[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Stanford University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":671},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,369,0,25,[9,48,71,93,117,140,162,197,227,254,275,295,318,341,361,384,414,440,498,524,543,561,585,616,646],{"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":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100547455","phase-1-autologous-cd22-car-t-cells-following-commercial-cd19-car-t-cells-in-b-cell-malignancies-100547455",false,"NCT06408194","Autologous CD22 CAR T Cells Following Commercial CD19 CAR T Cells in B Cell Malignancies","Phase I\u002FIb Clinical Trial of Autologous CD22 Chimeric Antigen Receptor (CAR) T Cells Following Commercial CD19 CAR T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies","Inclusion Criteria:\n\n1. Diagnosis of histologically confirmed relapsed\u002Frefractory (R\u002FR) B cell acute lymphoblastic leukemia (ALL)\n2. Must be eligible to receive commercial KYMRIAH® (tisagenlecleucel) according to FDA approved package insert (refractory disease or in second or later relapse)\n3. CD19 and CD22 expression must be demonstrated on malignant cells by immunohistochemistry or flow cytometry. CD19 and CD22 expression at any level of expression will be acceptable, as that is the standard for commercial KYMRIAH® (tisagenlecleucel) and the optimal level of CD22 expression is not well defined.\n4. Age: ≥ 1 year of age and ≤ 25 years and 364 days of age at time of enrollment.\n5. Performance Status: Participants \\> 16 years of age: Karnofsky ≥ 50%; Participants ≤ 16 years of age: Lansky scale ≥ 50%.\n6. Normal Organ and Marrow Function\n\n   * Absolute Neutrophil Count (ANC) ≥ 750\u002FuL\\*\n   * Platelet count ≥ 50,000\u002FuL\\*\n   * Absolute Lymphocyte Count ALC \\> 150\u002FuL\\*\n   * Adequate renal, hepatic, pulmonary and cardiac function defined as:\n\n     * Baseline oxygen saturation \\> 92% on room air\n     * Creatinine within ULN for age or Creatinine clearance (as estimated by Cockcroft Gault Equation) ≥ 60 mL\u002Fmin\n     * Total bilirubin ≤ 1.5 mg\u002Fdl, except in Participants with Gilbert's syndrome. \\[Elevations related to leukemia involvement of the liver will not disqualify a subject\\]\n     * Alanine Transaminase (ALT) or Aspartate Aminotransferase (AST) ≤ 10 x ULN (except in Participants with liver involvement by leukemia)\n     * Cardiac ejection fraction ≥ 40%, no evidence of pericardial effusion as determined by an Echocardiogram.\n     * if these cytopenias are not judged by the investigator to be due to underlying disease (i.e. potentially reversible with anti-neoplastic therapy); A subject will not be excluded because of pancytopenia ≥ Grade 3 if it is due to disease, based on the results of bone marrow studies.\n7. Participants with Central Nervous System (CNS) involvement or a history of CNS involvement are eligible only in the absence of neurologic symptoms that may mask or interfere with neurological assessment of toxicity\n8. Participants who have undergone autologous SCT with disease progression or relapse following SCT are eligible. Participants with history of allogeneic SCT must be at least 100 days from SCT, have no evidence of Graft versus Host Disease (GvHD), and no longer taking immunosuppressive agents for at least 30 days prior to enrollment.\n9. Females of child bearing potential and males of child fathering potential must be willing to practice birth control during and for 4 months post chemotherapy or for as long as Chimeric Antigen Receptor (CAR) T cells are detectable in peripheral blood.\n10. Females of child bearing potential must have negative pregnancy test.\n11. Must meet wash out period since prior therapies according to commercial KYMRIAH® (tisagenlecleucel) SOPs.\n12. Must have recovered from acute side effects from prior therapy to meet eligibility.\n13. If had prior CAR therapy, will be eligible if at least 30 days has elapsed prior to apheresis.\n14. Ability to give informed consent. All Participants ≥ 18 years of age must be able to give informed consent. For participants \\\u003C18 years old their legal authorized representative (LAR) (i.e. parent or guardian) must give informed consent. Pediatric participants will be included in age appropriate discussion and assent per institutional SOPs will be obtained for those \\> 7 years of age, when appropriate. If a minor becomes of age during participation of this study, he\u002Fshe will be asked to reconsent as an adult.\n\n    * A subject will not be excluded because of pancytopenia ≥ Grade 3 if it is felt by the investigator to be due to underlying disease.\n\nExclusion Criteria:\n\n1. May not have Human Immunodeficiency Virus (HIV)\u002FHepatitis B (HBV) or Hepatitis C (HCV infection) or uncontrolled, symptomatic, intercurrent illness.\n2. May not have hyperleukocytosis (≥ 50,000 blasts\u002FμL) or rapidly progressive disease that in the estimation of the investigator and sponsor would compromise ability to complete study therapy.\n3. May not have severe, immediate hypersensitivity reaction attributed to compounds of similar chemical or biologic composition to any agents used in study.\n4. May not have active CNS disorder, or history of MI, cardiac angioplasty or stenting, unstable angina or other clinically significant cardiac disease with 12 months of enrollment.\n5. May not have primary immunodeficiency or history of autoimmune disease (e.g. Crohns, rheumatoid arthritis, systemic lupus) requiring systemic immunosuppression\u002Fsystemic disease modifying agents within the last 2 years.","ALL","1 Year","25 Years",{"count":21,"type":22},28,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","The primary purpose of this study is to determine safety, feasibility, and the Maximum Tolerated Dose (MTD)\u002FRecommended Phase 2 Dose (RP2D) of CD22 Chimeric Antigen Receptor T-Cell Therapy (CART) cells when administered 28 to 42 days after an infusion of a commercial CAR called Tisagenlecleucel, to children and young adults with relapsed or refractory B-cell leukemia.",[28,29],"Leukemia","Acute Lymphoblastic Leukemia",[31,32,33,34],"KYMRIAH","CAR T","Tisagenlecleucel","Lymphodepletion","RECRUITING","2026-07-01",{"date":38,"type":39},"2026-07-02","ACTUAL",{"date":41,"type":39},"2024-05-13",{"date":43,"type":22},"2026-07",{"name":45,"class":46},"Stanford University","OTHER",1,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100406345","phase-1-kidney-and-hematopoietic-cell-transplants-using-a-regimen-to-promote-hematopoietic-cell-engraftment-100406345","NCT04571203","Kidney and Hematopoietic Cell Transplants Using a Regimen to Promote Hematopoietic Cell Engraftment","Phase I Study of Combined Deceased Donor Kidney and Hematopoietic Cell Transplants Using a Regimen to Promote Hematopoietic Cell Engraftment","Inclusion Criteria:\n\nRECIPIENT INCLUSION CRITERIA:\n\n1. Patient is ≥ 18 years old, and \\\u003C65 years of age.\n2. Has End Stage Renal Disease (ESRD) and is a de novo kidney transplant candidate part Stanford standard of care.\n3. Listed with the Organ Procurement and Transplantation Network (OPTN) for deceased donor transplantation.\n4. A serotypic (Human Leucocyte Antigen) HLA match with the donor of a least 1 locus in A, B or DR.\n5. Males and females of reproductive potential who agree to practice a reliable form of contraception for at least 1 year post transplant.\n6. Females have a negative serum pregnancy test.\n7. Ability to understand and the willingness to sign a written informed consent document. Patients must have signed informed consent to participate in the trial.\n8. No known contraindication to administration of rabbit ATG or low dose irradiation.\n\nDONOR INCLUSION CRITERIA:\n\n1. Brain dead donor aged ≥ 16 and ≤ 55\n2. Organ Procurement Organization (OPO) consent for vertebral body procurement\n3. Organ Procurement Organization consent for research\n4. Projected cold ischemia time \\\u003C24 hours.\n\nExclusion Criteria:\n\nRECIPIENT EXCLUSION CRITERIA:\n\n1. Known allergy to rabbit protein.\n2. History of malignancy with the exception of non melanoma skin malignancy.\n3. Pregnant woman or nursing mother.\n4. Body weight \\>90kg or BMI \\>35.\n5. Evidence of HIV 1\u002F2 antibody (Ab), HTLV 1 and HTLV 2 Ab (Human T-Lymphotropic Virus), Hepatitis B sAg (surface antigen), Hepatitis C Ab, or positive syphilis screen.\n6. EBV (Epstein Bar Virus)Ab positive donor to EBV Ab negative recipient.\n7. Active bacterial, viral or fungal infection defined as currently taking medication for the infection.\n8. Leukopenia (white blood cell count \\\u003C 3000\u002Fmm3) or thrombocytopenia (with a platelet count \\\u003C 100,000\u002Fmm3).\n9. Psychiatric disorder(s) or psychosocial circumstance(s) which in the opinion of the Stanford Transplant team caring for this potential patient would place the patient at an unacceptable risk.