10,232 Clinical Trials for Various Conditions
The goal of this multi-center, randomized, double-blind, placebo-controlled study is to evaluate the safety and immunogenicity of CHIKV VLP Vaccine in children 2 to \<12 years of age.
This study is the pilot of a 12 - week positive food parenting intervention focused on structure-based and autonomy promoting practices. The intervention aims to give parents the tools to promote healthy child growth and improve diet quality. The investigators are piloting to assess feasibility and efficacy of the intervention through examining participant retention, impact on parent feeding practices, and impact on parent and child diet quality.
The Trajectory study aims to determine whether childhood aerobic fitness, sleep quality, and diet quality predict cardiometabolic health during puberty and early adulthood, independently of adiposity.
Thirty percent of children with autism barely talk or do not talk at all despite years of intervention. This study aims to address this important and long-standing challenge by developing a novel intervention to increase the quantity and quality of vocalizations (i.e., sounds children make before words) and expressive language in young children with autism (aged 2 to 5 years) with minimal verbal skills. The intervention includes contingent responses to the child's vocalizations and vocal elicitation strategies. We also collect social validity information from parents about how they perceive the novel intervention.
The objective of this study is to develop central nervous system (CNS) biomarkers of pain experienced during medical procedures and pain relief induced by Virtual Reality Pain Alleviation Therapy (VR-PAT). The study team plans to use innovative functional near-infrared spectroscopy (fNIRS) to identify and quantify the targeted CNS biomarkers. The ultimate goal of this project is to optimize the CNS biomarkers for predicting and/or monitoring response to virtual reality (VR)-based pain reduction approaches for pain management in clinical trials. 20 healthy children will be recruited for a 1-hour research visit where they will wear a blood pressure cuff to simulate pain and an fNIRS neuroimaging device while playing an immersive/engaging VR game, a passive VR video, and an iPad game.
The Para Salud study is a longitudinal, community-based participatory research (CBPR) initiative aimed at preventing and controlling obesity among preschool children in rural Texas. The study will implement evidence-based interventions targeting nutrition, physical activity, and gardening. The interventions are designed to improve health outcomes, specifically in reducing obesity-related metrics among young Hispanic children, who are at a higher risk of obesity due to social determinants of health. Primary Objective: To assess the effectiveness of the Para Salud interventions in reducing obesity-related metrics, including BMI percentile, waist-to-height ratio, and percentage body fat, among preschool children aged 3-4 years in the Texas High Plains over a 24-month period. Secondary Objective: To evaluate the impact of the Para Salud interventions on increasing physical activity levels, improving dietary habits (such as increasing fruit and vegetable intake), and reducing sedentary behavior and sugar-sweetened beverage consumption among the study participants.
The main objectives of this study are to determine the treatment preferences of children with narcolepsy type 1 between Extended-release sodium oxybate and Non-extended-release oxybates (Sodium oxybate or a medication with the combination of Calcium, magnesium, potassium, and sodium oxybates). The study will also assess the safety, convenience, and tolerability of Extended-release sodium oxybate. Additionally, the researchers aim to assess how well Extended-release sodium oxybate works in treating narcolepsy type 1.
Regular fish consumption may support brain health. Trout lines developed in Idaho contain higher levels of omega-3 fatty acids, nutrients important for human cognition and mental wellbeing. Developed to support aquaculture sustainability, consumer preferences and human health benefits of these fish are unknown. The long-term goal of this project is to utilize nutrition education strategies to increase adult and child consumption of fish to improve brain health as measured by cognitive and emotional wellbeing. Research objectives and activities include, (1) adult and child consumer panels to provide sensory evaluation on three strains of trout, (2) effects of repeated exposure (RE) and child-centered nutrition phrases (CCNP) on eating behaviors and brain health will be determined using one control and two treatment groups of children in childcare settings, (3) effects of nutrition education, incorporating CCNP and fish preparation techniques, and RE targeting family meals on eating behaviors of children and brain health of adults and children will be determined using four treatment groups in the home setting.
