[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Children's Hospital of Philadelphia\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":697},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,75,0,25,[9,43,67,91,119,151,174,191,224,252,280,303,328,356,382,422,450,479,502,534,560,582,611,629,659],{"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":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100557149","transpyloric-versus-gastric-feeding-in-bronchopulmonary-dysplasia-100557149",false,"NCT06534359","Transpyloric Versus Gastric Feeding in Bronchopulmonary Dysplasia","Pilot Trial Comparing Transpyloric to Gastric Feeding in Very Preterm Infants With Bronchopulmonary Dysplasia","Inclusion Criteria:\n\n1. Birth \\\u003C32 weeks' gestation\n2. Current postmenstrual age of 36-65 weeks\n3. Grade 2-3 bronchopulmonary dysplasia (BPD: treatment with positive airway pressure at 36 weeks' PMA) or grade 1 BPD (treatment with ≤2L\u002Fmin flow nasal cannular at 36 weeks' PMA) with subsequent need for prolonged positive airway pressure and full enteral tube feedings\n4. Treatment with positive airway pressure (high flow nasal cannula, non-invasive positive airway pressure, or invasive ventilation) at enrollment\n\n(4) Full gastric tube feedings (≥100mL\u002Fkg\u002Fd) at the time of enrollment (5) Parental consent to participate\n\nNote: At least 20 infants receiving invasive ventilation will be enrolled to enable endotracheal biomarker testing.\n\nExclusion Criteria:\n\n1. Transpyloric feedings received within 7d of enrollment\n2. Use of a gastric acid suppression, GI promotility drug, or caffeine within 7d of enrollment\n3. History of gastrostomy tube placement, gastric fundoplication, or bowel resection resulting in short gut with contraindication to transpyloric feeding\n4. Plan to wean off positive airway pressure (for non-intubated subjects) or to be extubated to non-invasive support (for subjects receiving invasive ventilation) within the 2wk trial\n5. Known intolerance to transpyloric feeding\n6. Persistent \\>20% endotracheal tube leak (for intubated subjects only)\n7. Active treatment with an investigational therapy as part of another interventional trial\n8. severe congenital or genetic abnormality that adversely affects GI or cardiopulmonary function","ALL","1 Month","12 Months",{"count":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this clinical trial is to learn if transpyloric tube feeding (feeding directly into the small intestine) versus gastric tube feeding tolerably and effectively reduces gastroesophageal reflux in infants born premature who have been diagnosed with bronchopulmonary dysplasia. The main questions this trial aims to answer are:\n\nDoes transpyloric as compared to gastric tube feeding result in differences in the amount of experienced hypoxemia (low oxygen level in the blood) or serious adverse events?\n\nDoes transpyloric as compared to gastric tube feeding reduce the frequency and severity of gastroesophageal reflux (GER) measured using 24 hour esophageal pH-multichannel intraluminal impedance (pH-MII) monitoring?\n\nParticipants will:\n\nUndergo pre-trial 24 hour pH-MII monitoring to determine baseline severity of GER.\n\nBe randomly assigned to receive transpyloric or gastric tube feeding for 2 weeks.\n\nUndergo repeat pH-MII at the end of the 2 week trial to assess for change in GER.\n\nUndergo continuous pulse oximetry to record level of hypoxemia during the 2 week trial.\n\nUndergo saliva and airway (if supported by a breathing tube) fluid collection to measure biomarkers of GER.\n\nBe monitored clinically for possible adverse events.",[28,29],"Bronchopulmonary Dysplasia","Gastroesophageal Reflux","RECRUITING","2026-06-26",{"date":33,"type":34},"2026-06-30","ACTUAL",{"date":36,"type":34},"2025-07-15",{"date":38,"type":22},"2027-06-30",{"name":40,"class":41},"Children's Hospital of Philadelphia","OTHER",4,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100378899","sleep-and-glycemic-control-in-type-2-diabetes-adolescents-100378899","NCT04213547","Sleep and Glycemic Control in Type 2 Diabetes Adolescents","Sleep Duration and Glycemic Control in Adolescents With Type 2 Diabetes Mellitus","Inclusion Criteria:\n\nAim 1 for child:\n\n1. Subjects age 12-20\n2. Diagnosed with T2DM by standard laboratory criteria without pancreatic autoimmunity\n3. Low probability of obstructive sleep apnea (OSA) assessed via validated sleep survey\n4. Subjects will be included if they are taking T2DM treatments (i.e., diet modification, Metformin and\u002For insulin)\n5. Parental\u002Fguardian permission and child assent\n\nAim 1 for parent:\n\n1\\. Parent or legal guardian of child that meets inclusion criteria for Aim 1.\n\nAim 2 for child:\n\n1. Completed Aim 1 evaluation\n2. Average sleep duration \\\u003C 8 hours per night as determined by actigraphy in Aim 1\n3. HbA1c ≤ 10% as HbA1c \\>10 correlates to poor adherence\n4. Adherence \\> 80%\n\nFocus group for child:\n\n1. Subjects aged 12-20\n2. Diagnosed with type 2 diabetes without pancreatic autoimmunity\n\nExclusion Criteria:\n\nAim 1 for child:\n\n1. Non-English speaking subject (as questionnaires used are validated in English)\n2. Institutionalized patients as sleep duration will not be of their own accord, and therefore is not generalizable to the rest of the adolescent T2DM population.\n3. Patients with other forms of Diabetes Mellitus (e.g. Type 1 Diabetes)\n4. Behavioral disorders that may affect data collection (e.g. autism spectrum disorder) will be determined on a case-by-case basis. These include patients that are unable to answer questionnaires on their own, participate in a sleep diary, wear devices and\u002For understand incentives.\n5. Oral or IV steroid treatment within the past month\n6. Females with known pregnancies as these patients will not be generalizable to the rest of the adolescent T2DM population and pregnancy may alter sleep duration.\n7. Subjects with known hyperthyroidism, pain syndrome, or serious medical condition that can affect sleep.\n8. Subjects with hemoglobinopathies that affect hemoglobin A1c measurement.\n9. Unable to obtain point-of-care hemoglobin A1c in clinic on date of recruitment\n10. Known diagnosis of obstructive sleep apnea or other sleep disorder\n\nAim 1 for Parent:\n\n1. Non-English speaking subject (as questionnaires used are validated in English)\n2. Parent\u002Fguardians with cognitive disorders that may affect data collection (determined on a case-by-case basis)\n\nAim 2 for child:\n\n1\\. Do not own a smart phone or tablet\n\nFocus group for child:\n\n1. Non-English speaking subject (as focus group will be conducted in English)\n2. Lack of access to a computer, tablet or smartphone that can accommodate participation in video conferencing","12 Years","20 Years",{"count":53,"type":22},90,[25],"The primary objective is to determine the cross-sectional relationship between sleep duration (as measured by 14 days of actigraphy) and glycemic control in an adolescent Type 2 Diabetes (T2DM) cohort (age 12-20y, n=67). A secondary objective is to determine if a loss-framed incentive for achieving sleep goals can increase sleep duration in 15 adolescent patients diagnosed with T2DM with insufficient sleep. Another secondary objective is to test if increasing sleep duration leads to improved glycemic control in 15 adolescents with T2DM identified in Aim 1 as having \\\u003C8 hr sleep\u002Fevening. A focus group will be conducted prior to this intervention with patients ineligible for the intervention in order to determine appropriate text messaging.",[57],"Type 2 Diabetes","2026-06-25",{"date":60,"type":34},"2026-06-29",{"date":62,"type":34},"2020-09-16",{"date":64,"type":22},"2028-07-01",{"name":40,"class":41},1,{"id":68,"slug":69,"hasResults":12,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":73,"enrollmentInfo":74,"targetDuration":4,"studyType":76,"phases":4,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":66},"100317946","electrographic-seizure-management-and-neurobehavioral-outcomes-in-critically-ill-children-100317946","NCT03419260","Electrographic Seizure Management and Neurobehavioral Outcomes in Critically Ill Children","Inclusion Criteria:\n\n1. Care in the Children's Hospital of Philadelphia Pediatric ICU.\n2. Clinically indicated continuous EEG monitoring.\n3. Age \\> 1 month to 18 years.\n\nExclusion Criteria:\n\n1. Admitted for Phase 2 (intracranial) EEG monitoring.\n2. Intensivist expects to discontinue technological support in the next two days given underlying medical or neurological problems.","18 Years",{"count":75,"type":22},2500,"OBSERVATIONAL","Electrographic seizures are common in critically ill patients leading to increased use of resource-intense continuous EEG monitoring for seizure identification and management. When identified, electrographic seizures are generally treated with anti-seizure medications, but there are very limited data available regarding optimal treatment in terms of the efficacy or safety of specific anti-seizure medications or overall management strategies.