\n10. Concern for alcohol or other substance abuse.\n11. Kidney disease at high risk for post transplant recurrence: aHUS (atypical hemolytic- uremic syndrome) and C3 glomerulopathy\n12. Panel reactive antibody (PRA) \\>80%.\n13. Positive donor specific antibody (DSA).\n14. Prior or combined organ transplant.\n15. Patients with \\>5 pack year smoking history, smoking within 10 years of enrollment, or first degree relative with lung cancer.\n\nDONOR EXCLUSION CRITERIA:\n\n1. History of malignancy with the exception of non melanoma skin malignancy.\n2. History of autoimmune disease.\n3. Known medical diagnosis of Zika virus infection within the prior 6 months, including post mortem screening.\n4. Serological evidence of HIV, Hepatitis B (surface antigen positive), or Hepatitis C infection.\n5. Evidence of systemic infection.\n6. Kidney Donor Profile Index (KDPI) \\> 70%.","18 Years","65 Years",{"count":58,"type":22},30,[25],"This is a single arm phase 1 non randomized dose finding study for safety, feasibility and efficacy of deceased donor vertebral body (VB) marrow cell infusion and kidney transplantation.",[62],"Immune Tolerance","2026-06-29",{"date":36,"type":39},{"date":66,"type":39},"2022-05-06",{"date":68,"type":22},"2029-10-01",{"name":45,"class":46},2,{"id":72,"slug":73,"hasResults":12,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":23,"phases":79,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":87,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":47},"100382160","phase-2-mogamulizumab--low-dose-total-skin-electron-beam-tx-in-mycosis-fungoides--szary-syndrome-100382160","NCT04256018","Mogamulizumab + Low-Dose Total Skin Electron Beam Tx in Mycosis Fungoides & Sézary Syndrome","A Phase 2 Single Center, Single Arm, Open Label Mogamulizumab Combined Upfront With Low Dose Total Skin Electron Beam Therapy (LD TSEBT) in Patients With Mycosis Fungoides (MF) and Sézary Syndrome (SS)","Inclusion Criteria:\n\n* Stages IB-IV MF or SS\n\n  1. Stages IB-IV MF or SS\n  2. At least 1 prior standard-of-care therapy\n  3. Prior LD-TSEBT (\\> 3 months prior) and prior mogamulizumab is allowed, as long as progressive disease (PD) did not occur while on therapy, and did not discontinue due to toxicities\n  4. ≥ 18 years of age\n  5. ECOG performance status of 0 to 2\n  6. All clinically-significant toxic effects of prior cancer therapy resolved to Grade ≤ 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE, v 5.0).\n  7. MF and a known history of non-complicated staphylococcus colonization\u002Finfection is eligible provided that stable doses of prophylactic antibiotics continue.\n  8. The following minimum wash-out from previous treatments are required (prior to 1st day of treatment), if applicable.\n\n     • ≥ 2weeks for retinoids, interferons, Vorinostat, romidepsin, pralatrexate, or other systemic anti-cancer\u002FCTCL therapies\n\n     • ≥ 2 weeks for phototherapy, local radiation therapy\n\n     • ≥ 2 weeks for topical therapy (including topical steroid, retinoid, nitrogen mustard, or imiquimod)\n\n     • ≥ 12 weeks for total skin electron beam therapy\n\n     • \\> 12 weeks for alemtuzumab\n\n     • Rapidly progressive malignant disease may be enrolled prior to above periods after discussion with the Protocol Director.\n  9. Adequate hematologic function\n\n     • Absolute neutrophil count (ANC) ≥ 1,000 cells\u002FμL (≥ 1,000\u002Fmm3)\n\n     • Platelets ≥ 75,000 cells\u002FμL (≥ 75,000\u002Fmm3).\n  10. Adequate hepatic function\n\n      * Bilirubin ≤ 1.5 times the specific institutional upper limit of normal (ULN). Exception: If Gilbert's syndrome; then ≤ 5 times ULN.\n      * Aspartate transaminase (AST) and alanine transaminase (ALT) each ≤ 2.5 x ULN; or ≤ 5.0 x ULN in the presence of known hepatic involvement by CTCL.\n  11. Adequate renal function\n\n      • Calculated creatinine clearance ≥ 30 mL\u002Fmin using the Cockcroft-Gault formula.\n  12. If prior allogeneic hematopoietic stem cell transplant (HSCT), then must be free of graft-vs-host disease (GvHD) and receiving immunosuppressive therapy.\n  13. Women of childbearing potential (WOCBP) must have a negative pregnancy test.\n  14. WOCBP must agree to use effective contraception during the study and for 3 months after the last dose.\n  15. Male participants and their female partners of child bearing potential must be willing to use an appropriate method of contraception during the study and for 3 months after the last dose.\n\n      Exclusion Criteria:\n\n  \u003C!-- -->\n\n  1. MF with limited disease (Stage IA) or central nervous system (CNS) disease\n  2. Concomitant corticosteroid use. (with the exception that topical steroid and oral prednisone are allowed at ≤ 20 mg\u002Fday, if patient has been on a stable dose for at least 2 weeks prior to 1st day of treatment)\n  3. Pregnant or breastfeeding\n  4. Active autoimmune disease or history deemed by the investigator to be clinically significant\n  5. Known human immunodeficiency virus (HIV) positivity; or active hepatitis B or C.\n  6. Active herpes simplex or herpes zoster. Those receiving prophylaxis for herpes and who started taking medication at least 30 days prior to the Screening Visit, and have no active signs of active infection, and whose last active infection was more than 6 months ago, may enter the study, and should continue to take the prescribed medication for the duration of the study.",{"count":58,"type":22},[80],"PHASE2","The purpose of this study is to determine the efficacy of the combination of LD-TSEBT and mogamulizumab in patients with MF and SS. And to evaluate the secondary measures of clinical benefit of the combination therapy and to evaluate the safety and tolerability of the combination in patients with MF and SS.",[83,84],"Sezary Syndrome","Mycosis Fungoides",[86],"CTCL",{"date":36,"type":39},{"date":89,"type":39},"2020-03-30",{"date":91,"type":22},"2026-12",{"name":45,"class":46},{"id":94,"slug":95,"hasResults":12,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":56,"enrollmentInfo":100,"targetDuration":4,"studyType":23,"phases":102,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":111,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":70},"100358144","phase-1-tli-tbi-atg--hematopoietic-stem-cell-transplantation-and-recipient-t-regs-therapy-in-living-donor-kidney-transplantation-100358144","NCT03943238","TLI, TBI, ATG & Hematopoietic Stem Cell Transplantation and Recipient T Regs Therapy in Living Donor Kidney Transplantation","Phase 1 Study of Total Lymphoid Irradiation, Total Body Irradiation, Anti-Thymocyte Globulin and Purified Donor CD34+, T-cell and Recipient T Regulatory Cell Transfusion in Human Leukocyte Antigen Mismatched Living Donor Kidney Transplantation","Inclusion Criteria:\n\n1. All consenting adults who are 18 to 65 years, living donor renal transplant recipients at Stanford University Medical Center or Northwestern Medicine who have a haplotype matched (minimum single Human Leukocyte Antigen - DR locus (HLA-DR) and HLA-A or B match) living related or unrelated donor.\n2. Patients who agree to participate in the study and sign an Informed Consent.\n3. Patients who have no known contraindication to administration of rabbit ATG or radiation.\n4. Males and females of reproductive potential who agree to practice a reliable form of contraception for at least 1 year posttransplant\n\nExclusion Criteria:\n\n1. Previous treatment with rabbit ATG or a known allergy to rabbit proteins.\n2. History of malignancy with the exception of non-melanoma skin malignancies.\n3. Pregnant women or nursing mothers.\n4. Serological evidence of HIV, Hepatitis B surface antigen positive (HBsAg+), or Hepatitis C infection. Epstein Barr Virus (EBV) positive to EBV negative.\n5. Leukopenia (with a white blood cell count \\\u003C 3000\u002Fmm3) or thrombocytopenia (with a platelet count \\\u003C 100,000\u002Fmm3).\n6. Panel Reactive Antibody (PRA) greater than 80% or demonstration of historic and\u002For current donor specific antibody (DSA)\n7. Prior organ transplantation\n8. High risk of primary kidney disease recurrence\n9. Advanced coronary or vascular disease.",{"count":101,"type":22},22,[25],"This study will determine whether a preparatory regimen including total lymphoid irradiation (TLI), total body irradiation (TBI), anti-thymocyte globulin (ATG) and infusion of the donor hematopoietic stem cells when given along with recipient regulatory T cells (Tregs) will allow for eventual discontinuation of anti-rejection drugs after living donor kidney transplantation.",[105],"Living Donor Kidney Transplantation",[107,108,109,110],"kidney transplant","Immunological Tolerance","Tregs","Stem cells",{"date":36,"type":39},{"date":113,"type":39},"2020-02-01",{"date":115,"type":22},"2029-12-01",{"name":45,"class":46},{"id":118,"slug":119,"hasResults":12,"nctId":120,"briefTitle":121,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":123,"sex":124,"minAge":125,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":23,"phases":128,"briefSummary":130,"conditions":131,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":134,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":47},"100135628","magnetic-resonance-imaging-of-breast-cancer-100135628","NCT01035112","Magnetic Resonance Imaging of Breast Cancer","INCLUSION CRITERIA\n\n* Female\n* Documented breast physical examination,\n* Documented mammography within 3 months of the MR studies\n* Palpable or mammographically-detected suspect breast lesions\n* Women who have already undergone lumpectomy for breast cancer and have post-biopsy\u002Fpost-radiation changes will be eligible if they have mammographically-detected or palpable breast abnormalities which are sufficiently suspicious to merit core needle or surgical biopsy.