The purpose of this research study is to investigate the effects of a combination of weekly distribution of healthy foods and intensive nutrition counseling as complementary therapies to the standard insulin therapy in children with new diagnosis of stage 3 type 1 diabetes (T1D). Feasibility, acceptability, and fidelity of this intervention will be measured. We will also explore the likelihood of prolonging the honeymoon phase of T1D in the intervention study group. Comparisons will be made between this combined nutrition intervention and free healthy foods vs. current standard nutrition counseling. Both study groups will receive standard of care treatment for T1D (insulin therapy). The results of this study could inform future research that will ultimately lead to design of a larger clinical trial testing implementation of novel medical nutrition therapies for children newly diagnosed with stage 3 of T1D, and may lead to prolongation of the honeymoon phase. The overall goal is to promote the beta cell function survival and to reduce the progression to stage 4 of T1D. Condition or Disease: * Type 1 Diabetes Mellitus * New Diagnosis of Stage 3 Type 1 Diabetes ≤ 60days Intervention/Treatment: - Weekly Free Healthy Foods + Intensive Nutrition Counseling for 12 weeks
This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in children (aged 6 to \<12 years) with heterozygous familial hypercholesterolemia (HeFH) and elevated low density lipoprotein cholesterol (LDLC).
Seizures are common in children (\~350 per 100,000 patients per year) and require immediate medical attention. If the seizure is prolonged (\> 5 minutes) it is called status epilepticus and delayed treatment leads to higher risk in drug resistance and brain injury. The current standard of care for children admitted to the ICU with established or suspected status epilepticus is to start a conventional continuous EEG study that helps diagnosing seizures by typical electro graphic patterns. It takes on average 4 hours to start and another two hours to obtain a reading by epileptologists. This is far beyond the time window of starting an EEG study (60 minutes) as recommended by the neurocritical care society. In adult ICUs, point of care "Rapid Response EEG" are becoming a new standard of care and our ICU adopted this practice in 2020. It can be easily placed by the ICU staff rather than a specifically trained EEG technician but has a lower resolution due to fewer leads (10 vs. 20). The purpose of this study is to determine wether and by how much time RR-EEG yields faster preliminary EEG reports that the previously available conventional EEG (cEEG) and wether the detection of electro graphic seizures is comparable. This is a retrospective cohort study following patients who are admitted to the PICU and are placed on either cEEG or RR-EEG for status epilepticus.
This clinical trial tests how well entrectinib works to treat patients less than 3 years of age with NTRK 1/2/3 or ROS1 fused, high grade glioma or other central nervous system (CNS) tumors.
The overall objective of this study is to determine the effect of posterior tibial nerve stimulation (PTNS) on children with constipation due to pelvic floor dyssynergia. Our main hypothesis is that PTNS effectively treats children with constipation secondary to pelvic floor dyssynergia through modulation of anorectal function. We will perform a single-center, randomized controlled pilot study comparing PTNS to sham stimulation in children with constipation secondary to pelvic floor dyssynergia.
The sevoflurane concentrations (as well as vital signs, child's date of birth, type of surgery) will be recorded during the first 10 minutes of anesthesia.
Children with sensory processing challenges participated in an 8-week play-based aquatic program addressing goals on behavior, sensory, and participation. It is expected that after the 8-week group, the child's goals will improve demonstrating an effective intervention to address sensory difficulties.
This is a naturalistic, observational study of children and adolescents with obsessive-compulsive disorder who were treated with exposure and response prevention via video teletherapy.
The primary purpose of this study is to evaluate the efficacy of bimekizumab administered subcutaneously (sc) compared to active control (ustekinumab) in children and adolescents aged 6 to \<18 years of age with moderate to severe plaque psoriasis (PSO).
