[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Boston Children's Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":656},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,135,0,25,[9,47,80,106,132,168,199,230,252,287,306,339,360,380,401,424,447,471,493,519,544,571,590,610,634],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100584583","study-of-an-oral-fluid-testing-approach-100584583",false,"NCT06891235","Study of an Oral Fluid Testing Approach","Oral Fluid Testing to Assess Cannabis Non-Use in Remote Clinical Trials","SOFTA","Inclusion Criteria:\n\n* Age 18 to 30 years\n* Cannabis use on \\>=1x\u002Fweek in the past 30 days\n* Ownership of a portable device that is capable of videoconference and videorecording (i.e., smartphone, tablet computer, or laptop computer)\n* Ability to read and speak English\n* Availability for duration of the study (3-4 weeks).\n* To proceed to oral fluid testing, positive result for urinary TCH-COOH\n\nExclusion Criteria:\n\n• Inability\u002Funwillingness to provide contact information","ALL","18 Years","30 Years",{"count":22,"type":23},200,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to identify and evaluate oral fluid testing as a biologic measure of cannabis use days that can be assessed remotely. The researchers will conduct this fully virtual study among a community sample of 200 individuals aged 18-30 years who have used cannabis at least 1 time per week on average in the past 30 days. Participants will complete oral fluid (saliva) tests, urine tests, and Timeline Follow-back interviews (self-report) that indicate their recent cannabis use (delta-9-THC). Participants will present for 3 virtual study visits across \\~3-4 weeks and be asked to complete activities in between: Study Visit 1 (Day 0; informed consent, baseline survey, TLFB interview), Study Visit 2 (\\~Day 7; TLFB interview, urine testing), 6 days of at-home videorecorded oral fluid testing, Study Visit 3 (\\~Day 21; TLFB interview, urine test, oral fluid test, survey, interview).",[27,28,29],"Cannabis Use","Cannabis Intoxication","Cannabis Use Disorder",[31,32,33],"cannabis use","young adult","oral fluid testing","RECRUITING","2026-06-27",{"date":37,"type":38},"2026-07-01","ACTUAL",{"date":40,"type":38},"2025-10-27",{"date":42,"type":23},"2027-05",{"name":44,"class":45},"Boston Children's Hospital","OTHER",1,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":18,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":66,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":46},"100644761","my01-pressure-monitoring-in-adolescent-tibia-fractures-100644761","NCT07674043","MY01 Pressure Monitoring in Adolescent Tibia Fractures","Continuous Compartment Pressure Monitoring in Adolescent Tibia Fractures","Inclusion Criteria:\n\n* Between the ages of 10 to 21 on the day of surgery\n* Undergoing operative fixation for a fracture of the proximal tibia or tibial shaft\n\nExclusion Criteria:\n\n* Preoperative diagnosis of acute compartment syndrome\n* Preexisting neuromuscular or vascular condition affecting the injured extremity\n* MY01 device malfunction","10 Years","21 Years",{"count":57,"type":23},50,"INTERVENTIONAL",[60],"NA","The goal of this clinical trial is to learn more about anterior leg compartment pressures in adolescents who have sustained tibia fractures. It will also examine whether measuring anterior compartment pressure helps physicians diagnose acute compartment syndrome (ACS), a rare but dangerous complication that can develop following surgical treatment of a tibia fracture.\n\nThe main questions it aims to answer are:\n\n1. Are there differences in anterior compartment pressures between healthy patients and patients who develop ACS?\n2. Does compartment pressure monitoring aid physicians in accurately diagnosing ACS?\n\nParticipants will have a continuous pressure monitoring sensor placed in their knee anterior knee compartment during their surgery. This sensor will record pressure data following a patient's surgical treatment for 18+ hours.",[63,64,65],"Proximal Tibia Fracture","Tibial Shaft Fracture","Acute Compartment Syndrome",[67,68,69,70],"Tibia fracture","acute compartment syndrome","compartment pressure","pediatric","NOT_YET_RECRUITING","2026-06-25",{"date":74,"type":38},"2026-06-29",{"date":76,"type":23},"2026-06-01",{"date":78,"type":23},"2028-06-01",{"name":44,"class":45},{"id":81,"slug":82,"hasResults":12,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":12,"sex":18,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":58,"phases":90,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":100,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":46},"100498996","randomized-controlled-crossover-trial-of-postpyloric-feedings-to-improve-pulmonary-outcomes-in-high-risk-preterm-infants-100498996","NCT05777512","Randomized Controlled Crossover Trial of Postpyloric Feedings to Improve Pulmonary Outcomes in High-risk Preterm Infants","A Randomized Controlled Crossover Trial of Postpyloric Versus Gastric Feedings to Improve Pulmonary Outcomes in High-risk Preterm Infants","Inclusion Criteria:\n\nPreterm infants born \\\u003C 32 weeks' gestation may enroll at 34-44 weeks post-menstrual age, who:\n\n1. Remain on either invasive ventilation or non-invasive ventilation (continuous positive airway pressure or nasal intermittent positive pressure ventilation) for minimum 48 hours at the time of study entry. The minimum support required for inclusion is CPAP \\> 5cm H2O or CPAP 5 with FiO2 \\> 21%.\n2. Have ongoing need for respiratory support due to underlying lung disease from prematurity.\n3. Are tolerating \\> 80 ml\u002Fkg\u002Fday of enteral feedings at baseline, either via nasogastric (NG) or nasojejunal (NJ) tube. Patients may be receiving gastric (NG) or postpyloric (NJ) feedings.\n\nExclusion Criteria:\n\n1. Infants who are transiently on respiratory support at the time of study entry due to another reason than underlying lung disease from prematurity; for example, recovery from a surgical intervention.\n2. Infants who have other comorbidities that significantly contribute to lung disease, including cyanotic congenital heart disease, or other genetic, congenital, or pulmonary abnormalities.\n3. Infants who were evaluated for necrotizing enterocolitis (including holding feedings) in the 7 days prior to study enrollment.\n4. Infants with known gastrointestinal or airway malformations that would affect tolerance of feeds or the route of delivery of enteral feedings.","0 Hours","1 Year",{"count":57,"type":23},[60],"The purpose of this study is to determine if postpyloric feedings effectively improve objective measures of pulmonary health in preterm infants with chronic lung disease when compared with nasogastric (NG) feedings. This research will (1) determine the optimal nutritional management to prevent a common and costly complication of prematurity, and (2) use a novel crossover design that examines outcomes of clinical endpoints alongside biomarkers.",[93],"Bronchopulmonary Dysplasia",[95,96,97,93,98,99],"Chronic Lung Disease of Prematurity","Postpyloric Feeding","Nasojejunal Feeding","GERD","Gastro-esophageal Reflux",{"date":74,"type":38},{"date":102,"type":38},"2024-04-26",{"date":104,"type":23},"2028-02",{"name":44,"class":45},{"id":107,"slug":108,"hasResults":12,"nctId":109,"briefTitle":110,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":12,"sex":112,"minAge":19,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":114,"conditions":115,"keywords":118,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":129,"leadSponsor":131,"locationsCount":46},"100644854","continuous-wireless-ultrasound-to-monitor-fetal-health-100644854","NCT07676474","Continuous Wireless Ultrasound to Monitor Fetal Health","Inclusion Criteria:\n\n1. Pregnant individual 18 years or older\n2. Singleton uterine pregnancy\n3. Gestational age 20 to 39 gestational weeks\n4. Able to provide written informed consent\n5. Willing to go an single visit lasting 45 minutes - 1 hour including device placement, monitoring and removal\n6. Willing to permit placement of the wireless bioadhesive ultrasound device on their abdomen for approximately 10-30 minutes\n\nExclusion Criteria:\n\n1. Multiple gestation\n2. Maternal abdominal skin condition at the potential site of attachment, such as rash, open wound, etc., preventing placement\n3. Known allergy or hypersensitivity to adhesive material or hydrogel products\n4. Need for urgent clinical management\u002Ftriage\n5. BMI \\> 35, as the signal quality could be impacted by BMI and not the device specifically","FEMALE",{"count":57,"type":23},"This study is a single-center, prospective, and non-randomized feasibility study designed to evaluate the practicality, tolerability, and data quality of short-duration continuous fetal monitoring using a wireless bioadhesive ultrasound device. The study involves a single visit per participant and does not include any therapeutic intervention.