\n\nEXCLUSION CRITERIA:\n\n* Male by birth\n* Able to complete the MR examination. Subjects will be interviewed by one of the investigators for the usual contraindications to\n* MR contraindications including\n* Pacemakers\n* Metallic implants\n* Severe claustrophobia\n* Aneurysm clips\n* Pregnancy\n* Current lactation\n* Other conditions precluding proximity to a strong magnetic field.\n* Received an enhanced MR procedure within 48 hours,\n* Iodinated contrast within six hours,\n* Known sensitivity to MR contrast agents,\n* Not likely to complete the study in full or\n* Other clinical reason which would preclude participation in the protocol.",true,"FEMALE","21 Years",{"count":127,"type":22},500,[129],"NA","To compare magnetic resonance imaging (MRI) with more well established diagnostic imaging techniques to determine which method best finds and defines breast cancer.",[132,133],"Breast Cancer","Breast Cancer Non-invasive Breast Cancer",{"date":36,"type":39},{"date":136,"type":39},"1995-04-01",{"date":138,"type":22},"2027-05",{"name":45,"class":46},{"id":141,"slug":142,"hasResults":12,"nctId":143,"briefTitle":144,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":148,"phases":4,"briefSummary":149,"conditions":150,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":156,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":47},"100100354","identification-of-secreted-markers-for-tumor-hypoxia-in-patients-with-head-and-neck-or-lung-cancers-100100354","NCT00568490","Identification of Secreted Markers for Tumor Hypoxia in Patients With Head and Neck or Lung Cancers","Inclusion Criteria:\n\n* Histologically confirmed squamous cell carcinoma of the head and neck sites or non-small cell lung cancer, or relatives of patients with histologically confirmed squamous cell carcinoma of the head and neck.\n* Able to sign a Stanford IRB approved consent form\n\nExclusion criteria:\n\n* Refuse or unable to sign an IRB approved consent form.\n* Refuse to be contacted in the future for follow up.",{"count":147,"type":22},200,"OBSERVATIONAL","The purpose of this study is to identify and confirm new blood and tissue markers for prognosis and tumor hypoxia. Tumor hypoxia, or the condition of low oxygen in the tumor, has been shown to increase the risk of tumor spread and enhance tumor resistance to the standard treatment of radiation and chemotherapy in head and neck and lung cancers. We have recently identified several proteins or markers in the blood and in tumors (including osteopontin, lysyl oxidase, macrophage inhibiting factor and proteomic technology) in the laboratory that may be able to identify tumors with low oxygen levels or more aggressive behaving tumors.",[151,152,153,154,155],"Head and Neck Cancer","Lung Cancer","Lip Cancer","Lip Neoplasms","Head and Neck Cancers",{"date":36,"type":39},{"date":158,"type":39},"1998-09-01",{"date":160,"type":22},"2027-06-30",{"name":45,"class":46},{"id":163,"slug":164,"hasResults":12,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":123,"sex":124,"minAge":169,"maxAge":170,"enrollmentInfo":171,"targetDuration":4,"studyType":23,"phases":173,"briefSummary":174,"conditions":175,"keywords":181,"overallStatus":190,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":193,"completionDateStruct":194,"leadSponsor":196,"locationsCount":47},"100645213","overvaluation-of-weight-and-shape-intervention-vs-the-body-project-100645213","NCT07678554","Overvaluation of Weight and Shape Intervention vs The Body Project","Pilot Testing Overvaluation of Weight and Shape Intervention vs The Body Project","Inclusion Criteria:\n\n* Female-identifying\n* High School\n* College Adolescents\n* Ages 14-22\n\nExclusion Criteria:\n\n* Non-female identifying\n* Outside of the United States","14 Years","22 Years",{"count":172,"type":22},90,[129],"Priorities aims to reduce body image concerns, prevent eating disorders, bolster self-esteem, and promote mental and emotional health by helping participants identify and nurture alternative sources of self-worth. Priorities would use group discussions, role-plays \\& behavioral challenges, homework assignments \\& letter-writing, and self-worth activism to achieve this. The Priorities intervention will be compared to The Body Project (an existing and successful harm reduction and eating disorder prevention program) for its effectiveness of reducing body image concerns and eating disorder outcomes. This study aims to evaluate whether there is a more effective eating disorder prevention program than The Body Project.",[176,177,178,179,180],"Body Image","Mental Health Outcomes","Eating Disorders","Body Dysmorphic Disorders","Self-esteem",[182,183,184,185,186,187,188,189],"Eating disorder","Female","Body project","Priorities","self-esteem","adolescent mental health","Body dysmorphia","Disordered eating","NOT_YET_RECRUITING","2026-06-28",{"date":36,"type":39},{"date":36,"type":22},{"date":195,"type":22},"2027-06-01",{"name":45,"class":46},{"id":198,"slug":199,"hasResults":12,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":203,"eligibilityCriteria":204,"healthyVolunteers":123,"sex":17,"minAge":4,"maxAge":205,"enrollmentInfo":206,"targetDuration":4,"studyType":23,"phases":208,"briefSummary":209,"conditions":210,"keywords":215,"overallStatus":190,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":47},"100637574","perinatal-mortality-outcomes-through-household-infection-pathways-100637574","NCT07620613","Perinatal Mortality Outcomes Through Household Infection Pathways","Effect of Cement Floors on Perinatal and Neonatal Mortality in Bangladesh: a Randomized Trial in Rural Bangladesh","POTH","Inclusion Criteria:\n\n* Prior enrollment in the CRADLE trial (NCT05372068), in either arm, and currently residing in the original CRADLE-enrolled household\n* Residence in Sirajganj or Tangail districts in Bangladesh\n* No major non-compliance (e.g., no removal of concrete floor in intervention arm or installation of concrete floor in control arm)\n* No plan to relocate within the study follow-up period\n* Incident pregnancy occurring after CRADLE trial enrollment, confirmed after 26 weeks gestation","6 Years",{"count":207,"type":22},196,[129],"The goal of this trial is to learn if replacing household soil floors with concrete floors can prevent deaths of infants around the time of birth, including stillbirths and deaths in the first month of life in rural Bangladesh. The primary question the study aims to answer is: Does residing in a home with a concrete vs. soil floor reduce the perinatal and neonatal morality in index children and their younger siblings up to 6 years post-installation of concrete floors?\n\nResearchers will compare participants in households with concrete floors (intervention) vs. soil floors (comparison group) to see if concrete floors reduce the rate of perinatal death and child death up the 6 years post-intervention.