[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Kansas Medical Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":624},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,98,0,25,[9,41,72,101,124,156,182,209,229,254,278,300,323,351,368,391,415,441,463,483,507,527,552,579,598],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100652499","phase-1-early-cognitive-behavioral-therapy-for-insomnia-cbt-i-in-people-planning-to-under-hematopoietic-stem-cell-transplant-hsct-100652499",false,"NCT07774039","Early Cognitive Behavioral Therapy for Insomnia (CBT-I) in People Planning to Under Hematopoietic Stem Cell Transplant (HSCT)","Feasibility, Acceptability, and Preliminary Treatment Efficacy of Early Cognitive Behavioral Therapy for Insomnia (CBT-I) to Mitigate Insomnia Symptoms and Fatigue and Improve Health-related Quality of Life in Individuals Planning to Undergo Hematopoietic Stem Cell Transplant (HSCT)","Inclusion Criteria:\n\n* ≥18 years old\n* ≥10 on Insomnia Severity Index\n* Primary HSCT physician approval\n* English speaking\n\nExclusion Criteria:\n\n* Known untreated sleep disorder (such as sleep apnea or restless legs syndrome)\n* \\>3 on STOP BANG indicating increased risk of sleep apnea\n* Increased risk of Restless legs syndrome as determined by RLS-Diagnosis Index\n* Parasomnia as determined by the Sleep Disorders-Revised\n* If taking benzodiazepines, non-benzodiazepines, or melatonin supplements or agonists for insomnia, taking \\\u003C 3 months or dose has changed in past 3 months\n* T-score ≥70 on PROMIS 29+2 Anxiety or PROMIS 29+2 Depression domains indicating moderate\u002Fsevere anxiety or depression\n* Current or history (up to 2 years) of substance use disorder involving drugs or alcohol as defined by DSM-5-TR criteria\n* History of other nervous system disorder such as stroke or Parkinson's disease\n* Severe mental illness such as schizophrenia or bipolar disorder\n* Severe neurological or sensory impairments that would interfere significantly with testing\n* History of (within 5 years) or currently conducting overnight shift work including hours of midnight-4am\n* Currently receiving a behavioral sleep health intervention or other behavioral health interventions that may impact sleep (such as exercise, mindfulness, CBT)","ALL","18 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This proposed study is a prospective, randomized, controlled Phase 1 clinical trial to determine feasibility, acceptability (Aim 1) and preliminary effect (Aim 2) to mitigate insomnia symptoms and fatigue and improve health-related quality of life in patients who are planning to undergo HSCT. The investigators plan to enroll n=30 with insomnia symptoms (Insomnia Severity Index ≥10) who will be randomized into one of two groups: 1. A group that starts CBT-I after the initial evaluation visit with the HSCT care team (Early CBT-I), or 2. Treatment as usual (TAU). Participants in the CBT-I group will receive six sessions of telehealth-delivered CBT-I that is completed prior to transplant. Reassessments will occur post-intervention (\\~1-2 weeks before HSCT) and 1- and 3-months post-HSCT.",[27],"Hematopoietic Stem Cell Transplant","NOT_YET_RECRUITING","2026-08-14",{"date":31,"type":32},"2026-08-19","ACTUAL",{"date":34,"type":21},"2026-09-08",{"date":36,"type":21},"2027-06-30",{"name":38,"class":39},"University of Kansas Medical Center","OTHER",1,{"id":42,"slug":43,"hasResults":12,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":49,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":50,"targetDuration":52,"studyType":53,"phases":4,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100232367","triple-negative-breast-cancer-and-germline-hereditary-breast-and-ovarian-cancer-mutation-carrier-registry-100232367","NCT02302742","Triple Negative Breast Cancer and Germline Hereditary Breast and Ovarian Cancer Mutation Carrier Registry","PROspective Evaluation of GErmline Mutations, Cancer Outcome and Tissue Biomarkers: A Registry for Patients With Triple Negative Breast Cancer and Germline Mutations","PROGECT","Inclusion criteria include:\n\nTriple Negative Breast Cancer\n\n* ER\u002FPR \\\u003C10% and HER negative per current ASCO\u002FCAP guidelines\n* Stages I-IV\n* Any age at diagnosis\n* Patient must be within 5 years of diagnosis\n* Eligible regardless of genetic testing status\n* Genetic testing recommended for patients meeting NCCN and Medicare guidelines\n\nAND\u002FOR\n\nGermline mutation Carriers\n\n* Patients with deleterious or uncertain mutations in HBOC genes (BRCA, PTEN, P53, -PALB2 etc) are eligible regardless of type\u002Fsite of cancer\n* Healthy patients harboring mutations also eligible\n* There is no time limit from the time of diagnosis of cancer and enrollment.\n* Eligible regardless of personal history of cancer\n\nExclusion Criteria include:\n\nTriple Negative Breast Cancer -Patient is not within five years of diagnosis\n\nGermline mutation Carriers:\n\n-Patient only carries a HBOC mutation that is classified as \"polymorphism\" of \"favor polymorphism\"",true,{"count":51,"type":21},3000,"10 Years","OBSERVATIONAL","PROGECT is a registry for patients with Triple Negative breast cancer (TNBC) or patients who have an identified germline mutations (such as a mutation on the BRCA1 or BRCA2 genes).",[56,57],"Breast Cancer","Hereditary Breast and Ovarian Cancer",[59,60,57,61,62],"Triple Negative Breast Cancer","TNBC","HBOC","Prospective Registry","RECRUITING",{"date":65,"type":32},"2026-08-18",{"date":67,"type":32},"2011-03-22",{"date":69,"type":21},"2026-12",{"name":38,"class":39},11,{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":40},"100589990","cooking-skills-to-improve-long-term-weight-loss-in-young-adults-with-intellectual-disabilities-100589990","NCT06961591","Cooking Skills to Improve Long-Term Weight Loss in Young Adults With Intellectual Disabilities","CHEF-ID","Inclusion Criteria:\n\n1. Diagnosis of mild-to-moderate intellectual disability (ID).\n2. 18-35 years of age.\n3. BMI \\>24.9, Body weight \\\u003C350lbs.\n4. Sufficient functional ability to understand directions, communicate preferences, e.g., foods, wants, and can communicate through spoken language e.g., request more to eat\u002Fdrink, asks for assistance with food preparation.\n5. Living at home with a parent\u002Fguardian, or in a supported living environment with a caregiver who assists with food shopping, meal planning, and meal preparation and agrees to serve as a study partner.\n6. Plan to attend all study required visits over the next 24 mos.\n\nExclusion Criteria:\n\n1. Unable to participate in PA.\n2. Insulin dependent diabetes as this condition requires medical monitoring beyond the scope of this study.\n3. Participation in a weight management program involving diet, PA, or pharmacotherapy in the past 6 mos.\n4. Diagnosis of Prader-Willi Syndrome.\n5. Pregnancy during the previous 6 mos., currently lactating or planned pregnancy in the following 24 mos. Participants who become pregnant will be removed from the study and referred to appropriate agencies for consultation.\n6. Serious medical risk, e.g., cancer, recent heart attack, stroke, angioplasty as determined by the PCP.\n7. Unwilling to be randomized.\n8. Unable to participate in small group, in-person instruction.\n9. Use of wheelchair or power chair as primary locomotion.","35 Years",{"count":81,"type":21},114,[83],"NA","The goal of this study is to see if adding hands-on cooking classes to a weight management program (called Chef-ID) helps young adults with intellectual disabilities lose more weight and keep it off compared to a standard weight loss program. The study will last 24 months and include three phases: 6 months of active support, 12 months of maintenance, and 6 months with no contact.\n\nThe investigators will look at how much weight participants lose over the first 18 months. Changes in cooking skills, body fat, health markers (like blood pressure and cholesterol), daily living skills, and caregiver stress will be tracked. Finally, factors that might help or prevent weight loss, and how changes in weight and body fat are linked to overall health will be explored.\n\nThis research will help inform on how to better support healthy lifestyles for people with intellectual disabilities.",[86,87],"Intellectual Disability","Overweight and Obesity",[89,90,91,92],"Weight Loss Maintenance","Cooking Skills","Weight loss","Down syndrome","2026-08-10",{"date":95,"type":32},"2026-08-11",{"date":97,"type":32},"2025-05-19",{"date":99,"type":21},"2029-07-01",{"name":38,"class":39},{"id":102,"slug":103,"hasResults":12,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":22,"phases":111,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":40},"100625679","adapting-rdad-for-ds-100625679","NCT07425769","Adapting RDAD for DS","Adapting the RDAD Intervention for Individuals With Down Syndrome Phase 3- Pilot Test","CareFit DS\u002FAD","Inclusion Criteria - Adults with Down syndrome:\n\n* Age \\>35 yrs. with a diagnosis of DS as self-reported or reported by caregiver. This age range was selected as cognitive decline related to AD is observed at age \\~31 in adults with DS.\n* Sufficient functional ability to understand directions, communicate preferences, wants, and needs through spoken language.\n* Living at home or in a supported living environment with a parent\u002Fcaregiver who agrees to serve as a study partner.\n* Self-reported ability to participate in physical activity.\n\nExclusion Criteria - Adults with Down syndrome:\n\n* Unable to participate in moderate-to-vigorous physical activity.\n* Self-reported, cardiovascular, metabolic or renal disease and\u002For signs or symptoms.\n\nInclusion Criteria - Caregivers\n\n* Age ≥18 yrs.\n* Reports being a primary caregiver of an adult with DS.\n* English speaking.\n* Self-reported ability to participate in physical activity.\n\nExclusion Criteria - Caregivers\n\n* Unable to participate in moderate PA, i.e., brisk walking.\n* Self-reported, cardiovascular, metabolic or renal disease and\u002For signs or symptoms.",{"count":110,"type":21},40,[83],"The goal of this clinical trial is to observe feasibility and initial efficacy of a remotely delivered exercise and dementia caregiving intervention in older adults with Down syndrome and their caregivers.",[114,115],"Down Syndrome (DS)","Alzheimer's Disease (AD)","2026-07-31",{"date":118,"type":32},"2026-08-03",{"date":120,"type":32},"2026-03-31",{"date":122,"type":21},"2026-12-31",{"name":38,"class":39},{"id":125,"slug":126,"hasResults":12,"nctId":127,"briefTitle":128,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":49,"sex":131,"minAge":18,"maxAge":132,"enrollmentInfo":133,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":135,"conditions":136,"keywords":140,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":40},"100650184","gestational-response-outcomes-and-weight-after-glp-1-use-100650184","NCT07743567","Gestational Response, Outcomes, and Weight After GLP-1 Use","GROW","Inclusion Criteria:\n\n* Adult women\n* Less than or equal to 20 weeks gestation at first visit\n* English speaking\n\nExclusion Criteria:\n\n* \\\u003C18 years at time of initial visit\n* Type 2 diabetes\n* History of bariatric surgery\n* Multiple gestation\n* Cannot consent for themselves\n* Cannot read and speak English\n* Incarcerated","FEMALE","45 Years",{"count":134,"type":21},400,"The goal of this observational study is to learn if using GLP-1RA medications for weight loss before pregnancy influences gestational weight gain and pregnancy outcomes. The main aims of the study are to:\n\n* Compare gestational weight gain between women with preconception GLP-1RA exposure and those without exposure.\n* Compare obstetrical outcomes between women with preconception GLP-1RA exposure and those without exposure.\n\nResearchers will compare pregnant women with a history of GLP-1RA use to pregnant women who have not used a GLP-1RA to compare differences.\n\nParticipants will be asked to complete questionnaires at multiple timepoints during and after pregnancy that ask questions about medication history, thoughts and feelings around food, etc.",[137,138,139],"Pregnant Individuals","Obesity & Overweight","Gestational Weight Gain",[141,142,143,144,145,146,147],"Glucagon-like peptide 1 receptor agonist","Pregnancy","Gestational weight gain","Maternal obesity","Pregnancy outcomes","Food noise","Preconception","2026-07-30",{"date":150,"type":32},"2026-08-04",{"date":152,"type":32},"2026-04-13",{"date":154,"type":21},"2028-04",{"name":38,"class":39},{"id":157,"slug":158,"hasResults":12,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":162,"eligibilityCriteria":163,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":164,"targetDuration":4,"studyType":22,"phases":166,"briefSummary":168,"conditions":169,"keywords":170,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":176,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":4},"100650163","phase-2-neoadjuvant-angiogenesis-targeting-bispecific-chemoimmunotherapy-for-tnbc-100650163","NCT07743632","Neoadjuvant Angiogenesis-Targeting Bispecific Chemoimmunotherapy for TNBC","Neoadjuvant Angiogenesis-Targeting Bispecific Chemoimmunotherapy for TNBC (NeoASPECT)","NeoASPECT","Inclusion Criteria:\n\nAbility of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent\n\n18 years of age or older\n\nHistologically confirmed cT1c-T3 N0 or cT1-T3 N1-N2 triple-negative breast cancer\n\n* The invasive tumor must be hormone receptor poor, defined as both estrogen receptor (ER) and progesterone receptor staining in ≤ 10% of invasive cancer cells by IHC.