[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Children's Hospital Medical Center, Cincinnati\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":620},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,119,0,25,[9,43,78,99,116,144,168,191,228,254,279,304,327,350,373,394,416,438,461,486,515,536,560,583,603],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100652185","optimization-of-therapeutic-drug-monitoring-in-pediatric-kidney-transplant-100652185",false,"NCT07769567","Optimization of Therapeutic Drug Monitoring in Pediatric Kidney Transplant","Optimization of Therapeutic Drug Monitoring for Tacrolimus and Mycophenolate in Pediatric Kidney Transplant Recipients: a PK\u002FPD Study","Inclusion Criteria:\n\n* Recipient of a solid organ transplant and at least 1 year of age\n* Receiving tacrolimus and\u002For mycophenolate\n* Patient and\u002For caregiver is willing to receive text notifications and has a mobile device capable of receiving and sending text and multimedia messages.\n* Ability to understand and willingness to sign a written informed consent\n* Ability to understand, read, and speak English.\n\nExclusion Criteria:\n\n* History of allergy to tape adhesives","ALL","1 Year",{"count":7,"type":20},"ESTIMATED","OBSERVATIONAL","The goal of this observational, pharmacokinetic study is to evaluate factors that change drug exposure in pediatric kidney transplant recipients so investigators can make better dosing decisions. The main question it aims to answer is:\n\nCan investigators quantify the impact of factors that change with time (like food intake and medication adherence) on tacrolimus and mycophenolate? Our hypothesis is that inconsistent drug and food intake will increase day to day variability in drug exposure, and investigators can use this information to help us make decisions about what is the best dose.\n\nParticipants will participate in the study on 7 days over the course of 1 year. On day 1, participants will be asked questions to see if participants are able to be in this study. Investigators will ask what immunosuppression participants are taking, how tall and how much participants weigh.\n\nOn day 2, participants and their parent\u002Fguardian will be taught how to use the device to collect the blood samples and decide on which days to collect them.\n\nOn days 3-6, participants will collect blood samples 4 separate times over about 1 year. Collection days should try to be scheduled every 3 months (+\u002F- 2 weeks).\n\nOn each collection day, participants will collect a sample 7 different times over 9 hours. Each collection will only take approximately 5 minutes. Participants will be asked to collect a blood sample immediately before the morning dose of tacrolimus or mycophenolate, and 20 min, 1hr, 3hr, 4hr, 6hr, 9hr after the dose.\n\nAlso on collection days, participants will receive text messages and be asked to complete different assessments about their medications, diet, and how they feel by responding to the texts.\n\nOn day 7, participants will have the opportunity to participate in an interview where investigators will ask about participants' experience in the study.",[24],"Kidney Transplant",[26,27,28,29,30],"tacrolimus","mycophenolate","pharmacokinetics","pediatrics","microsampling","NOT_YET_RECRUITING","2026-08-17",{"date":34,"type":35},"2026-08-19","ACTUAL",{"date":37,"type":20},"2026-09-01",{"date":39,"type":20},"2028-12-31",{"name":41,"class":42},"Children's Hospital Medical Center, Cincinnati","OTHER",{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":51,"targetDuration":53,"studyType":21,"phases":4,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":71,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},"100496919","a-link-improving-outcomes-in-autoimmune-liver-disease-100496919","NCT05750498","A-LiNK: Improving Outcomes in Autoimmune Liver Disease","Autoimmune Liver Disease Network for Kids (A-LiNK): Using Patient Data to Transform Care and Improve Outcomes for Children, Adolescents, and Young Adults With Autoimmune Liver Disease","ALINK","Inclusion Criteria:\n\n* Clinical diagnosis of autoimmune hepatitis (AIH)\n* Clinical diagnosis of primary sclerosing cholangitis (PSC)\n* Clinical diagnosis of autoimmune sclerosing cholangitis (ASC)\n\nExclusion Criteria:\n\n• History of liver transplant",{"count":52,"type":20},800,"10 Years","The Autoimmune Liver disease Network for Kids (A-LiNK) is a multi-institutional group with the mission to deliver the best care to kids with pediatric autoimmune liver disease (AILD).\n\nThis study will establish a shared clinical registry and a learning health network for the participating sites focusing on collecting and transmitting clinical measurement data, information about processes, and participation in an improvement collaborative.\n\nPediatric Autoimmune Hepatitis (AIH) and Primary Sclerosing Cholangitis (PSC), represent a spectrum of AILD which present unique diagnostic and therapeutic challenges.A lack of accepted guidelines for disease monitoring or symptom management results in wide treatment variation with liver transplants indicated in refractory, progressive disease.\n\nThe aims of A-LiNK are to:\n\n1.) Create a learning health network focused on patient-centered outcomes research characterized by transparent sharing among centers, common priorities, and feasible plans for implementing new practices; 2) shift from traditional investigator-driven study to a patient and family-centered approach, and 3.) improve clinical outcomes and quality of life for pediatric AILD patients.",[56,57],"Autoimmune Hepatitis","Primary Sclerosing Cholangitis",[59,56,57,60,61,62,63,64,65,66,67,68,69],"Pediatrics","Autoimmune Sclerosing Cholangitis","Chronic Liver Disease","End-stage Liver Disease","Clinical Registry","Research Registry","Quality Improvement","Outcomes Research","Comparative Effectiveness Research","Patient Reported Outcomes","Health Services Research","RECRUITING",{"date":34,"type":35},{"date":73,"type":35},"2022-04-28",{"date":75,"type":20},"2033-06-30",{"name":41,"class":42},8,{"id":79,"slug":80,"hasResults":12,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":12,"sex":17,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":92,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},"100299483","mri-biomarkers-in-as-predictor-of-clinical-endpoints-in-pediatric-autoimmune-liver-disease-100299483","NCT03178630","MRI Biomarkers in as Predictor of Clinical Endpoints in Pediatric Autoimmune Liver Disease","Longitudinal Study for the Assessment of MRI Based Biomarkers as a Predictors of Clinical Endpoints in Pediatric Onset Autoimmune Liver Disease","Inclusion Criteria:\n\n1. Age 6-23 years old.\n2. Established clinical diagnosis of AIH or PSC.\n\nExclusion Criteria:\n\n1. History of liver transplantation.\n2. Chronic Hepatitis B or untreated hepatitis C virus infection.\n3. Pregnancy.\n4. Absolute contraindication for MRI (e.g. pacemaker, metallic implants, claustrophobia).\n5. Diagnosis of cystic fibrosis or biliary atresia\n6. Diagnosis of cardiac hepatopathy.\n7. Diagnosis of Wilson's disease, Alpha-1 Antitrypsin deficiency, or Glycogen storage disease.\n8. Skin conditions which could be aggravated by MREL (i.e. Epidermolysis bullosa).","6 Years","23 Years",{"count":88,"type":20},150,"Autoimmune liver diseases (AILD), which include Primary Sclerosing Cholangitis (PSC) and Autoimmune Hepatitis (AIH) are a common etiological factor for chronic liver disease among adolescents. This is a longitudinal study to identify surrogate endpoints with an accurate predictive value for the progression of hepatobiliary damage in subjects with pediatric onset AILD. This study will involve collection of MRI-based data at the time of enrollment and at year 1 and 2 of follow up, and collection of clinical data for 10 years following enrollment. There is a strong possibility that MRI quantitative techniques may be more sensitive to disease progression than standard clinical and laboratory tests. To investigate predictivity of MRI based biomarkers, summary measures of MRCP\u002FMREL from baseline, Year 1 and Year 2, e.g. change rate, maximum, and average will be calculated as predictors for Year 10 clinical outcomes. The same predictors will also be used to model native liver survival in a proportional hazard regression. Findings from this study may be used to assess disease progression and to predict complications and survival of liver disease patients.",[91,56,57],"Autoimmune Liver Disease",{"date":34,"type":35},{"date":94,"type":35},"2017-02-20",{"date":96,"type":20},"2031-02",{"name":41,"class":42},1,{"id":100,"slug":101,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":12,"sex":17,"minAge":85,"maxAge":86,"enrollmentInfo":106,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":110,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":98},"100299240","mri-based-biomarkers-in-pediatric-autoimmune-liver-disease-100299240","NCT03175471","MRI Based Biomarkers in Pediatric Autoimmune Liver Disease","Cross-sectional Study for Assessment of MRI Based Biomarkers of Bile Duct Injury and Hepatic Fibrosis in Pediatric Onset Autoimmune Liver Disease","Inclusion Criteria:\n\n1. Age 6-23 years old.