[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Seattle Children's Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":708},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,37,0,25,[9,39,65,101,133,159,185,208,244,267,302,325,363,390,422,450,475,504,531,555,583,607,635,658,680],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100625555","long-term-follow-up-of-subjects-treated-with-seattle-childrens-therapeutics-gene-therapy-products-100625555",false,"NCT07424157","Long-Term Follow-Up of Subjects Treated With Seattle Children's Therapeutics Gene Therapy Products","LTFU-01","Inclusion Criteria:\n\n1. Enrolled in an SCTx GTP clinical trial;\n2. Received or planned to receive an SCTx GTP;\n3. Subject and\u002For legally authorized representative have provided consent\u002Fassent for study participation.","ALL",{"count":19,"type":20},500,"ESTIMATED","OBSERVATIONAL","Subjects exposed to gene therapy products (GTPs) may be at risk for delayed or long-term adverse events. This is a long-term follow-up (LTFU) protocol designed to evaluate the long-term safety of Seattle Children's Therapeutics (SCTx) GTPs and incorporates in monitoring guidance from the U.S. Food and Drug Administration (FDA). Subjects will be followed for up to 15 years starting from the date of the most recent infusion of an SCTx GTP. Subjects planning to receive, or who have received, at least one infusion of an SCTx GTP will be offered participation in this LTFU study. Subjects enrolled in this study will have safety assessments and laboratory evaluations performed at scheduled intervals for each unique SCTx GTP received. No treatment is administered in this LTFU study.",[24,25],"CAR T Cell","CAR T Cell Therapy","RECRUITING","2026-06-23",{"date":29,"type":30},"2026-06-25","ACTUAL",{"date":32,"type":30},"2026-06-15",{"date":34,"type":20},"2041-03-31",{"name":36,"class":37},"Seattle Children's Hospital","OTHER",1,{"id":40,"slug":41,"hasResults":12,"nctId":42,"briefTitle":43,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":12,"sex":17,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":50,"conditions":51,"keywords":53,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":4},"100644126","home-air-pollution-in-children-with-cystic-fibrosis-study-100644126","NCT07665203","Home Air Pollution in Children With Cystic Fibrosis Study","HEROIC-CF","Inclusion Criteria:\n\n* Age 6 to 18 years old\n* Hispanic of any race or non-Hispanic white\n* Diagnosed with cystic fibrosis\n\nExclusion Criteria:\n\n* Cannot perform spirometry\n* Planning to move in next 12 months\n* Spends \\\u003C4 nights a week in one residence\n* Active smoking in the home","6 Years","18 Years",{"count":49,"type":20},200,"Cystic Fibrosis (CF) is a devastating chronic pulmonary disease that continues to cause significant morbidity and mortality despite great advances in therapies. Hispanic children with CF have worse outcomes, including higher mortality and more severe pulmonary disease, than non-Hispanic white children with CF. It is not known why Hispanic children with CF have more severe disease as it is not explained by CFTR genetic severity, diagnosis age, or socioeconomic status. The health disparities have worsened, not improved, for Hispanic children with CF since the development of new disease-altering therapeutics, CFTR modulators. It is critical to determine what is contributing to lung disease severity in Hispanic children with CF. Non-genetic factors, including environmental exposures, are estimated to account for 50% of lung disease severity variability in CF. Air pollution exposure during early childhood is associated with lower pulmonary function in healthy children and severe lung disease in children with asthma. However, air pollution exposure is vastly understudied in other chronic pulmonary diseases of childhood, such as CF. Investigating air pollution exposure in CF may provide vital information about the drivers of health disparities in Hispanic children with CF and about the environmental exposures influencing lung disease severity across all children with CF. To investigate air pollution exposure in children with CF, the investigators have assembled a multidisciplinary team of international experts in air pollution exposure, CF lung disease, health disparities, and pulmonary microbiome. The investigators will use two phenomenally rich databases, the CF Foundation Patient Registry and the University of Washington Spatiotemporal Air Pollution Exposure Model, to investigate the first aim: 1A) To determine whether neighborhood-level ambient air pollution exposure during childhood differs between 1500 Hispanic and 8500 non-Hispanic white cwCF in the CF Foundation Patient Registry, and 1B) To determine if neighborhood-level ambient air pollution exposure is associated with lung disease severity in Hispanic and non-Hispanic white cwCF. Across six geographically diverse clinical research CF centers, the investigators will enroll 100 Hispanic and 100 non-Hispanic children with CF to investigate the following aims: 2) To assess differences in residential indoor and ambient air pollution exposures by ethnicity in 200 cwCF, as well as the association between such exposure and pulmonary function by ethnicity, 3) To investigate the association of indoor and ambient air pollution exposure on airway inflammation and microbiome diversity and composition in Hispanic and non-Hispanic white cwCF using metatranscriptomic RNA sequencing. The HEROIC-CF Study is poised to advance the knowledge of the effect of air pollution exposure on not only CF lung disease severity, but may be a model to understand environmental exposures on disease severity in other chronic pulmonary diseases of childhood.",[52],"Cystic Fibrosis (CF)",[54,55],"cystic fibrosis","air pollution","NOT_YET_RECRUITING","2026-06-17",{"date":59,"type":30},"2026-06-24",{"date":61,"type":20},"2026-09-01",{"date":63,"type":20},"2031-04-30",{"name":36,"class":37},{"id":66,"slug":67,"hasResults":12,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":72,"sex":73,"minAge":47,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":38},"100639390","effects-of-copper-versus-levonorgestrel-intrauterine-devices-on-mucosal-microbiota-and-barrier-function-among-young-african-women-100639390","NCT07627958","Effects of Copper Versus Levonorgestrel Intrauterine Devices on Mucosal Microbiota and Barrier Function Among Young African Women","Effects of Copper Versus Levonorgestrel Intrauterine Devices on Mucosal Microbiota and Barrier Function: a Randomized Trial Among Young African Women","Inclusion Criteria:\n\n* Willing and able to provide written informed consent for screening and trial participation\n* Desire and willingness to use either IUD or IUS for contraception for at least one year\n* Clear understanding of study randomization and commitment to use the assigned IUD\n* Between 18 and 40 years of age (inclusive)\n* Willing and able to actively participate in the study for 12 months\n* Willing to be tested for HIV\n* Sexually active\n* HIV-negative\n* Would benefit from STI prevention\n\nExclusion Criteria:\n\n* Living with HIV or HIV screening results that are not definitively negative\n* Currently pregnant or planning to become pregnant within the next 12 months\n* Documented or known history of infertility or sterilization\n* Prior history of ectopic pregnancy\n* Use of contraceptive implant, IUD or injectable progestin in the past 3 months\n* Use of oral contraceptives in the past 30 days\n* Planning to use alternative contraception except condoms for the trial duration\n* 0-6 weeks postpartum\n* Has had a hysterectomy or sterilization\n* History of challenges using and IUD\u002FIUS, including frequent expulsion\n* Medical contraindications (Category 3 or 4 criteria as detailed in the WHO MEC1 to copper IUDs or LNG-IUS, including:\n\n  * Endometrial, ovarian, or cervical cancer\n  * Unexplained vaginal bleeding between menstrual periods or bleeding after intercourse\n  * History of pelvic tuberculosis\n  * Anatomical abnormality of the uterus incompatible with IUD insertion\n  * A recent septic abortion\n  * Untreated mucopurulent cervicitis on exam, untreated pelvic inflammatory disease (PID), or untreated known gonorrhoea or chlamydia\n* Has any condition (social or medical), which in the opinion of the investigator, would make study participation unsafe or complicate data interpretation",true,"FEMALE","40 Years",{"count":76,"type":20},120,"INTERVENTIONAL",[79],"NA","The goal of this clinical trial is to definitively determine whether copper intrauterine device (IUD) or hormonal intrauterine system (IUS) results in greater vaginal microbial diversity after 1 year in women (n= approximately 120) aged 18-40 years, who desire to use a copper IUD or hormonal IUS as contraception, are HIV-negative and could benefit from STI prevention.\n\nThe main questions it aims to answer are:\n\n1. Whether women assigned to copper IUD vs hormonal IUS have differences in vaginal microbial diversity after 1 year of use\n2. Whether women randomized to Copper IUD have reduced genital mucosal barrier integrity as indicated by proteomic signatures\n3. Whether women randomized to Copper IUD have greater incidence of high-risk HPV or curable STIs (Ct, Ng, Tv)\n\nParticipants will be assigned to have either the copper IUD or the hormonal IUS inserted as contraception. After that, they will have blood and vaginal fluids collected every 3 months for one year to look at the bacteria in their vagina, test for sexually transmitted infections, and examine markers of vaginal health.