[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Ann & Robert H Lurie Children's Hospital of Chicago\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":690},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,32,0,25,[9,49,73,98,126,149,185,213,232,253,274,308,328,351,385,413,441,471,500,523,546,579,612,638,660],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100513199","neural-prediction-to-enhance-language-100513199",false,"NCT05962359","Neural Prediction to Enhance Language","Neural Prediction to Enhance Language Outcomes in Children With Cochlear Implant","Inclusion Criteria (Arm 1):\n\n1. Children with sensorineural hearing loss who meet clinical criteria for cochlear implantation in both ears who meet the following age criteria at time cochlear implant evaluation begins:\n\n   * Age 5 years and under.\n   * English or Spanish as the dominant language.\n2. English or Spanish dominant language in the home.\n\nInclusion Criteria (Arm 2):\n\n1. Children with bilateral sensorineural hearing loss who meet clinical criterial for cochlear implantation\n2. English dominant spoken language by family\n3. Age at implantation of 36 months and younger when treatment begins\n4. Parent or caregiver that is willing to participate who understands spoken English\n5. Child is exposed to spoken language by at least one parent (total communication or auditory\u002Foral) in the home\n\nExclusion Criteria (Arm 1):\n\n1. Severe motor and \u002For cognitive disability that would preclude evaluation of progress\n2. Limited electrode insertion likely to significantly impact development of speech perception\n3. Hearing loss due to bacterial meningitis\n4. Neither English or Spanish as the dominant family language in the home\n\nExclusion Criteria (Arm 2):\n\n1. Severe motor and \u002For cognitive disability that would preclude evaluation of progress\n2. Limited electrode insertion likely to significantly impact development of speech perception\n3. Hearing loss due to bacterial meningitis\n4. Dominant language other than English\n5. Diagnoses or medical conditions expected to impact language development independent of hearing loss\n6. Cochlear nerve deficiency in implanted ears or severe cochlear malformation\n7. Children already having spoken language who score better than 25th percentile on the Words and Sentences portion of the CDI language evaluation.\n8. Child with more than two months CI experience prior to start of treatment","ALL","0 Months","5 Years",{"count":21,"type":22},700,"ESTIMATED","INTERVENTIONAL",[25],"NA","The language outcome of children receiving cochlear implantation to address bilateral sensorineural hearing loss is more variable than that of typical hearing children. The research is focused upon development of neural predictive models based upon brain imaging to forecast language after cochlear implantation on the individual child level. The long-term goal is improving children's language by using predictive models to enable a custom \"predict to prescribe\" approach to intervene with more effective behavioral therapy for children at risk to develop poorer language. The investigators previously developed models for short term language outcome of English-learning implanted children. The aims of this study are to 1. Develop models able to predict long term outcome for English- learning and Spanish-learning children; and 2. To evaluate whether English-learning children predicted to achieve lower language based on the investigators' previously constructed models can demonstrate significant gains from Parent Implemented Communication Treatment (PICT). PICT is an intensive parent education program about strategies to improve children's communication.",[28,29,30],"Bilateral Sensorineural Hearing Loss","Speech and Language Development Delay Due to Hearing Loss","Social Communication",[32,33,34,35],"Hearing Loss","Children","Parent-mediated intervention","Language prediction","RECRUITING","2026-06-30",{"date":39,"type":40},"2026-07-02","ACTUAL",{"date":42,"type":40},"2023-01-23",{"date":44,"type":22},"2028-01-23",{"name":46,"class":47},"Ann & Robert H Lurie Children's Hospital of Chicago","OTHER",1,{"id":50,"slug":51,"hasResults":12,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":23,"phases":61,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100449377","distal-radius-interventions-for-fracture-treatment-100449377","NCT05131685","Distal Radius Interventions for Fracture Treatment","Reduction and Nonreduction Treatment of Displaced Pediatric Distal Radius Fractures (Peds-DRIFT Trial - Distal Radius Interventions for Fracture Treatment)","DRIFT","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form by parent or legal guardian\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or female, aged 4-10 years\n4. Diagnosis of 100% dorsally displaced radius metaphyseal fracture with any or no ulna involvement\n5. Fracture is less than 5cm from the distal radial growth plate\n6. Willing to adhere to the immobilization regimen\n7. Fracture is acute (occurred less than 10 days prior to consent and assignment of treatment arm AND with ability to be taken to operating room (OR) or reduced in the emergency department (ED)\n\nExclusion Criteria:\n\n1. Physeal involvement of fracture\n2. Presence of open fracture, pathologic fracture, neuromuscular disease, or metabolic disease\n3. Fractures other than the ulna near the same level in the ipsilateral arm\n4. Fracture cannot be treated with acute reduction due to being older than 10 days\n5. Patient and parents are unable to adhere to procedures or complete follow-up due to insufficient comprehension of consent form or surveys or developmental delay","4 Years","10 Years",{"count":60,"type":22},334,[25],"This protocol describes a multicenter, prospective randomized superiority trial with a patient preference cohort comparing functional outcomes between children treated with sedated reduction versus no formal reduction.",[64],"Fracture Distal Radius",{"date":66,"type":40},"2026-07-01",{"date":68,"type":40},"2023-04-09",{"date":70,"type":22},"2031-07-31",{"name":46,"class":47},24,{"id":74,"slug":75,"hasResults":12,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":12,"sex":17,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":85,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":92,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":48},"100123147","the-treatment-of-type-i-open-fractures-in-pediatrics-100123147","NCT00870064","The Treatment of Type I Open Fractures in Pediatrics","The Treatment of Type I Open Fractures in Pediatrics: Evaluating the Necessity of Formal Irrigation and Debridement","PROOF","Inclusion Criteria:\n\n* open fracture amenable to treatment by closed reduction\n* low energy mechanism of injury (e.g., falls from less than 10 feet, bicycle accidents)\n* wound less than 1cm in length and the bone not visualized through the skin\n\nExclusion Criteria:\n\n* open fracture not amenable to treatment by closed reduction\n* open fracture that would typically require operative reduction and fixation\n* high energy mechanism of injury (e.g., struck by vehicle, motor vehicle accidents, fall from height greater than 10 feet)\n* wound greater than 1cm in length\n* gross contamination of wound\n* open fractures involving hands or feet (the current standard of care to treat open injuries involving hands or feet is only emergency room management)","3 Years","14 Years",{"count":84,"type":22},300,[25],"Open fractures are frequently encountered in orthopaedics. Treatment usually calls for a formal, operative procedure in which the bone is exposed, foreign tissue is debrided and the wound is irrigated. While this is the current standard of care, not all open fractures are equal. In retrospective studies, centers are reporting less aggressive operative management for open fractures may result in equal results without the time and expense of the operative theater. The investigators propose a prospective, randomized trial of children with type I open fractures to evaluate whether formal operative treatment is necessary. The investigators' hypothesis is that minor open fractures can be safely treated in the emergency room with irrigation, closed reduction and home antibiotics without an increased risk of infection or other complications. Children who meet the study criteria will be randomized into two treatment arms - formal operative management (OR) and emergency department (ED) management. Outcomes from each group will be evaluated and compared, including rate of infection, number of return visits to the operating room, time to union, and other complications.",[88],"Fractures, Open",[90,88,91],"Surgical Procedures, Operative","Fracture Fixation",{"date":66,"type":40},{"date":94,"type":40},"2010-03",{"date":96,"type":22},"2027-09",{"name":46,"class":47},{"id":99,"slug":100,"hasResults":12,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":12,"sex":17,"minAge":82,"maxAge":106,"enrollmentInfo":107,"targetDuration":4,"studyType":23,"phases":109,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":48},"100641432","reducing-disparities-in-knee-arthroscopy-for-adolescents-100641432","NCT07580625","Reducing Disparities in Knee Arthroscopy for Adolescents","RED KARD: Reducing Disparities in Knee Arthroscopy for Adolescents","RED KARD","Inclusion Criteria:\n\n* Predominantly Hispanic soccer team\n* Players between 14-18 years of age\n\nExclusion Criteria:\n\n-Players younger than 14 or older than 18 years of age","18 Years",{"count":108,"type":22},80,[25],"Hundreds of thousands of youth athletes require surgery for knee injuries annually. The incidence of operative knee injuries has skyrocketed, but surgery can be delayed due to late recognition and barriers, such as insurance, language, and difficulty navigating the healthcare system. Delays may have lifelong effects, including arthritis, persistent instability, poor patient reported outcomes, and reoperation. There is little patient-centered research on barriers to orthopaedic care, and none on interventions to reduce disparities in pediatric sports medicine. This study will focus on