\n2. Established or suspected clinical diagnosis of AIH or PSC.\n\nExclusion Criteria:\n\n1. History of liver transplantation.\n2. Chronic Hepatitis B or untreated hepatitis C virus infection.\n3. Pregnancy.\n4. Absolute contraindication for MRI (e.g. pacemaker, metallic implants, claustrophobia).\n5. Diagnosis of cystic fibrosis or biliary atresia\n6. Diagnosis of cardiac hepatopathy.\n7. Diagnosis of Wilson's disease, Alpha-1 Antitrypsin deficiency, or Glycogen storage disease.\n8. Skin conditions which could be aggravated by MREL (i.e. Epidermolysis bullosa).",{"count":107,"type":20},115,"Autoimmune liver diseases (AILD), which include Primary Sclerosing Cholangitis (PSC) and Autoimmune Hepatitis (AIH) are a common etiological factors for chronic liver disease among adolescents. In all these conditions, autoimmune lymphocyte responses are thought to orchestrate inflammatory injury against hepatocytes (primarily in AIH) or cholangiocytes (in PSC). In this proposal we aim to evaluate the Magnetic Resonance Imaging (MRI) modalities; MR cholangiopancreatography (MRCP) and MR elastography (MREL), as non-invasive biomarkers to assess two primary pathophysiological processes of AILD: bile duct damage and liver fibrosis. In this cross-sectional study MRI based findings of bile duct injury and liver fibrosis will be correlated with both liver histology and circulating biomarkers of these disease processes.",[91,57,56],{"date":34,"type":35},{"date":112,"type":35},"2017-01-17",{"date":114,"type":20},"2030-01-30",{"name":41,"class":42},{"id":117,"slug":118,"hasResults":12,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":12,"sex":17,"minAge":124,"maxAge":125,"enrollmentInfo":126,"targetDuration":4,"studyType":128,"phases":129,"briefSummary":131,"conditions":132,"keywords":135,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":141,"leadSponsor":143,"locationsCount":98},"100652277","phase-4-semaglutide-in-youth-with-autism-spectrum-disorder-100652277","NCT07770152","Semaglutide in Youth With Autism Spectrum Disorder","Semaglutide for Metabolic and Adiposity-Related Targets in Youth With Autism Spectrum Disorder (SMART-ASD)","GLP1","Inclusion Criteria (Semaglutide Group):\n\n* 12-18 years of age\n* Epic-confirmed diagnosis of ASD\n* Obesity defined as BMI ≥95th percentile for age and sex\n* Have Medicaid or other insurance that will cover semaglutide or the parent is willing to pay for semaglutide out of pocket\n* Have a parent who is willing to provide informed consent\n* Can attend in-person, e-visits, or telehealth visits for 12 months\n* English speaking\n\nExclusion Criteria (Semaglutide Group):\n\n* Healthworks patient who has lost \\>5% body weight over the past 3 months\n* Are on a weight loss-promoting medication such as Metformin or Topamax with a dose change in the past 3 months\n* Have Type 1 or Type 2 diabetes\n* Have a personal or first-degree family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia 2\n* Have been on GLP-1 RAs in the past 12 months\n* Have significant GI conditions (e.g., pancreatitis),\n* Are pregnant or breastfeeding\n* Have catatonia or a condition that may affect compliance and safety\n\nInclusion Criteria (Historical Control Group):\n\n* Healthworks patients treated between January 1, 2021-December 31, 2025\n* 12-18 years of age\n* Confirmed diagnosis of ASD\n* Have obesity defined as BMI ≥95th percentile for age and sex\n* Have BMI and SMM outcomes assessed at M0, M6, or M12\n* Age groups 12-14 years old and 15-18 years old and sex matched to youth in the semaglutide group","12 Years","18 Years",{"count":127,"type":20},42,"INTERVENTIONAL",[130],"PHASE4","This study is a 6-month, two-arm, RCT which will evaluate the effectiveness and safety of semaglutide in adolescents aged 12-18 years with autism spectrum disorder (ASD) and obesity. The primary outcome is change in body mass index (BMI, kg\u002Fm²) from baseline to Month 6. Secondary, descriptive outcomes are changes in metabolic parameters (e.g., lipid levels), side effects, and compliance with semaglutide.",[133,134],"Autism Spectrum Disorder","Obesity",[133,134,136],"Semaglutide","2026-08-14",{"date":139,"type":35},"2026-08-18",{"date":37,"type":20},{"date":142,"type":20},"2029-09-01",{"name":41,"class":42},{"id":145,"slug":146,"hasResults":12,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":12,"sex":17,"minAge":152,"maxAge":153,"enrollmentInfo":154,"targetDuration":4,"studyType":128,"phases":156,"briefSummary":158,"conditions":159,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":98},"100646968","impact-of-short-and-mistimed-sleep-on-adolescents-with-adhd-the-adolescent-attention-and-circadian-timing-study-100646968","NCT07684417","Impact of Short and Mistimed Sleep on Adolescents With ADHD: The Adolescent Attention and Circadian Timing Study","Impact of Circadian Misalignment for Adolescents With ADHD: Observational and Mechanistic Data","AACT","Inclusion Criteria:\n\n* Ages 13-17 years at time of informed consent\u002Fassent\n* Based on semi-structured clinical interview, participants must meet full DSM-5 criteria for ADHD inattentive or ADHD combined presentation.\n\nExclusion Criteria:\n\n* Non-traditional school setting (morning-afternoon Monday-Friday).\n* Exclusionary diagnoses. We will exclude adolescents with known intellectual disability, autism spectrum disorder, psychosis, bipolar disorder, or neurologic conditions (e.g., epilepsy), per caregiver-report.\n* Exclusionary sleep disorders. We will exclude adolescents with symptoms of obstructive sleep apnea or periodic limb movement disorder based on published cutoffs on a validated questionnaire.\n* High caffeine intake. To promote adherence to directives not to consume caffeine the day of office visits without withdrawal effects, adolescents with daily intake of \\>1 coffee or \"energy drink\" or \\>2 caffeinated sodas per day based on caregiver- and adolescent-report will be excluded.\n\n  * Unwillingness or inability to take part in study procedures (e.g., visits, prescribed sleep conditions).\n  * Medication use or unwillingness to discontinue melatonin and\u002For stimulant medications during the 3-week study protocol.\n* Refusal to refrain from automobile driving during the sleep restriction condition.\n* \"Intermediate\" Chronotypes (neither morning larks nor night owls) based on habitual sleep timing on nights when adolescent has no morning obligations such as school or work.","13 Years","17 Years",{"count":155,"type":20},50,[157],"NA","Many adolescents go to bed late and wake up early for school. Science is only beginning to understand how sleep schedules can affect them. The investigators are interested in whether changing adolescents' sleep patterns affects their functioning, attention, and how they feel. The investigators are especially interested in the effects of changing both how much sleep adolescents get and when that sleep happens.\n\nThis study focuses on healthy 13-17-year-olds with ADHD. This study asks adolescents to systematically change their sleeping habits across a 3 week span. The first week, they follow a sleep schedule that fits reasonably well with the schedule they keep when they do not have to wake up early for any specific obligation (e.g., for school). The second week, they spend several nights in a \"short sleep\" condition, during which they get 6.5 hours in bed per night. The final week, they enter a sleep condition that allows for healthy sleep duration, but with a timing that is randomly assigned to either fit well with their preferred schedule or fit poorly with that schedule. During each week, they and their parents complete measures of their attention and other factors. At the end of each week, they attend an evening session to measure their internal body clock (\"circadian phase\"), as well as measures of attention and other thinking skills. The goal is to understand whether the benefits of healthy sleep duration depend on the timing of when that sleep occurs.",[160],"ADHD","2026-08-13",{"date":32,"type":35},{"date":164,"type":35},"2026-07-10",{"date":166,"type":20},"2030-08",{"name":41,"class":42},{"id":169,"slug":170,"hasResults":12,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":12,"sex":17,"minAge":175,"maxAge":125,"enrollmentInfo":176,"targetDuration":4,"studyType":128,"phases":178,"briefSummary":180,"conditions":181,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":98},"100621797","zoledronate-to-prevent-bone-health-complications-in-pediatric-hematopoietic-stem-cell-transplant-survivors-100621797","NCT07375290","Zoledronate to Prevent Bone Health Complications in Pediatric Hematopoietic Stem Cell Transplant Survivors","Early Intervention With Zoledronate to Safely Prevent Bone Health Complications in Pediatric Hematopoietic Stem Cell Transplant Survivors","Inclusion Criteria:\n\n* Patients ≥5 and ≤18 years old who are preparing for HSCT with a height-for-age corrected DXA Z-score of \\\u003C-2.0 and admitted to a CCHMC inpatient unit.