\n\nThis study will extend an ongoing NIH-funded randomized trial in which households with soil floors where a pregnant woman resided were randomly chosen to receive a concrete floor intervention or to retain their existing soil floor. This study will track pregnancies, births, and deaths among infants born to pregnant mothers in the original study to measure effects of household concrete flooring up to 6 years after the concrete floors were installed.",[211,212,213,214],"Stillbirth and Neonatal Mortality","Perinatal Mortality","Infant Mortality","Child Mortality",[216,217,218,219],"concrete floor","soil floor","dirt floor","housing intervention","2026-06-27",{"date":36,"type":39},{"date":223,"type":22},"2026-06-01",{"date":225,"type":22},"2029-05-01",{"name":45,"class":46},{"id":228,"slug":229,"hasResults":12,"nctId":230,"briefTitle":231,"officialTitle":231,"acronym":4,"eligibilityCriteria":232,"healthyVolunteers":12,"sex":17,"minAge":233,"maxAge":169,"enrollmentInfo":234,"targetDuration":4,"studyType":23,"phases":236,"briefSummary":237,"conditions":238,"keywords":241,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":70},"100604914","phase-ii-engagement-and-clinical-impact-of-the-teleo-virtual-therapy-platform-in-clinical-settings-100604914","NCT07155707","Phase II: Engagement and Clinical Impact of the Teleo Virtual Therapy Platform in Clinical Settings","Inclusion Criteria:\n\n* Diagnosed with a mood and\u002For anxiety disorder\n* Have proficiency to participate in psychotherapy in English\n* Scheduled to begin therapy at one of the study sites\n* RCADS score \\> 65\n\nExclusion Criteria:\n\n\\- Comorbid diagnosis of intellectual disability, autism spectrum disorder, psychotic disorders, high-risk suicidal behaviors requiring immediate hospitalization, substance use disorders, or other physical or mental condition that would prohibit them from engaging in telehealth settings.","5 Years",{"count":235,"type":22},156,[129],"This Phase II trial will examine engagement in telehealth for children undergoing psychotherapy. Specifically, the trial will examine patient engagement in Teleo, a virtual therapy platform specifically designed for psychotherapy with youth, as compared to standard video conferencing.",[239,240],"Anxiety","Mood Disorders",[242,243,239,244,245,246],"Teletherapy","Therapeutic Engagement","Depression","Youth Mental Health","Digital Mental Health","2026-06-26",{"date":63,"type":39},{"date":250,"type":39},"2026-06-24",{"date":252,"type":22},"2027-09-15",{"name":45,"class":46},{"id":255,"slug":256,"hasResults":12,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":4,"eligibilityCriteria":260,"healthyVolunteers":12,"sex":17,"minAge":261,"maxAge":19,"enrollmentInfo":262,"targetDuration":4,"studyType":23,"phases":264,"briefSummary":265,"conditions":266,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":47},"100369097","phase-1-panitumumab-irdye800-to-detect-pediatric-neoplasms-during-neurosurgical-procedures-100369097","NCT04085887","Panitumumab-IRDye800 to Detect Pediatric Neoplasms During Neurosurgical Procedures","Phase 1\u002FPhase 2, Open Label Study Evaluating the Safety, Dosing and Efficacy of Panitumumab IRDye800 as an Optical Imaging Agent to Detect Pediatric Neoplasms During Neurosurgical Procedures","Inclusion Criteria:\n\n* Subjects with suspected brain tumors undergoing surgical removal as their standard of care will be eligible. These may include subjects status post chemotherapy and\u002For radiation or subjects who have undergone diagnostic biopsy for their original diagnosis and are felt to be candidates for resection.\n* Subjects must be eligible for resection as determined by the operating surgeon.\n* Planned standard of care surgery\n* Subject age 6 months to 25 years\n* Life expectancy of more than 12 weeks\n\nExclusion Criteria:\n\n* Received an investigational drug within 30 days prior to first dose of Panitumumab IRDye800\n* Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment\n* History of infusion reactions to monoclonal antibody therapies\n* Pregnant or breastfeeding\n* Evidence of QTc prolongation on pretreatment ECG (greater than 440 ms in children 1 8 years or 8 to 18 year old males or greater than 460 ms in infants up to 1 year or 8 to 18 year old females)\n* Magnesium, potassium and calcium \\\u003C the lower limit of normal per institution normal lab values\n* Serum creatinine \\> 1.5 times upper reference range\n* Other lab values that in the opinion of the primary surgeon would prevent surgical resection\n* Subjects receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.\n* Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis\n* Subjects not deemed to be appropriate candidates for optimal resection of tumor based on location, involvement of eloquent brain, satellite lesions, or other factors not specifically listed here","6 Months",{"count":263,"type":22},12,[25,80],"The objective of the study is to assess safety of panitumumab-IRDye800 in pediatric patients undergoing brain surgery to remove suspected tumors.",[267],"Brain Tumor",{"date":269,"type":39},"2026-06-30",{"date":271,"type":22},"2026-08",{"date":273,"type":22},"2028-12",{"name":45,"class":46},{"id":276,"slug":277,"hasResults":12,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":4,"eligibilityCriteria":281,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":282,"targetDuration":4,"studyType":23,"phases":284,"briefSummary":285,"conditions":286,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":289,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":47},"100324915","phase-1-panitumumab-irdye800-in-diagnosing-participants-with-malignant-glioma-undergoing-surgery-100324915","NCT03510208","Panitumumab-IRDye800 in Diagnosing Participants With Malignant Glioma Undergoing Surgery","Phase I\u002FII, Open-Label Study Evaluating the Efficacy and Pharmacokinetics of Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Neoplasms During Neurosurgical Procedures","Inclusion Criteria:\n\n1\\) One of the following:\n\n1. Cohorts 1, 2, and 3: Participants with suspected or confirmed diagnosis of glioblastoma\n2. Cohort 4: Participants with suspected or confirmed diagnosis of vestibular schwannoma\n\n   2.) Planned surgical removal of the tumor as part of standard of care. This may include participants postchemotherapy, post-radiation, and\u002For participants who have undergone diagnostic biopsy for their original diagnosis and are felt to be candidates for resection.\n\n   3\\) Participant age ≥ 18 years.\n\n   4\\) Participants or their designated advocates must be willing to and capable of providing informed consent and willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.\n\nExclusion Criteria:\n\n1. Received an investigational drug within 30 days prior to first dose of Panitumumab-IRDye800.\n2. Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease as determined by PI; or unstable angina within 6 months prior to enrollment.\n3. History of infusion reactions to monoclonal antibody therapies\n4. Pregnant or breastfeeding.\n5. Evidence of QTc prolongation on pretreatment ECG (greater than 440 ms in males or greater than 460 ms in females).\n6. Any of the following lab values:\n\n   1. Platelet count \\\u003C 75,000\u002Fmm3\n   2. TSH ≥ 13 micro International Units\u002FmL.\n   3. Magnesium, potassium, or calcium \\\u003C each respective upper limit of normal\n   4. Serum creatinine \\> 1.5 times upper limit of normal\n7. Participants receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.\n8. Participants with a history or evidence of interstitial pneumonitis or pulmonary fibrosis.\n9. Participants not deemed by PI to be appropriate candidates for optimal resection of tumor based on location, involvement of eloquent brain, satellite lesions, or other factors not specifically listed here.",{"count":283,"type":22},46,[25,80],"The phase I\u002FII trial studies the side effects and best dose of panitumumab-IRDye800 in diagnosing participants with malignant glioma who undergo surgery. Panitumumab-IRDye800 can attach to tumor cells and make them more visible using a special camera during surgery, which may help surgeons better distinguish tumor cells from normal brain tissue and identify small tumors that cannot be seen using current imaging methods.",[287,288],"Malignant Brain Neoplasm","Malignant Glioma",{"date":63,"type":39},{"date":291,"type":39},"2018-05-16",{"date":293,"type":22},"2026-11",{"name":45,"class":46},{"id":296,"slug":297,"hasResults":12,"nctId":298,"briefTitle":299,"officialTitle":299,"acronym":4,"eligibilityCriteria":300,"healthyVolunteers":123,"sex":17,"minAge":55,"maxAge":56,"enrollmentInfo":301,"targetDuration":4,"studyType":23,"phases":303,"briefSummary":304,"conditions":305,"keywords":308,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":47},"100514198","blossom-smart-expander-device-for-tissue-expanderimplant-based-breast-reconstruction-100514198","NCT05975372","Blossom® Smart Expander Device for Tissue Expander\u002FImplant-Based Breast Reconstruction","Inclusion Criteria:\n\n* Women ages 18 or older; pursuing non-oncologic breast reconstruction or augmentation; and ability to understand and the willingness to sign a written informed consent document (english language). Only patients desiring 2-staged tissue expander\u002F implant-based breast reconstruction will be approached for potential enrollment in the study.