[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Medical College of Wisconsin\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":624},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,116,0,25,[9,54,80,106,130,152,177,198,227,256,275,297,317,343,369,396,418,443,465,487,510,536,560,579,598],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":34,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100610399","dosing-physical-activity-among-older-cancer-survivors-who-experience-chronic-pain-a-micro-randomized-trial-100610399",false,"NCT07227077","Dosing Physical Activity Among Older Cancer Survivors Who Experience Chronic Pain: a Micro-randomized Trial","An Adaptive Design for Dosing Physical Activity Among Older Cancer Survivors Who Experience Chronic Pain: a Micro-randomized Trial","Inclusion Criteria:\n\n1. Age greater than or equal to 65 years.\n2. Patients with a history of bladder, breast, cervical, colorectal, endometrial, lung, and prostate cancer diagnosis and treatment.\n3. Fluent in spoken and written English.\n4. Patient has access to smartphone\n5. Ability to understand a written informed consent document, and the willingness to sign it.\n\nExclusion Criteria:\n\n1. Patient has metastatic disease.\n2. Patient has cancer recurrence.","ALL","65 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of this study is to assess the best time to deliver a message to increase physical activity and how often participants will experience a pain episode in the 24 hours following their receipt of a message to increase physical activity.",[27,28,29,30,31,32,33],"Breast Cancer","Cervical Cancer","Bladder Cancer","Colorectal Cancer","Endometrial Cancer","Lung Cancer","Prostate Cancer",[35,36,37,38,39,40],"Physical Activity","Exercise","Survivorship","Supportive Care","Pain","Symptom Management","RECRUITING","2026-08-19",{"date":44,"type":45},"2026-08-20","ACTUAL",{"date":47,"type":45},"2026-02-07",{"date":49,"type":21},"2027-05-01",{"name":51,"class":52},"Medical College of Wisconsin","OTHER",1,{"id":55,"slug":56,"hasResults":12,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":12,"sex":17,"minAge":61,"maxAge":4,"enrollmentInfo":62,"targetDuration":4,"studyType":22,"phases":64,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":53},"100652449","phase-2-immunotherapy-and-nodal-sparing-irradiation-for-t-cell-induction-and-unmasking-of-tumor-antigenicity-in-the-microenvironment-for-head-and-neck-cancer-100652449","NCT07773987","Immunotherapy and Nodal-Sparing Irradiation for T-Cell Induction and Unmasking of Tumor Antigenicity in the Microenvironment for Head and Neck Cancer","INITIUM","Inclusion Criteria:\n\n* Patients 18 years or older.\n* Patients with surgically resectable squamous cell carcinoma of the oral cavity or HPV-negative squamous cell carcinoma of the oropharynx. Resectability will be determined by the treating surgeon. Patients must have locoregionally advanced disease defined by clinical T3-4 staging and\u002For clinical node positive staging.\n* A CPS score of at least 1 on initial biopsy.\n* Zubrod, or Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n* Pregnancy. It is not known what effects this treatment has on human pregnancy or development of the embryo or fetus. Therefore, female patients participating in this study should avoid becoming pregnant, and male patients should avoid impregnating a female partner. Non-sterilized female patients of reproductive age and male patients should use effective methods of contraception through defined periods during and after study treatment as specified below.\n\nFemale patients must meet one of the following:\n\n* Postmenopausal for at least one year before the screening visit, OR\n* Surgically sterile (i.e., undergone a hysterectomy or bilateral oophorectomy), OR\n* If subject is of childbearing potential (defined as not satisfying either of the above two criteria):\n\n  * Agree to practice two effective methods of contraception (combination methods requires use of two of the following: diaphragm with spermicide, cervical cap with spermicide, contraceptive sponge, male or female condom, hormonal contraceptive, intrauterine device, etonogestrel implant, etc.) from the time of signing of the informed consent form through 90 days after the last dose of study agent, AND\n  * Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\n  * Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \\[e.g., calendar, ovulation, symptom-thermal, post ovulation methods\\] and withdrawal are not acceptable contraception methods).\n\nMale patients, even if surgically sterilized (i.e., status post vasectomy), must agree to one of the following:\n\n* Practice effective barrier contraception during the entire study treatment period and through 90 days after the last study drug dose, OR\n* Must also adhere to the guidelines of any study-specific pregnancy prevention program, if applicable, OR\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \\[e.g., calendar, ovulation, symptom-thermal, post ovulation methods\\] and withdrawal are not acceptable methods of contraception.) - Ability to understand a written informed consent document, and the willingness to sign it.\n\nExclusion Criteria:\n\n* HPV-positive squamous cell carcinoma of the oropharynx.\n* Tumor inaccessible for clinic-based biopsy as determined by the treating surgeon.\n* Solid organ transplant requiring chronic immunosuppression.\n* Autoimmune disease requiring use of steroids or chronic immunosuppression.\n* Prior invasive malignancy within the past 3 years (except for T1a surgically treated melanoma with negative margins, any early-stage non-melanomatous skin cancer, early-stage prostate cancer, or differentiated thyroid cancer). Patients with benign non-metastasizing tumors are eligible.\n* Life expectancy less than 12 months.\n* Performance status Zubrod ≥ 3.\n* Patients with prior external beam radiation therapy (RT) to the head and neck that overlaps the expected treatment fields.\n\n  a. Note: Patients receiving prior Iodine-131 therapy will be eligible.\n* Prior systemic therapy, including cytotoxic chemotherapy, biologic\u002Ftargeted therapy, or immune therapy for the study cancer.\n* Body weight ≤ 30 kg.\n* Any of the following severe laboratory abnormalities within 30 days of registration, unless corrected prior to it:\n\n  1. Sodium \\\u003C 125 mmol\u002FL or \\> 155 mmol\u002FL\n  2. Potassium \\\u003C 3.5 mmol\u002FL or \\> 6 mmol\u002FL\n  3. Glucose \\> 400 mg\u002Fdl\n  4. Serum calcium (ionized or adjusted for albumin) \\\u003C 7 mg\u002Fdl or \\> 12.5 mg\u002Fdl\n  5. Magnesium \\\u003C 0.9 mg\u002Fdl or \\> 3 mg\u002Fdl\n* Unstable angina and\u002For congestive heart failure requiring hospitalization within three months of registration.\n* Transmural myocardial infarction within three months of registration.\n* Medical or psychiatric illness that would compromise the patient's ability to tolerate treatment or limit compliance with study requirements.\n* Pregnancy or women of childbearing potential and men who are sexually active and not willing\u002Fable to use medically acceptable forms of contraception during treatment and for 6 months after radiation. This exclusion is necessary because the treatment involved in this study may be significantly teratogenic. Women who are breastfeeding are also excluded.","18 Years",{"count":63,"type":21},20,[65],"PHASE2","This is a non-comparative randomized Phase 2 study using the INITIUM regimen with or without elective nodal irradiation (ENI) delivered before surgery for resectable head and neck squamous cell carcinoma (HNSCC).",[68],"Head and Neck Cancer Squamous Cell Carcinoma",[70,71],"elective nodal irradiation","immunotherapy","NOT_YET_RECRUITING","2026-08-12",{"date":42,"type":45},{"date":76,"type":21},"2026-10",{"date":78,"type":21},"2029-10",{"name":51,"class":52},{"id":81,"slug":82,"hasResults":12,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":12,"sex":17,"minAge":61,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":22,"phases":90,"briefSummary":92,"conditions":93,"keywords":96,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":103,"leadSponsor":105,"locationsCount":53},"100609934","ft836-car-t-cell-therapy-in-combination-with-daratumumab-in-patients-with-relapsed-andor-refractory-multiple-myeloma-100609934","NCT07221032","FT836 CAR T-cell Therapy in Combination With Daratumumab in Patients With Relapsed and\u002For Refractory Multiple Myeloma","Phase I Study of FT836 CAR T-cell Therapy in Combination With Daratumumab in Patients With Relapsed and\u002For Refractory Multiple Myeloma","Inclusion Criteria:\n\n1. Patients must ≥18 years and \\\u003C 80 years old.\n2. Patients must have received \\>=3 prior lines of therapies, including proteasome inhibitor, immunomodulator and a CD38 monoclonal antibody:\n\n   • International Myeloma Working Group (IMWG) criteria define refractory disease as disease progression on or within 60 days of receiving therapy.\n3. Patients must have measurable disease, including at least one or more of the following criteria:\n\n   1. Serum M-protein ≥ 0.5 g\u002Fdl;\n   2. Urine M-protein ≥ 200 mg\u002F24 hrs;\n   3. Involved serum light chain ≥100 mg\u002FL with abnormal light chain ratio;\n4. Karnofsky performance score ≥70.\n5. Adequate hepatic function, defined as:\n\n   1. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase \\\u003C3x upper limit of normal (ULN);\n   2. Serum bilirubin \\\u003C2.0 mg\u002FdL except for patients with Gilbert's syndrome, who must have serum bilirubin of \\\u003C3 mg\u002FdL.\n6. Absolute neutrophil count (ANC) ≥1,000 with no G-CSF within 72 hours or pegylated G-CSF within 10 days.\n7. Platelets ≥50,000 with no transfusion within 72 hours of eligibility testing.\n8. Adequate renal function, defined as creatinine clearance ≥50 mL\u002Fmin calculated using the Cockroft-Gault formula.\n9. Able to provide written informed consent.\n10. Agree to practice birth control during the study.\n11. Adequate cardiac function as indicated by New York Heart Association (NYHA) classification I or II AND left ventricular ejection fraction of ≥45% -- by cardiac echocardiogram (ECHO) or multigated acquisition scan (MUGA) -- and adequate pulmonary function as indicated by room air oxygen saturation of ≥90%.\n12. Expected survival \\>12 weeks.\n13. Negative urine or serum pregnancy test in females of childbearing potential at study entry.\n14. No contraindication to central line access. Female subjects of reproductive potential (women who have reached menarche or women who have not been post-menopausal for at least 24 consecutive months, i.e., who have had menses within the preceding 24 months, or have not undergone a sterilization procedure \\[hysterectomy or bilateral oophorectomy\\]) must have a negative serum or urine pregnancy test performed as part of the eligibility criteria. Lactating women are eligible for this study but will be asked not to provide breast milk to their child from Day -11 through Day +90 after CAR T-cell therapy. It is possible they may no longer be able to lactate after receiving chemotherapy and treatment.\n\nDue to the high-risk level of this study, while enrolled, all subjects must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization). Additionally, if participating in sexual activity that could lead to pregnancy, the study subject must agree to use reliable and double-barrier methods of contraception during the follow-up period of the protocol.\n\nAcceptable birth control includes a combination of two of the following methods:\n\n* Condoms (male or female) with or without a spermicidal agent.\n* Diaphragm or cervical cap with spermicide.\n* Intrauterine device (IUD).\n* Hormonal-based contraception. Subjects who are not of reproductive potential (women who are premenarche or have been post-menopausal for at least 24 consecutive months or have undergone hysterectomy, tubal ligation, salpingectomy, and\u002For bilateral oophorectomy or men who have documented azoospermia) are eligible without requiring the use of contraception.\n\nExclusion Criteria:\n\n1. Positive beta-Human Chorionic Gonadotropin (HCG) in female of child-bearing potential.\n2. Confirmed active human immunodeficiency virus (HIV), Hepatitis B or C infection.\n3. History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon requiring steroid therapy defined as \\>20 mg of prednisone or equivalent daily.\n4. Presence of ≥ Grade 3 non-hematologic toxicities as per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 from any previous treatment unless it is felt to be due to underlying disease.\n5. Concurrent use of investigational therapeutic agents or enrollment in another therapeutic clinical trial at any institution. A minimum of 14 days or five half-lives of the drug (whichever is shorter) washout prior to start of daratumumab.\n6. Refusal to participate in the long-term follow-up protocol.\n7. Patients with active Central Nervous System (CNS) involvement by malignancy on magnetic resonance imaging (MRI) or by lumbar puncture.