\n* Patients ≥5 and ≤18 years old recovering from HSCT and who have developed de novo acute or chronic GVHD and are admitted to a CCHMC inpatient unit.\n\nExclusion Criteria:\n\n* Age \\\u003C5 years and \\>18 years\n* Patients with Fanconi anemia or other radiation-sensitive syndromes with increased malignancy risk\n* history of prior bisphosphonate use\n* low 25-OH vitamin D levels (\\\u003C20 ng\u002FmL)\n* active febrile illness\n* uncontrolled infection\n* Elevated creatinine at the time of enrollment, history or renal failure, or documented low glomerular filtration rate (GFR≤90)\n* Active bone disease including history of abnormal PTH level for any reason, active bone fracture\u002Fhealing, or primary disorder of bone development or metabolism.\n* Women who are pregnant or breast feeding.","5 Years",{"count":177,"type":20},20,[179],"PHASE1","The purpose of this pilot study is to investigate the safety and preliminarily assess efficacy of early intervention with zoledronate in high risk pediatric hematopoietic stem cell transplantation (HSCT) patients to prevent the development of bone disease and fractures and reduce potential pain and suffering.",[182],"Hematopoietic Stem Cell Transplantation","2026-08-07",{"date":185,"type":35},"2026-08-10",{"date":187,"type":35},"2026-07-17",{"date":189,"type":20},"2028-11",{"name":41,"class":42},{"id":192,"slug":193,"hasResults":12,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":153,"enrollmentInfo":198,"targetDuration":4,"studyType":128,"phases":200,"briefSummary":201,"conditions":202,"keywords":211,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":227},"100507610","responding-with-evidence-and-access-for-childhood-headaches-100507610","NCT05889624","Responding With Evidence and Access for Childhood Headaches","Cognitive Behavioral Therapy Via Telehealth + Amitriptyline Compared to Cognitive Behavioral Therapy Via Telehealth: Pediatric Migraine Prevention (Responding With Evidence and Access for Childhood Headaches)","Inclusion Criteria:\n\n* Diagnosis: Migraine with or without aura that meets the International Classification of Headache Disorders (ICHD) criteria 5 or presentation of continuous headache that includes migranous episodes based upon headache history obtained by site PI or designee. (includes presentation with or without medication overuse headache as well)\n* Headache Frequency: 4 or more headache days based upon prospective headache diary of 28 days prior to randomization\n* Amitriptyline Eligible: Site PI or medical staff determined participant to be eligible for clinical prescription of amitriptyline as a preventive treatment for migraine\n* English fluency: Able to complete the study visits and questionnaires in English\n\nExclusion Criteria:\n\n* Current treatment includes amitriptyline and\u002For CBT specific to headache care\n* Current prescribed preventive antimigraine medication within a period equivalent to \\\u003C 5 half-lives of that medication before entering the baseline phase\n* Current treatment with onabotulinumtoxinA (Botox) or CGRP-based monoclonal antibody medications for migraine prevention\n* Youth who are pregnant\n* Report of current or ongoing suicidal thoughts. Suicide attempt within the past six months. History of bipolar disorder, prolonged QT, or pre-existing significant constipation or gastroparesis\n* Any and all other diagnoses or conditions which, in the opinion of the site investigator, would prevent the patient from being a suitable candidate for the study or interfere with the medical care needs of the participant",{"count":199,"type":20},400,[157],"This comparative effectiveness study will clarify current first-line preventive treatment approaches for use by neurologists, psychologists, and primary care providers in the context of real world care, and will demonstrate the feasibility of Cognitive Behavioral Therapy (CBT) via telehealth for youth with migraine. The focus is on applying evidence-based care and enhancing access to it. CBT via telehealth while taking a clinically-prescribed, pill-based prevention therapy (amitriptyline) will be compared to CBT via telehealth alone.",[203,204,205,206,207,208,209,210],"Headache","Headache Disorders","Headache, Migraine","Migraine","Migraine Disorders","Migraine With Aura","Migraine Without Aura","Chronic Migraine",[212,213,214,29,215,216,217,218,219],"headache","migraine","cognitive behavioral therapy","diaphragmatic breathing","progressive muscle relaxation","imagery","relaxation","biofeedback","2026-08-06",{"date":185,"type":35},{"date":223,"type":35},"2023-08-22",{"date":225,"type":20},"2027-12-31",{"name":41,"class":42},15,{"id":229,"slug":230,"hasResults":12,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":4,"eligibilityCriteria":234,"healthyVolunteers":12,"sex":17,"minAge":235,"maxAge":236,"enrollmentInfo":237,"targetDuration":4,"studyType":128,"phases":239,"briefSummary":241,"conditions":242,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":98},"100379157","phase-3-no-during-cpb-in-neonates-to-reduce-risk-of-aki-100379157","NCT04216927","NO During CPB in Neonates to Reduce Risk of AKI","Efficacy of Nitric Oxide Administration During Cardiopulmonary Bypass in Neonates at Reducing the Risk of Acute Kidney Injury","Inclusion Criteria:\n\n* All neonates (≤31 days) undergoing cardiac surgery with CPB for CHD will be deemed eligible for enrollment.\n\nExclusion Criteria:\n\n1. Failure to obtain informed consent from parent\u002Fguardian\n2. Clinical signs of preoperative persistent elevated pulmonary vascular resistance,\n3. Emergency surgery,\n4. Episode of cardiac arrest within 1 week before surgery,\n5. Recent treatment with steroids and\u002For a condition that may require treatment with steroids (excluding steroid administration specifically for CPB),\n6. Use of inhaled NO (iNO) immediately prior to surgery,\n7. Structural renal abnormalities by ultrasound,\n8. Preoperative AKI,\n9. Use of other investigational drugs,\n10. Weight less than \\\u003C2 kg,\n11. Gestational age \\\u003C36 weeks,\n12. Major extracardiac congenital anomalies,\n13. Non-English speakers.","1 Day","31 Days",{"count":238,"type":20},40,[240],"PHASE3","Acute kidney injury (AKI) following cardiac surgery for congenital heart defects (CHD) in children affects up to 60% of high risk-patients and is a major cause of both short- and long-term morbidity and mortality. Despite effort, to date, no successful therapeutic agent has gained widespread success in preventing this postoperative decline in renal function. Nitric oxide is an intricate regulator of acute inflammation and coagulation and is a potent vasodilator. The investigators hypothesize that nitric oxide, administered during cardiopulmonary bypass (CPB), may reduce the incidence of AKI.",[243,244,245],"AKI","CHD - Congenital Heart Disease","Surgery","2026-08-03",{"date":248,"type":35},"2026-08-05",{"date":250,"type":35},"2023-01-10",{"date":252,"type":20},"2027-06-30",{"name":41,"class":42},{"id":255,"slug":256,"hasResults":12,"nctId":257,"briefTitle":258,"officialTitle":258,"acronym":259,"eligibilityCriteria":260,"healthyVolunteers":12,"sex":17,"minAge":261,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":128,"phases":264,"briefSummary":266,"conditions":267,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":278},"100433534","phase-2-abatacept-for-the-treatment-of-common-variable-immunodeficiency-with-interstitial-lung-disease-100433534","NCT04925375","Abatacept for the Treatment of Common Variable Immunodeficiency With Interstitial Lung Disease","ABCVILD","Inclusion Criteria:\n\n1. Diagnosis of CVID according to the international consensus document (ICON)\n\n   1. Age 4 years or above\n   2. Serum IgG at least 2 standard deviations below the age adjusted normal\n   3. Decreased serum IgA and\u002For serum IgM\n   4. Abnormal specific antibody response to immunization\n   5. Exclusion of secondary immunodeficiency\n2. On replacement immunoglobulin for at least 6 months and willing to maintain throughout study\n3. Granulomatous-lymphocytic interstitial lung disease with a lymphocytic component diagnosed by lung biopsy prior to study entry, wedge biopsy preferred.\n4. Persistence or worsening of interstitial lung disease measured on serial CT imaging of the lung at least 6 months apart, with the latest assessment within 3 months of study entry.\n5. Signed written informed consent\n6. Willing to allow storage of biological specimens for future use in medical research.