[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Baylor College of Medicine\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":702},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,107,0,25,[9,51,81,112,145,174,196,221,258,289,331,356,377,407,439,461,483,512,537,562,587,608,628,649,681],{"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":35,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100610081","feasibility-study-of-a-guided-imagery-therapy-mobile-application-for-functional-abdominal-pain-disorders-in-children-100610081",false,"NCT07222943","Feasibility Study of a Guided Imagery Therapy Mobile Application for Functional Abdominal Pain Disorders in Children","Open-Labelled Feasibility Study of a Guided Imagery Therapy Mobile Application for Functional Abdominal Pain Disorders in Children","Inclusion Criteria:\n\n* Texas Children's Pediatrics patients 7 to 12 years old at enrollment\n* A Rome IV Functional Abdominal Pain Disorder as defined by a 2-week abdominal pain and stooling diary\n* Both children and their primary caregivers must be able to read and communicate in English proficiently to understand the intervention's audio therapy sessions and psychometric instruments.\n\nExclusion Criteria:\n\n* Previous abdominal surgeries\n* Co-morbid conditions associated with abdominal pain (e.g., cystic fibrosis)\n* Autism\n* Significant development delay\n* Psychosis\n* Prior experience with cognitive behavioral therapy or guided imagery therapy to treat chronic abdominal pain\n* Alarm symptoms that warrant further medical evaluation (e.g., blood in stool)","ALL","7 Years","12 Years",{"count":21,"type":22},63,"ESTIMATED","INTERVENTIONAL",[25],"NA","Chronic abdominal pain is common among children, and the majority of cases are attributed to functional abdominal pain disorders. One approach to treating these disorders is by using psychological therapies. This clinical trial aims to see how well pre-recorded guided imagery therapy sessions help children's abdominal pain when delivered via a mobile application (app) on a smartphone or tablet.\n\nParticipants will complete a baseline abdominal pain and stooling diary to determine eligibility, as well as other surveys. Eligible participants will be given access to the guided imagery therapy mobile application.\n\nThis intervention asks participants to listen to a 10- to 15-minute GIT session 5 out of 7 days per week for 8 weeks, in addition to their usual care for their abdominal pain. Then, participants will complete another abdominal pain and stooling diary, along with other psychometric surveys, at the end of this intervention period. Participants will also collect another diary and surveys 3 months post-treatment.",[28,29,30,31,32,33,34],"Functional Abdominal Pain Disorders","Irritable Bowel Syndrome (IBS)","Functional Gastrointestinal Disorders (FGIDs)","Gastrointestinal and Digestive Disorder","Abdominal Pain\u002F Discomfort","Pain","Functional Dyspepsia",[36,37],"abdominal pain","irritable bowel syndrome","RECRUITING","2026-08-14",{"date":41,"type":42},"2026-08-17","ACTUAL",{"date":44,"type":22},"2026-09-01",{"date":46,"type":22},"2027-04-30",{"name":48,"class":49},"Baylor College of Medicine","OTHER",2,{"id":52,"slug":53,"hasResults":12,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":23,"phases":62,"briefSummary":64,"conditions":65,"keywords":69,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":50},"100292059","phase-1-autologous-t-cells-expressing-a-second-generation-car-for-treatment-of-t-cell-malignancies-expressing-cd5-antigen-100292059","NCT03081910","Autologous T-Cells Expressing a Second Generation CAR for Treatment of T-Cell Malignancies Expressing CD5 Antigen","Phase 1 Therapy With Manufactured Autologous T-Cells Expressing a Second Generation Chimeric Antigen Receptor (CAR) for Treatment of T-Cell Malignancies Expressing CD5 Antigen","MAGENTA","Procurement Inclusion Criteria for the Patient\n\nReferred patients (Group A - NOW CLOSED) or their previous HSCT donors (Group B) will initially be consented for procurement of blood for generation of the transduced ATL. Patient eligibility criteria at this stage include:\n\n1. Diagnosis of recurrent T-cell acute lymphoblastic leukemia (T-ALL), T-cell acute lymphoblastic lymphoma (T-LLy), or T-non-Hodgkin lymphoma (T-NHL, including Angioimmunoblastic T-cell lymphoma (AITL), Enteropathy-associated T-cell lymphoma (EATL), Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL), Peripheral T-cell lymphoma (PTCL) NOS, Anaplastic large cell lymphoma (ALCL), Adult T-cell leukemia\u002Flymphoma, T cell prolymphocytic leukemia with symptomatic disease, Extranodal NK\u002FT cell lymphoma, Mycosis fungoides\u002F Sezary Syndrome Stage IIB or higher))\n\n   AND\n\n   Group A (auto arm - NOW CLOSED): Transplant naïve or relapsed post-allogeneic HSCT OR\n\n   Group B (allo arm): Relapsed post-allogeneic HSCT with previous HSCT donor from whom allogeneic MAGENTA CAR T cells can be manufactured\n\n   AND\n   * Suitable for allogeneic hematopoietic stem cell transplant (HSCT) with confirmation of an identified eligible allo-HSCT donor by FACT accredited institution\n   * Confirmation that the center plans to proceed with transplant if CD5.CAR treatment induces a complete remission.\n\n     * For T-NHL subjects, eligibility will be confined to disease stages where allogeneic HSCT is indicated.\n2. CD5-positive tumor (result can be pending at this time). \\> 50% CD5 + blasts by flow cytometry or immunohistochemistry (tissue) assessed by a CLIA certified Flow Cytometry\u002FPathology laboratory.\n3. Age ≤75 years old. NOTE: The first six (6) patients treated on the study should be adults (\\>18 yrs of age).\n4. Life expectancy of greater than 12 weeks.\n5. Patients must have an available partially-HLA matched allogeneic EBV-specific T cell line on a BCM IRB approved protocol which can be used as treatment in the event of uncontrolled EBV reactivation\n6. Informed consent explained to, understood by and signed by patient\u002Fguardian. Patient\u002Fguardian given copy of informed consent.\n7. Hgb greather than or equal to 7.0 g\u002FdL (can be transfused)\n8. If pheresis required to collect blood:\n\n   * Creatinine \\\u003C1.5 × upper limit normal\n   * AST \\\u003C1.5 × upper limit normal\n   * PT and APTT \\\u003C1.5 × upper limit normal\n\nProcurement Exclusion Criteria for the Patient (Group A)\n\n1. Active infection requiring antibiotics.\n2. Active infection with HIV\n3. History of other cancer (except non-melanoma skin cancer or in situ breast cancer or cervix cancer) unless the tumor was successfully treated with curative intent at least 2 years before trial entry.\n\nProcurement Inclusion Criteria for Normal Healthy Donor (Group B):\n\n1. Donor must be prior hematopoietic stem cell transplant donor for patients relapsed post-allogeneic HSCT. Prior transplant donors will be screened with the standard blood bank donor questionnaire, medical history, and testing for infectious disease markers (IDMs; which may be pending at the time of blood collection). Medical history may be obtained by the patient's primary\u002Freferring transplant team if collection is being done remotely. The physician assessment, donor questionnaire, and IDMs will be reviewed by the principle investigator or appropriate designee to confirm\u002Fprovide final eligibility determination and documented in the donor's medical record.\n2. Informed consent explained to, understood by and signed by donor\u002FLAR. Donor\u002FLAR given copy of informed consent.\n\nTreatment Inclusion Criteria\n\nPatients must meet the following eligibility criteria to be included for treatment:\n\n1. Diagnosis of recurrent T-cell acute lymphoblastic leukemia (T-ALL), T-cell acute lymphoblastic lymphoma (T-LLy), or T-non-Hodgkin lymphoma (T-NHL, including Angioimmunoblastic T-cell lymphoma (AITL), Enteropathy-associated T-cell lymphoma (EATL), Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL), Peripheral T-cell lymphoma (PTCL) NOS, Anaplastic large cell lymphoma (ALCL), Adult T-cell leukemia\u002Flymphoma, T cell prolymphocytic leukemia with symptomatic disease, Extranodal NK\u002FT cell lymphoma, Mycosis fungoides\u002F Sezary Syndrome Stage IIB or higher))\n\n   AND\n\n   Group A (auto arm - NOW CLOSED): Transplant naïve or relapsed post-allogeneic HSCT OR\n\n   Group B (allo arm): Relapsed post-allogeneic HSCT with previous HSCT donor from whom allogeneic MAGENTA CAR T cells can be manufactured\n\n   AND\n   * Suitable for allogeneic hematopoietic stem cell transplant (HSCT) with confirmation of an identified eligible allo-HSCT donor by FACT accredited institution\n   * Confirmation that the center plans to proceed with transplant if CD5.CAR treatment induces a complete remission.\n\n     * For T-NHL subjects, eligibility will be confined to disease stages where allogeneic HSCT is indicated.\n2. CD5-positive tumor. \\>50% CD5 + blasts by flow cytometry or immunohistochemistry (tissue) assessed by a CLIA certified Flow Cytometry\u002FPathology laboratory.\n3. Age \\\u003C75 years old. NOTE: The first six (6) patients treated on the study should be adults (\\>18 yrs of age).\n4. Bilirubin less than 3 times the upper limit of normal.\n5. AST less than 5 times the upper limit of normal.\n6. Estimated GFR \\> 60 mL\u002Fmin.\n7. Pulse oximetry of \\> 90% on room air.\n8. Karnofsky or Lansky score of ≥ 60%.\n9. Recovered from acute toxic effects of prior chemotherapy at least one week before entering this study.\n10. ≥ 60 days post-allogeneic HSCT at time of treatment.\n11. Patients must have an available partially-HLA matched allogeneic EBV-specific T cell line on a BCM IRB approved protocol which can be used as treatment in the event of uncontrolled EBV reactivation.\n12. Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded. The male partner should use a condom.\n13. Informed consent explained to, understood by, and signed by patient\u002Fguardian. Patient\u002Fguardian given copy of informed consent.\n\nTreatment Exclusion Criteria\n\n1. Currently receiving any investigational agents or having received any tumor vaccines within the previous 6 weeks.\n2. History of hypersensitivity reactions to murine protein-containing products.\n3. Pregnant or lactating.\n4. Tumor in a location where enlargement could cause airway obstruction.\n5. Active infection with HIV.\n6. Clinically significant viral infection or uncontrolled viral reactivation of EBV, CMV, Adv, BK-virus, or HHV-6.\n7. Evidence of acute GVHD \\> Grade II or active chronic GVHD \\> mild global severity score\n8. Currently taking corticosteroids for therapy of GVHD at a dose of \\>0.5mg\u002Fkg prednisone equivalent\n9. Patients who have received Immunosuppressive Treatment (IST) for GVHD within 28 days of infusion\n10. Patients who have received donor lymphocyte infusion (DLI) within 28 days of infusion\n11. Any of the following cardiac criteria: Atrial fibrillation\u002Fflutter; Myocardial infarction within the last 12 months; Prolonged QT syndrome or secondary prolonged QT, per investigator discretion. Cardiac echocardiography with LVSF\\\u003C30% or LVEF\\\u003C50%; or clinically significant pericardial effusion. Cardiac dysfunction NYHA III or IV (Confirmation of absence of these conditions within 12 months of treatment)\n12. CNS abnormalities: Presence of CNS-3 disease defined as detectable cerebrospinal blast cells in a sample of CSF with ≥ 5 WBCs per mm3; History or presence of any CNS disorder such as a uncontrolled seizure disorder, cerebrovascular ischemia\u002Fhemorrhage within prior 6 months, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.","75 Years",{"count":61,"type":22},54,[63],"PHASE1","Patients eligible for this study have a type of blood cancer called T-cell leukemia or lymphoma (lymph gland cancer).\n\nThe body has different ways of fighting infection and disease. No one way seems perfect for fighting cancers. This research combines two different ways of fighting disease, antibodies and T cells. Antibodies are proteins that protect the body from bacterial and other diseases. T cells, or T lymphocytes, are special infection-fighting blood cells that can kill other cells including tumor cells. Both antibodies and T cells have shown promise treating patients with cancers, but have not been strong enough to cure most patients.\n\nT lymphocytes can kill tumor cells but there normally are not enough of them. Some researchers have taken T cells from a person's blood, grown more in the lab then given them back to the person. In some patients who've had recent bone marrow or stem cell transplant, the number of T cells in their blood may not be enough to grow in the lab. In this case, T cells may be collected from their previous transplant donor, who has a similar tissue type.\n\nThe antibody used in this study, called anti-CD5, first came from mice that have developed immunity to human leukemia. This antibody sticks to T-cell leukemia or lymphoma cells because of a substance on the outside of these cells called CD5. CD5 antibodies have been used to treat people with T-cell leukemia and lymphoma. For this study, anti-CD5 has been changed so that instead of floating free in the blood it is now joined to the T cells. When an antibody is joined to a T cell in this way it is called a chimeric receptor. In the lab, investigators have also found that T cells work better if stimulating proteins, such as one called CD28, are also added. Adding the CD28 makes the cells grow better and last longer in the body, giving them a better chance of killing the leukemia or lymphoma cells.\n\nIn this study investigators will attach the CD5 chimeric receptor with CD28 added to it to the patient's T cells or the previous bone marrow transplant donor's T cells. The investigators will then test how long the cells last. The decision to use the bone marrow transplant donor's T cells instead of the patient's will be based on 1) whether there is an available and willing donor and 2) the likelihood of the patient's T cells being able to grow in the lab. These CD5 chimeric receptor T cells with CD28 are investigational products not approved by the FDA.