\n\n   a. Patients with prior CNS disease that has been effectively treated will be eligible providing last treatment was ≥2 weeks before start of daratumumab and a remission documented within four weeks of planned CAR T-cell infusion by MRI brain and Cerebrospinal Fluid (CSF) analysis.\n8. Previous recipients of allogeneic hematopoietic stem cell transplantation (AHCT) are excluded if they are \\\u003C6 months post-transplant, have evidence of active graft-versus-host-disease (GVHD) of any grade, or are currently on immunosuppression.\n9. Plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, and AL amyloidosis.\n10. Prior treatment with gene therapy or any gene-modified cellular therapy.\n11. Cytotoxic chemotherapy, oral chemotherapeutic agents, or antibody-directed treatment within 14 days of starting daratumumab or after starting daratumumab.\n\n    1. Corticosteroids are allowable up until seven days prior to starting daratumumab and after starting daratumumab for disease control up until the day prior to cell infusion (Day -1).\n    2. Radiation is allowed to a single symptomatic site.\n12. Patients post solid organ transplant who develop high-grade lymphomas or leukemias.\n13. Concurrent active malignancy other than basal or squamous cell carcinomas of the skin.\n14. Active bacterial, viral, or fungal infection requiring systemic treatment.\n15. Patients who have received major surgery one week prior to starting daratumumab and three weeks prior to lymphodepletion.\n16. Active malignancy that required therapy in the last two years except successfully treated non-metastatic basal or squamous cell carcinoma, or prostate carcinoma that does not require therapy. Other similar conditions may be discussed with and permitted by the medical monitor.","80 Years",{"count":89,"type":21},12,[91],"PHASE1","This is a phase I, interventional, single-arm, open-label, dose-finding treatment study designed to evaluate the safety and preliminary efficacy of FT836 in combination with daratumumab in adult patients with relapsed and\u002For refractory myeloma who have failed prior therapies.",[94,95],"Relapse Multiple Myeloma","Refractory Multiple Myeloma",[97,98],"multiple myeloma","CAR-T therapy","2026-08-06",{"date":101,"type":45},"2026-08-10",{"date":76,"type":21},{"date":104,"type":21},"2030-03",{"name":51,"class":52},{"id":107,"slug":108,"hasResults":12,"nctId":109,"briefTitle":110,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":12,"sex":17,"minAge":61,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":124,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":53},"100593704","bcma-bispecific-antibody-therapy-for-post-bcma-car-t-cell-therapy-relapse-reclaim-100593704","NCT07009899","BCMA Bispecific Antibody Therapy for Post-BCMA CAR T-Cell Therapy Relapse (RECLAIM)","RECLAIM","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Eastern Cooperative Oncology Group (ECOG) Performance Status criteria of 0-3.\n3. Received any standard of care or investigational BCMA CAR T-cell therapy as their last line of therapy ≥ 6 months prior to enrollment.\n\n   a. Note: Up to 15% of patients who are \\\u003C 6 months out from their standard of care of investigational BCMA CAR T-cell therapy will be included in the study as long as i) their bone marrow biopsy sample tests positive for BCMA expression by immunohistochemistry and ii) they have stem cells available for a stem cell boost therapy prior to linvoseltamab administration.\n4. Must have measurable disease for response assessment as per the IMWG response assessment criteria.\n\n   a. Note: if a patient does not have measurable serum M or free light chain, evidence of measurable disease by imaging is acceptable (e.g., extramedullary disease, new lesions).\n5. Adequate hepatic function as defined below:\n\n   1. Total bilirubin ≤ 1.5 x the upper limit of the normal range (ULN).\n   2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN.\n6. Ability to understand a written informed consent document, and the willingness to sign it.\n\nExclusion Criteria:\n\n1. Previously on a BCMA-directed therapy other than BCMA CAR T-cell therapy (e.g., BCMA bispecific antibody, BCMA antibody drug conjugate) or T cell engaging therapy (e.g., GPRC5D bispecific antibody, GPRC5D CAR T-cell therapy).\n2. History of neurodegenerative condition, Central Nervous System (CNS) movement disorder, or patients with a history of seizure within 12 months prior to study enrollment.\n3. Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.\n4. Prior organ transplant requiring immunosuppressive therapy.\n5. Known to be human immunodeficiency virus (HIV) positive.\n6. Known to have hepatitis A, B, or C active infection.\n7. Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.\n8. Concurrent hematologic or non-hematologic malignancy requiring treatment (other than multiple myeloma and secondary amyloidosis).\n9. Cardiac syncope, uncompensated New York Heart Association (NYHA) Class 3 or 4 congestive heart failure, myocardial infarction within the previous six months, unstable angina pectoris, clinically significant repetitive ventricular arrhythmias despite antiarrhythmic treatment, cardiac ejection fraction \\\u003C 40% by echocardiogram or multi-gated acquisition (MUGA) scan, severe orthostatic hypotension, or clinically important autonomic disease.\n10. Major surgery within 14 days prior to start of study treatment (Note: vertebroplasty and kyphoplasty are not considered major surgery).\n11. Infection requiring systemic antibiotic therapy or other serious infection within 14 days prior to start of study treatment.\n12. Active treatment in other clinical trials, including those where a subject received an investigational drug within 30 days or five half-lives of the investigational drug prior to start of study treatment, whichever is longer.\n13. Any clinically significant, uncontrolled medical conditions that, in the investigator's opinion, would expose the subject to excessive risk or may interfere with compliance or interpretation of the study results.\n14. Pregnant or breastfeeding women.\n15. Women of childbearing potential (WOCBP) or sexually active men who are unwilling to practice highly effective contraception prior to the start of study therapy, during the study, and for at least 6 months after the last dose of the study drug.\n\n    1. WOCBP are defined as women who are fertile following menarche until becoming postmenopausal (defined as no menses for 12 months without an alternative medical cause), unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy.\n    2. Male study participants with WOCBP partners are required to use condoms unless they are vasectomized or practice sexual abstinence. Male study participants should not donate sperm during the study, and for at least 6 months after the last dose\n16. Highly effective contraceptive measures include stable use of combined (estrogen and progestogen-containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation initiated two or more menstrual cycles prior to screening; intrauterine device; intrauterine hormone-releasing system; bilateral tubal ligation; vasectomized partner (provided that the vasectomized partner is the sole sexual partner of the WOCBP study participant); and or sexual abstinence.",{"count":114,"type":21},34,[65],"This is a single-center, single-arm, phase 2 study designed to evaluate the efficacy and safety of linvoseltamab in multiple myeloma (MM) patients who relapsed following BCMA CAR T-cell therapy, whether standard of care or investigational.",[118],"Multiple Myeloma",[120,121,122,123,118],"Bispecific Antibody","BCMA","BCMA CAR T-Cell Therapy","linvoseltamab",{"date":101,"type":45},{"date":126,"type":21},"2026-10-01",{"date":128,"type":21},"2029-02-01",{"name":51,"class":52},{"id":131,"slug":132,"hasResults":12,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":12,"sex":17,"minAge":61,"maxAge":87,"enrollmentInfo":137,"targetDuration":4,"studyType":22,"phases":139,"briefSummary":140,"conditions":141,"keywords":142,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":146,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":53},"100514289","phase-i-trial-of-bcma-tgf-beta-car-t-cells-in-relapsed-refractory-myeloma-100514289","NCT05976555","Phase I Trial of BCMA-TGF-BETA CAR-T Cells in Relapsed, Refractory Myeloma","Phase I Study of BCMA-TGF-BETA Insensitive Armored CAR T Cells in Patients With Relapsed and\u002For Refractory Multiple Myeloma","Inclusion Criteria:\n\n1. Patients must be aged ≥18 years to 80 years old.\n2. Patients must have received three prior lines of therapies, including proteasome inhibitor, immunomodulator and a cluster of differentiation (CD) 38 monoclonal antibody:\n\n   • International Myeloma Working Group (IMWG) criteria defines refractory disease as disease progression on or within 60 days of receiving therapy.\n3. Patients must have measurable disease, including at least one or more of the following criteria:\n\n   1. Serum M-protein ≥0.5 g\u002Fdl;\n   2. Urine M-protein ≥200 mg\u002F24 hrs;\n   3. Involved serum light chain ≥100 mg\u002FL with abnormal light chain ratio;\n4. Absolute CD 3 count ≥50 mm\\^3.\n5. Karnofsky performance score ≥70.\n6. Adequate hepatic function, defined as:\n\n   1. aspartate aminotransferase (AST), alanine transaminase (ALT), and alkaline phosphatase \\\u003C3x upper limit of normal (ULN);\n   2. Serum bilirubin \\\u003C2.0 mg\u002FdL except for patients with Gilbert's syndrome, who must have serum bilirubin of \\\u003C3 mg\u002FdL.\n7. Absolute neutrophil count (ANC) ≥1,000 with no Granulocyte colony-stimulating factor (G-CSF) within 72 hours or pegylated G-CSF within 10 days.\n8. Platelets ≥50,000\u002FµL with no transfusion within 72 hours of eligibility testing.\n9. Adequate renal function, defined as creatinine clearance ≥50 mL\u002Fmin calculated using the Cockroft-Gault formula.\n10. Able to provide written informed consent.\n11. Agree to practice birth control during the study.\n12. Adequate cardiac function as indicated by New York Heart Association (NYHA) classification I or II AND left ventricular ejection fraction of ≥45% (by cardiac echocardiogram (ECHO) or multigated acquisition (MUGA)) and adequate pulmonary function as indicated by room air oxygen saturation of ≥90%.\n13. Expected survival \\>12 weeks.\n14. Negative urine or serum pregnancy test in females of childbearing potential at study entry.\n15. Meet criteria for regarding fertility and contraception detailed below.\n16. No contraindication to central line access.\n\nPhase I Dose-Expansion Cohort A: BCMA Naïve The inclusion criteria for dose-expansion Cohort A are the same as that listed above but are limited to BCMA naïve patients.\n\nPhase I Dose-Expansion Cohort B: BCMA Exposed The inclusion criteria for dose expansion Cohort B are the same as that above but require prior exposure to BCMA directed therapies (e.g., CAR-BCMA, bispecific T\u002F Natural Killer (NK) cell engagers of BCMA).\n\nPatients with prior antibody drug conjugate, bispecific T and NK cell engager and prior gene-modified cellular immune therapy against BCMA are allowed. Patients must be \\> 3 months out from therapy and must have achieved stable disease or better with prior BCMA-directed therapy.\n\nExclusion Criteria:\n\n1. Positive beta- Human chorionic gonadotropin (HCG) in female of child-bearing potential defined as per the Schedule of Events table.\n2. Confirmed active human immunodeficiency virus (HIV), Hepatitis B or C infection.\n3. History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon requiring steroid therapy defined as \\>20 mg of prednisone or equivalent daily.\n4. Presence of ≥ Grade 3 non-hematologic toxicities as per CTCAE version 5.0 from any previous treatment unless it is felt to be due to underlying disease.\n5. Concurrent use of investigational therapeutic agents or enrollment on another therapeutic clinical trial at any institution. Minimum of 14 days or 5 half-lives of the drug (whichever is shorter) washout prior to apheresis.\n6. Refusal to participate in the long-term follow-up protocol.\n7. Patients with active central nervous system (CNS) involvement by malignancy on MRI or by lumbar puncture.\n\n   a. Patients with prior CNS disease that has been effectively treated will be eligible providing last treatment was ≥2 weeks before apheresis and a remission documented within 4 weeks of planned CAR T-cell infusion by MRI brain and CSF analysis.\n8. Previous recipients of allogeneic hematopoietic stem cell transplantation (AHCT) are excluded if they are \\\u003C6 months post-transplant, have evidence of active graft-versus-host-disease (GVHD) of any grade, or are currently on immunosuppression.\n9. Plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, and AL amyloidosis.\n10. Prior treatment with gene therapy or any gene modified cellular therapy (only permitted in cohort B for the dose expansion phase).\n11. Prior BCMA-directed therapy (only permitted in cohort B for the dose expansion phase).\n12. Cytotoxic chemotherapy, oral chemotherapeutic agents, or antibody-directed treatment within 14 days of apheresis or after apheresis.\n\n    1. Corticosteroids are allowable up until 7 days prior to apheresis and after apheresis for disease control up until the day prior to cell infusion (Day -1).