\n\nAfter enrolment, each participant will be followed for 12 months, and at the end of the trial, the participant can continue to use the IUD\u002FIUS or the study clinician can remove it.",[82],"Vaginal Microbial Diversity",[84,85,86,87,88,89,90,91,92],"IUD","IUS","intrauterine devices","Copper intrauterine device","Long-acting reversible contraception","contraception","Women","STI prevention","STI","2026-06-02",{"date":95,"type":30},"2026-06-04",{"date":97,"type":20},"2026-07",{"date":99,"type":20},"2030-07",{"name":36,"class":37},{"id":102,"slug":103,"hasResults":12,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":72,"sex":17,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":77,"phases":112,"briefSummary":113,"conditions":114,"keywords":117,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},"100504750","comparing-a-team-based-approach-to-standard-well-child-visits-to-improve-preventive-care-services-100504750","NCT05852392","Comparing a Team-Based Approach to Standard Well-Child Visits To Improve Preventive Care Services","Parent-focused Redesign for Encounters, Newborns to Toddlers (PARENT) Trial: Comparing Two Models of Well-Child Care for Black Families","Inclusion Criteria:\n\nParticipants are not individually recruited or enrolled; rather we collect de-identified Electronic Health Record (EHR) and administrative data on all children in the practices who:\n\n1. are age ≥9 and ≤15 months on day of data collection,\n2. have ≥1 visit at the practice in previous 9 months\n3. are insured by Partners for Kids, the Accountable Care Organization (ACO) for NCH-PCN\n\nExclusion Criteria:\n\n* N\u002FA","9 Months","15 Months",{"count":111,"type":20},12,[79],"Parent-focused Redesign for Encounters, Newborns to Toddlers (PARENT) is a team-based approach to care that utilizes a community health worker in a health educator role (\"Parent's Coach\") to provide many of the Well-Child Care (WCC) services that children and families should receive, addresses specific needs faced by families in low-income communities, and decreases reliance on the clinician as the primary provider of WCC services. The model was developed in partnership with clinics and parents in low-income communities and previously tested among largely Latino, Medicaid-insured populations. The aims of this study are to (1) Adapt the PARENT intervention to meet the needs of a diverse, largely Black population of underserved families, (2) Determine the effect of adapted PARENT on receipt of nationally recommended preventive care services, emergency department utilization, and parent experiences of care, (3) Determine whether the effectiveness of adapted PARENT differs by family-level factors, (4) Explore parents' experiences in receiving adapted PARENT, (5) Examine the economic impact of adapted PARENT from the parent stakeholder perspective, (6) Examine the economic impact of adapted PARENT from the pediatric provider and clinic stakeholder perspective, and (7) Examine the economic impact of adapted PARENT on healthcare utilization, from the perspectives of parents and families.\n\nThis study will evaluate the effectiveness of the adapted PARENT model as compared to traditional guideline-based WCC and assess the patient-centered economic outcomes of the adapted PARENT model.",[115,116],"Pediatric","Well Child Care",[118,116,119,120,121,122,123],"Community Health Workers","Black Children","Black Families","Preventive Care","Early Childhood","Patient-centered economic outcomes","2026-04-30",{"date":126,"type":30},"2026-05-07",{"date":128,"type":30},"2023-06-30",{"date":130,"type":20},"2028-12-01",{"name":36,"class":37},3,{"id":134,"slug":135,"hasResults":12,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":77,"phases":143,"briefSummary":144,"conditions":145,"keywords":147,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":38},"100635451","a-vaccine-communication-training-intervention-for-pediatric-inpatient-clinicians-100635451","NCT07552857","A Vaccine Communication Training Intervention for Pediatric Inpatient Clinicians","Presumptively Initiating Vaccines and Optimizing Talk for Inpatients (PIVOT-IN): A Vaccine Communication Training Intervention for Pediatric Inpatient Clinicians","PIVOT-IN","Patient Inclusion Criteria:\n\n* Hospitalized on medical or surgical unit (non-critical care) at Seattle Children's\n* Age 0-17 years during hospitalization\n* Eligible for vaccination during hospitalization\n\nPatient Exclusion Criteria:\n\n* Medical contraindication to vaccination\n* Died during hospitalization\n* Discharged from intensive care unit\n* Discharged to hospice care\n\nClinician Inclusion Criteria:\n\n* Nurse, physician, or advanced practice provider (APP)\n* Cares for patients hospitalized on medical or surgical unit (non-critical care) at Seattle Children's\n* Practices on general medicine, general surgery, pulmonology, or ENT service (physician, APP)\n\nClinician Exclusion Criteria:\n\n* Works only night shifts or on short-term contract (i.e., travel nurse)\n* Will complete residency training during intervention period",{"count":142,"type":20},2000,[79],"This study will examine a novel stakeholder-informed intervention to identify vaccine-eligible children and promote evidence-based clinician vaccine communication with families with the goal of increasing vaccine uptake during hospitalization.",[146],"Preventive Health Services (PREV HEALTH SERV)",[148,149,150],"Hospital","Communication","Immunization","2026-04-29",{"date":153,"type":30},"2026-05-05",{"date":155,"type":20},"2026-04",{"date":157,"type":20},"2027-02",{"name":36,"class":37},{"id":160,"slug":161,"hasResults":12,"nctId":162,"briefTitle":163,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":12,"sex":17,"minAge":165,"maxAge":166,"enrollmentInfo":167,"targetDuration":4,"studyType":77,"phases":169,"briefSummary":170,"conditions":171,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":38},"100521698","the-influence-of-feeding-source-on-the-gut-microbiome-and-time-to-full-feeds-in-neonates-with-congenital-gastrointestinal-pathologies-100521698","NCT06072976","The Influence of Feeding Source on the Gut Microbiome and Time to Full Feeds in Neonates With Congenital Gastrointestinal Pathologies","Inclusion Criteria:\n\n* Infants with gastroschisis, giant omphalocele, intestinal atresia, mid-gut volvulus, hirschsprungs disease.\n\nExclusion Criteria:\n\n1. Infant has already been on feeds\n2. Infants \\\u003C34 weeks gestation\n3. Parents with contraindications to providing milk (i.e. drug use-cocaine, fentanyl, meth BUT oxy\u002Fsuboxone\u002Fmarijuana OK)\n4. Complicated gastroschisis\n5. Short gut syndrome\n6. Additional congenital anomalies that affect ability to tolerate milk (i.e. cyanotic congenital heart disease BUT kidney disease ok)","0 Days","55 Years",{"count":168,"type":20},116,[79],"This study explores the use of an exclusive human milk diet versus standard feeding practices to compare the influence on feeding outcomes and the gut bacteria in infants with intestinal differences.",[172,173,174,175,176,177],"Gastrointestinal Complication","Intestinal Obstruction","Gastroschisis","Hirschsprung Disease","Omphalocele","Midgut Volvulus","2026-04-28",{"date":124,"type":30},{"date":181,"type":30},"2023-06-09",{"date":183,"type":20},"2027-06-09",{"name":36,"class":37},{"id":186,"slug":187,"hasResults":12,"nctId":188,"briefTitle":189,"officialTitle":189,"acronym":4,"eligibilityCriteria":190,"healthyVolunteers":72,"sex":17,"minAge":191,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":77,"phases":194,"briefSummary":195,"conditions":196,"keywords":198,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":38},"100494773","using-shared-decision-making-to-improve-family-media-use-planning-100494773","NCT05722535","Using Shared Decision Making to Improve Family Media Use Planning","Inclusion Criteria:\n\n* Children between the ages of 11 and 17\n* Parent\u002Fguardian of a child between the ages of 11 and 17\n* English speaking\n\nExclusion Criteria:\n\n* Parent\u002Fguardian or child does not want to participate (i.e., dyads only)\n* Non-English speaking","11 Years",{"count":193,"type":20},300,[79],"Investigators will conduct a pilot randomized controlled trial assessing the efficacy and feasibility of the newly developed Family Media Check-In (FMC).",[197],"Adolescent Behavior",[199],"Screen Media Use","2026-04-22",{"date":202,"type":30},"2026-04-27",{"date":204,"type":30},"2022-07-10",{"date":206,"type":20},"2026-08",{"name":36,"class":37},{"id":209,"slug":210,"hasResults":12,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":214,"eligibilityCriteria":215,"healthyVolunteers":12,"sex":17,"minAge":46,"maxAge":216,"enrollmentInfo":217,"targetDuration":218,"studyType":21,"phases":4,"briefSummary":219,"conditions":220,"keywords":233,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":38},"100540310","seattle-spatial-transcriptomic-research-in-inflammatory-bowel-disease-evaluation-stride-100540310","NCT06315179","Seattle Spatial Transcriptomic Research in Inflammatory Bowel Disease Evaluation (STRIDE)","Seattle Spatial Transcriptomic Research in Inflammatory Bowel Disease Evaluation","STRIDE","Inclusion Criteria:\n\n* Suspected diagnosis of CD (Crohn's Disease), UC (Ulcerative Colitis) or Indeterminate colitis (IC)\n\nExclusion Criteria:\n\n* Evidence of Other Complicating Medical Issues:\n* Other serious medical conditions, such as neurological, liver, kidney, or systemic disease\n* Pregnancy\n* Tobacco, alcohol, or illicit drug abuse","21 Years",{"count":49,"type":20},"3 Years","This is a prospective observational study collecting long-term clinical data and samples for research in pediatric inflammatory bowel disease (IBD) patients with gut inflammation and a control cohort of pediatric patients with disorders of the brain-gut interactions (DBGI) with no detectable gut inflammation.",[221,222,223,224,225,226,227,228,229,230,231,232],"Inflammatory Bowel Diseases","Crohn Disease","Ulcerative Colitis","Indeterminate Colitis","Functional Abdominal Pain Syndrome","Functional Bowel Disorder","Esophageal Diseases","Gastroduodenal Disorder","Bowel Dysfunction","Gallbladder Diseases","Sphincter of Oddi Dysfunction","Anorectal Disorder",[234,235],"IBD","DGBI","2026-04-21",{"date":238,"type":30},"2026-04-24",{"date":240,"type":30},"2024-05-10",{"date":242,"type":20},"2030-01",{"name":36,"class":37},{"id":245,"slug":246,"hasResults":12,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":4,"eligibilityCriteria":250,"healthyVolunteers":72,"sex":17,"minAge":47,"maxAge":4,"enrollmentInfo":251,"targetDuration":4,"studyType":77,"phases":253,"briefSummary":254,"conditions":255,"keywords":257,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":38},"100633086","evaluating-a-shared-decision-making-intervention-for-families-about-firearm-storage-100633086","NCT07522112","Evaluating