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NCT03869515
Recruitment of a carefully characterized cohort of chILD patients, to generate a database and biobank via collecting data on chILD in China. Importantly, compatibility with ongoing United States and Europe chILD data base developments will be factored in.
NCT07201038
Cambridge University Hospitals NHS Foundation Trust (CUHNFT) is the Principal Treatment Centre for the East of England region, responsible for 120-150 patients \<16 years with a new diagnosis of paediatric malignancy annually; leukaemia comprises \~25% of these cases. Current molecular diagnosis of subgroups of childhood malignancies, particularly leukaemia, is based on flow cytometry, fluorescent in situ hybridisation (FISH) and single nucleotide polymorphim (SNP) arrays, for which the usual turnaround time (TAT) is 7-14 days. In the current era of access to targeted therapy, rapid diagnosis and treatment of patients in high-risk molecular subgroups is critical for improving outcomes. Children and adolescents with Philadelphia-chromosome positive (Ph+) acute lymphoblastic leukaemia (ALL) have significantly improved survival when treated with tyrosine kinase inhibitors (TKIs). Patients with Ph+-like mutations (10- 20% of paediatric ALL), also have a poor prognosis, requiring escalation of treatment and addition of targeted therapy. Rapidly identifying MYCN amplification is also of critical prognostic importance in embryonal tumours of childhood including neuroblastoma (25%) and medulloblastoma, and directly impacts on treatment from the outset of the patient journey. Overnight whole genome sequencing (WGS) entails taking an additional 5ml Peripheral Blood (PB) and Bone Marrow (BM) samples after samples for routine diagnostic workup have been collected, and could replace current standard of care (SOC), which has a median turnaround time (TAT) of up to 28 days, and up to 84 days for specific gene mutations, which can delay appropriate prognostication and management of high-risk patients. Rapid, point of care information on somatic and germline mutations will allow early risk stratification and expedite treatment for high-risk patients with cancer.
NCT07469787
The transition from pediatric to adult care is a critical period for young people with chronic inflammatory rheumatic diseases (CIRD) and is associated with risks of poor self-management, loss to follow-up, and disease worsening. Although structured transition programs have been recommended, real-world data on their effectiveness in rheumatology remain limited. Since 2018, a structured transition program has been implemented at Bicêtre University Hospital (AP-HP, France), combining early transition preparation, a therapeutic patient education (TPE) workshop, and a joint pediatric-adult transition consultation. Some patients benefit from both components, while others receive a transition consultation only. The BOOST-R study is a monocentric, non-interventional observational study designed to evaluate the impact of different transition modalities on self-management after transfer to adult care. The primary objective is to compare transition readiness, assessed using the validated French version of the Transition Readiness Assessment Questionnaire (TRAQ-FR), between patients who received a TPE workshop plus a transition consultation and those who received a transition consultation only. Secondary objectives include evaluating continuity of care after transition, identifying factors associated with successful transition, assessing the contribution of the RESRIP support network, and describing patients who did not benefit from structured transition support.
NCT05967468
Anxiety and obsessive-compulsive disorders are among the most common in children. Although cognitive behavioral therapy (CBT) is an effective and evidence-based treatment for such disorders, access to CBT is often limited. Family-based and internet-delivered therapy is one method to increase access to care. The purpose of this project is to evaluate the comparative efficacy and treatment mechanisms of two lower-intensity but effective treatments for families of children with anxiety or obsessive compulsive disorder (OCD) via telehealth compared to an adapted Relaxation and Mentorship Training (RMT) intervention involving breathing exercises with a therapist.
NCT06525259
The goal of the DISCOVERY study is to provide innovative critical information regarding the unique natural history of glycemic control, insulin sensitivity, and β-cell function, and their mechanistic determinates, in obese adolescents at risk for developing type 2 diabetes.
NCT04266080
This study will test whether a game-based exercise plan can help increase the level of physical activity in childhood cancer survivors. The game-based exercise plan will involve participation by both a childhood cancer survivor and his/her parent or caregiver. This study will also look at whether the game-based exercise plan improves childhood cancer survivors' quality of life.
