Clinical Research Directory

Laughter Yoga Integrated PRECEDE-PROCEED Health Education Program in Adolescents

Adolescence is a critical developmental period in which lifelong health behaviors are shaped, and behaviors acquired during this stage significantly influence health outcomes in adulthood. Physical activity, healthy nutrition, adequate sleep, stress management, and positive social relationships are among the key determinants of adolescent health. However, current evidence indicates that physical inactivity, unhealthy dietary habits, sedentary lifestyles, and psychosocial problems remain highly prevalent among adolescents globally. In addition, insufficient access to health information and inadequate health information-seeking behaviors among adolescents have been reported to be associated with risky health behaviors. Therefore, the development of healthy lifestyle behaviors in adolescents is considered a public health priority. Schools are recognized as strategic settings for health-promoting interventions targeting adolescents due to their significant social and educational influence on health behaviors. Recent systematic reviews and meta-analyses report that school-based and multi-component interventions have positive effects on adolescents' health behaviors and psychosocial well-being. The integration of behavioral and psychosocial components in school-based health education programs has been associated with more effective and sustainable improvements in adolescent health outcomes . In this process, school health nurses play a critical role in planning and implementing preventive and health-promoting interventions for adolescents . Moreover, it has been reported that healthy behaviors gained through school health nursing interventions may persist into adulthood . Additionally, a systematic review of health education interventions has shown that multi-component approaches-such as classroom education combined with school policies, parental involvement, and school-community collaboration-produce more significant effects on adolescent health outcomes. In recent years, there has been increasing interest in complementary approaches supporting stress management and emotional well-being in school-based interventions. In this context, laughter yoga is described as a low-cost, feasible, and group-based method associated with reduced stress, improved psychological well-being, and enhanced social interaction. Experimental studies conducted with adolescents have also demonstrated that laughter yoga has positive effects on school burnout, hope, and educational stress. However, the literature indicates a limited number of studies examining the integration of laughter yoga into structured school-based health education programs and its effects on healthy lifestyle behaviors. In line with the life-course health perspective, school-based interventions aimed at health promotion during childhood and adolescence are reported to be critical for the sustainability of healthy lifestyle behaviors. In this context, the PRECEDE-PROCEED Model is a theoretical framework widely used in the planning and implementation of health promotion programs, systematically assessing behavioral, environmental, and psychosocial factors influencing health behaviors. Studies based on the PRECEDE-PROCEED Model have demonstrated its effectiveness in improving health behaviors among adolescents. Furthermore, current evidence emphasizes that parental involvement in school-based health interventions strengthens the sustainability of behavior change, highlighting the need for further research in this area. The literature indicates that no studies have examined the effects of a health education program based on the PRECEDE-PROCEED Model integrated with laughter yoga on adolescents' healthy lifestyle behaviors. This gap highlights an important research need for interventions that combine a theoretical behavior change framework with complementary practices that may enhance psychosocial well-being. Study aim Accordingly, the aim of this study is to evaluate the effect of a health education program based on the PRECEDE-PROCEED Model and integrated with laughter yoga on healthy lifestyle behaviors of secondary school students. Study hypotheses H1: Students who receive a health education program based on the PRECEDE-PROCEED Model and integrated with laughter yoga will have significantly higher healthy lifestyle behavior scores compared to the control group.

Nicotine and Cannabis Vape Labeling Experiment - Spring 2025

This study assesses how the ways in which nicotine and cannabis vaping devices are labeled impact use susceptibility, anticipated effects, and health harm.

Analysis of Factors Associated With Delayed Medical Consultation for Testicular Torsion Among Adolescents in the Haut-Rhin Department Between 2020 and 2025

The objective of this observational study is to identify the factors that influence whether or not an adolescent seeks immediate medical attention upon the onset of symptoms of testicular torsion. The main question it aims to answer is as follows: What factors are associated with a delay in seeking medical care-defined as a time interval of 6 hours or more between the onset of symptoms and the first visit to Colmar Hospital-among adolescents aged 10 to 18 who underwent surgery for testicular torsion? Participation in this study involves completing a questionnaire: the "Questionnaire for Assessing Factors Associated with Delay in Seeking Medical Care for Testicular Torsion in Adolescents."