\n* The invasive tumor must be HER2-negative based on the current ASCO-CAP guidelines 79.\n* Subjects with bilateral synchronous triple-negative breast cancer are eligible if they meet other eligibility criteria.\n\nNo previous ipsilateral breast surgery for the current breast cancer\n\nNo previous chemotherapy, immunotherapy, targeted therapy, endocrine therapy, or radiotherapy for the current breast cancer\n\nECOG Performance Status 0 or 1, documented within 21 days prior to the start of study treatment (Appendix A)\n\nBreast and axillary imaging (including MRI and either mammogram and\u002For ultrasound, per standard of care) within 56 days (8 weeks) prior to treatment initiation\n\nSubjects with clinically and\u002For radiographically abnormal axillary or internal mammary lymph nodes should have pathologic assessment of disease status with image-guided biopsy or fine needle aspiration unless deemed medically unsafe\n\nCo-enrollment in the PROGECT (HSC #12614) observational registry protocol\n\nArchival breast tumor tissue has been obtained or has been requested for use, which should include either a formalin-fixed paraffin-embedded (FFPE) block, or sixteen slides (fourteen 5-micron uncharged unstained slides plus either two H\\&E slides or two 5-micron charged unstained slides) - from primary breast tumor only.\n\nNeuropathy: No baseline grade 2 or above neuropathy\n\nNot pregnant, not breastfeeding, and at least one of the following applies:\n\n* Not a woman of reproductive potential as defined by institutional standards and treating physician's discretion\n* A woman of reproductive potential who agrees to follow contraceptive guidelines per institutional standards during the treatment period and for at least 3 months after the last dose of ivonescimab, or until 6 months after last dose of carboplatin or doxorubicin, 2 months after last dose of docetaxel, or 12 months after last dose of cyclophosphamide (whichever is longer).\n\nAdequate organ function, defined as follows:\n\nHematologic (assessed ≤ 21 days of treatment initiation):\n\n* Absolute neutrophil count ≥ 1,500\u002FμL (with the exception of patients with documented Fy(a-\u002Fb-) (Duffy null) immunophenotype, in which case absolute neutrophil count ≥1,200\u002FuL is allowed)\n* Platelets ≥ 100,000\u002FμL\n* Leukocytes ≥ 3,000\u002FμL\n* Hemoglobin ≥ 9.0 g\u002FdL or ≥ 5.6 mmol\u002FL (must be met without erythropoietin dependency and without erythrocyte transfusion within the last two weeks)\n\nCoagulation (assessed ≤ 21 days of treatment initiation):\n\nFor patients who are not on therapeutic anti-coagulation:\n\n* Prothrombin time (PT) or international normalized ratio (INR) ≤ 1.5x ULN\n* Partial prothrombin time (PTT) or activated partial prothrombin time (aPTT) ≤ 1.5x ULN (unless abnormalities are unrelated to coagulopathy). Patients receiving therapeutic anti-coagulation should be on a stable dose.\n\nRenal (assessed ≤ 21 days of treatment initiation):\n\n* Creatinine ≤ 1.5 mg\u002FdL and\u002For creatinine clearance ≥ 60 mL\u002Fmin\n* Urine protein test \\\u003C2+ or 24-hour urine protein quantification \\\u003C1.0 g\n\nHepatic (assessed ≤ 21 days of treatment initiation):\n\n* Total bilirubin ≤ 1.5x ULN\n* AST(SGOT) and ALT(SPGT) ≤ 2x ULN\n* Serum albumin ≥ 3.0 g\u002FdL\n\nCardiac (assessed ≤ 56 days of treatment initiation):\n\n* Subjects with heart failure are not eligible, nor are patients with myocardial infarction, unstable angina pectoris, an arterial thrombotic event, stroke, or transient ischemic attack within the past 12 months, uncontrolled hypertension (systolic BP \\> 150 mmHg, diastolic BP \\> 100 mmHg), uncontrolled or symptomatic arrythmia, or greater than grade 2 peripheral vascular disease\n* LVEF ≥ 50% by echocardiogram or MUGA scan, per standard of care\n\nExclusion Criteria:\n\nCurrent or anticipated use of other investigational agents while participating in this study\n\nClinically or radiographically detected metastatic disease\n\nInflammatory breast cancer\n\nPrior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the treatment regimen.\n\n\\- Note: Patients with squamous cell or basal cell carcinoma of the skin, ductal carcinoma in situ (DCIS) of the breast, or carcinoma in situ (CIS) of the uterine cervix who have undergone definitive therapy are not excluded from participation\n\nHistory of allergic reactions attributed to carboplatin, docetaxel, doxorubicin, or cyclophosphamide\n\nHistory of severe (≥ grade 3) hypersensitivity to ivonescimab or any of its excipients, or to any other monoclonal antibody\n\nPrior treatment with a VEGF inhibitor or with an anti-PD-1, anti-PD-L1, anti-PD-L2 inhibitor or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA4, OX40, CD137)\n\nHistory of bleeding tendencies or coagulopathy and\u002For clinically significant bleeding symptoms or risk within 4 weeks prior to starting study treatment, including but not limited to:\n\n* Hemoptysis (defined as coughing up ≥ 0.5 teaspoon of fresh blood or small blood clots). Note: Transient hemoptysis associated with diagnostic bronchoscopy is allowed.\n* Nasal bleeding \u002Fepistaxis (bloody nasal discharge is allowed)\n* Current use of prophylactic or full-dose anticoagulants or anti-platelet agents for therapeutic purposes that is not stable prior to starting study treatment. The use of full-dose anticoagulants is permitted as long as the international normalized ratio (INR) or activated partial thromboplastin time (aPTT) is within therapeutic limits according to institutional guidelines.\n\nPoorly controlled hypertension with repeated systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy\n\nMajor surgical procedures or serious trauma within 4 weeks prior to start of study treatment, major surgical procedures planned for within 4 weeks after the first dose of study treatment, or minor local procedures within 3 days prior to start of study treatment (as determined by the investigator).\n\n\\- Note: Central venous catheterization and port implantation within 3 days prior to start of study treatment are allowed.\n\nSubject has received a live vaccine within 30 days prior to treatment initiation\n\n* Live vaccines include (but are not limited to) measles, mumps, rubella, varicella\u002Fzoster (chicken pox and shingles), yellow fever, rabies, Bacillus-Calmette-Guérin (BCG), typhoid.\n* Note: Seasonal injectable influenza vaccines are killed virus and are allowed\n\nSubject is currently receiving treatment or has received treatment with an investigational agent within four weeks prior to treatment initiation, or has used an investigational device within four weeks prior to treatment initiation\n\nHas a diagnosis of immunodeficiency or is receiving chronic steroid therapy (in doses exceeding 10 mg daily prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment\n\nActive autoimmune or lung disease that has required systemic treatment (e.g., disease-modifying agents, corticosteroids in doses exceeding 10 mg daily prednisone equivalent, immunosuppressive drugs) in the past two years.\n\n* Note: Patients using replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid therapy) are eligible\n* Note: Intermittent use of bronchodilators, inhaled corticosteroids, topical corticosteroids, or local corticosteroid injections is permitted\n\nHistory of major diseases before starting study treatment, specifically any of the following:\n\n* Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association \\[NYHA\\] classification ≥ grade 2) or unstable vascular disease (e.g., aortic aneurysm at risk of rupture, Moyamoya disease) that required hospitalization within 12 months prior to starting study treatment, or other cardiac impairment that may affect the safety evaluation of the study drug (e.g., poorly controlled arrhythmias, myocardial ischemia)\n* History of esophageal gastric varices, severe ulcers, wounds that do not heal, abdominal fistula, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months before starting study treatment\n* History of any grade arterial thromboembolic event, Grade 3 and above venous thromboembolic event, as specified in National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 12 months prior to starting study treatment\n* Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks before starting study treatment\n* History of perforation of the gastrointestinal tract and\u002For fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months prior to starting study treatment\n\nCurrently has or has history of (within the past one year) non-infectious pneumonitis requiring steroids\n\nNon-infectious pneumonia requiring systemic corticosteroids within the past 30 days, or current interstitial lung disease\n\nInfection requiring systemic therapy within 2 weeks prior to starting study treatment (excluding antiviral therapy for hepatitis B or C)\n\nPeripheral neuropathy grade 2 or higher by CTCAE version 6\n\nCurrent or history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)\n\nKnown history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation\n\nKnown history of human immunodeficiency virus (HIV) infection.\n\n\\- Note: Patients with controlled viral load are eligible.\n\nActive hepatitis B (defined as HBsAg reactive) or hepatitis C (detectable HCV RNA or positive for HCV antibody)\n\n* Note: Patients with active hepatitis B are eligible if on appropriate antiviral therapy with acceptable tolerability for 4 weeks prior to starting study treatment, with stable or declining levels of hepatitis B DNA by polymerase chain reaction testing.\n* Note: Testing for hepatitis B and C is not required unless mandated by local health authority\n\nHistory or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of this study, interfere with the subject's participation for the full duration of the study, or it is not in the best interest of the subject to participate, in the opinion of the treating investigator\n\nPregnancy, breastfeeding or planning to breastfeed during study treatment, or expecting to conceive within the projected duration of the study, starting with the screening visit through 90 days after the last dose of trial treatment. There is a potential for congenital abnormalities and for this regimen to harm breastfeeding infants.\n\nSubject is a female of reproductive potential per institutional guidelines and treating physician's discretion and within 24 hours of starting treatment:\n\n* Serum pregnancy test is positive, or\n* Urine pregnancy test is positive or cannot be confirmed as negative, and serum pregnancy test has not been done or is positive\n* Note: In the event that 24 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for subject to start receiving study medication.",{"count":165,"type":21},110,[167],"PHASE2","This study will test the effectiveness of two standard neoadjuvant chemotherapy regimens plus an investigational drug (ivonescimab) that has dual action as both immunotherapy and therapy targeting the tumor's blood supply. This investigational drug is called ivonescimab.",[56,59],[171,172,173,174,175],"Tumor-infiltrating lymphocytes","Neoadjuvant chemotherapy","Neoadjuvant immunotherapy","Angiogenesis","VEGF",{"date":150,"type":32},{"date":178,"type":21},"2026-09",{"date":180,"type":21},"2033-12",{"name":38,"class":39},{"id":183,"slug":184,"hasResults":12,"nctId":185,"briefTitle":186,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":189,"enrollmentInfo":190,"targetDuration":4,"studyType":22,"phases":192,"briefSummary":193,"conditions":194,"keywords":195,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":206,"leadSponsor":208,"locationsCount":40},"100646006","changes-in-body-composition-including-muscle-with-anti-obesity-medications-both-with-and-without-exercise-100646006","NCT07698145","Changes in Body Composition Including Muscle With Anti-Obesity Medications, Both With and Without Exercise","M3-E","Inclusion Criteria:\n\n* Both males and females of all race\u002Fethnic groups are eligible for participation in this study.\n* 18 to \\\u003C65 years of age.\n* Newly prescribed FDA-approved obesity manage medication that can include Tirzepatide, Semaglutide, or up to 4 additional next-generation obesity management medications (will receive DSMB approval prior to inclusion), approval for treatment (pharmacy, insurance, etc.), and the participant agreeing to start this treatment and continue treatment for at least 6 months (the participant will be recruited prior to this medication being initiated).