[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Children's National Research Institute\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":637},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,36,0,25,[9,56,85,114,132,160,190,215,238,259,277,308,330,351,372,393,418,440,465,487,510,534,556,585,612],{"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":34,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":4},"100644286","phase-1-ngfus-nivo-neuronavigation-guided-focused-ultrasound-with-nivolumab-in-relapsed-and-progressive-dmg-and-other-high-grade-brain-tumors-100644286",false,"NCT07664176","NgFUS NIVO: NeuroNavigation-Guided Focused Ultrasound With Nivolumab in Relapsed and Progressive DMG and Other High Grade Brain Tumors","A Safety and Feasibility Study of NeuroNavigation-Guided Low Intensity Focused Ultrasound With Microbubbles to Enhance Nivolumab Delivery for the Treatment of Relapsed and Progressive Diffuse Midline Glioma and Other High Grade Brain Tumors","Inclusion Criteria:\n\n* Age ≥ 3 and ≤ 25 years.\n* Diagnosis of brainstem DMG\u002FDIPG or any high-grade brain tumor.\n\n  * Group A: Relapsed or progressive brainstem DMG.\n  * Group B: Relapsed or progressive high-grade intracranial brain tumor requiring surgical resection.\n* Lansky\u002FKarnofsky rating ≥ 60.\n* Patients must have received at least one line of prior therapy upfront for their disease.\n* At least four weeks from radiation therapy, prior immunotherapy, or monoclonal antibody therapy.\n* At least 2 weeks from prior myelosuppressive chemotherapy and post nadir meeting organ function criteria.\n* At least 1 week or 5 half-lives (whichever is longer) from last targeted therapy.\n* If on steroids, stable or decreasing dose for at least 7 days prior to study entry and ≤ 0.4 mg\u002Fm2\u002Fday of dexamethasone or equivalent.\n* Stable or improving neurological status for 7 days prior to study entry.\n* Organ function:\n\n  * Absolute Neutrophil Count (ANC) ≥750\u002FμL.\n  * Absolute Lymphocyte Count (ALC) \\>500\u002FμL.\n  * Platelets ≥75K, unsupported.\n  * Coagulation studies: PT and PTT \\\u003C1.5 ULN and INR (\\\u003C1.5).\n  * Bilirubin ≤1.5x upper limit of normal (ULN).\n  * AST\u002FALT ≤5x ULN.\n  * Serum creatinine within normal limits for age.\n  * Pulse oximetry \\>93% on room air.\n  * Ejection Fraction (EF) above institutional lower limit of normal (LLN).\n* For females of childbearing potential (FOCBP): negative pregnancy test within 7 days of study entry.\n* Patients of childbearing or child-fathering potential must agree to use contraceptive measures for at least 5 months following nivolumab infusion.\n* Patient or parent\u002Fguardian capable of providing informed consent.\n\nExclusion Criteria:\n\n* Symptoms and signs of increased intracranial pressure.\n* Patients with metallic ventricular peritoneal shunts. Subjects with nonmetallic VP shunts or similar will have a technical evaluation of the screening non-contrast CT scan of the head. During the mapping of the target area, if the technical NaviFUS specialist determines that the patient cannot be treated within the safety limits of the system, the patient will not be eligible and will be considered a screen failure.\n* Tumor presenting with the following imaging characteristics:\n\n  * Evidence of uncal herniation.\n  * Edema and\u002For mass effect that causes hydrocephalus.\n  * Significant areas of necrosis within the tumor that the neurosurgeon feels cannot be avoided during the ultrasound sonication.\n  * Evidence of a significant new hemorrhage. Area of microhemorrhage (defined as less than 5 mm in diameter) in the treatment area can be acceptable but requires the review of the neurosurgeon.\n  * Containing calcifications in the focused ultrasound sonication beam path and system tools cannot tailor the treatment around these calcification spots.\n  * Patients who are deemed to have overly bulky tumor by the PI of the study.\n* The sonication pathway to the tumor involves:\n\n  * More than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp.\n  * Clips, or other non-MRI compatible metallic implanted objects in the skull or the brain, except for shunts.\n* Patients receiving anti-coagulant therapy, or medications known to increase risk of hemorrhage, (e.g., ASA, non-steroidal anti-inflammatory drugs \\[NSAIDs\\], statins). There is no required washout for eligibility assessment, but patients should be off agents for at least 3 days at the time of procedure or until 5 half-lives of the agent, whichever is longer.\n* History of a bleeding disorder, coagulopathy or with a history of clinically significant spontaneous tumor hemorrhage.\n* Cerebral or systemic vasculopathy, including intracranial thrombosis, vascular malformation, cerebral aneurysm, or vasculitis.\n* Immunosuppression (corticosteroids to prevent\u002Ftreat brain edema are permitted).\n* Patients with uncontrolled HIV.\n* Active seizure disorder or epilepsy (clinically significant seizures despite medical treatment) within four weeks prior to first cycle\u002FNaviFUS BBBO procedure captured by history.\n* Known sensitivity to gadolinium-based contrast agents.\n* Known sensitivity to Lumason® ultrasound contrast agent or known hypersensitivity to sulphur hexafluoride microsphere or its components, e.g., polyethylene glycol.\n* Patients unable to fit comfortably into the MRI scanner (generally \\>250 lbs.).\n* Evidence of cranial or systemic infection.","ALL","3 Years","25 Years",{"count":21,"type":22},30,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This is an open-label phase 1 safety and feasibility study evaluating a novel combination therapy for progressive and relapsed diffuse midline glioma (DMG) and other progressive and relapsed high-grade brain tumors. This study combines intravenous nivolumab therapy infused following transient blood-brain barrier opening (BBBO) using low-intensity focused ultrasound with microbubble (LIFU-MB) treatment using NeuroNavigation-Guided Focused Ultrasound (NgFUS).\n\nThere are two groups in this study:\n\n* Group A: Patients with relapsed or progressive diffuse midline glioma in the brainstem\n* Group B: Patients with relapsed or progressive high grade brain tumor that clinically require surgical resection\n\nThe primary outcome is to evaluate the safety and feasibility of 3 cycles of nivolumab with BBB disruption using NgFUS with microbubbles in pediatric patients with progressive or relapsed brainstem DMG or with high grade brain tumors after surgery. Secondary outcomes include preliminary efficacy and immunological effects.",[28,29,30,31,32,33],"Diffuse Midline Glioma or Diffuse Intrinsic Pontine Glioma","High Grade Gliomas","Medulloblastoma Recurrent","Ependymoma Recurrent","Atypical Teratoid\u002FRhabdoid Tumor (ATRT) of the CNS","Brain Tumor Recurrent",[35,36,37,38,39,40,41,42,43],"Focused Ultrasound","Pediatrics","Diffuse Midline Glioma","DMG","Diffuse Intrinsic Pontine Glioma","DIPG","High Grade Glioma","HGG","Nivolumab","NOT_YET_RECRUITING","2026-06-17",{"date":47,"type":48},"2026-06-24","ACTUAL",{"date":50,"type":22},"2026-06-01",{"date":52,"type":22},"2030-12",{"name":54,"class":55},"Children's National Research Institute","OTHER",{"id":57,"slug":58,"hasResults":12,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":4,"eligibilityCriteria":62,"healthyVolunteers":12,"sex":63,"minAge":64,"maxAge":4,"enrollmentInfo":65,"targetDuration":4,"studyType":66,"phases":4,"briefSummary":67,"conditions":68,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},"100546657","navigating-pregnancy-and-parenthood-with-lyme-disease-100546657","NCT06397794","Navigating Pregnancy and Parenthood With Lyme Disease","Mixed Methods Study on Navigating Pregnancy and Parenthood With Lyme Disease","Inclusion Criteria:\n\n* Over 18 years of age and reside in the United States or Canada\n* Diagnosed with acute Lyme disease, PTLDS, and\u002For Chronic Lyme by a health care provider while they were pregnant OR PTLDS\u002FCL prior to becoming pregnant with ongoing symptoms during pregnancy\n\nExclusion Criteria:\n\n* Under 18 years of age\n* Live outside of the United States or Canada\n* Never been diagnosed with Lyme disease by a medical provider\n* Never been pregnant\n* Never given birth to a liveborn infant\n* Previously participated in a qualitative study about their experience with Lyme disease\n* Do not want to agree to having their interviews audio recorded","FEMALE","18 Years",{"count":21,"type":22},"OBSERVATIONAL","This is a mixed methods study exploring the experiences of pregnancy and parenting among participants with Lyme disease. Eligible participants will have been diagnosed with Lyme disease (LD), post-treatment Lyme disease syndrome (PTLDS), and\u002For chronic Lyme (CL) either during or before a prior pregnancy. Participants will complete quantitative surveys on topics such as their medical history, their child(ren)'s development, and demographic information. They will then participate in a qualitative interview where they will be asked about their experiences with pregnancy and with parenting their child(ren) in the context of their condition.",[69,70,71,72,73,74,75],"Lyme Disease","Post Treatment Lyme Disease","Chronic Lyme Disease","Tick-Borne Infections","Tick-Borne Diseases","Pregnancy Complications","Parenting","RECRUITING","2026-06-15",{"date":45,"type":48},{"date":80,"type":48},"2024-03-20",{"date":82,"type":22},"2026-12",{"name":54,"class":55},1,{"id":86,"slug":87,"hasResults":12,"nctId":88,"briefTitle":89,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":12,"sex":17,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":4,"studyType":23,"phases":96,"briefSummary":97,"conditions":98,"keywords":105,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":108,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":84},"100530974","phase-1-immunotherapy-for-malignant-pediatric-brain-tumors-employing-adoptive-cellular-therapy-impact-100530974","NCT06193759","Immunotherapy for Malignant Pediatric Brain Tumors Employing Adoptive Cellular Therapy (IMPACT)","IMPACT","RECIPIENT SCREENING INCLUSION CRITERIA\n\n1. Diagnosis (select one group):\n\n   * Group A: New diagnosis of CNS embryonal tumors: medulloblastoma, embryonal tumor with multilayered rosettes, pineoblastoma, atypical teratoid\u002Frhabdoid tumor, and embryonal tumor, not otherwise specified (NOS).\n   * Group B: Radiographic evidence consistent with recurrent ependymoma, with planned or recent re-resection.\n2. Age:\n\n   * Group A: \\\u003C5 years of age at enrollment\n   * Group B: \\>1 year and \\\u003C30 years of age at enrollment\n3. Tissue:\n\n   o Group A: Availability of sufficient fresh or frozen tumor tissue (approximately 50 mg).\n\n   o Group B: Expectation of sufficient fresh or frozen tumor tissue, in the opinion of study PI or sub-I (based upon radiographic evidence of disease).\n4. Non-pregnant:\n\n   * Group A: N\u002FA\n   * Group B: For female of childbearing potential, must have negative pregnancy test.\n\n   Common to both groups:\n5. Karnofsky or Lansky score of ≥60%.\n6. Adequate organ function, defined below:\n\n   i. ANC ≥750\u002FµL. ii. Absolute lymphocyte count (ALC) \\>500\u002FμL. iii. Platelets ≥75K. iv. Bilirubin ≤3xULN. v. Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) \\\u003C5x upper limit of normal (ULN).\n\n   vi. Serum creatinine ≤1.0 mg\u002FdL or 1.5x ULN for age (whichever is higher). vii. Pulse oximetry \\>90% on room air.\n7. The patient (if ≥18 years old), or the patient's parent(s)\u002Flegal guardian(s) (if the patient is a minor), is capable of providing informed consent.\n8. Patient deemed to be of sufficient size to undergo MNC apheresis for TSA-T generation (Groups A and B) and PBSC rescue (Group A only).\n9. Patient is a surgical candidate for placement of a Rickham reservoir in the opinion of study PI or medically licensed sub-I.\n\nRECIPIENT INCLUSION CRITERIA FOR PROCUREMENT\n\n1\\. Karnofsky or Lansky score of ≥60%. 2. Adequate organ function, defined below: i. ANC ≥750\u002FµL. ii. Absolute lymphocyte count (ALC) \\>500\u002FμL. iii. Platelets ≥75K. iv. Bilirubin ≤3xULN. v. Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) \\\u003C5x upper limit of normal (ULN).\n\nvi. Serum creatinine ≤1.0mg\u002FdL or 1.5x ULN for age (whichever is higher). vii. Pulse oximetry \\>90% on room air. 3. Non-pregnant:\n\n* Group A: N\u002FA\n* Group B: For female of childbearing potential (if applicable), must have negative pregnancy test.\n\nRECIPIENT INCLUSION CRITERIA FOR INITIAL TSA-T ADMINISTRATION AND FOR ADDITIONAL INFUSIONS\n\n1. Applicable to TSA-T infusion #1 only: Group B participants must have histopathologic confirmation of recurrent ependymoma.\n2. Karnofsky or Lansky score of ≥60%.\n3. Adequate organ function, defined as below:\n\n   i. Bilirubin ≤3x ULN. ii. AST and ALT ≤5x ULN. iii. Serum creatinine ≤1.0mg\u002FdL or 1.5x ULN for age (whichever is higher). iv. Pulse oximetry \\>90% on room air.\n4. Applicable to TSA-T Infusion #1 only: Adequate count recovery, as described below, from prior therapies:\n\n   i. Absolute Neutrophil Count (ANC) \\>1000\u002FμL ii. Absolute Lymphocyte Count (ALC) \\>500\u002FμL\n5. Patients must have received their last dose of:\n\n   a. Myelosuppressive chemotherapy (if applicable) ≥14 days prior to TSA-T infusion b. Focal radiation (if applicable) ≥14 days prior to TSA-T infusion c. Craniospinal irradiation (if applicable) ≥28 days prior to TSA-T infusion\n6. Patients must have recovered from all acute effects of prior surgical intervention\u002Fs.