The primary purpose of this study is to learn whether personalized assessment of obsessive-compulsive disorder (OCD) symptoms in childhood OCD using mobile health technology are feasible and acceptable for youth and parents. The investigators will also examine whether personalized cognitive-behavioral therapy (CBT) that is informed by personalized OCD assessments yields better clinical outcomes when compared to standard CBT for youth with OCD
This is a clinical trial testing whether the addition of one of two chemotherapy agents, dasatinib or venetoclax, can improve outcomes for children and young adults with newly diagnosed T-cell acute lymphoblastic leukemia and lymphoma or mixed phenotype acute leukemia. Primary Objective * To evaluate if the end of induction MRD-negative rate is higher in patients with T-ALL treated with dasatinib compared to similar patients treated with 4-drug induction on AALL1231. * To evaluate if the end of induction MRD-negative rate is higher in patients with ETP or near-ETP ALL treated with venetoclax compared to similar patients treated with 4-drug induction on AALL1231. Secondary Objectives * To assess the event free and overall survival of patients treated with this therapy. * To compare grade 4 toxicities, event-free survival (EFS) and overall survival (OS) of patients treated with this therapy in induction and reinduction to toxicities of similar patients treated on TOT17.
The FLIGHT study is an open-label, single-arm, pilot and feasibility study of a personalized and multimodality intervention focusing upon modifiable lifestyle factors, environmental modifications, and transdisciplinary clinical care for children with chronic illness. A mixed methods outcomes evaluation will be performed. The primary goal of this study is to evaluate the most feasible and promising strategies to inform a more streamlined and scalable intervention in the future. Up to 14 participants may be enrolled, but fewer are expected to achieve the primary goal of the study.
The PI propose to conduct a genomic epidemiology study of pneumococcal carriage among children and adults in a large metropolitan city. These data will allow PI to assess the post-pandemic population structure, investigate the phylogenetic relationship between isolates from children and adults, and compare pneumococcal populations across diverse geographic areas.
The purpose of this study is to investigate the impact of an intensive activities-based locomotor training program as compared to traditional physical therapy on activity, participation, and central and peripheral neurophysiological adaptation in children with cerebral palsy.
The participants of this study will be children, adolescents, and young adults with residual osteosarcoma, which cannot be removed completely through surgery. Participants will have achieved a partial response or stable disease at the end of conventional chemotherapy. Osteosarcoma is cancer of the bone. The cancer cells make immature bone cells, known as osteoid. Osteosarcoma is very rare, but it is the most common type of bone cancer in children and teens. It is most common in teens and young adults. In this study, participants will receive either cabozantinib and best supportive care or the best supportive care alone. Best supportive care will be provided at the investigator's discretion and according to institutional guidelines. It includes antibiotics, nutritional support, correction of metabolic disorders, optimal symptom control and pain management (including radiotherapy), etc. but does not include tumor specific therapy. Cabozantinib will be taken by mouth (orally), as a tablet, once a day. Cabozantinib will be provided to participants who tolerate it for as long as their disease does not progress. Participants in the study receiving best supportive care alone may switch to treatment with cabozantinib and best supportive care if their disease progresses and if other eligibility criteria are met. Participants may withdraw consent to participate at any time. The estimated duration of the study for participants is 24 months, however a participant could remain in the study longer if demonstrating treatment benefit.
objectives: identify physiologic, dietary, and environment triggers of severe pain exacerbations in children with CRPS.
The goal of this observational study is to build psychometric evidence for the Home-Based Child Care Toolkit for Nurturing School-Age Children (HBCC-NSAC Toolkit) provider questionnaire. The main objectives of the study are to: 1) assess the reliability of the HBCC-NSAC Toolkit provider questionnaire, 2) assess the evidence for its validity compared to other existing measures of HBCC quality, and 3) examine invariance across subgroups (that is, look for the absence of any differential item functioning \[DIF\]). HBCC provider participants will complete a questionnaire in the HBCC-NSAC Toolkit. A subset of providers will also participate in an observation of their child care setting. Parents or guardians of children receiving care from HBCC providers will complete a survey.