\n7. Female subjects of childbearing potential must agree to an effective form of birth control such as hormone based contraceptive, intrauterine device, condoms\u002Fbarrier, surgically sterile partner, or abstinence.\n8. Fertile, non-vasectomized males with a female partner of childbearing potential should use condoms throughout the study and for 3 months after the last dose\n\nExclusion Criteria:\n\n1. History of hypersensitivity to abatacept or any of its components\n2. Has received any lymphocyte depleting agents including anti-CD20 monoclonal antibodies, alemtuzumab, ATG in the preceding 6 months\n3. Has received abatacept, cyclophosphamide, tumor necrosis factor inhibitors, or pulse steroids (defined as \\>15mg\u002Fkg\u002Fday of methylprednisone or corticosteroid equivalent) within the past 3 months\n4. Have started or increased any of the following immune modulating drugs within 3 months of enrolling and 3 months from initial CT chest: azathioprine, cyclosporine, tacrolimus, mercaptopurine, methotrexate, mycophenolate mofetil, or sirolimus\n5. History of HIV infection (positive PCR)\n6. Chronic untreated hepatitis B or C (positive PCR)\n7. Active tuberculosis (TB) by positive QuantiFERON gold. If history of latent TB, then must supply evidence of completing treatment.\n8. Persistent Epstein-Barr Virus (EBV) load ≥ 1,000 units\u002FmL blood checked twice at least 1 month apart\n9. Other uncontrolled infections\n10. Live vaccine given within 6 weeks of the start of the trial\n11. Malignancy or treated for malignancy within the past year\n12. Currently pregnant or breast feeding\n13. Life expectancy less than 1 month\n14. Subjects unwilling to self-administer or have a parent\u002Fcaregiver self-administer subcutaneous injections at home\n15. Other conditions that the investigators feel contraindicate participation in the study\n\nInclusion criteria for Extended Treatment Plan:\n\n* Patients must have completed the abatacept for the treatment of Interstitial Lung Disease in Common Variable Immunodeficiency (ABCVILD) trial\n* Patients must have demonstrated positive response to abatacept.\n* Patients must provide informed consent to participate in the Extended Treatment Plan.\n\nExclusion criteria for Extended Treatment Plan:\n\n• Patients who experienced SAEs during the original trial, and such SAEs were determined as related to treatment, or patients who in the opinion of the investigator would not benefit from the extended treatment option.","4 Years",{"count":263,"type":20},38,[265],"PHASE2","There is no standard of care therapy for patients with granulomatous-lymphocytic interstitial lung disease (GLILD) seen in common variable immunodeficiency (CVID). Abatacept has recently looked promising for the treatment of patients with complex CVID. This study is a multi-site, phase II, randomized, blinded\u002Fplacebo-controlled clinical trial in pediatric and adult subjects to determine the efficacy of abatacept compared to placebo for treatment of subjects with GLILD in the context of CVID.\n\nFunding Source - FDA OOPD",[268,269],"Interstitial Lung Disease","Common Variable Immunodeficiency","2026-07-21",{"date":272,"type":35},"2026-07-22",{"date":274,"type":35},"2021-07-14",{"date":276,"type":20},"2028-07",{"name":41,"class":42},6,{"id":280,"slug":281,"hasResults":12,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":285,"eligibilityCriteria":286,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":287,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":289,"conditions":290,"keywords":294,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":298,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":98},"100648398","fst-analysis-supporting-timely-therapy-and-risk-assessment-via-clinical-decision-support-for-kids-100648398","NCT07718464","FST Analysis Supporting Timely Therapy and Risk Assessment Via Clinical Decision Support for Kids","Furosemide Stress Test Implementation and Outcomes in Critically Ill Children at High Risk for Acute Kidney Injury: A Hybrid Study","FAST TRACK","Inclusion Criteria:\n\n* Admitted to the pediatric intensive care unit (PICU)\n* Renal Angina Index (RAI) greater than or equal to 8 (RAI+)\n* Urine NGAL greater than or equal to 150 ng\u002FmL (NGAL+)\n\nExclusion Criteria:\n\n* Receipt of renal replacement therapy prior to PICU admission",{"count":288,"type":20},120,"The goal of this study is to learn whether adding a clinical decision support tool to the electronic medical record helps clinicians use the furosemide stress test in critically ill children at high risk for severe acute kidney injury (AKI). The main question it aims to answer is: Does implementing the decision support tool reduce fluid overload and help predict which children will receive dialysis?\n\nResearchers will identify children admitted to the pediatric intensive care unit who are at high risk for AKI using risk stratification and biomarker testing, then compare outcomes in the two years after the tool is introduced with the two years before.",[291,292,293],"Acute Kidney Injury","Renal Replacement Therapy","Pediatric Intensive Care Unit",[295,296,297],"NGAL","Renal Angina Index","Furosemide Stress Test",{"date":272,"type":35},{"date":300,"type":35},"2026-05-27",{"date":302,"type":20},"2028-06",{"name":41,"class":42},{"id":305,"slug":306,"hasResults":12,"nctId":307,"briefTitle":308,"officialTitle":308,"acronym":309,"eligibilityCriteria":310,"healthyVolunteers":12,"sex":17,"minAge":311,"maxAge":125,"enrollmentInfo":312,"targetDuration":4,"studyType":128,"phases":314,"briefSummary":315,"conditions":316,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":98},"100647503","phase-1-optimizing-hydroxyurea-therapy-in-children-with-sickle-cell-anemia-in-malaria-endemic-areas-the-noharm-maximum-tolerated-dose-mtd-study-100647503","NCT07708714","Optimizing Hydroxyurea Therapy in Children With Sickle Cell Anemia In Malaria Endemic Areas: The NOHARM Maximum Tolerated Dose (MTD) Study","NOHARM MTD","Adolescents with confirmed SCA who are currently enrolled in the NOHARM MTD Study of hydroxyurea at the Mulago Hospital Sickle Cell Clinic (MHSCC), will be eligible for the NOHARM MTD LT version 2.0 extension study after completing re-consent. An age-matched untreated (hydroxyurea-naïve) group of adolescents will also be enrolled as a Comparator Cohort. This will comprise 75 children from Kampala and surrounding districts, ages 11 - 18 years of age, with confirmed SCA.","11 Years",{"count":313,"type":20},250,[179,265],"NOHARM MTD is an extension of a previous study for children with Sickle Cell Anemia (SCA) who were enrolled in the NOHARM study. All children enrolled in NOHARM received hydroxyurea treatment at a fixed daily dose of 20 mg\u002Fkg\u002Fday. This dose was selected as a likely safe dose, but does not escalate hydroxyurea to maximum tolerated dose \"MTD\" as is commonly done in the US. Without this information, we cannot know whether hydroxyurea treatment at the MTD would be feasible (since it requires closer monitoring to avoid hematological toxicities), safe (since adverse events may be greater with MTD, risk of malaria may be altered by MTD, and risk of infections as a result of neutropenia could also be greater with MTD) or beneficial (MTD is associated with higher hemoglobin and fetal hemoglobin concentration).",[317,318],"Sickle Cell Disease","Sickle Cell Anemia in Children","2026-07-13",{"date":321,"type":35},"2026-07-16",{"date":323,"type":35},"2026-05-13",{"date":325,"type":20},"2032-11-30",{"name":41,"class":42},{"id":328,"slug":329,"hasResults":12,"nctId":330,"briefTitle":331,"officialTitle":331,"acronym":332,"eligibilityCriteria":333,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":334,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":336,"conditions":337,"keywords":339,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":344,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":98},"100644246","adapting-enhanced-supports-to-improve-patient-adherence-to-secondary-antibiotic-prophylaxis-for-rheumatic-heart-disease-100644246","NCT07666048","Adapting Enhanced Supports to Improve Patient Adherence to Secondary Antibiotic Prophylaxis for Rheumatic Heart Disease","SHIELD 3 Adapt","Inclusion Criteria:\n\n* Adults living with rheumatic heart disease (RHD): age ≥18 years; diagnosed with RHD; prescribed secondary antibiotic prophylaxis (SAP)\n* Guardians of children living with RHD: age ≥18 years; caregiver\u002Fguardian of a child aged 5-17 years with diagnosed RHD who is prescribed SAP\n* Children living with RHD: age 12-17 years; diagnosed with RHD; prescribed SAP\n* Community health workers (CHWs): age ≥18 years; associated with a healthcare center providing care to patients with RHD\n* Healthcare workers (HCWs): age ≥18 years; employed at a healthcare center providing care to patients with RHD; able to provide informed consent in English or the local language\n\nExclusion Criteria:\n\n* Adults living with RHD: medical contraindication to SAP; inability to provide informed consent (e.g., significant cognitive or communication impairment precluding participation)\n* Guardians of children living with RHD: child has a medical contraindication to SAP; inability to provide informed consent\n* Children living with RHD: medical contraindication to SAP; inability to provide informed assent (e.g., significant cognitive or communication impairment precluding participation)\n* Community health workers: none\n* Healthcare workers: none",{"count":335,"type":20},308,"The goal of this clinical trial is to test the effectiveness and implementation of enhanced Secondary Antibiotic Prophylaxis (SAP) supports using a hybrid type 1 effectiveness-implementation design. The purpose is to determine whether enhanced SAP supports will increase average SAP adherence in Brazil and Timor-Leste. The study will enroll people living with Rheumatic Heart Disease (RHD) and Community Health Workers (CHWs) participating in the intervention.