\n* Body mass index (BMI) of \\>=27.0 kg\u002Fm2 with at least one weight-related complication (hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease) provided it does not compromise the ability to safely complete the screening or outcome measures or to engage in the prescribed exercise interventions), or \\>=30 kg\u002Fm2 without weight-related complications. We will not limit enrollment based on an upper BMI level provided that the participant meets the other eligibility requirements. However, the participant will be excluded if they exceed the weight or size limits of the dual-energy x-ray absorptiometry (DXA) system that is used to assess body composition or the MRI that is used to assess muscle quality.\n* Ability to provide informed consent prior to participation in this study.\n* Clearance from the study physician for meeting all eligibility criteria for this study.\n\nExclusion Criteria:\n\n* Type 2 diabetes.\n* Report moderate-to-vigorous exercise for \\>60 min\u002Fweek, and \\>1 day\u002Fweek of structured cardiovascular or resistance exercise over the past 3 months.\n* Report sustained weight loss of \\>=3% in the past 3 months.\n* History of metabolic\u002Fbariatric surgery.\n* Females who are pregnant or breastfeeding or reporting a planned pregnancy during the study period.\n* Report a current medical condition or treatment for a medical condition that could affect body weight or contradict engagement in any aspect of the outcome measures or interventions.\n* History of muscle conditions that may impact the quality of muscle or response to the study interventions (e.g., myopathy, muscular dystrophy, rhabdomyolysis, etc.).\n* Contraindications to MRI (e.g., metal implants that are not MRI safe, etc.). NOTE: Participants who are otherwise eligible other than being contraindicated for the MRI scan will be eligible and the MRI scan will not be performed as a research procedure.\n* Current congestive heart failure, angina, uncontrolled arrhythmia, symptoms indicative of an increased acute risk for a cardiovascular event, prior myocardial infarction or history of cardiomyopathy, coronary artery bypass grafting or angioplasty, conditions requiring chronic anticoagulation (i.e., recent or recurrent DVT).\n* Resting systolic blood pressure of \\>=160 mmHg or resting diastolic blood pressure of \\>=100 mmHg. If medicated for blood pressure control, the medication dose needs to be stable for \\>=6 months.\n* Eating disorders that would contraindicate weight loss or physical activity.\n* Alcohol or substance abuse.\n* Current psychological condition that is untreated, hospitalization for a psychological condition within the past 12 months, or not being on a stable dose of treatment for at least 6 months.\n* Report plans to relocate to a location not accessible to the study site or having employment, personal, or travel commitments that prohibit attendance at scheduled intervention sessions or assessments.","64 Years",{"count":191,"type":21},198,[83],"The goal of this clinical trial is to learn whether adding either cardiovascular exercise or resistance exercise to pharmacotherapy treatment for obesity improves the retention of lean mass compared to pharmacotherapy alone in adults with overweight or obesity who are prescribed pharmacotherapy for obesity treatment by their personal physician. It will also provide information about whether either form of exercise added to pharmacotherapy for obesity treatment has additional benefits on other health and fitness measurements. The main questions it aims to answer are:\n\n* Is there a difference in the change in total lean body mass between pharmacotherapy alone and either pharmacotherapy plus cardiovascular exercise or pharmacotherapy plus resistance exercise?\n* Is there a difference in the change in muscle mass between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)?\n* Is there a difference in the change in muscle quality between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)?\n* Is there a difference in the change in body weight between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)?\n* Is there a difference in the change in body composition (fat mass, fat mass distribution) between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)?\n* Is there a difference in the change in cardiorespiratory fitness between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)?\n* Is there a difference in the change in muscle strength between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)?\n* Is there a difference in the change in physical function between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)?\n* Is there a difference in the change in bone mineral density between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)?\n* Is there a difference in the change in bone biomarkers between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)?\n* Is there a difference in the change in resting blood pressure between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)?\n* Is there a difference in the change in energy intake between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)?\n* Is there a difference in the change in physical activity between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)?\n* Is there an effect of sex, race\u002Fethnicity, age, menopausal status, obesity management medication type, or other demographic characteristics on the outcomes that are being measured.\n* What is the extent to which the retention of lean body mass or muscle mass mediates the effect of exercise on weight changes.\n\nParticipants will:\n\n* Initiate and continue throughout the study period an eligible obesity management medication that is prescribed by their healthcare provider, and to report their adherence to this medication to the investigators.\n* Participant in this study for a period of 6-8 months to complete outcome assessments that occur at baseline and at the conclusion of 6 months of the intervention period, and monitoring visits that occur at weeks 3, 6, 9, 12, 15, 18, and 21.\n* If attend 3 supervised exercise sessions per week if assigned to either the cardiovascular exercise intervention or the resistance training intervention for a period of 24 weeks.",[138],[196,197,198,199,200,201],"overweight","obesity","exercise","physical activity","pharmacotherapy","body composition","2026-07-13",{"date":204,"type":32},"2026-07-15",{"date":116,"type":21},{"date":207,"type":21},"2030-03-31",{"name":38,"class":39},{"id":210,"slug":211,"hasResults":12,"nctId":212,"briefTitle":213,"officialTitle":213,"acronym":214,"eligibilityCriteria":215,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":22,"phases":217,"briefSummary":218,"conditions":219,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":40},"100347369","holep-prior-to-radiation-therapy-for-patients-with-lutsretention-and-concurrent-prostate-cancer-100347369","NCT03802851","HoLEP Prior to Radiation Therapy for Patients With LUTS\u002FRetention and Concurrent Prostate Cancer","HOLEP-RTPC","Inclusion Criteria:\n\n* Patients must be 18 years of age or older\n* Patients must have bothersome lower urinary tract symptoms (LUTS), defined by American Urological Association Symptom Score (AUA SS) of greater than or equal to 15 and\u002For as defined by a post-void residual of greater than or equal to 350mL and\u002For as defined by catheter dependence\n* Patients must be diagnosed with prostate cancer by pathological tissue analysis\n* Patients must have elected for radiation with androgen deprivation therapy as the primary treatment modality for their prostate cancer\n\nExclusion Criteria:\n\n* Patients who are under 18 years of age are not eligible\n* Patients who have a diagnosis of bladder cancer are not eligible.\n* Patients with prior treatment for prostate cancer are not eligible.\n* Patients with any type of prior prostate surgery (minimally invasive, endoscopic, or otherwise) including prior transurethral resection of the prostate (but excluding prior prostate biopsy) are ineligible.\n* Patients with known metastatic prostate cancer are ineligible\n* Patients who are enrolled in other surgical or international trials at the time of this study are not eligible",{"count":20,"type":21},[83],"To determine if holmium laser enucleation of the prostate (HoLEP) for the treatment of lower urinary tract symptoms (LUTS) and\u002For urinary retention alters the treatment course for patients concurrently diagnosed with prostate cancer.",[220,221],"Prostate Cancer","Lower Urinary Tract Symptoms","2026-07-09",{"date":202,"type":32},{"date":225,"type":32},"2019-09-19",{"date":227,"type":21},"2035-01",{"name":38,"class":39},{"id":230,"slug":231,"hasResults":12,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":236,"targetDuration":238,"studyType":53,"phases":4,"briefSummary":239,"conditions":240,"keywords":243,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":40},"100560873","lidocaine-infusion-treatment-for-subarachnoid-hemorrhage-headaches-100560873","NCT06582810","Lidocaine Infusion Treatment for Subarachnoid Hemorrhage Headaches","Lidocaine Infusion As A Treatment Modality For Headache Following Non-Traumatic Subarachnoid Hemorrhage: A Prospective, Single-Center, Observational Cohort Study","Inclusion Criteria:\n\n* Patients \\> 18 years;\n* Have a favorable neurological status defined as Hunt and Hess score ≤ 3 (as it accounts for patient awareness);\n* Can communicate numeric pain scores;\n* Are diagnosed with non-traumatic subarachnoid hemorrhage\n\nExclusion Criteria:\n\n* The patient is diagnosed with traumatic subarachnoid hemorrhage;\n* If the patient is \\\u003C 18 years of age;\n* If numeric pain scores could not be captured for \\> 3 days of hospitalization;\n* If the patient had a prior aneurysm;\n* Chronic pain not associated with non-traumatic subarachnoid hemorrhage diagnosis;\n* A disability before the stroke (\\> 2 on modified Rankin Scale score);\n* A Hunt and Hess score \\> 3;\n* Contraindications to lidocaine (significant cardiac disease, arrhythmia, seizures, previous allergic reaction to lidocaine",{"count":237,"type":21},20,"7 Days","The goal of this observational study is to evaluate intravenous lidocaine efficacy and safety in treating headache following non-traumatic subarachnoid hemorrhage. Through this prospective analysis, the investigators hope to:\n\n1. show that intravenous lidocaine infusion causes a clinically significant reduction in pain scores in patients with moderate\u002Fsevere headache pain following non-traumatic subarachnoid hemorrhage;\n2. show that intravenous lidocaine infusion is safe in treating headache following non-traumatic subarachnoid hemorrhage;\n3. and report vasospasm prevalence in the cohort.\n\nParticipants will receive lidocaine infusion as treatment for non-traumatic subarachnoid hemorrhage headache and provide pain scores (on a numeric pain scale) every two hours the patients are awake for a maximum of seven days. Monitoring for vasospasm will occur as part of the patients regular medical care.",[241,242],"Subarachnoid; Hemorrhage, Nontraumatic","Headache",[244,242,245],"Nontraumatic Subarachnoid Hemorrhage","Lidocaine Infusion","2026-07-08",{"date":248,"type":32},"2026-07-10",{"date":250,"type":32},"2025-01-31",{"date":252,"type":21},"2028-07",{"name":38,"class":39},{"id":255,"slug":256,"hasResults":12,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":260,"eligibilityCriteria":261,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":262,"targetDuration":52,"studyType":53,"phases":4,"briefSummary":264,"conditions":265,"keywords":271,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":272,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":40},"100469443","interstitial-lung-disease-research-unit-biobank-100469443","NCT05392881","Interstitial Lung Disease Research Unit Biobank","University of Kansas Medical Center Interstitial Lung Disease Research Unit (ILDRU) Biobank","ILDRU","Inclusion Criteria:\n\n1. The participant is a patient at TUKHS or has agreed to participate in a study approved by the KUMC Human Research Protection Program (HRPP)\n2. The participant is being followed for the presence of autoimmune disease, ILD or other rare lung diseases at TUKHS.\n3. The participant is ≥ 18 years of age.