a Shared Decision-making Intervention for Families About Firearm Storage","Randomized Trial of a Shared Decision-making Intervention for Families About Firearm Storage","Inclusion Criteria:\n\n* Parent or guardian of child aged 17 or younger\n* At least two adults living in the home\n* Firearms in household\n* Unsafe storage practices\n\nExclusion Criteria:\n\n* Not a parent or guardian\n* Child is age 18 or older\n* No other adults living in the home\n* No firearms in household Safe storage practices",{"count":252,"type":20},548,[79],"Investigators will conduct a randomized controlled trial assessing effectiveness of the Family Safety Check-In website on firearm storage practices. Prior to conducting the RCT, investigators will engage in a robust, participatory process of language adaptation to ensure the intervention meets the expressed needs of the large and growing proportion of parents in the United States who identify as Hispanic and speak primarily Spanish.",[256],"Safety",[258],"Firearms","2026-04-13",{"date":261,"type":30},"2026-04-16",{"date":263,"type":20},"2026-10-01",{"date":265,"type":20},"2030-05-31",{"name":36,"class":37},{"id":268,"slug":269,"hasResults":12,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":4,"eligibilityCriteria":273,"healthyVolunteers":12,"sex":17,"minAge":274,"maxAge":275,"enrollmentInfo":276,"targetDuration":4,"studyType":77,"phases":278,"briefSummary":280,"conditions":281,"keywords":293,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":295,"lastUpdatePostDateStruct":296,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":38},"100376708","phase-1-study-of-b7-h3-specific-car-t-cell-locoregional-immunotherapy-for-diffuse-intrinsic-pontine-gliomadiffuse-midline-glioma-and-recurrent-or-refractory-pediatric-central-nervous-system-tumors-100376708","NCT04185038","Study of B7-H3-Specific CAR T Cell Locoregional Immunotherapy for Diffuse Intrinsic Pontine Glioma\u002FDiffuse Midline Glioma and Recurrent or Refractory Pediatric Central Nervous System Tumors","Phase 1 Study of B7-H3-Specific CAR T Cell Locoregional Immunotherapy for Diffuse Intrinsic Pontine Glioma\u002FDiffuse Midline Glioma and Recurrent or Refractory Pediatric Central Nervous System Tumors","Inclusion Criteria:\n\n1. Age ≥ 1 and ≤ 26 years\n2. Diagnosis of refractory or recurrent CNS disease for which there is no standard therapy, or diagnosis of DIPG or DMG at any time point following completion of standard therapy\n3. Able to tolerate apheresis, or has apheresis product available for use in manufacturing\n4. CNS reservoir catheter, such as an Ommaya or Rickham catheter\n5. Life expectancy ≥ 8 weeks\n6. Lansky or Karnofsky score ≥ 60\n7. If patient does not have previously obtained apheresis product, patient must have discontinued, and recovered from acute toxic effects of, all prior chemotherapy, immunotherapy, and radiotherapy and discontinue the following prior to enrollment:\n\n   1. ≥ 7 days post last chemotherapy\u002Fbiologic therapy administration\n   2. 3 half lives or 30 days, whichever is shorter post last dose of anti-tumor antibody therapy\n   3. Must be at least 30 days from most recent cellular infusion\n   4. All systemically administered corticosteroid treatment therapy must be stable or decreasing within 1 week prior to enrollment with maximum dexamethasone dose of 2.5 mg\u002Fm2\u002Fday. Corticosteroid physiologic replacement therapy is allowed.\n8. Adequate organ function\n9. Adequate laboratory values\n10. Patients of childbearing\u002Ffathering potential must agree to use highly effective contraception\n\nExclusion Criteria:\n\n1. Presence of Grade ≥ 3 cardiac dysfunction or symptomatic arrhythmia requiring intervention\n2. Presence of primary immunodeficiency\u002Fbone marrow failure syndrome\n3. Presence of clinical and\u002For radiographic evidence of impending herniation\n4. Presence of \\>Grade 3 dysphagia\n5. Presence of active malignancy other than the primary CNS tumor under study\n6. Presence of active severe infection\n7. Receiving any anti-cancer agents or chemotherapy\n8. Pregnant or breastfeeding\n9. Subject and\u002For authorized legal representative unwilling or unable to provide consent\u002Fassent for participation in the 15 year follow up period\n10. Presence of any condition that, in the opinion of the investigator, would prohibit the patient from undergoing treatment under this protocol","1 Year","26 Years",{"count":277,"type":20},90,[279],"PHASE1","This is a Phase 1 study of central nervous system (CNS) locoregional adoptive therapy with autologous CD4+ and CD8+ T cells lentivirally transduced to express a B7H3-specific chimeric antigen receptor (CAR) and EGFRt. CAR T cells are delivered via an indwelling catheter into the tumor resection cavity or ventricular system in children and young adults with diffuse intrinsic pontine glioma (DIPG), diffuse midline glioma (DMG), and recurrent or refractory CNS tumors.\n\nA child or young adult meeting all eligibility criteria, including having a CNS catheter placed into the tumor resection cavity or into their ventricular system, and meeting none of the exclusion criteria, will have their T cells collected. The T cells will then be bioengineered into a second-generation CAR T cell that targets B7H3-expressing tumor cells. Patients will be assigned to one of 3 treatment arms based on location or type of their tumor. Patients with supratentorial tumors will be assigned to Arm A, and will receive their treatment into the tumor cavity. Patients with either infratentorial or metastatic\u002Fleptomeningeal tumors will be assigned to Arm B, and will have their treatment delivered into the ventricular system. The first 3 patients enrolled onto the study must be at least 15 years of age and assigned to Arm A or Arm B. Patients with DIPG will be assigned to Arm C and have their treatment delivered into the ventricular system. The patient's newly engineered T cells will be administered via the indwelling catheter for two courses. In the first course patients in Arms A and B will receive a weekly dose of CAR T cells for three weeks, followed by a week off, an examination period, and then another course of weekly doses for three weeks. Patients in Arm C will receive a dose of CAR T cells every other week for 3 weeks, followed by a week off, an examination period, and then dosing every other week for 3 weeks. Following the two courses, patients in all Arms will undergo a series of studies including MRI to evaluate the effect of the CAR T cells and may have the opportunity to continue receiving additional courses of CAR T cells if the patient has not had adverse effects and if more of their T cells are available.\n\nThe hypothesis is that an adequate amount of B7H3-specific CAR T cells can be manufactured to complete two courses of treatment with 3 or 2 doses given on a weekly schedule followed by one week off in each course. The other hypothesis is that B7H3-specific CAR T cells can safely be administered through an indwelling CNS catheter or delivered directly into the brain via indwelling catheter to allow the T cells to directly interact with the tumor cells for each patient enrolled on the study. Secondary aims of the study will include evaluating CAR T cell distribution with the cerebrospinal fluid (CSF), the extent to which CAR T cells egress or traffic into the peripheral circulation or blood stream, and, if tissues samples from multiple timepoints are available, also evaluate disease response to B7-H3 CAR T cell locoregional therapy.",[282,283,284,285,286,287,288,289,290,291,292],"Central Nervous System Tumor","Diffuse Intrinsic Pontine Glioma","Diffuse Midline Glioma","Ependymoma","Medulloblastoma, Childhood","Germ Cell Tumor","Atypical Teratoid\u002FRhabdoid Tumor","Primitive Neuroectodermal Tumor","Choroid Plexus Carcinoma","Pineoblastoma, Childhood","Glioma",[294],"CNS, CAR T cell, B7-H3, pediatric, young adult, brain tumor, DIPG, DMG","2026-04-07",{"date":259,"type":30},{"date":298,"type":30},"2019-12-11",{"date":300,"type":20},"2042-05",{"name":36,"class":37},{"id":303,"slug":304,"hasResults":12,"nctId":305,"briefTitle":306,"officialTitle":306,"acronym":4,"eligibilityCriteria":307,"healthyVolunteers":72,"sex":17,"minAge":308,"maxAge":4,"enrollmentInfo":309,"targetDuration":4,"studyType":77,"phases":310,"briefSummary":311,"conditions":312,"keywords":314,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":321,"completionDateStruct":322,"leadSponsor":324,"locationsCount":4},"100582538","evaluating-huddles-as-a-novel-approach-to-improving-concussion-safety-100582538","NCT06864611","Evaluating Huddles as a Novel Approach to Improving Concussion Safety","Inclusion Criteria:\n\n* Children between the ages of 9 and 13 on eligible teams in participating leagues.\n* Soccer coaches of children between the ages of 9 and 13 on eligible teams in participating leagues.\n* Read and write English\n\nExclusion Criteria:\n\n* Cannot read and write English","9 Years",{"count":142,"type":20},[79],"Investigators will conduct a randomized controlled trial assessing the effectiveness and implementations of Pre-Game Safety Huddles (Huddles) in youth soccer.",[313],"Mild Traumatic Brain Injury",[315,316,317],"concussion","brain injury","prevention","2026-03-17",{"date":320,"type":30},"2026-03-20",{"date":61,"type":20},{"date":323,"type":20},"2030-04-30",{"name":36,"class":37},{"id":326,"slug":327,"hasResults":12,"nctId":328,"briefTitle":329,"officialTitle":329,"acronym":330,"eligibilityCriteria":331,"healthyVolunteers":12,"sex":17,"minAge":274,"maxAge":275,"enrollmentInfo":332,"targetDuration":4,"studyType":77,"phases":334,"briefSummary":335,"conditions":336,"keywords":347,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":356,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":38},"100604325","phase-1-immunotherapy-for-solid-tumor-malignancies-in-pediatrics-using-interleukin-15-and--21-armored-glypican-3-specific-chimeric-antigen-receptor-t-cells-100604325","NCT07148050","Immunotherapy for Solid Tumor Malignancies in Pediatrics Using Interleukin-15 and -21 Armored Glypican-3-specific Chimeric Antigen Receptor T Cells","IMPACT","1. Procurement Eligibility\n\n   Inclusion Criteria:\n   * Diagnosis of a solid tumor expressing GPC3\n   * Lansky or Karnofsky score of \\>=60%\n   * Life expectancy of \\>16 weeks\n   * Informed consent explained to, understood by and signed by patient\u002Fguardian.