\n\nThe main questions it aims to answer are:\n\n* Whether CHW-led supports delivered within the community improve mean SAP adherence at 12 months post-intervention.\n* Whether the intervention demonstrates acceptability, feasibility, uptake and engagement.\n\nResearchers will compare baseline and post-intervention SAP adherence data for the 12 months prior to and following intervention rollout to see if CHW-delivered supports increase adherence.",[338],"Rheumatic Heart Disease in Children",[340,341,342,343],"Secondary Antibiotic Prophylaxis for Rheumatic Heart Disease","SAP for RHD","SAP Adherence","Secondary Antibiotic Prophylaxis Adherence",{"date":319,"type":35},{"date":346,"type":20},"2026-08-01",{"date":348,"type":20},"2030-12-31",{"name":41,"class":42},{"id":351,"slug":352,"hasResults":12,"nctId":353,"briefTitle":354,"officialTitle":355,"acronym":356,"eligibilityCriteria":357,"healthyVolunteers":358,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":359,"targetDuration":4,"studyType":128,"phases":361,"briefSummary":362,"conditions":363,"keywords":365,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":368,"startDateStruct":369,"completionDateStruct":370,"leadSponsor":372,"locationsCount":98},"100638280","testing-a-registry-based-strategy-act-to-reduce-loss-to-follow-up-in-rheumatic-heart-disease-screening-in-uganda-100638280","NCT07606131","Testing a Registry-Based Strategy (ACT+) to Reduce Loss to Follow-Up in Rheumatic Heart Disease Screening in Uganda","Developing and Testing a Registry-Enabled Strategy (ACT+) to Reduce Loss to Follow-Up Between Screening and Confirmation of Rheumatic Heart Disease in Uganda","SHIELD 2","Inclusion Criteria: Community Members\n\n* 18 years of age or older\n* Received a positive ADUNU echocardiographic screening result within the past 24 months OR parent\u002Flegal guardian of a minor who received a positive ADUNU echocardiographic screening result within the past 24 months\n\nInclusion Criteria: Providers\n\n* Employed at an ADUNU-participating facility or confirmatory echo facilities at the time of study\n* Holds a designated ADUNU role (nurse screener, confirmatory provider, or referral support staff) or is involved in RHD screening, diagnosis or care\n* Ability to provide informed consent in Acholi, Luo, or English\n\nInclusion Criteria: Regional RHT ACT Nurse Coordinator\n\n* Employed as a Regional ACT Nurse at the time of study\n* Has familiarity with ADUNU program\n* Ability to provide informed consent in Acholi, Luo, or English\n\nInclusion Criteria: District Health Office Team Members and District RHD Focal Persons\n\n* Employed at District Health Office within an ADUNU-participating district\n* Has familiarity with ADUNU program\n* Ability to provide informed consent in Acholi, Luo, or English\n\nExclusion Criteria:\n\n* No formal exclusion criteria beyond inability to provide informed consent. Individuals with significant cognitive or communication impairment precluding interview participation will not be enrolled.",true,{"count":360,"type":20},16,[157],"This study aims to improve follow-up care after positive rheumatic heart disease (RHD) screening in Northern Uganda. It will identify barriers and co-develop an enhanced ACT+ strategy, then evaluate its effectiveness in increasing linkage to confirmatory echocardiography, along with its adoption, acceptability, and feasibility. Secondary outcomes include time to diagnosis, initiation of treatment, and factors influencing implementation.",[364],"Rheumatic Heart Disease",[366,367],"Rheumatic heart disease","SHIELD",{"date":319,"type":35},{"date":346,"type":20},{"date":371,"type":20},"2028-06-01",{"name":41,"class":42},{"id":374,"slug":375,"hasResults":12,"nctId":376,"briefTitle":377,"officialTitle":377,"acronym":4,"eligibilityCriteria":378,"healthyVolunteers":358,"sex":17,"minAge":379,"maxAge":380,"enrollmentInfo":381,"targetDuration":4,"studyType":128,"phases":383,"briefSummary":384,"conditions":385,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":389,"completionDateStruct":391,"leadSponsor":393,"locationsCount":98},"100559139","tracking-early-emergence-of-sound-perception-impairments-in-fxs-with-multimodal-fnirseeg--infant-100559139","NCT06560242","Tracking Early Emergence of Sound Perception Impairments in FXS With Multimodal fNIRS\u002FEEG- Infant","Inclusion Criteria:\n\n* Diagnoses of Fragile X Syndrome, Typical Development, or History of Premature Birth\n* able to sit independently\n* English is spoken at home\n\nExclusion Criteria:\n\n* For all participants: no seizures in the past 6 months\n* For typical development group and Fragile X group: not born prior to 32 weeks gestation","6 Months","26 Months",{"count":382,"type":20},30,[157],"Individuals with Fragile X Syndrome show differences in how they understand and learn language from infancy. They frequently have lifelong delays in speech and language as well. In addition, they experience other auditory symptoms, including being very sensitive to certain sounds as well as being more sensitive than others to loud sounds. The underlying brain activity for sound perception and speech learning in Fragile X is not well understood, especially in the infant and toddler years. This study uses behavioral assessment of speech and language abilities, neuroimaging, and hearing tests to understand how speech and hearing are different in children with Fragile X Syndrome.",[386],"Fragile X Syndrome","2026-07-08",{"date":164,"type":35},{"date":390,"type":35},"2022-10-31",{"date":392,"type":20},"2027-03-01",{"name":41,"class":42},{"id":395,"slug":396,"hasResults":12,"nctId":397,"briefTitle":398,"officialTitle":399,"acronym":4,"eligibilityCriteria":400,"healthyVolunteers":12,"sex":17,"minAge":401,"maxAge":402,"enrollmentInfo":403,"targetDuration":4,"studyType":128,"phases":405,"briefSummary":406,"conditions":407,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":98},"100500983","evaluating-additive-effects-of-including-canines-in-regulating-together-100500983","NCT05803343","Evaluating Additive Effects of Including Canines in Regulating Together","Evaluating Additive Effects of Including Canines in Regulating Together: A Group Treatment to Address Emotion Dysregulation in Youth With Autism Spectrum Disorder","Inclusion Criteria:\n\n* Concern of emotion dysregulation (ED) as measured by a score of 6 or greater on the Emotion Dysregulation Inventory-Reactivity (EDI-R)\n* Diagnosis of autism spectrum disorder (ASD)\n* Diagnosis confirmed by an experienced ASD clinician and further supported by scoring in the range for ASD on the Autism Diagnostic Observation Schedule (ADOS-2)\n* A Full Scale Intelligence Quotient score of 65 or greater on the Weschler Abbreviated Scale Intelligence (WASI-II)\n* English is the primary language\n* Family willing to keep prescribed medication stable over the course of the study period\n\nExclusion Criteria:\n\n* Participant has a phobia toward or is allergic to canines\n* Participant has a history of aggression toward animals\n* Participant has had any physical aggression toward other children outside the home in the past 2 weeks that resulted in injury\n* Presence of comorbid major neuropsychiatric illness warranting other treatment approaches as determined by the study clinician(s) including substance use disorders, psychotic disorders\u002Fschizophrenia, and bipolar disorder, among others\n* Presence of any major sensory impairment that would limit participating in the material including blindness or uncorrected hearing loss\n* A legal guardian is not available to provide informed consent","8 Years","15 Years",{"count":404,"type":20},240,[157],"The primary objective is to evaluate the potential additive effect of animal-assisted intervention (AAI) on a manualized behavioral treatment targeting emotion dysregulation (ED) in children with autism spectrum disorder (ASD).