\n\nEligible participants will undergo placement of a wireless bioadhesive ultrasound (ABAUS) device on the maternal abdomen for a short-duration monitoring session. The device will acquire continuous or semi-continuous ultrasound data for a total of 10-30 minutes per participant, without altering standard clinical care. The study is observational and is intended to assess the technical feasibility of device placement, the stability of the coupling during routine maternal movement, image quality over time, and the ability to monitor fetal motion, heart rate, and uterine activity using the investigational device under controlled yet realistic clinical conditions.\n\nThe study is non-interventional. No diagnostic or therapeutic decisions will be made based on the ultrasound data collected as part of this research protocol, and all standard prenatal care will proceed independently of participation in this study.",[116,117],"Pregnant Woman With Single Pregnancy","Ultrasound Fetal Medicine",[119,120,121,122,123,124],"Ultrasound","Fetal Ultrasound","Investigational Device","Pregnancy","Singleton","Single pregnancy","2026-06-24",{"date":127,"type":38},"2026-06-30",{"date":127,"type":23},{"date":130,"type":23},"2028-06-30",{"name":44,"class":45},{"id":133,"slug":134,"hasResults":12,"nctId":135,"briefTitle":136,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":139,"sex":18,"minAge":140,"maxAge":55,"enrollmentInfo":141,"targetDuration":143,"studyType":24,"phases":4,"briefSummary":144,"conditions":145,"keywords":152,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":167},"100444723","advanced-spinal-innovations-with-robotics-and-enabling-technology-registry-100444723","NCT05071144","Advanced SPinal Innovations With Robotics and Enabling Technology Registry","ASPIRE","Inclusion Criteria:\n\n* Diagnosis of a spine deformity\n* Scheduled for surgery using robotics and navigation and\u002For patient-specific rods\n* Up to and including 21 years of age\n* Speak and read English or Spanish\n\nExclusion Criteria:\n\n• None",true,"0 Years",{"count":142,"type":23},700,"5 Years","Creation of a pediatric robotic spine surgery registry will allow for data collection and analysis on the coupled use of robotics and navigation, as well as patient-specific rods in pediatric spine deformity surgery across participating study institutions. Eventually, an educational and informative framework for this technology will be established.",[146,147,148,149,150,151],"Spine Deformity","Idiopathic Scoliosis","Adolescent Idiopathic Scoliosis","Spondylolisthesis","Congenital Scoliosis","Neuromuscular Scoliosis",[153,154,155,156,157,158],"Pediatric","Spine","Surgery","Registry","Robotic","Navigation","2026-06-18",{"date":161,"type":38},"2026-06-22",{"date":163,"type":38},"2021-12-13",{"date":165,"type":23},"2031-12",{"name":44,"class":45},10,{"id":169,"slug":170,"hasResults":12,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":12,"sex":18,"minAge":175,"maxAge":176,"enrollmentInfo":177,"targetDuration":4,"studyType":58,"phases":179,"briefSummary":181,"conditions":182,"keywords":184,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":46},"100641724","phase-4-eeg-biomarkers-for-adhd-stimulant-treatment-100641724","NCT07650643","EEG Biomarkers for ADHD Stimulant Treatment","EEG Biomarkers for Pediatric ADHD Treatment Stratification","Inclusion Criteria:\n\n1. Ages 7:0 - 10:11 (years:months)\n2. Has a diagnosis of ADHD or being evaluated for ADHD\n3. Stimulant naïve or previously trialed stimulant medications for \\\u003C 6 months without achieving symptom remission, per caregiver report and\u002For medical chart review (if available)\n4. CGI-Severity rating of 4 \"Moderately ill\" through 6 \"Severely ill.\"\n5. Willing and able to comply with study procedures\n\nExclusion Criteria:\n\n1. Use of stimulants or other psychotropic medications within 7 days before Eligibility Visit\n2. History of severe side effects to stimulants (suicidality, complete loss of appetite, cardiopulmonary complications) per caregiver report or medical chart review, determined by the study MD\n3. Intellectual disability or IQ \\\u003C 75 per medical chart review or performance on standardized cognitive testing during the Eligibility Visit\n4. Diagnosis of Autism spectrum disorder (ASD) per medical chart review or caregiver report\n5. Fetal alcohol exposure per medical chart review or caregiver report\n6. Current suicidal ideation per caregiver or child report on CSSRS\n7. Non-febrile seizures per caregiver report or medical chart review\n8. Cardiopulmonary conditions, pregnancy or other medical conditions that contraindicate psychostimulant use per determination by the study MD","7 Years","11 Years",{"count":178,"type":23},220,[180],"PHASE4","Pediatric attention deficit hyperactivity disorder (ADHD) affects up to 10% of children in the U.S. and more than 90% are prescribed stimulant medications according to clinical guidelines. The standard of care for pharmacological treatment of ADHD is a \"trial-and-error\" approach that requires frequent dose adjustments, side effects management, and communication among doctors, parents, and school personnel over weeks, months, and years. In the first year following prescription of stimulant medications, \\>50% of doctors are not able to conduct the recommended follow-up with their patients. Many patients stop taking medications or keep taking medications that do not work well, as a result.\n\nThis investigation will use a non-invasive brain imaging technique called EEG to look for activity in the brain that can predict which children with ADHD will respond well to two commonly prescribed stimulant medication groups, methylphenidate and amphetamines. Based on a previous study, it is expected that EEG signals can differentiate among children whose ADHD symptoms will get better on methylphenidate, and those whose ADHD symptoms will get better on amphetamines.\n\n220 participants ages 7-11 with ADHD will be enrolled. Participants will not have autism or intellectual disabiltiy. They will not currently be taking psychiatric medications. Participants will not have not taken stimulant medications before or have tried stimulant medications \\>6 months or experienced an improvement in their ADHD symptoms by taking a stimulant medication before.\n\nStudy Participation Includes:\n\n1. Participant and caregiver complete a 3-hour visit at the Arnett Laboratory at 2 Brookline Place. During this visit, participants complete a brief IQ test and an EEG while their caregiver completes questionnaires and a clinical interview. The caregiver will give permission to request survey responses from the participant's teacher.\n2. The next day, the participant and caregiver will come back to the laboratory for a 1-hour visit. The participant will do another EEG while the caregiver fills out more surveys. The doctor will take the participant's vital signs and prescribe the medication.\n3. The participant will be randomly assigned to take either methylphenidate HCl or amphetamines every morning for 3 weeks. At the end of each week, the caregiver and teacher will fill out a questionnaire about the participant's behaviors and symptoms, including side effects.\n4. For one week, the participant will not take medications. They will come back into the lab for another EEG at the end of that week.\n5. The participant will then take the other medication every morning for 3 weeks. At the end of each week, the caregiver and teacher will fill out a questionnaire about the participant's behaviors and symptoms, including side effects.\n6. It will take participants about 7 weeks to complete this study. During this time, they will complete 3 in-person and 6 virtual study visits.\n7. The research funds will cover cost associated with the study. The participant's health insurer will not be billed for the medications or treatment. Medications will be provided through the research pharmacy.