\n\nUPDATE: Please note that the Autologous Arm of this study is now closed.",[66,67,68],"T-cell Acute Lymphoblastic Lymphoma","T-non-Hodgkin Lymphoma","T-cell Acute Lymphoblastic Leukemia",[70,71,67,68,72],"Autologous CAR T cells","T-cell acute lymphoblastic lymphoma","Allogeneic CAR T cells","2026-08-07",{"date":75,"type":42},"2026-08-11",{"date":77,"type":42},"2017-11-01",{"date":79,"type":22},"2040-09-01",{"name":48,"class":49},{"id":82,"slug":83,"hasResults":12,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":12,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":4,"studyType":23,"phases":94,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},"100632010","phase-4-topical-steroids-to-prevent-recurrent-urinary-tract-infections-in-uncircumcised-male-infants-a-pilot-study-100632010","NCT07508124","Topical Steroids to Prevent Recurrent Urinary Tract Infections in Uncircumcised Male Infants: a Pilot Study","Topical Steroids to Prevent Recurrent Urinary Tract Infections in Uncircumcised Male Infants With a First Febrile Urinary Tract Infection: a Multi-center Pilot Study","STRUMI-T","Inclusion Criteria:\n\n1. Uncircumcised male infants \\\u003C 6 months old\n2. Both physician and laboratory confirmed diagnosis of first UTI\n3. Fever (temperature ≥38.0 C) or hypothermia (temperature \\\u003C36.0 C) per ED\u002Fhospitalization or parental report\n\nExclusion Criteria:\n\n1. Legal guardian not available to provide informed consent\n2. Infant in Child Protective Services (CPS) custody\n3. Legal guardian would like Urology referral for circumcision\n4. Circumcision is medically indicated due to recurrent episodes of balanitis or ballooning of foreskin during urination\n5. Past diagnosis of penile abnormalities (diagnoses of epispadius, hypospadias or congenital penile curvature (chordee))\n6. Prior use of topical steroid therapy for phimosis\n7. History of hypersensitivity to topical steroids\n8. Legal guardian is not fluent in English OR Spanish\n9. Foreskin assessed to be fully retractable\n10. Open wounds present on penis or in groin region","MALE","0 Months","5 Months",{"count":93,"type":22},40,[95],"PHASE4","The goal of this smaller clinical trial is to evaluate the study design of this research to help prepare for a larger research study in the future. The future larger study would focus on whether steroid cream can reduce recurrent urinary tract infections in male infants, who are not circumcised.\n\nMale infants, who are enrolled in this study, would receive either the steroid cream or a placebo cream (a look alike cream without steroids). The cream would be applied twice a week for four weeks. Then there would be two follow up visits with the research team to measure whether the infant experienced any urinary tract infections and to measure parent perceptions of their experience participating in the study.",[98],"Urinary Tract Infection",[100,101,102,103],"urinary tract infection","uncircumcised male infants","betamethasone cream","steroid cream","2026-08-05",{"date":73,"type":42},{"date":107,"type":42},"2026-05-08",{"date":109,"type":22},"2027-12",{"name":48,"class":49},3,{"id":113,"slug":114,"hasResults":12,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":12,"sex":17,"minAge":119,"maxAge":120,"enrollmentInfo":121,"targetDuration":4,"studyType":23,"phases":123,"briefSummary":124,"conditions":125,"keywords":132,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},"100417400","phase-1-interleukin-15-and--21-armored-glypican-3-specific-chimeric-antigen-receptor-expressed-in-t-cells-for-pediatric-solid-tumors-100417400","NCT04715191","Interleukin-15 and -21 Armored Glypican-3-specific Chimeric Antigen Receptor Expressed in T Cells for Pediatric Solid Tumors","Interleukin-15 and -21 Armored Glypican-3-specific Chimeric Antigen Receptor Expressing Autologous T Cells as an Immunotherapy for Children With Solid Tumors (CARE)","Procurement Eligibility\n\nInclusion Criteria:\n\n* Diagnosis of GPC3-positive\\* solid tumors (as determined by immunohistochemistry with an extent score of \\>=Grade 2 \\[\\>25% positive tumor cells\\] and an intensity score of \\>= 2 \\[scale 0-4\\]).\n* Age ≥1 year and ≤ 21 years\n* Lansky or Karnofsky score ≥60%\n* Life expectancy ≥16 weeks\n* Barcelona Clinic Liver Cancer Stage A, B or C (for patients with hepatocellular carcinoma only)\n* Child-Pugh-Turcotte score \\\u003C7 (for patients with hepatocellular carcinoma only)\n* Informed consent explained to, understood by and signed by patient\u002Fguardian. Patient\u002Fguardian given copy of informed consent\n\nExclusion Criteria:\n\n* History of hypersensitivity reactions to murine protein-containing products OR presence of human anti-mouse antibody (HAMA) prior to enrollment (only patients who have received prior therapy with murine antibodies).\n* History of organ transplantation\n* Known HIV positivity\n* Active bacterial, fungal or viral infection (except Hepatitis B or Hepatitis C virus infections)\n\nTreatment Eligibility\n\nInclusion Criteria:\n\n* Age ≥ 1 year and ≤ 21 years\n* Barcelona Clinic Liver Cancer Stage A, B or C (for patients with hepatocellular carcinoma only)\n* Lansky or Karnofsky score ≥ 60%\n* Child-Pugh-Turcotte score \\\u003C 7 (for patients with hepatocellular carcinoma only)\n* Adequate organ function:\n* Creatinine clearance as estimated by Cockcroft Gault or Schwartz ≥ 60 ml\u002Fmin\n* Total bilirubin \\\u003C 3 times ULN for age\n* INR ≤1.7 (for patients with hepatocellular carcinoma only)\n* Absolute neutrophil count \\> 750\u002Fµl\n* Platelet count \\> 75,000\u002Fµl (Needs to be confirmed prior to treatment whether with or without transfusion)\n* Hgb ≥ 8.0 g\u002Fdl (Needs to be confirmed prior to treatment whether with or without transfusion)\n* Pulse oximetry ≥ 92% on room air\n* Incurable disease after treatment with up- front therapy (Patients who have relapsed disease despite a standard of care salvage therapy)\n* Wash out period, such that patient has recovered from acute toxic effects of all prior chemotherapy and investigational agents before entering this study, and returned to their clinical baseline, as determined by history and physical exam.\n* Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the T-cell infusion.\n* Informed consent explained to, understood by and signed by patient\u002Fguardian. Patient\u002Fguardian given copy of informed consent\n\nExclusion Criteria:\n\n* Pregnancy or lactation\n* Uncontrolled infection\n* Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent\u002Fkg\u002Fday, dose adjustment or discontinuation of medication must occur at least 24 hours prior to CAR T cell infusion)\n* Known HIV positivity\n* Active bacterial, fungal or viral infection \\[except Hepatitis B (HBV patients with active disease who meet the criteria for anti-HBV therapy should be on a suppressive antiviral therapy prior to initiation of cancer therapy) or Hepatitis C virus infections (should have completed curative antiviral treatment with HCV viral load below the limit of quantification\\]\n* Congestive heart failure (as defined by New York Heart Association Functional Classification III or IV), unstable angina, serious uncontrolled cardiac arrhythmia, a myocardial infarction within 6 months prior to study entry or a history of myocarditis\n* Active autoimmune or inflammatory disorder\n* Live vaccines within 30 days prior to enrollment\n* History of organ transplantation\n* History of hypersensitivity reactions to murine protein-containing products OR presence of human anti-mouse antibody (HAMA) prior to enrollment (only patients who have received prior therapy with murine antibodies)","1 Year","21 Years",{"count":122,"type":22},24,[63],"Patients may be considered if the cancer has come back, has not gone away after standard treatment or the patient cannot receive standard treatment. This research study uses special immune system cells called CARE T cells, a new experimental treatment.\n\nThe body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting cancer: antibodies and T cells. Antibodies are types of proteins that protect the body from infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. Both antibodies and T cells have been used to treat patients with cancers. They have shown promise, but have not been strong enough to cure most patients.\n\nInvestigators have found from previous research that they can put a new gene (a tiny part of what makes-up DNA and carries a person's traits) into T cells that will make them recognize cancer cells and kill them. In the lab, investigators made several genes called a chimeric antigen receptor (CAR), from an antibody called GPC3. The antibody GPC3 recognizes a protein found solid tumors including pediatric liver cancers. This CAR is called GPC3-CAR. To make this CAR more effective, investigators also added two genes that includes IL15 and IL21, which are protein that helps CAR T cells grow better and stay in the blood longer so that they may kill tumors better. The mixture of GPC3-CAR and IL15 plus IL21 killed tumor cells better in the laboratory when compared with CAR T cells that did not have IL15 plus IL21 .This study will test T cells that investigators made (called genetic engineering) with GPC3-CAR and the IL15 plus IL21 (CARE T cells) in patients with GPC3-positive solid tumors.\n\nT cells made to carry a gene called iCasp9 can be killed when they encounter a specific drug called AP1903. The investigators will insert the iCasp9 and IL15 plus IL21 together into the T cells using a virus that has been made for this study. The drug (AP1903) is an experimental drug that has been tested in humans with no bad side-effects. The investigators will use this drug to kill the T cells if necessary due to side effects.\n\nThis study will test T cells genetically engineered with a GPC3-CAR and IL15 plus IL21 (CARE T cells) in patients with GPC3-positive solid tumors.\n\nThe CARE T cells are an investigational product not approved by the Food and Drug Administration.\n\nThe purpose of this study is to find the biggest dose of CARE T cells that is safe, to see how long they last in the body, to learn what the side effects are and to see if the CARE T cells will help people with GPC3-positive solid tumors.",[126,127,128,129,130,131],"Liver Cancer","Rhabdomyosarcoma","Malignant Rhabdoid Tumor","Liposarcoma","Wilms Tumor","Yolk Sac Tumor",[133,134,135],"15.21.GPC3-CAR T cells","GPC3","Glypican","2026-08-04",{"date":138,"type":42},"2026-08-06",{"date":140,"type":42},"2024-05-24",{"date":142,"type":22},"2042-07-03",{"name":48,"class":49},1,{"id":146,"slug":147,"hasResults":12,"nctId":148,"briefTitle":149,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":151,"enrollmentInfo":152,"targetDuration":4,"studyType":23,"phases":154,"briefSummary":155,"conditions":156,"keywords":163,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":144},"100537143","telehealth-behavioral-activation-for-teens-100537143","NCT06273995","Telehealth Behavioral Activation for Teens","Inclusion Criteria:\n\n1. Participants must be enrolled in the Texas Youth Depression Suicide Research Network (TX-YDSRN) Registry Study;\n2. Be between the ages of 12- 18 or currently enrolled in high school;\n3. Have a caregiver that is willing to participate in the program;\n4. Be able to commit to weekly sessions for eight weeks;\n5. Be currently experiencing depressive symptoms;\n6. Be able to participate in telehealth services within the state of Texas;\n7. Be willing to provide consent\u002Fassent (parents\u002Flegally authorized representative (LAR)\u002Fguardian or young adult participant, aged 18 or older, must be willing to provide consent; youth, aged 12-17, must be willing to provide assent);\n8. Be able to read, write and speak English or Spanish sufficiently to understand the study procedures and provide written informed consent to participate in the study;\n9. Be willing to dedicate appropriate time to complete scheduled study assessment and measures and attend intervention sessions (both parent\u002FLAR\u002Fguardian and youth)\n10. Be able to provide a reliable means of contact.\n\nExclusion Criteria:\n\n1. Have an acute medical or psychological condition(s) that that would, in the judgment of the study medical clinician, make participation difficult or unsafe;\n2. Have an acute medical or psychological condition(s) that would result in an inability to accurately complete study requirements (e.g., neurological conditions or significant neurodevelopmental concerns);\n3. Have active psychotic or manic symptoms resulting in altered mental status and inability to provide assent or requiring immediate attention and\u002For higher level of intervention;\n4. Have a parent\u002FLAR\u002Fguardian who is deemed cognitively unable to provide consent (if youth participant, aged 12-17).","18 Years",{"count":153,"type":22},250,[25],"Behavioral activation is one such empirically supported intervention. Derived from cognitive-behavioral therapy, a well-established treatment for depression, behavioral activation uses psychoeducation and skill-building to increase an individual's engagement in valued and enjoyable activities (e.g., socializing with family and friends, exercising, participating in a hobby) in order to improve depressive symptoms. Research has shown that behavioral activation is an effective intervention for depressed youth. Additionally, it has been shown as a promising intervention that can be conducted in a brief, virtual format and can be effectively implemented by both trained clinicians and trained, non-licensed interventionists. This project will provide Behavioral Activation for youth (12-17) experiencing depression or suicidal ideation who are currently enrolled in the Youth Depression Suicide Network study in Texas.",[157,158,159,160,161,162],"Depression","Suicide and Self-harm","Depression in Adolescence","Depression Mild","Depression Moderate","Depression Severe",[164,165,166],"behavioral activation","depression","adolescents","2026-08-03",{"date":136,"type":42},{"date":170,"type":42},"2024-03-01",{"date":172,"type":22},"2029-12-01",{"name":48,"class":49},{"id":175,"slug":176,"hasResults":12,"nctId":177,"briefTitle":178,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":180,"enrollmentInfo":181,"targetDuration":4,"studyType":23,"phases":183,"briefSummary":184,"conditions":185,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":190,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":144},"100486118","cbt-augmentation-to-promote-medication-discontinuation-in-pediatric-ocd-100486118","NCT05609916","CBT Augmentation to Promote Medication Discontinuation in Pediatric OCD","Inclusion Criteria:\n\n* The child is between the ages of 7 to 17 at enrollment with a primary diagnosis of OCD of \\> 6 months duration based on the Kiddie Schedule for Affective Disorders and Schizophrenia Lifetime Version for DSM-5 (KSADS-PL) and have a CY-BOCS ≥ 16.\n* The child is on stable and maximally tolerated SRI medication (i.e., clomipramine, fluoxetine, fluvoxamine, sertraline, citalopram, escitalopram) for ≥12 weeks given that they are persistently and moderately symptomatic. Paroxetine is exclusionary due to safety concerns.\n* Both the child and parent participating in the study are English speaking.\n* Both the child and their parent participating in the study reside in Texas.\n\nExclusion Criteria:\n\n* The child has a diagnosis of lifetime DSM-5 bipolar disorder, psychotic disorder, and\u002For intellectual disability.