\n4. The participant has signed an approved consent for this study (living patients only)",{"count":263,"type":21},1000,"Establish a interstitial lung disease (ILD) registry and biorepository to lead towards a further understanding of the disease.",[266,267,268,269,270],"Interstitial Lung Disease","Sarcoidosis","Idiopathic Pulmonary Fibrosis","Pulmonary Fibrosis","Hypersensitivity Pneumonitis",[266,267,268,269,270],{"date":248,"type":32},{"date":274,"type":32},"2021-08-09",{"date":276,"type":21},"2032-03-01",{"name":38,"class":39},{"id":279,"slug":280,"hasResults":12,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":4,"eligibilityCriteria":284,"healthyVolunteers":12,"sex":131,"minAge":18,"maxAge":4,"enrollmentInfo":285,"targetDuration":4,"studyType":22,"phases":287,"briefSummary":288,"conditions":289,"keywords":291,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":293,"lastUpdatePostDateStruct":294,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":40},"100625283","preliminary-effectiveness-of-enhanced-text-message--incentives-100625283","NCT07420621","Preliminary Effectiveness of Enhanced Text Message + Incentives","Preliminary Studies on Implementation of Smoking Cessation Interventions for Low-Income Women","Inclusion Criteria:\n\n* Pregnant women aged: 18+\n* Enrolled in the Special Supplemental Nutrition Program for women, Infants, and Children (WIC) or Medicaid (or applied\u002Fapplying)\n* Self-reported current daily smokers\n* Able to communicate in English\n* Access to a mobile phone capable of receiving text messages\n\nExclusion Criteria:\n\n* Not at all interested in quitting\n* Smoke less than 24 days in the past month\n* Greater than 30 weeks gestation",{"count":286,"type":21},50,[83],"This study is a preliminary evaluation of a smoking cessation intervention designed for pregnant women that combines text message support and financial incentives.\n\nThe aims of this study are to determine the preliminary feasibility and acceptability of text message + incentives (intervention) vs. text message only (control).",[290,142],"Smoking Cessation",[290,292],"Maternal Health","2026-07-06",{"date":246,"type":32},{"date":296,"type":32},"2026-04-09",{"date":298,"type":21},"2027-01-29",{"name":38,"class":39},{"id":301,"slug":302,"hasResults":12,"nctId":303,"briefTitle":304,"officialTitle":305,"acronym":306,"eligibilityCriteria":307,"healthyVolunteers":12,"sex":17,"minAge":308,"maxAge":309,"enrollmentInfo":310,"targetDuration":4,"studyType":22,"phases":311,"briefSummary":312,"conditions":313,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":293,"lastUpdatePostDateStruct":316,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":322},"100519999","healthy-weight-intervention-families-during-all-treatment-nourish-all-100519999","NCT06050850","Healthy Weight Intervention Families During ALL Treatment: NOURISH-ALL","A Healthy Weight Intervention for Family Stress During the Early Phases of ALL Treatment: NOURISH-ALL","NOURISH-ALL","Inclusion Criteria:\n\n* Children ages 2-12 years old and their primary caregiver ages 18-90\n* Child diagnosed with acute lymphoblastic leukemia (ALL)\n* Child completed induction phase of therapy and not yet in maintenance phase of therapy\n* Primary caregiver and child English language proficient\n* Primary caregiver able to provide permission for child to participate in research\n* Primary caregiver identifies as being involved with child's oncology care\n* Primary caregiver lives with child at least 50% of the time\n* Primary oncology provider confirms child is eligible to participate\n\nExclusion Criteria:\n\n* Primary oncology provider identifies safety concerns regarding the child's participation in the study.","2 Years","12 Years",{"count":237,"type":21},[83],"The purpose of this study is to conduct a single arm pilot of the NOURISH-ALL (Nourishing Our Understanding of Role modeling to Improve Support and Health in Acute Lymphoblastic Leukemia) intervention focused on three components of participant engagement. This is a single arm intervention study that involves participation in a 6-session family intervention and three time points of multimethod data collection. The primary outcome is participant engagement, measured as recruitment, retention, and intended dose received.\n\nThis study will be conducted over 5 years in three phases:\n\n* Aim 1a: Adapting the NOURISH-ALL Intervention for Families of Youth with ALL (Year 1)\n* Aim 1b: Iteratively Refining the NOURISH-ALL Intervention (Year 2)\n* Aim 2: Pilot Single-Arm Trial of NOURISH-ALL Focused on Participant Engagement (Years 3-5)",[314,315],"ALL, Childhood","Behavior, Health",{"date":246,"type":32},{"date":318,"type":21},"2026-09-01",{"date":320,"type":21},"2028-09-01",{"name":38,"class":39},2,{"id":324,"slug":325,"hasResults":12,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":329,"eligibilityCriteria":330,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":331,"targetDuration":4,"studyType":22,"phases":333,"briefSummary":334,"conditions":335,"keywords":339,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":40},"100565284","feasibility-and-plausible-effectiveness-of-a-lifestyle-intervention-in-kidney-transplant-recipients-heal-100565284","NCT06640179","Feasibility and Plausible Effectiveness of a Lifestyle Intervention in Kidney Transplant Recipients (HEAL)","Prevention of Weight Gain and Impaired Glucose Metabolism Post Kidney Transplantation: A Pilot and Feasibility Study","HEAL","Inclusion Criteria:\n\n* Receiving a kidney transplant within the prior 3-5 months, with the transplant received from a deceased donor or living donor. NOTE: The patient will be eligible for randomization at 3 months following the kidney transplant, or at a subsequent time once clearance from the kidney transplant physician is given, provided that the time does not exceed 5 months following the kidney transplant.\n* Both males and females of all race\u002Fethnic groups are eligible for participation in this study.\n* \\>=18 years of age.\n* Body mass index (BMI) \\>22 kg\u002Fm2. There is no maximal BMI provided that the weight does not exceed the weight allowance of the dual-energy x-ray absorptiometer (DXA) that is used to assess body composition (maximal weight for the DXA is 350 pounds).\n* Ability to provide informed consent prior to participation in this study.\n* Ability to provide clearance from their kidney transplant physician to engage in the diet and physical activity components of the proposed intervention and to safely complete the proposed outcome measures.\n* Ability to walk for exercise.\n\nExclusion Criteria:\n\n* Females who are pregnant, breastfeeding, or reporting a planned pregnancy during the study period. Female participants of childbearing age who are not currently taking contraceptive medication, are not post-menopausal, or have not been surgically sterilized will need to agree to use a double barrier method of contraception.\n* History of bariatric surgery.\n* Currently prescribed an anti-obesity medication.\n* Report current medical condition or treatment for a medical condition that could affect body weight. These may include the following: diabetes mellitus; hyperthyroidism; inadequately controlled hypothyroidism; chronic liver disease; cancer; gastrointestinal disorders including ulcerative colitis, Crohn's disease, or malabsorption syndromes; etc.\n* Current congestive heart failure, angina, uncontrolled arrhythmia, symptoms indicative of an increased acute risk for a cardiovascular event, prior myocardial infarction, coronary artery bypass grafting or angioplasty, conditions requiring chronic anticoagulation (i.e., recent or recurrent DVT).\n* Resting systolic blood pressure of \\>=160 mmHg or resting diastolic blood pressure of \\>=100 mmHg or not on a stable medical treatment to control hypertension (stable dose is defined as the same dose and type of medication for a period of at least 6 months).\n* Eating disorders that would contraindicate modifying eating or physical activity behaviors.\n* Alcohol or substance abuse.\n* Currently treated for psychological issues (i.e., depression, bipolar disorder, etc.) that is accompanied by the following: 1) not on a stable dose of medications for treatment within the previous 12 months, or 2) hospitalized for depression within the previous 5 years.\n* Report plans to relocate to a location not accessible to the study site or having employment, personal, or travel commitments that prohibit attendance at scheduled intervention sessions or assessments.",{"count":332,"type":21},60,[83],"The goal of this clinical trial is to learn whether if it is feasible to implement a study of patients receiving kidney transplantation, to learn if these patients will complete selective outcomes measurements, and to examine if a lifestyle intervention may assist with preventing weight gain compared to standard medical care. The main questions it aims to answer are:\n\n* Is it feasible to recruit and retain patients who have undergone kidney transplantation into a study to compare standard medical care to standard medical care plus a lifestyle intervention focused on prevention of weight gain?\n* Will participants engage in the interventions and be compliant to the components of the interventions?\n* Will there be any difference between the interventions between the interventions for the occurrence of adverse events specific to kidney transplantation?\n* Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on preventing weight gain compared to standard medical care alone?\n* Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on body composition compared to standard medical care alone?\n* Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on fasting glucose compared to standard medical care alone?\n* Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on fasting insulin compared to standard medical care alone?\n* Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on insulin sensitivity compared to standard medical care alone?\n* Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on physical function compared to standard medical care alone?\n* Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on health-related quality of life compared to standard medical care alone?\n* Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on changes in dietary intake compared to standard medical care alone?\n* Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on physical activity and sedentary behavior compared to standard medical care alone?\n\nParticipants will:\n\n* Participants will continue with their standard medical care following kidney transplantation.\n* Participants only receiving standard medical care will also complete brief monitoring visits at week 6, 12, and 18.\n* Participants receiving the lifestyle intervention will attend weekly intervention sessions and will be recommended to modify their diet and physical activity behaviors in an effort to prevent weight gain.\n* Participants will complete outcome measurements as the start of the study and again after 6 months in the study.\n* After 6 months in the study, participants will also complete a brief intervention and answer other questions about their experience in the study.",[336,337,338],"Kidney Transplant","Overweight or Obese Adults","Glucose Control",[340,196,197,341,342],"kidney transplant","glucose control","weight control","2026-06-30",{"date":345,"type":32},"2026-07-02",{"date":347,"type":32},"2024-12-17",{"date":349,"type":21},"2027-03-01",{"name":38,"class":39},{"id":352,"slug":353,"hasResults":12,"nctId":354,"briefTitle":355,"officialTitle":355,"acronym":4,"eligibilityCriteria":356,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":357,"targetDuration":4,"studyType":22,"phases":358,"briefSummary":359,"conditions":360,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":363,"completionDateStruct":365,"leadSponsor":367,"locationsCount":40},"100647034","contingency-management-to-promote-smoking-cessation-a-pilot-randomized-clinical-trial-100647034","NCT07685899","Contingency Management to Promote Smoking Cessation: A Pilot Randomized Clinical Trial","Inclusion Criteria:\n\n* Smoked in the past 30 days\n* Smoke at least 1 cigarette per day when they smoke\n* ≥ 18 years old\n* Kansas resident\n* Speak\u002Fread English\n* Access to a mobile phone\n* Mobile phone receives text messages\n* No varenicline contraindications (no acute renal impairment)\n* Have no significant co-morbidity (i.e., life-threatening illness, communication barriers or altered mental status)\n* Cognitively able to participate\n* Physically able to participate\n* Not pregnant\u002Fbreastfeeding\n\nExclusion Criteria:\n\n* Medically ineligible for varenicline\n* Patient on smoking cessation medication within 2 weeks of admission date\n* Patient already talked to quitline in the past 2 weeks.