\n8. Participants will be given a report at the end of the study with details about the medication trials, symptom response, and any other findings. They will receive up to $270 for the completion of the study. Some travel-related costs will be covered by the study.",[183],"ADHD",[185,186,187,188,183,189,190],"stimulants","EEG","biomarker","randomized crossover","treatment","stratification","2026-06-12",{"date":193,"type":38},"2026-06-16",{"date":195,"type":23},"2026-09-15",{"date":197,"type":23},"2031-08-31",{"name":44,"class":45},{"id":200,"slug":201,"hasResults":12,"nctId":202,"briefTitle":203,"officialTitle":203,"acronym":204,"eligibilityCriteria":205,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":208,"conditions":209,"keywords":215,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":46},"100095145","genetic-study-of-chronic-prostatitischronic-pelvic-pain-syndrome-cpcpps-100095145","NCT00499317","Genetic Study of Chronic Prostatitis\u002FChronic Pelvic Pain Syndrome (CP\u002FCPPS)","CP\u002FCPPS","Inclusion Criteria:\n\n* Have symptoms for at least 3 months within the preceding 6 months:\n* Pain in the pelvic area\n* Urinary frequency and\u002For\n* Urinary urgency and\u002For\n* Sexual dysfunction (erectile dysfunction)\n* Have CP\u002FCPPS, Interstitial Cystitis (IC), Bladder Pain Syndrome BPS, or Bladder Fasciculation Syndrome (BFS)\n* Be willing to provide a blood\u002Fsaliva, bladder tissue (from previous biopsy) and urine sample\n* Agree to complete several brief questionnaires\n* Family member of someone with CP\u002FCPPS, BPS, IC or BFS\n* Live in the USA or Canada\n\nExclusion Criteria:\n\n* Major structural\u002Fanatomical urinary tract abnormalities\n* Underlying inborn or congenital conditions which affect the urinary tract\n* Surgery\u002Fchemotherapy in the pelvic area\n* Bacterial cause to CP\u002FCPPS or recurrent Urinary tract infections (UTI)\n* Traumatic cause to CP\u002FCPPS",{"count":207,"type":23},500,"Chronic Prostatitis\u002FChronic Pelvic Pain Syndrome (CP\u002FCPPS) is a condition with several causes of which some remain unknown. It is believed that some types of CP may be genetic or passed down (inherited) from one generation to the next.\n\nIn this study, we are collecting genetic material and medical information to try to determine if genetic factors play a role in CP\u002FCPPS. We will be collecting DNA (from Blood\u002FSaliva sample) and urine from each participant. Bladder tissue from affected individuals will also be collected. Individuals and families with CP\u002FCPPS will be enrolled. Family members of an individual with CP\u002FCPPS are eligible whether or not they also experience CP\u002FCPPS symptoms.",[210,211,212,213,214],"Chronic Prostatitis (CP)","Chronic Pelvic Pain Syndrome (CPPS)","Painful Bladder Syndrome (PBS)","Benign Frequency Syndrome (BFS)","Interstitial Cystitis",[216,217,218,219,220,221],"Urgency","Frequency","Pelvic pain","Sexual dysfunction","Erectile dysfunction","Painful intercourse","2026-06-10",{"date":224,"type":38},"2026-06-11",{"date":226,"type":38},"2007-01-15",{"date":228,"type":23},"2028-12-31",{"name":44,"class":45},{"id":231,"slug":232,"hasResults":12,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":237,"targetDuration":4,"studyType":58,"phases":239,"briefSummary":240,"conditions":241,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":4},"100637846","validation-of-ecg-based-ventricular-arrhythmia-localization-algorithms-in-patients-with-repaired-tetralogy-of-fallot-100637846","NCT07607821","Validation of ECG-Based Ventricular Arrhythmia Localization Algorithms in Patients With Repaired Tetralogy of Fallot","Validation of ECG-Based Ventricular Arrhythmia Localization Algorithms in Patients With Repaired Tetralogy of Fallot: A Prospective Pace Mapping Study","Inclusion Criteria:\n\n* Adult patients \\>\u002F= 18 years with repaired tetralogy of Fallot with pulmonary stenosis scheduled for clinically-indicated diagnostic electrophysiology (EP) study.\n\nExclusion Criteria:\n\n* Dextrocardia or mesocardia.\n* Double outlet right ventricle.\n* Tetralogy of Fallot with pulmonary atresia.\n* Contraindication to femoral arterial access.\n* Mechanical aortic prosthesis.\n* Inability to provide informed consent.",{"count":238,"type":23},30,[60],"Doctors use patterns on heart rhythm tracings (ECGs) to predict where abnormal heart rhythms originate, but these prediction methods were developed in people with normal heart structure. Patients with repaired Tetralogy of Fallot have hearts that developed differently, and cardiologists do not know if these prediction methods work accurately for them. In this study, the investigators will test whether three commonly used prediction methods work in Tetralogy of Fallot patients by pacing the heart from known locations during an already-scheduled heart procedure and comparing the predicted location to the actual location. Participation adds approximately 15 minutes to the procedure and does not require additional visits. The results will help cardiologists understand whether current methods can be trusted when planning treatments for abnormal heart rhythms in this patient population, or whether new prediction methods need to be developed.",[242,243],"Tetralogy of Fallot (TOF)","Ventricular Tachycardia","2026-06-04",{"date":246,"type":38},"2026-06-05",{"date":248,"type":23},"2026-07",{"date":250,"type":23},"2027-07",{"name":44,"class":45},{"id":253,"slug":254,"hasResults":12,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":12,"sex":18,"minAge":143,"maxAge":259,"enrollmentInfo":260,"targetDuration":4,"studyType":58,"phases":262,"briefSummary":265,"conditions":266,"keywords":276,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":286},"100609745","phase-2-double-blind-trial-of-everolimus-for-improving-social-abilities-in-pten-germline-mutations-100609745","NCT07218575","Double-Blind Trial of Everolimus for Improving Social Abilities in PTEN Germline Mutations","A Randomized, Placebo Controlled Double-Blind Trial of Everolimus for Improving Social Abilities in PTEN Germline Mutations","Inclusion Criteria:\n\n1. Diagnosis of PTEN Harmartoma Tumor Syndrom (PHTS), confirmed by genetic testing (the testing may be done as part of study screening)\n2. Experiences at least moderate levels of social difficulties, based on SRS T score \\> 60 (measured during screening Have at least a moderate impairment in social abilities, based on SRS score during study screening\n3. Fluent in English\n4. Females of child-bearing potential must have no plans to become pregnant and be using contraception during the study (if sexually active).\n5. Availability of parent, care-giver, partner or other suitable individual who can provide observation reports and provide transportation to attend clinic visits\n6. Adequate liver, kidney and bone-marrow function (checked during screening)\n7. Medically stable\n8. No plans to change school, behavioral therapies, home services or speech therapy during the study period\n9. Ability to swallow medicine in pill form\n\nExclusion Criteria:\n\n1. Ongoing or planned treatment with any medication with known or possible ant-mTOR activity (e.g. sirolimus), or strong inducers or inhibitors of CYP3A, CYP2D6, P450 or PgP (e.g. cyclosporine, ketoconazole, erythromycin, rifampin, phenytoin, phenobarbital) or ACE inhibitors\n2. Chronic treatment with systemic corticosteroids or other immunosuppressive treatments (topical or inhaled corticosteroids are allowed).\n3. Major surgery or any anti-cancer therapies (including radiotherapy) within 4 weeks of enrollment\n4. Neurosurgery within 6 months of enrollment\n5. Uncontrolled diabetes defined as HbA1c \\>8% despite treatment\n6. Uncontrolled hyperlipidemia (defined as fasting serum cholesterol \\> 300 mg\u002FdL OR \\>7.75 mmol\u002FL AND fasting triglycerides \\> 2.5 x ULN, assessed during screening)\n7. History of Hepatitis B, Hepatitis C or HIV\n8. Participation in a clinical trial in the 60 days prior to study entry\n9. Known intolerance or hypersensitivity to everolimus or other rapamycin analogs (e.g. sirolimus, temsirolimus)\n10. Patients who have a history of another primary malignancy, with the exceptions of non-melanoma skin cancer, and carcinoma in situ of the cervix, uteri, or breast from with the patient has been disease free for \\> 3 years","45 Years",{"count":261,"type":23},60,[263,264],"PHASE2","PHASE3","The goal of this study is to examine the safety and treatment effects of everolimus in adults and children with PTEN Hamartoma Tumor Syndrome (PHTS) who experience social difficulties. The study will measure if everolimus can safely improve social abilities and functioning in this study population.\n\nPTEN Hamartoma Tumor Syndrome (PHTS) is a genetic condition that results from alteration (germline variant) to the PTEN gene. It is associated with a wide range of symptoms and characteristics, which vary from individual to individual. These include symptoms such as harmatomas (non-cancerous lesions), an increased risk of certain types of cancer, having a larger than average head, and abnormalities in blood vessels. Some people also have neurobehavioral problems including social difficulties. It is estimated approximately 25% (1 in 4) of people with PHTS meet the criteria for an autism diagnosis.\n\nThe study lasts for one year. In the first 6 months half of participants will receive everolimus as a once daily oral tablet, and half will receive placebo tablets. For the second 6 months all participants will receive everolimus. Visits to the study clinic are required at the start, month 3, month 6, month 9 and month 12, with phone calls or virtual visits in between. Assessments include questionnaires, blood tests and urine tests, physical and neurological exams, and vital signs.