\n* The child has severe current suicidal\u002Fhomicidal ideation and\u002For self-injury requiring medical intervention.\n* The child is receiving concurrent psychotherapy for OCD.\n* Initiation of a psychotropic medication less than 4 weeks prior to study enrollment or a stimulant\u002Fpsychoactive medication less than 2 weeks prior to study enrollment.","17 Years",{"count":182,"type":22},200,[25],"The purpose of this study is to examine whether youth with OCD who benefit from CBT augmentation to SRI can discontinue their medication without relapse over 24 weeks.",[186,187,188,189],"Cognitive Behavioral Therapy","Obsessive-Compulsive Disorder","Obsessive-Compulsive Disorder in Children","Obsessive-Compulsive Disorder in Adolescence",{"date":136,"type":42},{"date":192,"type":42},"2022-11-30",{"date":194,"type":22},"2027-08-30",{"name":48,"class":49},{"id":197,"slug":198,"hasResults":12,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":12,"sex":17,"minAge":151,"maxAge":4,"enrollmentInfo":203,"targetDuration":4,"studyType":23,"phases":205,"briefSummary":207,"conditions":208,"keywords":210,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":215,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":111},"100449440","phase-2-neoadjuvant-folfirinox-combined-with-pembrolizumab-followed-by-surgery-for-patients-with-resectable-pancreatic-cancer-100449440","NCT05132504","Neoadjuvant Folfirinox Combined With Pembrolizumab Followed by Surgery for Patients With Resectable Pancreatic Cancer","Phase II Study of Neoadjuvant Folfirinox Chemotherapy Followed by Pembrolizumab Followed by Surgery for Patients With Localized, Resectable Adenocarcinoma of the Pancreas","Inclusion Criteria:\n\n1. Patient is ≥18 years of age and has histologically or cytologically confirmed localized adenocarcinoma of the pancreas that is potentially resectable. Patients with islet cell or other neuroendocrine neoplasms are excluded.\n2. Definition of localized, potentially resectable disease: a) Adequate CT or MRI to determine staging and eligibility based on radiologic interpretation. b) No extension to superior mesenteric artery (SMA) and hepatic artery. Patent superior mesenteric vein\u002Fportal vein (SMV\u002FPV) with \\\u003C 180-degree abutment and no evidence of invasion. c) Clear fat plane between the SMA and celiac axis. d) No extension to celiac axis and hepatic artery. e) Patent superior mesenteric vein and portal vein. f) No evidence of distant metastatic disease 3. If a female patient is of childbearing potential, she must have a negative urine pregnancy test documented within 72 hours of first intervention. 4. Fertile participants must use contraception considered adequate and appropriate as stated in Appendix 3 (pages 61-62).\n\n5\\. Male participants: A male participant must agree to use contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 220 days after the last dose of study treatment and refrain from donating sperm during this period.\n\n6\\. Patient must not have received prior chemotherapy or radiation for pancreatic cancer. 7. Patient has an ECOG performance status PS 0-1. 8. Patient has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent Form before participation in any study-related activities.\n\n9\\. A female participant is eligible to participate if:\n\na. Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 (pages 61-62). OR b. A WOCBP who is not pregnant, not breastfeeding, and agreeing to use proper contraception defined by the protocol (Appendix 3 \\[pages 61 - 62\\] and Table 18 \\[page 63\\]) for at least 160 days after the last dose of study treatment.\n\n10\\. Have adequate organ function as defined in the following table (Table 3). Specimens must be collected within 14 days before the start of interventions.\n\nHematological Absolute neutrophil count (ANC) ≥1500\u002FμL Platelets ≥100 000\u002FμL Hemoglobin ≥9.0 g\u002FdL or ≥5.6 mmol\u002FLa Renal Creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR ≥30 mL\u002Fmin for participant with creatinine levels \\>1.5 × institutional ULN Hepatic Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \\>1.5 × ULN AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver metastases) Coagulation International normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n\nExclusion Criteria:\n\n1. Patient has borderline resectable, locally advanced unresectable, or advanced metastatic disease. Patients with neuroendocrine tumors, adenosquamous cancer, lymphoma of the pancreas, or ampullary cancer are also ineligible.\n2. Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.\n3. Patient has known infection with HIV.\n4. Patient has undergone major surgery, other than diagnostic surgery (-e.g. diagnostic laparoscopy or placement of a central venous catheter), within 4 weeks before registration.\n5. Patient has a history of allergy or hypersensitivity to the study drugs.\n6. Patient has serious medical risk factors involving any of the major organ systems such that the Investigator considers it unsafe for the patient to receive chemotherapy and\u002For radiation therapy.\n7. Has a known additional malignancy that is progressing or has required active treatment within the past 2 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.\n8. Patient has had clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before registration.\n9. Patient is unwilling or unable to comply with study procedures.\n10. Patient is enrolled in any other therapeutic clinical protocol or investigational trial.\n11. Patients aged ≥ 80 are not excluded. However, candidates in this age group should be thoroughly evaluated before registration in the study, to ensure they are fit to receive chemotherapy, and to potentially undergo pancreaticoduodenectomy. In addition to meeting all of the baseline patient selection criteria, clinical judgment on their susceptibility to infection and expected stability of their performance status and suitability to receive intensive chemotherapy cycles, should be paid special attention to. Patients should not be enrolled in the study should there be any hesitation on any of these considerations. Baseline criteria for all patients enrolled in the study must be carefully evaluated and all criteria followed appropriately.\n12. Patient has evidence of peripheral neuropathy Grade 2 or higher.\n13. A WOCBP who has a positive urine pregnancy test within 72 hours prior to first intervention (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a second urine pregnancy test will be required. In the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another urine pregnancy test must be performed and must be negative in order for the subject to start receiving study medication.\n14. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).\n15. Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug.\n16. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.\n17. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n18. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.\n19. Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n20. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as detectable HCV by RNA) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authorities.\n21. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n22. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n23. Has had an allogenic tissue\u002Fsolid organ transplant.",{"count":204,"type":22},30,[206],"PHASE2","Abbreviated Title: Neoadjuvant FOLFIRINOX combined with Pembrolizumab followed by surgery for patients with resectable pancreatic cancer Trial Phase: Phase II Clinical Indication: Pancreatic ductal adenocarcinoma; Adenocarcinoma; AJCC I, II, or III; 1st Line neoadjuvant Trial Type: Interventional prospective Type of control: Historical Route of administration: IV Treatment Groups: Neoadjuvant FOLFIRINOX combined with Pembrolizumab followed by surgery for patients with resectable pancreatic cancer Number of trial participants: 30 Estimated enrollment period: 24 months Estimated duration of trial: 3.5 Years Duration of Participation:16 months Estimated average length of treatment per patient: 16 months",[209],"Pancreatic Ductal Adenocarcinoma",[211,212,213,214],"pembrolizumab","pancreatic cancer","pancreas adenocarcinoma","folfirinox",{"date":136,"type":42},{"date":217,"type":42},"2022-08-31",{"date":219,"type":22},"2027-05-21",{"name":48,"class":49},{"id":222,"slug":223,"hasResults":12,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":12,"sex":17,"minAge":228,"maxAge":229,"enrollmentInfo":230,"targetDuration":4,"studyType":23,"phases":232,"briefSummary":233,"conditions":234,"keywords":239,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":144},"100370165","phase-1-c7r-gd2car-t-cells-for-patients-with-gd2-expressing-brain-tumors-gail-b-100370165","NCT04099797","C7R-GD2.CAR T Cells for Patients With GD2-expressing Brain Tumors (GAIL-B)","Phase I Study of Autologous T Lymphocytes Expressing GD2-specific Chimeric Antigen and Constitutively Active IL-7 Receptors for the Treatment of Patients With GD2-expressing Brain Tumors (GAIL-B)","Procurement Inclusion Criteria:\n\nCohort 1:\n\n1. Histologically confirmed, GD2-expressing newly diagnosed DMG\u002FHGG (including pontine) or confirmation of H3K27 alteration if sufficient tissue for GD2 staining by IHC is not available. Newly diagnosed is defined as prior to radiographic progression or recurrence.\n\n   OR\n\n   Histologically confirmed, GD2-expressing recurrent, refractory, or progressive DMG\u002FHGG (except pontine) or confirmation of positive H3K27 alteration if sufficient tissue for GD2 staining by IHC is not available.\n\n   OR\n\n   Recurrent, refractory, or progressive high-grade CNS tumor with confirmed GD2-expression. Examples include: medulloblastoma \"CNS embryonal tumors, AT\u002FRT, ependymal tumors, diffuse gliomas or glioneuronal tumors.\n\n   Cohort 2:\n\n   Recurrent, refractory, or progressive pontine HGG with confirmed GD2-expression or H3K27-altered DMG\n2. Tumors less than 5 cm in maximum dimension at enrollment\n\n   1. Tumors with ≤25% increase in size (on any dimension) on MRI 4-8 weeks post-radiotherapy remain eligible for study\n   2. Tumors with \\>25% increase in size on post-radiation imaging may be reassessed with repeat MRI in 4-6 weeks, and are eligible if tumor size is subsequently ≤ 25% increased compared with pre-irradiation MRI.\n   3. Tumors with sizes between 5 and 5.5 cm are eligible if the tumor was surgically debulked\n3. Measurable disease on at least 2 dimensions on MRI\n4. Age 12 months to 25 years\n5. Functional score (Karnofsky\u002FLansky) ≥ 50 expected at infusion (≥60 for cohort 2)\n\nProcurement Exclusion Criteria:\n\n1. Patients who are pregnant or breast feeding\n2. Any patient with other risk factors for whom administration of investigational agent is deemed not in the patient's best interest, in the opinion of the investigator.\n\nTreatment Inclusion Criteria\n\nCohort 1:\n\n1. Histologically confirmed, GD2-expressing newly diagnosed DMG\u002FHGG (including pontine) or confirmation of H3K27 alteration if sufficient tissue for GD2 staining by IHC is not available. Newly diagnosed is defined as prior to radiographic progression or recurrence.\n\n   OR\n\n   Histologically confirmed, GD2-expressing recurrent, refractory, or progressive DMG\u002FHGG (except pontine) or confirmation of positive H3K27 alteration if sufficient tissue for GD2 staining by IHC is not available.\n\n   OR\n\n   Recurrent, refractory, or progressive high -grade CNS tumor with confirmed GD2-expression. Examples include: medulloblastoma, CNS embryonal tumors, AT\u002FRT, ependymal tumors, diffuse gliomas, or glioneuronal tumors.\n\n   Cohort 2:\n\n   Recurrent, refractory, or progressive pontine H3K27-altered for DMG or HGG with confirmed GD2-expression.\n2. Tumors less than 5 cm in maximum dimension at enrollment\n\n   1. Tumors with ≤25% increase in size (on any dimension) on MRI 4-8 weeks post-radiotherapy remain eligible for study\n   2. Tumors with \\>25% increase in size on post-radiation imaging may be reassessed with repeat MRI in 4-6 weeks, and are eligible if tumor size is subsequently ≤ 25% increased compared pre-irradiation MRI\n   3. Tumors with sizes between 5 and 5.5 cm are eligible if the tumor was surgically debulked\n3. Measurable disease on at least 2 dimensions on MRI\n4. Central line (PICC or other) and Ommaya reservoir or VP shunt in place or planned to be placed. Central line\u002FPICC may be omitted for cycles that do not include lymphodepletion\n5. Age 12 months to 25 years\n6. Functional score (Karnofsky\u002FLansky) ≥ 50 (≥60 for cohort 2)\n7. Patients must have completed standard of care radiation therapy at least 4 weeks prior to administration of investigational agent. If bevacizumab was administered for management of radiation necrosis, therapy must be completed at least 4 weeks prior to administration of investigational agent.\n8. Stable neurologic exam for 7 days prior to enrollment\n9. Stable or decreasing dose of steroids (max. allowable dose of dexamethasone is 0.1 mg\u002Fkg\u002Fday over the past 7 days prior to infusion of investigational therapy)\n10. Organ function:\n\n    1. ANC \\> 1000 cells\u002Ful\n    2. Platelet count \\> 100,000 cells\u002Ful\n    3. Total bilirubin \\\u003C 1.5x ULN\n    4. ALT and AST \\\u003C 5x ULN\n    5. Serum creatinine or kidney within 2x ULN for age\n\nTreatment Exclusion Criteria\n\n1. Patients who received any other forms of immunotherapy ≤ 42 days before administration of investigational agent\n2. Patients who received colony-stimulating factors within 14 days prior to administration of lymphodepletion\n3. Patients receiving any concurrent anti-cancer therapy (treatment must occur at least three half-lives following prior anti-cancer therapy)\n4. Patients who are pregnant or breast feeding\n5. Any patient with other risk factors for whom administration of investigational agent is deemed not in the patient's best interest, in the opinion of the investigator.","12 Months","25 Years",{"count":231,"type":22},56,[63],"In this study, there are two treatment groups called Cohort 1 and Cohort 2. Cohort 1 is for patients with diffuse midline glioma, diffuse intrinsic pontine glioma, medulloblastoma, or another rare high-grade glioma that expresses GD2. Cohort 2 is for patients with a type of cancer called progressive diffuse intrinsic pontine glioma that expresses GD2.\n\nBecause there is no standard treatment at this time, patients are asked to volunteer in a gene transfer research study using special immune cells called T cells. T cells are a type of white blood cell that help the body fight infection.\n\nThis research study combines two different ways of fighting cancer: antibodies and T cells. Both antibodies and T cells have been used to treat cancer patients. They have shown promise but have not been strong enough to cure most patients.