\n7. Group B female of childbearing potential or male capable of fathering a child (if applicable): Agree to use contraceptive measures during TSA-T treatment participation through 6 months following last administration of TSA-Ts\n8. Group B female of childbearing potential (if applicable), must have negative pregnancy test.\n9. Neurologic status: Patient must have a stable neurologic exam for 2 weeks, on a stable or decreasing dose of steroids, prior to administration of the first dose of TSA-T cells, and stability for 1 week prior to all subsequent infusions. The exams demonstrating stability must be performed by the study team, although these may occur via telemedicine if necessary. Patient must agree to a brief (\\\u003C72 hours) course of steroids if the PI or medically-licensed sub-I deems it clinically necessary in the context of clinical deterioration.\n10. Presence of a Rickham reservoir and catheter for intracerebroventricular administration of TSA-T therapy, placed \\>7 days prior to TSA-T infusion.\n11. For patients with programmable VP shunts: Able to tolerate the shunt being closed for at least 4 hours, in the opinion of study PI or medically licensed sub-I.\n\nEXCLUSION CRITERIA RECIPIENT SCREENING EXCLUSION CRITERIA\n\n1\\. Patients with uncontrolled infections. 2. Patients with known HIV infection. 3. Group A patients with medulloblastoma of the SHH subtype.\n\nRECIPIENT EXCLUSION CRITERIA FOR PROCUREMENT\n\n1\\. Patients with a fever above 38.0°C. 2. Patients with known HIV infection. 3. Prior immunotherapy with an investigational agent within the 28 days prior to planned date of procurement collection for TSA-T manufacturing.\n\n4\\. Patients who will be unable to tolerate the apheresis procedure, including inability to tolerate placement of apheresis line (if applicable), in the opinion of PI or medically licensed sub-I.\n\n5\\. Patients who have overly bulky tumors on imaging are ineligible. These include the following: i. Tumor with any evidence of herniation or significant midline shift. ii. Tumor with a significant brainstem component. iii. Patients who are deemed to have overly bulky tumor by the PI of the study.\n\nIf, due to complications during apheresis or subsequent manufacturing, procurement is repeated at a later date using peripheral whole blood collection, exclusion criterion #4 does not apply.\n\nRECIPIENT EXCLUSION CRITERIA FOR INITIAL AND SUBSEQUENT TSA-T INFUSIONS\n\n1. Patients with progressive disease based on most recent evaluation (for subsequent infusions).\n\n   a. Patients with progressive disease based on most recent evaluation may receive initial TSA-T infusion but would be ineligible if the tumor is found to be progressive before subsequent infusions\n2. Patients with uncontrolled infections.\n3. Patients who have overly bulky tumors on imaging are ineligible. These include the following:\n\n   i. Tumor with any evidence of herniation or significant midline shift. ii. Tumor with a significant brainstem component. iii. Patients who are deemed to have overly bulky tumor by the PI of the study.\n4. Patients who received ATG, Campath or other immunosuppressive T cell monoclonal antibodies within 28 days of TSA-T infusion.\n5. Patients receiving steroids (e.g., dexamethasone) at a dose of \\>0.05 mg\u002Fkg\u002Fday.\n6. Patients who have non-programmable VP shunts.","1 Year","30 Years",{"count":95,"type":22},12,[25],"This is an open-label phase 1 safety and feasibility study that will employ multi-tumor antigen specific cytotoxic T lymphocytes (TSA-T) directed against proteogenomically determined personalized tumor-specific antigens (TSA) derived from a patient's primary brain tumor tissues. Young patients with embryonal central nervous system (CNS) malignancies typically are unable to receive irradiation due to significant adverse effects and are treated with intensive chemotherapy followed by autologous stem cell rescue; however, despite intensive therapy, many of these patients relapse. In this study, individualized TSA-T cells will be generated against proteogenomically determined tumor-specific antigens after standard of care treatment in children less than 5 years of age with embryonal brain tumors. Correlative biological studies will measure clinical anti-tumor, immunological and biomarker effects.",[99,100,101,102,103,104],"Medulloblastoma, Childhood","Atypical Teratoid\u002FRhabdoid Tumor of CNS","Embryonal Tumor With Multilayered Rosettes","Pineoblastoma","Embryonal Brain Tumor Not Otherwise Specified","Ependymoma",[106,107],"Cellular Therapy","Pediatric Brain Tumors",{"date":45,"type":48},{"date":110,"type":48},"2024-09-20",{"date":112,"type":22},"2032-12-29",{"name":54,"class":55},{"id":115,"slug":116,"hasResults":12,"nctId":117,"briefTitle":118,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":12,"sex":17,"minAge":64,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":66,"phases":4,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":131,"locationsCount":84},"100518163","pregnancy-and-early-neurodevelopmental-outcomes-following-in-utero-lyme-disease-exposure-100518163","NCT06026969","Pregnancy and Early Neurodevelopmental Outcomes Following In Utero Lyme Disease Exposure","Inclusion Criteria:\n\n* English speaker\n* Currently reside in the United States or Canada\n* Meet CDC criteria for: (1) clinical and\u002For laboratory diagnosis of Lyme disease during any stage of current pregnancy, OR (2) clinical diagnosis of PTLDS\u002FChronic Lyme within 3 years of current pregnancy\n* Able to be contacted for follow-up\n\nExclusion Criteria:\n\n* Intellectually unable to comprehend study procedures\n* Health issues or metallic implant that precludes undergoing MRI\n* Incapable of completing study requirements (note: inability to travel to Children's National for in-person follow-up \\[for example, due to bedrest, travel restrictions, or financial inability to travel\\] is NOT an exclusion criterion; any interested and eligible participants requiring \"remote only\" participation will be permitted to join the study and complete all requirements besides in-person follow-up)",{"count":121,"type":22},40,"The purpose of this pilot study is to assess the feasibility of longitudinal neurodevelopmental evaluation of fetuses and infants exposed to Lyme disease in utero. Participants with Lyme disease or Post-Treatment Lyme Disease Syndrome (PTLDS) will be recruited during pregnancy. Pregnancies will be monitored and infant development will be assessed from birth until age 18 months.",[69,124,71,72,74,125],"Post-Treatment Lyme Disease","Child Development",{"date":127,"type":48},"2026-06-16",{"date":129,"type":48},"2023-07-01",{"date":82,"type":22},{"name":54,"class":55},{"id":133,"slug":134,"hasResults":12,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":12,"sex":17,"minAge":139,"maxAge":140,"enrollmentInfo":141,"targetDuration":4,"studyType":23,"phases":143,"briefSummary":145,"conditions":146,"keywords":149,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":84},"100518873","focused-ultrasound-pallidotomy-for-dyskinetic-cerebral-palsy-in-pediatric-and-young-adult-subjects-100518873","NCT06036199","Focused Ultrasound Pallidotomy for Dyskinetic Cerebral Palsy in Pediatric and Young Adult Subjects","Safety and Impact on Quality of Life of Focused Ultrasound Pallidotomy for Dyskinetic Cerebral Palsy in Pediatric and Young Adult Subjects","Inclusion Criteria:\n\n* The treating physician has chosen GPi-DBS or pallidotomy for the treatment of the secondary dystonia caused by cerebral palsy in this patient\n* Patient and\u002For legal representative, if the patient is underaged or not capable to give consent himself, have chosen pallidotomy as treatment\n* The consent to participate in the trial of the underaged patient, if he is capable to understand the study requirements, is required\n* Age at enrolment 8-22 years\n* Diagnosis of secondary dystonia due to cerebral palsy caused by perinatal hypoxic injury\n* Anti-dystonic pharmacotherapy insufficient\n* Stable anti-dystonic medication over the last 30 days\n* Globus pallidus internus (pars posterior) and thalamus (motor part) intact on MRI (not older than 2 years - if possible)\n* No fixed severe skeletal deformations with loss of function, which need immediate orthopaedic surgical intervention\n* Sufficient compliance of the patient or the legal representative if the patient is underaged or not capable to give consent himself to take part in the study\n* Informed consent to take part in the study from patient and\u002For legal representative if the patient is underaged or not capable to give consent himself\n* Patient and\u002For legal representative if the patient is underaged or not capable to give consent himself, understands the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed\n\nExclusion Criteria:\n\n* Patients with known primary (e.g. DYT1) or idiopathic dystonia\n* Severe axial hypotonia with total loss of head control (e.g. absence of control at \"upper thoracic level\" in the SATCo score) (medication effect excluded)\n* Fixed hemi-dystonia\n* Severe spasticity in knee- and elbow-flexors and -extensors (Modified Ashworth Scale \\>3)\n* Fixed severe skeletal contractions with loss of function which require immediate orthopaedic surgical intervention\n* Patients with other severe concurrent neurological disease (e. g. brain tumor, neurodegenerative diseases, trauma etc.)\n* Condition likely to require use of MRI in the future\n* Any intracranial abnormality or medical condition that would contraindicate DBS surgery\n* Any findings in neuropsychological screening assessments that would contraindicate DBS surgery\n* Any current drug and \u002F or alcohol abuse\n* Any history of frequent grand-mal seizures without response to anticonvulsive treatment\n* Any other active implanted device (e.g. Cochlear implant, pacemaker), whether turned on or off, would be allowed provided that they do not interfere with functioning of the device.\n* The presence of DBS leads due the risks of these ferromagnetic devices in the MRI environment.\n* A history of neurostimulation intolerance in any area of the body.\n* Currently on any anticoagulant medications that cannot be discontinued during perioperative period.\n* Any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with survival \\\u003C24 months.\n* Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days; any other trial participation should be approved by the Principal Investigator.\n* A female that is breastfeeding or of childbearing potential with a positive urine pregnancy test or - if a person is sexually active - not using sufficient contraception with a Pearl Index of less than 1% including all forms of hormonal contraception (\"antibaby-pill\", hormonal plaster, NuvaRing®, Implanon®, hormonal depot injections, contraceptive coil), the tubal ligature (female sterilization). Alternatively, the female of child bearing potential is sexually abstinent.\n* Subjects who have contraindications to anesthesia, in the judgment of the attending anesthesiologist\n* Subjects who are unwilling or unable to undergo general anesthesia\n* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data.\n* Minimum head circumference \\\u003C 49cm\n* Skull Density Ratio (SDR) \\\u003C0.40.","8 Years","22 Years",{"count":142,"type":22},10,[144],"NA","The primary objective of the proposed study is to evaluate the safety of ExAblate Transcranial MRgFUS as a tool for creating bilateral or unilateral lesions in the globus pallidus (GPi) in patients with treatment-refractory secondary dystonia due to dyskinetic cerebral palsy",[147,148],"Cerebral Palsy, Dyskinetic","Secondary Dystonia",[150,151],"High intensity focused ultrasound (HIFU)","Pallidotomy","2026-06-09",{"date":154,"type":48},"2026-06-11",{"date":156,"type":48},"2024-01-26",{"date":158,"type":22},"2028-08",{"name":54,"class":55},{"id":161,"slug":162,"hasResults":12,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":166,"eligibilityCriteria":167,"healthyVolunteers":12,"sex":17,"minAge":92,"maxAge":168,"enrollmentInfo":169,"targetDuration":4,"studyType":23,"phases":171,"briefSummary":172,"conditions":173,"keywords":178,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":189},"100606238","phase-1-selective-antigen-specific-t-cells-and-car-t-cells-in-subjects-with-relapsedrefractory-embryonal-tumors-sabre-100606238","NCT07172958","Selective Antigen Specific T Cells and CAR T Cells in Subjects With Relapsed\u002FRefractory Embryonal Tumors (SABRE)","Selective Antigen Specific dTβRII-expressing T Cells and B7-H3 CAR T Cells in Subjects With Relapsed\u002FRefractory Embryonal Tumors (SABRE)","SABRE","Inclusion Criteria:\n\nRecipient Inclusion Criteria for Procurement:\n\n* Diagnosis of relapsed\u002Frefractory rhabdomyosarcoma, Ewing sarcoma, neuroblastoma, or Wilms tumor\n* Refractory disease, residual detectable disease or relapsed disease following available standard of care therapies with known clinical benefit for their specific tumor type, or unable to receive such therapies due to unacceptable toxicity or contraindication\n* Measurable or evaluable disease by imaging, as determined following most recent therapy\n* Age ≥ 1 year and \\\u003C 24 years\n* Weight \\> 10 kg\n* No systemic steroid exposure within 1 week of procurement\n* Karnofsky\u002FLansky score of ≥ 60 (See Appendix 3)\n* Participants of childbearing potential or capable of fathering a child must agree to use effective contraceptive measure\u002Fs (as described in Appendix 5) during study protocol participation through 6 months following the administration of the CAR-TA T cells\n* ANC \\> 500\u002FµL\n* ALC \\> 1000\u002FµL\n* Platelet count \\> 50,000\u002FuL (level can be achieved with transfusion)\n* Bilirubin ≤ 2.5 mg\u002FdL\n* Aspartate aminotransferase (AST)\u002FAlanine transaminase (ALT) ≤ 5x the upper limit of normal for age\n* Serum creatinine Maximum serum creatinine (mg\u002FdL) Age Male Female\n\n  1. to \\\u003C 2 years 0.6 0.6\n  2. to \\\u003C 6 years 0.8 0.8\n\n  6 to \\\u003C 10 years 1 1 10 to \\\u003C 13 years 1.2 1.2 13 to \\\u003C 16 years 1.5 1.2\n\n  ≥ 16 years 1.7 1.4 OR Creatinine clearance or glomerular filtration rate (GFR) ≥ 70 mL\u002Fmin\u002F1.73 m for patients with levels above\n* For FOCBP: Negative pregnancy test\n* Pulse oximetry of \\> 90% on room air\n* Adequate cardiac function defined as: o Shortening fraction of ≥ 27% by echocardiogram, or o Ejection fraction of \\> 50% by echocardiogram or radionuclide angiogram (i.e., MUGA).