\n\nAim 1: Evaluate whether Regulating Together-Canine demonstrates earlier and greater improvement in emotion dysregulation than Regulating Together-Standard.\n\nAim 2: Evaluate if Regulating Together-Canine increases child engagement and learning compared to Regulating Together-Standard.\n\nExploratory Aim: Explore association of physiological arousal (via heart rate tracking) with emotion dysregulation, treatment engagement, and learning.",[133,408],"Emotion Regulation","2026-07-07",{"date":387,"type":35},{"date":412,"type":35},"2023-02-28",{"date":414,"type":20},"2028-01-21",{"name":41,"class":42},{"id":417,"slug":418,"hasResults":12,"nctId":419,"briefTitle":420,"officialTitle":421,"acronym":4,"eligibilityCriteria":422,"healthyVolunteers":12,"sex":17,"minAge":124,"maxAge":125,"enrollmentInfo":423,"targetDuration":4,"studyType":128,"phases":424,"briefSummary":425,"conditions":426,"keywords":429,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":98},"100528312","smarthome-feasibility-trial-100528312","NCT06159127","SMART@Home Feasibility Trial","Self-Management Assistance for Recommended Treatment (SMART)@Home Care","Inclusion Criteria:\n\n* Patients diagnosed with a chronic medical condition requiring regular treatment, i.e., asthma\n* Ages 12-18\n* English fluency for patient and caregiver\n\nExclusion Criteria:\n\n* Diagnosis of pervasive developmental disorder in patient or caregiver as determined by medical chart review\n* Diagnosis of serious mental illness (e.g., schizophrenia) in patient or caregiver as determined by medical chart review",{"count":7,"type":20},[157],"The proposed research addresses the limitations or lack of a digital platform to provide remote care of medically complex patients. Previous attempts have had poor clinical validity and suffered lack of patient engagement. The study team will deconstruct the previously implemented SMART platforms to create a roadmap, platform, and template to guide clinicians to create new tools.\n\nResults from Phase 1 of this project highlighted the need for connectivity between the SMART@Home app and Bluetooth-enable devices to provide objective disease activity data as well as integration with Epic electronic health record so that providers can use the data to inform treatment planning and decision making. A subsequent pilot user validation trial is also needed to confirm development goals were met. Conducting a pilot user validation trial of the SMART@Home asthma tracker, spirometer, and action plan is the purpose of the next phases of this study.\n\nA beta test the SMART@Home Asthma Tracker and asthma action plan algorithm will take place with approximately 8 participants. Beta testing will have participants record simulated increases in symptoms to ensure appropriate levels of care is communicated via the app. Then, a group of 40 adolescent (ages 12-17) patients with asthma for a 6-month pilot Randomized Control Trial (RCT). Participants will be randomized into either the IMAAP SMART@Home (n=20) or control (n=20) groups following the completion of baseline measures to test the interactive asthma action plan functionality and impact.",[427,428],"Asthma","Asthma in Children",[427],"2026-06-30",{"date":432,"type":35},"2026-07-02",{"date":434,"type":35},"2024-09-09",{"date":436,"type":20},"2027-07-31",{"name":41,"class":42},{"id":439,"slug":440,"hasResults":12,"nctId":441,"briefTitle":442,"officialTitle":443,"acronym":4,"eligibilityCriteria":444,"healthyVolunteers":358,"sex":17,"minAge":445,"maxAge":175,"enrollmentInfo":446,"targetDuration":4,"studyType":128,"phases":447,"briefSummary":448,"conditions":449,"keywords":451,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":453,"lastUpdatePostDateStruct":454,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":460,"locationsCount":98},"100570906","comparing-stainless-steel-crowns-with-prefabricated-resin-crowns-in-primary-molar-teeth-100570906","NCT06713330","Comparing Stainless Steel Crowns With Prefabricated Resin Crowns in Primary Molar Teeth","A 36-Month Prospective Randomized Clinical Pilot Trial Comparing Stainless Steel Crowns With Prefabricated Resin Crowns in Primary Molar Teeth","Inclusion Criteria:\n\n* CCHMC pediatric dental patients between the ages of 2 years to 5 years and 11 months, at the time of recruitment, who present to any CCHMC dental clinic location and then are found to need full mouth dental rehabilitation.\n* Patients who speak the most common languages at CCHMC will be able to be recruited for the study.\n\n  o English, Spanish, Arabic, Uzbek, Nepali, Chinese Mandarin, Russian, French.\n* These patients must qualify for treatment at the CCHMC dental in-office general anesthesia (IOGA) area or the Procedure Center (PC). IOGA and the PC will be selected as a venue of treatment to control behavioral factors. This is not specific to the study and would occur due to their treatment needs.\n* Participants will have at least one pair of contralateral primary molars with the need for a full coverage restoration in the same arch.\n\n  * For example, tooth A \\& J, B \\& I, S \\& L, or T \\& K\n  * For each participant, a minimum of one SSC or one PRC will be randomly assigned via a split mouth design to be placed as part of the study.\n* Need for Full coverage and high caries risk will be defined by AAPD Best Practice Guidelines 2,16\n\n  o Teeth With\n  1. Extensive caries\n  2. Cervical decalcification\n  3. Developmental defects (e.g., hypoplasia, hypocalcification)\n  4. When failure of other available restorative materials is likely (e.g., interproximal caries extending beyond line angles, patients with bruxism)\n  5. Following pulpotomy or pulpectomy\n  6. For definitive restorative treatment for high caries-risk children as defined by the AAPD\n  7. For patients who exhibit high caries risk and whose treatment is performed under sedation or general anesthesia. This would be normal and not specific to the study.\n* Participants who consent to the study, and who can be available for follow-up recall appointments.\n* All participants will be ASA I or ASA II as defined by the American Society of Anesthesiologists.15\n\nExclusion Criteria:\n\n* Participants who do not meet inclusion criteria will be excluded.\n\n  * Participants whose teeth do not meet the inclusion criteria.\n  * Participants who do not wish to participate in the study.\n  * Patients who do not wish to or cannot reliably return for follow-up visits.\n  * Red dye allergy as patient will not be able to be plaque disclosed during follow-up visits.\n  * Participants who do not speak English, Spanish, Arabic, Uzbek, Nepali, Chinese Mandarin, Russian, French.","2 Years",{"count":155,"type":20},[157],"The main reason for this research study is to learn more about a new flexible white dental crown (BioFLX) by comparing it to an existing flexible metal crown (Stainless Steel Crown). It is of interest to see if this new white crown is clinically equivalent to the existing silver crown that is mainly used in pediatric dentistry. A potential participant for this study would have cavities that require a crown, a type of filling that covers the entire tooth, and recommended dental work be done under general anesthesia.",[450],"Dental Caries",[452],"Pediatric dentistry","2026-06-24",{"date":455,"type":35},"2026-06-29",{"date":457,"type":35},"2024-05-17",{"date":459,"type":20},"2027-12-29",{"name":41,"class":42},{"id":462,"slug":463,"hasResults":12,"nctId":464,"briefTitle":465,"officialTitle":465,"acronym":4,"eligibilityCriteria":466,"healthyVolunteers":12,"sex":17,"minAge":402,"maxAge":467,"enrollmentInfo":468,"targetDuration":4,"studyType":128,"phases":470,"briefSummary":471,"conditions":472,"keywords":475,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":480,"startDateStruct":481,"completionDateStruct":482,"leadSponsor":484,"locationsCount":485},"100610121","a-tailored-medication-adherence-promotion-intervention-for-adolescents-and-young-adults-with-cancer-100610121","NCT07223463","A Tailored Medication Adherence-Promotion Intervention for Adolescents and Young Adults With Cancer","Inclusion Criteria:\n\n* Patient is 15.00 to 24.99 years of age\n* Patient is diagnosed with cancer\n* Patient is prescribed an oral anticancer\u002Fantitumor agent or prophylaxis\n\nExclusion Criteria:\n\n* Patient is not fluent in English\n* Patient evidences significant cognitive deficits\n* Patient's medical status or treatment precludes participation\n* Patient enrolled on a medical trial requiring medication storage in a trial-provided container\n* Patient demonstrates greater than or equal to 95% adherence during run-in period\n* Patient declines to use or has difficulty using electronic adherence monitoring device during run-in","24 Years",{"count":469,"type":20},160,[157],"The goal of this clinical trial is to learn if a tailored intervention can help make it easier for adolescents and young adults with cancer to take their medications. The main questions the researchers are trying to answer are:\n\n* Does the tailored intervention increase adherence?