\n\nResearchers have found from previous research that they can put a new antibody gene into T cells that will make them recognize cancer cells and kill them. GD2 is a protein found on several different cancers. Researchers testing brain cancer cells found that many of these cancers also have GD2 on their surface.\n\nIn a study for neuroblastoma in children, a gene called a chimeric antigen receptor (CAR) was made from an antibody that recognizes GD2. This gene was put into the patients own T cells and given back to 11 patients. The cells did grow for a while but started to disappear from the blood after 2 weeks. The researchers think that if T cells are able to last longer they may have a better chance of killing tumor cells.\n\nIn this study, a new gene will be added to the GD2 T cells that can potentially cause the cells to live longer. T cells need substances called cytokines to survive. The gene C7R has been added that gives the cells a constant supply of cytokine and helps them to survive for a longer period of time.\n\nIn other studies using T cells researchers found that giving chemotherapy before the T cell infusion can improve the amount of time the T cells stay in the body and therefore the effect the T cells can have. This is called lymphodepletion and it will allow the T cells to expand and stay longer in the body and potentially kill cancer cells more effectively.\n\nAfter treating 11 patients, the largest safe dose of GD2-CAR T cells given in the vein (IV) was determined. We are now combining an IV infusion with an infusion directly into the brain through the Ommaya reservoir or programmable VP shunt. The goal is to find the largest safe dose of GD2-C7R T cells that can be administered in this way.\n\nPatients will now be assigned to Cohort 1 and 2 based on their tumor type.\n\nThe GD2.C7R T cells are an investigational product not approved by the FDA.\n\nThe purpose of this study is to combine infusions into the vein in the first treatment cycle with infusions directly into the cerebrospinal fluid (CSF) in the brain (intracerebroventricularly) through the ommaya reservoir or programmable VP shunt for infusions cycles 2-24. The goal is to find the largest safe dose of GD2-C7R T cells that can be administered in this way, and additionally to evaluate how long they can be detected in the blood and CSF and what affect they have on brain cancer.",[235,236,237,238],"Diffuse Intrinsic Pontine Glioma","High Grade Glioma","Embryonal Tumor","Ependymal Tumor",[240,241,242,243,244,245,246,247,248,249,250],"Gene Therapy","CAR T-cells","chimeric antigen receptor","Brain Cancer","Immunotherapy","Glioma","Brain tumor","DIPG","ETMRs","Medulloepithelioma","Atypical teratoid\u002Frhabdoid tumors","2026-07-31",{"date":167,"type":42},{"date":254,"type":42},"2020-02-03",{"date":256,"type":22},"2041-02",{"name":48,"class":49},{"id":259,"slug":260,"hasResults":12,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":4,"eligibilityCriteria":264,"healthyVolunteers":12,"sex":17,"minAge":265,"maxAge":266,"enrollmentInfo":267,"targetDuration":4,"studyType":23,"phases":269,"briefSummary":270,"conditions":271,"keywords":273,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":50},"100319374","dbs-for-depression-100319374","NCT03437928","DBS for Depression","Deep Brain Stimulation (DBS) for Depression Using Directional Current Steering and Individualized Network Targeting","Inclusion Criteria:\n\n1. Men and women (non-pregnant) between ages 22 and 70;\n2. DSM-5 diagnosis (assessed by Structured Clinical Interview for DSM-5 Axis I disorders SCID-5) of major depression disorder (MDD) as the primary diagnosis. A current major depressive episode (MDE), recurrent or single episode with first episode before age 60, secondary to nonpsychotic unipolar major depressive disorder;\n3. Chronic illness with current MDE ≥24 months duration and\u002For recurrent illness with at least a total of 2 lifetime episodes (including current episode \\>12 months);\n4. Treatment resistance (defined by criteria on the Antidepressant Treatment History Form ATHF): Failure (i.e. persistence of the major depressive episode) to respond to a minimum of four adequate depression treatments from at least two different treatment categories (e.g. SSRIs, SNRIs, TCAs, other antidepressants, lithium-addition, irreversible MAOIs, antidepressant augmentation with an atypical antipsychotic medication);\n5. Previous trial of Electroconvulsive Therapy (ECT) (lifetime): either did not respond, relapsed, poorly tolerated or refused. If refused, will discuss reasons and ensure subject understands relative risks of ECT versus DBS. We will try to enrich sample with patients who had previously shown response to ECT (or another intervention) that was partial or un-sustained;\n6. Symptom severity for Screening: Hamilton Depression Rating Scale-17 item (HDRS17) ≥20;\n7. The HDRS17 must remain greater than or equal to 20 on two separate assessments (at initial screening and 1 week before surgery), over a 1-month period;\n8. Symptom severity for Outcome: Montgomery Asberg Rating Scale (MADRS) ≥27 to be met at assessment one-week pre-op;\n9. Lifetime exposure to minimal 6 weeks of psychotherapy without sustained response;\n10. Must have a brain MRI within 3 months of enrollment that is \"normal\", according to the radiology report, or does not reveal any findings that in the opinion of the Investigator preclude participation in the study;\n11. Stable antidepressant medication regimen for the month preceding surgery;\n12. Modified mini-mental state examination (MMSE) score ≥ 24;\n13. Normal thyroid stimulating hormone (TSH) level within 12 months of study entry;\n14. The patient does not have any medical or physical conditions which, in the opinion of the Investigator, make it unlikely the patient will be able to participate for the duration of the study;\n15. Able and willing to give informed consent and agree to attend regular clinic visits for at least 12 months following surgery;\n16. Must have a treating psychiatrist, a family member, significant other\u002Fliving partner, a caregiver, or a person known by the subject present at the Screening visit for the discussion about the study before co-signing the informed consent form;\n17. Willingness to sign Treatment Contract;\n18. Agrees to be followed at regular intervals by a licensed psychiatrist and to provide written permission allowing any and all forms of communication between the research team and the subject's healthcare providers, for the entirety of the study.\n\nExclusion Criteria:\n\n1. DSM-5 Axis I Disorders: any lifetime history of psychotic disorder (e.g., schizophrenia, schizoaffective disorder);\n2. Bipolar disorder with rapid cycling and history of manic episode requiring hospitalization within the past 5 years;\n3. Clinically significant Cluster A or B personality disorder;\n4. Alcohol or substance use disorder within 6 months, excluding nicotine;\n5. Urine drug test positive for illicit drugs;\n6. Any evidence or indication of suicidal intent, suicidal attempt, or suicidal behavior, including but not limited to the C-SSRS score, within the past one year;\n7. Neurological\u002FMedical condition that makes the patient, in the opinion of the surgeon, a poor surgical candidate (e.g., progressive neurodegenerative disorder, significant cardiopulmonary disorder, need for chronic anticoagulation);\n8. Any history of seizure disorder, hemorrhagic stroke, or has high risk of seizure (history of congenital malformation, history of brain injury, neuro-developmental disorder, currently taking medication that is known to lower seizure threshold, or other factors that predispose seizures);\n9. Any medical contraindication to surgery such as infection;\n10. Coagulopathy: Bleeding propensity and\u002For one of the following: INR \\> 1.5; prolonged activated partial thromboplastin time (aPTT) ≥ 45 sec; platelet count \\\u003C 100×103\u002FuL;\n11. A blood pressure of ≥ 180\u002F110 mmHg at a single visit and evidence of cardiovascular disease (CVD);\n12. Participation in another drug, device, or biological trial within 90 days;\n13. Current implanted stimulation devices including cardiac pacemakers, defibrillators, and neurostimulators including spinal cord stimulators and deep brain stimulators;\n14. Pregnant or has plans to become pregnant in the next 24 months;\n15. Anticipated need for MRI;\n16. Need for Diathermy;\n17. Chronic use of anticoagulant or anti-platelet agents that cannot be safely stopped for a sufficient duration (minimum 2.5 weeks) in the peri-operative period;\n18. Any Psychiatric\u002FNeurological\u002FMedical condition that makes the subject, in the opinion of the Investigator, a poor candidate.","22 Years","70 Years",{"count":268,"type":22},12,[25],"The goal of the study is to address the unmet need of TRD patients by identifying brain networks critical for treating depression and to use next generation precision DBS with steering capability to engage these targeted networks. The study's goal will be achieved through 3 specific aims:\n\n1. Demonstrate device capability to selectively and predictably engage distinct brain networks\n2. Delineate depression-relevant networks and demonstrate behavioral changes with network-targeted stimulation\n3. Demonstrate that chronic DBS using steered, individualized targeting is feasible and safe for reducing depressive symptoms",[272],"Major Depressive Disorder",[274,275,276,277,278,279,280],"Major Depressive Disorder (MDD)","MDD","Neuromodulation","Deep Brain Stimulation (DBS)","DBS","Electrophysiology","Imaging","2026-07-29",{"date":283,"type":42},"2026-07-30",{"date":285,"type":42},"2019-08-20",{"date":287,"type":22},"2026-08-19",{"name":48,"class":49},{"id":290,"slug":291,"hasResults":12,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":295,"eligibilityCriteria":296,"healthyVolunteers":12,"sex":17,"minAge":151,"maxAge":266,"enrollmentInfo":297,"targetDuration":4,"studyType":23,"phases":299,"briefSummary":300,"conditions":301,"keywords":303,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":144},"100644678","salud-m-acceptance-based-coping-skills-for-hispaniclatinx-military-patients-with-type-2-diabetes-100644678","NCT07674628","SALUD-M: Acceptance Based Coping Skills for Hispanic\u002FLatinx Military Patients With Type 2 Diabetes","Supporting Access for Latinx Underserved in Diabetes Management (SALUD-M): An Equity-Driven Study of Acceptance Based Coping Skills for Hispanic\u002FLatinx Military Patients With Type 2 Diabetes Mellitus","SALUD-M","Inclusion Criteria:\n\n* Patients ages 18-70\n* Diagnosis of T2DM\n* Current HbA1c (drawn within 6 months) of 7% or greater (may be taking oral agents or injectables for diabetes control)\n* Evidence of avoidance coping (score \\\u003C48.4 \\[published mean\\] on the Acceptance and Action Diabetes Questionnaire) or poor self-management skills (score \\\u003C published mean on 2+ subscales of the Summary of Diabetes Self-Care, Activities)\n* Self-described as Hispanic\u002FLatino\u002FLatina\u002FLatinx\n* Preferred language of English or Spanish, (g) receiving care at the study site clinic.\n\nExclusion Criteria:\n\n* End-stage renal disease (on dialysis)\n* A medical condition or life circumstance that would contraindicate participation\n* Proliferative diabetic retinopathy precluding participation\n* Inability to read\u002Fcomprehend the informed consent process or study instructions\n* Pregnant or planning to become pregnant in the next 6 months.",{"count":298,"type":22},100,[25],"People of Hispanic or Latino\u002Fa\u002Fx (\"H\u002FL\") ethnicity, including US military servicemembers, Veterans, and their families, experience a higher prevalence of type 2 diabetes and more challenges managing diabetes than non-Hispanic White populations. Uncontrolled diabetes is linked with lower quality of life, diabetes-related emotional distress, and severe medical problems. There are many reasons for this difference, including lack of culturally appropriate and bilingual Spanish healthcare services. Additionally, military patients may have additional barrier accessing behavioral health care, which an important part of treatment for many people with diabetes, such as stigma and unique schedule challenges.\n\nTherefore, this study aims to overcome these barriers and improve healthcare and health outcomes for H\u002FL military patients. The investigators will test a values-based behavior change program, delivered using video telehealth by a bilingual English-Spanish language health coach. The 10-week Acceptance Based Coping (ABaCo) skills program includes 7 virtually-delivered lessons and was developed by the study team in partnership with civilian community health workers and patients. This study will test the helpfulness of ABaCo delivered by a health coach fluent in English and Spanish to military H\u002FL patients. This randomized controlled trial will examine changes in physical and mental health over 6 months for those who receive ABaCo, compared to those who receive usual healthcare. This project will also identify steps for implementing the ABaCo program in other military treatment facilities.\n\nThe ultimate goal of this study is to establish a helpful, easy-to-access, widely available program for H\u002FL military patients with type 2 diabetes that improves quality of life and blood sugar control, and lowers distress about diabetes. This study will also identify best approaches to providing ABaCo in military treatment facilities, providing lessons learned to other large healthcare systems.",[302],"Type 2 Diabetes",[304,305,306,307,308,309,310,311,312,313,314,315,316,317,318,319,320,321,322],"type 2 diabetes","acceptance","Latino","Hispanic","Latinx","military","health coach","paraprofessional","virtual","telehealth","acceptance and committment therapy","diabetes distress","blood glucose","HbA1c","veteran","military treatment facility","randomized controlled trial","quality of life","values","2026-07-26",{"date":325,"type":42},"2026-07-28",{"date":327,"type":42},"2026-07-16",{"date":329,"type":22},"2027-06-30",{"name":48,"class":49},{"id":332,"slug":333,"hasResults":12,"nctId":334,"briefTitle":335,"officialTitle":335,"acronym":4,"eligibilityCriteria":336,"healthyVolunteers":12,"sex":17,"minAge":265,"maxAge":337,"enrollmentInfo":338,"targetDuration":4,"studyType":23,"phases":340,"briefSummary":341,"conditions":342,"keywords":344,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":50},"100561921","neurophysiological-investigation-of-the-approach-avoidance-axis-in-ocd-applications-to-neuromodulation-100561921","NCT06596447","Neurophysiological Investigation of the Approach-avoidance Axis in OCD: Applications to Neuromodulation","Inclusion Criteria:\n\n1. Principal diagnosis of OCD per DSM-5;\n2. Adult between ages 22 and 64;\n3. At least a five-year history of treatment-refractory OCD that causes substantial subjective distress and impairment in functioning;\n4. Minimum score of 28 on the Y-BOCS;\n5. Failed an adequate trial of at least three SSRIs;\n6. Failed an adequate trial of clomipramine;\n7. Failed augmentation of one or more of the aforementioned drugs with at least one anti-psychotic medication;\n8. Failed an adequate trial of CBT for OCD, defined as 25 hours of documented exposure and response prevention (ERP) by an expert therapist;\n9. Stable psychotropic medical regimen for the month preceding surgery;\n10. Principal diagnosis of OCD who are approved by our multi-disciplinary team to undergo DBS surgery within two months of enrollment;\n11. Ability to provide fully informed, written consent;\n12. Availability of a family member or significant other who is willing to accompany patients to study visits if necessary.