\n\nExclusion Criteria:\n\n* Patients with active breast cancer; recent steroid use; major medical comorbidities (defined as ASA III or greater); a connective tissue disorder; are pregnant or nursing; are unable to understand and sign the english language consent forms; or age over 65 years, will be excluded from the study.",{"count":302,"type":22},20,[129],"The conventional breast tissue expander used for breast reconstruction\u002F augmentation requires weekly or biweekly injections of saline through the skin and into an integrated port in the implant using a needle and syringe in order to expand breast skin, which is an in-office procedure and can be uncomfortable for patients. Blossom Smart Expander Technology, currently available on the market, aims to achieve the same tissue expansion while avoiding frequent injections through the skin by means of an expansion device that slowly and continuously injects a very small amount of saline. Expansion of the device is based on pressure and volume in the expander, allowing for a tailored expansion process for individual patients' physiology. The purpose of this study is to assess the clinical effectiveness of Blossom Smart Expander Technology in 2-staged tissue expander\u002Fimplant-based breast reconstruction\u002F augmentation compared to standard tissue expansion methods.",[306,307],"Tissue Expansion","Implant Based Breast Reconstruction",[309,310],"Implant based breast reconstruction","Tissue expansion","2026-06-25",{"date":269,"type":39},{"date":314,"type":39},"2023-11-17",{"date":316,"type":22},"2028-07",{"name":45,"class":46},{"id":319,"slug":320,"hasResults":12,"nctId":321,"briefTitle":322,"officialTitle":322,"acronym":4,"eligibilityCriteria":323,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":324,"targetDuration":4,"studyType":23,"phases":326,"briefSummary":327,"conditions":328,"keywords":334,"overallStatus":190,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":338,"completionDateStruct":339,"leadSponsor":340,"locationsCount":47},"100645017","a-pilot-study-using-gut-directed-hypnotherapy-for-hospitalized-patients-100645017","NCT07676136","A Pilot Study Using Gut-Directed Hypnotherapy for Hospitalized Patients","Inclusion Criteria:\n\n* Adults admitted to the GI inpatient service with expected length of stay \\>24 hours\n* Prior diagnosis of a disorder of gut-brain interaction, esophageal disorder, or inflammatory bowel disease\n* Reason for hospitalization related to symptom management for exacerbation of visceral pain and\u002For nausea.\n\nExclusion Criteria:\n\n* Currently using hypnosis\n* severe developmental delay or cognitive impairment\n* serious mental illness (i.e. psychosis or dissociation)\n* hearing impairment\n* Non-English speaking\n* enrolled in another trial for GI symptom management\n* admitted for GI procedure",{"count":325,"type":22},26,[129],"The purpose of the study is to compare the effectiveness of recorded gut-directed hypnosis to an educational recording in people with chronic problems in their gastrointestinal (GI) system. Patients who are hospitalized at Stanford Hospital for worsening pain and\u002For nausea will be considered for enrollment.",[329,330,331,332,333],"Disorders of Gut-brain Interaction","Inflammatory Bowel Disease (IBD)","Irritable Bowel Syndrome","Abdominal Pain","Esophageal Disease",[335],"hypnosis","2026-06-23",{"date":269,"type":39},{"date":43,"type":22},{"date":316,"type":22},{"name":45,"class":46},{"id":342,"slug":343,"hasResults":12,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":4,"eligibilityCriteria":347,"healthyVolunteers":123,"sex":17,"minAge":348,"maxAge":349,"enrollmentInfo":350,"targetDuration":4,"studyType":23,"phases":352,"briefSummary":353,"conditions":354,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":356,"startDateStruct":357,"completionDateStruct":358,"leadSponsor":360,"locationsCount":47},"100617661","early-introduction-and-sustained-ingestion-eisi-using-two-educational-opportunities-in-infants-100617661","NCT07321522","Early Introduction and Sustained Ingestion (EISI) Using Two Educational Opportunities in Infants","Early Introduction and Sustained Ingestion (EISI) Using Two Educational Opportunities - A Pilot Study","Inclusion Criteria for both Infant and Caregiver\u002FParent Participants\n\n* Born term (37 weeks - 41 weeks gestation)\n* Infants with or without a family history of allergic disease\n* Infants with or without mild to moderate eczema\n* Infants who have not yet started consuming known allergenic foods (excluding cow's milk or soy if it is in their infant formula)\n* Parent or caregiver ≥ 18 years of age\n* Agree to infant blood draw (two)\n* Agree to participate in the 6 month research study\n\nExclusion Criteria:\n\n* Infants with a physician confirmed food allergy\n* Infants who do not eat fully by an oral route such as tube-fed or tube-supplemented babies\n* Infants with developmental delay\n* Infants with severe eczema\n* Infants who are already consuming known allergenic foods\n* Infants participating in another study looking at diet, oral immunotherapy or the use of a biological agent","4 Months","11 Months",{"count":351,"type":22},92,[129],"The objective of the study is to see whether early feeding of potentially allergic foods can be increased with educational materials alone or with educational materials and additional in-person support opportunities. This study will help guide what types of support pediatricians and allergists give to new parents.",[355],"Food Allergy",{"date":247,"type":39},{"date":269,"type":22},{"date":359,"type":22},"2028-02",{"name":45,"class":46},{"id":362,"slug":363,"hasResults":12,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":4,"eligibilityCriteria":367,"healthyVolunteers":123,"sex":17,"minAge":368,"maxAge":4,"enrollmentInfo":369,"targetDuration":4,"studyType":23,"phases":371,"briefSummary":372,"conditions":373,"keywords":375,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":378,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":47},"100585955","better-breaks-strength-breaks-vs-walk-breaks-for-sedentary-behavior-breaks-100585955","NCT06909097","Better Breaks: Strength Breaks vs Walk Breaks for Sedentary Behavior Breaks","MOV'D Strength Snacks vs Walk Breaks Study: Health Performance Gains Across Domains","Inclusion Criteria:\n\n\\-\n\nIdentify inclusion criteria.\n\n1. Sedentary occupation (e.g., clerical work, data entry, call center, receptionists)\n2. Full time employment remote or on-site\n3. Able to safely perform bodyweight squats and lunges\n4. Over 30 years old\n5. Not currently doing a strength training program\n6. Not currently taking planned activity breaks at work\n7. Has a smart phone with a camera and unlimited text plans\n8. Interested in participating\n9. Fluent in English\n10. Not currently on insulin or any glucose lowering medication\n\nExclusion Criteria:\n\n1. Yes to any of the physical activity readiness criteria questionnaire (e.g. cardiac symptoms with increasing heart rate, dizziness upon performing exercise)\n2. Participating in another research study on diet, weight loss, or any physical activity.\n3. If their doctor has ever said to not strength train\n4. Having insulin dependence","30 Years",{"count":370,"type":22},40,[129],"This study investigates the benefits of two different types of 2 minute activity breaks during sedentary workdays for people who sit for long periods of time in sedentary jobs.",[374],"Sedentary Employees",[376,377],"physical activity breaks","prolonged sitting breaks",{"date":311,"type":39},{"date":380,"type":39},"2024-10-05",{"date":382,"type":22},"2026-12-01",{"name":45,"class":46},{"id":385,"slug":386,"hasResults":12,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":4,"eligibilityCriteria":390,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":391,"targetDuration":4,"studyType":23,"phases":392,"briefSummary":393,"conditions":394,"keywords":397,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":413,"locationsCount":47},"100580375","using-continuous-glucose-monitoring-to-quantify-the-effects-of-nourishs-culturally-modified-meals-on-asian-americans-with-type-2-diabetes-100580375","NCT06836479","Using Continuous Glucose Monitoring to Quantify the Effects of NOURISH's Culturally Modified Meals on Asian Americans With Type 2 Diabetes","Validation of NOURISH Project's Culturally Tailored Meals on Postprandial Glycemic Response Using Continuous Glucose Monitoring: A Quantitative and Qualitative Study","Inclusion Criteria:\n\n* Self-identification as Asian Indian or Filipino\n* Diagnosed with T2DM\n* Can pick up meals from a designated area on the Stanford Campus\n* Willing to wear a CGM for 30 days\n\nExclusion Criteria:\n\n* Currently taking insulin, GLP -1 and SGLT 2\n* Known severe allergic reactions and\u002For food intolerances that would interfere with the ability to eat\n* Those who, in the opinion of the investigators, cannot reliably complete the study protocol.",{"count":58,"type":22},[129],"The investigators are hoping to determine whether tailoring the diet of someone with type 2 diabetes to their ethnic group while following American Diabetes Association guidelines can make a significant difference in their blood sugar controls. Participants will be required to wear a Continuous Glucose Monitor (CGM) for 1-month so that the investigators can compare blood sugar levels when participants are eating their routine diet vs. the culturally tailored diabetes diet.",[395,396],"Type 2 Diabetes Mellitus (T2DM)","Type 2 Diabetes",[396,398,399,400,401,402,403,404,405,406,407],"Asian