Hispanic children, a growing population nationally and 38% of the Chicago's children, who are at increased risk of delayed knee surgery and its sequelae compared to white, non-Hispanic patients. The overall objectives are to identify barriers to timely knee surgery in Hispanic athletes and develop an intervention to implement evidence on expedient treatment. The aim of this study is to evaluate feasibility, acceptability, and appropriateness of a culturally-tailored intervention in a pilot study of Hispanic youth soccer leagues. The proposed study will drive creation of a future community trial of a culturally-tailored intervention.",[112,113,114,115,116],"Knee Injury","ACL Injury","Meniscus Tear","Hispanic or Latino","Adolescent","NOT_YET_RECRUITING","2026-06-16",{"date":120,"type":40},"2026-06-18",{"date":122,"type":22},"2027-10-01",{"date":124,"type":22},"2029-07",{"name":46,"class":47},{"id":127,"slug":128,"hasResults":12,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":12,"sex":17,"minAge":133,"maxAge":134,"enrollmentInfo":135,"targetDuration":4,"studyType":23,"phases":137,"briefSummary":138,"conditions":139,"keywords":141,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":143,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":48},"100596308","caring-contacts-via-text-message-for-suicidal-adolescents-after-emergency-department-discharge-100596308","NCT07043764","Caring Contacts Via Text Message for Suicidal Adolescents After Emergency Department Discharge","Caring Texts for Adolescents to Reduce Suicide Risk","Inclusion Criteria:\n\n* 12 to \\\u003C18 years of age\n* Present to the emergency department with suicidal thoughts or behaviors as indicated by the Ask Suicide-Screening Questions (ASQ)\n* Have a cell phone that can receive text messages\n* Proficient in English\n* Anticipated disposition of discharge from the emergency department\n\nExclusion Criteria:\n\n* In care of the Department of Children and Family Services\n* Unable to participate meaningfully in assent, assessments, or the intervention, as determined by the treating clinician, including any of the following: acute or chronic cognitive impairment, acute psychosis, current severe agitation, current alcohol or drug intoxication","12 Years","17 Years",{"count":136,"type":22},56,[25],"The goal of this pilot clinical trial is to learn if Caring Contacts (brief, hopeful, supportive text messages) can be delivered to adolescents with suicidal thoughts or behaviors after discharge from the emergency department, and to understand if adolescents find it acceptable to receive Caring Contacts. Researchers will also begin to explore how suicidal thoughts and behaviors change over time among participants who receive Caring Contacts along with treatment as usual, compared to participants who only receive treatment as usual.\n\nAll participants will be invited to answer survey questions when they first enroll in the study and 1, 3, 6, and 12 months after their emergency department visit. Some participants will receive Caring Contacts (brief, hopeful, supportive text messages) after their emergency department visit. Some participants will be invited to complete an interview about their experiences receiving Caring Contacts.",[140],"Suicide Prevention",[116,142],"Text Messaging",{"date":120,"type":40},{"date":145,"type":22},"2026-07",{"date":147,"type":22},"2028-08",{"name":46,"class":47},{"id":150,"slug":151,"hasResults":12,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":157,"sex":17,"minAge":158,"maxAge":159,"enrollmentInfo":160,"targetDuration":4,"studyType":23,"phases":161,"briefSummary":162,"conditions":163,"keywords":167,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":48},"100609572","our-voices-matter-intervention-for-depression-in-youth-100609572","NCT07216326","Our Voices Matter: Intervention for Depression in Youth","Our Voices Matter: Racial Justice Activism Intervention to Address Structural Racism and Prevent Depression in Black and Latinx Youth","OVM","Inclusion Criteria:\n\n1. 15-20 years old\n2. Identify as Black and\u002F or Latinx\n3. Speak English\n\nExclusion Criteria:\n\n1. Younger than 15 years old, or older than 20 years old\n2. Unable to attend the in-person sessions\n3. Non-fluent English speaker\n4. Do not identify as Black or Latinx",true,"15 Years","20 Years",{"count":84,"type":22},[25],"Over 15 million people participated in racial justice protests nationwide during 2020-2021 spotlighting activism as a collective tool against structural racism and discrimination (SRD). SRD manifests as policies and practices (e.g., redlining, voter suppression, mass incarceration) that produce hostile environments that contribute to psychological distress, elevated allostatic load, and an elevated risk for chronic diseases and premature death, concentrated within Black and Latinx populations. While the connection between SRD and health is well documented, few studies provide evidence on strategies to reduce SRD and mitigate consequences on psychological and physiological outcomes. Thus, there is a critical need to rigorously test interventions that improve the mental and physical health of Black and Latinx populations, beginning in adolescence. The study's specific aims are to 1) Determine whether a racial justice activism behavioral intervention prevents and reduces depressive symptoms in Black and Latinx adolescents and young adults and 2) Determine whether a racial justice activism behavioral intervention lowers allostatic load scores in Black and Latinx adolescents and young adults. To accomplish these aims, the team will conduct a stage II group-based, multi-component, and multilevel randomized behavioral clinical trial. The investigators will collect psychological and physiological measures at baseline, then at defined intervals for 2 years post the racial justice activism intervention.",[164,165,166],"Depressive Symptoms","Allostatic Load","Metabolic Syndrome",[168,169,170,171,172,173,174,175,176],"mental health","youth intervention","allostatic load","stress","depressive symptoms","depression","metabolic syndrome","prevention","inflammation","2026-06-12",{"date":179,"type":40},"2026-06-15",{"date":181,"type":40},"2025-06-06",{"date":183,"type":22},"2028-12-29",{"name":46,"class":47},{"id":186,"slug":187,"hasResults":12,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":12,"sex":17,"minAge":193,"maxAge":134,"enrollmentInfo":194,"targetDuration":4,"studyType":23,"phases":196,"briefSummary":198,"conditions":199,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":48},"100534153","phase-1-safety-and-feasibility-of-intraoperative-visualization-with-cytalux-in-children-100534153","NCT06235125","Safety and Feasibility of Intraoperative Visualization With Cytalux in Children","A Pilot Study of Near-Infrared Imaging Using the Novel Imaging Agent Cytalux for Adolescent Patients With Metastatic Osteosarcoma Undergoing Pulmonary Metastasectomy","Cytalux","Inclusion Criteria:\n\n1. Patients 6-17 years of age at the time of study enrollment\n2. Willingness of research participant or legal guardian\u002Frepresentative to give written informed consent\n3. Willingness of patients (subjects) age 12-17 to provide written adolescent assent\n4. Patient weight greater than or equal to 20 kg\n5. Histologically confirmed diagnosis of osteosarcoma, synovial sarcoma, hepatoblastoma, rhabdomyosarcoma, Ewing sarcoma, Wilms tumor or other non-rhabdomyosarcoma soft tissue sarcoma\n6. Imaging findings highly suspicious for pulmonary metastatic disease based on CT, PET-CT or other imaging and warranting pulmonary surgery based on the judgment of the treating team. At least one nodule ≥4mm measured by preoperative imaging.\n7. Female (assigned female at birth) participant is not pregnant and agrees to an acceptable form of contraception from the time of consent through 30 days after study intervention. Confirmed abstinence is an acceptable form of contraception.\n8. Female (assigned female at birth) participant must agree to not donate ova from time of consent until 30 days after study intervention\n9. Male (assigned male at birth) participant must agree to not donate sperm from time of consent until 30 days after study intervention.\n\nExclusion Criteria:\n\n1. Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the subject\n2. History of anaphylactic reactions to products containing indocyanine green for near infrared imaging. Subjects with a medical history of 'idiopathic anaphylaxis' will also be excluded.\n3. History of allergy to any of the components of CYTALUX™ (PAFOLACIANINE) INJECTION\n4. Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol or follow-up schedule\n5. Impaired renal function defined as eGFR\\\u003C 50 mL\u002Fmin\u002F1.73m2\n6. Impaired liver function defined as values \\> 3x the upper limit of normal (ULN) for alanine aminotransferase (ALT) or aspartate aminotransferase (AST), alkaline phosphatase (ALP), or \\>2x ULN for total bilirubin except in subjects with Gilbert's syndrome.\n7. Patient unable or unwilling to discontinue folate, folic acid, or folate-containing supplements 48 hours before study drug administration\n8. History of drug-related serious adverse event with prior Cytalux administration will be an exclusion for re-enrollment for contralateral surgery (see section 5.7).