\n\nThis is a single-center prospective observational study. The investigators aim to: (1) track critically ill patients undergoing clinically indicated EEG monitoring and seizure management to identify risk factors for electrographic seizures, (2) create prediction models guiding EEG monitoring resources to the patients at highest risk for seizures, and (3) evaluate our current management strategy in terms of safety.",[79],"Seizures",[81,82,83],"seizures","status epilepticus","EEG monitoring","2026-06-24",{"date":60,"type":34},{"date":87,"type":34},"2017-03-13",{"date":89,"type":22},"2028-01-01",{"name":40,"class":41},{"id":92,"slug":93,"hasResults":12,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":12,"sex":17,"minAge":98,"maxAge":99,"enrollmentInfo":100,"targetDuration":4,"studyType":23,"phases":102,"briefSummary":104,"conditions":105,"keywords":108,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":66},"100569400","phase-2-ceus-evaluation-of-hydrocephalus-in-neonates-and-infants-100569400","NCT06693752","CEUS Evaluation of Hydrocephalus in Neonates and Infants","Pilot Study of Improved Diagnosis and Monitoring of Hydrocephalus in Neonates and Infants Using Contrast-Enhanced Ultrasound","Inclusion Criteria:\n\n1. Males and females younger than 1.5 years old with diagnosed and\u002For suspected hydrocephalus.\n2. Post menstrual age of 26 weeks or older.\n3. Inpatients at the Children's Hospital of Philadelphia.\n4. Parental\u002FLegally authorized representative permission.\n\nExclusion Criteria:\n\n1. Medical history of Lumason hypersensitivity.\n2. Hemodynamic instability as defined by rapid escalation of cardiopulmonary support in the past 12-24 hours, as defined by the clinical care team.\n3. Respiratory instability as defined by rapid escalation of respiratory support in the past 12-24 hours (Increased fraction of inspired oxygen (FiO2) requirement and\u002For nitric oxide).","1 Minute","18 Months",{"count":101,"type":22},20,[103],"PHASE2","Hydrocephalus affects up to 2 out of every 500 births and results in long-term disability in up to 78% of those affected. The standard treatment of hydrocephalus is cerebrospinal fluid (CSF) diversion via placement of an invasive ventricular shunt to relieve elevated intracranial pressure (ICP). The clinical decision for CSF diversion is based on the ventricular size and clinical symptoms which are not robust indicators of brain health in neonatal hydrocephalus. The purpose of this study is to assess the safety and feasibility of performing brain contrast-enhanced ultrasound (CEUS) in neonates and infants with diagnosed and\u002For suspected hydrocephalus.",[106,107],"Hydrocephalus in Infants","Hydrocephalus Acquired",[109,110,111],"Ultrasound","Contrast-enhanced ultrasound","Infant hydrocephalus","2026-06-22",{"date":58,"type":34},{"date":115,"type":22},"2026-07-15",{"date":117,"type":22},"2028-08-01",{"name":40,"class":41},{"id":120,"slug":121,"hasResults":12,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":12,"sex":17,"minAge":127,"maxAge":128,"enrollmentInfo":129,"targetDuration":4,"studyType":23,"phases":130,"briefSummary":131,"conditions":132,"keywords":139,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":66},"100308878","phase-2-rifampin-in-cyp24a1-related-hypercalcemia-and-hypercalciuria-100308878","NCT03301038","Rifampin in CYP24A1-related Hypercalcemia and Hypercalciuria","Rifampin to Reduce Elevated Levels of Blood and Urine Calcium in Patients With Inactivating Mutations in the CYP24A1 Gene","RICHH","Inclusion Criteria:\n\n* Males or females age 6 months to 65 years.\n* at least one mutations of CYP24A1\n* Serum and\u002For urinary calcium above the normal reference range for age\n* Serum PTH concentration \\\u003C20 pg\u002Fml\n* Elevated or normal serum concentration of 1,25-dihydroxyvitamin D3.\n\nExclusion Criteria:\n\n* Parents\u002Fguardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.\n* Allergy to rifampin or related medications\n* Current therapies with medications that have significant drug-drug interactions with rifampin, defined as a medication considered to interact with CYP3A4 or CYP3A5 and either induce or inhibit expression or function of these P450 enzymes. By \"drug-drug\" interactions we are looking for medications that will affect metabolism or action of rifampin as exclusionary, not medications that will be affected by rifampin.\n* Pregnancy or breastfeeding\n* Laboratory abnormalities that indicate clinically significant hepatic, or renal disease:\n* Aspartate Aminotransferase (AST\u002FSGOT) \\> 2.0 times the upper limit of normal Alanine aminotransferase (ALT\u002FSGPT) \\> 2.0 times the upper limit of normal Total bilirubin \\> 2.0 times the upper limit of normal Creatinine \\> 2.0 times the upper limit of normal","6 Months","65 Years",{"count":21,"type":22},[103],"This study evaluates the efficacy of rifampin in the treatment of hypercalcemia and\u002For hypercalciuria in participants with at least one inactivating mutation of the CYP24A1 gene. Eligible subjects will receive rifampin for a total of 16 weeks during this study.",[133,134,135,136,137,138],"Idiopathic Infantile Hypercalcaemia - Severe Form","Genetic Disease","Hypercalcemia, Idiopathic, of Infancy","Hypercalciuric Hypercalcemia","Idiopathic Infantile Hypercalcemia - Mild Form","Hypercalciuria",[140,141,142,143],"hypercalcemia","nephrocalcinosis","CYP24A1","hypercalciuria","2026-06-18",{"date":112,"type":34},{"date":147,"type":34},"2018-07-25",{"date":149,"type":22},"2030-12",{"name":40,"class":41},{"id":152,"slug":153,"hasResults":12,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":12,"sex":17,"minAge":158,"maxAge":159,"enrollmentInfo":160,"targetDuration":4,"studyType":23,"phases":162,"briefSummary":163,"conditions":164,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":66},"100594524","improving-mood-for-adolescents-through-teaming-with-end-users-in-routine-care-the-imatter-project-100594524","NCT07020572","Improving Mood for Adolescents Through Teaming With End-Users in Routine Care (The iMATTER Project)","The iMATTER Project: Preventing Adolescent Depression in Pediatric Primary Care","Inclusion Criteria:\n\nFor Adolescent Participants\n\n1. Adolescents ages 13 to 17 years.\n2. Adolescents must be English-speaking.\n3. Legal guardian permission (informed consent) and child consent\u002Fassent.\n4. A score of 5-10 on the Patient Health Questionnaire 9-Item: Modified for Teens (PHQ-9-M) at the primary care well-visit.\n5. Access to a phone, computer, or other electronic device that could be used for study activities\n\nFor Legal guardian Participants\n\n1. Legal guardian of an adolescents ages 13 to 17 years who scored 5-10 on the PHQ-9-M at the primary care well-visit.\n2. Consent to participate.\n3. English-speaking.\n4. Access to a phone, computer, and\u002For tablet to complete remote evaluations.\n\nExclusion Criteria:\n\nExclusion criteria will be determined based on electronic health record (EHR) review, eligibility screening questions, the baseline evaluation, and any other interactions with the family.\n\n1. Suicidal ideation or behaviors reported on the PHQ-9-M at their well-visit (score of 1 or higher on item 9 \"In the past week, have you had thoughts that you would be better off dead, or of hurting yourself in some way?\" and\u002For yes to either of the supplemental questions which ask, \"Has there been a time in the past month when you have had serious thoughts about ending your life?\" and \"Have you ever, in your whole life, tried to kill yourself or made a suicide attempt?\") based on medical record review. For the PHQ-9-M administered at baseline, adolescents who mark yes to the supplemental item about serious suicidal ideation in the past month (\"Has there been a time in the past month when you have had serious thoughts about ending your life?\") will be excluded.\n2. Major medical illness, significant behavioral problems or intellectual or developmental disabilities that may interfere with the completion of all study procedures.