American","Asian Indian","Filipino","Medically Tailored Meals","Culture","Culturally Tailored Meals","Continuous Glucose Monitoring","Nutritional Interventions","Dietary Adherence","Diabetes Management","2026-06-22",{"date":250,"type":39},{"date":411,"type":39},"2026-01-08",{"date":293,"type":22},{"name":45,"class":46},{"id":415,"slug":416,"hasResults":12,"nctId":417,"briefTitle":418,"officialTitle":418,"acronym":419,"eligibilityCriteria":420,"healthyVolunteers":123,"sex":17,"minAge":421,"maxAge":422,"enrollmentInfo":423,"targetDuration":4,"studyType":23,"phases":425,"briefSummary":426,"conditions":427,"keywords":431,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":434,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":439,"locationsCount":47},"100543965","modified-pivotal-response-treatment-for-insistence-on-sameness-in-autistic-youth-100543965","NCT06362733","Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth","M-PRT-IS","Participants will include children with:\n\n1. parent\u002Fguardian aged 18 years or older with a child aged between 4.0 to 17.11 years old at the time of parental consent;\n2. diagnosed with ASD (based on history, review of available medical records including diagnostic testing, e.g., ADOS) or suspicion of ASD diagnosis and confirmed with Autism Diagnostic Interview-Revised (ADI-R);\n3. parent-reported clinically significant concerns regarding insistence on sameness and behavioral inflexibility;\n4. stable behavioral and pharmacological treatment for at least two weeks with no anticipated changes;\n5. English-speaking parent and youth able to consistently participate in study procedures;\n6. family resides in United States.","4 Years","17 Years",{"count":424,"type":22},44,[129],"The purpose of this open label trial is to examine the preliminary feasibility, acceptability, and effectiveness of a 12-week behavioral intervention program (1 hour\u002Fweek) to treat insistence on sameness (e.g., difficulty tolerating changes in routine) in youth with autism spectrum disorder (ASD). Treatment will be delivered via secure telemedicine platform and consist of a combination of parent-training and parent-mediated intervention with the child.",[428,429,430],"Autism Spectrum Disorder","Restricted Behavior","Autism",[432,433],"Intervention","Pivotal Response Treatment",{"date":311,"type":39},{"date":436,"type":39},"2024-07-11",{"date":438,"type":22},"2028-07-01",{"name":45,"class":46},{"id":441,"slug":442,"hasResults":12,"nctId":443,"briefTitle":444,"officialTitle":445,"acronym":4,"eligibilityCriteria":446,"healthyVolunteers":123,"sex":17,"minAge":205,"maxAge":447,"enrollmentInfo":448,"targetDuration":4,"studyType":23,"phases":450,"briefSummary":451,"conditions":452,"keywords":481,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":492,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":497,"locationsCount":47},"100454745","interventions-in-mathematics-and-cognitive-skills-100454745","NCT05201534","Interventions in Mathematics and Cognitive Skills","Interventions in Math Learning Disabilities: Cognitive and Neural Correlates","Inclusion Criteria:\n\n1. Elementary school aged children starting from first grade (6-12 years old)\n2. IQ: Participants with a Full Scale IQ \\> 70 on the Wechsler Abbreviated Scle of Intelligence (WASI-II).\n3. Identification of Mathematical Learning Disabilities: Scores below the 35th percentile percentile on symbolic number processing test in Numeracy Screener and two or more Wechsler Individual Achievement Test (WIAT-IV) math subtests\n4. Identification of typically developing children: Scores at or above the 35th percentile percentile on symbolic number processing test in Numeracy Screener and all WIAT-IV math subtests\n5. Normal or corrected-to-normal vision and no hearing impairments\n6. Inclusion in MRI scan session: Right-handed\n\nExclusion Criteria:\n\n1. History of neurological or psychiatric disorder (i.e., schizophrenia, psychosis, depression, or attention deficit hyperactivity disorder.)\n2. History of trauma involving head injury\n3. Consistent psychiatric medications\n4. Exclusion from MRI scan session: No major contraindication for magnetic resonance imaging (MRI) - braces, metal implants, pacemakers, vascular stents, metallic ear tubes, consistent exposure to metal, claustrophobia)","12 Years",{"count":449,"type":22},180,[129],"The purpose of this study is to investigate neurocognitive mechanisms underlying response to intervention aimed at enhancing, and remediating weaknesses in, numerical skills in children, including those with mathematical learning disabilities (MLD).",[453,454,455,456,457,458,459,460,461,462,463,464,465,466,467,468,469,470,471,472,473,474,475,476,477,478,479,480],"Math Learning Disability","Child Development","Developmental Disability","Learning Disabilities","Learning Disabled","Learning Curve","Mathematics Disorder","Dyscalculia","Dyscalculia, Primary","Dyscalculia, Acquired","Specific Learning Disorder, With Impairment in Mathematics","Individuality","Behavior, Child","Behavior and Behavior Mechanisms","Behavior","Decision Making","Neuronal Plasticity","Cognition","Cognition Disorder","Cognitive Dysfunction","Cognitive Change","Cognitive Impairment, Mild","Cognitive Developmental Delay","Cognitive Orientation","Cognitive Delay, Mild","Cognitive Deficits, Mild","Cognitive Abnormality","Neuroscience",[482,483,484,485,486,487,488,489,490,491],"Numerical skills in children","Low math abilities","Mathematical Learning Disabilities","Mathematical Concepts","Mathematics","Transfer, Psychology","Generalization, Psychology","Early Intervention, Educational","Neural Pathways","Neural Networks, Computer",{"date":311,"type":39},{"date":494,"type":39},"2023-05-05",{"date":496,"type":22},"2026-08-31",{"name":45,"class":46},{"id":499,"slug":500,"hasResults":12,"nctId":501,"briefTitle":502,"officialTitle":503,"acronym":504,"eligibilityCriteria":505,"healthyVolunteers":12,"sex":17,"minAge":506,"maxAge":233,"enrollmentInfo":507,"targetDuration":4,"studyType":23,"phases":509,"briefSummary":510,"conditions":511,"keywords":513,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":518,"startDateStruct":519,"completionDateStruct":521,"leadSponsor":523,"locationsCount":47},"100431550","trial-of-center-based-vs-in-home-pivotal-response-treatment-prt-in-autism-100431550","NCT04899544","Trial of Center-Based vs. In-Home Pivotal Response Treatment (PRT) in Autism","Randomized Controlled Trial of Center-Based vs. In-Home Pivotal Response Treatment (PRT) in Autism","PRT-HvC","Inclusion Criteria:\n\n* Diagnosis of Autism Spectrum Disorder (ASD) based on Autism Diagnostic Interview Revised (ADI-R), Autism Diagnostic Observation Schedule, Second Edition (ADOS-2) or Childhood Autism Rating Scale, Second Edition (CARS-2), Diagnostic and Statistical Manual 5th Edition (DSM-5), and expert clinical opinion;\n* Boys and girls between 2.0 and 5.11 years;\n* Ability to participate in the testing procedures to the extent that valid standard scores can be obtained;\n* Language delay as measured by the Preschool Language Scale, 5th Edition (PLS-5): Standard score at least 1 standard deviation below average for expressive language ability for 2 and 3 year olds; 2 standard deviations for 4 year olds, and 3 standard deviations for 5 year olds;\n* Stable treatment (e.g., Applied Behavior Analysis - ABA), speech therapy, school placement, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements;\n* No anticipated changes on treatment during study participation for Center-Based Pivotal Response Treatment (PRT-C) and In-Home Pivotal Response Treatment (PRT-H);\n* No more than 60 minutes of individual 1:1 speech therapy per week;\n* Availability of at least one parent or primary caregiver who can consistently participate in parent training and research measures.\n\nExclusion Criteria:\n\n* Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.);\n* Receiving ABA of 15 hours or more;\n* Presence of active medical problem (e.g., unstable seizure disorder or heart disease);\n* Previous adequate Pivotal Response Treatment (PRT) trial;\n* Participants living more than 30 miles from Stanford University;\n* Child's primary language other than English.","2 Years",{"count":508,"type":22},120,[129],"The aim of this clinical trial is to compare the efficacy of a 16-week center-based Pivotal Response Treatment (PRT-C) versus home-based Pivotal Response Treatment (PRT-H) in targeting social communication deficits in young children with autism spectrum disorder (ASD) with significant language delay. The two groups will also be compared to a control group that consists of children who are receiving treatment as usual (TAU).",[430,428,512],"ASD",[514,515,516,517],"pivotal response treatment","PRT","center based","social and communication",{"date":250,"type":39},{"date":520,"type":39},"2022-10-18",{"date":522,"type":22},"2028-09-15",{"name":45,"class":46},{"id":525,"slug":526,"hasResults":12,"nctId":527,"briefTitle":528,"officialTitle":528,"acronym":4,"eligibilityCriteria":529,"healthyVolunteers":12,"sex":17,"minAge":506,"maxAge":233,"enrollmentInfo":530,"targetDuration":4,"studyType":23,"phases":532,"briefSummary":533,"conditions":534,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":537,"startDateStruct":538,"completionDateStruct":540,"leadSponsor":542,"locationsCount":47},"100364526","a-center-based-early-intervention-program-for-preschoolers-with-developmental-disorders-100364526","NCT04026386","A Center Based Early Intervention Program For Preschoolers With Developmental Disorders","Inclusion Criteria:\n\n* Diagnosis of Developmental Disorder, such as Autism Spectrum Disorder, neurogenetic disorder, or intellectual disability, based on clinical interview;\n* Boys and girls between 2.0 years and 5.11 years at time of enrollment;\n* Ability to participate in the testing procedures to the extent that valid standard scores can be obtained.