\n    2. Radiation is allowed to a single symptomatic site.\n13. Patients post solid organ transplant who develop high grade lymphomas or leukemias.\n14. Concurrent active malignancy other than basal or squamous cell carcinomas of the skin.\n15. Active bacterial, viral, or fungal infection requiring systemic treatment.\n16. Patients who have received major surgery 1 week prior to leukapheresis and 3 weeks prior to lymphodepletion.\n17. Active malignancy that required therapy in the last 2 years except successfully treated non metastatic basal or squamous cell carcinoma, or prostate carcinoma that does not require therapy. Other similar conditions may be discussed with and permitted by the medical monitor.\n\nSpecial Criteria Regarding Fertility and Contraception\n\nFemale subjects of reproductive potential (women who have reached menarche or women who have not been post-menopausal for at least 24 consecutive months, i.e., who have had menses within the preceding 24 months, or have not undergone a sterilization procedure \\[hysterectomy or bilateral oophorectomy\\]) must have a negative serum or urine pregnancy test performed as part of eligibility criteria. Lactating women are eligible for this study but will be asked to not provide breast milk to their child from Day -4 through Day +90 after CAR T-cell therapy.\n\nDue to the high-risk level of this study, while enrolled, all subjects must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization). Additionally, if participating in sexual activity that could lead to pregnancy, the study subject must agree to use reliable and double barrier methods of contraception during the follow-up period of the protocol.\n\nAcceptable birth control includes a combination of two of the following methods:\n\n* Condoms (male or female) with or without a spermicidal agent.\n* Diaphragm or cervical cap with spermicide.\n* Intrauterine device (IUD).\n* Hormonal-based contraception. Subjects who are not of reproductive potential (women who are premenarche or have been post-menopausal for at least 24 consecutive months or have undergone hysterectomy, tubal ligation, salpingectomy, and\u002For bilateral oophorectomy or men who have documented azoospermia) are eligible without requiring the use of contraception.",{"count":138,"type":21},30,[91],"This is a phase I, interventional, single-arm, open-label, dose-finding treatment study designed to evaluate the safety and efficacy of interleukin-7(IL-7) \u002F interleukin-15 (IL-15) manufactured CAR T cells in adult patients with relapsed and\u002For refractory myeloma that have failed prior therapies.",[118],[143,144,145],"CAR-T","Chimeric antigen receptor T-cell therapy","CAR Therapy",{"date":101,"type":45},{"date":148,"type":45},"2026-05-15",{"date":150,"type":21},"2029-05",{"name":51,"class":52},{"id":153,"slug":154,"hasResults":12,"nctId":155,"briefTitle":156,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":12,"sex":17,"minAge":61,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":22,"phases":160,"briefSummary":162,"conditions":163,"keywords":165,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":53},"100601515","impact-of-glucagon-like-peptide-1-glp-1-analogs-on-disease-outcomes-in-psoriatic-arthritis-a-pragmatic-randomized-controlled-trial-100601515","NCT07111494","Impact of Glucagon-like Peptide-1 (GLP-1) Analogs on Disease Outcomes in Psoriatic Arthritis: A Pragmatic Randomized Controlled Trial","Inclusion Criteria:\n\n* Adult patients (age 18 and older) who present to rheumatology clinic\n* Participants must be able to read, understand, and provide documented informed consent as approved by the Institutional Review Board (IRB).\n* Meet the Classification of Psoriatic Arthritis (CASPAR) criteria for PsA\n* Participants must have a Body Mass Index (BMI) of 30kg\u002Fm\\^2\n* Participants must be treated for PsA in accordance with guidelines\n* Have not achieved MDA in PsA patients\n* Have a minimum TJC \\> 1 and SJC \\> at baseline\n* Eligible for GLP-1 agonist treatment in accordance with Food Drug Administration (FDA) labeling as determined by the investigator.\n\nExclusion Criteria:\n\n* Any prior use of GLP-1 agonists\n* Inability to provide informed consent\n* Current participation in another PsA study\n* Treatment initiation by GLP-1 agonists contraindicated by FDA\n* Patients with hemoglobin A1c (HbA1c) \\> 10 at baseline",{"count":159,"type":21},22,[161],"PHASE4","Psoriatic arthritis (PsA) is a chronic inflammatory condition that affects the joints but can also have an effect on multiple parts of the body. This study will assess if the effectiveness of Glucagon-like peptide-1 (GLP-1) medications used to treat type 2-diabetes and weight management, or nutrition counseling can better treat individuals with Psoriatic Arthritis who are also needing treatment for obesity and type 2 diabetes.\n\nThe main objectives it aims to answer are:\n\nTo assess disease outcomes of PsA patients undergoing treatment for concomitant obesity and type 2 diabetes with GLP-1 analogs vs nutrition counseling.\n\nTo assess effectiveness as measured by clinical and patient reported outcome measures in patients treated with GLP-1 and nutrition counseling.\n\nParticipants will be randomized to receive a GLP-1 or nutrition counseling. Participants will be asked to come to the study center at most four times during a 24-week period. During this time participants will be asked to fill out questionnaires, receive a physical exam, and have their blood drawn.",[164],"Psoriatic Arthritis (PsA)",[166,167,168,169],"Psoriatic Arthritis","GLP-1","Minimal Disease Activity","Nutrition Counseling","2026-08-05",{"date":101,"type":45},{"date":173,"type":45},"2026-05-01",{"date":175,"type":21},"2028-10-15",{"name":51,"class":52},{"id":178,"slug":179,"hasResults":12,"nctId":180,"briefTitle":181,"officialTitle":181,"acronym":4,"eligibilityCriteria":182,"healthyVolunteers":12,"sex":17,"minAge":61,"maxAge":4,"enrollmentInfo":183,"targetDuration":4,"studyType":22,"phases":185,"briefSummary":186,"conditions":187,"keywords":189,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":53},"100651078","off-label-treatment-with-immune-checkpoint-inhibitor-blockade-100651078","NCT07754292","Off-Label Treatment With Immune Checkpoint Inhibitor Blockade","Inclusion Criteria:\n\n* Age ≥18 years.\n* Zubrod Performance Status 0-2.\n* Patients must have a documented malignancy where an off-label ICI is being considered by a physician.\n* Patients must have adequate organ function as specified below:\n\n  * Absolute Neutrophil Count (ANC) ≥1,000\u002FmcL\n  * Platelets ≥75,000\u002FmcL\n  * Total Bilirubin ≤2.0 × upper limit of normal (ULN), unless the patient has changes consistent with Gilbert's Syndrome.\n  * Alanine Aminotransferase (ALT) ≤3.0 × ULN\n  * Serum Creatinine ≤2.0 × ULN or CrCl ≥50 mL\u002Fmin as calculated by the Cockcroft-Gault equation.\n* 5\\. Females of child-bearing potential must have a negative pregnancy test and must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from the time of informed consent, for the duration of study participation, and for 6 months following completion of therapy. Should a female patient become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception from the time of informed consent, for the duration of study participation, and 6 months after completion of administration.\n\nNOTE: A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\n\n* Has not undergone a hysterectomy or bilateral oophorectomy\n* Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \\> 12 months)\n\n  * Ability to understand a written informed consent document and the willingness to sign it.\n  * Physician has verified coverage of the cost of the drug(s) via insurance, specialty pharmacy, patient assistance programs, or other means, as documented by physician\u002Fmid-level or nursing notes, pharmacist notes, or MCW\u002FFH insurance approval.\n\nExclusion Criteria:\n\n* Uncontrolled illness, including symptomatic congestive heart failure (NYHA III\u002FIV), unstable angina, or cardiac procedure within 2 weeks of start of ICI.\n* Concurrent therapy: use of other investigational (no FDA approval for any indication) anti-cancer agents within 14 days of registration.\n* Although other therapy is allowed together with the off-label ICI use as outlined in the protocol, before starting the study ICI off-label drug, the patient must be off other anti-cancer therapies for at least 2 weeks or 5 half-lives, whichever is shorter.\n* Major surgery (as defined by the treating medical oncologist) within two weeks of the start date of immunotherapy.\n* Other: pregnancy or lactation.",{"count":184,"type":21},231,[65],"This is a phase II therapeutic interventional clinical trial that will evaluate the efficacy, safety, and outcomes of off-label immune checkpoint blockade use across malignancies.",[188],"Malignancy",[190],"immune checkpoint inhibitor","2026-08-04",{"date":101,"type":45},{"date":194,"type":21},"2026-11-01",{"date":196,"type":21},"2036-11-01",{"name":51,"class":52},{"id":199,"slug":200,"hasResults":12,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":12,"sex":17,"minAge":61,"maxAge":205,"enrollmentInfo":206,"targetDuration":4,"studyType":22,"phases":207,"briefSummary":208,"conditions":209,"keywords":216,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":221,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":53},"100515358","phase-1-lv2019-car-t-cells-in-combination-with-pirtobrutinib-for-relapsed-refractory-b-cell-malignancies-100515358","NCT05990465","LV20.19 CAR T-Cells in Combination With Pirtobrutinib for Relapsed, Refractory B-cell Malignancies","Phase I Study of LV20.19 CAR T-cells in Combination With Pirtobrutinib for Relapsed, Refractory B-cell Malignancies","To facilitate rapid start of pirtobrutinib, there will be separate inclusion\u002Fexclusion for pirtobrutinib and LV20.19 CAR T-cells in addition to the general inclusion as outlined below.\n\nGeneral inclusion criteria for trial:\n\n1. Patients must be aged ≥18 years and \\\u003C81 years with relapsed or refractory B-cell non-Hodgkin Lymphoma (NHL).\n2. Diagnosis of relapsed or refractory B-cell NHL including Follicular Lymphoma, Marginal Zone Lymphoma (splenic, nodal, extranodal), Mantle Cell Lymphoma, Burkitt Lymphoma and DLBCL with associated subtypes (aggressive B-cell lymphoma, high grade B-cell lymphoma, T-cell\u002Fhistocyte rich B-cell lymphoma, primary mediastinal B-cell lymphoma, Epstein-Barr virus-positive (EBV)+ diffuse large B-cell lymphoma, transformed lymphoma such as transformed follicular or marginal zone, and Richter's transformation).\n3. Disease specific criteria as follows:\n\n   1. DLBCL and associated subtypes (listed above)\n\n   i. Must have received Rituximab or another cluster of differentiation 20 (CD20) antibody with combination anthracycline based chemotherapy regimen and have ONE of the following:\n\n\u003C!-- -->\n\n1. Primary refractory lymphoma or early relapse ≤6 months after one line of therapy.\n2. For relapse \\>6.00 months, failure of two different chemotherapy regimens appropriate for their disease and be ineligible to receive autologous transplant.\n\nii. Relapse post-autologous transplant. iii. Relapse post-allogeneic transplant. iv. Relapse post-CAR T-cell therapy (maximum 2 patients allowed with this designation).\n\nb. Mantle Cell Lymphoma\n\ni. Must have received Rituximab or another CD 20 antibody with one chemotherapy regimen appropriate for this disease (bendamustine or cytarabine, or anthracycline based treatment) and have ONE of the following:\n\n1. Relapsed disease after two lines of cytotoxic chemotherapy including administration of anti-CD20 antibody.\n2. Progressive disease after ≥second line BTK inhibitor.\n3. Relapse post-autologous transplant.\n4. Relapse post-allogeneic transplant.\n\n   c. Marginal Zone Lymphoma and Follicular Lymphoma\n\n   i. Must have received Rituximab or another CD20 antibody with chemotherapy regimen appropriate for the disease and have ONE of the following:\n\n\u003C!-- -->\n\n1. Relapsed disease after two lines of therapy including administration of anti-CD20 antibody.\n2. Relapse post-autologous transplant.\n3. Relapse post-allogeneic transplant.\n\n   d. Burkitt's Lymphoma\n\n   i. Must have received Rituximab or another CD20 antibody in combination with anthracycline based chemotherapy regimen and have ONE of the following:\n\n\u003C!-- -->\n\n1. Primary refractory lymphoma.\n2. Relapse within 6 months.\n3. For relapse \\>6 months, failure of two different chemotherapy regimens appropriate for their disease and be ineligible to receive autologous transplant.\n\n   i. Relapse post-autologous transplant. ii. Relapse post-allogeneic transplant.\n4. Able to provide written informed consent.\n5. Negative urine or serum pregnancy test in females of childbearing potential at screening.\n6. Willingness of women of reproductive potential and their partners to observe highly effective birth control methods for duration of treatment and for 1 month following the last dose if study treatment.\n7. Karnofsky performance score ≥70.