The goal of this randomized cross-over trial is to learn about the effect of a single bout of 20-min mindfulness-based high-intensity interval training (MF-HIIT), MF-only, and HIIT-only in relative to sitting rest on executive function (EF) in 10-12 years old children. The main question it aims to answer are: Question 1: Whether a single bout of 20-min MF-HIIT has larger beneficial effect on EF performance than that following a 20-min session of MF-only and HIIT-only in relative to the sitting rest Question 2: Whether a single bout of 20-min MF-HIIT has a larger beneficial effect on brain functioning, as measured by the N2 and P3 components of event-related potential (ER) during EF performance than that following a 20-min session of MF-only and HIIT-only in relative to the sitting rest Participants will visit the laboratory on 5 separate days (\> 2-day washout between days) in which they have not previously participated in structured physical activities. Participants will complete the testing and/or receive treatments below: Day 1: * Kaufman Brief Intelligence Test (KBIT) to assess intelligence quotient * Treadmill-based exercise test to measure cardiorespiratory fitness (maximum oxygen consumption) Days 2-5 * Each day, participants will complete each of the four intervention conditions (MF-HIIT, MF-only, HIIT-only, sitting) * Participants' heart rate and self-reported affect and rating of physical exertion will be measured * Participants will complete a modified flanker task and a task-switching task to assess inhibitory control and cognitive flexibility * Participants will wear an EEG cap to measure the N2 and P3 components of the event-related potential during the inhibitory control and cognitive flexibility performance Researcher will compare the cognitive outcome measures following the MF-HIIT, MF-only, and HIIT-only conditions with the sitting condition to see if MF and HIIT has beneficial effects on children's EF. Further, researcher will compare the cognitive outcome measures following the MF-HIIT compared with MF-only and HIIT-only conditions to see if combining MF with HIIT has greater beneficial effects on children's EF than MF and HIIT alone.
The goal of this randomized controlled trial is to learn about the effect of a 12-week school-based intervention combining mindfulness with high-intensity interval training (MF-HIIT), MF-only intervention, and HIIT-only intervention in relative to sedentary activities on executive function (EF) in 8-12 years old children. The main question it aims to answer is whether a 12-week school-based MF-HIIT intervention has larger beneficial effect on EF performance than that following a 12-week school-based MF-only and HIIT-only in relative to the sedentary activities. Multiple cohorts of participants will be recruited to participate this one-semester study, including the pretest, intervention, and posttest phases. During the pretest phase, participants an their parents will complete the following 1. Kaufman Brief Intelligence Test (KBIT) to assess intelligence quotient 2. Fitnessgram test to assess aerobic capacity, muscle endurance, flexibility, and body mass index 3. Child and Adolescent Mindfulness Measure (CAMM) questionnaire to assess dispositional mindfulness 4. Computerized tasks to assess EF 5. Parent-reported demographic and health information Following the pretest phase, participants will receive the 12-week classroom-based intervention, with the classroom as the intervention unit. Following the intervention and during the posttest phase, participants will complete the fitness, measures, EF measures, and dispositional mindfulness measure again. Researcher will compare the EFn outcome measures following the MF-HIIT, MF-only, and HIIT-only interventions with the sedentary activity intervention to see if MF and HIIT has beneficial effects on children's EF. Further, researcher will compare the EF measures following the MF-HIIT compared with MF-only and HIIT-only interventions to see if combining MF with HIIT has greater beneficial effects on children's EF than MF and HIIT alone.
Parents of children with food allergies that are medically established will be able to participate in 6 one-hour weekly virtual Cognitive Behavioral Therapy (CBT) groups, and outcomes will be measured for anxiety, depression and quality of life. Possible benefits include improvement in psychological functioning and quality of life of families, as well as improved understanding of the use of group Cognitive Behavioral Therapy (CBT) for parents of children with medically established food allergies.
The aim of this study is to evaluate the pharmacokinetic (PK) profile of vonoprazan (10 or 20 mg once daily \[QD\]) in children ≥ 6 to \< 12 years of age who have symptomatic Gastroesophageal Reflux Disease (GERD).
The MATIC-2 is a multicenter clinical trial enrolling children who are less than 18 years of age with hemorrhagic shock potentially needing significant blood transfusion. The primary objective of the clinical trial is to determine the effectiveness of Low Titer Group O Whole Blood (LTOWB) compared to component therapy (CT), and Tranexamic Acid (TXA) compared to placebo in decreasing 24-hour all-cause mortality in children with traumatic life threatening hemorrhage.