\n3. Youth may be excluded on a case-by-case basis if the EHR review, eligibility screener, baseline evaluation, or other interactions with the family suggests that the group program would not be appropriate.","13 Years","17 Years",{"count":161,"type":22},45,[25],"This pilot randomized controlled trial will examine the feasibility, acceptability and preliminary efficacy of an adolescent depression prevention program, Brief Interpersonal Psychotherapy-Adolescent Skills Training (B-IPT-AST), in primary care.",[165],"Depressive Symptoms","2026-06-12",{"date":168,"type":34},"2026-06-15",{"date":170,"type":34},"2025-03-20",{"date":172,"type":22},"2027-06",{"name":40,"class":41},{"id":175,"slug":176,"hasResults":12,"nctId":177,"briefTitle":178,"officialTitle":178,"acronym":179,"eligibilityCriteria":180,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":73,"enrollmentInfo":181,"targetDuration":4,"studyType":76,"phases":4,"briefSummary":183,"conditions":184,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":185,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":42},"100388454","autosomal-dominant-polycystic-kidney-disease-adpkd-study-100388454","NCT04338048","Autosomal Dominant Polycystic Kidney Disease (ADPKD) Study","ADPKD","Inclusion Criteria:\n\n* Demonstration of ADPKD by clinical information, imaging studies, biopsy, autopsy, or genetic testing.\n\nExclusion Criteria:\n\n* Patients with Autosomal Recessive Polycystic Kidney disease (ARPKD), urinary tract malformations or major congenital anomalies of other systems suggesting a diagnosis other than recessive hepato-renal fibrocystic diseases.",{"count":182,"type":22},300,"Autosomal Dominant Polycystic Kidney Disease (ADPKD) is the most common genetic cause of renal failure. For several decades, ADPKD was regarded as an adult-onset disease. In the last decade, it has become more widely appreciated that the disease course begins in childhood. However, evidence-based guidelines on how to manage and approach children diagnosed with or at-risk for of ADPKD are lacking. Overall, there is insufficient data on the clinical course during childhood. The study intends to get more information on Autosomal Dominant Polycystic Kidney Disease (ADPKD) and other hepato\u002Frenal fibrocystic diseases. Additionally, the study intends to expand web-based resources so anyone can learn about ADPKD or other hepato\u002Frenal fibrocystic diseases. Individuals diagnosed with the dominant form of a hepato\u002Frenal fibrocystic condition are invited to be in the study.",[179],{"date":168,"type":34},{"date":187,"type":34},"2019-10-10",{"date":189,"type":22},"2030-10-30",{"name":40,"class":41},{"id":192,"slug":193,"hasResults":12,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":73,"enrollmentInfo":199,"targetDuration":4,"studyType":76,"phases":4,"briefSummary":201,"conditions":202,"keywords":213,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":218,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":222,"locationsCount":223},"100163551","arpkd-database-study-100163551","NCT01401998","ARPKD Database Study","Core A: The Hepato\u002FRenal Fibrocystic Diseases Translational Resource (ARPKD Database Study)","ARPKD","Inclusion Criteria:\n\n* Demonstration of hepato\u002Frenal fibrocystic disease by clinical information, imaging studies, biopsy, autopsy, or genetic testing.\n\nExclusion Criteria:\n\n* ADPKD Urinary tract malformations Major congenital anomalies of other systems",{"count":200,"type":22},200,"Hepato-renal fibrocystic diseases (HRFD) is a term developed that encompasses rare diseases such as Autosomal Recessive Polycystic Kidney Disease (ARPKD), and other diseases with common features (Joubert syndrome, Bardet Biedl syndrome, Meckel-Gruber syndrome, congenital hepatic fibrosis (CHF), Caroli syndrome (CS), polycystic liver disease, oro-facial-digital syndrome, nephronophithisis (NPHP), and glomerulocystic Kidney Disease).\n\nThe lack of enough routinely available resources for these diseases to be well diagnosed and treated, would be best resolved by coordinated case accrual and sharing of clinical data and bio-specimens (DNA and tissues) among participating institutions, thereby leading to the centralization and sharing of clinical and genetic information, as well as bio-materials, providing an important engine for more rapid research progress and community understanding through the creation of research networks.\n\nThis study aims to build a registry of a clinical database (medical health information), a mutational database (genetic information) and an educational resource about HRFD to eventually provide information about these diseases to families, physicians and genetic counselors via our existing HIPAA- approved study website.\n\nGoals for the Core A: The Hepato\u002FRenal Fibrocystic Diseases Translational Resource are:\n\n1. \\- Clinical Database:\n\n   • Expand our comprehensive Clinical Database to include information from all patients who meet the inclusion criteria for hepato\u002Frenal fibrocystic diseases.\n2. \\- Mutational Database:\n\n   * Test children with ARPKD and other hepato\u002Frenal fibrocystic disease to identify genetic mutations, establish a DNA bank for patients with hepato\u002Frenal fibrocystic diseases and develop a Mutational Database. This Database will be capable of linking clinical and mutational information via a unique identifier in a searchable format to facilitate genetic research (e.g. genotype-phenotype correlations, new disease gene studies, and modifier gene studies), translational studies, and clinical trials.\n\n     3- Tissue Resource:\n   * Much of the research that is performed on diseases of the kidney, including recessive genetic diseases, requires human tissue from both affected as well as non-affected (controls) individuals. In this Core Resource, we are establishing an independent tissue resource which would supply investigators throughout North America with samples of hepato\u002Frenal fibrocystic disease affected tissues for studies of these disorders.\n\n     4- Educational Resource:\n   * Expand our multi-media, web-based resource to provide a reliable up-to-date, and comprehensive informational resource for ARPKD and Hepato\u002FRenal Diseases families, their physicians, and genetic counselors.",[203,204,205,206,207,208,209,210,211,212],"Hepato\u002FRenal Fibrocystic Disease","Autosomal Recessive Polycystic Kidney Disease","Joubert Syndrome","Bardet Biedl Syndrome","Meckel-Gruber Syndrome","Congenital Hepatic Fibrosis","Caroli Syndrome","Oro-Facial-Digital Syndrome Type I","Nephronophthisis","Glomerulocystic Kidney Disease",[214,215,216,217],"cystic kidney disease","polycystic kidney disease","congenital hepatic fibrosis","genetic disease",{"date":168,"type":34},{"date":220,"type":4},"2011-06",{"date":149,"type":22},{"name":40,"class":41},6,{"id":225,"slug":226,"hasResults":12,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":231,"enrollmentInfo":232,"targetDuration":4,"studyType":23,"phases":234,"briefSummary":236,"conditions":237,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":66},"100580644","phase-1-cd19-directed-chimeric-antigen-receptor-autologous-t-cells-cart19-for-lupus-100580644","NCT06839976","CD19-Directed Chimeric Antigen Receptor Autologous T Cells (CART19) for Lupus","CD19-Directed Chimeric Antigen Receptor Autologous T Cells (CART19) for Adolescents and Young Adults With Systemic Lupus Erythematosus (SLE)","Inclusion Criteria:\n\n1. Signed informed consent form must be obtained prior to any study procedure. Labs or other procedures obtained during routine clinical care may be used for eligibility if obtained within the protocol required window.\n2. Patient age must be 12-29 years, inclusive, at time of enrollment.\n3. Meeting ACR\u002FEULAR Classification Criteria for SLE\n4. ANA positive \\> 1:80 and\u002For double-stranded DNA (dsDNA) positive\n5. Active (refractory) disease, defined as follows:\n\n   a. Lupus nephritis subjects must meet both the following criteria: i. ISN\u002FRPS active nephritis Class III\u002FIV +\u002F- V lupus nephritis diagnosed by biopsy within past 12 months.\n\nii. Persistent and clinically significant: ≥2 measurements with urine protein with either of the following:\n\n1. \\> 1mg\u002Fmg creatinine\n2. \\> 0.5 mg\u002Fmg creatinine associated with renal dysfunction or low albumin.\n3. \\> 0.5 mg\u002Fmg creatinine in a patient with rising proteinuria after prior complete renal response b. Non-renal SLE subjects must meet either of the following criteria: i. SLEDAI-2K ≥ 8 and clinical SLEDAI-2K ≥ 6 ii. Inability to decrease prednisone ≤7.5mg\u002Fday or 0.15mg\u002Fkg\u002Fday, whichever is lower, due to active disease.\n\n6\\. Patients must have had at least 3 months of cumulative conventional therapy defined as:\n\n1. Conventional induction immunosuppressive agent(s) (e.g., mycophenolate mofetil, cyclophosphamide), and\n2. At least one additional therapy:\n\ni. B-cell directed biologic therapy (e.g., rituximab, belimumab, ofatumumab, obinutuzumab) ii. Calcineurin inhibitor (e.g., tacrolimus, cyclosporine, voclosporin) iii. Other immunosuppressive medication for SLE (e.g., anifrolumab, abatacept, JAK inhibitor) 7. Adequate organ function status\n\n1. Renal: eGFR must be ≥30 and subject cannot be receiving dialysis.