\n* Patients participating in other quit smoking program or research study",{"count":110,"type":21},[83],"Adherence to medication and counseling are strong predictors of smoking cessation success. To provide these two components of care, healthcare providers typically provide people who smoke with prescriptions for cessation medications, and refer them to state-sponsored tobacco quitlines. However, most people who smoke that are referred to quitlines never actually enroll, and those who do enroll participate in very few sessions. Similarly, most people who smoke that receive prescriptions for cessation medications rarely fill or use them, even when they have no co-pay or pre-authorization requirements. To address this problem we will recruit 40 patients for a pilot 2-arm effectiveness trial. We will recruit patients from the University of Kansas Medical Center. Participants will then be randomized either to control or Health Reward. All participants will receive 12 weeks of varenicline and referrals to their state tobacco quitline (Control condition). In Health rewards arm, participants will additionally receive CM for medication (MedCM) and for counseling (CounsCM). The use of medication will be tracked using an electronic pill dispenser (Wisepill). All participants will be contacted for follow up 3, 6 and 12 weeks after starting the treatment. Feasibility data will include recruitment and retention rates. Preliminary effectiveness outcomes will include treatment engagement and cessation rates.",[290],"2026-06-29",{"date":293,"type":32},{"date":364,"type":21},"2026-08-20",{"date":366,"type":21},"2027-05-30",{"name":38,"class":39},{"id":369,"slug":370,"hasResults":12,"nctId":371,"briefTitle":372,"officialTitle":373,"acronym":4,"eligibilityCriteria":374,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":375,"targetDuration":4,"studyType":22,"phases":377,"briefSummary":379,"conditions":380,"keywords":382,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":384,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":40},"100606353","phase-3-trial-to-evaluate-iraes-with-different-standard-of-care-dosing-strategies-of-standard-of-care-immunotherapies-100606353","NCT07174453","Trial to Evaluate irAEs With Different Standard of Care Dosing Strategies of Standard of Care Immunotherapies","A Late Phase Randomized Open-Label Multi Cohort Trial to Evaluate irAEs With Different Standard of Care Dosing Strategies of Standard of Care Immunotherapies","Inclusion Criteria:\n\n1. Ability of participant to understand this study, and participant willingness to sign a written informed consent.\n2. Males and females age ≥ 18 years\n3. ECOG Performance Status (PS) 0 - 2 (Appendix A.)\n4. Females of childbearing potential must have a negative urine pregnancy test 72 hours prior to initiating treatment.\n5. Histologically or cytologically confirmed diagnosis of solid tumor malignancy\n6. Eligible to receive pembrolizumab or nivolumab based therapy\n7. Any disease setting (neoadjuvant, adjuvant, unresectable, metastatic) or any line of therapy is allowed. NOTE: Standard of care combination agents(chemotherapy, targeted therapy, biologics) are allowed because irAEs are the primary objective\n8. Adequate organ function, defined as follows:\n\nLeukocytes (White Blood Cell \\[WBC\\]) \\>1.0 K\u002FUL Absolute Neutrophil Count \\>1.0 K\u002FUL Platelets \\> 50 K\u002FUL Hemoglobin ≥ 7 g\u002FdL Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 50 mL\u002Fmin using the Cockcroft-Gault equation Total bilirubin ≤ 1.5 x ULN Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN\n\nExclusion Criteria:\n\n1. Simultaneously enrolled in any therapeutic clinical trial\n2. Concurrent or planned use of other immunotherapies or radiation\n3. Has not recovered from irAEs due to prior immunotherapy treatment (\\>=grade 2 is considered not recovered). Conditions that meet grade 2 criteria but are considered clinically stable at the discretion of the investigator will be allowed.\n4. Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements\n5. Currently pregnant or breastfeeding\n6. Has a known allergic reaction to any excipient contained in the study drug formulation\n7. Active Grade 3 (per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0 ) or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment.",{"count":376,"type":21},192,[378],"PHASE3","Phase 3\u002F4 open label, randomized two cohort study (2 arms in each cohort).\n\nIt is hypothesized that for people with a histologically or cytologically confirmed diagnosis of malignancy, the higher dose immunotherapy (every 6 weeks Pembrolizumab 400mg dose and every 4 weeks Nivolumab 480mg dose) has more immune-related adverse events irAEs compared to lower dose (every 3 weeks Pembrolizumab 200mg dose and every 2 weeks Nivolumab 240mg dose).",[381],"Solid Tumor Malignancies",[383],"Immunotherapy",{"date":385,"type":32},"2026-07-01",{"date":387,"type":32},"2025-10-07",{"date":389,"type":21},"2029-10-01",{"name":38,"class":39},{"id":392,"slug":393,"hasResults":12,"nctId":394,"briefTitle":395,"officialTitle":395,"acronym":4,"eligibilityCriteria":396,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":397,"enrollmentInfo":398,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":400,"conditions":401,"keywords":406,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":414,"locationsCount":40},"100591807","evaluation-of-ventilation-defects-downstream-of-mucus-plugs-in-patients-with-muco-obstructive-lung-disease-100591807","NCT06985225","Evaluation of Ventilation Defects Downstream of Mucus Plugs in Patients With Muco-Obstructive Lung Disease","Inclusion Criteria:\n\n* Adequate completion of informed consent process with written documentation\n* Patients 18 - 65 years old\n* • Physician diagnosis of muco-obstructive pulmonary disease, including cystic fibrosis, severe asthma, chronic obstructive pulmonary disease, or non-cystic fibrosis bronchiectasis for \\> 1 year\n* Able to perform reproducible spirometry according to ATS criteria based on clinical PFTs.\n\nExclusion Criteria:\n\n* Respiratory tract infection within the 4 weeks prior to Visit 1\n* Body mass index (BMI) \\> 30 at Visit 1\n* One-time doses such as intra-articular injections require a 4-week washout prior to Visit 1\n* ER visit related to pulmonary condition within the previous 4 weeks of Visit 1\n* Significant concomitant medical illness, including (but not limited to) heart disease, cancer, uncontrolled diabetes, other chronic lung diseases (determined by the Investigator.)\n* Resting O2 saturation \\\u003C90% with maximum supplemental O2 delivered by nasal canula\n* Positive urine pregnancy test\n* Participation in an intervention study (including bronchoscopy) or use of investigative drugs within the past 30 days or plans to enroll in such a trial during the study\n* Unable or unlikely to complete study assessments in the opinion of the Investigator\n* Study intervention poses undue risk to patient in the opinion of the Investigator\n* Conditions that will prohibit MRI scanning determined by the MRI safety screening.","65 Years",{"count":399,"type":21},8,"In this study, xenon MRI will be used to evaluate regional functional consequences of mucus plugs in the lungs of patients with muco-obstructive pulmonary disease. Mucus plugs will be identified using CT imaging, and xenon MRI will be used to evaluate ventilation and gas exchange impairments in regions of the lungs corresponding to the airways downstream of mucus plugs.",[402,403,404,405],"Severe Asthma","COPD","Non-CF Bronchiectasis","Cystic Fibrosis (CF)",[407,408,402,403,404],"Xenon MRI","Mucus Plug","2026-06-26",{"date":385,"type":32},{"date":412,"type":32},"2025-06-01",{"date":69,"type":21},{"name":38,"class":39},{"id":416,"slug":417,"hasResults":12,"nctId":418,"briefTitle":419,"officialTitle":420,"acronym":421,"eligibilityCriteria":422,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":397,"enrollmentInfo":423,"targetDuration":4,"studyType":22,"phases":425,"briefSummary":426,"conditions":427,"keywords":430,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":434,"startDateStruct":436,"completionDateStruct":438,"leadSponsor":440,"locationsCount":40},"100548977","phase-2-efficacy-of-cognitive-behavioral-therapy-for-insomnia-to-treat-insomnia-symptoms-in-individuals-with-multiple-sclerosis-100548977","NCT06428006","Efficacy of Cognitive Behavioral Therapy for Insomnia to Treat Insomnia Symptoms in Individuals With Multiple Sclerosis","Efficacy of Cognitive Behavioral Therapy for Insomnia to Treat Insomnia Symptoms and Fatigue in Individuals With Multiple Sclerosis","CALM","Inclusion Criteria:\n\n* 18-65 years old\n* Diagnosis of relapsing-remitting or secondary progressive MS based on established guidelines20 and verified by their neurologist\n* Mild-to-moderately severe disability (≤ 6 on Patient Determined Disability Steps (PDDS) scale)\n* Report of difficulty falling asleep, maintaining sleep, or waking up too early at least 3 nights\u002Fweek for the past 3 months with significant distress and impact on function despite adequate opportunity for sleep and not due to other sleep disorders as indicated in the DSM-5\n* ≥10 on Insomnia Severity Index\n* English speaking\n* ≥31 on modified Telephone Interview of Cognitive Status23\n* Has a high school diploma or equivalent to serve as a proxy measurement of reading ability to ensure adequate reading ability to participate in the study\n* Report having access to internet service or a data plan and access to a computer, tablet, or smart phone\n\nExclusion Criteria:\n\n* Known untreated sleep disorder (such as sleep apnea or restless legs syndrome)\n* \\>3 on STOP BANG indicating increased risk of sleep apnea\n* Restless legs syndrome as determined by RLS-Diagnosis Index\n* Circadian rhythm sleep-wake disorder as determined by the Sleep Disorders-Revised\n* Parasomnia as determined by the Sleep Disorders-Revised\n* Currently taking benzodiazepines, non-benzodiazepines, or melatonin supplements or agonists for insomnia\n* Score of ≥20 on the Patient Health Questionnaire (PHQ-9) indicating severe depression or endorsement of suicidal ideation (answer 1, 2 or 3 on #9 of the PHQ-9)\n* Score of ≥15 on the Generalized Anxiety Disorder (GAD-7) indicating severe anxiety\n* Current or history (up to 2 years) of alcohol or drug or alcohol abuse as indicated by DSM-5 criteria\n* History of other nervous system disorder such as stroke or Parkinson's disease\n* Currently pregnant or intending to become pregnant in the next 6 months\n* Severe mental illness such as schizophrenia or bipolar disorder\n* Severe neurological or sensory impairments that would interfere significantly with testing\n* Relapse and\u002For corticosteroid use in the past 8 weeks\n* History of (within 5 years) or currently conducting overnight shift work including hours of midnight-4am\n* Currently receiving a behavioral sleep health intervention",{"count":424,"type":21},70,[167],"The incidence of insomnia is estimated to be as high as 90% in individuals with MS due to insomnia being underdiagnosed. Sleep disturbances in people with MS have been associated with reduced cognitive performance, physical function, psychological well-being, quality of life, and occupational function, as well as increased prevalence of fatigue, pain, depression, and anxiety. The objective of the proposed study is to determine the efficacy of cognitive behavioral therapy for insomnia (CBT-I) to improve insomnia symptoms (Aim 1) fatigue, and health-related quality of life (Aim 2) in individuals with multiple sclerosis compared to an active control group, and to determine the characteristics of participants that predict improvement in sleep outcomes (Exploratory Aim 3).",[428,429],"Multiple Sclerosis","Insomnia",[431,432],"Cognitive behavioral therapy for insomnia","CBT-I","2026-06-09",{"date":435,"type":32},"2026-06-12",{"date":437,"type":32},"2024-07-30",{"date":439,"type":21},"2027-05-31",{"name":38,"class":39},{"id":442,"slug":443,"hasResults":12,"nctId":444,"briefTitle":445,"officialTitle":446,"acronym":447,"eligibilityCriteria":448,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":449,"enrollmentInfo":450,"targetDuration":4,"studyType":22,"phases":452,"briefSummary":453,"conditions":454,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":456,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":462,"locationsCount":4},"100643100","phase-2-de-escalation-of-axillary-management-in-advanced-nodal-disease-100643100","NCT07643584","De-Escalation of Axillary Management in Advanced Nodal Disease","DEMAND - A Phase II Trial of De-Escalation of Axillary Management in Advanced Nodal Disease","DEMAND","Inclusion Criteria:\n\n1. Ability of participant to understand this study, and participant willingness to sign a written informed consent. NOTE Remote consenting allowed per IRB policy and approval.\n2. Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study\n3. Males and\u002For females age ≥ 18 to 80 years\n4. Clinical stage T1-3 N2-3 M0 breast cancer at diagnosis (prior to the start of neoadjuvant chemotherapy).\n5. Patients stage T1-3 cN1 (prior to start of neoadjuvant chemotherapy) and pN2-3 breast cancer based on number of positive nodes on final surgical pathology.\n6. All patients must have had an axillary ultrasound with FNA or core needle biopsy of axillary lymph nodes documenting axillary metastasis at the time of diagnosis, prior to or at most 14 days after starting neoadjuvant chemotherapy.\n7. Patients must have had estrogen receptor, progesterone receptor and HER2 status (by IHC and\u002For ISH) evaluated on diagnostic core biopsy prior to start of neoadjuvant chemotherapy. Note: If HER2 status has not been clearly determined (i.e. equivocal\u002Findeterminate), then patients should not be enrolled (see exclusion criteria).