\n\nEverolimus is an existing FDA approved medication used to treat other conditions, including a genetic condition called tuberous sclerosis complex which has some similarities to PHTS, and several types of cancer.",[267,268,269,270,271,272,273,274,275],"Cowden's Disease","Cowden's Syndrome","Lhermitte-Duclos Disease","Cerebellum Dysplastic Gangliocytoma","Bannayan Zonana Syndrome","Myhre Riley Smith Syndrome","Riley Smith Syndrome","PTEN Hamartoma Tumor Syndrome","Bannayan Riley Ruvalcaba Syndrome",[277,278],"PTEN mutation","Autism","2026-06-02",{"date":244,"type":38},{"date":282,"type":23},"2026-09-01",{"date":284,"type":23},"2030-09",{"name":44,"class":45},3,{"id":288,"slug":289,"hasResults":12,"nctId":290,"briefTitle":291,"officialTitle":291,"acronym":4,"eligibilityCriteria":292,"healthyVolunteers":12,"sex":18,"minAge":293,"maxAge":88,"enrollmentInfo":294,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":295,"conditions":296,"keywords":297,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":46},"100461185","implementation-of-a-consensus-based-discharge-protocol-for-preterm-infants-with-lung-disease-100461185","NCT05285345","Implementation of a Consensus-Based Discharge Protocol for Preterm Infants With Lung Disease","Inclusion Criteria:\n\n* Preterm infants born \\\u003C32 weeks with at least mild BPD, defined as 28 days of respiratory support after birth.\n* Efforts will be made to include a mix of infants with mild, moderate, and severe BPD, including infants discharged on oxygen.\n\nExclusion Criteria:\n\n* Discharge to a location other than home.\n* Infants with other congenital disease (cardiac, genetic, neurological) thought to contribute significantly to their respiratory disease.","0 Days",{"count":57,"type":23},"The researchers have worked to create consensus recommendations among national efforts to help with the transition and coordination of care for preterm infants with lung disease around discharge from the neonatal intensive care unit to home. This study looks to evaluate implementation of the recommendations at Boston Children's Hospital and referring NICU's (Beth Israel Deaconess Medical Center and Brigham and Women's Hospital). Specifically, the research team will be looking at follow-up rates, healthcare utilization, and parental satisfaction\u002Ffeedback with implementation of these guidelines.",[93],[93,298],"NICU Discharge","2026-05-31",{"date":279,"type":38},{"date":302,"type":38},"2023-09-27",{"date":304,"type":23},"2027-11",{"name":44,"class":45},{"id":307,"slug":308,"hasResults":12,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":4,"eligibilityCriteria":312,"healthyVolunteers":12,"sex":18,"minAge":88,"maxAge":313,"enrollmentInfo":314,"targetDuration":4,"studyType":58,"phases":316,"briefSummary":317,"conditions":318,"keywords":325,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":46},"100621323","phase-4-propofol-only-versus-dexmedetomidine-propofol-in-children-undergoing-magnetic-resonance-imaging-100621323","NCT07369128","Propofol-Only Versus Dexmedetomidine-Propofol in Children Undergoing Magnetic Resonance Imaging","A Randomized, Dose-Ranging Trial of Propofol-Only and Dexmedetomidine-Propofol in Children Undergoing Magnetic Resonance Imaging","Inclusion Criteria:\n\n* Patients presenting as outpatients, scheduled to receive an anesthetic for MRI of brain, body (spine, chest, abdomen, and\u002For pelvis) and\u002For extremity (arm and\u002For leg).\n* Patients must be a candidate for the sedation technique described in this study with a natural airway. This decision will be made by a staff member of the Department of Anesthesiology.\n* Between 1 and 12 years of age.\n* ASA status I, II, or III\n\nExclusion Criteria:\n\n* Inpatient at BCH\n* Diagnosis of a difficult airway, severe obstructive sleep apnea that is not compatible with spontaneous ventilation in a supine position, or requires an oral airway.\n* Congenital heart disease or history of dysrhythmia.\n* Taking digoxin or beta-blocker\n* Anxiolytic medication is ordered before the MRI (e.g., midazolam or ketamine).\n* History or a family (parent or sibling) history of malignant hyperthermia.\n* Allergy to or has a contraindication to propofol, lidocaine, or dexmedetomidine.\n* Tracheostomy or other mechanical airway device present\n* Received within the past 12 hours an oral or intravenous alpha-adrenergic, beta-adrenergic agonist, or antagonist drugs (e.g., clonidine, propranolol, albuterol).\n* Patient is not scheduled to receive anesthesia-sedation care or is noted to \"try-without anesthesia\" for the MRI\n* Patient has significant developmental or psychological delays\n* Patient scheduled for scan of duration \\\u003C30 minutes or \\>90 minutes","12 Years",{"count":315,"type":23},105,[180],"The most common imaging procedure requiring sedation\u002Fanesthesia for the pediatric population is magnetic resonance imaging (MRI). However, the optimal anesthetic\u002Fsedation plan has not been determined for these procedures. Historically, common medications have included the use of pentobarbital and propofol, but in 2015, publication in the New England Journal of Medicine highlighted the accumulating evidence for the possible neurotoxic effects of these types of anesthetics in animal models and a collection of epidemiologic studies in humans. Although these initial possibilities have since been proven as less of a concern, in the interim, data has shown that alternative sedative agents, such as dexmedetomidine, may not have the same neurotoxic effect and could possibly even provide neuroprotection. Dexmedetomidine also possesses other beneficial traits such as reducing risks of pulmonary atelectasis or upper airway collapse, typically found with the administration of propofol.\n\nA concern raised by previous studies has been the possibility that the addition of dexmedetomidine could increase recovery times, leading to disruptions in workflow. Although it has been shown that large doses of dexmedetomidine exposure may lead to longer PACU stays, it is uncertain whether a small dose of dexmedetomidine would have such a significant impact. Based on the investigators' pilot trial6, the investigators found that a bolus of 1 mcg\u002Fkg dose of dexmedetomidine with a bolus of titrated propofol of 2-3 mg\u002Fkg and an infusion of propofol of 100 mcg\u002Fkg\u002Fmin provided adequate sedation for successful scans, reduced propofol (infusion) exposure by 60%, and did not significantly increase recovery times.\n\nFinally, there is a paucity in literature for studies examining a range of doses subsequently; often, a control group is compared to a single, self-selected dose of choice. Here, the investigators hope to provide a range of doses to minimize selection bias in our study design and determine the dose that would provide the optimal sedation for these scans and minimize excess anesthetic exposure.",[319,320,321,322,323,324],"MRI Sedation","Pediatric Sedation","Propofol Dosage","Emergence Delirium, Anesthesia","Recovery Time","Dexmedetomidine",[326,327,328,329,330],"pediatrics","sedation","dexmedetomidine","propofol","MRI","2026-05-27",{"date":333,"type":38},"2026-05-29",{"date":335,"type":23},"2026-06",{"date":337,"type":23},"2028-03",{"name":44,"class":45},{"id":340,"slug":341,"hasResults":12,"nctId":342,"briefTitle":343,"officialTitle":343,"acronym":4,"eligibilityCriteria":344,"healthyVolunteers":12,"sex":18,"minAge":345,"maxAge":346,"enrollmentInfo":347,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":349,"conditions":350,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":352,"lastUpdatePostDateStruct":353,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":359,"locationsCount":46},"100607124","assessment-of-microvascular-circulation-in-the-pediatric-cardiac-surgery-patient-100607124","NCT07184476","Assessment of Microvascular Circulation in the Pediatric Cardiac Surgery Patient","Inclusion Criteria:\n\n* All patients with primary diagnosis of ventricular septal defect or tetrology of Fallot\n\nExclusion Criteria:\n\n* Critical airway, congenital genetic abnormality of the mouth\u002Ftongue","1 Day","17 Years",{"count":348,"type":23},40,"The pediatric cardiac surgery patient endures a tremendous number of physiologic alterations during surgery and cardiopulmonary bypass (CPB) that lasts well into the recovery period. Most of the hemodynamic data are assessed and treated with macrovascular assessment tools such as blood pressure and central venous line measures. Studies show there may be an incoherence of macrovascular to microvascular assessment; i.e. a patient with a stable macrovascular status may not be in the state of microvascular stability. The use of a handheld device called Cytocam incident dark-field (IDF) microcirculatory