\n2. Hepatic: Transaminases \\\u003C 5x upper limit of normal and serum conjugated (Direct) bilirubin \\\u003C1.5x upper limit of normal unless attributable to SLE. If attributable to autoimmune disease, Child-Pugh score must be class A or class B. Child-Pugh score cannot be class C.\n3. Cardiac: Shortening fraction \\> 28%, left ventricular ejection fraction \\>45%, and no evidence of severe pulmonary hypertension\n4. Pulmonary: Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and \\\u003CGrade 3 hypoxia; DLCO ≥40% (corrected for anemia and\u002For VA volume if necessary) if PFTs are clinically appropriate as determined by the treating investigator.\n\n   8\\. Subjects of reproductive potential must agree to use acceptable birth control methods.\n\nExclusion Criteria:\n\n1. Active, untreated infections\n2. HIV infection\n3. Active Hepatitis B\n\n   a. Patients must have a negative hepatitis B surface antigen to be enrolled on this study.\n4. Active Hepatitis C\n5. Patients with severe neuropsychiatric lupus or neurologic manifestations of SLE (e.g. stroke, seizure, psychosis, demyelinating syndromes, organic brain syndrome, or lupus related headaches)\n6. Monogenic lupus (known)\n7. Previous autologous or allogenic stem cell transplant\n8. Previous kidney transplant\n9. History of seizure disorder\n10. Patients who are on anti-epileptic therapy\n11. Participation in a clinical trial in which the patient receives an investigational drug within a time period equal or less than 5.5 half-lives of the investigational agent prior to study enrollment.\n12. Subjects who are unwilling or unable to discontinue immunosuppressive medications at the times of CART19 infusion will be excluded from the trial\n13. Any comorbidity that in the opinion of the investigators would jeopardize the ability of the subject to tolerate therapy.\n14. Pregnant patients. All participants of childbearing potential must have negative pregnancy test.\n15. Lactating participants who want to continue breastfeeding.\n16. Patients who are unwilling to consent to LTFU","29 Years",{"count":233,"type":22},24,[235,103],"PHASE1","This is a single-center, single-arm, open-label phase 1\u002F2 study of CART19 in children and young adults with refractory Systemic lupus erythematosus (SLE), including both patients diagnosed with lupus nephritis (LN) and patients with non-renal Systemic lupus erythematosus (SLE).\n\nPhase 1 will evaluate the safety of CART19 in 6-12 patients with Systemic lupus erythematosus (SLE). There is no planned dose escalation, but a dose de-escalation will be made based on the incidence of Dose Limiting Toxicities. Phase 2 will evaluate the efficacy and further evaluate the safety of CART19 in this population.",[238,239,240,241,242,243,244],"SLE","Systemic Lupus Erythematosus (SLE)","CAR T Cell","CART19","Cell Therapy","Lupus","Lupus Nephritis (LN)","2026-06-11",{"date":168,"type":34},{"date":248,"type":34},"2025-05-06",{"date":250,"type":22},"2030-02-28",{"name":40,"class":41},{"id":253,"slug":254,"hasResults":12,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":259,"targetDuration":261,"studyType":76,"phases":4,"briefSummary":262,"conditions":263,"keywords":265,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":66},"100509198","synovial-sarcoma-registry--biospecimen-repository-100509198","NCT05910307","Synovial Sarcoma Registry \u002F Biospecimen Repository","Synovial Sarcoma Registry and Biospecimen Repository","Inclusion Criteria:\n\n1. Males or females of any age\n2. Reported diagnosis of synovial sarcoma\n3. Informed consent from subject (aged ≥18 years) or parent\u002Fguardian\n\nExclusion Criteria:\n\n1. Individuals with sarcomas that do not fit the definition of those considered for this registry\n2. Individuals who are unwilling to participate\n3. Individuals who are unwilling or unable to provide written consent",{"count":260,"type":22},1000,"10 Years","The purpose of this study is to collect and store data and samples for future research to attempt to improve outcomes for patients with synovial sarcoma. The future research will involve various types of genetic testing.\n\nParticipants will be asked to allow access to medical records and leftover tumor tissue and may be asked to give a blood or saliva sample. Participants will also be asked to completed questionnaires about their medical history and may be contacted every 6 to 12 months for updates for up to 10 years.",[264],"Synovial Sarcoma",[266,267,268,269,270,271],"registry","biorepository","sarcoma","oncology","cancer","rare tumor","2026-06-05",{"date":274,"type":34},"2026-06-09",{"date":276,"type":34},"2023-06-12",{"date":278,"type":22},"2033-06",{"name":40,"class":41},{"id":281,"slug":282,"hasResults":12,"nctId":283,"briefTitle":284,"officialTitle":285,"acronym":286,"eligibilityCriteria":287,"healthyVolunteers":12,"sex":17,"minAge":288,"maxAge":289,"enrollmentInfo":290,"targetDuration":4,"studyType":23,"phases":291,"briefSummary":293,"conditions":294,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":298,"completionDateStruct":300,"leadSponsor":302,"locationsCount":66},"100385002","early-phase-1-treatment-of-bk-virus-infection-with-ctl-cells-in-immunocompromised-transplant-patients-100385002","NCT04293042","Treatment of BK Virus Infection With CTL Cells in Immunocompromised Transplant Patients","A Pilot Study in the Treatment of BK Virus Infection With Cytotoxic T Cells in Immunocompromised Transplant Patients","BK-CTLs","Inclusion Criteria:\n\nPatient Eligibility\n\n* Patients with symptoms of cystitis and elevated BK virus DNA by screening PCR as above (section 4) post allogeneic HSCT, post chemotherapy\n\n  1. Symptoms of cystitis may include: hematuria (microscopic or gross), pain with urination, frequency, bladder spasms.\n  2. Patient may be otherwise treated for cystitis as per local institutional standards. Such treatments may include hydration, antiviral medications, or surgical intervention as deemed appropriate by treating physician.\n* Consent: Written informed consent given (by patient or legal representative) prior to any study-related procedures.\n* Performance Status \\> 30% (Lansky \\\u003C 16 yrs and Karnofsky \\> 16 yrs)\n* Age: 0.1 to 25 years\n* Females of childbearing potential with a negative urine pregnancy test.\n\nDonor Eligibility\n\n* Related donor available with a T-cell response to the BK-virus MACS® PepTivator® antigen(s).\n\n  1. Original allogeneic donor if available, IgG positive for BKV or confirmatory testing to respond to BKV MACS Peptivator®.\n  2. Third Party Allogeneic Donor: If original donor is not available or does not have a T-cell response: third party allogeneic donor (family donor \\> 1 HLA A, B, DR match to recipient) with a T-cell response to the BK MACS® PepTivator.\n\n     AND\n* Allogeneic donor disease screening is complete similar to hematopoietic stem cell donors (Appendix 1).\n\nAND\n\n• Obtained informed consents by donor or donor legally authorized representative prior to donor collection.\n\nExclusion Criteria:\n\nPatient exclusion criteria:\n\nA patient meeting any of the following criteria is not eligible for the present study:\n\n* Patient with acute GVHD \\> grade 2 or extensive chronic GVHD at the time of BK Virus CTL infusion\n* Patient receiving steroids (\\>0.5 mg\u002Fkg prednisone equivalent) at the time of BK Virus CTL infusion or within 3 days of planned infusion.\n* Thymoglobulin (ATG), campath or T cell immunosuppressive monoclonal antibodies within 30 days\n* Patient with poor performance status determined by Karnofsky (patients \\>16 years) or Lansky (patients ≤16 years) score ≤30%\n* Concomitant enrollment in another experimental clinical trial investigating the treatment of refractory BK virus infection.\n* Any medical condition which could compromise participation in the study according to the investigator's assessment\n* Known HIV infection\n* Female patient of childbearing age who is pregnant or breast-feeding or not willing to use an effective method of birth control during study treatment.\n* Known hypersensitivity to iron dextran\n* Patients unwilling or unable to comply with the protocol or unable to give informed consent.\n* Known human anti-mouse antibodies","5 Weeks","25 Years",{"count":101,"type":22},[292],"EARLY_PHASE1","This is a pilot study using cytotoxic T lymphocytes (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Gamma-capture system will be effective in decreasing specific viral load in patients with BK virus viremia and BK virus-associated symptoms post-allogeneic hematopoietic stem cell transplantation (HSCT), renal transplantation, and chemotherapy.",[295],"BK Polyomavirus","2026-06-04",{"date":272,"type":34},{"date":299,"type":34},"2019-10-07",{"date":301,"type":22},"2029-01-30",{"name":40,"class":41},{"id":304,"slug":305,"hasResults":12,"nctId":306,"briefTitle":307,"officialTitle":307,"acronym":4,"eligibilityCriteria":308,"healthyVolunteers":309,"sex":17,"minAge":310,"maxAge":50,"enrollmentInfo":311,"targetDuration":4,"studyType":23,"phases":313,"briefSummary":314,"conditions":315,"keywords":318,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":327,"locationsCount":66},"100493299","optimizing-a-mobile-health-platform-for-sleep-promotion-and-obesity-prevention-in-children-100493299","NCT05703347","Optimizing a Mobile Health Platform for Sleep Promotion and Obesity Prevention in Children","Inclusion Criteria:\n\n1. Aged 8-12 years olds.