Telpegfilgrastim vs Filgrastim for Secondary Prevention of Chemotherapy-Induced Neutropenia in Pediatric Solid Tumors

The goal of this clinical trial is to evaluate the efficacy and safety of Telpegfilgrastim (a PEGylated recombinant human granulocyte colony-stimulating factor, PEG-rhG-CSF) compared to Filgrastim (short-acting rhG-CSF) in preventing chemotherapy-induced neutropenia (CIN) in children and adolescents aged 6-24 years with malignant solid tumors receiving high-intensity chemotherapy regimens. The main questions it aims to answer are: * Does Tuopefilgrastim reduce the incidence of febrile neutropenia (FN) in the first chemotherapy cycle (Cx+1) compared to Filgrastim? * How do the two treatments compare in terms of duration and severity of neutropenia, chemotherapy delays/dose reductions, antibiotic use, and bone pain incidence? Researchers will compare the Telpegfilgrastim group (3:1 ratio, 99 participants) with the Filgrastim group (33 participants) to determine if Telpegfilgrastim demonstrates superior efficacy and safety. Participants will: * Receive subcutaneous injections of either Telpegfilgrastim (33 μg/kg, single dose) or Filgrastim (5 μg/kg/day, multiple doses) 24 hours after each chemotherapy cycle. * Undergo blood tests, physical exams, and temperature monitoring during follow-up visits. * Be assessed for bone pain severity using age-appropriate scales (FLACC or Wong-Baker). * Complete two chemotherapy cycles with close safety and efficacy monitoring.

Romiplostim N01 for Chemotherapy-Induced Thrombocytopenia in Pediatric Cancer Patients

The goal of this clinical trial is to evaluate the efficacy and safety of romiplostim N01 in treating chemotherapy-induced thrombocytopenia (CIT) in children and adolescents/young adults (CAYA; aged 6-24 years) with hematologic malignancies or solid tumors. The main questions it aims to answer are: * What proportion of participants achieve platelet count recovery (≥100×10⁹/L or an increase of ≥30×10⁹/L from baseline) within 3 weeks of romiplostim N01 treatment? * What is the safety profile of romiplostim N01 in this population, including the incidence and severity of adverse events (especially bleeding and thrombosis)? This is a single-arm study (no comparison group). Researchers will assess the outcomes against predefined efficacy thresholds and historical data (e.g., a 60.7% response rate reported for another TPO-RA, hetrombopag). Participants will: * Receive weekly subcutaneous injections of romiplostim N01 (starting dose: 2 µg/kg). * Have their romiplostim dose adjusted weekly based on platelet counts (increase by 1-2 µg/kg if platelets \<99×10⁹/L, maximum dose 10 µg/kg, stop when target recovery is met). * Undergo frequent monitoring, including blood tests (especially platelet counts), vital signs, physical exams, and assessment for adverse events and bleeding throughout the treatment and follow-up period.

Parent-Adolescent Relationships, Emotional Regulation, and HRV in Adolescents With Depression

This cross-sectional study examines associations among heart rate variability (HRV), emotional dysregulation, and parent-adolescent relationship quality in adolescents with Major Depressive Disorder (MDD). We hypothesize that lower HRV will be linked to greater emotional dysregulation and that more supportive parent-adolescent relationships will correlate with higher HRV. Participants will wear a Fitbit Charge 5 during nighttime sleep for 7 consecutive nights and complete validated measures of emotional regulation and relationship quality.

Screen Culture's Impact on Generation Z Adolescents' Physical Activity, Posture and Well-being in Egypt

Ubiquitous adoption of screen-based technologies has transformed the behavioral and physiological environment of Generation Z youth. In Egypt, where digital adoption speeds up with apace urbanisation, teens (13-18) have greater exposure to computers, mobile phones, and other screen-based devices. Growing evidence points towards excessive viewing of screens in compromised well-being, including sleep issues, inactive lifestyles, weight loss/gain, and musculoskeletal disturbances. Contextual evidence for the Egyptian teenager is scarce. This study fills the gap by investigating the multi-dimensional influence of screen culture on physical well-being, focusing on sleep quality, body mass index (BMI), posture, physical activity, and disability outcomes.

TECH App Marijuana Use Intervention for Court-Involved Adolescents

The study is about helping teens who are involved in the court system to cut down or quit using marijuana. Teens may be asked to test out an experimental smartphone app, called TECH, that will be used only by teens in this study. This app is a private online community where teens can work towards changing their substance use and other behavior with the help of other anonymous teens. We will use this information to learn how the app may help teens make a change and to improve the TECH app.