\n9. Participants will be excluded if their 12th or 18th birthday would occur during study participation\n10. Male sex at birth and commitment to acceptable form of contraception from time of consent through 30 days after study intervention with confirmed abstinence as an acceptable form of contraception as an inclusion criterion.","6 Years",{"count":195,"type":22},10,[197],"PHASE1","Pediatric subjects aged 6-17 with biopsy confirmed cancer and imaging findings suspicious for pulmonary metastatic disease scheduled to undergo pulmonary metastasectomy via and open or minimally invasive approach.",[200,201,202,203,204],"Osteosarcoma","Pulmonary Metastasis","Fluorescence","Metastatic Sarcoma","Pediatrics","2026-06-03",{"date":207,"type":40},"2026-06-05",{"date":209,"type":40},"2024-04-08",{"date":211,"type":22},"2026-08-31",{"name":46,"class":47},{"id":214,"slug":215,"hasResults":12,"nctId":216,"briefTitle":217,"officialTitle":217,"acronym":4,"eligibilityCriteria":218,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":219,"targetDuration":4,"studyType":221,"phases":4,"briefSummary":222,"conditions":223,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":48},"100448520","post-mortem-tissue-donation-of-pediatric-tumor-tissues-and-cells-100448520","NCT05120518","Post Mortem Tissue Donation of Pediatric Tumor Tissues and Cells","Inclusion Criteria:\n\n* Pediatric patients with cancer and non-cancer tumor types (solid, liquid, neuro-oncology)\n* Signed consent for post mortem tissue donation and autopsy\n\nExclusion Criteria:\n\n* Signed consent for post mortem tissue donation and autopsy not obtained",{"count":220,"type":22},150,"OBSERVATIONAL","The objective of this study is to utilize all donated pediatric tumor tissues and cells obtained from autopsy to prospectively develop novel patient derived orthotopic xenograft (PDOX) mouse models as well as in vitro cell culture model systems for pediatric cancers, and also provide tissue samples to other researchers and organizations (eg, CBTN, DIPG Registry, COG).",[224],"Pediatric Cancer","2026-06-02",{"date":205,"type":40},{"date":228,"type":40},"2019-08-14",{"date":230,"type":22},"2029-08-14",{"name":46,"class":47},{"id":233,"slug":234,"hasResults":12,"nctId":235,"briefTitle":236,"officialTitle":236,"acronym":237,"eligibilityCriteria":238,"healthyVolunteers":12,"sex":17,"minAge":239,"maxAge":158,"enrollmentInfo":240,"targetDuration":4,"studyType":23,"phases":242,"briefSummary":243,"conditions":244,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":48},"100448927","adaptive-mechanisms-responsible-for-weight-change-in-youth-with-obesity-100448927","NCT05125822","Adaptive Mechanisms Responsible for Weight Change in Youth With Obesity","ADMIRE","Inclusion Criteria:\n\n* 11 to less than 16 years old\n* BMI \\> 30 kg\u002Fm\\^2 or 95th BMI percentile\n* Tanner stage 2, 3, or 4\n\nExclusion Criteria:\n\n* Tanner stage 1 and 5\n* Prior bariatric surgery\n* Current or recent (\\\u003C 3 months prior to enrollment) use of anti-obesity medication(s) defined as orlistat, metformin, phentermine, topiramate, combination phentermine\u002Ftopiramate, liraglutide, and\u002For combination naltrexone\u002Fbupropion (monotherapy use of naltrexone or bupropion is not an exclusion)\n* Monogenic and hypothalamic obesity\n* Polycystic ovary syndrome (diagnosed by a physician)\n* Pregnancy or planned pregnancy\n* Current use of supplemental hormones\n* Individuals with a diagnosed eating disorder of anorexia nervosa, bulimia or binge eating disorder\n* Type 1 or 2 diabetes\n* Treatment with growth hormones\n* Thyroid disease\u002Fproblem\n* Has had cancer in the last 10 years","11 Years",{"count":241,"type":22},260,[25],"In this study, doctors want to find out more about why people who lose weight often regain the weight that they have lost once they resume a regular diet and whether hormones might play a role in weight regain. The study is divided into two parts, called the meal replacement period and the follow-up period. The meal replacement period will consist of drinking a shake for breakfast and lunch and eating a frozen meal for dinner that is calorie controlled. Individuals will also be asked to eat two servings of fruit and three servings of vegetables each day. The study will provide the shakes and the frozen entrees, participants are asked to supply the fruits and vegetables.\n\nParticipation in this study will last for up to 35 weeks. There will be 10 in-person visits and 13 visits by phone or over Zoom over the 35 weeks.",[245],"Childhood Obesity","2026-05-29",{"date":225,"type":40},{"date":249,"type":40},"2023-08-26",{"date":251,"type":22},"2028-01-01",{"name":46,"class":47},{"id":254,"slug":255,"hasResults":12,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":259,"eligibilityCriteria":260,"healthyVolunteers":157,"sex":17,"minAge":4,"maxAge":106,"enrollmentInfo":261,"targetDuration":4,"studyType":23,"phases":263,"briefSummary":264,"conditions":265,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":48},"100425869","the-pediatric-all-evaluation-and-trial-100425869","NCT04825587","The Pediatric ALL Evaluation and Trial","The Pediatric ALL Evaluation and Trial: A Randomized, Controlled Trial","PALLET","Inclusion Criteria:\n\n* Age 18 and under\n* Surgery within 6 months of injury\n* Undergoing primary ACL reconstruction without previous injury or surgery\n* Quadriceps tendon autograft ACL reconstruction\n* Closing or closed physes\n\nExclusion Criteria:\n\n* Over 18 years old\n* Previous ipsilateral knee injury or surgery\n* Neuromuscular or developmental disorders affecting knee anatomy, cognition, or neuromuscular control\n* Other concomitant ligament reconstruction aside from the ALL (i.e., MCL, PCL, PLC)\n* Revision ACL reconstruction\n* ACL reconstruction with graft other than quadriceps tendon\n* IT band (modified MacIntosh) ACL reconstruction\n* A cartilage lesion requiring anything more than debridement\n* Open physes requiring both femoral and tibial physeal-sparing technique",{"count":262,"type":22},240,[25],"The overall aim of this multicenter RCT is to determine whether concomitant ALL reconstruction in children undergoing and ACL reconstruction will longitudinally result in a lower rate of graft failure than ACL reconstruction alone.",[113,266],"ACL Tear","2026-05-27",{"date":246,"type":40},{"date":270,"type":40},"2021-04-28",{"date":272,"type":22},"2030-04-01",{"name":46,"class":47},{"id":275,"slug":276,"hasResults":12,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":280,"eligibilityCriteria":281,"healthyVolunteers":12,"sex":17,"minAge":81,"maxAge":106,"enrollmentInfo":282,"targetDuration":4,"studyType":23,"phases":284,"briefSummary":285,"conditions":286,"keywords":290,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":307},"100546492","early-detection-of-infection-using-the-fitbit-in-pediatric-surgical-patients-100546492","NCT06395636","Early Detection of Infection Using the Fitbit in Pediatric Surgical Patients","Using the Fitbit for Early Detection of Infection and Reduction of Healthcare Utilization After Discharge in Pediatric Surgical Patients","i-DETECT","Inclusion Criteria:\n\n* children aged 3-18 years\n* must be post-surgical laparoscopic appendectomy for complicated appendicitis (Appendicitis is categorized as complicated if perforation, phlegmon, or abscess was present at surgery.)\n\nExclusion Criteria:\n\n* children who are non-ambulatory or have any pre-existing mobility limitations\n* children who have a doctor-ordered physical activity limit \\>48 hours post-surgery\n* children who have a comorbidity which will impact a patient's recovery\n* children and\u002For parents who do not speak English or Spanish (Translation services beyond Spanish will not be available at this time)",{"count":283,"type":22},500,[25],"The purpose of this study is to analyze Fitbit data to predict infection after surgery for complicated appendicitis and the effect this prediction has on clinician decision making.",[287,288,289],"Appendectomy","Appendicitis","Appendicitis Acute",[291,292,293,294,295,296,297,298],"consumer wearables","machine learning","ML","Fitbit","infection","detection","algorithm","prediction","2026-05-11",{"date":301,"type":40},"2026-05-13",{"date":303,"type":40},"2025-01-07",{"date":305,"type":22},"2027-06-30",{"name":46,"class":47},4,{"id":309,"slug":310,"hasResults":12,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":314,"eligibilityCriteria":315,"healthyVolunteers":157,"sex":17,"minAge":158,"maxAge":159,"enrollmentInfo":316,"targetDuration":4,"studyType":23,"phases":317,"briefSummary":318,"conditions":319,"keywords":320,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":327,"locationsCount":4},"100635564","rise--thrive-community-engagement-intervention-for-stress-and-depression-in-youth-100635564","NCT07554326","Rise & Thrive: Community-Engagement Intervention for Stress and Depression in Youth.","Rise & Thrive: Community-Engagement Intervention to Address Chronic Stress and Prevent Depression in Adolescents and Young Adults","R&T","Inclusion Criteria:\n\n1. 15-20 years old\n2. Identify as Black and\u002F or Hispanic\u002FLatine\n3. Speak English\n\nExclusion Criteria:\n\n1. Younger than 15 years old, or older than 20 years old\n2. Unable to attend the in-person sessions\n3. Non-fluent English speaker\n4. Do not identify as Black or Hispanic\u002FLatine",{"count":84,"type":22},[25],"American youth and young adults face persistent and chronic stressors, which have contributed to a mental health crisis in the United States. Four in 10 American high school students experience chronic feelings of sadness and hopelessness, 2 in 10 report suicidal ideation, and 1 in 10 attempt suicide. For adolescents and young adults, chronic stress translates to weathering, or wear and tear on the mind and body. Chronic stress in youth contributes to psychological distress, elevated allostatic load, and an elevated risk for chronic diseases and premature death. While the connection between chronic stress and health is well documented, few studies provide evidence on innovative, non-medication strategies to reduce stress and mitigate the consequences of chronic stress on psychological and physiological outcomes. Thus, there is a critical need to rigorously test interventions that prevent the negative influence of chronic stress on mental and physical health, beginning in adolescence. The specific aims of the study are to 1) Determine whether a community-engagement, peer-based behavioral intervention reduces depressive symptoms in adolescents and young adults, 2) Determine whether a community-engagement behavioral intervention lowers allostatic load scores in adolescents and young adults, and 3) Identify factors that help sustain or inhibit community-engagement and intervention effects for adolescents and young adults. To accomplish these aims, the team will conduct a phase II community-engaged, peer group-based, multi-component randomized behavioral clinical trial. We will collect psychological and physiological measures at baseline, then at 6-month intervals for 2 years post-community-engaged, skills training.",[164,165,166],[168,169,170,171,172,173,174,175],"2026-04-21",{"date":323,"type":40},"2026-04-28",{"date":325,"type":22},"2026-06-09",{"date":183,"type":22},{"name":46,"class":47},{"id":329,"slug":330,"hasResults":12,"nctId":331,"briefTitle":332,"officialTitle":332,"acronym":4,"eligibilityCriteria":333,"healthyVolunteers":12,"sex":17,"minAge":334,"maxAge":335,"enrollmentInfo":336,"targetDuration":19,"studyType":221,"phases":4,"briefSummary":337,"conditions":338,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":48},"100454591","eosinophilic-gastrointestinal-disorders-registry-100454591","NCT05199532","Eosinophilic Gastrointestinal Disorders Registry","Inclusion Criteria:\n\n* Patients with an established diagnosis of an EGID, based on pathology findings from an endoscopy or colonoscopy with biopsies.