\n* No acute neurological toxicity \\> grade 1 (with the exception of peripheral sensory neuropathy or controlled seizure disorder on anti-epileptics).\n* The following time frames must have elapsed between prior therapy completion and apheresis cell collection:\n\n  * Myelosuppressive chemotherapy\u002Fimmunomodulatory medications: At least 3 weeks, or 6 weeks if prior nitrosourea.\n  * Hematopoietic growth factors: At least 7 days since the completion of therapy with a growth factor. At least 14 days after receiving pegfilgrastim.\n  * Biological agent, tyrosine kinase inhibitor, targeted agent, metronomic chemotherapy: At least 7 days since the completion of therapy with a biologic agent, tyrosine kinase inhibitor, targeted agent, or metronomic non-myelosuppressive regimen.\n  * Monoclonal antibodies and checkpoint inhibitors: At least 3 weeks or 5 half-lives (whichever is shorter) since the last dose of a monoclonal antibody or checkpoint inhibitor.\n  * Radiotherapy (XRT): At least 3 weeks since XRT, and at least 6 weeks if radiation involved the CNS or lung fields. Exception: There is no time restriction for palliative radiation with minimal bone marrow involvement and the patient has measurable\u002Fevaluable disease outside the radiation port or the site of radiation has documented progression.\n  * Autologous stem cell transplant\u002Finfusion: At least 6 weeks from their infusion after an autologous stem cell infusion following myeloablative therapy. Patients who received an autologous stem cell infusion following non-myeloablative therapy do not have a wash-out period; they are eligible once they meet all other eligibility requirements, including recovery from acute side effects.\n  * Investigational agent: at least 28 days since receiving an investigational agent.\n* Patient or parent\u002Fguardian capable of providing informed consent.\n\nRecipient Inclusion Criteria for CAR-TA T cell product Infusion:\n\n* No systemic steroid exposure within 1 week prior to protocol therapy initiation\n* Karnofsky\u002FLansky score of ≥ 60 (See Appendix 3)\n* ANC \\> 750\u002FuL\n* Platelet count \\> 75,000\u002FuL\n* Bilirubin ≤ 2.5 mg\u002FdL\n* AST\u002FALT ≤ 5x the upper limit of normal for age\n* Serum creatinine Maximum serum creatinine (mg\u002FdL) Age Male Female\n\n  1 to \\\u003C 2 years 0.6 0.6 2 to \\\u003C 6 years 0.8 0.8 6 to \\\u003C 10 years 1 1 10 to \\\u003C 13 years 1.2 1.2 13 to \\\u003C 16 years 1.5 1.2\n\n  ≥ 16 years 1.7 1.4 OR Creatinine clearance or glomerular filtration rate (GFR) ≥ 70 mL\u002Fmin\u002F1.73 m for patients with levels above\n* For FOCBP: Negative pregnancy test\n* Participants of childbearing potential or capable of fathering a child must agree to use effective contraceptive measure\u002Fs (as described in Appendix 5) through 6 months following the administration of the CAR-TA T cells\n* Adequate respiratory function defined as oxygen saturation 90% or higher on room air\n* No acute neurological toxicity \\> grade 1 (with the exception of peripheral sensory neuropathy or controlled seizure disorder on anti-epileptics).\n* Adequate cardiac function defined as:\n\n  * Shortening fraction of ≥ 27% by echocardiogram, or\n  * Ejection fraction of \\> 50% by echocardiogram or radionuclide angiogram\n* The following time frames must have elapsed between completion of prior therapy and the initiation of SABRE protocol therapy:\n\n  * Myelosuppressive chemotherapy: At least 2 weeks from last dose of chemotherapy.\n  * Hematopoietic growth factors: At least 7 days since the completion of therapy with a growth factor. At least 14 days after receiving pegfilgrastim.\n  * Biological agent, tyrosine kinase inhibitor, targeted agent, metronomic chemotherapy: At least 7 days since the completion of therapy with a biologic agent, tyrosine kinase inhibitor, targeted agent, or metronomic non-myelosuppressive regimen.\n  * Monoclonal antibodies and checkpoint inhibitors: At least 3 weeks or 5 half-lives (whichever is shorter) since the last dose of a monoclonal antibody or checkpoint inhibitor.\n  * Radiotherapy (XRT): At least 3 weeks since XRT, and at least 6 weeks if radiation involved CNS or lung fields. Exception: There is no time restriction for palliative radiation with minimal bone marrow involvement and the patient has measurable\u002Fevaluable disease outside the radiation port or the site of radiation has documented progression.\n  * Investigational agent: At least 28 days since receiving an investigational agent.\n* Patient or parent\u002Fguardian capable of providing informed consent.\n\nExclusion Criteria:\n\nRecipient Procurement Exclusion Criteria:\n\n* Patients with known CNS disease.\n* Patients with uncontrolled infection\u002Fs or known HIV infection\n* Pregnant or lactating females.\n* Patients who have undergone previous allogeneic stem cell transplant.\n\nRecipient Exclusion Criteria for CAR-TA T cell product Infusions:\n\n* Patients with uncontrolled infections or known HIV infection.\n* Pregnant or lactating females\n* Whole lung\u002Fmediastinal radiation within 12 weeks\n* Clinically significant systemic illness or medical condition likely to interfere with assessment of safety or efficacy","23 Years",{"count":170,"type":22},18,[25],"This is a phase I dose-escalation study to determine the safety and feasibility of autologous CAR-TA T cells (B7-H3 CAR+ T cells administered with DNR-PRAME Tumor Antigen-specific T cells) following lymphodepleting chemotherapy in participants with relapsed\u002Frefractory rhabdomyosarcoma, Ewing sarcoma, neuroblastoma and Wilms tumor.\n\nPatients will be enrolled to one of three planned dose levels with B7-H3 CAR T cell dose determined based on the percentage of B7-H3 transduced cells (B7-H3+ population of cells), and dTBRII-transduced PRAME TA-specific T cell dose based on the total cell population. Both doses will be based on the recipient's body weight.\n\nThe safety of the CAR-TA T cell product will be evaluated and the maximum tolerated dose (MTD) will be determined. The safety endpoint will be assessed by monitoring for dose limiting toxicities for 28 days following CAR-TA T cell administration.",[174,175,176,177],"Rhabdomyosarcoma","Ewing Sarcoma","Neuroblastoma","Wilms Tumor",[179,180],"CAR T Therapy for Embryonal tumors","T cell Therapy for Embryonal tumors","2026-05-20",{"date":183,"type":48},"2026-05-22",{"date":185,"type":48},"2026-01-27",{"date":187,"type":22},"2038-12",{"name":54,"class":55},2,{"id":191,"slug":192,"hasResults":12,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":196,"eligibilityCriteria":197,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":198,"enrollmentInfo":199,"targetDuration":4,"studyType":23,"phases":200,"briefSummary":202,"conditions":203,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":84},"100594313","early-phase-1-a-phase-01-study-of-cdna-for-tp53-checkpoint-inhibition-and-radiation-in-children-with-recurrent-progressive-or-refractory-cns-malignancies-100594313","NCT07017816","A Phase 0\u002F1 Study of cDNA for TP53, Checkpoint Inhibition and Radiation in Children With Recurrent, Progressive or Refractory CNS Malignancies.","JACOB: Joint Administration of cDNA for TP53, checkpOint Inhibition and Boost\u002FHypofractionated Radiation. A Phase 0\u002F1 Study in Children With Recurrent, Progressive or Refractory CNS Malignancies.","JACOB","Inclusion Criteria:\n\n* Tumor\n\n  a. Patients must have a recurrent, progressive, or refractory CNS malignancy for which there are not known curative options.\n\n  i. Medulloblastoma, ATRT, High grade gliomas, pineoblastomas, embryonal tumors NOS, CNS sarcomas, ependymomas, other high-grade malignancies that failed first line therapies.\n\nii. Patients should have received radiation for standard up-front therapy. iii. Patients must have received at least one line of standard of care treatment without limitation to the number of treatments received. b. Evidence of clinical and\u002For radiological progressive disease as defined by RAPNO criteria.\n\nc. Patients with metastatic disease are eligible d. Patients must have available archival (formalin-fixed paraffin embedded) or fresh tumor tissue for correlative studies.\n\n* Patient Characteristics a. The first 3 patients will be \\>7 years old to \\\u003C22 years old i. Following initial successful treatment of the first 3 patients: Patients must be ≥3yrs and \\\u003C22 years of age.\n\n  b. Must have recovered from all surgical interventions prior to the start of the radiation and maintenance phases c. Patients must have a BSA of 0.6m2 or more to be enrolled. 3. Previous treatment\n  1. Patients must have recovered from the acute effects of prior therapy. Adverse events resulting from prior surgical intervention will not be an ineligibility criterion.\n  2. Chemotherapy: Patients must have received their last dose of known chemotherapy at least two (2) weeks prior to receipt of SGT-53.\n  3. Biologic therapy: Patients must have received their last dose of biological agent \\>7 days prior to receipt of SGT-53.\n  4. Radiation therapy: Patients must be deemed to be a reasonable candidate for hypofractionated irradiation from a clinical standard of care perspective.\n\n  i. At least 3 months from craniospinal radiation therapy, ii. Other substantial bone marrow irradiation ≥6 weeks prior to enrollment, iii. Local palliative XRT (small volume) ≥2 weeks. iv. if progressive disease is documented by radiological evidence of disease in areas not previously radiated, no minimum time required.\n\n  e. Corticosteroids: Patients who are receiving dexamethasone or other corticosteroids must be on a stable or decreasing dose for at least one (1) week prior to enrollment. There will be a maximum allowable steroid dose of 0.5mg\u002Fm2\u002Fday dexamethasone equivalents f. Growth factors: Patients must have received their last dose of any short acting growth factor at least one week prior to treatment, for long acting or pegylated growth factors, the last dose must be at least two (2) weeks prior to start of treatment.\n\n  4\\. Neurologic Status\n\n  a. Patients should be at their neurological baseline for a minimum of one week prior to enrollment.\n\n  5\\. Performance Status\n\n  a. Performance status (KarnofskyPS for \\>16yrs, or Lansky PS for \\\u003C16yrs) assessed within two weeks must be \\>50.\n\n  i. Patients who are unable to walk because of neurologic deficits, but who are up in a wheelchair, will be considered ambulatory for assessing the performance score.\n\n  6\\. Organ Function - Patients must have normal organ and marrow function as defined below:\n  1. Absolute neutrophil count \\>750\u002Ful\n  2. Platelets ≥75,000\u002Ful\n  3. Hemoglobin ≥8g\u002FdL (may be supported with transfusion)\n  4. Total bilirubin ≤1.5x ULN\n  5. ALT\u002FAST ≤3x ULN\n  6. Serum albumin ≥2g\u002FdL\n  7. Normal cardiac function defined as ejection fraction within normal limits for age and gender\n  8. a serum creatinine based on age\u002Fgender as below or a creatinine clearance or serum GFR ≥ 70ml\u002Fmin\u002F1.73m2: Serum Creatinine for age\u002Fsex Age Maximum Serum Creatinine (mg\u002FdL) Male Female\n\n     1. \\\u003C2 years 0.6 0.6\n     2. \\\u003C6 years 0.8 0.8\n\n     6-\\\u003C10 years 1 1 10-\\\u003C13 years 1.2 1.2 13- \\\u003C16 years 1.5 1.4 \\> 16 years 1.7 1.4 The threshold creatinine values in this table were adapted from the Schwartz formula for estimating GFR (Schwartz et al. J. Peds 106:.522, 1985) utilizing child length and stature data published by the CDC.\n\n     7\\. Pregnancy prevention- all patients of childbearing or child fathering potential must be willing to use an acceptable form of birth control while being treated on this study and at least 5 months after receiving the last study treatment.\n\n     8\\. Pregnancy status: Female patients must not be pregnant or nursing. Female patients of reproductive potential must also have a negative serum pregnancy test at the time of enrollment.\n\n     9\\. Informed Consent - Patient and\u002For guardian have the ability to understand and the willingness to sign a written informed consent document according to institutional guidelines.