\n\n   For patients with hepatocellular carcinoma only:\n   * Barcelona Liver Cancer Stage A, B or C\n   * Child-Pugh Turcotte Score \\\u003C7\n\n   Exclusion Criteria:\n   * History of hypersensitivity reactions to murine protein-containing products OR presence of human anti-mouse antibody (HAMA) prior to enrollment for patients who have received prior therapy with murine antibodies.\n\n     * History of organ transplantation\n     * Known HIV positivity\n     * Active bacterial, fungal, or viral infection (except Hepatitis B or Hepatitis C virus infections)\n2. Treatment eligibility\n\nInclusion Criteria:\n\n* Lansky or Karnofsky score of \\>=60%\n* Life expectancy of \\>16 weeks\n* Informed consent explained to, understood by and signed by patient\u002Fguardian.\n* Adequate organ function\n* Adequate laboratory values\n* Refractory or relapsed disease after treatment with up- front therapy and at least one salvage treatment cycle\n* Recovered from acute toxic effects of all prior chemotherapy and investigational agents before entering this study\n* Sexually active patients must be willing to utilize one of the more effective birth control methods for 12 months after the T-cell infusion.\n* Informed consent explained to, understood by and signed by patient\u002Fguardian.\n\nFor patients with hepatocellular carcinoma only:\n\n* Barcelona Liver Cancer Stage A, B or C\n* Child-Pugh Turcotte Score \\\u003C7\n\nExclusion Criteria:\n\n* History of hypersensitivity reactions to murine protein-containing products OR presence of human anti-mouse antibody (HAMA) prior to enrollment for patients who have received prior therapy with murine antibodies.\n\n  * History of organ transplantation\n  * Known HIV positivity\n* Active autoimmune or inflammatory disorder\n* Live vaccines within 30 days prior to enrollment\n\n  • Active bacterial, fungal, or viral infection (except Hepatitis B or Hepatitis C virus infections)\n* Pregnancy or lactation\n* Uncontrolled infection\n* Systemic steroid treatment (≥ 0.5 mg prednisone equivalent\u002Fkg\u002Fday, dose adjustment or discontinuation of medication must occur at least 24hrs prior to CAR T cell infusion)\n* Congestive heart failure (as defined by New York Heart Association Functional Classification III or IV), unstable angina, serious uncontrolled cardiac arrhythmia, a myocardial infarction within 6 months prior to study entry or a history of myocarditis.",{"count":333,"type":20},21,[279],"This Phase 1, open-label, non-randomized study will enroll pediatric and young adult subjects with relapsed or refractory non-central nervous system (CNS) malignant solid tumors expressing glypican-3 (GPC3) to examine the safety, feasibility, and efficacy of administering T cell products derived from peripheral blood mononuclear cells (PBMC) that have been genetically modified to co-express a GPC3-specific chimeric antigen receptor (CAR), interleukin (IL)-15 and IL-21 as well as the inducible caspase 9 (iC9) suicide gene (SC-CAR.GPC3xIL15.21 T cells).\n\nA child or young adult meeting all eligibility criteria and meeting none of the exclusion criteria will have a blood sample collected, which will be used to bioengineer the CAR T cells targeting their tumor.",[337,338,339,340,341,342,343,344,345,346],"Solid Tumor (Excluding CNS)","Liver Cell Carcinoma","Malignant Rhabdoid Tumor","Yolk Sac Tumor","Liposarcoma","Rhabdomyosarcoma","Embryonal Sarcoma of Liver","Wilms Tumor","Hepatocellular Carcinoma","Hepatoblastoma",[348,115,349,350,351,352,353,354],"CAR T cell","Young Adult","Non-CNS Tumor","Liver Cancer","Solid Tumor","GPC3","Glypican","2026-02-13",{"date":357,"type":30},"2026-02-17",{"date":359,"type":30},"2025-12-22",{"date":361,"type":20},"2044-04-22",{"name":36,"class":37},{"id":364,"slug":365,"hasResults":12,"nctId":366,"briefTitle":367,"officialTitle":367,"acronym":4,"eligibilityCriteria":368,"healthyVolunteers":12,"sex":17,"minAge":369,"maxAge":4,"enrollmentInfo":370,"targetDuration":4,"studyType":77,"phases":372,"briefSummary":374,"conditions":375,"keywords":378,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":383,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":389,"locationsCount":38},"100532094","phase-2-the-what-is-important-to-us-communication-intervention-pilot-clinical-trial-100532094","NCT06208332","The \"What Is Important to Us\" Communication Intervention Pilot Clinical Trial","Children with SNI\n\nInclusion\n\n* Hospitalized at study sites\n* Ages 6 months through 25 years old\n* Has had SNI for \\>6 months, defined as permanent static or progressive central nervous system injury resulting in motor\u002Fcognitive impairment and medical complexity\n\nExclusion\n\n* Has never previously been home\u002Fdischarged\n* Has an expected hospital length of stay \\\u003C2 days\n* Has a life expectancy of \\\u003C4 weeks\n* Previous study participation\n\nParents\n\nInclusion\n\n* Parent\u002Flegally authorized representative of an eligible child with SNI\n* Preferred language of care English and\u002For Spanish\n\nClinicians\n\nInclusion -Licensed physicians, nurses, advanced practice providers, respiratory therapists at study site\n\nExclusion\n\n-Previous study participation","6 Months",{"count":371,"type":20},160,[373],"PHASE2","The objective of this study is to conduct a pilot randomized controlled trial (RCT) of a photo-narrative communication intervention developed by our study team with patients\u002Fparents of children with severe neurological impairment (SNI) and their pediatric intensive care unit (PICU) clinicians to assess feasibility, acceptability, and early efficacy.",[376,377],"Critical Illness","Neurologic Disorder",[379,380,381],"pediatric palliative care","communication","severe neurological impairment","2026-02-12",{"date":384,"type":30},"2026-02-18",{"date":386,"type":30},"2025-02-10",{"date":388,"type":20},"2027-05-15",{"name":36,"class":37},{"id":391,"slug":392,"hasResults":12,"nctId":393,"briefTitle":394,"officialTitle":395,"acronym":396,"eligibilityCriteria":397,"healthyVolunteers":12,"sex":17,"minAge":47,"maxAge":4,"enrollmentInfo":398,"targetDuration":4,"studyType":77,"phases":400,"briefSummary":401,"conditions":402,"keywords":405,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":416,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":38},"100495384","online-social-learning-program-for-parents-with-irritable-bowel-syndrome-raising-resilient-children-100495384","NCT05730491","Online Social Learning Program for Parents With Irritable Bowel Syndrome: Raising Resilient Children","Randomized Controlled Trial of an Internet-based Prevention Intervention for Parents With Irritable Bowel Syndrome","REACH","Inclusion criteria for parents and their children (including biological\u002Fstep-parents or legal guardians):\n\n* Parent\u002Fcaregiver at least 18 years old\n* Parent diagnosed with IBS or idiopathic abdominal pain in the last five years OR\n* Parent meets ROME criteria for IBS (abdominal pain at least weekly; pain related to defecation, change in stool frequency, and change in stool form at least 30% of the time)\n* Is the parent primarily responsible for caring for the child on a day-to-day basis\n* Child is 4 to 7 years old at the time of screening. If multiple children are present in the family, the parent will be asked to select one child for study participation.\n* Child must currently live at least half of the time with the parent involved in intervention.\n* Parent and child must reside in the U.S.\n\nExclusion criteria for parents and their children:\n\n* Not able to read\u002Fspeak\u002Funderstand English.\n* Child has a developmental disability that requires full-time special education\n* Child has chronic abdominal pain (pain most\u002Fevery day for more than 3 months)\n* Child has a current doctor's diagnosis of a painful\\* gastrointestinal disorder like functional constipation, lactose\u002Ffructose\u002Fgluten intolerance, celiac disease, Inflammatory Bowel Disorder, etc. (\\*does not include nonpainful disorders like GERD)\n* Child has another severe chronic disease such as juvenile arthritis, cancer, or other severe condition(s) requiring chronic medical treatment.\n* Does not have regular access to the Internet on a desktop, tablet, phone, or laptop computer",{"count":399,"type":20},460,[79],"The goal of this clinical trial is to test efficacy of the REACH program in parents with irritable bowel syndrome (IBS) and their young children. The main question it aims to answer is:\n\n-How can parents with IBS help their young kids develop healthy habits?\n\nParticipants will be asked to complete online surveys and to use a website. Researchers will compare results from parents who use one of two websites chosen by chance, like flipping a coin. One website focuses on child health and safety behaviors. The other website focuses on strategies to promote child wellness behaviors.",[403,404],"Irritable Bowel Syndrome","Abdominal Pain",[406,407,408,409,410,411,412,413,414,415],"social learning","cognitive behavioral therapy","prevention intervention","irritable bowel syndrome","solicitous behavior","protective factors","psychosocial intervention","abdominal pain","risk factors","illness behavior",{"date":357,"type":30},{"date":418,"type":30},"2023-10-16",{"date":420,"type":20},"2027-04-30",{"name":36,"class":37},{"id":423,"slug":424,"hasResults":12,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":4,"eligibilityCriteria":428,"healthyVolunteers":12,"sex":17,"minAge":429,"maxAge":430,"enrollmentInfo":431,"targetDuration":4,"studyType":77,"phases":433,"briefSummary":434,"conditions":435,"keywords":437,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":442,"lastUpdatePostDateStruct":443,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":449,"locationsCount":38},"100623177","bypass-clear-priming-vsd-cardiopulmonary-bypass-circuit-reduce-bypass-associated-inflammation-100623177","NCT07393243","Bypass Clear Priming VSD Cardiopulmonary Bypass Circuit Reduce Bypass Associated Inflammation?","Does Clear Priming of the Cardiopulmonary Bypass Circuit Reduce Bypass Associated Inflammation in Ventricular Septal Defect Patients?","Inclusion Criteria:\n\n* Weight between 5-10kg\n* Age 1-18 months\n* Requiring cardiopulmonary bypass as part of clinically indicated surgery\n* Surgery performed by Dr. Bohuta or Dr. Greene\n\nExclusion Criteria:\n\n* Hemoglobin\u002Fhematocrit too low for clear CPB prime (post-dilution Hct \\\u003C24%)\n* Pre-operative ECMO support\n* Active infection\n* Not clinically appropriate for clear prime (instability, arrhythmias, desaturation, etc.)