Efficacy and Safety of Sodium-Glucose Cotransporter-2 Inhibitors in Adolescents With Early Stages of Chronic Kidney Disease

Chronic kidney disease (CKD) is highly prevalent in the state of Aguascalientes, Mexico, particularly among adolescents and young adults. Epidemiologic and histologic studies suggest that this burden is largely driven by reduced nephron endowment of prenatal origin, leading to compensatory glomerular hyperfiltration, adaptive podocytopathy, and persistent albuminuria at early stages of disease. Sodium-glucose cotransporter-2 inhibitors (SGLT2i) have demonstrated nephroprotective effects in adult populations with CKD, including reductions in albuminuria and slowing of disease progression, independent of diabetes status. However, no randomized controlled trials have evaluated the efficacy and safety of SGLT2 inhibitors in adolescents with early-stage CKD and persistent albuminuria. This randomized, double-blind, placebo-controlled clinical trial aims to evaluate whether treatment with an SGLT2 inhibitor reduces albuminuria in adolescents aged 14 to 18 years with persistent microalbuminuria (albumin-to-creatinine ratio 30-300 mg/g) and preserved kidney function. Participants will be randomized in a 2:1 ratio to receive dapagliflozin 10 mg daily or placebo for six months. The primary outcome is the change in urinary albumin-to-creatinine ratio from baseline to six months. Secondary outcomes include changes in estimated glomerular filtration rate and safety outcomes.

An Evidence-based Family Support Program for Parents and Children in Palestine: A Theory-based Intervention

Few evidence-based programs exist to support children and families affected by sociopolitical conflict, despite documented evidence of their heightened risk for emotional and behavioral adjustment problems associated with exposure to conflict and violence at multiple levels of the social ecology (e.g., political, community, and family). Thus, a critical need exists for an evidence-based program to ameliorate the impact of political violence on the overall well-being of children and families. The current study will conduct a rigorous evaluation of a theoretically-driven, family-based intervention program in Palestine, including both the West Bank and Gaza. Firmly grounded in the cultural context of Palestine but with broad implications for individuals exposed to sociopolitical violence, the long-term goal of this project is to provide a family-focused intervention program (Promoting Positive Family Futures; PPFF) that may facilitate individuals' sense of safety and support in the context of chronic adversity. The objective is to evaluate this intervention program in the context of a randomized clinical trial (RCT) in the West Bank and Gaza (N=300). The central hypothesis is that the program will have direct positive effects on family conflict, parent psychopathology and parental security in the family as well as on adolescent emotional security in the family, with cascading effects on adolescent adjustment. Consistent with family systems theory, we further hypothesize that treatment effects on parents will mediate on the effects of the treatment on adolescent adjustment. The rationale is that bolstering resilience in family systems is a key approach to promoting positive functioning in families exposed to chronic violence. The hypothesis will be evaluated with three specific aims: 1) evaluate the efficacy of an evidence-based family support program; 2) examine process models of treatment change, and 3) examine interrelations between parent and child functioning. To achieve these aims, the study will be an RCT employing a longitudinal design (N=300) with multi-method assessments at baseline (T1), post-test (T2), 6-month follow-up (T3) and 12-month follow-up (T4). Families included in the study will be evenly divided between the West Bank (n=150) and Gaza Strip (n=150). Families will be randomized into the intervention condition (PPFF) or treatment as usual (TAU). Each territory will have an implementing partner, and implementing partners and investigators will work together to ensure the study procedures are implemented in parallel across sites. Data collection will be conducted by trained research staff from a third-party survey and policy research organization. The proposal seeks to shift current research and clinical paradigms in these contexts by employing novel theoretical concepts, approaches, and methodologies. The contribution will be significant by 1) further developing new directions for empirically-based interventions in these high-risk contexts, and 2) advancing a relatively brief, cost-effective program that can be readily implemented to help children and families exposed to continuing conflict in Palestine, with the potential to be brought to scale in other contexts.