camera (Braedius Medical, Huizen, Netherlands) gives real-time video screening and data feedback to assess the microvasculature in the hemodynamically labile patient.",[351],"Tetrology of Fallot","2026-05-26",{"date":354,"type":38},"2026-05-28",{"date":356,"type":38},"2026-03-18",{"date":358,"type":23},"2027-03-17",{"name":44,"class":45},{"id":361,"slug":362,"hasResults":12,"nctId":363,"briefTitle":364,"officialTitle":365,"acronym":4,"eligibilityCriteria":366,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":367,"enrollmentInfo":368,"targetDuration":4,"studyType":58,"phases":369,"briefSummary":370,"conditions":371,"keywords":373,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":352,"lastUpdatePostDateStruct":374,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":379,"locationsCount":46},"100599662","striae-distensae-treatment-using-deep-skin-abrasion-100599662","NCT07087405","Striae Distensae Treatment Using Deep Skin Abrasion","Stretch Mark Treatment Using Subcutaneous Skin Abrasion","Inclusion Criteria:\n\n* Striae distensae\n\nExclusion Criteria:\n\n* Smoking\n* coagulation deficiency","70 Years",{"count":167,"type":23},[60],"The goal of this clinical trial is to learn if a device works to treat striae distensae. It will also learn about the safety of the device. The main questions it aims to answer are:\n\n1. Does the device improve the appearance of striae distensae?\n2. Does the device cause any problems when treating striae distensae? Researchers will compare the appearance of striae distensae before and after treatment with the device.\n\nParticipants will:\n\n1. Undergo treatment with the device in the clinic\n2. Visit the clinic 1 week, 3 months, and 1 year for checkups and tests",[372],"Striae Distensae",[372],{"date":354,"type":38},{"date":376,"type":38},"2025-10-01",{"date":378,"type":23},"2026-12-01",{"name":44,"class":45},{"id":381,"slug":382,"hasResults":12,"nctId":383,"briefTitle":384,"officialTitle":384,"acronym":4,"eligibilityCriteria":385,"healthyVolunteers":12,"sex":18,"minAge":386,"maxAge":387,"enrollmentInfo":388,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":390,"conditions":391,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":396,"completionDateStruct":398,"leadSponsor":400,"locationsCount":46},"100397498","mechanisms-of-increased-disease-severity-in-ad-patients-with-the-il-4ra-r576-polymorphism-100397498","NCT04455906","Mechanisms of Increased Disease Severity in AD Patients With the IL-4Ra R576 Polymorphism","Inclusion Criteria:\n\n1. Male or female participants ≥6 to 65 yrs of age\n2. Meet AD Standard Diagnostic Criteria\n\nExclusion Criteria:\n\n1. Enrollment in another clinical trial\n2. Hypersensitivity to an agent used for the skin decolonization protocol\n3. Use within 4 weeks of systemic treatment with immunosuppressive\u002Fimmunomodulating drugs (corticosteroids, cyclosporine, mycophenolate, JAK inhibitors, azathioprine, methotrexate)\n4. Phototherapy for AD within 4 weeks\n5. Treatment with biologics (dupilumab, omalizumab, benralizumab, etc) within sixteen weeks\n6. Use of topical steroids, topical calcineurin inhibitors or crisaborale within 7 days\n7. Bleach baths within 7 days of the first Visit\n8. Use of oral or topical antibiotics within 21 days of the beginning of the study\n9. Asthmatics receiving more than 500 μg per day of inhaled corticosteroids\n10. History of (HIV, hepatitis B, hepatitis C, tuberculosis malignancy\n11. Skin comorbidities that may interfere with assessments: psoriasis, cutaneous T Cell lymphoma,,\n12. Severe ongoing medical illnesses e.g. cardiovascular, renal disease, autoimmune disease.\n13. Febrile illness at time of visits\n14. Suspected immune deficiency or family history of primary immunodeficiency","6 Years","65 Years",{"count":389,"type":23},111,"This protocol is primarily looking to see if the IL-4Ra R576 polymorphism is associated with increased clinical, immunological and microbial markers of disease activity in patients with Atopic dermatitis.",[392],"Atopic Dermatitis","2026-05-15",{"date":395,"type":38},"2026-05-18",{"date":397,"type":38},"2020-11-30",{"date":399,"type":23},"2027-09-15",{"name":44,"class":45},{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":405,"acronym":4,"eligibilityCriteria":406,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":407,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":408,"conditions":409,"keywords":413,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":423,"locationsCount":46},"100229949","using-microbial-genomics-to-elucidate-the-source-of-central-line-associated-bloodstream-infections-100229949","NCT02271243","Using Microbial Genomics to Elucidate the Source of Central-line Associated Bloodstream Infections","Inclusion Criteria:\n\n* Hospitalized at Boston Children's Hospital\n* Central venous catheter of any type including peripherally inserted central catheters (PICC) in any location.\n* Laboratory-confirmed bloodstream infection (LCBI) diagnosed by a clinical blood culture growing certain Gram-negative rods\n\nExclusion Criteria:\n\n* Patients with CDC-defined secondary bloodstream infections",{"count":261,"type":23},"Central line-associated bloodstream infections (CLABSIs) are the most common healthcare-associated infection in children and are associated with morbidity and mortality. This study will attempt to identify the source of bloodstream infections (BSIs) in children with CLABSI because we hypothesize that many of the BSIs that are currently classified as CLABSIs are actually laboratory-confirmed bloodstream infections (LCBI) that may be a result of mucosal barrier injury (MBI), also known as MBI-LCBI. In order to study this, we will isolate bacteria from multiple body sites of children that have BSI in order to compare these bacteria to the strain growing in their blood using whole-genome DNA sequencing. We will also evaluate biomarkers of MBI of the respiratory tract and GI tract.",[410,411,412],"Laboratory-confirmed Bloodstream Infection","Central Line-associated Bloodstream Infections","Mucosal Barrier Injury",[414,415,416],"Central line-associated bloodstream infections","mucosal barrier injury","laboratory-confirmed bloodstream infection","2026-05-13",{"date":393,"type":38},{"date":420,"type":38},"2014-11",{"date":422,"type":23},"2027-12",{"name":44,"class":45},{"id":425,"slug":426,"hasResults":12,"nctId":427,"briefTitle":428,"officialTitle":428,"acronym":429,"eligibilityCriteria":430,"healthyVolunteers":12,"sex":18,"minAge":431,"maxAge":19,"enrollmentInfo":432,"targetDuration":4,"studyType":58,"phases":434,"briefSummary":435,"conditions":436,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":440,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":446,"locationsCount":46},"100543465","gf-nourish-gluten-free-nutrition-optimization-through-ultra-processed-food-reduction-and-improved-strategies-for-health-100543465","NCT06356220","GF-NOURISH (Gluten Free Nutrition Optimization Through Ultra-processed Food Reduction and Improved Strategies for Health)","GF-NOURISH","Inclusion Criteria:\n\n* Age 2-18 years of age with recent celiac disease diagnosis\n\nExclusion Criteria:\n\n* Allergic to \\\u003C3 of the top 8 food allergens\n* Co-morbid conditions treated with dietary modifications or that influence nail arsenic values","2 Years",{"count":433,"type":23},120,[60],"The investigators propose the Gluten Free Nutrition Optimization through Ultra-processed food Reduction and Improved Strategies for Health (GF-NOURISH) study to demonstrate the feasibility and success of a nutritional education program focused on naturally occurring gluten-free foods and minimizing ultra-processed gluten-free foods. The investigators hypothesize that nutritional educational (GF-NOURISH) intervention will have multiple health benefits",[437,438],"Celiac Disease in Children","Nutrition Disorder, Child","2026-05-08",{"date":441,"type":38},"2026-05-12",{"date":443,"type":38},"2025-04-29",{"date":445,"type":23},"2026-12",{"name":44,"class":45},{"id":448,"slug":449,"hasResults":12,"nctId":450,"briefTitle":451,"officialTitle":452,"acronym":4,"eligibilityCriteria":453,"healthyVolunteers":12,"sex":18,"minAge":345,"maxAge":313,"enrollmentInfo":454,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":456,"conditions":457,"keywords":459,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":465,"startDateStruct":466,"completionDateStruct":468,"leadSponsor":470,"locationsCount":46},"100492065","application-of-a-clinical-decision-support-system-to-reduce-mechanical-ventilation-duration-after-cardiac-surgery-in-children-100492065","NCT05687292","Application of a Clinical Decision Support System to Reduce Mechanical Ventilation Duration After Cardiac Surgery in Children","Application of a Clinical Decision Support System to Reduce Mechanical Ventilation Duration After Cardiac Surgery","Inclusion Criteria:\n\n* Children \\\u003C 12 years old\n* Post-cardiac surgery\n* Receiving mechanical ventilation for ≥ 48 hours in the Cardiac Intensive Care Unit at Boston Children's Hospital following surgery\n\nExclusion Criteria:\n\n* Premature infants (\\\u003C37 weeks' gestation)\n* Weight \\\u003C 2kg\n* Baseline ventilator (via tracheostomy) or noninvasive positive pressure dependence",{"count":455,"type":23},330,"The goal of this study is to evaluate the impact of a clinical decision support system (CDSS) in children receiving mechanical ventilation (MV) after surgery for congenital heart disease (CHD). The main question it aims to answer is:\n\n-What is the impact of a CDSS designed to facilitate weaning and discontinuation of MV on the duration of MV in post-operative congenital cardiac surgery patients?