\n\nExclusion Criteria:\n\n1. Lifetime diagnosis of psychotic disorder such as schizophrenia;\n2. Alcohol or substance abuse\u002Fdependence within 6 months, excluding nicotine;\n3. Concern for high risk of suicidal behavior or impulsivity;\n4. Patient is \\[regnant or plans to become pregnant in the next 24 months;\n5. Need for diathermy;\n6. Existence of any neurological or medical condition\u002Fdisorder that makes the individual, in the opinion of the study team, a poor candidate to participate in the intended study procedures\n7. Comorbid psychiatric disorder that, in the opinion of the study team, may interfere with the candidate's ability to participate in study activities;\n8. Primary diagnosis of a Hoarding Disorder.","64 Years",{"count":339,"type":22},10,[25],"We will recruit 10 patients with OCD meeting established criteria for surgical evaluation. Following informed consent and baseline evaluations, each will be implanted with permanent DBS SenSight leads and the Medtronic Percept RC IPG, which has on-device neural recording capability and rechargeability.\n\nWe will collect a broad array of neurobehavioral data across two environments with complementary advantages: the clinic and the home. The first 2 Aims test our mechanistic hypothesis by studying the pattern of VS neural activity in the controlled environment of the lab\u002Fclinic during two complementary paradigms: one based on a psychophysical behavioral task, the other based on ERP, a therapeutic behavioral intervention. The third aim tests this hypothesis in an ambulatory, naturalistic setting with chronic neural on-device recordings paired with time resolved behavioral measures. We will investigate a possible common neural basis underlying approach and avoidance across these 3 paradigms.\n\nSubjects will participate in research at 7 critical timepoints during routine clinic visits (Fig. 4): before implant, 1 day before DBS activation, immediately after DBS activation, 2 weeks, 3 months, 6 months, and 12 months after DBS initiation. At these timepoints, patients will complete clinical assessments, perform the Probabilistic Approach Avoidance Task (PAAT), and conduct exposure trials under the guidance of a psychologist. The clinic offers the most controlled environment and provides opportunities for collecting high temporal resolution behavior synchronized to local field potential (LFP) recordings. These data will allow us to identify the degree of overlap in the time-resolved neural activity driving individual decisions to approach potential rewards or avoid potential aversive stimuli (Aim 1), and resist performing compulsions in order to achieve relief after OCD symptoms are triggered (Aim 2).\n\nAt home, our goal is to investigate patient trajectories along the approach-avoidance axis as OCD symptoms improve (Aim 3). We will leverage passive, on device recordings that occur in the background of everyday life activities and synchronize these neural recordings with data collected via wearables, ecological assessments, and video diaries. Capturing neural and behavioral data in the home environment is essential for understanding the neural and behavioral changes that occur over longer timescales than individual clinical visits. The neurobehavioral biomarkers generated by this dataset will provide trackable readouts of clinical status that could inform therapeutic decision-making and enable data driven intervention.",[343,276],"Obsessive Compulsive Disorder (OCD)",[345,346,347,278],"Obsessive Compulsive Disorder","OCD","Deep Brain Stimulation","2026-07-22",{"date":350,"type":42},"2026-07-23",{"date":352,"type":42},"2025-08-01",{"date":354,"type":22},"2030-07-31",{"name":48,"class":49},{"id":357,"slug":358,"hasResults":12,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":4,"eligibilityCriteria":362,"healthyVolunteers":12,"sex":17,"minAge":151,"maxAge":4,"enrollmentInfo":363,"targetDuration":364,"studyType":365,"phases":4,"briefSummary":366,"conditions":367,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":376,"locationsCount":144},"100648544","gelpoint-path-assisted-endoscopic-removal-of-colon-and-rectal-polyps-a-feasibility-and-safety-study-100648544","NCT07723937","GelPOINT® Path-Assisted Endoscopic Removal of Colon and Rectal Polyps: A Feasibility and Safety Study","GelPOINT® Path-Assisted Endoscopic Submucosal Dissection for Colorectal Polyps: A Feasibility and Safety Study","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Able and willing to provide written informed consent.\n* Colorectal polyps located in the transverse colon, descending colon, rectosigmoid colon, or rectum (rectal lesions located at least 2 cm from the anal verge).\n* Referred for endoscopic submucosal dissection (ESD) of colorectal neoplastic lesions meeting at least one of the following criteria:\n* Lesions with prior resection or scarring proximal to the sigmoid colon.\n* Granular lateral spreading tumors (GLST) \\>30 mm.\n* Non-granular lateral spreading tumors (NGLST) \\>20 mm.\n* Lesions with suspected submucosal invasion, including Paris classification IIa+IIc lesions or lesions with a positive non-lifting sign\n\nExclusion Criteria:\n\n* Younger than 18 years of age.\n* Unable or unwilling to provide informed consent.\n* Pregnant.\n* Pedunculated lesions (Paris classification Ip or Isp).\n* Lesions involving the appendix or ileocecal valve",{"count":204,"type":22},"4 Weeks","OBSERVATIONAL","This prospective, single-center, observational feasibility and safety study will evaluate the use of the GelPOINT® Path transanal access platform during endoscopic submucosal dissection (ESD) for the removal of colorectal polyps. The GelPOINT® Path system is designed to improve access, maintain stable insufflation, and enhance visualization during advanced endoscopic procedures.\n\nThe study will enroll adult patients undergoing ESD for eligible colorectal lesions. The primary objective is to evaluate the technical feasibility, procedural performance, and safety of GelPOINT® Path-assisted ESD. Procedural outcomes, including procedure speed, technical success, resection outcomes, and procedure-related adverse events, will be collected prospectively. Participants will receive standard clinical care and will be followed for approximately 4 weeks after the procedure to assess delayed adverse events.",[368,369,370],"Polyp Colorectal","Rectal Adenoma","Adenoma Colon Polyp","2026-07-20",{"date":350,"type":42},{"date":374,"type":42},"2026-05-19",{"date":46,"type":22},{"name":48,"class":49},{"id":378,"slug":379,"hasResults":12,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":4,"eligibilityCriteria":383,"healthyVolunteers":12,"sex":17,"minAge":119,"maxAge":384,"enrollmentInfo":385,"targetDuration":4,"studyType":23,"phases":387,"briefSummary":388,"conditions":389,"keywords":394,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":400,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":406,"locationsCount":144},"100609221","phase-1-nkg2dzeta-nk-cell-conditioning-with-c7rgd2car-t-cells-for-patients-with-relapsed-or-refractory-osteosarcoma-or-neuroblastoma-100609221","NCT07211737","NKG2D.Zeta-NK Cell Conditioning With C7R.GD2.CAR-T Cells for Patients With Relapsed or Refractory Osteosarcoma or Neuroblastoma","(INCITE-ON) Phase I Study of i15.NKG2D.Zeta-NK Cell Conditioning in the Tumor Micro-environment in Combination With C7R.GD2.CAR-T for the Treatment of Patients With Relapsed or Refractory Osteosarcoma or Neuroblastoma","PROCUREMENT INCLUSION:\n\n1. Patients with Neuroblastoma that have persistent disease after standard treatment or have relapsed\u002Frefractory disease.\n\n   Or\n\n   Patients with Osteosarcoma that have persistent disease after standard treatment or have relapsed\u002Frefractory disease.\n2. Karnofsky\u002FLansky score of 60% or greater.\n3. Informed consent and assent (as applicable) obtained from parent\u002Fguardian and child.\n4. Greater than 1 year of age.\n\nPROCUREMENT EXCLUSION:\n\n1. History of hypersensitivity to murine protein-containing products.\n2. Known presence of Human Anti-Mouse Antibodies (HAMA).\n3. Active autoimmune disease (requiring immunosuppressive treatment in the past 6 months).\n4. Primary brain tumor or known brain metastases (on evaluation by MIBG and\u002For PET if applicable, CT\u002FMRI\u002FLP not required).\n\nTREATMENT INCLUSION:\n\n1. Patients with Neuroblastoma that have persistent disease after standard treatment or have relapsed\u002Frefractory disease.\n\n   Or\n\n   Patients with Osteosarcoma that have persistent disease after standard treatment or have relapsed\u002Frefractory disease.\n2. Karnofsky\u002FLansky score of 50% or greater\n3. Pulse Ox greater than or equal to 90% on room air\n4. AST less than 5 times upper limit of normal (less than 10 times upper normal if known with metastatic liver disease)\n5. Total bilirubin less than 3 times the upper limit of normal\n6. Serum creatinine less than 3 times upper limit of normal\n7. Available autologous T-cells with greater than or equal to 20% expressing GD2.CAR\n8. Informed consent and assent (as applicable) obtained from parent\u002Fguardian and child.\n9. Greater than 1 year of age.\n10. Recovered from acute toxic effects of all prior chemotherapy and investigational agents before entering this study.\n\nTREATMENT EXCLUSION:\n\n1. History of hypersensitivity to murine protein containing products (patients who have undergone desensitization and successful re-challenge without hypersensitivity reaction are eligible).\n2. Known presence of Human Anti-Mouse Antibodies (HAMA).\n3. Tumor potentially causing airway obstruction per investigator discretion.\n4. Pregnancy or lactation \u002F will not use birth control methods.\n5. Currently receiving immunosuppressive drugs (patients on low dose corticosteroids are eligible: less than 0.25 mg\u002Fkg\u002Fday of prednisone\u002Fequivalent).\n6. Primary brain tumor or known brain metastases (on evaluation by MIBG and\u002For PET if applicable, CT\u002FMRI\u002FLP not required).","24 Years",{"count":386,"type":22},27,[63],"The purpose of this study is to find the largest safe dose of i15.NKG2D.zeta-NK cells in combination with C7R.GD2.CAR-T cells, and additionally to evaluate how long they can be detected in patients' blood and what affect they have on patients' cancer.\n\nPatients eligible for this study have neuroblastoma or osteosarcoma that expresses a substance on the cancer cells called GD2. This cancer has either come back after treatment or did not respond to the standard or other investigational treatments or therapies used to treat it. There is no standard treatment for these types of advanced cancers at this time. This is a gene transfer research study using special immune cells called NK cells and T cells. NK cells and T cells are types of white blood cell that help the body fight infection.\n\nThe body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting cancer: NK cells and T cells. T cells are special infection-fighting blood cells that can kill cells infected with viruses and tumor cells. NK cells, another kind of infection-fighting cell, can recognize a wide range of cells in distress, including tumor cells and cells that help protect tumor cells in the cancer environment. Both NK cells and T cells have been used individually to treat patients with cancers. They have shown promise, but have not been strong enough individually to cure most patients.\n\nInvestigators have found from previous research that we can put a new gene into T cells that will make them recognize GD2, a substance found on almost all neuroblastoma and osteosarcoma cells. We can also put a new gene into NK cells that help them fight the tumor environment. Investigators know that T cells and NK cells need substances called cytokines to survive but the cells do not get enough cytokines after infusion into the body; therefore, the investigators have added the genes C7R and IL15 into the T and NK cells, respectively, to give each cell a constant supply of cytokine that helps them to survive longer.\n\nThe C7R.GD2.CAR-T cells and i15.NKG2D.zeta-NK cells are investigational products not approved by the Food and Drug Administration.",[390,391,392,393],"Relapsed Neuroblastoma","Refractory Neuroblastoma","Relapsed Osteosarcoma","Refractory Osteosarcoma",[240,395,396,397,244,242,398],"CAR T cells","Neuroblastoma","Osteosarcoma","NK Cell","2026-07-18",{"date":401,"type":42},"2026-07-21",{"date":403,"type":42},"2026-07-15",{"date":405,"type":22},"2044-04",{"name":48,"class":49},{"id":408,"slug":409,"hasResults":12,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":413,"eligibilityCriteria":414,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":59,"enrollmentInfo":415,"targetDuration":4,"studyType":23,"phases":417,"briefSummary":418,"conditions":419,"keywords":427,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":433,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":438,"locationsCount":50},"100529662","phase-1-constitutive-il7r-c7r-modified-banked-allogeneic-cd30car-ebvsts-for-cd30-positive-lymphomas-100529662","NCT06176690","Constitutive IL7R (C7R) Modified Banked Allogeneic CD30.CAR EBVSTS for CD30-Positive Lymphomas","Constitutive IL7R (C7R) Modified Banked Allogeneic CD30 Chimeric Antigen Receptor Epstein-Barr Virus-Specific T Lymphocytes (CD30.CAR-EBVSTs) in Patients With Relapsed or Refractory CD30-Positive Lymphomas","CABAL2","Inclusion Criteria:\n\n1. Diagnosis and clinical course falling into one of the following categories:\n\n   1. Hodgkin lymphoma\n   2. CD30+ aggressive B-cell lymphoma\n   3. ALK-negative anaplastic T cell lymphoma or other peripheral T- cell lymphoma\n   4. ALK-positive anaplastic T cell lymphoma\n2. CD30-positive tumor as assayed in a CLIA certified Pathology Laboratory.\n3. Age 12 to 75.