. The study compares the MT1 algorithm's results with a clinical diagnosis made by specialists using standardized interviews and rating scales based on DSM-5 criteria. This evaluation also compares the MT1 algorithm's agreement with clinician diagnosis to that of the FDA-cleared Test of Visual Attention (TOVA) device. Participants will undergo assessments using well-established interviews such as the K-SADS and ADHD-RS-5 rating scale, with IQ estimated by two subtests of the WASI. The study involves two groups: one diagnosed with ADHD and one without, both evaluated with the same clinical tools. The MT1 algorithm's output derived from the MindTension device will be compared to these clinical standards and the TOVA device. During the study, participants will complete the clinical assessments, rating scales, and biometric testing over approximately 1 to 2 days. Researchers will measure the overall agreement rate between the MT1 algorithm and clinical diagnosis, along with secondary measures like sensitivity, specificity, and predictive values. These outcomes will help determine how well the MT1 algorithm performs as a diagnostic aid for ADHD in youth.
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This research aims to evaluate a digital treatment combining an iPad-based cognitive training program called AKL-T01 with metacognitive strategy coaching to improve executive dysfunction, depression symptoms, and daily function in individuals who have experienced a stroke. The study focuses on those with post-stroke depression and executive dysfunction, conditions linked to ongoing mood and cognitive challenges. Researchers will assess whether this combined treatment enhances brain connectivity and overall functioning compared to a control group. Participants in the intervention group will use the AKL-T01 program for 25 minutes a day, five days a week, over six weeks. This program involves multitasking exercises in a video game-like environment using an iPad. Alongside this, they will receive weekly 45-minute coaching sessions with a clinician to reflect on their experiences and develop strategies for daily activities. The control group will engage in general cognitive games on the iPad for the same duration and frequency, also paired with similar coaching sessions. Throughout the study, participants will undergo assessments at the start and end of the six-week treatment period. These include tests measuring executive function, depression symptoms, daily functioning, and brain connectivity through MRI scans. Researchers will monitor adherence to the treatment and evaluate changes using standardized tools such as the Oral Symbol Digit Modalities Test, Montgomery Asberg Depression Rating Scale, and resting state functional MRI. The total study duration for each participant is six weeks.
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Suicide is the second leading cause of death among youth, and rates in the US are rising despite prevention efforts. Researchers are evaluating a digital platform called Vira to improve how care is delivered to adolescents at high risk for suicide. This platform aims to use smartphone data and secure communication tools to better understand and manage risk factors like psychological distress, anhedonia, behavioral withdrawal, and sleep problems in young people receiving intensive outpatient treatment. The study compares two groups of adolescent patients aged 13 to 18 years old who are in an intensive outpatient Dialectical Behavior Therapy (DBT) program. One group uses the Vira platform, which collects data passively from smartphone sensors about activity, sleep, mobility, and mood-related language. Vira also prompts daily check-ins and supports practitioners with reminders to encourage behavior changes. The other group receives the usual treatment with the addition of a passive monitoring app called EARS. Participants will use their assigned app during their intensive outpatient treatment. Researchers will assess outcomes using tools like the Columbia Suicide Severity Rating Scale and Scale for Suicidal Ideation over six months. Other measures include anxiety, risky behaviors, sleep quality, mood, and pleasure scales at three and six months. The study monitors clinical outcomes to determine if the digital platform enhances care for youth at risk of suicide.
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Researchers are evaluating a family-centred approach to prevent cardiovascular diseases (CVD) among adolescents and their families in Uganda. This 5-year study focuses on reducing risk factors like unhealthy diet and physical inactivity that contribute to CVD and other non-communicable diseases (NCDs). The study adapts a proven intervention from Asia to the Ugandan context, aiming to support healthier lifestyle behaviors during the critical adolescence period when habits form that affect adult health. The study includes two groups: one receiving the FaCe-D intervention, which involves home visits by Village Health Teams delivering diet, physical activity, and health messaging; and a control group receiving standard care with usual health promotion activities. The study is divided into three phases: adapting the intervention, implementing it, and evaluating its effectiveness and feasibility in 32 villages. Participants will be involved for at least 12 months, during which researchers will assess changes in cardiovascular health and sleep quality. Evaluations include monitoring behavior changes, health outcomes, and implementation costs. The study also considers adoption and feasibility to understand how well the intervention works in real community settings.
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Researchers are evaluating a new tablet game-based tool designed to assess neurodevelopment in young children aged 3 to 8 years. This study aims to determine if the game can accurately distinguish between typically developing children and those with neurodevelopmental disorders such as ADHD, Autism Spectrum Disorder, Specific Learning Disorder, or Communication Disorder. It also seeks to assess how valid and reliable the game-based assessment is for evaluating a child's neuropsychological functions. Participants will complete the tablet game-based assessment, which evaluates attention, memory, language, motor skills, executive functions, and social-emotional abilities. Parents or caregivers will fill out a demographic questionnaire and the Adaptive Behavior Assessment System, Third Edition (ABAS-3), to provide additional developmental information. Some children may be asked to repeat the game assessment about two weeks later to check the consistency and validity of the tool. Children's involvement includes playing the game-based assessment and having their caregivers complete questionnaires about their development and background. The study will measure diagnostic accuracy, validity, internal consistency, predictive validity, and safety of the assessment over a period of 16 months. Researchers will also collect preliminary normative data, evaluate the acceptability of the tool, and assess test-retest reliability to ensure the assessment's usefulness and safety throughout the study.
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Researchers are evaluating the effectiveness and feasibility of Narrative Enhancement and Cognitive Therapy (NECT), a group-based treatment designed to reduce self-stigma in people with mental disorders. Self-stigma involves internalizing negative stereotypes which can harm treatment adherence, self-esteem, quality of life, and increase despair or suicide risk. This pragmatic, multicenter, randomized controlled trial includes 416 patients from 26 mental health centers in Northeast Italy, aiming to improve psychological outcomes like self-esteem, hope, empowerment, recovery perception, and mental well-being. Participants in the intervention group will attend 20 one-hour NECT group sessions divided into five parts: orientation, psychoeducation, cognitive restructuring, narrative enhancement, and conclusion. The therapy helps challenge stigmatizing beliefs and fosters a positive self-narrative. This group therapy is provided alongside participants' usual care, which may include medication and psychosocial treatments. The control group will continue their standard care without NECT. The study lasts about 12 months, with a 2-month recruitment phase, 5 months of intervention, and 5 months for data analysis and publication. Participants will undergo assessments at enrollment and after the 20-week intervention to measure changes in self-stigma, self-esteem, hope, empowerment, recovery perception, mental well-being, and stigma-related stress. Treatment fidelity will be monitored through session recordings. The study also tracks feasibility by evaluating participation rates and feedback. All participants remain under their usual care throughout the study, and data collection includes monitoring care received during the trial.
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