\n\n     Exclusion Criteria:\n* 1\\. Low-grade-glioma, craniopharyngioma, and other non-malignant CNS tumors are excluded.\n\n  2\\. Patients with diagnosis of diffuse midline gliomas (DMGs) are excluded. 3. Patients with any clinically significant unrelated systemic illness (serious infection or significant cardiac, pulmonary, hepatic, or other organ dysfunction) that is likely to interfere with ability to tolerate study therapy or study procedure results.\n\n  4\\. Patients with pre-existing cardiac dysfunction defined as baseline EF of less than 35% 5. Patients with pre-existing pulmonary fibrosis, interstitial lung disease, and clinically significant pulmonary lung disease.\n\n  6\\. Patients who are receiving any other investigational drug therapy 7. Patients who in the opinion of the investigator cannot adhere to protocol requirements 8. Patients with history of autoimmune diseases that required treatment in the last 2 years are not eligible. Asymptomatic laboratory abnormalities (e.g. ANA, rheumatoid factor, altered thyroid function studies) will not render a patient ineligible in the absence of a diagnosis of an autoimmune disorder. Replacement therapy (e.g. thyroxine, insulin or physiologic corticosteroid replacement therapy) is not considered a form of systemic treatment.\n\n  9\\. Patients who have received a live vaccine within 30 days of start of study treatment are not eligible.\n\n  10\\. Patients with known HIV\u002FAIDS or acute\u002Fchronic Hepatitis B or C are excluded.\n\n  11\\. Patients who are prohibited from receiving radiation therapy (reached maximum lifetime dose) are not eligible.","21 Years",{"count":170,"type":22},[201],"EARLY_PHASE1","This clinical trial is studying a drug called SGT-53 along with radiation and another drug called Nivolumab. It's for children with brain tumors that have come back, gotten worse, or didn't get better with earlier treatments. The main questions it aims to answer are:\n\nWhat is the right dose of SGT-53 that children can safely receive when it is used with radiation and Nivolumab? This dose will be used in the second phase of the trial.\n\nWhat side effects are there of SGT-53 when it is used with radiation and Nivolumab?\n\nHow does SGT-53 move through the body when given with radiation and Nivolumab?\n\nHow much of the SGT-53 drug is found in the tumor tissue? This will be tested in a small group of patients?\n\nParticipants will:\n\nFor the first treatment cycle:\n\nGet SGT-53 twice per week Get Nivolumab every 2 weeks Receive radiation therapy during week 2\n\nFor Cycles 2-6:\n\nGet SGT-53 once per week during even cycles and twice per week during odd cycles Get Nivolumab every 2 weeks For Cycles 7+ Get both SGT-53 and Nivolumab every 2 weeks In the phase 0 part of the study, 4 participants will have genetic testing performed on their tumor tissue after receiving SGT-53. These samples will be compared to another sample taken from the skin.",[204,30,205,102,206,31,29],"CNS Malignancies","ATRT Recurrent","Embryonal Neoplasm","2026-04-24",{"date":209,"type":48},"2026-04-29",{"date":211,"type":48},"2025-12-16",{"date":213,"type":22},"2028-05-01",{"name":54,"class":55},{"id":216,"slug":217,"hasResults":12,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":4,"eligibilityCriteria":221,"healthyVolunteers":12,"sex":17,"minAge":222,"maxAge":198,"enrollmentInfo":223,"targetDuration":4,"studyType":66,"phases":4,"briefSummary":225,"conditions":226,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":84},"100521102","therapeutic-endpoint-in-pediatric-ibd-conditions-100521102","NCT06065228","Therapeutic Endpoint in Pediatric IBD Conditions","Development of a Therapeutic Endpoint in Pediatric IBD Conditions","Inclusion Criteria:\n\n* Male or female ≥ 6 years of age at screening.\n* Documentation of an IBD diagnosis as evidenced by history\n\nExclusion Criteria:\n\n* Documented history of eye disease precluding pupillometry\n* Patients who are unwilling or unable to participate due to developmental delays or ongoing psychological diagnoses.","6 Years",{"count":224,"type":22},60,"The purpose of this clinical study is the development of physiologic endpoint of inflammation in pediatric patients diagnosed with inflammatory bowel disease (IBD), specifically subtypes Crohn's disease (CD) and ulcerative colitis (UC). The novel medical device evaluates the patient's sensory response to each of the three sensory nerve fiber types. Data from the device provides an assessment of disease activity and a more precise approach to treatment.",[227,228,229],"Inflammatory Bowel Diseases","Colitis, Ulcerative","Crohn Disease","2026-04-03",{"date":232,"type":48},"2026-04-08",{"date":234,"type":48},"2023-11-27",{"date":236,"type":22},"2027-12",{"name":54,"class":55},{"id":239,"slug":240,"hasResults":12,"nctId":241,"briefTitle":242,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":12,"sex":17,"minAge":244,"maxAge":198,"enrollmentInfo":245,"targetDuration":4,"studyType":66,"phases":4,"briefSummary":247,"conditions":248,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":84},"100426473","development-of-a-therapeutic-endpoint-in-pediatric-rheumatologic-conditions-100426473","NCT04833465","Development of a Therapeutic Endpoint in Pediatric Rheumatologic Conditions","Inclusion Criteria:\n\nIn order to be eligible for inclusion in the study, an individual must meet all of the following criteria:\n\n* Male or female ≥ 5 years of age at screening.\n* Documentation of a JIA, SLE or FM diagnosis as evidenced by history\n\nExclusion Criteria:\n\nAny individual who meets any of the following criteria will be excluded from participation in this study:\n\n• Documented history of eye disease precluding pupillometry","5 Years",{"count":246,"type":22},90,"The overarching goal of this study is the development of a physiologic endpoint of pain and treatment effect in three distinct rheumatology populations. This would enable objective assessment of pain and treatment in these populations and enable a much more precise approach to treatment. Such an endpoint stands to significantly improve outcomes in these patients by eliminating the need for a trial-and-error approach to treatment. This is a single site observational study that aims to collect initial pilot data in three distinct patient groups. As this is observational, there is no randomization or blinding in the study. Patients will be followed for a period of one year after enrollment. Baseline measurements will be taken at the time of enrollment, and at each subsequent standard of care clinic visit as feasible, for a period of one year. As this is an observational study, there will be no change to the treatment for any patient due to research activities. The primary objective of this study is the characterization of the nociceptive index in three pediatric rheumatology populations. The secondary objective is the characterization of the nociceptive index in these populations in response to standard of care interventions. This is necessary to demonstrate the ability of this approach to serve as an endpoint of treatment effect.",[249,250,251],"Juvenile Idiopathic Arthritis","Systemic Lupus Erythematosus","Fibromyalgia",{"date":253,"type":48},"2026-04-06",{"date":255,"type":48},"2021-07-16",{"date":257,"type":22},"2027-04",{"name":54,"class":55},{"id":260,"slug":261,"hasResults":12,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":4,"eligibilityCriteria":265,"healthyVolunteers":266,"sex":17,"minAge":222,"maxAge":64,"enrollmentInfo":267,"targetDuration":4,"studyType":66,"phases":4,"briefSummary":268,"conditions":269,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":271,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":84},"100422910","physiologic-measure-of-vipn-100422910","NCT04786977","Physiologic Measure of VIPN","Development of a Physiologic Measure of Vincristine Induced Peripheral Neuropathy in Children and Adolescents","Inclusion Criteria:\n\n* 6-18 years of age at the start of the study, are receiving vincristine in DI (clinical study population) and are willing and able to provide informed consent or assent to study participation.\n\nExclusion Criteria:\n\n* have eye pathology which precludes pupillometry, are hemodynamically unstable, or are pregnant.",true,{"count":121,"type":22},"The purpose of this study is the development of a physiologic endpoint using a novel technology that would provide an objective, easy to use and more sensitive assessment of VIPN in children and adolescents. The ability to more easily detect and monitor VIPN, even before it is clinically evident, would facilitate optimizing the dosing of vincristine for maximal disease response while minimizing the risk of lifelong functional deficits affecting quality of life. This approach would also enable the development of specific therapies to minimize or eliminate the occurrence of VIPN in children and adolescents. This is a single site study that aims to develop a novel device to evaluate and characterize vincristine-induced neuropathic pain. The investigators will enroll patients with ALL following the Delayed Intensification (DI) phase of treatment. At each study visit, the investigators will evaluate the nPRD as well as the TNS-PV. The nPRD will inform the neuropathy index which will be used to compare to the TNS-PV. We anticipate a correlation between the two.",[270],"Chemotherapy-induced Peripheral Neuropathy",{"date":253,"type":48},{"date":273,"type":48},"2021-09-20",{"date":275,"type":22},"2027-05-01",{"name":54,"class":55},{"id":278,"slug":279,"hasResults":12,"nctId":280,"briefTitle":281,"officialTitle":281,"acronym":282,"eligibilityCriteria":283,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":284,"enrollmentInfo":285,"targetDuration":287,"studyType":66,"phases":4,"briefSummary":288,"conditions":289,"keywords":294,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":142},"100492878","international-rare-brain-tumor-registry-100492878","NCT05697874","International Rare Brain Tumor Registry","IRBTR","Inclusion Criteria:\n\n* Patients with a known or suspected CNS Sarcoma.\n* Patients with a known or suspected BCOR-altered brain tumor\n* Patients with a known or suspected Astroblastoma\u002FNM-1 altered brain tumor\n* Patients with known or suspected histologically ambiguous\u002Funclassifiable brain tumor\n* Patients with a known or suspected rare brain tumor.\n* Signed informed consent by patient\u002F parent or guardian (assent where applicable) to participate in the study.\n\nExclusion Criteria:\n\n* The patient has an extra-CNS primary tumor.\n* The patient is older than 46 years of age at diagnosis.\n* The patient or family is not willing to participate or does not sign informed consent.","45 Years",{"count":286,"type":22},5800,"10 Years","The objective of the International Rare Brain Tumor Registry (IRBTR) is to better understand rare brain tumors through the collection of biospecimens and matched clinical data of children, adolescents, and young adult patients diagnosed with rare brain tumors.",[290,291,292,293],"Astroblastoma","BCOR ITD Sarcoma","CNS Sarcoma","Unclassified Tumor, Malignant",[295,296,297,298,299],"Rare Brain Tumor","Pediatric Brain Tumor Registry","Unclassifiable tumor","Pediatric Neuro-Oncology","Rare Disease","2026-03-26",{"date":302,"type":48},"2026-03-31",{"date":304,"type":48},"2023-01-01",{"date":306,"type":22},"2033-12",{"name":54,"class":55},{"id":309,"slug":310,"hasResults":12,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":4,"eligibilityCriteria":314,"healthyVolunteers":266,"sex":17,"minAge":315,"maxAge":198,"enrollmentInfo":316,"targetDuration":4,"studyType":23,"phases":318,"briefSummary":319,"conditions":320,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":84},"100391122","health-information-technology-to-reduce-disparities-in-adolescent-health-outcomes-a-pragmatic-trial-100391122","NCT04372875","Health Information Technology to Reduce Disparities in Adolescent Health Outcomes: A Pragmatic Trial","Leveraging Health Information Technology to Reduce Health Disparities in Adolescent Health Outcomes: A Patient-Centered Approach","Inclusion Criteria:\n\n* Adolescents aged 15-21 years seeking care in the emergency department\n\nExclusion Criteria:\n\n* Patients will be excluded if unable to understand English, are critically ill, cognitively impaired, or otherwise unable to provide consent for completion of the sexual health survey (SHS) and STI screening.","15 Years",{"count":317,"type":22},18500,[144],"We will compare differences in sexually transmitted infection (STI) detection rates between sexual health survey (SHS)-derived electronic clinical decision support (CDS) versus usual care (e.g. no provision of CDS) using an interrupted time series design. We hypothesize that population-based STI detection rates will be higher when SHS-derived electronic CDS is provided compared to usual care. Secondary analysis will include a comparison of STI detection rates by sexual risk strata (high risk vs. at risk) and race\u002Fethnicity.",[321],"Sexually Transmitted Diseases","2026-03-16",{"date":324,"type":48},"2026-03-18",{"date":326,"type":48},"2023-03-08",{"date":328,"type":22},"2027-01-15",{"name":54,"class":55},{"id":331,"slug":332,"hasResults":12,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":4,"eligibilityCriteria":336,"healthyVolunteers":12,"sex":17,"minAge":222,"maxAge":337,"enrollmentInfo":338,"targetDuration":4,"studyType":23,"phases":339,"briefSummary":340,"conditions":341,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":84},"100457607","phase-1-multi-tumor-associated-antigen-specific-t-lymphocytes-to-treat-patients-with-high-risk-solid-tumors-100457607","NCT05238792","Multi Tumor-Associated Antigen-Specific T Lymphocytes to Treat Patients With High Risk Solid Tumors","Phase I Research Study Utilizing Allogeneic Multi Tumor-Associated Antigen-Specific T Lymphocytes to Advance the Care of Patients With High-Risk Solid Tumors","Inclusion Criteria:\n\nPARTICIPANT INCLUSION CRITERIA\n\nRECIPIENT SCREENING INCLUSION CRITERIA\n\n* Diagnosis of high-risk solid tumors known to express at least 2 targeted antigens by either histology or historical reference: Ewing sarcoma, Wilms tumor, neuroblastoma, rhabdomyosarcoma, soft tissue sarcoma, and osteosarcoma.