The Effects of Thrower's Ten Exercises Performed With an External Focus

The aim of this study is to comprehensively investigate the effects of the Thrower's Ten exercise program-commonly recommended to enhance shoulder stability and strength in athletes-when applied using an external focus of attention approach (i.e., directing attention toward an object or movement outside the body), on functional performance, shoulder stability, balance, and throwing performance in adolescent basketball players. This study has been designed to examine the effects of performing the Thrower's Ten exercises with an external focus of attention on functional performance, shoulder stability, balance, and throwing performance in adolescent basketball players. Athletes will be randomly assigned to two groups: the experimental group will perform the exercises using an external focus of attention, whereas the control group will perform the same exercises without any specific attentional focus. The methods employed in this study are expected to effectively address the research objectives. The data collection tools and analytical techniques to be used are based on validated and widely accepted tests in the literature. Functional performance will be assessed using the Closed Kinetic Chain Upper Extremity Stability Test, balance will be evaluated using the Upper Extremity Y Balance Test, and throwing performance will be measured using the Medicine Ball Throw Test.

Time to Healing in Displaced Pediatric Diaphyseal Forearm Fractures Treated With Bioabsorbable Compared to Titanium Intramedullary Nails

This study looks at children with forearm fractures that need surgery. The standard treatment uses titanium nails, which usually need to be removed in a second operation later. This study compares titanium nails with bioabsorbable nails, which gradually dissolve in the body and may help some children avoid another operation. The study will compare how quickly the fractures heal on X-ray, and also look at complications, recovery, function, and the family's experience. Children who need surgery will be randomly assigned to one of the two treatments so the comparison is fair. Hypothesis: The researchers expect that fractures treated with bioabsorbable nails will heal almost as quickly as fractures treated with titanium nails, while reducing the need for later implant removal surgery.

A Scalable, Teacher-delivered, School-based Oral Health Intervention for Pakistani Lower Secondary Schoolchildren

This was a pragmatic, two-arm, and parallel-group, superiority cluster-randomized controlled trial with 1:1 allocation of clusters (schools) to either the Smile Smarts-PK intervention arm or the control arm. The trial settings were lower secondary schools (classes 5-8) in the Punjab, Pakistan. Punjab is the most populous province of Pakistan; it has many public and low-cost private schools that serve lower- and middle-income communities.

Guardians Receiving Information Through Navigators

A multi-arm study, experimental and control groups, to explore the impact of an online training program to help community health workers conduct effective outreach to support the dental health of high-risk youth via their guardians.

Implementation & Dissemination of a Digital Health Intervention for Adolescent Sleep

The goal of this study is to form a Teen Advisory Board (TAB), who will partner with our study team to co-design a beta-test a new prototype of the Firefly program, a mobile-native insomnia cognitive behavioral therapy intervention for teens. This new prototype will have addressed issues that adolescents who had used the first version of the program deemed to be barriers to engaging with the treatment.

Suicidal Behavior in Adolescents and Executive Functions

Suicide is a major public health concern, particularly among young people. In France, around 400 adolescents die by suicide every year, and suicide attempts are most frequent during adolescence. This stage of life is marked by profound emotional, social, and biological changes, which can increase vulnerability to stress and psychological distress. Current research shows that suicidal behaviors do not result from a single cause. Instead, they emerge from a complex interaction between individual vulnerabilities and stressful life events. Among these vulnerabilities, cognitive functioning-and more specifically executive functions-has attracted growing scientific interest. Executive functions refer to a set of high-level mental abilities that allow individuals to regulate their thoughts, emotions, and actions. They include skills such as controlling impulses, adapting to new situations, planning ahead, and holding information in mind. These abilities are essential for everyday life, school learning, social interactions, and emotional regulation. Importantly, the brain networks supporting executive functions continue to develop throughout adolescence, making them particularly sensitive to psychological and environmental challenges. In adults, several studies have shown that people with suicidal ideation or a history of suicide attempts often present difficulties in executive functioning. Such difficulties may contribute to poorer emotional regulation, increased rumination, reduced impulse control, and impaired decision-making during periods of crisis. However, in adolescents, research in this area remains limited, often involving small samples or focusing on only one or two cognitive abilities. The main aim of this study is therefore to better understand the relationship between executive functions and suicidal behaviors in adolescents, using a comprehensive assessment tool specifically designed and validated for children and teenagers. This tool allows for a global evaluation of key executive components, including inhibition, working memory, cognitive flexibility, and planning. A secondary objective of the study is to compare executive functioning between adolescents who experience suicidal thoughts and those who have attempted suicide. Some findings in adults suggest that these two groups may show different cognitive profiles, but this distinction has rarely been explored in younger populations. In addition, cognitive difficulties may not only appear during testing but also have a real-life impact, affecting academic performance, emotional regulation, and social relationships. For this reason, the study also examines how executive difficulties affect everyday functioning, by collecting information from adolescents themselves, their parents, and the school environment. Finally, suicidal behaviors in adolescents are influenced by many other factors, particularly psychiatric disorders such as depression, anxiety, and the consequences of traumatic experiences. Depression, in particular, is one of the strongest risk factors for suicide. This study therefore also aims to explore how these psychiatric conditions may influence executive functioning and shape the relationship between cognitive difficulties and suicidal behavior. By improving our understanding of these mechanisms, this research seeks to support the development of more effective prevention strategies and better-targeted clinical interventions for adolescents at risk.