\n\nExclusion Criteria:\n\n* Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.);\n* Lack of availability during program hours.",{"count":531,"type":22},75,[129],"The purpose of this study is to examine the effectiveness of a 12-week early intervention program that will include 12 weekly hours in an intensive center-based preschool environment or in the home to treat social communication deficits in children with developmental disorders. The study will include children with developmental disorders, such as Autism Spectrum Disorder, neurogenetic disorders, or intellectual disability.",[535,455,536,428],"Development Disorder, Child","Development Delay",{"date":311,"type":39},{"date":539,"type":39},"2019-10-19",{"date":541,"type":22},"2034-12-30",{"name":45,"class":46},{"id":544,"slug":545,"hasResults":12,"nctId":546,"briefTitle":547,"officialTitle":548,"acronym":4,"eligibilityCriteria":549,"healthyVolunteers":12,"sex":17,"minAge":506,"maxAge":205,"enrollmentInfo":550,"targetDuration":4,"studyType":23,"phases":551,"briefSummary":552,"conditions":553,"keywords":554,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":556,"startDateStruct":557,"completionDateStruct":559,"leadSponsor":560,"locationsCount":47},"100352269","phase-2-a-study-of-esomeprazole-in-children-with-autism-100352269","NCT03866668","A Study of Esomeprazole in Children With Autism","An Open-Label Pilot Study of Esomeprazole in Children With Autism","Inclusion Criteria:\n\n* outpatients 2 to 6 years of age;\n* males and females who are physically healthy;\n* diagnosis of autism spectrum disorder based on clinical evaluation and DSM-5 criteria, and confirmed using the Autism Diagnostic Interview-Revised, and the Autism Diagnostic Observation Schedule or Childhood Autism Rating Scale second edition (CARS-2)\n* care provider who could reliably bring subject to clinic visits, could provide trustworthy ratings, and interacted with subject on a regular basis;\n* ability of subject to swallow the compound;\n* stable concomitant medications for at least 2 weeks (4 weeks if patient took fluoxetine);\n* no planned changes in psychosocial interventions during the open-label trial.\n\nExclusion Criteria:\n\n* DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder not otherwise specified;\n* prior adequate trial of Esomeprazole;\n* active medical problems such as unstable seizures, or significant physical illness (e.g., serious liver or renal pathology).",{"count":7,"type":22},[80],"Autism is a pervasive developmental disorder characterized by core deficits in social behavior and communication and the presence of repetitive\u002Fstereotyped behaviors. The objective of the study is to evaluate the efficacy of Esomeprazole as a treatment for social communication deficits in children with Autism Spectrum Disorder (ASD). This prospective 12 week open-label study will invite 25 children with ASD between the ages of 2 and 6 years of age to participate.",[430,428],[555],"Esomeprazole",{"date":311,"type":39},{"date":558,"type":39},"2019-05-29",{"date":273,"type":22},{"name":45,"class":46},{"id":562,"slug":563,"hasResults":12,"nctId":564,"briefTitle":565,"officialTitle":566,"acronym":4,"eligibilityCriteria":567,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":568,"targetDuration":4,"studyType":23,"phases":570,"briefSummary":571,"conditions":572,"keywords":574,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":578,"lastUpdatePostDateStruct":579,"startDateStruct":580,"completionDateStruct":582,"leadSponsor":584,"locationsCount":47},"100561625","phase-2-gemcitabine--docetaxel--toripalimab-induction-in-epstein-barr-virus-ebv-associated-nasopharyngeal-carcinomanpc-100561625","NCT06592599","Gemcitabine + Docetaxel + Toripalimab Induction in Epstein-Barr Virus (EBV) Associated Nasopharyngeal Carcinoma(NPC)","A Safety, Feasibility and Efficacy Study of Gemcitabine Plus Docetaxel Plus Toripalimab (GDT) Induction as Part of a Curative Sequential Chemoradiation for Patients With Locoregional EBV Associated Nasopharyngeal Carcinoma (NPC)","Inclusion Criteria:\n\n1. Eligible disease(s) \u002F stage(s): Locoregionally advanced EBV positive NPC (T3-4, any N OR any T, N1-3. No M1) per AJCC v 8\n2. Prior therapy: None for NPC permitted\n3. Life expectancy: 3 months at least\n4. Contraception requirements: Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control during treatment with toripalimab and for 4 months after the last dose.\n5. ECOG Performance Status of 0,1, or 2\n6. Age: At least 18 years old.\n\n   CBC\u002Fdifferential obtained within 21 days prior to day 1 of treatment, with adequate bone marrow function defined as follows:\n7. Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm3\n8. Platelets ≥ 100,000 cells\u002Fmm3;\n9. Hemoglobin ≥ 8.0 g\u002Fdl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g\u002Fdl is acceptable.);\n\n   Adequate hepatic function within 21 days prior to day 1 of treatment, defined as follows:\n10. Total bilirubin ≤ 1.5 x institutional ULN;\n11. AST and ALT ≤ 1.5 x institutional ULN;\n\n    Adequate renal function within 21 days prior to day 1 of treatment, defined as follows:\n12. Serum creatinine ≤ 1.5 mg\u002Fdl or calculated or measured creatinine clearance (CC) ≥ 50 ml\u002Fmin\n13. Negative serum pregnancy test within 14 days prior to day 1 of treatment for women of childbearing potential\n14. Ability to understand and the willingness to personally sign the written IRB approved informed consent document.\n\nExclusion Criteria:\n\n1. Prior systemic anticancer treatment for NPC\n2. Prior radiation to head and neck region or regions necessitating overlapping fields\n3. Concurrent use of any anti- cancer treatment, standard, alternative or investigational.\n4. History of allergic reactions to any agents in this study\n5. Autoimmune disease or organ transplant which in the judgment of the PI would increase the risk of immune checkpoint inhibition.\n6. Pregnant or breastfeeding\n7. Severe, active co-morbidity, defined as follows:\n\n   * Major medical or psychiatric illness, which in the investigator's opinion would interfere with the completion of therapy and follow up or with full understanding of the risks and potential complications of the therapy;\n   * Unstable angina and\u002For uncontrolled congestive heart failure within past 6 months;\n   * Myocardial infarction within the last 6 months;\n   * Current acute bacterial or fungal infection requiring intravenous antibiotics; note that patients receiving IV antibiotics or currently on oral antibiotics whose infection is assessed to be adequately treated or controlled are eligible.\n   * Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to day 1 of treatment;\n8. Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive\n9. Patients with hearing loss assessed to be primarily sensorineural in nature, requiring a hearing aid, or intervention (i.e. interfering in a clinically significant way with activities of daily living); a conductive hearing loss that is tumor-related is allowed\n10. ≥ grade 2 peripheral sensory neuropathy",{"count":569,"type":22},24,[80],"The purpose of the research is to test the safety and efficacy of the investigational drug in human subjects with cancer.",[573],"Nasopharyngeal Carcinoma",[575,576,577],"gemcitabine","docetaxel","toripalimab","2026-06-19",{"date":336,"type":39},{"date":581,"type":39},"2024-09-03",{"date":583,"type":22},"2029-01",{"name":45,"class":46},{"id":586,"slug":587,"hasResults":12,"nctId":588,"briefTitle":589,"officialTitle":590,"acronym":4,"eligibilityCriteria":591,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":592,"targetDuration":4,"studyType":23,"phases":594,"briefSummary":595,"conditions":596,"keywords":598,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":578,"lastUpdatePostDateStruct":610,"startDateStruct":611,"completionDateStruct":613,"leadSponsor":615,"locationsCount":47},"100556552","stress-management-program-100556552","NCT06526585","Stress Management Program","Examining the Immediate and Training Effects of Regular Stress Reduction Practices on Psychophysiological Markers of Anxiety","Inclusion Criteria:\n\n* Age 18 or older\n* No contraindications to MRI imaging (like ferromagnetic metal in their body)\n\nExclusion Criteria:\n\n* Pregnant or planning to get pregnant during study participation.