\n8. Expected survival \\>12 weeks.\n9. Patient has demonstrated compliance with prior therapies.\n10. Able to take oral medications.\n11. Adequate coagulation, defined as activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) and prothrombin (PT) or (international normalized ratio (INR) not greater than 1.5 x upper limit of normal (ULN).\n12. Patients are required to have the following washout periods prior to planned Cycle 1 Day 1 (C1D1). In addition, prior treatment-related adverse events (AEs) must have recovered to Grade ≤ 1 with the exception of alopecia and Grade 2 peripheral neuropathy.\n\n    1. Targeted agents, investigational agents, therapeutic monoclonal antibodies or cytotoxic chemotherapy: 5 half-lives or 2 weeks, whichever is shorter.\n    2. immunoconjugated antibody treatment within 10 weeks prior to randomization.\n    3. broad field radiation (≥ 30% of the bone marrow or whole brain radiotherapy) must be completed 14 days prior to study enrollment.\n    4. palliative limited field radiation must be completed 7 days prior to study enrollment.\n\nInclusion Criteria to START Pirtobrutinib Bridging:\n\n1. Absolute neutrophil count (ANC) ≥1000 with no G-CSF within 7 days or pegylated G-CSF within 14 days unless patient has biopsy proven bone marrow involvement.\n2. Platelets≥50,000 with no transfusion within 7 days unless patient has biopsy proven bone marrow involvement.\n3. Hemoglobin ≥8g\u002FdL (≥80 g\u002FL) \\[blood transfusions are allowable to reach this goal\\].\n4. Adequate hepatic function, defined as aspartate aminotransferase (AST) and alanine transaminase (ALT) \\\u003C3 x upper limit of normal (ULN) or \\\u003C 5 x ULN with documented liver involvement; serum bilirubin \\\u003C1.5 x ULN or \\\u003C3 x ULN with documented liver involvement , or considered not clinically significant as per the clinical PIs discretion (e.g. Gilbert's or indirect hyperbilirubinemia) or felt to be due to underlying disease.\n5. Adequate renal function, defined as creatinine clearance≥50 ml\u002Fmin.\n\n   1. No IV hydration within 24 hours of eligibility.\n   2. No dialysis dependent renal failure.\n\nInclusion criteria for Pirtobrutinib Maintenance (part B)\n\n1. Recovery of neutrophils count after CAR T-cell infusion with ANC ≥1000\u002FdL without G-CSF within the last 7 days.\n2. Recovery of platelet count after CAR T-cell infusion with platelet count ≥50,000\u002FdL.\n3. Adequate hepatic function, defined as back to baseline or AST and ALT \\\u003C3 x upper limit of normal (ULN); serum bilirubin and alkaline phosphatase \\\u003C3 x ULN, or considered not clinically significant as per the clinical PI's discretion (e.g., Gilbert's or indirect hyperbilirubinemia) or felt to be due to underlying disease.\n4. Adequate renal function, defined as creatinine clearance≥40 ml\u002Fmin.\n5. Evidence of response or stable disease (complete response\u002Fpartial response\u002Fstable disease) at day 28 after CAR T-cell therapy.\n\nInclusion Criteria for Apheresis and LV20.19 CAR T-cells:\n\n1. Active Measurable disease must be documented within 4 weeks of lymphodepletion start defined as nodal lesions greater than 15 mm in the long axis or extranodal lesions \\>10 mm in long and short axis OR bone marrow involvement that is biopsy proven for B-cell NHL.\n2. Absolute cluster of differentiation (CD) 3 count≥50 mm\\^3.\n3. MRI brain and Lumbar Puncture with cerebrospinal fluid (CSF) analysis by cytology and flow cytometry without evidence of central nervous system (CNS) involvement ONLY in patients with history of CNS involvement or clinical suspicion at the time of enrollment.\n4. Adequate cardiac function as indicated by New York Heart Association (NYHA) classification I or II AND left ventricular ejection fraction of ≥45% (by echocardiogram (ECHO) or MUGA) and adequate pulmonary function as indicated by room air oxygen saturation of ≥92%.\n5. No contraindication to central line access.\n6. ANC≥1000 with no pegylated G-CSF within 14 days unless patient has biopsy proven bone marrow involvement.\n7. Platelets≥50,000 with no transfusion within 72 hours unless patient has biopsy proven bone marrow involvement.\n8. Adequate hepatic function, defined as AST and ALT \\\u003C3 x upper limit of normal (ULN); serum bilirubin and alkaline phosphatase \\\u003C3 x ULN, or considered not clinically significant as per the clinical PIs discretion (e.g. Gilbert's or indirect hyperbilirubinemia) or felt to be due to underlying disease.\n9. Adequate renal function, defined as creatinine clearance≥50 ml\u002Fmin. a. No IV hydration within 24 hours of eligibility. b. No dialysis dependent renal failure.\n\nExclusion Criteria:\n\nA potential subject who meets any of the following exclusion criteria is ineligible to participate in the study.\n\n1. Positive beta-human chorionic gonadotropin (HCG) in female of child-bearing potential or plan to become pregnant during the study or within 1 month of the last dose of study treatment and women who are current lactating or plan to breastfeed during the study or within 1 week of the last dose of study treatment.\n2. Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection based on criteria below:\n\n   1. HBV: Patients with positive hepatitis B surface antigen (HBsAg) are excluded. Patients with positive hepatitis B core antibody (anti-HBc) and negative HBsAg require hepatitis B polymerase chain reaction (PCR) evaluation before randomization. Patients who are hepatitis B PCR positive will be excluded.\n   2. Hepatitis C virus (HCV): positive hepatitis C antibody. If positive hepatitis C antibody result, patient will need to have a negative result for hepatitis C ribonucleic acid (RNA) before randomization. Patients who are hepatitis C RNA positive will be excluded.\n3. Known active cytomegalovirus (CMV) infection (Unknown or negative status are eligible).\n4. History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon requiring steroid therapy defined as \\>20 mg of prednisone or equivalent daily.\n5. Presence of ≥ grade 3 non-hematologic toxicities as per CTCAE version 5.0 from any previous treatment unless it is felt to be due to underlying disease.\n6. Concurrent use of investigational therapeutic agents or enrollment on another therapeutic clinical trial at any institution. Minimum of 14 days or 5 half-lives of the drug (whichever is shorter) washout prior to apheresis.\n7. Refusal to participate in the long-term follow-up protocol.\n8. Patients with active CNS involvement by malignancy on MRI or by lumbar puncture.\n\n   1. Patients with prior CNS disease that has been effectively treated will be eligible providing treatment was \\>4 weeks before enrollment and a remission documented within 8 weeks of planned CAR-T cell infusion by MRI brain and CSF analysis.\n9. Previous recipients of allogeneic hematopoietic stem cell transplantation (AHCT) are excluded if they are \\\u003C100 days post-transplant, have evidence of active graft-versus-host-disease (GVHD) of any grade, or are currently on immunosuppression.\n10. Prior allogeneic CAR T-cell therapy \\\u003C100 days from prior CAR T-cell treatment.\n11. Previous recipients of autologous CAR-T cell therapy directed at either cluster of differentiation 19 (CD19) or CD20 are excluded if they are \\\u003C100 days post prior CAR-T cell treatment (does not include re-enrollment) or have \\>5% residual circulating CAR-T as measured by flow cytometry using a CD19 CAR detection reagent (Miltenyi Biotec).\n\n    a. Patients with prior CAR-T treatment against CD19 or CD20 must have repeat biopsy post-CAR-T cell therapy confirming a minimum of 5% CD19 or CD20 positivity by immunohistochemistry or flow cytometry.\n12. Anti-CD20 antibody treatment within 4 weeks of cell infusion.\n13. Anti-CD19 antibody treatment within 4 weeks of cell infusion.\n14. Cytotoxic chemotherapy treatment within 14 days or steroid treatment (other than replacement dose steroids) within 7 days prior to apheresis collection for CAR-T cells.\n15. No other oral chemotherapeutic agents or antibody directed treatment after starting pirtobrutinib other than steroids or radiation to a single site in a palliative fashion.\n16. Patients post solid organ transplant who develop high grade lymphomas or leukemias.\n17. Concurrent active malignancy other than basal or squamous cell carcinomas of the skin (underlying low-grade lymphoma chronic lymphocytic leukemia\u002FFollicular lymphoma (FL) \u002F Marginal zone lymphoma (MZL) is allowable in patients with transformed large cell lymphoma\u002FRichter's.\n18. Patients who experienced a major bleeding event or grade ≥ 3 arrhythmia on prior treatment with a BTK inhibitor.\n19. History of stroke or intracranial hemorrhage within 6 months of randomization.\n20. Significant cardiovascular disease defined as myocardial infarction within 6 months of randomization, congestive heart failure with ejection fraction \\\u003C30%, active unstable angina, QT prolongation (QTcF)\\>470 msec on ECG.\n21. Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal (GI) absorption of the study drug.\n22. Patients requiring therapeutic anticoagulation with warfarin or another vitamin K antagonist.\n23. Patients who had surgery within 4 weeks prior to randomization.\n24. Patients who have received vaccination with live vaccine within 28 days prior to randomization.\n25. Patients with known hypersensitivity to any of the excipients of pirtobrutinib.\n\n    Special Criteria Regarding Fertility and Contraception\n\n    Female subjects of reproductive potential (women who have reached menarche or women who have not been post-menopausal for at least 24 consecutive months, i.e., who have had menses within the preceding 24 months, or have not undergone a sterilization procedure \\[hysterectomy or bilateral oophorectomy\\]) must have a negative serum or urine pregnancy test performed at screening.\n\n    Due to the high-risk level of this study, while enrolled, all subjects must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization). Additionally, if participating in sexual activity that could lead to pregnancy, the study subject must agree to use reliable and double barrier methods of contraception during the follow-up period of the protocol.\n\n    Acceptable birth control includes a combination of two of the following methods:\n\n    • Combined estrogen and progestin containing hormonal contraception associated with inhibition of ovulation given orally, intravaginally, or transdermally\n\n    • Progestin-only hormonal contraception associated with inhibition of ovulation given orally, by injection, or by implant\n\n    • Intrauterine device (IUD)\n\n    • Intrauterine hormone-releasing system (IUS)\n\n    • Vasectomized partner\n\n    • Sexual abstinence: considered a highly effective method only if defined as refraining from heterosexual intercourse during an entire period of risk associated with the study treatment. The reliability of sexual abstinence will be evaluated in relation to the duration of the study and to the usual lifestyles of the patient.\n\n    • Female sterilization\n\n    • Fallopian tube implants (if confirmed by hysterosalpingogram) Oocyte donation is prohibited during the duration of participation on this protocol and for 1 month after the last dose of study drug.\n\n    Subjects who are not of reproductive potential (women who are premenarche or have been post-menopausal for at least 24 consecutive months which is non-therapy induced or have undergone hysterectomy tubal ligation, salpingectomy, and\u002For bilateral oophorectomy or men who have documented azoospermia) are eligible without requiring the use of contraception.","81 Years",{"count":89,"type":21},[91],"This is a phase I, interventional, single arm, open label, treatment study designed to evaluate the safety and efficacy of LV20.19 CAR -T cells with pirtobrutinib bridging and maintenance in adult patients with B cell malignancies that have failed prior therapies.",[210,211,212,213,214,215],"Non Hodgkin Lymphoma","Diffuse Large B Cell Lymphoma","Follicular Lymphoma","Marginal Zone Lymphoma","Mantle Cell Lymphoma","Burkitt Lymphoma",[143,144,145,217,218,219,220],"Pirtobrutinib","B Cells","BTK inhibitor","Bruton's tyrosine kinase",{"date":99,"type":45},{"date":223,"type":45},"2025-02-06",{"date":225,"type":21},"2030-07",{"name":51,"class":52},{"id":228,"slug":229,"hasResults":12,"nctId":230,"briefTitle":231,"officialTitle":231,"acronym":4,"eligibilityCriteria":232,"healthyVolunteers":12,"sex":17,"minAge":61,"maxAge":4,"enrollmentInfo":233,"targetDuration":4,"studyType":22,"phases":234,"briefSummary":235,"conditions":236,"keywords":237,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":53},"100524265","impact-of-intermittent-fasting-on-biomarkers-of-inflammation-and-health-related-quality-of-life-a-feasibility-trial-for-women-with-hrher2--early-breast-cancer-100524265","NCT06106477","Impact of Intermittent Fasting on Biomarkers of Inflammation and Health-Related Quality of Life: A Feasibility Trial for Women With HR+\u002FHER2- Early Breast Cancer","Inclusion Criteria:\n\n1. Breast cancer patients ≥ 18 years old who are willing to consent to an approximately 14-hour nighttime fasting period and an approximately 10-hour daytime eating period.