\n* Patients suspected of having an EGID and undergoing endoscopic evaluation for further assessment\n\nExclusion Criteria:\n\n* Patients who do not consent to participate","1 Year","25 Years",{"count":283,"type":22},"The purpose of this study is to learn more about Eosinophilic Gastrointestinal Disorders (EGIDs). With this registry we hope to find out more about the symptoms that patients have during their treatment, the quality of life they have with the diagnosis, what the disease looks like throughout the different treatment methods, and if there is a connection between EGIDs and connective tissue disorders.\n\nThe goal of this study is to be able to better understand EGIDs and use information gained from all the information collected on this study for more precise treatments in the future. We want to create a large collection of samples, called a biorepository, to learn the most about EGIDs as possible. When the samples are collected, which will occur at procedures directed by your child's doctor as part of their standard of care, they will be stored for an unlimited amount of time to perform experiments on these samples and to gather information about EGIDs",[339,340,341,342],"Eosinophilic Esophagitis","Eosinophilic Gastroenteritis","Eosinophilic Colitis","Eosinophilic Gastrointestinal Disease","2026-03-16",{"date":345,"type":40},"2026-03-18",{"date":347,"type":40},"2020-12-18",{"date":349,"type":22},"2035-12",{"name":46,"class":47},{"id":352,"slug":353,"hasResults":12,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":4,"eligibilityCriteria":357,"healthyVolunteers":12,"sex":17,"minAge":358,"maxAge":106,"enrollmentInfo":359,"targetDuration":4,"studyType":23,"phases":361,"briefSummary":362,"conditions":363,"keywords":366,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":378,"startDateStruct":380,"completionDateStruct":382,"leadSponsor":383,"locationsCount":384},"100434949","phase-1-rhsc-dipgvax-plus-checkpoint-blockade-for-the-treatment-of-newly-diagnosed-dipg-and-dmg-100434949","NCT04943848","rHSC-DIPGVax Plus Checkpoint Blockade for the Treatment of Newly Diagnosed DIPG and DMG","A Phase I Clinical Trial of Neo-antigen Heat Shock Protein Vaccine (rHSC-DIPGVax) in Combination With Checkpoint Blockade for the Treatment of Diffuse Intrinsic Pontine Glioma (DIPG) and Diffuse Midline Glioma in Childhood","Inclusion Criteria:\n\n* Subjects with newly diagnosed typical or non-typical, biopsy-proven DIPG or DMG are eligible for study enrollment. Biopsy is not required for subjects with radiographically typical DIPG meeting imaging criteria. Biopsy is required for DMG's and non-radiographically typical DIPG. Histone mutation must be confirmed by pathology report. Radiographically typical DIPG defined as a tumor with a pontine epicenter and diffuse involvement of more than 2\u002F3 of the pons.\n\n  = Subjects ages \\> or = to 12 months and \\\u003C or = 18 years (\"Lead In\", Part A, and Part B require first three patients be \\> or = to 12 years of age)\n* BSA \\> or = 0.35m2 at the time of study enrollment\n* Performance score: Karnofsky \\>50% of subjects \\>16 years of age and Lansky \\> or = 50 for subjects \\\u003C or = 16 years of age. Subjects who are unable to walk because of paralysis but are up in a wheelchair will be considered ambulatory for the purpose of assessing the performance score.\n* Must start radiation therapy within 42 days from date of diagnostic imaging. C1D1 must be within 42 days to 70 days post radiation (6-10 weeks). Patients CANNOT receive temozolomide during radiation\n* Corticosteroids should be weaned as tolerated after radiation therapy with the goal of \\\u003C or = 0.5mg\u002Fkg\u002Fday for a minimum of 7 days prior to enrollment.\n* Subjects must have measurable disease\n\nExclusion Criteria:\n\n* Patients cannot receive temozolomide during radiation\n* Disseminated disease\n* Subjects who have received any cancer therapy except for radiation\n* Autoimmune or immune disorders\n* Active respiratory disorder or infection\n* Active viral infection","12 Months",{"count":360,"type":22},36,[197],"This is a phase I, open label, plus expansion clinical trial evaluating the safety and tolerability of rHSC-DIPGVax in combination with BALSTILIMAB and ZALIFRELIMAB. rHSC-DIPGVax is an off-the-shelf neo-antigen heat shock protein containing 16 peptides reflecting neo-epitopes found in the majority of DIPG and DMG tumors. Newly diagnosed patients with DIPG and DMG who have completed radiation six to ten weeks prior to enrollment are eligible.",[364,365],"Diffuse Intrinsic Pontine Glioma","Diffuse Midline Glioma, H3 K27M-Mutant",[367,368,369,370,371,372,373,374,375,376,377],"Immunotherapy","Cancer vaccine","Checkpoint blockade","DIPG","Diffuse intrinsic pontine glioma","High grade glioma","DMG","Diffuse midline glioma","rHSC-DIPGVax","Balstilimab","Zalifrelimab",{"date":379,"type":40},"2026-03-17",{"date":381,"type":40},"2022-01-10",{"date":96,"type":22},{"name":46,"class":47},3,{"id":386,"slug":387,"hasResults":12,"nctId":388,"briefTitle":389,"officialTitle":389,"acronym":390,"eligibilityCriteria":391,"healthyVolunteers":12,"sex":17,"minAge":133,"maxAge":335,"enrollmentInfo":392,"targetDuration":4,"studyType":23,"phases":394,"briefSummary":396,"conditions":397,"keywords":400,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":406,"lastUpdatePostDateStruct":407,"startDateStruct":409,"completionDateStruct":411,"leadSponsor":412,"locationsCount":48},"100549182","early-phase-1-feasibility-trial-of-sodium-glucose-cotransporter-2-inhibitors-in-pediatric-chronic-kidney-disease-100549182","NCT06430684","Feasibility Trial of Sodium-GLucose coTransporter 2 INhibitors in Pediatric Chronic KIDney DiSease","SGLT2I-IN-KIDS","Inclusion Criteria:\n\n* Stage 3-4 CKD; estimated GFR using CKiD U25-creatinine equation 20-60mL\u002Fmin\u002F1.73m2\n\nExclusion Criteria:\n\n* Heart Disease\n* Diabetes\n* Pregnancy\n* Recipient of solid organ transplant\n* history of chemotherapy or stem cell transplant\n* moderate to severe persistent asthma\n* liver disease\n* class 2 or greater obesity\n* inability to follow study procedures due to cognitive impairment\n* obstructive uropathy or requirement for intermittent urinary catheterization\n* systolic blood pressure \\\u003C100mgHg\n* orthostatic hypotension\n* current use of an SGLT2i\n* anticipated need for titration of anti-hypertensives within 3 months\n* active use of any immunosuppressive medications\n* lack of clearance by primary nephrologist for participation",{"count":393,"type":22},40,[395],"EARLY_PHASE1","The goal of this study is to learn if a clinical trial of sodium-glucose co-transporter 2 inhibitors (SGLT2i) is possible in youth with chronic kidney disease (CKD). The investigators also plan to explore whether treatment with SGLT2i (Empagliflozin) helps improve risk factors for worsening kidney and heart disease. The main questions are:\n\n1. Is enrolling 40 youth with CKD into a clinical trial of empagliflozin feasible (ie achievable)?\n2. Does taking empagliflozin for 3 months result in positive changes in blood, urine, and heart function tests?\n\nParticipants will be randomly selected (like flipping a coin) to either receive empagliflozin or not start treatment with empagliflozin and remain on their usual care.\n\nStudy Procedures Include\n\n* For participants randomly selected for treatment, take empagliflozin once daily for 3 months\n* Phone calls with researchers every 2 weeks for check-ins\n* For participants taking empagliflozin, clinic visits 4 and 8 weeks after starting for check-ups and tests\n* All study participants will have clinic visits at the beginning and end (3 months) where researchers will collect information about their health and perform tests",[398,399],"Chronic Kidney Diseases","Pediatric Kidney Disease",[401,402,403,404,405],"Sodium Glucose Co-Transporter 2 Inhibitor","SGLT2i","Pediatric CKD","Feasibility Study","Clinical Trial","2026-02-19",{"date":408,"type":40},"2026-02-20",{"date":410,"type":40},"2024-08-23",{"date":66,"type":22},{"name":46,"class":47},{"id":414,"slug":415,"hasResults":12,"nctId":416,"briefTitle":417,"officialTitle":417,"acronym":418,"eligibilityCriteria":419,"healthyVolunteers":12,"sex":17,"minAge":58,"maxAge":134,"enrollmentInfo":420,"targetDuration":4,"studyType":23,"phases":422,"briefSummary":423,"conditions":424,"keywords":428,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":434,"lastUpdatePostDateStruct":435,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":440,"locationsCount":48},"100624566","supporting-caregivers-following-mental-health-emergency-department-visits-100624566","NCT07411300","Supporting Caregivers Following Mental Health Emergency Department Visits","SCFMHEDV","Inclusion Criteria:\n\n* Participants are eligible for participation in the current study if they are parent\u002Fguardians of youth ages 10-17 who received a psychiatric evaluation in the ED for suicidal thoughts or behaviors and are being discharged with a safety plan\n\nExclusion Criteria:\n\n* Parents\u002Fguardians will be excluded from recruitment if the youth is in state custody, if they are not proficient in English