\n2. Insufficient sleep duration (\\\u003C8.5 hours per night).\n3. Body mass index (BMI) between the 50th and 95th percentile for age and sex.\n4. One child per family.\n\nExclusion Criteria:\n\n1. Diagnosed with a chronic disease.\n2. Diagnosed with a behavioral health problem.\n3. Diagnosed with a condition that can impact sleep or growth.\n4. Diagnosed with a condition affecting physical growth and maturation or dietary intake.\n5. Children with a history of cancer, kidney, GI, musculoskeletal, or sleep disorders.\n6. Children who will transition to high-school during the study.\n7. Children using steroids\u002Fhormones.\n8. Children regularly taking medications related to exclusionary medical conditions or that impact sleep.\n9. Children with a history of significant behavioral health concerns.\n10. Parent reported PROMIS Parent Proxy Sleep Disturbance - Short Form 8a raw score of ≥28.",true,"8 Years",{"count":312,"type":22},5000,[25],"The overall objective of this application is to develop a mobile health platform for the pediatric care setting to promote longer sleep duration for childhood obesity prevention.",[316,317],"Insufficient Sleep","Obesity",[319,320],"insufficient sleep","obesity","2026-05-22",{"date":323,"type":34},"2026-05-27",{"date":325,"type":34},"2023-09-21",{"date":172,"type":22},{"name":40,"class":41},{"id":329,"slug":330,"hasResults":12,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":4,"eligibilityCriteria":334,"healthyVolunteers":12,"sex":17,"minAge":158,"maxAge":73,"enrollmentInfo":335,"targetDuration":4,"studyType":23,"phases":337,"briefSummary":338,"conditions":339,"keywords":344,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":350,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":66},"100496221","facilitating-access-to-specialty-treatment-100496221","NCT05741411","Facilitating Access to Specialty Treatment","Utilizing Mobile Health to Expedite Access to Specialty Care for Youth Presenting to the Emergency Department With Concussion at Highest Risk of Developing Persisting Symptoms","Inclusion Criteria for concussed subjects:\n\n* Males and females age 13 - 18\n* Present to the Children's Hospital of Philadelphia (CHOP) Emergency Department (ED) within 72 hours of head injury\n* Meet criteria for concussion as defined by the most recent International Consensus Statement on Concussion\n* Own a smartphone\n* Meet criteria for moderate-to-high risk for Persistent Post-Concussion Symptoms according to 5P rule (score \\>3\u002F12)\n\nExclusion Criteria for concussed subjects:\n\n* Glasgow Coma Scale score \\\u003C13\n* Lower extremity trauma\n* A prior concussion within 1 month\n* Non-English speaking\n* Admission to the hospital at the initial head injury visit\n* Previously enrolled in the study\n* Inability to complete study procedures.\n\nInclusion Criteria for parents:\n\n* Child meets the study eligibility criteria\n\nExclusion Criteria for parents:\n\n* Non-English speaking\n\nInclusion Criteria for providers:\n\n* ED or specialty provider caring for at least one patient via the mobile Health (mHealth)-facilitated care handoff strategy\n\nExclusion Criteria for providers:\n\n* Non-English speaking",{"count":336,"type":22},210,[25],"The goal of this hybrid implementation-effectiveness study is to evaluate the effectiveness (hastened recovery times) and feasibility (fidelity in connecting to concussion specialty care) of a novel mobile health intervention, designed to reduce disparities in access to specialty care through the use of remote patient monitoring (RPM) to facilitate care hand-off from the emergency department (ED) to concussion specialty care. Participants will report their symptoms and activity once daily through RPM chat technology that is linked to their electronic health record and prompts referral to specialty care.",[340,341,342,343],"Mild Traumatic Brain Injury","Concussion, Mild","Concussion, Severe","Concussion, Intermediate",[345,346,347,348],"mobile health","emergency department","persistent post-concussion symptoms","remote patient monitoring","2026-05-20",{"date":321,"type":34},{"date":352,"type":34},"2024-03-11",{"date":354,"type":22},"2027-08-01",{"name":40,"class":41},{"id":357,"slug":358,"hasResults":12,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":362,"eligibilityCriteria":363,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":159,"enrollmentInfo":364,"targetDuration":4,"studyType":23,"phases":365,"briefSummary":366,"conditions":367,"keywords":369,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":66},"100599410","phase-1-vancomycin-and-acute-kidney-injury-in-sepsis-treatment---intervention-100599410","NCT07084129","Vancomycin and Acute Kidney Injury in Sepsis Treatment - Intervention","Vancomycin and Acute Kidney Injury in Sepsis Treatment - Pharmacologic Modeling Intervention","VAST-i","Inclusion Criteria:\n\n1. Age \\>1 month and \\\u003C18 years\n2. Weight \\>5kg and \\\u003C50kg\n3. Vancomycin intended duration of therapy ≥48 hours\n4. Admitted to intensive care unit with suspected or confirmed sepsis\n5. Either sepsis-induced respiratory (invasive mechanical ventilation) or cardiovascular (vasoactive infusion) dysfunction as part of sepsis-associated organ dysfunction (these organ dysfunctions may be improving or resolved at the time of enrollment)\n\nExclusion Criteria:\n\n1. Serum creatinine elevated and meets criteria for trough-based dosing by local Clinical Pharmacy\n2. Methicillin resistant Staph aureus minimum inhibitory concentration (MIC)\\>1\n3. Central nervous system infection\n4. Extracorporeal support (extracorporeal membrane oxygenation, continuous renal replacement therapy)\n5. Pregnancy\n6. Patients on chronic dialysis therapy\n7. Patients with known history of delayed vancomycin clearance based on local pharmacy records",{"count":101,"type":22},[235],"The goal of this clinical trial is to determine if vancomycin dosing in children with sepsis can be improved by using updated, personalized dosing models that account for new markers of an individual's kidney function. Vancomycin is prescribed based on the known information of how the body breaks this medicine down. Vancomycin may not be effective if blood levels of the medicine are too low. Vancomycin has potential side effects, including the possibility of injury to the kidney. These side effects usually happen when blood levels of vancomycin are too high. There are guidelines for the range of vancomycin blood levels doctors should target to treat an infection and lower the risk of side effects. Children with sepsis may metabolize vancomycin at different rates, faster or slower, than children who do not have sepsis. For these reasons, the current dosing strategy may lead to a higher risk of kidney injury or a risk of not adequately treating an infection in children with sepsis. The investigators' goal is to use new vancomycin dosing equations to improve the ability to select the right dose of vancomycin. The main questions this trial aims to answer are:\n\n1. Is it feasible to use personalized models of vancomycin dosing in children with sepsis?\n2. Will personalized models of vancomycin dosing achieve vancomycin blood levels in acceptable ranges?",[368],"Sepsis",[370,371,372,373],"sepsis","vancomycin","biomarker","pharmacokinetics","2026-05-15",{"date":376,"type":34},"2026-05-18",{"date":378,"type":34},"2026-04-15",{"date":380,"type":22},"2027-05-31",{"name":40,"class":41},{"id":383,"slug":384,"hasResults":12,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":388,"eligibilityCriteria":389,"healthyVolunteers":309,"sex":390,"minAge":391,"maxAge":231,"enrollmentInfo":392,"targetDuration":4,"studyType":23,"phases":394,"briefSummary":395,"conditions":396,"keywords":401,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":415,"startDateStruct":416,"completionDateStruct":418,"leadSponsor":420,"locationsCount":421},"100561090","the-collaborative-care-prtner-study-100561090","NCT06585631","The Collaborative Care PrTNER Study","The Collaborative Care PrTNER (Prevention, Treatment, Navigation, Engagement, Resource) Project","PrTNER","Inclusion Criteria:\n\nAim 1:\n\n* 15-24 years old;\n* Cisgender male;\n* History of condomless sex;\n* Moderate-to-high risk SU behaviors based upon a Car, Relax, Alone, Forget, Friends, Trouble (CRAFFT) score ≥2,\n* Living in Philadelphia, PA or Baltimore, MD, and surrounding areas;\n* Able to read and write in English\n\nAim 2:\n\n* 15-29 years old;\n* Cisgender male;\n* Living with a diagnosis of HIV;\n* CRAFFT score ≥2,\n* Living in Philadelphia, PA or Baltimore, MD, and surrounding areas;\n* Able to read and write in English\n\nAim 3\n\n• All randomized study participants will be included in Aim 3.