\n* Genetic syndrome\n* Pork allergy or family requests pork avoidance","1 Month","18 Months",{"count":432,"type":20},60,[79],"The purpose of this trial is to study if priming the pump used during cardiac surgery with non-blood fluids instead of donated blood products reduces the inflammation that occurs after heart surgery. The study will focused on pediatric participants who require open heart surgery to repair certain types holes in the heart.\n\nTypically for pediatric patients, the cardiopulmonary bypass pump is \"primed\" (filled) with donated blood products. This project is going to test if the exposure to these blood products causes inflammation. Patients experience significant inflammation (swelling) after undergoing cardiopulmonary bypass. This inflammation can interfere and slow down the patient's recovery from cardiac surgery. With this project, the investigator are studying if filling the bypass pump with non-blood products reduces the bypass-associated inflammation.\n\nThe investigators are also studying if using non-blood fluids to fill the bypass pump reduces bypass associated side effects.\n\nThe investigators are also trying to understand how the inflammation starts. The investigators also want to study genetic material called DNA that is collected from a person's blood. Instructions for the body are contained in parts of DNA called genes. Genes determine things like hair and eye color. The investigator hope by studying genes the investigator can learn more about the inflammation that occurs after heart surgery, but the investigators might use participant's genetic information to study other diseases or conditions other the inflammation that occurs after heart surgery.\n\nThe investigators will be studying the recovery of 60 participants between 1 month to 18 months of age who require open heart surgery to repair ventricular septal defects (VSDs), a congenital heart defect where there a hole between the lower chambers of the heart.\n\nParticipants will:\n\nAllow for information about how the participants recover from surgery to be collected.\n\nAllow blood samples during and after surgery to be collected to understand how the markers of inflammation change between the two groups (blood versus non-blood priming).",[436],"Ventricular Septal Defect",[438,439,440,441],"cardiac surgery","cardiopulmonary bypass","inflammation","blood product","2026-02-05",{"date":444,"type":30},"2026-02-06",{"date":446,"type":20},"2026-02-25",{"date":448,"type":20},"2030-12",{"name":36,"class":37},{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":456,"eligibilityCriteria":457,"healthyVolunteers":12,"sex":17,"minAge":458,"maxAge":459,"enrollmentInfo":460,"targetDuration":4,"studyType":77,"phases":462,"briefSummary":463,"conditions":464,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":466,"lastUpdatePostDateStruct":467,"startDateStruct":469,"completionDateStruct":471,"leadSponsor":473,"locationsCount":474},"100611674","i-decide-after-bronchiolitis-hospitalization-100611674","NCT07243652","I-DECIDE After Bronchiolitis Hospitalization","Cluster Randomized Trial of a Moderate vs High Resource Implementation Strategy to Increase As-needed Post-hospitalization Follow-up for Children With Bronchiolitis","I-DECIDE","Inclusion Criteria:\n\n* Primary diagnosis of bronchiolitis, discharged by a generalist inpatient service from a non-ICU, non-emergency department, non-step down unit\n\nExclusion Criteria:\n\n* Children with a history of gestational age \\\u003C28 weeks, chronic lung disease, complex or hemodynamically significant heart disease, immunodeficiency, or neuromuscular disease\n* Children being discharged with home oxygen therapy","0 Months","24 Months",{"count":461,"type":20},2700,[79],"Although automatic follow-up is a nearly universal practice, research has shown that these visits are often unnecessary after hospitalizations caused by bronchiolitis. Despite endorsement by national pediatric authorities, robust evidence, and family enthusiasm for as-needed (PRN) follow-up, it remains substantially underutilized for children hospitalized for bronchiolitis.\n\nThe goal of I-DECIDE is to compare the effects of two multi-component implementation strategies, both of which aim to (a) increase PRN follow-up prescribing by hospitalists (physicians who care for hospitalized children) and (b) decrease unnecessary follow-up visit attendance by families.",[465],"Bronchiolitis Acute","2026-02-02",{"date":468,"type":30},"2026-02-04",{"date":470,"type":30},"2025-11-01",{"date":472,"type":20},"2029-12",{"name":36,"class":37},56,{"id":476,"slug":477,"hasResults":12,"nctId":478,"briefTitle":479,"officialTitle":480,"acronym":481,"eligibilityCriteria":482,"healthyVolunteers":12,"sex":17,"minAge":47,"maxAge":4,"enrollmentInfo":483,"targetDuration":4,"studyType":77,"phases":485,"briefSummary":486,"conditions":487,"keywords":491,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":496,"lastUpdatePostDateStruct":497,"startDateStruct":499,"completionDateStruct":501,"leadSponsor":503,"locationsCount":38},"100545770","internet-delivered-pain-self-management-for-persons-with-acute-recurrent-and-chronic-pancreatitis-pain-100545770","NCT06386224","Internet-Delivered Pain Self-Management for Persons With Acute Recurrent and Chronic Pancreatitis Pain","Internet-Delivered Pain Self-Management to Reduce Pain and Interference in Chronic Pancreatitis","IMPACT-2","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Willingness to use personal device with internet access (smart phone, computer, iPad) or to borrow a study iPad\u002Fhotspot\n* Diagnosis of CP defined as having obvious morphological features of CP (i.e., Cambridge 3-4 stage or the presence of pancreatic calcifications on CT scan and\u002For magnetic resonance cholangiopancreatography)\n* Diagnosis of RAP defined as having abdominal pain of a duration of \\>=3 months, one episode of acute pancreatitis (AP), or RAP.\n* Having experienced moderate pain intensity (rated as 4 or higher on a 0-10 Numerical Rating Scale) in the last month from RAP or CP.\n\nExclusion Criteria:\n\n* Undergoing treatment for cancer\n* Unable to read English well enough to complete questionnaires or read the study website\n* Currently experiencing suicidal ideation\n* Having received endoscopic therapy in the past 30 days\n* Currently receiving treatment from a psychologist (\\> 4 sessions)",{"count":484,"type":20},280,[79],"Severe and disabling abdominal pain is common in individuals with chronic pancreatitis. Although pain is associated with reduced quality of life and high economic and societal costs, there are limited effective options for pain management in this population. This study proposes an evidence-based psychological intervention approach using an internet-delivered pain self-management program to minimize the impact of pain and improve quality of life. The ultimate goal is to maximize the public health impact of the intervention with successful implementation and dissemination to pancreas clinics and to the community.",[488,489,490],"Pancreatitis","Chronic Pancreatitis","Acute Recurrent Pancreatitis",[488,492,493,494,495],"Pain","Internet Intervention","Behavioral Intervention","Cognitive Behavioral Therapy","2026-01-19",{"date":498,"type":30},"2026-01-21",{"date":500,"type":30},"2024-05-01",{"date":502,"type":20},"2026-09-30",{"name":36,"class":37},{"id":505,"slug":506,"hasResults":12,"nctId":507,"briefTitle":508,"officialTitle":509,"acronym":510,"eligibilityCriteria":511,"healthyVolunteers":12,"sex":17,"minAge":218,"maxAge":4,"enrollmentInfo":512,"targetDuration":4,"studyType":77,"phases":513,"briefSummary":514,"conditions":515,"keywords":518,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":523,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":529,"locationsCount":530},"100459350","brain-injury-education-and-outpatient-navigation-1stbien-100459350","NCT05261477","Brain Injury Education and Outpatient Navigation-1stBIEN","Brain Injury Education and Outpatient Navigation for Hispanic Children and Their Caregivers-1stBIEN","1st-BIEN","Children Inclusion criteria:\n\n1. Children 3 to 17 years of age,\n2. Hispanic ethnicity\n3. Diagnosis of mild, moderate or severe TBI.\n4. Hospitalization at one of the 5 academic institutions participating in this trial,\n5. Treatment requiring at least one type of rehabilitation therapy as outpatient\n\nParent Inclusion Criteria:\n\n1. Hispanic ethnicity\n2. Being the primary caregiver for the child (For longitudinal follow-up purposes)\n\nExclusion criteria:\n\nChild:\n\n1. Prior neurological deficits,\n2. Acquired brain injuries secondary to other conditions different from trauma.\n3. Traumatic brain injuries secondary to abusive trauma.