\n\nParticipants will be identified as eligible to initiate weaning from mechanical ventilation. Providers will decide whether or not to initiate weaning based on recommendations provided by the CDSS. Researchers will compare patients exposed to the CDSS with a historical cohort to see if the CDSS facilitated a decrease in MV duration.",[458],"Congenital Heart Disease",[460,461,462,326,463],"cardiac surgery","congenital heart disease","critical care","mechanical ventilation","2026-05-07",{"date":441,"type":38},{"date":467,"type":38},"2024-11-18",{"date":469,"type":23},"2027-03-01",{"name":44,"class":45},{"id":472,"slug":473,"hasResults":12,"nctId":474,"briefTitle":475,"officialTitle":476,"acronym":477,"eligibilityCriteria":478,"healthyVolunteers":12,"sex":18,"minAge":431,"maxAge":4,"enrollmentInfo":479,"targetDuration":4,"studyType":58,"phases":481,"briefSummary":482,"conditions":483,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":485,"startDateStruct":487,"completionDateStruct":489,"leadSponsor":491,"locationsCount":492},"100391727","phase-2-extended-vs-short-term-abatacept-dosing-for-graft-versus-host-disease-prophylaxis-100391727","NCT04380740","Extended vs Short-term Abatacept Dosing for Graft Versus Host Disease Prophylaxis","A Randomized Double-Blind Trial of Abatacept Extended Dosing Versus Abatacept Short-term Dosing for Graft Versus Host Disease Prophylaxis: \"ABA3\"","ABA3","Inclusion Criteria:\n\n1. Must be at least 2 years old and weigh 10 kg.\n2. Must have a willing unrelated adult donor (bone marrow or peripheral blood). Donors may have a single mismatch (i.e. be a 7\u002F8) and this mismatch may be at the allele or antigen level; however, donors with allele level disparity should be given preference over those with antigen level disparity. Patients for whom a donor is available with disparity only in the host versus graft direction (because of recipient homozygosity), will not be eligible, since this mismatching does not increase the risk for GVHD. Centers may perform extended typing (e.g. DQB1 and DPB1) according to institutional practices and use these results in selecting donors; however, it is recommended that this extending typing be used only to select between donors who are equally well matched with the recipient at the A, B, C and DRB1.\n3. All patients and\u002For their parents or legal guardians must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.\n4. Must have a hematologic malignancy treatable by HCT (except for those stipulated below under study Exclusion Criteria), which is in remission by standard testing (no patients in relapse will be included).\n5. Patients with an inherited predisposition to leukemia or otherwise hematologic malignancies that have not been associated with predisposition to transplant morbidities or non-hematologic cancers.\n6. Karnofsky performance score or Lanskey Play-Performance Scale score \\>\u002F= 80.\n\n   * If the patient does not meet defined eligibility requirements, the PI\u002Fstudy committee must be contacted to determine eligibility.\n\nExclusion Criteria:\n\n1. Patients with the following hematologic malignancies will be excluded: Chronic Lymphocytic Leukemia, Myeloma and Primary Myelofibrosis.\n2. Active Relapse (\\>5% blasts) of their primary malignancy.\n3. For patients with Acute Lymphocytic Leukemia (ALL) with pre-transplant MRD testing performed as standard practice at the treating institution, patients with MRD \\>0.01% will be ineligible.\n4. For patients with Acute Myeloid Leukemia (AML) with pre-transplant MRD testing as standard of practice at the treating institution, patients with any MRD status are eligible and should be enrolled at the discretion of provider.\n5. For patients with MDS, those with \\>5% blasts will be excluded.\n6. Prior allogeneic HCT.\n7. Uncontrolled viral, bacterial, fungal or protozoal infection at the time of study enrollment.\n8. HIV infection.\n9. Serious psychiatric disease including schizophrenia, bipolar disorder and severe depression.\n10. Prisoners or others who are compulsorily detained.\n11. Any patient with a known or suspected inherited predisposition to cancer should be discussed with the study team prior to screening for eligibility.\n\n    1. Patients with a known inherited or constitutional predisposition to transplant morbidities, including, but not limited to Fanconi Anemia, Dyskeratosis Congenita, Shwachman-Diamond Syndrome and Down Syndrome will be excluded.\n    2. Patients with known inherited or constitutional predisposition to non-hematologic cancers including, but not limited to Li-Fraumeni syndrome, BRCA1 and BRCA2 mutations will be excluded.\n12. Patients with active non-hematological malignancies (except non-melanoma skin cancers) or those with non-hematological malignancies (except non-melanoma skin cancers) who have been rendered with no evidence of disease, and are disease free for \\\u003C2 years.\n13. Incompletely treated active tuberculosis Infection.\n14. Pregnancy (positive serum b-HCG) or breastfeeding.\n15. Estimated GFR of \\\u003C 50 mL\u002Fmin\u002F1.73m2.\n16. Cardiac ejection fraction \\\u003C 50 (using M-Mode if assessment is done by ECHO)\n17. T.bilirubin \\> 2 × upper limit of normal or ALT \\> 4 × upper limit of normal or unresolved veno-occlusive disease.\n18. Pulmonary disease with FVC, FEV1 or DLCO parameters \\\u003C45% predicted (corrected for hemoglobin) or requiring supplemental oxygen. Children who are developmentally unable to perform pulmonary function testing will be assessed solely on their need for supplemental oxygen.\n19. Presence of antibodies to a mismatched donor HLA antigen (please refer to Section 3.4.g).\n20. Patients who have developed severe AGVHD, severe CGVHD or relapse will be excluded at the time of randomization.\n21. Exclusion Criteria Prior to Randomization (prior to 5th dose of abatacept\u002Fplacebo):\n\n    1. Severe allergic reaction during the first 4 doses of abatacept\n    2. If any clinical events occur that preclude further dosing of abatacept, those patients will be deemed ineligible for randomization",{"count":480,"type":23},160,[263],"This is a multicenter randomized, double blind, Phase 2 trial for patients receiving transplants from 7 of 8 HLA matched donors, in which an extended dosing regimen of abatacept, and a short-term dosing regimen + placebo, when added to standard calcineurin inhibitor + methotrexate-based prophylaxis, will be compared for their ability to improve outcomes in patients with a minimum follow-up of one year post-transplant. All patients will receive 4 doses of abatacept (Days -1, +5, +14, +28). Prior to the fifth dose, patients will be randomly assigned to the 4-dose abatacept arm and receive 4 doses of placebo or 8-dose abatacept arm and receive 4 more doses of abatacept. The primary endpoint of the study will be severe AGVHD-free, severe CGVHD-free, relapse-free survival (SGRFS). The study will end when the last patient has reached 2 years after transplant. Results will first be calculated and the study unblinded when the last patient has reached one year post-transplant.",[484],"Graft Vs Host Disease",{"date":486,"type":38},"2026-05-11",{"date":488,"type":38},"2022-03-30",{"date":490,"type":23},"2028-06",{"name":44,"class":45},15,{"id":494,"slug":495,"hasResults":12,"nctId":496,"briefTitle":497,"officialTitle":497,"acronym":4,"eligibilityCriteria":498,"healthyVolunteers":139,"sex":112,"minAge":499,"maxAge":4,"enrollmentInfo":500,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":501,"conditions":502,"keywords":504,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":512,"startDateStruct":514,"completionDateStruct":516,"leadSponsor":518,"locationsCount":46},"100636909","pharmacokinetic-and-pharmacodynamic-investigations-of-fetal-anesthesia-during-maternal-fetal-surgery-100636909","NCT07571811","Pharmacokinetic and Pharmacodynamic Investigations of Fetal Anesthesia During Maternal Fetal Surgery","Inclusion Criteria:\n\n* Pregnant and undergoing maternal-fetal surgery requiring clinically indicated fetal anesthesia