\n* HLA type and match through at least one allele with antigen-specific activity.\n* Refractory disease, residual detectable disease following conventional therapy or relapsed disease.\n* Arm A: age ≥18 years and \\\u003C70 years\n* Arm B: age ≥6 years to \\\u003C18 years\n* Patient or parent\u002Fguardian capable of providing informed consent.\n\nRECIPIENT INCLUSION CRITERIA FOR INITIAL TAA-T ADMINISTRATION AND FOR SUBSEQUENT INFUSION\n\n* No systemic steroid exposure within 1 week of TAA-T infusion.\n* Karnofsky\u002FLansky score of ≥50% (see Appendix 4).\n* Left ventricular ejection fraction (LVEF) \\>50% or left ventricular systolic dysfunction (LVSD) \\>27% if history of total body irradiation (TBI) (may be performed within the last 6 months).\n* Hemoglobin \\>7.0 g\u002FdL (level can be achieved with transfusion).\n* Bilirubin ≤2.5 mg\u002FdL.\n* Aspartate transaminase (AST)\u002FAlanine transaminase (ALT) ≤5 x the upper limit of normal for age.\n* Serum creatinine \\\u003C1.0 mg\u002FdL or 2x the upper limit of normal for age (whichever is higher).\n* Pulse oximetry of \\>90% on room air.\n* Negative pregnancy test in female patient of childbearing age.\n* Agree to use contraceptive measures during study protocol participation (when age appropriate).\n* Patients receiving lymphodepleting chemotherapy must have:\n\n  * Absolute neutrophil count (ANC) \\>1000 \u002Ful.\n  * Platelet count \\>75,000 \u002Ful.\n\nExclusion Criteria:\n\nPARTICIPANT EXCLUSION CRITERIA RECIPIENT SCREENING EXCLUSION CRITERIA\n\n* Patients with known human immunodeficiency virus (HIV) infection.\n* Pregnant or lactating females.\n* Patients who have undergone previous allogeneic stem cell transplant.\n* Patients who have undergone previous autologous stem cell transplant within the past 60 days.\n\nRECIPIENT EXCLUSION CRITERIA FOR INITIAL AND SUBSEQUENT TAA-T INFUSION\n\n* Patients with uncontrolled infections. Uncontrolled infections are defined as bacterial, fungal, or viral infections with either clinical signs of worsening despite standard therapy. Progressing infection is defined as hemodynamic instability, worsening physical signs, or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.\n\n  * For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection within 7 days prior to TAA-T infusion.\n  * For fungal infections, patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection within 7 days prior to TAA-T infusion.\n* Patients who received ATG, Campath or other immunosuppressive T cell monoclonal antibodies within 28 days prior to TAA-T infusion.\n* For patients receiving lymphodepleting chemotherapy: exposure to chemotherapy or immunomodulatory medications within the last 2 weeks prior to treatment.\n* Pregnant or lactating females.","70 Years",{"count":5,"type":22},[25],"This is a phase I dose-escalation study to evaluate the safety of partially human leukocyte antigen (HLA)-matched multi tumor-associated antigen-specific T cell (TAA-T) therapy for patients with high-risk solid tumors due to the presence of refractory, relapsed and\u002For minimal residual detectable disease following conventional therapy. Conventional therapy may include chemotherapy, surgery, radiation, autologous stem cell transplant, or targeted therapy.",[342],"Solid Tumor","2026-03-11",{"date":345,"type":48},"2026-03-12",{"date":347,"type":48},"2021-11-17",{"date":349,"type":22},"2029-10",{"name":54,"class":55},{"id":352,"slug":353,"hasResults":12,"nctId":354,"briefTitle":355,"officialTitle":355,"acronym":356,"eligibilityCriteria":357,"healthyVolunteers":12,"sex":17,"minAge":358,"maxAge":359,"enrollmentInfo":360,"targetDuration":4,"studyType":23,"phases":362,"briefSummary":363,"conditions":364,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":366,"startDateStruct":367,"completionDateStruct":369,"leadSponsor":371,"locationsCount":189},"100450097","phase-1-t-cell-therapy-opposing-novel-covid-19-infection-in-immunocompromised-patients-100450097","NCT05141058","T Cell Therapy Opposing Novel COVID-19 Infection in Immunocompromised Patients","TONI","Inclusion Criteria:\n\nParticipant Inclusion Criteria for CST Infusion:\n\n1. For recipient of CSTs derived from an HSCT donor under Arm A:\n\n   a. Patients aged ≥18 years and \\\u003C80 years who were recipients of prior myeloablative or non-myeloablative allogeneic HSCT using either bone marrow or peripheral blood stem cells or single or double cord blood ≥28 days and \\\u003C4 months ago who are at risk of SARS-CoV-2 infection.\n2. For recipient of CSTs derived from an HSCT donor under Arms B and C:\n\n   a. Patients aged ≥2 years and \\\u003C18 years who were recipients of prior myeloablative or non-myeloablative allogeneic HSCT using either bone marrow or peripheral blood stem cells or single or double cord blood ≥28 days and \\\u003C4 months ago who are at risk of SARS-CoV-2 infection.\n3. Have evidence of primary engraftment following HSCT (defined by ANC ≥500\u002Fmm3 for three consecutive measurements on different days, respectively)\n4. Participants receiving calcineurin inhibitors for treatment of GVHD, or for other reasons, should not have any dosage changes within 7 days prior to infusion\\*\\*\n\n   a. For patients receiving steroids, dosage must have been tapered to \\\u003C0.5 mg\u002Fkg\u002Fday of prednisone (or equivalent) at least 7 days prior to infusion.\n5. Karnofsky\u002FLansky score \\>70.\n6. ≥2 years to \\\u003C80 years of age at enrollment.\n7. Absolute neutrophil count (ANC) ≥500\u002Ful.\n8. Hemoglobin ≥8.0g\u002Fdl (level can be achieved with transfusion).\n9. Platelets ≥20 K\u002Ful (level can be achieved with transfusion)\\*.\n10. Bilirubin ≤2x upper limit normal.\n11. Aspartate transaminase (AST) ≤2.5x upper limit of normal.\n12. Alanine transaminase (ALT) ≤2.5x upper limit of normal.\n13. Estimated GFR \\>60mL\u002Fmin\u002F1.73m2 (calculated per institutional standards).\n14. Pulse oximetry of ≥92% on room air for at least 7 days prior to infusion.\n15. Age appropriate mean arterial pressure without the use of vasopressors.\n16. Negative pregnancy test in female participant of childbearing potential.\n17. Male and female participants of childbearing potential must use highly effective birth control measures or practice abstinence for a minimum of 6 months after receiving study therapy\n18. Written informed consent and\u002For signed assent line from participant, parent or guardian.\n\nDonor Inclusion Criteria:\n\n1. Donors for allogeneic (i.e. HLA matched or mismatched related or unrelated) stem cell transplants who have fulfilled eligibility as per FDA regulations outlined in 21 Code of Federal Regulations (CFR) 1271 subpart C. This includes that donors have been deemed in good health by donor physician based on physical examination and laboratory testing. If a donor has been chosen for the transplant based on urgent medical need that same donor will also be used for CST generation provided that there are no new reasons for ineligibility since the stem cell collection.\n2. Donor or guardian of pediatric donor capable of providing informed consent.\n3. 2 to 80 years of age.\n4. Female donors of childbearing potential must have a negative pregnancy test.\n\nExclusion Criteria:\n\nParticipants Exclusion Criteria for CST Infusion:\n\n1. Participants receiving biological or immunosuppressive monoclonal antibodies targeting T cells within 28 days prior to CST infusion, including ATG, Alemtuzumab, Basiliximab, Tociluzimab, Brentuximab, or other medications under this category as determined by the investigators.\n\n   a. If alemtuzumab has been received within 6 weeks prior to CST infusion, plasma levels should be obtained to ensure drug clearance (≤0.16 pg\u002Fml).\n2. Participants who have received donor lymphocyte infusion (DLI), chimeric antigen receptor T cell infusion, or other experimental cellular therapies within 28 days prior to CST infusion.\n3. Participants who have received ruxolitinib or other JAK inhibitors within 7 days prior to CST infusion.\n4. Participants with uncontrolled or progressing infections or active infections causing fever (temperature ≥38.1°C). Uncontrolled infections are defined as bacterial, fungal, or viral infections (including HIV and Hepatitis B and C) with either clinical signs of worsening despite standard therapy that may be attributed to the uncontrolled infection. Progressing infection is defined as hemodynamic instability, worsening physical signs, or radiographic findings attributable to infection.\n\n   1. For bacterial infections, participants must be receiving definitive therapy and have no signs of progressing infection within 7 days prior to CST infusion.\n   2. For fungal infections, participants must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection within 7 days prior to CST infusion.\n5. Participants with unexplained fever (temperature ≥38.1°C) within 7 days prior to CST infusion.\n6. Participants with evidence of active SARS-CoV-2 infection based on SARS-CoV-2 RT-PCR positivity.\n7. Participants with hypotension (mean arterial pressure \\\u003C50mmHg in participants \\\u003C5 years of age, \\\u003C55 mmHg in participants ≥5 and \\\u003C14 years of age or \\\u003C60 mmHg in participants ≥14 years of age).\n8. Participants with pulse pressure \\>40 mmHg.\n9. Participants with respiratory rate \\>20 breaths per minute.\n10. Participants with heart rate ≥140 beats per minute.\n11. Participants with uncontrolled hypertension as defined by systolic blood pressure \\>99th percentile for age (participants \\\u003C18 years), and systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg (participants ≥18 years).\n12. Participants with metabolic instability.\n13. Pediatric participants with modified Ross heart failure Class II disease and adult participants with NYHA Class II disease.\n14. Participants with advanced pulmonary disease as defined by requirement for supplemental oxygen or positive pressure ventilation due to pulmonary disease. (This includes participants with active interstitial lung disease (ILD)\u002Fpneumonitis, advanced pulmonary disease, a history of ILD\u002Fpneumonitis requiring treatment with systemic steroids or a baseline oxygen requirement).\n15. Participants with neurological or psychiatric disorders that would, in the opinion of the investigators, place them at increased risk of harm, impact the investigator's abilities to screen for adverse events in the subject, or impair the subject's ability to provide informed consent.\n16. Participants receiving checkpoint inhibitors within the previous 3 months prior to CST infusion, including nivolumimab, pembroluzimab, or other related medications.\n17. Participants with proven or suspected MIS (in both adults and children) based on the CDC definition and investigator judgement.\n18. Participants who are breastfeeding.\n19. Participants who have received live vaccines within 30 days, or any SARS-CoV-2 vaccine in the past 28 days prior to enrollment.\n20. Participants with any other unrelated medical conditions that would impact the participant's safety in the opinions of the investigators.\n21. Participants anticipated to need a blood transfusion within 48 hours of CST infusion.\n22. Participants unwilling to utilize effective contraception during the study period (if applicable)\n\nDonor Exclusion Criteria:\n\n1. Donation of cells would pose a physical or psychological risk to the donor.\n2. Prior or current complicated course of COVID-19, including but not limited to MIS, CRS, or thromboembolic complications based on investigator judgement.","2 Years","80 Years",{"count":361,"type":22},24,[25],"This is an open label, phase I dose-escalation study to evaluate the safety of coronavirus-specific T cell (CST) therapy for prevention of SARS-CoV-2 infection in immunocompromised patients following hematopoietic stem cell transplantation (HSCT).\n\nParticipants will receive donor-derived CSTs for prevention of SARS-CoV-2 infection after HSCT (≥28 days and \\\u003C4 months after HSCT).