Enhancing Brain And Mental Health Through Breathing Practice

The purpose of this study is to evaluate the feasibility of a structured breathing intervention in rural and non-rural adolescents diagnosed with anxiety and depression, recruited from outpatient pediatric and child/adolescent psychiatry clinics.

A Master Protocol (LY900023) That Includes Several Clinical Trials of Drugs for Children and Young Adults With Cancer

The main purpose of the master is to help the research sites and sponsor carry out several clinical trials more efficiently by providing a common research protocol. Individual clinical trials under this master protocol define drug/disease-specific research goals and activities to test them. New studies will be added as new drugs emerge against different cancers. Participation in the trial will depend on how long the benefit lasts.

Brentuximab Vedotin for Newly Diagnosed cHL in Chinese CAYA Based on PET/CT Assessment

Generally, pediatric patients tolerate acute toxicities but are vulnerable to late effects. Thus, increasing chemotherapy intensity to achieve more rapid complete early response to limit radiation therapy is worth testing. In this CCCG-HL-2024 study, Brentuximab vedotin (Bv) was used to replace VCR and bleomycin in the ABVE-PC regimen in the previous CCCG-HD-2018 study, respectively, to form a Bv-AEPC regimen for the treatment of newly diagnosed classic Hodgkin lymphoma (cHL) in children, adolescents and young adults. On the premise of maintaining a 4-year event free survival (EFS)\>90% in the low-, intermediate-and high-risk groups, increase the early assessment complete response rate (the overall early complete response rate increased by 20%, that is, from 54.0% to 74.0%) to further reduce the proportion of children receiving radiotherapy to benefit them.

Effectiveness of an mHealth Innovation on the Impact of Menstrual Complaints in Adolescents

The aim of this study is to improve menstrual health-related quality of life in adolescents by using a mobile menstrual health tracker. We will perform a randomized controlled trial to evaluate the (cost)-effectiveness of this mHealth intervention.

Pediatric Normative Markerless Movement Analysis

The objective of this project is to collect baseline data from a normative population of 20 children that gender and age matches the population of patients expected to be treated by Mary Bridge Children's Research \& Movement Lab.

START NOW Adapted: Culturally Adapted Version of START NOW

The goal of this clinical trial is to test the effectiveness of the culturally adapted skills-training START NOW in youth migrant populations. The main question it aims to answer is: Is the culturally adapted skills training START NOW more effective than treatment as usual (TAU) in reducing mental health problems in migrants? Participants will be randomly assigned to the intervention group receiving the skills training START NOW Adapted or the control group receiving TAU. Researchers will compare both groups to see if START NOW Adapted is more effective than TAU in reducing mental health problems in migrants.

The Effect of Three-Dimensional Exercises ( Schroth Method ) on Trunk Muscle Endurance, Sleep Quality, and Quality of Life in Adolescents With Hyperkyphosis

Adolescence is a critical period for spinal growth, and progression of thoracic hyperkyphosis may lead to pain, weak trunk muscles, sleep disturbances, and reduced quality of life. This study aims to investigate the effects of three-dimensional exercise program based on the Schroth Method on trunk muscle endurance, thoracic kyphosis angle, pain, sleep quality and quality of life in adolescents aged 12-18 years with hyperkyphosis.

Neural Connectivity During Therapy for Adolescent PTSD

Posttraumatic stress disorder in adolescence impairs neurobiological networks underlying cognitive, social and emotional skills. Neuroimaging research that seeks to identify the neural mechanisms of treatments for PTSD could lead to novel treatments, but progress has been slow using current methods. The proposed study uses an innovative approach to identify neural mechanisms of specific phases of trauma-focused therapy for youth with PTSD, allowing a new understanding of brain changes associated with the process of therapy.