NCT06620302
This phase I/II trial tests the safety, side effects and best dose of DT2216 in combination with irinotecan and how well it works in treating children, adolescents and young adults with solid tumors and fibrolamellar cancer that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). DT2216 is an anti-apoptotic protein B-cell lymphoma-extra large targeted protein degrader. It may stop the growth of tumor cells by blocking Bcl-xL, a protein needed for tumor cell survival. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and deoxyribonucleic acid repair and may kill tumor cells. Giving DT2216 in combination with irinotecan may be safe, tolerable, and/or effective in treating children, adolescents and young adults with relapsed or refractory solid tumors or fibrolamellar cancer.
NCT06247787
This phase I trial tests the safety, side effects, and best dose of imetelstat in combination with fludarabine and cytarabine in treating patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) or juvenile myelomonocytic leukemia (JMML) that has not responded to previous treatment (refractory) or that has come back after a period of improvement (recurrent). Imetelstat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as fludarabine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving imetelstat in combination with fludarabine and cytarabine may work better in treating patients with refractory or recurrent AML, MDS, and JMML.
NCT07418528
The goal of this observational study is to analyze early development in infants and young children from a biopsychosocial perspective, with a particular focus on cognitive, language, motor, social-emotional, and adaptive functioning during the first years of life. The study will include infants and young children from 16 days of age up to 42 months of age, assessed during a single diagnostic session conducted by qualified specialists. The developmental assessment will include standardized diagnostic tasks and direct observation of behavior in the form of play and natural interaction, carried out in the presence of a parent or legal guardian. In addition, information regarding the child's everyday functioning will be collected from parents or caregivers using standardized questionnaires, including data on social-emotional competencies, communication, and adaptive skills. The main research questions addressed by this study are: What is the developmental profile of infants and young children in the first years of life? What relationships exist between different domains of early development within a biopsychosocial model of child functioning? Can specific developmental patterns be identified that indicate an increased risk of developmental difficulties in early childhood? How does age differentiate the structure and variability of developmental functioning across assessed domains? The study is non-invasive and observational in nature. Data will be analyzed exclusively in aggregated form and will contribute to a better understanding of early child development as well as to the development of norms and tools supporting early diagnosis and developmental intervention.
NCT07412769
Standardization According to GINA 2025 Recommendations for the Treatment, Management, and Follow-up of Acute Asthma Attacks: Observational, Multicenter Cohort Study.
NCT06158828
This trial represents a single institution phase I/II pilot study with the primary objective of establishing the safety and feasibility of generating and infusing ML NK cells after TCRαβ haplo-HCT.
NCT06977438
The rapid emergence of new and highly effective obesity medications has turned the field of pediatric weight management on its head. Adolescents living with obesity, their caregivers, healthcare providers, healthcare systems, policymakers, and payors are now wondering what role health behavior and lifestyle treatment (HBLT) has in terms of body mass index (BMI) reduction, improvements in quality of life and cardiometabolic health, and mitigating nutritional concerns when medications are used. Is intensive (26+ hours) of HBLT needed or could low intensity HBLT be an equally effective alternative; and if so, for whom? Our proposed project will answer these important questions that arise daily in the clinical setting and will generate critical new insights to guide decision-making for teens with obesity and the stakeholders who care deeply about them.
NCT03155620
This phase II Pediatric MATCH screening and multi-sub-trial studies how well treatment that is directed by genetic testing works in pediatric patients with solid tumors, non-Hodgkin lymphomas, or histiocytic disorders that have progressed following at least one line of standard systemic therapy and/or for which no standard treatment exists that has been shown to prolong survival. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic changes or abnormalities (mutations) may benefit more from treatment which targets their tumor's particular genetic mutation, and may help doctors plan better treatment for patients with solid tumors or non-Hodgkin lymphomas.
NCT05377372
This study is being conducted to determine the relationship between early childhood exposures, such as Adverse Childhood Experiences, Social Determinants of Health and nutrition/breastfeeding, among children with sickle cell disease, and behavioral interventions aimed to reshape psychological resilience and lifestyle factors towards positive health outcomes.