and planned fetal blood sampling as part of usual fetal care\n* Fetus is with or without congenital heart disease\n\nExclusion Criteria:\n\n* Patient or fetus have any known liver or kidney disease\n* Patient or fetus has any known allergy to fentanyl, rocuronium, or atropine\n* Patient has taken inhibitors, inducers or substrates of CYP3A4 other than midazolam (including erythromycin, ranitidine, verapamil, antihistamines, and dextromethorphan) within 24 hours of surgery.","13 Years",{"count":167,"type":23},"This study examines how three medications commonly used during fetal surgery, fentanyl, rocuronium, and atropine, behave in the fetus. The primary goal is to understand their pharmacokinetics (how the drugs are absorbed, distributed, and cleared), pharmacodynamics (how they affect fetal physiology), and how they transfer between mother and fetus through the placenta. The secondary goal is to measure drug levels in discarded fetal blood samples collected during clinically indicated procedures and relate those levels to fetal heart rate, heart rate variability, movement, gestational age, and fetal size. An optional maternal blood draw component will allow comparison of maternal and fetal drug concentrations to better understand placental transfer. The study does not change clinical care or require extra fetal procedures, and findings may help create safer, evidence-based fetal anesthesia dosing strategies tailored to gestational age.",[503],"Fetal Anesthesia",[505,506,507,508,509,510],"fetal anesthesia","fetal","intrauterine","fetal cardiac intervention","iut","intrauterine transfusion","2026-04-30",{"date":513,"type":38},"2026-05-06",{"date":515,"type":23},"2026-05-01",{"date":517,"type":23},"2027-05-01",{"name":44,"class":45},{"id":520,"slug":521,"hasResults":12,"nctId":522,"briefTitle":523,"officialTitle":523,"acronym":4,"eligibilityCriteria":524,"healthyVolunteers":12,"sex":18,"minAge":525,"maxAge":526,"enrollmentInfo":527,"targetDuration":4,"studyType":58,"phases":528,"briefSummary":529,"conditions":530,"keywords":532,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":538,"startDateStruct":540,"completionDateStruct":542,"leadSponsor":543,"locationsCount":46},"100558808","promoting-resilience-among-adolescents-and-young-adults-with-sickle-cell-disease-100558808","NCT06555939","Promoting Resilience Among Adolescents and Young Adults With Sickle Cell Disease","Inclusion Criteria:\n\n* Aged ≥ 8 and ≤ 25 years of age at baseline\n* Diagnosed with Sickle Cell Disease (HbSS, HbSC, HbS-Beta Thalassemia, and other related hemoglobinopathies)\n* Receiving Medical Care at the DFCI\u002FBCH Blood Disorders Center.\n* Scored \\> 9 on Patient Health Questionnaire 9-item (PHQ-9) or Generalized Anxiety Disorder (GAD)\n* Able to speak English or Spanish language (for PRISM sessions)\n* Able to read English or Spanish language (for completion of surveys)\n* Cognitively able to participate in PRISM sessions and complete written questionnaires and surveys, as judged by the site investigator\n* Willing and able to adhere to the study visit schedule and other protocol requirements\n\nExclusion Criteria:\n\n\\* does not meet above criteria","8 Years","25 Years",{"count":7,"type":23},[60],"Adolescents and young adults with sickle cell disease (SCD) face challenges managing their illness and maintaining their well-being. This study proposes to test the feasibility and acceptability of a resilience-promoting intervention through a Collaborative Care Model. The primary goal is to determine with the resilience intervention (PRISM) is feasible and acceptable for adolescents and young adults with SCD. Exploratory outcomes include whether this intervention improves depression, anxiety, and pain interference.",[531],"Sickle Cell Disease",[533,534,535,536,537],"adolescents","young adults","resilience","sickle cell disease","collaborative care",{"date":539,"type":38},"2026-05-05",{"date":541,"type":38},"2025-10-23",{"date":284,"type":23},{"name":44,"class":45},{"id":545,"slug":546,"hasResults":12,"nctId":547,"briefTitle":548,"officialTitle":548,"acronym":549,"eligibilityCriteria":550,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":19,"enrollmentInfo":551,"targetDuration":4,"studyType":58,"phases":553,"briefSummary":554,"conditions":555,"keywords":559,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":563,"lastUpdatePostDateStruct":564,"startDateStruct":565,"completionDateStruct":567,"leadSponsor":569,"locationsCount":570},"100600660","balloon-inflation-time-for-esophageal-strictures-bites-a-randomized-multi-center-study-100600660","NCT07100379","Balloon Inflation Time for Esophageal Strictures (BITES): A Randomized Multi-Center Study","BITES","Inclusion Criteria:\n\n* Diagnosed with esophageal atresia with and without tracheoesophageal fistula, surgically repaired esophageal atresia, esophageal anastomotic strictures requiring endoscopic balloon dilation, and at least 1 endoscopic balloon dilation for esophageal anastomotic strictures within a 6 month period.\n\nExclusion Criteria:\n\n* Patients who need endoscopic incisional therapy to manage anastomotic stricture during their first follow up endoscopy, patients requiring administration of intralesional steroid within 4 weeks of repair, have no follow up endoscopy within 6 months period, have any anastomosis type other than esophago-esophageal (e.g. jejunal or colonic interposition), and\u002For failure to meet target dilation time.",{"count":552,"type":23},128,[60],"Esophageal atresia (EA) is one of the most common gastrointestinal congenital anomalies that affects 1 in 2500 to 1 in 4000 live births. It is characterized by abnormal development of the esophagus, which requires surgical intervention to be compatible with life. Surgical repair of EA is associated with risk of developing esophageal strictures or narrowing, which nearly affects 40% of cases. Strictures can be treated using endoscopic balloon dilation, which consists of introducing a catheter with a balloon into the esophagus via endoscopy and positioning it across stricture followed by balloon inflation. The inflated balloon is held in position for a set amount of time with the goal to dilate the narrowed area. At this time there are no pediatric studies comparing difference balloon dilation times and outcomes. Our study's goal is to evaluate balloon dilation inflation time in treating esophageal anastomotic strictures to understand if inflation time is associated with outcome.",[556,557,558],"Esophageal Atresia With Tracheo-esophageal Fistula","Esophageal Atresia","Esophageal Strictures",[560,561,562],"endoscopic balloon dilation","post-surgical correction","esophageal strictures","2026-04-27",{"date":511,"type":38},{"date":566,"type":38},"2025-10-28",{"date":568,"type":23},"2028-06-24",{"name":44,"class":45},2,{"id":572,"slug":573,"hasResults":12,"nctId":574,"briefTitle":575,"officialTitle":576,"acronym":577,"eligibilityCriteria":578,"healthyVolunteers":12,"sex":18,"minAge":525,"maxAge":176,"enrollmentInfo":579,"targetDuration":4,"studyType":58,"phases":581,"briefSummary":582,"conditions":583,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":585,"lastUpdatePostDateStruct":586,"startDateStruct":587,"completionDateStruct":588,"leadSponsor":589,"locationsCount":4},"100584157","cognitive-control-and-metacognition-training-100584157","NCT06885684","Cognitive Control and Metacognition Training","Developing Cognitive Control and Metacognition to Reduce the Functional Impact of Restricted and Repetitive Behaviors in Autism","CoMeT","Inclusion Criteria:\n\n* Children should be 8 to 11 years of age\n* Children should have an existing diagnosis of an autism spectrum disorder, which will be confirmed using research measures and criteria\n* Children must have general cognitive ability in the average range or above (above 80 using the Wechsler Abbreviated Scale of Intelligence-2 Full Scale IQ)\n* Caregivers and children must be fluent in English or Spanish\n\nExclusion Criteria:\n\n* Children must not have a known genetic condition related to autism (e.g., Fragile X)\n* Children must not have medical conditions\u002Finjuries, exposure to substances, or significant deprivation with implications for the central nervous system or that require regular psychoactive medications that alter EEG responses (anticonvulsants, barbiturates) \\*\n* Children must not have seizures or a seizure disorder (other than history of febrile seizures)\n* Children must not have significant sensory or motor impairment or major physical abnormalities that would limit the ability to participate in table top or EEG testing, or make responding during computer activities difficult\n* Children must not have a failed screening for colorblindness",{"count":580,"type":23},95,[60],"95 autistic children (ages 8-11yrs) will be randomly assigned to a novel computer-based Cognitive Control