\n2. Histologically and\u002For cytologically confirmed diagnosis of estrogen receptor (ER) positive (ER+) and human epidermal growth factor receptor (HER) 2 negative (HER2-) localized breast cancer (stages I-III).\n\n   1. Progesterone receptor positive or negative patients are allowed.\n   2. Hormone receptor positivity is defined as ER positivity in at least 1% cells by immunohistochemistry (IHC). HER 2-negative breast cancer is defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization fluorescence in situ hybridisation (FISH), chromogenic in situ hybridization (CISH), or silver-enhanced in situ hybridization (SISH) test is required.\n3. Body mass index (BMI) ≥ 25.\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.\n5. Subject must be willing to start the intermittent fasting (IF) intervention within three months of starting adjuvant endocrine therapy (AET), or at the discretion of the treating providers, and within 30 days of study enrollment.\n6. Subjects who received neoadjuvant or adjuvant chemotherapy must have recovered completely from chemotherapy-related side effects such as nausea\u002Femesis as determined by the treating providers.\n7. Subjects who received neoadjuvant endocrine therapy are eligible only after completion of their definitive surgery (i.e., when ready to start adjuvant endocrine therapy) and treating provider ensures complete closure and healing of surgical incisions.\n8. Subjects who had adjuvant systemic chemotherapy within two to four weeks prior to starting the IF intervention are eligible if they have recovered from acute effects of prior therapy to near baseline as determined by the treating physician.\n9. Subjects on a targeted therapy, such as cyclin-dependent kinase (CDK) 4\u002F6 inhibitor, or selective estrogen receptor degrader (SERD), or other clinical trial participants in the adjuvant setting are eligible at the discretion of the treating physician.\n10. Subject co-administered with any prescriptions that may cause dizziness, hypoglycemia, or hypotension need to be evaluated and deemed eligible by the treating physician.\n11. Adequate hepatic, renal function and adequate bone marrow reserve as determined by the treating physician:\n\n    1. aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 × institutional upper limit.\n    2. Total bilirubin ≤ 1.5 × upper limit of normal (ULN), except for subjects with Gilbert's syndrome who may be included if their total bilirubin is ≤ 3.0 × ULN and direct bilirubin ≤ 1.5 × ULN.\n    3. alkaline phosphatase (ALP) ≤ 2.5 × institutional upper limit with exception that ALP of \\\u003C 5 × ULN is acceptable in patients with elevated with ALP due to bone metastases (in the absence of liver metastases).\n    4. Serum creatinine \\\u003C1.5 × ULN.\n    5. Absolute neutrophil count (ANC) ≥1000\u002FµL.\n    6. Subjects with lymphopenia are eligible at the discretion of the treating provider.\n\n    i. Hemoglobin (Hb) ≥ 8g\u002FdL. ii. Platelet count ≥ 100,000\u002FµL.\n12. Premenopausal woman:\n\n    1. Premenopausal is defined as someone who has had menses at any time in the last 12 months. For premenopausal women who are eligible for this trial, the treating physician may choose to monitor ovarian function with laboratory tests e.g., follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol as clinically indicated to assess their menopausal status.\n    2. Subjects must agree not to conceive throughout the study and must use accepted methods of contraception.\n    3. Women of childbearing potential must have a negative pregnancy test within seven days of registration and or seven to 10 days prior to starting study treatment.\n13. Subjects who have an atypical sleep-wake schedule or different eating schedules are eligible at the discretion of the study investigators and dietitians as long as they agree to nightly fasting.\n14. Ability to understand a written informed consent document, and the willingness to sign it.\n\nExclusion Criteria:\n\n1. Subject who works late night shifts.\n2. Subject that was or currently on a fasting diet (e.g., Keto diets), intervention, or an agent (e.g., Ozempic) for the explicit purpose of inducing weight loss in the past one year.\n3. Subject with a history of an eating disorder (e.g., anorexia nervosa, bulimia nervosa).\n4. Presence of diabetes.\n5. Presence of chronic dizziness or vertigo.\n6. Presence of endocrine disorders prone to fluctuations in blood sugar (e.g., multiple neuroendocrine disorders, adrenal disorders, chronic hypoglycemia).\n7. Poorly controlled neurological disorders as determined by the treating physician (e.g., epilepsy, Parkinson's disease, myasthenia gravis, syncope, pre-syncopal episodes).\n8. Poorly controlled co-existing cardiac disease as determined by the treating physician, such as chronic hypotension, symptomatic congestive heart failure (New York Heart Association III-IV), unstable angina, arrythmia (e.g., atrial fibrillation, bradycardia, tachycardia).\n9. History of heavy alcohol use as determined by the treating physician.\n10. History of liver disease (cirrhosis, active hepatitis) or chronic renal disease.\n11. Untreated or active infections such as hepatitis, human immunodeficiency virus (HIV), chronic unhealed infections.\n12. Clinically significant illness or systemic disease as determined by the treating physician.\n13. Recent hospitalization for a major illness, as determined by the treating physicians, within one month of enrollment.\n14. Subject who is pregnant or breastfeeding. Subjects who become pregnant while on the study will be excluded.",{"count":63,"type":21},[24],"This single-arm study is designed to test the hypothesis that a six-month intermittent fasting (IF) intervention is feasible for patients to adhere to and improves health-related quality of life while subjects are on adjuvant endocrine therapy (AET).",[27],[238,239,240,241,242,243,244,245,246,247,248],"intermittent fasting","obesity","overweight","breast cancer","hormone receptor positive","HER2-negative","human epidermal growth factor receptor 2-negative","HR-positive","HR+\u002FHER2-","early breast cancer","adjuvant endocrine therapy","2026-08-03",{"date":170,"type":45},{"date":252,"type":45},"2024-07-19",{"date":254,"type":21},"2027-07-15",{"name":51,"class":52},{"id":257,"slug":258,"hasResults":12,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":4,"eligibilityCriteria":262,"healthyVolunteers":12,"sex":17,"minAge":61,"maxAge":4,"enrollmentInfo":263,"targetDuration":4,"studyType":265,"phases":4,"briefSummary":266,"conditions":267,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":269,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":53},"100431033","social-relationships-and-accelerated-aging-in-hematopoietic-cell-transplant-survivors-100431033","NCT04892823","Social Relationships and Accelerated Aging in Hematopoietic Cell Transplant Survivors","Accelerated Biological and Phenotypic Aging in Hematopoietic Cell Transplant Survivors: Social Support as a Protective Factor","Inclusion Criteria:\n\n* Aged 18 years and older who are competent to give their informed consent.\n* Ability to read, speak, and understand English.\n* Received a hematopoietic cell transplant within the previous 100 days.\n\nExclusion Criteria:\n\n* Less then Aged 18 years and older who are competent to give their informed consent.\n* Cannot read, speak, and understand English.\n* Has not received a hematopoietic cell transplant within the previous 100 days.",{"count":264,"type":21},110,"OBSERVATIONAL","This project aims to elucidate the important protective elements of social relationships and identify concrete, modifiable behavioral factors that contribute to biological and phenotypic aging in hematopoietic cell transplantation (HCT) survivors and can be used to develop biologically informed interventions to improve quality of life and prolong the healthspan of individuals with accelerated aging.",[268],"Hematopoietic and Lymphoid Cell Neoplasm",{"date":170,"type":45},{"date":271,"type":45},"2021-05-18",{"date":273,"type":21},"2027-07-16",{"name":51,"class":52},{"id":276,"slug":277,"hasResults":12,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":4,"eligibilityCriteria":281,"healthyVolunteers":282,"sex":17,"minAge":61,"maxAge":4,"enrollmentInfo":283,"targetDuration":4,"studyType":265,"phases":4,"briefSummary":285,"conditions":286,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":296},"100601948","blinatumomab-consolidation-in-real-world-100601948","NCT07117136","Blinatumomab Consolidation in Real World","Real World Outcomes of Blinatumomab Consolidation in Patients With B-cell Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n* 1\\) aged 18 years or older 2) diagnosed with B-ALL on or after December 1st 2022 3) Not received blinatumomab in an interventional clinical trial setting 4) Willing and able to give informed consent (or retrospective data for deceased patients\n\nExclusion Criteria:\n\n* N\u002FA",true,{"count":284,"type":21},200,"This will be a multi-center registry for patients with B-ALL. Patient data will be collected both retrospectively and prospectively. The data forms and surveys will be built and managed through REDCap, a secure web application managed by the Clinical \\& Translational Science Institute.",[287],"B-Cell Acute Lymphoblastic Leukaemia","2026-07-30",{"date":290,"type":45},"2026-07-31",{"date":292,"type":45},"2025-08-28",{"date":294,"type":21},"2029-05-14",{"name":51,"class":52},3,{"id":298,"slug":299,"hasResults":12,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":4,"eligibilityCriteria":303,"healthyVolunteers":12,"sex":17,"minAge":61,"maxAge":4,"enrollmentInfo":304,"targetDuration":4,"studyType":265,"phases":4,"briefSummary":305,"conditions":306,"keywords":309,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":311,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":53},"100559156","continuous-glucose-monitoring-and-ogtt-screen-for-cystic-fibrosis-related-diabetes-in-cystic-fibrosis-100559156","NCT06560463","Continuous Glucose Monitoring and OGTT Screen for Cystic Fibrosis Related Diabetes in Cystic Fibrosis","Comparison of Continous Glucose Monitor and OGTT as a Screen for Cystic Fibrosis Related Diabetes and Impaired Glucose Tolerance","Inclusion Criteria:\n\n1. An adult patient, diagnosed with CF, established with Froedtert Multidisciplinary CF Clinic.\n2. Normal glucose tolerance or impaired glucose tolerance per OGTT completed in 2024.\n3. At healthy baseline status at time of CGM wear and OGTT.\n\nExclusion Criteria:\n\n1. Diagnosed with CFRD and treating with diabetogenic medications.\n2. s\u002Fp transplant\n3. pregnancy\n4. failure to wear CGM for entirety of 10 days",{"count":138,"type":21},"Cystic Fibrosis (CF) related diabetes (CFRD) is a unique form of diabetes mellitus, different from type 1 diabetes and type 2 diabetes. The diagnosis of CFRD is associated with a decline in pulmonary function, decreased nutritional status, and increased mortality. CFRD is extremely common in people with CF, occurring in approximately 40-50% of adults with CF. Impaired glucose tolerance or dysglycemia is also very common in CF. It is standard of care to screen for CFRD annually from the age of 10 years with a two-hour Oral Glucose Tolerance Test (OGTT) with 75 g dextrose. The gold standard screening for CFRD is the OGTT which is problematic as it is time consuming for patient and staff and adherence to annual screening is low among CF centers.