\n\nExclusion Criteria:\n\nAim 2:\n\n* Participants will be excluded if they are:\n* Assigned female sex at birth\n* Identify as transgender\n* Outside the age criteria (\\\u003C15 or \\>29 years old)\n* Cognitively unable to complete study requirements\n* Living outside of the two geographic areas\n* Do not screen positive for SU\n* No prior substance use history\n* No prior condomless sex;\n* Unable to read or write in English,\n* Plan to move in the next 12 months.","MALE","15 Years",{"count":393,"type":22},275,[25],"A randomized controlled trial to assess the ability of a Collaborative Care Prevention, Treatment, Navigation, Engagement, Resource (PrTNER) intervention to increase initiation of preexposure prophylaxis (PrEP) (for those at-risk for HIV) and decrease viral load (for those living with HIV) among young aged 15 to 29 through engagement in SU treatment.",[397,398,399,400],"HIV","Substance Use Disorders","Substance Use","AIDS",[397,400,402,403,404,405,406,407,408,409,410,411,412,413,414],"Substance use","Substances use disorder","drug use","alcohol use","preexposure prophylaxis","PrEP","peer coaches","community health worker","young men","adolescents","young male","young males","adolescent males",{"date":376,"type":34},{"date":417,"type":34},"2025-01-02",{"date":419,"type":22},"2028-06-30",{"name":40,"class":41},2,{"id":423,"slug":424,"hasResults":12,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":4,"eligibilityCriteria":428,"healthyVolunteers":12,"sex":17,"minAge":73,"maxAge":4,"enrollmentInfo":429,"targetDuration":4,"studyType":23,"phases":431,"briefSummary":432,"conditions":433,"keywords":436,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":444,"startDateStruct":446,"completionDateStruct":448,"leadSponsor":449,"locationsCount":421},"100635582","nutrition-intervention-for-pancreatic-cancer-100635582","NCT07554560","Nutrition Intervention for Pancreatic Cancer","Feasibility, Tolerance, and Fat Metabolism Pilot Study of a Structured Lipid Medical Food in Patients With Pancreatic Cancer","Inclusion Criteria:\n\n* Pancreatic ductal adenocarcinoma or pancreatic neuroendocrine tumor diagnosis and age greater than or equal to 18 years\n* Life expectancy of 4 months or greater\n* Oral or enteral tube feeding for \\> 60% daily calories\n* For patients with NET, evidence of GI dysfunction such as \\>5% unintentional weight loss, increased number of bowel movements¸change in stool consistency (e.g., soft stool or diarrhea), as documented in the medical record and confirmed by the treating oncologist.\n\nExclusion Criteria:\n\n* Pregnant or lactating\n* Unable to consume food by mouth (oral intake)\n* Allergy to soy lecithin product ingredients\n* Psychosocial environment for which study participation may be difficult for subject or family, as confirmed by medical team\n* Military service members, Reserve Service members, National Guard members, Department of Defense (DoD) civilians, and DoD contractors\n* Patients with diminished capacity to consent",{"count":430,"type":22},18,[25],"Patients with pancreatic cancer (pancreatic ductal adenocarcinoma (PDAC) and pancreatic neuroendocrine tumor (NET)) commonly experience fat malabsorption due to exocrine pancreatic insufficiency (EPI) and leads to gastrointestinal (GI) symptoms, malnutrition, weight loss, and reduced quality of life (QoL). Current standard treatment, pancreatic enzyme replacement therapy (PERT), is limited by suboptimal adherence, high cost, and partial effectiveness to prevent fat malabsorption. The objective of the study is to assess the feasibility and maintenance of lipid absorption function of a structured lipid medical food (SLMF; Encala®) powder in subjects with PDAC and NET with EPI.",[434,435],"Pancreatic Ductal Adenocarcinoma (PDAC)","Pancreatic Neuroendocrine Tumor (NET)",[437,438,439,440,441,442],"Pancreatic Ductal Adenocarcinoma","Pancreatic Neuroendocrine Tumor","Exocrine pancreatic insufficiency","Fat malabsorption","Quality of life","Gastrointestinal symptoms","2026-05-01",{"date":445,"type":34},"2026-05-07",{"date":447,"type":34},"2026-04-07",{"date":172,"type":22},{"name":40,"class":41},{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":4,"eligibilityCriteria":456,"healthyVolunteers":12,"sex":17,"minAge":457,"maxAge":458,"enrollmentInfo":459,"targetDuration":4,"studyType":23,"phases":461,"briefSummary":462,"conditions":463,"keywords":469,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":66},"100481940","early-phase-1-evaluation-of-18f-fluciclovine-positron-emission-tomography---magnetic-resonance-imaging-pet-mri-in-lgg-100481940","NCT05555550","Evaluation of 18F-Fluciclovine Positron Emission Tomography - Magnetic Resonance Imaging (PET-MRI) in LGG","Evaluation of 18F-Fluciclovine PET-MRI as a Biomarker of Response in Pediatric and Young Adult Patients With Low Grade Gliomas (LGG)","Inclusion Criteria\n\n1. LGG including the brainstem and supratentorial only (WHO grade I-II), confirmed by biopsy unless in NF1 participants with classic appearance.\n2. Participants must have evaluable disease (1x1 cm tumor on MRI)\n3. Scheduled to receive systemic therapy for LGG\n4. Performance Score: Karnofsky ≥ 50 for participants \\> 16 years of age and Lansky ≥ 50 for participants ≤ 16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n5. Age: Participants must be ≥ 1 years but ≤21 years of age at registration\n6. Being on a treatment regimen does not exclude a subject from enrollment.\n\nExclusion Criteria\n\n1. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician\n2. Pregnant participants\n3. Participants who weigh less than 8 kg.\n4. Participants who cannot avoid contact with a pregnant woman or infant for at least 12 hours following injection.\n5. Participants with a history of abnormal kidney function or creatinine \\>= CTCAE v5.0 grade 2 at time of study registration.\n6. Participants with primary tumors of the spinal cord.","1 Year","21 Years",{"count":460,"type":22},30,[292],"The purpose of this study is to see if 18F-Fluciclovine (Axumin®) is useful and safe in the management of children with Low Grade Gliomas (LGG). Imaging with 18F-Fluciclovine PET-MRI will be performed prior to initiation of therapy for LGG, and then 3 months, and 1 year after starting therapy. Changes in 18F-Fluciclovine uptake will be compared to changes in MRI measurements at 3 months and 1 year as compared to baseline.",[464,465,466,467,468],"Glioma","Low-grade Glioma","Low Grade Glioma of Brain","Glioma, Malignant","Glioma Intracranial",[464,465,466,467,468,470],"18F-Fluciclovine","2026-04-24",{"date":473,"type":34},"2026-04-29",{"date":475,"type":22},"2026-07-29",{"date":477,"type":22},"2027-09",{"name":40,"class":41},{"id":480,"slug":481,"hasResults":12,"nctId":482,"briefTitle":483,"officialTitle":484,"acronym":485,"eligibilityCriteria":486,"healthyVolunteers":12,"sex":17,"minAge":127,"maxAge":4,"enrollmentInfo":487,"targetDuration":4,"studyType":23,"phases":489,"briefSummary":490,"conditions":491,"keywords":493,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":495,"startDateStruct":497,"completionDateStruct":499,"leadSponsor":501,"locationsCount":66},"100374548","phase-1-rh-genotype-matched-rbc-transfusions-100374548","NCT04156893","RH Genotype Matched RBC Transfusions","RH Genotype Matched Red Cell Transfusions for Patients With Sickle Cell Disease","RBC","Inclusion Criteria:\n\n* Subjects age \\>6 months\n* Diagnosis of SCD, all genotypes\n* Require a period of chronic red cell transfusion therapy\n* Subject\u002Fparental\u002Fguardian permission (informed consent) and if appropriate, child assent\n\nExclusion Criteria:\n\n* Rare RH genotype that would preclude identification of sufficient RBC units\n* Antigen negative requirements due to alloimmunization that would preclude identification of sufficient RBC units\n* Alloimmunized to D antigen\n* Rh alloimmunized patients for whom providing RH genotype matched blood would expose the patient to an antigen that would not be consistent with standard of care and blood bank protocols\n* Parents\u002Fguardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures",{"count":488,"type":22},35,[235,103],"To determine the feasibility and efficacy of matching donor red cells by RH genotype for a cohort of chronically transfused patients with SCD.",[492],"Sickle Cells Disease",[494],"Chronic Transfusion",{"date":496,"type":34},"2026-04-27",{"date":498,"type":34},"2020-01-30",{"date":500,"type":22},"2029-10",{"name":40,"class":41},{"id":503,"slug":504,"hasResults":12,"nctId":505,"briefTitle":506,"officialTitle":507,"acronym":4,"eligibilityCriteria":508,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":509,"phases":4,"briefSummary":510,"conditions":511,"keywords":515,"overallStatus":530,"whyStopped":4,"lastUpdateSubmitDate":531,"lastUpdatePostDateStruct":532,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":533,"locationsCount":66},"100202772","18f-l-fluoro-dopa-petct-scan-localization-of-focal-pancreatic-lesions-in-subjects-with-hyperinsulinemic-hypoglycemia-100202772","NCT01916148","18F-L-Fluoro-DOPA PET\u002FCT Scan Localization of Focal Pancreatic Lesions in Subjects With Hyperinsulinemic Hypoglycemia","Expanded Access Use of 18F-L-Fluoro-DOPA PET\u002FCT Scan Localization of Focal Pancreatic Lesions in Subjects With Hyperinsulinemic Hypoglycemia","Inclusion Criteria:\n\n* Subjects of any age with hyperinsulinemic hypoglycemia, diagnosed by a fasting test and\u002For response to glucagon stimulation.