\n\nIn this dose escalation trial, three doses (1x107\u002Fm2, 2x107\u002Fm2, and 4x107\u002Fm2) will be tested for safety, with study arms for adult (≥18 years of age and \\\u003C80 years) HSCT recipients (Arm A) and two arms for pediatric (≥12 years of age and \\\u003C18 years; ≥2 years and \\\u003C12 years) HSCT recipients (Arm B and Arm C, respectively), and defined dose escalations in each study arm. The study agent will be assessed for safety (stopping rules defined) and antiviral activity.",[365],"SARS-CoV-2 Infection",{"date":345,"type":48},{"date":368,"type":48},"2021-10-19",{"date":370,"type":22},"2029-12-15",{"name":54,"class":55},{"id":373,"slug":374,"hasResults":12,"nctId":375,"briefTitle":376,"officialTitle":377,"acronym":4,"eligibilityCriteria":378,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":379,"targetDuration":4,"studyType":23,"phases":380,"briefSummary":381,"conditions":382,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":386,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":392,"locationsCount":84},"100564039","the-exhale-study-treating-maternal-depression-in-an-urban-pediatric-asthma-clinic-100564039","NCT06623981","The Exhale Study: Treating Maternal Depression in an Urban Pediatric Asthma Clinic","Testing the Effectiveness and Implementation of an Evidence-Based Maternal Depression Treatment in an Urban Pediatric Asthma Clinic","Inclusion Criteria:\n\nMaternal:\n\n* Primary caregiver of the child with asthma seen at the community-based asthma clinic\n* Female (self-identified)\n* Black (self-identified)\n* ≥ 18 years of age\n* English-speaking\n* PHQ-9 ≥ 8 during standardized screening at the child with asthma's clinic visit\n\nChild:\n\n* \\\u003C18 years old for the duration of the 6-month study period\n* Publicly insured\n* Physician-diagnosed persistent asthma\n\nExclusion Criteria:\n\nMaternal:\n\n* Acutely suicidal (high risk on the C-SSRS at child's asthma clinic visit)\n* Bipolar disorder or mania\n* Schizophrenia\n* Current substance abuse\u002Fdependence\n* Current serious physical intimate partner violence (IPV)\n* Lack of capacity to meaningfully participate in study procedures, as assessed by study staff during screening\n\nChild:\n\n* Significant medical co-morbidity (e.g., disorders of the cardiorespiratory system, significant developmental delay, diabetes, seizure disorder, and sickle cell disease)\n* Enrolled in another intervention with a behavioral component and\u002For novel asthma therapeutics",{"count":224,"type":22},[144],"The goal of this clinical trial is to test the effectiveness and implementation of delivering Enhanced Brief Interpersonal Psychotherapy (IPT-B), an evidence-based maternal depression treatment, to mothers of children under the age of 18 in an urban pediatric asthma clinic. Researchers will compare Enhanced IPT-B and supplemented usual care (brief care coordination). The main questions the trial aims to answer are:\n\n1. Does Enhanced IPT-B decrease maternal depressive symptoms?\n2. Does Enhanced IPT-B improve child asthma management and health outcomes (exacerbations, symptoms, control)?\n3. What are the preliminary implementation outcomes of delivering Enhanced IPT-B in an urban pediatric asthma clinic?",[383,384],"Asthma in Children","Depression","2026-02-23",{"date":387,"type":48},"2026-02-24",{"date":389,"type":48},"2024-10-15",{"date":391,"type":22},"2027-03-15",{"name":54,"class":55},{"id":394,"slug":395,"hasResults":12,"nctId":396,"briefTitle":397,"officialTitle":397,"acronym":398,"eligibilityCriteria":399,"healthyVolunteers":12,"sex":17,"minAge":400,"maxAge":359,"enrollmentInfo":401,"targetDuration":4,"studyType":23,"phases":403,"briefSummary":404,"conditions":405,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":417},"100415591","phase-1-adoptive-t-lymphocyte-administration-for-chronic-norovirus-treatment-in-immunocompromised-hosts-100415591","NCT04691622","Adoptive T Lymphocyte Administration for Chronic Norovirus Treatment in Immunocompromised Hosts","ATLANTIC","Inclusion Criteria:\n\nParticipant Inclusion Criteria for NST Infusion:\n\n1. Participants must meet one of the following criteria:\n\n   1. Recipient of prior myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant using either bone marrow or peripheral blood stem cells or single or double cord blood OR\n   2. Primary immunodeficiency disorder (as defined by clinical and laboratory evaluations)81 and have not undergone HSCT, OR\n   3. Recipients of solid organ transplant.\n2. Documentation of chronic norovirus infection:\n\n   a. Chronic norovirus infections will be defined as having consecutive positive norovirus stool tests (2 or more) spanning a minimum three-month period with attributable signs and symptoms of norovirus disease.\n3. Participants receiving steroids for treatment of GVHD or for other reasons, dosage must have been tapered to \\\u003C0.5 mg\u002Fkg\u002Fday of prednisone (or equivalent) a minimum of 7 days prior to infusion.\n\n   a. Treatment with enteral topical steroids such as Budesonide at standard doses may be continued if previously utilized but should not be newly initiated in the 3 months after NST therapy.\n4. For participants who have undergone HSCT, participants must have stable donor chimerism within the 30 days prior to NST infusion.\n\n   a. Stability will be defined as i. \\>95% donor chimerism in CD33 and\u002For whole blood chimerism. OR ii. \\>90% donor chimerism with \\\u003C5% change between subsequent tests separated by at least 1 week.\n5. For recipients of solid organ transplants, participants must have stable graft function on maintenance immunosuppression, without evidence of rejection in the past 2 months prior to infusion, as defined by:\n\n   a. Stability of relevant functional testing in the previous 2 months, defined as: i. Renal transplant: renal function ≥ grade 3 per the National Kidney Foundation K\u002FDOQI Clinical Practice Guidelines for Chronic Kidney Disease (2002) ii. Cardiac transplant: maintenance of LVEF \\>40% iii. Lung transplant: lack of baseline oxygen requirement iv. Liver transplant: AST\u002FALT ≤3x upper limit normal and bilirubin ≤2x upper limit normal b. Donor-derived cell free DNA \\\u003C2x upper limits for assay in the previous 2 months, c. Stable donor-specific antibody profile in the previous 2 months. i. No increase in antibody titers between most recent testing in the previous 2 months and prior testing.\n6. Karnofsky\u002FLansky score \\>50\n7. 3 months to 80 years of age at enrollment.\n8. ANC ≥500\u002Ful.\n9. Hemoglobin ≥7.0g\u002Fdl (level can be achieved with transfusion).\n10. Platelets ≥20 K\u002Ful (level can be achieved with transfusion).\n11. Bilirubin ≤2x upper limit normal.\n12. AST ≤3x upper limit normal.\n13. Serum creatinine ≤2x upper limit normal OR estimated GFR ≥30 ml\u002Fhr.\n14. Pulse oximetry of ≥90% on room air.\n15. Negative pregnancy test in female participant of childbearing age.\n16. Written informed consent and\u002For signed assent line from participant, parent or guardian.\n\nDonor Inclusion Criteria:\n\n1. Donors who have fulfilled eligibility as per United States Food and Drug Administration (FDA) regulations outlined in 21 Code of Federal Regulations (CFR) 1271 subpart C. This includes that donors have been deemed in good health by donor physician based on physical examination and laboratory testing. If a donor has been chosen for the transplant based on urgent medical need, that same donor will also be used for NST generation provided that there are no new reasons for ineligibility since the stem cell collection.\n2. For third-party banking, donors must be between 2 to 35 years of age (females) or 2 to 40 years of age (males).\n3. Donor or guardian of pediatric donor capable of providing informed consent.\n4. Donor (related or unrelated) must have completed Infectious Disease (ID) testing up to 7 days before or after the collection of blood for NST manufacturing. The following tests will be performed:\n\n   * HBsAg\n   * HBc Antibody\n   * HCV Antibody\n   * HIV 1\u002F2 Antibody\n   * HTLV I\u002FII Antibody\n   * T. Cruzi Antibody (Chagas)\n   * CMV Total Antibody\n   * Syphilis (T. Pallidum IgG and IgM)\n   * HBV, HCV, HIV Nucleic Acid testing (NAT)\n   * WNV NAT\n5. Female donors of childbearing age must have a negative pregnancy test and not be lactating.\n\nExclusion Criteria:\n\nParticipants Exclusion Criteria for NST Infusion:\n\n1. Participants receiving biological or immunosuppressive monoclonal antibodies targeting T cells within 28 days prior to NST infusion, including ATG, Alemtuzumab, Basiliximab, Tocilizumab, Brentuximab, or other medications under this category as determined by the investigators.\n\n   a) If alemtuzumab has been received within 6 weeks prior to NST infusion, plasma levels should be obtained to ensure drug clearance (≤0.16 pg\u002Fml).\n2. Participants who have received donor lymphocyte infusion (DLI), chimeric antigen receptor T cell infusion, or other experimental cellular therapies within 28 days prior to NST infusion.\n3. Participants with SCID who have undergone α\u002Fβ TCR depleted HSCT within the past 100 days post-transplant.\n4. Participants who have received ruxolitinib or other JAK inhibitors within 7 days prior to NST infusion.\n5. Participants with uncontrolled or progressing infections other than norovirus. Uncontrolled infections are defined as bacterial, fungal, or non-targeted viral infections with either clinical signs of worsening despite standard therapy, or chronic gastrointestinal symptoms that may be attributed to the uncontrolled infection. Progressing infection is defined as hemodynamic instability, worsening physical signs, or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.\n\n   1. For bacterial infections, participants must be receiving definitive therapy and have no signs of progressing infection within 7 days prior to NST infusion and or no chronic gastrointestinal symptoms associated with this bacterial infection.\n   2. For fungal infections, participants must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection within 7 days prior to NST infusion.\n6. Participants must not have other active gastrointestinal infections to which symptoms may be attributable, including parasitic infections (cryptosporidium, giardiasis), viral infections aside from norovirus (CMV colitis, rotavirus, adenovirus), or bacterial infections with C. difficile, Yersinia, Campylobacter, Salmonella, Shigella, or enteroinvasive or enterotoxigenic E. coli.\n\n   a) Testing for unrelated gastrointestinal (GI) infections must be performed within 14 days prior to NST infusion, and must include: i. Crytosporidium\u002FGiardia testing via antigen or PCR testing. ii. Stool viral testing for rotavirus and adenovirus via antigen or PCR testing.\n\n   iii. Stool bacterial culture or PCR testing. iv. C. difficile toxin PCR. b) Determination of active infection versus chronic carriage\u002Fshedding will be made by the investigators and clinical providers and will depend on the presence of clinical symptoms corresponding with the timing of positive test results, presence of a clinical response to targeted therapy, and by histological or other testing if clinically indicated.\n7. Participants with active and uncontrolled relapse of malignancy (if applicable).\n\n   1. Failure of primary engraftment is defined as failure to achieve platelet and\u002For neutrophil engraftment (ANC \\\u003C500\u002Ful and\u002For platelets \\\u003C20 K\u002Ful) following HSCT.\n   2. Secondary graft failure is defined as \\\u003C5% donor chimerism (CD3+ or CD34+) or permanent loss of neutrophil and\u002For platelet engraftment (ANC \\\u003C500\u002Ful and\u002For platelets \\\u003C20 K\u002Ful) at any time after primary engraftment.\n8. Participants with symptomatic gastrointestinal conditions aside from norovirus, including active inflammatory bowel disease or graft versus host disease (grades 2 to 4).\n9. Participants who have received a small bowel transplant.\n10. Participants receiving checkpoint inhibitors within the previous 3 months prior to NST infusion, including nivolumab, pembrolizumab, or other related medications.\n11. For SOT recipients, alteration in immunosuppression as follows:\n\n    1. Any intensification of immunosuppression (including but not limited to pulse dose corticosteroids or new biologic therapies) in the previous 2 months,\n    2. Alteration of maintenance immunosuppression (including changes in the number of agents or dosing goals) in the previous month.\n12. Participants who have received enteral immunoglobulin, nitazoxanide, or other experimental therapies for norovirus infection within 28 days prior to NST infusion.\n13. Co-enrollment in other trials is restricted, other than enrollment on natural history or observational studies. Study staff should be notified of co-enrollment as it may require the approval of the investigator or sponsor.