\n\nSurvival has improved dramatically with the advent of CFTR modulators and it is presumed that the incidence of CFRD will increase with increased life expectancy. The Cystic Fibrosis Foundation (CFF) has developed the oldest disease specific patient registry, consisting of approximately 35000 patients, so there is vast historical information available on individual patients and larger datasets on the CF community as a whole. Based on the 2021 CFF patient registry data, the current life expectancy for CF patients born between 2017 and 2021 is 53 years - a 15 year increase from a decade ago.",[307,308],"Cystic Fibrosis-related Diabetes","Cystic Fibrosis",[310],"cystic fibrosis",{"date":290,"type":45},{"date":313,"type":45},"2025-01-13",{"date":315,"type":21},"2027-09-30",{"name":51,"class":52},{"id":318,"slug":319,"hasResults":12,"nctId":320,"briefTitle":321,"officialTitle":322,"acronym":4,"eligibilityCriteria":323,"healthyVolunteers":12,"sex":17,"minAge":324,"maxAge":325,"enrollmentInfo":326,"targetDuration":4,"studyType":22,"phases":328,"briefSummary":329,"conditions":330,"keywords":332,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":53},"100649855","mechanisms-underlying-late-life-prolonged-grief-disorder-100649855","NCT07738133","Mechanisms Underlying Late-Life Prolonged Grief Disorder","Probing Brain Network Mechanisms Underlying Late-Life Prolonged Grief Disorder","Inclusion Criteria:\n\n* Male or female greater than or equal to 40 years of age\n* Bereavement \\>6 months\n* Score greater than or equal to 25 on the Inventory of Complicated Grief (ICG)\n* Presence of PGD (subsyndromal and syndromal)\n* Adequate visual and auditory acuity\n\nExclusion Criteria:\n\n* Delirium\u002Funstable medical conditions\n* Lifetime history of neurological illnesses: seizures, stroke, dementia of any -etiology, severe head injury, brain tumor or surgery\n* Serious back, joint or neck injuries within the past 3 months\n* Currently practicing yoga\n* Gross structural abnormalities on T1-weighted images\n* Lifetime history of the following psychiatric disorders: bipolar or psychotic -disorders, including psychotic depression\n* Current alcohol\u002Fdrug abuse or dependence\n* Magnetic resonance imaging (MRI) contraindications\n* Acute suicidality","40 Years","89 Years",{"count":327,"type":21},126,[24],"After losing a loved one, most successfully navigate acute grief and adapt to the loss within about 1 year, but in about 10%, prolonged grief disorder (PGD) ensues. This study is anticipated to provide novel evidence regarding the neurobiological mechanisms of PGD in older adults. The biological alterations identified here could provide targets to elucidate how currently available therapies work and inform novel mechanism-based interventions for treating late-life PGD.",[331],"Prolonged Grief Disorder",[333,334,335],"Grief","Yoga","Health Education","2026-07-28",{"date":290,"type":45},{"date":339,"type":21},"2027-01",{"date":341,"type":21},"2031-06",{"name":51,"class":52},{"id":344,"slug":345,"hasResults":12,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":4,"eligibilityCriteria":349,"healthyVolunteers":282,"sex":17,"minAge":61,"maxAge":350,"enrollmentInfo":351,"targetDuration":4,"studyType":22,"phases":352,"briefSummary":353,"conditions":354,"keywords":357,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":362,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":368,"locationsCount":53},"100391341","transcranial-alternating-current-stimulation-tacs-in-aphasia-100391341","NCT04375722","Transcranial Alternating Current Stimulation (tACS) in Aphasia","Exogenous Tuning of Neural Oscillations as a Mode of Treatment in Post-stroke Aphasia","Inclusion Criteria:\n\nHealthy Controls\n\n* 18 years of age or older\n* Fluent in English\n* No history of neurological or psychiatric disorders\n\nStroke Patients\n\n* Diagnosed with post-stroke aphasia by referring physician\u002Fneuropsychologist\n* Consent date \\>=1 months after stroke onset\n* Right-handed\n* Fluent in English\n* 18 years of age or older\n\nExclusion Criteria:\n\n* Severe cognitive, auditory or visual impairments that would preclude cognitive and language testing\n* Presence of major untreated or unstable psychiatric disease\n* A chronic medical condition that is not treated or is unstable\n* The presence of cardiac stimulators or pacemakers\n* Any metal implants in the skull\n* Contraindications to MRI or tACS\n* History of seizures\n* History of dyslexia or other developmental learning disabilities","85 Years",{"count":20,"type":21},[24],"This study will assess the effects of transcranial alternating current stimulation (tACS) on language recovery after stroke as well as healthy language functions.",[355,356],"Aphasia","Stroke",[358,359,360,361],"language","language impairment","transcranial alternating current stimulation","tACS",{"date":363,"type":45},"2026-07-29",{"date":365,"type":45},"2020-01-04",{"date":367,"type":21},"2030-12",{"name":51,"class":52},{"id":370,"slug":371,"hasResults":12,"nctId":372,"briefTitle":373,"officialTitle":373,"acronym":4,"eligibilityCriteria":374,"healthyVolunteers":12,"sex":17,"minAge":61,"maxAge":4,"enrollmentInfo":375,"targetDuration":4,"studyType":22,"phases":376,"briefSummary":377,"conditions":378,"keywords":382,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":389,"lastUpdatePostDateStruct":390,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":395,"locationsCount":53},"100585785","phase-2-pulso-trial-pulsed-low-dose-rate-pldr-radiation-chemoradiation-crt-vs-standard-crt-for-esophageal-cancer-100585785","NCT06906887","PULSO Trial: Pulsed Low-Dose-Rate (PLDR) Radiation Chemoradiation (CRT) vs. Standard CRT for Esophageal Cancer","Inclusion Criteria:\n\nA potential study subject who meets all of the following inclusion criteria is eligible to participate in the study.\n\n1. Age ≥ 18 years.\n2. Stage II-IVb adenocarcinoma of the esophagus (if IVb, oligometastatic only, felt to be eligible for definitive dose CRT treatment by treating physician).\n3. Currently receiving or have received induction chemotherapy and planned for definitive dose chemoradiation (+\u002F- esophagectomy).\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n5. Adequate hematologic function within 30 days prior to registration defined as follows:\n\n   1. Absolute Neutrophil Count ≥ 1,500\u002Fmcg\n   2. Hemoglobin ≥ 8 gm\u002FdL\n   3. Platelets ≥ 100,000\u002FmcL.\n6. Adequate renal function within 30 days prior to registration, defined as a creatinine clearance of ≥ 50 ml\u002Fmin as calculated by the Cockcroft-Gault equation.\n7. Adequate hepatic function within 30 days prior to registration, defined as total bilirubin ≤ 1.5 x ULN\n\n   a. Note: patients with known Gilbert Syndrome can have a total bilirubin \\\u003C 2.5 x upper limit of normal (ULN).\n8. Female patients \\\u003C65 years of age and of childbearing potential must have a negative serum\u002Furine pregnancy test within 14 days prior to study entry. A female not of childbearing potential is one who has undergone a hysterectomy, bilateral oophorectomy, tubal ligation, or who has had no menses for 12 consecutive months.\n9. Patients of reproductive potential must agree to use effective contraception for the duration of study treatment. Effective contraception includes oral contraceptives, implantable hormonal contraception, double-barrier method, or intrauterine device.\n10. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n11. Ability to understand a written informed consent document, and the willingness to sign it.\n\nExclusion Criteria:\n\nA potential study subject who meets any of the following exclusion criteria is ineligible to participate in the study.\n\n1. Age \\\u003C 18 years.\n2. Extensive distant metastatic cancer, defined as \\>5 metastases.\n3. Recurrent esophageal cancer.\n\n   a. Note: prior or concurrent malignancies are allowed if they do not impact the study's primary endpoint (i.e., treatment-associated toxicity).\n4. Prior non-approved chemotherapy for the treatment of cancer.\n5. Prior radiotherapy to the region of the study cancer that would result in an overlap of radiation therapy fields.\n6. Women must not be pregnant or breast-feeding.",{"count":20,"type":21},[65],"This is a prospective, randomized, open-label, two-arm phase 2 trial that will evaluate whether the use of Pulsed Low-Dose-Rate radiation technique, as compared to standard radiation, is associated with reduced rates of clinically significant esophagitis during and following chemoradiation.",[379,380,381],"Esophageal Cancer","Oesophageal Cancer","GastroEsophageal Cancer",[383,384,385,386,379,380,381,387,388],"Pulsed Low-Dose-Rate Radiation","Chemoradiation","esophagitis","Esophagectomy","Pulsed reduced dose rate radiation","Pulsed radiation","2026-07-27",{"date":336,"type":45},{"date":392,"type":45},"2025-06-17",{"date":394,"type":21},"2032-06-01",{"name":51,"class":52},{"id":397,"slug":398,"hasResults":12,"nctId":399,"briefTitle":400,"officialTitle":401,"acronym":4,"eligibilityCriteria":402,"healthyVolunteers":12,"sex":17,"minAge":61,"maxAge":4,"enrollmentInfo":403,"targetDuration":4,"studyType":22,"phases":405,"briefSummary":406,"conditions":407,"keywords":409,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":389,"lastUpdatePostDateStruct":412,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":416,"locationsCount":417},"100442789","phase-2-optimizing-neurocognition-with-whole-brain-radiation-therapy-wbrt-using-upfront-pulsed-reduced-dose-rate-prdr-technique-100442789","NCT05045950","Optimizing Neurocognition With Whole Brain Radiation Therapy (WBRT) Using Upfront Pulsed Reduced Dose-Rate (PRDR) Technique","Optimizing Neurocognition With Whole Brain Radiation Therapy (WBRT) Using Upfront Pulsed Reduced Dose-Rate (PRDR) Technique (ONCO-RT) - A Phase II Trial of Upfront Pulsed Reduced Dose Rate Whole-Brain Radiation Therapy for Brain Metastases","Inclusion Criteria:\n\n1. Age ≥18 years at diagnosis of brain metastases.\n2. Eastern Cooperative Oncology Group (ECOG) Performance Score of \\\u003C2.\n3. Participants must have a biopsy-proven solid malignancy (histologic proof or unequivocal cytologic proof solid tumor malignancy from either the primary or any metastatic site) with intracranial lesions radiographically consistent with or pathologically proven to be brain metastases.\n4. Patients who have undergone prior systemic therapy are eligible.\n5. Life expectancy from extracranial disease greater than six months.\n6. Patients with measurable brain metastasis.\n7. Patients may have had prior therapy for brain metastasis, including stereotactic radiosurgery (SRS)and surgical resection. Patients must have completed prior therapy by at least 7 days prior to study enrollment for SRS and at least 14 days for surgical resection\n8. If an open biopsy is performed, the patient must be at least one-week post-biopsy. This requirement is not necessary for stereotactic biopsies.\n9. Creatinine clearance is ≥ 30 mL\u002Fmin.\n10. Start of PRDR WBRT within two weeks following registration.\n11. Ability to complete the Neurocognitive Function (NCF) test battery (including people whose primary language is English).\n12. Patients with previous or other malignancies whose disease is controlled and not impacting ECOG performance or life expectancy.\n13. Willing and able to give consent and to comply with treatment and follow-up schedule.\n\nExclusion Criteria:\n\n1. Metastases from hematological malignancy, or central nervous system malignancy.\n2. Patients whose malignancy is being treated with curative intent.\n3. Leptomeningeal metastases.\n4. Contraindication to MRI imaging with contrast.\n5. Contraindication to memantine including concurrent use of N-methyl-D-aspartate (NMDA) antagonists.\n6. Stage IV-V chronic kidney disease or end-stage renal disease.\n7. Participants with a maximum tumor diameter exceeding 5 cm (if not resected).\n8. Prior cranial whole brain radiation therapy.\n9. Past medical history of dementia which is thought to be unrelated to the brain metastases.\n10. Women of childbearing potential who are known to be pregnant or are unwilling to use an acceptable method of contraception from the time of informed consent until completion of the course of radiotherapy.\n11. Patients must not have a serious medical or psychiatric illness that would, in the opinion of the treating physician, prevent informed consent or completion of protocol treatment, and\u002For follow-up visits.\n12. Non-native English speakers will be excluded since patients often lose their faculty with the language they acquired second before their native language is affected in the context of cognitive decline. This could adversely affect performance on verbal cognitive tasks.",{"count":404,"type":21},53,[65],"Study patients will receive Whole-brain radiation therapy (WBRT) - pulsed reduced dose rate (PRDR) within 14 days of registration. All patients will receive single daily fractions using 3D conformal radiotherapy. A dose of 30 Gy in 10 fractions will be delivered using the PRDR technique.",[408],"Brain Metastases",[410,411],"whole-brain radiation therapy","upfront pulsed reduced dose-rate",{"date":363,"type":45},{"date":414,"type":45},"2021-11-17",{"date":150,"type":21},{"name":51,"class":52},2,{"id":419,"slug":420,"hasResults":12,"nctId":421,"briefTitle":422,"officialTitle":423,"acronym":4,"eligibilityCriteria":424,"healthyVolunteers":12,"sex":17,"minAge":61,"maxAge":4,"enrollmentInfo":425,"targetDuration":4,"studyType":22,"phases":427,"briefSummary":428,"conditions":429,"keywords":433,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":389,"lastUpdatePostDateStruct":436,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":441,"locationsCount":442},"100365588","phase-2-abemaciclib-for-bone-and-soft-tissue-sarcoma-with-cyclin-dependent-kinase-cdk-pathway-alteration-100365588","NCT04040205","Abemaciclib for Bone and Soft Tissue Sarcoma With Cyclin-Dependent Kinase (CDK) Pathway Alteration","Abemaciclib for Treatment of Advanced Bone and Soft Tissue Sarcoma Identified as Having CDK Pathway Alteration","Inclusion Criteria:\n\n1. Diagnosis of soft tissue sarcoma or conventional chondrosarcoma, dedifferentiated chondrosarcoma, chordoma, or osteosarcoma (see exclusion criteria below)\n2. Metastatic or locally advanced disease that is unresectable\n3. There is no limit to the number of prior therapies a subject may have had, but the following requirements must be met:\n\n   1. Conventional chondrosarcoma low-grade osteosarcoma, and chordoma: No requirements regarding prior therapy\n   2. Osteosarcoma (high-grade), Dedifferentiated chondrosarcoma: at least 1 prior anthracycline chemotherapy, alone or in combination, required either as adjuvant, neoadjuvant or in the metastatic setting. If anthracycline chemotherapy is contraindicated, alternative prior first line chemotherapy is acceptable.