or Spanish, if the patient is being admitted or transferred for medical or psychiatric hospital admission, or they are not willing to enroll in MyChart through the EMR. The investigators are also only enrolling one caregiver per patient. In other words, if a patient returns to the ED with a different caregiver, the investigators will not enroll the other caregiver.",{"count":421,"type":22},75,[25],"The investigators plan to conduct a pilot hybrid effectiveness-implementation type 1 randomized controlled trial comparing 3 arms of varying follow-up intervention. Caregivers of youth ages 10-17 who present to the Lurie Children's Hospital ED with suicidal thoughts or behaviors (STBs) and are discharged with a safety plan will be included in the current study. Families will be randomized to receive either 1) treatment as usual, 2) follow-up phone calls, or 3) automatic electronic medical record (EMR) MyChart messages",[425,426,427],"Caregiver Participation","Emergency Department Presentation","Safety Plan",[429,430,431,432,433],"pediatric","randomized","caregivers","suicide","emergency department","2026-02-11",{"date":436,"type":40},"2026-02-13",{"date":438,"type":40},"2026-01-26",{"date":211,"type":22},{"name":46,"class":47},{"id":442,"slug":443,"hasResults":12,"nctId":444,"briefTitle":445,"officialTitle":446,"acronym":447,"eligibilityCriteria":448,"healthyVolunteers":12,"sex":17,"minAge":358,"maxAge":449,"enrollmentInfo":450,"targetDuration":4,"studyType":23,"phases":452,"briefSummary":453,"conditions":454,"keywords":457,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":464,"startDateStruct":466,"completionDateStruct":468,"leadSponsor":470,"locationsCount":307},"100591878","comparing-antibiotic-treatment-strategies-for-children-with-pneumonia-in-outpatient-settings-stampp-100591878","NCT06986148","Comparing Antibiotic Treatment Strategies for Children With Pneumonia in Outpatient Settings: (STAMPP)","Comparing Antibiotic Treatment Strategies for Children With Community-Acquired Pneumonia in Outpatient Settings (Safety-Net Antibiotic Prescribing to Manage Pediatric Pneumonia [STAMPP])","STAMPP","Inclusion Criteria:\n\n* Aims 1 and 2:\n* Presenting with signs and symptoms of lower respiratory tract infection\n* Diagnosed with community-acquired pneumonia (CAP) by a clinician\n* The treating clinician intends to prescribe antibiotics for CAP, AND\n* Well enough, as determined by the clinician at the time of the study enrollment visit, to be managed as an outpatient.\n* Aim 3:\n* Parent\u002Fguardian of child enrolled in the trial, OR\n* Clinician who makes prescribing decision at the study site, OR\n* Other practice-based parties (e.g. nurses, pharmacists, medical assistants, practice leaders) at study sites who can comment on the implementation of each prescribing strategy.\n\nExclusion Criteria:\n\n* Aims 1 and 2:\n* Hospitalization within the previous 7 days\n* Oxygen saturation below 90%, if measured\n* Incomplete immunization status (e.g., lacking at least 3 doses of the pneumococcal vaccines, typically given as part of the 2-, 4-, and 6-month vaccinations)\n* Chronic medical conditions that increase the risk of bacterial CAP (e.g., chronic lung disease, cystic fibrosis, sickle cell disease),\n* Substantially immunocompromised status (e.g., immunodeficiency, active cancer treatment, organ transplant with concurrent immunosuppressive agents)\n* Receipt of oral or parenteral antibiotics within the previous 7 days\n* Diagnosis of complicated pneumonia (e.g., empyema, lung abscess)\n* Known bacterial source of infection warranting immediate antibiotics\n* Pneumonia diagnosis within the previous 6 months, OR\n* Prior enrollment in the trial\n* Inability of the parent or guardian to speak English or Spanish\n* Aim 3:\n* Inability of the parent or guardian to speak English","71 Months",{"count":451,"type":22},2000,[25],"The goal of this clinical trial is to determine if a \"watch and wait\" antibiotic strategy, called Safety Net Antibiotic Prescribing (SNAP), can safely reduce unnecessary antibiotic use while ensuring that children diagnosed with community-acquired pneumonia get better from their illness. The main aims of this study are:\n\n* To compare the effectiveness of SNAP versus immediate antibiotic prescribing in children with mild community-acquired pneumonia (CAP)\n* To identify which patient groups benefit most from the SNAP strategy\n* To identify factors that shape implementation of each prescribing strategy.\n\nResearchers will compare the SNAP strategy (where parents or guardians are instructed to give antibiotics only if their child is not improving after 72 hours, or sooner if they are worsening) to the immediate antibiotic prescribing strategy (where parents or guardians are instructed to give the antibiotics right after their healthcare visit) to see if one strategy is more effective than the other.\n\nParticipants will be randomly assigned to either the immediate antibiotic group or the SNAP group at enrollment. Participation lasts 14 days with follow-up surveys at 4, 7, and 14 days after enrollment.",[455,456],"Community Acquired Pneumonia (CAP)","Community Acquired Pneumonia",[458,459,460,461,462],"Community-acquired Pneumonia","Pediatric Respiratory Diseases","Pneumonia","Antibiotic Use","SNAP","2026-01-24",{"date":465,"type":40},"2026-01-27",{"date":467,"type":40},"2025-09-09",{"date":469,"type":22},"2029-07-16",{"name":46,"class":47},{"id":472,"slug":473,"hasResults":12,"nctId":474,"briefTitle":475,"officialTitle":476,"acronym":477,"eligibilityCriteria":478,"healthyVolunteers":12,"sex":17,"minAge":479,"maxAge":480,"enrollmentInfo":481,"targetDuration":4,"studyType":23,"phases":482,"briefSummary":483,"conditions":484,"keywords":487,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":493,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":499,"locationsCount":48},"100621613","impact-of-hospital-to-home-optimizing-preterm-infant-environment-for-surgical-neonates-and-their-parents-h-hope-100621613","NCT07372898","Impact of Hospital to Home: Optimizing Preterm Infant Environment for Surgical Neonates and Their Parents (H-HOPE)","Impact of the Hospital to Home: Optimizing Preterm Infant Environment (H-HOPE) Intervention on Infants With Congenital Defects Requiring Neonatal Surgery and Their Parents.","H-HOPE","Inclusion criteria:\n\n* Infants and one or both of their parents, born with a congenital defect and requiring major surgery during the neonatal period, including congenital heart disease.\n* At the time of H-HOPE initiation, infants must be \\\u003C48 weeks post-menstrual age (PMA), clinically stable (no vital sign instability during routine nursing care) on respiratory support \\\u003C a nasal cannula at 2 liters per minute, and off all intravenous (IV) pain medications.\n\nExclusion criteria:\n\n* Infants born at \\\u003C34 weeks gestation,\n* Infants born with congenital defects involving the nervous system (i.e., spina bifida, congenital hydrocephalus),\n* Infants with genetic syndromes,\n* Infants with a history of Extracorporeal Membrane Oxygenation,\n* Infants with a history of mechanical ventilation lasting 30 or more days, or\n* Infants that are wards of the state.","1 Week","8 Weeks",{"count":393,"type":22},[25],"Infants born with congenital defects may require major surgery in the neonatal period. These infants are at risk for neurodevelopmental impairments. Additionally, their parents are at higher risk for adverse mental health outcomes.\n\nEarly relationships are essential to healthy growth and development in all children. Relationships between parents and infants born with a congenital defect are negatively impacted by separation due to hospitalization; parental and infant stress exposures; and alterations in infant behavior and parental mental health. Benefits of H-HOPE intervention on infant neurodevelopment outcomes have been observed in healthy and at-risk term and preterm infant populations but never evaluated in infants with congenital defects. The purpose of this study is to examine impact of the Hospital to Home: Optimizing Preterm Infant Environment (H-HOPE) intervention versus standard ICU care for infants born with a congenital defect requiring neonatal surgery, and their parents. The main questions to be answered include:\n\n1. Does H-HOPE improve pre-feeding state and behavior, oral feeding progression, and growth in infants born with a congenital defect requiring neonatal surgery?\n2. Does H-HOPE neurodevelopmental outcomes in infants born with a congenital defect requiring neonatal surgery?\n3. Does H-HOPE improve parental mental health outcomes among parents of infants born with a congenital defect requiring neonatal surgery?\n4. Does H-HOPE improve parent-infant interactions among infants born with a congenital defect requiring neonatal surgery and their parents?\n5. Does H-HOPE improve neuroendocrine function among infants born with a congenital defect requiring neonatal surgery and their parents?\n6. Do parents of infants born with congenital defects requiring surgery experience participating in the H-HOPE intervention positively?\n\nResults of this study may provide preliminary evidence supporting use of H-HOPE to positively impact short- and long-term outcomes for these infants and their parents.",[485,486],"Oral Feeding Outcomes","Neurodevelopment Outcome",[477,488,489,490,491],"Infant","Surgical","Congenital defect","Neonatal intensive care","2026-01-20",{"date":494,"type":40},"2026-01-28",{"date":496,"type":40},"2025-07-31",{"date":498,"type":22},"2027-03-30",{"name":46,"class":47},{"id":501,"slug":502,"hasResults":12,"nctId":503,"briefTitle":504,"officialTitle":505,"acronym":506,"eligibilityCriteria":507,"healthyVolunteers":157,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":508,"targetDuration":4,"studyType":23,"phases":509,"briefSummary":510,"conditions":511,"keywords":514,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":467,"lastUpdatePostDateStruct":516,"startDateStruct":518,"completionDateStruct":520,"leadSponsor":522,"locationsCount":48},"100579153","technology-enhanced-asthma-care-in-children-at-clinic-and-home-study-100579153","NCT06820593","Technology-Enhanced Asthma Care in Children at Clinic and Home Study","Technology-Enhanced Asthma Care in Children at Clinic and Home (TEACCCH) Study (Aim 2): A Feasibility Randomized Controlled Trial","TEACCCH","Inclusion into the study will not depend on sex, ethnicity, or race. We will monitor enrollment to ensure a diversity of sex and race\u002Fethnicity are represented.