\n\nDonor Exclusion Criteria:\n\n1\\. Donation of cells would pose a physical or psychological risk to the donor","3 Months",{"count":402,"type":22},48,[25],"This is a Phase I dose-escalation study to evaluate the safety of norovirus -specific T-cell (NST) therapy for chronic norovirus infection in participants following hematopoietic stem cell transplantation (HSCT) or who are immunocompromised due to PID and have not undergone HSCT, or Solid Organ Transplant (SOT) recipients.",[406,407,408],"Viral Infection","Hematopoietic Stem Cell Transplantation (HSCT)","Primary Immunodeficiency Disorders (PID)","2026-01-23",{"date":411,"type":48},"2026-01-26",{"date":413,"type":48},"2022-03-17",{"date":415,"type":22},"2028-10-30",{"name":54,"class":55},3,{"id":419,"slug":420,"hasResults":12,"nctId":421,"briefTitle":422,"officialTitle":423,"acronym":4,"eligibilityCriteria":424,"healthyVolunteers":12,"sex":17,"minAge":222,"maxAge":198,"enrollmentInfo":425,"targetDuration":4,"studyType":66,"phases":4,"briefSummary":427,"conditions":428,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":433,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":439,"locationsCount":84},"100618795","characterization-of-acute-pain-100618795","NCT07336264","Characterization of Acute Pain","Characterization of Acute Nociceptive Pain and Analgesic Response in Pediatric and Adolescent Patients","Inclusion Criteria:\n\n* Children and adolescents ages 6 to 21 years\n* Undergoing elective surgical procedures without a history of chronic pain, OR undergoing or planning to undergo bone marrow transplantation (BMT)\n* Able to provide written informed assent and parental permission\u002Fconsent, as applicable\n\nExclusion Criteria:\n\n* Documented history of eye disease that precludes pupillometry\n* Unwilling or unable to participate",{"count":426,"type":22},100,"This study aims to better understand how acute pain and responses to pain treatment can be measured in children and adolescents using a non-invasive device. Pain is usually assessed using self-reported or observational scales, which can be difficult to interpret, especially in pediatric patients. This study will evaluate whether a novel device, the AlgometRx Nociometer, can provide an objective measure of nociceptive pain. Participants ages 6 to 21 years who are undergoing elective surgery or bone marrow transplantation will be enrolled at Children's National Hospital. The device measures changes in pupil size in response to gentle electrical stimulation, which reflects activity in pain-related nerve pathways. Measurements will be taken before and after procedures and during routine hospital care, alongside standard pain assessments. This is an observational study. Participation will not change or guide any medical treatment, and all pain management will follow standard clinical care. The information collected may help improve future pain assessment and treatment for pediatric patients.",[429,430,431],"Acute Pain, Postoperative","Postoperative Pain","Acute Pain","2026-01-12",{"date":434,"type":48},"2026-01-14",{"date":436,"type":48},"2025-12-02",{"date":438,"type":22},"2028-06-02",{"name":54,"class":55},{"id":441,"slug":442,"hasResults":12,"nctId":443,"briefTitle":444,"officialTitle":445,"acronym":446,"eligibilityCriteria":447,"healthyVolunteers":12,"sex":17,"minAge":358,"maxAge":19,"enrollmentInfo":448,"targetDuration":4,"studyType":23,"phases":449,"briefSummary":451,"conditions":452,"keywords":454,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":464,"locationsCount":84},"100543651","phase-2-sickle-cell-disease-transplant-using-a-nonmyeloablative-approach-for-patients-with-anti-donor-red-cell-antibody-100543651","NCT06358638","Sickle Cell Disease Transplant Using a Nonmyeloablative Approach for Patients With Anti-donor Red Cell Antibody","Sickle Cell Disease Transplant Using a Nonmyeloablative Approach: Adding Daratumumab for Patients With Anti-donor Red Cell AntibodY","SUN-RAY","Inclusion Criteria:\n\nGeneral:\n\n* Patients with SCD age 2-24.99 years who have a healthy HLA-identical sibling donor with major ABO incompatibility OR patients with RBC alloantibodies against other donor RBC antigens.\n* Patients must have an absolute neutrophil count of 1 x 109\u002FL and a platelet count of 100 x 109\u002FL.\n* Lansky\u002FKarnofsky score of, at least, 70.\n\nPatients with genotypes hemoglobin SS and Sβ0 thalassemia must have at least one of the following:\n\n* History of an abnormal transcranial Doppler measurement defined as TCD velocity ≥200 cm\u002Fsec by the non-imaging technique measured at a minimum of two separate occasions.\n* Progression of CNS vasculopathy on MRA determined to be secondary to SCD.\n* History of cerebral infarction on brain MRI (overt stroke, or silent stroke if ≥3 mm in one dimension, visible in two planes on fluid-attenuated inversion recovery T2-weighted images).\n* History of two or more episodes of Acute Chest Syndrome (ACS) in lifetime.\n* History of three or more SCD pain events requiring treatment with an opiate or IV pain medication in lifetime.\n* History of any hospitalization for a complication secondary to SCD (does NOT include empiric hospitalizations for fever only).\n* History of two or more episodes of priapism.\n* Administration of regular RBC transfusions (≥8 transfusions episodes in the previous 12 months).\n* At least two episodes of splenic sequestration requiring red blood cell transfusion or splenectomy after at least one episode of splenic sequestration.\n\nPatients with all other sickle genotypes (e.g. hemoglobin SC, Sβ+ thalassemia, etc.) must have at least one of the following:\n\n* Clinically significant neurologic event (overt stroke).\n* History of two or more episodes of ACS in the 2-year period preceding enrollment.\n* History of three or more SCD pain events requiring treatment with an opiate or IV pain medication (inpatient or outpatient) in the 1-year period preceding enrollment.\n* History of any hospitalization for SCD pain or ACS while receiving hydroxyurea treatment.\n* History of two or more episodes of priapism (erection lasting ≥4 hours or requiring emergent medical care).\n* Administration of regular RBC transfusions (≥8 transfusions in the previous 12 months)\n* At least two episodes of splenic sequestration requiring red blood cell transfusion or splenectomy after at least one episode of splenic sequestration.\n\nExclusion Criteria:\n\n* Life expectancy less than 6 month\n* Pregnant or breastfeeding patients.\n* Infectious Disease: Uncontrolled bacterial, viral or fungal infections (undergoing appropriate treatment and with progression of clinical symptoms) within 1 month prior to conditioning. Patients with febrile illness or suspected minor infection should await clinical resolution prior to starting conditioning. Patients with confirmed seropositivity for HIV and patients with active or resolved Hepatitis B or C determined by serology and\u002For NAAT are excluded.\n* Liver: Direct (conjugated) bilirubin \\> 1.5 mg\u002FdL. Transaminases \\>5x upper limit of normal for age.\n* Cardiac: Left ventricular shortening fraction \\\u003C25% or ejection fraction \\\u003C50% by ECHO. Uncontrolled cardiac arrhythmia.\n* Kidney: Estimated creatinine clearance less than 60 mL\u002Fmin\u002F1.73m2.\n* Pulmonary function: Diffusion capacity of carbon monoxide (DLCO) \\\u003C35% (adjusted for hemoglobin). Baseline oxygen saturation \\\u003C94% at rest or PaO2 \\\u003C70. Known moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification.\n* Heme: Available, medically suitable, and equivalent HLA-matched sibling donor, who does not have major ABO incompatibility or express RBC antigens against which the patient is alloimmunized.",{"count":95,"type":22},[450],"PHASE2","This multicenter prospective study seeks to determine if daratumumab given, prior to HLA-identical sibling donor transplantation using alemtuzumab, low dose total-body irradiation, and sirolimus, can prevent pure red blood cell aplasia with an acceptable safety profile in patients with anti-donor red blood cell antibodies, achieving an event-free survival similar to transplanted patients without such antibodies.",[453],"Sickle Cell Disease",[453,455,446,456],"ABO Mismatch","Matched Sibling Donor (MSD)","2025-09-23",{"date":459,"type":48},"2025-09-26",{"date":461,"type":48},"2024-04-03",{"date":463,"type":22},"2054-09",{"name":54,"class":55},{"id":466,"slug":467,"hasResults":12,"nctId":468,"briefTitle":469,"officialTitle":470,"acronym":4,"eligibilityCriteria":471,"healthyVolunteers":266,"sex":17,"minAge":18,"maxAge":198,"enrollmentInfo":472,"targetDuration":4,"studyType":23,"phases":473,"briefSummary":474,"conditions":475,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":480,"startDateStruct":482,"completionDateStruct":484,"leadSponsor":486,"locationsCount":84},"100533370","augmented-reality-for-mri-guided-interventions-100533370","NCT06224933","Augmented Reality For MRI-Guided Interventions","Augmented Reality Real-Time Guidance for MRI-Guided Interventions","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male or female, ages 3 to 21\n* Patient referred to Interventional Radiology for image-guided needle injection, aspiration, or biopsy.\n\nExclusion Criteria:\n\n* Patients who are unable to give informed consent themselves or through their parents.\n* Patients under 3 years of age\n* Patients over 300 pounds.\n* Patients who are claustrophobic and unable to tolerate MRI-guided procedure.\n* Contraindications to MRI such as MR-unsafe implants.",{"count":7,"type":22},[144],"The purpose of this study is to determine feasibility and safety of using an augmented reality system in patients undergoing MRI-Guided needle procedures.",[476,477,478],"Infections","Pain","Diagnosis","2025-08-28",{"date":481,"type":48},"2025-09-05",{"date":483,"type":48},"2024-02-06",{"date":485,"type":22},"2026-05-31",{"name":54,"class":55},{"id":488,"slug":489,"hasResults":12,"nctId":490,"briefTitle":491,"officialTitle":491,"acronym":492,"eligibilityCriteria":493,"healthyVolunteers":12,"sex":17,"minAge":494,"maxAge":198,"enrollmentInfo":495,"targetDuration":4,"studyType":23,"phases":497,"briefSummary":498,"conditions":499,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":502,"lastUpdatePostDateStruct":503,"startDateStruct":505,"completionDateStruct":507,"leadSponsor":509,"locationsCount":84},"100601795","efficacy-of-a-novel-prototype-gastrostomy-tube-anchor-dressing-100601795","NCT07115134","Efficacy of a Novel Prototype Gastrostomy Tube Anchor Dressing","Tube Anchor","Inclusion Criteria:\n\n* Patients who are undergoing gastrostomy tube placement or are within five days post-operatively of gastrostomy tube placement.\n\nExclusion Criteria:\n\n* 1\\. Patients with a skin condition that limits the placement of the dressing, this will be confirmed with the clinical team","7 Years",{"count":496,"type":22},75,[144],"This is a single-center prospective study evaluating the efficacy of a prototype gastrostomy anchor dressing for use with button gastrostomy tubes. The anchor dressing has been previously evaluated for usability by parents, patients, and nurses. This study compares several outcomes related to complications from gastrostomy tube placement using a prospective cohort of patients and a retrospective analysis of complications associated with gastrostomy tubes. Prospective patients will initially be monitored until they have completed their last dressing change or for a maximum of 50 days. They will then complete their final survey. Their charts will be reviewed for up to one year from their initial gastrostomy placement. The study's primary objective is to determine if the novel gastrostomy tube anchor dressing reduces rates of gastrostomy tube dislodgement and ED\u002Fclinic visits for gastrostomy tube complications.",[500,501],"Gastroenterology Surgery","Tube Feeding","2025-08-04",{"date":504,"type":48},"2025-08-11",{"date":506,"type":48},"2024-09-24",{"date":508,"type":22},"2027-12-18",{"name":54,"class":55},{"id":511,"slug":512,"hasResults":12,"nctId":513,"briefTitle":514,"officialTitle":514,"acronym":515,"eligibilityCriteria":516,"healthyVolunteers":12,"sex":17,"minAge":517,"maxAge":4,"enrollmentInfo":518,"targetDuration":4,"studyType":23,"phases":520,"briefSummary":521,"conditions":522,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":526,"lastUpdatePostDateStruct":527,"startDateStruct":529,"completionDateStruct":531,"leadSponsor":533,"locationsCount":84},"100476756","pained-project-addressing-inequities-in-the-emergency-department-100476756","NCT05488080","PAINED: Project Addressing INequities in the Emergency Department","PAINED","Inclusion Criteria:\n\n* All Children's National Hospital Emergency Department clinicians\n* Patients 0-21 years with symptoms suggestive of appendicitis or long bone fracture\n\nExclusion Criteria:\n\n* Emergency Severity Index (ESI 1)","0 Years",{"count":519,"type":22},22032,[144],"Racial and ethnic inequities in health care quality have been described across a broad range of clinical settings, patient populations, and outcomes. Our overarching goal is to eradicate health care inequities through evidence-based interventions. The objectives of this proposal are to develop and test the impact of two interventions on overcoming clinician implicit bias and mitigating inequities in the management of pain among children seeking care in the emergency department for the treatment of appendicitis or long bone fractures.",[477,523,524,525],"Appendicitis","Bias, Racial","Fractures, Bone","2025-07-14",{"date":528,"type":48},"2025-07-17",{"date":530,"type":48},"2023-02-27",{"date":532,"type":22},"2026-08-23",{"name":54,"class":55},{"id":535,"slug":536,"hasResults":12,"nctId":537,"briefTitle":538,"officialTitle":538,"acronym":539,"eligibilityCriteria":540,"healthyVolunteers":12,"sex":17,"minAge":222,"maxAge":541,"enrollmentInfo":542,"targetDuration":4,"studyType":23,"phases":544,"briefSummary":545,"conditions":546,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":549,"lastUpdatePostDateStruct":550,"startDateStruct":551,"completionDateStruct":553,"leadSponsor":555,"locationsCount":84},"100464774","phase-2-omalizumab-before-onset-of-exacerbations-100464774","NCT05332067","Omalizumab Before Onset of Exacerbations","OBOE","Inclusion Criteria at Study Entry:\n\nParticipants must meet the following:\n\n1. Parent or guardian must be able to understand and provide informed consent in English and participants ≥7 must be able to provide assent\n2. 