\n\nParent:\n\n1. Loss of custody of the child (i.e. abusive head trauma)\n2. Inability to be contacted by phone",{"count":193,"type":20},[79],"Traumatic brain injury (TBI) is a significant problem for U.S. Hispanic children. Compared to non-Hispanic children, Hispanic children have higher long-term disability and lower health related quality of life, even though differences are not present at hospital discharge. Rehabilitation decreases disability, but needs timely initiation, and long treatments in hospitals, community healthcare facilities and schools. Parents play a key role in their child's recovery. Hispanic parents face additional barriers to initiate and maintain outpatient treatments. They report knowledge gaps in TBI-education, community, and school support systems; language and health literacy barriers. The investigators developed, a bilingual bicultural theory-based program for Hispanic families consisting of Brain Injury Education and outpatient care Navigation (1st BIEN). It integrates in-person education enriched by video content delivered through mobile phones, with navigation during transitions to outpatient care and school return. The pilot established feasibility and acceptability of the program. This randomized control trial will determine efficacy to maintain long-term adherence to rehabilitation and reduce disability. It will enroll 150 parent-child dyads: children (6-17 y), with mild-complicated, moderate-severe TBI in 5 centers in Washington, Texas, Dallas, Utah and Oregon and their parents. Intervention group parents receive: One in-person education session, plus bi-weekly videos tailored to the child's TBI and therapies; and, 3-months of bilingual outpatient care navigation. Attention control parents receive one in person-education session, monthly well-child texts and usual institutional follow up care. Primary outcome is treatment adherence at 6 months post-discharge measured by percentage of follow-up appointments attended during the prescribed time at hospitals, and community care facilities. Secondary outcomes are functional status of the child using PROMIS parental report measures; and parental health literacy, self-efficacy, and mental health at 3, 6, and 12 months after discharge. Child's academic performance will be assessed using school records. The study evaluates a flexible and scalable intervention using mobile phones to aid transitions of care, improve treatment adherence and TBI outcomes. It addresses the needs of an understudied population and can serve as a model for TBI family centered care for at risk groups.",[516,517],"Brain Injuries, Traumatic","Rehabilitation",[519,520,516,521,517],"Hispanic or Latino","Child","Patient Navigation","2026-01-11",{"date":524,"type":30},"2026-01-13",{"date":526,"type":30},"2022-07-07",{"date":528,"type":20},"2026-12",{"name":36,"class":37},6,{"id":532,"slug":533,"hasResults":12,"nctId":534,"briefTitle":535,"officialTitle":536,"acronym":4,"eligibilityCriteria":537,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":538,"enrollmentInfo":539,"targetDuration":4,"studyType":77,"phases":541,"briefSummary":542,"conditions":543,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":547,"lastUpdatePostDateStruct":548,"startDateStruct":550,"completionDateStruct":552,"leadSponsor":554,"locationsCount":38},"100447339","phase-1-plat-08-a-study-of-sc-daric33-car-t-cells-in-pediatric-and-young-adults-with-relapsed-or-refractory-cd33-aml-100447339","NCT05105152","PLAT-08: A Study Of SC-DARIC33 CAR T Cells In Pediatric And Young Adults With Relapsed Or Refractory CD33+ AML","Pediatric And Young Adult Leukemia Adoptive Therapy (PLAT)-08: A Phase 1 Study Of SC-DARIC33 In Pediatric And Young Adults With Relapsed Or Refractory CD33+ AML","Inclusion Criteria:\n\n1. Subject age ≤ 30 years. The first three enrolled subjects must be ≥ 18 years of age.\n2. AML that expresses CD33 by flow cytometry and meets one of the below definitions:\n\n   1. For subjects who have previously received an allogeneic HCT, any evidence of AML re-emergence post HCT detectable by flow cytometry\n   2. First relapse of AML ≤ 6 months of initial diagnosis\n   3. First relapse of AML \\> 6 months after initial diagnosis, with MRD of \\>0.1% by flow cytometry (MPF) after at least one re-induction (single cycle) attempt\n   4. Second or greater relapse AML\n   5. Refractory AML, defined as \\>1% leukemic cells determined by flow cytometry after 2 cycles of induction chemotherapy\n3. Able to tolerate apheresis, or subject with sufficient existing apheresis product or T cells for manufacturing investigational product.\n4. Life expectancy ≥ 8 weeks\n5. Has an appropriate stem cell donor source identified\n6. Lansky performance status score of ≥ 50 for subjects \\\u003C16 years of age or Karnofsky score ≥ 50 for subjects ≥ 16 years. Subjects who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for purposes of assessing performance status\n7. If a subject does not have a previously obtained apheresis product that is acceptable and available for manufacturing of DARIC T cells, the subject must discontinue all anticancer agents and radiotherapy and, in the opinion of the investigator, have fully recovered from significant acute toxic effects of all prior chemotherapy, immunotherapy, and radiotherapy:\n\n   a. Chemotherapy and biologic agents: All chemotherapy and biologic therapy not specifically mentioned below must be discontinued ≥ 7 days prior to enrollment, with the exception of intrathecal chemotherapy for which there is not a required washout period b. Must be ≥ 30 days from last gemtuzumab ozogamicin dose. c. Steroid use: All corticosteroid therapy (unless physiologic replacement dosing) must be discontinued ≥ 7 days prior to enrollment d. Tyrosine Kinase Inhibitor (TKI) use: All TKIs must be discontinued ≥ 3 days prior to enrollment e. Hydroxyurea: must be discontinued ≥ 1 day prior to enrollment. f. Gene Modified cellular therapy: i. must be at least 30 days from most recent gene modified cell therapy infusion and document no evidence of modified cells in the peripheral blood OR ii. must be at least 60 days from most recent gene modified cell therapy\n8. Adequate organ function as indicated by:\n\n   1. Renal: Serum creatinine ≤ 1.5 X the upper limit of normal (ULN)\n   2. Hepatic: Total bilirubin ≤ 3 times ULN for age OR conjugated bilirubin ≤ 2 mg\u002FdL AND ALT (SGPT) ≤ 5 times ULN\n   3. Cardiac: Shortening fraction ≥ 28% OR ejection fraction ≥ 50% as measured by echocardiogram\n   4. Respiratory: Oxygen saturation ≥ 92% on room air without supplemental oxygen or mechanical ventilation\n9. Laboratory values meet the following criteria:\n\n   a. Subjects requiring apheresis: Absolute Lymphocyte Count (ALC) ≥ 100 cells\u002FuL b. Virology Testing negative within 3 months prior to enrollment, to include: i. HIV antigen \\& antibody ii. Hepatitis B surface antigen iii. Hepatitis C antibody OR if positive, Hepatitis C PCR is negative\n10. If subject is of childbearing or child-fathering potential, must agree to use highly effective contraception from the time of initial consent through 12 months following the infusion of investigational product on this trial.\n11. Subject and\u002For legally authorized representative has signed the Informed Consent Form for this study\n\nExclusion Criteria:\n\n1. Active malignancy other than acute myeloid leukemia\n2. History of symptomatic non-AML CNS disease or ongoing symptomatic CNS disease requiring medical intervention, including paresis, aphasia, cerebrovascular ischemia\u002Fhemorrhage, severe brain injury, dementia, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder (subjects with non-febrile seizure disorder controlled on anti-epileptic medication and without seizure activity within 1 month are eligible).\n3. CNS AML involvement that is symptomatic and in the opinion of the investigator, cannot be controlled during the interval between enrollment and DARIC T cell infusion\n4. If history of allogeneic stem cell transplant: active GVHD, or receiving immunosuppressive therapy for treatment or prevention of GVHD within 4 weeks prior to enrollment\n5. Presence of active severe infection, defined as:\n\n   i. positive blood culture within 48 hours of enrollment, OR ii. fever above 38.2° C, AND clinical signs of infection within 48 hours of enrollment\n6. Primary immunodeficiency syndrome\n7. Subject has received prior virotherapy\n8. Pregnant or breastfeeding\n9. Subject and\u002For legally authorized representative unwilling to provide consent\u002Fassent for participation in the 15-year follow-up period, required if DARIC T cell therapy is administered\n10. Presence of any condition that, in the opinion of the investigator, would prohibit the subject from undergoing treatment under this protocol\n11. Considered by the investigator to be unable to tolerate a lymphodepleting regimen\n12. Subject has a contraindication to receiving rapamycin","30 Years",{"count":540,"type":20},18,[279],"A phase 1, open-label, non-randomized study enrolling pediatric and young adult patients with relapsed or refractory CD33+ leukemia with and without prior history of allogeneic hematopoietic cell transplantation, to examine the safety and feasibility of administering an autologous T cell product that has been genetically modified to express a Dimerizing Agent Regulated Immunoreceptor Complex (DARIC).",[544,545,546],"Acute Myeloid Leukemia","Acute Myeloid Leukemia Refractory","Acute Myeloid Leukemia, in Relapse","2025-12-16",{"date":549,"type":30},"2025-12-23",{"date":551,"type":30},"2021-11-29",{"date":553,"type":20},"2041-01-31",{"name":36,"class":37},{"id":556,"slug":557,"hasResults":12,"nctId":558,"briefTitle":559,"officialTitle":560,"acronym":4,"eligibilityCriteria":561,"healthyVolunteers":12,"sex":17,"minAge":562,"maxAge":563,"enrollmentInfo":564,"targetDuration":4,"studyType":77,"phases":566,"briefSummary":567,"conditions":568,"keywords":571,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":575,"startDateStruct":577,"completionDateStruct":579,"leadSponsor":581,"locationsCount":582},"100614553","comparative-efficacy-of-organizational-skills-training-ost-and-mindfulness-based-intervention-mbi-100614553","NCT07281092","Comparative Efficacy of Organizational Skills Training (OST) and Mindfulness-Based Intervention (MBI)","Comparing Psychosocial Supports for Adolescents With ADHD: What Works Best for Whom and Why?","Inclusion Criteria:\n\n* Adolescent between the ages of 13-17 years\n* Pre-existing diagnosis of ADHD in medical record\n* Seeking treatment at the Seattle Children's Hospital BAM Clinic\n\nExclusion Criteria:\n\n* Psychiatric comorbidity that interferes with treating ADHD as the presenting concern per the study team.