\n4. Bilirubin less than or equal to 2 times the upper limit of normal (except for Gilbert syndrome, where the criteria will be Bilirubin less than or equal to 3 times the upper limit of normal).\n5. AST less than 3 times the upper limit of normal.\n6. Estimated GFR \\> 70 mL\u002Fmin.\n7. Pulse oximetry of \\> 90% on room air\n8. Karnofsky or Lansky score of \\> 60%.\n9. Recovered from all acute non-hematologic toxic effects of all prior chemotherapy.\n10. Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded. The male partner should use a condom.\n11. Informed consent explained to, understood by and signed by patient or guardian. Patient or guardian given a copy of the informed consent form.\n\nExclusion Criteria:\n\n1. Received an investigational cell therapy or vaccine within the past 6 weeks.\n2. Received an investigational small molecule drug within the past 2 weeks.\n3. Received anti-CD30 antibody-based therapy within the previous 4 weeks.\n4. History of hypersensitivity reactions to murine protein-containing products.\n5. Pregnant or lactating.\n6. Tumor in a location where enlargement could cause airway obstruction (determined at the investigators' discretion).\n7. Current use of systemic corticosteroids at a dose equivalent to or higher than 10 mg\u002Fday of prednisone.\n8. Active significant, uncontrolled bacterial, viral or fungal infection.\n9. Symptomatic cardiac disease (NYHA Class III or IV disease).",{"count":416,"type":22},90,[63],"This study involves patients with diffuse large B cell lymphoma (DLBCL), natural killer\u002FT-cell lymphoma (NKTL), or classical Hodgkin lymphoma (cHL) (referred to collectively as lymphoma) whose disease has returned or not responded to treatment.\n\nPrevious research combined antibodies and T cells to treat cancer. Antibodies bind to foreign substances, and T cells are infection-fighting white blood cells that can kill tumor cells. Both approaches have shown promise but have not been sufficient to cure most patients. In prior studies, an antibody targeting CD30, a protein found on some T cells and cancer cells, was joined to T cells through gene transfer to create CD30.CAR T cells.\n\nAnother study showed encouraging responses using CD30.CAR T cells made from a patient's own blood and returned to the same patient (autologous cells). In an ongoing study, patients have been treated with CD30.CAR T cells derived from healthy donors (allogeneic cells), allowing use of banked cells without individualized manufacturing. This approach has shown promising clinical activity with no safety concerns to date.\n\nIn this study, investigators are evaluating CD30.CAR-EBVST cells modified with an additional molecule called C7R, which has been shown in laboratory studies to enhance anti-cancer effects. The study aims to assess the safety and effectiveness of these allogeneic, banked C7R-modified CD30.CAR-EBVST cells and determine whether they may help treat lymphoma.\n\nAs an added safety measure, the modified T cells include a marker called iC9. If significant side effects occur, patients may receive rimiducid, which can eliminate the infused T cells. Rimiducid is not yet FDA approved but has been tested in patients without significant side effects.",[420,421,422,423,424,425,426],"CD30-Positive Diffuse Large B-Cell Lymphoma","Anaplastic Large Cell Lymphoma, T Cell and Null Cell Type","Anaplastic Large Cell Lymphoma, ALK-Positive","Peripheral T-cell Lymphoma","Anaplastic Large Cell Lymphoma, ALK-negative","Non-Hodgkin Lymphoma","Hodgkin Lymphoma",[428,429,430,431],"CD30-Positive Lymphoma","Hodgkin lymphoma","non-Hodgkin lymphoma","CD30 CAR","2026-07-17",{"date":371,"type":42},{"date":435,"type":42},"2025-10-27",{"date":437,"type":22},"2043-06-27",{"name":48,"class":49},{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":445,"eligibilityCriteria":446,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":151,"enrollmentInfo":447,"targetDuration":4,"studyType":365,"phases":4,"briefSummary":448,"conditions":449,"keywords":451,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":455,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":460,"locationsCount":144},"100587478","leukemia-adapted-protocol-100587478","NCT06928909","Leukemia Adapted Protocol","Evaluating the Feasibility of an Intensity-Adapted Pediatric Acute Myeloid Leukemia Treatment Guideline in Malawi","LEAP","Inclusion Criteria:\n\n1. Age Patients must be \\\u003C18 years of age at time of study enrollment.\n2. Diagnosis\n\n   Patients must be diagnosed with de novo AML according to 2022 WHO 5th Edition classification with or without extramedullary disease. Patients must have one of the following:\n   * Bone marrow myeloblasts ≥20%. In cases of dry taps due to fibrosis, myeloblast percentage can be estimated from a bone marrow biopsy core specimen. Due to unavailable molecular\u002Fcytogenetic diagnostics in Malawi, patients with \\\u003C20% bone marrow myeloblasts can be included in the study at the discretion of the treating oncologist with rationale documented.\n   * In cases where a bone marrow evaluation is not safe\u002Ffeasible, a peripheral blood sample may be used with a documented absolute myeloblast percentage of ≥1000\u002FμL calculated based on a total white blood cell count and percentage circulating blasts.\n3. Therapy Patients must begin treatment according to the 2023 KCH AML therapy CPG.\n\nExclusion Criteria:\n\n1. Patients with any of the following conditions or criteria will be excluded from the study:\n\n   * Juvenile myelomonocytic leukemia\n   * Transient myeloproliferative disorder\n   * Acute promyelocytic leukemia\n   * Mixed phenotype acute leukemia\n   * Trisomy 21\n   * Current pregnancy\n   * Previous or concurrent malignancy\n   * Isolated myeloid sarcoma\n2. Patients previously treated with antineoplastic therapy with the following exceptions:\n\n   * Hydroxyurea\n   * Corticosteroids\n   * Intrathecal chemotherapy at diagnosis",{"count":204,"type":22},"In resource-constrained settings such as Malawi, survival rates for pediatric acute myeloid leukemia (AML) are dismally low compared to high-resource environments. This disparity highlights the urgent need for feasible treatment protocols tailored to the realities of these regions where most children with cancer are treated. In 2023, after reviewing favorable clinical trials results in other resource-limited settings, the Kamuzu Central Hospital (KCH) pediatric cancer unit adopted an evidence-based intensity-adapted clinical practice guideline (CPG) developed by the International Society of Paediatric Oncology (SIOP) as its standard of care for the treatment of pediatric AML, aiming to balance curative intent with manageable toxicity. The current study is a prospective evaluation of outcomes of standard of care in Malawi using the SIOP CPG in a real-world setting.\n\nThe LEAP study aims to assess the implementation of the SIOP AML guidelines at KCH in an effort to continually improve outcomes in Malawi. The study is an observational-implementation design with a composite effectiveness-implementation outcome called Implementation Success. Implementation Success combines feasibility, the ability of patients to complete all aspects of the CPG, with effectiveness, the ability to maintain historical rates of complete remission of 40% at the treatment center.\n\nThis prospective cohort study will enroll children under 18 years diagnosed with de novo AML at KCH. Implementation Success will be the primary endpoint, with secondary endpoints including CPG fidelity, long-term survival, adverse events, and hematologic recovery times. Patient-reported outcomes will also be collected to assess the impact of treatment on quality of life.\n\nThis will be the first prospective study of pediatric AML in sub-Saharan Africa, providing critical data on the management of AML in low-resource settings. By assessing the implementation of a context-adapted CPG, the study will contribute to the global effort to improve pediatric AML outcomes in resource-constrained environments. The findings will serve to guide practitioners in Malawi and similar settings, and the data generated will be invaluable for future clinical decisions and CPG development.",[450],"Acute Myeloid Leukaemia",[452,453],"Pediatric Acute Myeloid Treatment","Acute myeloid leukemia (AML)","2026-07-14",{"date":403,"type":42},{"date":457,"type":42},"2025-01-01",{"date":459,"type":22},"2030-12-31",{"name":48,"class":49},{"id":462,"slug":463,"hasResults":12,"nctId":464,"briefTitle":465,"officialTitle":466,"acronym":4,"eligibilityCriteria":467,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":59,"enrollmentInfo":468,"targetDuration":4,"studyType":23,"phases":470,"briefSummary":471,"conditions":472,"keywords":475,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":476,"lastUpdatePostDateStruct":477,"startDateStruct":478,"completionDateStruct":480,"leadSponsor":482,"locationsCount":50},"100384670","phase-1-allogeneic-cd30car-ebvsts-in-patients-with-relapsed-or-refractory-cd30-positive-lymphomas-100384670","NCT04288726","Allogeneic CD30.CAR-EBVSTs in Patients With Relapsed or Refractory CD30-Positive Lymphomas","A Phase 1 Study Evaluating the Safety and Activity of Allogeneic CD30 Chimeric Antigen Receptor Epstein-Barr Virus-Specific T Lymphocytes (CD30.CAR-EBVSTs) in Patients With Relapsed or Refractory CD30-Positive Lymphomas","Inclusion Criteria:\n\n1. Diagnosis and clinical course falling into one of the following categories:\n\n   1. Hodgkin lymphoma\n   2. Aggressive non-Hodgkin lymphoma\n   3. ALK-negative anaplastic T cell lymphoma or other peripheral T-cell lymphoma\n   4. ALK-positive anaplastic T cell lymphoma\n2. CD30-positive tumor as assayed in a CLIA certified Pathology Laboratory.\n3. Age 12 to 75.\n4. Bilirubin 2 times (or 3 times if the patient has Gilbert syndrome) or less than the upper limit of normal.\n5. AST 3 times or less than the upper limit of normal.\n6. Estimated GFR \\> 70 mL\u002Fmin.\n7. Pulse oximetry of \\> 90% on room air\n8. EKG shows no significant arrhythmias\n9. Karnofsky or Lansky score of \\> 60%.\n10. Available allogeneic T cells with ≥15% expression of CD30CAR determined by flow-cytometry.\n11. Recovered from all acute non-hematologic toxic effects of all prior chemotherapy.\n12. Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded. The male partner should use a condom.\n13. Informed consent explained to, understood by and signed by patient or guardian. Patient or guardian given a copy of the informed consent form.\n\nExclusion Criteria:\n\n1. Received an investigational cell therapy or vaccine within the past 6 weeks.\n2. Received an investigational small molecule drug within the past 2 weeks.\n3. Received CD30 antibody-based therapy within the previous 4 weeks.\n4. Received gemcitabine-containing chemotherapy within the previous 12 weeks\n5. History of hypersensitivity reactions to murine protein-containing products.\n6. Pregnant or lactating.\n7. Tumor in a location where enlargement could cause airway obstruction (determined at the investigators' discretion).\n8. Current use of systemic corticosteroids at a dose equivalent to higher than 10 mg\u002Fday of prednisone.\n9. Active significant, uncontrolled bacterial, viral or fungal infection.\n10. Symptomatic cardiac disease (NYHA Class III or IV disease).",{"count":469,"type":22},18,[63],"This study involved patients that have a cancer called diffuse large B cell lymphoma (DLBCL), NK and T cell lymphomas (NK\u002FTL) or classical Hodgkin lymphoma (cHL) (hereafter these 3 diseases will be referred to as lymphoma). Patients lymphoma has come back or not gone away after treatment. Because there is no standard treatment for the patients cancer at this time or because the currently used treatments do not work fully in all cases, the patients are being asked to volunteer in this research study.\n\nIn this study the investigators want to test a type of T cell made from a normal donor. The T cells the investigators will use are called Epstein Barr virus (EBV) specific T cells (EBVSTs) and are cells that the investigators have trained in the laboratory to recognize a EBV which is the virus that causes mono or kissing disease. Some patients with lymphoma have EBV in their cancer cells. Researchers have given T cell lines from normal donor EBVSTs to lymphoma patients who have EBV in their lymphoma cells and have seen responses in about half the patients. The cells have have been generated and are frozen in a bank. The cells are called \"allogeneic\" (meaning the donor is not related to the patient). CD30.CAR in EBV-specific T cells (called allogeneic CD30.CAR-EBVST) from the blood of healthy donors. The investigators are giving the cells to patients with lymphoma cells that express CD30. If the lymphoma cells also express EBV there may be some benefit from targeting both proteins.