6-17 years, inclusive at time of screening\n3. Physician-diagnosed persistent asthma\n4. ≥1 exacerbation of asthma requiring systemic corticosteroids in the 6-month period before the planned start of the participant's upcoming school year or ≥2 exacerbations of asthma requiring systemic corticosteroids in the 12-month period before the planned start of the participant's upcoming school year\n5. Sensitization to ≥1 perennial aeroallergen\n6. Total serum IgE and weight appropriate for omalizumab dosing\n7. Insurance that covers standard of care medications\n8. Primary family residence (home where child sleeps a majority of nights) in a Metropolitan Statistical Area where ≥10% of families have income below poverty line and\u002For publicly funded health insurance\n9. At least one of the following criteria:\n\n   1. peripheral eosinophilia \\>300µL\n   2. total serum IgE \\>300kU\u002FL\n   3. sensitization to ≥3 perennial aeroallergens\n10. Females of childbearing potential must have a negative pregnancy test upon study entry\n11. Females with reproductive potential must agree to use FDA approved methods of birth control for the duration of the study\n\nAdditional Inclusion Criteria (these must be met prior to randomization at the fall season sick visit A (SVa) during the 90-day outcome period):\n\nIn order to be eligible for randomization at the SVa visit, participants must also meet all of the following criteria:\n\n1. Reporting onset of URI symptoms within 72 hours prior to SVa, confirmed by the study physician\n2. Report no use of nasal corticosteroids or nasal vaccinations within 14 days prior to SVa\n3. Have a negative rapid nasal swab antigen test for SARS-CoV-2\n4. Be more than 14 days from the onset of any previous asthma exacerbation requiring systemic steroids\n5. Have no current lower respiratory symptoms that, in the opinion of the study physician, require systemic corticosteroid treatment\n6. Complete collection of nasal absorption sample within 72 hours of onset URI \\[defined by onset of (or substantial worsening of) rhinorrhea, nasal congestion or sneezing (single or multiple symptoms)\\] as determined by the study physician's assessment at the SVa visit\n\nExclusion Criteria:\n\n1. Inability or unwillingness of a participant's parent or guardian to give written informed consent or comply with study protocol or inability or unwillingness of a participant ≥7 to provide assent\n2. Contraindication to receipt of omalizumab\n3. Presence of a second chronic medical condition (including but not limited to serious cardiorespiratory disorders, cancer, sickle cell disease, uncontrolled seizure disorder, auto-immune disorders, or type 1 diabetes)\n4. Pregnancy or active lactation\n5. History of latex allergy\n6. Treatment with omalizumab or other monoclonal antibody, or aeroallergen immunotherapy in the prior six months\n7. Plan for home schooling during the 90-day outcome period\n8. History of life-threatening asthma defined by requirement for intubation or cardiorespiratory arrest\n9. Inability of primary caregiver and child to speak English\n10. In the opinion of the investigator, participant will not be able to wean from nasal steroids or to avoid nasal vaccinations during the 90-day fall outcome period\n11. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study","17 Years",{"count":543,"type":22},300,[450],"OBOE is a prospective, pilot, parallel group RCT with the overall aim of examining the effect of a single dose of anti-IgE (omalizumab) vs. placebo administered at the onset of URIs in the fall season among highly exacerbation-prone, urban, and atopic youth aged 6-17 years with persistent asthma. OBOE will recruit and randomize participants over 3 years (3 annual cohorts of participants). Recruitment for each of the yearly cohorts of OBOE will begin in February. Each cohort will be followed for a 2-6-month run-in period with the objective to gain control of each participant's asthma and to stabilize the required controller medication step level. Participants will receive routine asthma care every 1-2 months (a total of 2-4 times) during run-in using a previously described algorithm developed by the Inner-city Asthma Consortium and successfully employed in the PROSE study. The primary outcome is the change in the amount of nasal IFN-α recovered by nasal fluid absorption between two time points, within 72 hours of onset of a URI as defined by onset of (or substantial worsening of) rhinorrhea, nasal congestion or sneezing (single or multiple symptoms) and 3-6 days after study drug injection.",[383,547,548],"Atopy","Viral Upper Respiratory Infection","2025-07-10",{"date":526,"type":48},{"date":552,"type":48},"2022-05-01",{"date":554,"type":22},"2028-03-01",{"name":54,"class":55},{"id":557,"slug":558,"hasResults":12,"nctId":559,"briefTitle":560,"officialTitle":561,"acronym":562,"eligibilityCriteria":563,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":564,"enrollmentInfo":565,"targetDuration":4,"studyType":23,"phases":567,"briefSummary":568,"conditions":569,"keywords":572,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":577,"lastUpdatePostDateStruct":578,"startDateStruct":580,"completionDateStruct":582,"leadSponsor":584,"locationsCount":84},"100536563","individualized-nutrition-to-optimize-preterm-infant-growth-and-neurodevelopment-100536563","NCT06266455","Individualized Nutrition to Optimize Preterm Infant Growth and Neurodevelopment","Transforming Health and Resilience Via Individualized Nutrition in Very Preterm Infants for Extrauterine Growth and Development","THRIVE","Inclusion Criteria:\n\n* Birth gestational age (GA) of ≤32 weeks\n* Postnatal age ≤4 weeks at time of enrollment\n* Maternal plan to provide human milk to infant, and consent to providing donor human milk if insufficient maternal milk supply\n* Maternal age \\> 18 years old\n\nExclusion Criteria:\n\n* Formula feeding prior to 36 weeks PMA or discharge home (whichever achieved first), either secondary to parental preference or medical necessity\n* Dysmorphic features or congenital anomalies suggestive of a genetic syndrome, metabolic disorder, chromosomal abnormality, or congenital infection\n* Dysgenetic or major destructive brain lesions detected by head ultrasound before enrollment","4 Weeks",{"count":566,"type":22},150,[144],"Human milk has several well-established benefits but does not adequately meet the increased nutritional demands of the growing preterm infant, necessitating additional nutrient supplementation in a process known as fortification. In U.S. neonatal intensive care units (NICUs), human milk is primarily supplemented using standardized fortification, in which a multicomponent fortifier is added to human milk to achieve assumed nutrient content based on standard milk reference values. However, this method does not account for the significant variability in human milk composition or in preterm infant metabolism, and up to half of all very premature infants experience poor growth and malnutrition using current nutritional practices. Poor postnatal growth has adverse implications for the developing preterm brain and long-term neurodevelopment.\n\nRecent advances allow for individualized methods of human milk fortification, including adjustable and targeted fortification. Adjustable fortification uses laboratory markers of protein metabolism (BUN level) to estimate an infant's protein requirements. In targeted fortification, a milk sample is analyzed to determine its specific macronutrient and energy content, with additional macronutrient supplementation provided as needed to achieve goal values. Emerging data suggest that both methods are safe and effective for improving growth, however information on their comparable efficacy and neurodevelopmental implications are lacking, particularly using advanced quantitative brain MRI (qMRI) techniques.\n\nThrough this prospective, randomized-controlled trial, the investigators will compare the impact of individualized human milk fortification on somatic growth and neurodevelopment in preterm infants. Infants will be randomized to receive one of three nutritional interventions: standardized (control group), adjustable, or targeted human milk fortification. Infants will undergo their assigned nutritional intervention until term-equivalent age or discharge home, whichever is achieved first. Brain qMRI will be performed at term-corrected age, and neurodevelopmental follow-up will be performed through 5 years of age.",[570,571],"Very Preterm Maturity of Infant","Very Low Birth Weight Infant",[573,574,575,576],"Magnetic Resonance Imaging","Neurodevelopment","Nutrition","Fortification","2025-07-08",{"date":579,"type":48},"2025-07-11",{"date":581,"type":48},"2024-02-08",{"date":583,"type":22},"2034-01",{"name":54,"class":55},{"id":586,"slug":587,"hasResults":12,"nctId":588,"briefTitle":589,"officialTitle":590,"acronym":4,"eligibilityCriteria":591,"healthyVolunteers":12,"sex":17,"minAge":287,"maxAge":592,"enrollmentInfo":593,"targetDuration":4,"studyType":23,"phases":595,"briefSummary":596,"conditions":597,"keywords":599,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":577,"lastUpdatePostDateStruct":606,"startDateStruct":607,"completionDateStruct":609,"leadSponsor":611,"locationsCount":84},"100518756","evaluation-of-the-food-allergy-mastery-program-100518756","NCT06034678","Evaluation of The Food Allergy Mastery Program","Evaluation of a Behavioral Intervention to Promote Food Allergy Self-Management Among Early Adolescents: The Food Allergy Mastery Program","Inclusion Criteria:\n\n1. age 10-14 years\n2. physician diagnosis (i.e., history of a reaction to the food and\u002For recent positive skin prick test or IgE-specific testing) of at least 1 of the 9 most common IgE-mediated food allergies (peanut, tree nut, cow's milk, egg, soy, wheat, shellfish, fish, sesame) for ≥1 year, with accompanying allergen avoidance prescribed by an allergist\n3. English fluency\n4. access to a device with internet access\n5. either a food allergy knowledge score of \\\u003C80% correct on the Food Allergy Knowledge Test (FAKT) or a food allergy impact score of ≥3 on the Food Allergy Independent Measure (FAIM).\n\nExclusion Criteria:\n\n1. diagnosis of a non-IgE-mediated food allergy or food intolerance, a non-atopic chronic illness or pervasive developmental disorder\u002Fcognitive limitation\n2. Current participation in psychotherapy with a therapist with food allergy expertise","14 Years",{"count":594,"type":22},240,[144],"The proposed research project will evaluate a novel behavioral intervention that promotes early adolescent food allergy self-management and adjustment through 1) food allergy education, 2) problem-solving, communication, assertiveness, and anxiety management skill building, and 3) peer support.",[598],"Food Allergy in Children",[600,601,602,603,604,605],"food allergy","knowledge","management","adolescents","caregivers","social support",{"date":579,"type":48},{"date":608,"type":48},"2023-06-26",{"date":610,"type":22},"2027-11-30",{"name":54,"class":55},{"id":613,"slug":614,"hasResults":12,"nctId":615,"briefTitle":616,"officialTitle":616,"acronym":617,"eligibilityCriteria":618,"healthyVolunteers":12,"sex":17,"minAge":619,"maxAge":541,"enrollmentInfo":620,"targetDuration":4,"studyType":23,"phases":622,"briefSummary":623,"conditions":624,"keywords":626,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":630,"lastUpdatePostDateStruct":631,"startDateStruct":632,"completionDateStruct":634,"leadSponsor":636,"locationsCount":189},"100563581","pragmatic-clinic-based-trial-of-a-mindfulness-based-intervention-for-mood-concerns-in-youth-with-type-1-diabetes-100563581","NCT06618027","Pragmatic Clinic-Based Trial of a Mindfulness Based Intervention for Mood Concerns in Youth With Type 1 Diabetes","BREATHE-T1D","Inclusion Criteria:\n\n* Type 1 diabetes diagnosed for at least 1 year\n* Elevated score on depression measure OR elevated score on anxiety measure\n\nExclusion Criteria:\n\n* Cognitive or developmental delays that restrict ability to complete study interventions or assessments\n* Teen not fluent in English\n* No other serious medical conditions (e.g., cystic fibrosis, cancer)","13 Years",{"count":621,"type":22},200,[144],"Type 1 diabetes (T1D) is a common chronic illness among children requiring a high degree of self-management for good glycemic control. Adolescents are at risk for poor disease management and health outcomes due to a number of factors, including high rates of depression, anxiety, and stress. Accessing support for these challenges can be a barrier to care, so the current study, BRinging Empowerment and Attention to Teen HEalth-T1D, evaluates the efficacy of a virtual, group-based mindfulness based intervention and a virtual group-based diabetes education intervention on improving symptoms of depression and anxiety, and diabetes self management in teens with T1D. The study also aims to study how these interventions might be implemented in diabetes clinic settings.",[625],"Type 1 Diabetes (T1D)",[627,603,628,629],"type 1 diabetes","depression","anxiety","2025-07-07",{"date":577,"type":48},{"date":633,"type":48},"2025-05-15",{"date":635,"type":22},"2029-08-06",{"name":54,"class":55},""]