\n8. Patients must have completed planned chemotherapy (neoadjuvant chemotherapy \\[NAC\\]) prior to surgery. Sandwich chemotherapy is not allowed (i.e. chemotherapy planned to be given after surgery). Adjuvant systemic therapy based on final surgical pathology is allowed and at the discretion of the treating medical oncologist. Note: Delays\u002Fdose modifications due to toxicities\u002Fadverse events are allowed per the treating medical oncologist.\n9. Patients with HER-2 positive tumors must have received neoadjuvant trastuzumab, or trastuzumab + pertuzumab, or other approved anti-HER-2 therapy (either with all or with a portion of the neoadjuvant chemotherapy regimen). Therapy must be FDA-approved targeted anti-HER2 therapy, but additional therapies are allowed as are non-trastuzumab regimens if administered in the context of an IRB-approved clinical trial.\n10. Benign breast disease, LCIS or DCIS of contralateral breast is allowed\n11. All patients must have a clinically negative axilla (no bulky adenopathy) on physical examination documented at the completion of neoadjuvant chemotherapy. Note: A partial or complete imaging response that includes all lymph nodes measuring ≤ 1cm clinically is required for eligibility.\n12. ECOG (Zubrod) Performance Status 0-1 (Appendix A)\n13. A minimum of 1 sentinel node must be identified and excised by the surgeon. Patients who do not have an identifiable sentinel lymph node will not proceed to omission of ALND.\n14. Patients that have a pathologic complete response (pCR) in the breast and axilla can be considered for discussion at the Breast Multidisciplinary Tumor Conference for omission of radiation. Note: Isolated tumor cells (metastases less than or equal to 0.2 mm) will be treated as node negative disease (N0i+).\n15. Breast surgery (lumpectomy or mastectomy) and sentinel lymph node surgery must be completed within 56 days of the completion of the last dose of neoadjuvant chemotherapy. Negative margin (by either breast conservation or mastectomy) on final pathology where negative margin is defined as no tumor on ink.\n16. Females of childbearing potential must have a negative serum pregnancy at day of surgery in pre-operative holding prior to initiating treatment.\n17. Females of child-bearing potential and males with partners of child-bearing potential must agree not to donate sperm, to practice sexual abstinence or to use the forms of contraception listed in Child-Bearing Potential\u002FPregnancy section for the duration of study participation and, following the last administration of therapy , for as long as directed per standard or care chemotherapy (investigational regimen allowed) and radiation therapy, whichever is longer. Note: Peri-menopausal women must be amenorrheic for ≥ 12 months to be considered not of childbearing potential.\n\nDefinition of medically fit for surgery:\n\n* ECOG status of 0-1\n* NOTE - participants are eligible for surgery if they have nicotine in the blood or high A1c. These values will be monitored per SOC.\n\nExclusion Criteria:\n\n1. Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements and \u002F or giving informed consent.\n2. Medical condition such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus or cardiac disease which, in the opinion of the treating physician, would make this study unreasonably hazardous for the patient.\n3. Inflammatory breast cancer.\n4. Any other malignancy within 5 years of enrollment with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix.\n5. HER2 status has not been clearly determined (i.e. equivocal\u002Findeterminate)\n6. Patient has had neoadjuvant endocrine therapy \\> than 8 weeks prior to the start of neoadjuvant chemotherapy.\n7. Neoadjuvant radiation therapy.\n8. SLN surgery\u002Fexcisional biopsy for pathological confirmation of axillary status prior to or during neoadjuvant chemotherapy.\n9. Prior history of ipsilateral breast cancer (invasive disease or DCIS). NOTE LCIS and benign breast disease is allowed.\n10. Prior ipsilateral axillary surgery, such as excisional biopsy of lymph node(s) or treatment of hidradenitis.\n11. History of prior or concurrent contralateral invasive breast cancer. .\n12. Patient pregnant or nursing.","80 Years",{"count":451,"type":21},120,[167],"This is a prospective, phase 2, single arm trial to evaluate whether Axillary Lymph Node Dissection (ALND) can be safely omitted for patients with cN2 and cN3 breast cancer who achieve a complete clinical response on exam with a complete or partial response by end-of-treatment (EOT) imaging and have either a partial or complete pathologic nodal response after neoadjuvant chemotherapy (NAC) by performing nodal assessment of sentinel lymph node surgery (with or without targeted axillary dissection (TAD) followed by Regional Nodal Irradiation (RNI).\n\nThis study aims to demonstrate that performing only a sentinel node dissection, which includes the removal of palpably gross disease followed by radiation, will not impact distant disease and thus survival.",[56],"2026-06-08",{"date":457,"type":32},"2026-06-11",{"date":459,"type":21},"2026-07",{"date":461,"type":21},"2031-07",{"name":38,"class":39},{"id":464,"slug":465,"hasResults":12,"nctId":466,"briefTitle":467,"officialTitle":467,"acronym":4,"eligibilityCriteria":468,"healthyVolunteers":12,"sex":131,"minAge":18,"maxAge":469,"enrollmentInfo":470,"targetDuration":4,"studyType":22,"phases":472,"briefSummary":473,"conditions":474,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":476,"lastUpdatePostDateStruct":477,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":482,"locationsCount":40},"100523101","espbs-vs-taps-for-satisfactory-analgesia-following-diep-surgery-100523101","NCT06091241","ESPBs vs TAPs for Satisfactory Analgesia Following DIEP Surgery","Inclusion Criteria:\n\n* Adult women with breast cancer, ASA 1-3, undergoing DIEP flap surgery\n\nExclusion Criteria:\n\n* Chronic opioid use contraindications to local anesthetics or regional analgesia Inability to communicate intensity of pain on a numeric analog scale","70 Years",{"count":471,"type":21},102,[83],"Breast cancer is the second most common cancer diagnosed in American women . For patients who have undergone surgical mastectomy, autologous breast reconstruction is an alternative option to breast implants. Deep Inferior Epigastric Perforator (DIEP) flaps are the gold standard for autologous breast reconstruction . Effective pain control following surgery is imperative and ultrasound-guided bilateral transversus abdominis plane blocks (TAPs) with the infiltration of local anesthetics, such a ropivacaine are a common regional technique of choice . A newer described technique, bilateral Erector Spinae Plane blocks (ESPBs) (which also are an infiltration of local anesthetic) present as an alternative approach for post-operative analgesia. ESPBs have been proven efficacious in reducing intra- and post-operative opioid requirements, lessening the need for rescue analgesics in other similar surgical procedures.\n\nThe hypothesis is that preoperative bilateral ESPBs could provide equivalent pain control as a regional analgesic for patients undergoing DIEP flap surgery when compared to preoperative bilateral TAPs",[475],"Pain","2026-06-02",{"date":478,"type":32},"2026-06-04",{"date":480,"type":32},"2023-11-01",{"date":122,"type":21},{"name":38,"class":39},{"id":484,"slug":485,"hasResults":12,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":4,"eligibilityCriteria":489,"healthyVolunteers":49,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":490,"targetDuration":4,"studyType":22,"phases":492,"briefSummary":493,"conditions":494,"keywords":496,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":500,"lastUpdatePostDateStruct":501,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":506,"locationsCount":4},"100564979","adapting-changing-talk-online-chato-to-chato-inclusive-100564979","NCT06636214","Adapting Changing Talk: Online (CHATO) to CHATO-Inclusive","Adapting the CHATO Communication Intervention for Diverse Nursing Home Communities","Inclusion Criteria:\n\n* Medicare certified NHs (N=40) caring for residents diagnosed with AD\u002FADRD.\n* CNAs, nurses, and other direct care staff who are permanent employees of participating NHs and who provide direct care at least 8 hours weekly will complete the CHATO-I training, available by URL link.\n* All staff will be encouraged to participate as high staff participation is desired to achieve facility-wide communication change. NHs will provide the number of eligible staff participants.\n* Data for residents in participating NHs with AD\u002FADRD documented on the MDS Active Diagnoses list will be included in the analyses as well as MDS data for: age, sex, race and ethnicity, frailty (MDS-CHESS scale), and level of cognitive function (MDS Cognitive Performance Scale).\n\nExclusion Criteria:\n\n* NHs serving 25% of residents admitted prior to age 65 will be excluded (screening out NHs serving primarily younger persons with serious mental illnesses).\n* CNAs, nurses, and other direct care staff who do not meet the inclusion criteria.\n* Resident data excluded from MDS includes active psychiatric diagnoses (bipolar disorder, major depressive episode, schizophrenia or schizoaffective disorder, mood disorder with psychotic features, psychotic symptoms, hallucinations, or delusions); terminal illness (on hospice); and lack of response to staff (MDS section B).",{"count":491,"type":21},1200,[83],"This study will adapt and test online interactive training for nursing home staff that improves staff communication and reduces behavioral symptoms of persons with dementia that they care for. This research will adapt and test communication training to meet the needs of nursing homes to improve dementia care.",[495],"Dementia",[497,498,499],"ADRD","Nursing Home Staff Communication","Elderspeak","2026-05-28",{"date":476,"type":32},{"date":503,"type":21},"2027-01",{"date":505,"type":21},"2029-08-31",{"name":38,"class":39},{"id":508,"slug":509,"hasResults":12,"nctId":510,"briefTitle":511,"officialTitle":511,"acronym":4,"eligibilityCriteria":512,"healthyVolunteers":12,"sex":17,"minAge":513,"maxAge":4,"enrollmentInfo":514,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":516,"conditions":517,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":500,"lastUpdatePostDateStruct":521,"startDateStruct":522,"completionDateStruct":524,"leadSponsor":526,"locationsCount":40},"100524379","changes-in-resting-metabolic-rate-following-orthopedic-surgery-100524379","NCT06107959","Changes in Resting Metabolic Rate Following Orthopedic Surgery","Inclusion Criteria:\n\n* Any individual over 15 undergoing an orthopedic surgery.\n\nExclusion Criteria:\n\n* Pregnant female\n* \\\u003C 15 years old","15 Years",{"count":515,"type":21},100,"This project is intended to determine the magnitude and duration of RMR changes in patients receiving orthopedic surgery. The result will help to guide postoperative nutrition recommendations in patients receiving orthopedic surgery.",[518,519,520],"Metabolism; Disorder, Postprocedural","Resting Metabolic Rate","Post Operative Nutrition",{"date":476,"type":32},{"date":523,"type":32},"2023-10-10",{"date":525,"type":21},"2027-12",{"name":38,"class":39},{"id":528,"slug":529,"hasResults":12,"nctId":530,"briefTitle":531,"officialTitle":532,"acronym":4,"eligibilityCriteria":533,"healthyVolunteers":12,"sex":17,"minAge":534,"maxAge":4,"enrollmentInfo":535,"targetDuration":4,"studyType":22,"phases":536,"briefSummary":538,"conditions":539,"keywords":542,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":546,"startDateStruct":547,"completionDateStruct":549,"leadSponsor":551,"locationsCount":40},"100552830","phase-4-knee-osteoarthritis-treatment-with-zilretta-vs-kenalog-in-the-context-of-type-ii-diabetes-100552830","NCT06478186","Knee Osteoarthritis Treatment With Zilretta vs. Kenalog in the Context of Type II Diabetes","RCT to Evaluate the Effects of Zilretta (Triamcinolone Acetonide- Extended Release) and Kenalog (Triamcinolone Acetonide- Immediate Release) on Blood Glucose in Subjects With Osteoarthritis of the Knee and Type 2 Diabetes Mellitus","Inclusion Criteria:\n\n* 1\\. Written consent to participate in the study. 2. Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions.\n\n  3\\. Male or female ≥40 years of age. 4. Females with negative pregnancy test, who are not breastfeeding and have no intention to become pregnant during the time from screening through EOS.\n\n  5\\. Type 2 DM for at least 1 year prior to Screening. 6. Currently being treated with injectable (except insulin) and\u002For oral antidiabetic agents with stable doses for at least 1 month prior to Screening.\n\n  7\\. HbA1c 6.5-9% (in past 8 weeks). 