\n* Does the tailored intervention improve quality of life?\n* Does the tailored intervention reduce health care utilization?\n\nThe researchers will compare the tailored intervention to a uniform standard of care intervention (an intervention designed to be similar to what is currently happening in clinical care) to see if the tailored intervention works to improve adherence.\n\nParticipants will:\n\n* Use an electronic pill bottle or box to store their medication\n* Participate in intervention sessions\n* Complete surveys before the intervention, after the intervention, and 6-months later",[473,474],"Cancer","Medication Adherence",[476,477,478],"adolescents and young adults","cancer","adherence","2026-06-23",{"date":453,"type":35},{"date":37,"type":20},{"date":483,"type":20},"2030-08-31",{"name":41,"class":42},4,{"id":487,"slug":488,"hasResults":12,"nctId":489,"briefTitle":490,"officialTitle":491,"acronym":4,"eligibilityCriteria":492,"healthyVolunteers":12,"sex":17,"minAge":152,"maxAge":153,"enrollmentInfo":493,"targetDuration":4,"studyType":128,"phases":495,"briefSummary":496,"conditions":497,"keywords":500,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":507,"startDateStruct":509,"completionDateStruct":511,"leadSponsor":513,"locationsCount":514},"100562884","epilepsy-journey-an-executive-functioning-intervention-for-teens-with-epilepsy-100562884","NCT06608966","Epilepsy Journey-An Executive Functioning Intervention for Teens With Epilepsy","Epilepsy Journey 2.0: An Intervention to Improve Executive Functioning in Adolescents With Epilepsy","Inclusion Criteria:\n\n1. Age between 13-17 years at the time of enrollment\n2. Child lives at home with primary caregiver and is enrolled in school (excluding summer breaks).\n3. Confirmed diagnosis of epilepsy with seizures that are categorized as either generalized or focal in onset. Epilepsy is defined as: 1) At least two unprovoked seizures occurring more than 24-hours apart; or 2) One unprovoked seizure and a probability of further seizures similar to the general recurrence risk after two unprovoked seizures.\n4. Primary language of English\n5. Screening Inclusion: On the parent-reported Behavior Rating Inventory of Executive Function-2nd edition (BRIEF-2), have executive functioning deficits defined as at least 2 subclinical (60\\\u003CT\\\u003C65) or one clinical BRIEF-2 subscale T scores (T≥65).\n6. Parent\u002Flegal guardian(s) willing to sign an IRB approved informed consent\n7. Participant willing to sign an Institutional Review Board approved assent\n\nExclusion Criteria:\n\n1. Parent or clinician-reported history in the adolescent of:\n\n   1. developmental delay (e.g., autism spectrum disorder, pervasive development disorder, history of services for developmental delay or intellectual impairment in the past 5 years, known IQ\\\u003C70)\n   2. severe mental illness (e.g., schizophrenia, bipolar disorder, eating disorder within the past 12 months, depression with active suicidal ideation or suicidal ideation\u002Fintent in the past 3 months)\n   3. prior (3-months) or current history of trauma and\u002For stressor-related disorders (e.g. PTSD)\n   4. recent or current significant medical disease (i.e., cardiovascular, hepatic, renal, gynecologic, musculoskeletal, metabolic or endocrine)\n   5. brain injury or brain tumor; and\u002For\n   6. epilepsy surgery\n   7. any other medical and\u002For psychological condition that takes treatment precedence over the study intervention\n2. Clinician-reported diagnosis in the adolescent of\n\n   1. epilepsy whose seizures are categorized only as either unknown onset or unclassified onset (defined as insufficient information to determine onset)\n   2. epilepsy currently being treated at the time of enrollment by 3 or more antiseizure medications (ASMs) (excluding rescue medication use)\n   3. epilepsy with a history of failure to achieve seizure freedom despite adequate use of 4 different anti-seizure medications\n   4. a confirmed or suspected epileptic encephalopathy (e.g., electrical status epilepticus in sleep, Landau Kleffner syndrome, West syndrome)\n   5. a confirmed or suspected progressive and degenerative disorder (e.g., mitochondrial disorders, metabolic disorders, autoimmune disorders)\n   6. one or more episodes of status epilepticus within the 24 weeks prior to enrollment; and\u002For\n   7. treatable causes of seizures, for example identified etiologies including metabolic, neoplastic, or active infectious origin.\n   8. non-epileptic event\u002Fseizures\n3. Adolescents currently on the ketogenic diet\n4. Participation in a trial of an investigational drug or device within 30 days prior to screening",{"count":494,"type":20},310,[157],"The goal of this multi-site clinical trial is to determine the effectiveness of two components of a web-based intervention (Epilepsy Journey) to improve executive functioning in adolescents with epilepsy. The two components include web-based modules and problem-solving telehealth sessions with a therapist focused on executive functioning. This trial aims to answer the following questions:\n\n1. Which components of Epilepsy Journey (web-based modules or telehealth sessions with a therapist) are essential for improving executive functioning in adolescents with epilepsy?\n2. Which components of Epilepsy Journey (web-based modules or telehealth sessions with a therapist) are essential for improving quality of life in adolescents with epilepsy?\n\nParticipants will be randomly assigned to one of four groups: 1) Epilepsy Journey web-based modules and telehealth sessions, 2) Epilepsy Journey web-based modules only, 3) telehealth sessions with a therapist only, or 4) treatment as usual.\n\nParticipants will:\n\n* Independently review Epilepsy Journey web-based modules focused on executive functioning skills (\\~15-30 minutes) and\u002For have weekly telehealth sessions (\\~30-45 minutes) with a therapist for 14 weeks.\n* Complete measures of executive functioning (parent and teen-report) and quality of life (teen-report) at the start of the study, 14-, 26-, and 66- weeks after randomization. The NIH toolbox will be completed at the start of the study and 26-weeks after randomization. Additional measures will also be collected.",[498,499],"Epilepsy in Children","Executive Dysfunction",[501,502,503,504,505,506],"adolescents","executive functioning","seizures","epilepsy","behavioral trial","web-based intervention",{"date":508,"type":35},"2026-06-25",{"date":510,"type":35},"2024-11-11",{"date":512,"type":20},"2029-01-31",{"name":41,"class":42},3,{"id":516,"slug":517,"hasResults":12,"nctId":518,"briefTitle":519,"officialTitle":520,"acronym":521,"eligibilityCriteria":522,"healthyVolunteers":12,"sex":17,"minAge":85,"maxAge":523,"enrollmentInfo":524,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":526,"conditions":527,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":529,"lastUpdatePostDateStruct":530,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":535,"locationsCount":98},"100462134","office-home-and-ambulatory-blood-pressure-100462134","NCT05297708","Office, Home, and Ambulatory Blood Pressure","Office, Home, and Ambulatory Blood Pressure Measurements in Pediatric Patients","HBPA","Inclusion Criteria:\n\n1. Age 6 years to \\\u003C19 years old;\n2. Elevated blood pressure defined as 15% lower than the 95%ile BP based on clinical practice guidelines(CPG) but less than stage II hypertension based on CPG;\n3. Tolerate ABPM 24 hours;\n4. Tolerate HBP; and\n5. Can have diabetes mellitus, obstructive sleep apnea, and attention deficit hyperactivity disorder managed by medication.