\n\nThe purpose of this study is to find out the highest safe dose of allogeneic CD30.CAR-EBVST cells given following chemotherapy and used to treat lymphoma. The investigators will learn the side effects of CD30.CAR-EBVST cells in patients and see whether this therapy may help lymphoma patients",[473,474],"Extranodal Natural Killer\u002FT-Cell Lymphoma, Nasal Type","Classical Hodgkin Lymphoma",[428,429,430,431],"2026-07-13",{"date":454,"type":42},{"date":479,"type":42},"2020-09-16",{"date":481,"type":22},"2037-06-01",{"name":48,"class":49},{"id":484,"slug":485,"hasResults":12,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":489,"eligibilityCriteria":490,"healthyVolunteers":491,"sex":17,"minAge":19,"maxAge":151,"enrollmentInfo":492,"targetDuration":4,"studyType":23,"phases":493,"briefSummary":494,"conditions":495,"keywords":498,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":504,"lastUpdatePostDateStruct":505,"startDateStruct":507,"completionDateStruct":509,"leadSponsor":511,"locationsCount":144},"100589860","paths-up-health-behavior-self-monitoring-mobile-app-for-adolescents-100589860","NCT06959901","PATHS-UP Health Behavior Self-monitoring Mobile App for Adolescents","Investigating the Efficacy of Mobile Health Monitoring and Self-care to Improve Obesity Outcomes in Hispanic Adolescence Populations","PATHS-UP","Inclusion Criteria:\n\n* self-identify as Hispanic or Latino\n* 12-18 years\n* BMI% in the 85th-95th range,\n* Owns their own iphone\n\nExclusion Criteria:\n\n* Currently enrolled in a health program\n* Diagnosed with T2D\n* Present with a disease or condition that would prevent one from engaging in activity",true,{"count":204,"type":22},[25],"Hispanic adolescents in the U.S. are disproportionately burdened by type 2 diabetes (T2D) compared to non-Hispanic white youth (0.079% vs. 0.017%) contributing to higher rates of T2D-related vascular complications, cardiovascular disease, and mortality, among this population. Disparities in T2D are driven in part by independent, modifiable risk factors including low levels of physical activity, sleep, and poor diet. Lifestyle interventions are the cornerstone for maintaining glucose control and managing T2D. However, few studies have developed and tested lifestyle interventions for Hispanic youth with T2D. Digital health interventions that promote healthy lifestyle behaviors like physical activity, sleep, and diet, have demonstrated effectiveness among adults. Studies that use health-based smartphone applications have demonstrated preliminary efficacy for improving health-related lifestyle behaviors as these digital tools leverage behavior change techniques (e.g. self-monitoring, goal-setting, feedback) that have proven effective. Use of digital technology allows for the continuous delivery of intervention content into the home environment extending the reach of clinical care while engaging youth in a format that is age-appropriate given that today's youth are digital frontrunners. Unfortunately, while the use of digital health interventions have increased, few studies have focused on adolescents with overweight and obesity who are at high risk for T2D. The purpose of this study is to 1) develop a mobile health platform for remote and continuous monitoring of activity, sleep, and nutrition and 2) conduct a pilot study (30 days) to evaluate the efficacy of a novel digital health platform in improving obesity-related health outcomes outcomes in Hispanic adolescents (12-18 years; N=30) population.",[496,497],"Obesity and Diabetes Mellitus, Type 2","Diabetes Prevention",[499,500,501,502,503],"mHealth","Digital health","teen health","lifestyle intervention","mobile phone app","2026-07-03",{"date":506,"type":42},"2026-07-07",{"date":508,"type":42},"2025-04-30",{"date":510,"type":22},"2026-08-01",{"name":48,"class":49},{"id":513,"slug":514,"hasResults":12,"nctId":515,"briefTitle":516,"officialTitle":516,"acronym":517,"eligibilityCriteria":518,"healthyVolunteers":491,"sex":17,"minAge":519,"maxAge":520,"enrollmentInfo":521,"targetDuration":4,"studyType":23,"phases":522,"briefSummary":523,"conditions":524,"keywords":526,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":504,"lastUpdatePostDateStruct":531,"startDateStruct":532,"completionDateStruct":534,"leadSponsor":536,"locationsCount":144},"100588561","adapting-and-assessing-the-feasibility-of-a-telehealth-diabetes-prevention-program-for-hispanic-adolescents-100588561","NCT06943001","Adapting and Assessing the Feasibility of a Telehealth Diabetes Prevention Program for Hispanic Adolescents","Fit24+","Inclusion Criteria:\n\n* Self-report as Hispanic\n* obese, defined as body mass index percentile (BMI%) ≥ 95th percentile\n* ages of 12-16 years\n* owns his or her own cellphone\n\nExclusion Criteria:\n\n* Taking a medication (i.e. steroids) or diagnosed with a condition (i.e. sleep apnea) that influences activity, sleep, and\u002For cognition\n* Recent hospitalization or injury that prevents normal physical activity\n* Pregnant\n* Currently enrolled in an exercise program or currently using a personal activity monitoring device like Fitbit\n* Taking medications or diagnosed with a condition that influences activity, glucose metabolism, and\u002For cognition.","14 Years","16 Years",{"count":93,"type":22},[25],"Hispanic adolescents are disproportionately burdened by type 2 diabetes (T2D). Social determinants of health (SDoH) serve as barriers to behavior change and participation in disease prevention efforts, especially among vulnerable adolescents. Telehealth is a potentially effective approach for delivering disease prevention programs as it addresses some SDoH like transportation, childcare needs, and parent work schedules. Unfortunately, there are no theory- or evidence-based telehealth diabetes prevention program for Hispanic adolescents. Therefore the purpose of this study is to adapt an evidence-based diabetes prevention program for delivery via telehealth and to test the feasibility of this study among Hispanic adolescents (12-16 years) with obesity.",[525],"Obesity and Type 2 Diabetes",[527,528,529,530],"adolescents health","wearable sensors","user-centered design approac","T2D prevention",{"date":506,"type":42},{"date":533,"type":42},"2025-04-12",{"date":535,"type":22},"2026-08-31",{"name":48,"class":49},{"id":538,"slug":539,"hasResults":12,"nctId":540,"briefTitle":541,"officialTitle":542,"acronym":4,"eligibilityCriteria":543,"healthyVolunteers":12,"sex":17,"minAge":544,"maxAge":337,"enrollmentInfo":545,"targetDuration":4,"studyType":23,"phases":547,"briefSummary":548,"conditions":549,"keywords":551,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":554,"lastUpdatePostDateStruct":555,"startDateStruct":557,"completionDateStruct":559,"leadSponsor":561,"locationsCount":111},"100461067","understanding-prefrontal-and-medial-temporal-neuronal-responses-to-algorithmic-cognitive-variables-in-epilepsy-patients-100461067","NCT05283811","Understanding Prefrontal and Medial Temporal Neuronal Responses to Algorithmic Cognitive Variables in Epilepsy Patients","Mapping Algorithmic State Space in the Human Brain","Inclusion Criteria:\n\n* Eligible subjects include both male and female patients, between 10 years of age and 64 years of age, who undergo placement of intracranial electrodes for clinical characterization of epilepsy.\n\nExclusion Criteria:\n\n* Grounds for exclusion would include inability to understand and follow instructions, or inability to concentrate sufficiently to achieve a high proportion of correct responses.","10 Years",{"count":546,"type":22},205,[25],"Humans have a remarkable ability to flexibly interact with the environment. A compelling demonstration of this cognitive flexibility is human's ability to respond correctly to novel contextual situations on the first attempt, without prior rehearsal. The investigators refer to this ability as 'ad hoc self-programming': 'ad hoc' because these new behavioral repertoires are cobbled together on the fly, based on immediate demand, and then discarded when no longer necessary; 'self-programming' because the brain has to configure itself appropriately based on task demands and some combination of prior experience and\u002For instruction. The overall goal of our research effort is to understand the neurophysiological and computational basis for ad hoc self-programmed behavior. The previous U01 project (NS 108923) focused on how these programs of action are initially created. The results thus far have revealed tantalizing notions of how the brain represents these programs and navigates through the programs. In this proposal, therefore, the investigators focus on the question of how these mental programs are executed. Based on the preliminary findings and critical conceptual work, the investigators propose that the medial temporal lobe (MTL) and ventral prefrontal cortex (vPFC) creates representations of the critical elements of these mental programs, including concepts such as 'rules' and 'locations', to allow for effective navigation through the algorithm. These data suggest the existence of an 'algorithmic state space' represented in medial temporal and prefrontal regions. This proposal aims to understand the neurophysiological underpinnings of this algorithmic state space in humans. By studying humans, the investigators will profit from our species' powerful capacity for generalization to understand how such state spaces are constructed. The investigators therefore leverage the unique opportunities available in human neuroscience research to record from single cells and population-level signals, as well as to use intracranial stimulation for causal testing, to address this challenging problem. In Aim 1 the investigators study the basic representations of algorithmic state space using a novel behavioral task that requires the immediate formation of unique plans of action. Aim 2 directly compares representations of algorithmic state space to that of physical space by juxtaposing balanced versions of spatial and algorithmic tasks in a virtual reality (VR) environment. Finally, in Aim 3, the investigators test hypotheses regarding interactions between vPFC and MTL using intracranial stimulation.",[550],"Epilepsy",[552,553],"Single-neuron","Local-field potentials","2026-07-02",{"date":556,"type":42},"2026-07-06",{"date":558,"type":42},"2021-06-01",{"date":560,"type":22},"2028-03-31",{"name":48,"class":49},{"id":563,"slug":564,"hasResults":12,"nctId":565,"briefTitle":566,"officialTitle":567,"acronym":4,"eligibilityCriteria":568,"healthyVolunteers":12,"sex":17,"minAge":151,"maxAge":4,"enrollmentInfo":569,"targetDuration":4,"studyType":23,"phases":570,"briefSummary":571,"conditions":572,"keywords":574,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":579,"lastUpdatePostDateStruct":580,"startDateStruct":582,"completionDateStruct":584,"leadSponsor":586,"locationsCount":144},"100505916","phase-2-high-dose-albumin-in-refractory-ascites-100505916","NCT05867602","High Dose Albumin in Refractory Ascites","Clinical Efficacy of High-dose Albumin Administration Versus Standard Dose in Patients With Advanced Cirrhosis: Open Label Randomized Clinical Trial","Inclusion Criteria:\n\n1. Age \\> 18 years.\n2. patients diagnosed with liver cirrhosis.\n3. Refractory ascites which is defined as ascites failing to resolve after maximum tolerable dose of diuretics, and usually require frequent paracentesis.\n\nExclusion Criteria:\n\n1. Patients \\\u003C 18y\n2. patients with no history of liver cirrhosis\n3. patients with refractory ascites but have transjagular intrahepatic portosystemic shunts (TIPS) with previous 3 months\n4. Patients with ascites due to other causes, including cardiac, malignant",{"count":298,"type":22},[206],"Advanced cirrhosis with complications is a serious problem imposing a heavy financial burden on health care system. Moreover, ascites is associated with increase in mortality rates among cirrhotic patients. Ascites pathogenesis is multifactorial including: portal hypertension; splanchnic and peripheral arterial vasodilation; and neurohumoral activation. Current management strategies include dietary sodium restriction and diuretic therapy, however, this strategy put patients at the risk of intravascular volume depletion, renal impairment, hepatic encephalopathy and hyponatremia. Moreover, around 10% of patients do not respond to this strategy (termed: diuretics resistant) with 50% of them die within 6 months. This sub-group is managed by frequent large volume paracentesis along with intravenous albumin administration and are usually considered for liver transplantation (LT) and TIPS. Nonetheless, Frequent paracentesis increases the risk of infection, bleeding, bowel perforation, paracentesis-induced circulatory dysfunction (PICD) and renal dysfunction in this sub-group of patients. The beneficial effect of human albumin might result from blood volume expansion tapering activated vasoconstrictor and sodium-retaining systems improving renal perfusion, hence regular infusion of albumin may be beneficial to prevent development of ascites and to improve survival. The positive effects of albumin are supported by previous studies; Romanelli et al, showed a significant increase in survival rate among cirrhotic patients with ascites when compared to those who did not receive albumin. Moreover, a randomized multicenter open label trial published in lancet last year, demonstrated that long term albumin administration improved 18-month survival, decreased the use of paracentesis and decrease in the incidence of cirrhosis related complications among cirrhotic patients with ascites. As of today, there's a limited use of regular high dose albumin in cirrhotic patients with ascites in US, despite being used elsewhere in the world as previously stated.\n\nThe investigators wish to study long-term efficacy of human albumin administration in patients with decompensated cirrhosis to assess safety and efficacy, and prevention of complications of cirrhosis.",[573],"Ascites",[575,576,577,578],"refractory ascites","liver cirrhosis","HRS","High dose albumin","2026-06-26",{"date":581,"type":42},"2026-06-30",{"date":583,"type":42},"2019-03-25",{"date":585,"type":22},"2027-06-25",{"name":48,"class":49},{"id":588,"slug":589,"hasResults":12,"nctId":590,"briefTitle":591,"officialTitle":592,"acronym":4,"eligibilityCriteria":593,"healthyVolunteers":491,"sex":17,"minAge":151,"maxAge":4,"enrollmentInfo":594,"targetDuration":4,"studyType":23,"phases":596,"briefSummary":597,"conditions":598,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":579,"lastUpdatePostDateStruct":602,"startDateStruct":603,"completionDateStruct":605,"leadSponsor":607,"locationsCount":144},"100464108","improving-comprehensive-care-of-cancer-patients-100464108","NCT05323409","Improving Comprehensive Care of Cancer Patients","Optimise: Improving Comprehensive Care of Cancer Patients With Comorbidities","Inclusion Criteria:\n\n* For patients: 1) new diagnosis or within three months of treatment initiation for early-stage breast (I-IIIB), GI (Stage I-III), or hematologic (Stage I-III) cancer 2) treatment with standard, definitive therapies (may include one or more modalities) 3) presence of one or more chronic comorbidities (e.g., diabetes, hypertension) and\u002For unhealthy lifestyle behaviors (e.g., overweight\u002Fobesity, current smoker, alcohol use) that require ongoing management during cancer treatment 4) age \\>18 years 5) fluency in English or Spanish 6) ability to provide informed consent 7) assignment to a Harris Health oncologist and PCP who are willing to participate and will provide informed consent.\n\nFor healthcare providers: 1) Person is an oncologist or PCP who treats patients with breast, GI, or hematologic malignancies at Harris Health BT\u002FSmith Clinic\n\nExclusion Criteria:\n\n* For Patients: Significant cognitive impairment or Lack of capacity to consent For Providers: None",{"count":595,"type":22},340,[25],"Cancer survivors have unique healthcare needs, including managing serious late effects, ongoing surveillance, lifestyle modifications to reduce second cancer risk, and psychosocial support. Nearly 70% of survivors have at least one comorbid chronic condition in addition to cancer, which complicates the delivery of quality cancer care. Medically underserved patients, who bear the highest burden of multiple chronic conditions, are at increased risk for poor outcomes during and after cancer treatment. Enhancing communication and collaboration between oncologists and primary care providers (PCPs) could improve health outcomes and care transitions for these patients, who often lack healthcare knowledge and access to supportive care.