8. Estimated glomerular filtration rate (eGFR) ≥50 mL\u002Fmin\u002F1.73 m2. (in past 8 weeks) 9. Triglycerides \\\u003C500 mg\u002FdL (in past 8 weeks) 10. Painful symptoms associated with OA of the knee for ≥6 months prior to Screening (NRS of 4-9 during most of the 30 days prior to enrollment).\n\n  11\\. Currently meets modified ACR criteria (clinical and radiological) for OA (Altman et al, 1986) as follows:\n  1. Knee pain\n  2. At least 1 of the following:\n\n     * Stiffness \\\u003C30 minutes\n     * Crepitus\n  3. Osteophytes 12. Index knee pain more than 15 days over the last month (as reported by the subject).\n\n     13\\. Kellgren-Lawrence Grade 2-4. 14. Willingness to wear a CGM device uninterrupted for 24 hours per day throughout the required time during the study and comply to the correct use requirements of CGM throughout the trial and perform self BG checks as directed.\n\n     15\\. Adequate BG data collected during the pretreatment phase (Day -10 through Day -1) ≥70% data available.\n\n     Exclusion Criteria:\n\n     Disease-related Criteria\n     1. Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease.\n     2. History of infection in the index knee joint.\n     3. Clinical signs and symptoms of active knee infection or crystal disease of the index knee within 1 month of Screening.\n     4. Presence of surgical hardware or other foreign body in the index knee.\n     5. Unstable joint (such as a torn anterior cruciate ligament) within 12 months of Screening.\n     6. Moderate or severe kidney, liver, or thyroid disease.\n     7. Glaucoma.\n     8. Active cancer. Previous or Concomitant Treatment-related Criteria\n     9. IA corticosteroid (investigational or marketed) in any joint within 3 months of Screening.\n     10. IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening.\n     11. IV or intramuscular (IM) corticosteroids (investigational or marketed) within 3 months of Screening.\n     12. Oral corticosteroids (investigational or marketed) within 1 month of Screening.\n     13. Inhaled, intranasal, or topical corticosteroids (investigational or marketed) within 2 weeks of Screening.\n     14. Any other IA investigational device, drug\u002Fbiologic within 6 months of Screening or 5 half-lives (whichever is longer).\n     15. Prior arthroscopic or open surgery of the index knee within 12 months of Screening.\n     16. Planned\u002Fanticipated surgery of the index knee or any other surgery during the study period.\n     17. Use of acetaminophen, or acetaminophen-containing products, from Screening through Day 14 (completion of post-treatment BG monitoring).\n     18. Subjects on Coumadins with INR ≥5 will be excluded (Bashir et al, 2015) Subject-related Criteria\n     19. Known hypersensitivity to any form of triamcinolone.\n     20. History of sarcoidosis or amyloidosis.\n     21. Active or history of malignancy within the last 3 years, except for resected basal cell carcinoma, squamous cell carcinoma of the skin, or effectively managed cervical carcinoma.\n     22. Known active or quiescent systemic fungal, bacterial (including tuberculosis), viral, or parasitic infections or ocular herpes simplex.\n     23. Any infection requiring IV antibiotics within 4 weeks of Screening or infection requiring oral antibiotics within 2 weeks of Screening.\n     24. History of osteomyelitis.\n     25. Known or clinically suspected infection with human immunodeficiency virus (HIV) or hepatitis B or C viruses.\n     26. Requiring or likely to require treatment with corticosteroids during the study period based on subject medical history.\n     27. History or active Cushing's or Addison's syndrome.\n     28. Active substance abuse (drugs or alcohol), history of chronic substance abuse within the last year, or prior chronic substance abuse judged by the Investigator likely to recur during the study.\n     29. Skin breakdown at the knee where the injection would take place.\n     30. Use of immunomodulators, immunosuppressives, or chemotherapeutic agents within 2 years of Screening.\n     31. Receipt of a live or live attenuated vaccine within 3 months of Screening.\n     32. Any other clinically significant psychiatric acute or chronic medical conditions that, in the judgment of the Investigator, would preclude the use of an IA corticosteroid or NSAIDs or that could compromise subject safety, limit the subject's ability to complete or adhere to the study, and\u002For compromise the objectives of the study.","40 Years",{"count":451,"type":21},[537],"PHASE4","A Phase 2 Randomized Study to Evaluate the Effects of triamcinolone acetonide extended-release (TA-ER; Zilretta) vs. triamcinolone acetonide immediate-release (TA-IR; Kenalog) on Blood Glucose Levels in Diabetic Subjects with Knee Osteoarthritis. Subjects should have Type 2 Diabetes Mellitus (T2DM) with HbA1C ≤9 that is managed without insulin and have been diagnosed with symptomatic unilateral or bilateral osteoarthritis (OA) of the knee, based on clinical and radiological criteria (if bilateral, then a target knee will be selected).Total study duration for individual subject will be about 4 months, which includes 3 weeks of Screening period, 10 days of pretreatment phase, treatment day, and 12 weeks of post-treatment period.",[540,541],"Osteoarthritis, Knee","Diabetes Mellitus, Type 2",[543,544],"Zilretta","Kenalog","2026-05-27",{"date":500,"type":32},{"date":548,"type":32},"2024-08-16",{"date":550,"type":21},"2027-01-16",{"name":38,"class":39},{"id":553,"slug":554,"hasResults":12,"nctId":555,"briefTitle":556,"officialTitle":556,"acronym":557,"eligibilityCriteria":558,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":559,"enrollmentInfo":560,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":562,"conditions":563,"keywords":565,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":571,"lastUpdatePostDateStruct":572,"startDateStruct":574,"completionDateStruct":576,"leadSponsor":578,"locationsCount":40},"100588273","pain-outcomes-associated-with-exogenous-hormone-therapy-in-adults-100588273","NCT06939257","Pain Outcomes Associated With Exogenous Hormone Therapy in Adults","TRANSPIRE","Inclusion Criteria:\n\n* Informed consent provided by the participant\n* Ages 18-50 years\n* English speaking\n* GM persons who have been deemed to be an appropriate medical candidate to take gender-affirming hormone therapy for gender incongruence -OR- GM persons who are not taking gender-affirming hormone therapy\n\nAim 2 (QST and MRI) Additional Inclusion Criteria:\n\n* GM persons who have been deemed to be an appropriate medical candidate to take gender- affirming hormone therapy for gender incongruence\n* Stable doses of analgesic medications for at least 30 days prior to screening\n* Right handed\n* Normal visual acuity or correctable to at least 20\u002F40 for reading instructions in the MRI\n* Willingness to refrain from pain medications such as NSAIDs, acetaminophen, and opioid medications for 12 hours prior to neuroimaging and QST\n* Willingness to refrain from alcohol and nicotine on day of QST and neuroimaging\n* Willingness to refrain from physical activity or exercise that would cause muscle and\u002For joint soreness for 48 hours prior to testing (routine exercise or activity that does not lead to soreness is acceptable)\n* Investigators will attempt to recruit individuals with no chronic daily use of adjunctive pain medications, including tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors, and gabapentinoids as these drugs can influence neuroimaging and QST findings, or have individuals be weaned off of these meds at least two weeks prior to being studied. In previous smaller imaging studies investigators could accomplish this, but this may not be possible in this large of a study. If the study team does need to allow individuals into these cohorts while on such medications because of pragmatic issues, this information will be recorded and patients will be asked to remain on a stable dose for at least two weeks prior to MRI and QST assessments.\n* Able to lie still on their back for 1.5 hours for MRI scans\n\nExclusion Criteria:\n\n* Inability to provide informed consent\n* Age less than 18 years or greater than 50 years\n* Severe physical impairment (e.g., blindness, deafness, paraplegia)\n* Co-morbid medical conditions that may significantly impair physical functional status (e.g., history of non-skin malignancy, or autoimmune disorder)\n* Pregnant or nursing\n* Liver failure\n* Self-reported liver cirrhosis\n* Self-reported hepatitis\n* Severe Cardiovascular disease (examples: history of myocardial infarction, unstable angina, severe coronary artery disease, congestive heart failure, or severe valvular abnormalities) that are self-reported by patient or by medical record\n* Prisoner\n* Current litigation for chronic pain\n* Current disability proceedings\n* Active psychotic or suicidal symptoms\n* Current drug or alcohol use disorder\n* History of gonadectomy surgery\n\nAim 2 (QST and MRI) Additional Inclusion Criteria:\n\n* Contraindications to MRI (e.g., metal implants, pacemaker, etc.)\n* Severe claustrophobia precluding MRI and evoked pain testing during scanning\n* BMI \\> 40 or unable to lie comfortably in MRI\n* Current, recent (within the last 6 months), or habitual use of artificial nails or nail enhancements. (Artificial nails can influence pressure pain sensitivity at the thumbnail)\n* Peripheral neuropathy\n* Diagnosed epilepsy or seizure history","50 Years",{"count":561,"type":21},200,"TRANSPIRE is an observational study of \\~200 individuals who (1) will be initiating gender-affirming hormone therapy (GHT) or (2) are gender minority individuals who do not use GHT. The primary outcome will be to identify how the presence of chronic pain changes overtime with GHT through the use of surveys, quantitative sensory testing (QST), brain MRIs, and qualitative interviews.\n\nFollowing recruitment and consent, participants will complete baseline survey measures and will repeat those measures at 1 months, 3 month, 6 months, and 12 months. QST measures, brain MRIs, and Qualitative Interviews will be offered to participants in cohort (1) and will be completed at baseline and 12 months.",[475,564],"Gender Minority Individuals",[566,567,568,569,570],"GHT","Gender Minority","HRT","Gender Affirming Hormone Therapy","GM","2026-05-11",{"date":573,"type":32},"2026-05-14",{"date":575,"type":32},"2025-03-31",{"date":577,"type":21},"2029-09-16",{"name":38,"class":39},{"id":580,"slug":581,"hasResults":12,"nctId":582,"briefTitle":583,"officialTitle":584,"acronym":4,"eligibilityCriteria":585,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":586,"targetDuration":4,"studyType":22,"phases":588,"briefSummary":589,"conditions":590,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":571,"lastUpdatePostDateStruct":593,"startDateStruct":594,"completionDateStruct":595,"leadSponsor":597,"locationsCount":40},"100583670","phase-1-evaluating-the-safety-and-efficacy-of-duocar201922-d95-in-adult-patients-with-relapsed-or-refractory-b-cell-malignancies-100583670","NCT06879340","Evaluating the Safety and Efficacy of DuoCAR20.19.22-D95 in Adult Patients With Relapsed or Refractory B-cell Malignancies","A Phase 1 Multicenter, Open Label Trial Evaluating the Safety and Efficacy of DuoCAR20.19.22-D95 in Adult Patients With Relapsed or Refractory B-cell Malignancies","Inclusion Criteria:\n\n1. Ability of participant to understand this study, and participant willingness to sign a written informed consent\n2. Women of childbearing potential must have a negative serum pregnancy test 48 hours prior to the start of preparatory regimen\n3. Patients must have histologically confirmed aggressive B-Cell NHL or ALL as stated below:\n\n   A. Patients with relapsed or refractory B-Cell ALL i. Demonstration of one or more antigens of interest (CD19, CD20, CD22) in most recent disease evaluation prior to study entry and within 30 days of study entry.\n\n   ii. Patients with relapsed\u002Frefractory disease in blood, marrow, and extramedullary sites including CSF will be eligible when there is immunophenotypic evidence of CD19 and\u002For CD20 and\u002For CD22 expression\n\n   iii. Primary refractory disease at study entry defined as: A morphologic complete response has never been achieved prior to study entry.\n\n   iv. Early first relapse at study entry defined as: Disease recurrence by morphologic assessment after duration of first remission at ≤ 18 months\n\n   v. Relapsed Refractory disease (first or later relapse) at study entry defined as: Morphologic complete response was not achieved after initiation of a second-line (or later) systemic therapy\n\n   vi. Second or greater relapse at study entry defined as: Any disease recurrence following a second or later complete response (with treatment history including two or more lines of systemic therapy)\n\n   vii. Additional considerations beyond above criteria:\n   * Patients with relapsed or refractory disease after allogeneic stem cell transplantation must be \\>100 days from HSCT to be eligible for study participation. Furthermore, post-HSCT immunosuppressive medications must be discontinued for at least 4 weeks prior to study entry\n   * Prior CAR-T therapy is permissible if ≥ 3 months from therapy completion\n   * Morphological disease in the bone marrow Note: Morphologic disease is defined as blasts being at least 5% in the bone marrow.