\n6. On stable doses of medications known to affect BP such as:\n\n   1. Corticosteroids\n   2. Calcineurin inhibitors\n   3. Oral decongestants;\n7. Clinically stable\n\nExclusion Criteria:\n\n1. On antihypertension medications or treated in the last 6 months;\n2. Pregnant;\n3. Structural heart disease such as:\n\n   1. Obstructive valvular disease\n   2. Coarctation of the aorta\n   3. Cardiomyopathy;\n4. Other secondary causes such as:\n\n   1. Renal artery stenosis\n   2. Neurological condition with dysautonomia;\n5. Recent initiation of medications known to affect BP such as:\n\n   1. Corticosteroids\n   2. Calcineurin inhibitors\n   3. Oral decongestants;","19 Years",{"count":525,"type":20},52,"This will be a prospective observational study. The population would be pediatric patients 6 years to \\\u003C19 years of age who were referred for elevated blood pressure to investigate if home blood pressure (HBP) can determine blood pressure phenotype (normotensive, hypertensive, masked hypertension, white coat hypertension) as accurately as ambulatory blood pressure monitor (ABPM) in childhood and adolescence.",[528],"Elevated Blood Pressure","2026-06-22",{"date":508,"type":35},{"date":532,"type":35},"2022-03-24",{"date":534,"type":20},"2028-01-01",{"name":41,"class":42},{"id":537,"slug":538,"hasResults":12,"nctId":539,"briefTitle":540,"officialTitle":540,"acronym":541,"eligibilityCriteria":542,"healthyVolunteers":12,"sex":17,"minAge":175,"maxAge":543,"enrollmentInfo":544,"targetDuration":4,"studyType":128,"phases":546,"briefSummary":547,"conditions":548,"keywords":549,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":553,"lastUpdatePostDateStruct":554,"startDateStruct":555,"completionDateStruct":557,"leadSponsor":559,"locationsCount":98},"100604171","phase-3-a-non-inferiority-trial-of-stopping-penicillin-in-early-rheumatic-heart-disease-goal-stop-100604171","NCT07146048","A Non-Inferiority Trial of Stopping Penicillin in Early Rheumatic Heart Disease: GOAL-Stop","GOAL-Stop","Inclusion Criteria:\n\n* Participated in GOALIE\n* Concluded GOALIE with either echocardiographic normalization or stable mild RHD\n* Between ages 5-20 years at time of enrollment\n\nExclusion Criteria:\n\n* RHD Stage C\u002FD at GOALIE end of study echocardiogram\n* Relocation to extremely distant residence or school\n* Clinically documented penicillin allergy","20 Years",{"count":545,"type":20},922,[240],"GOAL-Stop is a randomized, controlled, non-inferiority trial designed to evaluate whether discontinuing secondary antibiotic prophylaxis (SAP) is non-inferior to continuing SAP in preventing progression of rheumatic heart disease (RHD) among children and adolescents. The trial will enroll participants aged 5-20 years with previously diagnosed mild RHD who have received at least 2 years of SAP and who demonstrate either echocardiographic normalization or stability (persistent mild RHD). Participants will be randomized to either continue SAP or discontinue SAP for 2 years. The primary outcome is echocardiographic progression of RHD at 2 years, assessed by blinded adjudicators using the 2023 World Heart Federation criteria. Subgroup analyses will evaluate outcomes in participants with echocardiographic normalization versus stable mild RHD, and an exploratory analysis will assess whether outcomes differ by prior prophylaxis route (oral vs. intramuscular).",[364],[366,550,551,552],"global health","secondary prophylaxis","children","2026-06-18",{"date":529,"type":35},{"date":556,"type":35},"2026-03-23",{"date":558,"type":20},"2029-12-31",{"name":41,"class":42},{"id":561,"slug":562,"hasResults":12,"nctId":563,"briefTitle":564,"officialTitle":564,"acronym":4,"eligibilityCriteria":565,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":467,"enrollmentInfo":566,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":568,"conditions":569,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":575,"lastUpdatePostDateStruct":576,"startDateStruct":577,"completionDateStruct":579,"leadSponsor":581,"locationsCount":582},"100370061","transpire-lung-injury-in-a-longitudinal-cohort-of-pediatric-hsct-patients-100370061","NCT04098445","TRANSPIRE: Lung Injury in a Longitudinal Cohort of Pediatric HSCT Patients","Inclusion Criteria:\n\n* Subjects ≤ 24 years of age undergoing allogeneic or autologous HSCT.\n\nExclusion Criteria:\n\n* Subjects over 24 years of age.",{"count":567,"type":20},2000,"Hematopoietic stem cell transplant (HSCT) is an effective but toxic therapy and pulmonary morbidity affects as many as 25% of children receiving transplant. Early pulmonary injury includes diffuse alveolar hemorrhage (DAH), thrombotic microangiopathy (TMA) interstitial pneumonitis (IPS) and infection, while later, bronchiolitis obliterans is a complication of chronic GVHD associated with severe morbidity and mortality. Improved diagnosis and treatment of pulmonary complications are urgently needed as survival after HSCT improves, and as HSCT is increasingly used for non-malignant disorders such as sickle cell disease. Currently, there are large and important gaps in the investigator's knowledge regarding incidence, etiology and optimal treatment of pulmonary complications. Moreover, young children unable to perform spirometry are often diagnosed late, and strategies for monitoring therapeutic response are limited.\n\nThis is a prospective multi-institutional cohort study in pediatric patients undergoing allogeneic hematopoietic stem cell transplantation (alloHSCT). Assembly of a large prospective uniformly screened cohort of children receiving HSCT, together with collection of biological samples, will be an effective strategy to identify mechanisms of lung injury, test novel diagnostic strategies for earlier diagnosis, and novel treatments to reduce morbidity and mortality from lung injury after transplant.",[570,571,572,573,574],"Hematopoietic Stem Cell Transplant (HSCT)","Diffuse Alveolar Hemorrhage","Thrombotic Microangiopathies","Interstitial Pneumonitis","Bronchiolitis Obliterans","2026-06-17",{"date":529,"type":35},{"date":578,"type":35},"2021-09-08",{"date":580,"type":20},"2033-09",{"name":41,"class":42},9,{"id":584,"slug":585,"hasResults":12,"nctId":586,"briefTitle":587,"officialTitle":587,"acronym":588,"eligibilityCriteria":589,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":590,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":592,"conditions":593,"keywords":595,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":597,"lastUpdatePostDateStruct":598,"startDateStruct":599,"completionDateStruct":601,"leadSponsor":602,"locationsCount":98},"100369718","hydroxyurea-exposure-limiting-pregnancy-and-follow-up-lactation-100369718","NCT04093986","Hydroxyurea Exposure Limiting Pregnancy and Follow-Up Lactation","HELPFUL","Inclusion Criteria:\n\n* Medical records or data available from previous clinical care prior to June 20, 2019 of pregnant females with SCD, including women who miscarried, had a still birth, or completed labor at any gestational stage, with any hydroxyurea exposure during either pregnancy and\u002For while breastfeeding.\n* Medical records or data available from previous clinical care prior to June 20, 2019 about pregnancy and breastfeeding outcomes, both for babies with hydroxyurea exposure and other babies by these same women.\n\nExclusion Criteria:\n\n* Unavailable medical records or lack of information about hydroxyurea exposure.",{"count":591,"type":20},200,"The purpose of this research study is to document and understand the effects of hydroxyurea exposure for women with SCD and their babies, during both gestation and lactation.",[317,594],"Sickle Cell Anemia",[596],"Hydroxyurea","2026-06-16",{"date":553,"type":35},{"date":600,"type":35},"2019-12-22",{"date":348,"type":20},{"name":41,"class":42},{"id":604,"slug":605,"hasResults":12,"nctId":606,"briefTitle":607,"officialTitle":607,"acronym":4,"eligibilityCriteria":608,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":609,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":610,"conditions":611,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":613,"lastUpdatePostDateStruct":614,"startDateStruct":615,"completionDateStruct":617,"leadSponsor":619,"locationsCount":98},"100641598","congenital-hemolytic-and-dyserythropoietic-anemias-100641598","NCT07649213","Congenital Hemolytic and Dyserythropoietic Anemias","Inclusion Criteria:\n\n1. Patients who have been diagnosed, by medical history and review of the laboratory data obtained for clinical care, including CBC\u002Freticulocyte count and review of the blood smear, with a hereditary hemolytic anemia, where the genetic etiology is challenging to be identified.\n2. Parents and\u002For grandparents of children that have the above diagnosis. The parents and\u002For grandparents may or may not have non-immune hemolytic anemia (these will serve as positive or negative inherent controls)\n\nExclusion:\n\n1\\) Patients with anemias known to be acquired and not associated with a genetic etiology.",{"count":199,"type":20},"The main reason for this research study is to further understand how some red blood cells are formed incorrectly or they have an abnormal metabolism in a way that they break easier in the circulation or during their passage through the spleen.\n\nParticipants and\u002For family members diagnosed with non-immune hemolytic anemia due to a genetic disorder, such as, hemoglobin disorder, erythrocyte membrane skeleton disorders (e.g. spherocytosis, elliptocytosis, or stomatocytosis) or hydration defect (e.g. xerocytosis, overhydrocytosis) or red blood cell (RBC) enzyme disorders, or with a congenital dyserythropoietic anemia (CDA) will be asked to participate.",[612],"Hemolytic Anemia","2026-06-15",{"date":575,"type":35},{"date":616,"type":35},"2011-07-25",{"date":618,"type":20},"2052-07",{"name":41,"class":42},""]