\n   3. Soft tissue sarcoma: at least 1 line of systemic therapy, unless the sarcoma subtype is one that is generally considered unresponsive to standard chemotherapy.\n4. Age ≥ 18 years.\n5. Provide study specific (step 1) informed consent prior to study entry\n6. Documented CDK pathway abnormality on a commercially available mutation profiling test (Foundation, Tempus xT, etc), if performed previously as part of routine\u002Fstandard care on tumor (metastatic or primary), having at least one of the following (a and\u002For b)\n\n   1. Cyclin D1 (CCND1), cyclin D2 (CCND2), cyclin D3 (CCND3), cyclin dependent kinase 4 (CDK4), and\u002For cyclin dependent kinase 6 (CDK6) amplification\u002Fcopy number gain\n   2. Cyclin Dependent Kinase Inhibitor 2A (CDKN2A) or CDKN2B copy number loss\n7. Provide study-specific (step 2) informed consent\n8. Rb positive confirmed by immunohistochemistry testing of archived tumor tissue specimen (metastatic or primary site) performed centrally at Medical College of Wisconsin Precision Medicine Laboratory.\n9. All subjects must have measurable disease as defined by RECIST 1.1. (See RECIST 1.1 criteria in Appendix 10.\n10. Subjects must also have had evidence of disease progression by RECIST 1.1 within 6 months of enrollment, or newly diagnosed within the last 6 months (refer to step 1 criteria regarding previous lines of therapy).\n11. A washout period of at least 21 days is required between last chemotherapy dose and enrollment.\n12. A washout period of at least 14 days is required between end of radiotherapy and enrollment.\n13. At least 14 days after surgery, and absence of significant wound healing issues that would pose infection risk.\n14. Subjects with brain metastasis that have been treated with definitive surgery or radiation and have been clinically stable for 3 months are eligible.\n15. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n16. Adequate organ and marrow function as defined below (ULN indicates institutional upper limit of normal):\n\n    * Hemoglobin ≥ 8.0 g\u002FdL\n\n      a. Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion.\n    * Platelets ≥ 100 x 10\\^9\u002FL\n    * Total bilirubin ≤ 1.5 x ULN\n\n      a. Patients with Gilbert's syndrome with a total bilirubin ≤2.0 times ULN and direct bilirubin within normal limits are permitted.\n    * Aspartate aminotransferase (AST)(SGOT)\u002Falanine aminotransferase (ALT)(SGPT) ≤ 3 x institutional ULN\n    * Renal function (at least one of the following): Estimated Creatinine Clearance (CrCl) ≥ 30 mL\u002Fmin (Cockcroft-Gault), estimated glomerular filtration rate (eGFR) ≥ 30 mL\u002Fmin\u002F1.73 m\\^2 (MDRD or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula), or actual CrCl as determined by 24-hour urine collection\n17. Female subjects must meet one of the following:\n\n    * Postmenopausal for at least one year before enrollment, OR\n    * Surgically sterile (i.e. undergone a hysterectomy or bilateral oophorectomy), OR\n    * If subject is of childbearing potential (defined as not satisfying either of the above two criteria), must have a negative serum pregnancy test within 21 days of step 2 enrollment AND\n\n      * Agree to practice two acceptable methods of contraception (combination methods requires use of two of the following: diaphragm with spermicide, cervical cap with spermicide, contraceptive sponge, male or female condom with spermicidal agent added, hormonal contraceptive) from the time of signing of the informed consent form through 90 days after the last dose of study agent, OR\n      * Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \\[e.g., calendar, ovulation, symptothermal, postovulation methods\\] and withdrawal are not acceptable contraception methods.)\n18. Male subjects, even if surgically sterilized (i.e., status post vasectomy), must agree to one of the following:\n\n    * Practice effective barrier contraception during the entire study period and through 60 calendar days after the last dose of study agent, OR\n    * Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \\[e.g., calendar, ovulation, symptothermal, post ovulation methods\\] and withdrawal are not acceptable methods of contraception.)\n19. Subjects must be deemed able to comply with the study plan by the local PI.\n20. Ability to swallow oral medications\n\nExclusion Criteria:\n\n1. Diagnosis of well differentiated (WD) or dedifferentiated (DD) liposarcoma\n2. Prior treatment with a specific CDK 4 or CDK 6 inhibitor - (such as palbociclib, abemaciclib, or ribociclib).\n3. Subjects who have not recovered (Common Terminology Criteria for Adverse Events \\[CTCAE v5.0\\] Grade ≤1) from the acute effects of chemotherapy (except for residual alopecia or Grade 2 peripheral neuropathy) prior to enrollment, or other toxicity or serious preexisting medical condition(s) (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea) that in the opinion of the site PI is expected to preclude participation in this study.\n4. Subjects currently receiving any other investigational agents.\n5. Current ongoing treatment with strong Cytochrome P450, family 3, subfamily A (CYP3A) inducers or inhibitors.\n6. Uncontrolled intercurrent illness including, but not limited to, known ongoing or active bacterial infection (requiring IV antibiotics), fungal infection, detectable viral infection (such as known HIV or active hepatitis B or C) (screening tests is not required for enrollment), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (specifically, atrial fibrillation or ventricular dysrhythmias except ventricular premature contractions), or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n7. The subject has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.\n8. Pregnant women and women who are breast-feeding.\n9. Subjects must not have current evidence of another malignancy that requires treatment.\n10. Subjects who received treatment with live attenuated viruses within 30 days prior to eligibility confirmation or might receive the treatment through the duration of the trial.",{"count":426,"type":21},44,[65],"This is a single-arm, phase II study that will enroll a total of 45 subjects. All subjects will have a confirmed diagnosis of metastatic or unresectable soft tissue sarcoma or bone sarcoma. All subjects must have intact Rb, identified at the time of screening, by immunohistochemistry testing of submitted tumor specimen. Subjects will receive Abemaciclib 200 mg twice daily until progression or discontinuation criteria are met.",[430,431,432],"Chondrosarcoma","Osteosarcoma","Soft Tissue Sarcoma",[434,435,430,431,432],"Rb","Retinoblastoma",{"date":336,"type":45},{"date":438,"type":45},"2019-10-07",{"date":440,"type":21},"2027-06-01",{"name":51,"class":52},4,{"id":444,"slug":445,"hasResults":12,"nctId":446,"briefTitle":447,"officialTitle":447,"acronym":448,"eligibilityCriteria":449,"healthyVolunteers":12,"sex":17,"minAge":450,"maxAge":4,"enrollmentInfo":451,"targetDuration":4,"studyType":22,"phases":452,"briefSummary":453,"conditions":454,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":458,"lastUpdatePostDateStruct":459,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":464,"locationsCount":4},"100649405","voice-activated-and-touchscreen-controlled-smart-speaker-intervention-for-older-adults-with-poorly-controlled-type-2-diabetes-100649405","NCT07734259","Voice-activated and Touchscreen-controlled Smart Speaker Intervention for Older Adults With Poorly Controlled Type 2 Diabetes","VATC-SS","Inclusion Criteria:\n\n* 1\\) Aged 50 and older; 2) clinical diagnosis of poorly controlled type 2 diabetes, defined as HbA1C greater than or equal to 8% at the screening visit; 3) willing to install and use the VATC-SS for the 3 months of the study.\n\nExclusion Criteria:\n\n* 1\\) Mental confusion at screening assessment suggesting significant dementia; 2) alcohol or drug abuse\u002Fdependency at screening assessment; 3) active psychosis or acute mental disorder at screening assessment.","50 Years",{"count":138,"type":21},[24],"This is a pre-post pilot study that will test the feasibility and acceptability of a health educator delivered diabetes education and skills training intervention using a voice-activated, touch screen controlled, smart speaker. We will enroll 30 adults aged 50 and older with poorly controlled type 2 diabetes as defined by a hemoglobin A1C of 8% in the study.",[455,456,457],"Diabetes","Diabetes (DM)","Type 2 Diabetes","2026-07-24",{"date":363,"type":45},{"date":461,"type":21},"2026-09-01",{"date":463,"type":21},"2028-03-30",{"name":51,"class":52},{"id":466,"slug":467,"hasResults":12,"nctId":468,"briefTitle":469,"officialTitle":470,"acronym":4,"eligibilityCriteria":471,"healthyVolunteers":282,"sex":17,"minAge":61,"maxAge":4,"enrollmentInfo":472,"targetDuration":473,"studyType":265,"phases":4,"briefSummary":474,"conditions":475,"keywords":478,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":458,"lastUpdatePostDateStruct":481,"startDateStruct":482,"completionDateStruct":484,"leadSponsor":486,"locationsCount":53},"100610432","utility-of-mucosal-impedance-device-in-chronic-esophageal-disorders-100610432","NCT07227506","Utility of Mucosal Impedance Device in Chronic Esophageal Disorders:","Diagnostic Utility of Mucosal Impedance Device in Patients With GERD and Chronic Esophageal Disorders:","Inclusion Criteria:\n\n1\\. Patients with chronic esophageal symptoms such as atypical or typical reflux symptoms and dysphagia, is here for upper endoscopy testing.\n\nExclusion Criteria:\n\n1. Presence of esophageal stricture\n2. Unstable patients who cannot undergo this testing.\n3. Patients on anticoagulation on the day of procedure.\n4. Presence of esophageal cancer.\n5. Pregnancy.\n6. Minor patients.",{"count":20,"type":21},"1 Year","Background \\& Significance Chronic benign esophageal disorders such as Gastroesophageal reflux disease (GERD) and eosinophilic esophagitis are common gastrointestinal disorders affecting nearly 20% and 0.1% of the population, respectively. Although these conditions are frequent, the diagnosis of GERD or EoE requires complex decision making involving endoscopic examination, histopathological examination, and esophageal pH testing. This translates into significant economic burden; For example, burden due to GERD is about $24 billion annually. Additionally, there may be a delay in the diagnosis of GERD or EoE as Investigators might have to do multiple procedures such as upper endoscopy, esophageal pH testing, etc for the same participant for confirmation of the diagnosis. In addition, there could be overlay between GERD and EoE in the diagnosis which make cause delay in the diagnosis and decision making.\n\nAim:\n\nHere, Investigators will plan to identify the diagnostic utility and cost-effectiveness of this novel Mivu device(FDA approved) in the diagnosis of gastroesophageal reflux disease or chronic esophageal inflammatory disorders in participants with reflux symptoms or chronic esophageal symptoms.",[476,477],"Gerd","Eosinophilic Esophagitis",[479,480],"gerd","eosinophilic esophagitis",{"date":389,"type":45},{"date":483,"type":45},"2025-11-20",{"date":485,"type":21},"2028-07-01",{"name":51,"class":52},{"id":488,"slug":489,"hasResults":12,"nctId":490,"briefTitle":491,"officialTitle":491,"acronym":492,"eligibilityCriteria":493,"healthyVolunteers":12,"sex":17,"minAge":61,"maxAge":4,"enrollmentInfo":494,"targetDuration":4,"studyType":22,"phases":496,"briefSummary":497,"conditions":498,"keywords":500,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":502,"lastUpdatePostDateStruct":503,"startDateStruct":505,"completionDateStruct":507,"leadSponsor":509,"locationsCount":417},"100611124","moving-forward-with-myeloma-a-lifestyle-intervention-for-individuals-with-multiple-myeloma-100611124","NCT07236502","Moving Forward With Myeloma: A Lifestyle Intervention for Individuals With Multiple Myeloma","MFM","Inclusion Criteria:\n\n1. Adult (≥ 18 years)\n2. Diagnosed with MM at least one year prior to study enrollment\n3. Has access to a cell phone\n4. Be deemed \"clinically stable\" by their physician guided by the following:\n\n   1. no near-term changes in planned myeloma-directed therapy anticipated. (e.g., patient who is 3 months from autologous stem cell transplant just starting on maintenance lenalidomide is eligible since maintenance is planned therapy following transplant)\n   2. no new significant myeloma symptoms (e.g., fractures) meriting changes in anti-neoplastic therapies; AND\n   3. stable performance status (ECOG 0-2)\n5. No reports of severe pain \\> Grade 3 \\[defined by the NCI CTCAE as tumor, neurologic, bone, or other pain interfering with self-care ADLs (bathing, dressing, toileting, continence, feeding)\\].