\n\n   B. Histologically confirmed aggressive B cell NHL, including the following types defined by WHO 2008 after 2 or more lines of prior therapy:\n\n   i. DLBCL not otherwise specified; T cell\u002Fhistiocyte rich large B cell lymphoma; DLBCL associated with chronic inflammation; Epstein-Barr virus (EBV)+ DLBCL of the elderly; Primary cutaneous DLBCL, leg type; OR ii. Primary mediastinal (thymic) large B cell lymphoma iii. Follicular lymphoma 3b and transformation of follicular lymphoma to DLBCL will also be included iv. High-grade B cell lymphoma v. Chemotherapy-refractory disease, defined as one or more of the following:\n   * Refractory disease is defined as progressive or stable disease as the best response to the most recent prior therapy or relapse within 12 months of autologous stem cell transplantation. Two prior lines of therapy are required for LBCL eligibility. The second line therapy may be chemotherapy based, autologous stem cell transplantation, or CAR-T.\n   * Relapsed or refractory disease after allogeneic transplant provided patient is at least 100 days from stem cell transplant at the time of enrollment and off of immunosuppressive medications for at least 4 weeks prior to enrollment\n   * Patients must have received 2 or more lines of adequate prior therapy including at a minimum:\n\n     * anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20- negative and\n     * an anthracycline containing chemotherapy regimen\n     * for patients with transformed FL must have received prior chemotherapy for follicular lymphoma and subsequently have chemorefractory disease after transformation to DLBCL vi. Prior CAR T therapy permissible if ≥ 3 months from the therapy vii. At least 1 measurable lesion according to the revised IWG Response Criteria for Malignant Lymphoma (Cheson 2007). Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy C. Relapsed or refractory indolent non-Hodgkin lymphoma i. Histologically confirmed indolent non-Hodgkin lymphoma, including grade 1-3b follicular lymphoma or nodal or extranodal marginal zone lymphoma (both per WHO 2016 classification criteria) ii. Relapsed or refractory disease (per Lugano criteria) after two or more previous lines of therapy, iii. Previous lines of therapy to include an anti-CD20 monoclonal antibody combined with an alkylating agent iv. Prior CAR T therapy permissible if ≥ 3 months from the therapy v. At least 1 measurable lesion according to the revised IWG Response Criteria for Malignant Lymphoma (Cheson 2007). Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy vi. Relapsed or refractory disease after allogeneic transplant provided patient is at least 100 days from stem cell transplant at the time of enrollment and off of immunosuppressive medications for at least 4 weeks prior to enrollment D. Relapsed or Refractory Mantle-Cell Lymphoma i. Histologically confirmed mantle-cell lymphoma with either cyclin D1 overexpression or presence of the translocation (T11:14) ii. Disease that is either relapsed or refractory to at least 2 prior lines of previous regimens for mantle-cell lymphoma iii. Previous therapy must have included anthracycline- or bendamustine-containing chemotherapy, an anti-CD20 monoclonal antibody, and BTK inhibitor therapy\n4. Prior CAR T therapy permissible if ≥ 3 months from the therapy\n5. At least 1 measurable lesion according to the revised IWG Response Criteria for Malignant Lymphoma (Cheson 2007). Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy\n6. Relapsed or refractory disease after allogeneic transplant provided patient is ≥ 3 months from stem cell transplant at the time of enrollment and off of immunosuppressive medications for at least 4 weeks prior to enrollment\n7. Meet institutional criteria for leukapheresis procedure or have availability of previously- collected and stored leukapheresis product that satisfies minimum requirements\n8. Eastern cooperative oncology group (ECOG) performance status of 0 to 2.\n9. Adequate hematologic and organ function NOTE: Patients with established diagnosis of benign neutropenia are eligible to participate with ANC between 1000-1500 if in the opinion of treating physician the trial treatment does not pose excessive risk of infection to the patient.\n10. Adults ≥ 18 years of age, with no upper limit of age\n11. Life expectancy \\>2 months\n12. ≥ 3 months from prior CAR\n13. Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence or to use the forms of contraception listed in Child-Bearing Potential\u002FPregnancy section from the time of signing informed consent to at least 12 months following DuoCAR20.19.22-D95 infusion and until CAR positive viable T cells are no longer present by quantitative polymerase chain reaction (qPCR) on two consecutive tests. Men must agree not to donate sperm for the same time period.\n\nExclusion Criteria:\n\n1. Patients with CLL, Richter's transformation, and Burkitt lymphoma\n2. Active CNS involvement by malignancy - CNS3 disease, i.e., patients with WBC count in CSF ≥5 and having blasts in the CSF in patients with ALL or detection of NHL on CSF by flow cytometry or active CNS involvement on imaging)\n3. Chemotherapy other than lymphodepleting chemotherapy within 2 weeks of infusion\n4. Investigational medicinal product within the last 30 days prior to screening Note: Investigational therapies must not be used at any time while on study until the first progression following DuoCAR20.19.22-D95 CAR T infusion.\n5. The following medications are excluded:\n\n   1. Steroids: Therapeutic doses of steroids must be stopped \\> 72 hours prior to leukapheresis and \\> 72 hours prior to DuoCAR20.19.22-D95 infusion. However, the following physiological replacement doses of steroids are allowed: \\\u003C12 mg\u002Fm2\u002Fday hydrocortisone or equivalent\n   2. Immunosuppression: Any other immunosuppressive medication must be stopped ≥ 2 weeks prior to leukapheresis and ≥ 2 weeks prior to DuoCAR20.19.22-D95 infusion. This could include check point inhibitors (monoclonal antibodies and small molecule modulators).\n   3. Antiproliferative therapies other than lymphodepleting chemotherapy within 2 weeks prior to infusion\n   4. Short acting drugs used to treat leukemia or lymphoma (e.g., tyrosine kinase inhibitors, and hydroxyurea) must be stopped \\> 72 hour prior to leukapheresis and \\> 72 hours prior to DuoCAR20.19.22-D95 infusion\n   5. Other cytotoxic drugs, including low dose daily or weekly maintenance chemotherapy, must not be given within 2 weeks prior to leukapheresis and within 2 weeks prior to DuoCAR20.19.22-D95 infusion.\n   6. Antibody use including anti-CD20 therapy within 4 weeks prior to infusion or 5 half-lives of the respective antibody, whichever is longer. Note: Rituximab is excluded within 4 weeks prior to infusion.\n   7. CNS disease prophylaxis or treatment must be stopped \\> 1 week prior to DuoCAR20.19.22-D95 infusion (e.g., intrathecal methotrexate)\n6. Prior radiation therapy within 2 weeks of infusion\n7. Active replication of or prior infection with hepatitis B or active hepatitis C (HCV RNA positive)\n8. HIV positive patients (excluding false positive HIV test resulting from the viral vector used in prior CAR T)\n9. Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g., blood culture positive ≤ 72 hours prior to infusion)\n10. Unstable angina and\u002For myocardial infarction within 6 months prior to screening\n11. Previous or concurrent malignancy with the following exceptions:\n\n    1. Adequately treated basal cell or squamous cell carcinoma (adequate wound healing is required prior to study entry)\n    2. In situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to the study\n    3. A primary malignancy which has been completely resected and in complete remission for ≥ 5 years\n12. Simultaneously enrolled in any therapeutic clinical trial (except for long-term follow up studies)\n13. Current or anticipating use of other anti-neoplastic or investigational agents while participating in this study\n14. Either diagnosed with a psychiatric illness or under the impact of a social situation that would limit compliance with study requirements in the opinion of the investigator\n15. Is pregnant or breastfeeding\n16. Intolerance to the excipients of the cell product\n17. Cardiac arrhythmia not controlled with medical management\n18. Active COVID-19 (follow ASTCT guidelines)\n19. Presence of active grade 2 to 4 acute, extensive chronic graft-versus-host disease (GVHD) or that require systemic steroids\n20. Patients with active neurological auto immune or inflammatory disorders (e.g., Guillain-Barré Syndrome, Amyotrophic Lateral Sclerosis)",{"count":587,"type":21},54,[24],"This multicenter phase 1 trial with \"3 + 3\" dose escalation design seeks to examine the feasibility and safety of the administration of autologous T cells that have been modified through the introduction of chimeric antigen receptors targeting the B cell surface antigens CD19\u002F20\u002F22 following administration of a chemotherapy lymphodepletion regimen in adults with relapsed\u002Frefractory B-cell acute lymphoblastic leukemia (ALL) or Non-Hodgkin's lymphoma (NHL). The overall goals of this study are to estimate maximum tolerated dose (MTD) level, establish the overall safety profile and evaluate initial efficacy of administering duo-CAR-T cell treatment in this patient population.",[591,592],"B-Cell Non-Hodgkin Lymphoma","B-cell Acute Lymphoblastic Leukemia",{"date":573,"type":32},{"date":575,"type":32},{"date":596,"type":21},"2040-03",{"name":38,"class":39},{"id":599,"slug":600,"hasResults":12,"nctId":601,"briefTitle":602,"officialTitle":603,"acronym":604,"eligibilityCriteria":605,"healthyVolunteers":12,"sex":131,"minAge":18,"maxAge":559,"enrollmentInfo":606,"targetDuration":4,"studyType":22,"phases":608,"briefSummary":609,"conditions":610,"keywords":612,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":618,"lastUpdatePostDateStruct":619,"startDateStruct":620,"completionDateStruct":621,"leadSponsor":623,"locationsCount":40},"100638216","is-nipple-stimulation-effective-for-inducing-labor-and-acceptable-to-patients-nurses-and-providers-100638216","NCT07588529","Is Nipple Stimulation Effective for Inducing Labor and Acceptable to Patients, Nurses, and Providers?","Nipple Stimulation Acceptability for Induction of Labor","NSAIL","Inclusion Criteria:\n\nAll patients presenting to KUMC labor \\& delivery for IOL will be considered for this study.\n\nMaternal\n\n* ≥18 years old and ≤ 50 years old\n* ≥37wga and ≤ 42wga\n* Intact amniotic membranes\n* English speaking Fetal\n* Cephalic presentation\n\nExclusion Criteria:\n\nMaternal\n\n* Inability to give informed consent\n* History of cesarean delivery or uterine myomectomy\n* History of uterine rupture\n* Intrahepatic cholestasis of pregnancy\n* Maternal life-threatening conditions\n* Active HSV\n* Gestational hypertension, Preeclampsia (severe or w\u002Fo severe features), HELLP, chronic hypertension on medications\n\nPlacental\n\n* Placenta previa, vasa previa\n* Suspicion for abnormally adherent placenta\n* Chorioamnionitis\n* Placental abruption\n\nFetal\n\n* Multifetal gestation\n* category 2 or 3 fetal heart tracing upon presentation (does not include isolated variable deceleration)\n* EFW \\> 5000 grams in mother with diabetes\n* EFW \\> 4500 grams in mother without diabetes\n* Fetal demise\n* Fetal growth restriction \\\u003C10th centile\n* Any other contraindication for vaginal birth or anticipation of need for NICU for care of baby",{"count":607,"type":21},48,[83],"In this study the investigators will be testing the use of the Symphony PLUS® breast pump for nipple stimulation. Typically, breast pumps are used to start breast milk production and collect breast milk in patients after delivering their baby. The device uses cup-shaped pieces called flanges that are placed over the patient's nipples and then a gentle vacuum or suction is applied. The mechanical effect of the suction on the nipple is thought to cause the release of a substance called oxytocin in one's body, which encourages labor and contractions to begin. Some reasons why nipple stimulation might be better than other induction of labor methods are that it allows the patient to have more control over their induction process, it uses the patient's own oxytocin instead of synthetic (or factory-produced) oxytocin, and it may shorten the time that it takes to deliver the baby.",[142,611],"Induction of Labor",[613,614,615,616,617],"nipple stimulation","breast stimulation","induction","labor","induction of labor","2026-05-08",{"date":573,"type":32},{"date":459,"type":21},{"date":622,"type":21},"2028-12",{"name":38,"class":39},""]