NCT07387133
This study aims to examine the relationship between parental technoference (parents' use of smartphones or other digital devices while spending time with their children) and behavioral and emotional development in early childhood. The study will include parents of children aged 24 to 60 months who attend a pediatric outpatient clinic. At the beginning of the study, parents will complete an online questionnaire that includes questions about their own smartphone screen time, their child's screen exposure, and standardized questionnaires assessing parental technoference and children's behavioral and emotional characteristics. Six months after the initial assessment, parents will be contacted again to complete a short follow-up questionnaire, including the behavioral and emotional assessment. The study does not involve any medical intervention or experimental treatment. All participation is voluntary, and responses will be collected anonymously. The findings of this study are expected to contribute to a better understanding of how parental digital device use during daily interactions may be associated with children's emotional and behavioral development in early childhood.
NCT07369817
The goal of this study is to pilot test the feasibility of a mobile health clinical decision support tool called ALRITE for the diagnosis and management of acute lower respiratory illnesses in young children in Uganda. Asthma/wheezing illness, in particular, is underdiagnosed in this setting. The main questions the study aims to answer are: * Are the intervention structure, processes, outcomes, and implementations strategies feasible to conduct in the desired settings? * Does ALRITE increase the diagnosis of wheezing illness among children seen at Ugandan health centers? Researchers will compare outcomes before and after ALRITE deployment to healthcare workers at 4 Ugandan healthcare centers using an interrupted time series design. Study participants are healthcare workers. There will be12 months of baseline data collection ("baseline period"), at the beginning of which healthcare workers will be enrolled at each site. Following the baseline period, health workers will receive ALRITE training and will be encouraged but not required to use ALRITE in clinical care for a 6-month intervention period. Health worker participants will fill out surveys and participate in focus group discussions to provide feedback.
NCT04087772
The purpose of this study is to compare two versions of Mental Health Enhanced Positive Behavioral Interventions and Supports in reducing aggression in middle school students.
NCT05122988
Childhood experiences affect psychosocial well-being and mental health across the life course for better or worse. The aim of the present study is to investigate how adverse childhood experiences before the age of 18 impact psychological functioning in young adulthood, and whether social information processing and emotion regulation may mediate these associations.
NCT06989463
Childhood cancer survivors are at risk for accelerated aging due to the specific treatments they have received to cure their cancer. Several interventions, including exercise, cognitive training, and mindfulness practice, have been developed and studied for effectiveness among participants in the St. Jude Lifetime Cohort (SJLIFE) to mitigate these effects. The interventions offered thus far have not included two components at the same time. The purpose of this study is to determine whether or not adult cancer survivors enrolled in SJLIFE will participate in two interventions at the same time. The combined interventions will include exercise plus cognitive training or exercise plus mindfulness practice. Each intervention will be conducted over a 12-week period. Participants will also be asked to complete follow-up testing after the 12-week intervention period is completed. Primary Objectives • To determine the acceptability of a two-component intervention (exercise (EX) plus cognitive training (CT) or exercise (EX) plus mindfulness practice (MP)) among survivors of childhood cancer with either cognitive impairment or emotional distress. Hypotheses: * 45% of those approached for participation in each arm of this study will enroll on the study. * Among those who enroll, 70% will complete the follow-up testing at 12 weeks. * Among those who completed the follow-up testing, the mean attendance to the intervention sessions will be 70% on each of their two interventions. That is, they will complete 70% of exercise sessions and 70% of either cognitive training or mindfulness practice. * To identify barriers and facilitators to intervention adherence. Hypotheses: * Participants will identify features of the study processes that either facilitate or discourage adherence. * Participants will identify features of the intervention technology and intervention components that either facilitate or discourage adherence. * Participants will identify personal factors that facilitate or discourage adherence.
NCT07291713
This study evaluated psychological health in patients with myasthenia gravis (MG) using an online behavioral program called the "Positive Mental Health BMI Learning Program." The program consisted of four short video units focused on interpersonal support, emotional regulation, and personal meaning. Patients receiving care in the neurology outpatient clinic were invited to complete questionnaires before and after viewing the online program. Psychological well-being, depressive symptoms, daily functioning, and quality of life were assessed to describe participants' mental health status and changes observed over the course of the program.