\n\nPARENT-CHILD PAIR INCLUSION CRITERIA\n\n1. Caregivers must be at least 18 years old (defined as parent or legal guardian)\n2. The child (patient) has a diagnosis of asthma associated with a clinic visit in the electronic health record\n3. The child is between the ages of 4-17 years old at the time of recruitment\n\n   1. The study is interested in the self-management of asthma by caregivers, whom are still primarily responsible for their child's chronic disease management.\n   2. Children younger than 4 years old will not be included in this study as the diagnosis of asthma is typically difficult to confirm in younger ages.\n4. The child is prescribed inhaled corticosteroid or corticosteroid\u002Flong-acting beta agonist combination for daily use. The patient can have an inhaled corticosteroid\u002Flong-acting beta agonist for both daily preventive and rescue use, as in Single Maintenance and Reliever Therapy (SMART).\n5. Persistent or un controlled asthma based on NHLBI guidelines40; Any 1 of the following:\n\n   1. In past month, \\>2 days per week with asthma symptoms\n   2. \\>2 days per week with rescue medication use\n   3. \\>2 days per month with nighttime awakenings (for children who are not taking a controller asthma medication) OR \\>2 days per month with nighttime awakenings (for children who are currently taking a controller asthma medication)\n   4. \\>2 asthma episodes during the past year that required systemic corticosteroids\n6. The child is a patient in Primary Care Uptown, Primary Care Deming, Allergy, or Pulmonary Clinics at LCH\n\nPARENT-CHILD PAIR EXCLUSION CRITERIA\n\n1. The caregiver has a smartphone that is not compatible with the Hailie® app.\n2. The patient is prescribed a controller (preventive) or rescue inhaler medication to which the Hailie electronic sensor cannot affix.\n3. The caregiver is unable to speak and understand English.\n\n   a. With this trial, the intent is to first establish feasibility and broaden to different languages in future.\n4. The child has clinically significant, comorbid diagnoses, such as cystic fibrosis, cyanotic heart disease, or bronchopulmonary dysplasia, that could interact with their assessment of asthma-related measures.\n5. The family has active Department of Child and Family Services (DCFS) involvement\n6. The participant is enrolled in another asthma intervention study at the time of enrollment to this study.\n7. Child or sibling living in the same home was previously enrolled in this study.\n8. Consent is not obtained from the parent\u002Fguardian.\n9. Parent\u002Fguardian does not pass the test of understanding at study enrollment.\n\nHEALTH CARE PROVIDER INCLUSION CRITERIA (IMPLEMENTATION OUTCOMES)\n\n1. Participant is an employee of LCH system\n2. Works at or supports the operations of Primary Care Uptown, Primary Care Deming, Allergy, or Pulmonary Clinics at LCH\n3. Able to provide informed consent\n\nHEALTH CARE PROVIDER EXCLUSION CRITERIA (IMPLEMENTATION OUTCOMES)\n\n1\\. Participant departs LCH and is no longer an active employee at the time of assessment",{"count":108,"type":22},[25],"A randomized controlled trial with parent-child pairs of children with persistent or uncontrolled asthma. An intervention group (n=40 parent-child pairs) will receive the mobile health (mHealth) app and digital sensors with enhanced support from a population health manager role, hereinafter referred to as an asthma coordinator, to provide remote patient monitoring (RPM). A comparison group (n=40 parent-child pairs) will receive the mHealth app and sensors without RPM support to silently collect inhaler use information without mHealth app features. The focus of this project is to evaluate the feasibility and acceptability of delivering a digital intervention for pediatric asthma with RPM in the outpatient setting.",[512,513],"Asthma in Children","Chronic Diseases in Children",[515],"Digital Health",{"date":517,"type":40},"2025-09-10",{"date":519,"type":40},"2025-03-14",{"date":521,"type":22},"2027-01",{"name":46,"class":47},{"id":524,"slug":525,"hasResults":12,"nctId":526,"briefTitle":527,"officialTitle":528,"acronym":4,"eligibilityCriteria":529,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":530,"targetDuration":158,"studyType":221,"phases":4,"briefSummary":532,"conditions":533,"keywords":535,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":538,"lastUpdatePostDateStruct":539,"startDateStruct":541,"completionDateStruct":543,"leadSponsor":545,"locationsCount":48},"100558680","cchs-secure-health-hub-advancing-research-efforts-cchs-share-100558680","NCT06554275","CCHS Secure Health-hub Advancing Research Efforts (CCHS SHARE)","CCHS SHARE: A Multi-center Longitudinal Natural History Study","Inclusion Criteria:\n\nParticipants with a confirmed CCHS diagnosis (confirmed alveolar hypoventilation and PHOX2B mutation testing results), of all ages and genders, who are followed clinically.\n\nExclusion Criteria:\n\nAn unconfirmed diagnosis of CCHS or unconfirmed PHOX2B mutation or not followed clinically",{"count":531,"type":22},125,"The purpose of this study is to capture longitudinal natural history data in Congenital Central Hypoventilation Syndrome (CCHS). This will include capturing standardized clinical data from standard of care assessments at several CCHS referral centers. Funding source-FDA OOPD",[534],"Congenital Central Hypoventilation Syndrome",[536,537],"Natural History","Rare Disease","2025-07-11",{"date":540,"type":40},"2025-07-16",{"date":542,"type":40},"2024-09-01",{"date":544,"type":22},"2028-08-31",{"name":46,"class":47},{"id":547,"slug":548,"hasResults":12,"nctId":549,"briefTitle":550,"officialTitle":551,"acronym":552,"eligibilityCriteria":553,"healthyVolunteers":12,"sex":17,"minAge":334,"maxAge":335,"enrollmentInfo":554,"targetDuration":4,"studyType":23,"phases":555,"briefSummary":557,"conditions":558,"keywords":564,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":571,"lastUpdatePostDateStruct":572,"startDateStruct":574,"completionDateStruct":576,"leadSponsor":578,"locationsCount":48},"100570128","phase-1-pre-emptive-anakinra-for-cytokine-event-reduction-100570128","NCT06703216","Pre-emptive Anakinra for Cytokine Event Reduction","Pilot Study of Pre-emptive Anakinra for the Prevention of Severe Cytokine Release Syndrome in Children and Young Adults With B-Acute Lymphoblastic Leukemia Receiving Chimeric Antigen Receptor (CAR) T Cells","PACER","• Patient consent and parental assent will be obtained.\n\nNOTE: Signed consent form must be obtained prior to any study procedures. Labs, marrows or other procedures obtained during routine clinical care maybe used for eligibility if obtained within the protocol required windows.\n\n* Patients or their parents\u002Flegally authorized representatives (LARs) must have the ability to understand and the willingness to sign a written informed consent document.\n* The effects of Anakinra on the developing human fetus are largely unknown. For this reason, patients of child-bearing potential (POCBP) and their partners with sperm-producing reproductive capacity must agree to use adequate contraception from time of informed consent, for the duration of study participation, and for 90 days following completion of Anakinra therapy. Should a POCBP become pregnant or suspect they are pregnant while they or their partner are participating in this study, they should inform their treating physician immediately. Patients with sperm-producing reproductive capacity (PWSPRC) treated or enrolled on this protocol must also agree to use adequate contraception with partners of childbearing potential from time of informed consent, for the duration of study participation, and 90 days after completion of administration.\n\nNote: A POCBP is any patient (regardless of gender, sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) with an egg-producing reproductive tract who meets the following criteria:\n\n* Has not undergone a hysterectomy or bilateral oophorectomy\n* Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \\> 12 months)\n* POCBP must have a negative serum or urine pregnancy test (women who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential)\n* Patients who are between the age of 1 to 26 years\n* Relapsed or refractory B-acute lymphoblastic leukemia\n\n  * 2nd or greater marrow relapse OR\n  * Central nervous system (CNS) relapse OR\n  * Any relapse after allogeneic hematopoietic stem cell transplant (HSCT) OR\n  * Refractory disease defined by not achieving an minimal residual disease (MRD)-negative complete remission (CR) after ≥ 2 chemotherapy cycles (1 cycle for relapsed patients) OR\n  * Ineligible for allogeneic HSCT because of:\n\n    * Comorbid disease\n    * Other contraindications to allogeneic HSCT conditioning\n    * No suitable donor\n    * Prior HSCT\n    * Declines HSCT as the therapeutic option after documented discussion, with expected outcomes, about the role of HSCT with a HSCT physician\n  * Documentation of CD19+ tumor expression in the bone marrow, peripheral blood, cerebrospinal fluid (CSF), or tumor tissue by flow cytometry at relapse, or a recent sample in the case of refractory disease. If the patient has received CD19-directed Pre-emptive anakinra for severe CRS prevention therapy, the flow cytometry should be obtained after this therapy to show CD19 expression.\n* Adequate organ function defined as:\n\n  * Alanine aminotransferase (ALT) \\\u003C 500 U\u002FL\n  * Bilirubin ≤2.0 mg\u002FdL\n  * Minimum pulmonary reserve defined as ≤Grade 1 dyspnea, pulse oximetry \\>92% on room air; diffusing capacity of the lungs for carbon monoxide (DLCO) ≥40% (corrected for anemia) if pulmonary function tests (PFTs) are clinically appropriate as determined by the treating investigator.