\n6. Able to participate in moderate PA and strength training per clinician approval and confirmed by participant\n7. Able to understand and willing to sign a written informed consent document\n8. English proficient for reading and writing\n\nExclusion Criteria:\n\n1. Individuals with \\\u003C6 months of life anticipated, coexistent amyloidosis, and\u002For receiving appetite stimulants will not be approached\n2. Fully adherent to the ACS nutrition and physical activity guidelines\n3. Currently pregnant or lactating, or anticipating pregnancy\n4. On another interventional clinical trial that precludes co-enrollment\n5. Psychiatric or other clinical conditions that preclude study compliance\n6. Other important medical or safety considerations at the discretion of the investigator(s) and\u002For approving clinician",{"count":495,"type":21},184,[24],"The purpose of this project is to evaluate the impact of a 16-week lifestyle program that promotes changes in eating and exercise patterns. The main questions the study will answer are:\n\nDo improvements in eating and exercise patterns lead to improved physical function, quality of life and blood biomarkers of biologial aging among individuals with multiple myeloma? Participants will complete study activities 3-4 times during the study.\n\n1. In-person assessment to measure physical function, height\u002Fweight, body composition, and includes a blood draw\n2. Surveys completed online or on paper at home",[499],"Multiple Myeloma (MM)",[501],"Lifestyle Intervention","2026-07-20",{"date":504,"type":45},"2026-07-22",{"date":506,"type":45},"2026-01-30",{"date":508,"type":21},"2030-02-28",{"name":51,"class":52},{"id":511,"slug":512,"hasResults":12,"nctId":513,"briefTitle":514,"officialTitle":515,"acronym":516,"eligibilityCriteria":517,"healthyVolunteers":12,"sex":518,"minAge":61,"maxAge":4,"enrollmentInfo":519,"targetDuration":4,"studyType":22,"phases":521,"briefSummary":522,"conditions":523,"keywords":525,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":529,"lastUpdatePostDateStruct":530,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":535,"locationsCount":417},"100609719","mindfulness-and-wearable-biosensors-to-prevent-hypertensive-disorders-of-pregnancy-100609719","NCT07218237","Mindfulness and Wearable Biosensors to Prevent Hypertensive Disorders of Pregnancy","Mindfulness and Wearable Biosensors to Prevent Hypertensive Disorders of Pregnancy Study: MINDBP","MINDBP","Inclusion Criteria:\n\n* Pregnant patients at gestational age \\\u003C= 16 weeks\n* Live, non-anomalous gestation\n* Normotensive at enrollment\n* Meet criteria consistent with 'moderate' to 'high' risk for preeclampsia based on ACOG\u002FUSPSTF guidelines for low-dose aspirin administration to prevent hypertensive disorders of pregnancy\n\nExclusion Criteria:\n\n* Multiple gestation\n* Chronic (pregestational hypertension)\n* Inability of unwillingness to provide informed consent\n* Active suicidality or psychosis\n* Ongoing mind-body practice (e.g., yoga, meditation, mindfulness \\>= once per week)","FEMALE",{"count":520,"type":21},90,[24],"The MINDBP study will enroll 90 pregnant women at risk for HDP across two sites (MCW and Brown) and randomize them to: (1) mindfulness training (MT) plus wearable biosensors, (2) MT alone, or (3) routine prenatal care. MT participants will receive 8 weekly phone-based MT sessions plus two booster sessions at 1 and 2 months post-intervention. The primary outcome is study feasibility.",[524],"Preeclampsia",[526,527,528],"Hypertensive disorders of pregnancy","Mindfulness","Biofeedback","2026-07-16",{"date":502,"type":45},{"date":532,"type":45},"2026-04-28",{"date":534,"type":21},"2028-10",{"name":51,"class":52},{"id":537,"slug":538,"hasResults":12,"nctId":539,"briefTitle":540,"officialTitle":541,"acronym":542,"eligibilityCriteria":543,"healthyVolunteers":12,"sex":518,"minAge":61,"maxAge":4,"enrollmentInfo":544,"targetDuration":4,"studyType":22,"phases":546,"briefSummary":547,"conditions":548,"keywords":550,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":529,"lastUpdatePostDateStruct":554,"startDateStruct":555,"completionDateStruct":557,"leadSponsor":559,"locationsCount":417},"100607180","postpartum-preeclampsia-early-detection-and-treatment-nepal-pilot-study-100607180","NCT07185204","Postpartum Preeclampsia Early Detection and Treatment: Nepal Pilot Study","Postpartum Preeclampsia Early Detection and Treatment: Using Biomarkers to Implement Risk-stratified Intervention (Nepal Pilot Randomized Controlled Trial)","PREDiCT-NPL","Inclusion Criteria:\n\n* Pregnant patients ≥ 36 weeks gestation without major fetal anomalies\n* Age ≥ 18 years\n* Admitted for labor at Dhulikhel Hospital, or intend to deliver at Dhulikhel Hospital\n* At risk for preeclampsia, using the Clinical Risk Assessment for Preeclampsia according to ACOG and USPSTF\n\n  * 1 or more high risk factors:\n\n    * History of preeclampsia\n    * Type 1 or 2 diabetes\n    * Multifetal gestation?\n    * Renal disease\n    * Autoimmune disease\n  * 2 or more moderate risk factors:\n\n    * Nulliparity\n    * BMI \\> 30\n    * First-degree relative with a history of preeclampsia\n    * African American race\n    * Low socioeconomic status\n    * Age \\> 35 years\n    * History of low birthweight or small for gestational age\n    * Previous adverse pregnancy outcome\n    * Interpregnancy interval \\> 10 years\n\nExclusion Criteria:\n\n* Antenatal hypertensive disorder of pregnancy diagnosis, including gestational hypertension, preeclampsia, eclampsia, or HELLP syndrome, according to ACOG guidelines\n* Chronic hypertension, according to ACOG guidelines\n* Known allergy or contraindication to nifedipine\n* Inability or unwillingness to provide informed consent\n* Two or more blood pressures with an SBP ≥140 or DBP ≥90 after consent and prior to sFlt-1\u002FPlGF testing (screen failure criteria)",{"count":545,"type":21},60,[24],"The goal of this study is to address the significant morbidity associated with preeclampsia diagnosed after delivery. All participants will undergo biomarker evaluation with soluble fms-like tyrosine kinase-1 and placental growth factor (sFlt-1\u002FPlGF) ratio testing before delivery to assess the predictive ability of these biomarkers with new-onset postpartum preeclampsia. High-risk participants will be randomized to a bundle of care strategies aimed at early detection and management of postpartum preeclampsia.",[549],"Postpartum Preeclampsia",[524,551,552,553],"Hypertension","Pregnancy","Postpartum",{"date":502,"type":45},{"date":556,"type":45},"2026-03-03",{"date":558,"type":21},"2027-06",{"name":51,"class":52},{"id":561,"slug":562,"hasResults":12,"nctId":563,"briefTitle":564,"officialTitle":564,"acronym":565,"eligibilityCriteria":566,"healthyVolunteers":12,"sex":518,"minAge":61,"maxAge":4,"enrollmentInfo":567,"targetDuration":4,"studyType":22,"phases":569,"briefSummary":570,"conditions":571,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":529,"lastUpdatePostDateStruct":573,"startDateStruct":574,"completionDateStruct":576,"leadSponsor":578,"locationsCount":417},"100533046","reducing-the-risk-of-chronic-hypertension-and-improving-vascular-function-following-preeclampsia-100533046","NCT06220721","Reducing the Risk of Chronic Hypertension and Improving Vascular Function Following Preeclampsia","REPAIR","Inclusion Criteria:\n\n* Hypertensive disorders of pregnancy (HDP) diagnosis, specifically gestational hypertension, preeclampsia, eclampsia, or HELLP syndrome, according to ACOG guidelines\n* Postpartum day 0-4\n* Age ≥ 18 years\n* Able to communicate in English or in Spanish\n* Has an established OBGYN at an MCW or NU health system practice that has access to Epic electronic medical records.\n\nExclusion Criteria:\n\n* Pre-gestational hypertension\n* Type 1 or type 2 diabetes mellitus\n* Admitted to intensive care unit at the time of screening\n* Diagnosed with HDP during postpartum readmission after discharge from delivery hospitalization\n* Getting discharged on the day of screening\n* Known allergy or contraindication to nifedipine ER\n* Inability or unwillingness to provide informed consent\n* Already taking long-acting antihypertensive medication for standard care\n* Maternal conditions that impact study outcomes: sickle cell disease, systemic lupus erythematosus",{"count":568,"type":21},618,[24],"The long-term goal of our work is to evaluate the effect of intensive postpartum blood pressure control on maternal cardiovascular health, risk of chronic hypertension, and reversal of vascular dysfunction generated by hypertensive disorders of pregnancy, thus attenuating the lifelong trajectory of cardiovascular disease risk.",[572],"Hypertension, Pregnancy-Induced",{"date":502,"type":45},{"date":575,"type":45},"2024-10-23",{"date":577,"type":21},"2029-06-30",{"name":51,"class":52},{"id":580,"slug":581,"hasResults":12,"nctId":582,"briefTitle":583,"officialTitle":583,"acronym":584,"eligibilityCriteria":585,"healthyVolunteers":12,"sex":518,"minAge":61,"maxAge":18,"enrollmentInfo":586,"targetDuration":4,"studyType":22,"phases":588,"briefSummary":589,"conditions":590,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":529,"lastUpdatePostDateStruct":592,"startDateStruct":593,"completionDateStruct":595,"leadSponsor":597,"locationsCount":53},"100515606","building-trust-and-uniting-teams-through-doula-partnership---bundle-100515606","NCT05993689","Building TrUst and UNiting Teams Through DouLa partnErship - BUNDLE","BUNDLE","Inclusion Criteria:\n\n* Self-reported Black or African American\n* Pregnant with singleton gestation\n* Has an established OBGY at Froedtert \\& the Medical College of Wisconsin (F\\&MCW) Health System\n\nExclusion Criteria:\n\n* Planning to deliver outside of F\\&MCW Health System\n* Receiving support beyond routing prenatal care, such as group prenatal care or has their own doula\n* Inability or unwillingness to provide informed consent",{"count":587,"type":21},412,[24],"The BUNDLE study is a prospective mixed-methods study focused on the early integration of community doula into prenatal care. The study will have three phases: Phase 1 is the qualitative phase of conducting focus groups with Black\u002FAfrican American (AA) birthing people and with medical and community healthcare providers to elicit feedback on how best to integrate community-based doulas and obstetricians into one united model of prenatal care to promote trust and improved maternal health outcomes. Phase 2 tests the effectiveness of the newly developed model on healthcare engagement, trust, and adverse maternal outcomes using randomized control trial of 412 Black\u002FAA pregnant participants. Phase 3 is dissemination of BUNDLE findings in scholarly and community-based forums, including with healthcare leaders and policy makers in Wisconsin, advocating for doula coverage and health system sustainability of the integrated model.",[591],"Pregnancy Related",{"date":502,"type":45},{"date":594,"type":45},"2025-01-02",{"date":596,"type":21},"2030-06-30",{"name":51,"class":52},{"id":599,"slug":600,"hasResults":12,"nctId":601,"briefTitle":602,"officialTitle":603,"acronym":4,"eligibilityCriteria":604,"healthyVolunteers":12,"sex":17,"minAge":605,"maxAge":325,"enrollmentInfo":606,"targetDuration":4,"studyType":22,"phases":608,"briefSummary":609,"conditions":610,"keywords":613,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":616,"lastUpdatePostDateStruct":617,"startDateStruct":619,"completionDateStruct":621,"leadSponsor":623,"locationsCount":53},"100620251","hybrid-group-singing-100620251","NCT07355192","Hybrid Group Singing","Group Singing (Hybrid Format) or Solo Singing in Older Adults With Coronary Artery Disease: A Feasibility Study","Inclusion Criteria:\n\n* history of coronary artery disease (defined as having at least 1 of the following: myocardial infarction, coronary stent, PCI, CABG, coronary stenosis at least 50%, or coronary artery calcification score at least 300 Agatston units)\n\nExclusion Criteria:\n\n* Parkinson's disease or tremor\n* upper arm fistula\n* fingernail onychomycosis\n* pregnancy\n* current tobacco use\n* current illicit drug use\n* current excessive alcohol use (defined as more than 14 drinks\u002Fweek for women, more than 28 drinks\u002Fweek for men)\n* unstable CAD (active symptoms of chest discomfort)\n* supplemental oxygen use\n* more than mild cognitive impairment (as documented in the medical record by patient's treatment teams)\n* inability to follow study procedures\n* non-English speaking","55 Years",{"count":607,"type":21},32,[24],"The overall objective of the planned future clinical trial is to test the investigator's central hypothesis that habitual singing over several weeks, similar to habitual exercise, will lead to sustained and favorable vascular adaptation, thereby lowering cardiovascular disease (CVD) risk. The overall objective of this study is to refine and protocolize the singing interventions and test the feasibility of the future trial design. The investigative team has previously studied solo singing. Collective singing, as in a choir or small group, is associated with a positive sense of social inclusion, well-being, and improved mood, including in older adults.",[611,612],"Coronary Artery Disease","Elderly",[614,615],"group singing","individual singing","2026-07-09",{"date":618,"type":45},"2026-07-13",{"date":620,"type":45},"2026-05-11",{"date":622,"type":21},"2028-02",{"name":51,"class":52},""]