\n\nThis study evaluates a novel shared care model for cancer survivors with chronic comorbidities, called OPTIMISE (Oncology-Primary Care Partnership to Improve Comprehensive Survivorship Care), in the largest safety-net healthcare system in Houston, Texas. Three hundred newly diagnosed breast, gastrointestinal, and hematological cancer patients being treated with curative intent and having comorbidities requiring ongoing management will be randomized to either OPTIMISE or Usual Medical Care (UMC). UMC patients will receive cancer treatment directed by their oncologist, a survivorship care plan (SCP) at the end of active treatment, and surveillance visits based on national guidelines.\n\nOPTIMISE patients will: 1) have an oncology nurse navigator assigned to their care team at diagnosis to facilitate oncologist-PCP communication; 2) receive coordinated care between their oncologist and PCP throughout cancer treatment and surveillance, facilitated by structured communication and referral processes; 3) receive an SCP that incorporates comorbidity management; and 4) follow a risk-stratified shared care model where some routine oncologist follow-up visits are replaced by PCP visits. Aim 1a evaluates OPTIMISE's impact on patient chronic disease self-management (primary outcome) and quality of life (secondary outcome). Aim 1b explores OPTIMISE's effects on healthcare use and patient unmet needs during and after treatment. Aim 2 examines OPTIMISE's impact on oncologist and PCP attitudes and care coordination. Aim 3 elucidates patient- and system-level factors influencing implementation outcomes. If effective, OPTIMISE could expand to other cancers and enhance care transitions in various medical settings.",[599,600,601],"Breast Cancer","Gastrointestinal Cancer","Hematologic Cancer",{"date":581,"type":42},{"date":604,"type":42},"2022-04-01",{"date":606,"type":22},"2027-06",{"name":48,"class":49},{"id":609,"slug":610,"hasResults":12,"nctId":611,"briefTitle":612,"officialTitle":613,"acronym":4,"eligibilityCriteria":614,"healthyVolunteers":12,"sex":17,"minAge":151,"maxAge":615,"enrollmentInfo":616,"targetDuration":4,"studyType":365,"phases":4,"briefSummary":618,"conditions":619,"keywords":620,"overallStatus":621,"whyStopped":4,"lastUpdateSubmitDate":579,"lastUpdatePostDateStruct":622,"startDateStruct":623,"completionDateStruct":625,"leadSponsor":627,"locationsCount":111},"100309842","locating-biomarkers-in-ocd-through-behavioral-tasks-100309842","NCT03313622","Locating Biomarkers in OCD Through Behavioral Tasks","Locating Biomarkers of Medically Intractable Obsessive Compulsive Disorder (OCD) Through the Use of Behavioral Tasks","Inclusion Criteria:\n\n* Diagnosis of OCD\n* Non-pregnant if female\n* Minimum score of 16 on Y-BOCS\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Those not meeting inclusion criteria listed above\n* Lifetime diagnosis of psychotic disorders such as schizophrenia\n* Alcohol or substance abuse\u002Fdependence within 6 months, excluding nicotine\n* Deemed at high risk of suicidal behavior or impulsivity\n* Pregnant or plans to become pregnant in the next 24 months","65 Years",{"count":617,"type":22},20,"Subjects that have a diagnosis of OCD will participate in a clinical interview and cognitive tasks, during which they will be exposed to their individual OC stressors or will be asked to make decisions related to information value and quantity while measuring neural activity and filming facial reactions. This will assist investigators to look for biomarkers of that change. This study offers a unique opportunity to develop biomarkers for key domains of OCD, and other neuropsychiatric disorders, that are grounded in brain neurocircuitry at the individual-patient level.\n\nSubjects will participate in a clinical interview (Day 1), and then tasks+EEG (Day 2). Day 1 will be 4 hours or less, and Day 2 will be 2.5 hours or less.",[346,187],[346,345],"NOT_YET_RECRUITING",{"date":581,"type":42},{"date":624,"type":22},"2027-03",{"date":626,"type":22},"2028-03",{"name":48,"class":49},{"id":629,"slug":630,"hasResults":12,"nctId":631,"briefTitle":632,"officialTitle":633,"acronym":4,"eligibilityCriteria":634,"healthyVolunteers":12,"sex":17,"minAge":635,"maxAge":151,"enrollmentInfo":636,"targetDuration":4,"studyType":365,"phases":4,"briefSummary":637,"conditions":638,"keywords":4,"overallStatus":621,"whyStopped":4,"lastUpdateSubmitDate":642,"lastUpdatePostDateStruct":643,"startDateStruct":645,"completionDateStruct":647,"leadSponsor":648,"locationsCount":144},"100644743","postoperative-pain-after-pediatric-adenotonsillectomy-with-ketorolac-or-ibuprofen-100644743","NCT07672418","Postoperative Pain After Pediatric Adenotonsillectomy With Ketorolac or Ibuprofen","Assessment of Postoperative Pain Outcomes Following Pediatric Adenotonsillectomy and the Impact on Non-Steroidal Anti-Inflammatory Drugs","Inclusion Criteria:\n\nScheduled for outpatient adenotonsillectomy Age 13-18 years ASA physical status I-III Patient or parent has access to a phone with text-messaging capability Patient assent Parent or legal guardian consent\n\nExclusion Criteria:\n\nInpatient admission or planned 23-hour observation Known hematologic condition or prior bleeding disorder Current anticoagulant use Known or suspected chronic kidney disease or solitary kidney Known or suspected liver disease or prior liver transplant Known or suspected mitochondrial disease or genetic anomaly Inability to self-report pain History of gastrointestinal ulcer or bleeding Allergy to acetaminophen, ibuprofen, or ketorolac Non-English or non-Spanish speaking Chronic pain or condition requiring frequent routine NSAID use Patient refusal Parent or guardian refusal","13 Years",{"count":182,"type":22},"This prospective observational study will evaluate postoperative pain after outpatient pediatric adenotonsillectomy in adolescents prescribed either acetaminophen with ibuprofen or acetaminophen with oral ketorolac after discharge, based on the prescribing preference of the otolaryngology surgeon. Participants will complete text-message surveys after discharge to assess pain severity, medication administration, and functional recovery for up to 14 days.",[639,640,641],"Sleep","Pediatrics","Adenotonsillectomy","2026-06-23",{"date":644,"type":42},"2026-06-29",{"date":646,"type":22},"2026-06-24",{"date":329,"type":22},{"name":48,"class":49},{"id":650,"slug":651,"hasResults":12,"nctId":652,"briefTitle":653,"officialTitle":654,"acronym":655,"eligibilityCriteria":656,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":657,"targetDuration":4,"studyType":23,"phases":659,"briefSummary":660,"conditions":661,"keywords":665,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":672,"lastUpdatePostDateStruct":673,"startDateStruct":675,"completionDateStruct":677,"leadSponsor":679,"locationsCount":680},"100413483","phase-1-ebv-specific-t-lymphocytes-for-treatment-of-ebv-positive-lymphoma-100413483","NCT04664179","EBV Specific T-Lymphocytes for Treatment of EBV-Positive Lymphoma","Constitutive IL7 (C7R) Modified EBV Specific T-Lymphocytes for Treatment of EBV-Positive Lymphoma","CILESTE","1. INCLUSION CRITERIA AT TIME OF PROCUREMENT\n\n   1. Any patient, regardless of age or sex, with EBV-positive Hodgkin's or non Hodgkin's Lymphoma, (regardless of the histological subtype) or EBV (associated)- T\u002FNK-lymphoproliferative disease who may subsequently be eligible for the treatment component\n   2. EBV positive tumor (can be pending)\n   3. Weighs at least 10 kg\n   4. Informed consent explained to, understood by and signed by patient\u002Fguardian. Patient\u002Fguardian given a copy of informed consent.\n2. INCLUSION CRITERIA AT TIME OF INFUSION\n\n   1\\) Any patient regardless of age or sex, with diagnosis of either\n   1. EBV positive Hodgkin's lymphoma\n   2. EBV positive non-Hodgkin's Lymphoma (regardless of histologic subtype)\n   3. EBV (associated)-T\u002FNK-lymphoproliferative disease\n\n   AND either\n\n   A) In first or subsequent relapse or with persistent active disease despite therapy; OR\n\n   B) With active disease if immunosuppressive chemotherapy is contraindicated as determined by the study PI, in consultation with the primary provider as needed, e.g. patients who develop Hodgkin's disease after solid organ transplantation or if the lymphoma is a second malignancy, e.g. a Richter's transformation of CLL.\n\n   2\\) EBV positive tumor confirmed by pathology\n\n   3\\) Patients with life expectancy ≥ 6 weeks\n\n   4\\) Patients with bilirubin ≤ 3x upper limit of normal, AST ≤ 3x upper limit of normal, creatinine ≤ 2x upper limit of normal for age and Hgb ≥ 7.0 (may be a transfused value)\n\n   5\\) Pulse oximetry of \\>90% on room air\n\n   6\\) Patients should have been off other investigational therapy for 4 weeks prior to entry in this study.\n\n   7\\) Patients with a Karnofsky\u002FLansky score of ≥ 50\n\n   8\\) Informed consent explained to, understood and signed by patient\u002Fguardian. Patient\u002Fguardian given a copy of informed consent.\n3. EXCLUSION CRITERIA AT TIME OF PROCUREMENT\n\n   1\\. Known pregnancy or actively breastfeeding (pregnancy test is not required at the time of procurement).\n4. EXCLUSION CRITERIA AT TIME OF INFUSION\n\n   1. Pregnant or breastfeeding\n   2. Active and uncontrolled bacterial, viral or fungal infection\n   3. Current use of systemic corticosteroids (prednisone equivalent \\>0.5 mg\u002Fkg\u002Fday)\n   4. Bulky disease resulting in airway obstruction or risk for airway obstruction with further enlargement.",{"count":658,"type":22},52,[63],"This study is for patients that have a type of lymph gland disease called Hodgkin or non-Hodgkin Lymphoma or T\u002FNK-lymphoproliferative disease which has come back or has not gone away after treatment, including the best treatment the investigators know for these diseases.\n\nSome patients with Lymphoma or T\u002FNK-lymphoproliferative disease show signs of virus that is sometimes called Epstein Barr virus (EBV) that causes mononucleosis or glandular fever (\"mono\") before or at the time of their diagnosis. EBV is found in the cancer cells of up to half the patients with Hodgkin's and non-Hodgkin Lymphoma, suggesting that plays a role in causing Lymphoma. The cancer cells (in lymphoma) and some immune system cells infected by EBV are able to hide from the body's immune system and escape destruction.\n\nT cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. T cells have been used to treat patients with cancers. T cells, that have been trained to kill EBV infected cells can survive in the blood and affect the tumor. The investigators have treated over 80 people on studies using T cells to target these diseases. About half of those patients who had disease at the time they got the cells had responses including some patients with complete responses.\n\nThe investigators think that if T cells are able to last longer in the body, they may have a better chance of killing EBV and EBV infected tumor cells. Therefore, in this study the investigators will add a new gene to the EBV T cells that can cause the cells to live longer called C7R. The investigators know that T cells need substances called cytokines to survive and the cells may not get enough cytokines after infusion into the body. The investigators have added the gene C7R that gives the cells a constant supply of cytokine and helps them to survive for a longer period of time.\n\nThe purpose of this study is to find the largest safe dose of C7R-EBV T cells, and additionally to evaluate how long they can be detected in the blood and what affect they have on cancer.",[662,663,664],"EBV-Related Hodgkin Lymphoma","EBV-Related Lymphoproliferative Disorder","EBV Related Non-Hodgkin's Lymphoma",[666,667,668,669,670,671],"non-Hodgkin's Lymphoma","EBV (associated)-T\u002FNK-lymphoproliferative disease","EBV SPECIFIC T-LYMPHOCYTES","EBV","Hodgkin's Lymphoma","lymphoma relapse","2026-06-22",{"date":674,"type":42},"2026-06-25",{"date":676,"type":42},"2022-10-31",{"date":678,"type":22},"2042-11",{"name":48,"class":49},4,{"id":682,"slug":683,"hasResults":12,"nctId":684,"briefTitle":685,"officialTitle":686,"acronym":687,"eligibilityCriteria":688,"healthyVolunteers":12,"sex":17,"minAge":151,"maxAge":4,"enrollmentInfo":689,"targetDuration":4,"studyType":365,"phases":4,"briefSummary":690,"conditions":691,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":694,"lastUpdatePostDateStruct":695,"startDateStruct":697,"completionDateStruct":699,"leadSponsor":701,"locationsCount":144},"100631143","clinical-outcomes-safety-and-effectiveness-of-speedboat-ultraslim-in-per-oral-endoscopic-myotomy-poem-100631143","NCT07496840","Clinical Outcomes, Safety, and Effectiveness of Speedboat UltraSlim™ in Per-Oral Endoscopic Myotomy (POEM)","Clinical Outcome, Safety, and Effectiveness Assessment of Speedboat Ultraslim™ Surgical Device in the Performance of Per-Oral Endoscopic Myotomy (POEM)","SU-POEM","Inclusion Criteria:\n\n* Adult patients (≥18 years of age)\n* Diagnosed with achalasia or other esophageal motility disorders\n* Scheduled to undergo clinically indicated per-oral endoscopic myotomy (POEM) using the Speedboat UltraSlim™ device\n* Able and willing to provide informed consent\n\nExclusion Criteria:\n\n* Patients under 18 years of age\n* Patients not considered appropriate candidates for POEM by the principal investigator or treating physician",{"count":93,"type":22},"This study is a prospective registry designed to evaluate the clinical outcomes, safety, and effectiveness of per-oral endoscopic myotomy (POEM) performed using the Speedboat UltraSlim™ device in patients with achalasia or other esophageal motility disorders.\n\nParticipants included in this registry are those undergoing clinically indicated POEM as part of standard of care. No experimental interventions will be performed as part of this study. Patients will be approached for participation after the clinical decision to perform POEM has already been made.\n\nData will be collected through review of electronic medical records and procedural documentation, including patient demographics, procedural details, and clinical outcomes. Follow-up data will be collected at predefined time points (e.g., 30 days, 3 months, 6 months, and up to 1 year) to assess symptom improvement, procedural success, and adverse events.\n\nThe primary objective of the study is to assess technical success, clinical success, and safety outcomes associated with the use of the Speedboat UltraSlim™ device during POEM procedures.\n\nThis registry poses minimal risk to participants, as all procedures are performed as part of routine clinical care. No additional interventions beyond standard care are required for participation.",[692,693],"Esophageal Motility Disorders","Achalasia","2026-06-16",{"date":696,"type":42},"2026-06-17",{"date":698,"type":42},"2026-01-15",{"date":700,"type":22},"2027-09-30",{"name":48,"class":49},""]