\n* Not able or willing to come to research location twice for MRI assessments",{"count":593,"type":22},80,[129],"This study will test the immediate and long term (post 4 weeks of daily practice) effectiveness of two breathwork practices, cyclic sighing and box breathing, in comparison to hypnosis and an audiobook about stress, on psychological and physiological variables.",[597,239],"Stress",[597,599,600,601,602,603,239,604,605,606,607,608,609],"Breathwork","Cyclic Sighing","Box Breathing","Hypnosis","Mood","Physiology","Heart Rate Variability","Respiratory Rate","fMRI","Brain Activity","Sleep",{"date":250,"type":39},{"date":612,"type":39},"2025-03-12",{"date":614,"type":22},"2026-08-30",{"name":45,"class":46},{"id":617,"slug":618,"hasResults":12,"nctId":619,"briefTitle":620,"officialTitle":621,"acronym":4,"eligibilityCriteria":622,"healthyVolunteers":123,"sex":17,"minAge":55,"maxAge":56,"enrollmentInfo":623,"targetDuration":4,"studyType":23,"phases":625,"briefSummary":626,"conditions":627,"keywords":629,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":639,"lastUpdatePostDateStruct":640,"startDateStruct":641,"completionDateStruct":643,"leadSponsor":645,"locationsCount":47},"100579447","sleep-tms-for-depression-100579447","NCT06824415","Sleep TMS for Depression","Optimizing Depression Treatment Through Sleep-state Brain Stimulation","Inclusion Criteria:\n\n* Adults ages 18-65 years\n* Current Major Depressive Disorder (MDD) diagnosis\n* Failed ≥1 antidepressant medication\n* Moderate-to-severe depression\n* Stable antidepressant medication dose for ≥ 6 weeks prior to enrollment\n* Healthy control participants are adults ages 18-65 years without current MDD symptoms, not taking antidepressant or antipsychotic medications, and without major psychiatric, neurological, substance use, medical conditions affecting brain function, or TMS\u002FMRI contraindications.\n\nExclusion Criteria:\n\n* Intellectual disability\n* Significant head injury\u002Fneurological disorder\n* Pregnancy or postpartum\n* TMS\u002FMRI contraindications\n* Active substance use\u002Fsuicidal ideation",{"count":624,"type":22},55,[129],"The goal of this study is to establish the feasibility, tolerability, and preliminary efficacy of sleep-state transcranial magnetic stimulation (TMS) for enhancing plasticity in depression treatment.",[628,609],"Major Depression",[630,631,632,633,634,635,636,637,638],"sleep","tms","eeg","iTBS","real-time","closed-loop","NREM","sleep spindle","slow oscillations","2026-06-18",{"date":336,"type":39},{"date":642,"type":39},"2025-05-01",{"date":644,"type":22},"2028-05-30",{"name":45,"class":46},{"id":647,"slug":648,"hasResults":12,"nctId":649,"briefTitle":650,"officialTitle":651,"acronym":4,"eligibilityCriteria":652,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":653,"enrollmentInfo":654,"targetDuration":4,"studyType":23,"phases":655,"briefSummary":656,"conditions":657,"keywords":662,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":639,"lastUpdatePostDateStruct":666,"startDateStruct":667,"completionDateStruct":669,"leadSponsor":670,"locationsCount":47},"100558474","phase-1-trial-for-patients-w-advanced-hematologic-malignancies-undergoing-allogeneic-hct-100558474","NCT06551584","Trial for Patients w\u002F Advanced Hematologic Malignancies Undergoing Allogeneic HCT","Trial for Patients With Advanced Hematologic Malignancies Undergoing Allogeneic Hematopoietic Cell Transplantation From an HLA-Mismatched Donor (7\u002F8) With Orca-T","Inclusion Criteria:\n\n1. Eligible diseases:\n\n   * Acute myeloid, lymphoid or mixed phenotype leukemia in complete remission (CR) or CR with incomplete hematologic recovery (CRi) as defined in Section 6.1.3; with or without the presence of known minimal residual disease, or\n   * Myelodysplasic syndrome (MDS) myelodysplastic syndromes eligible for alloHSCT and\u002For treatment-related MDS \\\u003C10% blasts\n2. Age ≥ 18 and ≤ 70 years at the time of enrollment.\n3. Eligible for myeloablative alloHCT including one of two the myeloablative conditioning regimens (fractionated total body irradiation plus cyclophosphamide or busulfan, fludarabine, and thiotepa)\n4. Has a related or unrelated donor available who is 7\u002F8 match (single allele mismatched) at HLA-A, -B, -C, and -DRB1, all typed using DNA-based high-resolution methods.\n5. Estimated glomerular filtration rate (eGFR) ≥ 50 mL\u002Fminute or creatinine \\\u003C 2 mg\u002FdL.\n6. Cardiac ejection fraction at rest ≥ 45% or shortening fraction of ≥ 27% by echocardiogram or radionuclide scan (MUGA).\n7. Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) ≥ 50%.\n8. Total bilirubin \\\u003C 2 times upper limit of normal (ULN) (patients with Gilbert's syndrome may be included once hemolysis has been excluded).\n9. Ability to understand and the willingness to provide written informed consent.\n10. Negative serum or urine beta-HCG test in females of childbearing potential (FCBP) within 3 weeks of enrollment.\n\n    A female of childbearing potential (FCBP) is a female who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).\n11. Able to give informed consent. Legal authorized representative (LAR) is permitted if subject is cognitively able to provide verbal assent.\n12. Karnofsky Performance Score ≥70%\n\nExclusion Criteria:\n\n1. Prior allogeneic HCT.\n2. Currently receiving corticosteroids or other immunosuppressive therapy. Topical corticosteroids or oral systemic corticosteroid doses less than or equal to 10 mg\u002Fday are allowed.\n3. Planned donor lymphocyte infusion (DLI).\n4. Planned pharmaceutical in vivo or ex vivo T cell depletion, e.g., post-transplant cyclophosphamide (Cy), peri-transplant anti-thymocyte globulin (ATG), or alemtuzumab. For patients that have previously been exposed to a T cell-depleting agent, a 5 half-life washout of the agent must occur prior to planned Day 0 (day of infusion of Orca-T HSPC and Tregs ).\n5. Recipient positive anti-donor HLA antibodies against a mismatched allele in the selected donor determined by either:\n\n   1. Positive crossmatch test of any titer (by complement-dependent cytotoxicity or flow cytometric testing), or\n   2. Presence of anti-donor HLA antibody to any of the following HLA loci: HLA-A, -B, -C, -DRB1, -DQB1, -DQA1, -DPB1, or -DPA1, with mean fluorescence intensity (MFI) \\>1000 by solid phase immunoassay.\n6. Uncontrolled bacterial, viral, or fungal infections (currently taking antimicrobial therapy and with progression or no clinical improvement) at time of enrollment including known, active tuberculosis infection.\n7. Seropositive for HIV-1 or -2, HTLV-1 or -2, Hepatitis B sAg, and\u002For Hepatitis C antibody.\n\n   \\*History of hepatitis B or hepatitis C is permitted if viral load is undetectable per quantitative PCR and\u002For NAT. In this case, monitoring for hepatitis B or hepatitis C by PCR at 3, 6, and 12 months is recommended.\n8. Known allergy or hypersensitivity to, or intolerance of, any investigational agent or ingredient therein, or planned GVHD prophylactic medications.\n9. Documented allergy or hypersensitivity to iron dextran or bovine, murine, algal or Streptomyces avidinii proteins.\n10. Any uncontrolled autoimmune disease requiring active immunosuppressive treatment.\n11. Concurrent malignancy diagnosed within 12 months of enrollment, except non-melanoma skin cancers that have been curatively resected.\n12. Females of childbearing potential (FCBP) or men who have sexual contact with FCBP unwilling to use effective forms of birth control or abstinence for one year after transplantation.\n\n    (FCBP definition: A female of childbearing potential (FCBP) is a female who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).\n13. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment. History of stroke or pulmonary embolism within 6 months of enrollment.\n14. Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the recipient's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results.","70 Years",{"count":569,"type":22},[25],"The study goal is to characterize the safety of the combination of Orca-T with dual agent GVHD prophylaxis.",[658,659,660,661],"Acute Myeloid Leukemia","Acute Lymphoid Leukemia","Mixed Phenotype Acute Leukemia","Myelodysplastic Syndromes",[663,664,665],"Orca-T","Hematopoietic Cell Transplantation","Advanced Hematologic Malignancies",{"date":336,"type":39},{"date":668,"type":39},"2025-12-01",{"date":91,"type":22},{"name":45,"class":46},""]