\n* Other concerns besides ADHD that would interfere with study participation according to the study team.","13 Years","17 Years",{"count":565,"type":20},36,[79],"This randomized control trial comparing Organizational Skills Training (OST) and Mindfulness-Based Intervention (MBI) among adolescents with a pre-existing ADHD diagnosis presenting to the Duke ADHD Program.\n\nBoth treatments are eight 90 minute sessions.\n\nThe research component will involve a pre-treatment assessment and post-treatment assessment. Both assessments will involve adolescents and one caregiver to complete questionnaires over REDCap. Rating scales will include ADHD symptom severity (Conners 3: self and parent report), functional impairment (IRS: self and parent report), executive functioning (BRIEF-2: parent report), emotion dysregulation (DERS: self and parent report), trait mindfulness (FFMQ: self report), organizational skills (BRIEF-2: parent report), treatment satisfaction (self report and parent report) and credibility (self report and parent report). Post-treatment assessments for feasibility will include attendance (measured over the course of treatment) and homework completion rates on a scale of 1 to 5 in which 5 indicates higher homework completion. We will also assess acceptability via individual items on a Likert scale (self report): overall satisfaction, how much was learned about ADHD, usefulness of information learned, content relevance to individual experience, comprehension of strategies, confidence about using strategies, likelihood of using strategies, helpfulness to share with the group, benefits from hearing from other group members, willingness to recommend the same treatment to others, and whether or not treatment was beneficial.",[569,570],"ADHD","ADHD - Attention Deficit Disorder With Hyperactivity",[572,573],"adhd","attention deficit hyperactivity disorder","2025-12-08",{"date":576,"type":30},"2025-12-15",{"date":578,"type":30},"2025-10-01",{"date":580,"type":20},"2026-08-01",{"name":36,"class":37},2,{"id":584,"slug":585,"hasResults":12,"nctId":586,"briefTitle":587,"officialTitle":587,"acronym":4,"eligibilityCriteria":588,"healthyVolunteers":12,"sex":17,"minAge":589,"maxAge":538,"enrollmentInfo":590,"targetDuration":4,"studyType":77,"phases":591,"briefSummary":592,"conditions":593,"keywords":595,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":599,"lastUpdatePostDateStruct":600,"startDateStruct":602,"completionDateStruct":604,"leadSponsor":606,"locationsCount":38},"100551827","phase-1-react-01-reversing-autoimmunity-through-cell-therapy-100551827","NCT06465147","REACT-01: Reversing Autoimmunity Through Cell Therapy","Inclusion Criteria:\n\n* Male and female subjects aged between 2-30 years old. The first 3 subjects will be aged ≥ 17. The FDA will review safety data to determine if the age can be lowered first to ≥ 12 then, following the treatment of 3 further subjects aged 12-17, to ≥ 2\n* Serologically active Systemic Lupus Erythematosus that is refractory to treatment\n* Able to tolerate apheresis or already has an apheresis product available for use in manufacturing.\n* ≥ 24 weeks post last Rituximab or related B cell depleting therapy\n* ≥ 12 weeks post last Belimumab \u002F Anifrolumab therapy\n* ≥ 4 weeks post last calcineurin inhibitor treatment\n* For subjects receiving non-calcineurin immunosuppressive therapy, on a stable dose for ≥ 8 weeks before enrollment\n* For subjects receiving corticosteroid therapy, on a stable dose for ≥ 2 weeks before enrollment\n* Adequate organ function\n* Adequate laboratory values\n* Subjects of childbearing or child-fathering potential must agree to use highly effective contraception from consent through 12 months following infusion of investigational product on trial\n* Subjects must be willing to remain within 1 hour's drive of Seattle Children's Hospital for 4 weeks following CAR T cell infusion.\n* Subject and\u002For legally authorized representative has signed the informed consent form for this study\n\nExclusion Criteria:\n\n* History or presence of active CNS lupus or other CNS disease\n* Kidney dysfunction requiring renal replacement therapy\n* Pregnant or breastfeeding\n* Insufficient pulmonary reserve including history of COPD, \\>10 pack year smoking history or SLE lung disease with hypoxia at rest with oxygen saturation ≤92% on room air\n* Unable to tolerate repletion with any formulation of IgG.\n* Active or prior malignancy, unless the malignancy was treated and there is no evidence of recurrent disease \\\u003C5 years from enrollment.\n* Prior solid organ transplantation.\n* Presence of an active severe infection\n* Presence of any condition that, in the opinion of the investigator, would prohibit the subject from undergoing treatment under this protocol","2 Years",{"count":111,"type":20},[279],"This is a phase 1, open-label, non-randomized study enrolling pediatric and young adult research participants with treatment-refractory Systemic Lupus Erythematosus (SLE), to examine the safety, feasibility, and efficacy of administering T cell products derived from peripheral blood mononuclear cells (PBMC) that have been genetically modified to express CD19 specific chimeric antigen receptor (CAR)\n\nA child or young adult meeting all eligibility criteria and meeting none of the exclusion criteria will have their T cells collected. The T cells will then be bioengineered into a CAR T cell that targets circulating and tissue residing B cells.",[594],"Systemic Lupus Erythematosus",[596,597,594,598],"CAR T cells","Lupus","SLE","2025-12-05",{"date":601,"type":30},"2025-12-12",{"date":603,"type":30},"2024-12-16",{"date":605,"type":20},"2041-10",{"name":36,"class":37},{"id":608,"slug":609,"hasResults":12,"nctId":610,"briefTitle":611,"officialTitle":612,"acronym":613,"eligibilityCriteria":614,"healthyVolunteers":12,"sex":17,"minAge":47,"maxAge":615,"enrollmentInfo":616,"targetDuration":4,"studyType":77,"phases":618,"briefSummary":619,"conditions":620,"keywords":623,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":627,"lastUpdatePostDateStruct":628,"startDateStruct":630,"completionDateStruct":632,"leadSponsor":634,"locationsCount":582},"100600461","concussion-recovery-and-support-program-100600461","NCT07097792","Concussion Recovery and Support Program","Pilot Study of Concussion Recovery and Support Program (CRISP)","CRISP","Inclusion Criteria:\n\n* Diagnosed with a concussion and at least 2 weeks from injury but less than two years.\n* New or worsening headache since concussion\n* Had at least one day with headache last week of moderate severity or two days with headache of any severity\n\nExclusion Criteria:\n\n* Non-English speaking\n* Chronic medical illness\u002F medical complexity\n* Housing instability\n* Acute mental health issues such as active suicidality, psychiatric hospitalization within the past 6 months, ER visit for suicidality in the past 6 months or experiencing psychosis or delusions","29 Years",{"count":617,"type":20},40,[79],"Pilot randomized controlled trial (RCT) comparing a novel intervention Concussion Recovery and Support Program (CRISP) for adolescents and young adults (AYA) 18-29 yo with concussion\u002F mild TBI.",[621,313,622],"Brain Concussion","Headache",[624,625,626],"mental health","therapy","emotional awareness and expression therapy","2025-11-14",{"date":629,"type":30},"2025-11-18",{"date":631,"type":30},"2025-10-13",{"date":633,"type":20},"2026-07-31",{"name":36,"class":37},{"id":636,"slug":637,"hasResults":12,"nctId":638,"briefTitle":639,"officialTitle":639,"acronym":640,"eligibilityCriteria":641,"healthyVolunteers":72,"sex":17,"minAge":191,"maxAge":563,"enrollmentInfo":642,"targetDuration":4,"studyType":77,"phases":644,"briefSummary":645,"conditions":646,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":651,"lastUpdatePostDateStruct":652,"startDateStruct":653,"completionDateStruct":655,"leadSponsor":657,"locationsCount":582},"100445325","advancing-suicide-intervention-strategies-for-teens-during-high-risk-periods-100445325","NCT05078970","Advancing Suicide Intervention Strategies for Teens During High Risk Periods","ASSIST","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Youth, aged 11-17\n3. Endorse suicidal ideation and\u002For behavior\n4. Admitted to acute care (emergency, inpatient medical or inpatient psychiatric) due to suicidality\n\nExclusion Criteria:\n\n1. Presence of psychosis, intellectual disability, autism spectrum disorder, eating disorder with unstable vitals\n2. Limited English proficiency that would interfere with the ability to complete study assessments",{"count":643,"type":20},306,[79],"To inform the effective management of adolescent suicide risk by evaluating promising treatments and developing the evidence-base for interventions that are well suited for widespread adoption, sustained quality, and impact.",[647,648,649,650],"Suicide Attempts","Suicidal Ideation","Suicide and Self-harm","Suicide Threat","2025-11-13",{"date":627,"type":30},{"date":654,"type":30},"2022-08-11",{"date":656,"type":20},"2027-01-31",{"name":36,"class":37},{"id":659,"slug":660,"hasResults":12,"nctId":661,"briefTitle":662,"officialTitle":663,"acronym":664,"eligibilityCriteria":665,"healthyVolunteers":12,"sex":17,"minAge":216,"maxAge":4,"enrollmentInfo":666,"targetDuration":4,"studyType":77,"phases":667,"briefSummary":668,"conditions":669,"keywords":670,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":672,"lastUpdatePostDateStruct":673,"startDateStruct":675,"completionDateStruct":677,"leadSponsor":679,"locationsCount":38},"100610206","phase-1-cytokine-armored-gpc3-specific-chimeric-antigen-receptor-expressing-t-cells-in-adults-with-solid-tumors-100610206","NCT07224568","Cytokine Armored GPC3 Specific Chimeric Antigen Receptor Expressing T-cells in Adults With Solid Tumors","INTERCEPT-GPC3: Interleukin-15 and -21 Armored Glypican-3 Specific Chimeric Antigen Receptor Expressing Autologous T-cells in Adults With GPC3-positive Solid Tumors","INTERCEPT","1. Procurement Eligibility\n\n   Inclusion Criteria:\n   * Diagnosis of a solid tumor expressing GPC3\n   * Karnofsky score of \\>=60%\n   * Life expectancy of \\>16 weeks\n   * Informed consent explained to, understood by and signed by participant or participant's legally authorized representative\n\n   For patients with hepatocellular carcinoma only:\n   * Barcelona Liver Cancer Stage A, B or C\n   * Child-Pugh-Turcotte Score \\\u003C7\n\n   Exclusion Criteria:\n   * History of hypersensitivity reactions to murine protein-containing products OR presence of human anti-mouse antibody (HAMA) prior to enrollment for patients who have received prior therapy with murine antibodies.