Training combined with Metacognition Coaching or to a comparison group that receives the intervention after a delay. Before and after intervention, electroencephalography (EEG) will be used to examine engagement of the target neural responses.",[278,584],"Autism Spectrum Disorder","2026-04-22",{"date":563,"type":38},{"date":127,"type":23},{"date":130,"type":23},{"name":44,"class":45},{"id":591,"slug":592,"hasResults":12,"nctId":593,"briefTitle":594,"officialTitle":595,"acronym":4,"eligibilityCriteria":596,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":597,"targetDuration":4,"studyType":58,"phases":599,"briefSummary":600,"conditions":601,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":585,"lastUpdatePostDateStruct":604,"startDateStruct":605,"completionDateStruct":607,"leadSponsor":609,"locationsCount":46},"100569964","molecular-genetic-mechanisms-of-infantile-epilepsies-and-the-impact-of-genetic-diagnosis-100569964","NCT06701084","Molecular Genetic Mechanisms of Infantile Epilepsies and the Impact of Genetic Diagnosis","Molecular Genetic Mechanisms of Infantile Epilepsies and the Impact of Genetic Diagnosis: Gene-Shortening Time of Evaluation in Pediatric Epilepsy Services (Gene-STEPS)","Infant Criteria\n\nInclusion Criteria:\n\n* Seizure onset at less than 12 months of age\n* Enrollment within 6 weeks of seizure-related presentation\n* Patient at Boston Children's Hospital\n\nExclusion Criteria:\n\n* Simple febrile seizures\n* Acute provoked seizures (e.g., due to sepsis, hemorrhage, electrolyte abnormality, cerebral infarction, hypoxic ischemic encephalopathy, non-accidental injury)\n* Genetic or acquired cause of epilepsy already identified, including brain magnetic resonance imaging findings consistent with a specific genetic etiology (e.g., tuberous sclerosis complex)\n* Deceased prior to enrollment\n\nParent Criteria Inclusion Criteria - Parent of eligible infant (see above)\n\nExclusion Criteria\n\n\\- Not the legal guardian of the eligible infant",{"count":598,"type":23},600,[60],"The goal of this study is to discover new genetic causes of infantile epilepsies and evaluate the impact of these discoveries on infants with epilepsy and their families.",[602,603],"Neonatal Epilepsy","Infantile Epilepsy",{"date":563,"type":38},{"date":606,"type":38},"2021-09-02",{"date":608,"type":23},"2029-11",{"name":44,"class":45},{"id":611,"slug":612,"hasResults":12,"nctId":613,"briefTitle":614,"officialTitle":615,"acronym":616,"eligibilityCriteria":617,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":618,"targetDuration":4,"studyType":58,"phases":619,"briefSummary":620,"conditions":621,"keywords":623,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":626,"lastUpdatePostDateStruct":627,"startDateStruct":629,"completionDateStruct":631,"leadSponsor":633,"locationsCount":46},"100624166","piloting-the-competence-in-romance-and-understanding-sexual-health-curriculum-100624166","NCT07406100","Piloting the Competence in Romance and Understanding Sexual Health Curriculum","A Pilot Investigation of the Competence in Romance and Understanding Sexual Health Curriculum","CRUSH","Inclusion Criteria:\n\n* 18;0 to 30;11 years old;\n* Either documentation of a prior diagnosis of autism spectrum disorder or receipt of services based on an autism spectrum diagnosis OR self identification as being autistic \u002F on the autism spectrum and meeting the clinical cut-off on either the Autism Diagnostic Observation Schedule or the Autism Spectrum Quotient;\n* Ability to provide consent for the protocol and understand task demands. The Wechsler Abbreviated Scale of Intelligence, Second Edition (WASI-2) may be used to confirm cognitive level. In prior work, adults with full scale IQ of 70 or above on the WASI-2 typically meet this criterion, but a licensed clinician will review individuals who fall below an IQ of 70 on an individual basis to determine eligibility;\n* Fluent in English.\n\nExclusion Criteria:\n\n* Non-English-speaking participants (less than 50% of speech in English);\n* Known genetic etiology of ASD (e.g., Fragile X);\n* Major mental illness (e.g., bipolar disorder, schizophrenia, or psychosis);\n* Medical conditions that impact sexual function (e.g., pituitary tumor);\n* Significant sensory, motor, or physical conditions that would prevent valid participation in assessments or intervention;\n* Live more than 50 miles from the site in Brookline, MA where intervention and assessment sessions will be offered.\n* Receipt of other sexual health\u002Fdating curricula as an adult.",{"count":348,"type":23},[60],"The goal of this clinical trial is to learn whether the CRUSH curriculum is possible (feasible), whether it fits the needs of the adults it is designed for (acceptable), and shows initial signs of being helpful (efficacious). CRUSH is a group-based behavioral intervention plus 1-1 coaching designed to provide sexual education and improve the skills of autistic adults for intimate relationships.\n\nThe main goals of the project are to:\n\n* Evaluate the feasibility and acceptability of the CRUSH curriculum in the context of a clinical trial with a waitlist control condition.\n* Initial exploration of how the CRUSH curriculum works and whether it is helpful.\n\nParticipants will complete:\n\n* A screening call.\n* Confirmation of clinical characteristics (autism features, language ability, cognitive ability).\n* 3 visits to assess knowledge and behaviors related to dating and sexual health at each point throughout the training curriculum (before beginning, midway, and after finishing).\n* 20 sessions of the CRUSH curriculum plus 1-1 coaching sessions. After each session, provide feedback about the session.",[278,622,584],"Autism Disorder",[624,625],"sexual health","romantic relationships","2026-04-21",{"date":628,"type":38},"2026-04-24",{"date":630,"type":38},"2026-04-01",{"date":632,"type":23},"2027-07-31",{"name":44,"class":45},{"id":635,"slug":636,"hasResults":12,"nctId":637,"briefTitle":638,"officialTitle":639,"acronym":4,"eligibilityCriteria":640,"healthyVolunteers":139,"sex":18,"minAge":499,"maxAge":346,"enrollmentInfo":641,"targetDuration":4,"studyType":58,"phases":643,"briefSummary":644,"conditions":645,"keywords":648,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":626,"lastUpdatePostDateStruct":651,"startDateStruct":652,"completionDateStruct":654,"leadSponsor":655,"locationsCount":46},"100342680","comparison-of-residual-gastric-volume-between-children-who-drink-different-clear-oral-fluid-volume-100342680","NCT03741777","Comparison of Residual Gastric Volume Between Children Who Drink Different Clear Oral Fluid Volume","Comparison of Residual Gastric Volume Between Children Who Drink Different Clear Oral Fluid Volume Before Undergoing Elective Esophago-gastro-duodenoscopy (EGD) Procedure","Inclusion Criteria:\n\n* ASA classification: I and II\n* 13-17 years\n* IPD cases or the first OPD case\n* Scheduled for elective EGD procedure.\n* All participants, families or guardians will be fluent in English.\n\nExclusion Criteria:\n\n* Emergent EGD procedures\n* Patients with active upper GI bleeding\n* Patients who received preoperative oral medication\n* Patients who are diagnosed as GERD, achalasia or suspected to have gastroparesis status such as uncontrolled diabetes or end stage kidney disease.",{"count":642,"type":23},288,[60],"According to the American Society of Anesthesiologists (ASA) fasting guideline for patients undergoing elective surgery, the 2-hour fasting period is suggested for clear oral fluid (including water, pulp-free juice and tea or coffee without milk). This guideline does not give any suggestions for proper volume of clear oral fluid intake.\n\nThis study is a prospective randomized control trials in children aged 13 through 17 years who are scheduled for an elective upper GI endoscopy procedure in the Gastroenteral Procedure Unit (GPU) at Boston Children's Hospital. The participants will be randomly assigned into one of four groups: Group 1 will consume 3 ml\u002Fkg of clear fluid by mouth at 2-hour period before surgical scheduled time, Group 2 will consume 5 ml\u002Fkg, Group 3 will consume 7 ml\u002Fkg, and Group 4 will consume 10 ml\u002Fkg. The investigators plan to recruit 72 patients in each group and 288 patients for the whole study. Research team will collect patient's demographic data, vital signs, information about their EGD procedure. Then actual volume of the stomach content and acidity will be measured from the content that is suctioned from patient's stomach during upper GI endoscopy procedure.\n\nThe investigators believe that the information from this study will help establish a comprehensive NPO guideline.",[646,647],"Fasting","Gastric Emptying",[649,650],"NPO time","Gastric content",{"date":628,"type":38},{"date":653,"type":38},"2024-02-29",{"date":422,"type":23},{"name":44,"class":45},""]