\n  * Left ventricular shortening fraction ≥ 28% or ejection fraction ≥40% confirmed by echocardiography (ECHO), or adequate ventricular function documented by imaging or a cardiologist.\n  * Serum creatinine below the values in the below table, based on age\u002Fsex assigned at birth: Maximum Serum Creatinine (mg\u002FdL) Age (years) Male Female 1 to \\\u003C2 0.6 0.6 2 to \\\u003C6 0.8 0.8 6 to \\\u003C10 1.0 1.0 10 to \\\u003C13 1.2 1.2 13 to \\\u003C16 1.5 1.4 ≥16 1.7 1.4\n* Bone marrow disease burden of ≥5% or peripheral blasts within 2 weeks of the start of lymphodepleting chemotherapy\n* Receiving commercially available tisagenlecleucel",{"count":72,"type":22},[197,556],"PHASE2","Objectives: The primary objective of this study will be to evaluate the impact of pre-emptive use of anakinra on the rate of severe cytokine release syndrome (CRS) following CD19-directed chimeric antigen receptor (CAR) T-cell therapy for B-acute lymphoblastic leukemia (B-ALL) in children and young adults.\n\nPatient Population: Children and young adults \\\u003C25 years of age undergoing CAR T-cell therapy for B-ALL with bone marrow disease burden of ≥5% involvement or detectable peripheral blasts within 2 weeks of the initiation of lymphodepleting chemotherapy.\n\nStudy Design: This is a pilot single arm study. The investigators will inquire into the efficacy and safety of using anakinra pre-emptively to reduce the rate of severe CRS in patients with \\>\u002F=5% bone marrow blasts or lymphoblasts in the peripheral blood.\n\nTreatment Plan:\n\nThis is a single arm unblinded study in which patients will receive anakinra, 2.5 mg\u002Fkg (max 100mg), IV every 12 hours starting at the onset of persistent fever (fever \\>38.5⁰ C x 2 occurrences separated by at least 4 hours in a 24 hour period). If there is persistence or progression of CRS, anakinra frequency will be increased to 2.5mg\u002Fkg IV (max 100mg), every 6 hours. Anakinra will be continued until 48 hours after resolution of CRS and ICANS, and at least 7 days post-CAR T infusion. If dose and frequency of anakinra is increased, the increased dose of anakinra will be continued until 48 hours after resolution of CRS and immune effector cell-associated neurotoxicity syndrome (ICANS) and at least 7 days post-CAR T infusion. For CRS worsening beyond dose escalation of anakinra, CRS will be managed as per standard of care management. Participants will be followed for 12 months following enrollment in the study and disease evaluations will be performed as per routine clinical care following CAR T-cell therapy.",[559,560,561,562,563],"B-Acute Lymphoblastic Leukemia","CAR-T Cell Therapy","Cytokine Release Syndrome","Immune Effector Cell Associated Neurotoxicity Syndrome","Immune Effector Cell Associated Hemophagocytic Lymphohistiocytosis-like Syndrome",[565,561,566,567,568,569,570,562],"Anakinra","CAR-T Therapy","Pediatric","B-acute lymphoblastic leukemia","Prophylaxis","Inflammatory Toxicity","2025-06-12",{"date":573,"type":40},"2025-06-15",{"date":575,"type":22},"2025-08",{"date":577,"type":22},"2030-02-28",{"name":46,"class":47},{"id":580,"slug":581,"hasResults":12,"nctId":582,"briefTitle":583,"officialTitle":584,"acronym":4,"eligibilityCriteria":585,"healthyVolunteers":12,"sex":17,"minAge":334,"maxAge":586,"enrollmentInfo":587,"targetDuration":4,"studyType":23,"phases":589,"briefSummary":590,"conditions":591,"keywords":594,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":604,"lastUpdatePostDateStruct":605,"startDateStruct":607,"completionDateStruct":609,"leadSponsor":611,"locationsCount":384},"100570871","phase-1-mapk-inhibition-combined-with-anti-pd1-therapy-for-braf-altered-pediatric-gliomas-100570871","NCT06712875","MAPK Inhibition Combined With Anti-PD1 Therapy for BRAF-altered Pediatric Gliomas","A Pilot Study Evaluating the Toxicity and Clinical Benefit of Mitogen-activated Protein Kinase (MAPK) Pathway Inhibition Combined With Programmed Cell Death-1 Checkpoint Blockade (Anti-PD1) for the Treatment of BRAF-altered Pediatric Gliomas","Inclusion Criteria:\n\nCohort A Only:\n\n* Patients with histologically confirmed diagnosis of pediatric high- or low-grade glioma harboring a KIAA1549-BRAF fusion: Low-grade glioma that is recurrent or progressive OR High-grade glioma that is newly diagnosed or recurrent OR\n* Patients with NF1-associated gliomas or NF1-altered glioma: Low-grade glioma that is recurrent or progressive OR High-grade glioma that is newly diagnosed or recurrent OR Transforming glioma that is newly diagnosed or recurrent\n\nCohort B Only:\n\n* Patients with histologically confirmed diagnosis of pediatric low-grade glioma harboring a BRAFV600 mutation that is recurrent or progressive OR\n* Patients with histologically confirmed diagnosis of non-brainstem pediatric high-grade glioma harboring BRAFV600 mutation that is newly diagnosed, recurrent, or progressive\n\nAll Cohorts:\n\n* Patients must be ≥1 and ≤26 years of age at the time of enrollment.\n* Patients must have a performance status of Karnofsky \\>50% for patients \\>16 years old and Lansky \\>50% for patients \\\u003C16 years old.\n* Patients must have adequate organ and bone marrow function\n* The effects of dabrafenib, trametinib, and nivolumab on the developing human fetus are unknown. For this reason, patients of childbearing potential (POCBP) and patients with sperm-producing reproductive capacity (PWSPRC) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from time of informed consent for the duration of study participation and for 30 days following completion of therapy. POCBP must have a negative pregnancy test.\n* Patients with neurological deficits that are stable for a minimum of 1 week prior to enrollment are eligible.\n\nNote: A baseline detailed neurological exam should clearly document the neurological status of the patient at the time of enrollment on the study.\n\n\\- Patients who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to enrollment. Total dexamethasone dose at time of enrollment must be less than or equal to 2 mg\u002Fday total or 0.5 mg\u002Fkg\u002Fday, whichever is smaller.\n\nLGG Only\n\n* Patients must have received a prior BRAF inhibitor (first or second generation), MEK inhibitor, or a combination. The response to this therapy must be known and information provided at study enrollment.\n* Patients must have recovered from acute treatment-related toxicities (defined as \\\u003CGrade 1, excludes alopecia) prior to entering this study.\n\nHGG Only\n\n* Patients must have received prior radiotherapy \\>12 weeks prior to enrollment.\n* Patients must have recovered from acute treatment-related toxicities (defined as \\\u003CGrade 1, excludes alopecia) prior to entering this study.\n* NF1 patients with transforming gliomas and high-grade gliomas are eligible regardless of prior systemic therapy.\n* Patients who have received prior radiation therapy must have experienced progression post-radiation OR have measurable disease defined as residual tumor \\>1cm in at least one dimension\n\nExclusion Criteria:\n\n* Patients with disseminated disease.\n* Patients who have had prior radiation therapy \\\u003C12 weeks prior to registration.\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 1) (with the exception of alopecia).\n* Patients who receiving any other investigational agents. Note: There will be a 21-day washout period for all chemotherapeutic agents, a washout period of two half-lives for any targeted agents (e.g., MAPK inhibitors), and\u002For a washout period of 4 weeks for any antibody therapies (e.g., bevacizumab).\n* Patients who have a history of allergic reactions attributed to compounds of similar chemical or biological composition to dabrafenib, trametinib, or nivolumab.\n* Patients who have received MAPK inhibitor and checkpoint blockade combination therapy.\n\nNote: Patients may have received MAPK inhibitor monotherapy or checkpoint blockade monotherapy.\n\n* Patients who previously discontinued BRAF inhibitor (type 1 inhibitor or dimer inhibitor, such as, DAY101), MEK inhibitor, or the combination because of grade 3 or higher toxicity or clinically significant grade 2 toxicity requiring discontinuation of therapy are not eligible.\n* Patients with the following:\n\n  * Known autoimmune disorders\n  * Immune disorders\n  * Immunodeficiencies\n* Patients with Crohn's disease, ulcerative colitis, or other inflammatory bowel disease.\n* Patients with active pancreatitis or history of pancreatitis within the last 3 months.\n* Patients with active interstitial lung disease (ILD)\u002Fpneumonitis or a history of ILD\u002Fpneumonitis requiring treatment with systemic steroids.\n* Patients who have a known active Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C infection are ineligible. Patient must have documented evidence of negative tests for the presence of HIV, Hepatitis B surface antigen, and Hepatitis C (anti-HCV antibody OR Hep C RNA-qualitative).\n* Patients who have received a major surgical procedure ≤ 28 days of beginning study treatment, or minor surgical procedures (including VP shunt placement or stereotactic biopsy of the tumor) ≤ 7 days are not eligible.\n* Patients who are taking herbal preparations. These medications include but are not limited to St. John's wort, kava, ephedra (ma hung), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng. Cannabis products of any type are not allowed throughout the study. Patients should stop using these herbal medications or cannabis products 7 days prior to enrollment.\n* Patients who are pregnant. Patients of childbearing potential must have a negative serum or urine pregnancy test. (If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.)\n* Patients who are lactating (unless they have agreed to not breastfeed). Breastfeeding patients are excluded from this study due to risks of fetal and teratogenic adverse events as seen in animal\u002Fhuman studies.\n* Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic, or other organ dysfunction), that in the opinion of the investigator would compromise the patient's ability to tolerate protocol therapy, put them at additional risk for toxicity or would interfere with the study procedures or results.