\n* Subjects who are eligible for pancreatic surgery regardless of prior pancreatic surgery\n\nExclusion Criteria:\n\n* Pregnant or lactating females\n* Any other major illness or condition that in the investigator's judgment will substantially increase the risk associated with the subject's participation in this study\n* Subjects who are not a candidate for pancreatic surgery","EXPANDED_ACCESS","This purpose of this study is to determine the ability of an 18F-fluoro-L-dihydroxyphenylalanine (18F-DOPA) PET (Positron Emission Tomography) scan to detect a focal lesion of hyperinsulinism and determine the location in patients with congenital hyperinsulinism, Beckwith Wiedemann Syndrome and suspected insulinoma. Safety data will be collected.",[512,513,514],"Congenital Hyperinsulinism (CHI)","Beckwith-Wiedemann Syndrome","Insulinoma",[516,517,518,519,520,521,522,523,524,525,526,527,528,529],"Hypoglycemia","Hyperinsulinism (HI)","F-DOPA","PET","18-F DOPA","18F-L-Fluoro-DOPA","18F-fluoro-L-dihydroxyphenylalanine","focal pancreatic lesions","congenital hyperinsulinism","Beckwith Wiedemann Syndrome","insulinoma","Hyperinsulinemic Hypoglycemia","F-DOPA PET","CHI (Congenital hyperinsulinism)","AVAILABLE","2026-04-22",{"date":496,"type":34},{"name":40,"class":41},{"id":535,"slug":536,"hasResults":12,"nctId":537,"briefTitle":538,"officialTitle":538,"acronym":4,"eligibilityCriteria":539,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":540,"enrollmentInfo":541,"targetDuration":4,"studyType":76,"phases":4,"briefSummary":543,"conditions":544,"keywords":548,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":551,"lastUpdatePostDateStruct":552,"startDateStruct":554,"completionDateStruct":556,"leadSponsor":558,"locationsCount":559},"100491005","international-study-of-cerebral-oxygenation-and-electrical-activity-during-major-neonatal-surgery-100491005","NCT05673499","International Study of Cerebral Oxygenation and Electrical Activity During Major Neonatal Surgery","Inclusion Criteria:\n\n1. Infants ≤ 60 weeks post-menstrual age on day of surgery.\n2. Neonatal surgery for congenital abdominal\u002Fgastrointestinal malformations (diaphragmatic hernia, gastroschisis, omphalocele, intestinal atresia, Hirschsprung's disease, imperforate anus, necrotizing enterocolitis), congenital cystic adenomatoid\u002Fpulmonary airway malformation (CCAM\u002FCPAM), esophageal\u002Ftracheoesophageal fistula (EF\u002FTEF), and spinal malformations (myelomeningocele, sacrococcygeal teratoma).\n3. The same patient may be enrolled multiple times for repeat or different procedures that meet the above criteria. These subjects will be counted more than once towards the enrollment goal.\n4. Parental\u002Fguardian permission.\n\nExclusion Criteria:\n\n1\\) Patients with hydrocephalus limiting frontal-parietal brain volume, interventricular hemorrhage (grades 3 or 4), malformation or cerebral infarction of frontal-parietal brain.","60 Weeks",{"count":542,"type":22},900,"The goal of this observational study is to determine the incidence of perioperative cerebral desaturation in neonates undergoing surgery for congenital malformations. The main questions it aims to answer are:\n\n1. The perioperative factors associated with occurrence of cerebral desaturation\n2. The association between perioperative cerebral desaturation, perioperative\u002Fhospital outcomes, and physiological conditions.\n\nParticipants will undergo Near-infrared spectroscopy (NIRS) and electroencephalogram (EEG) monitoring for one hour before surgery, during surgery, and up to 24 hours after surgery.",[545,546,547],"Congenital Disorders","Cerebral Desaturation","Neonatal Surgery",[549,550],"Electroencephalography","Near-infrared spectroscopy","2026-04-20",{"date":553,"type":34},"2026-04-23",{"date":555,"type":34},"2022-08-12",{"date":557,"type":22},"2027-12-31",{"name":40,"class":41},15,{"id":561,"slug":562,"hasResults":12,"nctId":563,"briefTitle":564,"officialTitle":565,"acronym":566,"eligibilityCriteria":567,"healthyVolunteers":12,"sex":17,"minAge":310,"maxAge":73,"enrollmentInfo":568,"targetDuration":4,"studyType":23,"phases":569,"briefSummary":570,"conditions":571,"keywords":573,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":575,"lastUpdatePostDateStruct":576,"startDateStruct":577,"completionDateStruct":579,"leadSponsor":581,"locationsCount":66},"100473267","itone-trial-exercise-training-in-pulmonary-hypertension-exercise-program-for-pediatric-ph-100473267","NCT05442671","iTONE Trial (exercIse Training in pulmONary hypertEnsion) Exercise Program for Pediatric PH","Home Exercise Training in Pediatric Pulmonary Hypertension","iTONE","Inclusion Criteria:\n\n* Age 8-18 years\n* PH World Health Organization (WHO) diagnostic groups 1, 2, 3, or 4 (pulmonary arterial hypertension, PH due to left heart disease, PH due to lung disease, chronic thromboembolic PH)\n* WHO functional class I or II\n* Ambulatory status\n* Mean pulmonary to systemic arterial pressure ratio \\\u003C0.75 if the patient has not undergone a pulmonary to systemic artery shunt (\"Potts\" shunt) OR the placement of a Potts shunt ≥ 6 months prior to study enrollment\n* Stable PH medication regimen for 3 months prior to the intervention\n* Home Wifi connection\n* Mobile device in family capable of receiving text messages\n\nExclusion Criteria:\n\n* WHO functional class III or IV\n* Single ventricle physiology\n* Moderate to severe renal disease (\\>stage 3)\n* Severe hepatic impairment \\[aspartate aminotransferase (AST)\u002Falanine transaminase (ALT) \\> 2x upper limit of normal\\]\n* Current pregnancy\n* Significant developmental delay\u002Finability to comply with verbal instructions to complete the study procedures",{"count":7,"type":22},[25],"Children with pulmonary hypertension (PH) engage in less physical activity than their peers. This is a concern since adult data support exercise as a non-pharmacologic treatment for PH. Despite adult data, therapeutic exercise has not been widely adopted in pediatric PH. Investigators have previously demonstrated that children with PH have less skeletal muscle mass in association with worse exercise performance. Interventions to increase physical activity and skeletal muscle mass may improve exercise performance and quality of life in children with PH. This study will use wearable activity monitoring devices to promote physical activity in a 16-week pilot intervention in children and teenager with PH.",[572],"Pulmonary Hypertension",[574],"Actigraphy","2026-04-17",{"date":531,"type":34},{"date":578,"type":34},"2024-04-03",{"date":580,"type":22},"2026-12-31",{"name":40,"class":41},{"id":583,"slug":584,"hasResults":12,"nctId":585,"briefTitle":586,"officialTitle":587,"acronym":588,"eligibilityCriteria":589,"healthyVolunteers":12,"sex":17,"minAge":590,"maxAge":50,"enrollmentInfo":591,"targetDuration":4,"studyType":23,"phases":593,"briefSummary":594,"conditions":595,"keywords":600,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":603,"lastUpdatePostDateStruct":604,"startDateStruct":606,"completionDateStruct":608,"leadSponsor":610,"locationsCount":66},"100468666","home-apnea-testing-in-children-trial-100468666","NCT05382754","Home Apnea Testing in CHildren Trial","Home Sleep Apnea Testing Compared to In-lab Polysomnography for the Evaluation of Obstructive Sleep Apnea in Children","HATCH","Inclusion Criteria:\n\n* Male and female children age 5-12 years old inclusive\n* Referred for diagnostic PSG at the Children's Hospital of Philadelphia (CHOP) Sleep Laboratory for evaluation of OSA as part of clinical care\n* Parental\u002Fguardian permission (informed consent) and if appropriate, child assent.\n\nExclusion Criteria:\n\n* Children without Down syndrome who have had a PSG within 3 years of enrollment\n* Children with Down syndrome who have had a PSG within 1 year of enrollment.