\n\n     * History of organ transplantation\n     * Known HIV positivity\n     * Active bacterial, fungal, or viral infection (except Hepatitis B or Hepatitis C virus infections)\n2. Treatment eligibility\n\nInclusion Criteria:\n\n* Karnofsky score of \\>=60%\n* Life expectancy of \\>16 weeks\n* Informed consent explained to, understood by and signed by patient\u002Fguardian.\n* Adequate organ function\n* Adequate laboratory values\n* Refractory or relapsed disease after treatment with up- front therapy and at least one salvage treatment cycle\n* Recovered from acute toxic effects of all prior chemotherapy and investigational agents before entering this study\n* Sexually active patients must be willing to utilize one of the more effective birth control methods for 3 months after the T-cell infusion.\n* Informed consent explained to, understood by and signed by patient\u002Fguardian.\n\nFor patients with hepatocellular carcinoma only:\n\n* Barcelona Liver Cancer Stage A, B or C\n* Child-Pugh Turcotte Score \\\u003C7\n\nExclusion Criteria:\n\n* History of hypersensitivity reactions to murine protein-containing products OR presence of human anti-mouse antibody (HAMA) prior to enrollment for patients who have received prior therapy with murine antibodies.\n\n  * History of organ transplantation\n  * Known HIV positivity\n  * Active bacterial, fungal, or viral infection (except Hepatitis B or Hepatitis C virus infections)\n* Pregnancy or lactation\n* Systemic steroid treatment (≥ 0.5 mg prednisone equivalent\u002Fkg\u002Fday, dose adjustment or discontinuation of medication must occur at least 24hrs prior to CAR T cell infusion)",{"count":333,"type":20},[279],"This Phase 1, open-label, non-randomized study will enroll adult subjects with relapsed or refractory non-central nervous system (CNS) malignant solid tumors expressing glypican-3 (GPC3) to examine the safety, feasibility, and efficacy of administering T cell products derived from peripheral blood mononuclear cells (PBMC) that have been genetically modified to co-express a GPC3-specific chimeric antigen receptor (CAR), interleukin (IL)-15 and IL-21 as well as the inducible caspase 9 (iC9) suicide gene (SC-CAR.GPC3xIL15.21 T cells).\n\nAn adult participant meeting all eligibility criteria and meeting none of the exclusion criteria will have a blood sample collected, which will be used to bioengineer the CAR T cells targeting their tumor.",[337,345,338,341,340,342],[348,671,350,351,352,353,354],"Adult","2025-10-31",{"date":674,"type":30},"2025-11-04",{"date":676,"type":20},"2026-04-01",{"date":678,"type":20},"2045-08",{"name":36,"class":37},{"id":681,"slug":682,"hasResults":12,"nctId":683,"briefTitle":684,"officialTitle":685,"acronym":4,"eligibilityCriteria":686,"healthyVolunteers":12,"sex":17,"minAge":46,"maxAge":687,"enrollmentInfo":688,"targetDuration":4,"studyType":77,"phases":690,"briefSummary":691,"conditions":692,"keywords":696,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":700,"lastUpdatePostDateStruct":701,"startDateStruct":703,"completionDateStruct":705,"leadSponsor":707,"locationsCount":582},"100539134","phase-2-efficacy-and-safety-of-phenterminetopiramate-in-youth-with-hypothalamic-obesity-100539134","NCT06299891","Efficacy and Safety of Phentermine\u002FTopiramate in Youth With Hypothalamic Obesity","Phentermine\u002FTopiramate in Children, Adolescents, and Young Adults With Hypothalamic Obesity: a Pilot and Feasibility Study","Inclusion Criteria:\n\n1. Males and Females; Ages 6-28 years (inclusive)\n2. History of rapid weight gain related to tumor onset or treatment, as assessed by an experienced endocrinologist (for example, change in BMI z-score \\> 0.2 and\u002For BMI +5% during the first 6 months following tumor treatment)\n3. Obesity (BMI \\> 95th%ile for age\u002Fsex using CDC 2000 reference for under 18; BMI \\> 30 kg\u002Fm2 for 18+ years)\n4. Recent evidence of hypothalamic injury by brain MRI with central review; \\>6 months status-post definitive therapy (surgery, chemotherapy, or radiation); no major operations\u002Fsurgeries planned during the study period.\n5. Stable on pituitary replacement\\* and\u002For appetite-modulating medications (including stimulants) for at least 2 months. \\*Adjustments of less than 25% (\\\u003C25%) are permitted to hydrocortisone, growth hormone or thyroid hormone. Sex steroids and DDAVP are exempt.\n6. Post-menarchal females must use a highly effective form of contraception, unless hypogonadotropic hypogonadism is documented. All participating females of child-bearing potential will have pregnancy testing as outlined in the protocol.\n7. Participants must be able to communicate well with the investigative team, must comply with requirements of the study, and be able to provide written informed consent and\u002For assent for individuals less than 18y with consent of a parent\u002Flegal guardian.\n\nExclusion Criteria:\n\n1. Contraindication to Phentermine, Topiramate, or Qsymia as assessed using current package inserts. Including: History of glaucoma and known hyperthyroidism.\n2. Known history of nephrolithiasis (kidney stones).\n3. Current clinical diagnosis of anorexia nervosa or bulimia nervosa in the medical record.\n4. Known history of metabolic acidosis, low bicarbonate on screening laboratory assessment (below lower limit of normal), or clinically significant bone disease requiring medication (beyond calcium and\u002For vitamin D).\n5. Current or recent (\\\u003C14 days) use of monoamine oxidase inhibitor.\n6. Known hypersensitivity to sympathomimetic amines.\n7. Clinically significant cardiovascular conditions, as defined as any of the following: i) abnormal blood pressure, defined as: under 13y, 95th%ile +12 mm Hg or \\> 140\u002F90, whichever is lower; 13y and older, \\> 140\u002F90 ; ii) history of cardiac arrhythmia or arrhythmia detected on screening ECG; iii) history of heart failure and\u002For cardiomyopathy; iv) prolonged QTc interval (QTc \\> 460 msec), and\u002For long QT syndrome phenotype and\u002For positive genotype for long QT syndrome pathogenic; v) history of cardiac disease including coronary artery disease.\n8. Females who are pregnant, breastfeeding, or planning to become pregnant during the trial.\n9. \"Brittle\" diabetes insipidus (in the opinion of the referring endocrinologist, e.g. requiring frequent hospitalizations and\u002For frequent abnormal sodium values).\n10. Diabetes mellitus requiring insulin\u002Fsecretagogue. HbA1c \\> 8.5% at Screening.\n11. Clinically significant hyperthyroidism as assessed using thyroid hormone measurements. Clinical measurements within 12 months of baseline\u002Fscreening may be used to assess this criterion.\n12. History of clinically significant hypokalemia (low potassium) or current clinically significant hypokalemia (low potassium) on baseline\u002Fscreening labs.\n13. Clinically significant liver disease and\u002For known severe hepatic impairment. ALT \\> 3 x Upper Limit of Normal (ULN) AST \\> 3 x ULN\n14. Clinically significant kidney disease. GFR\\\u003C60 ml\u002Fmin\u002F1.73m2\n15. History of seizure in the 12 months prior to Screening.\n16. History of substance abuse, depression of moderate or greater severity, psychiatric disorder and\u002For suicidality.\n17. History of abdominal surgery including gastric bypass.\n18. Current use of supra-physiologic steroids.\n19. History of allergy or sensitivity to test agents. Including individuals with known aspirin allergy or hypersensitivity and\u002For known allergy to FD\\&C Yellow No. 5 (tartrazine).\n20. Concurrent use of carbonic anhydrase inhibitors.\n21. Concurrent use of non-potassium sparing diuretics.\n22. New weight management medication (or \\>5% decrease in weight over prior 2 months on any current, stable regimen), stimulant, and\u002For investigational medication within 2 months prior to screening, and\u002For plans to initiate other new weight management regimen.\n23. Cognitive impairment that, in the opinion of the investigator, precludes participation in the study.\n24. Individuals considered, in the Investigator's opinion, not suitable to participate in the study for reasons other than those indicated above.","28 Years",{"count":689,"type":20},24,[373],"Hypothalamic obesity (HO) refers to the substantial weight gain that often complicates hypothalamic brain tumors. Children with this treatment-recalcitrant form of obesity have excess rates of metabolic sequelae compared to otherwise healthy children with similar obesity, and later experience excess mortality related to cardiometabolic disease. In this pilot trial, our objective is to gather key preliminary data about phentermine\u002Ftopiramate (Ph\u002FT) that is FDA-approved for \"common\" obesity but has never been tested in HO. The subset of individuals with HO who experience hyperphagia or excess daytime sleepiness may benefit from the Ph\u002FT-induced decrease in appetite and increase in alertness.\n\nPreliminary assessments of safety, adverse events, dosing (Aim 1), as well as of efficacy (% BMI loss, Aim 2) will be made in a 28-week parallel-arm double-blinded Phase 2 placebo-controlled clinical trial in 6-28-year-old individuals with HO.",[693,694,695],"Hypothalamic Obesity","Hypothalamic Tumor","Craniopharyngioma",[697,698,693,699],"Hypothalamic Lesion","Drug Intervention","Phentermine\u002FTopiramate","2025-07-23",{"date":702,"type":30},"2025-07-28",{"date":704,"type":30},"2025-03-01",{"date":706,"type":20},"2026-05-31",{"name":36,"class":37},""]