\n* Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen for this trial.\n* Patients with bulky tumor on imaging are ineligible. Bulky tumor is defined as:\n\n  * Tumor with any evidence of clinically significant uncal herniation or midline shift\n  * Tumor with diameter of \\>5cm in one dimension on T2\u002FFLAIR except for those patients with newly diagnosed HGG treated following irradiation without signs of tumor progression. For the latter group, a maximum diameter of contrast enhancing solid or necrotic tumor and of T2\u002FFLAIR abnormality will be 5 cm and 8 cm, respectively.\n  * Tumor that in the opinion of the site investigator, shows significant mass effect\n  * Metastatic disease: Patients with ≤ 5 separate foci of metastatic disease not causing mass effect on adjacent parenchyma and each measuring less than 0.5 cm in maximum diameter will be eligible for this arm of the study. Patients with leptomeningeal disease are eligible.\n  * Multi-focal disease (patients with multi-focal parenchymal disease will be eligible if the sum of the product of the maximum perpendicular diameters of all measurable non-contiguous lesions is less than 16 cm2 based on the T2\u002FFLAIR abnormality).","26 Years",{"count":588,"type":22},27,[197,556],"Pediatric gliomas harboring BRAF-alterations, commonly BRAFV600 mutation or KIAA1549-BRAF fusion, are currently treated with either chemotherapy or mitogen activated protein kinase (MAPK) inhibitors, such as, dabrafenib and\u002For trametinib. Unfortunately, some BRAF-altered gliomas can progress or have rebound growth after discontinuation of therapy. Data from BRAFV600E-mutant melanoma has shown potential synergy between MAPK inhibition and anti-programmed cell death 1 (anti-PD1) checkpoint blockade. Anti-PD1 therapy, such as, nivolumab can block the PD1 receptor on T cells, a marker of T cell exhaustion, allowing a continued or more robust anti-tumor immune response. Here, investigators will combine MAPK inhibition with anti-PD1 therapy in recurrent, refractory low grade BRAF-altered glioma and newly diagnosed or recurrent BRAF-altered or NF-altered high grade glioma.",[592,593],"Low Grade Glioma","High Grade Glioma",[595,596,597,598,599,600,601,602,603],"BRAF","BRAFV600","KIAA1549 BRAF fusion","nivolumab","dabrafenib","trametinib","MAPK inhibition combined with anti-PD1 immunotherapy","recurrent low grade glioma","high grade glioma","2025-05-23",{"date":606,"type":40},"2025-05-29",{"date":608,"type":40},"2025-04-01",{"date":610,"type":22},"2029-06",{"name":46,"class":47},{"id":613,"slug":614,"hasResults":12,"nctId":615,"briefTitle":616,"officialTitle":617,"acronym":4,"eligibilityCriteria":618,"healthyVolunteers":157,"sex":17,"minAge":106,"maxAge":4,"enrollmentInfo":619,"targetDuration":4,"studyType":23,"phases":620,"briefSummary":621,"conditions":622,"keywords":624,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":629,"lastUpdatePostDateStruct":630,"startDateStruct":632,"completionDateStruct":634,"leadSponsor":636,"locationsCount":637},"100526555","the-grief-navigation-trial-a-comparison-of-two-interventions-to-support-parents-after-their-childs-unexpected-or-traumatic-death-100526555","NCT06136260","The Grief Navigation Trial: A Comparison of Two Interventions to Support Parents After Their Child's Unexpected or Traumatic Death","The Grief Navigation Trial: A Multi-Site Pragmatic Comparative Effectiveness Trial of Interventions to Support Parents After Their Child's Unexpected or Traumatic Death","Inclusion Criteria:\n\n* Parents or caregivers of ME cases involving a person \\\u003C 25 years old from one of the following offices: Cook County Medical Examiners, Lake County Coroners, DuPage County Coroner, Will County Coroner, McHenry County Coroner, Kane County Coroner, Peoria County Coroner\n* Parents or caregivers who provide permission to the ME to be referred to Missing Pieces\n* Parent or caregivers who are referred to Missing Pieces by a ME\n* Parents or caregivers able to read and communicate in English or Spanish\n\nExclusion Criteria:\n\n* Parents or caregivers unable to read or communicate in English or Spanish\n* Parents or caregivers under the age of 18 years old",{"count":451,"type":22},[25],"Parents of children who die traumatically or unexpectedly from things like suicide or an overdose suffer from mental and physical health problems and can experience massive disruptions in their family life. For about half of these parents, the first, and sometimes only, interactions they have with the healthcare system when their child dies are with a medical examiner or coroner (hereafter 'ME'). But MEs have little to no training in helping grieving families, and there are no standards guiding medical examiners or coroners on how or even if they should help grieving families. This gap leaves parents to find the help they need on their own. This research will test two different strategies for addressing this gap in the healthcare system.",[623],"Bereavement",[625,431,626,429,627,628],"grief","community resources","self-efficacy","coroners and medical examiners","2025-04-28",{"date":631,"type":40},"2025-05-01",{"date":633,"type":40},"2024-03-04",{"date":635,"type":22},"2028-02",{"name":46,"class":47},7,{"id":639,"slug":640,"hasResults":12,"nctId":641,"briefTitle":642,"officialTitle":643,"acronym":4,"eligibilityCriteria":644,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":133,"enrollmentInfo":645,"targetDuration":4,"studyType":23,"phases":646,"briefSummary":647,"conditions":648,"keywords":650,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":653,"lastUpdatePostDateStruct":654,"startDateStruct":656,"completionDateStruct":657,"leadSponsor":659,"locationsCount":48},"100569107","phase-2-pain-after-strabismus-surgery-100569107","NCT06689943","Pain After Strabismus Surgery","Pain After Strabismus Surgery: Post-Operative Outcomes Using Courses of Acetaminophen in Children","Inclusion Criteria:\n\n* Children between 4-12 years old\n* Children receiving single muscle, bilateral horizontal strabismus surgery (that is, children who are having only one horizontal eye muscle in each eye operated on) at Lurie Children's hospital in Chicago, IL\n* ASA classification 1 or 2. Note: ASA is a physical status classification system (scale of 1-6) created by the American Society of Anesthesiologists to describe patients prior to surgery. ASA 1 or 2 means the patient is either healthy or has mild systemic disease prior to surgery.\n\nExclusion Criteria:\n\n* ASA classification 3 or higher (patient has severe systemic disease or worse)\n* Contraindication to toradol (anesthesia)\n* Contraindication to acetaminophen\n* Previous strabismus surgery",{"count":108,"type":22},[556],"At Ann \\& Robert H. Lurie Children's Hospital of Chicago (Lurie Children's), the current practice is to prescribe children with oral Tylenol as needed every 4-6 hours post strabismus surgery. Prescribing Tylenol \"as needed\" leaves more room for error for parents to be under-dosing their children, which can lead to avoidable pain. This study aims to figure out if children ages 4-12 years old will feel significantly less pain and discomfort when given regimented Tylenol every 6 hours for 48 hours after strabismus surgery (eye muscle surgery) compared to controls whose parents are instructed to give Tylenol every 4-6 hours as needed for 48 hours after surgery. To date, there have been no studies comparing patient outcomes between those taking Tylenol regimen and those receiving Tylenol as needed after pediatric surgery.",[649],"Strabismus",[651,652],"pain","strabismus surgery","2025-02-15",{"date":655,"type":40},"2025-02-19",{"date":608,"type":22},{"date":658,"type":22},"2028-12-31",{"name":46,"class":47},{"id":661,"slug":662,"hasResults":12,"nctId":663,"briefTitle":664,"officialTitle":665,"acronym":666,"eligibilityCriteria":667,"healthyVolunteers":157,"sex":17,"minAge":668,"maxAge":669,"enrollmentInfo":670,"targetDuration":4,"studyType":221,"phases":4,"briefSummary":672,"conditions":673,"keywords":678,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":682,"lastUpdatePostDateStruct":683,"startDateStruct":685,"completionDateStruct":687,"leadSponsor":689,"locationsCount":48},"100537525","families-filming-infants-learning-movement-100537525","NCT06278961","Families Filming Infants Learning Movement","The Ontogeny of Fidgety Movements in Infants At High-Risk of Cerebral Palsy","FILM","Inclusion Criteria:\n\n* Infants born full-term with typical development, bithweight \\>2500g\n* Infants with a history of brochopulmonary dysplasia, defined as having a preterm birth (\\\u003C33 weeks gestational age) and requiring supplemental oxygen beyond 36 weeks gestational age\n* Infants with neonatal encephalopathy, who required hypothermic cooling treatment\n* Infants born \\\u003C36 weeks gestational age\n* Infants born in a multiple gestation pregnancy\n* Infants with a diagnosis of Trisomy 21\n* Infants born and diagnosed with SMA prenatally, via newborn screening assessment or prior to 10 weeks corrected age\n* Infants are less than 10 weeks corrected age at time of enrollment\n\nExclusion Criteria:\n\n* Children who are enrolled in DCFS custody\n* Parent or infant guardian does not have a smartphone","10 Weeks","20 Weeks",{"count":671,"type":22},350,"The study objective is to improve accuracy in the early detection of neurodevelopmental impairment, especially CP, by evaluating the timepoint (in weeks post term age) that the Prechtl GMA is most useful for prediction of neurodevelopmental impairment at two years of age in children with and without medical complexity. The study team plans to recruit 100 healthy, term-born infants and 250 infants at risk of developing CP for a total of 350 enrolled infants.",[674,675,676,677],"Infant Development","Cerebral Palsy","Motor Disorders","Neurological Disorder",[679,680,681],"fidgety movements","general movement assessment","cerebral palsy","2025-02-11",{"date":684,"type":40},"2025-02-13",{"date":686,"type":40},"2021-01-28",{"date":688,"type":22},"2026-09-30",{"name":46,"class":47},""]