\n* Children with a history of hypoventilation or hypoxemia or who require supplemental oxygen or positive airway pressure during sleep\n* Children with a tracheostomy or tracheocutaneous fistula\n* Children who live in a facility without their parent","5 Years",{"count":592,"type":22},317,[25],"This clinical trial will compare home sleep apnea testing with the gold standard in-lab polysomnography in terms of 1) accuracy, 2) therapeutic decision-making, and 3) parent\u002Fchild acceptability in children referred for evaluation of obstructive sleep apnea.",[596,597,598,599],"Sleep Apnea, Obstructive","Sleep Disorder","Sleep Apnea Syndromes","Sleep Disturbance",[601,602],"obstructive sleep apnea","home sleep apnea testing","2026-04-16",{"date":605,"type":34},"2026-04-21",{"date":607,"type":34},"2023-03-29",{"date":609,"type":22},"2027-07",{"name":40,"class":41},{"id":612,"slug":613,"hasResults":12,"nctId":614,"briefTitle":615,"officialTitle":616,"acronym":4,"eligibilityCriteria":617,"healthyVolunteers":12,"sex":17,"minAge":261,"maxAge":159,"enrollmentInfo":618,"targetDuration":4,"studyType":76,"phases":4,"briefSummary":620,"conditions":621,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":623,"lastUpdatePostDateStruct":624,"startDateStruct":625,"completionDateStruct":627,"leadSponsor":628,"locationsCount":421},"100625673","space-for-youth-with-chronic-pain-100625673","NCT07425691","SPACE for Youth With Chronic Pain","Development of a Parent Training Intervention for Pediatric Patients With Pain","Inclusion Criteria:\n\n* Children aged 10-17 with chronic pain (≥3 months) and associated functional impairment\n* Parent\u002Fguardian living with the child ≥50% of the time\n* Parent and child are fluent in English\n\nExclusion Criteria:\n\n* Pain better explained by another medical condition\n* History of psychosis, bipolar disorder, autism spectrum disorder, or intellectual disability (child)\n* Current emotional, cognitive, or physical barrier to participation for caregiver, as determined by clinical judgment of study personnel\n* Severe psychiatric symptoms requiring immediate intervention\n* Ongoing individual Cognitive Behavioral Therapy (CBT) for pain",{"count":619,"type":22},48,"The primary objective is to assess the feasibility and acceptability of a group-based parent training intervention for parents of youth with chronic pain. Secondary objectives include evaluating changes in child functional impairment, pain intensity, and parent accommodation.",[622],"Chronic Pain","2026-04-14",{"date":378,"type":34},{"date":626,"type":34},"2026-03-13",{"date":33,"type":22},{"name":40,"class":41},{"id":630,"slug":631,"hasResults":12,"nctId":632,"briefTitle":633,"officialTitle":634,"acronym":4,"eligibilityCriteria":635,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":458,"enrollmentInfo":636,"targetDuration":4,"studyType":23,"phases":638,"briefSummary":639,"conditions":640,"keywords":647,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":652,"lastUpdatePostDateStruct":653,"startDateStruct":654,"completionDateStruct":656,"leadSponsor":658,"locationsCount":421},"100584654","massage-impact-on-sleep-in-pediatric-oncology-100584654","NCT06892158","Massage Impact on Sleep in Pediatric Oncology","Massage Impact on Sleep in Hospitalization for Pediatric Oncology and Stem Cell Transplant Patients","Inclusion Criteria:\n\n1. Diagnosis of cancer, such as acute myeloid leukemia (AML) or relapsed acute lymphoblastic leukemia (rALL) OR admitted to receive autologous or allogeneic HSCT for any indication\n2. Expected to be an inpatient for at least 21 days\n3. Aged 12 to 21 years at enrollment.\n4. Inpatient at Children's National or Children's Hospital of Philadelphia (CHOP).\n\nExclusion Criteria:\n\n1. Cognitive impairment sufficient to preclude completing questionnaires appropriately\n2. Insufficient knowledge of English or Spanish that would prohibit completing the study instruments\n3. Previous enrollment",{"count":637,"type":22},70,[25],"This study aims to determine the impact of massage therapy for pediatric patients receiving intensive chemotherapy or stem cell transplant (SCT).",[641,642,643,644,645,646],"Cancer","Pediatric Cancer","Chemotherapy Effect","Acute Myeloid Leukemia","Acute Lymphoblastic Leukemia, Pediatric","Hematopoietic Stem Cell Transplantation (HSCT)",[648,649,650,651],"Stem cell transplant (SCT)","Decreased sleep efficiency","Pediatric cancer diagnosis","Circadian activity rhythm (CAR)","2026-04-13",{"date":378,"type":34},{"date":655,"type":34},"2025-01-23",{"date":657,"type":22},"2028-07",{"name":40,"class":41},{"id":660,"slug":661,"hasResults":12,"nctId":662,"briefTitle":663,"officialTitle":664,"acronym":4,"eligibilityCriteria":665,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":289,"enrollmentInfo":666,"targetDuration":4,"studyType":23,"phases":668,"briefSummary":669,"conditions":670,"keywords":685,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":652,"lastUpdatePostDateStruct":691,"startDateStruct":692,"completionDateStruct":694,"leadSponsor":696,"locationsCount":66},"100580604","phase-1-phase-12-cd45ra-depleted-stem-cell-addback-to-prevent-viral-or-fungal-infections-post-tcrabcd19-depleted-hsct-100580604","NCT06839456","Phase 1\u002F2: CD45RA Depleted Stem Cell Addback to Prevent Viral or Fungal Infections Post TCRab\u002FCD19 Depleted HSCT","Phase 1\u002F2 Study: CD45RA Depleted Peripheral Stem Cell Addback to Prevent Viral and Fungal Infections Following Alternative Donor TCRab\u002FCD19 Depleted Hematopoietic Stem Cell Transplant","Inclusion Criteria:\n\n1. Disease for which allogeneic HSCT may be curative.\n2. Remission status of hematologic malignancies and additional disease-specific eligibility determinations will be according to standards of practice within the CHOP Cellular Immunotherapy and Transplant Program (CTTS).\n3. Patients must be 25 years of age and less\n4. Evaluation for organ and infectious status as per our CTTS standard operating procedure.\n5. Signed consent by parent\u002Fguardian or able to give consent if 18 years of age and older.\n6. Participants of childbearing potential must have a negative pregnancy test as per institutional SOP.\n\nExclusion Criteria:\n\n1. Patients who have performance score less than 60.\n2. No suitable donor available for mobilized peripheral stem cells.\n3. Patients with Hodgkin lymphoma or non-Burkitt, non-lymphoblastic lymphoma.\n4. Planned receipt of alemtuzumab during conditioning.\n5. Patients with an available 10\u002F10 HLA matched sibling donor.\n6. Patients who do not meet institutional disease, organ or infectious criteria.\n\nDonor selection and eligibility:\n\n1. Unrelated donor meets National Marrow Donor Program criteria for donation.\n2. Related donor (at least haploidentical) willing and able to donate mobilized peripheral stem cells.\n3. HLA testing\u002Fmatching\n\n   * HLA testing to be done by molecular methods for A, B, C, DRB1, DQB1\n   * Related donor: Must be ≥ 5\u002F10 match\n   * Unrelated donor: 10\u002F10 or 9\u002F10 match\n   * KIR typing for haploidentical donor for hematologic malignancies\n   * Donor specific HLA antibodies (DSA) should be assessed for all subjects receiving an HLA mismatched graft (≤ 9\u002F10).\n4. Donor must be willing to undergo granulocyte colony stimulating factor (GCSF) mobilization and peripheral blood stem cell collection\n5. Donors must be willing to sign consent to participate in this study.",{"count":667,"type":22},100,[235,103],"The major morbidities of allogeneic hematopoietic stem cell transplant (HSCT) using donors that are not human leukocyte antigen (HLA) matched siblings are graft vs host disease (GVHD) and life- threatening infections. T cell receptor alpha beta (TCRαβ) T lymphocyte depletion and CD19+ B lymphocyte depletion of alternative donor hematopoietic stem cell (HSC) grafts is effective in preventing GVHD, but immune reconstitution may be delayed, increasing the risk of infections. The central hypothesis of this study is that an addback of CD45RO memory T lymphocytes, derived from a fraction of the original donor peripheral stem cell product depleted of CD45RA naïve T lymphocytes, will accelerate immune reconstitution and help decrease the risk of infections in TCRab\u002FCD19 depleted PSCT.",[671,672,673,674,675,676,677,678,679,680,681,682,683,684],"Leukemia","High Risk Acute Lymphoblastic Leukemia","High Risk Acute Myeloid Leukemia","Relapse Leukemia","MDS (Myelodysplastic Syndrome)","Relapsed Non-Hodgkin Lymphoma","Acquired Aplastic Anemia","Inherited BMF Syndrome","Immunodeficiency","Primary Immune Regulatory Disorder","Hemoglobinopathies","Bone Marrow Failure","Inborn Errors of Metabolism","HLH",[686,687,688,689,690],"alpha beta T cell depletion","CD45RA","CD45RO","GVHD prevention","Memory T cells",{"date":378,"type":34},{"date":693,"type":34},"2025-03-21",{"date":695,"type":22},"2032-03",{"name":40,"class":41},""]